Study of the anesthetic efficacy of inferior alveolar nerve block using articaine in irreversible pulpitis.

PubMed

Ahmad, Zeeshan H; Ravikumar, H; Karale, Rupali; Preethanath, R S; Sukumaran, Anil

2014-01-01

The purpose of this study was to determine the anesthetic efficacy of inferior alveolar nerve block (IANB) using 4% articaine and 2% lidocaine supplemented with buccal infiltration. Forty five patients, diagnosed with irreversible pulpitis of a mandibular posterior tooth were included in the study. The first group of 15 patients received 2% lidocaine with 1:200000 epinephrine, the second group 2% lidocaine with 1: 80,000 epinephrine and the third group of 15 subjects received 4% articaine with 1:100000 epinephrine. During the access cavity preparation those patients who complained of pain received an additional buccal infiltration. The percentage of subjects who got profound anesthesia and failure to achieve anesthesia were calculated and tabulated using a visual analog scale. The results revealed that 87% of subjects who received 4% Articaine with 1:100,000 epinephrine got satisfactory anesthesia with inferior alveolar nerve block alone. Only 2 (13%) subjects received an additional buccal infiltration and none of the patients failed to obtain complete anesthesia with articaine. In comparison only 40% of subjects got complete anesthesia with 2% lidocaine with 1:200000 and 60% with 2% lidocaine with 1:80,000. It can be concluded that 4% articaine can be used effectively for obtaining profound anesthesia for endodontic procedures in patients with irreversible pulpitis.

Oral glutamine in addition to parenteral nutrition improves mortality and the healing of high-output intestinal fistulas.

PubMed

de Aguilar-Nascimento, J E; Caporossi, C; Dock-Nascimento, D Borges; de Arruda, I S; Moreno, K; Moreno, W

2007-01-01

Anastomotic leakage is one of the most important causes of morbidity and mortality in gastrointestinal surgery. We investigated the effect of oral glutamine on the healing of high-output intestinal fistula. A tertiary Universitary Hospital of the University of Mato Grosso, Cuiaba, Brazil. 28 patients (25 males and 3 females; median age = 45 [18-71] years old) admitted with high output post-operative small bowel fistulas (median volume in 24 h: 850 [600-2,200] mL) during a 4 years period were retrospectively studied. In the first two years 19 (67.9%) patients received only TPN as the initial nutritional support. In the last two years however, due to a change in the protocol for the nutritional support in cases of intestinal fistula 9 patients (32.1%) received oral glutamine (0.3 g/kg/day; 150 mL/day) in addition to TPN. Endpoints of the study were mortality, resolution of the fistula, and length of hospital stay (LOS). The overall mortality was 46.4% (13 patients). Fistula closure was observed in all other 15 patients (53.6%) that survived. In the subset of survived patients LOS was similar in those who received or not received glutamine. The multivariate regression analysis showed that resolution of the fistula was 13 times greater in patients that received oral glutamine (OR = 13.2 (95% CI = 1.1-160.5); p = 0.04) and 15 times greater in non-malnourished patients (OR = 15.4 [95% CI = 1.1-215.5]; p = 0.04). We conclude that oral glutamine accelerated the healing and diminished the mortality in this series of patients with post-operative high-output intestinal fistula receiving TPN.

[Comparative assessment of prolonged femoral nerve blockade and epidural analgesia for postoperative pain in total knee joint arthroplasty].

PubMed

Churadze, B T; Sevalkin, S A; Zadorozhnyĭ, M V; Volkov, P A; Gur'ianov, V A

2013-01-01

The study deals with two mostly discussed techniques of postoperative analgesia for total knee joint arthroplasty. Surgeries were performed under subarachnoid anaesthesia with intravenous sedation. 9 patients of first group in received prolonged femoral nerve blockade as a component of multimodal analgesia. 8 patients of second group received epidural infusion of naropine. If basic technique of analgesia was not effective patients received trimeperidine 20 mg intramuscular. Patients of second group had less pain syndrome (in order to visual analogue scale) and did not need additional administration of opioids.

Ticagrelor for Neuroendovascular Procedures: A Case Series.

PubMed

Davis, Kyle; Morrison, Christopher

2018-02-01

The development of thromboembolism is one of the most common complications of neuroendovascular procedures. Although several small studies have deemed clopidogrel safe and effective in the prevention of intracranial stent thrombosis, ticagrelor has yet to be assessed in this setting. The objective of this study was to retrospectively evaluate the safety and efficacy of ticagrelor in patients undergoing neuroendovascular procedures. A retrospective review of patients receiving ticagrelor following neuroendovascular aneurysm repair. A total of 5 patients undergoing neuroendovascular aneurysm repair received ticagrelor for a median of 5 days while hospitalized. Three patients were treated with stent-assisted coiling, while 2 received pipeline embolization devices. All patients received additional low-dose aspirin therapy. One patient received ticagrelor after experiencing a thrombotic event on clopidogrel, while a second patient was treated with ticagrelor after developing a dermatologic reaction to clopidogrel. Three (60%) patients were successfully treated and discharged on ticagrelor therapy. Two patients experienced cerebrovascular accidents following aneurysm repair while receiving ticagrelor, one of which was potentially due to medication omission. One (20%) patient receiving ticagrelor experienced a small retroperitoneal hematoma; however, ticagrelor therapy was continued without further complication. Therapy with ticagrelor may be a safe and effective treatment option for patients undergoing neuroendovascular aneurysm repair. However, future studies are warranted to substantiate these findings.

Hemodialysis patients receiving a greater Kt dose than recommended have reduced mortality and hospitalization risk.

PubMed

Maduell, Francisco; Ramos, Rosa; Varas, Javier; Martin-Malo, Alejandro; Molina, Manuel; Pérez-Garcia, Rafael; Marcelli, Daniele; Moreso, Francesc; Aljama, Pedro; Merello, Jose Ignacio

2016-12-01

Achieving an adequate dialysis dose is one of the key goals for dialysis treatments. Here we assessed whether patients receiving the current cleared plasma volume (Kt), individualized for body surface area per recommendations, had improved survival and reduced hospitalizations at 2 years of follow-up. Additionally, we assessed whether patients receiving a greater dose gained more benefit. This prospective, observational, multicenter study included 6129 patients in 65 Fresenius Medical Care Spanish facilities. Patients were classified monthly into 1 of 10 risk groups based on the difference between achieved and target Kt. Patient groups with a more negative relationship were significantly older with a higher percentage of diabetes mellitus and catheter access. Treatment dialysis time, effective blood flow, and percentage of on-line hemodiafiltration were significantly higher in groups with a higher dose. The mortality risk profile showed a progressive increase when achieved minus target Kt became more negative but was significantly lower in the group with 1 to 3 L clearance above target Kt and in groups with greater increases above target Kt. Additionally, hospitalization risk appeared significantly reduced in groups receiving 9 L or more above the minimum target. Thus, prescribing an additional 3 L or more above the minimum Kt dose could potentially reduce mortality risk, and 9 L or more reduce hospitalization risk. As such, future prospective studies are required to confirm these dose effect findings. Copyright © 2016 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

Performing bone marrow biopsies with or without sedation: a comparison.

PubMed

Giannoutsos, I; Grech, H; Maboreke, T; Morgenstern, G

2004-06-01

Although intravenous sedation (ISED) in addition to a local anaesthetic (LA) is commonly used in the performance of a bone marrow aspirate and trephine (BMAT), it is not clear under what circumstances and in which way sedation may be most beneficial. In this study, information was gathered using a questionnaire, from 112 patients shortly after undergoing BMAT; the duration of the procedures and the length of the biopsy cores were measured and any complications noted. Most patients (68%) chose to receive LA only, and almost all (74/76) were happy with their decision. Patients who received sedation gave lower pain scores than patients receiving LA only (1 vs. 3) and were found to have lower levels of apprehension at the thought of having a repeat procedure. Patients having a repeat BMAT showed a slightly increased preference for having sedation compared with patients who were undergoing it for the first time. There is some concern that guidelines regarding the use of ISED for procedures other than BMAT are not always adhered to, and current practice may be best revealed by a large-scale audit of sedation practice for the performance of BMAT. Patients should be given the choice of having ISED if the appropriate resources are available, but in most cases the additional small risk of receiving sedation can be avoided.

Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial.

PubMed

Micks, Elizabeth A; Edelman, Alison B; Renner, Regina-Maria; Fu, Rongwei; Lambert, William E; Bednarek, Paula H; Nichols, Mark D; Beckley, Ethan H; Jensen, Jeffrey T

2012-11-01

Although hydrocodone-acetaminophen is commonly used for pain control in first-trimester abortion, the efficacy of oral opioids for decreasing pain has not been established. Our objective was to estimate the effect of hydrocodone-acetaminophen on patient pain perception during first-trimester surgical abortion. We conducted a randomized, double-blinded, placebo-controlled trial. Patients (before 11 weeks of gestation) received standard premedication (ibuprofen and lorazepam) and a paracervical block with the addition of 10 mg hydrocodone and 650 mg acetaminophen or placebo 45-90 minutes before surgical abortion. A sample size of 120 was calculated to provide 80% power to show a 15-mm difference (α=0.05) in the primary outcome of pain with uterine aspiration (100-mm visual analog scale). Secondary outcomes were pain at additional time points, satisfaction, side effects, adverse events, and need for additional pain medications. There were no significant differences in demographics or baseline pain between groups. There were no differences in pain scores between patients receiving hydrocodone-acetaminophen compared with placebo during uterine aspiration (65.7 mm compared with 63.2 mm, P=.59) or other procedural time points. There were no differences in satisfaction or need for additional pain medications. Patients who received hydrocodone-acetaminophen had more postoperative nausea than those receiving placebo (P=.03) when controlling for baseline nausea. No medication-related adverse events were noted. Hydrocodone-acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea. Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459. I.

Patterns of care in palliative radiotherapy: a population-based study.

PubMed

Murphy, James D; Nelson, Lorene M; Chang, Daniel T; Mell, Loren K; Le, Quynh-Thu

2013-09-01

Approximately one half of the radiotherapy (RT) prescribed in the United States is delivered with palliative intent. The purpose of this study was to investigate the patterns of delivery of palliative RT across the United States. Using the Surveillance, Epidemiology, and End Results-Medicare linked database, 51,610 patients were identified with incident stage IV breast, prostate, lung, or colorectal cancer diagnosed between 2000 and 2007 and observed through 2009. Multivariate logistic regression determined predictors of palliative RT. Forty-one percent of the study population received palliative RT, including 53% of patients with lung cancer, followed by those with breast (42%), prostate (40%), and colorectal cancers (12%). Multivariate analysis revealed that older patients (P<.001) and those with higher Charlson comorbidity scores (P<.001) were less likely to receive palliative RT. Black patients with prostate cancer were 20% less likely (P<.001), and black patients with colorectal cancer were 28% less likely (P<.001), than white patients to receive palliative RT. Among those treated with RT, 23% of patients with lung cancer died within 2 weeks of completing treatment, followed by those with colorectal (12%), breast (11%), and prostate cancers (8%). In addition to tumor site, significant predictors (P<.05) of death within 2 weeks of receiving RT included increased age, increased comorbidity, and male sex. Inequality in the receipt of palliative RT exists among the elderly and patients with comorbid conditions and varies with race. In addition, a significant number of patients die shortly after receiving RT. Understanding these patterns of care, along with further research into the underlying causes, will improve access and quality of palliative RT.

Disparities in the Utilization of Laparoscopic Surgery for Colon Cancer in Rural Nebraska: A Call for Placement and Training of Rural General Surgeons

PubMed Central

Gruber, Kelli; Soliman, Amr S.; Schmid, Kendra; Rettig, Bryan; Ryan, June; Watanabe-Galloway, Shinobu

2015-01-01

Background Advances in medical technology are changing surgical standards for colon cancer treatment. The laparoscopic colectomy is equivalent to the standard open colectomy while providing additional benefits. It is currently unknown what factors influence utilization of laparoscopic surgery in rural areas and if treatment disparities exist. The objectives of this study were to examine demographic and clinical characteristics associated with receiving laparoscopic colectomy and to examine the differences between rural and urban patients who received either procedure. Methods This study utilized a linked dataset of Nebraska Cancer Registry and hospital discharge data on colon cancer patients diagnosed and treated in the entire state of Nebraska from 2008–2011 (N=1,062). Multiple logistic regression analysis was performed to identify predictors of receiving the laparoscopic treatment. Results Rural colon cancer patients were 40% less likely to receive laparoscopic colectomy compared to urban patients. Independent predictors of receiving laparoscopic colectomy were younger age (<60), urban residence, ≥3 comorbidities, elective admission, smaller tumor size, and early stage at diagnosis. Additionally, rural patients varied demographically compared to urban patients. Conclusions Laparoscopic surgery is becoming the new standard of treatment for colon cancer and important disparities exist for rural cancer patients in accessing the specialized treatment. As cancer treatment becomes more specialized, the importance of training and placement of general surgeons in rural communities must be a priority for health care planning and professional training institutions. PMID:25951881

The impact on quality of life of dialysis patients with renal insufficiency.

PubMed

Dąbrowska-Bender, Marta; Dykowska, Grażyna; Żuk, Wioletta; Milewska, Magdalena; Staniszewska, Anna

2018-01-01

The aim of the study was the subjective assessment of the quality of life (QoL) of 140 patients treated with dialysis (peritoneal dialysis and hemodialysis). Chronic kidney disease and the methods of its treatment play an important part in shaping the QoL of patients receiving dialysis. As a result, kidney failure causes many limitations in patients' physical, mental, and social activities. The instrument to measure the QoL was the authors' own questionnaire made on the basis of Kidney Disease and Quality of Life Short Form version 1.2 (KDQOL - SF 1.2) and their selection of areas influencing the perceived QoL of chronically ill patients. The research showed that patients receiving peritoneal dialysis assessed their QoL in its different dimensions as much higher than patients receiving hemodialysis. The parameter having the biggest negative impact on the QoL of patients receiving hemodialysis was an impeded possibility to continue work or studies and a change of life plans. The will to live was more highly assessed by patients receiving peritoneal dialysis as compared to patients receiving hemodialysis. In order to improve the functioning of hemodialysis patients in a manner most similar to healthy persons, the renal replacement therapy should consider patients' individual needs and expectations, ie, guarantee flexible hours of work or study and of receiving dialysis. In addition, patients treated with hemodialysis should receive psychological care, in particular those demonstrating emotional problems, in order to achieve better results in therapy and improve their QoL.

Cisplatin neuropathy. Risk factors, prognosis, and protection by WR-2721

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mollman, J.E.; Glover, D.J.; Hogan, W.M.

1988-06-01

A prospective study of patients receiving cis-diaminedichloroplatin II (DDP) was carried out to determine if risk factors could be identified related to the patient's living habits or past medical history that would predict in which patients DDP neuropathy might develop. Sixty-nine patients receiving six different combinations of chemotherapeutic agents, including DDP were examined. Twenty-eight of these patients received DDP in combination with the radioprotective agent S-2-(3-aminopropylamino)-ethylphosporothioic acid (WR 2721). No risk factors were identified relating to personal habits or past medical history of the patients. However, patients receiving DDP (40 mg/m2) on 5 consecutive days had a significantly higher incidencemore » of neuropathy. Patients receiving DDP in combination with WR 2721 had a significantly lower incidence of neuropathy, and the mean dose at onset was significantly higher than the mean dose at onset of neuropathy for all other groups. In addition, five of six patients who were available for long-term follow-up demonstrated nearly complete reversal of the signs and symptoms of neuropathy.« less

Effect of preoperative counseling on fear from visual sensations during phacoemulsification under topical anesthesia.

PubMed

Haripriya, Aravind; Tan, Colin S H; Venkatesh, Rengaraj; Aravind, Srinivasan; Dev, Anand; Au Eong, Kah-Guan

2011-05-01

To determine whether preoperative counseling on possible intraoperative visual perceptions during cataract surgery helps reduce the patients' fear during surgery. Aravind Eye Hospital, Madurai, India. Randomized masked clinical trial. Patients having phacoemulsification under topical anesthesia were randomized to receive additional preoperative counseling or no additional preoperative counseling on potential intraoperative visual perceptions. After surgery, all patients were interviewed about their intraoperative experiences. Of 851 patients, 558 (65.6%) received additional preoperative counseling and 293 (34.4%) received no additional counseling. A lower proportion of patients in the counseled group were frightened than in the group not counseled for visual sensation (4.5% versus 10.6%, P<.001). Analyzed separately by specific visual sensations, similar results were found for light perception (7/558 [1.3%] versus 13/293 [4.4%], P=.007), colors (P=.001), and movement (P=.020). The mean fear score was significantly lower in the counseled group than in the not-counseled group for light perception (0.03 versus 0.12, P=.002), colors (P=.001), movement (P=.005), and flashes (P=.035). Preoperative counseling was a significant factor affecting fear after accounting for age, sex, operated eye, and duration of surgery (multivariate odds ratio, 4.3; 95% confidence interval, 1.6-11.6; P=.003). Preoperative counseling on possible visual sensations during cataract surgery under topical anesthesia significantly reduced the mean fear score and the proportion of patients reporting being frightened. Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Comparison of granisetron alone and granisetron plus dexamethasone in the prophylaxis of cytotoxic-induced emesis.

PubMed Central

Carmichael, J.; Bessell, E. M.; Harris, A. L.; Hutcheon, A. W.; Dawes, P. J.; Daniels, S.; Bessel, E. M.

1994-01-01

Two hundred and seventy-eight adult chemonaive patients, receiving moderately emetogenic chemotherapy were randomly allocated to receive either intravenous (i.v.) granisetron 3 mg plus i.v. dexamethasone 8 mg or i.v. granisetron 3 mg plus i.v. placebo dexamethasone prior to chemotherapy. Eight-two per cent of all patients recruited were female, and 91% of all patients consumed less than 10 units of alcohol per week, suggesting a study population with an increased risk of nausea and vomiting. In the first 24 h 85% of patients who received granisetron plus dexamethasone were complete responders compared with 75.9% of the patients receiving granisetron alone (P = 0.053). There were statistically significant improvements in complete response over 7 days (P = 0.029) and in the numbers of patients receiving rescue antiemetic (P = 0.0004). Toxicity was minimal with no significant differences between treatment groups. These results confirm the antiemetic activity of granisetron and show that it has an additive effect in combination with dexamethasone. PMID:7981069

Survival and Neurocognitive Outcomes After Cranial or Craniospinal Irradiation Plus Total-Body Irradiation Before Stem Cell Transplantation in Pediatric Leukemia Patients With Central Nervous System Involvement

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hiniker, Susan M.; Agarwal, Rajni; Modlin, Leslie A.

Purpose: To evaluate survival and neurocognitive outcomes in pediatric acute lymphoblastic leukemia (ALL) patients with central nervous system (CNS) involvement treated according to an institutional protocol with stem cell transplantation (SCT) and a component of craniospinal irradiation (CSI) in addition to total-body irradiation (TBI) as preparative regimen. Methods and Materials: Forty-one pediatric ALL patients underwent SCT with TBI and received additional cranial irradiation or CSI because of CNS leukemic involvement. Prospective neurocognitive testing was performed before and after SCT in a subset of patients. Cox regression models were used to determine associations of patient and disease characteristics and treatment methodsmore » with outcomes. Results: All patients received a cranial radiation boost; median total cranial dose was 24 Gy. Eighteen patients (44%) received a spinal boost; median total spinal dose for these patients was 18 Gy. Five-year disease-free survival (DFS) for all patients was 67%. Those receiving CSI had a trend toward superior DFS compared with those receiving a cranial boost alone (hazard ratio 3.23, P=.14). Patients with isolated CNS disease before SCT had a trend toward superior DFS (hazard ratio 3.64, P=.11, 5-year DFS 74%) compared with those with combined CNS and bone marrow disease (5-year DFS 59%). Neurocognitive testing revealed a mean post-SCT overall intelligence quotient of 103.7 at 4.4 years. Relative deficiencies in processing speed and/or working memory were noted in 6 of 16 tested patients (38%). Pre- and post-SCT neurocognitive testing revealed no significant change in intelligence quotient (mean increase +4.7 points). At a mean of 12.5 years after transplant, 11 of 13 long-term survivors (85%) had completed at least some coursework at a 2- or 4-year college. Conclusion: The addition of CSI to TBI before SCT in pediatric ALL with CNS involvement is effective and well-tolerated. Craniospinal irradiation plus TBI is worthy of further protocol investigation in children with CNS leukemia.« less

Rationale, design, and baseline characteristics of the DANish randomized, controlled, multicenter study to assess the efficacy of Implantable cardioverter defibrillators in patients with non-ischemic Systolic Heart failure on mortality (DANISH).

PubMed

Thune, Jens Jakob; Pehrson, Steen; Nielsen, Jens Cosedis; Haarbo, Jens; Videbæk, Lars; Korup, Eva; Jensen, Gunnar; Hildebrandt, Per; Steffensen, Flemming Hald; Bruun, Niels Eske; Eiskjær, Hans; Brandes, Axel; Thøgersen, Anna Margrethe; Egstrup, Kenneth; Hastrup-Svendsen, Jesper; Høfsten, Dan Eik; Torp-Pedersen, Christian; Køber, Lars

2016-09-01

The effect of an implantable cardioverter defibrillator (ICD) in patients with symptomatic systolic heart failure (HF) caused by coronary artery disease is well documented. However, the effect of primary prophylactic ICDs in patients with systolic HF not due to coronary artery disease is much weaker. In addition, HF management has improved, since the landmark ICD trials and a large proportion of patients now receive cardiac resynchronization therapy (CRT) where the effect of ICD treatment is unknown. In the DANISH study, 1,116 patients with symptomatic systolic HF not caused by coronary artery disease have been randomized to receive an ICD or not, in addition to contemporary standard therapy. The primary outcome of the trial is time to all-cause death. Follow-up will continue until June 2016 with a median follow-up period of 5 years. Baseline characteristics show that enrolled patients are treated according to current guidelines. At baseline, 97% of patients received an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 92% received a β-blocker, 58% a mineralocorticoid receptor antagonist, and 58% were scheduled to receive CRT. Median age was 63 years (range, 21-84 years) at baseline, and 28% were women. DANISH will provide pertinent information about the effect on all-cause mortality of a primary prophylactic ICD in patients with symptomatic systolic HF not caused by coronary artery disease on contemporary standard therapy including CRT. Copyright © 2016 Elsevier Inc. All rights reserved.

Paul Coverdell National Acute Stroke Registry Surveillance - four states, 2005-2007.

PubMed

George, Mary G; Tong, Xin; McGruder, Henraya; Yoon, Paula; Rosamond, Wayne; Winquist, Andrea; Hinchey, Judith; Wall, Hilary K; Pandey, Dilip K

2009-11-06

Each year, approximately 795,000 persons in the United States experience a new or recurrent stroke. Data from the prototype phase (2001-2004) of the Paul Coverdell National Acute Stroke Registry (PCNASR) suggested that numerous acute stroke patients did not receive treatment according to established guidelines. This report summarizes PCNASR data collected during 2005-2007 from Georgia, Illinois, Massachusetts, and North Carolina, the first states to have PCNASRs implemented in and led by state health departments. PCNASR was established by CDC in 2001 to track and improve the quality of hospital-based acute stroke care. The prototype phase (2001-2004) registries were led by CDC-funded clinical investigators in academic and medical institutions, whereas the full implementation of the 2005-2007 statewide registries was led by CDC-funded state health departments. Health departments in each state recruit hospitals to collect data. To be included in PCNASR, patients must be aged >or=18 years and have a clinical diagnosis of acute ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (TIA) or an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code indicative of a stroke or TIA. Data for patients who are already hospitalized at the time of stroke are not included. The following 10 performance measures of care, based on established guidelines for care of acute stroke patients, were developed by CDC in partnership with neurologists who specialize in stroke care: 1) received deep venous thrombosis prophylaxis, 2) received antithrombotic therapy at discharge, 3) received anticoagulation therapy for atrial fibrillation, 4) received tissue plasminogen activator (among eligible patients), 5) received antithrombotic therapy within 48 hours of admission or by the end of the second hospital day, 6) received lipid level testing, 7) received dysphagia screening, 8) received stroke education, 9) received smoking cessation counseling, and 10) received assessment for rehabilitation services. Adherence to these performance measures of care was calculated using predefined inclusion and exclusion criteria. A total of 195 hospitals from Georgia, Illinois, Massachusetts, and North Carolina contributed data to PCNASR during 2005-2007, representing 56,969 patients. Approximately half (53.3%) the cases of stroke in the registry occurred among females. A total of 2.5% of cases were among Hispanics; however, the proportion varied significantly by state. Cases among black patients ranged from 5.6% in Massachusetts to 35.8% in Georgia. The age at which patients experienced stroke varied significantly by state. On average, patients were oldest in Massachusetts (median age: 77 years) and youngest in Georgia (median age: 67 years). Overall, the clinical diagnosis for registry stroke cases was hemorrhagic stroke (13.8% of cases), ischemic stroke (56.2%), ill-defined stroke (i.e., medical record did not specify ischemic or hemorrhagic stroke; 7.3%), and TIA (21.6%). A total of 18.5% of patients with stroke symptoms arrived at the hospital within 2 hours of symptom onset; however, the time from onset of symptoms to hospital arrival was not recorded or was not known for the majority (57.8%) of patients. Of the 56,969 patients, 47.6% were transported by emergency medical services (EMS) from the scene of symptom onset, 11.1% were transferred by EMS from another hospital, and 39.4% used private or other transportation. Adherence to acute stroke care measures defined by PCNASR were as follows: received antithrombotic therapy at discharge (97.6%), received antithrombotic therapy within 48 hours of admission or by the end of the second hospital day (94.6%), assessed for rehabilitation services (90.1%), received deep venous thrombosis prophylaxis (85.5%), received anticoagulation therapy for atrial fibrillation (82.5%), received smoking cessation counseling (78.6%), received lipid level testing (69.9%), received stroke education (58.8%), received dysphagia screening (56.7%), and received tissue plasminogen activator (among eligible patients) (39.8%). Between 2001-2004 (prototype phase) and 2005-2007 (implementation by state health departments), substantial improvement occurred in dysphagia screening, lipid testing, smoking cessation counseling, and antithrombotic therapy prescribed at discharge. These initial improvements indicate that a surveillance system to track and improve the quality of hospital-based stroke care can be led successfully by state health departments, although further evaluations over time are needed. Despite these improvements, additional increases are needed in adherence to these and other performance measures. Nearly 40% of stroke patients did not use EMS services for transport to hospitals, and no change occurred in the proportion of patients who arrived at the hospital in time to receive thrombolytic therapy for ischemic stroke. Patients who are not promptly transported to hospitals after symptom onset are ineligible for thrombolytic therapy and other timely interventions for acute stroke. Results from PCNASR indicate the need for additional public health measures to inform the public of the need for timely activation of EMS services for signs and symptoms of stroke. In addition, low rates of adherence to certain measures of stroke care underscore the need for continuing coordinated programs to improve stroke quality of care. Additional analyses are needed to assess improvements in adherence to guidelines over time.

[Cryopresipitate in comprehensive conservative therapy of patients with acute purulent pyelonephritis].

PubMed

Neimark, A I; Samchuk, Yu G; Gatkin, M Ya; Momot, A P

2017-06-01

To investigate the effectiveness of cryoprecipitate in the comprehensive conservative therapy of patients with acute purulent pyelonephritis. We conducted a retrospective analysis of medical records of patients who were diagnosed with acute non-obstructive pyelonephritis from 2007to 2015. During this period, a total of 3912 patients with acute non-obstructive pyelonephritis were treated at the Department of Urology. Patients were assigned to either receive or not receive cryoprecipitate in the comprehensive conservative therapy. The comprehensive conservative therapy of both groups included antibacterial agents, detoxification, anti-inflammatory therapy. In the study group, patients received additional treatment with cryoprecipitate. By that way we estimated the number of patients who avoided surgery in both groups. There were 3912 patients divided into two groups. The first group included 756 patients (19.3%) who received cryoprecipitate in the comprehensive therapy of pyelonephritis. Of them, 735 patients (97.3%) did not require surgical treatment, and only 21 patients (2.7%) underwent surgery. The second group comprised 3156 patients (80.7%) who did not receive cryoprecipitate. Of them, 2974 patients (94.2%) were treated conservatively without surgical intervention and 182 patients (5.8%) received conservative therapy concurrently with surgical treatment. Therefore, including cryoprecipitate in the comprehensive conservative therapy of acute non-obstructive pyelonephritis results in twice smaller percentage of patients (2.7% vs 5.8%) requiring surgery compared to the comprehensive conservative therapy alone.

Additive treatment improves survival in elderly patients after non-curative endoscopic resection for early gastric cancer.

PubMed

Jung, Da Hyun; Lee, Yong Chan; Kim, Jie-Hyun; Lee, Sang Kil; Shin, Sung Kwan; Park, Jun Chul; Chung, Hyunsoo; Park, Jae Jun; Youn, Young Hoon; Park, Hyojin

2017-03-01

Endoscopic resection (ER) is accepted as a curative treatment option for selected cases of early gastric cancer (EGC). Although additional surgery is often recommended for patients who have undergone non-curative ER, clinicians are cautious when managing elderly patients with GC because of comorbid conditions. The aim of the study was to investigate clinical outcomes in elderly patients following non-curative ER with and without additive treatment. Subjects included 365 patients (>75 years old) who were diagnosed with EGC and underwent ER between 2007 and 2015. Clinical outcomes of three patient groups [curative ER (n = 246), non-curative ER with additive treatment (n = 37), non-curative ER without additive treatment (n = 82)] were compared. Among the patients who underwent non-curative ER with additive treatment, 28 received surgery, three received a repeat ER, and six experienced argon plasma coagulation. Patients who underwent non-curative ER alone were significantly older than those who underwent additive treatment. Overall 5-year survival rates in the curative ER, non-curative ER with treatment, and non-curative ER without treatment groups were 84, 86, and 69 %, respectively. No significant difference in overall survival was found between patients in the curative ER and non-curative ER with additive treatment groups. The non-curative ER groups were categorized by lymph node metastasis risk factors to create a high-risk group that exhibited positive lymphovascular invasion or deep submucosal invasion greater than SM2 and a low-risk group without risk factors. Overall 5-year survival rate was lowest (60 %) in the high-risk group with non-curative ER and no additive treatment. Elderly patients who underwent non-curative ER with additive treatment showed better survival outcome than those without treatment. Therefore, especially with LVI or deep submucosal invasion, additive treatment is recommended in patients undergoing non-curative ER, even if they are older than 75 years.

Efficacy and safety of a non-acetylated salicylate, choline magnesium trisalicylate, in the treatment of rheumatoid arthritis.

PubMed

Rothwell, K G

1983-01-01

The results of three double-blind, multicentre trials are reviewed to compare the efficacy of acetysalicylic acid (ASA) and a non-acetylated salicylate, choline magnesium trisalicylate (CMT), in the treatment of rheumatoid arthritis. In each trial, patients were randomly assigned to receive comparable doses of salicylate as either ASA or CMT. Mean values for clinical indicators of rheumatoid arthritis (number of painful joints, articular index, number of swollen joints, swelling index, duration of morning stiffness) showed similar or greater improvement among groups of patients receiving CMT, compared to those receiving ASA. In addition, the incidence of gastro-intestinal side-effects was lower among patients receiving CMT.

Recent advances in treatment of aplastic anemia

PubMed Central

Shin, Seung Hwan; Lee, Sung Eun

2014-01-01

Recent advances in the treatment of aplastic anemia (AA) made most of patients to expect to achieve a long-term survival. Allogeneic stem cell transplantation (SCT) from HLA-matched sibling donor (MSD-SCT) is a preferred first-line treatment option for younger patients with severe or very severe AA, whereas immunosuppressive treatment (IST) is an alternative option for others. Horse anti-thymocyte globuline (ATG) with cyclosporin A (CsA) had been a standard IST regimen with acceptable response rate. Recently, horse ATG had been not available and replaced with rabbit ATG in most countries. Subsequently, recent comparative studies showed that the outcomes of patients who received rabbit ATG/CsA were similar or inferior compared to those who received horse ATG/CsA. Therefore, further studies to improve the outcomes of IST, including additional eltrombopag, are necessary. On the other hand, the upper age limit of patients who are able to receive MSD-SCT as first-line treatment is a current issue because of favorable outcomes of MSD-SCT of older patients using fludarabine-based conditioning. In addition, further studies to improve the outcomes of patients who receive allogeneic SCT from alternative donors are needed. In this review, current issues and the newly emerging trends that may improve their outcomes in near futures will be discussed focusing the management of patients with AA. PMID:25378968

TH-AB-207A-03: Skin Dose to Patients Receiving Multiple CTA and CT Exams of the Head

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nawfel, RD; Young, G

Purpose: To measure patient skin dose from CT angiography (CTA) and CT exams of the head, and determine if patients having multiple exams could receive cumulative doses that approach or exceed deterministic thresholds. Methods: This study was HIPAA compliant and conducted with IRB approval. Patient skin doses were measured over a 4 month period using nanoDot OSL dosimeters placed on the head of 52 patients for two CT scanners. On each scanner, 26 patients received CT exams (scanner 1: 10 females, 16 males, mean age 64.2 years; scanner 2: 18 females, 8 males, mean age 61.2 years). CT exam dosemore » metrics, CTDIvol and dose-length product (DLP) were recorded for each exam. Additionally, skin dose was measured on an acrylic skull phantom in each scanner and on a neuro-interventional imaging system using clinical protocols. Measured dose data was used to estimate peak skin dose (PSD) for 4 patients receiving multiple exams including CTA, head CT, and cerebral angiography. Results: For scanner 1, the mean PSD for CTA exams (98.9 ± 5.3 mGy) and for routine head CT exams (39.2 ± 3.7 mGy) agreed reasonably well with the PSD measured on the phantom, 105.4 mGy and 40.0 mGy, respectively. Similarly for scanner 2, the mean PSD for CTA exams (98.8 ± 7.4 mGy) and for routine head CT exams (42.9 ± 9.4 mGy) compared well with phantom measurements, 95.2 mGy and 37.6 mGy, respectively. In addition, the mean PSD was comparable between scanners for corresponding patient exams, CTA and routine head CT respectively. PSD estimates ranged from 1.9 – 4.5 Gy among 4 patients receiving multiple exams. Conclusion: Patients having several exams including both CTA and routine head CT may receive cumulative doses approaching or exceeding the threshold for single dose deterministic effects.« less

Percutaneous coronary intervention and antiplatelet therapy in patients with atrial fibrillation receiving apixaban or warfarin: Insights from the ARISTOTLE trial.

PubMed

Kopin, David; Jones, W Schuyler; Sherwood, Matthew W; Wojdyla, Daniel M; Wallentin, Lars; Lewis, Basil S; Verheugt, Freek W A; Vinereanu, Dragos; Bahit, M Cecilia; Halvorsen, Sigrun; Huber, Kurt; Parkhomenko, Alexander; Granger, Christopher B; Lopes, Renato D; Alexander, John H

2018-03-01

We assessed antiplatelet therapy use and outcomes in patients undergoing percutaneous coronary intervention (PCI) during the ARISTOTLE trial. Patients were categorized based on the occurrence of PCI during follow-up (median 1.8 years); PCI details and outcomes post-PCI are reported. Of the 18,201 trial participants, 316 (1.7%) underwent PCI (152 in apixaban group, 164 in warfarin group). At the time of PCI, 84% (267) were on study drug (either apixaban or warfarin). Of these, 19% did not stop study drug during PCI, 49% stopped and restarted <5 days post-PCI, and 30% stopped and restarted >5 days post-PCI. At 30 days post-PCI, 35% of patients received dual -antiplatelet therapy (DAPT), 23% received aspirin only, and 13% received a P2Y 12 inhibitor only; 29% received no antiplatelet therapy. Triple therapy (DAPT + oral anticoagulant [OAC]) was used in 21% of patients, 23% received OAC only, 15% received OAC plus aspirin, and 9% received OAC plus a P2Y 12 inhibitor; 32% received antiplatelet agents without OAC. Post-PCI, patients assigned to apixaban versus warfarin had numerically similar rates of major bleeding (5.93 vs 6.73 events/100 patient-years; P = .95) and stroke (2.74 vs 1.84 events/100 patient-years; P = .62). PCI occurred infrequently during follow-up. Most patients on study drug at the time of PCI remained on study drug in the peri-PCI period; 19% continued the study drug without interruption. Antiplatelet therapy use post-PCI was variable, although most patients received DAPT. Additional data are needed to guide the use of antithrombotics in patients undergoing PCI. Copyright © 2017 Elsevier Inc. All rights reserved.

Use of Intranasal Naloxone by Basic Life Support Providers.

PubMed

Weiner, Scott G; Mitchell, Patricia M; Temin, Elizabeth S; Langlois, Breanne K; Dyer, K Sophia

2017-01-01

Intranasal delivery of naloxone to reverse the effects of opioid overdose by Advanced Life Support (ALS) providers has been studied in several prehospital settings. In 2006, in response to the increase in opioid-related overdoses, a special waiver from the state allowed administration of intranasal naloxone by Basic Life Support (BLS) providers in our city. This study aimed to determine: 1) if patients who received a 2-mg dose of nasal naloxone administered by BLS required repeat dosing while in the emergency department (ED), and 2) the disposition of these patients. This was a retrospective review of patients transported by an inner-city municipal ambulance service to one of three academic medical centers. We included patients aged 18 and older that were transported by ambulance between 1/1/2006 and 12/12/2012 and who received intranasal naloxone by BLS providers as per a state approved protocol. Site investigators matched EMS run data to patients from each hospital's EMR and performed a chart review to confirm that the patient was correctly identified and to record the outcomes of interest. Descriptive statistics were then generated. A total of 793 patients received nasal naloxone by BLS and were transported to three hospitals. ALS intervened and transported 116 (14.6%) patients, and 11 (1.4%) were intubated in the field. There were 724 (91.3%) patients successfully matched to an ED chart. Hospital A received 336 (46.4%) patients, Hospital B received 210 (29.0%) patients, and Hospital C received 178 (24.6%) patients. Mean age was 36.2 (SD 10.5) years and 522 (72.1%) were male; 702 (97.1%) were reported to have abused heroin while 21 (2.9%) used other opioids. Nasal naloxone had an effect per the prehospital record in 689 (95.2%) patients. An additional naloxone dose was given in the ED to 64 (8.8%) patients. ED dispositions were: 507 (70.0%) discharged, 105 (14.5%) admitted, and 112 (15.5%) other (e.g., left against medical advice, left without being seen, or transferred). Only a small percentage of patients receiving prehospital administration of nasal naloxone by BLS providers required additional doses of naloxone in the ED and the majority of patients were discharged.

[Potential of specialized outpatient palliative care].

PubMed

Geist, M J P; Bardenheuer, H J; Weigand, M A; Frankenhauser, S; Kessler, J

2018-05-01

Palliative care patients with incurable advanced disease suffering from complex symptoms can receive specialized outpatient palliative care in addition to the existing ambulatory care system. Qualified physicians and nurses care for patients and their dependents in cooperation with other professionals. In addition to a 24/7 on-call service for emergencies or acute crises, patients and their dependents are offered regular visits.

Hypofibrinolytic state in HIV-1-infected patients treated with protease inhibitor-containing highly active antiretroviral therapy.

PubMed

Koppel, Kristina; Bratt, Göran; Schulman, Sam; Bylund, Håkan; Sandström, Eric

2002-04-15

Decreased insulin sensitivity, hyperlipidemia, and body fat changes are considered as risk factors for coronary heart disease (CHD). A clustering of such factors (metabolic syndrome [MSDR]) exponentially increases the risk. Impaired fibrinolysis and increased coagulation are additional independent risk factors for CHD. We studied the effects of protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) on metabolic and hemostatic parameters in 363 HIV-infected individuals, of whom 266 were receiving PI-containing HAART and 97 were treatment naive. The fasting plasma levels of insulin, glucose, triglycerides, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, plasminogen activator inhibitor type 1 (PAI-1), and fibrinogen were evaluated together with the areas of visceral adipose tissue and the visceral adipose tissue/subcutaneous adipose tissue area ratio. The levels of insulin, triglycerides, cholesterol, and low-density lipoprotein cholesterol; visceral adipose tissue area; low-density lipoprotein/high-density lipoprotein ratio; and visceral adipose tissue/subcutaneous adipose tissue area ratio were significantly increased in patients receiving PI-containing HAART compared with treatment-naive patients. The levels of PAI-1 and fibrinogen were significantly higher in patients receiving PI-containing HAART. PAI-1 levels were higher in individuals with MSDR but also in patients without MSDR who were receiving PI-containing HAART. PAI-1 was independently correlated to use of PI-containing HAART, triglyceride level, insulin level, and body mass index (p <.001). These findings suggest that patients receiving PI-containing HAART have decreased fibrinolysis and increased coagulability, which may thus represent additional risk factors for cardiovascular disease in this patient group.

Clinical relevance of metronidazole and peripheral neuropathy: a systematic review of the literature.

PubMed

Goolsby, Tiffany A; Jakeman, Bernadette; Gaynes, Robert P

2018-03-01

The objective of this paper was to review and evaluate the literature on metronidazole-associated peripheral neuropathy and determine the relevance in clinical practice. MEDLINE/PubMed, EBSCO, and Google Scholar were searched through February 2017 using the search terms metronidazole and peripheral neuropathy, or polyneuropathy, or paresthesia, or neurotoxicity. Relevant case reports, retrospective studies, surveys, and review articles were included. Bibliographies of all relevant articles were reviewed for additional sources. Overall, metronidazole is generally well tolerated, but serious neurotoxicity, including peripheral neuropathy, has been reported. The overall incidence of peripheral neuropathy associated with metronidazole is unknown. Our review found 36 case reports (40 unique patients) of metronidazole-associated peripheral neuropathy, with most cases (31/40) receiving a >42 g total (>4 weeks) of therapy. In addition, we reviewed 13 clinical studies and found varying rates of peripheral neuropathy from 0 to 50%. Within these clinical studies, we found a higher incidence of peripheral neuropathy in patients receiving >42 g total (>4 weeks) of metronidazole compared with those patients receiving ≤42 g total (17.9% vs. 1.7%). Nearly all patients had complete resolution of symptoms. In conclusion, peripheral neuropathy is rare in patients who receive ≤42 g total of metronidazole. Patients who receive higher total doses may be at higher risk of peripheral neuropathy, but symptoms resolve after discontinuation of therapy in most patients. Antimicrobial stewardship programs may consider use of antibiotic combinations that include metronidazole over broad-spectrum alternatives when treating with ≤42 g total of the drug (≤4 weeks). Published by Elsevier B.V.

Identifying Recipients of Electroconvulsive Therapy: Data From Privately Insured Americans.

PubMed

Wilkinson, Samuel T; Agbese, Edeanya; Leslie, Douglas L; Rosenheck, Robert A

2018-05-01

Despite the effectiveness of electroconvulsive therapy (ECT), limited epidemiologic research has been conducted to identify rates of ECT use and characteristics of patients who receive ECT. Sociodemographic and clinical characteristics associated with ECT use were examined among patients with mood disorders in the MarketScan commercial insurance claims database. Among individuals with major depressive disorder or bipolar disorder, sociodemographic and clinical characteristics of those who received ECT and those who did not were compared by using bivariate effect size comparisons and multivariate logistic regression. Among unique individuals in the 2014 MarketScan database (N=47,258,528), the ECT utilization rate was 5.56 ECT patients per 100,000 in the population. Of the 969,277 patients with a mood disorder, 2,471 (.25%) received ECT. Those who received ECT had substantially higher rates of additional comorbid psychiatric disorders (risk ratio [RR]=5.70 for any additional psychiatric disorder), numbers of prescription fills for any psychotropic medication (Cohen's d=.77), rates of any substance use disorder (RR=1.97), and total outpatient psychotherapy visits (Cohen's d=.49). The proportion of patients with a mood disorder who received ECT in the West (.19%) was substantially lower than in other U.S. regions (.28%). This difference was almost entirely accounted for by one western state comprising 59.1% of patients in that region. Use of ECT is exceptionally uncommon and limited to patients with extensive multimorbidity and high levels of service use. ECT utilization is most limited in areas of the country where regulatory restrictions are greatest.

Comparison of Two Anesthetic Methods for Intravitreal Ozurdex Injection

PubMed Central

Karabaş, V. Levent; Özkan, Berna; Koçer, Çiğdem Akdağ; Altıntaş, Özgül; Pirhan, Dilara; Yüksel, Nurşen

2015-01-01

Purpose. To determine whether subconjunctival lidocaine injection maintains additional anesthetic effect during intravitreal Ozurdex injection. Methods. 63 patients who were diagnosed as central or branch retinal vein occlusion and planned to receive Ozurdex injection for macular edema were prospectively included in the study. The patients were randomized into one of the two anesthetic groups. The first group received topical proparacaine drop and lidocaine applied pledget. The second group received subconjunctival lidocaine injection in addition to the anesthetics in group 1. Results. Mean pain score was 1.90 ± 2.39 in group 1 and 1.71 ± 2.09 in group 2 (p = 0.746). Mean subconjunctival hemorrhage grade was 1.67 ± 0.17 in group 1 and 0.90 ± 0.14 in group 2 (p = 0.001). There was no relationship between the amount of subconjunctival hemorrhage and pain score of the patients. Conclusions. There was no difference in pain scores between the two anesthetic methods. The addition of subconjunctival lidocaine injection offered no advantage in pain relief compared to lidocaine-applied pledgets. PMID:25949822

Comparison of two anesthetic methods for intravitreal ozurdex injection.

PubMed

Karabaş, V Levent; Özkan, Berna; Koçer, Çiğdem Akdağ; Altıntaş, Özgül; Pirhan, Dilara; Yüksel, Nurşen

2015-01-01

Purpose. To determine whether subconjunctival lidocaine injection maintains additional anesthetic effect during intravitreal Ozurdex injection. Methods. 63 patients who were diagnosed as central or branch retinal vein occlusion and planned to receive Ozurdex injection for macular edema were prospectively included in the study. The patients were randomized into one of the two anesthetic groups. The first group received topical proparacaine drop and lidocaine applied pledget. The second group received subconjunctival lidocaine injection in addition to the anesthetics in group 1. Results. Mean pain score was 1.90 ± 2.39 in group 1 and 1.71 ± 2.09 in group 2 (p = 0.746). Mean subconjunctival hemorrhage grade was 1.67 ± 0.17 in group 1 and 0.90 ± 0.14 in group 2 (p = 0.001). There was no relationship between the amount of subconjunctival hemorrhage and pain score of the patients. Conclusions. There was no difference in pain scores between the two anesthetic methods. The addition of subconjunctival lidocaine injection offered no advantage in pain relief compared to lidocaine-applied pledgets.

Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia.

PubMed

Isakov, Vasily; Nikitin, Igor; Chulanov, Vladimir; Ogurtsov, Pavel; Lukyanova, Ekaterina; Long, Jianmin; Wahl, Janice; Helmond, Frans A

2016-02-28

To evaluate addition of boceprevir to peginterferon/ribavirin (PR) in Russian patients with chronic hepatitis C virus (HCV). Treatment-naive (TN) and treatment-experienced (TE) patients (who had failed prior treatment with PR for ≥ 12 wk) with chronic HCV genotype 1 infection were enrolled in this placebo-controlled, double-blind study. All patients initially received PR for 4 wk. Patients randomized to control treatment then received PR for an additional 44 wk. TN patients randomized to triple therapy received boceprevir (800 mg three times daily) plus PR for 24 wk and then further therapy according to treatment week 8 (TW8) HCV RNA levels. TE patients received boceprevir plus PR for 32 wk and then further therapy according to TW8 HCV RNA levels. Treatment was discontinued for TN patients with detectable HCV RNA at TW24 and TE patients with detectable HCV RNA at TW12 because of futility. The primary efficacy end point was sustained virologic response (SVR) defined as undetectable HCV RNA 24 wk after completing all study therapy. SVR was 74.8% in the boceprevir plus PR arm compared with 46.2% in the control arm, with a stratification-adjusted treatment difference of 29.2% (95%CI: 16.4-41.5; P < 0.0001). Rates of SVR were higher in the boceprevir arm in both TN and TE patient groups (TN 78.4% vs 56.3%; TE 69.4% vs 30.0%). Within TE patients, the rates of SVR were higher with boceprevir plus PR compared with PR, regardless of treatment failure type (null responder, partial responder, and relapser). Most patients receiving boceprevir plus PR in both TN (86%) and TE (71%) populations were eligible for reduced treatment duration. Anemia was increased in patients receiving boceprevir plus PR vs PR alone (47.2% vs 24.4%); there was a corresponding increase in ribavirin dose reduction and erythropoietin use. Among patients receiving boceprevir plus PR, SVR rates were similar in patients with anemia (< 10 g/dL) and those without anemia (71.2% vs 77.4%). Regulatory approval has been obtained for boceprevir plus PR in Russian patients with HCV genotype 1 infection based on the results of this study.

Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia

PubMed Central

Isakov, Vasily; Nikitin, Igor; Chulanov, Vladimir; Ogurtsov, Pavel; Lukyanova, Ekaterina; Long, Jianmin; Wahl, Janice; Helmond, Frans A

2016-01-01

AIM: To evaluate addition of boceprevir to peginterferon/ribavirin (PR) in Russian patients with chronic hepatitis C virus (HCV). METHODS: Treatment-naive (TN) and treatment-experienced (TE) patients (who had failed prior treatment with PR for ≥ 12 wk) with chronic HCV genotype 1 infection were enrolled in this placebo-controlled, double-blind study. All patients initially received PR for 4 wk. Patients randomized to control treatment then received PR for an additional 44 wk. TN patients randomized to triple therapy received boceprevir (800 mg three times daily) plus PR for 24 wk and then further therapy according to treatment week 8 (TW8) HCV RNA levels. TE patients received boceprevir plus PR for 32 wk and then further therapy according to TW8 HCV RNA levels. Treatment was discontinued for TN patients with detectable HCV RNA at TW24 and TE patients with detectable HCV RNA at TW12 because of futility. The primary efficacy end point was sustained virologic response (SVR) defined as undetectable HCV RNA 24 wk after completing all study therapy. RESULTS: SVR was 74.8% in the boceprevir plus PR arm compared with 46.2% in the control arm, with a stratification-adjusted treatment difference of 29.2% (95%CI: 16.4-41.5; P < 0.0001). Rates of SVR were higher in the boceprevir arm in both TN and TE patient groups (TN 78.4% vs 56.3%; TE 69.4% vs 30.0%). Within TE patients, the rates of SVR were higher with boceprevir plus PR compared with PR, regardless of treatment failure type (null responder, partial responder, and relapser). Most patients receiving boceprevir plus PR in both TN (86%) and TE (71%) populations were eligible for reduced treatment duration. Anemia was increased in patients receiving boceprevir plus PR vs PR alone (47.2% vs 24.4%); there was a corresponding increase in ribavirin dose reduction and erythropoietin use. Among patients receiving boceprevir plus PR, SVR rates were similar in patients with anemia (< 10 g/dL) and those without anemia (71.2% vs 77.4%). CONCLUSION: Regulatory approval has been obtained for boceprevir plus PR in Russian patients with HCV genotype 1 infection based on the results of this study. PMID:26962399

Use of Antibiotic Prophylaxis for Tooth Extractions, Dental Implants, and Periodontal Surgical Procedures

PubMed Central

Henschel, Heather; Patel, Ursula; Fitzpatrick, Margaret A; Evans, Charlesnika T

2018-01-01

Abstract Background Guidelines for antibiotics prior to dental procedures for patients with specific cardiac conditions and prosthetic joints have changed, reducing indications for antibiotic prophylaxis. In addition to guidelines focused on patient comorbidities, systematic reviews specific to dental extractions and implants support preprocedure antibiotics for all patients. However, data on dentist adherence to these recommendations are scarce. Methods This was a cross-sectional study of veterans undergoing tooth extractions, dental implants, and periodontal procedures. Patients receiving antibiotics for oral or nonoral infections were excluded. Data were collected through manual review of the health record. Results Of 183 veterans (mean age, 62 years; 94.5% male) undergoing the included procedures, 82.5% received antibiotic prophylaxis (mean duration, 7.1 ± 1.6 days). Amoxicillin (71.3% of antibiotics) and clindamycin (23.8%) were prescribed most frequently; 44.7% of patients prescribed clindamycin were not labeled as penicillin allergic. Of those who received prophylaxis, 92.1% received postprocedure antibiotics only, 2.6% received preprocedural antibiotics only, and 5.3% received pre- and postprocedure antibiotics. When prophylaxis was indicated, 87.3% of patients received an antibiotic. However, 84.9% received postprocedure antibiotics when preprocedure administration was indicated. While the majority of antibiotics were indicated, only 8.2% of patients received antibiotics appropriately. The primary reason was secondary to prolonged duration. Three months postprocedure, there were no occurrences of Clostridium difficile infection, infective endocarditis, prosthetic joint infections, or postprocedure oral infections. Conclusion The majority of patients undergoing a dental procedure received antibiotic prophylaxis as indicated. Although patients for whom antibiotic prophylaxis was indicated should have received a single preprocedure dose, most antibiotics were prescribed postprocedure. Dental stewardship efforts should ensure appropriate antibiotic timing, indication, and duration. PMID:29326959

Patient-reported frequency, awareness and patient-physician communication of hypoglycaemia in Belgium.

PubMed

Peene, B; D'Hooge, D; Vandebrouck, T; Mathieu, C

2014-12-01

Limited data exist on the frequency of non-severe hypoglycaemic events in patients with insulin-treated diabetes outside of clinical trial settings. Our study investigated the rates of self-reported non-severe events in a sample of Belgian patients. We also investigated self-reported awareness of the symptoms of hypoglycaemia and communication about hypoglycaemia between patients and their physicians. Patients aged >15 years with Type 1 (T1DM) and insulin-treated Type 2 (T2DM) diabetes were recruited via existing panels in Belgium to complete four questionnaires at weekly intervals. In addition to demographics, data on frequency of non-severe hypoglycaemic events (7-day recall), severe hypoglycaemic events (1-year recall), awareness of hypoglycaemia and reporting of hypoglycaemia to physicians were recorded. In total, 412 patients (44% T1DM, 56% T2DM) completed 1148 patient-week records. Mean insulin-treatment duration was 11 years, mean HbA(1c) 7·7%. Mean reported non-severe hypoglycaemic events per patient-week were 2·3 in T1DM patients, 0·3 in T2DM patients receiving basal-only therapy, 0·7 in T2DM patients receiving basal-bolus therapy and 0·8 in T2DM patients receiving another form of insulin. Mean reported annual frequencies of severe hypoglycaemic events were 0·9 in T1DM and 0·4 in T2DM. Impaired awareness or unawareness of hypoglycaemia was reported by 70% of T1DM patients, 55% of T2DM patients receiving basal-only therapy, 61% of T2DM patients receiving basal-bolus therapy and 73% of T2DM patients receiving another form of insulin. Overall, 60% of T1DM patients and 46% of T2DM patients rarely/never discuss hypoglycaemia with their GP/specialist. In addition, 10% of T1DM patients and 13% of T2DM patients stated that GPs/specialists did not ask them about their hypoglycaemia in routine appointments. Hypoglycaemic events and unawareness of these events are common in Belgian insulin-treated diabetes patients. Patients often fail to report hypoglycaemic events to their physician and many physicians do not inquire about hypoglycaemia, meaning the current burden of hypoglycaemic events may be underestimated.

Web-Based Education Prior to Outpatient Orthopaedic Surgery Enhances Early Patient Satisfaction Scores: A Prospective Randomized Controlled Study.

PubMed

van Eck, Carola F; Toor, Aneet; Banffy, Michael B; Gambardella, Ralph A

2018-01-01

A good patient-surgeon relationship relies on adequate preoperative education and counseling. Several multimedia resources, such as web-based education tools, have become available to enhance aspects of perioperative care. The purpose of this study was to evaluate the effect of an interactive web-based education tool on perioperative patient satisfaction scores after outpatient orthopaedic surgery. It was hypothesized that web-based education prior to outpatient orthopaedic surgery enhances patient satisfaction scores. Randomized controlled trial; Level of evidence, 1. All patients undergoing knee arthroscopy with meniscectomy, chondroplasty, or anterior cruciate ligament reconstruction or shoulder arthroscopy with rotator cuff repair were eligible for inclusion and were randomized to the study or control group. The control group received routine education by the surgeon, whereas the study group received additional web-based education. At the first postoperative visit, all patients completed the OAS CAHPS (Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems) survey. Differences in patient satisfaction scores between the study and control groups were determined with an independent t test. A total of 177 patients were included (104 [59%] males; mean age, 42 ± 14 years); 87 (49%) patients were randomized to receive additional web-based education. Total patient satisfaction score was significantly higher in the study group (97 ± 5) as compared with the control group (94 ± 8; P = .019), specifically for the OAS CAHPS core measure "recovery" (92 ± 13 vs 82 ± 23; P = .001). Age, sex, race, workers' compensation status, education level, overall health, emotional health, procedure type and complexity, and addition of a video did not influence patient satisfaction scores. Supplemental web-based patient education prior to outpatient orthopaedic surgery enhances patient satisfaction scores.

Potential curability and perception of received information in esophageal cancer patients.

PubMed

Pinto, Eleonora; Cavallin, Francesco; Saadeh, Luca Maria; Bellissimo, Maria Cristina; Alfieri, Rita; Mantoan, Silvia; Cagol, Matteo; Castoro, Carlo; Scarpa, Marco

2018-06-01

This study aimed to evaluate patients' perceived receipt of information according to the possibility of cure in esophageal cancer. One hundred and twelve consecutive patients presenting at the multidisciplinary visit at the Veneto Institute of Oncology for esophageal cancer between 2014 and 2016 were included in the study. The Italian version of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires C30 (core questionnaire), OG25 (esophago-gastric cancer module), and INFO25 (information module) were used. Candidates for palliative treatment were less informed about the disease (adjusted mean difference - 11.5, 95% CI - 23.0 to - 0.02) and less satisfied with information provided (adjusted mean difference - 18.3, 95% CI - 31.9 to - 4.7) than candidates for curative treatment. In addition, candidates for palliative treatment wanted to receive more information than candidates for curative treatment (adjusted mean difference 26.1, 95% CI 0.5 to 51.6). Better quality of life was associated with satisfaction of received information (β = 0.77, p < 0.0001) and of receiving information about things that the patient can do to help himself (β = 0.26, p = 0.04). More anxiety was associated to receiving more information about disease (β = 0.46, p = 0.02) but less information about things that the patient can do to help himself (β = - 0.38, p = 0.02). Candidates for palliative treatment were less satisfied with information about the disease and wanted to receive more information. Additionally, some aspects of quality of life were found to be associated with perceived receipt of information. Appropriate training in communication of prognostic information may improve clinical management of incurable cancer patients.

A dose-finding, placebo-controlled study on extended-release felodipine once daily in treatment of hypertension.

PubMed

Cambell, L M; Ross, J R; Goves, J R; Lees, C T; McCullagh, A; Barnes, P; Timerick, S J; Richardson, P D

1989-12-01

Hypertensive patients received a beta-blocker plus placebo once daily for 4 weeks. If their diastolic blood pressure (DBP) was then 95-115 mm Hg, they were randomized to receive, in addition to the beta-blocker, placebo (n = 36), felodipine-extended release (ER) 10 mg (n = 36), or felodipine-ER 20 mg (n = 37) in a 4-week double-blind parallel-group trial. All medication was administered once daily and, when BP was measured 24 h after the last dose, felodipine-ER 10 mg reduced DBP by 14 +/- 9 mm Hg (mean +/- SD) from a mean of 103 mm Hg and felodipine-ER 20 mg reduced DBP by 18 +/- 9 mm Gg from 101 mm Hg. The reductions in DBP with both doses of felodipine were greater than reductions with placebo (5 +/- 8 mm Hg, from 102 mm Hg--both p less than 0.001). At the end of the study, 21% of patients receiving placebo had a DBP less than or equal to 90 mm Hg. In contrast, 69% of patients receiving felodipine-ER 10 mg and 82% receiving 20 mg attained this level. More than 90% of patients receiving 10 mg felodipine-ER once daily had a reduction in DBP greater than 5 mm Hg 24 h postdose. Felodipine-ER was well tolerated. Felodipine-ER once daily is an effective antihypertensive drug for patients who require therapy in addition to a beta-blocker; the tolerability in this study was good, and a starting dose greater than 10 mg once daily is not indicated.

The impact on quality of life of dialysis patients with renal insufficiency

PubMed Central

Dąbrowska-Bender, Marta; Dykowska, Grażyna; Żuk, Wioletta; Milewska, Magdalena; Staniszewska, Anna

2018-01-01

Aim The aim of the study was the subjective assessment of the quality of life (QoL) of 140 patients treated with dialysis (peritoneal dialysis and hemodialysis). Background Chronic kidney disease and the methods of its treatment play an important part in shaping the QoL of patients receiving dialysis. As a result, kidney failure causes many limitations in patients’ physical, mental, and social activities. Methods The instrument to measure the QoL was the authors’ own questionnaire made on the basis of Kidney Disease and Quality of Life Short Form version 1.2 (KDQOL – SF 1.2) and their selection of areas influencing the perceived QoL of chronically ill patients. Results The research showed that patients receiving peritoneal dialysis assessed their QoL in its different dimensions as much higher than patients receiving hemodialysis. The parameter having the biggest negative impact on the QoL of patients receiving hemodialysis was an impeded possibility to continue work or studies and a change of life plans. The will to live was more highly assessed by patients receiving peritoneal dialysis as compared to patients receiving hemodialysis. Conclusion In order to improve the functioning of hemodialysis patients in a manner most similar to healthy persons, the renal replacement therapy should consider patients’ individual needs and expectations, ie, guarantee flexible hours of work or study and of receiving dialysis. In addition, patients treated with hemodialysis should receive psychological care, in particular those demonstrating emotional problems, in order to achieve better results in therapy and improve their QoL. PMID:29720873

[Investigation of the effects of cytoflavin on symptoms of depression and autonomic dysfunction in patients with organic depressive disorder].

PubMed

Gudkova, A N; Osinovskaia, N A; Polunina, A G; Gekht, A B

2013-01-01

The present observational study addressed effects of cytoflavin as an adjunctive nootropic therapy in patients with organic depressive disorder (F06.36). 54 female and 46 male in-patients were included into the study. All patients received standard antidepressant therapy (controls) and 48 patients additionally received 2 pills of cytoflavin twice per day. Age, gender distribution, education and severity of depression were equal in cytoflavin and control groups. The follow-up assessment at discharge showed a significantly more pronounced decline in the severity of depression symptoms in patients receiving cytoflavin in comparison with the controls. Importantly, the effect of cytoflavin on the depression symptoms was prominent only in females. Moreover, women receiving cytoflavin demonstrated the more pronounced normalization of autonomic regulation in comparison with control women. The present results allow to recommend cytoflavin in dose 4 pills daily as an adjunctive therapy in female patients with organic depressive disorder.

The effectiveness of zinc supplementation in men with isolated hypogonadotropic hypogonadism.

PubMed

Liu, Yan-Ling; Zhang, Man-Na; Tong, Guo-Yu; Sun, Shou-Yue; Zhu, Yan-Hua; Cao, Ying; Zhang, Jie; Huang, Hong; Niu, Ben; Li, Hong; Guo, Qing-Hua; Gao, Yan; Zhu, Da-Long; Li, Xiao-Ying

2017-01-01

A multicenter, open-label, randomized, controlled superiority trial with 18 months of follow-up was conducted to investigate whether oral zinc supplementation could further promote spermatogenesis in males with isolated hypogonadotropic hypogonadism (IHH) receiving sequential purified urinary follicular-stimulating hormone/human chorionic gonadotropin (uFSH/hCG) replacement. Sixty-seven Chinese male IHH patients were recruited from the Departments of Endocrinology in eight tertiary hospitals and randomly allocated into the sequential uFSH/hCG group (Group A, n = 34) or the sequential uFSH plus zinc supplementation group (Group B, n = 33). In Group A, patients received sequential uFSH (75 U, three times a week every other 3 months) and hCG (2000 U, twice a week) treatments. In Group B, patients received oral zinc supplementation (40 mg day-1 ) in addition to the sequential uFSH/hCG treatment given to patients in Group A. The primary outcome was the proportion of patients with a sperm concentration ≥1.0 × 106 ml-1 during the 18 months. The comparison of efficacy between Groups A and B was analyzed. Nineteen of 34 (55.9%) patients receiving sequential uFSH/hCG and 20 of 33 (60.6%) patients receiving sequential uFSH/hCG plus zinc supplementation achieved sperm concentrations ≥1.0 × 106 ml-1 by intention to treat analyses. No differences between Group A and Group B were observed as far as the efficacy of inducing spermatogenesis (P = 0.69). We concluded that the sequential uFSH/hCG plus zinc supplementation regimen had a similar efficacy to the sequential uFSH/hCG treatment alone. The additional improvement of 40 mg day-1 oral zinc supplementation on spermatogenesis and masculinization in male IHH patients is very subtle.

Training auscultatory skills: computer simulated heart sounds or additional bedside training? A randomized trial on third-year medical students

PubMed Central

2010-01-01

Background The present study compares the value of additional use of computer simulated heart sounds, to conventional bedside auscultation training, on the cardiac auscultation skills of 3rd year medical students at Oslo University Medical School. Methods In addition to their usual curriculum courses, groups of seven students each were randomized to receive four hours of additional auscultation training either employing a computer simulator system or adding on more conventional bedside training. Cardiac auscultation skills were afterwards tested using live patients. Each student gave a written description of the auscultation findings in four selected patients, and was rewarded from 0-10 points for each patient. Differences between the two study groups were evaluated using student's t-test. Results At the auscultation test no significant difference in mean score was found between the students who had used additional computer based sound simulation compared to additional bedside training. Conclusions Students at an early stage of their cardiology training demonstrated equal performance of cardiac auscultation whether they had received an additional short auscultation course based on computer simulated training, or had had additional bedside training. PMID:20082701

Diagnosis and treatment of shock due to massive pulmonary embolism: approach with transesophageal echocardiography and intrapulmonary thrombolysis.

PubMed

Krivec, B; Voga, G; Zuran, I; Skale, R; Pareznik, R; Podbregar, M; Noc, M

1997-11-05

To evaluate the diagnostic value of transesophageal echocardiography (TEE) as an initial diagnostic tool in shocked patients. The second objective was to study therapeutic impact of intrapulmonary thrombolysis in patients with diagnosed massive pulmonary embolism. Prospective observational study. Medical ICU in 800-bed general hospital. Twenty-four consecutive patients with unexplained shock and distended jugular veins. In 18 patients, right ventricular dilatation with global or segmental hypokinesis was documented. In addition, central pulmonary thromboemboli (12 patients), reduced contrast flow in right pulmonary artery (one patient), and right ventricular free wall akinesis (one patient) were found. No additional echocardiographic findings were apparent in four patients. According to pulmonary scintigraphy or autopsy, sensitivity of TEE for diagnosis of massive pulmonary embolism (MPE) in patients with right ventricular dilatation was 92% and specificity was 100%. In patients without right ventricular dilatation, left ventricular dysfunction (four patients) or cardiac tamponade (two patients) was confirmed. Intrapulmonary thrombolysis was evaluated in 11 of 13 patients with MPE. Two patients died prior to attempted thrombolysis. Three patients received streptokinase and eight received urokinase. Twenty-four hours after beginning of treatment, total pulmonary resistance index significantly decreased for 59% and mean pulmonary artery pressure for 31%. Cardiac index increased for 74%. Nine of 11 patients receiving thrombolysis survived to hospital discharge. Bedside TEE is a valuable tool for diagnosis of MPE. It enables immediate intrapulmonary thrombolysis, which seems to be an effective therapeutic alternative in our group of patients with obstructive shock.

Proton Therapy for Reirradiation of Progressive or Recurrent Chordoma

DOE Office of Scientific and Technical Information (OSTI.GOV)

McDonald, Mark W., E-mail: mmcdona2@iuhealth.org; Indiana University Health Proton Therapy Center, Bloomington, Indiana; Linton, Okechuckwu R.

2013-12-01

Purpose: To report the results in patients reirradiated with proton therapy for recurrent or progressive chordoma, with or without salvage surgery. Methods and Materials: A retrospective review of 16 consecutive patients treated from 2005 to 2012 was performed. All patients had received at least 1 prior course of radiation therapy to the same area, and all but 1 patient had at least 1 surgical resection for disease before receiving reirradiation. At the time of recurrence or progression, half of the patients underwent additional salvage surgery before receiving reirradiation. The median prior dose of radiation was 75.2 Gy (range, 40-79.2 Gy).more » Six patients had received prior proton therapy, and the remainder had received photon radiation. The median gross tumor volume at the time of reirradiation was 71 cm{sup 3} (range, 0-701 cm{sup 3}). Reirradiation occurred at a median interval of 37 months after prior radiation (range, 12-129 months), and the median dose of reirradiation was 75.6 Gy (relative biological effectiveness [RBE]) (range. 71.2-79.2 Gy [RBE]), given in standard daily fractionation (n=14) or hyperfractionation (n=2). Results: The median follow-up time was 23 months (range, 6-63 months); it was 26 months in patients alive at the last follow-up visit (range, 12-63 months). The 2-year estimate for local control was 85%, overall survival 80%, chordoma-specific survival 88%, and development of distant metastases 20%. Four patients have had local progression: 3 in-field and 1 marginal. Late toxicity included grade 3 bitemporal lobe radionecrosis in 1 patient that improved with hyperbaric oxygen, a grade 4 cerebrospinal fluid leak with meningitis in 1 patient, and a grade 4 ischemic brainstem stroke (out of radiation field) in 1 patient, with subsequent neurologic recovery. Conclusions: Full-dose proton reirradiation provided encouraging initial disease control and overall survival for patients with recurrent or progressive chordoma, although additional toxicities may develop with longer follow-up times.« less

Post-recurrence chemotherapy for mesothelioma patients undergoing extrapleural pneumonectomy.

PubMed

Takuwa, Teruhisa; Hashimoto, Masaki; Matsumoto, Seiji; Kondo, Nobuyuki; Kuribayash, Kozo; Nakano, Takashi; Hasegawa, Seiki

2017-10-01

Additional chemotherapy is often not feasible in patients with recurrent malignant pleural mesothelioma (MPM) undergoing extrapleural pneumonectomy (EPP), due to deteriorated cardiopulmonary reserve. We thus examined the feasibility and efficacy of additional chemotherapy in patients with recurrent MPM after EPP. A retrospective review was conducted of 59 consecutive patients who underwent bi-/tri-modal treatment with induction chemotherapy, EPP, and radiation therapy from July 2004 to August 2013 at Hyogo College of Medicine (Nishinomiya, Japan). Of 59 patients, 39 (male/female = 31/8, right/left = 15/24, pathological stage I/II/III/IV = 1/7/23/3, bi-/tri-modality = 27/12) relapsed at a median age of 62 (range 37-71) years. The median time to recurrence after EPP was 11.6 months. Of the 39 relapsed patients, 12 received best supportive care alone, six started but discontinued chemotherapy, and the remaining 21 (53%) completed more than three cycles of intravenous chemotherapy. The median survival time after EPP was significantly longer in 21 patients who received additional chemotherapy than in 18 patients who did not (39.2 vs. 12.2 months, P = 0.009). Additional systemic chemotherapy was successfully administered in more than 50% of relapsed patients after bi-/tri-modal treatment, which included EPP, and resulted in a longer survival in comparison with best supportive care alone.

[Clinical experience of supplying sodium chloride for the treatment of patients with severe heart failure].

PubMed

He, Li-xia; Sun, Lu-lu; Yang, Yue-jin; Zhang, Jian; Zhang, Yu-hui; Song, Wei-hua; Huang, Yan; Lü, Rong; Ji, Shi-ming

2012-09-01

To observe the effect and safety of supplying sodium chloride in the treatment of patients with severe heart failure. Consecutive 51 hospitalized patients with severe heart failure and cardiac edema were included in this study. Normal diet (6 g NaCl/d) was supplied to all patients. On the basis of controlling fluid intake and treating related etiological factors as well as standard medications including furosemide for severe heart failure, patients with mild hyponatremia (serum sodium level 130 - 134 mmol/L) ate additional salted vegetables, patients with moderate hyponatremia (serum sodium level 125 - 129 mmol/L) and severe hyponatremia (serum sodium level < 125 mmol/L) ate additional salted vegetables and were received additionally intravenous 3%NaCl hypertonic saline infusion (10 ml/h) until reaching normal serum sodium level. On admission, 37.25% (19/51) patients had hyponatremia. During the first two weeks hospitalization period, 88.24% (45/51) patients were treated with intravenous diuretics and total incidence of hyponatremia was 64.71% (33/51), mild hyponatremia was 50.98% (26/51), middle and severe hyponatremia was 13.73% (7/51); among them, hyponatremia lasted less than 3 d in 57.58% (19/33) patients and ≥ 3 d in 42.42% (14/33) patients. Heart failure exacerbation and hypernatremia were not observed in patients receiving additional sodium chloride therapy. Hospitalization time was similar among patients with different blood natrium levels [average (16 ± 12) d]. Fifty out of 51 (98%) patients discharged from the hospital with improved heart failure symptoms and signs. Supplying additional sodium chloride could rapid correct hyponatremia in heart failure patients with or without intravenous diuretics therapy which might contribute to a favorable prognosis in hospitalized heart failure patients.

High prevalence of risk factors in elderly patients using drugs associated with acquired torsades de pointes chronically in Colombia.

PubMed

Moreno-Gutiérrez, Paula Andrea; Gaviria-Mendoza, Andrés; Cañón, Mauricio Montoya; Machado-Alba, Jorge Enrique

2016-08-01

Medication is one of the main causes of long QT syndrome (LQTS) and torsades de pointes (TdP), and the older adult population is at particularly high risk. The aim of the present study was to describe the prescription patterns of drugs with a risk of TdP in the Colombian older adult population. Patients older than 65 years who received medication with a risk of TdP during three consecutive months were selected. The medication was obtained and classified according to the QT Drug List from Crediblemeds.org. The data were analysed using SPSS-22. A total of 55 932 patients were chronically receiving QT-prolonging drugs; 61.9% (n = 34 ,632) were women and the mean age of the sample was 75.6 years. Drugs with a conditional risk were consumed by 95.2% of patients, 5.3% received drugs with a known risk and 2.9% received drugs with a possible risk. Two or more QT-prolonging drugs were consumed by 10.3% of the patients (n = 5786). Most of the sample (96.8%, n = 54 170) had at least one additional risk factor for LQTS, with a mean of 3.1 ± 0.9 risk factors. Patients receiving QT-prolonging drugs for psychiatric and neurological disease were at a higher risk of major polypharmacy [odds ratio (OR) 3.0; 95% confidence interval (CI) 2.80, 3.22) and of receiving high doses of QT-prolonging drugs (OR 3.8; 95% CI 3.52, 4.05). The widespread use of medication that causes TdP and the high prevalence of additional risks in the older adult population raise the need for accurate prediction of risk and constant patient monitoring. Patients taking psychiatric drugs are at a higher risk of TdP. © 2016 The British Pharmacological Society.

High prevalence of risk factors in elderly patients using drugs associated with acquired torsades de pointes chronically in Colombia

PubMed Central

Moreno‐Gutiérrez, Paula Andrea; Gaviria‐Mendoza, Andrés; Cañón, Mauricio Montoya

2016-01-01

Aims Medication is one of the main causes of long QT syndrome (LQTS) and torsades de pointes (TdP), and the older adult population is at particularly high risk. The aim of the present study was to describe the prescription patterns of drugs with a risk of TdP in the Colombian older adult population. Methods Patients older than 65 years who received medication with a risk of TdP during three consecutive months were selected. The medication was obtained and classified according to the QT Drug List from Crediblemeds.org. The data were analysed using SPSS‐22. Results A total of 55 932 patients were chronically receiving QT‐prolonging drugs; 61.9% (n = 34 ,632) were women and the mean age of the sample was 75.6 years. Drugs with a conditional risk were consumed by 95.2% of patients, 5.3% received drugs with a known risk and 2.9% received drugs with a possible risk. Two or more QT‐prolonging drugs were consumed by 10.3% of the patients (n = 5786). Most of the sample (96.8%, n = 54 170) had at least one additional risk factor for LQTS, with a mean of 3.1 ± 0.9 risk factors. Patients receiving QT‐prolonging drugs for psychiatric and neurological disease were at a higher risk of major polypharmacy [odds ratio (OR) 3.0; 95% confidence interval (CI) 2.80, 3.22) and of receiving high doses of QT‐prolonging drugs (OR 3.8; 95% CI 3.52, 4.05). Conclusions The widespread use of medication that causes TdP and the high prevalence of additional risks in the older adult population raise the need for accurate prediction of risk and constant patient monitoring. Patients taking psychiatric drugs are at a higher risk of TdP. PMID:27060989

Adjuvant chemotherapy with sequential cytokine-induced killer (CIK) cells in stage IB non-small cell lung cancer.

PubMed

Li, Da-Peng; Li, Wei; Feng, Jun; Chen, Kai; Tao, Min

2015-01-01

For non-small cell lung cancer (NSCLC) patients at stage IB, adjuvant chemotherapy does not improve survival. Evidence suggests that dendritic cell (DC)-activated cytokine-induced killer (DC-CIK) cell therapy in addition to chemotherapy improves survival for stage I-IIIA NSCLC patients after surgery, but there are not enough data to confirm this benefit specifically for those at stage IB. Herein, we retrospectively evaluated the efficacy and safety of this therapy administered to stage IB NSCLC patients. Sixty-six patients were treated with four-cycle adjuvant chemotherapy initiated 3 weeks after surgical resection. In addition, 28 of these patients underwent DC-CIK therapy on a trimonthly basis (average 3.1 times, range 1-6) beginning 1 month after chemotherapy. The disease-free survival (DFS) rates of the two groups were statistically similar, although patients who received DC-CIK therapy showed slightly higher 1- and 2-year DFS rates (100.0% and 96.4%, respectively, compared with 81.6% and 76.3%). More importantly, patients in the DC-CIK therapy group had significantly longer overall survival (p=0.018). For patients who received treatment after recurrence, the DC-CIK therapy group had longer progression-free survival compared with the chemotherapy-only group. In addition, patients given DC-CIK therapy experienced less fatigue and appetite loss. The rate of adverse side effects was similar between the two groups. In conclusion, for these stage IB NSCLC patients, DC-CIK therapy significantly improved 2-year DFS rates compared with those who received chemotherapy only. DC-CIK therapy also benefited patients' quality of life, and adverse events were acceptable.

Ventilatory strategies and supportive care in acute respiratory distress syndrome.

PubMed

Luks, Andrew M

2013-11-01

While antiviral therapy is an important component of care in patients with the acute respiratory distress syndrome (ARDS) following influenza infection, it is not sufficient to ensure good outcomes, and additional measures are usually necessary. Patients usually receive high levels of supplemental oxygen to counteract the hypoxemia resulting from severe gas exchange abnormalities. Many patients also receive invasive mechanical ventilation for support for oxygenation, while in resource-poor settings, supplemental oxygen via face mask may be the only available intervention. Patients with ARDS receiving mechanical ventilation should receive lung-protective ventilation, whereby tidal volume is decreased to 6 ml/kg of their predicted weight and distending pressures are maintained ≤ 30 cm H2 O, as well as increased inspired oxygen concentrations and positive end-expiratory pressure (PEEP) to prevent atelectasis and support oxygenation. While these measures are sufficient in most patients, a minority develop refractory hypoxemia and may receive additional therapies, including prone positioning, inhaled vasodilators, extracorporeal membrane oxygenation, recruitment maneuvers followed by high PEEP, and neuromuscular blockade, although recent data suggest that this last option may be warranted earlier in the clinical course before development of refractory hypoxemia. Application of these "rescue strategies" is complicated by the lack of guidance in the literature regarding implementation. While much attention is devoted to these strategies, clinicians must not lose sight of simple interventions that affect patient outcomes including head of bed elevation, prophylaxis against venous thromboembolism and gastrointestinal bleeding, judicious use of fluids in the post-resuscitative phase, and a protocol-based approach to sedation and spontaneous breathing trials. © 2013 Blackwell Publishing Ltd.

Improving colon cancer screening in community clinics.

PubMed

Davis, Terry; Arnold, Connie; Rademaker, Alfred; Bennett, Charles; Bailey, Stacy; Platt, Daci; Reynolds, Cristalyn; Liu, Dachao; Carias, Edson; Bass, Pat; Wolf, Michael

2013-11-01

The authors evaluated the effectiveness and cost effectiveness of 2 interventions designed to promote colorectal cancer (CRC) screening in safety-net settings. A 3-arm, quasi-experimental evaluation was conducted among 8 clinics in Louisiana. Screening efforts included: 1) enhanced usual care, 2) literacy-informed education of patients, and 3) education plus nurse support. Overall, 961 average-risk patients ages 50 to 85 years were eligible for routine CRC screening and were recruited. Outcomes included CRC screening completion and incremental cost effectiveness using literacy-informed education of patients and education plus nurse support versus enhanced usual care. The baseline screening rate was <3%. After the interventions, the screening rate was 38.6% with enhanced usual care, 57.1% with education, and 60.6% with education that included additional nurse support. After adjusting for age, race, sex, and literacy, patients who received education alone were not more likely to complete screening than those who received enhanced usual care; and those who received additional nurse support were 1.60-fold more likely to complete screening than those who received enhanced usual care (95% confidence interval, 1.06-2.42; P = .024). The incremental cost per additional individual screened was $1337 for education plus nurse support over enhanced usual care. Fecal occult blood test rates were increased beyond enhanced usual care by providing brief education and nurse support but not by providing education alone. More cost-effective alternatives to nurse support need to be investigated. © 2013 American Cancer Society.

Infliximab after Boston Keratoprosthesis in Stevens-Johnson Syndrome: An Update.

PubMed

Robert, Marie-Claude; Črnej, Alja; Shen, Lucy Q; Papaliodis, George N; Dana, Reza; Foster, C Stephen; Chodosh, James; Dohlman, Claes H

2017-06-01

To report our experience using intravenous infliximab for the treatment of tissue melt after Boston keratoprosthesis (B-KPro) types I and II in patients with autoimmune disease. Case series. We identified four patients who were treated with intravenous infliximab in the context of tissue melt after B-KPro. Stevens-Johnson syndrome-associated corneal blindness was the primary surgical indication for B-KPro implantation in all patients. Two patients received a B-KPro type I and two patients received a B-KPro type II. The patients received intravenous infliximab for skin retraction around B-KPro type II, melting of the carrier graft or leak. Treatment resulted in a dramatic decrease in inflammation and, in some cases, arrest of the melting process. Cost and patient adherence were limiting factors to pursuing infliximab therapy. In addition, one patient developed infusion reactions. Intravenous infliximab may be considered as globe- and sight-saving therapy for tissue melt after B-KPro.

The incidence and risk factors of febrile neutropenia in chemotherapy-naïve lung cancer patients receiving etoposide plus platinum.

PubMed

Fujiwara, Takumi; Kenmotsu, Hirotsugu; Naito, Tateaki; Kawamura, Takahisa; Mamesaya, Nobuaki; Kotake, Mie; Kobayashi, Haruki; Omori, Shota; Nakashima, Kazuhisa; Wakuda, Kazushige; Ono, Akira; Taira, Tetsuhiko; Murakami, Haruyasu; Omae, Katsuhiro; Mori, Keita; Endo, Masahiro; Takahashi, Toshiaki

2017-06-01

This study was to determine the incidence and risk factors of febrile neutropenia in chemotherapy-naïve Japanese patients treated systemically with etoposide plus platinum for lung cancer. The study was a retrospective analysis of 244 patients who were monitored for febrile neutropenia through multiple cycles of the combination of etoposide with platinum, and the associations between incidence of febrile neutropenia and patient characteristics were evaluated. Eighty-eight patients were treated with etoposide plus cisplatin and 156 were treated with etoposide plus carboplatin. Of the 244 patients treated, 198 (81.1%) completed 4 cycles for chemotherapy. Febrile neutropenia was observed in 48 of 244 patients (19.7%), including 18 of 88 (20.5%) patients who received etoposide plus cisplatin and 30 of 156 (19.2%) patients who received etoposide plus carboplatin. Grade 3 or 4 of neutropenia was experienced by a total of 208 patients (85.2%); 79 of 88 (89.8%) receiving etoposide plus cisplatin and 129 of 156 (82.7%) receiving etoposide plus carboplatin. Male gender and previous radiotherapy were identified by multivariate analysis as independent risk factors for febrile neutropenia. These results contrast with findings in Western patients and suggest that ethnic differences exist in the incidence of febrile neutropenia in patients receiving etoposide plus platinum chemotherapy. In addition, our results suggest that primary prophylaxis with granulocyte colony-stimulating factor should be considered for patients with these risk factors for febrile neutropenia prior to treatment with etoposide plus platinum.

Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness.

PubMed

Marques, Elsa M R; Jones, Hayley E; Elvers, Karen T; Pyke, Mark; Blom, Ashley W; Beswick, Andrew D

2014-07-05

Surgical pain is managed with multi-modal anaesthesia in total hip replacement (THR) and total knee replacement (TKR). It is unclear whether including local anaesthetic infiltration before wound closure provides additional pain control. We performed a systematic review of randomised controlled trials of local anaesthetic infiltration in patients receiving THR or TKR. We searched MEDLINE, Embase and Cochrane CENTRAL to December 2012. Two reviewers screened abstracts, extracted data, and contacted authors for unpublished outcomes and data. Outcomes collected were post-operative pain at rest and during activity after 24 and 48 hours, opioid requirement, mobilisation, hospital stay and complications. When feasible, we estimated pooled treatment effects using random effects meta-analyses. In 13 studies including 909 patients undergoing THR, patients receiving local anaesthetic infiltration experienced a greater reduction in pain at 24 hours at rest by standardised mean difference (SMD) -0.61 (95% CI -1.05, -0.16; p = 0.008) and by SMD -0.43 (95% CI -0.78 -0.09; p = 0.014) at 48 hours during activity.In TKR, diverse multi-modal regimens were reported. In 23 studies including 1439 patients undergoing TKR, local anaesthetic infiltration reduced pain on average by SMD -0.40 (95% CI -0.58, -0.22; p < 0.001) at 24 hours at rest and by SMD -0.27 (95% CI -0.50, -0.05; p = 0.018) at 48 hours during activity, compared with patients receiving no infiltration or placebo. There was evidence of a larger reduction in studies delivering additional local anaesthetic after wound closure. There was no evidence of pain control additional to that provided by femoral nerve block.Patients receiving local anaesthetic infiltration spent on average an estimated 0.83 (95% CI 1.54, 0.12; p = 0.022) and 0.87 (95% CI 1.62, 0.11; p = 0.025) fewer days in hospital after THR and TKR respectively, had reduced opioid consumption, earlier mobilisation, and lower incidence of vomiting.Few studies reported long-term outcomes. Local anaesthetic infiltration is effective in reducing short-term pain and hospital stay in patients receiving THR and TKR. Studies should assess whether local anaesthetic infiltration can prevent long-term pain. Enhanced pain control with additional analgesia through a catheter should be weighed against a possible infection risk.

Correction of anemia in a transfusion-dependent patient with primary myelofibrosis receiving iron chelation therapy with deferasirox (Exjade®, ICL670)

PubMed Central

Di Tucci, Anna Angela; Murru, Roberta; Alberti, Daniele; Rabault, Bertrand; Deplano, Simona; Angelucci, Emanuele

2007-01-01

Transfusional iron overload in patients with chronic anemias can result in multiple organ failure. Experience in the management of iron overload in patients with myelodysplastic syndromes is limited, as many do not receive chelation therapy due to short-life expectancy and the difficulties associated with the administration of the current reference standard chelator, deferoxamine. There have, however, been some reports of reduced transfusion requirement associated with chelation therapy in patients with myelodysplastic syndromes and myelofibrosis. Here, we discuss a patient with primary myelofibrosis and related transfusion-dependent anemia who received chelation therapy with the once-daily oral iron chelator, deferasirox. In addition to the reduced iron levels, the patient demonstrated an unexpected reduction in blood transfusion requirement, ultimately resulting in long-lasting transfusion-free survival. PMID:17391307

Disseminating Comparative Effectiveness Research Through Community-based Experiential Learning.

PubMed

Hansen, Richard A; Williamson, Margaret; Stevenson, Lynn; Davis, Brandy R; Evans, R Lee

2017-02-25

Objectives. To launch and evaluate a comparative effectiveness research education and dissemination program as part of an introductory pharmacy practice experience (IPPE). Methods. First- through third-year PharmD students received training on comparative effectiveness research and disseminated printed educational materials to patients in the community who they were monitoring longitudinally (n=314). Students completed an assessment and initial visit documentation form at the first visit, and a follow-up assessment and documentation form at a subsequent visit. Results. Twenty-three diabetes patients, 29 acid-reflux patients, 30 osteoarthritis patients, and 50 hypertension patients received materials. Aside from the patient asking questions, which was the most common outcome (n=44), the program resulted in 38 additional actions, which included stopping, starting, or changing treatments or health behaviors, or having additional follow-up or diagnostic testing. Small but positive improvements in patient understanding, confidence, and self-efficacy were observed. Conclusions. Dissemination of comparative effectiveness research materials in an IPPE program demonstrated a positive trend in markers of informed decision-making.

Impact of depression on the intensity of patient navigation for women with abnormal cancer screenings.

PubMed

De La Cruz, Ignacio I; Freund, Karen M; Battaglia, Tracy A; Chen, Clara A; Bak, Sharon; Kalish, Richard; Lottero, Barbara; Egan, Patrick; Heeren, Tim; Kronman, Andrea C

2014-02-01

Patient navigation is increasingly being used to support vulnerable patients to receive timely and quality medical care. We sought to understand whether patients with depression utilize additional patient navigation services after abnormal cancer screening. We compared depressed and non-depressed women using three different measures of intensity of patient navigation: number of patient-navigator encounters, encounter time, and number of unique barriers to care. The study population consisted of 1,455 women who received navigation after abnormal screening for breast or cervical cancer at one of six community health centers in Boston. Navigators spent a median of 60-75 minutes over one or two encounters per participant, with 49% of participants having one or more documented barrier to care. Depressed women did not differ in total numbers of encounters, encounter time, or unique barriers compared with non-depressed women. Our findings suggest that pre-existing depression does not predict which women will utilize additional navigation services.

Complementary medicine use among cancer patients receiving radiotherapy and chemotherapy: methods, sources of information and the need for counselling.

PubMed

Pihlak, R; Liivand, R; Trelin, O; Neissar, H; Peterson, I; Kivistik, S; Lilo, K; Jaal, J

2014-03-01

Complementary medicine (CM) use is common among cancer patients. However, little is known about CM products that are utilised during radiotherapy and/or chemotherapy. Out of 62 cancer patients who completed a specialised survey, 35 (56%) consumed some type of CM during active anti-cancer therapy. Cancer patients reported the use of herbal teas (52%), vitamins and other dietary supplements (45%), vegetables and juices (39%), special diets (19%), herbal medicines, including Chinese medicines (19%) and 'immunomodulators' (3%). Most of patients (86%) consumed CM products every day. However, nearly 47% of CM users did not admit this to their oncologists. Majority of CM users (85%) were convinced that supplementary products increase the efficacy of standard anti-cancer therapy and prolong their survival. Information about CM was mainly obtained through internet sources (36%), books and brochures (25%). Although most CM users (82%) trusted the received information, 73% of them admitted that additional information about CM methods would be necessary. Patients would like to receive additional information through a specialised consultation (60%), but also from brochures (44%) and the internet (20%). Adequate counselling of patients is of paramount importance since some CM methods may cause significant side effects and decrease the efficacy of radiotherapy and/or chemotherapy. © 2013 John Wiley & Sons Ltd.

Treatment Outcomes and Prognostic Factors in Mexican Patients with Endometrial Carcinoma with Emphasis on Patients Receiving Radiotherapy after Surgery: An Institutional Perspective

PubMed Central

Flores, Christian; Mariscal, Carlos; Celis, Alfredo; Balcázar, Nidia M.; Meneses, Abelardo; Mohar, Alejandro; Mota, Aida; Trejo, Elizabeth

2012-01-01

Aim. To analyze the clinical characteristics and treatment outcomes in patients with endometrial carcinoma treated in a Latin American institute with emphasis in patients receiving adjuvant radiotherapy. Methods. A total of 412 patients with endometrial carcinoma admitted to our hospital between 1998 and 2008 were evaluated, retrospectively. The mean age was 55 years (28–87). Two hundred seventy patients received RT following surgery. Stage distribution was as follows: 221 patients (54%) stage I, 86 patients (21%) stage II, and 103 patients (24.5%) stage III and 2 patients (0.5%) stage IVA. Results. Overall survival rate was 95% at 2 years, 84% at 5 years, and 79% at 10 years. By the end of followup, 338 patients (82%) were disease-free, and 13 (3%) were alive with disease. Univariate and multivariate analyses identified age, grade, serosal and adnexial involvement as significant predictors for overall survival. Conclusion. The results of our study suggests that early-stage, low-grade endometrial cancer with no risk factors should not receive external beam radiotherapy, intermediate risk patients should receive only vaginal vault brachytherapy, and the use of chemotherapy with radiotherapy for patients high-risk and advanced-stage carcinoma the addition of radiotherapy is associated with a better survival being an effective therapeutic option. PMID:22675641

Mirror therapy enhances upper extremity motor recovery in stroke patients.

PubMed

Mirela Cristina, Luca; Matei, Daniela; Ignat, Bogdan; Popescu, Cristian Dinu

2015-12-01

The purpose of this study was to evaluate the effects of mirror therapy program in addition with physical therapy methods on upper limb recovery in patients with subacute ischemic stroke. 15 subjects followed a comprehensive rehabilitative treatment, 8 subjects received only control therapy (CT) and 7 subjects received mirror therapy (MT) for 30 min every day, five times a week, for 6 weeks in addition to the conventional therapy. Brunnstrom stages, Fugl-Meyer Assessment (upper extremity), the Ashworth Scale, and Bhakta Test (finger flexion scale) were used to assess changes in upper limb motor recovery and motor function after intervention. After 6 weeks of treatment, patients in both groups showed significant improvements in the variables measured. Patients who received MT showed greater improvements compared to the CT group. The MT treatment results included: improvement of motor functions, manual skills and activities of daily living. The best results were obtained when the treatment was started soon after the stroke. MT is an easy and low-cost method to improve motor recovery of the upper limb.

Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson's Disease Fluctuating Patients: Post hoc Analyses of Studies 016 and SETTLE.

PubMed

Cattaneo, Carlo; Sardina, Marco; Bonizzoni, Ermino

2016-01-01

Studies 016 and SETTLE showed that safinamide was safe and effective as adjunct therapy in patients with advanced Parkinson's disease (PD) and motor fluctuations. The addition of safinamide to a stable dose of levodopa alone or with other antiparkinsonian medications significantly increased ON time with no/non-troublesome dyskinesia, decreased OFF time and improved Parkinson's symptoms. To evaluate the clinical effects of safinamide 100 mg/day on motor fluctuations and cardinal Parkinson's symptoms in specific patient subgroups using pooled data from Studies 016 and SETTLE. Both studies were double blind, placebo-controlled, randomized, phase 3 trials which enrolled patients with mid- to late-stage PD experiencing motor fluctuations while receiving optimized and stable doses of levodopa, alone or with other dopaminergic treatments. The present post-hoc analyses assessed the change from baseline in ON time (with no or non-troublesome dyskinesia) and OFF time in subgroups of patients who were receiving only levodopa at baseline, who were classified as "mild fluctuators" (daily OFF time ≤4 h), and who were receiving concomitant dopaminergic therapy, with or without amantadine, and the effects of safinamide versus placebo on individual cardinal PD symptoms during ON time. Safinamide significantly increased mean ON time (with no or non-troublesome dyskinesia) and reduced mean OFF time when used as first adjunct therapy in levodopa-treated patients and patients with mild motor fluctuations. Mean daily ON time (with no or non-troublesome dyskinesia) and OFF time were favorably changed, compared with placebo, to similar extents regardless of whether patients were receiving concomitant dopamine agonists, catechol-O-methyltransferase inhibitors and amantadine. Additionally, safinamide improved bradykinesia, rigidity, tremor and gait. Safinamide was a safe and effective first adjunct therapy in levodopa-treated patients and improved 4/5 cardinal symptoms of PD while providing benefits to mild and non-mild fluctuators and patients receiving other concomitant dopaminergic therapies.

Efficacy of tropisetron in patients with advanced non-small-cell lung cancer receiving adjuvant chemotherapy with carboplatin and taxanes.

PubMed

Tsavaris, N; Kosmas, C; Kopterides, P; Vadiaka, M; Kosmas, N; Skopelitis, H; Karadima, D; Kolliokosta, G; Tzima, E; Loukeris, D; Pagouni, E; Batziou, E; Xyla, V; Koufos, C

2008-03-01

Even though significant progress has been made, chemotherapy-induced emesis remains a challenging problem. Few studies focus on emesis in patients treated with carboplatin and the observation period is limited to the initial 24 h following chemotherapy. Thus, we investigated if tropisetron (T) monotherapy can adequately prevent acute and delayed emesis in non-small-cell lung cancer (NSCLC) patients receiving a moderately emetogenic chemotherapy (MEC) (carboplatin-containing) regimen. Furthermore, we explored the merits of adding dexamethasone (D) or alprazolam (A) to T, especially in the setting of a pre-existing high level of stress. We studied 60 patients with advanced NSCLC receiving carboplatin and taxanes in three consecutive cycles. During the first cycle, patients received 5 mg of T intravenously before chemotherapy and the same dose per os on each of the following 3 days. In the second cycle, T was co-administered with 8 mg of D once a day, while, during the third cycle, T was combined with per os A 0.25 mg every 12 h and continued over the following 3 days. Finally, we evaluated the impact of stress on the anti-emetic response achieved with the previously described regimens. The combination of T + A was superior to T monotherapy and the combination of T + D, regarding the prevention of acute and delayed emesis. Both T + A and T + D combinations led to appetite improvement, while patients receiving T + A experienced sedation more frequently. Interestingly, subgroup analysis revealed that patients without underlying stress obtained no further benefit by the addition of A or D, while both T + A and T + D combinations led to a better anti-emetic response in patients with stress. In conclusion, T monotherapy provides a satisfactory result in controlling nausea and emesis caused by a MEC regimen in patients without stress. However, the addition of D and, mainly, A improves its anti-emetic effect in patients with obvious stress.

Parecoxib Possesses Anxiolytic Properties in Patients Undergoing Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Clinical Study.

PubMed

Sarridou, Despoina G; Chalmouki, Georgia; Braoudaki, Maria; Siafaka, Ioanna; Asmatzi, Chrisi; Vadalouka, Athina

2016-06-01

Intravenous administration of parecoxib could provide significant pain relief in surgical operations that require additional forms of analgesia. However, very little is known about its effects on the anxiety levels of patients before a surgical procedure. The aim of this prospective study was to investigate whether intravenous parecoxib, pre-emptively administered, has an effect on anxiety levels experienced post-surgically after total knee arthroplasty (TKA) and if it influences the reported pain of the procedure itself. A total of 90 patients who underwent TKA under spinal anesthesia were included in the study. Prior to TKA, all patients received continuous femoral nerve block (CFNB) and were randomized into two groups: Group D consisted of 45 patients who received the drug parecoxib intravenously in addition to CFNB, whereas Group P consisted of 45 patients who received a placebo drug (N/S 0.9 %) intravenously instead of parecoxib. All patients were asked to fill in the questionnaires STAI1 and STAI2 in order to evaluate anxiety levels pre- and post-surgically, respectively. One of the main aims was to distinguish personality-trait anxiety from state anxiety, i.e., anxiety experience due to the actual perioperative events and the actual pain endured. The group receiving parecoxib had statistically significant lower anxiety levels both for personality trait anxiety and state anxiety, as compared to the placebo group. Based on our findings, parecoxib had both analgesic and anxiolytic effects in patients undergoing TKA with CFNB. Current Controlled Trials: NCT02185924.

Deep Sternal Wound Infection after Open-Heart Surgery: A 13-Year Single Institution Analysis.

PubMed

Juhl, Alexander Andersen; Hody, Sofie; Videbaek, Tina Senholt; Damsgaard, Tine Engberg; Nielsen, Per Hostrup

2017-04-20

The present study aimed to compare the clinical outcome for patients with or without muscle flap reconstruction after deep sternal wound infection due to open-heart surgery. The study was a retrospective cohort study, including patients who developed deep sternal wound infection after open-heart surgery in the Western Denmark Region from 1999 to 2011. Journals of included patients were reviewed for clinical data regarding the treatment of their sternal defect. Patients were divided into two groups depending on whether they received a muscle-flap-based sternal reconstruction or traditional rewiring of the sternum. A total of 130 patients developed deep sternal wound infection in the study period. In all, 12 patients died before being discharged, leaving a total of 118 patients for analysis. Of these, 50 (42%) patients received muscle flap reconstruction. Muscle flap recipients had significantly longer total hospital stays (p <0.001). However, after receiving muscle flap reconstruction, patients were discharged after a median of 14 days, with 74% not needing additional surgery. It is difficult to predict which patients eventually require muscle flap reconstruction after deep sternal wound infection. Although patients receiving muscle flap reconstructions have longer hospital stays, they are quickly discharged after the reconstruction.

Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: Protocol for a three-armed randomized clinical trial

PubMed Central

2011-01-01

Background Hip osteoarthritis is a common and chronic condition resulting in pain, functional disability and reduced quality of life. In the early stages of the disease, a combination of non-pharmacological and pharmacological treatment is recommended. There is evidence from several trials that exercise therapy is effective. In addition, single trials suggest that patient education in the form of a hip school is a promising intervention and that manual therapy is superior to exercise. Methods/Design This is a randomized clinical trial. Patients with clinical and radiological hip osteoarthritis, 40-80 years of age, and without indication for hip surgery were randomized into 3 groups. The active intervention groups A and B received six weeks of hip school, taught by a physiotherapist, for a total of 5 sessions. In addition, group B received manual therapy consisting of joint manipulation and soft-tissue therapy twice a week for six weeks. Group C received a self-care information leaflet containing advice on "live as usual" and stretching exercises from the hip school. The primary time point for assessing relative effectiveness is at the end of the six weeks intervention period with follow-ups after three and 12 months. Primary outcome measure is pain measured on an eleven-point numeric rating scale. Secondary outcome measures are the hip dysfunction and osteoarthritis outcome score, patient's global perceived effect, patient specific functional scale, general quality of life and hip range of motion. Discussion To our knowledge this is the first randomized clinical trial comparing a patient education program with or without the addition of manual therapy to a minimal intervention for patients with hip osteoarthritis. Trial registration ClinicalTrials NCT01039337 PMID:21542914

Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: protocol for a three-armed randomized clinical trial.

PubMed

Poulsen, Erik; Christensen, Henrik W; Roos, Ewa M; Vach, Werner; Overgaard, Søren; Hartvigsen, Jan

2011-05-04

Hip osteoarthritis is a common and chronic condition resulting in pain, functional disability and reduced quality of life. In the early stages of the disease, a combination of non-pharmacological and pharmacological treatment is recommended. There is evidence from several trials that exercise therapy is effective. In addition, single trials suggest that patient education in the form of a hip school is a promising intervention and that manual therapy is superior to exercise. This is a randomized clinical trial. Patients with clinical and radiological hip osteoarthritis, 40-80 years of age, and without indication for hip surgery were randomized into 3 groups. The active intervention groups A and B received six weeks of hip school, taught by a physiotherapist, for a total of 5 sessions. In addition, group B received manual therapy consisting of joint manipulation and soft-tissue therapy twice a week for six weeks. Group C received a self-care information leaflet containing advice on "live as usual" and stretching exercises from the hip school. The primary time point for assessing relative effectiveness is at the end of the six weeks intervention period with follow-ups after three and 12 months.Primary outcome measure is pain measured on an eleven-point numeric rating scale. Secondary outcome measures are the hip dysfunction and osteoarthritis outcome score, patient's global perceived effect, patient specific functional scale, general quality of life and hip range of motion. To our knowledge this is the first randomized clinical trial comparing a patient education program with or without the addition of manual therapy to a minimal intervention for patients with hip osteoarthritis. ClinicalTrials NCT01039337.

Impact on survival of warfarin in patients with pulmonary arterial hypertension receiving subcutaneous treprostinil.

PubMed

Ascha, Mona; Zhou, Xuan; Rao, Youlan; Minai, Omar A; Tonelli, Adriano R

2017-10-01

Anticoagulation is a common treatment modality in patients with pulmonary arterial hypertension (PAH). Further studies are needed to appropriately assess the risk/benefit ratio of anticoagulation, particularly in PAH patients receiving PAH-specific therapies. We use observational long-term data on PAH patients treated with subcutaneous (SQ) treprostinil from a large open-label study. Patients were followed for up to 4 years. The use of warfarin and bleeding events were recorded. At total of 860 patients (age [mean±SD] 46±15 years, 76% female, 83% Caucasian, 49% idiopathic PAH, and 76% New York Heart Association [NYHA] functional class III) were included. All patients received SQ treprostinil (15% also other pulmonary hypertension [PH]-therapies) and 590 (69%) received warfarin during the study. The proportions of women, African American, and idiopathic pulmonary hypertension (IPAH) patients were higher in the group receiving warfarin. A higher proportion of patients with congenital heart disease and portopulmonary hypertension did not receive warfarin. There were no differences in unadjusted long-term survival between PAH patients receiving warfarin or not (log-rank test, P value=.69), even when only considering idiopathic PAH (P=.32). In addition, no difference was found in adjusted long-term survival both in PAH (P=.84) and idiopathic PAH patients (P=.44) based on the use of warfarin. Furthermore, no survival difference based on the use of warfarin were noted between propensity score-matched PAH patients (P=.37). Long-term anticoagulation with warfarin was not associated with any significant effect on survival in PAH or idiopathic PAH patients treated with SQ treprostinil. © 2017 John Wiley & Sons Ltd.

Effects of protein-rich supplementation and nandrolone on bone tissue after a hip fracture.

PubMed

Tengstrand, Birgitta; Cederholm, Tommy; Söderqvist, Anita; Tidermark, Jan

2007-08-01

Osteoporosis is a major health problem worldwide. Low weight is a major risk factor for low bone mass and fractures. The aim of this study was to investigate the effects on bone tissue of protein-rich supplementation alone or in combination with nandrolone decanoate in lean elderly women after a hip fracture. Sixty elderly women with BMI <24 kg/m(2) admitted to hospital due to a femoral neck fracture were randomised to a control group, to receive a protein-rich formula or to receive the same formula with an addition of nandrolone decanoate for 6 months. All patients received additional calcium and vitamin D. The effects after 6 and 12 months were measured by means of bone mineral density (BMD) using dual-energy X-ray absorptiometry (DXA), and with biochemical bone markers. Osteocalcin and C-terminal telopeptide of collagen-1 (CTX) were used to estimate bone formation and bone resorption, respectively. The analyses showed an increase in total body BMD at 6 and 12 months in patients who received protein-rich supplementation. Nandrolone decanoate did not appear to have any additional effect on BMD. Osteocalcin increased in all groups while no significant changes were found for CTX. The overall results of the study indicated that protein-rich supplementation given to lean elderly female hip fracture patients increased the total body BMD.

Brachytherapy Improves Survival in Stage III Endometrial Cancer With Cervical Involvement

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bingham, Brian; Orton, Andrew; Boothe, Dustin

Purpose: To evaluate the survival benefit of adding vaginal brachytherapy (BT) to pelvic external beam radiation therapy (EBRT) in women with stage III endometrial cancer. Methods and Materials: The National Cancer Data Base was used to identify patients with stage III endometrial cancer from 2004 to 2013. Only women who received adjuvant EBRT were analyzed. Women were grouped according to receipt of BT. Logistic regression modeling was used to identify predictors of receiving BT. Log–rank statistics were used to compare survival outcomes. Cox proportional hazards modeling was used to evaluate the effect of BT on survival. A propensity score–matched analysismore » was also conducted among women with cervical involvement. Results: We evaluated 12,988 patients with stage III endometrial carcinoma, 39% of whom received EBRT plus BT. Women who received BT were more likely to have endocervical or cervical stromal involvement (odds ratios 2.03 and 1.77; P<.01, respectively). For patients receiving EBRT alone, the 5-year survival was 66% versus 69% with the addition of BT at 5 years (P<.01). Brachytherapy remained significantly predictive of decreased risk of death (hazard ratio 0.86; P<.01) on multivariate Cox regression. The addition of BT to EBRT did not affect survival among women without cervical involvement (P=.84). For women with endocervical or cervical stromal invasion, the addition of BT significantly improved survival (log–rank P<.01). Receipt of EBRT plus BT was associated with improved survival in women with positive and negative surgical margins, and receiving chemotherapy did not alter the benefit of BT. Propensity score–matched analysis results confirmed the benefit of BT among women with cervical involvement (hazard ratio 0.80; P=.01). Conclusions: In this population of women with stage III endometrial cancer the addition of BT to EBRT was associated with an improvement in survival for women with endocervical or cervical stromal invasion.« less

High prevalence of iatrogenic hyperthyroidism in elderly patients with atrial fibrillation in an anticoagulation clinic.

PubMed

Krishnan, Sandeep Kumar; Dohrmann, Mary L; Brietzke, Stephen A; Fleming, David A; Flaker, Greg C

2011-01-01

In elderly patients with established atrial fibrillation (AF) who are receiving thyroid replacement, regular testing for thyroid function is often not performed, placing the patient at risk for iatrogenic hyperthyroidism. Of 215 patients followed in an anticoagulation clinic, 41 were receiving thyroid replacement and 15 of these were found to have hyperthyroidism. Eight had documented AF coincident with abnormal thyroid function. In addition, only 22 patients on thyroid replacement had an annual TSH. In conclusion, iatrogenic hyperthyroidism may frequently be missed in AF patients because of inadequate monitoring of serum TSH. Thyroid replacement is common in elderly patients with AF followed in an anticoagulation clinic. Laboratory evidence of hyperthyroidism occurred in 37%, usually in patients with higher doses of thyroid replacement, and often associated with AF. The frequency of iatrogenic hyperthyroidism may be underestimated in patients with AF since many patients who receive thyroid replacement therapy are not monitored regularly with serum TSH.

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes.

PubMed

Taylor, Nicholas F; Brusco, Natasha K; Watts, Jennifer J; Shields, Nora; Peiris, Casey; Sullivan, Natalie; Kennedy, Genevieve; Teo, Cheng Kwong; Farley, Allison; Lockwood, Kylee; Radia-George, Camilla

2010-11-12

Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial. This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services. Australian and New Zealand Clinical Trials Registry ACTRN12609000973213.

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes

PubMed Central

2010-01-01

Background Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. Methods/Design A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial. Discussion This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services. Clinical trial registration number Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 PMID:21073703

Diabetes quality improvement in Department of Veterans Affairs Ambulatory Care Clinics: a group-randomized clinical trial.

PubMed

Reiber, Gayle E; Au, David; McDonell, Mary; Fihn, Stephan D

2004-05-01

To conduct a group-randomized clinical trial to determine whether regular feedback to primary care providers of synthesized information on patients' health, function, and satisfaction would demonstrate improved outcomes for their patients with diabetes. Patients in General Internal Medicine Clinics Department of Veterans Affairs (VA) Medical Centers were randomized into seven intervention or control firms. Patient self-reported information was collected by mail on general health, diabetes, and up to five other chronic conditions. Patients with diabetes received the Seattle Diabetes Questionnaire, the 36-item Medical Outcomes Study short form (SF-36), and a validated patient satisfaction questionnaire at regular intervals. Data from self-report, clinical, pharmacy, and laboratory sources were synthesized into patient-specific feedback reports that intervention providers received before patients' visits. The timely delivery to primary care providers of state-of-the-art patient-feedback reports that identified patient issues and areas for improvement did not result in significant improvements in patient outcomes between the intervention and control firms. Outcomes in diabetic patients whose providers received synthesized patient data before visits were no better than in those receiving care from control firms. Future studies may benefit from substantial involvement in patients discussing, problem solving, and goal setting in addition to use of timely synthesized patient data.

Patients With Brain Tumors: Who Receives Postacute Occupational Therapy Services?

PubMed

Chan, Vincy; Xiong, Chen; Colantonio, Angela

2015-01-01

Data on the utilization of occupational therapy among patients with brain tumors have been limited to those with malignant tumors and small samples of patients outside North America in specialized palliative care settings. We built on this research by examining the characteristics of patients with brain tumors who received postacute occupational therapy services in Ontario, Canada, using health care administrative data. Between fiscal years 2004-2005 and 2008-2009, 3,199 patients with brain tumors received occupational therapy services in the home care setting after hospital discharge; 12.4% had benign brain tumors, 78.2% had malignant brain tumors, and 9.4% had unspecified brain tumors. However, patients with benign brain tumors were older (mean age=63.3 yr), and a higher percentage were female (65.2%). More than 90% of patients received in-home occupational therapy services. Additional research is needed to examine the significance of these differences and to identify factors that influence access to occupational therapy services in the home care setting. Copyright © 2015 by the American Occupational Therapy Association, Inc.

Secretion clearance strategies in Australian and New Zealand Intensive Care Units.

PubMed

Ntoumenopoulos, George; Hammond, Naomi; Watts, Nicola R; Thompson, Kelly; Hanlon, Gabrielle; Paratz, Jennifer D; Thomas, Peter

2017-06-26

To describe the processes of care for secretion clearance in adult, intubated and mechanically ventilated patients in Australian and New Zealand Intensive Care Units (ICUs). A prospective, cross-sectional study was conducted through the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) Point Prevalence Program. Forty-seven ICUs collected data from 230 patients intubated and ventilated on the study day. Secretion clearance techniques beyond standard suctioning were used in 84/230 (37%) of patients during the study period. Chest wall vibration 34/84 (40%), manual lung hyperinflation 24/84 (29%), chest wall percussion 20/84 (24%), postural drainage/patient positioning 17/84 (20%) and other techniques including mobilisation 15/84 (18%), were the most common secretion clearance techniques employed. On average (SD), patients received airway suctioning 8.8 (5.0) times during the 24-h study period. Mucus plugging events were infrequent (2.7%). The additional secretion clearance techniques were provided by physiotherapy staff in 24/47 (51%) ICUs and by both nursing and physiotherapy staff in the remaining 23/47 (49%) ICUs. One-third of intubated and ventilated patients received additional secretion clearance techniques. Mucus plugging events were infrequent with these additional secretion clearance approaches. Prospective studies must examine additional secretion clearance practices, prevalence of mucus plugging episodes and impact on patient outcomes. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Nutrition therapy cost analysis in the US: pre-mixed multi-chamber bag vs compounded parenteral nutrition.

PubMed

Turpin, Robin S; Canada, Todd; Liu, Frank Xiaoqing; Mercaldi, Catherine J; Pontes-Arruda, Alessandro; Wischmeyer, Paul

2011-09-01

Bloodstream infections (BSI) occur in up to 350 000 inpatient admissions each year in the US, with BSI rates among patients receiving parenteral nutrition (PN) varying from 1.3% to 39%. BSI-attributable costs were estimated to approximate $US12 000 per episode in 2000. While previous studies have compared the cost of different PN preparation methods, this analysis evaluates both the direct costs of PN and the treatment costs for BSI associated with different PN delivery methods to determine whether compounded or manufactured pre-mixed PN has lower overall costs. The purpose of this study was to compare costs in the US associated with compounded PN versus pre-mixed multi-chamber bag (MCB) PN based on underlying infection risk. Using claims information from the Premier Perspective™ database, multivariate logistic regression was used to estimate the risk of infection. A total of 44 358 hospitalized patients aged ≥18 years who received PN between 1 January 2005 and 31 December 2007 were included in the analyses. A total of 3256 patients received MCB PN and 41 102 received compounded PN. The PN-associated costs and length of stay were analysed using multivariate ordinary least squares regression models constructed to measure the impact of infectious events on total hospital costs after controlling for baseline and clinical patient characteristics. There were 7.3 additional hospital days attributable to BSI. After adjustment for baseline variables, the probability of developing a BSI was 30% higher in patients receiving compounded PN than in those receiving MCB PN (16.1% vs 11.3%; odds ratio = 1.56; 95% CI 1.37, 1.79; p < 0.0001), demonstrating 2172 potentially avoidable infections. The observed daily mean PN acquisition cost for patients receiving MCB PN was $US164 (including all additives and fees) compared with $US239 for patients receiving compounded PN (all differences p < 0.001). With a mean cost attributable to BSI of $US16 141, the total per-patient savings (including avoided BSI and PN costs) was $US1545. In this analysis of real-world PN use, MCB PN is associated with lower costs than compounded PN with regards to both PN acquisition and potential avoidance of BSI. Our base case indicates that $US1545 per PN patient may be saved; even if as few as 50% of PN patients are candidates for standardized pre-mix formulations, a potential savings of $US773 per patient may be realized.

Patients with MDR-TB on domiciliary care in programmatic settings in Myanmar: Effect of a support package on preventing early deaths

PubMed Central

Shewade, Hemant Deepak; Kyaw, Nang Thu Thu; Kyaw, Khine Wut Yee; Thein, Saw; Si Thu, Aung; Oo, Myo Minn; Htwe, Pyae Sone; Tun, Moe Myint Theingi; Win Maung, Htet Myet; Soe, Kyaw Thu; Aung, Si Thu

2017-01-01

Background The community-based MDR-TB care (CBMDR-TBC) project was implemented in 2015 by The Union in collaboration with national TB programme (NTP) in 33 townships of upper Myanmar to improve treatment outcomes among patients with MDR-TB registered under NTP. They received community-based support through the project staff, in addition to the routine domiciliary care provided by NTP staff. Each project township had a project nurse exclusively for MDR-TB and a community volunteer who provided evening directly observed therapy (in addition to morning directly observed therapy by NTP). Objectives To determine the effect of CBMDR-TBC project on death and unfavourable outcomes during the intensive phase of MDR-TB treatment. Methods In this cohort study involving record review, all patients diagnosed with MDR-TB between January 2015 and June 2016 in project townships and initiated on treatment till 31 Dec 2016 were included. CBMDR-TBC status was categorized as “receiving support” if project initiation in patient’s township was before treatment initiation, “receiving partial support” if project initiation was after treatment initiation, and “not receiving support” if project initiation was after intensive phase treatment outcome declaration. Time to event analysis (censored on 10 April 2017) and cox regression was done. Results Of 261 patients initiated on treatment, death and unfavourable outcomes were accounted for 13% and 21% among “receiving support (n = 163)”, 3% and 24% among “receiving partial support (n = 75)” and 13% and 26% among “not receiving support (n = 23)” respectively. After adjusting for other potential confounders, the association between CBMDR-TBC and unfavourable outcomes was not statistically significant. However, when compared to “not receiving support”, those “receiving support” and “receiving partial support” had 20% [aHR (0.95 CI: 0.8 (0.2–3.1)] and 90% lower hazard [aHR (0.95 CI: 0.1 (0.02–0.9)] of death, respectively. This was intriguing. Implementation of CBMDR-TBC coincided with implementation of decentralized MDR-TB centers at district level. Hence, patients that would have generally not accessed MDR-TB treatment before decentralization also started receiving treatment and were also included under CBMDR-TBC “received support” group. These patients could possibly be expected to sicker at treatment initiation than patients in other CBMDR-TBC groups. This could be the possible reason for nullifying the effect of CBMDR-TBC in “receiving support” group and therefore similar survival was found when compared to “not receiving support”. Conclusion CBMDR-TBC may prevent early deaths and has a scope for expansion to other townships of Myanmar and implications for NTPs globally. However, future studies should consider including data on extent of sickness at treatment initiation and patient level support received under CBMDR-TBC. PMID:29261669

A prospective audit of the impact of additional staff on the care of diabetic patients in a community podiatry service

PubMed Central

Ryan, Alexandra; Uppal, Meenakshi; Cunning, Imelda; Buckley, Claire M.

2015-01-01

Objective The purpose of this study was to evaluate the impact of the employment of additional podiatry staff on patients with diabetes attending a community-based podiatry service. Methods An audit was conducted to evaluate the intervention of two additional podiatry staff. All patients with diabetes referred to and attending community podiatry services in a specified area in the Republic of Ireland between June 2011 and June 2012 were included. The service was benchmarked against the UK gold standard outlined in the ‘Guidelines on prevention & management of foot problems in Type 2 Diabetes’ by the National Institute of Clinical Excellence (NICE). Process of care measures addressed were the number of patients with diabetes receiving treatment and the waiting times of patients with diabetes from referral to initial review. Results An increase in the number of patients with diabetes receiving treatment was seen in all risk categories (ranging from low risk to the emergency foot). Waiting times for patients with diabetes decreased post-intervention but did not reach the targets outlined in the NICE guidelines. The average time from referral to initial review of patients with an emergency diabetic foot was 37 weeks post-intervention. NICE guidelines recommend that these patients are seen within 24 hours. Discussion During the life cycle of this audit, increased numbers of patients were treated and waiting times for patients with diabetes were reduced. An internal re-organisation of the services coincided with the commencement of the additional staff. The improvements observed were due to the effects of a combination of additional staff and service re-organisation. Efficient organisation of services is key to optimal performance. Continued efforts to improve services are required to reach the standards outlined in the NICE guidelines. PMID:26048860

A prospective audit of the impact of additional staff on the care of diabetic patients in a community podiatry service.

PubMed

Ryan, Alexandra; Uppal, Meenakshi; Cunning, Imelda; Buckley, Claire M

2015-01-01

The purpose of this study was to evaluate the impact of the employment of additional podiatry staff on patients with diabetes attending a community-based podiatry service. An audit was conducted to evaluate the intervention of two additional podiatry staff. All patients with diabetes referred to and attending community podiatry services in a specified area in the Republic of Ireland between June 2011 and June 2012 were included. The service was benchmarked against the UK gold standard outlined in the 'Guidelines on prevention & management of foot problems in Type 2 Diabetes' by the National Institute of Clinical Excellence (NICE). Process of care measures addressed were the number of patients with diabetes receiving treatment and the waiting times of patients with diabetes from referral to initial review. An increase in the number of patients with diabetes receiving treatment was seen in all risk categories (ranging from low risk to the emergency foot). Waiting times for patients with diabetes decreased post-intervention but did not reach the targets outlined in the NICE guidelines. The average time from referral to initial review of patients with an emergency diabetic foot was 37 weeks post-intervention. NICE guidelines recommend that these patients are seen within 24 hours. During the life cycle of this audit, increased numbers of patients were treated and waiting times for patients with diabetes were reduced. An internal re-organisation of the services coincided with the commencement of the additional staff. The improvements observed were due to the effects of a combination of additional staff and service re-organisation. Efficient organisation of services is key to optimal performance. Continued efforts to improve services are required to reach the standards outlined in the NICE guidelines.

Automated pictographic illustration of discharge instructions with Glyph: impact on patient recall and satisfaction.

PubMed

Hill, Brent; Perri-Moore, Seneca; Kuang, Jinqiu; Bray, Bruce E; Ngo, Long; Doig, Alexa; Zeng-Treitler, Qing

2016-11-01

First, to evaluate the effect of standard vs pictograph-enhanced discharge instructions on patients' immediate and delayed recall of and satisfaction with their discharge instructions. Second, to evaluate the effect of automated pictograph enhancement on patient satisfaction with their discharge instructions. Glyph, an automated healthcare informatics system, was used to automatically enhance patient discharge instructions with pictographs. Glyph was developed at the University of Utah by our research team. Patients in a cardiovascular medical unit were randomized to receive pictograph-enhanced or standard discharge instructions. Measures of immediate and delayed recall and satisfaction with discharge instructions were compared between two randomized groups: pictograph (n = 71) and standard (n = 73). Study participants who received pictograph-enhanced discharge instructions recalled 35% more of their instructions at discharge than those who received standard discharge instructions. The ratio of instructions at discharge was: standard = 0.04 ± 0.03 and pictograph-enhanced = 0.06 ± 0.03. The ratio of instructions at 1 week post discharge was: standard = 0.04 ± 0.02 and pictograph-enhanced 0.04 ± 0.02. Additionally, study participants who received pictograph-enhanced discharge instructions were more satisfied with the understandability of their instructions at 1 week post-discharge than those who received standard discharge instructions. Pictograph-enhanced discharge instructions have the potential to increase patient understanding of and satisfaction with discharge instructions. It is feasible to automatically illustrate discharge instructions and provide them to patients in a timely manner without interfering with clinical work. Illustrations in discharge instructions were found to improve patients' short-term recall of discharge instructions and delayed satisfaction (1-week post hospitalization) with the instructions. Therefore, it is likely that patients' understanding of and interaction with their discharge instructions is improved by the addition of illustrations. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government employees and is in the public domain in the United States.

Notes from the Field: Fungal Bloodstream Infections Associated with a Compounded Intravenous Medication at an Outpatient Oncology Clinic - New York City, 2016.

PubMed

Vasquez, Amber M; Lake, Jason; Ngai, Stephanie; Halbrook, Megan; Vallabhaneni, Snigdha; Keckler, M Shannon; Moulton-Meissner, Heather; Lockhart, Shawn R; Lee, Christopher T; Perkins, Kiran; Perz, Joseph F; Antwi, Mike; Moore, Miranda S; Greenko, Jane; Adams, Eleanor; Haas, Janet; Elkind, Sandra; Berman, Marjorie; Zavasky, Dani; Chiller, Tom; Ackelsberg, Joel

2016-11-18

On May 24, 2016, the New York City Department of Health and Mental Hygiene notified CDC of two cases of Exophiala dermatitidis bloodstream infections among patients with malignancies who had received care from a single physician at an outpatient oncology facility (clinic A). Review of January 1-May 31, 2016 microbiology records identified E. dermatitidis bloodstream infections in two additional patients who also had received care at clinic A. All four patients had implanted vascular access ports and had received intravenous (IV) medications, including a compounded IV flush solution containing saline, heparin, vancomycin, and ceftazidime, compounded and administered at clinic A.

Effect of long-term clopidogrel treatment on platelet function and inflammation in patients undergoing coronary arterial stenting.

PubMed

Antonino, Mark J; Mahla, Elisabeth; Bliden, Kevin P; Tantry, Udaya S; Gurbel, Paul A

2009-06-01

A clopidogrel loading dose administered during stenting attenuates inflammation marker release. However, less is known of the anti-inflammatory effect of clopidogrel maintenance therapy. Platelet reactivity to adenosine diphosphate and inflammation markers were measured in 110 consecutive patients (69 clopidogrel-naive patients and 41 patients receiving long-term clopidogrel therapy for >6 months) before nonemergent stenting by turbidimetric aggregometry and flow cytometry and multianalyte profiling, respectively. All patients were treated with aspirin. Prestenting adenosine diphosphate-induced platelet aggregation, P-selectin, and activated glycoprotein IIb/IIIa expression were lower in patients receiving long-term clopidogrel therapy compared with the clopidogrel-naive group (p <0.001), accompanied by lower levels of selected inflammation markers (p < or = 0.05). Additionally, there were strong correlations between platelet aggregation and flow cytometric measurements (p < or = 0.04) and between specific inflammation markers (p < or = 0.02). In conclusion, in addition to markedly lowering platelet reactivity to adenosine diphosphate, long-term clopidogrel therapy is associated with an anti-inflammatory effect.

Five-Year Survival Rates for Treatment-Naive Patients With Advanced Melanoma Who Received Ipilimumab Plus Dacarbazine in a Phase III Trial

PubMed Central

Maio, Michele; Grob, Jean-Jacques; Aamdal, Steinar; Bondarenko, Igor; Robert, Caroline; Thomas, Luc; Garbe, Claus; Chiarion-Sileni, Vanna; Testori, Alessandro; Chen, Tai-Tsang; Tschaika, Marina; Wolchok, Jedd D.

2015-01-01

Purpose There is evidence from nonrandomized studies that a proportion of ipilimumab-treated patients with advanced melanoma experience long-term survival. To demonstrate a long-term survival benefit with ipilimumab, we evaluated the 5-year survival rates of patients treated in a randomized, controlled phase III trial. Patients and Methods A milestone survival analysis was conducted to capture the 5-year survival rate of treatment-naive patients with advanced melanoma who received ipilimumab in a phase III trial. Patients were randomly assigned 1:1 to receive ipilimumab at 10 mg/kg plus dacarbazine (n = 250) or placebo plus dacarbazine (n = 252) at weeks 1, 4, 7, and 10 followed by dacarbazine alone every 3 weeks through week 22. Eligible patients could receive maintenance ipilimumab or placebo every 12 weeks beginning at week 24. A safety analysis was conducted on patients who survived at least 5 years and continued to receive ipilimumab as maintenance therapy. Results The 5-year survival rate was 18.2% (95% CI, 13.6% to 23.4%) for patients treated with ipilimumab plus dacarbazine versus 8.8% (95% CI, 5.7% to 12.8%) for patients treated with placebo plus dacarbazine (P = .002). A plateau in the survival curve began at approximately 3 years. In patients who survived at least 5 years and continued to receive ipilimumab, grade 3 or 4 immune-related adverse events were observed exclusively in the skin. Conclusion The additional survival benefit of ipilimumab plus dacarbazine is maintained with twice as many patients alive at 5 years compared with those who initially received placebo plus dacarbazine. These results demonstrate a durable survival benefit with ipilimumab in advanced melanoma. PMID:25713437

Why are some HIV/AIDS patients reluctant to receive antiviral therapy as soon as possible in China?

PubMed

Sun, Yang; Lu, Hongzhou

2014-06-01

In more than 20 years of medical practice, a surprising phenomenon has often occurred: some patients with acquired immunodeficiency syndrome (AIDS) decide not to go to the hospital and they do not let others know that they are suffering from the disease unless they believe that they are dieing. Zhang Shan (a pseudonym) is one such patient with human immunodeficiency virus (HIV)/AIDS who was reluctant to receive antiviral therapy as soon as possible, and this paper shares Zhang's story as he related it. Clearly, there are numerous views as to why patients in China behave as Zhang did. Presented here are several reasons, including society, history, morality and ideology, family, and education. Although all of these reasons do play a role, the patient's mindset and behavior is the most significant reason for a patient's reluctance to seek treatment or disclose his/her status. If the individual patient's mindset and behavior are not dealt with effectively, then HIV/AIDS can continue to spread and threaten additional lives and even the fabric of society. This paper analyzes the reasons why patients are hesitant to receive antiviral therapy, but this paper also suggests steps healthcare personnel can take to encourage patients to seek treatment. Such steps can save the lives of current patients with HIV/AIDS. In addition, sound public health measures and a rational approach to treatment are important to helping potential patients with HIV/AIDS.

Outcomes in a series of 103 retroperitoneal sarcomas.

PubMed

Pierie, J-P E N; Betensky, R A; Choudry, U; Willett, C G; Souba, W W; Ott, M J

2006-12-01

To report the effect on outcome of selection in patients receiving intra-operative electron beam radiation (IOERT) and external beam radiation therapy (EBRT). One hundred and three patients treated for primary RS were studied. Median follow-up was 27 months. Clinical presentation, tumor characteristics, and treatment methods were analyzed to determine impact on survival and recurrence and if selection was occurring. Mean age was 55+/-17 years. Mean tumor size was 15+/-6cm and 88 were high-grade. Complete gross tumor resection (CR) occurred in 62 patients and improved survival vs. both debulking (p=0.0005) and biopsy (p<0.0001). The 5- and 10-year survival rates were 62% and 52% for those with CR vs. 29% and 20% after incomplete resection. Among the 62 CR patients, there was selection to receive additional EBRT+/-IOERT in patients with high-grade tumors (p=0.005) and/or microscopically positive margins (p=0.011). In these high-risk patients there was a trend for IOERT to further augment survival vs. EBRT alone and to increase the time to both local and distant recurrences (p=0.036). Complete gross resection is the primary form of curative treatment for retroperitoneal sarcomas. Selection led to patients with high-risk tumors receiving additional radiation therapy. There appears to be a beneficial effect of IOERT plus EBRT in these high-risk patients after complete tumor resection.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jones, G.A.; Purdy, R.B.; Stoker, H.W.

As cancer therapy becomes more successful and cancer survival rates increase, the dentist will be treating more patients who have received radiation therapy for head and neck cancer. Occasionally, patients and health professionals have indicated a belief that patients who have received irradiation to the head and neck regions should not be subjected to additional radiation through dental diagnostic X-ray exposures. A literature search failed to find any references that specifically addressed this question. This study reflects the opinions of 278 radiation oncologists (400 surveyed) who responded to questions about contraindications of dental X rays for the patient with headmore » and neck cancer.« less

Reconstruction of late craniofacial deformities after irradiation of the head and face during childhood

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cohen, S.R.; Bartlett, S.P.; Whitaker, L.A.

1990-08-01

Little is known about the results of surgical management of late craniofacial abnormalities arising after irradiation of the head and face for treatment of childhood cancers. The clinical records of 10 children (4 males and 6 females) who received 4500 to 6500 rads (mean 5160 rads) of craniofacial radiation between birth and 8 years of age (mean 5 years) and who subsequently had reconstructive surgery were reviewed. Six of the 10 patients received orbital radiation, 3 received maxillary-midfacial radiation, and 1 patient underwent radiation to the frontal bone. Histologic tumor types included retinoblastoma (4), rhabdomyosarcoma (3), Ewing's sarcoma (2), andmore » neurofibrosarcoma (1). In addition to radiation, 7 of the 10 patients underwent surgical resection or debulking of their tumors and 6 received adjuvant chemotherapy. All patients presented from 4 to 20 years after treatment (mean 10 years) with varying, but severe degrees of soft-tissue and bony hypoplasia of the irradiated territories. Onlay bone grafting with soft-tissue reconstruction by a combination of local pedicle flaps and dermal-fat grafts was initially performed in 9 patients, and an occipitoparietal bone-flap switch procedure was done in 1 patient. Late follow-up ranged from 11 months to 7.5 years (mean 34 months). A total of 8 secondary procedures were necessary in 4 of the 10 patients (40 percent). Of these 4 patients, major revisions were performed in 3 and minor adjustments in 1. In addition, 2 patients in whom secondary procedures had not been done would benefit from further reconstruction. Therapy for cancer of the head and face during childhood has profound and ongoing effects on the growth of soft tissue and bone.« less

Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer.

PubMed

Poort, Hanneke; Verhagen, Constans A H H V M; Peters, Marlies E W J; Goedendorp, Martine M; Donders, A Rogier T; Hopman, Maria T E; Nijhuis-van der Sanden, Maria W G; Berends, Thea; Bleijenberg, Gijs; Knoop, Hans

2017-01-28

Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as graded exercise therapy (GET) or cognitive behaviour therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT). The primary aim of our study is to assess the efficacy of GET or CBT compared to usual care (UC) in reducing fatigue in patients with incurable cancer. The TIRED study is a multicentre three-armed randomised controlled trial (RCT) for incurable cancer patients receiving systemic treatment with palliative intent. Participants will be randomised to GET, CBT, or UC. In addition to UC, the GET group will participate in a 12-week supervised exercise programme. The CBT group will receive a 12-week CBT intervention in addition to UC. Primary and secondary outcome measures will be assessed at baseline, post-intervention (14 weeks), and at follow-up assessments (18 and 26 weeks post-randomisation). The primary outcome measure is fatigue severity (Checklist Individual Strength subscale fatigue severity). Secondary outcome measures are fatigue (EORTC-QLQ-C30 subscale fatigue), functional impairments (Sickness Impact Profile total score, EORTC-QLQ-C30 subscale emotional functioning, subscale physical functioning) and quality of life (EORTC-QLQ-C30 subscale QoL). Outcomes at 14 weeks (primary endpoint) of either treatment arm will be compared to those of UC participants. In addition, outcomes at 18 and 26 weeks (follow-up assessments) of either treatment arm will be compared to those of UC participants. To our knowledge, the TIRED study is the first RCT investigating the efficacy of GET and CBT on reducing fatigue during treatment with palliative intent in incurable cancer patients. The results of this study will provide information about the possibility and efficacy of GET and CBT for severely fatigued incurable cancer patients. NTR3812 ; date of registration: 23/01/2013.

Treatment of out-of-hospital supraventricular tachycardia: adenosine vs verapamil.

PubMed

Brady, W J; DeBehnke, D J; Wickman, L L; Lindbeck, G

1996-06-01

To compare the use of adenosine and the use of verapamil as out-of-hospital therapy for supraventricular tachycardia (SVT). A period of prospective adenosine use (March 1993 to February 1994) was compared with a historical control period of verapamil use (March 1990 to February 1991) for SVT. Data were obtained for SVT patients treated in a metropolitan, fire-department-based paramedic system serving a population of approximately 1 million persons. Standard drug protocols were used and patient outcomes (i.e., conversion rates, complications, and recurrences) were monitored. During the adenosine treatment period, 105 patients had SVT; 87 (83%) received adenosine, of whom 60 (69%) converted to a sinus rhythm (SR). Vagal maneuvers (VM) resulted in restoration of SR in 8 patients (7.6%). Some patients received adenosine for non-SVT rhythms: 7 sinus tachycardia, 18 atrial fibrilation, 7 wide-complex tachycardia (WCT), and 2 ventricular tachycardia; no non-SVT rhythm converted to SR and none of these patients experienced an adverse effect. Twenty-five patients were hemodynamically unstable (systolic blood pressure < 90 mm Hg), with 20 receiving drug and 13 converting to SR; 8 patients required electrical cardioversion. Four patients experienced adverse effects related to adenosine (chest pain dyspnea, prolonged bradycardia, and ventricular tachycardia). In the verapamil period, 106 patients had SVT: 52 (49%) received verapamil (p < 0.001, compared with the adenosine period), of whom 43 (88%) converted to SR (p = 0.11). Two patients received verapamil for WCT; neither converted to SR and both experienced cardiovascular collapse. VM resulted in restoration of SR in 12 patients (11.0%) (p = 0.52). Sixteen patients were hemodynamically unstable, with 5 receiving drug (p = 0.005) and 5 converting to SR; 9 patients required electrical cardioversion (p = 0.48). Four patients experienced adverse effects related to verapamil (hypotension ventricular tachycardia, ventricular fibrillation). Recurrence of SVT was noted in 2 adenosine patients and 2 verapamil patients in the out-of-hospital setting and in 23 adenosine patients and 15 verapamil patients after ED arrival, necessitating additional therapy (p = 0.48 and 0.88, for recurrence rates and types of additional therapies, respectively). Hospital diagnoses, outcomes, and ED dispositions were similar for the 2 groups. Adenosine and verapamil were equally successful in converting out-of-hospital SVT in patients with similar etiologies responsible for the SVT. Recurrence of SVT occurred at similar rates for the 2 medications. Rhythm misidentification remains a common issue in out-of-hospital cardiac care in this emergency medical services system.

Upfront Androgen Deprivation Therapy With Salvage Radiation May Improve Biochemical Outcomes in Prostate Cancer Patients With Post-Prostatectomy Rising PSA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jang, Joanne W.; Hwang, Wei-Ting; Guzzo, Thomas J.

2012-08-01

Purpose: The addition of androgen deprivation therapy (ADT) to definitive external beam radiation therapy (RT) improves outcomes in higher-risk prostate cancer patients. However, the benefit of ADT with salvage RT in post-prostatectomy patients is not clearly established. Our study compares biochemical outcomes in post-prostatectomy patients who received salvage RT with or without concurrent ADT. Methods and Materials: Of nearly 2,000 post-prostatectomy patients, we reviewed the medical records of 191 patients who received salvage RT at University of Pennsylvania between 1987 and 2007. Follow-up data were obtained by chart review and electronic polling of the institutional laboratory database and Social Securitymore » Death Index. Biochemical failure after salvage RT was defined as a prostate-specific antigen of 2.0 ng/mL above the post-RT nadir or the initiation of ADT after completion of salvage RT. Results: One hundred twenty-nine patients received salvage RT alone, and 62 patients received combined ADT and salvage RT. Median follow-up was 5.4 years. Patients who received combined ADT and salvage RT were younger, had higher pathologic Gleason scores, and higher rates of seminal vesicle invasion, lymph node involvement, and pelvic nodal irradiation compared with patients who received salvage RT alone. Patients who received combined therapy had improved biochemical progression-free survival (bPFS) compared with patients who received RT alone (p = 0.048). For patients with pathologic Gleason scores {<=}7, combined RT and ADT resulted in significantly improved bPFS compared to RT alone (p = 0.013). Conclusions: These results suggest that initiating ADT during salvage RT in the post-prostatectomy setting may improve bPFS compared with salvage RT alone. However, prospective randomized data are necessary to definitively determine whether hormonal manipulation should be used with salvage RT. Furthermore, the optimal nature and duration of ADT and the patient subgroups in which ADT could provide the most benefit remain open questions.« less

Severe exacerbation and pneumonia in COPD patients treated with fixed combinations of inhaled corticosteroid and long-acting beta2 agonist.

PubMed

Yang, Hsi-Hsing; Lai, Chih-Cheng; Wang, Ya-Hui; Yang, Wei-Chih; Wang, Cheng-Yi; Wang, Hao-Chien; Chen, Likwang; Yu, Chong-Jen

2017-01-01

It remains unclear whether severe exacerbation and pneumonia of COPD differs between patients treated with budesonide/formoterol and those treated with fluticasone/salmeterol. Therefore, we conducted a comparative study of those who used budesonide/formoterol and those treated with fluticasone/salmeterol for COPD. Subjects in this population-based cohort study comprised patients with COPD who were treated with a fixed combination of budesonide/formoterol or fluticasone/salmeterol. All patients were recruited from the Taiwan National Health Insurance database. The outcomes including severe exacerbations, pneumonia, and pneumonia requiring mechanical ventilation (MV) were measured. During the study period, 11,519 COPD patients receiving fluticasone/salmeterol and 7,437 patients receiving budesonide/formoterol were enrolled in the study. Pairwise matching (1:1) of fluticasone/salmeterol and budesonide/formoterol populations resulted in to two similar subgroups comprising each 7,295 patients. Patients receiving fluticasone/salmeterol had higher annual rate and higher risk of severe exacerbation than patients receiving budesonide/formoterol (1.2219/year vs 1.1237/year, adjusted rate ratio, 1.08; 95% CI, 1.07-1.10). In addition, patients receiving fluticasone/salmeterol had higher incidence rate and higher risk of pneumonia than patients receiving budesonide/formoterol (12.11 per 100 person-years vs 10.65 per 100 person-years, adjusted hazard ratio [aHR], 1.13; 95% CI, 1.08-1.20). Finally, patients receiving fluticasone/salmeterol had higher incidence rate and higher risk of pneumonia requiring MV than patients receiving budesonide/formoterol (3.94 per 100 person-years vs 3.47 per 100 person-years, aHR, 1.14; 95% CI, 1.05-1.24). A similar trend was seen before and after propensity score matching analysis, intention-to-treat, and as-treated analysis with and without competing risk. Based on this retrospective observational study, long-term treatment with fixed combination budesonide/formoterol was associated with fewer severe exacerbations, pneumonia, and pneumonia requiring MV than fluticasone/salmeterol in COPD patients.

Clinical and imaging evaluation of the response to intravenous steroids in patients with Graves' orbitopathy and analysis on who requires additional therapy.

PubMed

Tsirouki, Theodora; Bargiota, Alexandra; Tigas, Stelios; Vasileiou, Agathi; Kapsalaki, Eftichia; Giotaki, Zoe; Asproudis, Ioannis; Tsatsoulis, Agathokles; Koukoulis, Georgios; Tsironi, Evangelia E

2016-01-01

The aim of this study was to evaluate the safety and efficacy of an individualized steroid regimen in patients with moderate-to-severe Graves' orbitopathy (GO) by monitoring clinical and imaging parameters. In total, 47 patients with active, moderate-to-severe GO were enrolled in this study. All the patients received the proposed treatment regimen by European Group on GO of 4.5 g of intravenous (IV) methylprednisolone for 12 weeks. At the end of the IV treatment, patients with persistent active GO (Group 1) who were assessed by clinical examination and orbital imaging with short tau inversion recovery-sequence magnetic resonance imaging (STIR MRI) received additional treatment with oral prednisolone, and those with inactive GO (Group 2) received no further treatment. Of the 42 patients who completed the study, 22 (52.4%) patients formed Group 1 and 20 (47.6%) patients Group 2. At the 12th week, the overall response to IV treatment was 76.2%, and clinical activity score (CAS) improvement was 69%. At the 24th week, the overall response was 92.8%, and CAS improvement was 97.6%, without statistically significant difference in CAS and total eye score between these two groups ( P =0.157 and P =0.856, respectively). Ophthalmic manifestations were improved, being absent or minimal in 78.6% of patients at the 24th week follow-up. Recurrence of disease activity occurred in 9.5% of patients up to 24 weeks after the completion of treatment, and major adverse events occurred in 6.4% of patients. In patients with moderate-to-severe GO, IV steroid treatment, followed by oral treatment, when needed, is an effective regimen with low rates of adverse events and recurrences. STIR MRI is a significant tool for recognizing patients who need additional steroid treatment.

Clinical and imaging evaluation of the response to intravenous steroids in patients with Graves’ orbitopathy and analysis on who requires additional therapy

PubMed Central

Tsirouki, Theodora; Bargiota, Alexandra; Tigas, Stelios; Vasileiou, Agathi; Kapsalaki, Eftichia; Giotaki, Zoe; Asproudis, Ioannis; Tsatsoulis, Agathokles; Koukoulis, Georgios; Tsironi, Evangelia E

2016-01-01

Objective The aim of this study was to evaluate the safety and efficacy of an individualized steroid regimen in patients with moderate-to-severe Graves’ orbitopathy (GO) by monitoring clinical and imaging parameters. Methods In total, 47 patients with active, moderate-to-severe GO were enrolled in this study. All the patients received the proposed treatment regimen by European Group on GO of 4.5 g of intravenous (IV) methylprednisolone for 12 weeks. At the end of the IV treatment, patients with persistent active GO (Group 1) who were assessed by clinical examination and orbital imaging with short tau inversion recovery-sequence magnetic resonance imaging (STIR MRI) received additional treatment with oral prednisolone, and those with inactive GO (Group 2) received no further treatment. Results Of the 42 patients who completed the study, 22 (52.4%) patients formed Group 1 and 20 (47.6%) patients Group 2. At the 12th week, the overall response to IV treatment was 76.2%, and clinical activity score (CAS) improvement was 69%. At the 24th week, the overall response was 92.8%, and CAS improvement was 97.6%, without statistically significant difference in CAS and total eye score between these two groups (P=0.157 and P=0.856, respectively). Ophthalmic manifestations were improved, being absent or minimal in 78.6% of patients at the 24th week follow-up. Recurrence of disease activity occurred in 9.5% of patients up to 24 weeks after the completion of treatment, and major adverse events occurred in 6.4% of patients. Conclusion In patients with moderate-to-severe GO, IV steroid treatment, followed by oral treatment, when needed, is an effective regimen with low rates of adverse events and recurrences. STIR MRI is a significant tool for recognizing patients who need additional steroid treatment. PMID:27895458

Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial.

PubMed

Maio, Michele; Grob, Jean-Jacques; Aamdal, Steinar; Bondarenko, Igor; Robert, Caroline; Thomas, Luc; Garbe, Claus; Chiarion-Sileni, Vanna; Testori, Alessandro; Chen, Tai-Tsang; Tschaika, Marina; Wolchok, Jedd D

2015-04-01

There is evidence from nonrandomized studies that a proportion of ipilimumab-treated patients with advanced melanoma experience long-term survival. To demonstrate a long-term survival benefit with ipilimumab, we evaluated the 5-year survival rates of patients treated in a randomized, controlled phase III trial. A milestone survival analysis was conducted to capture the 5-year survival rate of treatment-naive patients with advanced melanoma who received ipilimumab in a phase III trial. Patients were randomly assigned 1:1 to receive ipilimumab at 10 mg/kg plus dacarbazine (n = 250) or placebo plus dacarbazine (n = 252) at weeks 1, 4, 7, and 10 followed by dacarbazine alone every 3 weeks through week 22. Eligible patients could receive maintenance ipilimumab or placebo every 12 weeks beginning at week 24. A safety analysis was conducted on patients who survived at least 5 years and continued to receive ipilimumab as maintenance therapy. The 5-year survival rate was 18.2% (95% CI, 13.6% to 23.4%) for patients treated with ipilimumab plus dacarbazine versus 8.8% (95% CI, 5.7% to 12.8%) for patients treated with placebo plus dacarbazine (P = .002). A plateau in the survival curve began at approximately 3 years. In patients who survived at least 5 years and continued to receive ipilimumab, grade 3 or 4 immune-related adverse events were observed exclusively in the skin. The additional survival benefit of ipilimumab plus dacarbazine is maintained with twice as many patients alive at 5 years compared with those who initially received placebo plus dacarbazine. These results demonstrate a durable survival benefit with ipilimumab in advanced melanoma. © 2015 by American Society of Clinical Oncology.

Effectiveness of dental checkups incorporating tooth brushing instruction.

PubMed

Furusawa, Masahiro; Takahashi, Jun-ichi; Isoyama, Motoko; Kitamura, Yoshiko; Kashima, Tomoko; Ueshima, Fumie; Nakahama, Noriko; Araki, Misako; Rokukawa, Yasuko; Takahashi, Yoshikazu; Makiishi, Takemi; Yatabe, Ken-ichi

2011-01-01

The purpose of this study was to compare the effectiveness of dental checkups incorporating tooth-brushing instruction (TBI) with that of conventional dental checkups. A team consisting of one dentist and three dental hygienists saw an average of 60 employees per day on-site at an airline company. The patient's teeth were stained with a disclosing tablet and the results recorded on a Plaque Control Record (PCR) chart. The patient was then given TBI. After recording the relevant data, including TBI given and PCR scores, the charts were stored. Checkups were performed in a total of 3,854 patients between 2001 and 2005 and changes in annual scores investigated. In addition, annual shifts in mean score in patients receiving checkups over all five years were compared with those in patients receiving checkups for the first time in each of the five years. The mean score in patients receiving a checkup in 2001 was 35.1%, declining by 2.6 points to 32.5% in 2005. Among patients receiving checkups over all five years, the mean score in 2001 was 34.0%, declining by 11.2 points to 22.8% in 2005. Over the five-year period, the mean score in patients receiving checkups was 34.1%. In patients receiving checkups over all five years, the proportion with PCR scores <30% increased each year. This was because the number of patients with PCR scores ≥60% decreased each year. These findings suggest that TBI is effective in reducing poor plaque control. When compared with in patients who had not received TBI, five consecutive years of checkups was clearly effective. These results indicate that checkups incorporating TBI are more effective than conventional dental checkups that simply check for caries. In future, this type of checkup should contribute to improved preventative dentistry with minimal intervention.

Risk of chemotherapy-induced febrile neutropenia with early discontinuation of pegfilgrastim prophylaxis in US clinical practice.

PubMed

Weycker, Derek; Li, Xiaoyan; Barron, Rich; Li, Yanli; Reiner, Maureen; Kartashov, Alex; Figueredo, Jacqueline; Tzivelekis, Spiros; Garcia, Jacob

2016-06-01

Accumulating evidence suggests that not all cancer chemotherapy patients who receive first-cycle pegfilgrastim prophylaxis continue to receive it in subsequent cycles and that these patients may be subsequently at higher risk of febrile neutropenia (FN). Additional evidence from US clinical practice is warranted. Data from two US private healthcare claims repositories were employed. The source population comprised adults who received "intermediate-risk" or "high-risk" chemotherapy regimens for solid cancers or non-Hodgkin's lymphoma and first-cycle pegfilgrastim prophylaxis. From the source population, all patients who did not receive second-cycle pegfilgrastim prophylaxis ("comparison patients") were matched (1:1) to those who received it ("pegfilgrastim patients") based on cancer, regimen, and propensity score. Odds ratios (OR) for FN-broad and narrow definitions-during the second chemotherapy cycle were estimated for comparison patients versus pegfilgrastim patients using generalized estimating equations. A total of 2245 comparison patients (5.3 % of source population) were matched to pegfilgrastim patients; cohorts were well-balanced on baseline characteristics. Second-cycle FN incidence proportions for comparison and pegfilgrastim patients were 3.8 versus 2.2 % based on broad definition and 2.6 versus 0.8 % based on narrow definition; corresponding OR were 1.7 (95 % CI 1.2-2.5, p = 0.002) and 3.5 (95 % CI 2.0-6.0, p < 0.001). Results were similar within cancer/regimen-subgroups and were robust when using alternative methods for confounding adjustment. In this retrospective evaluation of cancer chemotherapy patients who received first-cycle pegfilgrastim prophylaxis in US clinical practice, a clinically relevant minority did not receive second-cycle prophylaxis. Second-cycle FN odds among this subset were significantly higher than they were among those who continued prophylaxis.

Comparing the clinical outcomes in patients with atrial fibrillation receiving dual antiplatelet therapy and patients receiving an addition of an anticoagulant after coronary stent implantation: A systematic review and meta-analysis of observational studies.

PubMed

Chaudhary, Nabin; Bundhun, Pravesh Kumar; Yan, He

2016-12-01

Data regarding the clinical outcomes in patients with atrial fibrillation (AF) receiving dual antiplatelet therapy (DAPT) and an anticoagulant in addition to DAPT (DAPT + vitamin K antagonist [VKA]) after coronary stent implantation are still controversial. Therefore, in order to solve this issue, we aim to compare the adverse clinical outcomes in AF patients receiving DAPT and DAPT + VKA after percutaneous coronary intervention and stenting (PCI-S). Observational studies comparing the adverse clinical outcomes such as major bleeding, major adverse cardiovascular events, stroke, myocardial infarction, all-cause mortality, and stent thrombosis (ST) in AF patients receiving DAPT + VKA therapy, and DAPT after PCI-S have been searched from Medline, EMBASE, and PubMed databases. Odds ratios (ORs) with 95% confidence intervals (CIs) were used to express the pooled effect on discontinuous variables, and the pooled analyses were performed with RevMan 5.3. Eighteen studies consisting of a total of 20,456 patients with AF (7203 patients received DAPT + VKA and 13,253 patients received DAPT after PCI-S) were included in this meta-analysis. At a mean follow-up period of 15 months, the risk of major bleeding was significantly higher in DAPT + VKA group, with OR 0.62 (95% CI 0.50-0.77, P < 0.0001). There was no significant differences in myocardial infarction and major adverse cardiovascular event between DAPT + VKA and DAPT, with OR 1.27 (95% CI 0.92-1.77, P = 0.15) and OR 1.17 (95% CI 0.99-1.39, P = 0.07), respectively. However, the ST, stroke, and all-cause mortality were significantly lower in the DAPT + VKA group, with OR 1.98 (95% CI 1.03-3.81, P = 0.04), 1.59 (95% CI 1.08-2.34, P = 0.02), and 1.41 (95% CI 1.03-1.94, P = 0.03), respectively. At a mean follow-up period of 15 months, DAPT + VKA was associated with significantly lower risk of stroke, ST, and all-cause mortality in AF patients after PCI-S compared with DAPT group. However, the risk of major bleeding was significantly higher in the DAPT + VKA group.

Psychiatric treatment received by primary care patients with panic disorder with and without agoraphobia.

PubMed

Marcks, Brook A; Weisberg, Risa B; Keller, Martin B

2009-06-01

Although the majority of individuals with panic disorder first present to the primary care setting, little is known about the psychiatric treatment that primary care patients with the disorder typically receive. The purpose of this study was to explore characteristics of treatment received by patients with panic disorder with agoraphobia and by those with panic disorder without agoraphobia, examine demographic and clinical predictors of receiving treatment, and explore treatment barriers. This study used data from the Primary Care Anxiety Project (PCAP), which is a naturalistic, longitudinal study of anxiety disorders among primary care patients. This study presents data for 235 PCAP participants diagnosed at the study intake assessment as having panic disorder with agoraphobia (N=150) or without agoraphobia (N=85). Many patients with panic disorder were not receiving psychiatric treatment at study intake (38%), with those without agoraphobia being less likely to receive treatment. Psychotropic medications were the treatment of choice, with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors being the most commonly received class of medications (34%). Only 38% of those with panic disorder with agoraphobia and 24% of those with panic disorder without agoraphobia were receiving psychotherapy, and the use of empirically supported interventions was rare. The most common treatment barriers were not believing in using medication or therapy for emotional problems and not receiving a treatment recommendation from one's provider. The findings suggest a need for better treatment dissemination, in addition to making interventions more accessible or adapting them to the particular needs of primary care patients.

Psychiatric treatment received by primary care patients with panic disorder with and without agoraphobia

PubMed Central

Marcks, Brook A.; Weisberg, Risa B.; Keller, Martin B.

2013-01-01

Objective Although the majority of individuals with panic disorder first present to the primary care setting, little is known about the psychiatric treatment primary care patients with the disorder typically receive. The purpose of the current study was to explore characteristics of treatment received by those with panic disorder with and without agoraphobia, examine demographic and clinical predictors of receiving treatment, and explore treatment barriers. Methods This study uses data from the Primary Care Anxiety Project (PCAP), which is a naturalistic, longitudinal study of anxiety disorders in primary care patients. This study presents data on 235 PCAP participants diagnosed with panic disorder with (N=150) or without agoraphobia (N=85) at the study intake assessment. Results Many patients with panic disorder were not receiving psychiatric treatment at study intake, with those without agoraphobia being less likely to receive treatment. Psychotropic medications were the treatment of choice, with SSRIs/SNRIs being the most commonly received class of medications. Only 39% of those with panic disorder with agoraphobia and 24% of those without agoraphobia were receiving psychotherapy, and use of empirically supported interventions was rare. The most common treatment barriers were: not believing in utilizing medication/therapy for emotional problems and not receiving a treatment recommendation from one’s provider. Conclusions The findings suggest a need for better treatment dissemination, in addition to making interventions more accessible and/or adapting them to the particular needs of primary care patients. PMID:19487354

Palonosetron versus granisetron in combination with aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with gynecologic cancer.

PubMed

Fujiwara, Satoe; Terai, Yoshito; Tsunetoh, Satoshi; Sasaki, Hiroshi; Kanemura, Masanori; Ohmichi, Masahide

2015-10-01

There is no research regarding the appropriate antiemetic agents for female patients, especially those receiving moderately emetogenic chemotherapy (MEC). We evaluated the antiemetic efficacy of a combination of 5-HT₃ receptor with/without aprepitant in patients with gynecological cancer treated with the TC (paclitaxel and carboplatin) regimen of MEC. We enrolled 38 patients diagnosed with gynecologic cancer and scheduled to receive the TC regimen. The patients were randomly assigned to receive a 5-HT₃ receptor antagonist, either palonosetron in the first cycle followed by granisetron in the second cycle or vice versa. In the third cycle, all patients received a combination of the 5-HT₃ receptor and dexamethasone with/without aprepitant. When three drugs were administered, palonosetron consistently produced an equivalent complete response (CR) rate to granisetron in the acute phase (89.5% vs. 86.8%, p=0.87) and delayed phase (60.5% vs. 65.8%, p=0.79). With regard to the change in dietary intake, palonosetron exhibited similar efficacy to granisetron in the acute phase (92.1% vs. 89.4%, p=0.19) and delayed phase (65.7% vs. 68.4%, p=0.14). However, in the delayed phase, the addition of aprepitant therapy with a 5-HT₃ receptor antagonist and dexamethasone produced a higher CR rate than a 5-HT₃ receptor antagonist with dexamethasone (93.3% vs. 47.8%, p<0.001) and allowed the patients to maintain a higher level of dietary intake (93.3% vs. 56.5%, p<0.001). The addition of aprepitant therapy was more effective than the control therapy of a 5-HT₃ receptor antagonist, and dexamethasone in gynecological cancer patients treated with the TC regimen.

Palonosetron versus granisetron in combination with aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with gynecologic cancer

PubMed Central

Fujiwara, Satoe; Tsunetoh, Satoshi; Sasaki, Hiroshi; Kanemura, Masanori; Ohmichi, Masahide

2015-01-01

Objective There is no research regarding the appropriate antiemetic agents for female patients, especially those receiving moderately emetogenic chemotherapy (MEC). We evaluated the antiemetic efficacy of a combination of 5-HT3 receptor with/without aprepitant in patients with gynecological cancer treated with the TC (paclitaxel and carboplatin) regimen of MEC. Methods We enrolled 38 patients diagnosed with gynecologic cancer and scheduled to receive the TC regimen. The patients were randomly assigned to receive a 5-HT3 receptor antagonist, either palonosetron in the first cycle followed by granisetron in the second cycle or vice versa. In the third cycle, all patients received a combination of the 5-HT3 receptor and dexamethasone with/without aprepitant. Results When three drugs were administered, palonosetron consistently produced an equivalent complete response (CR) rate to granisetron in the acute phase (89.5% vs. 86.8%, p=0.87) and delayed phase (60.5% vs. 65.8%, p=0.79). With regard to the change in dietary intake, palonosetron exhibited similar efficacy to granisetron in the acute phase (92.1% vs. 89.4%, p=0.19) and delayed phase (65.7% vs. 68.4%, p=0.14). However, in the delayed phase, the addition of aprepitant therapy with a 5-HT3 receptor antagonist and dexamethasone produced a higher CR rate than a 5-HT3 receptor antagonist with dexamethasone (93.3% vs. 47.8%, p<0.001) and allowed the patients to maintain a higher level of dietary intake (93.3% vs. 56.5%, p<0.001). Conclusion The addition of aprepitant therapy was more effective than the control therapy of a 5-HT3 receptor antagonist, and dexamethasone in gynecological cancer patients treated with the TC regimen. PMID:26197776

Intensification of antiretroviral therapy through addition of enfuvirtide in naive HIV-1-infected patients with severe immunosuppression does not improve immunological response: results of a randomized multicenter trial (ANRS 130 Apollo).

PubMed

Joly, Véronique; Fagard, Catherine; Grondin, Carine; Descamps, Diane; Yazdanpanah, Yazdan; Charpentier, Charlotte; Colin de Verdiere, Nathalie; Tabuteau, Sophie; Raffi, François; Cabie, André; Chene, Geneviève; Yeni, Patrick

2013-02-01

We studied whether addition of enfuvirtide (ENF) to a background combination antiretroviral therapy (cART) would improve the CD4 cell count response at week 24 in naive patients with advanced HIV disease. ANRS 130 Apollo is a randomized study, conducted in naive HIV-1-infected patients, either asymptomatic with CD4 counts of <100/mm(3) or stage B/C disease with CD4 counts of <200/mm(3). Patients received tenofovir-emtricitabine with lopinavir-ritonavir (LPV/r) or efavirenz and were randomized to receive ENF for 24 weeks (ENF arm) or not (control arm). The primary endpoint was the proportion of patients with CD4 counts of ≥ 200/mm(3) at week 24. A total of 195 patients were randomized: 73% had stage C disease, 78% were male, the mean age was 44 years, the median CD4 count was 30/mm(3), and the median HIV-1 RNA load was 5.4 log(10) copies/ml. Eighty-one percent of patients received LPV/r. One patient was lost to follow-up, and eight discontinued the study (four in each arm). The proportions of patients with CD4 counts of ≥ 200/mm(3) at week 24 were 34% and 38% in the ENF and control arms, respectively (P = 0.53). The proportions of patients with HIV-1 RNA loads of <50 copies/ml were 74% and 58% at week 24 in the ENF and control arms, respectively (P < 0.02), and the proportion reached 79% in both arms at week 48. Twenty (20%) and 12 patients (13%) in the ENF and control arms, respectively, experienced at least one AIDS event during follow-up (P = 0.17). Although inducing a more rapid virological response, addition of ENF to a standard cART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression.

Intensification of Antiretroviral Therapy through Addition of Enfuvirtide in Naive HIV-1-Infected Patients with Severe Immunosuppression Does Not Improve Immunological Response: Results of a Randomized Multicenter Trial (ANRS 130 Apollo)

PubMed Central

Fagard, Catherine; Grondin, Carine; Descamps, Diane; Yazdanpanah, Yazdan; Charpentier, Charlotte; Colin de Verdiere, Nathalie; Tabuteau, Sophie; Raffi, François; Cabie, André; Chene, Geneviève; Yeni, Patrick

2013-01-01

We studied whether addition of enfuvirtide (ENF) to a background combination antiretroviral therapy (cART) would improve the CD4 cell count response at week 24 in naive patients with advanced HIV disease. ANRS 130 Apollo is a randomized study, conducted in naive HIV-1-infected patients, either asymptomatic with CD4 counts of <100/mm3 or stage B/C disease with CD4 counts of <200/mm3. Patients received tenofovir-emtricitabine with lopinavir-ritonavir (LPV/r) or efavirenz and were randomized to receive ENF for 24 weeks (ENF arm) or not (control arm). The primary endpoint was the proportion of patients with CD4 counts of ≥200/mm3 at week 24. A total of 195 patients were randomized: 73% had stage C disease, 78% were male, the mean age was 44 years, the median CD4 count was 30/mm3, and the median HIV-1 RNA load was 5.4 log10 copies/ml. Eighty-one percent of patients received LPV/r. One patient was lost to follow-up, and eight discontinued the study (four in each arm). The proportions of patients with CD4 counts of ≥200/mm3 at week 24 were 34% and 38% in the ENF and control arms, respectively (P = 0.53). The proportions of patients with HIV-1 RNA loads of <50 copies/ml were 74% and 58% at week 24 in the ENF and control arms, respectively (P < 0.02), and the proportion reached 79% in both arms at week 48. Twenty (20%) and 12 patients (13%) in the ENF and control arms, respectively, experienced at least one AIDS event during follow-up (P = 0.17). Although inducing a more rapid virological response, addition of ENF to a standard cART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression. PMID:23165467

Different rectal toxicity tolerance with and without simultaneous conventionally-fractionated pelvic lymph node treatment in patients receiving hypofractionated prostate radiotherapy.

PubMed

McDonald, Andrew M; Baker, Christopher B; Popple, Richard A; Shekar, Kiran; Yang, Eddy S; Jacob, Rojymon; Cardan, Rex; Kim, Robert Y; Fiveash, John B

2014-06-03

To investigate added morbidity associated with the addition of pelvic elective nodal irradiation (ENI) to hypofractionated radiotherapy to the prostate. Two-hundred twelve patients, treated with hypofractionated radiotherapy to the prostate between 2004 and 2011, met the inclusion criteria for the analysis. All patients received 70 Gy to the prostate delivered over 28 fractions and 103 (49%) received ENI consisting of 50.4 Gy to the pelvic lymphatics delivered simultaneously in 1.8 Gy fractions. The mean dose-volume histograms were compared between the two subgroups defined by use of ENI, and various dose-volume parameters were analyzed for effect on late lower gastrointestinal (GI) and genitourinary (GU) toxicity. Acute grade 2 lower GI toxicity occurred in 38 (37%) patients receiving ENI versus 19 (17%) in those who did not (p = 0.001). The Kaplan-Meier estimate of grade ≥ 2 lower GI toxicity at 3 years was 15.3% for patients receiving ENI versus 5.3% for those who did not (p = 0.026). Each rectal isodose volume was increased for patients receiving ENI up to 50 Gy (p ≤ 0.021 for each 5 Gy increment). Across all patients, the absolute V70 of the rectum was the only predictor of late GI toxicity. When subgroups, defined by the use of ENI, were analyzed separately, rectal V70 was only predictive of late GI toxicity for patients who received ENI. For patients receiving ENI, V70 > 3 cc was associated with an increased risk of late GI events. Elective nodal irradiation increases the rates of acute and late GI toxicity when delivered simultaneously with hypofractioanted prostate radiotherapy. The use of ENI appears to sensitize the rectum to hot spots, therefore we recommend added caution to minimize the volume of rectum receiving 100% of the prescription dose in these patients.

Different rectal toxicity tolerance with and without simultaneous conventionally-fractionated pelvic lymph node treatment in patients receiving hypofractionated prostate radiotherapy

PubMed Central

2014-01-01

Purpose To investigate added morbidity associated with the addition of pelvic elective nodal irradiation (ENI) to hypofractionated radiotherapy to the prostate. Methods and materials Two-hundred twelve patients, treated with hypofractionated radiotherapy to the prostate between 2004 and 2011, met the inclusion criteria for the analysis. All patients received 70 Gy to the prostate delivered over 28 fractions and 103 (49%) received ENI consisting of 50.4 Gy to the pelvic lymphatics delivered simultaneously in 1.8 Gy fractions. The mean dose-volume histograms were compared between the two subgroups defined by use of ENI, and various dose-volume parameters were analyzed for effect on late lower gastrointestinal (GI) and genitourinary (GU) toxicity. Results Acute grade 2 lower GI toxicity occurred in 38 (37%) patients receiving ENI versus 19 (17%) in those who did not (p = 0.001). The Kaplan-Meier estimate of grade ≥ 2 lower GI toxicity at 3 years was 15.3% for patients receiving ENI versus 5.3% for those who did not (p = 0.026). Each rectal isodose volume was increased for patients receiving ENI up to 50 Gy (p ≤ 0.021 for each 5 Gy increment). Across all patients, the absolute V70 of the rectum was the only predictor of late GI toxicity. When subgroups, defined by the use of ENI, were analyzed separately, rectal V70 was only predictive of late GI toxicity for patients who received ENI. For patients receiving ENI, V70 > 3 cc was associated with an increased risk of late GI events. Conclusions Elective nodal irradiation increases the rates of acute and late GI toxicity when delivered simultaneously with hypofractioanted prostate radiotherapy. The use of ENI appears to sensitize the rectum to hot spots, therefore we recommend added caution to minimize the volume of rectum receiving 100% of the prescription dose in these patients. PMID:24893842

Effects of multimedia nursing education on disease-related depression and anxiety in patients staying in a coronary intensive care unit.

PubMed

Demircelik, Muhammed Bora; Cakmak, Muzaffer; Nazli, Yunus; Şentepe, Esra; Yigit, Derya; Keklik, Mevlude; Arslan, Muzeyyen; Cetin, Mustafa; Eryonucu, Beyhan

2016-02-01

We evaluated the effectiveness of an accessibility-enhanced multimedia informational educational program in reducing depression and anxiety increasing satisfaction with the information and materials received by patients in coronary care unit. We selected 100 patients from among the patients who stayed at or who underwent surgery at one of two ICUs for any reason who satisfied the eligibility criteria, and agreed to participate in the research. The participants were included in the control or experimental group by random selection. The patients completed the Hospital Anxiety Depression Scale during ICU admission and 1week after hospital discharge. The difference in HADSA score was significantly greater in patients who received education than in patients who did not receive multimedia nursing education (4.2±0.58 vs. 0.6±0.42; p<.01). Additionally, the difference in HADSD score was significantly greater in patients who received multimedia nursing education (2.2±0.53 vs. 0.64±0.46; p<.01). This study showed that anxiety and depression associated with hospital can be reduced with multimedia nursing education. Copyright © 2015 Elsevier Inc. All rights reserved.

Informed consent in rhinoplasty: prospective randomized study of risk recall in patients who are given written disclosure of risks versus traditional oral discussion groups.

PubMed

Hong, Paul; Makdessian, Ara Samuel; Ellis, David A F; Taylor, S Mark

2009-06-01

To determine the effectiveness of providing written information in enhancing patient understanding and retention. A multicentre prospective randomized study was conducted in university-affiliated ambulatory surgical centres. One hundred consecutive patients seen for rhinoplasty consultation were included. Patients were randomly assigned to (1) those receiving traditional oral dialogue of the surgical risks or (2) those receiving an oral discussion and a written pamphlet outlining the risks of the procedure. Fourteen to 18 days after the consultation, each patient was contacted for an assessment of risk recall. Overall risk recall was higher in the group that received written information (2.3 vs 1.3 of 5 risks; p < .008). As well, in the group that received a pamphlet, patients with university and postgraduate levels of education had a better rate of recall (p < .05). Female patients in both groups reported higher risk recall (p < .01). Patient risk recall of rhinoplasty is improved with the addition of written information during the informed consent process. As the process of informed consent plays a very decisive role in facial plastic surgery, enhanced postoperative satisfaction may result from the use of supplemental educational materials.

Epstein-Barr virus DNA loads in adult human immunodeficiency virus type 1-infected patients receiving highly active antiretroviral therapy

NASA Technical Reports Server (NTRS)

Ling, Paul D.; Vilchez, Regis A.; Keitel, Wendy A.; Poston, David G.; Peng, Rong Sheng; White, Zoe S.; Visnegarwala, Fehmida; Lewis, Dorothy E.; Butel, Janet S.

2003-01-01

Patients with human immunodeficiency virus type 1 (HIV-1) infection are at high risk of developing Epstein-Barr virus (EBV)-associated lymphoma. However, little is known of the EBV DNA loads in patients receiving highly active antiretroviral therapy (HAART). Using a real-time quantitative polymerase chain reaction assay, we demonstrated that significantly more HIV-1-infected patients receiving HAART than HIV-1-uninfected volunteers had detectable EBV DNA in blood (57 [81%] of 70 vs. 11 [16%] of 68 patients; P=.001) and saliva (55 [79%] of 68 vs. 37 [54%] of 68 patients; P=.002). The mean EBV loads in blood and saliva samples were also higher in HIV-1-infected patients than in HIV-1-uninfected volunteers (P=.001). The frequency of EBV detection in blood was associated with lower CD4+ cell counts (P=.03) among HIV-1-infected individuals, although no differences were observed in the EBV DNA loads in blood or saliva samples in the HIV-1-infected group. Additional studies are needed to determine whether EBV-specific CD4+ and CD8+ cells play a role in the pathogenesis of EBV in HIV-1-infected patients receiving HAART.

Multicenter Evaluation of Octreotide as Secondary Prophylaxis in Patients With Left Ventricular Assist Devices and Gastrointestinal Bleeding.

PubMed

Shah, Keyur B; Gunda, Sampath; Emani, Sitaramesh; Kanwar, Manreet K; Uriel, Nir; Colombo, Paolo C; Uber, Patricia A; Sears, Melissa L; Chuang, Joyce; Farrar, David J; Brophy, Donald F; Smallfield, George B

2017-11-01

Gastrointestinal (GI) bleeding is one of the most common complications after continuous-flow left ventricular assist device implantation. More than one third of patients with incident bleed go on to develop recurrent GI bleeding. Octreotide, a somatostatin analog, is proposed to reduce the risk of recurrent GI bleeding in this population. This multicenter, retrospective analysis evaluated 51 continuous-flow left ventricular assist device patients who received secondary prophylaxis with octreotide after their index GI bleed from 2009 to 2015. All patients had a hospitalization for GI bleed and received octreotide after discharge. Patient demographics, medical and medication history, and clinical characteristics of patients who rebled after receiving octreotide were compared with non-rebleeders. These data were also compared with matched historical control patients previously enrolled in the HMII (HeartMate II) clinical trials, none of whom received octreotide, to provide a context for the bleeding rates. Twelve patients (24%) who received secondary octreotide prophylaxis developed another GI bleed, whereas 39 (76%) did not. There were similar intergroup demographics; however, significantly more bleeders had a previous GI bleeding history before left ventricular assist device placement (33% versus 5%; P =0.02) and greater frequency of angiodysplasia confirmed during endoscopy (58% versus 23%; P =0.03). Fewer patients in this study experienced a recurrent GI bleed compared with a matched historical control group that did not receive octreotide (24% versus 43%; P =0.04). Patients with continuous-flow left ventricular assist device receiving secondary prophylaxis with octreotide had a significantly lower GI bleed recurrence compared with historical controls not treated with octreotide. Additional prospective studies are needed to confirm these data. © 2017 American Heart Association, Inc.

The impact of radiation therapy sequencing on survival and cardiopulmonary mortality in the combined modality treatment of patients with esophageal cancer.

PubMed

Wojcieszynski, Andrzej P; Berman, Abigail T; Wan, Fei; Plastaras, John P; Metz, James M; Mitra, Nandita; Apisarnthanarax, Smith

2013-06-01

The addition of chemoradiation (CRT) to surgery has been shown to improve survival in patients with esophageal cancer. In the current study, the authors determined whether the sequencing of CRT has an effect on survival and cardiopulmonary mortality in patients with esophageal cancer. Patients with the following inclusion criteria were identified within 17 Surveillance, Epidemiology, and End Results registries from 1988 through 2007: adenocarcinoma or squamous cell carcinoma of the esophagus and having undergone esophagectomy. Patients who died within 90 days of surgery were excluded. Demographic, tumor, and survival data were compared between patients receiving preoperative and postoperative RT. Cox proportional hazards regression models were calculated to identify parameters associated with cause-specific survival and overall survival. A competing risk analysis was performed to account for death due to esophageal cancer in the calculation of cardiopulmonary mortality. Of 5512 patients, 1881 received preoperative RT, 901 received postoperative RT, and 2730 did not receive RT. Patients receiving preoperative RT had improved 5-year cause-specific survival (41% vs 31%; P < .0001) and overall survival (33% vs 23%; P < .0001) compared with those receiving postoperative RT. No differences in adjusted cardiopulmonary mortality were found between patients who received RT versus those who did not (8% vs 10% at 10 years; hazards ratio [HR], 0.84 [95% confidence interval (95% CI), 0.64-1.12] [P = .24]) or between those treated with preoperative RT versus those treated with postoperative RT (HR, 0.70; 95% CI, 0.46-1.08 [P = .11]). These population-based data support the use of preoperative RT in patients with locally advanced esophageal cancer. RT should not be withheld out of concern for cardiopulmonary mortality. Copyright © 2013 American Cancer Society.

Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14.

PubMed

Konski, Andre; Desilvio, Michelle; Hartsell, William; Watkins-Bruner, Deborah; Coyne, James; Scarantino, Charles; Janjan, Nora

2006-09-01

The specific aim of this study was to evaluate outcome differences by gender and partner status for patients treated on Radiation Therapy Oncology Group (RTOG) protocol 97-14. RTOG 97-14 randomized patients with metastatic breast or prostate cancer to bone to receive 8 Gy in 1 fraction or 30 Gy in 10 fractions. Retreatment rates and overall survival were made based upon gender, marital status, and Karnofsky Performance Status (KPS). The cumulative incidence method was used to estimate retreatment time at 36 months from enrollment, and Gray's test was used to test for treatment differences within the same groupings. Marital status, gender, KPS, and treatment were variables tested in a univariate Cox model evaluating the time to retreatment. Married men and women and single women receiving 30 Gy had significantly longer time to retreatment, p = 0.0067, p = 0.0052, and p = 0.0009 respectively. We failed to show a difference in retreatment rates over time in single men receiving either 30 Gy or 8 Gy. Univariate analysis of the entire group determined patients receiving 30 Gy in 10 fractions significantly less likely to receive retreatment, p < 0.0001, with a trend toward single patients less likely to be re-treated, p = 0.07. Non-disease-related variables, such as social support, might influence the results of clinical trials with subjective endpoints such as retreatment rates. The statistically nonsignificant difference in the 36-month retreatment rates observed in single male patients receiving 8 Gy may be a result of inadequate social support systems in place to facilitate additional care. Patients receiving 8 Gy in a single fraction had significantly higher retreatment rates compared with patients receiving 30 Gy in 10 fractions.

Diuretic or Beta-Blocker for Hypertensive Patients Already Receiving ACEI/ARB and Calcium Channel Blocker.

PubMed

Tsai, Min-Shan; Tang, Chao-Hsiun; Lin, Chia-Ying; Chuang, Po-Ya; Chen, Nai-Chuan; Huang, Chien-Hua; Chang, Wei-Tien; Wang, Tzung-Dau; Yu, Ping-Hsun; Chen, Wen-Jone

2017-12-01

In patients already receiving combination of angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB) and calcium channel blocker (CCB), whether the choice of additional diuretic or beta-blocker affects the cardiovascular and cerebrovascular outcomes remains unclear. A total of 13,551 patients who were concurrently receiving three anti-hypertensive agents of different classes through outpatient clinics during 2004-2006 were identified from the National Health Insurance Research Database of Taiwan. Patients were further classified into two treatment groups according to the medication possession ratio of drug combinations; the A + B + C group as those who received concurrent therapy of ACEI/ARB, beta-blocker and CCB. The A + C + D group as patients who received ACEI/ARB, CCB, and diuretics. The event-free survival of stroke, acute myocardial infarction (AMI), mortality, and major adverse cardiovascular events (MACE) between the two treatment groups was investigated. After propensity score matching, there were 5120 patients in each group. There were no differences in the incidence of cardiovascular events between the two groups. In patients with prior history of cerebrovascular accident (CVA), the A + C + D group had a significantly higher AMI-free survival (adjusted HR = 1.56; 95% CI 1.051-2.307; p < 0.05) as compared with the A + B + C group. Adding a diuretic may be better than adding a beta-blocker for treating hypertensive patients with prior CVA history who have already received ACEIs/ARBs and CCBs.

Influence of vitamin C and E supplementation on the eradication rates of triple and quadruple eradication regimens for Helicobacter pylori infection.

PubMed

Demirci, Hakan; Uygun İlikhan, Sevil; Öztürk, Kadir; Üstündağ, Yücel; Kurt, Ömer; Bilici, Muammer; Köktürk, Furuzan; Uygun, Ahmet

2015-11-01

In our study, we aimed to assess the effect of vitamin E and C supplementation to triple and quadruple Helicobacter pylori eradication regimens. Four hundred patients with H. pylori infection were classified into four groups. Patients in group A (n=100) received amoxicillin, clarithromycin, and lansoprazole for 2 weeks. In group B, patients (n=100) received vitamins C and E for a month, in addition to amoxicillin, clarithromycin, and lansoprazole for 2 weeks. Patients in group C (n=100) received amoxicillin, clarithromycin, lansoprazole, and bismuth subcitrate for 2 weeks, whereas those in group D (n=100) received vitamins C and E for a month, in addition to amoxicillin, clarithromycin, lansoprazole, and bismuth subcitrate for 2 weeks. H. pylori eradication was assessed with the C14 urea breath test 2 months after the end of the therapy. The eradication rate was assessed using per-protocol (PP) and intention-to-treat (ITT) analyses. Three hundred forty-eight patients finished the study. The eradication of H. pylori was achieved in 63 of 84 patients (75%) by PP and 63 of 100 (63%) by ITT analysis in group A, 60 of 84 (71.4%) by PP and 60 of 100 (60%) by ITT analysis in group B, 72 of 89 (80.9 %) by PP and 72 of 100 (72%) by ITT analysis in group C, and 76 of 91 (83.5%) by PP and 76 of 100 (76%) by ITT analysis in group D. There was no remarkable change between groups A and B (p>0.05). Similar results were also found between groups D and C (p>0.05). This study revealed that supplementing vitamins C and E to either the triple or quadruple therapies did not provide an additional advantage for achieving significantly higher eradication rates for H. pylori.

Decreasing the complications of renal osteodystrophy secondary to high phosphorus levels by using an innovative self-monitoring educational program.

PubMed

Zagaroli, A M; Zimmer, S M; Bowes, J M; Hartley, K S

1995-01-01

We wanted continuous ambulatory peritoneal dialysis (CAPD) and continuous cycling peritoneal dialysis (CCPD) patients to become more cognitive of the complications of high-serum phosphorus levels (> 6.0 mg/dL). The phosphorus self-monitoring program was designed to encourage patients to be more responsible for preventing the complications of renal osteodystrophy. Patients' phosphorus levels were graphed monthly on a poster in the exam room. Additional posters discussed their responsibilities to control phosphorus and the complications associated with hyperphosphatemia. All patients received an informative letter regarding the inception of the program in March 1994 and also were assured total anonymity of their laboratory results. At monthly clinic appointments, they received additional written information on phosphorus and discussed their phosphorus levels. Our teaching method proved effective in our CAPD/CCPD population. In March 1994, 31% of our patients had a phosphorus level greater than 6.0 mg/dL versus 10% in September 1994. The ability of patients to see their monthly progress and the comparison with other patients encouraged much interest and questions regarding phosphorus control.

[Augmented antipsychotic therapy with pantogam active in patients with schizophrenia].

PubMed

Medvedev, V E; Frolova, V I; Gushanskaya, E V; Ter-Israelyan, A U

2015-01-01

to study the efficacy of the GABA-ergic drug pantogam active (D-, L-gopantenic acid) in patients with schizophrenia treated with typical neuroleptics and to assess the rate of treatment response and tolerability of the drug. A sample consisted of 70 patients with schizophrenia stratified into main (n=35) and control (n=35) groups. All patients received one of typical antipsychotics (haloperidol, zuclopenthixol, promazine or perphenazine). Patients of the main group received in addition pantogam active in dose of 1200-1800 mg daily. The maximum allowed dose of 1800 mg daily was used in 62.9% of the patients. The long-term combined therapy with the addition of D-, L-gopantenic acid (pantogam activ) allowed to achieve clinical improvement earlier (on 8th week in the main group versus 16th week in the control group). The frequency and severity of secondary negative symptoms associated with antipsychotic therapy were decreased as well. The high efficacy and tolerability of the combined therapy allow to improve quality of life in patients with schizophrenia and their compliance to treatment as well as to reduce costs of medical care.

Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness

PubMed Central

2014-01-01

Background Surgical pain is managed with multi-modal anaesthesia in total hip replacement (THR) and total knee replacement (TKR). It is unclear whether including local anaesthetic infiltration before wound closure provides additional pain control. Methods We performed a systematic review of randomised controlled trials of local anaesthetic infiltration in patients receiving THR or TKR. We searched MEDLINE, Embase and Cochrane CENTRAL to December 2012. Two reviewers screened abstracts, extracted data, and contacted authors for unpublished outcomes and data. Outcomes collected were post-operative pain at rest and during activity after 24 and 48 hours, opioid requirement, mobilisation, hospital stay and complications. When feasible, we estimated pooled treatment effects using random effects meta-analyses. Results In 13 studies including 909 patients undergoing THR, patients receiving local anaesthetic infiltration experienced a greater reduction in pain at 24 hours at rest by standardised mean difference (SMD) -0.61 (95% CI -1.05, -0.16; p = 0.008) and by SMD -0.43 (95% CI -0.78 -0.09; p = 0.014) at 48 hours during activity. In TKR, diverse multi-modal regimens were reported. In 23 studies including 1439 patients undergoing TKR, local anaesthetic infiltration reduced pain on average by SMD -0.40 (95% CI -0.58, -0.22; p < 0.001) at 24 hours at rest and by SMD -0.27 (95% CI -0.50, -0.05; p = 0.018) at 48 hours during activity, compared with patients receiving no infiltration or placebo. There was evidence of a larger reduction in studies delivering additional local anaesthetic after wound closure. There was no evidence of pain control additional to that provided by femoral nerve block. Patients receiving local anaesthetic infiltration spent on average an estimated 0.83 (95% CI 1.54, 0.12; p = 0.022) and 0.87 (95% CI 1.62, 0.11; p = 0.025) fewer days in hospital after THR and TKR respectively, had reduced opioid consumption, earlier mobilisation, and lower incidence of vomiting. Few studies reported long-term outcomes. Conclusions Local anaesthetic infiltration is effective in reducing short-term pain and hospital stay in patients receiving THR and TKR. Studies should assess whether local anaesthetic infiltration can prevent long-term pain. Enhanced pain control with additional analgesia through a catheter should be weighed against a possible infection risk. PMID:24996539

The impact of education and cooking methods on serum phosphate levels in patients on hemodialysis: 1-year study.

PubMed

Vrdoljak, Ivica; Panjkota Krbavčić, Ines; Bituh, Martina; Leko, Ninoslav; Pavlović, Draško; Vrdoljak Margeta, Tea

2017-04-01

Control of serum phosphate is important for patients on hemodialysis. The aim of the study was to determine if education based on phosphorus-reducing techniques in food preparation and thermal processing, and accordingly prepared and applied diets, will lead to better outcomes than a standard education program to improve phosphate control in patients on hemodialysis. Forty-seven patients on hemodialysis were divided between an intervention and a control group. All subjects received training about nutrition for hemodialysis patients by trained dietitian. In addition, subjects in the intervention group received additional training in phosphorus-reducing techniques in food preparation and received two hospital meals prepared using suggested cooking methods to reduce the phosphate content of food during dialysis treatment. Serum phosphate, serum albumin, and anthropometric parameters were measured, while nPCR was calculated, at the baseline and during the 1-year study. No differences in serum phosphate levels were observed between intervention (1.68 mmol/L [1.48-2.03]) and control group (1.88 mmol/L [1.57-2.2]) at baseline (P = 0.130). Although not statistically significant between groups the mean reduction was more apparent in the intervention group (-0.3 mmol/L (-0.4 to 0.1) vs. -0.2 (-0.5 to 0.1)), and lead to significantly reduction of phosphate binder therapy. During the study, the nPCR and anthropometric status of the patients did not change significantly. Providing additional education to hemodialysis patients on the specific cooking methods and accordingly prepared meals may decrease serum phosphate levels without significantly affecting nutritional status which may be useful in helping to prevent and treat hyperphosphatemia. © 2016 International Society for Hemodialysis.

Impact of sensory integration training on balance among stroke patients: sensory integration training on balance among stroke patients.

PubMed

Jang, Sang Hun; Lee, Jung-Ho

2016-01-01

This study attempts to investigate the impact that the sensory integration training has on the recovery of balance among patients with stroke by examining the muscle activity and limit of stability (LOS). A total of 28 subjects participated. The subjects were randomly allocated by the computer program to one of two groups: control (CON) group (n=15), sensory integration training (SIT) group (n=13). The research subjects received intervention five days a week for a total of four weeks. The CON group additionally received 30-minute general balance training, while the SIT group additionally received 30-minute sensory integration training. In the muscle activity, the improvement of Erector spinae (ES) and Gluteus medius (GM) was more significant in the SIT group than in the CON group. In the LOS, the improvement of affected side and forward side was significantly higher in the SIT group compared to the CON group. Sensory integration training can improve balance ability of patients with stroke by increasing muscle activity of stance limb muscles such as GM and trunk extensor such as ES along with enhancement of the limit of stability.

Factors influencing intensive care unit survival for critically ill elderly patients.

PubMed

Kleinpell, R M; Ferrans, C E

1998-01-01

To examine factors influencing intensive care unit (ICU) survival for critically ill elderly patients and to compare survivors and nonsurvivors of ICU on demographic and illness-related variables. Retrospective, ex post facto research design. Adult medical and surgical ICUs. The records of 164 survivors and 111 nonsurvivors from 2 medical-surgical ICUs were examined. Patients were placed into 3 age groups (middle-aged, young-old, and old-old) to compare outcomes for elderly ICU patients. ICU survival, ICU treatments received, severity of illness. The Acute Physiology Age and Chronic Health Evaluation II (APACHE II) was used to assess illness severity. Additional illness-related information was collected by chart review. Predictors of ICU nonsurvival were severity of illness (measured by APACHE II scores) and intubation. Comparison of survivors and nonsurvivors revealed no statistically significant differences in sex or age. For all age groups, nonsurvivors had significantly higher mean days of ICU hospitalization (F (1,239) = 7.20 P < .0078) and higher APACHE II scores (F (1,239) = 106.5 P < .0001). Analysis of ICU treatments received by the 3 age groups of survivors revealed a significant difference only on oxygen therapy, (chi-square = 10.2, df = 2, P = .006), with more young-old (aged 65 to 79) and old-old (aged 80 and older) ICU patients receiving oxygen therapy than middle-aged patients (aged 45 to 64). The findings of this study demonstrated that severity of illness was a predictor of ICU outcome; age was not. Additionally, age was not related to ICU treatments received.

Gender differences in treatment and clinical characteristics among patients receiving extended release naltrexone.

PubMed

Herbeck, Diane M; Jeter, Kira E; Cousins, Sarah J; Abdelmaksoud, Reham; Crèvecoeur-MacPhail, Desirée

2016-01-01

Further research is needed to investigate real-world acceptability of extended-release naltrexone for alcohol and opioid use disorders, and potential gender differences. This study examines treatment and clinical characteristics among men and women receiving extended-release naltrexone in a large, publicly funded substance use disorder treatment system (N = 465; 52% female). Patient demographics, treatment characteristics, and the number of extended-release naltrexone doses received were collected from administrative data and treatment program staff. Additionally, patients provided information on experiences with extended-release naltrexone in an open-ended format at 1, 2, and 3 weeks following their first injection. For a subsample of patients (N = 220), alcohol/opioid cravings and specific adverse effects were also assessed. Compared to men, women reported experiencing a higher rate and mean number of adverse effects. Overall, craving scores showed substantial reductions over time. However, among patients taking extended-release naltrexone for alcohol use, women showed a significantly greater reduction in craving scores compared to men. No gender differences were observed in the number of extended-release naltrexone doses received. Although women may have a greater need for additional support in managing early adverse effects, extended-release naltrexone as an adjunct to psychosocial treatment may be an acceptable and promising treatment approach for both men and women, and particularly for women prescribed extended-release naltrexone for alcohol use. This study contributes further information on patients' experiences during the early course of extended-release naltrexone treatment in real-world settings. Understanding these experiences may assist policy makers and treatment providers in addressing challenges of implementing this treatment into wider practice.

Positron Emission Tomography-Guided Therapy of Aggressive Non-Hodgkin Lymphomas (PETAL): A Multicenter, Randomized Phase III Trial.

PubMed

Dührsen, Ulrich; Müller, Stefan; Hertenstein, Bernd; Thomssen, Henrike; Kotzerke, Jörg; Mesters, Rolf; Berdel, Wolfgang E; Franzius, Christiane; Kroschinsky, Frank; Weckesser, Matthias; Kofahl-Krause, Dorothea; Bengel, Frank M; Dürig, Jan; Matschke, Johannes; Schmitz, Christine; Pöppel, Thorsten; Ose, Claudia; Brinkmann, Marcus; La Rosée, Paul; Freesmeyer, Martin; Hertel, Andreas; Höffkes, Heinz-Gert; Behringer, Dirk; Prange-Krex, Gabriele; Wilop, Stefan; Krohn, Thomas; Holzinger, Jens; Griesshammer, Martin; Giagounidis, Aristoteles; Raghavachar, Aruna; Maschmeyer, Georg; Brink, Ingo; Bernhard, Helga; Haberkorn, Uwe; Gaska, Tobias; Kurch, Lars; van Assema, Daniëlle M E; Klapper, Wolfram; Hoelzer, Dieter; Geworski, Lilli; Jöckel, Karl-Heinz; Scherag, André; Bockisch, Andreas; Rekowski, Jan; Hüttmann, Andreas

2018-05-11

Purpose Interim positron emission tomography (PET) using the tracer, [ 18 F]fluorodeoxyglucose, may predict outcomes in patients with aggressive non-Hodgkin lymphomas. We assessed whether PET can guide therapy in patients who are treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Patients and Methods Newly diagnosed patients received two cycles of CHOP-plus rituximab (R-CHOP) in CD20-positive lymphomas-followed by a PET scan that was evaluated using the ΔSUV max method. PET-positive patients were randomly assigned to receive six additional cycles of R-CHOP or six blocks of an intensive Burkitt's lymphoma protocol. PET-negative patients with CD20-positive lymphomas were randomly assigned or allocated to receive four additional cycles of R-CHOP or the same treatment with two additional doses rituximab. The primary end point was event-free survival time as assessed by log-rank test. Results Interim PET was positive in 108 (12.5%) and negative in 754 (87.5%) of 862 patients treated, with statistically significant differences in event-free survival and overall survival. Among PET-positive patients, 52 were randomly assigned to R-CHOP and 56 to the Burkitt protocol, with 2-year event-free survival rates of 42.0% (95% CI, 28.2% to 55.2%) and 31.6% (95% CI, 19.3% to 44.6%), respectively (hazard ratio, 1.501 [95% CI, 0.896 to 2.514]; P = .1229). The Burkitt protocol produced significantly more toxicity. Of 754 PET-negative patients, 255 underwent random assignment (129 to R-CHOP and 126 to R-CHOP with additional rituximab). Event-free survival rates were 76.4% (95% CI, 68.0% to 82.8%) and 73.5% (95% CI, 64.8% to 80.4%), respectively (hazard ratio, 1.048 [95% CI, 0.684 to 1.606]; P = .8305). Outcome prediction by PET was independent of the International Prognostic Index. Results in diffuse large B-cell lymphoma were similar to those in the total group. Conclusion Interim PET predicted survival in patients with aggressive lymphomas treated with R-CHOP. PET-based treatment intensification did not improve outcome.

Patient satisfaction survey of mandibular two-implant-retained overdentures in a predoctoral program.

PubMed

Dias, Renata; Moghadam, Marjan; Kuyinu, Esther; Jahangiri, Leila

2013-08-01

In response to the Commission of Dental Accreditation (CODA) mandate of a competency in the "replacement of teeth including fixed, removable and implant" prostheses, a predoctoral implant curriculum was implemented at New York University College of Dentistry. The assessment of the success or failure of a program should include an assessment of patient satisfaction with the treatment received in the predoctoral clinics. The purpose of this study was to measure patient satisfaction with the mandibular 2-implant-retained overdenture therapy received in the predoctoral program at New York University College of Dentistry. A telephone survey of patients who received an implant-retained overdenture in the predoctoral clinics at New York University, College of Dentistry (n=101) was conducted. Two of the authors contacted patients for participation in the survey and, using a prepared script, asked about their satisfaction with items such as function, comfort, and esthetics in addition to their overall satisfaction with the treatment they received. Data were analyzed with descriptive statistics. The study revealed that 79% of participants were satisfied with their masticatory ability, 84% were satisfied with the comfort of the prosthesis, and 89% were satisfied with the esthetics of their new prosthesis. Additionally, 85% of participants reported satisfaction with the overall treatment experience, and 90% would recommend that a friend receive the same treatment. The results of this study support the incorporation of treatment with an implant-retained mandibular overdenture as part of the routine care provided in the predoctoral education program to meet the mandates of CODA. Copyright © 2013 The Editorial Council of the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

Use of Piggyback Electrolytes for Patients Receiving Individually Prescribed vs Premixed Parenteral Nutrition.

PubMed

Busch, Rebecca A; Curtis, Caitlin S; Leverson, Glen E; Kudsk, Kenneth A

2015-07-01

Parenteral nutrition (PN) is available as individualized prescriptions frequently prepared with an automated compounding device or as commercially prepared premixed solutions. Our institution exclusively used individualized PN until an amino acid shortage forced a temporary switch to premixed solutions. In general, premixed solutions contain lower electrolyte levels than individualized formulations prescribed for patients with normal organ function. We aimed to quantify supplemental intravenous piggyback (IVPB) electrolyte use in adult patients receiving individualized and premixed PN and to quantify any effect on difference in the cost of therapy. We compared use of supplemental IVPB electrolytes administered to patients receiving PN during consecutive periods prior to and during the amino acid shortage. Electrolyte IVPBs tabulated were potassium chloride, 10 and 20 mEq; magnesium sulfate, 2 g and 4 g; potassium phosphate, 7.5 and 15 mmol; and sodium phosphate, 7.5 and 15 mmol IVPB. There was no statistical difference in the number of PN formulations administered per day during each period (14.7 ± 3.9 vs 14.0 ± 2.6, individualized vs premixed, respectively). Total IVPB electrolytes prescribed per day increased significantly from the individualized PN period to the premixed PN period (7.03 ± 3.8 vs 13.8 ± 6.8; P < .0001). The additional IVPB electrolyte supplementation required in patients receiving premixed PN was associated with an additional $11,855.74 cost per 30 days of therapy compared with those who received individualized PN. Inpatient use of premixed PN results in a significant increase in IVPB electrolyte supplementation and cost compared with individualized PN use. © 2014 American Society for Parenteral and Enteral Nutrition.

Penetration of topical, oral, and combined administered ofloxacin into the subretinal fluid

PubMed Central

Cekic, O.; Batman, C.; Yasar, U.; Totan, Y.; Basci, N.; Bozkurt, A.; Zilelioglu, O.; Kayaalp, S

1999-01-01

AIMS—To assess the subretinal fluid (SRF) levels of ofloxacin following topical, oral or combined administration.
METHODS—31 patients undergoing conventional retinal reattachment surgery were randomly assigned to three groups. Nine patients received topical ofloxacin, 11 patients received oral ofloxacin, and the other 11 patients received combined administration. Collected SRF samples were analysed for drug level by using high performance liquid chromatography.
RESULTS—SRF drug levels after oral and combined administration were significantly higher than that after topical administration (p=0.0002 and p=0.0002, respectively) while there was no significant difference between oral and combined administration (p=0.0844).
CONCLUSIONS—Ocular bioavailability of ofloxacin in SRF after oral and combined administration is equivalent. The addition of oral ofloxacin to topical therapy increased drug SRF penetration sixfold.

 PMID:10502583

Immunoadsorption (IAS) as a rescue therapy in SLE: considerations on safety and efficacy.

PubMed

Stummvoll, Georg H; Aringer, Martin; Jansen, Martin; Smolen, Josef S; Derfler, Kurt; Graninger, Winfried B

2004-11-30

In SLE, extracorporeal procedures aiming at reduction of immunoglobulin (Ig) and immune complexes (IC) are used as a rescue therapy. Plasma exchange (PE) has not been proven overall effective in SLE, and long-term treatment in particular has been associated with severe bacterial and viral infections. Immunoadsorption (IAS), in contrast, selectively removes Ig and IC and may thus be safer. We therefore investigated the rate of infections in SLE patients who were undergoing long-term IAS. 16 SLE patients were treated with > or = 10 courses of IAS, and nine patients with highly active disease received pulse cyclophosphamide (IVCP) therapy in parallel. We retrospectively analysed the records of all these patients for the occurrence of infections. Patients receiving IAS therapy plus IVCP were compared with 25 patients with similarly active disease treated with standard IVCP therapy within the same observation period. Patients receiving IAS without additional IVCP were compared with patients with similarly moderate disease activity receiving neither IAS nor IVCP. No potentially life-threatening viral infection occurred in IAS-treated patients and episodes of herpes zoster were equally distributed. No severe infection was observed during IAS without concomittant cyclophosphamide. As expected, more patients with highly active disease receiving IVCP experienced infections than those with less active disease (16 of 34 [47%] vs. 2 of 22 [9%], p < 0.04). On comparing the two groups with highly active disease, infections were similar (IAS+IVCP: 3 of 9 patients [33%], IVCP only: 5 of 25 [20%]), but one patient receiving IAS+IVCP died of septicaemia. Disease activity significantly decreased in both groups treated with IAS. IAS has an acceptable safety profile with regard to severe infections and appears safe with regard to severe viral disease. Highly active disease and IVCP therapy increase the risk of severe infections in SLE.

Survival benefit of patients with early-stage ovarian carcinoma treated with paclitaxel chemotherapeutic regimens

PubMed Central

2018-01-01

Objective Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer (OC). The benefit of standard chemotherapeutic regimens including taxane has not been established. Methods Patients with early-stage OC from the National Health Insurance Research database of Taiwan who received platinum plus cyclophosphamide (CP) or platinum plus paclitaxel (PT) for 3–6 cycles were recruited, and the disease-free survival (DFS) and overall survival (OS) were determined. Results A total of 1,510 early-stage OC patients, including 841 who received CP regimen and 699 who received PT regimen, were included. The 2 groups had a similar estimated probability of 5-year DFS (PT vs. CP, 79.0% vs. 77.6%; p=0.410) and OS (84.6% vs. 84.3%; p=0.691). Patients >50 years of age who received the CP regimen had a lower 5-year DFS than the patients ≤50 years of age who received the CP (p<0.001) or PT regimens (p=0.001). Additionally, patients >50 years of age who received the CP regimen had a worse 5-year OS compared with the other 3 groups (p=0.019) (p=0.179 for patients >50 years of age in the PT group; p=0.002 for patients ≤50 years of age in the CP group; and p=0.061 for patients ≤50 years of age in the PT group). Patients with the CP or PT regimen for 3–5 cycles had a similar 5-year DFS and OS compared to 6 cycles (p>0.050). Conclusion Chemotherapeutic regimens with taxane could be recommended for early-stage OC patients >50 years of age. PMID:29185274

Psychosocial support and cognitive deficits in adults with schizophrenia.

PubMed

Dalagdi, Aikaterini; Arvaniti, Aikaterini; Papatriantafyllou, John; Xenitidis, Kiriakos; Samakouri, Maria; Livaditis, Miltos

2014-08-01

In recent decades there has been an increasing interest in cognitive deficits in schizophrenia. However, only a few studies have examined the impact of psychosocial support on the prevention of cognitive deterioration in patients who suffer from schizophrenia. The aims of the present study are: (1) to confirm the presence of cognitive deficits among patients with schizophrenia; (2) to explore any correlations between such deficits and a range of clinical and/or demographic characteristics of the patients; and (3) to investigate any association between cognitive deficits and psychosocial support. A total of 118 patients with schizophrenia (the patient group) and 102 healthy volunteers (the control group) had a cognitive assessment using a battery of neuropsychological tests. The patients were allocated to one of the following groups: (1) patients under routine outpatient follow-up; or (2) patients receiving or having recently received intensive psychosocial support, in addition to follow-up. This included daily participation in vocational and recreational activities provided by dedicated mental health day centers. The findings of the neuropsychological testing of individuals in all groups were compared, after controlling for clinical or demographic factors. The scores in the neuropsychological tests were lower overall in the patients group compared to healthy volunteers. Within the patients group, those receiving/having received psychosocial support had higher scores compared to those on routine follow-up alone. There were no significant differences between patients currently receiving psychosocial support and those having received it in the past. Lower education, age and illness duration (but not severity of positive or negative symptoms) were factors associated with lower test scores. The study provides some evidence that psychosocial support may be beneficial for the cognitive functioning of patients with schizophrenia and this benefit may be a lasting one. © The Author(s) 2013.

A win for the patient: Direct patient notification improves treatment rates of active Helicobacter pylori infection.

PubMed

Selvaratnam, Sriharan; Yeoh, Joey; Hsiang, John; Patrick, Alasdair B

2014-01-01

Current international guidelines recommend the commencement of effective eradication therapy as soon as active Helicobacter pylori (H. pylori) infection is confirmed. At our institution, all positive Campylobacter-like Organism (CLO) test results were automatically communicated to general practitioners (GPs) via a standardised letter, which also advised the commencement of eradication therapy. Despite this endeavour, a clinical audit conducted in 2011 demonstrated that only 66 per cent of confirmed H. pylori-positive South Auckland patients received eradication treatment and only 83 per cent of these patients received treatment within one month. Improve the timely initiation of H. pylori eradication therapy through direct patient notification. A prospective clinical audit of 109 consecutive outpatients with a positive CLO test identified at gastroscopy. In addition to standard general practitioner notification, patients were also directly notified of their positive CLO test result via a standardised letter, which provided information about H. pylori and its disease associations as well as advising patients to seek consultation with their GP to commence eradication therapy. Dispensing data was examined using Test Safe electronic records to determine the total uptake and timing of treatment compared to data from a preliminary 2011 audit. Ninety-five per cent of H. pylori-positive patients received standard triple therapy; therefore, treatment of active H. pylori infection was significantly higher when patients were directly notified in addition to standard GP notification, when compared to GP notification alone (95 per cent vs 66 per cent, p<0.001). All patients who received eradication therapy did so within one month of notification, a significant improvement compared to data from the previous audit in 2011 (100 per cent vs. 83 per cent, p<0.001). Direct patient notification using a standardised letter is a simple and economical strategy that significantly improves the timely initiation of eradication therapy for active H. pylori infection. This has since been integrated into standard practice at our District Health Board (DHB).

Long-term outcome of patients with acute cholecystitis receiving antibiotic treatment: a retrospective cohort study.

PubMed

Wang, Chih-Hung; Chou, Hao-Chang; Liu, Kao-Lang; Lien, Wan-Ching; Wang, Hsiu-Po; Wu, Yao-Ming

2014-02-01

Few studies have followed patients who received antibiotic treatment for acute cholecystitis (AC). The present retrospective study investigated recurrence rates of AC and analyzed factors associated with recurrence after antibiotic treatment in adult AC patients. We analyzed patients treated with antibiotics for AC between October 1, 2004, and November 30, 2010. A Cox proportional hazards model was used to identify factors associated with early recurrence. Generalized additive models were applied to detect the nonlinear effects of continuous covariates. The study included 226 patients (mean age: 62.2 years; 144 men [63.7 %]). The average duration of parenteral antibiotics was 8.0 days. Second-generation cephalosporins were administered to 199 patients (88.1 %). The Kaplan-Meier plot indicated that recurrences were more frequent within 100 days of AC; these were defined as early recurrences. The recurrence rate was 13.7 % (31/226) at a median follow-up of 308.5 days (early recurrences: 19/226 [8.4 %]). The duration of parenteral antibiotic use significantly correlated with early recurrence (hazard ratio: 0.83; 95 % confidence interval, 0.73-0.95; p = 0.005). Generalized additive models revealed that patients using parenteral antibiotics longer than 8 days were less likely to suffer from early recurrence. The rate of recurrence of AC in patients who received antibiotics alone was low. The recurrence rate was higher within 100 days of AC. Because of the inherent limitations of a retrospective study, further research is needed to identify factors associated with early recurrence.

Efficacy and safety of additional 200-mg dose of celecoxib in adult patients with postoperative pain following extraction of impacted third mandibular molar: a multicenter, randomized, double-blind, placebo-controlled, phase II study in Japan.

PubMed

Saito, Ken'ichi; Kaneko, Akihiro; Machii, Katsuyuki; Ohta, Hiroyoshi; Ohkura, Masayuki; Suzuki, Makoto

2012-02-01

Although third mandibular molar extraction is a widely used and validated model of acute pain for evaluating analgesic efficacy, a large proportion of patients experience moderate or severe pain following this procedure and require analgesia. Current treatment options have been associated with safety concerns and alternative therapies are sought. Our aim was to assess the efficacy and safety of an additional 200-mg dose of celecoxib, administered 5 to 12 hours after an initial 400-mg dose of the drug for the treatment of moderate or severe acute pain following extraction of an impacted third mandibular molar. This was a multicenter, randomized, double-blind, placebo-controlled, Phase II study. Patients experiencing moderate or severe pain within 1 to 2 hours following extraction of an impacted third mandibular molar received an initial 400-mg dose of celecoxib. Patients requiring additional analgesia were subsequently randomized to receive either an additional 200-mg dose of celecoxib or placebo 5 to 12 hours after the initial dose. The study was designed and conducted by Pfizer Inc. for approval of celecoxib in Japan for the indication of acute pain. The primary end point was the patient's impression of efficacy (4-category global evaluation scale). Secondary efficacy end points included pain intensity on a 4-category pain intensity scale, pain intensity on a 100-mm visual analog scale (VAS), and the pain intensity difference (100-mm VAS). In an exploratory analysis, use of rescue medication was evaluated. Primary and secondary end points were analyzed using the full analysis set. Assessment of the safety profile included a physical examination, measurement of pulse rate and blood pressure, standard 12-lead ECG, and laboratory tests. A total of 69 patients (celecoxib, 42/64 [65.6%]; placebo, 27/58 [46.6%]) received the additional dose of study medication; all completed the study without the need for rescue medication. A significantly higher proportion of patients in the celecoxib 200 mg group (41/64 [64.1%]) compared with the placebo group (15/58 [25.9%]) rated the study medication as "good" or "excellent" ≥ 2 hours after the additional dose (P < 0.0001). Pain intensity (VAS) 2 hours after the additional dose was significantly higher in the placebo group than in the celecoxib 200 mg group (P = 0.0003). The reduction in pain intensity from baseline to 2 hours after the additional dose of study medication was also significantly greater in the celecoxib 200 mg group than in the placebo group (P < 0.0001). The incidence of treatment-related, all-cause adverse events was slightly lower in patients receiving celecoxib 200 mg (20.3%) compared with placebo (31.0%). Overall, an additional 200-mg dose of celecoxib was well tolerated and efficacious in reducing the pain associated with extraction of an impacted third mandibular molar in the study population. ClinicalTrials.gov identifier: NCT01062113. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson’s Disease Fluctuating Patients: Post hoc Analysesof Studies 016 and SETTLE

PubMed Central

Cattaneo, Carlo; Sardina, Marco; Bonizzoni, Ermino

2016-01-01

Background: Studies 016 and SETTLE showed that safinamide was safe and effective as adjunct therapy in patients with advanced Parkinson’s disease (PD) and motor fluctuations. The addition of safinamide to a stable dose of levodopa alone or with other antiparkinsonian medications significantly increased ON time with no/non-troublesome dyskinesia, decreased OFF time and improved Parkinson’s symptoms. Objective: To evaluate the clinical effects of safinamide 100 mg/day on motor fluctuations and cardinal Parkinson’s symptoms in specific patient subgroups using pooled data from Studies 016 and SETTLE. Methods: Both studies were double blind, placebo-controlled, randomized, phase 3 trials which enrolled patients with mid- to late-stage PD experiencing motor fluctuations while receiving optimized and stable doses of levodopa, alone or with other dopaminergic treatments. The present post-hoc analyses assessed the change from baseline in ON time (with no or non-troublesome dyskinesia) and OFF time in subgroups of patients who were receiving only levodopa at baseline, who were classified as “mild fluctuators” (daily OFF time ≤4 h), and who were receiving concomitant dopaminergic therapy, with or without amantadine, and the effects of safinamide versus placebo on individual cardinal PD symptoms during ON time. Results: Safinamide significantly increased mean ON time (with no or non-troublesome dyskinesia) and reduced mean OFF time when used as first adjunct therapy in levodopa-treated patients and patients with mild motor fluctuations. Mean daily ON time (with no or non-troublesome dyskinesia) and OFF time were favorably changed, compared with placebo, to similar extents regardless of whether patients were receiving concomitant dopamine agonists, catechol-O-methyltransferase inhibitors and amantadine. Additionally, safinamide improved bradykinesia, rigidity, tremor and gait. Conclusions: Safinamide was a safe and effective first adjunct therapy in levodopa-treated patients and improved 4/5 cardinal symptoms of PD while providing benefits to mild and non-mild fluctuators and patients receiving other concomitant dopaminergic therapies. PMID:26889632

The effect of heat and moisture exchanger and gas flow on humidity and temperature in a circle anaesthetic system.

PubMed

Poopalalingam, R; Goh, M H; Chan, Y W

2002-11-01

The aim of the study was to measure the humidity and temperature of the inspired gas in a circle absorber system at fresh gas flows of 11/min and 31/min and assess the need of a heat and moisture exchanger (HME). This prospective randomised controlled study received the Hospital Ethics Committee approval and informed consent. Forty adult ASA 1 and 11 patients were randomised into four groups to receive with or without HME fresh gas flow of 1L/min or 3L/min. Temperature and the relative humidity readings were taken at the start and every 10 minutes for the first hour of anaesthesia. There was a significantly higher relative humidity, absolute humidity and temperatures of the inspired gases at fresh gas flow of 1L/min and 3L/min with a HME compared to 3L/min without HME. Patients receiving fresh gas flows of lL/min had higher relative and absolute humidity than patients with fresh gas flows of 3L/min. However, the addition of the HME improved the absolute and relative humidity of the inspired gas in patients receiving fresh gas flow of 3l/min to a comparable level. However, the addition of a HME to a fresh gas flow of 1L/min did not significantly improve the humidity of the inspired gas. This suggests that the inherent humidifying property of the circle system at low fresh gas flow of 1L/min was sufficient in short surgeries lasting less than one hour and that the addition of a HME may not be necessary.

Plasma Aluminum Concentrations in Pediatric Patients Receiving Long-Term Parenteral Nutrition.

PubMed

Courtney-Martin, Glenda; Kosar, Christina; Campbell, Alison; Avitzur, Yaron; Wales, Paul W; Steinberg, Karen; Harrison, Debra; Chambers, Kathryn

2015-07-01

Patients receiving long-term parenteral nutrition (PN) are at increased risk of aluminium (Al) toxicity because of bypass of the gastrointestinal tract during PN infusion. Complications of Al toxicity include metabolic bone disease (MBD), Al-associated encephalopathy in adults, and impaired neurological development in preterm infants. Unlike the United States, there are no regulations regarding Al content of large- and small-volume parenterals in Canada. We, therefore, aimed to present our data on plasma Al concentration and Al intake from our cohort of pediatric patients receiving long-term PN. Plasma Al concentration was retrospectively gathered from the patient charts of all 27 patients with intestinal failure (IF) receiving long-term PN at The Hospital for Sick Children, Toronto, Canada, and compared with age- and sex-matched controls recruited for comparison. In addition, Al concentration was measured in PN samples collected from 10 randomly selected patients with IF and used to determine their Al intake. The plasma Al concentration of patients with IF receiving long-term PN was significantly higher than that of control participants (1195 ± 710 vs 142 ± 63 nmol/L; P < .0001). In the subgroup of 10 patients for whom Al intake from their PN solution was determined, mean ± SD Al intake from PN was 15.4 ± 15 µg/kg, 3 times the Food and Drug Administration upper recommended intake level, and Al intake was significantly related to plasma Al concentration (P = .02, r (2) = 0.52). Pediatric patients receiving long-term PN for IF in Canada are at risk for Al toxicity. © 2014 American Society for Parenteral and Enteral Nutrition.

Impact of body image on patients' attitude towards conventional, minimal invasive, and natural orifice surgery.

PubMed

Lamadé, Wolfram; Friedrich, Colin; Ulmer, Christoph; Basar, Tarkan; Weiss, Heinz; Thon, Klaus-Peter

2011-03-01

A series of investigations proposed that patients' preference on minimal invasive and scarless surgery may be influenced by age, sex, and surgical as well as endoscopic history of the individual patient. However, it is unknown which psychological criteria lead to the acceptance of increased personal surgical risk or increased personal expenses in patients demanding scarless operations. We investigated whether individual body image contributes to the patient's readiness to assume higher risk in favor of potentially increased cosmesis. We conducted a nonrandomized survey among 63 consecutive surgical patients after receiving surgery. Individual body image perception was assessed postoperatively applying the FKB-20 questionnaire extended by four additional items. The FKB-20 questionnaire is a validated tool for measuring body image disturbances resulting in a two-dimensional score with negative body image (NBI) and vital body dynamics (VBD) being the two resulting scores. A subgroup analysis was performed according to the conducted operations: conventional open surgery = group 1, traditional laparoscopic surgery = group 2, and no scar surgery = group 3. There was a significant correlation between a negative body image and the preference for scar sparing and scarless surgery indicated by a significantly increased acceptance of surgical risks and the willingness to spend additional money for receiving scarless surgery (r = 0.333; p = 0.0227). Allocated to operation subgroups, 17 of 63 patients belonged to group 1 (OS), 29 to group 2 (minimally invasive surgery), and 17 patients to group 3 (no scar). Although age and sex were unequally distributed, the groups were homogenous regarding body mass index and body image (NBI). Subgroup analysis revealed that postoperative desire for scar sparing approaches was most frequently expressed by patients who received no scar operations. Patients with an NBI tend towards scarless surgery and are willing to accept increased operative risk and to spend additional money for improved postoperative cosmesis.

Postoperative PET/CT and target delineation before adjuvant radiotherapy in patients with oral cavity squamous cell carcinoma.

PubMed

Dutta, Pinaki R; Riaz, Nadeem; McBride, Sean; Morris, Luc G; Patel, Snehal; Ganly, Ian; Wong, Richard J; Palmer, Frank; Schöder, Heiko; Lee, Nancy

2016-04-01

The purpose of this study was for us to present our evaluation of the effectiveness of positron emission tomography (PET)/CT imaging in postoperative patients with oral cavity squamous cell carcinoma (SCC) before initiating adjuvant radiation therapy. Treatment planning PET/CT scans were obtained in 44 patients with oral cavity SCC receiving adjuvant radiation. We identified target areas harboring macroscopic disease requiring higher radiation doses or additional surgery. Fourteen PET/CT scans were abnormal. Thirteen patients underwent surgery and/or biopsy, increased radiation dose, and/or addition of chemotherapy. Eleven patients received higher radiation doses. Patients undergoing imaging >8 weeks were more likely to have abnormal results (p = .01). One-year distant metastases-free survival was significantly worse in patients with positive PET/CT scans (61.5% vs 92.7%; p = .01). The estimated positive predictive value (PPV) was 38% for postoperative PET/CT scanning. We demonstrated that 32% of patients have abnormal PET/CT scans resulting in management changes. Patients may benefit from postoperative PET/CT imaging to optimize adjuvant radiation treatment planning. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1285-E1293, 2016. © 2015 Wiley Periodicals, Inc.

The effect of royal jelly on oral mucositis in patients undergoing radiotherapy and chemotherapy.

PubMed

Erdem, Ozden; Güngörmüş, Zeynep

2014-01-01

This study was conducted to evaluate the effect of royal jelly on oral mucositis in patients undergoing radiotherapy and chemotherapy. The study population consisted of 103 patients undergoing radiotherapy and chemotherapy. Oral mucositis was graded according to the World Health Organization criteria, and patients were divided into 2 groups. All patients received mouthwash therapy with benzydamine hydrochloride and nystatin rinses. In addition, patients in the experimental group received royal jelly. The mean resolution time of oral mucositis in the royal jelly group was significantly shorter than that of the control group. As a result, the study results demonstrate that royal jelly administrated by a certain procedure improved the signs and symptoms of oral mucositis and markedly shortened its healing time.

The impact of 5-hydroxytryptamine-receptor antagonists on chemotherapy treatment adherence, treatment delay, and nausea and vomiting.

PubMed

Palli, Swetha Rao; Grabner, Michael; Quimbo, Ralph A; Rugo, Hope S

2015-01-01

To determine the incidence of chemotherapy-induced nausea/vomiting (CINV) and chemotherapy treatment delay and adherence among patients receiving palonosetron versus other 5-hydroxytryptamine receptor antagonist (5-HT3 RA) antiemetics. This retrospective claims analysis included adults with primary malignancies who initiated treatment consisting of single-day intravenous highly emetogenic chemotherapy (HEC) or moderately EC (MEC) regimens. Treatment delay was defined as a gap in treatment at least twice the National Comprehensive Cancer Network-specified cycle length, specific to each chemotherapy regimen. Treatment adherence was determined by the percentage of patients who received the regimen-specific recommended number of chemotherapy cycles within the recommended time frame. We identified 1,832 palonosetron and 2,387 other 5-HT3 RA ("other") patients who initiated HEC therapy, and 1,350 palonosetron users and 1,379 patients on other antiemetics who initiated MEC therapy. Fewer patients receiving palonosetron experienced CINV versus other (HEC, 27.5% versus 32.2%, P=0.0011; MEC, 36.1% versus 41.7%, P=0.0026), and fewer treatment delays occurred among patients receiving palonosetron versus other (HEC, 3.2% versus 6.0%, P<0.0001; MEC, 17.0% versus 26.8%, P<0.0001). Compared with the other cohort, patients receiving palonosetron were significantly more adherent to the index chemotherapy regimen with respect to the recommended time frame (HEC, 74.7% versus 69.7%, P=0.0004; MEC, 43.1% versus 37.3%, P=0.0019) and dosage (HEC, 27.3% versus 25.8%, P=0.0004; MEC, 15.0% versus 12.6%, P=0.0019). Palonosetron more effectively reduced occurrence of CINV in patients receiving HEC or MEC compared with other agents in this real-world setting. Additionally, patients receiving palonosetron had better adherence and fewer treatment delays than patients receiving other 5-HT3 RAs.

The impact of 5-hydroxytryptamine-receptor antagonists on chemotherapy treatment adherence, treatment delay, and nausea and vomiting

PubMed Central

Palli, Swetha Rao; Grabner, Michael; Quimbo, Ralph A; Rugo, Hope S

2015-01-01

Purpose To determine the incidence of chemotherapy-induced nausea/vomiting (CINV) and chemotherapy treatment delay and adherence among patients receiving palonosetron versus other 5-hydroxytryptamine receptor antagonist (5-HT3 RA) antiemetics. Materials and methods This retrospective claims analysis included adults with primary malignancies who initiated treatment consisting of single-day intravenous highly emetogenic chemotherapy (HEC) or moderately EC (MEC) regimens. Treatment delay was defined as a gap in treatment at least twice the National Comprehensive Cancer Network-specified cycle length, specific to each chemotherapy regimen. Treatment adherence was determined by the percentage of patients who received the regimen-specific recommended number of chemotherapy cycles within the recommended time frame. Results We identified 1,832 palonosetron and 2,387 other 5-HT3 RA (“other”) patients who initiated HEC therapy, and 1,350 palonosetron users and 1,379 patients on other antiemetics who initiated MEC therapy. Fewer patients receiving palonosetron experienced CINV versus other (HEC, 27.5% versus 32.2%, P=0.0011; MEC, 36.1% versus 41.7%, P=0.0026), and fewer treatment delays occurred among patients receiving palonosetron versus other (HEC, 3.2% versus 6.0%, P<0.0001; MEC, 17.0% versus 26.8%, P<0.0001). Compared with the other cohort, patients receiving palonosetron were significantly more adherent to the index chemotherapy regimen with respect to the recommended time frame (HEC, 74.7% versus 69.7%, P=0.0004; MEC, 43.1% versus 37.3%, P=0.0019) and dosage (HEC, 27.3% versus 25.8%, P=0.0004; MEC, 15.0% versus 12.6%, P=0.0019). Conclusion Palonosetron more effectively reduced occurrence of CINV in patients receiving HEC or MEC compared with other agents in this real-world setting. Additionally, patients receiving palonosetron had better adherence and fewer treatment delays than patients receiving other 5-HT3 RAs. PMID:26124681

The clinical and economic impact of nurse to patient staffing ratios in women receiving intrapartum oxytocin.

PubMed

Clark, Steven L; Saade, George A; Meyers, Janet A; Frye, Donna R; Perlin, Jonathan B

2014-02-01

To examine the relationship between nurse-to-patient staffing ratios and perinatal outcomes in women receiving oxytocin during labor. A retrospective analysis of perinatal outcomes in women receiving oxytocin for induction or augmentation of labor during 2010. Outcomes examined were fetal distress, birth asphyxia, primary cesarean delivery, chorioamnionitis, endomyometritis, and a composite of adverse events. Frequency of 1:1 nurse-to-patient staffing was determined for each hospital. Outcomes were compared between hospitals categorized into quartiles of staffing ratios. In 208,033 women delivering during 2010, there was no relation between frequency of 1:1 nurse-to-patient staffing ratio and improved perinatal outcomes. Adoption of universal 1:1 staffing in the United States would result in the need for an additional 27,000 labor nurses and a cost of $1.6 billion. Available data do not support the imposition of mandatory 1:1 nurse-to-patient staffing ratios for women receiving oxytocin in all U.S. facilities. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Surgery Followed by Radiotherapy Versus Radiotherapy Alone for Metastatic Spinal Cord Compression From Unfavorable Tumors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rades, Dirk, E-mail: Rades.Dirk@gmx.net; Huttenlocher, Stefan; Bajrovic, Amira

Purpose: Despite a previously published randomized trial, controversy exists regarding the benefit of adding surgery to radiotherapy for metastatic spinal cord compression (MSCC). It is thought that patients with MSCC from relatively radioresistant tumors or tumors associated with poor functional outcome after radiotherapy alone may benefit from surgery. This study focuses on these tumors. Methods and Materials: Data from 67 patients receiving surgery plus radiotherapy (S+RT) were matched to 134 patients (1:2) receiving radiotherapy alone (RT). Groups were matched for 10 factors and compared for motor function, ambulatory status, local control, and survival. Additional separate matched-pair analyses were performed formore » patients receiving direct decompressive surgery plus stabilization of involved vertebrae (DDSS) and patients receiving laminectomy (LE). Results: Improvement of motor function occurred in 22% of patients after S+RT and 16% after RT (p = 0.25). Posttreatment ambulatory rates were 67% and 61%, respectively (p = 0.68). Of nonambulatory patients, 29% and 19% (p = 0.53) regained ambulatory status. One-year local control rates were 85% and 89% (p = 0.87). One-year survival rates were 38% and 24% (p = 0.20). The matched-pair analysis of patients receiving LE showed no significant differences between both therapies. In the matched-pair analysis of patients receiving DDSS, improvement of motor function occurred more often after DDSS+RT than RT (28% vs. 19%, p = 0.024). Posttreatment ambulatory rates were 86% and 67% (p = 0.30); 45% and 18% of patients regained ambulatory status (p = 0.29). Conclusions: Patients with MSCC from an unfavorable primary tumor appeared to benefit from DDSS but not LE when added to radiotherapy in terms of improved functional outcome.« less

A Single Dose of Intraoperative Antibiotics Is Sufficient to Prevent Urinary Tract Infection During Ureteroscopy.

PubMed

Chew, Ben H; Flannigan, Ryan; Kurtz, Michael; Gershman, Boris; Arsovska, Olga; Paterson, Ryan F; Eisner, Brian H; Lange, Dirk

2016-01-01

American Urology Association (AUA) Best Practice Guidelines for ureteroscopic stone treatment recommend antibiotic coverage for <24 hours following the procedure. The purpose of this study was to evaluate if the addition of postoperative antibiotics reduces urinary tract infections (UTIs) following ureteroscopic stone treatment beyond the recommended preoperative dose. A retrospective review was performed of consecutive patients at two institutions, University of British Columbia and Massachusetts General Hospital, Harvard. All patients received a single dose of antibiotics before ureteroscopic stone treatment. A subset of patients was also given postoperative antibiotics. The rate of UTI was compared in patients receiving only preoperative antibiotics (group 1) vs those who received pre- and postoperative antibiotics (group 2). Eighty-one patients underwent ureteroscopy for renal calculi. Mean time to follow up was 42 ± 88 days. Eight (9.9%) patients in total (two from group 1 and six from group 2, p = 0.1457) developed UTIs postoperatively. In group 1, both patients presented with pyelonephritis (n = 2); those patients with infections in group 2 presented with urosepsis (n = 2) and cystitis (n = 2) and two patients had asymptomatic bacteriuria. Risk factors such as preoperative stenting, nephrostomy tubes, and foley catheters neither differed between groups nor did they predispose patients to postoperative infections. The postoperative UTI rate in this study (9.9%) is consistent with previous reports. Our data suggest that a single preoperative dose of antibiotics is sufficient, and additional postoperative antibiotics do not decrease infection rates after ureteroscopic stone treatment. Risk for selection bias is a potential limitation.

Photodynamic therapy in treatment of severe oral lichen planus.

PubMed

Rabinovich, O F; Rabinovich, I M; Guseva, A V

2016-01-01

The aim of the study was to elaborate the rationale for the application of photodynamic therapy in complex treatment of patient with severe oral lichen planus. Complex clinical and laboratory examination and treatment was performed in 54 patients divided on 3 groups. Diagnosis of oral lichen planus was based on clinical, histological and immunohistochemical features. Group 1 received standard treatment, in the second group photodynamic therapy was conducted in addition to conventional treatment, patients in the third group received only photodynamic therapy. The study results proved photodynamic therapy to be useful tool in complex treatment of severe oral lichen planus.

Addition of sildenafil to long-term intravenous epoprostenol therapy in patients with pulmonary arterial hypertension: a randomized trial.

PubMed

Simonneau, Gérald; Rubin, Lewis J; Galiè, Nazzareno; Barst, Robyn J; Fleming, Thomas R; Frost, Adaani E; Engel, Peter J; Kramer, Mordechai R; Burgess, Gary; Collings, Lorraine; Cossons, Nandini; Sitbon, Olivier; Badesch, David B

2008-10-21

Oral sildenafil and intravenous epoprostenol have independently been shown to be effective in patients with pulmonary arterial hypertension. To investigate the effect of adding oral sildenafil to long-term intravenous epoprostenol in patients with pulmonary arterial hypertension. A 16-week, double-blind, placebo-controlled, parallel-group study. Multinational study at 41 centers in 11 countries from 3 July 2003 to 27 January 2006. 267 patients with pulmonary arterial hypertension (idiopathic, associated anorexigen use or connective tissue disease, or corrected congenital heart disease) who were receiving long-term intravenous epoprostenol therapy. Patients were randomly assigned to receive placebo or sildenafil, 20 mg three times daily, titrated to 40 mg and 80 mg three times daily, as tolerated, at 4-week intervals. Of 265 patients who received treatment, 256 (97%) patients (123 in the placebo group and 133 in the sildenafil group) completed the study. Change from baseline in exercise capacity measured by 6-minute walk distance (primary end point) and hemodynamic measurements, time to clinical worsening, and Borg dyspnea score (secondary end points). A placebo-adjusted increase of 28.8 meters (95% CI, 13.9 to 43.8 meters) in the 6-minute walk distance occurred in patients in the sildenafil group; these improvements were most prominent among patients with baseline distances of 325 meters or more. Relative to epoprostenol monotherapy, addition of sildenafil resulted in a greater change in mean pulmonary arterial pressure by -3.8 mm Hg (CI, -5.6 to -2.1 mm Hg); cardiac output by 0.9 L/min (CI, 0.5 to 1.2 L/min); and longer time to clinical worsening, with a smaller proportion of patients experiencing a worsening event in the sildenafil group (0.062) than in the placebo group (0.195) by week 16 (P = 0.002). Health-related quality of life also improved in patients who received combined therapy compared with those who received epoprostenol monotherapy. There was no effect on the Borg dyspnea score. Of the side effects generally associated with sildenafil treatment, the most commonly reported in the placebo and sildenafil groups, respectively, were headache (34% and 57%; difference, 23 percentage points [CI, 12 to 35 percentage points]), dyspepsia (2% and 16%; difference, 13 percentage points [CI, 7 to 20 percentage points]), pain in extremity (18% and 25%; difference, 8 percentage points [CI, -2 to 18 percentage points]), and nausea (18% and 25%; difference, 8 percentage points [CI, -2 to 18 percentage points]). The study excluded patients with pulmonary arterial hypertension associated with other causes. There was an imbalance in missing data between groups, with 8 placebo recipients having no postbaseline walk assessment compared with 1 sildenafil recipient. These patients were excluded from the analysis. In some patients with pulmonary arterial hypertension, the addition of sildenafil to long-term intravenous epoprostenol therapy improves exercise capacity, hemodynamic measurements, time to clinical worsening, and quality of life, but not Borg dyspnea score. Increased rates of headache and dyspepsia occurred with the addition of sildenafil.

Effect of food additives on hyperphosphatemia among patients with end-stage renal disease: a randomized controlled trial.

PubMed

Sullivan, Catherine; Sayre, Srilekha S; Leon, Janeen B; Machekano, Rhoderick; Love, Thomas E; Porter, David; Marbury, Marquisha; Sehgal, Ashwini R

2009-02-11

High dietary phosphorus intake has deleterious consequences for renal patients and is possibly harmful for the general public as well. To prevent hyperphosphatemia, patients with end-stage renal disease limit their intake of foods that are naturally high in phosphorus. However, phosphorus-containing additives are increasingly being added to processed and fast foods. The effect of such additives on serum phosphorus levels is unclear. To determine the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels among patients with end-stage renal disease. Cluster randomized controlled trial at 14 long-term hemodialysis facilities in northeast Ohio. Two hundred seventy-nine patients with elevated baseline serum phosphorus levels (>5.5 mg/dL) were recruited between May and October 2007. Two shifts at each of 12 large facilities and 1 shift at each of 2 small facilities were randomly assigned to an intervention or control group. Intervention participants (n=145) received education on avoiding foods with phosphorus additives when purchasing groceries or visiting fast food restaurants. Control participants (n=134) continued to receive usual care. Change in serum phosphorus level after 3 months. At baseline, there was no significant difference in serum phosphorus levels between the 2 groups. After 3 months, the decline in serum phosphorus levels was 0.6 mg/dL larger among intervention vs control participants (95% confidence interval, -1.0 to -0.1 mg/dL). Intervention participants also had statistically significant increases in reading ingredient lists (P<.001) and nutrition facts labels (P = .04) but no significant increase in food knowledge scores (P = .13). Educating end-stage renal disease patients to avoid phosphorus-containing food additives resulted in modest improvements in hyperphosphatemia. clinicaltrials.gov Identifier: NCT00583570.

Brief oral cryotherapy for the prevention of high-dose melphalan-induced stomatitis in allogeneic hematopoietic stem cell transplant recipients.

PubMed

Mori, Takehiko; Yamazaki, Rie; Aisa, Yoshinobu; Nakazato, Tomonori; Kudo, Masumi; Yashima, Tomoko; Kondo, Sakiko; Ikeda, Yasuo; Okamoto, Shinichiro

2006-04-01

We previously reported the efficacy of oral cryotherapy for the prevention of high-dose melphalan-induced stomatitis. The purpose of this study was to evaluate whether the further shortening of the duration of oral cryotherapy could minimize its side effects while sparing its efficacy. Seventeen consecutive recipients of allogeneic hematopoieic stem cell transplant conditioned with high-dose melphalan in combination with fludarabine alone or with fludarabine and additional radiation were enrolled in the study. The severity of stomatitis was graded according to the National Cancer Institute-Common Toxicity Criteria. Patients were kept on oral cryotherapy shortly before, during, and for additional 30 min after the completion of melphalan administration (60-min oral cryotherapy). Patients who were also enrolled in our previous study received the same type of oral cryotherapy but for additional 90 min after the completion of melphalan administration (120-min oral cryotherapy), and they served as controls. Only 2 (11.8%) of 17 patients receiving 60-min oral cryotherapy and 2 (11.1%) of 18 patients receiving 120-min oral cryotherapy developed grade 2 or 3 stomatitis, respectively. The difference between groups was not statistically significant (P = 0.677). The incidence of unpleasant symptoms such as chills and nausea during oral cryotherapy decreased significantly with 60-min oral cryotherapy, as compared with that associated with 120-min oral cryotherapy (P < 0.01). These results suggest that 60-min oral cryotherapy is as effective as 120-min oral cryotherapy at preventing high-dose melphalan-induced stomatitis, and shorter treatment might have contributed to relieve patient discomfort during oral cryotherapy.

Differences in major depressive disorder and generalised anxiety disorder symptomatology between prostate cancer patients receiving hormone therapy and those who are not.

PubMed

Sharpley, Christopher F; Bitsika, Vicki; Wootten, Addie C; Christie, David R H

2014-12-01

The aim of this study is to explore the associations between hormone treatment variables and depression, and the nature of depression in prostate cancer (PCa) patients by comparing the severity and symptom profile of anxiety and depression in men who were currently receiving hormone therapy (HT) versus those who were not. Self-reports of anxiety and depression on standardized scales of GAD and major depressive disorder (MDD) were collected from 156 PCa patients across two recruitment sites in Australia. Patients who were currently receiving HT were compared with patients not receiving HT for their severity and symptom profiles on GAD and MDD. Participants receiving HT had significantly higher GAD and MDD total scores than patients who were not receiving HT. In addition, the symptom profiles of these two HT subgroups were differentiated by significantly higher scores on the key criteria for GAD and MDD plus fatigue and sleeping difficulties but not the remaining symptoms of GAD and MDD. However, there were no significant differences between HT subgroups for the degree of functional impairment experienced by these symptoms. Although these data confirm the association between HT and anxiety/depression, the range of GAD and MDD symptoms influenced is relatively restricted. Moreover, functional ability does not appear to be impaired by HT. These findings clarify the ways in which HT affects PCa patients and suggests that a simple total scale score for anxiety and depression may not be as helpful in designing treatment as consideration of the symptomatic profiles of PCa patients receiving HT. Copyright © 2014 John Wiley & Sons, Ltd.

Severe exacerbation and pneumonia in COPD patients treated with fixed combinations of inhaled corticosteroid and long-acting beta2 agonist

PubMed Central

Yang, Hsi-Hsing; Lai, Chih-Cheng; Wang, Ya-Hui; Yang, Wei-Chih; Chen, Likwang; Yu, Chong-Jen

2017-01-01

Background It remains unclear whether severe exacerbation and pneumonia of COPD differs between patients treated with budesonide/formoterol and those treated with fluticasone/salmeterol. Therefore, we conducted a comparative study of those who used budesonide/formoterol and those treated with fluticasone/salmeterol for COPD. Methods Subjects in this population-based cohort study comprised patients with COPD who were treated with a fixed combination of budesonide/formoterol or fluticasone/salmeterol. All patients were recruited from the Taiwan National Health Insurance database. The outcomes including severe exacerbations, pneumonia, and pneumonia requiring mechanical ventilation (MV) were measured. Results During the study period, 11,519 COPD patients receiving fluticasone/salmeterol and 7,437 patients receiving budesonide/formoterol were enrolled in the study. Pairwise matching (1:1) of fluticasone/salmeterol and budesonide/formoterol populations resulted in to two similar subgroups comprising each 7,295 patients. Patients receiving fluticasone/salmeterol had higher annual rate and higher risk of severe exacerbation than patients receiving budesonide/formoterol (1.2219/year vs 1.1237/year, adjusted rate ratio, 1.08; 95% CI, 1.07–1.10). In addition, patients receiving fluticasone/salmeterol had higher incidence rate and higher risk of pneumonia than patients receiving budesonide/formoterol (12.11 per 100 person-years vs 10.65 per 100 person-years, adjusted hazard ratio [aHR], 1.13; 95% CI, 1.08–1.20). Finally, patients receiving fluticasone/salmeterol had higher incidence rate and higher risk of pneumonia requiring MV than patients receiving budesonide/formoterol (3.94 per 100 person-years vs 3.47 per 100 person-years, aHR, 1.14; 95% CI, 1.05–1.24). A similar trend was seen before and after propensity score matching analysis, intention-to-treat, and as-treated analysis with and without competing risk. Conclusions Based on this retrospective observational study, long-term treatment with fixed combination budesonide/formoterol was associated with fewer severe exacerbations, pneumonia, and pneumonia requiring MV than fluticasone/salmeterol in COPD patients. PMID:28860742

Myeloablative therapy against high risk Ewing's sarcoma: A single institution experience and literature review

PubMed Central

Lopez, Jose Luis; Pérez, Concepcion; Marquez, Catalina; Cabrera, Patricia; Perez, Jose Maria; Ramirez, Gema Lucia; Ordoñez, Rafael; Praena-Fernandez, Juan Manuel; Ortiz, Maria Jose

2011-01-01

Background Attempts to improve survival outcomes of patients with high risk Ewing's sarcoma (ES) have focused on chemotherapy dose intensification strategies. Aim The objective of this study is to retrospectively evaluate clinical characteristics and outcome of pediatric patients with high risk ES treated at a single institution. Materials and methods From 1995 to 2008, seventeen patients (male:female, 14:3) were treated with dose-intensive therapy in our institution. Median age at diagnosis was 10 years (range: 2–15). Seven patients had metastases at diagnosis (lung in 6 cases and bone in one case). Eleven patients presented with unresectable disease. Fifteen (88.2%) received the Spanish Society of Pediatric Oncology protocol which includes six cycles of vincristine, doxorubicin, ifosfamide and etoposide. Two out of the six cases that were resectable received postoperative radiation. In addition, eleven patients received definitive radiation therapy. Finally, twelve (70.5%) out of 17 patients received myeloablative therapy with melphalan/etoposide. The rest of patients (N = 5) received busulfan/melphalan. Results Median follow-up was 78 months (range: 15–155 months). Initial responses were complete in all patients, but 9 of them developed progression disease. Seven patients became long-term event-free survivors. No patient died of toxicity after transplantation. The 2- and 5-year overall survival rates for all patients were 93% and 73%, respectively. Event-free survival rates were 74% and 54% at 2 and 5 years, respectively. Conclusion This single-institution experience suggests that myeloablative therapy against high risk ES is effective and safe. PMID:24376974

DOE Office of Scientific and Technical Information (OSTI.GOV)

Qin, Rosie; Olson, Adam; Singh, Bhavana

Purpose: Ipilimumab and radiation therapy (RT) are standard treatments for advanced melanoma; preclinical models suggest the potential for synergy. However, limited clinical information exists regarding safety and optimal timing of the combination. Methods and Materials: We reviewed the records of consecutive patients with unresectable stage 3 or 4 melanoma treated with ipilimumab. Patients were categorized as having received RT or not. Differences were estimated between these 2 cohorts. Results: We identified 88 patients treated with ipilimumab. At baseline, the ipilimumab-plus-RT group (n=44) had more unfavorable characteristics. Despite this, overall survival, progression-free survival, and both immune-related and non–immune-related toxicity were notmore » statistically different (P=.67). Patients who received ipilimumab before RT had an increased duration of irradiated tumor response compared with patients receiving ipilimumab after RT (74.7% vs 44.8% at 12 months; P=.01, log-rank test). In addition, patients receiving ablative RT had non–statistically significantly improved median overall survival (19.6 vs 10.2 months), as well as 6-month (95.1% vs 72.7%) and 12-month (79.7% vs 48.5%) survival rates, compared with those treated with conventionally fractionated RT. Conclusions: We found that both ablative and conventionally fractionated RT can be safely administered with ipilimumab without a clinically apparent increase in toxicity. Patients who received ipilimumab before RT had an increased duration of irradiated tumor response.« less

Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients

PubMed Central

Miranda, Roberto N.; Aladily, Tariq N.; Prince, H. Miles; Kanagal-Shamanna, Rashmi; de Jong, Daphne; Fayad, Luis E.; Amin, Mitual B.; Haideri, Nisreen; Bhagat, Govind; Brooks, Glen S.; Shifrin, David A.; O'Malley, Dennis P.; Cheah, Chan Y.; Bacchi, Carlos E.; Gualco, Gabriela; Li, Shiyong; Keech, John A.; Hochberg, Ephram P.; Carty, Matthew J.; Hanson, Summer E.; Mustafa, Eid; Sanchez, Steven; Manning, John T.; Xu-Monette, Zijun Y.; Miranda, Alonso R.; Fox, Patricia; Bassett, Roland L.; Castillo, Jorge J.; Beltran, Brady E.; de Boer, Jan Paul; Chakhachiro, Zaher; Ye, Dongjiu; Clark, Douglas; Young, Ken H.; Medeiros, L. Jeffrey

2014-01-01

Purpose Breast implant–associated anaplastic large-cell lymphoma (ALCL) is a recently described clinicopathologic entity that usually presents as an effusion-associated fibrous capsule surrounding an implant. Less frequently, it presents as a mass. The natural history of this disease and long-term outcomes are unknown. Patients and Methods We reviewed the literature for all published cases of breast implant–associated ALCL from 1997 to December 2012 and contacted corresponding authors to update clinical follow-up. Results The median overall survival (OS) for 60 patients was 12 years (median follow-up, 2 years; range, 0-14 years). Capsulectomy and implant removal was performed on 56 of 60 patients (93%). Therapeutic data were available for 55 patients: 39 patients (78%) received systemic chemotherapy, and of the 16 patients (28%) who did not receive chemotherapy, 12 patients opted for watchful waiting and four patients received radiation therapy alone. Thirty-nine (93%) of 42 patients with disease confined by the fibrous capsule achieved complete remission, compared with complete remission in 13 (72%) of 18 patients with a tumor mass. Patients with a breast mass had worse OS and progression-free survival (PFS; P = .052 and P = .03, respectively). The OS or PFS were similar between patients who received and did not receive chemotherapy (P = .44 and P = .28, respectively). Conclusion Most patients with breast implant–associated ALCL who had disease confined within the fibrous capsule achieved complete remission. Proper management for these patients may be limited to capsulectomy and implant removal. Patients who present with a mass have a more aggressive clinical course that may be fatal, justifying cytotoxic chemotherapy in addition to removal of implants. PMID:24323027

Low-molecular-weight heparin and intermittent pneumatic compression for thromboprophylaxis in critical patients

PubMed Central

WAN, BING; FU, HAI-YAN; YIN, JIANG-TAO; REN, GUO-QING

2015-01-01

The efficacy and safety of physiotherapeutic prophylaxis for venous thromboembolism in critically ill patients with heparin contraindication remains unclear. In the present study it was hypothesized that physiotherapy prophylaxis with intermittent pneumatic compression (IPC) would be safe and effective for patients unable to receive low-molecular-weight heparin (LMWH). In addition, this study investigated whether a combined therapy of IPC with LMWH would be more effective for the prophylaxis of deep vein thrombosis (DVT) in critical patients. A total of 500 patients were divided into four groups according to the prophylaxis of DVT. The IPC group consisted of 95 patients with heparin contraindication that received IPC treatment; the LMWH group consisted of 185 patients that received an LMWH injection; the LMWH + IPC group consisted of 75 patients that received IPC treatment and LMWH injection; and the control group consisted of 145 patients that received no IPC treatment or injection of LMWH. Each patient was evaluated clinically for development of DVT and the diagnosis was confirmed by Doppler study. Venous thromboembolism was a common complication among the trauma patients with severe injuries. Patients responded positively to the treatment used in the intervention groups. Patients exhibited an improved response to LMWH + ICP compared with IPC or LMWH alone, while no significant difference was detected between the IPC and LMWH groups. These results were applicable to patients that had a Wells score of ≥3; however, no significant differences in DVT incidence were observed among the patients who had a Wells score of <3. In this observational study, LMWH + ICP appeared to be more effective than either treatment alone in treating critically ill trauma patients with severe injuries that are at high risk for VTE and bleeding simultaneously. PMID:26668637

Effect of live music therapy for patients undergoing magnetic resonance imaging.

PubMed

Walworth, Darcy D

2010-01-01

The purpose of the current study was to identify the effects of live music therapy interventions compared with preferred recorded music for patients undergoing MRI scans. To date, there has not been a published study involving the use of live music therapy during MRI scans. The current study investigated the differences between teenage through adult patients receiving live music therapy intervention during outpatient MRI scans versus the standard protocol of care listening to recorded music (N = 88). Subjects ranged in age from 15 to 93 years old. Results indicated subjects who received the live music therapy protocol reported significantly better perception of the MRI procedure (p < 0.05). Additionally, subjects receiving the live music therapy protocol had fewer scans repeated due to movement. Of the repeated images, 26% occurred in the live music group and 73% occurred in the recorded music group. Subjects receiving live music therapy also requested less breaks from the scan. Two percent of the live music subjects requested a break and 17.6% of the control patients requested breaks. When comparing the same type of scan between groups, subjects receiving the live music protocol required less time to complete the scans. For lumbar scans without contrast (N = 14, n = 7, n = 7), live music subjects spent an average of 4.63 less min per scan for a total of 32 less min for 7 subjects. For brain scans (N = 8, n = 4, n = 4), live music subjects spent an average of 5.8 less min per scan for a total of 23 less min for 4 subjects. Results of the current study supports the use of live music therapy intervention for teenage and adult patients undergoing MRI scans to reduce patient anxiety and improve patient perception of the scan experience. Additionally, live music therapy has the potential to shorten the length of time required for patients to complete MRI scans due to decreased patient movements and fewer breaks requested during the scans. The cost savings impact of reduced procedure time can positively impact the facility productivity by allowing more scans to be scheduled daily.

Explore Transplant at Home: a randomized control trial of an educational intervention to increase transplant knowledge for Black and White socioeconomically disadvantaged dialysis patients.

PubMed

Waterman, Amy D; McSorley, Anna-Michelle M; Peipert, John D; Goalby, Christina J; Peace, Leanne J; Lutz, Patricia A; Thein, Jessica L

2015-08-28

Compared to others, dialysis patients who are socioeconomically disadvantaged or Black are less likely to receive education about deceased donor kidney transplant (DDKT) and living donor kidney transplant (LDKT) before they reach transplant centers, often due to limited availability of transplant education within dialysis centers. Since these patients are often less knowledgeable or ready to pursue transplant, educational content must be simplified, made culturally sensitive, and presented gradually across multiple sessions to increase learning and honor where they are in their decision-making about transplant. The Explore Transplant at Home (ETH) program was developed to help patients learn more about DDKT and LDKT at home, with and without telephone conversations with an educator. In this randomized controlled trial (RCT), 540 low-income Black and White dialysis patients with household incomes at or below 250 % of the federal poverty line, some of whom receive financial assistance from the Missouri Kidney Program, will be randomly assigned to one of three education conditions: (1) standard-of-care transplant education provided by the dialysis center, (2) patient-guided ETH (ETH-PG), and (3) health educator-guided ETH (ETH-EG). Patients in the standard-of-care condition will only receive education provided in their dialysis centers. Those in the two ETH conditions will receive four video and print modules delivered over an 8 month period by mail, with the option of receiving supplementary text messages weekly. In addition, patients in the ETH-EG condition will participate in multiple telephonic educational sessions with a health educator. Changes in transplant knowledge, decisional balance, self-efficacy, and informed decision making will be captured with surveys administered before and after the ETH education. At the conclusion of this RCT, we will have determined whether an education program administered to socioeconomically disadvantaged dialysis patients, over several months directly in their homes, can help more individuals learn about the options of DDKT and LDKT. We also will be able to examine the efficacy of different educational delivery approaches to further understand whether the addition of a telephone educator is necessary for increasing transplant knowledge. ClinicalTrials.gov, NCT02268682.

The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy.

PubMed

Olutoye, Olutoyin A; Glover, Chris D; Diefenderfer, John W; McGilberry, Michael; Wyatt, Matthew M; Larrier, Deidre R; Friedman, Ellen M; Watcha, Mehernoor F

2010-08-01

The immediate postoperative period after tonsillectomy and adenoidectomy, one of the most common pediatric surgical procedures, is often difficult. These children frequently have severe pain but postoperative airway edema along with increased sensitivity to the respiratory-depressant effects of opioids may result in obstructive symptoms and hypoxemia. Opioid consumption may be reduced by nonsteroidal antiinflammatory drugs, but these drugs may be associated with increased bleeding after this operation. Dexmedetomidine has mild analgesic properties, causes sedation without respiratory depression, and does not have an effect on coagulation. We designed a prospective, double-blind, randomized controlled study to determine the effects of intraoperative dexmedetomidine on postoperative recovery including pain, sedation, and hemodynamics in pediatric patients undergoing tonsillectomy and adenoidectomy. One hundred nine patients were randomized to receive a single intraoperative dose of dexmedetomidine 0.75 microg/kg, dexmedetomidine 1 microg/kg, morphine 50 microg/kg, or morphine 100 microg/kg over 10 minutes after endotracheal intubation. There were no significant differences among the 4 groups in patient demographics, ASA physical status, postoperative opioid requirements, sedation scores, duration of oxygen supplementation in the postanesthetic care unit, and time to discharge readiness. The median time to first postoperative rescue analgesic was similar in patients receiving dexmedetomidine 1 microg/kg and morphine 100 microg/kg, but significantly longer compared with patients receiving dexmedetomidine 0.75 microg/kg or morphine 50 microg/kg (P < 0.01). In addition, the number of patients requiring >1 rescue analgesic dose was significantly higher in the dexmedetomidine 0.75 microg/kg group compared with the dexmedetomidine 1 microg/kg and morphine 100 microg/kg groups, but not the morphine 50 microg/kg group. Patients receiving dexmedetomidine had significantly slower heart rates in the first 30 minutes after surgery compared with those receiving morphine (P < 0.05). There was no significant difference in sedation scores among the groups. The total postoperative rescue opioid requirements were similar in tonsillectomy patients receiving intraoperative dexmedetomidine or morphine. However, the use of dexmedetomidine 1 microg/kg and morphine 100 microg/kg had the advantages of an increased time to first analgesic and a reduced need for additional rescue analgesia doses, without increasing discharge times.

Survival Outcomes of Whole-Pelvic Versus Prostate-Only Radiation Therapy for High-Risk Prostate Cancer Patients With Use of the National Cancer Data Base

DOE Office of Scientific and Technical Information (OSTI.GOV)

Amini, Arya; Jones, Bernard L.; Yeh, Norman

Purpose/Objectives: The addition of whole pelvic (WP) compared with prostate-only (PO) radiation therapy (RT) for clinically node-negative prostate cancer remains controversial. The purpose of our study was to evaluate the survival benefit of adding WPRT versus PO-RT for high-risk, node-negative prostate cancer, using the National Cancer Data Base (NCDB). Methods and Materials: Patients with high-risk prostate cancer treated from 2004 to 2006, with available data for RT volume, coded as prostate and pelvis (WPRT) or prostate alone (PO-RT) were included. Multivariate analysis (MVA) and propensity-score matched analysis (PSM) were performed. Recursive partitioning analysis (RPA) based on overall survival (OS) usingmore » Gleason score (GS), T stage, and pretreatment prostate-specific antigen (PSA) was also conducted. Results: A total of 14,817 patients were included: 7606 (51.3%) received WPRT, and 7211 (48.7%) received PO-RT. The median follow-up time was 81 months (range, 2-122 months). Under MVA, the addition of WPRT for high-risk patients had no OS benefit compared with PO-RT (HR 1.05; P=.100). On subset analysis, patients receiving dose-escalated RT also did not benefit from WPRT (HR 1.01; P=.908). PSM confirmed no survival benefit with the addition of WPRT for high-risk patients (HR 1.05; P=.141). In addition, RPA was unable to demonstrate a survival benefit of WPRT for any subset. Other prognostic factors for inferior OS under MVA included older age (HR 1.25; P<.001), increasing comorbidity scores (HR 1.46; P<.001), higher T stage (HR 1.17; P<.001), PSA (HR 1.81; P<.001), and GS (HR 1.29; P<.001), and decreasing median county household income (HR 1.15; P=.011). Factors improving OS included the addition of androgen deprivation therapy (HR 0.92; P=.033), combination external beam RT plus brachytherapy boost (HR 0.71; P<.001), and treatment at an academic/research institution (HR 0.84; P=.002). Conclusion: In the largest reported analysis of WPRT for patients with high-risk prostate cancer treated in the dose-escalated era, the addition of WPRT demonstrated no survival advantage compared with PO-RT.« less

The Role of Psychiatric Diagnoses for Outcome After Hip and Knee Arthroplasty.

PubMed

Gylvin, Silas H; Jørgensen, Christoffer C; Fink-Jensen, Anders; Gislason, Gunnar H; Kehlet, Henrik

2017-12-01

Surgical patients receiving psychopharmacologic treatment have been associated with adverse outcomes in total hip and knee arthroplasty (THA and TKA). The purpose of this study was to investigate whether a specific high-risk group of patients receiving psychopharmacologic treatment could be identified based upon a nationwide psychiatric diagnosis register. From 7 different orthopedic centers, 8288 THA and TKA patients were included from January 2010 to November 2012 of which 943 (11.4%) received psychopharmacologic treatment. Patients receiving preoperative psychopharmacologic treatment were divided into 2 groups based on the presence or absence of a psychiatric diagnosis in a nationwide administrative database and analyzed with respect to length of hospital stay (LOS >4 days) and 30- and 90-day readmissions using multivariable logistic regression models. A total of 191 patients receiving psychopharmacologic treatment were registered with a psychiatric diagnosis while 752 patients received psychopharmacologic treatment without a registered psychiatric diagnosis. No significantly increased risk was found in patients with a preoperative registered psychiatric diagnosis compared to patients without, with regard to LOS >4 days (odds ratio [OR], 1.19; P = .51), 30-day readmission (OR, 0.56; P = .086), or 90-day readmission (OR, 0.81; P = .446), respectively. However, both groups had an increased risk of LOS >4 days and readmissions compared to a control population without psychopharmacologic treatment or any registered psychiatric diagnoses. No further risk was found for psychopharmacologically treated THA/TKA patients with an additional hospital-related psychiatric diagnosis compared to patients without, suggesting that the psychopharmacologic treatment per se is an outcome risk factor independent of severity of the psychiatric disorder. Copyright © 2017 Elsevier Inc. All rights reserved.

E-cigarette use in patients receiving home oxygen therapy.

PubMed

Lacasse, Yves; Légaré, Martin; Maltais, François

2015-01-01

Current smokers who are prescribed home oxygen may not benefit from the therapy. In addition to being an obvious fire hazard, there is some evidence that the physiological mechanisms by which home oxygen is believed to operate are inhibited by smoking. Although their effectiveness is yet to be demonstrated, electronic cigarettes (e-cigarettes) are often regarded as an aid to smoking cessation. However, several burn accidents in e-cigarette smokers receiving home oxygen therapy have also been reported, leading Health Canada to release a warning of fire risk to oxygen therapy patients from e-cigarettes. It is the authors' position that patients receiving oxygen should definitely not use e-cigarettes. The authors provide suggestions for addressing the delicate issue of home oxygen therapy in current cigarette and⁄or e-cigarette smokers.

National Patterns of Care and Outcomes after Combined Modality Therapy for Stage IIIA Non-small Cell Lung Cancer

PubMed Central

Patel, Aalok P.; Crabtree, Traves D.; Bell, Jennifer M.; Guthrie, Tracey J.; Robinson, Clifford G.; Morgensztern, Daniel; Colditz, Graham A.; Kreisel, Daniel; Krupnick, A. Sasha; Bradley, Jeffrey D.; Patterson, G. Alexander; Meyers, Bryan F.; Puri, Varun

2014-01-01

Introduction The role of surgery in addition to chemotherapy and radiation for stage IIIA non-small cell lung cancer (NSCLC) remains controversial. Since there is limited data on the benefit from surgery in this setting, we evaluated the use of combined modality therapy nationally, and explored the outcomes with and without the addition of surgery. Methods Patient variables and treatment-related outcomes were abstracted for patients with clinical stage IIIA NSCLC from the National Cancer Database. Patients receiving chemotherapy and radiation (CR) were compared to those undergoing chemotherapy, radiation, and surgery in any sequence (CRS). Results Between 1998 and 2010, 61339 patients underwent combined modality treatment for clinical stage IIIA NSCLC. Of these, 51979 (84.7%) received CR while 9360 (15.3%) underwent CRS. Patients in the CRS group were younger, more likely females and Caucasians, had smaller tumors and lower Charlson comorbidity scores. The 30-day surgical mortality was 200/8993 (2.2%). The median overall survival favored the CRS group in both unmatched (32.4 months vs. 15.7 months, p<.001) and matched analysis based on patient characteristics (34.3 months vs. 18.4months, p<.001). Conclusion There is significant heterogeneity in the treatment of stage IIIA NSCLC in the United States. Patients selected for surgery in addition to chemoradiation therapy appear to have better long-term survival. PMID:24722151

Usefulness of ω-3 fatty acid supplementation in addition to mesalazine in maintaining remission in pediatric Crohn's disease: A double-blind, randomized, placebo-controlled study

PubMed Central

Romano, C; Cucchiara, S; Barabino, A; Annese, V; Sferlazzas, C; Diseases, SIGENP Italian Study Group of Pediatric Inflammatory Bowel

2005-01-01

AIM: To assess the value of long-chain ω-3 fatty acids (FAs) supplementation in addition to amino-salicylic-acid (5-ASA) in pediatric patients with Crohn's disease (CD). METHODS: Thirty-eight patients (20 males and 18 females, mean age 10.13 years, range 5-16 years) with CD in remission were randomized into two groups and treated for 12 mo. Group I (18 patients) received 5-ASA (50 mg/kg/d)+ω-3 FAs as triglycerides in gastro-resistant capsules, 3 g/d (eicosapentanoic acid, EPA, 400 mg/g, docosahexaenoic acid, DHA, 200 mg/g). Group II (20 patients) received 5-ASA (50 mg/kg/d)+olive oil placebo capsules. Patients were evaluated for fatty acid incorporation in red blood cell membranes by gas chromatography at baseline 6 and 12 mo after the treatment. RESULTS: The number of patients who relapsed at 1 year was significantly lower in group I than in group II (P<0.001). Patients in group I had a significant increase in the incorporation of EPA and DHA (P<0.001) and a decrease in the presence of arachidonic acids. CONCLUSION: Enteric-coated ω-3 FAs in addition to treatment with 5-ASA are effective in maintaining remission of pediatric CD. PMID:16437657

Incidence of hypocalcemia in patients receiving denosumab for prevention of skeletal-related events in bone metastasis.

PubMed

Yerram, Prakirthi; Kansagra, Shraddha; Abdelghany, Osama

2017-04-01

Background Denosumab therapy is commonly used for the prevention of skeletal-related events in patients with bone metastasis. However, a common side effect of denosumab is hypocalcemia. Objective The aim of the study is to determine the incidence of hypocalcemia in patients receiving denosumab for prevention of skeletal-related events in bone metastasis and evaluate risk factors for developing hypocalcemia. Methods This was a retrospective medication use evaluation reviewing the incidence of hypocalcemia in patients receiving outpatient denosumab for prevention of skeletal-related events at Yale-New Haven Hospital. Additionally, various risk factors were reviewed to determine their risk of developing hypocalcemia. Results As per Common Terminology Criteria for Adverse Events v4.03, of the 106 patients included in the study population, 37 (35%) patients had an incidence of hypocalcemia within 30 days of denosumab administration. Fourteen patients (13.2%) had an incidence of grade 1, 13 patients (12.3%) had an incidence of grade 2 hypocalcemia, and 7 patients (6.6%) had an incidence of grade 3 hypocalcemia. Grade 4 hypocalcemia occurred in three (2.8%) patients. Calcium supplementation did not decrease the risk of developing hypocalcemia. Patients who had one or more episodes of acute kidney insufficiency were at a higher risk of developing hypocalcemia (odds ratio = 7.5 (95% confidence interval = 1.8-36.3), p = 0.001). Conclusion This study found that the overall incidence of hypocalcemia and severe hypocalcemia was higher than reported in clinical trials. Additionally, calcium supplementation did not have an effect on incidence of hypocalcemia, while patients who experienced acute kidney insufficiency while on denosumab had a higher likelihood of developing hypocalcemia.

[Effectiveness of a micronized purified flavonoid fraction (MPFF) in the healing process of lower limb ulcers. An open multicentre study, controlled and randomized].

PubMed

Glinski, W; Chodynicka, B; Roszkiewicz, J; Bogdanowski, T; Lecewicz-Torun, B; Kaszuba, A; Bowszyc, J; Nowak, A; Wnorowski, J; Wasik, F; Glinska-Ferenz, M; Blaszczyk, M; Strzyga, P; Pachocki, R

2001-04-01

To determine the increase in healing rate of venous ulcer in patients receiving a micronised purified flavonoid fraction (MPFF) as supplementation to standard local care. A randomised, open, controlled, multicentre study. Departments of Dermatology and University Outpatients Clinics. One hundred and forty patients with chronic venous insufficiency and venous ulcers. PATIENTS received standard compressive therapy plus external treatment alone or 2 tablets of MPFF daily in addition to the above treatment for 24 weeks. Healing of ulcers and their reduction in size after 24 weeks of treatment. The percentage of patients whose ulcers healed completely was found to be markedly higher in those receiving MPFF in addition to standard external and compressive treatment than in those treated with conventional therapy alone (46.5% vs 27.5%; p<0.05. OR=2.3, 95% CI 1.1-4.6). Ulcers with diameters <3 cm were cured in 71% of patients in the MPFF group and in 50% of patients in the control group, whereas ulcers between 3 and 6 cm in diameter were cured in 60% and 32% of patients (p<0.05), respectively. The mean reduction in ulcer size was also found to be greater in patients treated with MPFF (80%) than in the control group (65%) (p<0.05). The cost-effectiveness ratio (cost per healed ulcer) in the MPFF group was 1026.2 compared with 1871.8 in the control group. These results indicate that MPFF significantly improves the cure rate in patients with chronic venous insufficiency.

Breast implant-associated anaplastic large-cell lymphoma: long-term follow-up of 60 patients.

PubMed

Miranda, Roberto N; Aladily, Tariq N; Prince, H Miles; Kanagal-Shamanna, Rashmi; de Jong, Daphne; Fayad, Luis E; Amin, Mitual B; Haideri, Nisreen; Bhagat, Govind; Brooks, Glen S; Shifrin, David A; O'Malley, Dennis P; Cheah, Chan Y; Bacchi, Carlos E; Gualco, Gabriela; Li, Shiyong; Keech, John A; Hochberg, Ephram P; Carty, Matthew J; Hanson, Summer E; Mustafa, Eid; Sanchez, Steven; Manning, John T; Xu-Monette, Zijun Y; Miranda, Alonso R; Fox, Patricia; Bassett, Roland L; Castillo, Jorge J; Beltran, Brady E; de Boer, Jan Paul; Chakhachiro, Zaher; Ye, Dongjiu; Clark, Douglas; Young, Ken H; Medeiros, L Jeffrey

2014-01-10

Breast implant-associated anaplastic large-cell lymphoma (ALCL) is a recently described clinicopathologic entity that usually presents as an effusion-associated fibrous capsule surrounding an implant. Less frequently, it presents as a mass. The natural history of this disease and long-term outcomes are unknown. We reviewed the literature for all published cases of breast implant-associated ALCL from 1997 to December 2012 and contacted corresponding authors to update clinical follow-up. The median overall survival (OS) for 60 patients was 12 years (median follow-up, 2 years; range, 0-14 years). Capsulectomy and implant removal was performed on 56 of 60 patients (93%). Therapeutic data were available for 55 patients: 39 patients (78%) received systemic chemotherapy, and of the 16 patients (28%) who did not receive chemotherapy, 12 patients opted for watchful waiting and four patients received radiation therapy alone. Thirty-nine (93%) of 42 patients with disease confined by the fibrous capsule achieved complete remission, compared with complete remission in 13 (72%) of 18 patients with a tumor mass. Patients with a breast mass had worse OS and progression-free survival (PFS; P = .052 and P = .03, respectively). The OS or PFS were similar between patients who received and did not receive chemotherapy (P = .44 and P = .28, respectively). Most patients with breast implant-associated ALCL who had disease confined within the fibrous capsule achieved complete remission. Proper management for these patients may be limited to capsulectomy and implant removal. Patients who present with a mass have a more aggressive clinical course that may be fatal, justifying cytotoxic chemotherapy in addition to removal of implants.

Association Between Low Trough Levels of Vedolizumab During Induction Therapy for Inflammatory Bowel Diseases and Need for Additional Doses Within 6 Months.

PubMed

Williet, Nicolas; Boschetti, Gilles; Fovet, Marion; Di Bernado, Thomas; Claudez, Pierre; Del Tedesco, Emilie; Jarlot, Camille; Rinaldi, Leslie; Berger, Anne; Phelip, Jean-Marc; Flourie, Bernard; Nancey, Stéphane; Paul, Stéphane; Roblin, Xavier

2017-11-01

We investigated whether serum trough levels of vedolizumab, a humanized monoclonal antibody against integrin α4β7, during the induction phase of treatment can determine whether patients will need additional doses (optimization of therapy) within the first 6 months. We conducted an observational study of 47 consecutive patients with Crohn's disease (CD; n = 31) or ulcerative colitis (UC; n = 16) who had not responded to 2 previous treatment regimens with antagonists of tumor necrosis factor and were starting therapy with vedolizumab at 2 hospitals in France, from June 2014 through April 2016. All patients were given a 300-mg infusion of vedolizumab at the start of the study, Week 2, Week 6, and then every 8 weeks; patients were also given corticosteroids during the first 4-6 weeks. Patients not in remission at Week 6 were given additional doses of vedolizumab at Week 10 and then every 4 weeks (extended therapy or optimization). Remission at Week 6 of treatment was defined as CD activity score below 150 points for patients with CD and a partial Mayo Clinic score of <3 points, without concomitant corticosteroids, for patients with UC. Blood samples were collected each week and serum levels of vedolizumab and antibodies against vedolizumab were measured using an enzyme-linked immunosorbent assay. Median trough levels of vedolizumab and interquartile ranges were compared using the nonparametric Mann-Whitney test. The primary objective was to determine whether trough levels of vedolizumab measured during the first 6 weeks of induction therapy associated with the need for extended treatment within the first 6 months. Based on response to therapy at Week 6, extended treatment was required for 30 of the 47 patients (23 patients with CD and 7 patients with UC). At Week 2, trough levels of vedolizumab for patients selected for extended treatment were 23.0 μg/mL (interquartile range, 14.0-37.0 μg/mL), compared with 42.5 μg/mL in patients who did not receive extended treatment (interquartile range, 33.5-50.7; P = .15). At Week 6, trough levels of vedolizumab <18.5 μg/mL were associated with need for extended therapy (100% positive predictive value, 46.2%; negative predictive value; area under the receiver operating characteristic curve, 0.72) within the first 6 months. Among patients who required extended treatment at Week 10, all of those with trough levels of vedolizumab <19.0 μg/mL at Week 6 had achieved clinical remission 4 weeks later (secondary responders). In a prospective study of patients with CD or UC receiving induction therapy with vedolizumab, low trough levels of vedolizumab at Week 6 (<19.0 μg/mL) are associated with need for additional doses (given at Week 10 and then every 4 weeks). All patients receiving these additional doses achieved a clinical response 4 weeks later. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Visual representation of statistical information improves diagnostic inferences in doctors and their patients.

PubMed

Garcia-Retamero, Rocio; Hoffrage, Ulrich

2013-04-01

Doctors and patients have difficulty inferring the predictive value of a medical test from information about the prevalence of a disease and the sensitivity and false-positive rate of the test. Previous research has established that communicating such information in a format the human mind is adapted to-namely natural frequencies-as compared to probabilities, boosts accuracy of diagnostic inferences. In a study, we investigated to what extent these inferences can be improved-beyond the effect of natural frequencies-by providing visual aids. Participants were 81 doctors and 81 patients who made diagnostic inferences about three medical tests on the basis of information about prevalence of a disease, and the sensitivity and false-positive rate of the tests. Half of the participants received the information in natural frequencies, while the other half received the information in probabilities. Half of the participants only received numerical information, while the other half additionally received a visual aid representing the numerical information. In addition, participants completed a numeracy scale. Our study showed three important findings: (1) doctors and patients made more accurate inferences when information was communicated in natural frequencies as compared to probabilities; (2) visual aids boosted accuracy even when the information was provided in natural frequencies; and (3) doctors were more accurate in their diagnostic inferences than patients, though differences in accuracy disappeared when differences in numerical skills were controlled for. Our findings have important implications for medical practice as they suggest suitable ways to communicate quantitative medical data. Copyright © 2013 Elsevier Ltd. All rights reserved.

Artificial neural network approach to predict surgical site infection after free-flap reconstruction in patients receiving surgery for head and neck cancer.

PubMed

Kuo, Pao-Jen; Wu, Shao-Chun; Chien, Peng-Chen; Chang, Shu-Shya; Rau, Cheng-Shyuan; Tai, Hsueh-Ling; Peng, Shu-Hui; Lin, Yi-Chun; Chen, Yi-Chun; Hsieh, Hsiao-Yun; Hsieh, Ching-Hua

2018-03-02

The aim of this study was to develop an effective surgical site infection (SSI) prediction model in patients receiving free-flap reconstruction after surgery for head and neck cancer using artificial neural network (ANN), and to compare its predictive power with that of conventional logistic regression (LR). There were 1,836 patients with 1,854 free-flap reconstructions and 438 postoperative SSIs in the dataset for analysis. They were randomly assigned tin ratio of 7:3 into a training set and a test set. Based on comprehensive characteristics of patients and diseases in the absence or presence of operative data, prediction of SSI was performed at two time points (pre-operatively and post-operatively) with a feed-forward ANN and the LR models. In addition to the calculated accuracy, sensitivity, and specificity, the predictive performance of ANN and LR were assessed based on area under the curve (AUC) measures of receiver operator characteristic curves and Brier score. ANN had a significantly higher AUC (0.892) of post-operative prediction and AUC (0.808) of pre-operative prediction than LR (both P <0.0001). In addition, there was significant higher AUC of post-operative prediction than pre-operative prediction by ANN (p<0.0001). With the highest AUC and the lowest Brier score (0.090), the post-operative prediction by ANN had the highest overall predictive performance. The post-operative prediction by ANN had the highest overall performance in predicting SSI after free-flap reconstruction in patients receiving surgery for head and neck cancer.

Extravasation of liposomal daunorubicin in patients with AIDS-associated Kaposi's sarcoma: a report of four cases.

PubMed

Cabriales, S; Bresnahan, J; Testa, D; Espina, B M; Scadden, D T; Ross, M; Gill, P S

1998-01-01

To report on four patients with AIDS-related Kaposi's sarcoma who were treated with liposomal daunorubicin (DaunoXome, NeXstar Pharmaceuticals, Inc., San Dimas, CA) as part of phase I/II and phase III clinical trials and who experienced extravasation during IV infusion. All patients were treated with ice as an immediate intervention. In addition, two patients received treatment with multiple subcutaneous injections of steroids. Two patients experienced erythema, swelling, and pain after the extravasation. Two patients who were treated aggressively reported erythema and swelling without pain. Three patients observed changes in the texture of their skin that was accompanied by decreased sensation, which developed after 8-16 weeks. These changes completely resolved in all patients receiving intervention after six months. None of the patients suffered tissue necrosis. Extravasation with liposomal daunorubicin is notable for the absence of tissue necrosis that typically is observed with anthracyclines. Long-term effects were limited to skin discoloration and decreased sensation, both of which resolved in all patients. The lack of observed skin necrosis with daunorubicin suggests a treatment advantage with a reduction in the required aggressive extravasation procedures for free anthracyclines as well as increased safety for the patient. Additional data is needed to confirm these observations.

AIDS mortality rates lower at sites with HIV experience.

PubMed

1999-11-01

HIV/AIDS patients are more likely to receive antiretroviral treatment and survive longer if they are treated by providers who have more experience treating the disease. Researchers examined data on more than 7,000 AIDS patients treated in 333 California hospitals to come to that conclusion. Another study discovered that pregnant HIV-infected women were more likely to receive treatment if they were at medical centers which performed HIV clinical trials or at State-funded sites with HIV services for people on Medicaid. Public hospitals had a higher mortality rate than for-profit and nonprofit hospitals. Part of the disparity can be linked to capitation arrangements by insurers that forces physicians to limit the time with HIV patients. In addition, private practice physicians rarely have time to keep up with medical advances related to HIV. HIV/AIDS patients might receive better care when a primary care physician shares efforts with specialists.

Exploring the Impact of Language Services on Utilization and Clinical Outcomes for Diabetics

PubMed Central

Hacker, Karen; Choi, Yoon Susan; Trebino, Lisa; Hicks, LeRoi; Friedman, Elisa; Blanchfield, Bonnie; Gazelle, G. Scott

2012-01-01

Background Significant health disparities exist between limited English proficient and English-proficient patients. Little is known about the impact of language services on chronic disease outcomes such as for diabetes. Methods/Principal Findings To determine whether the amount and type of language services received during primary care visits had an impact on diabetes-related outcomes (hospitalization, emergency room utilization, glycemic control) in limited English proficient patients, a retrospective cohort design was utilized. Hospital and medical record data was examined for 1425 limited English proficient patients in the Cambridge Health Alliance diabetes registry. We categorized patients receiving usual care into 7 groups based on the amount and combination of language services (language concordant providers, formal interpretation and nothing) received at primary care visits during a 9 month period. Bivariate analyses and multiple logistic regression were used to determine relationships between language service categories and outcomes in the subsequent 6 months. Thirty-one percent of patients (445) had no documentation of interpreter use or seeing a language concordant provider in any visits. Patients who received 100% of their primary care visits with language concordant providers were least likely to have diabetes-related emergency department visits compared to other groups (p<0001) in the following 6 months. Patients with higher numbers of co-morbidities were more likely to receive formal interpretation. Conclusions/Significance Language concordant providers may help reduce health care utilization for limited English proficient patients with diabetes. However, given the lack of such providers in sufficient numbers to meet patients' communication needs, strategies are needed to both increase their numbers and ensure that the highest risk patients receive the most appropriate language services. In addition, systems serving diverse populations must clarify why some limited English proficient patients do not receive language services at some or all of their visits and whether this has an impact on quality of care. PMID:22675571

The Addition of Postoperative Chemotherapy is Associated with Improved Survival in Patients with Pancreatic Cancer Treated with Preoperative Therapy.

PubMed

Roland, Christina L; Katz, Matthew H G; Tzeng, Ching-Wei D; Lin, Heather; Varadhachary, Gauri R; Shroff, Rachna; Javle, Milind; Fogelman, David; Wolff, Robert A; Vauthey, Jean N; Crane, Christopher H; Lee, Jeffrey E; Fleming, Jason B

2015-12-01

Preoperative/neoadjuvant therapy (NT) is increasingly utilized for the treatment of pancreatic ductal adenocarcinoma (PDAC). However, little data exist regarding information on the use of additional postoperative therapy following NT. The lymph node ratio (LNR) is a prognostic marker of oncologic outcomes after NT and resection. In this study, we evaluated the effectiveness of postoperative therapy following NT, stratified by LNR. A prospective tumor registry database was queried to identify patients with PDAC who underwent resection following NT from 1990 to 2008. Clinicopathologic factors were compared to identify associations with overall survival (OS) and time to recurrence (TTR) based on postoperative chemotherapy status. Thirty-six (14 %) of the 263 patients received additional postoperative therapy. No differences were observed in the pathologic characteristics between patients who received postoperative chemotherapy and those who did not. The median LNR was 0.12 for patients with N + disease. Following NT, the administration of postoperative therapy was associated with improved median OS (72 vs. 33 months; p = 0.008) for patients with an LNR < 0.15. There was no association between postoperative chemotherapy and OS for patients with LNR ≥ 0.15. Multivariate analysis demonstrated that the administration of postoperative systemic therapy in patients with a low LNR was associated with a reduced risk of death (hazard ratio 0.49; p = 0.02). Postoperative chemotherapy after NT in patients with low LNR is associated with improved oncologic outcomes.

Automated pictographic illustration of discharge instructions with Glyph: impact on patient recall and satisfaction

PubMed Central

Perri-Moore, Seneca; Kuang, Jinqiu; Bray, Bruce E; Ngo, Long; Doig, Alexa; Zeng-Treitler, Qing

2016-01-01

Objectives First, to evaluate the effect of standard vs pictograph-enhanced discharge instructions on patients’ immediate and delayed recall of and satisfaction with their discharge instructions. Second, to evaluate the effect of automated pictograph enhancement on patient satisfaction with their discharge instructions. Materials and Methods Glyph, an automated healthcare informatics system, was used to automatically enhance patient discharge instructions with pictographs. Glyph was developed at the University of Utah by our research team. Patients in a cardiovascular medical unit were randomized to receive pictograph-enhanced or standard discharge instructions. Measures of immediate and delayed recall and satisfaction with discharge instructions were compared between two randomized groups: pictograph (n = 71) and standard (n = 73). Results Study participants who received pictograph-enhanced discharge instructions recalled 35% more of their instructions at discharge than those who received standard discharge instructions. The ratio of instructions at discharge was: standard = 0.04 ± 0.03 and pictograph-enhanced = 0.06 ± 0.03. The ratio of instructions at 1 week post discharge was: standard = 0.04 ± 0.02 and pictograph-enhanced 0.04 ± 0.02. Additionally, study participants who received pictograph-enhanced discharge instructions were more satisfied with the understandability of their instructions at 1 week post-discharge than those who received standard discharge instructions. Discussion Pictograph-enhanced discharge instructions have the potential to increase patient understanding of and satisfaction with discharge instructions. Conclusion It is feasible to automatically illustrate discharge instructions and provide them to patients in a timely manner without interfering with clinical work. Illustrations in discharge instructions were found to improve patients’ short-term recall of discharge instructions and delayed satisfaction (1-week post hospitalization) with the instructions. Therefore, it is likely that patients’ understanding of and interaction with their discharge instructions is improved by the addition of illustrations. PMID:27234601

Rapid-onset hypogonadism secondary to crizotinib use in men with metastatic nonsmall cell lung cancer.

PubMed

Weickhardt, Andrew J; Rothman, Micol S; Salian-Mehta, Smita; Kiseljak-Vassiliades, Katja; Oton, Ana B; Doebele, Robert C; Wierman, Margaret E; Camidge, D Ross

2012-11-01

The objective of this study was to document the differences in testosterone (T) levels between crizotinib-treated and noncrizotinib-treated patients with metastatic nonsmall cell lung cancer (NSCLC). Testosterone levels were measured in 19 men with metastatic NSCLC who received crizotinib and in 19 men with metastatic NSCLC who did not receive crizotinib. Clinical characteristics of the patients were compared, and additional hormone assays were performed as appropriate. Two patients who began crizotinib and 4 patients who had dose interruptions or who stopped crizotinib therapy had serial hormone measurements, permitting the documentation of dynamic hormone changes on and off crizotinib treatment. Total T levels were low (<241 ng/dL) in 19 of 19 (100%) crizotinib-treated men and in 6 of 19 men (32%) with metastatic NSCLC who did not receive crizotinib (mean T levels, 131 ng/dL and 311 ng/dL, respectively; P = .0002). Only 1 in 5 patients who had anaplastic lymphoma kinase (ALK) gene rearrangements and had not yet received crizotinib had low T. The initiation of crizotinib in 2 patients who had previously normal T levels was associated with a rapid decreases in T and in luteinizing hormone and follicle stimulating hormone levels within 14 to 21 days. Discontinuation of crizotinib led to increases back to normal T levels. Crizotinib therapy caused rapid suppression of T levels in men. The current results indicated that the site of action must include a central (hypothalamic or pituitary) effect, but additional direct testicular effects could not be excluded. Further work is required to assess the correlation between low T levels and crizotinib side effects as well as the exact molecular mechanism and site of drug toxicity. Copyright © 2012 American Cancer Society.

Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study

PubMed Central

Yoo, Dae Hyun; Prodanovic, Nenad; Jaworski, Janusz; Miranda, Pedro; Ramiterre, Edgar; Lanzon, Allan; Baranauskaite, Asta; Wiland, Piotr; Abud-Mendoza, Carlos; Oparanov, Boycho; Smiyan, Svitlana; Kim, HoUng; Lee, Sang Joon; Kim, SuYeon; Park, Won

2017-01-01

Objectives To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions. Methods This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20% (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102 weeks (maintenance group) and for those who received RP for 54 weeks and then switched to CT-P13 (switch group). Results Overall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7% vs 71.8% for ACR20, 48.0% vs 51.4% for ACR50 and 24.3% vs 26.1% for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3% vs 44.8%, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5% and 53.8%, respectively). Conclusions Comparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years. Trial registration number NCT01571219; Results. PMID:27130908

The impact of religiosity and individual prayer activities on advanced cancer patients' health: is there any difference in function of whether or not receiving palliative anti-neoplastic therapy?

PubMed

Paiva, Carlos Eduardo; Paiva, Bianca Sakamoto Ribeiro; Yennurajalingam, Sriram; Hui, David

2014-12-01

Consecutive patients (n = 221) presenting for initial consultation at a palliative care outpatient clinic were prospectively interviewed and then followed until death. Individual prayer activity (IPA) and global religion scores were associated with quality of life, symptoms, inflammatory markers, and survival. Analyses were adjusted for whether patients were still receiving anti-neoplastic therapies (ANTs) or not. Higher religion scores were associated with lower levels of inflammation in advanced cancer patients still undergoing ANTs. Additionally, higher IPA was an independent good prognostic factor in patients on active ANTs. Further studies are necessary to confirm these findings and to investigate possible biological mechanisms involved.

How good are GPs at adhering to a pragmatic trial protocol in primary care? Results from the ADDITION-Cambridge cluster-randomised pragmatic trial

PubMed Central

Boothby, Clare E; Griffin, Simon J

2018-01-01

Objective To assess the fidelity of general practitioners’ (GPs) adherence to a long-term pragmatic trial protocol. Design Retrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care)-Cambridge trial, comparing intensive multifactorial treatment (IT) versus routine care (RC). Data were collected from the date of diagnosis until December 2010. Setting Primary care surgeries in the East of England. Study sample/participants A subsample (n=189, RC arm: n=99, IT arm: n=90) of patients from the ADDITION-Cambridge cohort (867 patients), consisting of patients 40–69 years old with screen-detected diabetes mellitus. Interventions In the RC arm treatment was delivered according to concurrent treatment guidelines. Surgeries in the IT arm received funding for additional contacts between GPs/nurses and patients, and GPs were advised to follow more intensive treatment algorithms for the management of glucose, lipids and blood pressure and aspirin therapy than in the RC arm. Outcome measures The number of annual contacts between patients and GPs/nurses, the proportion of patients receiving prescriptions for cardiometabolic medication in years 1–5 after diabetes diagnosis and the adherence to prescription algorithms. Results The difference in the number of annual GP contacts (β=0.65) and nurse contacts (β=−0.15) between the study arms was small and insignificant. Patients in the IT arm were more likely to receive glucose-lowering (OR=3.27), ACE-inhibiting (OR=2.03) and lipid-lowering drugs (OR=2.42, all p values <0.01) than patients in the RC arm. The prescription adherence varied between medication classes, but improved in both trial arms over the 5-year follow-up. Conclusions The adherence of GPs to different aspects of the trial protocol was mixed. Background changes in healthcare policy need to be considered as they have the potential to dilute differences in treatment intensity and hence incremental effects. Trial registration number ISRCTN86769081. PMID:29903781

The impact of the use of intraoperative radiotherapy on costs, travel time and distance for women with breast cancer in the Mexico City Metropolitan Area.

PubMed

Bargallo-Rocha, Juan Enrique; Soto-Perez-de-Celis, Enrique; Picó-Guzmán, Francisco Javier; Quintero-Rodríguez, Carlos Eduardo; Almog, David; Santiago-Concha, Gabriel; Flores-Balcazar, Christian Haydee; Corona, Jaime; Vazquez-Romo, Rafael; Villarreal-Garza, Cynthia; Mohar, Alejandro

2017-11-01

The low availability and poor access to external beam radiotherapy (EBRT) in developing countries makes it hard for women with breast cancer to receive breast conservation. We studied the effect of providing intraoperative radiotherapy (IORT) on the travel time, distance, and costs of in the Mexico City Metropolitan Area (MCMA). Sixty-nine patients treated between January 2013 and September 2014 were analyzed. Travel distance and transit time was calculated using Google Maps. The time and distance patients living in the MCMA treated with IORT would have spent if they had received EBRT was calculated. Cost analysis for each modality was performed. 71% (n = 49) lived in the MCMA. Sixteen (33%) received additional EBRT and 33 (66%) received IORT only. Mean driving distance and transit time of those 33 women was 132.6 km (SD 25.7) and 66 min (SD 32.9). Patients from the MCMA receiving IORT alone avoided 990 visits, 43 700 km and 65 400 min in transit. IORT led to a 12% reduction in costs per patient. By reducing costs and time needed for patients to receive radiotherapy, IORT could potentially enhance access to breast conservation in resource-limited developing countries. © 2017 Wiley Periodicals, Inc.

Modafinil effects on cognitive function in HIV+ patients treated for fatigue: a placebo controlled study.

PubMed

McElhiney, Martin; Rabkin, Judith; Van Gorp, Wilfred; Rabkin, Richard

2010-06-01

Both mild cognitive impairment and fatigue are common among people with HIV/AIDS. This study examined the efficacy of modafinil for HIV+ patients who sought treatment for fatigue in a placebo-controlled double-blind 4-week trial. A battery of standard neuropsychological tests was administered at study entry and Week 4, and change in performance was compared for 59 patients receiving modafinil versus 44 patients receiving placebo. A significant effect on fatigue was observed. In addition, cognitive performance, as measured by a global change score, improved more in the modafinil than in the placebo group although the effect was not specific to any cognitive domain.

Adjuvant use of antibiotics with corticosteroids in inflammatory bowel disease exacerbations requiring hospitalisation: a retrospective cohort study and meta-analysis.

PubMed

Gupta, V; Rodrigues, R; Nguyen, D; Sauk, J; Khalili, H; Yajnik, V; Ananthakrishnan, A N

2016-01-01

Patients hospitalised with an exacerbation of inflammatory bowel disease (IBD) often receive antibiotics in addition to intravenous steroids. However, their efficacy in this setting is unclear. To ascertain if the addition of antibiotics to intravenous steroids modifies short and long-term clinical outcomes. Our study included IBD patients hospitalised between 2009 and 2014 who received intravenous (IV) steroids with or without adjuvant antibiotics. Outcomes of interest included length of stay (LOS), need for medical and surgical rescue therapy during the hospitalisation, and at 90 and 365 days. A meta-analysis of previously published randomised trials was additionally performed. A total of 354 patients were included [145 ulcerative colitis (UC); 209 Crohn's disease (CD)]. In CD, combination of IV steroids and antibiotics did not change need for in-hospital medical rescue therapy, surgery or hospitalisations at 1 year but was associated with greater LOS (6.1 vs. 4.6 days, P = 0.02). In UC, patients receiving antibiotics were less likely to require in-hospital medical rescue therapy [odds ratio (OR): 0.42, 95% confidence interval (CI): 0.19-0.93] but experienced no statistically significant differences in LOS, in-hospital surgery, re-hospitalisations or surgery by 1 year. A meta-analysis of three relevant randomised trials demonstrated no difference in clinical improvement with antibiotics over placebo (OR: 1.08, 95% CI: 0.50-2.32). The addition of antibiotics to intravenous steroids for treatment of IBD exacerbations was associated with a reduced need for in-hospital medical rescue therapy in ulcerative colitis without significant long-term benefit, and did not affect short- or long-term outcomes in Crohn's disease. © 2015 John Wiley & Sons Ltd.

Addition of sulphonylurea to metformin does not relevantly change body weight: a prospective observational cohort study (ZODIAC-39).

PubMed

Schrijnders, Dennis; Wever, Raiza; Kleefstra, Nanne; Houweling, Sebastiaan T; van Hateren, Kornelis J J; de Bock, Geertruida H; Bilo, Henk J G; Groenier, Klaas H; Landman, Gijs W D

2016-10-01

To investigate changes in body weight trajectories after the addition of individual sulphonylureas (SUs) to metformin in patients with type 2 diabetes. We conducted a retrospective observational cohort study, in a primary care setting in the Netherlands. Patients aged ≥18 years with type 2 diabetes who were included in the ZODIAC cohort between 1998 and 2012 and who received metformin monotherapy at inclusion (n = 29 195), and had used metformin as monotherapy for at least 1 year before receiving dual therapy through the addition of an SU for at least 1 year were eligible for inclusion. The primary outcome was within-drug yearly change in body weight after receiving add-on therapy with individual SUs during 5 years of follow-up. The secondary outcome was within-drug yearly change in glycated haemoglobin (HbA1c). Annual changes in weight and HbA1c were estimated with linear mixed models, adjusted for age, gender and diabetes duration. A total of 2958 patients were included. No significant weight changes were observed within and between any of the individual SUs after treatment intensification (p = 0.24). In addition, no significant difference in weight between the add-on therapy combinations was observed (p = 0.26). The average HbA1c the year before intensification was 7.2% (55 mmol/mol) and dropped below 7.0% (53 mmol/mol) the year after. In patients with type 2 diabetes treated in primary care, strict glycaemic control can be maintained with SUs used as add-on therapy to metformin, without the offset of relevant weight changes. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Adjuvant Use of Antibiotics to Corticosteroids in Inflammatory Bowel Disease Exacerbations requiring Hospitalization: A Retrospective Cohort Study and Meta-analysis

PubMed Central

Gupta, Vikas; Rodrigues, Rodrigo; Nguyen, Deanna; Sauk, Jenny; Khalili, Hamed; Yajnik, Vijay; Ananthakrishnan, Ashwin N

2015-01-01

Background Patients hospitalized with an exacerbation of inflammatory bowel disease (IBD) often receive antibiotics in addition to intravenous steroids. However, their efficacy in this setting is unclear. Aim To ascertain if the addition of antibiotics to intravenous steroids modifies short and long-term clinical outcomes. Methods Our study included IBD patients hospitalized between 2009 – 2014 who received intravenous (IV) steroids with or without adjuvant antibiotics. Outcomes of interest included length of stay, need for medical and surgical rescue therapy during the hospitalization, and at 90 and 365 days. A meta-analysis of previously published randomized trials was additionally performed. Results A total of 354 patients were included (145 ulcerative colitis (UC); 209 Crohn’s disease (CD)). In CD, combination of IV steroids and antibiotics did not change need for in-hospital medical rescue therapy, surgery or hospitalizations at 1 year but was associated with greater LOS (6.1 vs. 4.6 days, p=0.02). In UC, patients receiving antibiotics were less likely to require in-hospital medical rescue therapy (Odds ratio (OR) 0.42, 95% confidence interval (CI) 0.19 – 0.93) but experienced no statistically significant differences in LOS, in-hospital surgery, re-hospitalizations or surgery by 1 year. A meta-analysis of 3 relevant randomized trials demonstrated no difference in clinical improvement with antibiotics over placebo (OR 1.08, 95% CI 0.50 – 2.32). Conclusions The addition of antibiotics to intravenous steroids for treatment of IBD exacerbations was associated with a reduced need for in-hospital medical rescue therapy in UC without significant long-term benefit and did not affect short- or long-term outcomes in CD. PMID:26541937

Randomized clinical trial of an intravenous hydromorphone titration protocol versus usual care for management of acute pain in older emergency department patients.

PubMed

Chang, Andrew K; Bijur, Polly E; Davitt, Michelle; Gallagher, E John

2013-09-01

Opioid titration is an effective strategy for treating pain; however, titration is generally impractical in the busy emergency department (ED) setting. Our objective was to test a rapid, two-step, hydromorphone titration protocol against usual care in older patients presenting to the ED with acute severe pain. This was a prospective, randomized clinical trial of patients 65 years of age and older presenting to an adult, urban, academic ED with acute severe pain. The study was registered at http://www.clinicaltrials.gov (NCT01429285). Patients randomized to the hydromorphone titration protocol initially received 0.5 mg intravenous hydromorphone. Patients randomized to usual care received any dose of any intravenous opioid. At 15 min, patients in both groups were asked, 'Do you want more pain medication?' Patients in the hydromorphone titration group who answered 'yes' received a second dose of 0.5 mg intravenous hydromorphone. Patients in the usual care group who answered 'yes' had their ED attending physician notified, who then could administer any (or no) additional medication. The primary efficacy outcome was satisfactory analgesia defined a priori as the patient declining additional analgesia at least once when asked at 15 or 60 min after administration of the initial opioid. Dose was calculated in morphine equivalent units (MEU: 1 mg hydromorphone = 7 mg morphine). The need for naloxone to reverse adverse opioid effects was the primary safety outcome. 83.0 % of 153 patients in the hydromorphone titration group achieved satisfactory analgesia compared with 82.5 % of 166 patients in the usual care group (p = 0.91). Patients in the hydromorphone titration group received lower mean initial doses of opioids at baseline than patients in the usual care group (3.5 MEU vs. 4.7 MEU, respectively; p ≤ 0.001) and lower total opioids through 60 min (5.3 MEU vs. 6.0 MEU; p = 0.03). No patient needed naloxone. Low-dose titration of intravenous hydromorphone in increments of 0.5 mg provides comparable analgesia to usual care with less opioid over 60 min.

Epidermal Growth Factor Receptor Is Related to Poor Survival in Glioblastomas: Single-Institution Experience

PubMed Central

Choi, Youngmin; Lee, Hyung-Sik; Hur, Won-Joo; Sung, Ki-Han; Kim, Ki-Uk; Choi, Sun-Seob; Kim, Su-Jin; Kim, Dae-Cheol

2013-01-01

Purpose There are conflicting results surrounding the prognostic significance of epidermal growth factor receptor (EGFR) status in glioblastoma (GBM) patients. Accordingly, we attempted to assess the influence of EGFR expression on the survival of GBM patients receiving postoperative radiotherapy. Materials and Methods Thirty three GBM patients who had received surgery and postoperative radiotherapy at our institute, between March 1997 and February 2006, were included. The evaluation of EGFR expression with immunohistochemistry was available for 30 patients. Kaplan-Meier survival analysis and Cox regression were used for statistical analysis. Results EGFR was expressed in 23 patients (76.7%), and not expressed in seven (23.3%). Survival in EGFR expressing GBM patients was significantly less than that in non-expressing patients (median survival: 12.5 versus 17.5 months, p=0.013). Patients who received more than 60 Gy showed improved survival over those who received up to 60 Gy (median survival: 17.0 versus 9.0 months, p=0.000). Negative EGFR expression and a higher radiation dose were significantly correlated with improved survival on multivariate analysis. Survival rates showed no differences according to age, sex, and surgical extent. Conclusion The expression of EGFR demonstrated a significantly deleterious effect on the survival of GBM patients. Therefore, approaches targeting EGFR should be considered in potential treatment methods for GBM patients, in addition to current management strategies. PMID:23225805

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial.

PubMed

Malhotra, Chetna; Sim, David Kheng Leng; Jaufeerally, Fazlur; Vikas, Nivedita Nadkarni; Sim, Genevieve Wong Cheng; Tan, Boon Cheng; Ng, Clarice Shu Hwa; Tho, Pei Leng; Lim, Jingfen; Chuang, Claire Ya-Ting; Fong, Florence Hui Mei; Liu, Joy; Finkelstein, Eric A

2016-06-10

Despite the promise and popularity of advance care planning, there is insufficient evidence that advance care planning helps patients to meet their end-of-life care preferences, especially in Asian settings. Thus, the proposed study aims to assess whether patients with advanced heart failure who are receiving advance care planning have a greater likelihood of receiving end-of-life care consistent with their preferences compared to patients receiving usual care. Secondary objectives are to compare differences in health care expenditures, quality of life, anxiety and depression, understanding of own illness, participation in decision-making and concordance with their caregiver's preferences for end-of-life care, between patients with advanced heart failure receiving advance care planning and usual care. This is a two-arm randomized controlled trial of advance care planning versus usual care (control) conducted at two institutions in Singapore. Two hundred and eighty-two patients with advanced heart failure (n = 94 in the advance care planning arm; n = 188 in the control arm receiving usual care) will be recruited from these centers and followed for 1 year or until they die, whichever is earlier. Additionally, the study will include up to one caregiver per patient enrolled. If advance care planning is proven to be effective, the results will help to promote its uptake among health care providers and patients both within Singapore and in other countries. NCT02299180 . Registered on 18 November 2014.

Androgen deprivation in veterans with prostate cancer: implications for skeletal health.

PubMed

Wilcox, Andrew; Carnes, Molly L; Moon, Timothy D; Tobias, Renee; Baade, Heather; Stamos, Emily; Elliott, Mary E

2006-12-01

Common risk factors for osteoporosis in older men include smoking, heavy use of alcohol, propensity to falls, and use of bone-toxic medications such as prednisone. There is also increasing appreciation of the skeletal risk faced by men receiving androgen deprivation therapy (ADT) for prostate cancer. Measures to prevent bone loss in such patients are available. To test the following hypotheses in a population of veterans receiving ADT for prostate cancer: (1) fracture risk factors in addition to androgen deprivation would be found in most patients, (2) bone mass measurements would be assessed in a minority of patients, and (3) a minority of the subjects would receive bisphosphonate therapy or have contraindications for such treatment. We conducted a retrospective chart review of male veterans receiving ADT from 1993 through 2001, at the Veterans Affairs Medical Center, Madison, WI. One hundred and seventy-four subjects met study criteria, with a mean age of 76 years and median duration of 21 months of ADT. Eighty-one percent had risk factors in addition to ADT. Only 13% underwent bone density measurement by dual energy X-ray absorptiometry (DXA) and, of those measured, more than half had osteoporosis. Only 19% of the men received both calcium and vitamin D supplements. Antiresorptive therapy was provided to 11% of men, although more than two-thirds had no contraindications to therapy. A total of 24 men sustained a fracture after starting ADT. For men who did undergo bone density measurement, 77% received antiresorptive therapy. Of those who exhibited osteoporosis by DXA scan, 85% received antiresorptive therapy. Male veterans receiving ADT for prostate cancer received inadequate evaluation and treatment for osteoporosis. Based on our data, a simple and practical strategy to prompt further evaluation and improved care may be to undertake bone density measurements in men prior to or soon after commencing ADT.

Phenytoin intoxication induced by sulthiame in epileptic patients

PubMed Central

Houghton, G. W.; Richens, A.

1974-01-01

Routine estimation of serum phenytoin levels in patients newly admitted to a Special Centre for Epilepsy showed that 40% of those receiving sulthiame in addition to phenytoin had levels in the toxic range. Four long-stay patients became drug intoxicated when sulthiame treatment was started. Sulthiame appears to inhibit the hepatic hydroxylation of phenytoin. PMID:4151416

Venous thromboembolism prophylaxis in the critically ill: a point prevalence survey of current practice in Australian and New Zealand intensive care units.

PubMed

Robertson, Megan S; Nichol, Alistair D; Higgins, Alisa M; Bailey, Michael J; Presneill, Jeffrey J; Cooper, D James; Webb, Steven A; McArthur, Colin; MacIsaac, Christopher M

2010-03-01

Critically ill patients are at high risk of morbidity and mortality caused by venous thromboembolism (VTE). In addition to premorbid predisposing conditions, critically ill patients may be exposed to prolonged immobility, invasive intravascular catheters and frequent operative procedures, and further may have contraindications to pharmaceutical prophylactic measures designed to attenuate VTE risk. There are limited data describing current VTE prophylaxis regimens in Australia and New Zealand. To document current Australian and New Zealand management of VTE prophylaxis in a large mixed cohort of critically ill patients. Prospective, multicentre point prevalence survey endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG). 30 public hospital ICUs in Australia and New Zealand surveyed on Wednesday 9 May 2007. For all patients in each ICU on the study day, demographic data, admission diagnosis and information on VTE prophylaxis were prospectively collected. 502 patients were included in the survey, and 431 of these (86%) received VTE prophylaxis. Of these, 64% (276/431) received pharmacological prophylaxis and 80% (345/431) received mechanical prophylaxis, with 44% (190/431) receiving both. Of those receiving pharmacological prophylaxis, unfractionated heparin was used in 74%, and enoxaparin (low molecular weight heparin) in 23%. Contraindications to pharmacological prophylaxis were reported in 122 patients. Overall, pharmacological prophylaxis was administered to 87% of potentially suitable patients. We observed a high prevalence of VTE prophylaxis, with many critically ill patients receiving two or more modalities of prophylaxis. These results show that the potential risk of VTE in critically ill patients is recognised in Australia and New Zealand, and strategies to mitigate this serious complication are widely implemented.

The dual-effects model of social control revisited: relationship satisfaction as a moderator.

PubMed

Knoll, Nina; Burkert, Silke; Scholz, Urte; Roigas, Jan; Gralla, Oliver

2012-05-01

The dual-effects model of social control states that receiving social control leads to better health behavior, but also enhances distress in the control recipient. Associated findings, however, are inconsistent. In this study we investigated the role of relationship satisfaction as a moderator of associations of received spousal control with health behavior and affect. In a study with five waves of assessment spanning two weeks to one year following radical prostatectomy (RP), N=109 married or cohabiting prostate-cancer patients repeatedly reported on their pelvic-floor exercise (PFE) to control postsurgery urinary incontinence and affect as primary outcomes, on received PFE-specific spousal control, relationship satisfaction, and covariates. Findings from two-level hierarchical linear models with repeated assessments nested in individuals suggested significant interactions of received spousal control with relationship satisfaction predicting patients' concurrent PFE and positive affect. Patients who were happy with their relationships seemed to benefit from spousal control regarding regular PFE postsurgery while patients less satisfied with their relationships did not. In addition, the latter reported lower levels of positive affect when receiving much spousal control. Results indicate the utility of the inclusion of relationship satisfaction as a moderator of the dual-effects model of social control.

Psychoactive medication use in intermediate-care facility residents.

PubMed

Beers, M; Avorn, J; Soumerai, S B; Everitt, D E; Sherman, D S; Salem, S

1988-11-25

Despite the large number of elderly patients in nursing homes and the intensity of medication use there, few current data are available on patterns of medication use in this setting. We studied all medication use among 850 residents of 12 representative intermediate-care facilities in Massachusetts. Data on all prescriptions and patterns of actual use were recorded for all patients during one month. On average, residents were prescribed 8.1 medications during the month (interquartile range, 7.4 to 8.8) and actually received 4.7 (range, 4.2 to 5.4) medications during this period. More than half of all residents were receiving a psychoactive medication, with 26% receiving antipsychotic medication. Twenty-eight percent of patients were receiving sedative/hypnotics during the study month, primarily on a scheduled rather than an as-needed basis. Of patients receiving a sedative/hypnotic, 26% (range, 14% to 41%) were taking diphenhydramine hydrochloride, a strongly anticholinergic hypnotic. Of those receiving one of the benzodiazepines, 30% were receiving long-acting drugs, generally not recommended for elderly patients. The typical benzodiazepine dose was equivalent to 7.3 mg per patient per day of diazepam. The most commonly used antidepressant was amitriptyline hydrochloride, the most sedating and anticholinergic antidepressant in common use. These data indicate that despite growing evidence of the risks of psychoactive drug use in elderly patients, the nursing home population studied was exposed to high levels of sedative/hypnotic and antipsychotic drug use. Suboptimal choice of medication within a given class was common, and use of standing vs as-needed orders was often not in keeping with current concepts in geriatric psychopharmacology. Additional research is needed to assess the impact of such drug therapy on cognitive and physical functioning, as well as to determine how best to improve patterns of medication use in this vulnerable population.

Rituximab in the treatment of diffuse large B-cell lymphoma primary of the lung.

PubMed

Aviles, Agustin; Nambo, Maria J; Huerta-Guzman, Judith; Silva, Luis; Neri, Natividad

2013-03-01

Diffuse large B-cell lymphoma primary of lung (DLBCL-PL) is a rare presentation of extranodal lymphoma, in most cases chemotherapy-based anthracyclines: CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) has been the treatment, with excellent outcome. The addition of rituximab to CHOP (R-CHOP) has been considered the gold standard in the treatment of nodal DLBCL. Thus, we assess in a large number of cases of DLBCL-PL whether the use of R-CHOP could improve survival in this setting of patients. Forty-two patients with DLBCL-PL, stage IE, age 65 years or younger, were treated with standard R-CHOP, no consolidation radiotherapy or maintenance therapy were considered. They were matched with patients who received CHOP alone to assess efficacy and toxicity. Complete response was observed in 35 patients (83%), and 7 patients were considered failure (16%). The study has a median follow-up of 42.8 months. Actuarial curves at 5 years showed that progression-free survival was 88 % and overall survival was 70 %. The results were not statistically different when compared retrospectively with patients who received CHOP alone. Treatment was well tolerated. The addition of rituximab to chemotherapy did not improve outcome in patients with DLBCL-PL.

Repeated combined endovascular therapy with milrinone and nimodipine for the treatment of severe vasospasm: preliminary results.

PubMed

Sherif, Camillo; Wambacher, Bernhard; Loyoddin, Michel; Karaic, Radenko; Krafft, Peter; Valentin, Andreas; Tscholakoff, Dimiter; Kleinpeter, Guenther

2015-01-01

Delayed vasospasm (VSP) following aneurysmal subarachnoid hemorrhage (aSAH) remains a major source of morbidity. Milrinone was recently suggested as an invasive VSP treatment option. It is a phosphodiesterase III inhibitor with vasodilating and additional positive inotrope and anti-inflammatory effects. In this preliminary series, we included patients with severe VSP and unsuccessful maximum conservative therapy. Inclusion criteria were (1) transcranial Doppler (TCD) mean >180 cm/s; (2) increase of >50 % of TCD mean values within 6 h to values >150 cm/s; and/or (3) neurological deterioration (after exclusion of hemorrhage, hydrocephalus, and other systemic reasons). Patients received endovascular therapy with nimodipine 2 mg followed by milrinone 4-8 mg. Reinterventions were indicated aggressively in cases of persistent neurological deficits or persistent high mean TCD >180 cm/s. Of 121 consecutive aSAH patients, 16 (13.2 %) received endovascular VSP therapy. Of these, 11 patients (68.5 %) received ≥ 3 interventions (median 4; maximum 9); 14 (87.5 %) showed postinterventional angiographic improvement of vessel diameters; and 11 (68.5 %) showed improvement of their neurological deficits after a mean follow-up time of 4.5 months. No cardiovascular adverse events attributed to milrinone were observed. Milrinone may be a useful supplementary substance for endovascular VSP therapy. Aggressive reintervention indications did not cause additional adverse events.

Hospital Rating Systems and Implications For Patient Travel to Better-rated Hospitals.

PubMed

Subramanian, Arun; Adler, Joel T; Shah, Nilay D; Hyder, Joseph A

2017-03-01

Publicly reported hospital ratings aim to encourage transparency, spur quality improvement, and empower patient choice. Travel burdens may limit patient choice, particularly for older adults (aged 65 years and more) who receive most medical care. For 3 major hospital ratings systems, we estimated travel burden as the additional 1-way travel distance to receive care at a better-rated hospital.Distances were estimated from publicly available data from the US Census, US News Top Hospitals, Society of Thoracic Surgeons composite rating for coronary artery bypass grafting (STS-CABG), and Centers for Medicare and Medicaid Services Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS).Hospitals were rated for HCAHPS (n = 4656), STS-CABG (n = 470), and US News Top Hospitals (n = 15). Older adults were commonly located within 25 miles of their closest HCAHPS hospital (89.6%), but less commonly for STS-CABG (62.9%). To receive care at a better-rated hospital, travel distances commonly exceeded 25 miles: HCAHPS (39.2%), STS-CABG (62.7%), and US News Top Hospital (85.2%). Additional 1-way travel distances exceeded 25 miles commonly: HCAHPS (23.7%), STS-CABG (36.7%), US News Top Hospitals (81.8%).Significant travel burden is common for older adults seeking "better" care and is an important limitation of current hospital ratings for empowering patient choice.

Magnetic resonance imaging of the sacroiliac joints in the early detection of spondyloarthritis: no added value of gadolinium compared with short tau inversion recovery sequence.

PubMed

de Hooge, Manouk; van den Berg, Rosaline; Navarro-Compán, Victoria; van Gaalen, Floris; van der Heijde, Désirée; Huizinga, Tom; Reijnierse, Monique

2013-07-01

To investigate the additional value of T1 fat-saturated after gadolinium (T1/Gd) compared with T1 and short tau inversion recovery (STIR) sequence in detecting active lesions of the SI joints typical of axial SpA (axSpA) in a prospective cohort study, the SpondyloArthritis Caught Early (SPACE) cohort, and to assess its influence on final MRI diagnosis of the SI joint (MRI-SIJ) based on the Assessment of Spondyloarthritis International Society (ASAS) definition of active sacroiliitis. Patients in the SPACE cohort received baseline and 3-month follow-up MRI-SIJ with coronal oblique T1, STIR and T1/Gd sequences. Bone marrow oedema (BME), capsulitis/enthesitis and synovitis and active sacroiliitis according to the ASAS definition were evaluated by three blinded readers. A total of 127 patients received an MRI-SIJ at baseline and 67 patients also received an MRI-SIJ at 3 months follow-up since the Gd protocol was added some months after the start of the SPACE project. Twenty-five of the 127 patients (19.7%) with a baseline MRI-SIJ and 14 of 67 patients (20.6%) with a follow-up MRI-SIJ presented BME on the STIR sequence sufficient to fulfill the ASAS definition for a positive MRI-SIJ. In eight patients, additional synovitis and/or capsulitis/enthesitis was observed; however, no additional BME was visualized on T1/Gd. One patient, without clinical diagnosis of axSpA, showed synovitis as an isolated finding. Synovitis and capsulitis/enthesitis are detectable with the administration of Gd. However, they are always observed in the presence of BME. Therefore T1 and STIR sequence alone are sufficient in the MRI assessment that, among others, is used for diagnosing patients with early axSpA.

Supplementation of fish oil and olive oil in patients with rheumatoid arthritis.

PubMed

Berbert, Alair Alfredo; Kondo, Cacilda Rosa Mitiko; Almendra, Cecília Lisete; Matsuo, Tiemi; Dichi, Isaias

2005-02-01

This study evaluated whether supplementation with olive oil could improve clinical and laboratory parameters of disease activity in patients who had rheumatoid arthritis and were using fish oil supplements. Forty-three patients (34 female, 9 male; mean age = 49 +/- 19y) were investigated in a parallel randomized design. Patients were assigned to one of three groups. In addition to their usual medication, the first group (G1) received placebo (soy oil), the second group (G2) received fish oil omega-3 fatty acids (3 g/d), and the third group (G3) received fish oil omega-3 fatty acids (3 g/d) and 9.6 mL of olive oil. Disease activity was measured by clinical and laboratory indicators at the beginning of the study and after 12 and 24 wk. Patients' satisfaction in activities of daily living was also measured. There was a statistically significant improvement (P < 0.05) in G2 and G3 in relation to G1 with respect to joint pain intensity, right and left handgrip strength after 12 and 24 wk, duration of morning stiffness, onset of fatigue, Ritchie's articular index for pain joints after 24 wk, ability to bend down to pick up clothing from the floor, and getting in and out of a car after 24 wk. G3, but not G2, in relation to G1 showed additional improvements with respect to duration of morning stiffness after 12 wk, patient global assessment after 12 and 24 wk, ability to turn faucets on and off after 24 wk, and rheumatoid factor after 24 wk. In addition, G3 showed a significant improvement in patient global assessment in relation to G2 after 12 wk. Ingestion of fish oil omega-3 fatty acids relieved several clinical parameters used in the present study. However, patients showed a more precocious and accentuated improvement when fish oil supplements were used in combination with olive oil.

Perioperative erythropoietin protects the CNS against ischemic lesions in patients after open heart surgery.

PubMed

Lakič, Nikola; Mrak, Miha; Šušteršič, Miha; Rakovec, Peter; Bunc, Matjaž

2016-12-01

The aim of this study was to establish erythropoietin as a protective factor against brain ischemia during open heart surgery. A total of 36 consecutive patients scheduled for revascularization heart surgery were included in the study. Of the patients 18 received 3 intravenous doses of recombinant human erythropoietin (rHuEpo, 24,000 IU) and 18 patients received a placebo. Magnetic resonance imaging (MRI) to detect new brain ischemic lesions was performed. Additionally, S100A, S100B, neuron-specific enolase A and B (NSE-A and B) and the concentration of antibodies against N‑methyl-D-aspartate receptors (NMDAR) to identify new neurological complications were determined. Patients who received rHuEpo showed no postoperative ischemic changes in the brain on MRI images. In the control group 5 (27.8 %) new ischemic lesions were found. The NMDAR antibody concentration, S100A, S100B and NSE showed no significant differences between the groups for new cerebral ischemia. High levels of lactate before and after external aortic compression (p = 0.022 and p = 0.048, respectively) and duration of operation could predict new ischemic lesions (p = 0.009). The addition of rHuEpo reduced the formation of lesions detectable by MRI in the brain and could be used clinically as neuroprotection in cardiac surgery.

Effect of rajyoga meditation on chronic tension headache.

PubMed

Kiran; Girgla, Kawalinder K; Chalana, Harsh; Singh, Harjot

2014-01-01

Chronic tension-type headache (CTTH) is the most common type of headache with no truly effective treatment. This study was designed to correlate the additive effect of meditation on CTTH patients receiving medical treatment. 50 patients (aged 18-58 years) presenting with a clinical diagnosis of CCTH, were divided in 2 groups. Group 1 (n=30) received 8 lessons and practical demonstration of Brahmakumaris spiritual based meditation known as Rajyoga meditation for relaxation therapy, in addition to routine medical treatment (analgesics and muscle relaxants). Group 2 (n=20) patients received analgesics and muscle relaxants twice a day but no relaxation therapy in the form of meditation. Both groups were followed up for 8 weeks period. The parameters studied were severity, frequency and duration of CCTH, and their headache index calculated. Patients in both groups showed a highly significant reduction in headache variables (P<0.001) after 8 weeks. But the percentage of patients showing highly significant relief in severity of headache, duration & frequency in Group 1 was 94%, 91% and 97% respectively whereas in Group 2 it was 36%, 36% and 49% respectively. Headache relief as calculated by headache index was 99% in Group 1 as compared to 51% in Group 2. Even Short term spiritual based relaxation therapy (Rajyoga meditation) was highly effective in causing earlier relief in chronic tension headache as measured by headache parameter.

Unresolved issues in hematopoietic stem cell transplantation for severe combined immunodeficiency: Need for safer conditioning and reduced late effects

PubMed Central

Horn, Biljana; Cowan, Morton J.

2017-01-01

In this review we discuss recent outcomes of hematopoietic cell transplantation (HCT) for patients with severe combined immunodeficiency (SCID), including survival, T- and B-cell reconstitution, and late effects, particularly those related to genotype, use of conditioning regimen, and use of alternative donors. We identify the following issues that require additional data, which can be obtained through cooperative studies: outcomes of patients with SCID who did not receive conditioning before alternative donor HCT; outcomes of patients with SCID who did not receive graft-versus-host disease prophylaxis after T cell–replete HCT; late effects of HCT for patients with SCID, including neurocognitive outcomes, growth, and development; and their relationship to genotype and use of alkylating agents for conditioning. Careful follow-up of outcomes of all newborns receiving diagnoses based on newborn screening programs for SCID is essential because data are scarce on the effects of conditioning regimens in very young patients. A consensus on the definition of T- and B-cell recovery, criteria for additional “boosts,” pharmacokinetic data of chemotherapy agents used in young children, and uniformity of the use of various chemotherapy agents are needed to compare results among institutions. Finally, development of new nontoxic conditioning regimens for HCT that can be safely used in very young children is required. PMID:23622119

A prospective study on the efficacy of two-dose influenza vaccinations in cancer patients receiving chemotherapy.

PubMed

Sanada, Yukinari; Yakushijin, Kimikazu; Nomura, Tetsuhiko; Chayahara, Naoko; Toyoda, Masanori; Minami, Yosuke; Kiyota, Naomi; Mukohara, Toru; Kawamoto, Shinichiro; Ito, Mitsuhiro; Matsuoka, Hiroshi; Minami, Hironobu

2016-05-01

Cancer patients receiving chemotherapy are at risk of acquiring influenza infections. Two-dose vaccination is a proposed strategy for increasing vaccination efficacy; however, this has yet to be confirmed in this population. The purpose of this study was to clarify the efficacy and safety of this strategy. We conducted a multicentre prospective study on a two-dose vaccination regimen in cancer patients receiving chemotherapy. Second vaccinations were performed in patients who did not respond to all three viral strains after the first vaccination. Serum haemagglutination inhibition titres were measured to determine the patients' immunological response, 2 weeks prior to the first vaccination, 3-5 weeks after each vaccination, and at the end of the influenza season. We enrolled 109 patients, including 70 with solid tumours, 36 with haematological malignancies, and 3 with both cancer types. Among the total patients, the proportion of patients with protective titres against the three viral strains increased significantly from 3 to 27% (P < 0.01) following vaccination. Among the 79 patients who received a second vaccination, the proportion of those with protective titres against the individual strains increased by 10% (H1N1), 8% (H3N2), and 3% (B) compared with after the first vaccination. Serious adverse events were not observed. We recommend influenza vaccinations for cancer patients, including those receiving chemotherapy. Also, the additional benefit of the second vaccination may be limited. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Combined enteral feeding and total parenteral nutritional support improves outcome in surgical intensive care unit patients.

PubMed

Hsu, Min-Hui; Yu, Ying E; Tsai, Yueh-Miao; Lee, Hui-Chen; Huang, Ying-Che; Hsu, Han-Shui

2012-09-01

For intensive care unit (ICU) patients with gastrointestinal dysfunction and in need of total parenteral nutrition (TPN) support, the benefit of additional enteral feeding is not clear. This study aimed to investigate whether combined TPN with enteral feeding is associated with better outcomes in surgical intensive care unit (SICU) patients. Clinical data of 88 patients in SICU were retrospectively collected. Variables used for analysis included route and percentage of nutritional support, total caloric intake, age, gender, body weight, body mass index, admission diagnosis, surgical procedure, Acute Physiology and Chronic Health Evaluation (APACHE) II score, comorbidities, length of hospital stay, postoperative complications, blood glucose values and hospital mortality. Wound dehiscence and central catheter infection were observed more frequently in the group of patients receiving TPN calories less than 90% of total calorie intake (p = 0.004 and 0.043, respectively). APACHE II scores were higher in nonsurvivors than in survivors (p = 0.001). More nonsurvivors received TPN calories exceeding 90% of total calorie intake and were in need of dialysis during ICU admission (p = 0.005 and 0.013, respectively). Multivariate analysis revealed that the percentage of TPN calories over total calories and APACHE II scores were independent predictors of ICU mortality in patients receiving supplementary TPN after surgery. In SICU patients receiving TPN, patients who could be fed enterally more than 10% of total calories had better clinical outcomes than patients receiving less than 10% of total calorie intake from enteral feeding. Enteral feeding should be given whenever possible in severely ill patients. 2012 Published by Elsevier B.V

Radiation Is an Important Component of Multimodality Therapy for Pediatric Non-Pineal Supratentorial Primitive Neuroectodermal Tumors

DOE Office of Scientific and Technical Information (OSTI.GOV)

McBride, Sean M.; Daganzo, Sally M.; Banerjee, Anuradha

Purpose: To review a historical cohort of pediatric patients with supratentorial primitive neuroectodermal tumors (sPNET), to clarify the role of radiation in the treatment of these tumors. Patients and Methods: Fifteen children aged <18 years with non-pineal sPNETs diagnosed between 1992 and 2006 were identified. Initial therapy consisted of surgical resection and chemotherapy in all patients and up-front radiotherapy (RT) in 5 patients. Five patients had RT at the time of progression, and 5 received no RT whatever. Kaplan-Meier estimates of overall survival were then calculated. Results: The median follow-up from diagnosis for all patients was 31 months (range, 0.5-165more » months) and for surviving patients was 49 months (range, 10-165). Of the 5 patients who received up-front RT, all were alive without evidence of disease at a median follow-up of 50 months (range, 25-165 months). Only 5 of the 10 patients who did not receive up-front RT were alive at last follow-up. There was a statistically significant difference in overall survival between the patient group that received up-front RT and the group that did not (p = 0.048). In addition, we found a trend toward a statistically significant improvement in overall survival for those patients who received gross total resections (p = 0.10). Conclusions: Up-front RT and gross total resection may confer a survival benefit in patients with sPNET. Local failure was the dominant pattern of recurrence. Efforts should be made to determine patients most likely to have local failure exclusively or as a first recurrence, in order to delay or eliminate craniospinal irradiation.« less

Low-cost implant overdenture option for patients treated in a predoctoral dental school curriculum.

PubMed

McCracken, Michael S; Aponte-Wesson, Ruth; O'Neal, S Jean; Rajdev, Kavita

2006-06-01

In an effort to make the implant overdenture more affordable for patients, a pricing package at the University of Alabama at Birmingham School of Dentistry was established. This package includes two implants, two dentures (upper and lower), and two implant abutments, all for $975. It is known as the "2-2-2" implant program. One concern regarding the program was whether patients would complete overdenture treatment or simply receive implants at this relatively low cost and have the implants restored outside the school. The purpose of this retrospective chart review was to determine how many patients in 2004 received implants as part of this program and how many of these patients completed overdenture treatment. Other data (age, distance from school, number of teeth at start of treatment, and gender) were collected to identify variables that might be associated with greater likelihood of completing overdenture treatment. In 2004, fifty-one patients received 102 implants as part of this program. Two patients had a failed implant prior to restoration (two of 102 implants), and one patient was referred to graduate prosthodontics for restoration. Of the remaining forty-eight patients, forty-one completed overdenture treatment (85 percent), and seven (15 percent) were lost to follow-up. The mean age of patients receiving this treatment was 60.7 years. The mean distance traveled to the school was 70.7 miles. While no variables showed significant predictive value, point estimates (estimate of the odds ratio) suggest that older patients and patients who travel greater distance to the school were less likely to complete treatment. The low-cost implant overdenture has been an important addition to our curriculum. The majority of patients who receive implants as part of this program complete overdenture treatment.

Irinotecan and Oxaliplatin Might Provide Equal Benefit as Adjuvant Chemotherapy for Patients with Resectable Synchronous Colon Cancer and Liver-confined Metastases: A Nationwide Database Study.

PubMed

Liang, Yi-Hsin; Shao, Yu-Yun; Chen, Ho-Min; Cheng, Ann-Lii; Lai, Mei-Shu; Yeh, Kun-Huei

2017-12-01

Although irinotecan and oxaliplatin are both standard treatments for advanced colon cancer, it remains unknown whether either is effective for patients with resectable synchronous colon cancer and liver-confined metastasis (SCCLM) after curative surgery. A population-based cohort of patients diagnosed with de novo SCCLM between 2004 and 2009 was established by searching the database of the Taiwan Cancer Registry and the National Health Insurance Research Database of Taiwan. Patients who underwent curative surgery as their first therapy followed by chemotherapy doublets were classified into the irinotecan group or oxaliplatin group accordingly. Patients who received radiotherapy or did not receive chemotherapy doublets were excluded. We included 6,533 patients with de novo stage IV colon cancer. Three hundred and nine of them received chemotherapy doublets after surgery; 77 patients received irinotecan and 232 patients received oxaliplatin as adjuvant chemotherapy. The patients in both groups exhibited similar overall survival (median: not reached vs. 40.8 months, p=0.151) and time to the next line of treatment (median: 16.5 vs. 14.3 months, p=0.349) in both univariate and multivariate analyses. Additionally, patients with resectable SCCLM had significantly shorter median overall survival than patients with stage III colon cancer who underwent curative surgery and subsequent adjuvant chemotherapy, but longer median overall survival than patients with de novo stage IV colon cancer who underwent surgery only at the primary site followed by standard systemic chemotherapy (p<0.001). Irinotecan and oxaliplatin exhibited similar efficacy in patients who underwent curative surgery for resectable SCCLM. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Compression-to-ventilation ratio and incidence of rearrest-A secondary analysis of the ROC CCC trial.

PubMed

Salcido, David D; Schmicker, Robert H; Buick, Jason E; Cheskes, Sheldon; Grunau, Brian; Kudenchuk, Peter; Leroux, Brian; Zellner, Stephanie; Zive, Dana; Aufderheide, Tom P; Koller, Allison C; Herren, Heather; Nuttall, Jack; Sundermann, Matthew L; Menegazzi, James J

2017-06-01

Previous work has demonstrated that when out-of-hospital cardiac arrest (OHCA) patients achieve return of spontaneous circulation (ROSC), but subsequently have another cardiac arrest prior to hospital arrival (rearrest), the probability of survival to hospital discharge is significantly decreased. Additionally, few modifiable factors for rearrest are known. We sought to examine the association between rearrest and compression-to-ventilation ratio during cardiopulmonary resuscitation (CPR) and to confirm the association between rearrest and outcomes. Rearrest incidence would be similar between cases treated with 30:2 or continuous chest compression (CCC) CPR, but inversely related to survival and good neurological outcome. We conducted a secondary analysis of a large randomized-controlled trial of CCC versus 30:2 CPR for the treatment of OHCA between 2011 and 2015 among 8 sites of the Resuscitation OUTCOMES: Consortium (ROC). Patients were randomized through an emergency medical services (EMS) agency-level cluster randomization design to receive either 30:2 or CCC CPR. Case data were derived from prehospital patient care reports, digital defibrillator files, and hospital records. The primary analysis was an as-treated comparison of the proportion of patients with a rearrest for patients who received 30:2 versus those who received CCC. In addition, we assessed the association between rearrest and both survival to hospital discharge and favorable neurological outcome (Modified Rankin Score≤3) in patients with and without ROSC upon ED arrival using multivariable logistic regression adjusting for age, sex, initial rhythm and measures of CPR quality. There were 14,109 analyzable cases that were determined to have definitively received either CCC or 30:2 CPR. Of these, 4713 had prehospital ROSC and 2040 (43.2%) had at least one rearrest. Incidence of rearrest was not significantly different between patients receiving CCC and 30:2 (44.1% vs 41.8%; adjusted OR: 1.01; 95% CI: 0.88, 1.16). Rearrest was significantly associated with lower survival (23.3% vs 36.9%; adjusted OR: 0.46; 95%CI: 0.36-0.51) and worse neurological outcome (19.4% vs 30.2%; adjusted OR: 0.46; 95%CI: 0.38, 0.55). Rearrest occurrence was not significantly different between patients receiving CCC and 30:2, and was inversely associated with survival to hospital discharge and MRS. Copyright © 2017 Elsevier B.V. All rights reserved.

[Danish experience with physical and occupational rehabilitation after heart transplantation. The heart transplantation group at Rigshospitalet].

PubMed

Aldershvile, J; Boesgaard, S; Kirchoff, G; Arendrup, H; Høyer, S

1993-01-11

Heart transplantations have been carried out for one year (1.9.1990-1.9.1991) in Denmark. Twenty-three out of 27 patients survived at the end of this period. Prior to transplantation, all of the patients were in NYHA groups III or IV. On discharge, all of the patients could manage a 45-60 minutes training programme followed by a stair test (two to six floors up). Prior to transplantation, 17 patients received financial aid in one form or another and one child received special schooling. On an average 165 days (1.9.1991) after transplantation, nine patients were in full or part-time employment, two were students, seven received financial aid and five were still in hospital. A correlation between the duration of financial aid before transplantation and return to work after transplantation was found. In addition, age was found to be of significance. It is concluded that physical status and return to work are satisfactory.

[Non-pharmaceutical therapy of candidates for geriatric rehabilitation: Non-pharmaceutical therapy prescribed by SHI-accredited doctors after application for outpatient geriatric rehabilitative care].

PubMed

Krupp, Sonja; Schnoor, Maike; Lohse, Kristina; Katalinic, Alexander; Willkomm, Martin

2015-06-01

The rejection of an application for ambulant geriatric rehabilitation (AGRV) is usually justified by the argument that non-pharmaceutical therapy prescribed by doctors accredited by social housing institutions (SHI) would suffice. The reality in healthcare during the 6 months following an application is unknown. In this study 203 patients who had made an application for AGRV in the second half of 2010 in Flensburg, Lübeck or Ratzeburg were interviewed by telephone. The survey revealed that 25.7% of the applications for AGRV had been rejected. The majority of these patients received no ambulant non-pharmaceutical therapy (e.g. physical therapy, physiotherapy, occupational therapy, speech therapy or psychological therapy), less than 20% received more than 12 therapy sessions and in most cases exclusively physiotherapy. The 141 successful AGRV applicants received additional ambulant therapies of a similar magnitude. The difference between the intensified interdisciplinary therapy offered in the AGRV and additionally and the offer to rejected applicants is substantial.

Pediatric Renal Transplantation in Oman: A Single-center Experience

PubMed Central

Al Riyami, Mohamed S.; Al Saidi, Sulaiman; Al Ghaithi, Badria; Al Maskari, Anisa; Lala, Sadiq; Mohsin, Nabil; Hirshikesan, Lekha; Al Kalbani, Naifain

2018-01-01

Objectives This study sought to report 22 years experience in pediatric kidney transplantation in Oman. Methods Electronic charts of all Omani children below 13 years of age who received a kidney transplant from January 1994 to December 2015 were reviewed. Data collected included patient demographics, etiology of end-stage kidney disease, modality and duration of dialysis, donor type, complication of kidney transplantation (including surgical complications, infections, graft rejection) graft and patient survival, and duration of follow-up. Results During the study period transplantation from 27 living related donors (LRDs), 42 living unrelated donors (LURDs), also referred to as commercial transplant, and one deceased donor were performed. The median age at transplantation was nine years for both groups. The most common primary diagnosis was congenital anomalies of the kidney and urinary tract in 32.8% of patients followed by familial nephrotic syndrome in 20.0% and polycystic kidney disease in 18.5%. Almost half the patients were on hemodialysis before transplantation, 35.7% were on peritoneal dialysis, and 14.2% received preemptive renal transplantation. Children who received LURD kidneys had high surgical complications (42.8%) compared to the LRDs group (17.8%). Five patients from LURDs group had early graft nephrectomy and four patients developed non-graft function or delayed graft function. In addition, patients in the LURDs group had a higher incidence of hypertension and acute rejection. Graft and patient survival were both better in the LRDs than the LURDs group. Conclusions Although our pediatric kidney transplant program is a young program it has had successful patient outcomes comparable to international programs. Our study provides evidence that in addition to legal and ethical issues with commercial transplant, it also carries significantly higher morbidity and reduced graft and patient survival. PMID:29467993

Corticosteroids augment BRAF inhibitor vemurafenib induced lymphopenia and risk of infection.

PubMed

Sondermann, Wiebke; Griewank, Klaus G; Schilling, Bastian; Livingstone, Elisabeth; Leyh, Julia C; Rompoti, Natalia; Cosgarea, Ioana; Schimming, Tobias; Schadendorf, Dirk; Zimmer, Lisa; Hillen, Uwe

2015-01-01

We have previously demonstrated an impact of the BRAF inhibitor vemurafenib on patient lymphocyte counts. In the current study, the extent to which concomitant use of corticosteroids in BRAF inhibitor treated patients affects lymphocyte counts and predisposes to infection was investigated. A cohort of 102 patients receiving either the selective BRAF inhibitor vemurafenib or dabrafenib was analyzed. The amount of patients receiving either medication with or without systemic corticosteroids (dexamethasone) was determined and lymphocyte counts before and under therapy assessed. Additionally, the number and severity of infections occurring in these groups was analyzed. Vemurafenib treatment led to a considerable decrease in lymphocyte cell counts, with 62.3% of patients having lymphopenia. Dabrafenib treated patients only rarely demonstrated lymphopenia (12.5%). Dexamethasone co-administration further diminished lymphocyte counts. Lymphopenias were observed in 84.6% of patients receiving vemurafenib and dexamethasone. In our cohort, infections were noted in 9 patients, 4 of these were severe and 2 eventually fatal. All 9 cases with infections demonstrated lymphopenia, 8 of these had received dexamethasone and 7 of these a therapy with vemurafenib. Our findings demonstrate a significant lymphopenia in patients treated with the BRAF inhibitor vemurafenib, which is further augmented by dexamethasone and predisposes to infection. If validated in other studies, risk of infection should be considered when applying corticosteroids in combination with BRAF inhibitors, in particular vemurafenib.

Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients.

PubMed

Nelson, Mark; Rubio, Rafael; Lazzarin, Adriano; Romanova, Svetlana; Luetkemeyer, Annie; Conway, Brian; Molina, Jean-Michel; Xu, Dong; Srinivasan, Subasree; Portsmouth, Simon

2017-03-01

To evaluate the efficacy and safety of pegylated interferon-lambda-1a (Lambda)/ribavirin (RBV)/daclatasvir (DCV) for treatment of patients coinfected with chronic hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Treatment-naive patients were assigned to cohort A [HCV genotype (GT)-2 or -3] or cohort B [HCV GT-1(a or b) or -4]. All patients received Lambda/RBV/DCV for the first 12 weeks; cohort A received Lambda/RBV for an additional 12 weeks, followed by 24 weeks of follow-up, and cohort B received response-guided therapy. The primary endpoint was the proportion of patients who achieved a sustained virologic response at post-treatment week 12 (SVR12). In cohort A (n = 104), 84.6% achieved SVR12 (95.0% in GT-2; 83.1% in GT-3). In cohort B (n = 196), 76.0% achieved SVR12 (71.7% in GT-1a; 86.0% in GT-1b; 70.7% in GT-4). Rates of discontinuation due to adverse events (AEs) (3.8% and 6.1%) and serious AEs (5.8% and 6.1%) were low in cohorts A and B, respectively. In addition, treatment with Lambda/RBV/DCV had little impact on CD4 counts. SVR12 rates with Lambda/RBV/DCV in an HCV/HIV-coinfected population ranged from 71.7% to 95.0%. Treatment was generally well tolerated, with a low proportion of patients discontinuing due to AEs. Clinical trial registration NCT01866930.

Elevated compartment pressures from copperhead envenomation successfully treated with antivenin.

PubMed

Mazer-Amirshahi, Maryann; Boutsikaris, Amy; Clancy, Cathleen

2014-01-01

Copperhead envenomation causes local soft tissue effects; however, associated compartment syndrome is rare. We report a case of a 17-month-old with significantly elevated compartment pressures successfully treated with antivenin and supportive care. A 17-month-old girl sustained a copperhead bite to the foot and presented with circumferential edema, erythema, and ecchymosis of the foot and distal ankle. The patient had palpable pulses and was neurologically intact. Four vials of Crotalidae polyvalent immune Fab was initiated and additional doses were administered in an attempt to achieve local control. Within 10 h of presentation, the patient's edema extended to the groin, although sensation was maintained and pulses were documented by Doppler. Lower-extremity compartment pressures were measured and were most notable for an anterior pressure of 85 mm Hg, despite having received 12 vials of antivenin. Fasciotomy was deferred and the patient received two additional six-vial doses of antivenin to achieve local control. Compartment pressures improved with a 2.2-cm mean decrease in limb diameter within 48 h. Maintenance dosing was initiated and the patient ultimately received a total of 26 vials of antivenin. The patient did not develop significant coagulopathy or thrombocytopenia. Swelling continued to improve with return of limb function. In this case, early and aggressive treatment with antivenin may have avoided invasive fasciotomy, and its use should be considered in patients with copperhead envenomation and significantly elevated compartment pressures. Copyright © 2014 Elsevier Inc. All rights reserved.

Two-level cervical corpectomy-long-term follow-up reveals the high rate of material failure in patients, who received an anterior approach only.

PubMed

Bayerl, Simon Heinrich; Pöhlmann, Florian; Finger, Tobias; Prinz, Vincent; Vajkoczy, Peter

2018-06-18

In contrast to a one-level cervical corpectomy, a multilevel corpectomy without posterior fusion is accompanied by a high material failure rate. So far, the adequate surgical technique for patients, who receive a two-level corpectomy, remains to be elucidated. The aim of this study was to determine the long-term clinical outcome of patients with cervical myelopathy, who underwent a two-level corpectomy. Outcome parameters of 21 patients, who received a two-level cervical corpectomy, were retrospectively analyzed concerning reoperations and outcome scores (VAS, Neck Disability Index (NDI), Nurick scale, modified Japanese Orthopaedic Association score (mJOAS), Short Form 36-item Health Survey Questionnaire (SF-36)). The failure rate was determined using postoperative radiographs. The choice over the surgical procedures was exercised by every surgeon individually. Therefore, a distinction between two groups was possible: (1) anterior group (ANT group) with a two-level corpectomy and a cervical plate, (2) anterior/posterior group (A/P group) with two-level corpectomy, cervical plate, and additional posterior fusion. Both groups benefitted from surgery concerning pain, disability, and myelopathy. While all patients of the A/P group showed no postoperative instability, one third of the patients of the ANT group exhibited instability and clinical deterioration. Thus, a revision surgery with secondary posterior fusion was needed. Furthermore, the ANT group had worse myelopathy scores (mJOAS ANT group  = 13.5 ± 2.5, mJOAS A/P group  = 15.7 ± 2.2). Patients with myelopathy, who receive a two-level cervical corpectomy, benefitted from surgical decompression. However, patients with a sole anterior approach demonstrated a very high rate of instability (33%) and clinical deterioration in a long-term follow-up. Therefore, we recommend to routinely perform an additional posterior fusion after two-level cervical corpectomy.

Incidence, course, and management of toxicities associated with cobimetinib in combination with vemurafenib in the coBRIM study.

PubMed

Dréno, B; Ribas, A; Larkin, J; Ascierto, P A; Hauschild, A; Thomas, L; Grob, J-J; Koralek, D O; Rooney, I; Hsu, J J; McKenna, E F; McArthur, G A

2017-05-01

In the coBRIM phase III trial, the addition of cobimetinib, an MEK inhibitor, to vemurafenib, a BRAF inhibitor, significantly improved progression-free survival [hazard ratio (HR), 0.58; P < 0.0001] and overall survival (HR, 0.70; P = 0.005) in advanced BRAF-mutated melanoma. Here, we report on the incidence, course, and management of key adverse events (AEs) in the coBRIM study. Patients were randomly assigned 1:1 to receive vemurafenib (960 mg twice a day) and either cobimetinib (60 mg once a day, 21 days on/7 days off) or placebo. In addition to standard safety evaluations, patients underwent regular ophthalmic, cardiac, and dermatologic surveillance examinations. Of 495 patients recruited to the study, 493 patients received treatment and constituted the safety population (cobimetinib combined with vemurafenib, 247; vemurafenib, 246). At data cut-off (30 September 2015), median follow-up was 18.5 months. Nearly every patient experienced an AE. In patients who received cobimetinib combined with vemurafenib, the frequency of grade ≥3 AEs was higher than in patients who received vemurafenib alone (75% versus 61%). Most AEs, including grade ≥3 AEs, occurred within the first treatment cycle. After the first cycle (28 days), the incidence of common AEs (rash, diarrhoea, photosensitivity, elevated creatine phosphokinase, serous retinopathy, pyrexia, and liver laboratory abnormalities) decreased substantially over time. Most AEs were managed conservatively by supportive care measures, dose modifications of study treatment, and, occasionally, permanent treatment discontinuation. These data indicate that most AEs arising from treatment with cobimetinib combined with vemurafenib generally occur early in the treatment course, are mild or moderate and are manageable by patient monitoring, dose modification and supportive care. NCT01689519. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Possible benefit of consolidation therapy with high-dose cytarabine on overall survival of adults with non-promyelocytic acute myeloid leukemia.

PubMed

Azevedo, M C; Velloso, E D R P; Buccheri, V; Chamone, D A F; Dorlhiac-Llacer, P E

2015-02-01

In adults with non-promyelocytic acute myeloid leukemia (AML), high-dose cytarabine consolidation therapy has been shown to influence survival in selected patients, although the appropriate doses and schemes have not been defined. We evaluated survival after calculating the actual dose of cytarabine that patients received for consolidation therapy and divided them into 3 groups according to dose. We conducted a single-center, retrospective study involving 311 non-promyelocytic AML patients with a median age of 36 years (16-79 years) who received curative treatment between 1978 and 2007. The 131 patients who received cytarabine consolidation were assigned to study groups by their cytarabine dose protocol. Group 1 (n=69) received <1.5 g/m2 every 12 h on 3 alternate days for up to 4 cycles. The remaining patients received high-dose cytarabine (≥1.5 g/m2 every 12 h on 3 alternate days for up to 4 cycles). The actual dose received during the entire consolidation period in these patients was calculated, allowing us to divide these patients into 2 additional groups. Group 2 (n=27) received an intermediate-high-dose (<27 g/m2), and group 3 (n=35) received a very-high-dose (≥27 g/m2). Among the 311 patients receiving curative treatment, the 5-year survival rate was 20.2% (63 patients). The cytarabine consolidation dose was an independent determinant of survival in multivariate analysis; age, karyotype, induction protocol, French-American-British classification, and de novo leukemia were not. Comparisons showed that the risk of death was higher in the intermediate-high-dose group 2 (hazard ratio [HR]=4.51; 95% confidence interval [CI]: 1.81-11.21) and the low-dose group 1 (HR=4.43; 95% CI: 1.97-9.96) than in the very-high-dose group 3, with no significant difference between those two groups. Our findings indicated that very-high-dose cytarabine during consolidation in adults with non-promyelocytic AML may improve survival.

Possible benefit of consolidation therapy with high-dose cytarabine on overall survival of adults with non-promyelocytic acute myeloid leukemia

PubMed Central

Azevedo, M.C.; Velloso, E.D.R.P.; Buccheri, V.; Chamone, D.A.F.; Dorlhiac-Llacer, P.E.

2014-01-01

In adults with non-promyelocytic acute myeloid leukemia (AML), high-dose cytarabine consolidation therapy has been shown to influence survival in selected patients, although the appropriate doses and schemes have not been defined. We evaluated survival after calculating the actual dose of cytarabine that patients received for consolidation therapy and divided them into 3 groups according to dose. We conducted a single-center, retrospective study involving 311 non-promyelocytic AML patients with a median age of 36 years (16-79 years) who received curative treatment between 1978 and 2007. The 131 patients who received cytarabine consolidation were assigned to study groups by their cytarabine dose protocol. Group 1 (n=69) received <1.5 g/m2 every 12 h on 3 alternate days for up to 4 cycles. The remaining patients received high-dose cytarabine (≥1.5 g/m2 every 12 h on 3 alternate days for up to 4 cycles). The actual dose received during the entire consolidation period in these patients was calculated, allowing us to divide these patients into 2 additional groups. Group 2 (n=27) received an intermediate-high-dose (<27 g/m2), and group 3 (n=35) received a very-high-dose (≥27 g/m2). Among the 311 patients receiving curative treatment, the 5-year survival rate was 20.2% (63 patients). The cytarabine consolidation dose was an independent determinant of survival in multivariate analysis; age, karyotype, induction protocol, French-American-British classification, and de novo leukemia were not. Comparisons showed that the risk of death was higher in the intermediate-high-dose group 2 (hazard ratio [HR]=4.51; 95% confidence interval [CI]: 1.81-11.21) and the low-dose group 1 (HR=4.43; 95% CI: 1.97-9.96) than in the very-high-dose group 3, with no significant difference between those two groups. Our findings indicated that very-high-dose cytarabine during consolidation in adults with non-promyelocytic AML may improve survival. PMID:25517921

A combined treatment approach emphasizing impairment-based manual physical therapy for plantar heel pain: a case series.

PubMed

Young, Brian; Walker, Michael J; Strunce, Joseph; Boyles, Robert

2004-11-01

Case series. To describe an impairment-based physical therapy treatment approach for 4 patients with plantar heel pain. There is limited evidence from clinical trials on which to base treatment decision making for plantar heel pain. Four patients completed a course of physical therapy based on an impairment-based model. All patients received manual physical therapy and stretching. Two patients were also treated with custom orthoses, and 1 patient received an additional strengthening program. Outcome measures included a numeric pain rating scale (NPRS) and self-reported functional status. Symptom duration ranged from 6 to 52 weeks (mean duration+/-SD, 33+/-19 weeks). Treatment duration ranged from 8 to 49 days (mean duration+/-SD, 23+/-18 days), with number of treatment sessions ranging from 2 to 7 (mode, 3). All 4 patients reported a decrease in NPRS scores from an average (+/-SD) of 5.8+/-2.2 to 0 (out of 10) during previously painful activities. Additionally, all patients returned to prior activity levels. In this case series, patients with plantar heel pain treated with an impairment-based physical therapy approach emphasizing manual therapy demonstrated complete pain relief and full return to activities. Further research is necessary to determine the effectiveness of impairment-based physical therapy interventions for patients with plantar heel pain/plantar fasciitis.

Preventive care delivered within Public Dental Service after caries risk assessment of young adults.

PubMed

Hänsel Petersson, G; Ericson, E; Twetman, S

2016-08-01

To study preventive care provided to young adults in relation to their estimated risk category over a 3-year period. The amount and type of preventive treatment during 3 years was extracted from the digital dental records of 982 patients attending eight public dental clinics. The baseline caries risk assessment was carried out by the patient's regular team in four classes according to a predetermined model, and the team was responsible for all treatment decisions. Based on the variables 'oral health information', 'additional fluoride' and 'professional tooth cleaning', a cumulative score was constructed and dichotomized to 'basic prevention' and 'additional prevention'. More additional preventive care was provided to the patients in the 'low-risk' and 'some risk' categories than to those classified as 'high' or 'very high' risk (OR = 2.0, 95% CI 1.4-3.0; P < 0.05). Professional tooth cleaning and additional fluorides were most frequently employed in the 'low-risk' and 'some risk' categories, respectively. Around 15% of the patients in the high-risk categories did not receive additional preventive measures over the 3-year period. There was an insignificant tendency that patients with additional prevention developed less caries than those that received basic prevention in all risk categories except for the 'very high-risk' group. The caries risk assessment process was not accompanied by a corresponding targeted individual preventive care in a cohort of young adults attending public dental service. Further research is needed how to reach those with the greatest need of primary and secondary prevention. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

FAILURE OF RADIOACTIVE IODINE IN TREATMENT OF HYPERTHYROIDISM

PubMed Central

Schneider, David F.; Sonderman, Philip E.; Jones, Michaela F.; Ojomo, Kristin A.; Chen, Herbert; Jaume, Juan C.; Elson, Diane F.; Perlman, Scott B.; Sippel, Rebecca S.

2015-01-01

Introduction Persistent or recurrent hyperthyroidism after treatment with radioactive iodine (RAI) is common, and many patients require either additional doses or surgery before they are cured. The purpose of this study was to identify patterns and predictors of failure of RAI in patients with hyperthyroidism. Methods We conducted a retrospective review of patients treated with RAI from 2007–2010. Failure of RAI was defined as receipt of additional dose(s) and/or total thyroidectomy. Using a Cox proportional hazards model, we conducted univariate analysis to identify factors associated with failure of RAI. A final multivariate model was then constructed with significant (p < 0.05) variables from the univariate analysis. Results Of the 325 patients analyzed, 74 patients (22.8%) failed initial RAI treatment. 53 (71.6%) received additional RAI, 13 (17.6%) received additional RAI followed by surgery, and the remaining 8 (10.8%) were cured after thyroidectomy. The percentage of patients who failed decreased in a step-wise fashion as RAI dose increased. Similarly, the incidence of failure increased as the presenting T3 level increased. Sensitivity analysis revealed that RAI doses < 12.5 mCi were associated with failure while initial T3 and free T4 levels of at least 4.5 pg/mL and 2.3 ng/dL, respectively, were associated with failure. In the final multivariate analysis, higher T4 (HR 1.13, 95% CI 1.02–1.26, p=0.02) and methimazole treatment (HR 2.55, 95% CI 1.22–5.33, p=0.01) were associated with failure. Conclusions Laboratory values at presentation can predict which patients with hyperthyroidism are at risk for failing RAI treatment. Higher doses of RAI or surgical referral may prevent the need for repeat RAI in selected patients. PMID:25001092

Failure of radioactive iodine in the treatment of hyperthyroidism.

PubMed

Schneider, David F; Sonderman, Philip E; Jones, Michaela F; Ojomo, Kristin A; Chen, Herbert; Jaume, Juan C; Elson, Diane F; Perlman, Scott B; Sippel, Rebecca S

2014-12-01

Persistent or recurrent hyperthyroidism after treatment with radioactive iodine (RAI) is common and many patients require either additional doses or surgery before they are cured. The purpose of this study was to identify patterns and predictors of failure of RAI in patients with hyperthyroidism. We conducted a retrospective review of patients treated with RAI from 2007 to 2010. Failure of RAI was defined as receipt of additional dose(s) and/or total thyroidectomy. Using a Cox proportional hazards model, we conducted univariate analysis to identify factors associated with failure of RAI. A final multivariate model was then constructed with significant (p < 0.05) variables from the univariate analysis. Of the 325 patients analyzed, 74 patients (22.8 %) failed initial RAI treatment, 53 (71.6 %) received additional RAI, 13 (17.6 %) received additional RAI followed by surgery, and the remaining 8 (10.8 %) were cured after thyroidectomy. The percentage of patients who failed decreased in a stepwise fashion as RAI dose increased. Similarly, the incidence of failure increased as the presenting T3 level increased. Sensitivity analysis revealed that RAI doses <12.5 mCi were associated with failure while initial T3 and free T4 levels of at least 4.5 pg/mL and 2.3 ng/dL, respectively, were associated with failure. In the final multivariate analysis, higher T4 (hazard ratio [HR] 1.13; 95 % confidence interval [CI] 1.02-1.26; p = 0.02) and methimazole treatment (HR 2.55; 95 % CI 1.22-5.33; p = 0.01) were associated with failure. Laboratory values at presentation can predict which patients with hyperthyroidism are at risk for failing RAI treatment. Higher doses of RAI or surgical referral may prevent the need for repeat RAI in selected patients.

Initial Experience With Gallium-68 DOTA-Octreotate PET/CT and Peptide Receptor Radionuclide Therapy for Pediatric Patients With Refractory Metastatic Neuroblastoma.

PubMed

Kong, Grace; Hofman, Michael S; Murray, William K; Wilson, Sharyn; Wood, Paul; Downie, Peter; Super, Leanne; Hogg, Annette; Eu, Peter; Hicks, Rodney J

2016-03-01

Pediatric patients with refractory neuroblastoma have limited therapeutic options. Neuroblastoma may express somatostatin receptors (SSTRs) allowing imaging with 68Ga-DOTA-Octreotate (GaTATE) positron emission tomography/computed tomography (PET/CT) and peptide receptor radionuclide therapy (PRRT). We reviewed our experience with this theranostic combination. GaTATE studies (8 patients; 2 to 9 years old) were reviewed and compared with 123I-MIBG or posttreatment 131I-MIBG studies. Immunohistochemistry (IHC) for SSTR subtype 2 was performed in 5 patients. Four patients received PRRT. GaTATE PET showed additional disease in 38% (3/8 patients), and upstaged 1 patient by detecting marrow involvement. IHC detected SSTR 2 in all patients assessed. Six patients were deemed suitable for PRRT on imaging. Four patients received 17 cycles of palliative PRRT (10 111In-DOTATATE; 5 177Lu-DOTATATE; 1 combined 111In and 177Lu-DOTATATE; 1 combined 177Lu and 90Y-DOTATATE) with no significant toxicity attributed to PRRT. All had objective responses. Two survivors are now 40 and 56 months from PRRT commencement. GaTATE PET was positive in a high proportion of patients with refractory neuroblastoma, correlating with SSTR 2 on IHC, with additional disease identified compared with MIBG imaging. PRRT seems safe, feasible, with responses observed in patients with progression despite multimodality treatment. These data support ongoing clinical trials in such patients.

Radiation therapy in the management of head-and-neck cancer of unknown primary origin: how does the addition of concurrent chemotherapy affect the therapeutic ratio?

PubMed

Chen, Allen M; Farwell, D Gregory; Lau, Derick H; Li, Bao-Qing; Luu, Quang; Donald, Paul J

2011-10-01

To determine how the addition of cisplatin-based concurrent chemotherapy to radiation therapy influences outcomes among a cohort of patients treated for head-and-neck cancer of unknown primary origin. The medical records of 60 consecutive patients treated by radiation therapy for squamous cell carcinoma of the head and neck presenting as cervical lymph node metastasis of occult primary origin were reviewed. Thirty-two patients (53%) were treated by concurrent chemoradiation, and 28 patients (47%) were treated by radiation therapy alone. Forty-five patients (75%) received radiation therapy after surgical resection, and 15 patients (25%) received primary radiation therapy. Thirty-five patients (58%) were treated by intensity-modulated radiotherapy. The 2-year estimates of overall survival, local-regional control, and progression-free survival were 89%, 89%, and 79%, respectively, among patients treated by chemoradiation, compared to 90%, 92%, and 83%, respectively, among patients treated by radiation therapy alone (p > 0.05, for all). Exploratory analysis failed to identify any subset of patients who benefited from the addition of concurrent chemotherapy to radiation therapy. The use of concurrent chemotherapy was associated with a significantly increased incidence of Grade 3+ acute and late toxicity (p < 0.001, for both). Concurrent chemoradiation is associated with significant toxicity without a clear advantage to overall survival, local-regional control, and progression-free survival in the treatment of head-and-neck cancer of unknown primary origin. Although selection bias cannot be ignored, prospective data are needed to further address this question. Copyright © 2011 Elsevier Inc. All rights reserved.

Activated Prothrombin Complex Concentrate Versus 4-Factor Prothrombin Complex Concentrate for Vitamin K-Antagonist Reversal.

PubMed

Rowe, A Shaun; Dietrich, Scott K; Phillips, John W; Foster, Kaci E; Canter, Joshua R

2018-06-01

To compare the international normalized ratio normalization efficacy of activated prothrombin complex concentrates and 4-factor prothrombin complex concentrates and to evaluate the thrombotic complications in patients treated with these products for warfarin-associated hemorrhage. Retrospective, Multicenter Cohort. Large, Community, Teaching Hospital. Patients greater than 18 years old and received either activated prothrombin complex concentrate or 4-factor prothrombin complex concentrate for the treatment of warfarin-associated hemorrhage. We excluded those patients who received either agent for an indication other than warfarin-associated hemorrhage, pregnant, had a baseline international normalized ratio of less than 2, received a massive transfusion as defined by hospital protocol, received plasma for treatment of warfarin-associated hemorrhage, or were treated for an acute warfarin ingestion. Patients in the activated prothrombin complex concentrate group (enrolled from one hospital) with an international normalized ratio of less than 5 received 500 IU and those with an international normalized ratio greater than 5 received 1,000 IU. Patients in the 4-factor prothrombin complex concentrate (enrolled from a separate hospital) group received the Food and Drug Administration approved dosing algorithm. A total of 158 patients were included in the final analysis (activated prothrombin complex concentrate = 118; 4-factor prothrombin complex concentrate = 40). Those in the 4-factor prothrombin complex concentrate group had a higher pretreatment international normalized ratio (2.7 ± 1.8 vs 3.5 ± 2.9; p = 0.0164). However, the posttreatment international normalized ratio was similar between the groups. In addition, even when controlling for differences in the pretreatment international normalized ratio, there was no difference in the ability to achieve a posttreatment international normalized ratio of less than 1.4 (odds ratio, 0.753 [95% CI, 0.637-0.890]; p = 0.0009). Those in the activated prothrombin complex concentrate group did have higher odds of achieving a posttreatment international normalized ratio of less than 1.2 (odds ratio, 3.23 [95% CI, 1.34-7.81]; p = 0.0088). There was only one posttreatment thrombotic complication reported. A low, fixed dose of activated prothrombin complex concentrate was as effective as standard dose 4-factor prothrombin complex concentrate for normalization of international normalized ratio. In addition, we did not see an increase in thrombotic events.

Topiramate increases the risk of valproic acid-induced encephalopathy.

PubMed

Noh, Young; Kim, Dong Wook; Chu, Kon; Lee, Soon-Tae; Jung, Keun-Hwa; Moon, Hye-Jin; Lee, Sang Kun

2013-01-01

Metabolic encephalopathy is a rare but serious complication of valproic acid (VPA) therapy that usually presents with impaired consciousness or increased seizure frequency. Although it has been suggested that topiramate (TPM) increases the risk of VPA-induced encephalopathy, the additional risk in patients receiving TPM therapy has not been evaluated. We reviewed all adult patients who took VPA between January 2005 and February 2009 at the Seoul National University Hospital and identified patients with VPA-induced encephalopathy based on clinical and electroencephalography (EEG) data. Information on sex, age, serum ammonia level, serum VPA level, liver function test, and EEG was collected from patient registry and medical data. We enrolled 8,372 patients who received VPA therapy and 1,236 patients who received VPA/TPM combination therapy. We identified 11 patients with VPA-induced encephalopathy (0.13%), 7 of whom received a combination therapy of VPA and TPM. The odds ratio of VPA-induced encephalopathy with TPM over that without TPM was 10.16. There were no significant differences in sex distribution, number of antiepileptic agents, ammonia level, VPA serum level, underlying diseases, dosage of VPA, duration of VPA treatment, treatment of encephalopathy, and outcomes between the two groups. Our study showed that the prevalence of VPA-induced encephalopathy is approximately 0.1% among patients treated with VPA and that the risk of this condition, although still low, can increase by approximately 10 times in the presence of TPM therapy. Based on these results, we suggest that TPM should be carefully used in patients receiving VPA treatment. Wiley Periodicals, Inc. © 2012 International League Against Epilepsy.

Patient perceptions of receiving test results via online portals: a mixed-methods study.

PubMed

Giardina, Traber D; Baldwin, Jessica; Nystrom, Daniel T; Sittig, Dean F; Singh, Hardeep

2018-04-01

Online portals provide patients with access to their test results, but it is unknown how patients use these tools to manage results and what information is available to promote understanding. We conducted a mixed-methods study to explore patients' experiences and preferences when accessing their test results via portals. We conducted 95 interviews (13 semistructured and 82 structured) with adults who viewed a test result in their portal between April 2015 and September 2016 at 4 large outpatient clinics in Houston, Texas. Semistructured interviews were coded using content analysis and transformed into quantitative data and integrated with the structured interview data. Descriptive statistics were used to summarize the structured data. Nearly two-thirds (63%) did not receive any explanatory information or test result interpretation at the time they received the result, and 46% conducted online searches for further information about their result. Patients who received an abnormal result were more likely to experience negative emotions (56% vs 21%; P = .003) and more likely to call their physician (44% vs 15%; P = .002) compared with those who received normal results. Study findings suggest that online portals are not currently designed to present test results to patients in a meaningful way. Patients experienced negative emotions often with abnormal results, but sometimes even with normal results. Simply providing access via portals is insufficient; additional strategies are needed to help patients interpret and manage their online test results. Given the absence of national guidance, our findings could help strengthen policy and practice in this area and inform innovations that promote patient understanding of test results.

[Magnetic therapy for complex treatment of chronic periodontal disease].

PubMed

P'yanzina, A V

The aim of the study was to elaborate the methodology of magnetic therapy for complex treatment of chronic periodontal disease (CPD). The study included 60 patients aged 35 to 65 years with moderate CPD divided in 2 groups. Patients in group 1 (controls) received impulse carbonate irrigation for 12 min №10, group 2 additionally received magnetic therapy for 5 min №10 in maxillary and mandibular areas. periodontal and rheological indices proved magnetic therapy to be useful tool for eradication of inflammation, periodontal tissue functional recovery and stabilization.

Pretreatment with myo-inositol in non polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study.

PubMed

Lisi, Franco; Carfagna, Piero; Oliva, Mario Montanino; Rago, Rocco; Lisi, Rosella; Poverini, Roberta; Manna, Claudio; Vaquero, Elena; Caserta, Donatella; Raparelli, Valeria; Marci, Roberto; Moscarini, Massimo

2012-07-23

Aim of this pilot study is to examine the effects of myo-inositol administration on ovarian response and oocytes and embryos quality in non PolyCystic Ovary Syndrome (PCOS) patients undergoing multiple follicular stimulation and in vitro insemination by conventional in vitro fertilization or by intracytoplasmic sperm injection. One hundred non-PCOS women aged <40 years and with basal FSH <10 mUI/ml were down-regulated with triptorelin acetate from the mid-luteal phase for 2 weeks, before starting the stimulation protocol for oocytes recovery. All patients received rFSH, at a starting dose of 150 IU for 6 days. The dose was subsequently adjusted according to individual response. Group B (n=50) received myo-inositol and folic acid for 3 months before the stimulation period and then during the stimulation itself. Group A (n-50) received only folic acid as additional treatment in the 3 months before and through treatment. Total length of the stimulation was similar between the two groups. Nevertheless, total amount of gonadotropins used to reach follicular maturation was found significantly lower in group B. In addition, the number of oocytes retrieved was significantly reduced in the group pretreated with myo-inositol. Clinical pregnancy and implantation rate were not significantly different in the two groups. Our findings suggest that the addition of myo-inositol to folic acid in non PCOS-patients undergoing multiple follicular stimulation for in-vitro fertilization may reduce the numbers of mature oocytes and the dosage of rFSH whilst maintaining clinical pregnancy rate. Further, a trend in favor of increased incidence of implantation in the group pretreated with myo-inositol was apparent in this study. Further investigations are warranted to clarify this pharmacological approach, and the benefit it may hold for patients.

The Impact of Adjuvant Postoperative Radiation Therapy and Chemotherapy on Survival After Esophagectomy for Esophageal Carcinoma.

PubMed

Wong, Andrew T; Shao, Meng; Rineer, Justin; Lee, Anna; Schwartz, David; Schreiber, David

2017-06-01

The objective of this study was to analyze the impact on overall survival (OS) from the addition of postoperative radiation with or without chemotherapy after esophagectomy, using a large, hospital-based dataset. Previous retrospective studies have suggested an OS advantage for postoperative chemoradiation over surgery alone, although prospective data are lacking. The National Cancer Data Base was queried to select patients diagnosed with stage pT3-4Nx-0M0 or pT1-4N1-3M0 esophageal carcinoma (squamous cell or adenocarcinoma) from 1998 to 2011 treated with definitive esophagectomy ± postoperative radiation and/or chemotherapy. OS was analyzed using the Kaplan-Meier method and compared using the log-rank test. Multivariate Cox regression analysis was used to identify covariates associated with OS. There were 4893 patients selected, of whom 1153 (23.6%) received postoperative radiation. Most patients receiving radiation also received sequential/concomitant chemotherapy (89.9%). For the entire cohort, postoperative radiation was associated with a statistically significant but modest absolute improvement in survival (hazard ratio 0.77; 95% CI, 0.71-0.83; P < 0.001). On subgroup analysis, postoperative radiation was associated with improved OS for patients with node-positive disease (3-yr OS 34.3 % vs 27.8%, P < 0.001) or positive margins (3-yr OS 36.4% vs 18.0%, P < 0.001). When chemotherapy usage was incorporated, sequential chemotherapy was associated with the best survival (P < 0.001). Multivariate analysis revealed that the addition of chemotherapy to radiation therapy, whether sequentially or concurrently, was a strong prognostic factor for OS. In this hospital-based study, the addition of postoperative chemoradiation (either sequentially or concomitantly) after esophagectomy was associated with improved OS for patients with node-positive disease or positive margins.

Family Treatment for Bipolar Disorder: Family Impairment by Treatment Interactions

PubMed Central

Miller, Ivan W.; Keitner, Gabor I.; Ryan, Christine E.; Uebelacker, Lisa A.; Johnson, Sheri L.; Solomon, David A.

2010-01-01

Objective There is a clear need for psychosocial treatments to supplement pharmacotherapy for bipolar disorder. In this study, the efficacy of 2 forms of adjunctive family intervention were compared to pharmacotherapy alone. In addition to evaluating overall differences between treatments, a chief goal was to examine whether family impairment levels moderated the effects of family intervention on outcome. Method Ninety-two patients diagnosed with bipolar I disorder (according to DSM-III-R) were randomly assigned to receive (1) pharmacotherapy alone, (2) family therapy + pharmacotherapy, or (3) multi-family psychoeducational group + pharmacotherapy. Treatments and assessments continued for up to 28 months. Primary outcome measures were number of episodes per year and percentage of time symptomatic throughout the entire follow-up period. The study was conducted from September 1992 through March 1999. Results No significant main effects were found for treatment condition. Thus, for the total sample, the addition of a family intervention did not improve outcome. However, there were significant treatment condition by family impairment interactions (p < .05). In patients from families with high levels of impairment, the addition of a family intervention (family therapy or psychoeducational group) resulted in a significantly improved course of illness, particularly the number of depressive episodes (p <.01) and proportion of time spent in a depressive episode (p <.01). These effects were relatively large (Cohen d = 0.7–1.0), with patients receiving either family intervention having roughly half the number of depressive episodes and amount of time spent depressed as those receiving pharmacotherapy alone. In contrast, for patients from low-impairment families, the addition of a family intervention did not improve course of illness. Conclusions Our findings build on previous literature suggesting the importance of treatment matching within the mood disorders and suggest that the utility of adding family interventions for bipolar patients and their families may depend upon the family’s level of impairment. PMID:18363424

The effectiveness of neurofeedback on cognitive functioning in patients with Alzheimer's disease: Preliminary results.

PubMed

Luijmes, Robin E; Pouwels, Sjaak; Boonman, Jacko

2016-06-01

Alzheimer's disease (AD) is the most common form of dementia. In quantified EEG (qEEG), the AD patients have a greater amount of theta activity compared with normal elderly individuals. Little is known about the effect of neurofeedback in patients with dementia. The objective of this study was to examine whether neurofeedback has a positive effect on cognitive performance in patients with AD. Ten patients with qEEG meeting criteria for AD received neurofeedback training. Participants were aged between 61 and 90 years. All patients underwent the CAMCOG test designed to assess cognitive functioning pre- and post-treatment. The individual results, analyzed with a reliable change index (RCI), showed that patients who received neurofeedback treatment had stable cognitive functions. These patients showed improvement in memory after neurofeedback and other cognitive functions were stable. In addition, an improvement was observed in recall of information and recognition. Patients with AD who received neurofeedback treatment had stable or improved cognitive performance. Future research should focus on the design of high quality randomized controlled trials to assess whether neurofeedback has a place in the treatment of AD. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

The benefit of lithium carbonate adjunct in refractory depression--fact or fiction?

PubMed

Kantor, D; McNevin, S; Leichner, P; Harper, D; Krenn, M

1986-06-01

Our group attempted to validate previous claims of rapid success with lithium carbonate adjunct therapy in antidepressant-resistant depression. Seven depressed patients volunteered for a study of placebo controlled, double-blind design. During their treatment on general hospital psychiatric wards, these patients received antidepressant medication for a period of at least 21 days. While continuing to receive antidepressant medication after the 21 day period, four of the patients then received lithium carbonate, and three received placebo. This combination pharmacological therapy continued for a 48 hour period. After this time, six of the seven patients showed no significant improvement. The remaining patient, who had received lithium carbonate, improved markedly over the 48 hour period. However, this patient relapsed within one week. A review of the two most extensive studies claiming significant results with the lithium carbonate adjunct therapy was performed. We feel that they, as presented, leave serious doubt as to the validity of their conclusions. We conclude that on the basis of our work up to this point in time and the analysis of previous reports claiming otherwise, no valid evidence exists for a consistent therapeutic effect of lithium carbonate adjunct in antidepressant-resistant depression. It was also found that methodologic contamination necessitated the exclusion of an additional six patients from the double-blind trial. We conclude that in order to objectively examine the rapidly expanding field of biological psychiatry, teaching of clinical staff in basic research procedure should be stressed as a part of routine ward orientation.

Prevalence of probiotic use among inpatients: A descriptive study of 145 U.S. hospitals.

PubMed

Yi, Sarah H; Jernigan, John A; McDonald, L Clifford

2016-05-01

To inform clinical guidance, public health efforts, and research directions, probiotic use in U.S. health care needs to be better understood. This work aimed to assess the prevalence of inpatient probiotic use in a sample of U.S. hospitals. Probiotic use among patients discharged in 2012 was estimated using the MarketScan Hospital Drug Database. In addition, the annual trend in probiotic use (2006-2012) was assessed among a subset of hospitals. Among 145 hospitals with 1,976,167 discharges in 2012, probiotics were used in 51,723 (2.6%) of hospitalizations occurring in 139 (96%) hospitals. Patients receiving probiotics were 9 times more likely to receive antimicrobials (P < .0001) and 21 times more likely to have a Clostridium difficile infection diagnosis (P < .0001). The most common probiotic formulations were Saccharomyces boulardii (32% of patients receiving probiotics), Lactobacillus acidophilus and Lactobacillus bulgaricus (30%), L acidophilus (28%), and Lactobacillus rhamnosus (11%). Probiotic use increased from 1.0% of 1,090,373 discharges in 2006 to 2.9% of 1,006,051 discharges in 2012 (P < .0001). In this sample of U.S. hospitals, a sizable and growing number of inpatients received probiotics as part of their care despite inadequate evidence to support their use in this population. Additional research is needed to guide probiotic use in the hospital setting. Published by Elsevier Inc.

Improving mammography screening among the medically underserved.

PubMed

Davis, Terry C; Rademaker, Alfred; Bennett, Charles L; Wolf, Michael S; Carias, Edson; Reynolds, Cristalyn; Liu, Dachao; Arnold, Connie L

2014-04-01

We evaluated the effectiveness and cost-effectiveness of alternative interventions designed to promote mammography in safety-net settings. A three-arm, quasi-experimental evaluation was conducted among eight federally qualified health clinics in predominately rural Louisiana. Mammography screening efforts included: 1) enhanced care, 2) health literacy-informed education of patients, and 3) education plus nurse support. Outcomes included mammography screening completion within 6 months and incremental cost-effectiveness. Overall, 1,181 female patients ages 40 and over who were eligible for routine mammography were recruited. Baseline screening rates were < 10%. Post intervention screening rates were 55.7% with enhanced care, 51.8% with health literacy-informed education and 65.8% with education and nurse support. After adjusting for race, marital status, self-efficacy and literacy, patients receiving health-literacy informed education were not more likely to complete mammographic screening than those receiving enhanced care; those additionally receiving nurse support were 1.37-fold more likely to complete mammographic screening than those receiving the brief education (95% Confidence Interval 1.08-1.74, p = 0.01). The incremental cost per additional women screened was $2,457 for literacy-informed education with nurse support over literacy-informed education alone. Mammography rates were increased substantially over existing baseline rates in all three arms with the educational initiative, with nurse support and follow-up being the most effective option. However, it is not likely to be cost-effective or affordable in resource-limited clinics.

Instituting a music listening intervention for critically ill patients receiving mechanical ventilation: Exemplars from two patient cases

PubMed Central

Heiderscheit, Annie; Chlan, Linda; Donley, Kim

2011-01-01

Music is an ideal intervention to reduce anxiety and promote relaxation in critically ill patients receiving mechanical ventilatory support. This article reviews the basis for a music listening intervention and describes two case examples with patients utilizing a music listening intervention to illustrate the implementation and use of the music listening protocol in this dynamic environment. The case examples illustrate the importance and necessity of engaging a music therapist in not only assessing the music preferences of patients, but also for implementing a music listening protocol to manage the varied and challenging needs of patients in the critical care setting. Additionally, the case examples presented in this paper demonstrate the wide array of music patients prefer and how the ease of a music listening protocol allows mechanically ventilated patients to engage in managing their own anxiety during this distressful experience. PMID:22081788

Analysis of Oxygen Saturations Recorded During Dental Intravenous Sedations: A Retrospective Quality Assurance of 3500 Cases

PubMed Central

Viljoen, Andre; Byth, Karen; Coombs, Malcolm; Mahoney, Greg; Stewart, Douglas

2011-01-01

The death of a patient under sedation in New South Wales, Australia, in 2002 has again raised the question of the safety of dental sedation. This study sought answers to 2 questions: Can safe oxygen saturation levels (≥94%) be consistently maintained by a single operator/sedationist? Does the additional use of propofol, in subanesthetic doses, increase the risk of exposure to hypoxemia? Three thousand five hundred cases generated between 1996 and 2006 were randomly examined and divided into 2 subcohorts: 1750 patients were sedated with midazolam and fentanyl, and 1750 patients received propofol, in subanesthetic increments, in addition to midazolam and fentanyl. Initial sedation was established using midazolam and fentanyl in both subcohorts. The second subcohort received propofol during times of noxious stimulation. Patient exposure to 2 or more oxygen desaturations below 94% was uncommon. The variables that were significantly associated with low saturations were age, gender, and weight. Neither the dose of midazolam nor the additional use of propofol was a significant risk factor. ASA classification (I or II) was not a determinant of risk. The data, within the limitations of the study, showed that a single operator/sedationist, supported by a well-trained team of nurses, can consistently maintain safe oxygen saturation levels. The additional use of propofol did not increase exposure to hypoxemia. PMID:21882986

Posaconazole plasma exposure correlated to intestinal mucositis in allogeneic stem cell transplant patients.

PubMed

Vanstraelen, Kim; Prattes, Juergen; Maertens, Johan; Lagrou, Katrien; Schoemans, Hélène; Peersman, Nele; Vermeersch, Pieter; Theunissen, Koen; Mols, Raf; Augustijns, Patrick; Annaert, Pieter; Hoenigl, Martin; Spriet, Isabel

2016-08-01

Low posaconazole plasma concentrations (PPCs) are frequently encountered in allogeneic hematopoietic stem cell transplant (HSCT) patients, due to variable gastrointestinal absorption. In this study, the impact of intestinal mucositis on posaconazole exposure is investigated. A prospective pharmacokinetic study was performed including allogeneic HSCT patients receiving posaconazole prophylaxis with the oral suspension or tablets. Steady state PPCs were determined using high-performance liquid chromatography-fluorescence detection at the day of transplantation (=day 0), day +7, and +14. Citrulline was measured using liquid chromatography-tandem mass spectrometry to evaluate severity of mucositis, at baseline (day -7 or -6), and at day 0, +7 and +14. Additionally, citrulline plasma concentrations and steady state trough PPCs were determined in hematological patients without HSCT or mucositis. Thirty-four HSCT patients received posaconazole oral suspension together with 25 cL of Coca Cola, 6 HSCT patients received posaconazole tablets and 33 hematological patients not receiving HSCT received posaconazole oral suspension. The median (interquartile range) average PPC was 0.26 mg/L (0.17-0.43), 0.67 mg/L (0.27-1.38), and 1.08 mg/L (0.96-1.38), with suspension in HSCT patients, suspension in hematological patients and tablets in HSCT patients, respectively. A higher trough PPC was encountered with the oral suspension when citrulline plasma concentrations were above 10 μmol/L compared to values below 10 μmol/L (p < 0.001), whereas for tablets, average PPCs remained high with citrulline plasma concentrations below or above 10 μmol/L (p = 0.64). Posaconazole tablets should be preferred to suspension in HSCT patients immediately after transplantation to prevent insufficient plasma exposure due to intestinal mucositis.

Growing trend of identity theft poses safety and billing loss threats.

PubMed

2010-08-01

Identity theft is more than just a legal issue. Patients with improper identification are at risk for receiving potentially harmful treatment. Have registration department require photo identification from all patients. Ask additional questions, such as the patient's date of birth. Ask staff members to be the "eyes and ears" of registration and security, and ask them to report anything suspicious.

Lack of Benefit for the Addition of Androgen Deprivation Therapy to Dose-Escalated Radiotherapy in the Treatment of Intermediate- and High-Risk Prostate Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Krauss, Daniel, E-mail: dkrauss@beaumont.edu; Kestin, Larry; Ye, Hong

2011-07-15

Purpose: Assessment of androgen deprivation therapy (ADT) benefits for prostate cancer treated with dose-escalated radiotherapy (RT). Methods and Materials: From 1991 to 2004, 1,044 patients with intermediate- (n = 782) or high-risk (n = 262) prostate cancer were treated with dose-escalated RT at William Beaumont Hospital. Patients received external-beam RT (EBRT) alone, brachytherapy (high or low dose rate), or high dose rate brachytherapy plus pelvic EBRT. Intermediate-risk patients had Gleason score 7, prostate-specific antigen (PSA) 10.0-19.9 ng/mL, or Stage T2b-T2c. High-risk patients had Gleason score 8-10, PSA {>=}20, or Stage T3. Patients were additionally divided specifically by Gleason score, presencemore » of palpable disease, and PSA level to further define subgroups benefitting from ADT. Results: Median follow-up was 5 years; 420 patients received ADT + dose-escalated RT, and 624 received dose-escalated RT alone. For all patients, no advantages in any clinical endpoints at 8 years were associated with ADT administration. No differences in any endpoints were associated with ADT administration based on intermediate- vs. high-risk group or RT modality when analyzed separately. Patients with palpable disease plus Gleason {>=}8 demonstrated improved clinical failure rates and a trend toward improved survival with ADT. Intermediate-risk patients treated with brachytherapy alone had improved biochemical control when ADT was given. Conclusion: Benefits of ADT in the setting of dose-escalated RT remain poorly defined. This question must continue to be addressed in prospective study.« less

Cardiac Complications, Earlier Treatment, and Initial Disease Severity in Kawasaki Disease.

PubMed

Abrams, Joseph Y; Belay, Ermias D; Uehara, Ritei; Maddox, Ryan A; Schonberger, Lawrence B; Nakamura, Yosikazu

2017-09-01

To assess if observed higher observed risks of cardiac complications for patients with Kawasaki disease (KD) treated earlier may reflect bias due to confounding from initial disease severity, as opposed to any negative effect of earlier treatment. We used data from Japanese nationwide KD surveys from 1997 to 2004. Receipt of additional intravenous immunoglobulin (IVIG) (data available all years) or any additional treatment (available for 2003-2004) were assessed as proxies for initial disease severity. We determined associations between earlier or later IVIG treatment (defined as receipt of IVIG on days 1-4 vs days 5-10 of illness) and cardiac complications by stratifying by receipt of additional treatment or by using logistic modeling to control for the effect of receiving additional treatment. A total of 48 310 patients with KD were included in the analysis. In unadjusted analysis, earlier IVIG treatment was associated with a higher risk for 4 categories of cardiac complications, including all major cardiac complications (risk ratio, 1.10; 95% CI, 1.06-1.15). Stratifying by receipt of additional treatment removed this association, and earlier IVIG treatment became protective against all major cardiac complications when controlling for any additional treatment in logistic regressions (OR, 0.90; 95% CI, 0.80-1.00). Observed higher risks of cardiac complications among patients with KD receiving IVIG treatment on days 1-4 of the illness are most likely due to underlying higher initial disease severity, and patients with KD should continue to be treated with IVIG as early as possible. Published by Elsevier Inc.

Review of recent studies on interventions for cognitive deficits in patients with cancer.

PubMed

Gehring, Karin; Roukema, Jan Anne; Sitskoorn, Margriet M

2012-02-01

Research has demonstrated that patients with cancer experience cognitive deficits, often due to aggressive anticancer treatments. In this article, we critically review the interventional studies that have been conducted to investigate beneficial effects on cognitive function in cancer patients. Pharmacological agents that have been studied include psychostimulants, such as methylphenidate and modafinil, erythropoietin, and hormonal (supplement) treatments for patients who receive hormonal suppression therapy. In addition, several cognitive rehabilitation programs have been evaluated in cancer patients. Recently, the approach of physical exercise to treat cognitive deficits has received great interest, and findings from novel studies are keenly anticipated. Although, in general, the studies reviewed were well designed, future studies may wish to include larger sample sizes and pay more attention to the accurate assessment of cognitive function.

Informational Needs of Head and Neck Cancer Patients.

PubMed

Fang, Carolyn Y; Longacre, Margaret L; Manne, Sharon L; Ridge, John A; Lango, Miriam N; Burtness, Barbara A

2012-04-01

Treatment for head and neck squamous cell carcinoma (HNSCC) can lead to considerable functional impairment. As a result, HNSCC patients experience significant decrements in quality of life, high levels of emotional distress, deteriorations in interpersonal relations, and increased social isolation. Studies suggest that HNSCC patients may have extensive informational and psychosocial needs that are not being adequately addressed. However, few programs have been developed to address the needs of HNSCC patients. Therefore, we conducted a pilot study of HNSCC patients to: 1) characterize patients' informational needs; and 2) describe preferred formats and time points for receiving such information. The majority of participants desired additional information regarding treatment options, managing changes in swallowing and speaking, and staying healthy after treatment. Overall, patients with early-stage disease reported more informational needs compared to patients with advanced disease. Female patients were more likely to desire information about coping with emotional stress and anxiety than male patients. Younger patients (29-49 years) were more interested in receiving information about sexuality after cancer compared to their older (50+) counterparts. Although information was requested throughout the cancer trajectory, most patients preferred to receive such information at diagnosis or within 1-3 months post-treatment. The majority of patients reported having computer and Internet access, and they were most receptive to receiving information delivered via the Internet, from a DVD, or from pamphlets and booklets. The relatively high percentage of patients with computer and Internet access reflects a growing trend in the United States and supports the feasibility of disseminating health information to this patient population via Internet-based programs.

Comparative analysis of length of stay, total costs, and treatment success between intravenous moxifloxacin 400 mg and levofloxacin 750 mg among hospitalized patients with community-acquired pneumonia.

PubMed

Friedman, Howard; Song, Xue; Crespi, Simone; Navaratnam, Prakash

2009-01-01

This study aimed to evaluate the length of stay (LOS), costs, and treatment consistency among patients hospitalized with community-acquired pneumonia (CAP) initially treated with intravenous (IV) moxifloxacin 400 mg or IV levofloxacin 750 mg. Adults with CAP receiving IV moxifloxacin or IV levofloxacin for > or =3 days were identified in the Premier Perspective comparative database. Primary outcomes were LOS and costs. Secondary outcomes included treatment consistency, which was defined as 1) no additional IV moxifloxacin or levofloxacin after > or =1 day off study drug; 2) no switch to another IV antibiotic; and 3) no addition of another IV antibiotic. A total of 7720 patients met inclusion criteria (6040 receiving moxifloxacin; 1680 receiving levofloxacin). Propensity matching created two cohorts (1300 patients each) well matched for demographic, clinical, hospital, and payor characteristics. Before the patients were matched, mean LOS (5.87 vs. 5.46 days; P = 0.0004) and total costs per patient ($7302 vs. $6362; P < 0.0001) were significantly greater with moxifloxacin. After the patients were matched, mean LOS (5.63 vs. 5.51 days; P = 0.462) and total costs ($6624 vs. $6473; P = 0.476) were comparable in both cohorts. Treatment consistency was higher for moxifloxacin before (81.0% vs. 78.9%; P = 0.048) and after matching (82.8% vs. 78.0%; P = 0.002). In-hospital treatment of CAP with IV moxifloxacin 400 mg or IV levofloxacin 750 mg was associated with similar hospital LOS and costs in propensity-matched cohorts.

Rapid resolution of cellulitis in patients managed with combination antibiotic and anti-inflammatory therapy.

PubMed

Dall, Lawrence; Peterson, Sandford; Simmons, Tom; Dall, Amy

2005-03-01

There is some evidence to suggest that host inflammatory response has some effect on the clinical manifestations of cellulitis. The objective of this pilot study was to investigate whether the addition of oral nonsteroidal anti-inflammatory (NSAI) therapy to antibiotic treatment hastens resolution of cellulitis-related inflammation. Patients presenting in the emergency department with signs and symptoms of class II cellulitis were assigned to receive treatment with either antibiotic therapy alone (intravenous, supplemented with oral cephalexin or an equivalent) for 10 days (n = 33) or antibiotic therapy for 10 days plus an oral anti-inflammatory (ibuprofen 400 mg every 6 hours) for 5 days (n = 31). Patients were discharged as soon as possible to complete their therapy on an outpatient basis. The addition of an oral anti-inflammatory agent significantly (P < .05) shortened the time to regression of inflammation and complete resolution of cellulitis. Twenty-four of 29 evaluable patients (82.8%) who received supplemental anti-inflammatory treatment showed regression of inflammation within 1 to 2 days compared with only 3 of 33 patients (9.1%) treated without an anti-inflammatory in the same time frame. All patients receiving adjunctive anti-inflammatory treatment experienced complete resolution of cellulitis in 4 to 5 days or less, while 24.2% (8/33) of patients treated with antibiotic alone required 6 to 7 days, and 6.1% (2/33) required 7 days or more (P < .05). This small preliminary study provides some promising data, suggesting that the supplemental use of anti-inflammatory therapy may hasten the time to regression of inflammation and complete resolution of cellulitis.

A Novel Approach to Supporting Relationship-Centered Care Through Electronic Health Record Ergonomic Training in Preclerkship Medical Education

PubMed Central

Silverman, Howard; Ho, Yun-Xian; Kaib, Susan; Ellis, Wendy Danto; Moffitt, Marícela P.; Chen, Qingxia; Nian, Hui; Gadd, Cynthia S.

2014-01-01

Problem How can physicians incorporate the electronic health record (EHR) into clinical practice in a relationship-enhancing fashion (“EHR ergonomics”)? Approach Three convenience samples of 40 second-year medical students with varying levels of EHR ergonomic training were compared in the 2012 spring semester. All participants first received basic EHR training and completed a pre-survey. Two study groups were then instructed to use the EHR during the standardized patient (SP) encounter in each of four regularly scheduled Doctoring (clinical skills) course sessions. One group received additional ergonomic training in each session. Ergonomic assessment data were collected from students, faculty, and SPs in each session. A post-survey was administered to all students, and data were compared across all three groups to assess the impact of EHR use and ergonomic training. Outcomes There was a significant positive effect of EHR ergonomics skills training on students’ relationship-centered EHR use (P < .005). Students who received training reported that they were able to use the EHR to engage with patients more effectively, better articulate the benefits of using the EHR, better address patient concerns, more appropriately position the EHR device, and more effectively integrate the EHR into patient encounters. Additionally, students’ self-assessments were strongly corroborated by SP and faculty assessments. A minimum of three ergonomic training sessions was needed to see an overall improvement in EHR use. Next Steps In addition to replication of these results, further effectiveness studies of this educational intervention need to be carried out in GME, practice, and other environments. PMID:24826851

A novel approach to supporting relationship-centered care through electronic health record ergonomic training in preclerkship medical education.

PubMed

Silverman, Howard; Ho, Yun-Xian; Kaib, Susan; Ellis, Wendy Danto; Moffitt, Marícela P; Chen, Qingxia; Nian, Hui; Gadd, Cynthia S

2014-09-01

How can physicians incorporate the electronic health record (EHR) into clinical practice in a relationship-enhancing fashion ("EHR ergonomics")? Three convenience samples of 40 second-year medical students with varying levels of EHR ergonomic training were compared in the 2012 spring semester. All participants first received basic EHR training and completed a presurvey. Two study groups were then instructed to use the EHR during the standardized patient (SP) encounter in each of four regularly scheduled Doctoring (clinical skills) course sessions. One group received additional ergonomic training in each session. Ergonomic assessment data were collected from students, faculty, and SPs in each session. A postsurvey was administered to all students, and data were compared across all three groups to assess the impact of EHR use and ergonomic training. There was a significant positive effect of EHR ergonomics skills training on students' relationship-centered EHR use (P<.005). Students who received training reported that they were able to use the EHR to engage with patients more effectively, better articulate the benefits of using the EHR, better address patient concerns, more appropriately position the EHR device, and more effectively integrate the EHR into patient encounters. Additionally, students' self-assessments were strongly corroborated by SP and faculty assessments. A minimum of three ergonomic training sessions were needed to see an overall improvement in EHR use. In addition to replication of these results, further effectiveness studies of this educational intervention need to be carried out in GME, practice, and other environments.

Use of medications and resources for treatment of nausea, vomiting, or constipation in hospitalized patients treated with analgesics.

PubMed

Suh, Dong-Churl; Kim, Myoung S; Chow, Wing; Jang, Eun-Jin

2011-01-01

Hospitalized patients often experience adverse events of the gastrointestinal tract due to analgesic treatment. The objectives of this study were to estimate use of medications for treatment of nausea, vomiting, or constipation (NVC medications) after initiation of analgesic treatment, and to compare differences in length of stay and treatment costs between patients who received NVC medications and those who did not. This retrospective cohort study used the Premier Perspective data from January 1, 2005 to December 31, 2007 and stratified inpatients into 4 groups based on the first analgesic agent they were given. Patients were observed for 14 days after the first analgesic use until a regimen change, first use of NVC medication, or hospital discharge, whichever occurred first. Data were analyzed using a Cox proportional hazards model and a generalized linear model. This study found that 239,183 (55.1%) of 434,304 patients received NVC medications after analgesic administration. Compared with oral nonopioid analgesics, the risk of using NVC medication was 4.8 times higher for injectable opioid analgesics after controlling for confounders. Patients who received NVC medications were hospitalized 0.26 days longer (P < 0.0001) at an additional cost of $756 per patient compared with patients who did not receive NVC medications (P < 0.0001). Use of an analgesic with improved gastrointestinal tolerability may potentially reduce use of NVC medications and hospital resources.

Design and analysis considerations in the Ebola_Tx trial evaluating convalescent plasma in the treatment of Ebola virus disease in Guinea during the 2014-2015 outbreak.

PubMed

Edwards, Tansy; Semple, Malcolm G; De Weggheleire, Anja; Claeys, Yves; De Crop, Maaike; Menten, Joris; Ravinetto, Raffaella; Temmerman, Sarah; Lynen, Lutgarde; Bah, Elhadj Ibrahima; Smith, Peter G; van Griensven, Johan

2016-02-01

The Ebola virus disease outbreak in 2014-2015 led to a huge caseload with a high case fatality rate. No specific treatments were available beyond supportive care for conditions such as dehydration and shock. Evaluation of treatment with convalescent plasma from Ebola survivors was identified as a priority. We evaluated this intervention in an emergency setting, where randomization was unacceptable. The original trial design was an open-label study comparing patients receiving convalescent plasma and supportive care to patients receiving supportive care alone. The comparison group comprised patients recruited at the start of the trial before convalescent plasma became available, as well as patients presenting during the trial for whom there was insufficient blood group-compatible plasma or no staffing capacity to provide additional transfusions. However, during the trial, convalescent plasma was available to treat all new patients. The design was changed to use a comparator group comprising patients previously treated at the same Ebola treatment center prior to the start of the trial. In the analysis, it was planned to adjust for any differences in prognostic variables between intervention and comparison groups, specifically baseline polymerase chain reaction cycle threshold and age. In addition, adjustment was planned for other potential confounders, identified in the analysis, such as patient presenting symptoms and time to treatment seeking. Because plasma treatment started up to 3 days after diagnosis and we could not define a similar time-point for the comparator group, patients who died before the third day after confirmation of diagnosis were excluded from both intervention and comparison groups in a per-protocol analysis. Some patients received additional experimental treatments soon after plasma treatment, and these were excluded. We also analyzed mortality including all patients from the time of confirmed diagnosis, irrespective of whether those in the trial series actually received plasma, as an intention-to-treat analysis. Per-protocol and intention-to-treat approaches gave similar conclusions. An important caveat in the interpretation of the findings is that it is unlikely that all potential sources of confounding, such as any variation in supportive care over time, were eliminated. Protocols and electronic data capture systems have now been extensively field-tested for emergency evaluation of treatment with convalescent plasma. Ongoing studies seek to quantify the level of neutralizing antibodies in different plasma donations to determine whether this influences the response and survival of treated patients. © The Author(s) 2016.

Repaglinide: a review of its therapeutic use in type 2 diabetes mellitus.

PubMed

Culy, C R; Jarvis, B

2001-01-01

Repaglinide, a carbamoylmethyl benzoic acid derivative, is the first of a new class of oral antidiabetic agents designed to normalise postprandial glucose excursions in patients with type 2 diabetes mellitus. Like the sulphonylureas, repaglinide reduces blood glucose by stimulating insulin release from pancreatic beta-cells, but differs from these and other antidiabetic agents in its structure, binding profile, duration of action and mode of excretion. In clinical trials of up to 1-year's duration, repaglinide maintained or improved glycaemic control in patients with type 2 diabetes mellitus. In comparative, 1-year, double-blind, randomised trials (n = 256 to 544), patients receiving repaglinide (0.5 to 4mg before 3 daily meals) achieved similar glycaemic control to that in patients receiving glibenclamide (glyburide) < or = 15 mg/day and greater control than patients receiving glipizide < or = 15 mg/day. Changes from baseline in glycosylated haemoglobin and fasting blood glucose levels were similar between patients receiving repaglinide and glibenclamide in all studies; however, repaglinide was slightly better than glibenclamide in reducing postprandial blood glucose in I short term study (n = 192). Patients can vary their meal timetable with repaglinide: the glucose-lowering efficacy of repaglinide was similar for patients consuming 2, 3 or 4 meals a day. Repaglinide showed additive effects when used in combination with other oral antidiabetic agents including metformin, troglitazone, rosiglitazone and pioglitazone, and intermediate-acting insulin (NPH) given at bedtime. In 1-year trials, the most common adverse events reported in repaglinide recipients (n = 1,228) were hypoglycaemia (16%), upper respiratory tract infection (10%), rhinitis (7%), bronchitis (6%) and headache (9%). The overall incidence of hypoglycaemia was similar to that recorded in patients receiving glibenclamide, glipizide or gliclazide (n = 597) [18%]; however, the incidence of serious hypoglycaemia appears to be slightly higher in sulphonylurea recipients. Unlike glibenclamide, the risk of hypoglycaemia in patients receiving repaglinide was not increased when a meal was missed in 1 trial. In conclusion, repaglinide is a useful addition to the other currently available treatments for type 2 diabetes mellitus. Preprandial repaglinide has displayed antihyperglycaemic efficacy at least equal to that of various sulphonylureas and is associated with a reduced risk of serious hypoglycaemia. It is well tolerated in a wide range of patients, including the elderly, even if a meal is missed. Furthermore, glycaemic control is improved when repaglinide is used in combination with metformin. Thus, repaglinide should be considered for use in any patient with type 2 diabetes mellitus whose blood glucose cannot be controlled by diet or exercise alone, or as an adjunct in patients whose glucose levels are inadequately controlled on metformin alone.

Long-Term Survival and Tumor Recurrence in Patients with Superficial Esophageal Cancer after Complete Non-Curative Endoscopic Resection: A Single-Center Case Series.

PubMed

Lee, Ji Wan; Cho, Charles J; Kim, Do Hoon; Ahn, Ji Yong; Lee, Jeong Hoon; Choi, Kee Don; Song, Ho June; Park, Sook Ryun; Lee, Hyun Joo; Kim, Yong Hee; Lee, Gin Hyug; Jung, Hwoon-Yong; Kim, Sung-Bae; Kim, Jong Hoon; Park, Seung-Il

2018-06-01

To report the long-term survival and tumor recurrence outcomes in patients with superficial esophageal cancer (SEC) after complete non-curative endoscopic resection (ER). We retrieved ER data for 24 patients with non-curatively resected SEC. Non-curative resection was defined as the presence of submucosal and/or lymphovascular invasion on ER pathology. Relevant clinical and tumor-specific parameters were reviewed. The mean age of the 24 study patients was 66.3±8.3 years. Ten patients were closely followed up without treatment, while 14 received additional treatment. During a mean follow-up of 59.0±33.2 months, the 3- and 5-year survival rates of all cases were 90.7% and 77.6%, respectively. The 5-year overall survival rates were 72.9% in the close observation group and 82.1% in the additional treatment group (p=0.958). The 5-year cumulative incidences of all cases of recurrence (25.0% vs. 43.3%, p=0.388), primary EC recurrence (10.0% vs. 16.4%, p=0.558), and metachronous EC recurrence (16.7% vs. 26.7%, p=0.667) were similar between the two groups. Patients with non-curatively resected SEC showed good long-term survival outcomes. Given the similar oncologic outcomes, close observation may be an option with appropriate caution taken for patients who are medically unfit to receive additional therapy.

Triiodothyronine accelerates and enhances the antipsychotic effect of risperidone in acute schizophrenia.

PubMed

Steibliene, Vesta; Bunevicius, Adomas; Savickas, Arunas; Prange, Arthur J; Nemeroff, Charles B; Bunevicius, Robertas

2016-02-01

In acute psychotic schizophrenia patients we investigated if the combination of triiodothyronine (T3) plus risperidone was more effective when compared to risperidone monotherapy. Thirty-two in-patients meeting the DSM-IV-TR diagnostic criteria for schizophrenia and without thyroid disease received risperidone (flexibly adjusted dose for tolerability) and were randomized to additionally receive either T3 (25 μg daily; risperidone plus T3 group) or placebo (risperidone plus placebo group). Treatment lasted until meeting the response to treatment criteria defined as score of ≤ 3 on the Clinical Global Impression Severity and Improvement scales. Acute psychotic episode symptom severity was evaluated using the Brief Psychiatric Rating Scale (BPRS) at treatment initiation and at the final study assessment. Fourteen patients were randomized to receive risperidone plus T3 and eighteen to receive risperidone plus placebo. The time until treatment response was shorter in the risperidone plus T3 group relative to the risperidone plus placebo group (25.5 ± 4.4 days vs 32.2 ± 8.2 days, respectively; p = 0.001). Moreover, there was a greater reduction of BPRS-total score (p = 0.01) in the risperidone plus T3 group relative to the risperidone plus placebo group. Treatment with T3 was associated with shorter time to treatment response (β = -0.440, p = 0.022) and with greater improvement in BPRS score (β = 0.240, p = 0.053), independent of patients' gender, age, baseline BPRS score and mean risperidone dose. The study confirms that addition of T3 to risperidone was associated with accelerated and enhanced treatment response in acutely psychotic schizophrenic patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

Artificial neural network approach to predict surgical site infection after free-flap reconstruction in patients receiving surgery for head and neck cancer

PubMed Central

Kuo, Pao-Jen; Wu, Shao-Chun; Chien, Peng-Chen; Chang, Shu-Shya; Rau, Cheng-Shyuan; Tai, Hsueh-Ling; Peng, Shu-Hui; Lin, Yi-Chun; Chen, Yi-Chun; Hsieh, Hsiao-Yun; Hsieh, Ching-Hua

2018-01-01

Background The aim of this study was to develop an effective surgical site infection (SSI) prediction model in patients receiving free-flap reconstruction after surgery for head and neck cancer using artificial neural network (ANN), and to compare its predictive power with that of conventional logistic regression (LR). Materials and methods There were 1,836 patients with 1,854 free-flap reconstructions and 438 postoperative SSIs in the dataset for analysis. They were randomly assigned tin ratio of 7:3 into a training set and a test set. Based on comprehensive characteristics of patients and diseases in the absence or presence of operative data, prediction of SSI was performed at two time points (pre-operatively and post-operatively) with a feed-forward ANN and the LR models. In addition to the calculated accuracy, sensitivity, and specificity, the predictive performance of ANN and LR were assessed based on area under the curve (AUC) measures of receiver operator characteristic curves and Brier score. Results ANN had a significantly higher AUC (0.892) of post-operative prediction and AUC (0.808) of pre-operative prediction than LR (both P<0.0001). In addition, there was significant higher AUC of post-operative prediction than pre-operative prediction by ANN (p<0.0001). With the highest AUC and the lowest Brier score (0.090), the post-operative prediction by ANN had the highest overall predictive performance. Conclusion The post-operative prediction by ANN had the highest overall performance in predicting SSI after free-flap reconstruction in patients receiving surgery for head and neck cancer. PMID:29568393

Aminocaproic Acid (amicar) as an alternative to aprotinin (trasylol) in liver transplantation.

PubMed

Mangus, R S; Kinsella, S B; Fridell, J A; Kubal, C A; Lahsaei, P; Mark, L O; Tector, A J

2014-06-01

This study compared clinical outcomes for a large number of liver transplant patients receiving intraoperative epsilon-aminocaproic acid (EACA), aprotinin, or no antifibrinolytic agent over an 8-year period. Records for deceased donor liver transplants were reviewed. Data included antifibrinolytic agent, blood loss, early graft function, and postoperative complications. Study groups included low-dose aprotinin, high-dose aprotinin, EACA (25 mg/kg, 1-hour infusion), or no antifibrinolytic agent. Data were included for 1170 consecutive transplants. Groups included low-dose aprotinin (n = 324 [28%]), high-dose aprotinin (n = 308 [26%]), EACA (n = 216 [18%]), or no antifibrinolytic (n = 322 [28%]). EACA had the lowest intraoperative blood loss and required the fewest transfusions of plasma. Patients receiving no agent required the most blood transfusions. Early graft loss was lowest in the EACA group, and 90-day and 1-year patient survival rates were significantly higher for the low-dose aprotinin and EACA groups according to Cox regression. Complications were similar, but there were more episodes of deep vein thrombosis in patients receiving EACA. These results suggest that transitioning from aprotinin to EACA did not result in worse outcomes. In addition to decreased intraoperative blood loss, a trend toward improved graft and patient survival was seen in patients receiving EACA. Copyright © 2014 Elsevier Inc. All rights reserved.

Effect of repaglinide addition to metformin monotherapy on glycemic control in patients with type 2 diabetes.

PubMed

Moses, R; Slobodniuk, R; Boyages, S; Colagiuri, S; Kidson, W; Carter, J; Donnelly, T; Moffitt, P; Hopkins, H

1999-01-01

To compare the effect of repaglinide in combination with metformin with monotherapy of each drug on glycemic control in patients with type 2 diabetes. A total of 83 patients with type 2 diabetes who had inadequate glycemic control (HbA1c > 7.1%) when receiving the antidiabetic agent metformin were enrolled in this multicenter, double-blind trial. Subjects were randomized to continue with their prestudy dose of metformin (n = 27), to continue with their prestudy dose of metformin with the addition of repaglinide (n = 27), or to receive repaglinide alone (n = 29). For patients receiving repaglinide, the optimal dose was determined during a 4- to 8-week titration and continued for a 3-month maintenance period. In subjects receiving combined therapy, HbA1c was reduced by 1.4 +/- 0.2%, from 8.3 to 6.9% (P = 0.0016) and fasting plasma glucose by 2.2 mmol/l (P = 0.0003). No significant changes were observed in subjects treated with either repaglinide or metformin monotherapy in HbA1c (0.4 and 0.3% decrease, respectively) or fasting plasma glucose (0.5 mmol/l increase and 0.3 mmol/l decrease respectively). Subjects receiving repaglinide either alone or in combination with metformin, had an increase in fasting levels of insulin between baseline and the end of the trial of 4.04 +/- 1.56 and 4.23 +/- 1.50 mU/l, respectively (P < 0.02). Gastrointestinal adverse events were common in the metformin group. An increase in body weight occurred in the repaglinide and combined therapy groups (2.4 +/- 0.5 and 3.0 +/- 0.5 kg, respectively; P < 0.05). Combined metformin and repaglinide therapy resulted in superior glycemic control compared with repaglinide or metformin monotherapy in patients with type 2 diabetes whose glycemia had not been well controlled on metformin alone. Repaglinide monotherapy was as effective as metformin monotherapy.

Text Messaging (SMS) Helping Cancer Care in Patients Undergoing Chemotherapy Treatment: a Pilot Study.

PubMed

Rico, Timóteo Matthies; Dos Santos Machado, Karina; Fernandes, Vanessa Pellegrini; Madruga, Samanta Winck; Noguez, Patrícia Tuerlinckx; Barcelos, Camila Rose Guadalupe; Santin, Mateus Madail; Petrarca, Cristiane Rios; Dumith, Samuel Carvalho

2017-10-09

Cancer treatment is an extremely stressful life experience that is accompanied by a range of psychological, social, physical, and practical difficulties. Cancer patients need to receive information that helps them to better understand the disease, assists them in decision-making, and helps them deal with treatment. Patients are interested in receiving such information. The degree of satisfaction with the information received has been associated with positive health outcomes, specifically regarding quality of life, severity of side effects, and psychological well-being. This study investigates a method of guiding cancer patients, in relation to outpatient chemotherapy treatment, using SMS (short message service) text messaging. A smartphone application called cHEmotHErApp was developed, and its primary function is to send out SMS text messages with guidance for self-care and emotional support for oncology patients undergoing chemotherapy. Thus, the main objective of this study is to evaluate the acceptance and perception of patients of the receipt of these SMS messages, as well as to evaluate the possible benefits reported by the participants. Adult patients diagnosed with cancer, who started the first outpatient chemotherapy treatment scheme between August and November 2016 at the School Hospital (HE) of the Federal University of Pelotas (UFPel), were invited to participate in this pilot study. In total, 14 cancer patients were adherent to this study. Each of these patients received a daily text message on their cell phone with some guidance on encouraging self-care and emotional support. Patients reported that, because of the SMS text messages they received, they felt more confident in their treatment, felt more supported and encouraged, and that the text messages facilitated self-care. In addition, patients reported that the SMS text messages they received helped them to take better care of themselves and to continue further treatment.

[Efficiency of combination therapy for acute otitis media].

PubMed

Poliakova, S D; Nekrasova, E A

2010-01-01

The clinical efficiency of treatment was evaluated in 60 patients aged 18 to 60 years with protracted acute otitis media (AOM) who had residual tympanic membrane inflammation and exudates in the tympanic cavity. The patients were divided into 2 groups of 30 each, who received equal basic medical treatment; Group 1 patients were additionally given eurespal (fenspiride) 80 mg thrice daily for 2 weeks. The patients were examined by clinical, endoscopic, and audiometric studies; the transport function of the nasal ciliated epithelium was also explored. The findings suggest the benefits of the additional use of eurespal in the treatment of the catarrhal stage of AOM.

Effect of travel distance and time to radiotherapy on likelihood of receiving mastectomy.

PubMed

Goyal, Sharad; Chandwani, Sheenu; Haffty, Bruce G; Demissie, Kitaw

2015-04-01

Breast-conserving surgery (BCS) followed by adjuvant radiation therapy (RT) is the standard of care for women with early-stage breast cancer as an alternative to mastectomy. The purpose of this study was to examine the relationship between receipt of mastectomy and travel distance and time to RT facility in New Jersey (NJ). Data were collected from a cohort of 634 NJ women diagnosed with early-stage breast cancer. In patients receiving RT, the precise RT facility was used, whereas in patients not receiving RT, surgeons were contacted to determine the location of RT referral. Travel distance and time to RT facility from the patients' residential address were modeled separately using multiple binomial regression to examine their association with choice of surgery while adjusting for clinical and sociodemographic factors. Overall, 58.5 % patients underwent BCS with median travel distance to the radiation facility of 4.8 miles (vs. 6.6 miles for mastectomy) and median travel time of 12.0 min (vs. 15.0 min for mastectomy). Patients residing > 9.2 miles compared with ≤ 9.2 miles from radiation facility were 44 % more likely to receive mastectomy. Additionally, patients requiring > 19 min compared with ≤ 19 min of travel time were 36 % more likely to receive mastectomy. These data found that travel distance and time from RT facility act as barriers to undergoing BCS in women with early-stage breast cancer. Despite being in an urban region, a significant number of women in NJ with early-stage breast cancer did not receive BCS.

Audiological outcomes of cochlear implantation in Waardenburg Syndrome.

PubMed

Magalhães, Ana Tereza de Matos; Samuel, Paola Angélica; Goffi-Gomez, Maria Valeria Schimdt; Tsuji, Robinson Koji; Brito, Rubens; Bento, Ricardo Ferreira

2013-07-01

 The most relevant clinical symptom in Waardenburg syndrome is profound bilateral sensorioneural hearing loss.  To characterize and describe hearing outcomes after cochlear implantation in patients with Waardenburg syndrome to improve preoperative expectations.  This was an observational and retrospective study of a series of cases. Children who were diagnosed with Waardenburg syndrome and who received a multichannel cochlear implant between March 1999 and July 2012 were included in the study. Intraoperative neural response telemetry, hearing evaluation, speech perception, and speech production data before and after surgery were assessed.  During this period, 806 patients received a cochlear implant and 10 of these (1.2%) were diagnosed with Waardenburg syndrome. Eight of the children received a Nucleus 24(®) implant and 1 child and 1 adult received a DigiSonic SP implant. The mean age at implantation was 44 months among the children. The average duration of use of a cochlear implant at the time of the study was 43 months. Intraoperative neural responses were present in all cases. Patients who could use the speech processor effectively had a pure tone average of 31 dB in free-field conditions. In addition, the MUSS and MAIS questionnaires revealed improvements in speech perception and production. Four patients did not have a good outcome, which might have been associated with ineffective use of the speech processor.  Despite the heterogeneity of the group, patients with Waardenburg syndrome who received cochlear implants were found to have hearing thresholds that allowed access to speech sounds. However, patients who received early intervention and rehabilitation showed better evolution of auditory perception.

Efficacy of ginger for prophylaxis of chemotherapy-induced nausea and vomiting in breast cancer patients receiving adriamycin-cyclophosphamide regimen: a randomized, double-blind, placebo-controlled, crossover study.

PubMed

Thamlikitkul, Lucksamon; Srimuninnimit, Vichien; Akewanlop, Charuwan; Ithimakin, Suthinee; Techawathanawanna, Sirisopa; Korphaisarn, Krittiya; Chantharasamee, Jomjit; Danchaivijitr, Pongwut; Soparattanapaisarn, Nopadol

2017-02-01

The purpose of this study is to determine the efficacy of ginger for reducing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients receiving adriamycin and cyclophosphamide (AC) regimens. We enrolled breast cancer patients receiving AC who experienced moderate to severe nausea or vomiting during the first chemotherapy cycle. Subjects were randomized to receive a 500-mg ginger capsule or placebo twice a day for 5 days starting on the first day of the second AC cycle and were switched to the other treatment in the third cycle. All participants also received ondansetron and dexamethasone for CINV prophylaxis. Nausea severity was recorded once a day during the first 5 days of each cycle. The primary outcome was reduction in nausea score. Thirty-four subjects (68 cycles of AC) were enrolled. Mean (range) maximum nausea score in the first AC cycle was 58 (40-90). Thirty-three subjects (97 %) received the same AC doses in the second as in the third cycle. Mean (±standard error) maximum nausea scores in patients receiving ginger and placebo were 35.36 (±4.43) and 32.17 (±3.71), respectively. The difference in mean maximum nausea scores was 3 (95 % confidence interval, -3 to 9; P = 0.3). There were no significant differences between ginger and placebo in terms of vomiting incidence and severity, rescue medication use, chemotherapy compliance, and adverse events. Ginger (500 mg) twice daily was safe, but conferred no additional benefit in terms of reducing nausea severity in breast cancer patients receiving AC and ondansetron and dexamethasone for CINV prophylaxis.

Efficacy and safety of parecoxib/phloroglucinol combination therapy versus parecoxib monotherapy for acute renal colic: a randomized, double-blind clinical trial.

PubMed

Fu, Weihua; Yao, Jiwei; Li, Qianwei; Wang, Yongquan; Wu, Xiaojun; Zhou, Zhansong; Li, Wei-Bing; Yan, Jun-An

2014-05-01

To investigate whether the addition of phloroglucinol to parecoxib could improve the efficacy in patients with acute renal colic. Patients of acute renal colic were randomly allocated to receive intravenous Parecoxib 40 mg plus placebo or Parecoxib 40 mg plus phloroglucinol 80 mg, respectively. Pain intensity was recorded using a visual analog scale (VAS) before drug administration and 5, 15, 30, 60, and 120 min after treatment start. The primary outcome was the mean pain intensity difference (PID) at each checkpoint and the effectiveness of drugs (≥ 50 % decrease in VAS score at the end checkpoint). The need for rescue analgesics and the incidence of adverse effects were considered as secondary outcome of the study. Among 236 patients enrolled in the study, 119 patients received intravenous parecoxib plus placebo and 114 patients received intravenous parecoxib plus phloroglucinol, the remaining 3 patients given up treatment. Baseline demographics were similar between two groups. There are significant differences in the PID at 15 and 30 min between two groups (P15 min = 0.011, P30 min = 0.013). Rescue analgesics were required by 17 patients (14.3 %) receiving parecoxib, 7 patients (6.1 %) receiving parecoxib plus phloroglucinol (P = 0.041). There were no differences in PID at other checkpoints between two groups, as well as in the incidence of adverse events and the drug effectiveness. Parecoxib in combination with phloroglucinol for acute renal colic has a faster action, also reduces the demand of rescue analgesics.

Intrathecal trastuzumab (Herceptin) and methotrexate for meningeal carcinomatosis in HER2-overexpressing metastatic breast cancer: a case report.

PubMed

Stemmler, Hans-Joachim; Mengele, Karin; Schmitt, Manfred; Harbeck, Nadia; Laessig, Dorit; Herrmann, Karin A; Schaffer, Pamela; Heinemann, Volker

2008-09-01

Leptomeningeal carcinomatosis represents a rare manifestation of metastatic breast cancer (MBC). We herewith report on a patient suffering from HER2 overexpressing MBC who received intrathecal methotrexate and trastuzumab for meningeal carcinomatosis. A 48-year-old woman was diagnosed with breast cancer in December 2002. Following surgery, six cycles of adjuvant FE100C plus irradiation and, subsequently for 1 year, trastuzumab were given. As a result of disseminated metastatic spread in October 2005, the patient received whole-brain radiotherapy for symptomatic central nervous system involvement, and was put on several trastuzumab-based combination regimens (capecitabine, vinorelbine, paclitaxel). In June 2006, the patient developed clinical signs of terminal cone involvement with overflow incontinence and paraparesis of the legs. Immediate radiation led to partial relief from clinical symptoms. Subsequently, the patient was put on the tyrosine kinase inhibitor lapatinib and capecitabine (August to October 2007), but on November 6th the patient suffered again from overflow incontinence and weakness of the legs. Failing to respond to lapatinib, the patient received gemcitabine/cisplatin and, additionally, was recommenced on intravenous trastuzumab. Owing to progressive leptomeningeal disease, the patient received repeated doses of intrathecal methotrexate and trastuzumab. Within 2 weeks and four intrathecal treatments, cerebrospinal fluid cytology showed the absence of tumor cells. Moreover, a striking clinical improvement with resolution of the paraparesis of the legs and overflow incontinence was observed. This case report gives details regarding the clinical course of a breast cancer patient who received intrathecal trastuzumab and methotrexate via lumbar puncture for meningeal carcinomatosis of HER2-overexpressing MBC.

Compliance with American Urological Association Guidelines for Post-Percutaneous Nephrolithotomy Antibiotics Does Not Appear to Increase Rates of Infection.

PubMed

Deshmukh, Sameer; Sternberg, Kevan; Hernandez, Natalia; Eisner, Brian H

2015-10-01

We compared infection rates after percutaneous nephrolithotomy in a group of patients without a history of infection or struvite calculi who received 24 hours or less of antibiotics postoperatively (ie compliance with AUA guidelines) vs a group that received 5 to 7 days of antibiotics postoperatively. We retrospectively reviewed the records of consecutive percutaneous nephrolithotomy procedures in patients without a history of urinary tract infection. Group 1 received 24 hours or less of antibiotics postoperatively and group 2 received a mean of 6 days of antibiotics postoperatively. A total of 52 patients in group 1 (24 hours or less of antibiotics) and 30 in group 2 (mean 6 days of antibiotics) met study inclusion criteria. In 5 group 1 patients (9.6%) fever developed within 72 hours of percutaneous nephrolithotomy but none demonstrated bacteriuria or bacteremia on cultures. No patient in group 1 was treated for urinary tract infection on postoperative days 3 to 14. In 4 group 2 patients (13.3%) fever developed within 72 hours of percutaneous nephrolithotomy. A single patient showed bacteriuria (less than 10,000 cfu mixed gram-positive bacteria) on culture while no patient demonstrated bacteremia. No patient in group 2 was treated for urinary tract infection on postoperative days 3 to 14. There was no difference in stone-free rates or the need for additional procedures between the 2 groups. In this pilot series compliance with AUA guidelines for antibiotic prophylaxis did not result in higher rates of infection than in a comparable group of 30 patients who received approximately 6 days of antibiotics postoperatively. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients

PubMed Central

Singla, Neil; Rock, Amy; Pavliv, Leo

2010-01-01

Objective To determine whether pre- and post-operative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design This was a multi-center, randomized, double-blind placebo-controlled trial. Setting This study was completed at eight hospitals; six in the United States and two in South Africa. Patients A total of 185 adult patients undergoing elective orthopedic surgery. Interventions Patients were randomized to receive either 800 mg IV-ibuprofen or placebo every 6 hours, with the first dose administered pre-operatively. Additionally, all patients had access to intravenous morphine for rescue. Outcome Measures Efficacy of IV-ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post-operative period was also assessed. Results In the immediate post-operative period, there was a 25.8% reduction in mean area under the curve-VAS assessed with movement (AUC-VASM) in patients receiving IV-ibuprofen (P < 0.001); a 31.8% reduction in mean AUC-VAS assessed at rest (AUC-VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV-ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events. Conclusion Pre- and post-operative administration of IV-ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo-controlled trial. PMID:20609131

Gentamicin may have no effect on mortality of staphylococcal prosthetic valve endocarditis.

PubMed

Ramos-Martínez, Antonio; Muñoz Serrano, Alejandro; de Alarcón González, Arístides; Muñoz, Patricia; Fernández-Cruz, Ana; Valerio, Maricela; Fariñas, María Carmen; Gutiérrez-Cuadra, Manuel; Miró, José Ma; Ruiz-Morales, Josefa; Sousa-Regueiro, Dolores; Montejo, José Miguel; Gálvez-Acebal, Juan; HidalgoTenorio, Carmen; Domínguez, Fernando

2018-07-01

To analyze the influence of adding gentamicin to a regimen consisting of β-lactam or vancomycin plus rifampicin on survival in patients suffering from Staphylococcal prosthetic valve endocarditis (SPVE). From January 2008 to September 2016, 334 patients with definite SPVE were attended in the participating hospitals. Ninety-four patients (28.1%) received treatment based on β-lactam or vancomycin plus rifampicin and were included in the study. Variables were analyzed which related to patient survival during admission, including having received treatment with gentamicin. Seventy-seven (81.9%) were treated with cloxacillin (or vancomycin) plus rifampicin plus gentamicin, and 17 patients (18.1%) received the same regimen without gentamicin. The causative microorganism was Staphylococcus aureus in 40 cases (42.6%) and coagulase-negative staphylococci in 54 cases (57.4%). Overall, 40 patients (42.6%) died during hospital admission, 33 patients (42.9%) in the group receiving gentamicin and 7 patients in the group that did not (41.2%, P = 0.899). Worsening renal function was observed in 42 patients (54.5%) who received gentamicin and in 9 patients (52.9%) who did not (p = 0.904). Heart failure as a complication of endocarditis (OR: 4.58; CI 95%: 1.84-11.42) and not performing surgery when indicated (OR: 2.68; CI 95%: 1.03-6.94) increased mortality. Gentamicin administration remained unrelated to mortality (OR: 1.001; CI 95%: 0.29-3.38) in the multivariable analysis. The addition of gentamicin to a regimen containing vancomycin or cloxacillin plus rifampicin in SPVE was not associated to better outcome. Copyright © 2018. Published by Elsevier Ltd.

Compliance with gastric cancer guidelines is associated with improved outcomes.

PubMed

Worhunsky, David J; Ma, Yifei; Zak, Yulia; Poultsides, George A; Norton, Jeffrey A; Rhoads, Kim F; Visser, Brendan C

2015-03-01

Limited data are available on the implementation and effectiveness of NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Gastric Cancer. We sought to assess rates of compliance with NCCN Guidelines, specifically stage-specific therapy during the initial episode of care, and to determine its impact on outcomes. The California Cancer Registry was used to identify cases of gastric cancer from 2001 to 2006. Logistic regression and Cox proportional hazard models were used to predict guideline compliance and the adjusted hazard ratio for mortality. Patients with TNM staging or summary stage (SS) were also analyzed separately. Compliance with NCCN Guidelines occurred in just 45.5% of patients overall. Patients older than 55 years were less likely to receive guideline-compliant care, and compliance was associated with a median survival of 20 versus 7 months for noncompliant care (P<.001). Compliant care was also associated with a 55% decreased hazard of mortality (P<.001). Further analysis revealed that 50% of patients had complete TNM staging versus an SS, and TNM-staged patients were more likely to receive compliant care (odds ratio, 1.59; P<.001). TNM-staged patients receiving compliant care had a median survival of 25.3 months compared with 15.1 months for compliant SS patients. Compliance with NCCN Guidelines and stage-specific therapy at presentation for the treatment of patients with gastric cancer was poor, which was a significant finding given that compliant care was associated with a 55% reduction in the hazard of death. Additionally, patients with TNM-staged cancer were more likely to receive compliant care, perhaps a result of having received more intensive therapy. Combined with the improved survival among compliant TNM-staged patients, these differences have meaningful implications for health services research. Copyright © 2015 by the National Comprehensive Cancer Network.

A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases.

PubMed

El-Hamamsy, Manal; Elwakil, Hesham; Saad, Amr S; Shawki, May A

2016-10-27

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

Effectiveness of prehospital continuous positive airway pressure in the management of acute pulmonary edema.

PubMed

Hubble, Michael W; Richards, Michael E; Jarvis, Roger; Millikan, Tori; Young, Dwayne

2006-01-01

To compare the effectiveness of continuous positive airway pressure (CPAP) with standard pharmacologic treatment in the management of prehospital acute pulmonary edema. Using a nonrandomized control group design, all consecutive patients presenting to two participating emergency medical services (EMS) systems with a field impression of acute pulmonary edema between July 1, 2004, and June 30, 2005, were included in the study. The control EMS system patients received standard treatment with oxygen, nitrates, furosemide, morphine, and, if indicated, endotracheal intubation. The intervention EMS system patients received CPAP via face mask at 10 cm H2O in addition to standard therapy. Ninety-five patients received standard therapy, and 120 patients received CPAP and standard therapy. Intubation was required in 8.9% of CPAP-treated patients compared with 25.3% in the control group (p = 0.003), and mortality was lower in the CPAP group than in the control group (5.4% vs. 23.2%; p = 0.000). When compared with the control group, the CPAP group had more improvement in respiratory rate (-4.55 vs. -1.81; p = 0.001), pulse rate (-4.77 vs. 0.82; p = 0.013), and dyspnea score (-2.11 vs. -1.36; p = 0.008). Using logistic regression to control for potential confounders, patients receiving standard treatment were more likely to be intubated (odds ratio, 4.04; 95% confidence interval, 1.64 to 9.95) and more likely to die (odds ratio, 7.48; 95% confidence interval, 1.96 to 28.54) than those receiving standard therapy and CPAP. The prehospital use of CPAP is feasible, may avert the need for endotracheal intubation, and may reduce short-term mortality.

Tranexamic acid use during total hip arthroplasty: A single center retrospective analysis.

PubMed

Stoicea, Nicoleta; Moran, Kenneth; Mahmoud, Abdel-Rasoul; Glassman, Andrew; Ellis, Thomas; Ryan, John; Granger, Jeffrey; Joseph, Nicholas; Salon, Nathan; Ackermann, Wiebke; Rogers, Barbara; Niermeyer, Weston; Bergese, Sergio D

2018-05-01

Tranexamic acid (TXA) is an antifibrinolytic agent that has shown promise in reducing blood loss during total hip arthroplasty (THA). Several studies have reported side effects of high-dose TXA administration, including myocardial infarction (MI), thromboembolic events, and seizures. These possible side effects have prevented the widespread adoption of TXA in the surgical community. We conducted a retrospective chart review of 564 primary and revision THAs performed at a single academic center. Surgical patients received either no TXA or 1 g IV TXA at the beginning of surgery followed by a second bolus just before the surgical wound closure, at the surgeon's discretion. We analyzed differences in hemoglobin (Hb), hematocrit (Hct), estimated blood loss (EBL), and adverse events in patients receiving TXA versus patients not receiving TXA up to 2 days following surgery. Significantly higher Hb and Hct values were found across all time points among patients undergoing primary posterior or revision THA who had received TXA. In addition, transfusion rates were significantly decreased in both primary posterior THAs and revision THAs when TXA was administered. Patients who received TXA experienced significantly fewer adverse events than those who did not for all surgery types. Administration of low-dose intravenous (IV) and intra-articular (IA) TXA does not appear to increase rates of adverse events and may be effective in minimizing blood loss, as reflected by Hb and Hct values following THA.

Treatment of oxaliplatin-induced peripheral neuropathy by intravenous mangafodipir

PubMed Central

Coriat, Romain; Alexandre, Jérôme; Nicco, Carole; Quinquis, Laurent; Benoit, Evelyne; Chéreau, Christiane; Lemaréchal, Hervé; Mir, Olivier; Borderie, Didier; Tréluyer, Jean-Marc; Weill, Bernard; Coste, Joel; Goldwasser, François; Batteux, Frédéric

2013-01-01

Background. The majority of patients receiving the platinum-based chemotherapy drug oxaliplatin develop peripheral neurotoxicity. Because this neurotoxicity involves ROS production, we investigated the efficacy of mangafodipir, a molecule that has antioxidant properties and is approved for use as an MRI contrast enhancer. Methods. The effects of mangafodipir were examined in mice following treatment with oxaliplatin. Neurotoxicity, axon myelination, and advanced oxidized protein products (AOPPs) were monitored. In addition, we enrolled 23 cancer patients with grade ≥2 oxaliplatin-induced neuropathy in a phase II study, with 22 patients receiving i.v. mangafodipir following oxaliplatin. Neuropathic effects were monitored for up to 8 cycles of oxaliplatin and mangafodipir. Results. Mangafodipir prevented motor and sensory dysfunction and demyelinating lesion formation. In mice, serum AOPPs decreased after 4 weeks of mangafodipir treatment. In 77% of patients treated with oxaliplatin and mangafodipir, neuropathy improved or stabilized after 4 cycles. After 8 cycles, neurotoxicity was downgraded to grade ≥2 in 6 of 7 patients. Prior to enrollment, patients received an average of 880 ± 239 mg/m2 oxaliplatin. Patients treated with mangafodipir tolerated an additional dose of 458 ± 207 mg/m2 oxaliplatin despite preexisting neuropathy. Mangafodipir responders managed a cumulative dose of 1,426 ± 204 mg/m2 oxaliplatin. Serum AOPPs were lower in responders compared with those in nonresponders. Conclusion. Our study suggests that mangafodipir can prevent and/or relieve oxaliplatin-induced neuropathy in cancer patients. Trial registration. Clinicaltrials.gov NCT00727922. Funding. Université Paris Descartes, Ministère de la Recherche et de l’Enseignement Supérieur, and Assistance Publique-Hôpitaux de Paris. PMID:24355920

INCIDENCE OF PULMONARY AND SKIN METASTASES IN WOMEN WITH BREAST CANCER WHO RECEIVED POSTOPERATIVE IRRADIATION

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dao, T.L.; Kovaric, J.

1962-07-01

The effect of x-ray treatment (total dose of 4500 r over a 3-week period) was evaluated in 354 patients, some of whom had previously undergone mastectomy. In clinically and pathologically comparable cases, ipsilateral pulmonary iaetastases and skin metastases in patients who had radical mastectomy were 14 and 34%, respectively, whereas in patients who received irradiation after mastectomy, incidences of metastases at those 2 sites were 37 and 52%. A similar change of patterns of metastases in lungs and skin was also observed in patients who have had simple mastectomy and irradiation. The increase in the incidence of ipsilateral skin andmore » pulmonary metastases is ascribed to the effect of irradiation, and the observations strongly support the postulate that irradiation favors development of metastases in the lungs. The fact that metastases developed in the skin within the portals of irradiation, and in the ipsilateral lung in the same patients, is evidence that the lymphatic and vascular obstructions due to fibrosis contribute to the development of the metastases in these tissues. The different patterns of skin and lung metastases in nonirradiated patients render additional support to the theory. The incidence of these injuries in 50 irradiated patients was: 18 had permanent disability of the upper extremities; 14 had necrosis of the bones with fractures of the clavicle and ribs; 25 had initial pneumonitis and subsequently pulmonary fibrosis; and 40 had skin changes, ranging from desquamation to ulceration. No significant difference was demonstrated in the survival of patients with cancer of the breast who received radical irradiation in addition to mastectomy. Furthermore, irradiation may favor the development of metastases in the lungs and skin, and cause disabling injuries. (TCO)« less

[Assessment of efficiency of dietotherapy with addition of a vitamin-mineral complex in patients with diabetes mellitus type 2].

PubMed

Lapik, I A; Sokol'nikov, A A; Sharafetdinov, Kh Kh; Sentsova, T B; Plotnikova, O A

2014-01-01

The influence of diet inclusion of vitamin and mineral complex (VMC), potassium and magnesium in the form of asparaginate on micronutrient status, body composition and biochemical parameters in patients with diabetes mellitus type 2 (DM2) has been investigated. 120 female patients with DM2 and obesity of I-III degree (mean age - 58 +/- 6 years) have been included in the study. The patients were divided into two groups: main group (n = 60) and control group (n = 60). For 3 weeks patients of both groups received a low-calorie diet (1600 kcal/day). Patients of the main group received VMC, providing an additional intake of vitamins C and E (100-120% RDA), beta-carotene (40% RDA), nicotinamide (38% RDA), pantothenic acid and biotin (60% RDA), vitamins B12, B2 and folic acid (75-83% RDA), vitamins B1 and B6 (160-300% RDA), zinc (100% RDA) and chromium (400% RDA), and also received magnesium (17.7% RDA) and potassium (9.4% RDA) in the form of asparaginate. Body composition, biochemical parameters and micronutrient status (blood serum level of vitamins C, D, B6, B12, folate, potassium, calcium, magnesium, zinc, phosphorus) were evaluated in all patients before and after the 3-week course of diet therapy. After the low-calorie diet therapy average body weight reduction was 4.2 +/- 0.2 kg in the main group, and 4.4 +/- 0.1 kg in the control group, without statistically significant differences between groups. Statistically significant decrease of total cholesterol, triglycerides, and glucose concentration in blood serum was registered in both groups. It should be noted that in the control group glycemia decreased on 1.2 +/- 0.1 mmol/l, while the main group showed a decrease on 1.8 +/- 0.1 (p < 0.05) to normal values (5.4 +/- 0.1 mmol/l). Initial assessment of vitamin and mineral status revealed that most patients were optimal supplied with vitamins and minerals. After the dietotherapy significant increase of vitamin C, 25-hydroxyvitamin D, vitamin B6, folate, vitamin B12, potassium, magnesium, calcium, zinc and phosphorus concentration in blood serum was observed in patients receiving VMC. While in the control group statistically significant decrease of vitamin C, magnesium, zinc and phosphorus concentration in blood serum after the treatment was revealed. The obtained data shows the necessity of addition of the vitamin-mineral complex to the diet of patients with DM2 and obesity.

The influence of personal message with music on anxiety and side effects associated with chemotherapy.

PubMed

Sabo, C E; Michael, S R

1996-08-01

The purpose of this pilot study was to evaluate the benefits of a message from a patient's physician audiotaped over music on reducing anxiety and side effects of patients receiving chemotherapy. A convenience sample of 97 adult patients receiving chemotherapy for the first time was assigned to either an experimental or control group. Before beginning the first chemotherapy treatment, all subjects completed a demographic questionnaire and the Spielberger State Anxiety Inventory (SSAI). Participants in the experimental group (n = 47) received taped music and a message from their physicians during the next four chemotherapy treatments. Participants in the control group (n = 50) received no intervention from the researchers and underwent their next four chemotherapy treatments as prescribed. After the fourth chemotherapy treatment, the SSAI and a side-effects self-assessment evaluation were completed by all subjects. A paired one-tailed t test found a significant difference between pre- and postintervention scores on the state anxiety scale (p < 0.001). In addition, anxiety remained the same over time in the control group. There was no significant difference in the severity of side effects experienced between control and experimental groups. These preliminary findings indicate that a simple and cost-effective intervention can decrease a patient's anxiety when receiving chemotherapy.

Predictive Value of Morphological Features in Patients with Autism versus Normal Controls

ERIC Educational Resources Information Center

Ozgen, H.; Hellemann, G. S.; de Jonge, M. V.; Beemer, F. A.; van Engeland, H.

2013-01-01

We investigated the predictive power of morphological features in 224 autistic patients and 224 matched-pairs controls. To assess the relationship between the morphological features and autism, we used the receiver operator curves (ROC). In addition, we used recursive partitioning (RP) to determine a specific pattern of abnormalities that is…

International Medical Graduates and the Discursive Patterns of Patient-Centred Communication

ERIC Educational Resources Information Center

Woodward-Kron, Robyn

2016-01-01

In many Western countries such as Australia, international medical graduates (IMGs) play a crucial role in meeting health workforce needs. For doctors for whom English is an additional language and who have received their medical education in non-Western settings, a challenge is the patient-centred approach to communication, which is well…

Comparative effectiveness of audit-feedback versus additional physician communication training to improve cancer screening for patients with limited health literacy.

PubMed

Price-Haywood, Eboni G; Harden-Barrios, Jewel; Cooper, Lisa A

2014-08-01

We designed a continuing medical education (CME) program to teach primary care physicians (PCP) how to engage in cancer risk communication and shared decision making with patients who have limited health literacy (HL). We evaluated whether training PCPs, in addition to audit-feedback, improves their communication behaviors and increases cancer screening among patients with limited HL to a greater extent than only providing clinical performance feedback. Four-year cluster randomized controlled trial. Eighteen PCPs and 168 patients with limited HL who were overdue for colorectal/breast/cervical cancer screening. Communication intervention PCPs received skills training that included standardized patient (SP) feedback on counseling behaviors. All PCPs underwent chart audits of patients' screening status semiannually up to 24 months and received two annual performance feedback reports. PCPs experienced three unannounced SP encounters during which SPs rated PCP communication behaviors. We examined between-group differences in changes in SP ratings and patient knowledge of cancer screening guidelines over 12 months; and changes in patient cancer screening rates over 24 months. There were no group differences in SP ratings of physician communication at baseline. At follow-up, communication intervention PCPs were rated higher in general communication about cancer risks and shared decision making related to colorectal cancer screening compared to PCPs who only received performance feedback. Screening rates increased among patients of PCPs in both groups; however, there were no between-group differences in screening rates except for mammography. The communication intervention did not improve patient cancer screening knowledge. Compared to audit and feedback alone, including PCP communication training increases PCP patient-centered counseling behaviors, but not cancer screening among patients with limited HL. Larger studies must be conducted to determine whether lack of changes in cancer screening were due to clinic/patient sample size versus ineffectiveness of communication training to change outcomes.

Usefulness of head injury instruction forms in home observation of mild head injuries.

PubMed

Warren, D; Kissoon, N

1989-06-01

We prospectively studied a group of patients with mild head injury discharged for home observation to determine whether written instructions assisted in recall of signs and symptoms, increased patient satisfaction, or resulted in any additional benefit over verbal explanations alone. We also evaluated the level of comprehension required to understand the written instructions in their present form. Over a three-month period, 72 patients (43 male, 29 female) with a mean age of 4.4 (SD +/- 3.9) years were studied. In addition to verbal explanations for all parents, 38 parents received written instructions. Each group remembered 4/7 (57%) of signs and symptoms and was equally satisfied with verbal explanations. The majority (84%) of parents who received instruction sheets intended to keep these for further reference. Low recall of two instructions may be due to poor comprehension of the language used. We conclude that written instructions (1) did not add significantly to recall, (2) may provide reassurance to parents, and (3) need to be written in simple lay terms in order to be understood by the parents/patients served.

Epilepsy.

PubMed

Devinsky, Orrin; Vezzani, Annamaria; O'Brien, Terence J; Jette, Nathalie; Scheffer, Ingrid E; de Curtis, Marco; Perucca, Piero

2018-05-03

Epilepsy affects all age groups and is one of the most common and most disabling neurological disorders. The accurate diagnosis of seizures is essential as some patients will be misdiagnosed with epilepsy, whereas others will receive an incorrect diagnosis. Indeed, errors in diagnosis are common, and many patients fail to receive the correct treatment, which often has severe consequences. Although many patients have seizure control using a single medication, others require multiple medications, resective surgery, neuromodulation devices or dietary therapies. In addition, one-third of patients will continue to have uncontrolled seizures. Epilepsy can substantially impair quality of life owing to seizures, comorbid mood and psychiatric disorders, cognitive deficits and adverse effects of medications. In addition, seizures can be fatal owing to direct effects on autonomic and arousal functions or owing to indirect effects such as drowning and other accidents. Deciphering the pathophysiology of epilepsy has advanced the understanding of the cellular and molecular events initiated by pathogenetic insults that transform normal circuits into epileptic circuits (epileptogenesis) and the mechanisms that generate seizures (ictogenesis). The discovery of >500 genes associated with epilepsy has led to new animal models, more precise diagnoses and, in some cases, targeted therapies.

Amino-oxyacetic acid as a palliative in tinnitus.

PubMed

Reed, H T; Meltzer, J; Crews, P; Norris, C H; Quine, D B; Guth, P S

1985-12-01

Amino-oxyacetic acid, previously shown to cause a reversible loss of hearing sensitivity and a reduction in endocochlear potential, was tried as a palliative in human tinnitus. Because the drug seemed to have a cochlear site of action, patients were selected for the study if their audiograms were indicative of cochlear lesions and if there was a reduction in tinnitus following intravenous lidocaine (lidocaine positive). Ten such patients received either 50 or 75 mg of amino-oxyacetic acid four times a day orally for one week or placebo administered in a random, crossover, double-blind design. Of these ten, three reported subjective lessening of tinnitus. One of those three and two others not reporting subjective lessening of tinnitus showed a substantial improvement in speech discrimination scores while receiving amino-oxyacetic acid but not placebo. One additional patient who did not receive lidocaine also reported a subjective lessening of tinnitus. Four patients who were lidocaine negative showed neither subjective nor objective improvement in tinnitus after treatment with amino-oxyacetic acid.

Utilisation of co-testing 
(human papillomavirus DNA testing and cervical cytology) after treatment of CIN: - a survey of GPs' awareness and knowledge.

PubMed

Munro, Aime; Codde, Jim; Semmens, James; Leung, Yee; Spilsbury, Katrina; Williams, Vincent; Steel, Nerida; Cohen, Paul; Pavicic, Heidi; Westoby, Vicki; O'Leary, Peter

2015-01-01

Patients have an increased risk of persistent/recurrent cervical disease if they received treatment for a high-grade squamous intraepithelial lesion (HSIL). Consequently, understanding whether co-testing (human papillomavirus [HPV] DNA testing and cervical cytology) is fully utilised by general practitioners (GPs) is paramount. After consultation with key stakeholders, an anonymous, self-completion questionnaire was developed and disseminated to GPs who had provided cervical cytology. Responses were received from 745 GPs (30.9% response rate). A significant number (34.3%) of GPs were unaware of the use of co-testing (HPV DNA testing and cervical cytology) for the management of patients after HSIL treatment. Additionally, the majority of GPs reported they did not 'always' receive a clear follow-up plan for patients after treatment of an HSIL. GPs require further support and education to ensure successful adoption of co-testing (HPV DNA testing and cervical cytology), specifically, for patients treated for an HSIL.

Pediatric procedural sedation with ketamine: time to discharge after intramuscular versus intravenous administration.

PubMed

Ramaswamy, Preeti; Babl, Franz E; Deasy, Conor; Sharwood, Lisa N

2009-02-01

Ketamine is an attractive agent for pediatric procedural sedation. There are limited data on time to discharge comparing intramuscular (IM) vs. intravenous (IV) ketamine. The authors set out to determine whether IM or IV ketamine leads to quicker discharge from the emergency department (ED) and how side effect profiles compare. All patients who had received ketamine IM or IV at a tertiary children's hospital ED during the 3-year study period (2004-2007) were identified. Prospective sedation registry data, retrospective medical records, and administrative data were reviewed for drug dosages, use of additional agents, time of drug administration to discharge, total ED time (triage to discharge), and adverse events. A subgroup analysis for patients requiring five or fewer sutures (short suture group) was performed. A total of 229 patients were enrolled (60% male) with median age of 2.8 years (IQR =1.8-4.3 years) and median weight of 15.7 kg (range = 8.7-74 kg). Ketamine was most frequently employed for laceration repair (80%) and foreign body removal (9%). Overall, 48% received ketamine IM and 52% received it IV. In the short-suture subgroup, 52% received ketamine IM, while 48% received it IV. Multivariate linear regression analysis determined time from drug administration to patient discharge as 21 minutes shorter for IV compared with IM administration, adjusted for age and number of additional doses (R(2) = -0.35; 95% CI = -0.5 to -0.19; p < 0.001). Total time in the ED (triage to discharge) comparing IV versus IM administration, adjusting for age and gender and number of additional doses, was not significantly different (p = 0.16). In the short-suture subgroup, time to discharge from administration was also shorter in the IV ketamine group (R(2) = -0.454; 95%CI = -0.66 to -0.25; p < 0.001) but similar for total time in ED (p = 0.16). Overall, adverse events occurred in 35% (95% CI = 27% to 45%) of the IM group and 20% (95% CI = 13% to 28%) of the IV group (p = 0.01). Only one patient required brief bag-mask ventilation. In this institution, time from drug injection to discharge was shorter in the IV compared to IM ketamine group, both overall and for the short-suture group. However, time from triage to discharge was similar.

Effectiveness of myofascial trigger point manual therapy combined with a self-stretching protocol for the management of plantar heel pain: a randomized controlled trial.

PubMed

Renan-Ordine, Rômulo; Alburquerque-Sendín, Francisco; de Souza, Daiana Priscila Rodrigues; Cleland, Joshua A; Fernández-de-Las-Peñas, César

2011-02-01

A randomized controlled clinical trial. To investigate the effects of trigger point (TrP) manual therapy combined with a self-stretching program for the management of patients with plantar heel pain. Previous studies have reported that stretching of the calf musculature and the plantar fascia are effective management strategies for plantar heel pain. However, it is not known if the inclusion of soft tissue therapy can further improve the outcomes in this population. Sixty patients, 15 men and 45 women (mean ± SD age, 44 ± 10 years) with a clinical diagnosis of plantar heel pain were randomly divided into 2 groups: a self-stretching (Str) group who received a stretching protocol, and a self-stretching and soft tissue TrP manual therapy (Str-ST) group who received TrP manual interventions (TrP pressure release and neuromuscular approach) in addition to the same self-stretching protocol. The primary outcomes were physical function and bodily pain domains of the quality of life SF-36 questionnaire. Additionally, pressure pain thresholds (PPT) were assessed over the affected gastrocnemii and soleus muscles, and over the calcaneus, by an assessor blinded to the treatment allocation. Outcomes of interest were captured at baseline and at a 1-month follow-up (end of treatment period). Mixed-model ANOVAs were used to examine the effects of the interventions on each outcome, with group as the between-subjects variable and time as the within-subjects variable. The primary analysis was the group-by-time interaction. The 2 × 2 mixed-model analysis of variance (ANOVA) revealed a significant group-by-time interaction for the main outcomes of the study: physical function (P = .001) and bodily pain (P = .005); patients receiving a combination of self-stretching and TrP tissue intervention experienced a greater improvement in physical function and a greater reduction in pain, as compared to those receiving the self-stretching protocol. The mixed ANOVA also revealed significant group-by-time interactions for changes in PPT over the gastrocnemii and soleus muscles, and the calcaneus (all P<.001). Patients receiving a combination of self-stretching and TrP tissue intervention showed a greater improvement in PPT, as compared to those who received only the self-stretching protocol. This study provides evidence that the addition of TrP manual therapies to a self-stretching protocol resulted in superior short-term outcomes as compared to a self-stretching program alone in the treatment of patients with plantar heel pain. Therapy, level 1b.

Efficacy and safety of a 14-day administration of tolvaptan in the treatment of patients with ascites in hepatic oedema.

PubMed

Sakaida, Isao; Yamashita, Satoyoshi; Kobayashi, Tomoo; Komatsu, Masafumi; Sakai, Terufumi; Komorizono, Yasuji; Okada, Mitsuru; Okita, Kiwamu

2013-06-01

To investigate the efficacy and safety of 14 days' orally administered tolvaptan as adjunctive treatment for hepatic oedema in Japanese liver cirrhosis patients with insufficient response to conventional diuretics, with the option to increase dose in those who did not respond initially. This multicentre, single-arm, phase 3 study allocated patients with liver cirrhosis and persistent ascites to 7-day treatment with 7.5 mg/day tolvaptan followed by an additional 7 days' treatment. Responders at day 7 (achieving ≥ 1 kg body-weight reduction) continued on 7.5 mg/day tolvaptan; nonresponders (<1 kg body-weight reduction) received 15 mg/day tolvaptan. Conventional diuretic treatment continued throughout. The primary endpoint was change in body weight from baseline, as a marker of ascites volume. A total of 51 patients received 7.5 mg/day tolvaptan for 7 days, which caused a significant reduction in mean body weight (55% response rate). During the second 7-day treatment period, 30 patients received 7.5 mg/day tolvaptan and 13 patients received tolvaptan 15 mg/day: response rates were 43% and 23%, respectively. Two serious adverse events were observed. Serum sodium was within normal range. Tolvaptan therapy for 14 days (with possible dose increase as necessary), in combination with conventional diuretics, effectively reduced body weight in patients with hepatic oedema.

A comparative study of negative pressure wound therapy with and without instillation of saline on wound healing.

PubMed

Omar, M; Gathen, M; Liodakis, E; Suero, E M; Krettek, C; Zeckey, C; Petri, M

2016-08-01

Negative pressure wound therapy (NPWT) has become an established treatment of traumatic and infected wounds. Negative pressure wound therapy with instillation (NPWTi) is a further development that combines the conventional NPWT with instillation of different fluids which continuously administer therapeutic reagents to the wound. The aim of this study was to compare the impact of additional saline instillation in NPWTi to NPWT alone. Between January and July 2014, consecutive patients with acute wounds of the lower limb were treated with NPWTi with saline instillation. The number of revision surgeries, length of hospital stay, and duration of treatment until final healing were recorded and compared with matched patients undergoing NPWT without instillation. There were 10 patients recruited with 10 matched controls examined restrospectivley. Patients who received NPWTi were found to have decreased time of hospitalisation (21.5 versus 26.5 days, p=0.43), and accelerated wound healing (9.0 versus 12.5 days, p=0.36) than patients who received NPWT. However, the difference in the outcomes of the patients who received NPWTi and patients who received NPWT was not found to be statisticallly significant. NPWTi with instillation of saline is a promising method and its effectiveness needs to be tested in a randomised controlled trial compared with NPWT alone. This study obtained support by KCI (Wiebsaden, Germany) for the surgical material.

Cancer treatment in older adults: implications for psychosocial research.

PubMed

Given, Barbara; Given, Charles W

2009-11-01

The purpose of this article is to describe areas in need of psychosocial research for older adults who are currently receiving cancer treatment. Areas in which there are gaps in knowledge related to psychosocial research are outlined. Topics discussed for future research include comorbidity, physical function, cognitive status, frailty, and geriatric syndromes. In addition, the need for intervention to support patients and family caregivers is outlined. There are numerous areas of concern to older patients with cancer receiving treatment that warrant further study. Research is needed to identify ways to support patients and families at the time of cancer treatment so that they can make informed decisions and actively participate in cancer treatment.

Additional weekend therapy may reduce length of rehabilitation stay after stroke: a meta-analysis of individual patient data.

PubMed

English, Coralie; Shields, Nora; Brusco, Natasha K; Taylor, Nicholas F; Watts, Jennifer J; Peiris, Casey; Bernhardt, Julie; Crotty, Maria; Esterman, Adrian; Segal, Leonie; Hillier, Susan

2016-07-01

Among people receiving inpatient rehabilitation after stroke, does additional weekend physiotherapy and/or occupational therapy reduce the length of rehabilitation hospital stay compared to those who receive a weekday-only service, and does this change after controlling for individual factors? Does additional weekend therapy improve the ability to walk and perform activities of daily living, measured at discharge? Does additional weekend therapy improve health-related quality of life, measured 6 months after discharge from rehabilitation? Which individual, clinical and hospital characteristics are associated with shorter length of rehabilitation hospital stay? This study pooled individual data from two randomised, controlled trials (n=350) using an individual patient data meta-analysis and multivariate regression. People with stroke admitted to inpatient rehabilitation facilities. Additional weekend therapy (physiotherapy and/or occupational therapy) compared to usual care (5 days/week therapy). Length of rehabilitation hospital stay, independence in activities of daily living measured with the Functional Independence Measure, walking speed and health-related quality of life. Participants who received weekend therapy had a shorter length of rehabilitation hospital stay. In the un-adjusted analysis, this was not statistically significant (MD -5.7 days, 95% CI -13.0 to 1.5). Controlling for hospital site, age, walking speed and Functional Independence Measure score on admission, receiving weekend therapy was significantly associated with a shorter length of rehabilitation hospital stay (β=7.5, 95% CI 1.7 to 13.4, p=0.001). There were no significant between-group differences in Functional Independence Measure scores (MD 1.9 points, 95% CI -2.8 to 6.6), walking speed (MD 0.06 m/second, 95% CI -0.15 to 0.04) or health-related quality of life (SMD -0.04, 95% CI -0.26 to 0.19) at discharge. Modest evidence indicates that additional weekend therapy might reduce rehabilitation hospital length of stay. ACTRN12610000096055, ACTRN12609000973213. [English C, Shields N, Brusco NK, Taylor NF, Watts JJ, Peiris C, et al. (2016) Additional weekend therapy may reduce length of rehabilitation stay after stroke: a meta-analysis of individual patient data.Journal of Physiotherapy62: 124-129]. Copyright © 2016 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

In vivo synergistic cytogenetic effects of aminophylline on lymphocyte cultures from patients with lung cancer undergoing chemotherapy.

PubMed

Mylonaki, Effie; Manika, Katerina; Zarogoulidis, Paul; Domvri, Kalliopi; Voutsas, Vasilis; Zarogoulidis, Kostas; Mourelatos, Dionysios

2012-12-01

The anti-cancer and cytogenetic effects of aminophylline (AM) have been demonstrated in several clinical trials. The aim of the present study was to investigate the in vivo cytogenetic effects of AM in newly diagnosed patients with small cell (SCLC) and non-small cell lung cancer (NSCLC), receiving chemotherapy for the first time. Sister chromatid exchanges (SCEs) and proliferation rate index (PRI) were evaluated in peripheral blood lymphocyte cultures from six patients with SCLC and six patients with NSCLC after the in vitro addition of AM and after the in vivo administration of AM in patients receiving chemotherapy. The in vitro addition of AM significantly increased SCEs only in SCLC patients (p<0.001). The in vivo administration of AM after chemotherapy increased SCEs in both cancer types (SCLC: p<0.001, NSCLC: p=0.003) and this increase was synergistic, the rates of SCEs in the presence of AM were higher than the expected SCE values if the increases above background for chemotherapy and AM were independent and additive (SCLC: p<0.001, NSCLC: p=0.008). Although in both groups of patients cell division delays were observed after the combined chemotherapy plus in vivo AM treatment, the correlation between the magnitude of the SCE response and the PRI depression was not statistically significant (p>0.05). These observations suggest that AM enhances the results of concurrently administered chemotherapy by synergistically increasing its cytogenetic effects in patients with lung cancer. Copyright © 2012 Elsevier B.V. All rights reserved.

Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639].

PubMed

Gasparovic, Hrvoje; Petricevic, Mate; Kopjar, Tomislav; Djuric, Zeljko; Svetina, Lucija; Biocina, Bojan

2012-08-25

Coronary artery disease remains the dominant cause of mortality in developed countries. While platelets have been recognized to play a pivotal role in atherothrombosis, the ideal antiplatelet regime after coronary artery surgery remains elusive. The evolution of CABG has presently moved beyond technical improvements to involve modulation of pharmacologic management designed to improve patient outcomes. The aim of this trial will be to test the hypothesis that the addition of clopidogrel to patients with documented postoperative aspirin resistance will reduce the incidence of major cardiovascular events. Patients scheduled for isolated coronary artery surgery will be eligible for the study. Patients in whom postoperative multiple electrode aggregometry documents aspirin resistance will be randomized into two groups. The control group will receive 300 mg of aspirin. The dual antiplatelet group will receive 75 mg of clopidogrel in addition to 300 mg of aspirin. Patients will be followed for 6 months. Major adverse cardiac and cerebrovascular events (death from any cause, myocardial infarction, stroke, hospitalization due to cardiovascular pathology) as well as bleeding events will be recorded. This will be the first trial that will specifically address the issue of dual antiplatelet therapy in patients undergoing coronary artery surgery who have been found to be aspirin resistant. In the event that the addition of clopidogrel proves to be beneficial in this subset of surgical patients, this study could significantly impact their future antiplatelet management. This randomized controlled trial has been registered at the ClinicalTrials.gov website (Identifier NCT01159639).

Electronic health communication: an educational application for this principle of the Patient-centered Medical Home.

PubMed

Barnhart, Amber; Lausen, Harald; Smith, Tracey; Lopp, Lauri

2010-05-01

The Patient-centered Medical Home (PCMH) relies on comprehensive, consistent, and accessible communication for the patient with all members of their health care team. "E-medicine" and health information technology (HIT) create many new possibilities in addition to standard face-to-face encounters. There is interest by both physicians and patients for enhanced access through electronic communication. However, there is little published literature regarding specific educational programs for medical professionals using electronic communication with patients. Faculty in a required 6-week family medicine clerkship developed, implemented, and evaluated an electronic health communication curriculum. This curriculum consists of a didactic session on electronic health communication including anticipated errors of communication and common clinical pitfalls. Each clerkship student receives a weekly e-mail from a standardized patient centered on a clinical question. Additionally, each e-mail contains a different communication challenge or predicted error. Students receive feedback each week on the e-mails and are evaluated with an objective structured clinical exam (OSCE) during the final week. The results of the weekly e-mails and the final OSCE show that students improve overall but continue to make predicted errors in communication despite didactic instruction and actual practice. These results reinforce the need for medical student education on electronic health communication with patients.

Hyperbaric oxygenation therapy for crush injuries reduces the risk of complications: research report.

PubMed

Yamada, Noriaki; Toyoda, Izumi; Doi, Tomoaki; Kumada, Keisuke; Kato, Hisaaki; Yoshida, Shozo; Shirai, Kunihiro; Kanda, Norihide; Ogura, Shinji

2014-01-01

Hyperbaric oxygen (HBO2) therapy has been adopted for crush injuries, but there are few studies supporting its use. We therefore investigated the effects of HBO2 on management of patients with complicated crush injuries. This historic cohort study included patients with crush injuries and open fractures with severities greater than or equal to Gustilo class IIIA. We divided the patients into two groups: Control and HBO2. The control group received conventional treatment, while the HBO2 group received conventional treatment plus HBO2. We compared the groups with respect to the incidence of infection, need for additional surgery, and length of intensive care unit (ICU) and hospital stays. There were 16 patients in the HBO2 group and 13 in the control group. There were no patients with infections in the HBO2 group, whereas in the control group six patients had infections and five needed another drainage procedure. These incidences were significantly lower in the HBO2 group (p = 0.003 and 0.013). However, the durations of ICU and hospital stays were similar across the two groups. HBO2 is effective in the management of crush injuries from the viewpoint of reducing complications and reoperations. These observations should be verified in additional studies with larger sample sizes because the patient number is limited.

Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial).

PubMed

Fagundes, Felipe Ribeiro Cabral; de Melo do Espírito Santo, Caique; de Luna Teixeira, Francine Mendonça; Tonini, Thaís Vanelli; Cabral, Cristina Maria Nunes

2017-01-31

The stratified model of care has been an effective approach for the treatment of low back pain. However, the treatment of patients with low risk of psychosocial-factor involvement is unclear. The addition of the therapeutic alliance to a minimal intervention may be an option for the treatment of low back pain. This paper reports on the rationale, design and protocol for a randomized controlled trial with blind assessor to assess the effectiveness of the addition of therapeutic alliance with minimal intervention on pain and disability in patients with chronic, nonspecific low back pain. Two hundred and twenty-two patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors will be assessed and randomly allocated into three groups (n = 74 patients per group). The Positive Therapeutic Alliance group will receive counseling and guidance with an emphasis on therapeutic alliance and empathy. The Usual Treatment group will receive the same information and counseling with limited interaction with the therapist. The Control group will not receive any intervention. The treatment will be composed by two intervention sessions with a 1-week interval. A blinded assessor will collect the following outcomes at baseline, 1 month, 6 months and 12 months after randomization: pain intensity (Pain Numerical Rating Scale), specific disability (Patient-specific Functional Scale), general disability (Oswestry Disability Index), global perceived effect (Global Perceived Effect Scale), empathy (Consultation and Relational Empathy Measure), credibility and expectations related to treatment. The analysis will be performed using linear mixed models. This will be the first study to understand the effect of combining enhanced therapeutic alliance to a treatment based on counseling, information and advice (minimal intervention). The addition of the therapeutic alliance to minimal intervention may improve the treatment of chronic, nonspecific low back pain. ClinicalTrials.gov, NCT 02497625. Registered on 10 July 2015.

Pilot Study of Nelarabine in Combination With Intensive Chemotherapy in High-Risk T-Cell Acute Lymphoblastic Leukemia: A Report From the Children's Oncology Group

PubMed Central

Dunsmore, Kimberly P.; Devidas, Meenakshi; Linda, Stephen B.; Borowitz, Michael J.; Winick, Naomi; Hunger, Stephen P.; Carroll, William L.; Camitta, Bruce M.

2012-01-01

Purpose Children's Oncology Group study AALL00P2 was designed to assess the feasibility and safety of adding nelarabine to a BFM 86–based chemotherapy regimen in children with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL). Patients and Methods In stage one of the study, eight patients with a slow early response (SER) by prednisone poor response (PPR; ≥ 1,000 peripheral blood blasts on day 8 of prednisone prephase) received chemotherapy plus six courses of nelarabine 400 mg/m2 once per day; four patients with SER by high minimal residual disease (MRD; ≥ 1% at day 36 of induction) received chemotherapy plus five courses of nelarabine; 16 patients with a rapid early response (RER) received chemotherapy without nelarabine. In stage two, all patients received six 5-day courses of nelarabine at 650 mg/m2 once per day (10 SER patients [one by MRD, nine by PPR]) or 400 mg/m2 once per day (38 RER patients; 12 SER patients [three by MRD, nine by PPR]). Results The only significant difference in toxicities was decreased neutropenic infections in patients treated with nelarabine (42% with v 81% without nelarabine). Five-year event-free survival (EFS) rates were 73% for 11 stage one SER patients and 67% for 22 stage two SER patients treated with nelarabine versus 69% for 16 stage one RER patients treated without nelarabine and 74% for 38 stage two RER patients treated with nelarabine. Five-year EFS for all patients receiving nelarabine (n = 70) was 73% versus 69% for those treated without nelarabine (n = 16). Conclusion Addition of nelarabine to a BFM 86–based chemotherapy regimen was well tolerated and produced encouraging results in pediatric patients with T-ALL, particularly those with a SER, who have historically fared poorly. PMID:22734022

A comparison of two methods of infiltration in breast reduction surgery.

PubMed

Armour, A D; Rotenberg, B W; Brown, M H

2001-08-01

The superwet technique has been shown in previous studies to dramatically reduce blood loss in breast reduction surgery, compared with standard infiltration. A retrospective chart review of 303 consecutive patients undergoing bilateral breast reduction surgery was undertaken to demonstrate additional differences in complication rate, operative time, or sponge use in the operating room. In this series, 132 consecutive patients received standard infiltration along incision lines (25 cc per breast of 1:100,000 epinephrine), and 171 patients received superwet infiltration with 240 cc per breast of 1:1,000,000 epinephrine. The average operative time was significantly reduced in the superwet group, from 78.5 minutes to 70.7 minutes (p < 0.01 level). The average number of sponges used intraoperatively was also decreased significantly (p < 0.01), from 26 to 20 sponges. Complication rates were equally low in both groups, demonstrating the safety of the superwet technique. In addition to limiting blood loss, the superwet infiltration effectively reduces operative time and sponge use without increasing complications in breast reduction surgery.

[Music as an adjuvant treatment for anxiety in pediatric oncologic patients].

PubMed

Sepúlveda-Vildósola, Ana Carolina; Herrera-Zaragoza, Octavio René; Jaramillo-Villanueva, Leonel; Anaya-Segura, Armando

2014-01-01

Music has been used as adjuvant therapy for anxiety and it is based on scientific principles. Tone, rhythm, harmony and time are crucial for its efficacy. Chemotherapy treatment frequently produces important stress in pediatric patients. This may delay treatment occasionally. Our objective was to determine if adjuvant therapy with music reduces anxiety in pediatric oncologic patients under ambulatory chemotherapy. Time series design. We included patients from 8 to 16 years of age who received ambulatory intravenous chemotherapy at the Hospital de Pediatría, Centro Médico Nacional Siglo XXI. They received treatment as usual on the first day, and music therapy during the second day of chemotherapy. A visual scale was used to categorize the level of anxiety prior and after treatment on both days. We included 22 patients. All patients experienced both moderate and high levels of anxiety prior to chemotherapy treatment on both days. There was a statistically significant reduction of anxiety on both groups after chemotherapy, but with lower levels of anxiety in the intervention group. There is an additional benefit with the use of music therapy in the reduction of anxiety in pediatric patients who receive ambulatory chemotherapy.

Cross-cultural medical education: can patient-centered cultural competency training be effective in non-Western countries?

PubMed

Ho, Ming-Jung; Yao, Grace; Lee, Keng-Lin; Beach, Mary Catherine; Green, Alexander R

2008-01-01

No evidence addresses the effectiveness of patient-centered cultural competence training in non-Western settings. To examine whether a patient-centered cultural competency curriculum improves medical students' skills in eliciting the patients' perspective and exploring illness-related social factors. Fifty-seven medical students in Taiwan were randomly assigned to either the control (n = 27) or one of two intervention groups: basic (n = 15) and extensive (n = 15). Both intervention groups received two 2-hour patient-centered cultural competency workshops. In addition, the extensive intervention group received a 2-hour practice session. The control group received no training. At the end of the clerkship, all students were evaluated with an objective structured clinical examination (OSCE). Students in the extensive intervention group scored significantly higher than the basic intervention and control groups in eliciting the patient's perspective (F = 18.38, p < 0.001, eta(2) = 0.40). Scores of both intervention groups were significantly higher than the control group in the exploring social factors (F = 6.66, p = 0.003, eta(2) = 0.20). Patient-centered cultural competency training can produce improvement in medical students' cross-cultural communication skills in non-Western settings, especially when adequate practice is provided.

Localized Unresectable Pancreatic Cancer Treated with High Energy Neutrons and Chemotherapy at Fermilab - Preliminary Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Saroja, K. R.; Cohen, Lionel; Hendrickson, Frank R.

1990-01-01

Between January 1985 and July 1989 a total of thirty-eight patients with locally advanced pancreatic cancer were treated with high energy neutrons at Fermilab. Twenty-one patients received only neutrons and seventeen were given chemotherapy in addition, either concurrently or subsequently following the completion of neutron irradiation. This is a retrospective study. Data were analyzed for tolerance, complications and survival. Three of the twenty-one (14%) patients who received only neutron beam therapy developed Grade ID or greater complications in the RTOG/EORTC scale. The median survival was 6.4 months. One of these patients is alive 10 months post treatment. Of seventeen patientsmore » who also received chemotherapy, five (29%) had severe complications. However, median survival was 13.5 months. Four of these seventeen patients are still alive at the time of this analysis. The preliminary results show that there is improvement in the survival of patients treated with combined neutron irradiation and chemotherapy. A pilot study to further evaluate these results in a larger group of patients is underway. Details of complications and chemotherapy regimen will be preseqted.« less

A randomized phase II trial evaluating different schedules of zoledronic acid on bone mineral density in patients with prostate cancer beginning androgen deprivation therapy.

PubMed

Lang, Joshua M; Wallace, Marianne; Becker, Jordan T; Eickhoff, Jens C; Buehring, Bjoern; Binkley, Neil; Staab, Mary Jane; Wilding, George; Liu, Glenn; Malkovsky, Miroslav; McNeel, Douglas G

2013-12-01

To assess the effects of timing and schedule of zoledronic acid (ZA) administration on bone mineral density (BMD) in patients beginning androgen deprivation therapy (ADT) for the treatment of recurrent prostate cancer. In this randomized, 3-arm trial, we evaluated changes in BMD after 3 different ZA administration schedules in men with recurrent prostate cancer who were beginning ADT. Forty-four patients were enrolled and randomized to receive a single dose of ZA given 1 week before beginning ADT (arm 1), a single dose of ZA given 6 months after beginning ADT (arm 2), or monthly administration of ZA starting 6 months after beginning ADT, for a total of 6 doses (arm 3). Patients who received ZA before ADT had a significant improvement in BMD at the total proximal femur and trochanter after 6 months compared with the other groups. In addition, only patients in the arm that received multiple doses improved lumbar spine BMD while on ADT, with these findings persisting to 24 months. However, this group also experienced more grade 1 adverse events. Analysis of these data suggests that ZA administration before initiation of ADT was superior to treatment 6 months after starting ADT in maintaining BMD. In addition, monthly ZA administration can increase BMD above baseline but is associated with more adverse events. Further study is needed to examine whether the timing and frequency of ZA therapy in patients on ADT can reduce fracture risk. Copyright © 2013 Elsevier Inc. All rights reserved.

Influence of recombinant human granulocyte colony-stimulating factor (filgrastim) on hematopoietic recovery and outcome following allogeneic bone marrow transplantation (BMT) from volunteer unrelated donors.

PubMed

Berger, C; Bertz, H; Schmoor, C; Behringer, D; Potthoff, K; Mertelsmann, R; Finke, J

1999-05-01

Effects of recombinant human granulocyte colony-stimulating factor (rhG-CSF, filgrastim) on hematopoietic recovery and clinical outcome in patients undergoing allogeneic bone marrow transplantation (BMT) from volunteer unrelated donors (VUD) were analyzed retrospectively. Additionally, the influence of baseline patient and transplant characteristics on hematopoietic recovery was evaluated. From January 1994 to March 1996, 47 consecutive adult patients received VUD-BMT. GVHD prophylaxis was cyclosporin A/short course methotrexate/prednisolone, and in four patients additional ATG. Post-transplantation, cohorts of patients received rhG-CSF (5 microg/kg/day) (n = 22) or no rhG-CSF (n = 25) in a non-randomized manner. The patient groups with and without rhG-CSF were rather comparable with respect to baseline patient and transplant characteristics. Median time to neutrophil counts (ANC) >500/microl was 14 days with rhG-CSF vs 16 days without rhG-CSF (P = 0.048), to ANC >1000/microl was 15 vs 18 days (P = 0.084). Neutrophil recovery was accelerated in patients receiving more than the median MNC dose of 2.54 x 10(8)/kg with a median time to ANC >1000/microl of 13 days vs 19 days (P = 0.017). RhG-CSF did not influence platelet recovery and incidence of infectious complications. Incidence of acute GVHD II-IV was 50% with rhG-CSF and 28% without rhG-CSF (P = 0.144), but death before acute GVHD II-IV occurred in 9% of patients with and 20% of patients without rhG-CSF. The median follow-up time was 38 and 36 months in patients with and without rhG-CSF, respectively. Survival at 2 years post-transplant was 39% (95% confidence interval (18%, 60%)) in patients with rhG-CSF and 24% (95% confidence interval (7%, 41%)) in patients without rhG-CSF. Administration of rhG-CSF after VUD-BMT may lead to more rapid neutrophil recovery, but did not influence the incidence of infectious complications. Patients receiving rhG-CSF showed a slightly higher incidence of acute GVHD II-IV. Higher numbers of MNC in the marrow graft accelerated hematopoietic engraftment.

Final report of the 70.2-Gy and 75.6-Gy dose levels of a phase I dose escalation study using three-dimensional conformal radiotherapy in the treatment of inoperable non-small cell lung cancer.

PubMed

Rosenzweig, K E; Mychalczak, B; Fuks, Z; Hanley, J; Burman, C; Ling, C C; Armstrong, J; Ginsberg, R; Kris, M G; Raben, A; Leibel, S

2000-01-01

Three-dimensional conformal radiotherapy (3D-CRT) is a mode of high-precision radiotherapy designed to increase the tumor dose and decrease the dose to normal tissues. This study reports the final results of the first two dose levels (70.2 Gy and 75.6 Gy) of a phase I dose-escalation study using 3D-CRT for the treatment of non-small cell lung cancer. Fifty-two patients were treated with 3D-CRT without chemotherapy. The median age was 67 years (range, 39-82 years). The majority of patients had locally advanced cancer. Tumor was staged as I/II in 10%, IIIA in 40%, and IIIB in 50%. Radiation was delivered in daily fractions of 1.8 Gy, 5 days a week. A radiation dose level was considered complete when 10 patients received the intended dose without unacceptable acute morbidity. Toxicity was scored according to the Radiation Therapy Oncology Group grading scheme. Twenty patients were initially assigned to the 70.2-Gy level; 14 of them received the intended dose. Three patients experienced severe acute toxicity, two with grade 3 (requiring steroids or oxygen) and a third with grade 5 (fatal) acute radiation pneumonitis. Because of the grade 5 pulmonary toxicity, the protocol was modified, and only patients with a calculated risk of normal tissue complication of less than 25% were eligible for dose escalation. Patients who had a normal tissue complication probability (NTCP) of greater than 25% received a lower dose of radiation. An additional 18 patients were entered on the modified study; 11 of them received 70.2 Gy. One patient experienced grade 3 acute pneumonitis. Despite dose reduction in four patients because of an unacceptably high NTCP, two additional patients developed grade 3 pulmonary toxicity. Fourteen patients were accrued to the 75.6-Gy dose level, and 10 received the intended dose. One of the 10 patients experienced grade 3 pulmonary toxicity and one developed grade 3 esophageal toxicity. Three patients were treated to lower doses as a result of their calculated NTCP without toxicity, and one patient refused treatment. The 2-year local control, disease-free survival, and overall survival rates were 37%, 12%, and 24%, respectively. The median survival time was 11 months. Treatment to 70.2 Gy and 75.6 Gy using 3D-CRT was delivered with acceptable morbidity when NTCP constraints were observed. Local control was encouraging in these patients with locally advanced disease. Patients are currently being accrued to the 81-Gy level of the study.

The effect of video information on anxiety levels in women attending colposcopy: a randomized controlled trial.

PubMed

Ketelaars, Pleun J W; Buskes, M H M; Bosgraaf, R P; van Hamont, D; Prins, Judith B; Massuger, L F A G; Melchers, Willem J G; Bekkers, Ruud L M

2017-12-01

The aim was to investigate whether additional information, in video form, reduces anxiety, depression and pain levels in women referred for colposcopy. Between September 2012 and March 2015, 136 patients referred for colposcopy were randomized into two study arms. Group A received video information in addition to the regular information leaflet, and group B (control group) received only the regular information leaflet. The patients were requested to complete standardized online questionnaires. The first online questionnaire (T1) was pre-randomization, and was completed at home, 5 days prior to the appointment. The second online questionnaire (T2) was completed directly before the colposcopy appointment, and the last online questionnaire (T3) was completed directly following colposcopy at the out-patient clinic. The questionnaires included the Spielberger State-Trait Anxiety Inventory (STAI), the Hospital Anxiety and Depression Scale (HADS), and the Numeric Rating Scale (NRS) to assess pain. The STAI state anxiety score was high (44.6), but there was no significant difference in STAI, HADS and NRS between the two groups at the three measuring points. A post hoc analysis showed that women with a generally higher baseline anxiety trait had significantly lower HADS anxiety levels following video information. Additional information (video) before colposcopy did not significantly reduce anxiety, depression, and expected or experienced pain, as measured by the STAI, HADS and NRS in patients attending their first colposcopy appointment. However, most patients positively appreciated the video information, which may reduce the anxiety of extremely anxious patients.

Changes in urinary Cu, Zn, and Se levels in cancer patients after treatment with Sha Shen Mai Men Dong Tang

PubMed Central

Lai, Tung-Yuan; Kuo, Hsien-Wen

2015-01-01

Sha Shen Mai Men Dong Tang (SMD-2; 沙參麥冬湯 shā shēn mài dōng tāng) is a Chinese medicinal herb (CMH; 中草藥 zhōng cǎo yào) used to treat symptoms associated with cancer therapy. The objective of this study was to assess the effect of SMD-2 on the levels of urinary copper (Cu), zinc (Zn), and selenium (Se) in lung cancer patients and head and neck cancer patients receiving chemoradiotherapy. Forty-two head and neck cancer patients and 10 lung cancer patients participated in our clinical trial. Each patient received chemoradiotherapy for 4 weeks. In addition, each patient was treated with SMD-2 for 8 weeks, including 2 weeks prior to and after the chemoradiotherapy treatment. Comparison of urinary Cu, Zn, and Se levels and the ratios of Zn to Cu and Se to Cu at three time points in the two types of cancer were assessed using the generalized estimating equations (GEEs). After the patients received chemoradiotherapy for 4 weeks, SMD-2 treatment was found to be associated with a significant decrease in urinary Cu levels, whereas urinary Zn and Se levels increased significantly. In addition, the ratios of Zn to Cu and Se to Cu in the urine samples of these patients also increased significantly. Both the urinary Zn levels and the ratio of Zn to Cu in head and neck cancer patients were significantly higher than in lung cancer patients. Urinary Zn and Se levels and the ratios of Zn to Cu and Se to Cu, but not urinary Cu levels, increased significantly during and after treatment when assessed using the GEE model. The SMD-2 treatments significantly increased Zn and Se levels in the urine of head and neck cancer patients. Increased Zn and Se levels in urine strengthened immune system. PMID:27114935

Effect of shoulder girdle strengthening on trunk alignment in patients with stroke.

PubMed

Awad, Amina; Shaker, Hussien; Shendy, Wael; Fahmy, Manal

2015-07-01

[Purpose] This study investigated the effect of shoulder girdle strengthening, particularly the scapular muscles, on poststroke trunk alignment. [Subjects and Methods] The study involved 30 patients with residual hemiparesis following cerebrovascular stroke. Patient assessment included measuring shoulder muscle peak torque, scapular muscles peak force, spinal lateral deviation angle, and motor functional performance. Patients were randomly allocated either to the control group or the study group and received an 18-session strengthening program including active resisted exercises for shoulder abductors and external rotators in addition to trunk control exercises. The study group received additional strengthening exercises for the scapular muscles. [Results] The two groups showed significant improvement in strength of all shoulder and scapular muscles, with higher improvement in the study group. Similarly, the lateral spinal deviation angles significantly improved in both groups, with significantly higher improvement in the study group. Transfer activity, sitting balance, upper limb functions, and hand movements significantly improved in the two groups, with higher improvement in the latter two functions in the study group. [Conclusion] Strengthening of shoulder girdle muscles, particularly scapular muscles, can significantly contribute to improving the postural alignment of the trunk in patients with poststroke hemiparesis.

Functional Outcomes of Persons Undergoing Dysvascular Lower Extremity Amputations

PubMed Central

Sauter, Carley N.; Pezzin, Liliana E.; Dillingham, Timothy R.

2012-01-01

Objective To examine the effect of post-acute rehabilitation setting on functional outcomes among patients undergoing major lower extremity dysvascular amputations. Design A population-based, prospective cohort study conducted in Maryland and Wisconsin. Data collected from medical records and patient interviews conducted during acute hospitalization following amputation and at six-month following the acute care discharge were analyzed using multivariate models and instrumental variable techniques. Results A total of 297 patients were analyzed based on post-acute care rehabilitation setting: acute inpatient rehabilitation (IRF), skilled nursing facility (SNF) or home. The majority (43.4%) received care in IRF, 32% in SNF, and 24.6% at home. On SF-36 subscales, significantly improved outcomes were observed for patients receiving post-acute care at an IRF relative to those cared for at a SNF in physical function (PF), role physical (RF) and physical component score (PCS). Patients receiving post-acute care in IRFs also experienced better RF and PCS outcomes compared to those discharged directly home. In addition, patients receiving post-acute care at an IRF were significantly more likely to score in the top quartile for general health in IRF compared to SNF or home, and less likely to score in the lowest quartile for PF, RF and PCS in IRF compared to SNF. Lower ADL impairment was observed in IRF compared to SNF. Conclusions Among this large and diverse cohort of patients undergoing major dysvascular lower limb amputations, receipt of interdisciplinary rehabilitation services at an IRF yielded improved functional outcomes six months after amputation relative to care received at SNFs or home. PMID:23291599

Pilot study of nelarabine in combination with intensive chemotherapy in high-risk T-cell acute lymphoblastic leukemia: a report from the Children's Oncology Group.

PubMed

Dunsmore, Kimberly P; Devidas, Meenakshi; Linda, Stephen B; Borowitz, Michael J; Winick, Naomi; Hunger, Stephen P; Carroll, William L; Camitta, Bruce M

2012-08-01

Children's Oncology Group study AALL00P2 was designed to assess the feasibility and safety of adding nelarabine to a BFM 86-based chemotherapy regimen in children with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL). In stage one of the study, eight patients with a slow early response (SER) by prednisone poor response (PPR; ≥ 1,000 peripheral blood blasts on day 8 of prednisone prephase) received chemotherapy plus six courses of nelarabine 400 mg/m(2) once per day; four patients with SER by high minimal residual disease (MRD; ≥ 1% at day 36 of induction) received chemotherapy plus five courses of nelarabine; 16 patients with a rapid early response (RER) received chemotherapy without nelarabine. In stage two, all patients received six 5-day courses of nelarabine at 650 mg/m(2) once per day (10 SER patients [one by MRD, nine by PPR]) or 400 mg/m(2) once per day (38 RER patients; 12 SER patients [three by MRD, nine by PPR]). The only significant difference in toxicities was decreased neutropenic infections in patients treated with nelarabine (42% with v 81% without nelarabine). Five-year event-free survival (EFS) rates were 73% for 11 stage one SER patients and 67% for 22 stage two SER patients treated with nelarabine versus 69% for 16 stage one RER patients treated without nelarabine and 74% for 38 stage two RER patients treated with nelarabine. Five-year EFS for all patients receiving nelarabine (n = 70) was 73% versus 69% for those treated without nelarabine (n = 16). Addition of nelarabine to a BFM 86-based chemotherapy regimen was well tolerated and produced encouraging results in pediatric patients with T-ALL, particularly those with a SER, who have historically fared poorly.

Influence of etanercept on leptin and ghrelin secretion in children with juvenile idiopathic arthritis.

PubMed

Maciejewska-Paszek, Izabela; Grochowska-Niedworok, Elżbieta; Siwiec, Andrzej; Gruenpeter, Anna; Dul, Lechosław; Irzyniec, Tomasz

2017-04-01

Objective To assess possible changes in leptin and ghrelin secretion due to etanercept in juvenile idiopathic arthritis (JIA). Methods 50 patients with JIA and 16 age-matched controls were enrolled into this prospective, cross-sectional study. Serum leptin, total and acyl ghrelin were measured in addition to white blood cell (WBC) and lymphocyte counts. Results 25 patients received etanercept and 25 conventional therapies (including methotrexate) for JIA. There was no difference between treatment and control groups in leptin or ghrelin levels and no evidence of a relationship between leptin and ghrelin in patients with JIA. In all children with JIA there was a correlation between leptin and body mass index (BMI). However, compared with children in the conventional treatment group, children in the etanercept group showed a positive correlation between total ghrelin and BMI and those with a low BMI showed a negative correlation between acyl ghrelin and BMI. Conclusion No differences in leptin and ghrelin concentrations were found when patients with JIA and controls were compared or when patients who received etanercept were compared with those who received conventional treatment for JIA.

Influence of etanercept on leptin and ghrelin secretion in children with juvenile idiopathic arthritis

PubMed Central

Maciejewska-Paszek, Izabela; Grochowska-Niedworok, Elżbieta; Siwiec, Andrzej; Gruenpeter, Anna; Dul, Lechosław

2017-01-01

Objective To assess possible changes in leptin and ghrelin secretion due to etanercept in juvenile idiopathic arthritis (JIA). Methods 50 patients with JIA and 16 age-matched controls were enrolled into this prospective, cross-sectional study. Serum leptin, total and acyl ghrelin were measured in addition to white blood cell (WBC) and lymphocyte counts. Results 25 patients received etanercept and 25 conventional therapies (including methotrexate) for JIA. There was no difference between treatment and control groups in leptin or ghrelin levels and no evidence of a relationship between leptin and ghrelin in patients with JIA. In all children with JIA there was a correlation between leptin and body mass index (BMI). However, compared with children in the conventional treatment group, children in the etanercept group showed a positive correlation between total ghrelin and BMI and those with a low BMI showed a negative correlation between acyl ghrelin and BMI. Conclusion No differences in leptin and ghrelin concentrations were found when patients with JIA and controls were compared or when patients who received etanercept were compared with those who received conventional treatment for JIA. PMID:28415953

Replacing Phosphorus-Containing Food Additives With Foods Without Additives Reduces Phosphatemia in End-Stage Renal Disease Patients: A Randomized Clinical Trial.

PubMed

de Fornasari, Margareth Lage Leite; Dos Santos Sens, Yvoty Alves

2017-03-01

The purpose of the study was to verify the effects of replacing phosphorus-containing food additives with foods without additives on phosphatemia in end-stage renal disease (ESRD) patients. Randomized clinical trial. Adult patients on hemodialysis for ≥6 months at a single center. A total of 134 patients with phosphorus levels of >5.5 mg/dL were included and were randomized into an intervention group (n = 67) and a control group (n = 67). The IG received individual orientation to replace processed foods that have phosphorus additives with foods of similar nutritional value without these additives. The CG received only the nutritional orientation given before the study. Clinical laboratory data, nutritional status, energy and protein intake, and normalized protein nitrogen appearance (nPNA) were evaluated at the beginning of the study and after 90 days. There was no initial difference between the groups in terms of serum phosphorus levels, nutritional status, and energy intake. After 3 months, there was a decline in phosphorus levels in the IG (from 7.2 ± 1.4 to 5.0 ± 1.3 mg/dL, P < .001), but there was no significant difference in the CG (from 7.1 ± 1.2 to 6.7 ± 1.2 mg/dL, P = .65). In the IG, 69.7% of the patients reached the serum phosphorus target of ≤5.5 mg/dL; however, only 18.5% of the CG subjects reached this level (P < .001). At the end, there was no difference between the two groups in terms of nutritional status, energy intake, protein intake, and nPNA. The replacing phosphorus-containing food additives with foods without additives reduced serum phosphorus without interfering in the nutritional status of ESRD patients. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Bifocal Intracranial Germinoma: A Retrospective Analysis of Treatment Outcomes in 20 Patients and Review of the Literature

DOE Office of Scientific and Technical Information (OSTI.GOV)

Weksberg, David C.; Shibamoto, Yuta; Paulino, Arnold C., E-mail: apaulino@tmhs.org

Purpose: Bifocal germinoma (BFG) is a rare intracranial neoplasm for which the choice of radiation therapy (RT) field is controversial. Some believe that BFG represents disseminated disease requiring craniospinal irradiation (CSI), whereas others believe that BFG represents localized disease and advocate for more limited fields. Methods and Materials: We analyzed 20 BFG patients at our institutions with classic bifocal lesions (pineal gland and suprasellar region). In addition, we identified 60 BFG patients from the literature. The RT fields, use of chemotherapy and extent of disease were recorded and analyzed for each patient. Results: There were 55 patients with bifocal lesionsmore » only (Group I), and 25 with bifocal lesions plus ventricular and/or CSF positive disease (Group II). The 5-year progression-free survival was 95% for Group I and 80% for Group II. In Group I, there were no failures in patients receiving CSI (n = 11), two spinal failures in those treated with more limited RT fields without chemotherapy (n = 17), and one spinal failure with chemotherapy (n = 23). In Group II, there were no failures in patients receiving CSI (n = 11), but four spinal failures were observed in patients receiving more limited RT fields with chemotherapy (n = 13); 1 patient who received whole-brain RT without chemotherapy experienced failure in the spine and brain. Conclusions: CSI is associated with excellent PFS in BFG. In Group I BFG patients, omission of spinal irradiation appears to be a reasonable approach, especially when chemotherapy is used. Patients with Group II BFG are best treated with CSI.« less

Mobile compression devices and aspirin for VTE prophylaxis following simultaneous bilateral total knee arthroplasty.

PubMed

Nam, Denis; Nunley, Ryan M; Johnson, Staci R; Keeney, James A; Barrack, Robert L

2015-03-01

Recently, Levy et al questioned the effectiveness of mobile compression devices (MCDs) as the sole method of thromboprophylaxis following simultaneous bilateral total knee arthroplasty (TKA). This study's purpose was to assess if the addition of aspirin to MCDs improves venous thromboembolism (VTE) prevention following simultaneous bilateral TKA. Ninety-six patients (192 TKAs) were retrospectively reviewed: 47 patients received MCDs for 10 days and aspirin for 6 weeks postoperatively based on a risk stratification protocol, while 49 patients received warfarin for 4 weeks postoperatively. One symptomatic VTE was noted in the warfarin cohort, while one patient in the MCD/aspirin cohort and three patients in the warfarin cohort were readmitted within 3 months of surgery. In appropriately selected patients, MCDs with aspirin shows promise in VTE prevention following simultaneous bilateral TKA. Copyright © 2014 Elsevier Inc. All rights reserved.

Adenoid cystic salivary gland carcinoma: treatment with irradiation and surgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Simpson, J.R.; Thawley, S.E.; Matsuba, H.M.

1984-05-01

The recrods of 71 patients with adenoid cystic carcinoma of the salivary glands were reviewed to determine the dose response relationships for this aggressive tumor. Local control after treament was determined for all patients and analyzed with respect to extent of surgery and dose of radiation. Of 70 patients who were available for evaluation of local control, 28 (40%) had a local recurrence and 42 (60%) did not. The highest control rates were found in patients who underwent both radiation therapy and surgery. Patients who received a dose equal to or greater than 6,000 rad (60 Gy) in addition tomore » surgery had significantly higher local control rates than those who received less than 6,000 rad (60 Gy). Distant metastases developed in 50% of patients regardless of local control, with the following distribution: 39% lung, 19% bone, and 10% disseminated soft-tissue metastases.« less

The addition of tramadol as a second opioid may improve pain relief in severe osteoarthritis: a prospective study.

PubMed

Di Lorenzo, Luigi; Foti, Calogero; Forte, Alfonso Maria; Palmieri, Enzo; Formisano, Rita; Vatakencherry, Abraham; Pappagallo, Marco

2010-01-01

Opioid combination has been shown to reduce the need for escalating doses for the treatment of cancer pain. A prospective study was planned to evaluate the addition of tramadol to a stronger opioid for the treatment of severe pain as a result of osteoarthritis, previously uncontrolled by non-opioid analgesics or weak opioids. All subjects received tramadol 200 mg and tizanidine 2 mg. At 2 weeks, tramadol was discontinued for patients still reporting poor pain relief (effectiveness ≤50%), and a stronger opioid was titrated to a morphine equivalent amount (MEA) of 40-60 mg orally. After two additional weeks, patients were then divided into two groups: the Strong Opioid Group (SO) and the Tramadol plus the Strong Opioid Group (TSO). The SO group was allowed to escalate opioid dose for lack of effectiveness; the TSO group received tramadol 150 mg daily, thereafter additional strong opioid titration was allowed. A total of 74 patients were studied: SO (n = 40) and TSOG (n = 34). All patients eventually achieved pain relief quality, with both groups reporting similar Karnofsky Performance Scale effectiveness. The SO group achieved satisfactory pain relief (>50%) at an average daily oral MEA of 120 mg. TSO subjects achieved satisfactory pain relief (>50%) at an average daily oral MEA of 95 mg. The addition of tramadol provided a synergistic effect resulting in a 30-mg decrease in necessary morphine equivalents with fewer opioid-related adverse effects. © 2010 The Authors. Pain Practice © 2010 World Institute of Pain.

Impact of high- versus low-dose neuromuscular blocking agent administration on unplanned 30-day readmission rates in retroperitoneal laparoscopic surgery.

PubMed

Boon, Martijn; Martini, Chris; Yang, H Keri; Sen, Shuvayu S; Bevers, Rob; Warlé, Michiel; Aarts, Leon; Niesters, Marieke; Dahan, Albert

2018-01-01

Recent data shows that a neuromuscular block (NMB) induced by administration of high doses of rocuronium improves surgical conditions in certain procedures. However, there are limited data on the effect such practices on postoperative outcomes. We performed a retrospective analysis to compare unplanned 30-day readmissions in patients that received high-dose versus low-dose rocuronium administration during general anesthesia for laparoscopic retroperitoneal surgery. This retrospective cohort study was performed in the Netherlands in an academic hospital where routine high-dose rocuronium NMB has been practiced since July 2015. Charts of patients receiving anesthesia between January 2014 and December 2016 were searched for surgical cases receiving high-dose rocuronium and matched with respect to procedure, age, sex and ASA classification to patients receiving low-dose rocuronium. The primary post-operative outcome was unplanned 30-day readmission rate. There were 130 patients in each cohort. Patients in the high- and low-dose rocuronium cohorts received 217 ± 49 versus 37 ± 5 mg rocuronium, respectively. In the high-dose rocuronium group neuromuscular activity was consistently monitored; matched patients were unreliably monitored. All patients receiving high-dose rocuronium were reversed with sugammadex, while just 33% of matched patients were reversed with sugammadex and 20% with neostigmine; the remaining patients were not reversed. Unplanned 30-day readmission rate was significantly lower in the high-dose compared to the low-dose rocuronium cohort (3.8% vs. 12.7%; p = 0.03; odds ratio = 0.33, 95% C.I. 0.12-0.95). This small retrospective study demonstrates a lower incidence of unplanned readmissions within 30-days following laparoscopic retroperitoneal surgery with high-dose relaxant anesthesia and sugammadex reversal in comparison to low-dose relaxant anesthesia. Further prospective studies are needed in larger samples to corroborate our findings and additionally assess the pharmacoeconomics of high-dose relaxant anesthesia taking into account the benefits (reduced readmissions) and harm (cost of relaxants and reversal agents) of such practice.

Usual Course of Treatment and Predictors of Treatment Utilization for Patients With Posttraumatic Stress Disorder.

PubMed

Nobles, Carrie J; Valentine, Sarah E; Zepeda, E David; Ahles, Emily M; Shtasel, Derri L; Marques, Luana

2017-05-01

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric illness that frequently remains undiagnosed and untreated. While extensive research has been conducted among veterans, little research has evaluated course of treatment for PTSD in a general hospital setting. We utilized data from the Partners HealthCare Research Patient Data Registry to evaluate mental health treatment utilization, including psychotherapy and pharmacotherapy, by patients with recently diagnosed primary PTSD following DSM-IV criteria between January 1, 2002, and June 30, 2011. We additionally evaluated predictors of treatment utilization 6 months postdiagnosis. Among 2,475 patients with recently diagnosed primary PTSD, approximately half (55.7%) had any therapy visit and 10% had at least 12 therapy visits in the 6 months following diagnosis. Approximately half (47.0%) received a psychiatric prescription, with 29.3% receiving a selective serotonin reuptake inhibitor (SSRI), 11.8% receiving an atypical antipsychotic, and 24.4% receiving a benzodiazepine. Latinos were 25% (95% CL = 1.09, 1.43) more likely to have an SSRI prescription, 35% (95% CL = 1.05, 1.75) more likely to have an atypical antipsychotic prescription, and 28% (95% CL = 1.19, 1.38) more likely to receive any psychotherapy. Women were 49% (95% CL = 0.42, 0.63) less likely to have an atypical antipsychotic prescription. Patients with Medicare were 23% (95% CL = 0.67, 0.88) less likely to have any psychotherapy, and patients with Medicaid were 35% (95% CL = 0.46, 0.92) less likely to have 12 or more therapy visits. Many patients with a primary diagnosis of PTSD do not receive psychotherapy, and psychiatric prescriptions, including atypical antipsychotics and benzodiazepines, are common. Future research is needed to determine the quality of care received and explore subpopulation-specific barriers limiting access to care. © Copyright 2017 Physicians Postgraduate Press, Inc.

The addition of low-dose-rate brachytherapy and androgen-deprivation therapy decreases biochemical failure and prostate cancer death compared with dose-escalated external-beam radiation therapy for high-risk prostate cancer.

PubMed

Shilkrut, Mark; Merrick, Gregory S; McLaughlin, P William; Stenmark, Matthew H; Abu-Isa, Eyad; Vance, Sean M; Sandler, Howard M; Feng, Felix Y; Hamstra, Daniel A

2013-02-01

The objective of this study was to determine whether the addition of low-dose-rate brachytherapy or androgen-deprivation therapy (ADT) improves clinical outcome in patients with high-risk prostate cancer (HiRPCa) who received dose-escalated radiotherapy (RT). Between 1995 and 2010, 958 patients with HiRPCa were treated at Schiffler Cancer Center (n = 484) or at the University of Michigan (n = 474) by receiving either dose-escalated external-beam RT (EBRT) (n = 510; minimum prescription dose, 75 grays [Gy]; median dose, 78 Gy) or combined-modality RT (CMRT) consisting of (103) Pd implants (n = 369) or (125) I implants (n = 79) both with pelvic irradiation (median prescription dose, 45 Gy). The cumulative incidences of biochemical failure (BF) and prostate cancer-specific mortality (PCSM) were estimated by using the Kaplan-Meier method and Fine and Gray regression analysis. The median follow-up was 63.2 months (interquartile range, 35.4-99.0 months), and 250 patients were followed for >8 years. Compared with CMRT, patients who received EBRT had higher prostate-specific antigen levels, higher tumor classification, lower Gleason sum, and more frequent receipt of ADT for a longer duration. The 8-year incidence BF and PCSM among patients who received EBRT was 40% (standard error, 38%-44%) and 13% (standard error, 11%-15%) compared with 14% (standard error, 12%-16%; P < .0001) and 7% (standard error 6%-9%; P = .003) among patients who received CMRT. On multivariate analysis, the hazard ratios (HRs) for BF and PCSM were 0.35 (95% confidence interval [CI], 0.23-0.52; P < .0001) and 0.41 (95% CI, 0.23-0.75; P < .003), favoring CMRT. Increasing duration of ADT predicted decreased BF (P = .04) and PCSM (P = .001), which was greatest with long-term ADT (BF: HR, 0.33; P < .0001; 95% CI, 0.21-0.52; PCSM: HR, 0.30; P = .001; 95% CI, 0.15-0.6) even in the subgroup that received CMRT. In this retrospective comparison, both low-dose-rate brachytherapy boost and ADT were associated with decreased risks of BF and PCSM compared with EBRT. Copyright © 2012 American Cancer Society.

Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: A randomized controlled open-label trial

PubMed Central

Adenis, A.; Blay, J.-Y.; Bui-Nguyen, B.; Bouché, O.; Bertucci, F.; Isambert, N.; Bompas, E.; Chaigneau, L.; Domont, J.; Ray-Coquard, I.; Blésius, A.; Van Tine, B. A.; Bulusu, V. R.; Dubreuil, P.; Mansfield, C. D.; Acin, Y.; Moussy, A.; Hermine, O.; Le Cesne, A.

2014-01-01

Background Masitinib is a highly selective tyrosine kinase inhibitor with activity against the main oncogenic drivers of gastrointestinal stromal tumor (GIST). Masitinib was evaluated in patients with advanced GIST after imatinib failure or intolerance. Patients and methods Prospective, multicenter, randomized, open-label trial. Patients with inoperable, advanced imatinib-resistant GIST were randomized (1 : 1) to receive masitinib (12 mg/kg/day) or sunitinib (50 mg/day 4-weeks-on/2-weeks-off) until progression, intolerance, or refusal. Primary efficacy analysis was noncomparative, testing whether masitinib attained a median progression-free survival (PFS) (blind centrally reviewed RECIST) threshold of >3 months according to the lower bound of the 90% unilateral confidence interval (CI). Secondary analyses on overall survival (OS) and PFS were comparative with results presented according to a two-sided 95% CI. Results Forty-four patients were randomized to receive masitinib (n = 23) or sunitinib (n = 21). Median follow-up was 14 months. Patients receiving masitinib experienced less toxicity than those receiving sunitinib, with significantly lower occurrence of severe adverse events (52% versus 91%, respectively, P = 0.008). Median PFS (central RECIST) for the noncomparative primary analysis in the masitinib treatment arm was 3.71 months (90% CI 3.65). Secondary analyses showed that median OS was significantly longer for patients receiving masitinib followed by post-progression addition of sunitinib when compared against patients treated directly with sunitinib in second-line [hazard ratio (HR) = 0.27, 95% CI 0.09–0.85, P = 0.016]. This improvement was sustainable as evidenced by 26-month follow-up OS data (HR = 0.40, 95% CI 0.16–0.96, P = 0.033); an additional 12.4 months survival advantage being reported for the masitinib treatment arm. Risk of progression while under treatment with masitinib was in the same range as for sunitinib (HR = 1.1, 95% CI 0.6–2.2, P = 0.833). Conclusions Primary efficacy analysis ensured the masitinib treatment arm could satisfy a prespecified PFS threshold. Secondary efficacy analysis showed that masitinib followed by the standard of care generated a statistically significant survival benefit over standard of care. Encouraging median OS and safety data from this well-controlled and appropriately designed randomized trial indicate a positive benefit–risk ratio. Further development of masitinib in imatinib-resistant/intolerant patients with advanced GIST is warranted. PMID:25122671

Influence of concomitant prednisolone on trimethoprim-associated hyperkalaemia.

PubMed

Mohan, Sumit; Jaitly, Manasvi; Pogue, Velvie A; Cheng, Jen-Tse

2009-10-01

Trimethoprim-sulfamethoxazole may cause hyperkalaemia by the amiloride-like effect of trimethoprim on sodium channels in the distal nephron. Hyperkalaemia usually occurs after 7-10 days and has been reported in 20%-50% of patients receiving trimethoprim-sulfamethoxazole. Patients with Pneumocystis jiroveci pneumonia and severe hypoxaemia benefit from the use of prednisolone as an adjuvant to trimethoprim-sulfamethoxazole. The addition of prednisolone may lower the incidence of trimethoprim-related hyperkalaemia due, in part, to its mineralocorticoid activity. We studied the effect of concomitant prednisolone on trimethoprim-related hyperkalaemia. Thirty patients qualified for inclusion and were reviewed. Patients were divided into two groups: one group received trimethoprim-sulfamethoxazole plus prednisolone (18 patients); and the other group received trimethoprim-sulfamethoxazole alone (12 patients). The two groups were comparable at baseline, except for the severity of the P. jiroveci pneumonia. Hyperkalaemia developed in seven patients: all in the prednisolone and trimethoprim-sulfamethoxazole group. The greater incidence of hyperkalaemia in this group is surprising and was counter to our expectation. Although it is possible that there is an unexplained interaction between trimethoprim and prednisolone, we postulate that our observation is a result of the catabolic effect of prednisolone. The patients treated with trimethoprim-sulfamethoxazole plus prednisolone appear to be more likely to develop hyperkalaemia than patients treated with trimethoprim-sulfamethoxazole alone.

Comparison of Downstream Health Care Utilization, Costs, and Long-Term Opioid Use: Physical Therapist Management Versus Opioid Therapy Management After Arthroscopic Hip Surgery.

PubMed

Rhon, Daniel I; Snodgrass, Suzanne J; Cleland, Joshua A; Greenlee, Tina A; Sissel, Charles D; Cook, Chad E

2018-05-01

Physical therapy and opioid prescriptions are common after hip surgery, but are sometimes delayed or not used. The objective of this study was to compare downstream health care utilization and opioid use following hip surgery for different patterns of physical therapy and prescription opioids. The design of this study was an observational cohort. Health care utilization was abstracted from the Military Health System Data Repository for patients who were 18 to 50 years old and were undergoing arthroscopic hip surgery between 2004 and 2013. Patients were grouped into those receiving an isolated treatment (only opioids or only physical therapy) and those receiving both treatments on the basis of timing (opioid first or physical therapy first). Outcomes included overall health care visits and costs, hip-related visits and costs, additional surgeries, and opioid prescriptions. Of 1870 total patients, 82.7% (n = 1546) received physical therapy only, 71.6% (n = 1339) received prescription opioids, and 1073 (56.1%) received both physical therapy and opioids. Because 24 patients received both opioids and physical therapy on the same day, they were eventually removed the final timing-of-care analysis. Adjusted hip-related mean costs were the same in both groups receiving isolated treatments (${\\$}$11,628 vs ${\\$}$11,579), but the group receiving only physical therapy had significantly lower overall total health care mean costs (${\\$}$18,185 vs ${\\$}$23,842) and fewer patients requiring another hip surgery. For patients receiving both treatments, mean hip-related downstream costs were significantly higher in the group receiving opioids first than in the group receiving physical therapy first (${\\$}$18,806 vs ${\\$}$16,955) and resulted in greater opioid use (7.83 vs 4.14 prescriptions), greater total days' supply of opioids (90.17 vs 44.30 days), and a higher percentage of patients with chronic opioid use (69.5% vs 53.2%). Claims data were limited by the accuracy of coding, and observational data limit inferences of causality. Physical therapy first was associated with lower hip-related downstream costs and lower opioid use than opioids first; physical therapy instead of opioids was associated with less total downstream health care utilization. These results need to be validated in prospective controlled trials.

Vitamin K status in patients with short bowel syndrome.

PubMed

Krzyżanowska, Patrycja; Książyk, Janusz; Kocielińska-Kłos, Małgorzata; Banaś, Elżbieta; Kaleta, Małgorzata; Popińska, Katarzyna; Szczapa, Tomasz; Walkowiak, Jarosław

2012-12-01

Available evidence suggests that patients with short bowel syndrome (SBS) might be at risk of vitamins A, D, E and B(1) deficiency. However, there is little clinical data describing the vitamin K status. Therefore, in the present study we aimed to assess the body resources of vitamin K in a subset of SBS patients. The study comprised 33 patients aged 1 month to 16 years. PIVKA-II concentrations were determined in all subjects. In all studied subjects, coagulation parameters were normal. PIVKA-II levels indicative of vitamin K deficiency was found in 3 (9.1%) SBS patients. One patient had been receiving an additional intravenous vitamin K dose of 5 mg/week. In all SBS patients with cirrhosis and cholestasis, PIVKA-II concentrations were low (<2 ng/ml). However, all patients with severe liver disease were receiving vitamin K several times a month. Vitamin K deficiency may appear in SBS patients. Copyright © 2012. Published by Elsevier Ltd.

The Influence of Various Parameters on the Success of Sensor-Controlled Scalp Cooling in Preventing Chemotherapy-Induced Alopecia.

PubMed

Schaffrin-Nabe, Dörthe; Schmitz, Inge; Josten-Nabe, Anke; von Hehn, Ulrike; Voigtmann, Rudolf

2015-01-01

The influence of systemic comorbidities on the success of scalp cooling during chemotherapy (CT) is widely unexplored. Comorbidities often require additional medication which itself can occasionally cause alopecia. This study investigates the influence of selected parameters on the efficacy of scalp cooling for the prevention of CT-induced alopecia. 226 cancer patients were treated with various CT regimens in combination with sensor-controlled scalp cooling. 136 breast cancer patients received (neo)adjuvant therapy, and 76 of these patients received epirubicine and cyclophosphamide (4× EC 3w) followed by paclitaxel (12× T w). The following parameters were prospectively investigated: chemotherapy-induced alopecia, systemic comorbidities and co-medication, nicotine abuse, hair treatment, menopausal status, and trichologic status. Scalp cooling was successful (no or not visible hair loss; common toxicity criteria 0-1) in 65% of all patients, in 65% of the 136 breast cancer patients, and in 68% of the 76 patients receiving EC/T. In this subgroup, premenopausal patients (p = 0.009) and those without systemic comorbidities (p = 0.003), without co-medication (p < 0.001) and with high hair density (p = 0.038) showed less hair loss during CT; an effect was also seen for nicotine abuse (p = 0.023). Hair length and hair treatment had no significant influence. Sensor-controlled scalp cooling represents an effective addition to supportive cancer therapy. The success of scalp cooling depends on the applied CT regimen. Parameters like menopausal status, systemic comorbidities, medication, nicotine abuse, and original hair density also influence the outcome of hair loss prevention. © 2015 S. Karger GmbH, Freiburg.

Peripheral nerve blocks in shoulder arthroplasty: how do they influence complications and length of stay?

PubMed

Stundner, Ottokar; Rasul, Rehana; Chiu, Ya-Lin; Sun, Xuming; Mazumdar, Madhu; Brummett, Chad M; Ortmaier, Reinhold; Memtsoudis, Stavros G

2014-05-01

Regional anesthesia has proven to be a highly effective technique for pain control after total shoulder arthroplasty. However, concerns have been raised about the safety of upper-extremity nerve blocks, particularly with respect to the incidence of perioperative respiratory and neurologic complications, and little is known about their influence, if any, on length of stay after surgery. Using a large national cohort, we asked: (1) How frequently are upper-extremity peripheral nerve blocks added to general anesthesia in patients undergoing total shoulder arthroplasty? (2) Are there differences in the incidence of and adjusted risk for major perioperative complications and mortality between patients receiving general anesthesia with and without nerve blocks? And (3) does resource utilization (blood product transfusion, intensive care unit admission, length of stay) differ between groups? We searched a nationwide discharge database for patients undergoing total shoulder arthroplasty under general anesthesia with or without addition of a nerve block. Groups were compared with regard to demographics, comorbidities, major perioperative complications, and length of stay. Multivariable logistic regressions were performed to measure complications and resource use. A negative binomial regression was fitted to measure length of stay. We identified 17,157 patients who underwent total shoulder arthroplasty between 2007 and 2011. Of those, approximately 21% received an upper-extremity peripheral nerve block in addition to general anesthesia. Patients receiving combined regional-general anesthesia had similar mean age (68.6 years [95% CI: 68.2-68.9 years] versus 69.1 years [95% CI: 68.9-69.3 years], p < 0.0043), a slightly lower mean Deyo (comorbidity) index (0.87 versus 0.93, p = 0.0052), and similar prevalence of individual comorbidities, compared to those patients receiving general anesthesia only. Addition of regional anesthesia was not associated with different odds ratios for complications, transfusion, and intensive care unit admission. Incident rates for length of stay were also similar between groups (incident rate ratio = 0.99; 95% CI: 0.97-1.02; p = 0.467) CONCLUSIONS: Addition of regional to general anesthesia was not associated with an increased complication profile or increased use of resources. In combination with improved pain control as known from previous research, regional anesthesia may represent a viable management option for shoulder arthroplasty. However, further research is necessary to better clarify the risk of neurologic complications. Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

Chemotherapy rechallenge after regorafenib treatment in metastatic colorectal cancer: still hope after the last hope?

PubMed

Bertocchi, Paola; Aroldi, Francesca; Prochilo, Tiziana; Meriggi, Fausto; Beretta, Giordano Domenico; Zaniboni, Alberto

2017-04-01

The introduction of biological agents in cancer therapy is changing the progression of metastatic colorectal cancer. Currently, resistance to biological agents is an emerging problem; the progression of the disease is caused by the development of resistant clones. According to some authors, these clones can be re-sensitized to traditional and previously utilized chemotherapy agents. The results of the CORRECT study demonstrated the efficacy of regorafenib monotherapy in both KRAS wild type and mutant pretreated patients (pts). Two recent reports showed the potential of reintroduction of chemotherapy, even after treatment with regorafenib. We performed a retrospective review of clinical data from patients treated with regorafenib at our institution between March 2012 and March 2013. We analysed patient characteristics, KRAS/NRAS status, response to treatment (evaluated by RECIST v1.1 criteria) and survival. Regorafenib was administered to 128 patients, and 11 (8.6%) received post-regorafenib therapy (to our knowledge). Seven (63.6%) patients were wild type for KRAS/NRAS. Post-regorafenib therapy represented for all the patients at least the fourth line: all the pts received both oxaliplatin- and irinotecan-based chemotherapy, all of them were treated with bevacizumab, and 7 patients also received cetuximab. Eight patients (72.7%) were treated with standard chemotherapy after regorafenib (irinotecan monotherapy, capecitabine plus oxaliplatin or irinotecan, dacarbazine or raltitrexed), while 3 patients received an experimental therapy (clinical trial). Nine of the 11 (81.8%) patients had PD and 2 patients had SD. The median progression-free survival was 1.6+ months (range 0.5-3.5), the median OS post-regorafenib was 2.1+ months (range 0.5-10.2) and the 6-month OS was 27.3%. Our retrospective analysis showed that after regorafenib therapy, re-introduction of chemotherapy is possible. Unfortunately, we reported a high percentage of disease progression beyond regorafenib, which is likely due to the high percentage of heavily pretreated patients (some received four or five types of therapy before regorafenib). We think that regorafenib could represent a chemotherapy resensitizing agent; however, additional studies are needed in patients who have received less pretreatment.

Small-dose hypobaric lidocaine-fentanyl spinal anesthesia for short duration outpatient laparoscopy. I. A randomized comparison with conventional dose hyperbaric lidocaine.

PubMed

Vaghadia, H; McLeod, D H; Mitchell, G W; Merrick, P M; Chilvers, C R

1997-01-01

A randomized, single-blind trial of two spinal anesthetic solutions for outpatient laparoscopy was conducted to compare intraoperative conditions and postoperative recovery. Thirty women (ASA physical status I and II) were assigned to one of two groups. Group I patients received a small-dose hypobaric solution of 1% lidocaine 25 mg made up to 3 mL by the addition of fentanyl 25 micrograms. Group II patients received a conventional-dose hyperbaric solution of 5% lidocaine 75 mg (in 7.5% dextrose) made up to 3 mL by the addition of 1.5 mL 10% dextrose. All patients received 500 mL of crystalloid preloading. Spinal anesthesia was performed at L2-3 or L3-4 with a 27-gauge Quincke point needle. Surgery commenced when the level of sensory anesthesia reached T-6. Intraoperative hypotension requiring treatment with ephedrine occurred in 54% of Group II patients but not in any Group I patients. Median (range) time for full motor recovery was 50 (0-95) min in Group I patients compared to 90 (50-120) min in Group II patients (P = 0.0005). Sensory recovery also occurred faster in Group I patients (100 +/- 22 min) compared with Group II patients (140 +/- 27 min, P = 0.0001). Postoperative headache occurred in 38% of all patients and 70% of these were postural in nature. Oral analgesia was the only treatment required. Spinal anesthesia did not result in a significant incidence of postoperative backache. On follow-up, 96% said they found spinal needle insertion acceptable, 93% found surgery comfortable, and 90% said they would request spinal anesthesia for laparoscopy in future. Overall, this study found spinal anesthesia for outpatient laparoscopy to have high patient acceptance and a comparable complication rate to other studies. The small-dose hypobaric lidocaine-fentanyl technique has advantages over conventional-dose hyperbaric lidocaine of no hypotension and faster recovery.

Safety of a Brief Emergency Department Observation Protocol for Patients With Presumed Fentanyl Overdose.

PubMed

Scheuermeyer, Frank X; DeWitt, Christopher; Christenson, Jim; Grunau, Brian; Kestler, Andrew; Grafstein, Eric; Buxton, Jane; Barbic, David; Milanovic, Stefan; Torkjari, Reza; Sahota, Indy; Innes, Grant

2018-03-09

Fentanyl overdoses are increasing and few data guide emergency department (ED) management. We evaluate the safety of an ED protocol for patients with presumed fentanyl overdose. At an urban ED, we used administrative data and explicit chart review to identify and describe consecutive patients with uncomplicated presumed fentanyl overdose (no concurrent acute medical issues) from September to December 2016. We linked regional ED and provincial vital statistics databases to ascertain admissions, revisits, and mortality. Primary outcome was a composite of admission and death within 24 hours. Other outcomes included treatment with additional ED naloxone, development of a new medical issue while in the ED, and length of stay. A prespecified subgroup analysis assessed low-risk patients with normal triage vital signs. There were 1,009 uncomplicated presumed fentanyl overdose, mainly by injection. Median age was 34 years, 85% were men, and 82% received out-of-hospital naloxone. One patient was hospitalized and one discharged patient died within 24 hours (combined outcome 0.2%; 95% confidence interval [CI] 0.04% to 0.8%). Sixteen patients received additional ED naloxone (1.6%; 95% CI 1.0% to 2.6%), none developed a new medical issue (0%; 95% CI 0% to 0.5%), and median length of stay was 173 minutes (interquartile range 101 to 267). For 752 low-risk patients, no patients were admitted or developed a new issue, and one died postdischarge; 3 (0.4%; 95% CI 0.01% to 1.3%) received ED naloxone. In our cohort of ED patients with uncomplicated presumed fentanyl overdose-typically after injection-deterioration, admission, mortality, and postdischarge complications appear low; the majority can be discharged after brief observation. Patients with normal triage vital signs are unlikely to require ED naloxone. Copyright © 2018 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Warm fresh whole blood and thoracic traumain iraq and afghanistan.

PubMed

Keneally, Ryan J; Parsons, Andrew M; Willett, Peter B

2015-01-01

Thoracic trauma occurred in 10% of the patients seen at US military treatment facilities in Iraq and Afghanistan and 52% of those patients were transfused. Among those transfused, 281 patients received warm fresh whole blood. A previous report documented improved survival with warm fresh whole blood in patients injured in combat without stratification by injury pattern. A later report described an increase in acute lung injuries after its administration. Survivorship and warm fresh whole blood have never been analyzed in a subpopulation at highest risk for lung injuries, such as patients with thoracic trauma. There may be a heterogeneous relationship between whole blood and survival based on likelihood of a concomitant pulmonary injury. In this report, the relationship between warm fresh whole blood and survivorship was analyzed among patients at highest risk for concomitant pulmonary injuries. Patients with thoracic trauma who received a transfusion were identified in the Joint Theater Trauma Registry. Gross mortality rates were compared between whole blood recipients and patients transfused with component therapy only. The association between each blood component and mortality was determined in a regression model. The overall mortality risk was compared between warm fresh whole blood recipients and non-recipients. Patients transfused with warm fresh whole blood in addition to component therapy had a higher mortality rate than patients transfused only separated blood components (21.3% vs. 12.8%, P < 0.001). When controlling for covariates, transfusion of warm fresh whole blood in addition to component therapy was not associated with increased mortality risk compared with the transfusion of component therapy only (OR 1.247 [95% CI 0.760-2.048], P = 0.382). Patients with combat related thoracic trauma transfused with warm fresh whole blood were not at increased risk for mortality compared to those who received component therapy alone when controlling for covariates.

Acceptance and commitment therapy as a novel treatment for eating disorders: an initial test of efficacy and mediation.

PubMed

Juarascio, Adrienne; Shaw, Jena; Forman, Evan; Timko, C Alix; Herbert, James; Butryn, Meghan; Bunnell, Douglas; Matteucci, Alyssa; Lowe, Michael

2013-07-01

Eating disorders are among the most challenging disorders to treat, with even state-of-the-art cognitive-behavioral treatments achieving only modest success. One possible reason for the high rate of treatment failure for eating disorders is that existing treatments do not attend sufficiently to critical aspects of the disorder such as high experiential avoidance, poor experiential awareness, and lack of motivation. These variables are explicit targets of Acceptance and Commitment Therapy (ACT). The current study examined the efficacy of an ACT-based group treatment for eating disorders by examining whether the addition of ACT groups to treatment-as-usual (TAU) at a residential treatment facility for eating disorders would improve treatment outcomes. TAU patients received an intensive residential treatment, while ACT patients received these services but additionally attended, depending on diagnosis, either ACT for anorexia nervosa groups or ACT for bulimia nervosa groups. Although individuals in both treatment conditions demonstrated large decreases in eating pathology, there were trends toward larger decreases among those receiving ACT. ACT patients also showed lower rates of rehospitalization during the 6 months after discharge. Overall, results suggest that ACT is a viable treatment option for individuals with eating pathology and further outcome research is warranted.

Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia.

PubMed

Byrd, John C; Furman, Richard R; Coutre, Steven E; Flinn, Ian W; Burger, Jan A; Blum, Kristie A; Grant, Barbara; Sharman, Jeff P; Coleman, Morton; Wierda, William G; Jones, Jeffrey A; Zhao, Weiqiang; Heerema, Nyla A; Johnson, Amy J; Sukbuntherng, Juthamas; Chang, Betty Y; Clow, Fong; Hedrick, Eric; Buggy, Joseph J; James, Danelle F; O'Brien, Susan

2013-07-04

The treatment of relapsed chronic lymphocytic leukemia (CLL) has resulted in few durable remissions. Bruton's tyrosine kinase (BTK), an essential component of B-cell-receptor signaling, mediates interactions with the tumor microenvironment and promotes the survival and proliferation of CLL cells. We conducted a phase 1b-2 multicenter study to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ibrutinib (PCI-32765), a first-in-class, oral covalent inhibitor of BTK designed for treatment of B-cell cancers, in patients with relapsed or refractory CLL or small lymphocytic lymphoma. A total of 85 patients, the majority of whom were considered to have high-risk disease, received ibrutinib orally once daily; 51 received 420 mg, and 34 received 840 mg. Toxic effects were predominantly grade 1 or 2 and included transient diarrhea, fatigue, and upper respiratory tract infection; thus, patients could receive extended treatment with minimal hematologic toxic effects. The overall response rate was the same in the group that received 420 mg and the group that received 840 mg (71%), and an additional 20% and 15% of patients in the respective groups had a partial response with lymphocytosis. The response was independent of clinical and genomic risk factors present before treatment, including advanced-stage disease, the number of previous therapies, and the 17p13.1 deletion. At 26 months, the estimated progression-free survival rate was 75% and the rate of overall survival was 83%. Ibrutinib was associated with a high frequency of durable remissions in patients with relapsed or refractory CLL and small lymphocytic lymphoma, including patients with high-risk genetic lesions. (Funded by Pharmacyclics and others; ClinicalTrials.gov number, NCT01105247.).

Targeting BTK with Ibrutinib in Relapsed Chronic Lymphocytic Leukemia

PubMed Central

Byrd, John C.; Furman, Richard R.; Coutre, Steven E.; Flinn, Ian W.; Burger, Jan A.; Blum, Kristie A.; Grant, Barbara; Sharman, Jeff P.; Coleman, Morton; Wierda, William G.; Jones, Jeffrey A.; Zhao, Weiqiang; Heerema, Nyla A.; Johnson, Amy J.; Sukbuntherng, Juthamas; Chang, Betty Y.; Clow, Fong; Hedrick, Eric; Buggy, Joseph J.; James, Danelle F.; O'Brien, Susan

2013-01-01

BACKGROUND The treatment of relapsed chronic lymphocytic leukemia (CLL) has resulted in few durable remissions. Bruton's tyrosine kinase (BTK), an essential component of B-cell–receptor signaling, mediates interactions with the tumor microenvironment and promotes the survival and proliferation of CLL cells. METHODS We conducted a phase 1b–2 multicenter study to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ibrutinib (PCI-32765), a first-in-class, oral covalent inhibitor of BTK designed for treatment of B-cell cancers, in patients with relapsed or refractory CLL or small lymphocytic lymphoma. A total of 85 patients, the majority of whom were considered to have high-risk disease, received ibrutinib orally once daily; 51 received 420 mg, and 34 received 840 mg. RESULTS Toxic effects were predominantly grade 1 or 2 and included transient diarrhea, fatigue, and upper respiratory tract infection; thus, patients could receive extended treatment with minimal hematologic toxic effects. The overall response rate was the same in the group that received 420 mg and the group that received 840 mg (71%), and an additional 20% and 15% of patients in the respective groups had a partial response with lymphocytosis. The response was independent of clinical and genomic risk factors present before treatment, including advanced-stage disease, the number of previous therapies, and the 17p13.1 deletion. At 26 months, the estimated progression-free survival rate was 75% and the rate of overall survival was 83%. CONCLUSIONS Ibrutinib was associated with a high frequency of durable remissions in patients with relapsed or refractory CLL and small lymphocytic lymphoma, including patients with high-risk genetic lesions. (Funded by Pharmacyclics and others; ClinicalTrials.gov number, NCT01105247.) PMID:23782158

Natalizumab plus interferon beta-1a reduces lesion formation in relapsing multiple sclerosis.

PubMed

Radue, Ernst-Wilhelm; Stuart, William H; Calabresi, Peter A; Confavreux, Christian; Galetta, Steven L; Rudick, Richard A; Lublin, Fred D; Weinstock-Guttman, Bianca; Wynn, Daniel R; Fisher, Elizabeth; Papadopoulou, Athina; Lynn, Frances; Panzara, Michael A; Sandrock, Alfred W

2010-05-15

The SENTINEL study showed that the addition of natalizumab improved outcomes for patients with relapsing multiple sclerosis (MS) who had experienced disease activity while receiving interferon beta-1a (IFNbeta-1a) alone. Previously unreported secondary and tertiary magnetic resonance imaging (MRI) measures are presented here. Patients received natalizumab 300 mg (n=589) or placebo (n=582) intravenously every 4 weeks plus IFNbeta-1a 30 microg intramuscularly once weekly. Annual MRI scans allowed comparison of a range of MRI end points versus baseline. Over 2 years, 67% of patients receiving natalizumab plus IFNbeta-1a remained free of new or enlarging T2-lesions compared with 30% of patients receiving IFNbeta-1a alone. The mean change from baseline in T2 lesion volume over 2 years decreased in patients receiving natalizumab plus IFNbeta-1a and increased in those receiving IFNbeta-1a alone (-277.5mm(3) versus 525.6mm(3); p<0.001). Compared with IFNbeta-1a alone, add-on natalizumab therapy resulted in a smaller increase in mean T1-hypointense lesion volume after 2 years (1821.3mm(3) versus 2210.5mm(3); p<0.001), a smaller mean number of new T1-hypointense lesions over 2 years (2.3 versus 4.1; p<0.001), and a slower rate of brain atrophy during the second year of therapy (-0.31% versus -0.40%; p=0.020). Natalizumab add-on therapy reduced gadolinium-enhancing, T1-hypointense, and T2 MRI lesion activity and slowed brain atrophy progression in patients with relapsing MS who experienced disease activity despite treatment with IFNbeta-1a alone. Copyright 2010 Elsevier B.V. All rights reserved.

Audiological outcomes of cochlear implantation in Waardenburg Syndrome

PubMed Central

Magalhães, Ana Tereza de Matos; Samuel, Paola Angélica; Goffi-Gomez, Maria Valeria Schimdt; Tsuji, Robinson Koji; Brito, Rubens; Bento, Ricardo Ferreira

2013-01-01

Summary Introduction: The most relevant clinical symptom in Waardenburg syndrome is profound bilateral sensorioneural hearing loss. Aim: To characterize and describe hearing outcomes after cochlear implantation in patients with Waardenburg syndrome to improve preoperative expectations. Method: This was an observational and retrospective study of a series of cases. Children who were diagnosed with Waardenburg syndrome and who received a multichannel cochlear implant between March 1999 and July 2012 were included in the study. Intraoperative neural response telemetry, hearing evaluation, speech perception, and speech production data before and after surgery were assessed. Results: During this period, 806 patients received a cochlear implant and 10 of these (1.2%) were diagnosed with Waardenburg syndrome. Eight of the children received a Nucleus 24® implant and 1 child and 1 adult received a DigiSonic SP implant. The mean age at implantation was 44 months among the children. The average duration of use of a cochlear implant at the time of the study was 43 months. Intraoperative neural responses were present in all cases. Patients who could use the speech processor effectively had a pure tone average of 31 dB in free-field conditions. In addition, the MUSS and MAIS questionnaires revealed improvements in speech perception and production. Four patients did not have a good outcome, which might have been associated with ineffective use of the speech processor. Conclusion: Despite the heterogeneity of the group, patients with Waardenburg syndrome who received cochlear implants were found to have hearing thresholds that allowed access to speech sounds. However, patients who received early intervention and rehabilitation showed better evolution of auditory perception. PMID:25992025

Adding Group Psychotherapy to Medication Treatment in Dysthymia

PubMed Central

Hellerstein, David J.; Little, Suzanne A. S.; Samstag, Lisa Wallner; Batchelder, Sarai; Muran, J. Christopher; Fedak, Michael; Kreditor, David; Rosenthal, Richard N.; Winston, Arnold

2001-01-01

Patients with dysthymia have been shown to respond to treatment with antidepressant medications, and to some degree to psychotherapy. Even patients successfully treated with medication often have residual symptoms and impaired psychosocial functioning. The authors describe a prospective randomized 36-week study of dysthymic patients, comparing continued treatment with antidepressant medication (fluoxetine) alone and medication with the addition of group therapy treatment. After an 8-week trial of fluoxetine, medication-responsive subjects were randomly assigned to receive either continued medication only or medication plus 16 sessions of manualized group psychotherapy. Results provide preliminary evidence that group therapy may provide additional benefit to medication-responding dysthymic patients, particularly in interpersonal and psychosocial functioning. PMID:11264333

Radiation Therapy in the Management of Head-and-Neck Cancer of Unknown Primary Origin: How Does the Addition of Concurrent Chemotherapy Affect the Therapeutic Ratio?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chen, Allen M., E-mail: allen.chen@ucdmc.ucdavis.edu; Farwell, D. Gregory; Lau, Derick H.

2011-10-01

Purpose: To determine how the addition of cisplatin-based concurrent chemotherapy to radiation therapy influences outcomes among a cohort of patients treated for head-and-neck cancer of unknown primary origin. Methods and Materials: The medical records of 60 consecutive patients treated by radiation therapy for squamous cell carcinoma of the head and neck presenting as cervical lymph node metastasis of occult primary origin were reviewed. Thirty-two patients (53%) were treated by concurrent chemoradiation, and 28 patients (47%) were treated by radiation therapy alone. Forty-five patients (75%) received radiation therapy after surgical resection, and 15 patients (25%) received primary radiation therapy. Thirty-five patientsmore » (58%) were treated by intensity-modulated radiotherapy. Results: The 2-year estimates of overall survival, local-regional control, and progression-free survival were 89%, 89%, and 79%, respectively, among patients treated by chemoradiation, compared to 90%, 92%, and 83%, respectively, among patients treated by radiation therapy alone (p > 0.05, for all). Exploratory analysis failed to identify any subset of patients who benefited from the addition of concurrent chemotherapy to radiation therapy. The use of concurrent chemotherapy was associated with a significantly increased incidence of Grade 3+ acute and late toxicity (p < 0.001, for both). Conclusions: Concurrent chemoradiation is associated with significant toxicity without a clear advantage to overall survival, local-regional control, and progression-free survival in the treatment of head-and-neck cancer of unknown primary origin. Although selection bias cannot be ignored, prospective data are needed to further address this question.« less

Effect of Selenium Supplementation on Recurrent Hyperthyroidism Caused by Graves' Disease: A Prospective Pilot Study.

PubMed

Wang, L; Wang, B; Chen, S R; Hou, X; Wang, X F; Zhao, S H; Song, J Q; Wang, Y G

2016-09-01

The effect of selenium supplementation on recurrent hyperthyroidism caused by Graves' disease is unclear. Our study aimed to assess the efficacy of selenium supplementation therapy on recurrent Graves' disease. Forty-one patients with recurrent Graves' disease were enrolled in this study. All patients received the routine treatment using methimazole (MMI), while patients allocated to the selenium group received additional selenium therapy for 6 months. The influence of selenium supplementation on the concentrations of thyroid stimulating hormone (TSH), anti-TSH-receptor antibodies (TRAb), free thyroxine (FT4), and free triiodothyronine (FT3) were assessed. The remission rate was also compared between 2 groups. There was no obvious difference in the demographic data and the levels of serum FT4, FT3, TSH, and TRAb between the 2 groups at baseline. Both FT4 and FT3 decreased more at 2 months in the selenium group than the controls, while the TSH level increased more in patients receiving selenium supplementation (p<0.05). The TRAb level was significantly lower in patients receiving selenium supplementation (2.4 IU/l vs. 5.6 IU/l, p=0.04). The percentages of patients with normal TRAb level at 6 months was also significantly higher in the selenium group (19.0 vs. 0%, p=0.016). Kaplan-Meier survival curve showed patients receiving selenium supplementation had a significantly higher rate of remission than controls (Log-rank test p=0.008). In conclusion, selenium supplementation can enhance the effect of antithyroid drugs in patients with recurrent Graves' disease. Randomized trials with large number of participants are needed to validate the finding above. © Georg Thieme Verlag KG Stuttgart · New York.

Patient perceptions of receiving test results via online portals: a mixed-methods study

PubMed Central

Giardina, Traber D; Baldwin, Jessica; Nystrom, Daniel T; Sittig, Dean F; Singh, Hardeep

2018-01-01

Abstract Objective Online portals provide patients with access to their test results, but it is unknown how patients use these tools to manage results and what information is available to promote understanding. We conducted a mixed-methods study to explore patients’ experiences and preferences when accessing their test results via portals. Materials and Methods We conducted 95 interviews (13 semistructured and 82 structured) with adults who viewed a test result in their portal between April 2015 and September 2016 at 4 large outpatient clinics in Houston, Texas. Semistructured interviews were coded using content analysis and transformed into quantitative data and integrated with the structured interview data. Descriptive statistics were used to summarize the structured data. Results Nearly two-thirds (63%) did not receive any explanatory information or test result interpretation at the time they received the result, and 46% conducted online searches for further information about their result. Patients who received an abnormal result were more likely to experience negative emotions (56% vs 21%; P = .003) and more likely to call their physician (44% vs 15%; P = .002) compared with those who received normal results. Discussion Study findings suggest that online portals are not currently designed to present test results to patients in a meaningful way. Patients experienced negative emotions often with abnormal results, but sometimes even with normal results. Simply providing access via portals is insufficient; additional strategies are needed to help patients interpret and manage their online test results. Conclusion Given the absence of national guidance, our findings could help strengthen policy and practice in this area and inform innovations that promote patient understanding of test results. PMID:29240899

Genetic and Non-genetic Factors Associated With Constipation in Cancer Patients Receiving Opioids.

PubMed

Laugsand, Eivor A; Skorpen, Frank; Kaasa, Stein; Sabatowski, Rainer; Strasser, Florian; Fayers, Peter; Klepstad, Pål

2015-06-18

To examine whether the inter-individual variation in constipation among patients receiving opioids for cancer pain is associated with genetic or non-genetic factors. Cancer patients receiving opioids were included from 17 centers in 11 European countries. Intensity of constipation was reported by 1,568 patients on a four-point categorical scale. Non-genetic factors were included as covariates in stratified regression analyses on the association between constipation and 75 single-nucleotide polymorphisms (SNPs) within 15 candidate genes related to opioid- or constipation-signaling pathways (HTR3E, HTR4, HTR2A, TPH1, ADRA2A, CHRM3, TACR1, CCKAR, KIT, ARRB2, GHRL, ABCB1, COMT, OPRM1, and OPRD1). The non-genetic factors significantly associated with constipation were type of laxative, mobility and place of care among patients receiving laxatives (N=806), in addition to Karnofsky performance status and presence of metastases among patients not receiving laxatives (N=762) (P<0.01). Age, gender, body mass index, cancer diagnosis, time on opioids, opioid dose, and type of opioid did not contribute to the inter-individual differences in constipation. Five SNPs, rs1800532 in TPH1, rs1799971 in OPRM1, rs4437575 in ABCB1, rs10802789 in CHRM3, and rs2020917 in COMT were associated with constipation (P<0.01). Only rs2020917 in COMT passed the Benjamini-Hochberg criterion for a 10% false discovery rate. Type of laxative, mobility, hospitalization, Karnofsky performance status, presence of metastases, and five SNPs within TPH1, OPRM1, ABCB1, CHRM3, and COMT may contribute to the variability in constipation among cancer patients treated with opioids. Knowledge of these factors may help to develop new therapies and to identify patients needing a more individualized approach to treatment.

Treatment decision-making strategies and influences in patients with localized prostate carcinoma.

PubMed

Gwede, Clement K; Pow-Sang, Julio; Seigne, John; Heysek, Randy; Helal, Mohamed; Shade, Kristin; Cantor, Alan; Jacobsen, Paul B

2005-10-01

Patients diagnosed with localized prostate carcinoma need to interpret complicated medical information to make an informed treatment selection from among treatments that have comparable efficacy but differing side effects. The authors reported initial results for treatment decision-making strategies among men receiving definitive treatment for localized prostate carcinoma. One hundred nineteen men treated with radical prostatectomy (44%) or brachytherapy (56%) consented to participate. Guided by a cognitive-affective theoretic framework, the authors assessed differences in decision-making strategies, and treatment and disease-relevant beliefs and affects, in addition to demographic and clinical variables. Approximately half of patients reported difficulty (49%) and distress (45%) while making treatment decisions, but no regrets (74%) regarding the treatment choice they made. Patients who underwent prostatectomy were younger, were more likely to be employed, had worse tumor grade, and had a shorter time since diagnosis (P < 0.01) compared with patients who did not undergo prostatectomy. In multivariate analyses, compared with patients who received radical prostatectomy, patients who received brachytherapy were more likely to say that they chose this treatment because it was "the least invasive" and they "wanted to avoid surgery" (P < 0.0001). In general, patients who received brachytherapy chose this treatment because of quality of life considerations, whereas "cure" and complete removal of the tumor were the main motivations for patients selecting radical prostatectomy. Long-term data are needed to evaluate distress and decisional regret as patients experience treatment-related chronic side effects and efficacy outcomes. Decision-making aids or other interventions to reduce decisional difficulty and emotional distress during decision making were indicated.

Access to diabetes self-management education: results of national surveys of patients, educators, and physicians.

PubMed

Peyrot, Mark; Rubin, Richard R; Funnell, Martha M; Siminerio, Linda M

2009-01-01

To examine factors related to access to diabetes self-management education (DSME), including services delivered and sought; patient, physician, and program barriers to access; educator outreach and expansion efforts; and perceptions of alternative DSME delivery strategies. Internet surveys were completed by 1169 adults with diabetes (661 with prior DSME, 508 with no prior DSME) from a national community survey panel, 1871 educators who were AADE members, and 629 physicians (212 diabetes specialists, 417 primary care practitioners) from a national physician survey panel. Physicians want patients to receive more self-management support, but some report that patients are told to do things with which the physician does not agree. Provider (physician and educator)-delivered DSME is more highly regarded among those who have received it than among those who have not received it. Physicians generally have positive perceptions of provider-delivered DSME, and educators see physicians as key to encouraging DSME use in patients. Some physicians are concerned about losing patients sent to DSME, and 11% of patients report changing physicians as a result of DSME. Most DSME programs have grown recently as a result of recruiting efforts and adding new programs/services; most programs plan more such efforts. Patients prefer traditional DSME sources/settings and are moderately accepting of media sources. Additional efforts are required to guarantee that all people with diabetes receive the DSME they need. This will require increased referral by physicians, increased follow-through by patients, and increased availability of DSME in forms that make it appealing to patients and physicians.

Efficacy and Safety of Fixed-Dose Perindopril Arginine/Amlodipine in Hypertensive Patients Not Adequately Controlled with Amlodipine 5 mg or Perindopril tert-Butylamine 4 mg Monotherapy.

PubMed

Hu, Dayi; Sun, Yihong; Liao, Yuhua; Huang, Jing; Zhao, Ruiping; Yang, Kan

2016-01-01

To assess the blood pressure-lowering efficacy and tolerability of perindopril/amlodipine fixed-dose combinations in Chinese patients with mild-to-moderate essential hypertension not adequately controlled with monotherapy alone. In 2 separate double-blind studies, patients received a 4-week run-in monotherapy of amlodipine 5 mg or perindopril 4 mg, respectively. Those whose blood pressure was uncontrolled were then randomized to receive the fixed-dose combination of perindopril 5 mg/amlodipine 5 mg (Per/Amlo group) or remain on the monotherapy for 8 weeks. Patients who were uncontrolled at the week 8 (W8) visit were up-titrated for the Per/Amlo combination, or received additional treatment if on monotherapy, for a further 4 weeks. The main efficacy assessment was at 8 weeks. After 8 weeks, systolic blood pressure (SBP; primary criterion) was statistically significantly lower in the Per/Amlo group (vs. Amlo 5 mg, p = 0.0095; vs. Per 4 mg, p < 0.0001). Uncontrolled patients at W8 who received an up-titration of the Per/Amlo combination showed a further SBP reduction. These changes were mirrored by reassuring reductions in diastolic blood pressure. The fixed-dose combinations were well tolerated. Single-pill combinations of perindopril and amlodipine provide hypertensive patients with a convenient and effective method of reducing blood pressure. © 2016 S. Karger AG, Basel.

Traditional Japanese Medicine Daikenchuto Improves Functional Constipation in Poststroke Patients

PubMed Central

Numata, Takehiro; Takayama, Shin; Tobita, Muneshige; Ishida, Shuichi; Katayose, Dai; Shinkawa, Mitsutoshi; Oikawa, Takashi; Aonuma, Takanori; Kaneko, Soichiro; Tanaka, Junichi; Kanemura, Seiki; Iwasaki, Koh; Ishii, Tadashi; Yaegashi, Nobuo

2014-01-01

Poststroke patients with functional constipation, assessed by the Rome III criteria, from 6 hospitals were recruited in a study on the effects of the traditional Japanese medicine Daikenchuto (DKT) on constipation. Thirty-four patients (17 men and 17 women; mean age: 78.1 ± 11.6 years) were randomly assigned to 2 groups; all patients received conventional therapy for constipation, and patients in the DKT group received 15 g/day of DKT for 4 weeks. Constipation scoring system (CSS) points and the gas volume score (GVS) (the measure of the intestinal gas volume calculated from plain abdominal radiographs) were recorded before and after a 4-week observation period. The total score on the CSS improved significantly in the DKT group compared to the control (P < 0.01). In addition, scores for some CSS subcategories (frequency of bowel movements, feeling of incomplete evacuation, and need for enema/disimpaction) significantly improved in the DKT group (P < 0.01, P = 0.049, and P = 0.03, resp.). The GVS was also significantly reduced in the DKT group compared to the control (P = 0.03). DKT in addition to conventional therapy is effective in treating functional constipation in poststroke patients. This study was a randomized controlled trial and was registered in the UMIN Clinical Trial Registry (no. UMIN000007393). PMID:25089144

Traditional Japanese medicine daikenchuto improves functional constipation in poststroke patients.

PubMed

Numata, Takehiro; Takayama, Shin; Tobita, Muneshige; Ishida, Shuichi; Katayose, Dai; Shinkawa, Mitsutoshi; Oikawa, Takashi; Aonuma, Takanori; Kaneko, Soichiro; Tanaka, Junichi; Kanemura, Seiki; Iwasaki, Koh; Ishii, Tadashi; Yaegashi, Nobuo

2014-01-01

Poststroke patients with functional constipation, assessed by the Rome III criteria, from 6 hospitals were recruited in a study on the effects of the traditional Japanese medicine Daikenchuto (DKT) on constipation. Thirty-four patients (17 men and 17 women; mean age: 78.1 ± 11.6 years) were randomly assigned to 2 groups; all patients received conventional therapy for constipation, and patients in the DKT group received 15 g/day of DKT for 4 weeks. Constipation scoring system (CSS) points and the gas volume score (GVS) (the measure of the intestinal gas volume calculated from plain abdominal radiographs) were recorded before and after a 4-week observation period. The total score on the CSS improved significantly in the DKT group compared to the control (P < 0.01). In addition, scores for some CSS subcategories (frequency of bowel movements, feeling of incomplete evacuation, and need for enema/disimpaction) significantly improved in the DKT group (P < 0.01, P = 0.049, and P = 0.03, resp.). The GVS was also significantly reduced in the DKT group compared to the control (P = 0.03). DKT in addition to conventional therapy is effective in treating functional constipation in poststroke patients. This study was a randomized controlled trial and was registered in the UMIN Clinical Trial Registry (no. UMIN000007393).

Adjuvant therapy for ampullary carcinomas: The Mayo Clinic experience

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bhatia, Sumita; Miller, Robert C.; Haddock, Michael G.

2006-10-01

Purpose: To determine the effects of adjuvant radiotherapy and chemotherapy for carcinoma of the ampulla of Vater. Methods and Materials: We retrospectively reviewed the records of 125 patients who underwent definitive surgery for carcinomas involving the ampulla of Vater between April 1977 and February 2005 and who survived more than 50 days after surgery. Twenty-nine of the patients also received adjuvant radiotherapy (median dose, 50.4 Gy in 28 fractions) with concurrent 5-fluorouracil chemotherapy. Adverse prognostic factors were investigated, and overall survival (OS) and local and distant failure were estimated. Results: Adverse prognostic factors for decreased OS by univariate analysis includedmore » lymph node (LN) involvement, locally advanced tumors (T3/T4), and poor histologic grade. By multivariate analysis, positive LN status (p = 0.02) alone was associated with decreased OS. The addition of adjuvant radiotherapy and chemotherapy improved OS for patients with positive LN (p = 0.01). Median survival for positive LN patients receiving adjuvant therapy was 3.4 years, vs. 1.6 years for those with surgery alone. Conclusions: The addition of adjuvant radiotherapy and 5-fluorouracil chemotherapy may improve OS in patients with LN involvement. The effect of adjuvant therapy on outcomes for patients with poor histologic grade or T3/T4 tumors without LN involvement could not be assessed.« less

Do patients with brain metastases selected for whole brain radiotherapy have worse baseline quality of life as compared to those for radiosurgery or neurosurgery (with or without whole brain radiotherapy)?

PubMed

Chow, Ronald; Tsao, May; Pulenzas, Natalie; Zhang, Liying; Sahgal, Arjun; Cella, David; Soliman, Hany; Danjoux, Cyril; DeAngelis, Carlo; Vuong, Sherlyn; Chow, Edward

2016-01-01

The purpose was to examine the baseline characteristics, symptoms and quality of life (QOL) in patients who receive different treatments for brain metastases. Eligible patients were divided and analysed based on their treatment: whole brain radiotherapy (WBRT) alone versus stereotactic radiosurgery (SRS) or neurosurgery with or without WBRT. The Functional Assessment of Cancer Therapy-Brain (FACT-Br) items were grouped according to different domains for summary scores. The domains used for summary scores were physical, social/family, emotional, functional well-being (FWB) and additional concerns. A total of 120 patients were enrolled, with 37 treated with WBRT alone and 83 with SRS or neurosurgery with or without WBRT. Of the 50 baseline FACT-Br items, only five items (I feel ill; I get support from my friends; I worry about dying; I have difficulty expressing my thoughts, I am able to put my thoughts into action) were statistically worse in patients treated with WBRT alone (P<0.05). Patients who received SRS or surgery with or without WBRT had statistically (P<0.05) higher scores for the FWB domain, additional concerns domain, and FACT-G total scores, indicating better QOL. Patients selected for WBRT alone reported statistically different baseline QOL as compared to patients who were treated with SRS or neurosurgery (with or without WBRT).

Efficacy of Vismodegib (Erivedge) for Basal Cell Carcinoma Involving the Orbit and Periocular Area.

PubMed

Demirci, Hakan; Worden, Francis; Nelson, Christine C; Elner, Victor M; Kahana, Alon

2015-01-01

Evaluate the effectiveness of vismodegib in the management of basal cell carcinoma with orbital extension and/or extensive periocular involvement. Retrospective chart review of 6 consecutive patients with biopsy-proven orbital basal cell carcinoma and 2 additional patients with extensive periocular basal cell carcinoma who were treated with oral vismodegib (150 mg/day) was performed. Basal cell carcinoma extended in the orbit in 6 of 8 patients (involving orbital bones in 1 patient), and 2 of 8 patients had extensive periocular involvement (1 with basal cell nevus syndrome). Vismodegib therapy was the only treatment in 6 patients, off-label neoadjuvant in 1 patient, and adjuvant treatment in 1 patient. Orbital tumors in all 4 patients who received vismodegib as sole treatment showed partial response with a mean 83% shrinkage in tumor size after a median of 7 months of therapy. In the 2 patients receiving vismodegib as neoadjuvant or adjuvant therapies, there was complete response after a median of 7 months of therapy and no evidence of clinical recurrence after discontinuing therapy for a median of 15 months. The 2 patients with extensive periocular involvement experienced complete clinical response after a median 14 months of treatment. During treatment, the most common side effects were muscle spasm (75%) followed by alopecia (50%), dysgeusia (25%), dysosmia, and episodes of diarrhea and constipation (13%). Basal cell carcinoma with orbital extension and extensive periocular involvement responds to vismodegib therapy. The long-term prognosis remains unknown, and additional prospective studies are indicated.

Embolic strokes of undetermined source: Prevalence and patient features in the ESUS Global Registry.

PubMed

Perera, Kanjana S; Vanassche, Thomas; Bosch, Jackie; Giruparajah, Mohana; Swaminathan, Balakumar; Mattina, Katie R; Berkowitz, Scott D; Arauz, Antonio; O'Donnell, Martin J; Ameriso, Sebastian F; Hankey, Graeme J; Yoon, Byung-Woo; Lavallee, Philippa; Cunha, Luis; Shamalov, Nikolay; Brouns, Raf; Gagliardi, Rubens J; Kasner, Scott E; Pieroni, Alessio; Vermehren, Philipp; Kitagawa, Kazuo; Wang, Yongjun; Muir, Keith; Coutinho, Jonathan; Vastagh, Ildiko; Connolly, Stuart J; Hart, Robert G

2016-07-01

Recent evidence supports that most non-lacunar cryptogenic strokes are embolic. Accordingly, these strokes have been designated as embolic strokes of undetermined source (ESUS). We undertook an international survey to characterize the frequency and clinical features of ESUS patients across global regions. Consecutive patients hospitalized for ischemic stroke were retrospectively surveyed from 19 stroke research centers in 19 different countries to collect patients meeting criteria for ESUS. Of 2144 patients with recent ischemic stroke, 351 (16%, 95% CI 15% to 18%) met ESUS criteria, similar across global regions (range 16% to 21%), and an additional 308 (14%) patients had incomplete evaluation required for ESUS diagnosis. The mean age of ESUS patients (62 years; SD = 15) was significantly lower than the 1793 non-ESUS ischemic stroke patients (68 years, p ≤ 0.001). Excluding patients with atrial fibrillation (n = 590, mean age = 75 years), the mean age of the remaining 1203 non-ESUS ischemic stroke patients was 64 years (p = 0.02 vs. ESUS patients). Among ESUS patients, hypertension, diabetes, and prior stroke were present in 64%, 25%, and 17%, respectively. Median NIHSS score was 4 (interquartile range 2-8). At discharge, 90% of ESUS patients received antiplatelet therapy and 7% received anticoagulation. This cross-sectional global sample of patients with recent ischemic stroke shows that one-sixth met criteria for ESUS, with additional ESUS patients likely among those with incomplete diagnostic investigation. ESUS patients were relatively young with mild strokes. Antiplatelet therapy was the standard antithrombotic therapy for secondary stroke prevention in all global regions. © 2016 World Stroke Organization.

Randomized Double-Blind Placebo-Controlled Trial of Bevacizumab Therapy for Radiation Necrosis of the Central Nervous System

DOE Office of Scientific and Technical Information (OSTI.GOV)

Levin, Victor A., E-mail: vlevin49@comcast.ne; Bidaut, Luc; Hou, Ping

Purpose: To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Methods and Materials: A total of 14 patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system radiation necrosis. All patients were required to have radiographic or biopsy proof of central nervous system radiation necrosis and progressive neurologic symptoms or signs. Eligible patients had undergone irradiation for head-and-neck carcinoma, meningioma, or low- to mid-grade glioma. Patients were randomized to receive intravenous saline or bevacizumab at 3-week intervals. The magnetic resonance imaging findings 3 weeksmore » after the second treatment and clinical signs and symptoms defined the response or progression. Results: The volumes of necrosis estimated on T{sub 2}-weighted fluid-attenuated inversion recovery and T{sub 1}-weighted gadolinium-enhanced magnetic resonance imaging scans demonstrated that although no patient receiving placebo responded (0 of 7), all bevacizumab-treated patients did so (5 of 5 randomized and 7 of 7 crossover) with decreases in T{sub 2}-weighted fluid-attenuated inversion recovery and T{sub 1}-weighted gadolinium-enhanced volumes and a decrease in endothelial transfer constant. All bevacizumab-treated patients-and none of the placebo-treated patients-showed improvement in neurologic symptoms or signs. At a median of 10 months after the last dose of bevacizumab in patients receiving all four study doses, only 2 patients had experienced a recurrence of magnetic resonance imaging changes consistent with progressive radiation necrosis; one patient received a single additional dose of bevacizumab and the other patient received two doses. Conclusion: The Class I evidence of bevacizumab efficacy from the present study in the treatment of central nervous system radiation necrosis justifies consideration of this treatment option for people with radiation necrosis secondary to the treatment of head-and-neck cancer and brain cancer.« less

Impact of dextrose dose on hypoglycemia development following treatment of hyperkalemia.

PubMed

Farina, Nicholas; Anderson, Christopher

2018-06-01

Hyperkalemia is an electrolyte abnormality that may cause ventricular dysrhythmias and cardiac arrest. The presence of hyperkalemia may necessitate prompt treatment via intravenous insulin and dextrose. One notable complication of this therapy is the development of hypoglycemia. Previous trials have examined the impact of altering the insulin dose administered on hypoglycemia development; no trials to date however, have examined the impact of altering the dextrose dose. This was a multicenter, retrospective, matched cohort study of patients who received intravenous insulin and dextrose for reversal of hyperkalemia. Patients received either 25 g or 50 g of dextrose in addition to 10 units of insulin. Study populations were matched based on preexisting rates of acute kidney injury, end-stage renal disease, and diabetes mellitus. Blood glucose levels were measured at 60 and 240 min following treatment. A total of 240 patients were included in the analysis. At 60 min following treatment, 15.8% of patients who received 25 g of dextrose developed hypoglycemia, as opposed to 8.3% of patients who received 50 g of dextrose ( p = 0.11). Hyperglycemia was more common in patients who received 50 g of dextrose at 60 min posttreatment; however, this difference did not persist at 240 min. Potassium reduction at 60 min did not differ between groups. In patients with a pretreatment blood glucose <110 mg/dl or without diabetes, rates of hypoglycemia were significantly lower when 50 g of dextrose was administered. In the overall patient population, use of 50 g of dextrose instead of 25 g does not reduce hypoglycemia incidence. However, it may be beneficial is select patient populations, such as patients without type 2 diabetes or patients with a baseline blood glucose <110 mg/dl. Administration of 50 g of dextrose did not appear to place patients at significant risk for hyperglycemia however and could be considered during treatment of hyperkalemia.

Treatment of Acute Hepatic Encephalopathy: Comparing the Effects of Adding Rifaximin to Lactulose on Patient Outcomes.

PubMed

Courson, Alesa; Jones, G Morgan; Twilla, Jennifer D

2016-06-01

Rifaximin is approved for the reduction of hepatic encephalopathy (HE) recurrence in patients with chronic liver disease (CLD); however, few studies have evaluated the benefit of adding rifaximin to lactulose for treatment of acute HE. The aim of this study was to determine the impact of combination therapy with lactulose and rifaximin on hospital length of stay (LOS) and readmission rates. A retrospective study of patients admitted to an adult hospital within the Methodist LeBonheur Healthcare (MLH) System in Memphis, Tennessee, between 2007 and 2012 was conducted. Patients were identified via International Classification of Diseases, Ninth Revision (ICD-9) coding for liver cirrhosis. Of the 173 patients included, 87 (50%) received lactulose monotherapy and 62 (36%) combination therapy, while 24 (14%) underwent therapy escalation. Median LOS was 6 days in monotherapy group and 8 days in combination group (P = .9). At 180 days, patients receiving combination therapy had fewer readmissions for HE than those receiving monotherapy (2.4% vs 16.2%, P = .02). Addition of rifaximin to lactulose for treatment of acute HE did not reduce hospital LOS; however, it did result in lower readmission rates for HE at 180 days. © The Author(s) 2015.

A multicenter phase 2 study of empirical low-dose liposomal amphotericin B in patients with refractory febrile neutropenia.

PubMed

Miyao, Kotaro; Sawa, Masashi; Kurata, Mio; Suzuki, Ritsuro; Sakemura, Reona; Sakai, Toshiyasu; Kato, Tomonori; Sahashi, Satomi; Tsushita, Natsuko; Ozawa, Yukiyasu; Tsuzuki, Motohiro; Kohno, Akio; Adachi, Tatsuya; Watanabe, Keisuke; Ohbayashi, Kaneyuki; Inagaki, Yuichiro; Atsuta, Yoshiko; Emi, Nobuhiko

2017-01-01

Invasive fungal infection (IFI) is a major life-threatening problem encountered by patients with hematological malignancies receiving intensive chemotherapy. Empirical antifungal agents are therefore important. Despite the availability of antifungal agents for such situations, the optimal agents and administration methods remain unclear. We conducted a prospective phase 2 study of empirical 1 mg/kg/day liposomal amphotericin B (L-AMB) in 80 patients receiving intensive chemotherapy for hematological malignancies. All enrolled patients were high-risk and had recurrent prolonged febrile neutropenia despite having received broad-spectrum antibacterial therapy for at least 72 hours. Fifty-three patients (66.3 %) achieved the primary endpoint of successful treatment, thus exceeding the predefined threshold success rate. No patients developed IFI. The treatment completion rate was 73.8 %, and only two cases ceased treatment because of adverse events. The most frequent events were reversible electrolyte abnormalities. We consider low-dose L-AMB to provide comparable efficacy and improved safety and cost-effectiveness when compared with other empirical antifungal therapies. Additional large-scale randomized studies are needed to determine the clinical usefulness of L-AMB relative to other empirical antifungal therapies.

Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

PubMed

Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

2014-04-01

To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

Effect of Adhesive Strips and Dermal Sutures vs Dermal Sutures Only on Wound Closure: A Randomized Clinical Trial.

PubMed

Custis, Trenton; Armstrong, April W; King, Thomas H; Sharon, Victoria R; Eisen, Daniel B

2015-08-01

Although applying adhesive strips to a wound closure has been shown to have outcomes equivalent to those with cuticular suturing, it is unknown whether adhesive strips provide additional benefit compared with dermal suturing alone. To determine whether the addition of adhesive strips to a wound closed with buried interrupted subcuticular sutures improves outcomes following wound closure. A prospective, randomized split-wound intervention was conducted between November 14, 2013, and May 16, 2014, in patients who underwent cutaneous surgical procedures at the University of California, Davis, outpatient dermatology clinic. Fifty-seven patients 18 years or older with postoperative defects of at least 3 cm, resulting from either Mohs micrographic surgical procedures or surgical excision, were screened for participation. Nine patients were excluded and 48 were enrolled. Half of each wound was randomized to receive buried interrupted subcuticular sutures and overlying adhesive strips and the other half received buried interrupted subcuticular sutures only. At 3 months' follow-up, each patient and 2 blinded observers evaluated the wound using the Patient Observer Scar Assessment Scale. The total mean (SD) Patient Observer Scar Assessment Scale score for observers for the side that received a combination of adhesive strips and buried interrupted subcuticular suturing (12.3 [4.8]) and the side that received sutures only (12.9 [6.3]) did not differ significantly at 3 months (P = .32). There was no significant difference in the total patient assessment scale score between the combination closure (14.0 [7.6]) and sutures only (14.7 [7.6]) sides at 3 months (P = .39). There was also no significant difference between the 2 closure methods in terms of mean (SD) scar width (both methods: 1.1 [0.8] mm, P = .89) at follow-up. Combination closure with adhesive strips and buried interrupted subcuticular suturing was not significantly associated with improved overall scar assessment compared with buried interrupted subcuticular suturing alone when evaluated by blinded observers or the patients themselves. Our results do not support the use of adhesive strips as a means to improve cosmetic outcomes or reduce scar width. clinicaltrials.gov Identifier: NCT01979497.

An observational study of patient satisfaction with fesoterodine in the treatment of overactive bladder: effects of additional educational material.

PubMed

Schneider, T; Arumi, D; Crook, T J; Sun, F; Michel, M C

2014-09-01

To compare the effects of additional educational material on treatment satisfaction of overactive bladder (OAB) patients treated with a muscarinic receptor antagonist. In an observational study of OAB patients being treated by their physician with fesoterodine for 4 months (FAKTEN study), sites were randomised to providing standard treatment or additional educational material including the SAGA tool. Patient satisfaction was assessed by three validated patient-reported outcomes including the Treatment Satisfaction Question. Because of premature discontinuation of the study, descriptive statistical analysis was performed. A total of 431 and 342 patients received standard treatment or additional educational material, respectively. At study end, 76.1% [95% CI = 71.3, 80.4] of patients with standard care and 79.6% [95% CI = 74.4, 84.1] with additional SAGA tool were satisfied with treatment (primary end-point). Comparable outcomes with and without the additional educational material were also found in various patient subgroups, at the 1-month time point, and for the other patient-reported outcomes. A notable exception was the subgroup of treatment-naïve patients in which the percentage of satisfied patients was 77.2% vs. 89.5% with standard treatment and additional SAGA tool, respectively (post hoc analysis). In an observational study, most overactive bladder patients were satisfied with fesoterodine treatment. Because of the small sample size, the study does not support or refute the hypothesis that adding the SAGA tool will improve patient satisfaction with treatment. The potential effect of additional educational material in treatment-naïve patients warrants further dedicated studies. © 2014 John Wiley & Sons Ltd.

Outcomes after out-of-hospital cardiac arrest treated by basic vs advanced life support.

PubMed

Sanghavi, Prachi; Jena, Anupam B; Newhouse, Joseph P; Zaslavsky, Alan M

2015-02-01

Most out-of-hospital cardiac arrests receiving emergency medical services in the United States are treated by ambulance service providers trained in advanced life support (ALS), but supporting evidence for the use of ALS over basic life support (BLS) is limited. To compare the effects of BLS and ALS on outcomes after out-of-hospital cardiac arrest. Observational cohort study of a nationally representative sample of traditional Medicare beneficiaries from nonrural counties who experienced out-of-hospital cardiac arrest between January 1, 2009, and October 2, 2011, and for whom ALS or BLS ambulance services were billed to Medicare (31,292 ALS cases and 1643 BLS cases). Propensity score methods were used to compare the effects of ALS and BLS on patient survival, neurological performance, and medical spending after cardiac arrest. Survival to hospital discharge, to 30 days, and to 90 days; neurological performance; and incremental medical spending per additional survivor to 1 year. Survival to hospital discharge was greater among patients receiving BLS (13.1% vs 9.2% for ALS; 4.0 [95% CI, 2.3-5.7] percentage point difference), as was survival to 90 days (8.0% vs 5.4% for ALS; 2.6 [95% CI, 1.2-4.0] percentage point difference). Basic life support was associated with better neurological functioning among hospitalized patients (21.8% vs 44.8% with poor neurological functioning for ALS; 23.0 [95% CI, 18.6-27.4] percentage point difference). Incremental medical spending per additional survivor to 1 year for BLS relative to ALS was $154,333. Patients with out-of-hospital cardiac arrest who received BLS had higher survival at hospital discharge and at 90 days compared with those who received ALS and were less likely to experience poor neurological functioning.

Association of socioeconomic status with diagnosis, treatment and control of hypertension in diabetic hypertensive individuals in Bangladesh: a population-based cross-sectional study.

PubMed

Rahman, Mosiur; H, Syed Emdadul; Islam, Md Jahirul; Mostofa, Md Golam; Saadat, Khandakar Asm

2015-10-01

This study aimed to examine if socioeconomic status could affect the likelihood of diagnosis, treatment and control of hypertension in diabetic hypertensive individuals. Cross-sectional nationally representative study. Bangladesh. This paper used data from the 2011 Bangladesh Demographic Health Survey. The analyses were based on the responses of 339 diabetes hypertensive individuals. Diagnosis, treatment and control of hypertension. The age-adjusted prevalence of hypertension in diabetes individuals was 38.4% in the study population. Among diabetic hypertensive subjects only 65.7% had been diagnosed, 58.4% were receiving treatment and 42% controlled their hypertension. Individuals from high socioeconomic status (AOR 2.60; 95% CI 1.16-5.83) had an increased likelihood of reporting diagnosis of hypertension. Individuals from medium (AOR 2.22; 95% CI 1.11-4.46) and high socioeconomic status (AOR 3.47; 95% CI 1.59-7.58) had increased chance of receiving treatment. In addition, individuals belonging to high socioeconomic status (AOR 2.53; 95% CI 1.14-5.63) were more likely to report of controlling hypertension. This study indicated that hypertension is more prevalent among diabetic patients. Furthermore, diabetic hypertensive patients from the low socioeconomic status group are also less likely to be diagnosed and also less likely to receive treatment for hypertension. In addition, diabetic hypertensive patients from the low socioeconomic status were less likely to control hypertension compared with an individual belonging to the high socioeconomic status group. This reduced likelihood of receiving proper treatment will lead to a rapid increase in the prevalence of macrovascular and microvascular diseases among diabetic hypertensive patients.

Strategies to Improve Repeat Fecal Occult Blood Testing Cancer Screening

PubMed Central

Davis, Terry C.; Arnold, Connie L.; Bennett, Charles L.; Wolf, Michael S.; Reynolds, Cristalyn; Liu, Dachao; Rademaker, Alfred

2013-01-01

Background A comparative effectiveness intervention by this team improved initial fecal occult blood testing (FOBT) rates from 3% to 53% among community clinic patients. The purpose of this study was to evaluate the effectiveness and costs associated with a literacy-informed intervention on repeat FOBT testing. Methods Between 2008 and 2011, a three-arm quasi-experiential comparative effectiveness evaluation was conducted in 8 community clinics in Louisiana. Clinics were randomly assigned to receive: enhanced care, a screening recommendation and FOBT kit annually; a brief educational intervention where patients additionally received a literacy appropriate pamphlet and simplified FOBT instructions; or nurse support where a nurse manager provided the education and followed up with phone support. In year 2 all materials were mailed. The study consisted of 461 patients, ages 50–85, with a negative initial FOBT. Results Repeat FOBT rates were 38% enhanced care, 33% education, and 59% with nurse support (p=0.017). After adjusting for age, race, gender, and literacy, patients receiving nurse support were 1.46 times more likely to complete repeat FOBT screening than those receiving education (95% CI 1.14–1.06, p=0.002) and 1.45 times more likely than those in enhanced care but this was not significant (95% CI 0.93–2.26 p=0.10). The incremental cost per additional person screened was $2,450 for nurse over enhanced care. Conclusion A mailed pamphlet and FOBT with simplified instructions did not improve annual screening. Impact Telephone outreach by a nurse manager was effective in improving rates of repeat FOBT yet this may be too costly for community clinics. PMID:24192009

Bicarbonate Balance and Prescription in ESRD

PubMed Central

2017-01-01

The optimal approach to managing acid-base balance is less well defined for patients receiving hemodialysis than for those receiving peritoneal dialysis. Interventional studies in hemodialysis have been limited and inconsistent in their findings, whereas more compelling data are available from interventional studies in peritoneal dialysis. Both high and low serum bicarbonate levels associate with an increased risk of mortality in patients receiving hemodialysis, but high values are a marker for poor nutrition and comorbidity and are often highly variable from month to month. Measurement of pH would likely provide useful additional data. Concern has arisen regarding high-bicarbonate dialysate and dialysis-induced alkalemia, but whether these truly cause harm remains to be determined. The available evidence is insufficient for determining the optimal target for therapy at this time. PMID:27881607

Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix.

PubMed

Peters, W A; Liu, P Y; Barrett, R J; Stock, R J; Monk, B J; Berek, J S; Souhami, L; Grigsby, P; Gordon, W; Alberts, D S

2000-04-01

To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma. Patients with clinical stage IA(2), IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m(2) and a 96-hour infusion of fluorouracil 1,000 mg/m(2)/d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT. Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P =.003) and 1.96 (P =. 007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group. The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix.

Colour coding for blood collection tube closures - a call for harmonisation.

PubMed

Simundic, Ana-Maria; Cornes, Michael P; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Ceriotti, Ferruccio; Theodorsson, Elvar; Panteghini, Mauro

2015-02-01

At least one in 10 patients experience adverse events while receiving hospital care. Many of the errors are related to laboratory diagnostics. Efforts to reduce laboratory errors over recent decades have primarily focused on the measurement process while pre- and post-analytical errors including errors in sampling, reporting and decision-making have received much less attention. Proper sampling and additives to the samples are essential. Tubes and additives are identified not only in writing on the tubes but also by the colour of the tube closures. Unfortunately these colours have not been standardised, running the risk of error when tubes from one manufacturer are replaced by the tubes from another manufacturer that use different colour coding. EFLM therefore supports the worldwide harmonisation of the colour coding for blood collection tube closures and labels in order to reduce the risk of pre-analytical errors and improve the patient safety.

Constraint-induced sound therapy for sudden sensorineural hearing loss – behavioral and neurophysiological outcomes

PubMed Central

Okamoto, Hidehiko; Fukushima, Munehisa; Teismann, Henning; Lagemann, Lothar; Kitahara, Tadashi; Inohara, Hidenori; Kakigi, Ryusuke; Pantev, Christo

2014-01-01

Sudden sensorineural hearing loss is characterized by acute, idiopathic hearing deterioration. We report here the development and evaluation of “constraint-induced sound therapy”, which is based on a well-established neuro-rehabilitation approach, and which is characterized by the plugging of the intact ear (“constraint”) and the simultaneous, extensive stimulation of the affected ear with music. The sudden sensorineural hearing loss patients who received the constraint-induced sound therapy in addition to the standard corticosteroid therapy showed significantly better recovery of hearing function compared to those who had only received corticosteroid treatments. Additionally, the brain activity obtained in a subgroup of patients suggested that the constraint-induced sound therapy could have prevented maladaptive auditory cortex reorganization. Constraint-induced sound therapy thus appears to be an effective, practical, and safe treatment option for sudden sensorineural hearing loss. PMID:24473277

Glioblastoma patients in Slovenia from 1997 to 2008

PubMed Central

Smrdel, Uros; Kovac, Viljem; Popovic, Mara; Zwitter, Matjaz

2014-01-01

Background Glioblastoma is the most common primary brain tumour. It has a poor prognosis despite some advances in treatment that have been achieved over the last ten years. In Slovenia, 50 to 60 glioblastoma patients are diagnosed each year. In order to establish whether the current treatment options have any influence on the survival of the Slovenian glioblastoma patients, their data in the period from the beginning of the year 1997 to the end of the year 2008 have been analysed. Patients and methods All patients treated at the Institute of Oncology Ljubljana from 1997 to 2008 were included in the retrospective study. Demographics, treatment details, and survival time after the diagnosis were collected and statistically analysed for the group as a whole and for subgroups. Results From 1997 to 2008, 527 adult patients were diagnosed with glioblastoma and referred to the Institute of Oncology for further treatment. Their median age was 59 years (from 20 to 85) and all but one had the diagnosis confirmed by a pathologist. Gross total resection was reported by surgeons in 261 (49.5%) patients; good functional status (WHO 0 or 1) after surgery was observed in 336 (63.7%) patients, radiotherapy was performed in 422 (80.1%) patients, in 317 (75.1%) of them with radical intent, and 198 (62.5 %) of those received some form of systemic treatment (usually temozolomide). The median survival of all patients amounted to 9.7 months. There was no difference in median survival of all patients or of all treated patients before or after the chemo-radiotherapy era. However, the overall survival of patients treated with radical intent was significantly better (11.4 months; p < 0.05). A better survival was also noticed in radically treated patients who received additional temozolomide therapy (11.4 vs. 13.1 months; p = 0.014). The longer survival was associated with a younger age and a good performance status as well as with a more extensive tumour resection. In patients treated with radical intent, having a good performance status, and receiving radiotherapy and additional temozolomide therapy, the survival was significantly longer, based on multivariate analysis. Conclusions We observed a gradual increase in the survival of glioblastoma patients who were treated with radical intent over the last ten years. Good functional surgery, advances in radiotherapy and addition of temozolomide all contributed to this increase. Though the increased survival seems to be more pronounced in certain subgroups, we have still not been able to exactly define them. Further research, especially in tumour biology and genetics is needed. PMID:24587783

Patient Navigation by Community Health Workers Increases Access to Surgical Care in Rural Haiti.

PubMed

Matousek, Alexi C; Addington, Stephen R; Kahan, Joseph; Sannon, Herriot; Luckner, Thelius; Exe, Chauvet; Jean Louis, Rodolphe R Eisenhower; Lipsitz, Stuart; Meara, John G; Riviello, Robert

2017-12-01

In the Hôpital Albert Schweitzer district in rural Haiti, patients from mountain areas receive fewer operations per capita than patients from the plains. Possible additional barriers for mountain patients include lower socioeconomic status, lack of awareness of financial support, illiteracy and unfamiliarity with the hospital system. We sought to increase the rate of elective surgery for a mountain population using a patient navigation program. Patient navigators were trained to guide subjects from a mountain population through the entire hospital process for elective surgery. We compared the rate of elective operations before and after the patient navigation intervention between three groups: a control group from a mountainous area, a control group from the plains and an intervention group from a mountainous area. The baseline elective operation rate differed significantly between the plains control group, the mountain control group and the mountain intervention group (361 vs. 57 vs. 68 operations per 100,000 population per year). The rate of elective surgery between the two mountain groups was not statistically different prior to the intervention. After the intervention, the elective operation rate in the mountain group that received patient navigation increased from 68 to 131 operations per 100,000 population per year (p = 0.017). Patient navigation doubled the elective operation rate for a mountain population in rural Haiti. While additional barriers to access remain for this vulnerable population, patient navigation is an essential augmentation to financial assistance programs to ensure that the poor gain access to surgical care.

Serotonin 2A Receptor SNP rs7330461 Association with Treatment Response to Pomaglumetad Methionil in Patients with Schizophrenia

PubMed Central

Nisenbaum, Laura K.; Downing, AnnCatherine M.; Zhao, Fangyi; Millen, Brian A.; Munsie, Leanne; Kinon, Bruce J.; Adams, David H.; Gomez, Juan Carlos; Penny, Michelle Ann

2016-01-01

This study aims to confirm the initial pharmacogenetic finding observed within the clinical proof-of-concept trial of an enhanced response to treatment with pomaglumetad methionil (LY2140023 monohydrate) in Caucasian schizophrenia patients homozygous for T/T at single nucleotide polymorphism rs7330461 in the serotonin (5-hydroxytryptamine) 2A receptor gene compared to A/A homozygous patients. The effect of the rs7330461 genotype on the response to pomaglumetad methionil treatment was assessed in three additional clinical trials and in an integrated analysis. Overall, this study includes data from 1115 Caucasian patients for whom genotyping information for rs7330461 was available, consisting of 513 A/A homozygous, 466 A/T heterozygous and 136 T/T homozygous patients. Caucasian T/T homozygous patients showed significantly (p ≤ 0.05) greater improvement in Positive and Negative Syndrome Scale (PANSS) total scores during treatment with pomaglumetad methionil 40 mg twice daily compared to A/A homozygous patients. Additionally, T/T homozygous patients receiving pomaglumetad methionil had significantly (p ≤ 0.05) greater improvements in PANSS total scores compared to placebo and similar improvements as T/T homozygous patients receiving standard-of-care (SOC) treatment. The findings reported here in conjunction with prior reports show that in Caucasian patients with schizophrenia, the T/T genotype at rs7330461 is consistently associated with an increased treatment response to pomaglumetad methionil compared to the A/A genotype. PMID:26861400

Serotonin 2A Receptor SNP rs7330461 Association with Treatment Response to Pomaglumetad Methionil in Patients with Schizophrenia.

PubMed

Nisenbaum, Laura K; Downing, AnnCatherine M; Zhao, Fangyi; Millen, Brian A; Munsie, Leanne; Kinon, Bruce J; Adams, David H; Gomez, Juan Carlos; Penny, Michelle Ann

2016-02-05

This study aims to confirm the initial pharmacogenetic finding observed within the clinical proof-of-concept trial of an enhanced response to treatment with pomaglumetad methionil (LY2140023 monohydrate) in Caucasian schizophrenia patients homozygous for T/T at single nucleotide polymorphism rs7330461 in the serotonin (5-hydroxytryptamine) 2A receptor gene compared to A/A homozygous patients. The effect of the rs7330461 genotype on the response to pomaglumetad methionil treatment was assessed in three additional clinical trials and in an integrated analysis. Overall, this study includes data from 1115 Caucasian patients for whom genotyping information for rs7330461 was available, consisting of 513 A/A homozygous, 466 A/T heterozygous and 136 T/T homozygous patients. Caucasian T/T homozygous patients showed significantly (p ≤ 0.05) greater improvement in Positive and Negative Syndrome Scale (PANSS) total scores during treatment with pomaglumetad methionil 40 mg twice daily compared to A/A homozygous patients. Additionally, T/T homozygous patients receiving pomaglumetad methionil had significantly (p ≤ 0.05) greater improvements in PANSS total scores compared to placebo and similar improvements as T/T homozygous patients receiving standard-of-care (SOC) treatment. The findings reported here in conjunction with prior reports show that in Caucasian patients with schizophrenia, the T/T genotype at rs7330461 is consistently associated with an increased treatment response to pomaglumetad methionil compared to the A/A genotype.

Whole Abdominopelvic Intensity-Modulated Radiation Therapy for Desmoplastic Small Round Cell Tumor After Surgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pinnix, Chelsea C.; Fontanilla, Hiral P.; Hayes-Jordan, Andrea

2012-05-01

Purpose: Desmoplastic small round cell tumor (DSCRT) is an uncommon pediatric tumor with a poor prognosis. Aggressive multimodality therapy is the current treatment approach; however. treatment toxicity is of concern. We report our results with whole abdominopelvic intensity-modulated radiation therapy (WAP-IMRT) as a component of multimodality therapy for DSCRT at a single institution. Materials/Methods: Medical records of all patients with DSCRT who received WAP-IMRT as part of definitive treatment at MD Anderson (2006-2010) were identified and reviewed. Results: Eight patients with DSRCT received WAP-IMRT with a median follow-up of 15.2 months. All patients received multiple courses of chemotherapy followed bymore » surgical debulking of intra-abdominal disease; seven also had intraoperative hyperthermic cisplatin. WAP-IMRT was delivered to a total dose of 30 Gy postoperatively; four patients received a simultaneous boost (6-10 Gy) to sites of gross residual disease. Seven patients received concurrent chemotherapy during WAP-IMRT. No Radiation Therapy Oncology Group Grade 4 nausea, vomiting, or diarrhea occurred during RT. Red-cell transfusions were given to two patients to maintain hemoglobin levels >10 g/dL. Grade 4 cytopenia requiring growth factor support occurred in only one patient; no other significant cytopenias were noted. WAP-IMRT resulted in 25% lower radiation doses to the lumbosacral vertebral bodies and pelvic bones than conventional RT plans. The median time to local or distant failure after WAP-IMRT was 8.73 months in seven patients. One patient who had completed RT 20 months before the last follow-up remains alive without evidence of disease. Five patients (63%) experienced treatment failure in the abdomen. Distant failure occurred in three patients (37.5%). Conclusions: WAP-IMRT with concurrent radiosensitizing chemotherapy was well tolerated after aggressive surgery for DSCRT. Enhanced bone sparing with IMRT probably accounts for the low hematologic toxicity (vs. conventional WAP-RT). This modality should be considered as an additional local-regional control option for DSRCT.« less

Ophthalmic patients' utilization of technology and social media: an assessment to improve quality of care.

PubMed

Aleo, Chelsea L; Hark, Lisa; Leiby, Benjamin; Dai, Yang; Murchison, Ann P; Martinez, Patricia; Haller, Julia A

2014-10-01

E-health tools have the potential to improve the quality of care for ophthalmic patients, many of whom have chronic conditions. However, little research has assessed ophthalmic patients' use or acceptance of technological devices and social media platforms for health-related purposes. The present study evaluated utilization of technological devices and social media platforms by eye clinic patients, as well as their willingness to receive health reminders through these technologies. A 31-item paper questionnaire was administered to eye clinic patients (n=843) at an urban, tertiary-care center. Questions focused on technology ownership, comfort levels, frequency of use, and preferences for receiving health reminders. Demographic data were also recorded. Eye clinic patients most commonly owned cellular phones (90%), landline phones (81%), and computers (80%). Overall, eye clinic patients preferred to receive health reminders through phone calls and e-mail and used these technologies frequently and with a high level of comfort. Less than 3% of patients preferred using social networking to receive health reminders. In addition, age was significantly associated with technology ownership, comfort level, and frequency of use (p<0.05). The majority of patients 18-45 years of age preferred to receive appointment reminders via text message (57%) and e-mail (53%). This age group also used these technologies more frequently and with a higher comfort level (p<0.001). These data support the proposal that e-mail and text-messaging e-health tools are likely to be immediately adopted by eye clinic patients and therefore have the greatest potential to improve health outcomes and increase quality of care. Eye clinic patients are interested in these technologies for appointment reminders, general eye and vision health information, asking urgent medical questions, and requesting prescription refills. Future controlled trials could further explore the efficacy of e-health tools for these purposes.

Post-operative analgesic effect of dexmedetomidine administration in wound infiltration for abdominal hysterectomy: A randomised control study

PubMed Central

Singh, Swati; Prasad, Chandrakant

2017-01-01

Background and Aims: Local infiltration of the surgical wound is one of the important components of multimodal analgesia for post-operative pain relief. This study determines the post-operative analgesic effect of addition of dexmedetomidine to bupivacaine for local infiltration of the surgical wound. Methods: Sixty women belonging to American Society of Anesthesiologists’ Grade 1 or 2 posted for abdominal hysterectomy were randomly allocated to Group I (control group) where patients received wound infiltration with 30 mL 0.25% bupivacaine at the end of surgery, or Group II, where patients received wound infiltration with 1.0 μg/kg dexmedetomidine diluted in 30 mL 0.25% bupivacaine. The primary objective of the study was to assess post-operative pain scores. Number of patients requiring rescue analgesia and total morphine consumption during 24 h after surgery were also recorded. Statistical significance for analgesic requirement was determined by one-way analysis of variance. Results: Pain scores were lower at rest for 12 h and on cough for 6 h in Group II (<0.01). All patients in Group I required supplemental morphine compared to only 3 patients in Group II (P < 0.003). Post-operative analgesia requirement was significantly less in patients receiving dexmedetomidine in wound infiltration compared to patients receiving bupivacaine alone (P < 0.001). Conclusions: Wound infiltration of dexmedetomidine with bupivacaine provides superior pain relief compared to bupivacaine alone. PMID:28655956

Stroke prevention in atrial fibrillation and 'real world' adherence to guidelines in the Balkan Region: The BALKAN-AF Survey.

PubMed

Potpara, Tatjana S; Dan, Gheorghe-Andrei; Trendafilova, Elina; Goda, Artan; Kusljugic, Zumreta; Manola, Sime; Music, Ljilja; Musetescu, Rodica; Badila, Elisabeta; Mitic, Gorana; Paparisto, Vilma; Dimitrova, Elena S; Polovina, Marija M; Petranov, Stanislav L; Djergo, Hortensia; Loncar, Daniela; Bijedic, Amira; Brusich, Sandro; Lip, Gregory Y H

2016-02-12

Data on the management of atrial fibrillation (AF) in the Balkan Region are limited. The Serbian AF Association (SAFA) prospectively investigated contemporary 'real-world' AF management in clinical practice in Albania, Bosnia&Herzegovina, Bulgaria, Croatia, Montenegro, Romania and Serbia through a 14-week (December 2014-February 2015) prospective, multicentre survey of consecutive AF patients. We report the results pertinent to stroke prevention strategies. Of 2712 enrolled patients, 2663 (98.2%) with complete data were included in this analysis (mean age 69.1 ± 10.9 years, female 44.6%). Overall, 1960 patients (73.6%) received oral anticoagulants (OAC) and 762 (28.6%) received antiplatelet drugs. Of patients given OAC, 17.2% received non-vitamin K antagonist oral anticoagulants (NOACs). CHA2DS2-VASc score was not significantly associated with OAC use. Of the 'truly low-risk' patients (CHA2DS2-VASc = 0 [males], or 1 [females]) 56.5% received OAC. Time in Therapeutic Range (TTR) was available in only 18.7% of patients (mean TTR: 49.5% ± 22.3%). Age ≥ 80 years, prior myocardial infarction and paroxysmal AF were independent predictors of OAC non-use. Our survey shows a relatively high overall use of OAC in AF patients, but with low quality of vitamin K antagonist therapy and insufficient adherence to AF guidelines. Additional efforts are needed to improve AF-related thromboprophylaxis in clinical practice in the Balkan Region.

Preoperative Radiotherapy of Advanced Rectal Cancer With Capecitabine and Oxaliplatin With or Without Cetuximab: A Pooled Analysis of Three Prospective Phase I-II Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Weiss, Christian, E-mail: christian.weiss@kgu.d; Arnold, Dirk; Dellas, Kathrin

2010-10-01

Purpose: A pooled analysis of three prospective trials of preoperative radiochemotherapy (RCT) for rectal cancer by using oxaliplatin and capecitabine with or without cetuximab was performed to evaluate the impact of additional cetuximab on pathologic complete response (pCR) rates and tumor regression (TRG) grades. Methods and Materials: Of 202 patients, 172 patients met the inclusion criteria (primary tumor stage II/III, M0). All patients received concurrent RCT, and 46 patients received additional cetuximab therapy. A correlation of pretreatment clinicopathologic factors and cetuximab treatment with early pCR rates (TRG > 50%) was performed with univariate and multivariate analyses. Toxicity data were recordedmore » for all patients. Results: Of 172 patients, 24 (14%) patients achieved a pCR, and 84 of 172 (71%) patients showed a TRG of >50% in the surgical specimen assessment after preoperative treatment. Age, gender, and T/N stages, as well as localization of the tumor, were not associated with pCR or good TRG. The pCR rate was 16% after preoperative RCT alone and 9% with concurrent cetuximab therapy (p = 0.32). A significantly reduced TRG of >50% was found after RCT with cetuximab compared to RCT alone (p = 0.0035). This was validated by a multivariate analysis with all available clinical factors (p = 0.0037). Acute toxicity and surgical complications were not increased with additional cetuximab. Conclusions: Triple therapy with RCT and cetuximab seems to be feasible, with no unexpected toxicity. Early response assessment (TRG), however, suggests subadditive interaction. A longer follow-up (and finally randomized trials) is needed to draw any firm conclusions with respect to local and distant failure rates.« less

The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ): testing the psychometric properties in patients receiving in-center hemodialysis.

PubMed

Kim, Youngmee; Evangelista, Lorraine S; Phillips, Linda R; Pavlish, Carol; Kopple, Joel D

2010-01-01

Reported treatment adherence rates of patients with end stage renal disease (ESRD) have been extremely varied due to lack of reliable and valid measurement tools. This study was conducted to develop and test an instrument to measure treatment adherence to hemodialysis (HD) attendance, medications, fluid restrictions, and diet prescription among patients with ESRD. This article describes the methodological approach used to develop and test the psychometric properties (such as reliability and validity) of the 46-item ESRD-Adherence Questionnaire (ESRD-AQ) in a cohort of patients receiving maintenance HD at dialysis centers in Los Angeles County. The ESRD-AQ is the first self-report instrument to address all components of adherence behaviors of patients with ESRD. The findings support that the instrument is reliable and valid and is easy to administer. Future studies are needed in a larger sample to determine whether additional modifications are needed.

Different mechanisms of risperidone result in improved interpersonal trust, social engagement and cooperative behavior in patients with schizophrenia compared to trifluoperazine.

PubMed

Tse, Wai Shing; Wong, Ann Siu Wah; Chan, Fu; Pang, Alfred Hin Tat; Bond, Alyson Jane; Chan, Chau Kiu Raymond

2016-05-01

Atypical antipsychotic treatment (e.g. risperidone) has been found to improve social functioning more than standard antipsychotic treatment. However, it is unclear which specific social behaviors are implicated in this improvement. The current study employed an interactive puzzle game to examine how social behaviors contribute to the improvement of social functioning by comparing patients receiving risperidone with those receiving trifluoperazine. Scores on the Positive and Negative Syndrome Scale, executive functioning, and social functioning were obtained from 24 patients with schizophrenia receiving either risperidone (n = 12) or trifluoperazine (n = 12), before their social behavior was measured in the interactive Tangrams Game. Immediately after the Tangrams Game, participants filled in two questionnaires measuring their interpersonal trust and rejection toward their game partner. Patients receiving risperidone showed more social engagement, cooperative behavior and interpersonal trust toward their game partners than those receiving trifluoperazine. Additional multivariate analysis of variance revealed that lower affiliative behavior was a function of positive symptoms; interpersonal trust had an impact on social engagement but executive functioning did not explain lower interpersonal trust or social disengagement. Improvement of social competence by risperidone might be related to the enhancement of both social behaviors and interpersonal trust as well as better symptom resolution. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: a randomized controlled trial.

PubMed

Moustafa, Ibrahim M; Diab, Aliaa A

2015-07-01

The aim of this study was to investigate the immediate and long-term effects of a one-year multimodal program, with the addition of upper cervical manipulative therapy, on fibromyalgia management outcomes in addition to three-dimensional (3D) postural measures. This randomized clinical trial with one-year follow-up was completed at the research laboratory of our university. A total of 120 (52 female) patients with fibromyalgia syndrome (FMS) and definite C1-2 joint dysfunction were randomly assigned to the control or an experimental group. Both groups received a multimodal program; additionally, the experimental group received upper cervical manipulative therapy. Primary outcomes were the Fibromyalgia Impact Questionnaire (FIQ), whereas secondary outcomes included Pain Catastrophizing Scale (PCS), algometric score, Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and 3D postural measures. Measures were assessed at three time intervals: baseline, 12 weeks, and 1 year after the 12-week follow-up. The general linear model with repeated measures indicated a significant group × time effect in favor of the experimental group on the measures of 3D postural parameters (P < .0005), FIQ (P < .0005), PCS (P < .0005), algometric score (F = P < .0005), PSQI (P < .0005), BAI (P < .0005), and BDI (P < .0005). The addition of the upper cervical manipulative therapy to a multimodal program is beneficial in treating patients with FMS.

Diagnosing periprosthetic joint infection: has the era of the biomarker arrived?

PubMed

Deirmengian, Carl; Kardos, Keith; Kilmartin, Patrick; Cameron, Alexander; Schiller, Kevin; Parvizi, Javad

2014-11-01

The diagnosis of periprosthetic joint infection (PJI) remains a serious clinical challenge. There is a pressing need for improved diagnostic testing methods; biomarkers offer one potentially promising approach. We evaluated the diagnostic characteristics of 16 promising synovial fluid biomarkers for the diagnosis of PJI. Synovial fluid was collected from 95 patients meeting the inclusion criteria of this prospective diagnostic study. All patients were being evaluated for a revision hip or knee arthroplasty, including patients with systemic inflammatory disease and those already receiving antibiotic treatment. The Musculoskeletal Infection Society (MSIS) definition was used to classify 29 PJIs and 66 aseptic joints. Synovial fluid samples were tested by immunoassay for 16 biomarkers optimized for use in synovial fluid. Sensitivity, specificity, and receiver operating characteristic curve analysis were performed to assess for diagnostic performance. Five biomarkers, including human α-defensin 1-3, neutrophil elastase 2, bactericidal/permeability-increasing protein, neutrophil gelatinase-associated lipocalin, and lactoferrin, correctly predicted the MSIS classification of all patients in this study, with 100% sensitivity and specificity for the diagnosis of PJI. An additional eight biomarkers demonstrated excellent diagnostic strength, with an area under the curve of greater than 0.9. Synovial fluid biomarkers exhibit a high accuracy in diagnosing PJI, even when including patients with systemic inflammatory disease and those receiving antibiotic treatment. Considering that these biomarkers match the results of the more complex MSIS definition of PJI, we believe that synovial fluid biomarkers can be a valuable addition to the methods utilized for the diagnosis of infection. Level II, diagnostic study. See Instructions for Authors for a complete description of levels of evidence.

Diabetes and risk of infections with immunomodulator therapy in inflammatory bowel diseases

PubMed Central

Ananthakrishnan, Ashwin N.; Cagan, Andrew; Cai, Tianxi; Gainer, Vivian S.; Shaw, Stanley Y; Churchill, Susanne; Karlson, Elizabeth W.; Murphy, Shawn N.; Kohane, Isaac; Liao, Katherine P.

2015-01-01

Background Infections are an important concern in patients using immunosuppressive therapy for their inflammatory bowel disease (IBD). Diabetes affects nearly 10% of Americans. Whether it confers an additional risk with immunosuppression in IBD has not been examined previously. Aim To examine the association between diabetes and infections with immunomodulator use in IBD Methods Using a validated, multi-institutional IBD cohort, we identified all patients who received at least one prescription for immunomodulators (thiopurines, methotrexate). Our primary outcome was infection within 1 year of the prescription of the immunomodulator. Multivariable logistic regression adjusting for relevant confounders was used to estimate the independent association with diabetes. Results Our study included 2,766 patients receiving at least one prescription for immunomodulators among whom 210(8%) developed an infection within 1 year. Patients who developed an infection were likely to be older, have more comorbidities, more likely to have received a prescription for steroids but similar in initiation of anti-TNF therapy within that year. Only 8% of those without an infection had diabetes compared to 19% of those who developed an infection within 1 year (Odds ratio (OR) 2.74, 95% confidence interval (CI) 1.88 – 3.98, p < 0.001). On multivariate analysis, diabetes was independently associated with a nearly two-fold increase in risk of infections (OR 1.80, 95% CI 1.20 – 2.68). There was no increase in risk of infections with addition of anti-TNF therapy (OR 1.14, 95% CI 0.80 – 1.63). Conclusions Diabetes is an independent risk factor for infection in IBD patients using immunomodulator therapy. PMID:25864945

Efficacy of adding the Kinesio Taping method to guideline-endorsed conventional physiotherapy in patients with chronic nonspecific low back pain: a randomised controlled trial.

PubMed

Added, Marco Aurélio Nemitalla; Costa, Leonardo Oliveira Pena; Fukuda, Thiago Yukio; de Freitas, Diego Galace; Salomão, Evelyn Cassia; Monteiro, Renan Lima; Costa, Lucíola da Cunha Menezes

2013-10-24

Chronic nonspecific low back pain is a significant health condition with high prevalence worldwide and it is associated with enormous costs to society. Clinical practice guidelines show that many interventions are available to treat patients with chronic low back pain, but the vast majority of these interventions have a modest effect in reducing pain and disability. An intervention that has been widespread in recent years is the use of elastic bandages called Kinesio Taping. Although Kinesio Taping has been used extensively in clinical practice, current evidence does not support the use of this intervention; however these conclusions are based on a small number of underpowered studies. Therefore, questions remain about the effectiveness of the Kinesio Taping method as an additional treatment to interventions, such as conventional physiotherapy, that have already been recommended by the current clinical practice guidelines in robust and high-quality randomised controlled trials. We aim to determine the effectiveness of the addition of the use of Kinesio Taping in patients with chronic nonspecific low back pain who receive guideline-endorsed conventional physiotherapy. One hundred and forty-eight patients will be randomly allocated to receive either conventional physiotherapy, which consists of a combination of manual therapy techniques, general exercises, and specific stabilisation exercises (Guideline-Endorsed Conventional Physiotherapy Group) or to receive conventional physiotherapy with the addition of Kinesio Taping to the lumbar spine (Conventional Physiotherapy plus Kinesio Taping Group) over a period of 5 weeks (10 sessions of treatment). Clinical outcomes (pain intensity, disability and global perceived effect) will be collected at baseline and at 5 weeks, 3 months, and 6 months after randomisation. We will also collect satisfaction with care and adverse effects after treatment. Data will be collected by a blinded assessor. All statistical analysis will be conducted following the principles of intention to treat, and the effects of treatment will be calculated using Linear Mixed Models. The results of this study will provide new information about the usefulness of Kinesio Taping as an additional component of a guideline-endorsed physiotherapy program in patients with chronic nonspecific low back pain.

Feasibility of a Cognitive-Behavioral and Environmental Intervention for Sleep-Wake Difficulties in Community-Dwelling Cancer Patients Receiving Palliative Care.

PubMed

Bernatchez, Marie Solange; Savard, Josée; Savard, Marie-Hélène; Aubin, Michèle

2018-05-14

High rates of sleep-wake difficulties have been found in patients with cancer receiving palliative care. Pharmacotherapy is the most frequently used treatment option to manage these difficulties despite numerous adverse effects and the absence of empirical evidence of its efficacy and innocuity in palliative care. This pilot study aimed to assess the feasibility and acceptability of a cognitive-behavioral and environmental intervention (CBT-E) to improve insomnia and hypersomnolence in patients with a poor functioning level and to collect preliminary data on its effects. Six patients with cancer receiving palliative care (Eastern Cooperative Oncology Group score 2-3), who had insomnia and/or hypersomnolence, received 1 CBT-E individual session at home. They applied the strategies for 3 weeks. Patients completed the Insomnia Severity Index, the Epworth Sleepiness Scale, a daily sleep diary, and a 24-hour actigraphic recording (7 days) at pretreatment and posttreatment, in addition to a semistructured interview (posttreatment). Participants found strategies easy to apply most of the time, and none was rated as impossible to use because of their health condition. However, their adherence and satisfaction toward CBT-E were highly variable. Results on the effects of CBT-E were heterogeneous, but improvements were observed in patients with a persistent insomnia disorder. The CBT-E protocol tested among this highly selected sample was fairly well received and suggested positive outcomes in some patients, particularly those with an insomnia complaint alone. Efforts should be pursued to adapt CBT-E and develop other nonpharmacological interventions, in order to provide an alternative to pharmacotherapy for sleep-wake difficulties in this population.

Postoperative analgesic efficacy of single-shot and continuous transversus abdominis plane block after laparoscopic cholecystectomy: A randomized controlled clinical trial.

PubMed

Choi, Yun-Mi; Byeon, Gyeong-Jo; Park, Soon-Ji; Ok, Young-Min; Shin, Sang-Wook; Yang, Kwangho

2017-06-01

To compare the analgesic efficacy of ultrasound-guided single-shot and continuous transversus abdominis plane (TAP) block to that of IV-PCA in patients undergoing laparoscopic cholecystectomy. Prospective randomized controlled trial. Post-anesthesia care unit and General ward. 108 American Society of Anesthesiologist (ASA) physical status I-II patients undergoing laparoscopic cholecystectomy. Group A received IV-PCA; group B received both ultrasound-guided single-shot TAP block with 0.2% ropivacaine (20mL) and IV-PCA; and group C received continuous TAP block using an ultrasound-guidance-inserted indwelling catheter. In group C, infusion of 0.2% ropivacaine at a basal rate of 3mL/h, bolus dose of 4mL, and a lockout interval of 30min was maintained for 48h postoperatively. The primary outcome was evaluated analgesic efficacy using the numeric rating scale (NRS) for 48h postoperatively. Other outcomes included the number of patients requiring additional analgesics, patient satisfaction with postoperative pain control, and incidence of postoperative adverse events. Compared to other groups, group C had higher deep abdominal NRS at 1h postoperatively (P<0.05), and lower incidence of postoperative urinary retention (P<0.05). There were no significant intergroup differences in the number of patients requiring additional analgesics, and patient satisfaction with postoperative pain control. Compared to IV-PCA with or without single-shot TAP block, ultrasound-guided continuous TAP block provided similar analgesia in somatic pain and less analgesia in visceral pain. Moreover, the latter resulted in a lower incidence of postoperative urinary retention. Copyright © 2017 Elsevier Inc. All rights reserved.

Impact of an Educational Program to Reduce Healthcare Resources in Community-Acquired Pneumonia: The EDUCAP Randomized Controlled Trial

PubMed Central

Simonetti, Antonella; Jiménez-Martínez, Emilio; Molero, Lorena; González-Samartino, Maribel; Castillo, Elena; Juvé-Udina, María-Eulalia; Alcocer, María-Jesús; Hernández, Carme; Buera, María-Pilar; Roel, Asunción; Abad, Emilia; Zabalegui, Adelaida; Ricart, Pilar; Gonzalez, Anna; Isla, Pilar; Dorca, Jordi; Garcia-Vidal, Carolina

2015-01-01

Background Additional healthcare visits and rehospitalizations after discharge are frequent among patients with community-acquired pneumonia (CAP) and have a major impact on healthcare costs. We aimed to determine whether the implementation of an individualized educational program for hospitalized patients with CAP would decrease subsequent healthcare visits and readmissions within 30 days of hospital discharge. Methods A multicenter, randomized trial was conducted from January 1, 2011 to October 31, 2014 at three hospitals in Spain. We randomly allocated immunocompetent adults patients hospitalized for CAP to receive either an individualized educational program or conventional information before discharge. The educational program included recommendations regarding fluid intake, adherence to drug therapy and preventive vaccines, knowledge and management of the disease, progressive adaptive physical activity, and counseling for alcohol and smoking cessation. The primary trial endpoint was a composite of the frequency of additional healthcare visits and rehospitalizations within 30 days of hospital discharge. Intention-to-treat analysis was performed. Results We assigned 102 patients to receive the individualized educational program and 105 to receive conventional information. The frequency of the composite primary end point was 23.5% following the individualized program and 42.9% following the conventional information (difference, -19.4%; 95% confidence interval, -6.5% to -31.2%; P = 0.003). Conclusions The implementation of an individualized educational program for hospitalized patients with CAP was effective in reducing subsequent healthcare visits and rehospitalizations within 30 days of discharge. Such a strategy may help optimize available healthcare resources and identify post-acute care needs in patients with CAP. Trial Registration Controlled-Trials.com ISRCTN39531840 PMID:26460907

Chest physiotherapy on the respiratory mechanics and elimination of sputum in paralyzed and mechanically ventilated patients with acute lung injury: a pilot study.

PubMed

Suh, Minhee; Heitkemper, Margaret; Smi, Choi-Kwon

2011-03-01

Chest physiotherapy (CPT) is commonly used for mechanically ventilated patients, but little is known about its physiological effects, particularly in patients with acute lung injury (ALI). The aim of the study was to determine the benefits and risks of delivering multimodal respiratory physiotherapy to mechanically ventilated patients with ALI receiving paralytic agents. A repeated measure-experimental design using a counterbalancing method was employed. Fifteen patients received CPT (vibration, percussion, or palm-cup percussion) in addition to the routine CPT in a randomized order. Another 15 patients, contraindicated for the percussion technique, received routine CPT including manual hyperinflation and position change, and were observed as a comparative group. The effects of CPT were evaluated by measuring the volume of aspirated secretions and the dynamic lung compliance (Cd) over time. For the adverse effects, peripheral oxygen saturation (SpO2) was recorded. Cd and SpO2 were recorded at the baseline period, immediately after the physiotherapy treatment, and at 10, 20, 30 and 60 minutes posttreatment. The volume of collected secretions did not differ significantly when compared between the groups (p = .838). Cd increased significantly over time in the manual percussion (p = .042) and palm-cup percussion (p = .046) group, where Cd in the latter remained elevated twice longer than in the former. None of the CPT techniques exerted major detrimental effects on SpO2. We found that the palm-cup percussion technique was the most effective in increasing Cd without any accompanying detrimental effects on SpO2. However, additional CPT did not affect the volume of aspirated secretions. Copyright © 2011 Korean Society of Nursing Science. Published by Elsevier B.V. All rights reserved.

Maraviroc Observational Study: The Impact of Expanded Resistance Testing and Clinical Considerations for Antiretroviral Regimen Selection in Treatment-Experienced Patients

PubMed Central

Wilkins, Sara-Anne; Tamhane, Ashutosh; Nevin, Christa R.; Mugavero, Michael J.; Raper, James L.; Napolitano, Laura A.; Saag, Michael S.

2013-01-01

Abstract Maraviroc (MVC) use has trailed that of other post-2006 antiretroviral therapy (ART) options for treatment-experienced patients. We explored the impact of free tropism testing on MVC utilization in our cohort and explored barriers to MVC utilization. The Maraviroc Outcomes Study (MOS) is an investigator-initiated industry-sponsored trial where consecutive ART-experienced patients receiving routine care with viral loads ≥1,000 copies/ml, and whose provider requested resistance testing and received standardized resistance testing (SRT; phenotype, genotype, coreceptor/tropism). Sociodemographic, clinical, and ART characteristics of those receiving SRT were compared to a historical cohort (HC). Subsequently, providers were surveyed regarding factors influencing selection of salvage ART therapy. The HC (n=165) had resistance testing 7/08–9/09, while prospective SRT (n=83) patients were enrolled 9/09–8/10. In the HC, 92% had genotypes, 2% had tropism assays, and 62% (n=102) changed ART after resistance testing (raltegravir 37%, etravirine 25%, darunavir 24%, MVC 1%). In the SRT cohort, 57% (n=48) changed regimens after standardized resistance testing (darunavir 48%, raltegravir 40%, and etravirine 19%). CCR5-tropic virus was identified in 43% of the SRT group, and MVC was used in 10% [or 20% of R5 tropic patients who underwent a subsequent regimen change (n=25)], a statistically significant (p=0.01) increase in utilization. The factors most strongly influencing utilization were unique patient circumstances (60%), clinical experience (55%), and potential side effects (40%). The addition of routine tropism testing to genotypic/phenotypic testing was associated with increased MVC utilization, raising the possibility that tropism testing may present a barrier to MVC use; however, additional barriers exist, and merit further evaluation. PMID:22881368

Interest in Integrative Medicine Among Postmenopausal Hormone Receptor–Positive Breast Cancer Patients in the EvAluate-TM Study

PubMed Central

Hack, Carolin C.; Fasching, Peter A.; Fehm, Tanja; de Waal, Johann; Rezai, Mahdi; Baier, Bernd; Baake, Gerold; Kolberg, Hans-Christian; Guggenberger, Martin; Warm, Mathias; Harbeck, Nadia; Wuerstlein, Rachel; Deuker, Jörg-Uwe; Dall, Peter; Richter, Barbara; Wachsmann, Grischa; Brucker, Cosima; Siebers, Jan W.; Fersis, Nikos; Kuhn, Thomas; Wolf, Christopher; Vollert, Hans-Walter; Breitbach, Georg-Peter; Janni, Wolfgang; Landthaler, Robert; Kohls, Andreas; Rezek, Daniela; Noesslet, Thomas; Fischer, Gunnar; Henschen, Stefan; Praetz, Thomas; Heyl, Volker; Kühn, Thorsten; Krauss, Thomas; Thomssen, Christoph; Hohn, Andre; Tesch, Hans; Mundhenke, Christoph; Hein, Alexander; Rauh, Claudia; Bayer, Christian M.; Jacob, Adib; Schmidt, Katja; Belleville, Erik; Hadji, Peyman; Brucker, Sara Y.; Wallwiener, Diethelm; Kümmel, Sherko; Beckmann, Matthias W.; Paepke, Daniela

2016-01-01

Background. Breast cancer patients often use complementary and alternative medicine, but few prospectively collected data on the topic are available specifically for postmenopausal breast cancer patients. A large prospective study was therefore conducted within a noninterventional study in order to identify the characteristics of patients interested in integrative medicine. Methods. The EvAluate-TM study is a prospective, multicenter noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor–positive primary breast cancer. Between 2008 and 2009, 5045 postmenopausal patients were enrolled at 339 certified breast centers in Germany. As part of the data collection process, patients were asked at the baseline about their interest in and information needs relating to integrative medicine. Results. Of the 5045 patients recruited, 3411 responded to the questionnaire on integrative medicine and took part in the analysis, 1583 patients expressed an interest in integrative medicine, and 1828 patients declared no interest. Relevant predictors of interest in integrative medicine were age, body mass index, tumor size, previous chemotherapy, and use of concomitant medications for other medical conditions. Interest in integrative medicine declined highly significantly (P < .001) with age (<50 years, 74.1%; 50-60 years, 54.1%; >65 years, 38.0%). Patients in favor of integrative medicine were significantly less satisfied with the information received about individual treatments and antihormonal therapy. Patients with interest in integrative medicine were more often interested in rehabilitation and fitness, nutritional counseling, and additional support from self-help organizations. These women were mostly interested in receiving information about their disease and integrative medicine from a physician, rather than from other sources. Conclusions. This study shows that a considerable proportion of postmenopausal breast cancer patients are interested in integrative medicine. Information about integrative medicine should therefore be provided as part of patient care for this group. It was found that receiving concomitant medication for other medical conditions is one of the main predictors for women not being interested in integrative medicine. This group of patients may need special attention and individualized information about integrative medicine. Additionally, most patients were interested in obtaining the relevant information from their doctor. PMID:27627986

Interest in Integrative Medicine Among Postmenopausal Hormone Receptor-Positive Breast Cancer Patients in the EvAluate-TM Study.

PubMed

Hack, Carolin C; Fasching, Peter A; Fehm, Tanja; de Waal, Johann; Rezai, Mahdi; Baier, Bernd; Baake, Gerold; Kolberg, Hans-Christian; Guggenberger, Martin; Warm, Mathias; Harbeck, Nadia; Wuerstlein, Rachel; Deuker, Jörg-Uwe; Dall, Peter; Richter, Barbara; Wachsmann, Grischa; Brucker, Cosima; Siebers, Jan W; Fersis, Nikos; Kuhn, Thomas; Wolf, Christopher; Vollert, Hans-Walter; Breitbach, Georg-Peter; Janni, Wolfgang; Landthaler, Robert; Kohls, Andreas; Rezek, Daniela; Noesslet, Thomas; Fischer, Gunnar; Henschen, Stefan; Praetz, Thomas; Heyl, Volker; Kühn, Thorsten; Krauss, Thomas; Thomssen, Christoph; Hohn, Andre; Tesch, Hans; Mundhenke, Christoph; Hein, Alexander; Rauh, Claudia; Bayer, Christian M; Jacob, Adib; Schmidt, Katja; Belleville, Erik; Hadji, Peyman; Brucker, Sara Y; Wallwiener, Diethelm; Kümmel, Sherko; Beckmann, Matthias W; Paepke, Daniela

2017-06-01

Breast cancer patients often use complementary and alternative medicine, but few prospectively collected data on the topic are available specifically for postmenopausal breast cancer patients. A large prospective study was therefore conducted within a noninterventional study in order to identify the characteristics of patients interested in integrative medicine. The EvAluate-TM study is a prospective, multicenter noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor-positive primary breast cancer. Between 2008 and 2009, 5045 postmenopausal patients were enrolled at 339 certified breast centers in Germany. As part of the data collection process, patients were asked at the baseline about their interest in and information needs relating to integrative medicine. Of the 5045 patients recruited, 3411 responded to the questionnaire on integrative medicine and took part in the analysis, 1583 patients expressed an interest in integrative medicine, and 1828 patients declared no interest. Relevant predictors of interest in integrative medicine were age, body mass index, tumor size, previous chemotherapy, and use of concomitant medications for other medical conditions. Interest in integrative medicine declined highly significantly ( P < .001) with age (<50 years, 74.1%; 50-60 years, 54.1%; >65 years, 38.0%). Patients in favor of integrative medicine were significantly less satisfied with the information received about individual treatments and antihormonal therapy. Patients with interest in integrative medicine were more often interested in rehabilitation and fitness, nutritional counseling, and additional support from self-help organizations. These women were mostly interested in receiving information about their disease and integrative medicine from a physician, rather than from other sources. This study shows that a considerable proportion of postmenopausal breast cancer patients are interested in integrative medicine. Information about integrative medicine should therefore be provided as part of patient care for this group. It was found that receiving concomitant medication for other medical conditions is one of the main predictors for women not being interested in integrative medicine. This group of patients may need special attention and individualized information about integrative medicine. Additionally, most patients were interested in obtaining the relevant information from their doctor.

Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

PubMed

Kilbourne, Amy M; Almirall, Daniel; Eisenberg, Daniel; Waxmonsky, Jeanette; Goodrich, David E; Fortney, John C; Kirchner, JoAnn E; Solberg, Leif I; Main, Deborah; Bauer, Mark S; Kyle, Julia; Murphy, Susan A; Nord, Kristina M; Thomas, Marshall R

2014-09-30

Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months. This study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N = 1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as < 50% patients receiving ≥ 3 EBP sessions) will be randomized to receive additional support from an EF or both EF/IF. Additionally, sites randomized to EF and still not responsive will be randomized to continue with EF alone or to receive EF/IF. The EF provides technical expertise in adapting LG in routine practice, whereas the on-site IF has direct reporting relationships to site leadership to support LG use in routine practice. The primary outcome is mental health-related quality of life; secondary outcomes include receipt of LG sessions, mood symptoms, implementation costs, and organizational change. This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF. ClinicalTrials.gov identifier: NCT02151331.

Pretreatment with myo-inositol in non polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study

PubMed Central

2012-01-01

Background Aim of this pilot study is to examine the effects of myo-inositol administration on ovarian response and oocytes and embryos quality in non PolyCystic Ovary Syndrome (PCOS) patients undergoing multiple follicular stimulation and in vitro insemination by conventional in vitro fertilization or by intracytoplasmic sperm injection. Methods One hundred non-PCOS women aged <40 years and with basal FSH <10 mUI/ml were down-regulated with triptorelin acetate from the mid-luteal phase for 2 weeks, before starting the stimulation protocol for oocytes recovery. All patients received rFSH, at a starting dose of 150 IU for 6 days. The dose was subsequently adjusted according to individual response. Group B (n = 50) received myo-inositol and folic acid for 3 months before the stimulation period and then during the stimulation itself. Group A (n-50) received only folic acid as additional treatment in the 3 months before and through treatment. Results Total length of the stimulation was similar between the two groups. Nevertheless, total amount of gonadotropins used to reach follicular maturation was found significantly lower in group B. In addition, the number of oocytes retrieved was significantly reduced in the group pretreated with myo-inositol. Clinical pregnancy and implantation rate were not significantly different in the two groups. Conclusions Our findings suggest that the addition of myo-inositol to folic acid in non PCOS-patients undergoing multiple follicular stimulation for in-vitro fertilization may reduce the numbers of mature oocytes and the dosage of rFSH whilst maintaining clinical pregnancy rate. Further, a trend in favor of increased incidence of implantation in the group pretreated with myo-inositol was apparent in this study. Further investigations are warranted to clarify this pharmacological approach, and the benefit it may hold for patients. PMID:22823904

Cognitive remediation therapy during treatment for alcohol dependence.

PubMed

Rupp, Claudia I; Kemmler, Georg; Kurz, Martin; Hinterhuber, Hartmann; Fleischhacker, W Wolfgang

2012-07-01

Cognitive impairments in individuals with alcohol dependence may interfere with the progress of treatment and contribute to the progression of the disease. This study aimed to determine whether cognitive remediation (CR) therapy applied during treatment for alcohol dependence improves cognitive functioning in alcohol-dependent inpatients. A secondary aim was to evaluate whether the benefits of CR generalize to noncognitive clinically meaningful outcomes at the end of inpatient treatment. Forty-one alcohol-dependent patients entering inpatient treatment for alcohol dependence were randomly assigned to receive conventional treatment (n = 21) or an additional 12 sessions of computer-assisted CR focusing on cognitive enhancement in attention/executive function and memory domains (n = 20). Assessments of cognitive abilities in these domains as well as of psychological well-being and alcohol craving were conducted at baseline (at the beginning of inpatient treatment) and after CR (at the end of treatment). Results indicated that, relative to patients completing conventional treatment, those who received supplemental CR showed significant improvement in attention/executive function and memory domains, particularly in attention (alertness, divided attention), working memory, and delayed memory (recall). In addition, patients receiving CR during alcohol-dependence treatment showed significantly greater improvements in psychological well-being (Symptom Checklist-90-Revised) and in the compulsion aspect of craving (Obsessive Compulsive Drinking Scale-German version). CR during inpatient treatment for alcohol dependence is effective in improving cognitive impairments in alcohol-dependent patients. The benefits generalize to noncognitive outcomes, demonstrating that CR may be an efficacious adjunctive intervention for the treatment of alcohol dependence.

Surface electrical stimulation in dysphagic Parkinson patients: a randomized clinical trial.

PubMed

Baijens, Laura W J; Speyer, Renée; Passos, Valéria Lima; Pilz, Walmari; van der Kruis, Jolien; Haarmans, Saskia; Desjardins-Rombouts, Christel

2013-11-01

A new treatment for oropharyngeal dysphagia in Parkinson's disease was evaluated in the present study. Prospective randomized controlled trial. The study describes the effects of surface electrical stimulation (SES) of the neck (submental region) in dysphagic Parkinson patients using different intensities of electrical current. Quasi-random allocation was performed when assigning patients to treatment groups. Three groups consisting of dysphagic patients with idiopathic Parkinson's disease (N = 90) received daily treatment for 15 days with periods of no treatment during the weekend. All three received traditional logopedic dysphagia treatment. In addition, two groups received SES, either motor-level or sensory-level stimulation. A standardized measurement protocol, including fiber optic endoscopic evaluation of swallowing (FEES) and videofluoroscopy of swallowing (VFS), was performed before and after therapy. A team of experienced raters was blinded to the treatment group and to the moment of measurement. Intrarater and interrater reliability were calculated. Using proportional odds models (POMs), some of the visuoperceptual ordinal outcome variables showed significant improvement in all groups following treatment. Following 15 days of SES of the submental region, few significant effects were found, suggesting a therapy effect of traditional logopedic dysphagia treatment without any additional influence of SES. On the grounds of this study, it is concluded that further research is needed on the exact mechanism of SES and its effects on the neural pathways involved in swallowing. Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Apatinib plus icotinib in treating advanced non-small cell lung cancer after icotinib treatment failure: a retrospective study

PubMed Central

Xu, Jianping; Liu, Xiaoyan; Yang, Sheng; Zhang, Xiangru; Shi, Yuankai

2017-01-01

Background Treatment failure frequently occurs in patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) who respond to EGFR tyrosine kinase inhibitors initially. This retrospective study tried to investigate the efficacy and safety of apatinib plus icotinib in patients with advanced NSCLC after icotinib treatment failure. Patients and methods This study comprised 27 patients with advanced NSCLC who had progressed after icotinib monotherapy. Initially, patients received oral icotinib (125 mg, tid) alone. When the disease progressed, they received icotinib plus apatinib (500 mg, qd, orally). Treatment was continued until disease progression, unacceptable toxicity or consent withdrawal. Results Followed up to December 2016, the median time of combined therapy was 7.47 months, and eight of 27 patients were dead. The median overall survival was not reached, and median progression-free survival (PFS) was 5.33 months (95% CI, 3.63–7.03 months). Moreover, the objective response rate (ORR) was 11.1%, and the disease control rate (DCR) was 81.5%. A total of 14 patients received combined therapy as the second-line treatment, and the ORR and DCR were 7.1% and 78.6%, respectively; 13 patients received drugs as the third- or later-line treatment, with an ORR and a DCR of 15.4% and 84.6%, respectively. In addition, 11 patients experienced icotinib monotherapy failure within 6 months with median PFS of 7.37 months, and 16 patients had progression after 6 months with median PFS of 2.60 months. The common drug-related toxic effects were hypertension (44.4%) and fatigue (37.0%). Conclusion Apatinib plus icotinib is efficacious in treating patients with advanced NSCLC after icotinib treatment failure, with acceptable toxic effects. PMID:29075129

Complications After Total Skin-Sparing Mastectomy and Expander-Implant Reconstruction: Effects of Radiation Therapy on the Stages of Reconstruction.

PubMed

Peled, Anne Warren; Sears, Marie; Wang, Frederick; Foster, Robert D; Alvarado, Michael; Wong, Jasmine; Ewing, Cheryl A; Sbitany, Hani; Esserman, Laura J; Fowble, Barbara

2018-01-01

Many patients undergoing total-skin sparing mastectomy (TSSM) and 2-staged expander-implant (TE-I) reconstruction require postmastectomy radiation therapy (PMRT). Additionally, many patients undergoing TSSM for recurrent cancer have a history of lumpectomy and radiation therapy (XRT). Few studies have looked at the impact of XRT on the stages of TE-I reconstruction. Patients undergoing TSSM and immediate TE-I reconstruction between 2006 and 2013 were identified from a prospectively maintained database. Rates of TE-I loss and severe infection requiring intravenous antibiotics were compared in patients with prior XRT (85 cases) and PMRT (133 cases). Complications were divided by stage of reconstruction: first stage (TSSM and TE placement) and second stage (TE-I exchange). Mean follow-up time was 2.5 years. Patients with prior XRT had more complications after the first stage of reconstruction than the second (TE-I loss: 15% vs 5%, P = 0.03; infection: 20% vs 8%, P = 0.04). Patients receiving PMRT had low complication rates after the first stage, when they had not yet received radiation (TE-I loss: 2%; infection: 5%). However, complication rates after TE-I exchange (TE-I loss, 18%; infection, 31%) were significantly higher, and nearly 4-fold higher than patients with prior XRT. Patients with prior XRT are at high risk for complications after the first stage of TE-I reconstruction after TSSM; however, the risk of complications at the second stage is comparable to patients without radiation exposure and significantly lower than patients receiving PMRT. Patients receiving radiation therapy should be given appropriate preoperative counseling regarding their risks.

Short Communication: Viral Suppression Is Associated with Increased Likelihood of Colorectal Cancer Screening Among Persons Living with HIV/AIDS.

PubMed

Burkholder, Greer A; Tamhane, Ashutosh R; Appell, Lauren E; Willig, James H; Saag, Michael S; Raper, James L; Westfall, Andrew O; Mugavero, Michael J

2015-05-01

With improved survival and aging, more persons living with HIV/AIDS (PLWHA) are at risk for colorectal cancer (CRC). This retrospective longitudinal study evaluated patient characteristics associated with CRC screening in our HIV cohort. Patients were followed beginning at age 50 years during a study period from January 1, 2003 to December 31, 2010 (n=265). During a median follow-up time of 1.7 years, only 30% of patients underwent CRC screening. The majority of screened patients received endoscopic screening (colonoscopy, 86%; sigmoidoscopy, 8%); among these patients, results were available for 68/75, and adenomatous polyps were found in 13%. No cases of CRC were reported. Among unscreened patients, only 23% had an external primary care provider, indicating an HIV provider was the expected source for CRC screening referral in the majority. Patients with time-varying suppressed HIV viral load were more likely to receive screening (HRadjusted=1.74; 95% CI: 1.05-2.87), independent of CD4 count. Our findings suggest HIV providers are more likely to address non-HIV-related healthcare maintenance when HIV is controlled. In addition, a significant number of neoplastic lesions are likely being missed in PLWHA who have not been screened for CRC. Provision of evidence-based preventive care in addition to HIV care is required for the aging population of PLWHA.

Safety and efficacy of uric acid in patients with acute stroke (URICO-ICTUS): a randomised, double-blind phase 2b/3 trial.

PubMed

Chamorro, Angel; Amaro, Sergio; Castellanos, Mar; Segura, Tomás; Arenillas, Juan; Martí-Fábregas, Joan; Gállego, Jaime; Krupinski, Jurek; Gomis, Meritxell; Cánovas, David; Carné, Xavier; Deulofeu, Ramón; Román, Luis San; Oleaga, Laura; Torres, Ferran; Planas, Anna M

2014-05-01

Uric acid is an antioxidant with neuroprotective effects in experimental models of stroke. We assessed whether uric acid therapy would improve functional outcomes at 90 days in patients with acute ischaemic stroke. URICO-ICTUS was a randomised, double-blind, placebo-controlled, phase 2b/3 trial that recruited patients with acute ischaemic stroke admitted to ten Spanish stroke centres. Patients were included if they were aged 18 years or older, had received alteplase within 4·5 h of symptom onset, and had an eligible National Institutes of Health Stroke Scale (NIHSS) score (>6 and ≤25) and premorbid (assessed by anamnesis) modified Rankin Scale (mRS) score (≤2). Patients were randomly allocated (1:1) to receive uric acid 1000 mg or placebo (both infused intravenously in 90 min during the infusion of alteplase), stratified by centre and baseline stroke severity. The primary outcome was the proportion of patients with excellent outcome (ie, an mRS score of 0-1, or 2 if premorbid score was 2) at 90 days, analysed in the target population (all randomly assigned patients who had been correctly diagnosed with ischaemic stroke and had begun study medication). The study is registered with ClinicalTrials.gov, number NCT00860366. Between July 1, 2011, and April 30, 2013, we randomly assigned 421 patients, of whom 411 (98%) were included in the target population (211 received uric acid and 200 received placebo). 83 (39%) patients who received uric acid and 66 (33%) patients who received placebo had an excellent outcome (adjusted risk ratio 1·23 [95% CI 0·96-1·56]; p=0·099). No clinically relevant or statistically significant differences were reported between groups with respect to death (28 [13%] patients who received uric acid vs 31 [16%] who received placebo), symptomatic intracerebral haemorrhage (nine [4%] vs six [3%]), and gouty arthritis (one [<1%] vs four [2%]). 516 adverse events occurred in the uric acid group and 532 in the placebo group, of which 61 (12%) and 67 (13%), respectively, were serious adverse events (p=0·703). The addition of uric acid to thrombolytic therapy did not increase the proportion of patients who achieved excellent outcome after stroke compared with placebo, but it did not lead to any safety concerns. Institute of Health Carlos III of the Spanish Ministry of Health and Fundación Doctor Melchor Colet. Copyright © 2014 Elsevier Ltd. All rights reserved.

Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study.

PubMed

Bussel, James B; de Miguel, Purificación Garcia; Despotovic, Jenny M; Grainger, John D; Sevilla, Julián; Blanchette, Victor S; Krishnamurti, Lakshmanan; Connor, Philip; David, Michèle; Boayue, Koh B; Matthews, Dana C; Lambert, Michele P; Marcello, Lisa M; Iyengar, Malini; Chan, Geoffrey W; Chagin, Karen D; Theodore, Dickens; Bailey, Christine K; Bakshi, Kalpana K

2015-08-01

The oral thrombopoietin receptor agonist eltrombopag is approved for treatment of adults with chronic immune thrombocytopenia. In the PETIT trial, we aimed to investigate the efficacy and safety of eltrombopag in children with persistent or chronic immune thrombocytopenia. PETIT was a three-part, randomised, multicentre, placebo-controlled study done at 22 centres in the USA, UK, Canada, Spain, France, and the Netherlands. Patients aged 1-17 years with immune thrombocytopenia lasting for 6 months or longer and platelets less than 30 × 10(9) per L who had received at least one previous treatment were enrolled. We enrolled patients into three cohorts consisting of patients aged 12-17, 6-11, and 1-5 years. We established patients' starting doses with an open-label, dose-finding phase with five patients in each cohort. During the dose-finding phase, patients aged 6-17 years started eltrombopag at 25 mg once per day (12·5 mg for those weighing <27 kg) and patients aged 1-5 years received 0·7 mg/kg per day to a maximum of 2 mg/kg unless otherwise approved. We permitted dose adjustments on the basis of platelet response up to a maximum dosage of 75 mg per day. Additional patients were then recruited and randomly assigned (2:1) to receive either eltrombopag or placebo tablets (or oral suspension formulation if aged 1-5 years) once per day for 7 weeks at the previously established doses. Starting doses for the double-blind phase were 37·5 mg/day for patients aged 12-17 years; 50 mg/day for patients weighing 27 kg or more (25 mg for east Asian patients) and 25 mg/day for patients weighing less than 27 kg (12·5 mg once per day for east Asian patients) for patients aged 6-11 years; and 1·5 mg/kg once per day (0·8 mg/kg once per day for east Asian patients) for patients aged 1-5 years. Randomisation was done by the GlaxoSmithKline Registration/Medication Ordering System and both patients and study personnel were masked to treatment assignments. Patients who completed treatment were then enrolled into an open-label phase and all patients could receive up to 24 weeks of eltrombopag. The primary outcome was the proportion of patients achieving a platelet count of 50 × 10(9) per L or more at least once from weeks 1-6 (days 8 to 43) of the randomised phase of the study in the absence of rescue therapy. We assessed efficacy in the intent-to-treat population, which consisted of all patients assigned to treatment, and we assessed safety in all patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT00908037. Between Oct 2, 2009, and June 22, 2011, we recruited 15 patients, with five patients in each age cohort, into the open-label dose-finding phase who did not progress into the double-blind phase. From March 17, 2010, to Jan 15, 2013, we randomly assigned 67 patients to treatment, with 45 patients assigned to receive eltrombopag (16 children aged 12-17 years, 19 aged 6-11 years, and ten aged 1-5 years) and 22 to receive placebo (eight children aged 12-17 years, nine aged 6-11 years, and five aged 1-5 years). However, two patients assigned to receive eltrombopag did not receive the study drug and one was lost to follow-up, and one patient assigned to receive placebo was given eltrombopag. From weeks 1 to 6, 28 (62%) patients who received eltrombopag, compared with seven (32%) who received placebo, achieved the primary endpoint of platelet count 50 × 10(9) per L or more at least once without rescue (odds ratio 4·31, 95% CI 1·39-13·34, p=0·011). The most common adverse events with eltrombopag were headache (13 [30%] patients receiving eltrombopag vs nine [43%] patients receiving placebo), upper respiratory tract infection (11 [25%] patients vs two [10%] patients), and diarrhoea (seven [16%] patients vs one [5%] patient). Grade 3 or 4 adverse events occurred in five (11%) patients receiving eltrombopag and four (19%) patients receiving placebo, and serious adverse events (four [9%] patients receiving eltrombopag and two (10%) patients receiving placebo) were similarly infrequent in both groups. No thrombotic events or malignancies occurred. Increased alanine aminotransferase concentrations caused two (3%) of 65 patients to discontinue eltrombopag in the open-label phase. Our results showed that eltrombopag could be used to increase platelet counts and reduce clinically significant bleeding in children with persistent or chronic immune thrombocytopenia. Prevalence of increased liver laboratory values was similar to that seen in adults. GlaxoSmithKline. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Use of physical factors in the complex therapy of patients with diabetic angio- and polyneuropathies of the lower extremities].

PubMed

Shablinskaia, N B

2002-01-01

Results are submitted of treatment of 110 patients with diabetes mellitus (61 male and 49 female subjects) presenting with angio- and polyneuropathies of the lower extremities. 70 patients, in addition to a drug therapy, were administered physiotherapeutic treatments, such as amplipulsetherapy, darsonvalization, and laserotherapy. Forty patients received medicamentous therapy only. Based on clinical findings and laboratory methods of investigation expediency has been shown of employment of physiotherapeutic methods in the treatment of the above pathology.

The anchor-based minimal important change, based on receiver operating characteristic analysis or predictive modeling, may need to be adjusted for the proportion of improved patients.

PubMed

Terluin, Berend; Eekhout, Iris; Terwee, Caroline B

2017-03-01

Patients have their individual minimal important changes (iMICs) as their personal benchmarks to determine whether a perceived health-related quality of life (HRQOL) change constitutes a (minimally) important change for them. We denote the mean iMIC in a group of patients as the "genuine MIC" (gMIC). The aims of this paper are (1) to examine the relationship between the gMIC and the anchor-based minimal important change (MIC), determined by receiver operating characteristic analysis or by predictive modeling; (2) to examine the impact of the proportion of improved patients on these MICs; and (3) to explore the possibility to adjust the MIC for the influence of the proportion of improved patients. Multiple simulations of patient samples involved in anchor-based MIC studies with different characteristics of HRQOL (change) scores and distributions of iMICs. In addition, a real data set is analyzed for illustration. The receiver operating characteristic-based and predictive modeling MICs equal the gMIC when the proportion of improved patients equals 0.5. The MIC is estimated higher than the gMIC when the proportion improved is greater than 0.5, and the MIC is estimated lower than the gMIC when the proportion improved is less than 0.5. Using an equation including the predictive modeling MIC, the log-odds of improvement, the standard deviation of the HRQOL change score, and the correlation between the HRQOL change score and the anchor results in an adjusted MIC reflecting the gMIC irrespective of the proportion of improved patients. Adjusting the predictive modeling MIC for the proportion of improved patients assures that the adjusted MIC reflects the gMIC. We assumed normal distributions and global perceived change scores that were independent on the follow-up score. Additionally, floor and ceiling effects were not taken into account. Copyright © 2017 Elsevier Inc. All rights reserved.

Geographic and socioeconomic factors in patients with malignant pleural mesothelioma in New South Wales and their impact upon clinical outcomes.

PubMed

Linton, Anthony; Soeberg, Matthew; Broome, Richard; Kao, Steven; van Zandwijk, Nico

2017-07-01

Whilst the impact of clinicopathological factors on the prognosis of malignant pleural mesothelioma (MPM) is well understood, socioeconomic and geographic factors have received less attention. We analysed the relationship between geographic and socioeconomic factors upon survival and treatment provision in a large series of patients with MPM. We assessed MPM patients awarded compensation between 2002 and 2009 with additional MPM incidence data from the New South Wales (NSW) Cancer Registry. The impact of geographic remoteness, distance from oncological multidisciplinary team (MDT) and Index of Relative Socioeconomic Advantage and Disadvantage (IRSAD) upon survival, clinical features and treatment received was analysed. We identified 910 patients (67% residing in major cities; 92% <50 km from MDT). Median overall survival was 10.0 months. On multivariate analysis, age >70 (hazard ratio (HR) = 1.39), male gender (HR =1.36), non-epithelioid histological subtype (HR = 2.18) and IRSAD status by decreasing quintile (HR = 1.06) were independent prognostic factors. There was no significant advantage for patients residing in major cities (10.6 months vs 8.8 months; P = 0.162) or within 50 km of MDT (10.3 months vs 7.8 months; P = 0.539). Patient's geographic location and distance to MDT did not impact chemotherapy, adjuvant radiotherapy or extrapleural pneumonectomy provision. Socioeconomically disadvantaged patients were significantly less likely to receive chemotherapy (37.4% vs 54.8%; P = 0.001). This study provides evidence for differences in the treatment and survival according to socioeconomic status for compensated MPM patients in NSW. Further research is warranted to seek additional explanations for the differences noted by comparing the treatments and outcomes of compensated and non-compensated MPM patients in NSW. © 2017 Asian Pacific Society of Respirology.

Complete filter-based cerebral embolic protection with transcatheter aortic valve replacement.

PubMed

Van Gils, Lennart; Kroon, Herbert; Daemen, Joost; Ren, Claire; Maugenest, Anne-Marie; Schipper, Marguerite; De Jaegere, Peter P; Van Mieghem, Nicolas M

2018-03-01

To evaluate the value of left vertebral artery filter protection in addition to the current filter-based embolic protection technology to achieve complete cerebral protection during TAVR. The occurrence of cerebrovascular events after transcatheter aortic valve replacement (TAVR) has fueled concern for its potential application in younger patients with longer life expectancy. Transcatheter cerebral embolic protection (TCEP) devices may limit periprocedural cerebrovascular events by preventing macro and micro-embolization to the brain. Conventional filter-based TCEP devices cover three extracranial contributories to the brain, yet leave the left vertebral artery unprotected. Patients underwent TAVR with complete TCEP. A dual-filter system was deployed in the brachiocephalic trunk and left common carotid artery with an additional single filter in the left vertebral artery. After TAVR all filters were retrieved and sent for histopathological evaluation by an experienced pathologist. Eleven patients received a dual-filter system and nine of them received an additional left vertebral filter. In the remaining two patients, the left vertebral filter could not be deployed. No periprocedural strokes occurred. We found debris in all filters, consisting of thrombus, tissue derived debris, and foreign body material. The left vertebral filter contained debris in an equal amount of patients as the Sentinel filters. The size of the captured particles was similar between all filters. The left vertebral artery is an important entry route for embolic material to the brain during TAVR. Selective filter protection of the left vertebral artery revealed embolic debris in all patients. The clinical value of complete filter-based TCEP during TAVR warrants further research. © 2017 Wiley Periodicals, Inc.

Probiotic Fermented Milk Containing Dietary Fiber Has Additive Effects in IBS with Constipation Compared to Plain Probiotic Fermented Milk.

PubMed

Choi, Sung Chul; Kim, Beom Jin; Rhee, Poong-Lyul; Chang, Dong Kyung; Son, Hee Jung; Kim, Jae J; Rhee, Jong Chul; Kim, Soon Im; Han, Young Sil; Sim, Ki Hyeon; Park, Seok Nam

2011-03-01

Although controversial, probiotics and dietary fiber are commonly used for patients with irritable bowel syndrome (IBS). We evaluated the effects of multistrain probiotics on the symptoms of IBS to determine whether the addition of dietary fi ber had an additive effect on constipation-predominant IBS. A total of 142 participants who met the Rome III criteria were recruited and randomized into a control group or a test group. Participants in the control group received multistrain probiotic fermented milk with Streptococcus thermophilus, Lactobacillus acidophilus and Bifidobacterium infantis; the participants in the test group received the same probiotic fermented milk mixed with dietary fi ber such as sea tangle extracts, radish extracts and glasswort extracts. The patients were treated for four weeks. Most of the symptoms of IBS, with the exception of fl atulence, stool consistency, and frequency of defecation, signifi cantly improved in both groups. In the analysis of IBS subtypes, especially constipation-predominant IBS, the frequency and duration of defecation and straining at stool were improved more in the test group than in the control group. Dietary fiber had additive benefits for the symptoms of constipation, especially in constipation-predominant IBS.

Significance of KRAS, NRAS, BRAF and PIK3CA mutations in metastatic colorectal cancer patients receiving Bevacizumab: a single institution experience

PubMed Central

Baltruškevičienė, Edita; Mickys, Ugnius; Žvirblis, Tadas; Stulpinas, Rokas; Pipirienė Želvienė, Teresė; Aleknavičius, Eduardas

2016-01-01

Background. KRAS mutation is an important predictive and prognostic factor for patients receiving anti-EGFR therapy. An expanded KRAS, NRAS, BRAF, PIK3CA mutation analysis provides additional prognostic information, but its role in predicting bevacizumab efficacy is unclear. The aim of our study was to evaluate the incidence of KRAS, NRAS, BRAF and PIK3CA mutations in metastatic colorectal cancer patients receiving first line oxaliplatin based chemotherapy with or without bevacizumab and to evaluate their prognostic and predictive significance. Methods. 55 patients with the first-time diagnosed CRC receiving FOLFOX ± bevacizumab were involved in the study. Tumour blocks were tested for KRAS mutations in exons 2, 3 and 4, NRAS mutations in exons 2, 3 and 4, BRAF mutation in exon 15 and PIK3CA mutations in exons 9 and 20. The association between mutations and clinico-pathological factors, treatment outcomes and survival was analyzed. Results. KRAS mutations were detected in 67.3% of the patients, BRAF in 1.8%, PIK3CA in 5.5% and there were no NRAS mutations. A significant association between the high CA 19–9 level and KRAS mutation was detected (mean CA 19–9 levels were 276 and 87 kIU/l, respectively, p = 0.019). There was a significantly higher response rate in the KRAS, NRAS, BRAF and PIK3CA wild type cohort receiving bevacizumab compared to any gene mutant type (100 and 60%, respectively, p = 0.030). The univariate Cox regression analysis did not confirm KRAS and other tested mutations as prognostic factors for PFS or OS. Conclusions. Our study revealed higher KRAS and lower NRAS, BRAF and PIK3CA mutation rates in the Lithuanian population than those reported in the literature. KRAS mutation was associated with the high CA 19–9 level and mucinous histology type, but did not show any predictive or prognostic significance. The expanded KRAS, NRAS, BRAF and PIK3CA mutation analysis provided additional significant predictive information. PMID:28356789

Factors influencing transitional care from adolescents to young adults with cancer in Taiwan: A population-based study.

PubMed

Jin, Yo-Ting; Chen, Chin-Mi; Chien, Wu-Chien

2016-08-02

To investigate the progress of transition from paediatric to adult health care for patients with cancer in Taiwan's medical system. The data were retrieved from the Longitudinal Health Insurance Database (LHID), which contains the original inpatient and outpatient medical claims data for 1,000,000 enrollees randomly sampled from the NHIRD between 1997 and 2010. Among the 1,411 cancer patients selected for this study, 98.09 % received adult-oriented therapy before the age of 18. In addition, only 1.91 % of the patients received paediatric-oriented therapy during adolescence. The primary factors that determine whether these patients would receive paediatric-oriented therapy or adult-oriented therapy at an early age were as follows: the age of the patient at the first visit and the performance-level of the hospital (p < 0.001). Previous studies conducted in developed countries have demonstrated that the unwillingness of patients to switch from paediatric-oriented therapy to adult-oriented therapy being the major obstacle that hinders the transition process. However, this study revealed a different result: the implementation of the National Health Insurance system in Taiwan makes healthcare affordable for the adolescent patients who may not possess adequate knowledge about paediatric health care and may not appreciate paediatric-oriented therapy, thereby hindering the transition process.

Delayed haemolysis secondary to treatment of severe malaria with intravenous artesunate: Report on the experience of a referral centre for tropical infections in Spain.

PubMed

Aldámiz-Echevarría Lois, Teresa; López-Polín, Ana; Norman, Francesca F; Monge-Maillo, Begoña; López-Vélez, Rogelio; Perez-Molina, Jose A

Post-artesunate delayed haemolysis is described as hemolytic anemia presenting days after malaria treatment in hyperparasitemic patients. Physiopathological mechanisms and clinical manifestations have not been thoroughly characterised. We conducted a retrospective study of hospitalised malaria patients who received artemisinin derivatives from January 1, 2010 to December 31, 2015. 21 patients were included in the study: 11 travellers, 8 travellers visiting friends and relatives and 2 immigrants. Median age was 35.5 years (IQR: 25.7-44.8) and 11 were men. Eight patients received oral and 13 received intravenous (IV) artemisinin-based drugs. Follow-up after the malaria episode was available for 15 patients (12 with IV treatment). Four patients presented with delayed haemolysis 9-14 days after artesunate treatment; all had been admitted with severe malaria, were treated IV and had hyperparasitaemia (17%-33%). Other than hyperparasitaemia, no other factors were associated with artesunate haemolysis. Patients' outcomes were favourable and the only additional therapeutic measure needed was a blood transfusion. Delayed haemolysis is a frequent complication in hyperparasitemic malaria treated with IV artesunate. Follow-up is mandatory for at least 2 weeks after treatment initiation. This condition is potentially severe but does not appear to be life threatening. Copyright © 2016 Elsevier Ltd. All rights reserved.

B-IGEV (bortezomib plus IGEV) versus IGEV before high-dose chemotherapy followed by autologous stem cell transplantation in relapsed or refractory Hodgkin lymphoma: a randomized, phase II trial of the Fondazione Italiana Linfomi (FIL).

PubMed

Balzarotti, Monica; Brusamolino, Ercole; Angelucci, Emanuele; Carella, Angelo Michele; Vitolo, Umberto; Russo, Eleonora; Congiu, Angelagiovanna; Gotti, Manuel; Massidda, Stefania; Botto, Barbara; Annechini, Giorgia; Spina, Michele; Re, Alessandro; Zilioli, Vittorio Ruggero; Merli, Francesco; Salvi, Flavia; Stelitano, Caterina; Bonfichi, Maurizio; Rodari, Marcello; Murru, Roberta; Magagnoli, Massimo; Anastasia, Antonella; Mazza, Rita; Giordano, Laura; Santoro, Armando

2016-10-01

This randomized, multicenter study evaluates the addition of bortezomib (13 mg/m(2)) to IGEV (B-IGEV) in patients with relapsed/refractory Hodgkin Lymphoma (HL). Patients received either four courses of IGEV alone (n = 40) or B-IGEV (n = 40). The primary endpoint was the complete response (CR) proportion, evaluated by FDG-PET, after induction chemotherapy. CR proportion was 39% with B-IGEV and 53% with IGEV. PFS and OS were similar between the two groups (two-year PFS: 58% vs 56%; two-year OS: 93% vs 81%). The PET-negative status after treatment was the only variable favorably influencing both PFS (two-year PFS: 77% vs 40%; p = 0.002) and OS (two-year OS: 100% vs 76%; p < 0.001). Toxicity was overall similar with the two regimens. The addition of bortezomib to IGEV does not improve response in relapsed/refractory HL patients. However, its favorable therapeutic and safety profile, and the prognostic role of pre-transplant PET negativity in patients receiving IGEV-based regimens are confirmed.

Comparison of the Safety and Effectiveness of Apixaban versus Warfarin in Patients with Severe Renal Impairment.

PubMed

Stanton, Brooke E; Barasch, Naomi S; Tellor, Katie B

2017-04-01

The U.S. Food and Drug Administration approval of the use of apixaban in patients with a creatinine clearance (CrCl) of < 15 ml/minute or in those receiving dialysis is based only on pharmacokinetic data as clinical trials of apixaban excluded patients with a CrCl of < 25 ml/minute or a serum creatinine concentration (SCr) of > 2.5 mg/dl. Thus, the objective of this study was to evaluate the safety and effectiveness of apixaban versus warfarin in patients with severe renal impairment. Retrospective, matched-cohort study. Community hospital. A total of 146 adults who received at least one dose of apixaban (73 patients) or warfarin (73 patients) while hospitalized between January 30, 2014, and December 31, 2015, and had a CrCl of < 25 ml/minute or SCr of > 2.5 mg/dl, or who received peritoneal dialysis or hemodialysis, were included. Patients who were taking warfarin and had a therapeutic international normalized ratio on admission were matched consecutively in a 1:1 fashion in chronologic order to patients taking apixaban based on renal function and indication for anticoagulation. The primary outcome was major bleeding. Secondary outcomes included the composite of bleeding (major bleeding, clinically relevant nonmajor bleeding, and minor bleeding) in addition to documented ischemic stroke or recurrent venous thromboembolism. A nonsignificant difference in the occurrence of major bleeding and composite bleeding was observed between patients who received apixaban compared with those who received warfarin (9.6% vs 17.8%, p=0.149, and 21.9% vs 27.4%, p=0.442, respectively). The occurrence of stroke was similar between the groups (7.5% in each group), and no recurrent venous thromboembolism events were noted in either group during the study period. Apixaban appears to be a reasonable alternative to warfarin in patients with severe renal impairment. © 2017 Pharmacotherapy Publications, Inc.

Patients' level of satisfaction and self-reports of intention to comply following consultation with nurses and midwives with prescriptive authority: a cross-sectional survey.

PubMed

Drennan, Jonathan; Naughton, Corina; Allen, Deirdre; Hyde, Abbey; O'Boyle, Kathy; Felle, Patrick; Treacy, Margaret Pearl; Butler, Michelle

2011-07-01

Prescriptive authority for nurses and midwives was introduced in Ireland in 2007. This allows nurses and midwives who have completed a prescribing preparation programme to independently prescribe a wide-range of medications. To date little is known of patient outcomes such as satisfaction with the consultation process and intention to comply as a consequence of the introduction of nurse and midwife prescribing. There are four principal objectives within this study: (1) to measure the level of patients' satisfaction with education and advice received from a nurse or midwife with a prescribing remit; (2) to measure patients' satisfaction with the consultation process; (3) to measure patients' self-reports of their intention to comply with the prescriber's prescription and advice; and (4) to identify the variables that predict patients' intention to comply with the prescription and advice provided by a nurse or midwife with prescriptive authority. Cross-sectional descriptive survey. A total of one hundred and forty respondents completed the survey. Respondents consisted of adult patients who had received a prescription from a nurse prescriber in a general hospital, women who had received a prescription from a midwife in a maternity hospital and parents whose child received a prescription from a nurse in a children's hospital. Instruments used to measure patient outcomes included the Consultation Satisfaction Questionnaire (CSQ) and the compliance intent subscale of the Medical Interview Satisfaction Scale (MISS). A linear multiple regression model was performed to identify the variables that predicted patients' intent to comply. Patients and parents surveyed were highly satisfied with the care they received from nurses and midwives with prescriptive authority. Respondents also reported that they received comprehensive education and advice. Predictors of compliance intent included patient satisfaction with the time spent with the nurse or midwife during the prescribing consultation, overall satisfaction with the consultation process and patients' health status. Extending a prescribing remit to nurses and midwives has been an effective addition to the provision of health care. Providing patients with time to address their questions and concerns during the consultation process impacts positively on patient outcomes and develops a philosophy of concordance between the patient and nurse/midwife prescriber. Copyright © 2011 Elsevier Ltd. All rights reserved.

Development and validation of a gene profile predicting benefit of postmastectomy radiotherapy in patients with high-risk breast cancer: a study of gene expression in the DBCG82bc cohort.

PubMed

Tramm, Trine; Mohammed, Hayat; Myhre, Simen; Kyndi, Marianne; Alsner, Jan; Børresen-Dale, Anne-Lise; Sørlie, Therese; Frigessi, Arnoldo; Overgaard, Jens

2014-10-15

To identify genes predicting benefit of radiotherapy in patients with high-risk breast cancer treated with systemic therapy and randomized to receive or not receive postmastectomy radiotherapy (PMRT). The study was based on the Danish Breast Cancer Cooperative Group (DBCG82bc) cohort. Gene-expression analysis was performed in a training set of frozen tumor tissue from 191 patients. Genes were identified through the Lasso method with the endpoint being locoregional recurrence (LRR). A weighted gene-expression index (DBCG-RT profile) was calculated and transferred to quantitative real-time PCR (qRT-PCR) in corresponding formalin-fixed, paraffin-embedded (FFPE) samples, before validation in FFPE from 112 additional patients. Seven genes were identified, and the derived DBCG-RT profile divided the 191 patients into "high LRR risk" and "low LRR risk" groups. PMRT significantly reduced risk of LRR in "high LRR risk" patients, whereas "low LRR risk" patients showed no additional reduction in LRR rate. Technical transfer of the DBCG-RT profile to FFPE/qRT-PCR was successful, and the predictive impact was successfully validated in another 112 patients. A DBCG-RT gene profile was identified and validated, identifying patients with very low risk of LRR and no benefit from PMRT. The profile may provide a method to individualize treatment with PMRT. ©2014 American Association for Cancer Research.

Perceived levels of pain associated with bone marrow aspirates and biopsies.

PubMed

Talamo, Giampaolo; Liao, Jason; Joudeh, Jamal; Lamparella, Nicholas E; Dinh, Hoang; Malysz, Jozef; Ehmann, W Christopher

2012-01-01

Little is known about the degree of pain experienced by patients undergoing a bone marrow aspiration and biopsy (BMAB). To evaluate the effectiveness of several strategies aimed at reducing the pain score. We conducted a retrospective analysis of 258 consecutive adult patients who underwent BMAB via 6 different approaches, the first 5 of which were performed by one physician. Group A received local anesthesia with 1% lidocaine hydrochloride (5 mL) and a 5-minute wait time before the procedure; group B received local anesthesia with a double dose (10 mL) of lidocaine; group C received 5 mL of local anesthesia with a 10-minute wait; group D received 5 mL of local anesthesia plus a topical spray with ethyl chloride; group E received oral analgesia and anxiolysis 30 minutes before the procedure in addition to the group A dosage of lidocaine; and group F received the same anesthesia as did group A, but the BMAD was performed by a less experienced practitioner. On a 0 to 10 scale, the mean pain level among the 258 patients was 3.2 (standard deviation = 2.6). Rate of complications was low (<1%). Several strategies failed to improve the pain level, including the administration of a double dose of local anesthesia, waiting longer for the anesthesia effect, and the additional use of a topical anesthetic spray or oral analgesia and anxiolysis. Pain levels were not increased when the procedure was done by a less experienced practitioner. Younger age and female gender were associated with higher pain levels. Given that the average level of perceived pain during BMAB is low to moderate (approximately 3 on a 0-10 scale), the routine use of conscious sedation for this procedure may not be indicated. Several strategies aimed at reducing the pain level, including doubling the dose of anesthesia and using an oral prophylactic regimen of analgesia and anxiolysis, failed to improve pain scores. Copyright © 2012 Elsevier Inc. All rights reserved.

Doula support during first-trimester surgical abortion: a randomized controlled trial.

PubMed

Chor, Julie; Hill, Brandon; Martins, Summer; Mistretta, Stephanie; Patel, Ashlesha; Gilliam, Melissa

2015-01-01

The objective of the study was to evaluate the impact of doula support on first-trimester abortion care. Women were randomized to receive doula support or routine care during first-trimester surgical abortion. We examined the effect of doula support on pain during abortion using a 100 mm visual analog scale. The study had the statistical power to detect a 20% difference in mean pain scores. Secondary measures included satisfaction, procedure duration, and patient recommendations regarding doula support. Two hundred fourteen women completed the study: 106 received doula support, and 108 received routine care. The groups did not differ regarding demographics, gestational age, or medical history. Pain scores in the doula and control groups did not differ at speculum insertion (38.6 [±26.3 mm] vs 43.6 mm [±25.9 mm], P = .18) or procedure completion (68.2 [±28.0 mm] vs 70.6 mm [±23.5 mm], P = .52). Procedure duration (3.39 [±2.83 min] vs 3.18 min [±2.36 min], P = .55) and patient satisfaction (75.2 [±28.6 mm] vs 74.6 mm [±27.4 mm], P = .89) did not differ between the doula and control groups. Among women who received doula support, 96.2% recommended routine doula support for abortion and 60.4% indicated interest in training as doulas. Among women who did not receive doula support, 71.6% of women would have wanted it. Additional clinical staff was needed to provide support for 2.9% of women in the doula group and 14.7% of controls (P < .01). Although doula support did not have a measurable effect on pain or satisfaction, women overwhelmingly recommended it for routine care. Women receiving doula support were less likely to require additional clinic support resources. Doula support therefore may address patient psychosocial needs. Copyright © 2015 Elsevier Inc. All rights reserved.

The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial.

PubMed

Myles, Paul S; Leslie, Kate; Chan, Matthew T V; Forbes, Andrew; Peyton, Philip J; Paech, Michael J; Beattie, W Scott; Sessler, Daniel I; Devereaux, P J; Silbert, Brendan; Schricker, Thomas; Wallace, Sophie

2014-10-18

Nitrous oxide is commonly used in general anaesthesia but concerns exist that it might increase perioperative cardiovascular risk. We aimed to gather evidence to establish whether nitrous oxide affects perioperative cardiovascular risk. We did an international, randomised, assessor-blinded trial in patients aged at least 45 years with known or suspected coronary artery disease having major non-cardiac surgery. Patients were randomly assigned via automated telephone service, stratified by site, to receive a general anaesthetic with or without nitrous oxide. Attending anaesthetists were aware of patients' group assignments, but patients and assessors were not. The primary outcome measure was a composite of death and cardiovascular complications (non-fatal myocardial infarction, stroke, pulmonary embolism, or cardiac arrest) within 30 days of surgery. Our modified intention-to-treat population included all patients randomly assigned to groups and undergoing induction of general anaesthesia for surgery. This trial is registered at ClinicalTrials.gov, number NCT00430989. Of 10,102 eligible patients, we enrolled 7112 patients between May 30, 2008, and Sept 28, 2013. 3543 were assigned to receive nitrous oxide and 3569 were assigned not to receive nitrous oxide. 3483 patients receiving nitrous oxide and 3509 not receiving nitrous oxide were assessed for the primary outcome. The primary outcome occurred in 283 (8%) patients receiving nitrous oxide and in 296 (8%) patients not receiving nitrous oxide (relative risk 0·96, 95% CI 0·83–1·12; p=0·64). Surgical site infection occurred in 321 (9%) patients assigned to nitrous oxide, and in 311 (9%) patients in the no-nitrous oxide group (p=0·61), and severe nausea and vomiting occurred in 506 patients (15%) assigned to nitrous oxide and 378 patients (11%) not assigned to nitrous oxide (p<0·0001). Our findings support the safety profile of nitrous oxide use in major non-cardiac surgery. Nitrous oxide did not increase the risk of death and cardiovascular complications or surgical-site infection, the emetogenic effect of nitrous oxide can be controlled with antiemetic prophylaxis, and a desired effect of reduced volatile agent use was shown. Australian National Health and Medical Research Council; Australian and New Zealand College of Anaesthetists; Heart and Stroke Foundation of Quebec, Heart and Stroke Foundation of Ontario, Canada; General Research Fund of the Research Grant Council, Hong Kong Special Administrative Region, China.

A Randomized Controlled Trial Examining the Effect of the Addition of the Mandibular Block to Cervical Plexus Block for Carotid Endarterectomy.

PubMed

Kavrut Ozturk, Nilgun; Kavakli, Ali Sait; Sagdic, Kadir; Inanoglu, Kerem; Umot Ayoglu, Raif

2018-04-01

Although the cervical plexus block generally provides adequate analgesia for carotid endarterectomy, pain caused by metal retractors on the inferior surface of the mandible is not prevented by the cervical block. Different pain relief methods can be performed for patients who experience discomfort in these areas. In this study, the authors evaluated the effect of mandibular block in addition to cervical plexus block on pain scores in carotid endarterectomy. A prospective, randomized, controlled trial. Training and research hospital. Patients who underwent a carotid endarterectomy. Patients scheduled for carotid endarterectomy under cervical plexus block were randomized into 2 groups: group 1 (those who did not receive a mandibular block) and group 2 (those who received a mandibular block). The main purpose of the study was to evaluate the mandibular block in addition to cervical plexus block in terms of intraoperative pain scores. Intraoperative visual analog scale scores were significantly higher in group 1 (p = 0.001). The amounts of supplemental 1% lidocaine and intraoperative intravenous analgesic used were significantly higher in group 1 (p = 0.001 and p = 0.035, respectively). Patient satisfaction scores were significantly lower in group 1 (p = 0.044). The amount of postoperative analgesic used, time to first analgesic requirement, postoperative visual analog scale scores, and surgeon satisfaction scores were similar in both groups. There was no significant difference between the groups with respect to complications. No major neurologic deficits or perioperative mortality were observed. Mandibular block in addition to cervical plexus block provides better intraoperative pain control and greater patient satisfaction than cervical plexus block alone. Copyright © 2017 Elsevier Inc. All rights reserved.

Perindopril and β-blocker for the prevention of cardiac events and mortality in stable coronary artery disease patients: A EUropean trial on Reduction Of cardiac events with Perindopril in stable coronary Artery disease (EUROPA) subanalysis.

PubMed

Bertrand, Michel E; Ferrari, Roberto; Remme, Willem J; Simoons, Maarten L; Fox, Kim M

2015-12-01

β-Blockers relieve angina/ischemia in stable coronary artery disease (CAD), and angiotensin-converting enzyme inhibitors prevent CAD outcomes. In EUROPA, the angiotensin-converting enzyme inhibitor perindopril reduced cardiovascular outcomes in low-risk stable CAD patients over 4.2 years. This post hoc analysis examined whether the addition of perindopril to β-blocker in EUROPA had additional benefits on outcomes compared with standard therapy including β-blocker. EUROPA was a multicenter, double-blind, placebo-controlled, randomized trial in patients with documented stable CAD. Randomized EUROPA patients who received β-blocker at baseline were identified, and the effect on cardiovascular outcomes of adding perindopril or placebo was analyzed. Endpoints were the same as those in EUROPA. At baseline, 62% (n = 7534 [3789 on perindopril and 3745 on placebo]) received β-blocker. Treatment with perindopril/β-blocker reduced the relative risk of the primary end point (cardiovascular death, nonfatal myocardial infarction, and resuscitated cardiac arrest) by 24% compared with placebo/β-blocker (HR, 0.76; 95% CI, 0.64-0.91; P = .002). Addition of perindopril also reduced fatal or nonfatal myocardial infarction by 28% (HR, 0.72; 95% CI, 0.59-0.88; P = .001) and hospitalization for heart failure by 45% (HR, 0.55; 95% CI, 0.33-0.93; P = .025). Serious adverse drug reactions were rare in both groups, and cardiovascular death and hospitalizations occurred less often with perindopril/β-blocker. The addition of perindopril to β-blocker in stable CAD patients was safe and resulted in reductions in cardiovascular outcomes and mortality compared with standard therapy including β-blocker. Copyright © 2015 Elsevier Inc. All rights reserved.

Long-term Surveillance Following Intralesional Steroid Injection for Benign Vocal Fold Lesions.

PubMed

Wang, Chi-Te; Lai, Mei-Shu; Cheng, Po-Wen

2017-06-01

The short-term outcomes of vocal fold steroid injection (VFSI) are well documented. However, few studies have reported the long-term outcomes following VFSI. To investigate the incidence rates of symptom recurrence and secondary interventions following VFSI for benign vocal fold lesions. This prospective cohort study was conducted at a tertiary referral medical center in Taipei, Taiwan. The cohort included 189 patients with vocal fold lesions who had received VFSI as the primary treatment between August 2011 and September 2013. All participants underwent VFSI. Long-term surveillance was conducted through structured telephonic interviews and by reviewing medical charts every 6 months over a 2-year period. We assessed the 10-item voice handicap index, dysphonic symptoms, and whether the patients had received any additional interventions after the initial VFSI. The 189 participants (32 men and 157 women; mean [SD] age, 39 [10] years [range, 20-74 years] included patients who had undergone VFSI for vocal fold nodules (n = 72), polyps (n = 72), or mucus-retention cysts (n = 45). Following VFSI, 141 patients (74.6%; 23 men and 118 women; mean age, 39 years [range, 20-70 years]) showed positive response (ie, clinically significant symptom resolution without the need for additional procedures) and received long-term surveillance. The median follow-up period was 19.4 months, and 2 patients were lost to follow-up postoperatively within 1 year. The cumulative failure rates (subjective symptom recurrence plus secondary treatments) at 6, 12, 18, and 24 months after VFSI were 12%, 17%, 24%, and 32%, respectively. When the initial response rate to VFSI (141 of 189, 74.6%) was considered altogether, VFSI remained effective after 2 years in 50% of the initially recruited 189 patients. The highest rate of long-term effectiveness of VFSI occurred in vocal polyps (54%), followed by nodules (49%) and cysts (43%). This study demonstrates that VFSI can be beneficial in managing benign vocal lesions, especially when first-line treatments are unsuitable. However, the long-term results of this study clarify that a substantial number of patients experience symptom recurrence or receive subsequent interventions within 2 years after VFSI; this should be considered in medical decision making.

Adoption of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer.

PubMed

Cercek, Andrea; Roxburgh, Campbell S D; Strombom, Paul; Smith, J Joshua; Temple, Larissa K F; Nash, Garrett M; Guillem, Jose G; Paty, Philip B; Yaeger, Rona; Stadler, Zsofia K; Seier, Kenneth; Gonen, Mithat; Segal, Neil H; Reidy, Diane L; Varghese, Anna; Shia, Jinru; Vakiani, Efsevia; Wu, Abraham J; Crane, Christopher H; Gollub, Marc J; Garcia-Aguilar, Julio; Saltz, Leonard B; Weiser, Martin R

2018-03-22

Treatment of locally advanced rectal (LARC) cancer involves chemoradiation, surgery, and chemotherapy. The concept of total neoadjuvant therapy (TNT), in which chemoradiation and chemotherapy are administered prior to surgery, has been developed to optimize delivery of effective systemic therapy aimed at micrometastases. To compare the traditional approach of preoperative chemoradiation (chemoRT) followed by postoperative adjuvant chemotherapy with the more recent TNT approach for LARC. A retrospective cohort analysis using Memorial Sloan Kettering Cancer Center (MSK) records from 2009 to 2015 was carried out. A total of 811 patients who presented with LARC (T3/4 or node-positive) were identified. Of the 811 patients, 320 received chemoRT with planned adjuvant chemotherapy and 308 received TNT (induction fluorouracil- and oxaliplatin-based chemotherapy followed by chemoRT). Treatment and outcome data for the 2 cohorts were compared. Dosing and completion of prescribed chemotherapy were assessed on the subset of patients who received all therapy at MSK. Of the 628 patients overall, 373 (59%) were men and 255 (41%) were women, with a mean (SD) age of 56.7 (12.9) years. Of the 308 patients in the TNT cohort, 181 (49%) were men and 127 (49%) were women. Of the 320 patients in the chemoRT with planned adjuvant chemotherapy cohort, 192 (60%) were men and 128 (40%) were women. Patients in the TNT cohort received greater percentages of the planned oxaliplatin and fluorouracil prescribed dose than those in the chemoRT with planned adjuvant chemotherapy cohort. The complete response (CR) rate, including both pathologic CR (pCR) in those who underwent surgery and sustained clinical CR (cCR) for at least 12 months posttreatment in those who did not undergo surgery, was 36% in the TNT cohort compared with 21% in the chemoRT with planned adjuvant chemotherapy cohort. Our findings provide additional support for the National Comprehensive Cancer Network (NCCN) guidelines that categorize TNT as a viable treatment strategy for rectal cancer. Our data suggest that TNT facilitates delivery of planned systemic therapy. Long-term follow-up will determine if this finding translates into improved survival. In addition, given its high CR rate, TNT may facilitate nonoperative treatment strategies aimed at organ preservation.

Cost-effectiveness of single dose cefotaxime plus metronidazole compared with three doses each of cefuroxime plus metronidazole for the prevention of wound infection after colorectal surgery.

PubMed

Davey, P; Lynch, B; Malek, M; Byrne, D; Thomas, P

1992-12-01

The cost-effectiveness of prophylaxis for colonic surgery with single dose cefotaxime plus metronidazole has been compared with that of three doses each of cefuroxime plus metronidazole, by analysing data from a previously published study supplemented with additional data on the hospital and community costs of wound infection after colonic surgery. The original trial included 942 patients having elective colonic surgery in 14 hospitals. The data on costs of wound infection were collected from a further 124 patients undergoing elective colonic surgery at Ninewells Hospital. All these patients received a three dose regimen of cefuroxime plus metronidazole. The Dundee patients received three injections of 0.75 g cefuroxime at 8-hourly intervals whereas the trial patients received a single dose of 1.5 g followed by two further doses of 0.75 g at 8-hourly intervals. The cefuroxime prophylaxis regimen used in the trial cost 24.16 pounds per patient more than the cefotaxime regimen. The components of the excess cost were drugs (15.18 pounds), equipment (6.14 pounds) and staff time (2.84 pounds). The median cost to the hospital of a wound infection was 978.04 pounds (95% CI 482.04 pounds to 1521.22 pounds). The components of the hospital cost of wound infection were: hotel costs 858 pounds (88%), dressing costs 83.02 pounds (8%) and drug costs (excluding prophylaxis) 37.02 pounds (4%). Only five patients received additional antibiotic treatment in the community, and only one required home visits from the District Nurse. Applying the difference in costs of prophylaxis as 21 pounds (costs of drugs plus equipment) and the cost per wound infection as 1000 pounds to the observed wound infection rate of 7% in the cefuroxime group, the wound infection rate in the cefotaxime group would have to be 2.1% higher for the two regimens to be equally cost-effective. The probability that such a difference in efficacy exists is 0.088. A model was developed to calculate the probability of equal cost-effectiveness over a range of costs of wound infection.

Biweekly irinotecan plus bolus 5-fluorouracil and folinic acid in patients with advanced stage colorectal cancer.

PubMed

Yalcin, Suayib; Oksuzoglu, Berna; Tekuzman, Gülten; Engin, Hüseyin; Celik, Ismail; Turker, Alev; Barista, Ibrahim; Gullu, Ibrahim; Guler, Nilufer; Altundag, Kadri; Ozisik, Yavuz; Kars, Ayse

2003-11-01

In this study, we evaluated the efficacy and tolerability of biweekly irinotecan (CPT-11) plus 5-fluorouracil (5-FU) and folinic acid (FA) regimen (IFL) in patients with advanced stage colorectal cancer. A total of 28 patients were examined. The median age was 51 years (range, 30-74 years). One treatment cycle consisted of CPT-11 180 mg/m(2) on days 1 and 15; 5-FU 425 mg/m(2) on days 1, 2, 15 and 16; and FA 20 mg/m(2) on days 1, 2, 15 and 16, every 4 weeks. A total of 119 cycles (median, 4.0 cycles) were administered. Of the 28 patients, 18 received the chemotherapy as first line treatment, seven received it as second line and three received it as third line. An overall objective response rate of 21.5% was achieved in the patient group. However, the overall response rate for the 18 patients receiving first line treatment was 27.7%. The median response duration was 10.5 months (range, 3-19 months). An additional 28.6% of the patients had stable disease for a median duration of 6.5 months (range, 3-8 months). Median time to disease progression was 4.5 months (range, 1-22+ months) and median overall survival time was 11+ months (95% confidence interval, 9-15 months). Toxicities were mild and manageable. We conclude that biweekly IFL is a practical and tolerable treatment option with a disease control rate of 50.1% in patients with advanced stage colorectal cancer.

Irradiation and Bevacizumab in High-Grade Glioma Retreatment Settings

DOE Office of Scientific and Technical Information (OSTI.GOV)

Niyazi, Maximilian; Ganswindt, Ute; Schwarz, Silke Birgit

2012-01-01

Purpose: Reirradiation is a treatment option for recurrent high-grade glioma with proven but limited effectiveness. Therapies directed against vascular endothelial growth factor have been shown to exert certain efficacy in combination with chemotherapy and have been safely tested in combination with radiotherapy in a small cohort of patients. To study the feasibility of reirradiation combined with bevacizumab treatment, the toxicity and treatment outcomes of this approach were analyzed retrospectively. Patients and Methods: After previous treatment with standard radiotherapy (with or without temozolomide) patients with recurrent malignant glioma received bevacizumab (10 mg/kg intravenous) on Day 1 and Day 15 during radiotherapy.more » Maintenance therapy was selected based on individual considerations, and mainly bevacizumab-containing regimens were chosen. Patients received 36 Gy in 18 fractions. Results: The data of the medical charts of the 30 patients were analyzed retrospectively. All were irradiated in a single institution and received either bevacizumab (n = 20), no additional substance (n = 7), or temozolomide (n = 3). Reirradiation was tolerated well, regardless of the added drug. In 1 patient treated with bevacizumab, a wound dehiscence occurred. Overall survival was significantly better in patients receiving bevacizumab (p = 0.03, log-rank test). In a multivariate proportional hazards Cox model, bevacizumab, Karnovsky performance status, and World Health Organization grade at relapse turned out to be the most important predictors for overall survival. Conclusion: Reirradiation with bevacizumab is a feasible and effective treatment for patients with recurrent high-grade gliomas. A randomized trial is warranted to finally answer the question whether bevacizumab adds substantial benefit to a radiotherapeutic retreatment setting.« less

The effect of tramadol plus paracetamol on consumption of morphine after coronary artery bypass grafting.

PubMed

Altun, Dilek; Çınar, Özlem; Özker, Emre; Türköz, Ayda

2017-02-01

To compare the effects of oral tramadol+paracetamol combination on morphine consumption following coronary artery bypass grafting (CABG) in the patient-controlled analgesia (PCA) protocol. A prospective, double-blind, randomized, clinical study. Single-institution, tertiary hospital. Fifty cardiac surgical patients undergoing primary CABG surgery. After surgery, the patients were allocated to 1 of 2 groups. Both groups received morphine according to the PCA protocol after arrival to the coronary intensive care unit (bolus 1 mg, lockout time 15 minutes). In addition to morphine administration 2 hours before operation and postoperative 2nd, 6th, 12th, 18th, 24th, 30th, 36th, 42th, and 48th hours, group T received tramadol+paracetamol (Zaldiar; 325 mg paracetamol, 37.5 mg tramadol) and group P received placebo. Sedation levels were measured with the Ramsay Sedation Scale, whereas pain was assessed with the Pain Intensity Score during mechanical ventilation and with the Numeric Rating Scale after extubation. If the Numeric Rating Scale score was ≥3 and Pain Intensity Score was ≥3, 0.05 mg/kg morphine was administered additionally. Preoperative patient characteristics, risk assessment, and intraoperative data were similar between the groups. Cumulative morphine consumption, number of PCA demand, and boluses were higher in group P (P<.01). The amount of total morphine (in mg) used as a rescue analgesia was also higher in group P (5.06±1.0), compared with group T (2.37±0.52; P<.001). The patients who received rescue doses of morphine were 8 (32%) in group T and 18 (72%) in group P (P<.001). Duration of mechanical ventilation in group P was longer than group T (P<.01). Tramadol+paracetamol combination along with PCA morphine improves analgesia and reduces morphine requirement up to 50% after CABG, compared with morphine PCA alone. Copyright © 2016 Elsevier Inc. All rights reserved.

[Features of Acquired Immunodeficiency Syndrome-related Lymphoma on (18)F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography].

PubMed

Niu, Na; Zhu, Zhao-hui; Ma, Yan-ru; Xing, Hai-qun; Li, Fang

2015-10-01

To analyze the imaging features of (18)F-fluorodeoxyglucose (¹⁸F-FDG) positron emission tomography(PET)/computed tomography (CT) in acquired immune deficiency syndrome-related lymphoma (ARL) patients correlated with their clinical signs, symptoms, and treatments. Five ARL patients underwent ¹⁸F-FDG PET/CT at Peking Union Medical College Hospital from October 2008 to January 2013. Two patients received two additional follow-up studies 6 months later. Among these 5 patients, ¹⁸FDG-PET/CT helped in diagnosis of two patient and changed therapeutic strategy in other two patients. In two patients underwent ¹⁸F-FDG PET/CT brain scans, low-metabolism lesion was newly found in cerebral cortex. Of 4 patients receiving highly active antiretroviral therapy, PET/CT also demonstrated diffusely elevated ¹⁸F-FDG uptake in subcutaneous adipose tissue in two patients. ¹⁸F-FDG PET/CT is a highly useful tool in the diagnosis and treatment of ARL patients, in particular in the identification of associated encephalopathy and lipodystrophy.

Predictors of outpatients' request for palliative care service at a medical oncology clinic of a German comprehensive cancer center.

PubMed

Tewes, Mitra; Rettler, Teresa; Wolf, Nathalie; Hense, Jörg; Schuler, Martin; Teufel, Martin; Beckmann, Mingo

2018-05-05

Early integration of palliative care (PC) is recommended. The determination of predictors for patients' request for PC may guide implementation in clinical practice. Toward this end, we analyzed the symptom burden and distress of cancer patients in outpatient care and examined their need and request for PC. Between October 2013 and March 2016, 705 patients receiving outpatient cancer treatment took part in the survey. We used the new MInimal DOcumentation System to detect symptom clusters. Additionally, patients' request for palliative and psychosocial support was assessed. Groups of patients with PC request were compared to patients without PC request regarding their symptom clusters. Logistic regression analysis was applied to discover significant predictors for the requested inclusion of PC. A total of 159 patients (25.5%) requested additional support by PC. Moderate and severe tiredness (40.3%), weakness (37.9%), pain (25.0%), loss of appetite (22.3%), and dyspnea (19.1%) were the most frequent symptoms. The group of patients requesting PC differed significantly in terms of pain, nausea, dyspnea, constipation, weakness, loss of appetite, tiredness, depression, and anxiety from patients without request for PC (p < .01). The perceived need for PC was identified by the significant predictors "depression," "anxiety," and "weakness" with an explained variance of 22%. Combining a standardized screening questionnaire and the assessment of patients' request for PC allows systematic monitoring for patients' need for PC in a large Medical Oncology clinic. Depression, anxiety, and weakness are predictors of requesting PC service by patients receiving outpatient cancer treatment.

The association between home care visits and same-day emergency department use: a case-crossover study.

PubMed

Jones, Aaron; Schumacher, Connie; Bronskill, Susan E; Campitelli, Michael A; Poss, Jeffrey W; Seow, Hsien; Costa, Andrew P

2018-04-30

The extent to which home care visits contribute to the delay or avoidance of emergency department use is poorly characterized. We examined the association between home care visits and same-day emergency department use among patients receiving publicly funded home care. We conducted a population-based case-crossover study among patients receiving publicly funded home care in the Hamilton-Niagara-Haldimand-Brant region of Ontario between January and December 2015. Within individuals, all days with emergency department visits after 5 pm were selected as cases and matched with control days from the previous week. The cohort was stratified according to whether patients had ongoing home care needs ("long stay") or short-term home care needs ("short stay"). We used conditional logistical regression to estimate the association between receiving a home care visit during the day and visiting the emergency department after 5 pm on the same day. A total of 4429 long-stay patients contributed 5893 emergency department visits, and 2836 short-stay patients contributed 3476 visits. Receiving a home care nursing visit was associated with an increased likelihood of visiting the emergency department after 5 pm on the same day in both long-stay (odds ratio [OR] 1.32, 95% confidence interval [CI] 1.17-1.48) and short-stay patients (OR 1.22, 95% CI 1.07-1.39). Stronger associations were observed for less acute visits to the emergency department. No associations were observed for other types of home care visits. Patients receiving home care were more likely to visit the emergency department during the evening on days they received a nursing visit. The mechanism of the association between home care visits and same-day emergency department use and the extent to which same-day emergency department visits could be prevented or diverted require additional investigation. © 2018 Joule Inc. or its licensors.

The association between home care visits and same-day emergency department use: a case–crossover study

PubMed Central

Jones, Aaron; Schumacher, Connie; Bronskill, Susan E.; Campitelli, Michael A.; Poss, Jeffrey W.; Seow, Hsien

2018-01-01

BACKGROUND: The extent to which home care visits contribute to the delay or avoidance of emergency department use is poorly characterized. We examined the association between home care visits and same-day emergency department use among patients receiving publicly funded home care. METHODS: We conducted a population-based case–crossover study among patients receiving publicly funded home care in the Hamilton–Niagara–Haldimand–Brant region of Ontario between January and December 2015. Within individuals, all days with emergency department visits after 5 pm were selected as cases and matched with control days from the previous week. The cohort was stratified according to whether patients had ongoing home care needs (“long stay”) or short-term home care needs (“short stay”). We used conditional logistical regression to estimate the association between receiving a home care visit during the day and visiting the emergency department after 5 pm on the same day. RESULTS: A total of 4429 long-stay patients contributed 5893 emergency department visits, and 2836 short-stay patients contributed 3476 visits. Receiving a home care nursing visit was associated with an increased likelihood of visiting the emergency department after 5 pm on the same day in both long-stay (odds ratio [OR] 1.32, 95% confidence interval [CI] 1.17–1.48) and short-stay patients (OR 1.22, 95% CI 1.07–1.39). Stronger associations were observed for less acute visits to the emergency department. No associations were observed for other types of home care visits. INTERPRETATION: Patients receiving home care were more likely to visit the emergency department during the evening on days they received a nursing visit. The mechanism of the association between home care visits and same-day emergency department use and the extent to which same-day emergency department visits could be prevented or diverted require additional investigation. PMID:29712671

Elevated serum levels of IL-2R, IL-1RA, and CXCL9 are associated with a poor prognosis in follicular lymphoma

PubMed Central

Mir, Muhammad A.; Maurer, Matthew J.; Ziesmer, Steven C.; Slager, Susan L.; Habermann, Thomas; Macon, William R.; Link, Brian K.; Syrbu, Sergei; Witzig, Thomas; Friedberg, Jonathan W.; Press, Oliver; LeBlanc, Michael; Cerhan, James R.; Novak, Anne

2015-01-01

Serum cytokines and chemokines may reflect tumor biology and host response in follicular lymphoma (FL). To determine whether the addition of these biological factors may further refine prognostication, 30 cytokines and chemokines were measured in pretreatment serum specimens from newly diagnosed FL patients (n = 209) and from 400 matched controls. Cytokine levels were correlated with clinical outcome in patients who were observed or received single agent rituximab, or those who received chemotherapy. Correlations with outcome in chemotherapy treated patients were further examined in a separate cohort of 183 South West Oncology Group (SWOG) patients and all patients were then included in a meta-analysis. Six cytokines were associated with outcome in the Molecular Epidemiology Resource (MER) after adjusting for the FL international prognostic index. In patients who were observed or treated with rituximab alone, increased serum IL-12 and interleukin 1 receptor antagonist (IL-1RA) (P = .005 and .02) were associated with a shorter event-free survival. In patients receiving chemotherapy, hepatocyte growth factor, IL-8, IL-1RA, and CXCL9 (P = .015, .048, .004, and .0005) predicted a shorter EFS. When the MER chemotherapy treated patients and SWOG patients were combined in a meta-analysis, IL-2R, IL-1RA, and CXCL9 (P = .013, .042, and .0012) were associated with a poor EFS. PMID:25422100

Measurement of radiation exposure in relatives of thyroid cancer patients treated with (131)I.

PubMed

Ramírez-Garzón, Y T; Ávila, O; Medina, L A; Gamboa-deBuen, I; Rodríguez-Laguna, A; Buenfil, A E; Ruíz-Trejo, C; Estrada, E; Brandan, M E

2014-11-01

This work evaluates the radiological risk that patients treated with I for differentiated thyroid cancer could present to relatives and occupationally exposed workers. Recently, the International Atomic Energy Agency issued document K9010241, which recommends that patient discharge from the hospital must be based on the particular status of each patient. This work measures effective dose received by caregivers of patients treated with I at the Instituto Nacional de Cancerología, Mexico City. Thermoluminescent dosimeters were carried during a 15-d period by 40 family caregivers after patient release from hospital. Relatives were classified into two groups, ambulatory and hospitalized, according to the release mode of the patient, and three categories according to the individual patient home and transport facilities. Categories A, B, and C were defined going from most to least adequate concerning public exposure risk. Measurements were performed for 20 family caregivers in each group. The effective dose received by all caregivers participating in this study was found to be less than 5 mSv, the recommended limit per event for caregivers suggested by ICRP 103. In addition, 70 and 90% of ambulatory and hospitalized groups, respectively, received doses lower than 1 mSv. Caregivers belonging to category C, with home situations that are not appropriate for immediate release, received the highest average doses; i.e., 2.2 ± 1.3 and 3.1 ± 1.0 mSv for hospitalized and ambulatory patients, respectively. Results of this work have shown that the proper implementation of radiation protection instructions for relatives and patients can reduce significantly the risk that differentiated thyroid cancer patients treated with I can represent for surrounding individuals. The results also stress the relevance of the patient's particular lifestyle and transport conditions as the prevailing factors related to the dose received by the caregiver. Therefore, the patient's status should be the criterion used to decide his/her release modality. This work provides support to recommend the implementation of the "patient specific release criteria" in accordance with ICRP 94, IAEA Safety Report No. 63, and IAE document K9010241 A for patients treated with radiopharmaceuticals.

Pregnancy in renal transplant recipients.

PubMed

Bouattar, T; Hakim, H; Rhou, H; Benamar, L; Bayahia, R; Ouzeddoun, N

2009-06-01

Renal transplantation with a well-functioning graft leads to a rapid restoration of endocrine and sexual functions. The aim of this study was to examine our experience with pregnancies among renal transplant patients, particularly with regard to their impact on graft function. We analyzed 10 pregnancies in 7 renal transplant recipients for long-term graft outcomes in terms of clinical and biological data. The mean patient age was 28.5 +/- 4 years. They all received a living donor kidney. The time between transplantation and the onset of pregnancy was 33.4 +/- 23.2 months. Regarding the immunosuppressive therapy, all patients received steroids and cyclosporine; 4 patients received in addition azathioprine and 2 received mycophenolate mofetil that was changed at 1 month before conception to azathioprine. There was no significant difference between the serum creatinine before and during pregnancy. We did not observe any acute rejection episode. Pregnancy complications were preclampsia in 1 case, hypertension in 1 case, urinary tract infection in 2 cases, and anemia in 80% of patients during the third trimester. Premature rupture of membranes occurred in 1 case and preterm delivery in 2 cases. Two cases of neonatal death were registered. Cesarean section was performed in 50% of cases. The follow-up revealed 2 cases of chronic rejection. A multidisciplinary approach is necessary for pregnancy which generally occurs at 2 years after kidney transplantation.

The Study of External Dose Rate and Retained Body Activity of Patients Receiving 131I Therapy for Differentiated Thyroid Carcinoma

PubMed Central

Zhang, Haiying; Jiao, Ling; Cui, Songye; Wang, Liang; Tan, Jian; Zhang, Guizhi; He, Yajing; Ruan, Shuzhou; Fan, Saijun; Zhang, Wenyi

2014-01-01

Radiation safety is an integral part of targeted radionuclide therapy. The aim of this work was to study the external dose rate and retained body activity as functions of time in differentiated thyroid carcinoma patients receiving 131I therapy. Seventy patients were stratified into two groups: the ablation group (A) and the follow-up group (FU). The patients’ external dose rate was measured, and simultaneously, their retained body radiation activity was monitored at various time points. The equations of the external dose rate and the retained body activity, described as a function of hours post administration, were fitted. Additionally, the release time for patients was calculated. The reduction in activity in the group receiving a second or subsequent treatment was more rapid than the group receiving only the initial treatment. Most important, an expeditious method was established to indirectly evaluate the retained body activity of patients by measuring the external dose rate with a portable radiation survey meter. By this method, the calculated external dose rate limits are 19.2, 8.85, 5.08 and 2.32 μSv·h−1 at 1, 1.5, 2 and 3 m, respectively, according to a patient’s released threshold level of retained body activity <400 MBq. This study is beneficial for radiation safety decision-making. PMID:25337944

Efficacy and safety of rituximab in systemic sclerosis: French retrospective study and literature review.

PubMed

Thiebaut, Mathilde; Launay, David; Rivière, Sébastien; Mahévas, Thibault; Bellakhal, Syrine; Hachulla, Eric; Fain, Olivier; Mekinian, Arsène

2018-06-01

To describe safety and efficacy of rituximab in patients with systemic sclerosis. We included 13 patients with systemic sclerosis treated with rituximab and pooled with 40 additional patients from the literature. SSc rituximab untreated patients were matched to rituximab treated ones. Thirteen patients who received rituximab and 26 rituximab-untreated patients were included. In comparison to 26 patients who did not received rituximab, FVC changes were not significantly different, whereas DLCO improved in 13 patients who received rituximab (0 [-4; 4] vs loss of -7 [-19; 0]; p=0.05). Considering 7 rituximab treated and 14 untreated diffuse SSc, FVC was improved during the 24 [12; 46] months of follow up in dSSc who received rituximab (gain of 12 [7.5:14] % vs loss of 1.5 [-16.8; 2.5], (p=0.003)). Pooled analysis of 53 patients (40 literature patients and 13 from personal series) showed significant improvement of median mRSS from 18 [8; 32] at baseline to 9 [4; 18] at M6 (p=0.007), 13 [8; 18] at M12 (p=0.008) and 10 [4; 16] at the last follow-up (p=0.0002). FVC increased from 71% [66; 80] at baseline to 84% [75; 90] at M12 (p=0.001). DLCO increased from 58% [39; 65] at M0 to 63% [53; 78] at M12 (p=0.04). Our personal data and pooled literature analysis suggest the efficacy of rituximab in the subset of diffuse SSc in particular in skin and interstitial disease involvements. The safety of rituximab seems to be reasonable and similar to previous data in other autoimmune diseases. Copyright © 2018 Elsevier B.V. All rights reserved.

Meeting vaccination quality measures for hepatitis A and B virus in patients with chronic hepatitis C infection.

PubMed

Kramer, Jennifer R; Hachem, Christine Y; Kanwal, Fasiha; Mei, Minghua; El-Serag, Hashem B

2011-01-01

Coinfection with hepatitis A virus (HAV) or hepatitis B virus (HBV) in patients with chronic hepatitis C virus (HCV) is associated with increased morbidity and mortality. The Center for Medicare and Medicaid Services has identified HAV and HBV vaccination as a priority area for quality measurement in HCV. It is unclear to what extent patients with HCV meet these recommendations. We used national data from the Department of Veterans Affairs HCV Clinical Case Registry to evaluate the prevalence and predictors of meeting the quality measure (QM) of receiving vaccination or documented immunity to HAV and HBV in patients with chronic HCV. We identified 88,456 patients who had overall vaccination rates of 21.9% and 20.7% for HBV and HAV, respectively. The QM rates were 57.0% and 45.5% for HBV and HAV, respectively. Patients who were nonwhite or who had elevated alanine aminotransferase levels, cirrhosis, or human immunodeficiency virus were more likely to meet the HBV QM. Factors related to HCV care were also determinants of meeting the HBV QM. These factors included receiving a specialist consult, genotype testing, or HCV treatment. Patients who were older, had psychosis, and had a higher comorbidity score were less likely to meet the HBV QM. With a few exceptions, similar variables were related to meeting the HAV QM. The incidence of superinfection with acute HBV and HAV was low, but it was significantly lower in patients who received vaccination than in those who did not. Quality measure rates for HAV and HBV are suboptimal for patients with chronic HCV. In addition, several patient-related factors and receiving HCV-related care are associated with a higher likelihood of meeting QMs. Copyright © 2010 American Association for the Study of Liver Diseases.

[Phase II clinical trial of autologous dendritic cell vaccine with immunologic adjuvant in cutaneous melanoma patients].

PubMed

Baldueva, I A; Novik, A V; Moiseenko, V M; Nekhaeva, T L; Danilova, A B; Danilov, A O; Protsenko, S A; Petrova, T Iu; Uleĭskaia, G I; Shchekina, L A; Semenova, A I; Mikhaĭlichenko, T D; Teletaeva, G M; Zhabina, A S; Volkov, N V; Komarov, Iu I

2012-01-01

This paper describes the clinical results and immunologic changes in cutaneous melanoma patients receiving active specific immunotherapy with autologous dendritic cell vaccine (DCV) in combination with cyclophosphamide used as immunologic adjuvant. Twenty eight patients with morphologically verified stage III-IV cutaneous melanoma receiving therapy in N. N. Petrov Research Institute of Oncology between 2008 and 2011 were included in the study. All patients signed an informed consent form. Nineteen patients (67,9%) received DCV in therapeutic setting, 9 (32,1%) received it in adjuvant setting. DCV therapy was well tolerated. No serious adverse events were registered. Frequent adverse events included Grade 1-2 unspecific symptoms (fever, fatigue, flu-like symptoms) observed in 22% patients after 3,5% of vaccinations. In therapeutic settings the use DCV lead to clinical effect (PR+SD) in 36,6% of patients. PR was observed in 5% of (95% CI 0-15%) patients, SD in 31,6% (95% CI 13-56%). Duration of the objective responses was 168-965+days. Addition of immunologic adjuvant (cyclophosphamide 300 mg/m2 IV 2 hours) 3 days before vaccination increased its efficacy. In this patients group (n=12) the therapy lead to clinical benefit in 42% (95% CI 17-69%) of cases, median time to progression was 91 (95% CI 55-126) days. This regimen was selected for adjuvant therapy. In the adjuvant therapy group (n=9) the median time to progression was 112 (95% CI 58-166) days. Immunologic monitoring showed correlation ofT- and B-cell immune response with DCV clinical efficacy (p<0,05), no correlation with delayed hypersensivity reaction was observed (p>0,1). DCV is well tolerated and shows immunological and clinical response in stage III-IV skin melanoma patients.

Comparison of intra-articular bupivacaine-morphine with bupivacaine-tenoxicam combinations on post-operative analgesia in patients with arthroscopic meniscectomy: a prospective, randomised study.

PubMed

Sanel, Selim; Arpaz, Osman; Unay, Koray; Turkmen, Ismail; Simsek, Selcuk; Ugutmen, Ender

2016-03-01

There are many alternatives for post-operative pain relief in patients who have had general anaesthesia. The aim of this study was to evaluate the efficacy of intra-articular bupivacaine + morphine and bupivacaine + tenoxicam applications in post-operative pain control in patients undergoing knee arthroscopy with general anaesthesia. This was a prospective study. Standard anaesthesia procedures were applied to each patient, and the 240 patients chosen at random were then divided into two groups. Each group received a different combination of drugs for this double-blind study. The first group (group A: 120 patients) received 0.5% bupivacaine 100 mg + tenoxicam 20 mg (22 ml); the second group (group B) received 0.5% bupivacaine 100 mg + morphine 2 mg (22 ml); both groups received their drugs at the end of the intra-articular operation before tourniquet deflation. Before the operation, patients were asked about their post-operative pain at particular periods over the following 24 hours using the visual analogue scale (VAS) and the numeric rating scale (NRS). An additional analgaesic requirement and possible side effects were also recorded. Group A patients needed analgaesics sooner after operation than patients in group B. In Group B, VAS and NRS values were statistically higher compared with group A at the 12th hour. There were also fewer side effects seen in group A versus group B. Effective and reliable results were obtained in post-operative pain control in bupivacaine added to the morphine or tenoxicam groups following arthroscopic meniscectomy. In the tenoxicam group, patients reported less pain, fewer side effects and less need for analgesics at 12 hours after the operation. level 1, therapeutic, randomised, multicentric study.

Apatinib plus icotinib in treating advanced non-small cell lung cancer after icotinib treatment failure: a retrospective study.

PubMed

Xu, Jianping; Liu, Xiaoyan; Yang, Sheng; Zhang, Xiangru; Shi, Yuankai

2017-01-01

Treatment failure frequently occurs in patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) who respond to EGFR tyrosine kinase inhibitors initially. This retrospective study tried to investigate the efficacy and safety of apatinib plus icotinib in patients with advanced NSCLC after icotinib treatment failure. This study comprised 27 patients with advanced NSCLC who had progressed after icotinib monotherapy. Initially, patients received oral icotinib (125 mg, tid) alone. When the disease progressed, they received icotinib plus apatinib (500 mg, qd, orally). Treatment was continued until disease progression, unacceptable toxicity or consent withdrawal. Followed up to December 2016, the median time of combined therapy was 7.47 months, and eight of 27 patients were dead. The median overall survival was not reached, and median progression-free survival (PFS) was 5.33 months (95% CI, 3.63-7.03 months). Moreover, the objective response rate (ORR) was 11.1%, and the disease control rate (DCR) was 81.5%. A total of 14 patients received combined therapy as the second-line treatment, and the ORR and DCR were 7.1% and 78.6%, respectively; 13 patients received drugs as the third- or later-line treatment, with an ORR and a DCR of 15.4% and 84.6%, respectively. In addition, 11 patients experienced icotinib monotherapy failure within 6 months with median PFS of 7.37 months, and 16 patients had progression after 6 months with median PFS of 2.60 months. The common drug-related toxic effects were hypertension (44.4%) and fatigue (37.0%). Apatinib plus icotinib is efficacious in treating patients with advanced NSCLC after icotinib treatment failure, with acceptable toxic effects.

Effect of Intraoperative Dexamethasone on Pain Scores and Narcotic Consumption in Patients Undergoing Total Knee Arthroplasty.

PubMed

Samona, Jason; Cook, Carrie; Krupa, Kyle; Swatsell, Krystle; Jackson, Andrew; Dukes, Chase; Martin, Sidney

2017-02-01

To examine whether the addition of intravenous dexamethasone during total knee arthroplasty (TKA) would be effective at reducing postoperative pain scores and postoperative opioid consumption. A total of 102 patients undergoing TKA were placed into two groups: 55 subjects received intraoperative dexamethasone 8 mg intravenously (treatment group) and 47 did not receive dexamethasone at any time during the perioperative period. Comparison was made using the 0-10 numeric pain rating scale and the amount of opioids used in each group. Patients who received dexamethasone required significantly less oral opioids compared to the control group. Pain scores at 24 h post-surgery were significantly less for the dexamethasone group compared to the control group. There was no difference between groups in regards to patient-controlled analgesic dose or pain scores in the post-anesthesia care unit, at 12 or 48 h post-surgery. A single dose of dexamethasone given intraoperatively significantly decreased oral narcotic consumption and decreased pain scores 24 h postoperatively. Dexamethasone appears to be a safe modality to use to control pain in patients undergoing TKA. © 2017 Chinese Orthopaedic Association and John Wiley & Sons Australia, Ltd.

Evaluation of Pharmacokinetic and Pharmacodynamic Drug–Drug Interaction of Sacubitril/Valsartan (LCZ696) and Sildenafil in Patients With Mild‐to‐Moderate Hypertension

PubMed Central

Langenickel, TH; Petruck, J; Kode, K; Ayalasomayajula, S; Schuehly, U; Greeley, M; Pal, P; Zhou, W; Prescott, MF; Sunkara, G; Rajman, I

2017-01-01

Sacubitril/valsartan (LCZ696) is indicated for the treatment of patients with heart failure and reduced ejection fraction (HFrEF). Since patients with HFrEF may receive sacubitril/valsartan and sildenafil, both increasing cyclic guanosine monophosphate, the present study evaluated the pharmacokinetic and pharmacodynamic drug interaction potential between sacubitril/valsartan and sildenafil. In this open‐label, three‐period, single sequence study, patients with mild‐to‐moderate hypertension (153.8 ± 8.2 mmHg mean systolic blood pressure (SBP)) received a single dose of sildenafil 50 mg, sacubitril/valsartan 400 mg once daily for 5 days, and sacubitril/valsartan and sildenafil coadministration. When coadministered with sildenafil, the AUC and Cmax of valsartan decreased by 29% and 39%, respectively. Coadministration of sacubitril/valsartan and sildenafil resulted in a greater decrease in BP (–5/–4/–4 mmHg mean ambulatory SBP/DBP/MAP (mean arterial pressure)) than with sacubitril/valsartan alone. Both treatments were generally safe and well tolerated in this study; however, the additional BP reduction suggests that sildenafil should be administered cautiously in patients receiving sacubitril/valsartan. Unique identifier: NCT01601470. PMID:28599060

Clinician-delivered contingency management increases engagement and attendance in drug and alcohol treatment.

PubMed

Fitzsimons, Heather; Tuten, Michelle; Borsuk, Courtney; Lookatch, Samantha; Hanks, Lisa

2015-07-01

This study examined the impact of a low-cost contingency management (CM) delivered by program clinicians on treatment attendance and utilization for patients enrolled in outpatient psychosocial substance abuse treatment. The study used a pre-posttest design to compare substance abuse patients who received Reinforcement-Based Treatment (RBT) plus low cost CM (n=130; RBT+CM) to patients who received RBT only (n=132, RBT). RBT+CM participants received a $10 incentive for returning to treatment the day following intake assessment (day one), and a $15 incentive for attending treatment on day five following admission. RBT clients received standard care intervention without the addition of the CM procedures. Groups were compared on proportion of participants who returned to treatment on day one, mean days of treatment attendance, individual sessions attended, and treatment utilization during the first week and the first month following treatment admission. Both the RBT+CM and RBT group participants returned to the clinic on day one at high rates (95% versus 89%, respectively). However, the RBT group participants were more likely to attend the intake assessment only (i.e., never return to treatment) compared to the RBT+CM participants. Additionally, the RBT+CM participants attended significantly more treatment days, attended more individual counseling sessions, and had higher rates of overall treatment utilization compared to the RBT participants during the one week and one month following treatment admission. Findings support the feasibility and effectiveness of a CM intervention delivered by clinicians for increasing treatment attendance and utilization in a community substance abuse program. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Factors influencing access to education, decision making, and receipt of preferred dialysis modality in unplanned dialysis start patients.

PubMed

Machowska, Anna; Alscher, Mark Dominik; Reddy Vanga, Satyanarayana; Koch, Michael; Aarup, Michael; Qureshi, Abdul Rashid; Lindholm, Bengt; Rutherford, Peter A

2016-01-01

Unplanned dialysis start (UPS) leads to worse clinical outcomes than planned start, and only a minority of patients ever receive education on this topic and are able to make a modality choice, particularly for home dialysis. This study aimed to determine the predictive factors for patients receiving education, making a decision, and receiving their preferred modality choice in UPS patients following a UPS educational program (UPS-EP). The Offering Patients Therapy Options in Unplanned Start (OPTiONS) study examined the impact of the implementation of a specific UPS-EP, including decision support tools and pathway improvement on dialysis modality choice. Linear regression models were used to examine the factors predicting three key steps: referral and receipt of UPS-EP, modality decision making, and actual delivery of preferred modality choice. A simple economic assessment was performed to examine the potential benefit of implementing UPS-EP in terms of dialysis costs. The majority of UPS patients could receive UPS-EP (214/270 patients) and were able to make a decision (177/214), although not all patients received their preferred choice (159/177). Regression analysis demonstrated that the initial dialysis modality was a predictive factor for referral and receipt of UPS-EP and modality decision making. In contrast, age was a predictor for referral and receipt of UPS-EP only, and comorbidity was not a predictor for any step, except for myocardial infarction, which was a weak predictor for lower likelihood of receiving preferred modality. Country practices predicted UPS-EP receipt and decision making. Economic analysis demonstrated the potential benefit of UPS-EP implementation because dialysis modality costs were associated with modality distribution driven by patient preference. Education and decision support can allow UPS patients to understand their options and choose dialysis modality, and attention needs to be focused on ensuring equity of access to educational programs, especially for the elderly. Physician practice and culture across units/countries is an important predictor of UPS patient management and modality choice independent of patient-related factors. Additional work is required to understand and improve patient pathways to ensure that modality preference is enacted. There appears to be a cost benefit of delivering education, supporting choice, and ensuring that the choice is enacted in UPS patients.

Patient Ethnicity Affects Triage Assessments and Patient Prioritization in U.S. Department of Veterans Affairs Emergency Departments

PubMed Central

Vigil, Jacob M.; Coulombe, Patrick; Alcock, Joe; Kruger, Eric; Stith, Sarah S.; Strenth, Chance; Parshall, Mark; Cichowski, Sara B.

2016-01-01

Abstract Ethnic minority patients receive lower priority triage assignments in Veteran's Affairs (VA) emergency departments (EDs) compared to White patients, but it is currently unknown whether this disparity arises from generalized biases across the triage assessment process or from differences in how objective and/or subjective institution-level or person-level information is incorporated into the triage assessment process, thus contributing to disparate treatment. The VA database of electronic medical records of patients who presented to the VA ED from 2008 to 2012 was used to measure patient ethnicity, self-reported pain intensity (PI) levels, heart rate (HR), respiratory rate (RR), and nurse-provided triage assignment, the Emergency Severity Index (ESI) score. Multilevel, random effects linear modeling was used to control for demographic and clinical characteristics of patients as well as age, gender, and experience of triage nurses. A total of 359,642 patient/provider encounters between 129,991 VA patients and 774 nurses were included in the study. Patients were 61% non-Hispanic White [NHW], 28% African-American, 7% Hispanic, 2% Asian-American, <1% American Indian/Alaska Native, and 1% mixed ethnicity. After controlling for demographic characteristics of nurses and patients, African-American, Hispanic, and mixed-ethnicity patients reported higher average PI scores but lower HRs and RRs than NHW patients. NHW patients received higher priority ESI ratings with lower PI when compared against African-American patients. NHW patients with low to moderate HRs also received higher priority ESI scoring than African-American, Hispanic, Asian-American, and Mixed-ethnicity patients; however, when HR was high NHWs received lower priority ESI ratings than each of the minority groups (except for African-Americans). This study provides evidence for systemic differences in how patients’ vital signs are applied for determining ESI scores for different ethnic groups. Additional prospective research will be needed to determine how this specific person-level mechanism affects healthcare quality and outcomes. PMID:27057847

Additional benefit of dietitian involvement in dialysis staffs-led diet education on uncontrolled hyperphosphatemia in hemodialysis patients.

PubMed

Tsai, Wan-Chuan; Yang, Ju-Yeh; Luan, Chia-Chin; Wang, Yuh-Jiun; Lai, Yu-Chuan; Liu, Lie-Chuan; Peng, Yu-Sen

2016-10-01

Sustained adherence to dietary phosphorus (P) restriction recommendations among hemodialysis patients is questionable. The aim of this study was to evaluate the effectiveness of additional diet education delivered by a dietitian on the control of hyperphosphatemia. We conducted an 8-month prospective observational study in hemodialysis patients who had uncontrolled hyperphosphatemia. In the first half of the study (experimental) period, the dialysis nurses and physicians provided the routine dietetic education with the control group (n = 31), while the experimental group (n = 30) received the routine dietetic education plus an additional diet education delivered by dietitians. Both groups received the routine dietetic education in the rest of the study period to test whether the improvement of serum P level was sustained. The primary outcomes were changes in serum P level. At baseline, there was no significant difference in serum P levels between groups (P = 0.27). In the experimental period, monthly serum P levels decreased significantly in both groups (P < 0.001) and the magnitudes of reduction were 1.81 ± 1.46 and 0.94 ± 1.33 mg/dL in the experimental and control groups, respectively (P = 0.02), at the end. The experimental group maintained such improvement for one more month (P = 0.02), but faded out over time. Renal diet education guided either by dietitians plus dialysis staffs or dialysis staffs alone reduces serum P level and dietitian-guided diet education provides an additional benefit on controlling hyperphosphatemia in hemodialysis patients.

Bicarbonate Balance and Prescription in ESRD.

PubMed

Abramowitz, Matthew K

2017-03-01

The optimal approach to managing acid-base balance is less well defined for patients receiving hemodialysis than for those receiving peritoneal dialysis. Interventional studies in hemodialysis have been limited and inconsistent in their findings, whereas more compelling data are available from interventional studies in peritoneal dialysis. Both high and low serum bicarbonate levels associate with an increased risk of mortality in patients receiving hemodialysis, but high values are a marker for poor nutrition and comorbidity and are often highly variable from month to month. Measurement of pH would likely provide useful additional data. Concern has arisen regarding high-bicarbonate dialysate and dialysis-induced alkalemia, but whether these truly cause harm remains to be determined. The available evidence is insufficient for determining the optimal target for therapy at this time. Copyright © 2017 by the American Society of Nephrology.

Measuring the effect of enhanced cleaning in a UK hospital: a prospective cross-over study.

PubMed

Dancer, Stephanie J; White, Liza F; Lamb, Jim; Girvan, E Kirsty; Robertson, Chris

2009-06-08

Increasing hospital-acquired infections have generated much attention over the last decade. There is evidence that hygienic cleaning has a role in the control of hospital-acquired infections. This study aimed to evaluate the potential impact of one additional cleaner by using microbiological standards based on aerobic colony counts and the presence of Staphylococcus aureus including meticillin-resistant S. aureus. We introduced an additional cleaner into two matched wards from Monday to Friday, with each ward receiving enhanced cleaning for six months in a cross-over design. Ten hand-touch sites on both wards were screened weekly using standardised methods and patients were monitored for meticillin-resistant S. aureus infection throughout the year-long study. Patient and environmental meticillin-resistant S. aureus isolates were characterised using molecular methods in order to investigate temporal and clonal relationships. Enhanced cleaning was associated with a 32.5% reduction in levels of microbial contamination at hand-touch sites when wards received enhanced cleaning (P < 0.0001: 95% CI 20.2%, 42.9%). Near-patient sites (lockers, overbed tables and beds) were more frequently contaminated with meticillin-resistant S. aureus/S. aureus than sites further from the patient (P = 0.065). Genotyping identified indistinguishable strains from both hand-touch sites and patients. There was a 26.6% reduction in new meticillin-resistant S. aureus infections on the wards receiving extra cleaning, despite higher meticillin-resistant S. aureus patient-days and bed occupancy rates during enhanced cleaning periods (P = 0.032: 95% CI 7.7%, 92.3%). Adjusting for meticillin-resistant S. aureus patient-days and based upon nine new meticillin-resistant S. aureus infections seen during routine cleaning, we expected 13 new infections during enhanced cleaning periods rather than the four that actually occurred. Clusters of new meticillin-resistant S. aureus infections were identified 2 to 4 weeks after the cleaner left both wards. Enhanced cleaning saved the hospital 30,000 pounds to 70,000 -pounds. Introducing one extra cleaner produced a measurable effect on the clinical environment, with apparent benefit to patients regarding meticillin-resistant S. aureus infection. Molecular epidemiological methods supported the possibility that patients acquired meticillin-resistant S. aureus from environmental sources. These findings suggest that additional research is warranted to further clarify the environmental, clinical and economic impact of enhanced hygienic cleaning as a component in the control of hospital-acquired infection.

Apixaban with antiplatelet therapy after acute coronary syndrome.

PubMed

Alexander, John H; Lopes, Renato D; James, Stefan; Kilaru, Rakhi; He, Yaohua; Mohan, Puneet; Bhatt, Deepak L; Goodman, Shaun; Verheugt, Freek W; Flather, Marcus; Huber, Kurt; Liaw, Danny; Husted, Steen E; Lopez-Sendon, Jose; De Caterina, Raffaele; Jansky, Petr; Darius, Harald; Vinereanu, Dragos; Cornel, Jan H; Cools, Frank; Atar, Dan; Leiva-Pons, Jose Luis; Keltai, Matyas; Ogawa, Hisao; Pais, Prem; Parkhomenko, Alexander; Ruzyllo, Witold; Diaz, Rafael; White, Harvey; Ruda, Mikhail; Geraldes, Margarida; Lawrence, Jack; Harrington, Robert A; Wallentin, Lars

2011-08-25

Apixaban, an oral, direct factor Xa inhibitor, may reduce the risk of recurrent ischemic events when added to antiplatelet therapy after an acute coronary syndrome. We conducted a randomized, double-blind, placebo-controlled clinical trial comparing apixaban, at a dose of 5 mg twice daily, with placebo, in addition to standard antiplatelet therapy, in patients with a recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic events. The trial was terminated prematurely after recruitment of 7392 patients because of an increase in major bleeding events with apixaban in the absence of a counterbalancing reduction in recurrent ischemic events. With a median follow-up of 241 days, the primary outcome of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 279 of the 3705 patients (7.5%) assigned to apixaban (13.2 events per 100 patient-years) and in 293 of the 3687 patients (7.9%) assigned to placebo (14.0 events per 100 patient-years) (hazard ratio with apixaban, 0.95; 95% confidence interval [CI], 0.80 to 1.11; P=0.51). The primary safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition occurred in 46 of the 3673 patients (1.3%) who received at least one dose of apixaban (2.4 events per 100 patient-years) and in 18 of the 3642 patients (0.5%) who received at least one dose of placebo (0.9 events per 100 patient-years) (hazard ratio with apixaban, 2.59; 95% CI, 1.50 to 4.46; P=0.001). A greater number of intracranial and fatal bleeding events occurred with apixaban than with placebo. The addition of apixaban, at a dose of 5 mg twice daily, to antiplatelet therapy in high-risk patients after an acute coronary syndrome increased the number of major bleeding events without a significant reduction in recurrent ischemic events. (Funded by Bristol-Myers Squibb and Pfizer; APPRAISE-2 ClinicalTrials.gov number, NCT00831441.).

Hypertrophic olivary degeneration following surgical resection or gamma knife radiosurgery of brainstem cavernous malformations: an 11-case series and a review of literature.

PubMed

Yun, Jung-Ho; Ahn, Jae Sung; Park, Jung Cheol; Kwon, Do Hoon; Kwun, Byung Duk; Kim, Chang Jin

2013-03-01

We describe 11 patients with hypertrophic olivary degeneration (HOD) after surgical resection or gamma knife radiosurgery for brainstem cavernous malformations. In addition, we statistically analyzed the predicting factors associated with the development of HOD. From January 2001 to May 2011, a total of 73 patients (30 in the surgical group and 43 in the radiosurgery group) with brainstem cavernous malformations were treated in our institute. Of them, 11 patients (incidence: 15 %) developed HOD with high signal intensity on T2-weighted MRI during follow-up. The predicting factors (location, size, age, and treatment method) associated with the development of HOD were statistically analyzed. Among the 11 HOD patients, seven patients received surgical resection and four patients received gamma knife radiosurgery. Six patients had bilateral HOD and the remaining five patients had unilateral HOD. Overall HOD-associated symptoms presented in four patients, including three palatal tremors and one ataxia. In all four patients with symptoms, these symptoms disappeared incompletely within the clinical follow-up period. The size of the cavernous malformation, age of patient, and treatment methods were not significantly correlated with the development of HOD. A significantly higher incidence of HOD was associated with midbrain cavernous malformations than with pontine or medulla cavernous malformations. HOD should be recognized as a non-infrequent complication of surgical resection or gamma knife radiosurgery within the brainstem, especially for midbrain cavernous malformations. In addition, to the best of our knowledge, this is the first report on HOD development after radiosurgery.

Randomized controlled trial of intramuscular droperidol versus midazolam for violence and acute behavioral disturbance: the DORM study.

PubMed

Isbister, Geoffrey K; Calver, Leonie A; Page, Colin B; Stokes, Barrie; Bryant, Jenni L; Downes, Michael A

2010-10-01

We determine whether droperidol, midazolam, or the combination is more effective for intramuscular sedation in violent and acute behavioral disturbance in the emergency department (ED). We conducted a blinded randomized controlled trial of intramuscular sedation for violent and acute behavioral disturbance, comparing droperidol (10 mg), midazolam (10 mg), and droperidol (5 mg)/midazolam (5 mg). Inclusion criteria were patients requiring physical restraint and parenteral sedation. The primary outcome was the duration of the violent and acute behavioral disturbance, defined as the time security staff were required. Secondary outcomes included time until additional sedation was administered, staff and patient injuries, further episodes of violent and acute behavioral disturbance, and drug-related adverse effects. From 223 ED patients with violent and acute behavioral disturbance, 91 patients were included; 33 received droperidol, 29 received midazolam, and 29 received the combination. There was no difference in the median duration of the violent and acute behavioral disturbance: 20 minutes (interquartile range [IQR] 11 to 37 min) for droperidol, 24 minutes (IQR 13 to 35 minutes) for midazolam, and 25 minutes (IQR 15 to 38 minutes) for the combination. Additional sedation was required in 11 (33%; 95% confidence interval [CI] 19% to 52%) droperidol patients, 18 (62%; 95% CI 42% to 79%) midazolam patients, and 12 (41%; 95% CI 24% to 61%) in the combination group. The hazard ratio for additional sedation in the midazolam versus droperidol group was 2.31 (95% credible interval 1.01 to 4.71); for the combination versus droperidol, 1.18 (95% credible interval 0.46 to 2.50). Patient and staff injuries and number of further episodes of violent and acute behavioral disturbance did not differ between groups. There were two adverse effects for droperidol (6%; 95% CI 1% to 22%), 8 for midazolam (28%; 95% CI 13% to 47%), and 2 for the combination (7%; 95% CI 1% to 24%). An abnormal QT occurred in 2 of 31 (6%; 95% CI 1% to 23%) droperidol patients, which was not different from the other groups. Intramuscular droperidol and midazolam resulted in a similar duration of violent and acute behavioral disturbance, but more additional sedation was required with midazolam. Midazolam caused more adverse effects because of oversedation, and there was no evidence of QT prolongation associated with droperidol compared with midazolam. Copyright © 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Randomized controlled trial on the effects of CCTV training on quality of life, depression, and adaptation to vision loss.

PubMed

Burggraaff, Marloes C; van Nispen, Ruth M A; Knol, Dirk L; Ringens, Peter J; van Rens, Ger H M B

2012-06-14

In addition to performance-based measures, vision-related quality of life (QOL) and other subjective measures of psychosocial functioning are considered important outcomes of training in the visually impaired. In a multicenter, masked, randomized controlled trial, subjective effects of training in the use of closed-circuit televisions (CCTV) were investigated. Patients (n = 122) were randomized either to a treatment group that received usual delivery instructions from the supplier combined with concise outpatient training, or to a control group that received delivery instructions only. Subjective outcomes were the low vision quality-of-life questionnaire (LVQOL), EuroQOL 5 dimensions, adaptation to age-related vision loss (AVL), and the Center of Epidemiologic Studies Depression scales. Linear mixed models were used to investigate treatment effects. Differential effects of patient characteristics were studied by implementing higher order interactions into the models. From baseline to follow-up, all patients perceived significantly less problems on the reading and fine work dimension (-28.8 points; P < 0.001) and the adaptation dimension (-4.67 points; P = 0.04) of the LVQOL. However, no treatment effect was found based on the intention-to-treat analysis. This study demonstrated the effect of receiving and using a CCTV on two vision-related QOL dimensions; however, outpatient training in the use of CCTVs had no additional value. (trialregister.nl number, NTR1031.).

tDCS combined with optokinetic drift reduces egocentric neglect in severely impaired post-acute patients.

PubMed

Turgut, Nergiz; Miranda, Marcela; Kastrup, Andreas; Eling, Paul; Hildebrandt, Helmut

2018-06-01

Visuospatial neglect is a disabling syndrome resulting in impaired activities of daily living and in longer durations of inpatient rehabilitation. Effective interventions to remediate neglect are still needed. The combination of tDCS and an optokinetic task might qualify as a treatment method. A total of 32 post-acute patients with left (n = 20) or right-sided neglect were allotted to an intervention or a control group (both groups n = 16). The intervention group received eight sessions of 1.5-2.0 mA parietal transcranial direct current stimulation (tDCS) during the performance of an optokinetic task distributed over two weeks. Additionally they received standard therapy for five hours per day. The control group received only the standard therapy. Patients were examined twice before (with 3-4 days between examinations) and twice after treatment (5-6 days between examinations). Compared to the control group and controlling for spontaneous remission, the intervention group improved on spontaneous body orientation and the Clock Drawing Test. Intragroup comparisons showed broad improvements on egocentric but not on allocentric symptoms only for the intervention group. A short additional application of tDCS during an optokinetic task led to improvements of severe neglect compared to a standard neurological early rehabilitation treatment. Improvements seem to concern primarily egocentric rather than allocentric neglect.

Refusal of Recommended Chemotherapy for Ovarian Cancer: Risk Factors and Outcomes; a National Cancer Data Base Study.

PubMed

Wallace, Sumer K; Lin, Jeff F; Cliby, William A; Leiserowitz, Gary S; Tergas, Ana I; Bristow, Robert E

2016-05-01

To identify risk factors associated with refusal of recommended chemotherapy and its impact on patients with epithelial ovarian cancer (EOC). We identified patients in the National Cancer Data Base diagnosed with EOC from January 1998 to December 2011. Patients who refused chemotherapy were identified and compared with those who received recommended, multiagent chemotherapy. Univariate and multivariable analyses were performed using chi-square test with Bonferroni correction, binary logistic regression, log-rank test, and Cox proportional hazards modeling. The threshold for statistical significance was set at a P value of less than 0.05. From a cohort of 147,713 eligible patients, 2,707 refused chemotherapy. These patients were compared with 92,212 patients who received recommended multiagent chemotherapy. Older age, more medical comorbidities, not having insurance, and later year of diagnosis were directly and significantly associated with chemotherapy refusal when analyzed using multivariable logistic regression. In addition, lower-than-expected facility adherence to NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Ovarian Cancer, treatment at low-volume center, lower grade, and higher stage were all significantly and independently associated with chemotherapy refusal. Median overall survival of patients who received multiagent chemotherapy was significantly longer than that of those who refused chemotherapy (43 vs 4.8 months; P<.0005). After controlling for known patient, facility, and disease prognostic factors, chemotherapy refusal is significantly associated with increased risk of death. Refusal of recommended chemotherapy carries significant risk of early death from ovarian cancer. Our data demonstrate that the decision to refuse chemotherapy is multifactorial and, in addition to unalterable factors (eg, stage/grade, age), involves factors that can be changed, including facility type and payor. Efforts at addressing these discrepancies in care can improve compliance with chemotherapy recommendations in the NCCN Guidelines for Ovarian Cancer and outcomes. Copyright © 2016 by the National Comprehensive Cancer Network.

Levosimendan for Hemodynamic Support after Cardiac Surgery.

PubMed

Landoni, Giovanni; Lomivorotov, Vladimir V; Alvaro, Gabriele; Lobreglio, Rosetta; Pisano, Antonio; Guarracino, Fabio; Calabrò, Maria G; Grigoryev, Evgeny V; Likhvantsev, Valery V; Salgado-Filho, Marcello F; Bianchi, Alessandro; Pasyuga, Vadim V; Baiocchi, Massimo; Pappalardo, Federico; Monaco, Fabrizio; Boboshko, Vladimir A; Abubakirov, Marat N; Amantea, Bruno; Lembo, Rosalba; Brazzi, Luca; Verniero, Luigi; Bertini, Pietro; Scandroglio, Anna M; Bove, Tiziana; Belletti, Alessandro; Michienzi, Maria G; Shukevich, Dmitriy L; Zabelina, Tatiana S; Bellomo, Rinaldo; Zangrillo, Alberto

2017-05-25

Acute left ventricular dysfunction is a major complication of cardiac surgery and is associated with increased mortality. Meta-analyses of small trials suggest that levosimendan may result in a higher rate of survival among patients undergoing cardiac surgery. We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving patients in whom perioperative hemodynamic support was indicated after cardiac surgery, according to prespecified criteria. Patients were randomly assigned to receive levosimendan (in a continuous infusion at a dose of 0.025 to 0.2 μg per kilogram of body weight per minute) or placebo, for up to 48 hours or until discharge from the intensive care unit (ICU), in addition to standard care. The primary outcome was 30-day mortality. The trial was stopped for futility after 506 patients were enrolled. A total of 248 patients were assigned to receive levosimendan and 258 to receive placebo. There was no significant difference in 30-day mortality between the levosimendan group and the placebo group (32 patients [12.9%] and 33 patients [12.8%], respectively; absolute risk difference, 0.1 percentage points; 95% confidence interval [CI], -5.7 to 5.9; P=0.97). There were no significant differences between the levosimendan group and the placebo group in the durations of mechanical ventilation (median, 19 hours and 21 hours, respectively; median difference, -2 hours; 95% CI, -5 to 1; P=0.48), ICU stay (median, 72 hours and 84 hours, respectively; median difference, -12 hours; 95% CI, -21 to 2; P=0.09), and hospital stay (median, 14 days and 14 days, respectively; median difference, 0 days; 95% CI, -1 to 2; P=0.39). There was no significant difference between the levosimendan group and the placebo group in rates of hypotension or cardiac arrhythmias. In patients who required perioperative hemodynamic support after cardiac surgery, low-dose levosimendan in addition to standard care did not result in lower 30-day mortality than placebo. (Funded by the Italian Ministry of Health; CHEETAH ClinicalTrials.gov number, NCT00994825 .).

A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study

PubMed Central

Salisbury, Lisa G; Boyd, Julia; Ramsay, Pamela; Merriweather, Judith; Huby, Guro; Forbes, John; Rattray, Janice Z; Griffith, David M; Mackenzie, Simon J; Hull, Alastair; Lewis, Steff; Murray, Gordon D

2012-01-01

Introduction Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life. Methods and analysis The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers. Ethics and dissemination Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according to a predefined analysis plan. Trial registration The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland. PMID:22761291

Does Regular Use of a Complementary Medicine of Olea Europe and Ficus carica Have Adverse Effects on Lipid Profile and Fasting Blood Glucose of Rheumatoid Arthritis (RA) Patients Under Treatment with DMARD Regimens Containing Methotrexate?

PubMed

Bahadori, Shahnaz; Ahmadzadeh, Arman; Shams Ardekani, Mohammad Reza; Kamalinejad, Mohammad; Keshavarz, Mansoor; Salamzadeh, Jamshid

2016-01-01

Rheumatoid arthritis (RA) patients are vulnerable to cardiovascular morbidity and mortality in which atherosclerosis plays a major role. In this study, the lipid profile and fasting blood sugar (FBS) of RA patients receiving a complementary medicine of olive and fig, as add-on therapy for routine disease-modifying antirheumatic drugs (DMARDs) regimen containing low dose methotrexate (MTX), were studied. A randomized controlled clinical trial was designed. Adult RA patients were randomly allocated in two groups receiving routine DMARDs regimen (control group) and routine DMARDs regimen plus the herbal supplementary formulation of olive oil, fig and olive fruits (intervention group). Patients were followed every 4 weeks for total study period of 16 weeks. In addition to demographic and medical history of the patients, the total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), the atherogenic index of plasma (AIP) defined as log(TG/HDL-C), and the fasting blood sugar (FBS) were determined and recorded. 56 patients (control = 27 and intervention = 29), with mean ± sd age of 50.9 ± 12.3 years completed the study. Average MTX dose received by intervention and control groups were 24.30 ± 18.39 and 17.61 ± 15.53 mg/week, respectively (p = 0.11). Repeated measures analysis of variance (ANOVA) revealed that differences between lipid profile indicators and FBS in the two study groups were not statistically significant (P>0.05). No additional substantial adverse reaction was seen in the study groups. Our findings are more reassuring for patients and their doctors to trust on the safety of the investigated complementary preparation to be used as add-on therapy to manage rheumatoid arthritis.

Epistaxis in end stage liver disease masquerading as severe upper gastrointestinal hemorrhage.

PubMed

Camus, Marine; Jensen, Dennis M; Matthews, Jason D; Ohning, Gordon V; Kovacs, Thomas O; Jutabha, Rome; Ghassemi, Kevin A; Machicado, Gustavo A; Dulai, Gareth S

2014-10-14

To describe the prevalence, diagnosis, treatment, and outcomes of end stage liver disease (ESLD) patients with severe epistaxis thought to be severe upper gastrointestinal hemorrhage (UGIH). This observational single center study included all consecutive patients with ESLD and epistaxis identified from consecutive subjects hospitalized with suspected UGIH and prospectively enrolled in our databases of severe UGIH between 1998 and 2011. A total of 1249 patients were registered for severe UGIH in the data basis, 461 (36.9%) were cirrhotics. Epistaxis rather than UGIH was the bleeding source in 20 patients. All patients had severe coagulopathy. Epistaxis was initially controlled in all cases. Fifteen (75%) subjects required posterior nasal packing and 2 (10%) embolization in addition to correction of coagulopathy. Five (25%) patients died in the hospital, 12 (60%) received orthotopic liver transplantation (OLT), and 3 (15%) were discharged without OLT. The mortality rate was 63% in patients without OLT. Severe epistaxis in patients with ESLD is (1) a diagnosis of exclusion that requires upper endoscopy to exclude severe UGIH; and (2) associated with a high mortality rate in patients not receiving OLT.

A simple method to obtain low density marrow cells for human marrow transplantation.

PubMed

de Witte, T; Plas, A; Vet, J; Koekman, E; Preyers, F; Wessels, J

1987-01-01

Removal of more than 99% of the erythrocytes and 74% of the nucleated cells from marrow grafts was achieved by density floatation separation in Percoll gradients with a density of 1.070 g/ml in eight 250-ml tubes, containing up to 3 X 10(9) nucleated cells per gradient. More than 90% of the myeloid and erythroid progenitor cells were recovered in the low density fraction. It appeared mandatory to use a centrifuge with the possibility of a gradual acceleration and deceleration. Twenty-five patients received a marrow graft from a histocompatible sibling after additional lymphocyte depletion by counterflow centrifugation, and 5 patients with T lymphoblastic malignancies received an autograft after in vitro purging with immunotoxins. All evaluable patients engrafted within normal limits, except 1 patient with an autoimmune pancytopenia who responded to steroids and 1 patient with a CMV infection. Four patients died too early for complete evaluation. The described separation method is easy, cheap and requires only 2 h for the complete processing of a marrow graft.

Prospective Observational Evaluation of Sedation and Pain Management Guideline Adherence Across New Jersey Intensive Care Units.

PubMed

Brophy, Alison; Cardinale, Maria; Andrews, Liza B; Kaplan, Justin B; Adams, Christopher; Opsha, Yekaterina; Brandt, Kimberly A; Dixit, Deepali; Nerenberg, Steven F; Saleh, Julie A

2018-01-01

The practice guidelines for the management of pain, agitation, and delirium (PAD) from the Society of Critical Care Medicine shifted from primarily focusing on the treatment of anxiety in 2002 to the treatment of pain in 2013. This prospective, observational, multicenter study aimed to assess the degree of practice adherence to the PAD guidelines for ventilated patients in New Jersey intensive care units (ICUs). Pharmacist investigators at 8 centers designated 4 days at least 10 days apart to evaluate all patients on mechanical ventilation. The primary outcomes included adherence to 4 guideline recommendations: treatment of pain before sedation, use of nonnarcotic analgesic medications, use of nonbenzodiazepine sedative medications, and use of goal-directed sedation. Of 138 patients evaluated, 50% had a primary medical diagnosis (as opposed to surgical, cardiac, or neurological diagnosis), and the median Sequential Organ Failure Assessment (SOFA) score was 7. Pain was treated prior to administration of sedatives in 55.4% of subjects, with fentanyl being the primary analgesic used. In addition, 19% received no analgesia, and 11.5% received nonopioid analgesia. Sedative agents were administered to 87 subjects (48 nonbenzodiazepine and 39 benzodiazepine). Of those receiving benzodiazepines, 22 received intermittent bolus regimens and 16 received continuous infusions, of which 5 were for another indication besides sedation. Validated scales measuring the degree of sedation were completed at least once in 56 (81.6%) patients receiving sedatives. Current sedation practices suggest that integration of evidence-based PAD guidelines across New Jersey adult ICUs is inconsistent despite pharmacist involvement.

Infliximab for the Treatment of Refractory Kawasaki Disease: A Nationwide Survey in Japan.

PubMed

Masuda, Hiroshi; Kobayashi, Tohru; Hachiya, Akira; Nakashima, Yasutaka; Shimizu, Hiroyuki; Nozawa, Tomo; Ogihara, Yoshihito; Ito, Shuichi; Takatsuki, Shinichi; Katsumata, Nobuyuki; Suzuki, Yasuo; Takenaka, Satoshi; Hirono, Keiichi; Kobayashi, Tomio; Suzuki, Hiroshi; Suganuma, Eisuke; Takahashi, Kei; Saji, Tsutomu

2018-04-01

To assess the safety and efficacy of infliximab (IFX) for the treatment of patients with Kawasaki disease (KD). This was a nationwide survey of 274 Japanese institutions exploring how IFX was used to treat patients with KD. The patients' sex, age, treatment course, pre- and post-IFX therapy blood test results, coronary artery lesions (CALs), and adverse events (AEs) were evaluated. We analyzed 434 patients with KD who received IFX between March 2005 and November 2014. The median age at onset was 33 months (range 1-138), and 66 patients (15.2%) were under 1 year old. In all cases, IFX was administered as additional treatment. The median days of illness at the initiation of IFX was 9 days. In 275 patients (63.4%), IFX was administered as third-line treatment, and in 106 patients (24.4%), IFX was administered as fourth-line treatment. Single dose IFX 5 mg/kg was administered to 412 patients (94.9%). After IFX, 363 patients (83.6%) became afebrile within 2 days, and the white blood cell count, percentage of neutrophils, and serum C-reactive protein levels significantly decreased (P < .001), although 119 patients (27.4%) received additional treatment. Before IFX, 132 patients (30.4%) had already developed CALs. In patients without CALs before IFX, 31 patients (10.3%) newly developed CAL after IFX, whereas 32 patients (24.2%) with CAL before IFX showed increased CAL severity. Eighty AEs were observed in 69 patients (15.9%); however, serious AEs were few and reversible. IFX might be an effective and tolerable treatment for refractory KD. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of aprepitant for acute chemotherapy-induced nausea and vomiting in children and adolescents with acute lymphoblastic leukemia receiving high-dose methotrexate.

PubMed

Felix-Ukwu, Femi; Reichert, Kate; Bernhardt, M Brooke; Schafer, Eric S; Berger, Amanda

2018-02-01

Chemotherapy-induced nausea and vomiting (CINV) negatively impacts patients' quality of life. The emetogenicity of high-dose methotrexate in children and adolescents with cancer is incompletely characterized. At our institution, a number of patients with acute lymphoblastic leukemia (ALL) have received aprepitant with courses of high-dose methotrexate after poor CINV control with prior courses. We conducted a retrospective cohort analysis on patients with ALL who received methotrexate 5 g/m 2 /dose with and without concomitant aprepitant at Texas. Children's Hospital between October 1, 2010 and January 31, 2016. We identified 16 patients who received a total of 69 courses of methotrexate. An enhanced antiemetic regimen containing aprepitant was administered with 42 methotrexate courses and resulted in a 54% reduction in the use of as-needed antiemetics (P = 0.002, 95% CI: 21-89%). There were no statistically significant differences in methotrexate area under the curve values (2,209 μM⋅hr/l ± 151 vs. 2,051 μM⋅hr/l ± 94, P = 0.355) or end-infusion methotrexate concentrations (80.5 μM ± 5.6 vs. 74.7 μM ± 3.2, P = 0.335) in patients receiving a standard versus an enhanced antiemetic regimen. The addition of aprepitant reduces both CINV and the use of rescue antiemetics. Aprepitant does not appear to affect the pharmacokinetics of methotrexate. Granisetron was prescribed more frequently than ondansetron, but selection of secondary and tertiary agents, if any, was highly variable. © 2017 Wiley Periodicals, Inc.

Postdischarge surveillance for infection following cesarean section: A prospective cohort study comparing methodologies.

PubMed

Halwani, Muhammad A; Turnbull, Alison E; Harris, Meredith; Witter, Frank; Perl, Trish M

2016-04-01

To assess how enhanced postdischarge telephone follow-up calls would improve case finding for surgical site infection (SSI) surveillance after cesarean section. We conducted a prospective cohort study of all patients who delivered by cesarean section between April 22 and August 22, 2010. In addition to our routine surveillance, using clinical databases and electronic patient records, we also made follow-up calls to the patients at 7, 14, and 30 days postoperation. A standard questionnaire with questions about symptoms of SSI, health-seeking behaviors, and treatment received was administered. Descriptive statistics and univariate analysis were performed to assess the effect of the enhanced surveillance. One hundred ninety-three patients underwent cesarean section during this study period. Standard surveillance identified 14 infections with telephone follow-ups identifying an additional 5 infections. Using the call as a gold standard, the sensitivity of the standard methodology to capture SSI was 73.3%. The duration of the calls ranged from 1 to 5 minutes and were well received by the patients. Results suggest that follow-up telephone calls to patients following cesarean section identifies 26.3% of the total SSIs. Enhanced surveillance can provide more informed data to enhance performance and avoid underestimation of rates. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Efficacy of combined electrostimulation in patients with acute exacerbation of COPD: randomised clinical trial.

PubMed

Lopez Lopez, Laura; Granados Santiago, Maria; Donaire Galindo, Maria; Torres Sanchez, Irene; Ortiz Rubio, Araceli; Valenza, Marie Carmen

2018-04-25

Muscle dysfunction is very common in patients with chronic obstructive pulmonary disease (COPD). Muscular strength depletion is a result of numerous hospitalisations and this causes an increase in the symptomatology. Numerous interventions have been used in these patients, but there is no consensus on the best. The main objective of this study is to compare the effectiveness of two physiotherapy interventions during hospitalisation in COPD patients. In this clinical trial, we included 39 patients who were randomised into three groups. A control group received standard medical treatment (oxygen therapy and pharmacotherapy), and two groups received, in addition to standard medical treatment, a physiotherapy intervention, one with functional electrostimulation and one with calisthenic exercises. The main variables were the ability to exercise using the Five-time sit-to-stand test as well as the functionality associated with symptomatology, as measured by the London Chest Activity of Daily Living Scale. After comparing the results, there was a significant improvement in dyspnea on discharge versus admission in all three groups. In addition, we found significant differences in functionality, exercise capacity, and fatigue in both intervention groups, being better in the electrostimulation with calisthenic exercises group than in the functional group. An electrostimulation treatment improves the exercise capacity, functionality and fatigue in hospitalised AECOPD patients. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Experiences of older women with cancer receiving hospice care: significance for physical therapy.

PubMed

Mackey, K M; Sparling, J W

2000-05-01

The number of older adults with cancer is growing, increasing the need for professionals who are able to meet these patients' special needs. In palliative care settings, physical therapists strive to promote quality of life. Minimal research exists, however, to guide therapists working with patients with terminal illness. The purpose of this study was to gain knowledge that can be used by physical therapists to more effectively assess and treat older people with cancer receiving hospice care. A qualitative single-case study with replication was conducted with 3 older women with cancer who were receiving hospice care. Interview data were analyzed using grounded theory techniques. Four themes emerged as central to the experience of the informants: social relationships, spirituality, outlook on mortality, and meaningful physical activity. In addition to maintaining physical function, physical therapists, who attend to nonphysical as well as physical aspects of care, may foster social cohesion, help maximize life's meaning, and support stabilizing strategies of older women with cancer who receive hospice care.

Out-of-Hospital Fluid in Severe Sepsis: Effect on Early Resuscitation in the Emergency Department

PubMed Central

Seymour, Christopher W.; Cooke, Colin R.; Mikkelsen, Mark E.; Hylton, Julie; Rea, Tom D.; Goss, Christopher H.; Gaieski, David F.; Band, Roger A.

2014-01-01

Background Early identification and treatment of patients with severe sepsis improves outcome, yet the role of out-of-hospital intravenous (IV) fluid is unknown. Objective To determine if the delivery of out-of-hospital fluid in patients with severe sepsis is associated with reduced time to achievement of goal-oriented resuscitation in the emergency department (ED). Methods We performed a secondary data analysis of a retrospective cohort study in a metropolitan, tertiary care, university-based medical center supported by a two-tiered system of out-of-hospital emergency medical services (EMS) providers. We studied the association between delivery of out-of-hospital fluid by advanced life support (ALS) providers and the achievement of resuscitation endpoints (central venous pressure [CVP] ≥8 mmHg, mean arterial pressure [MAP] ≥65 mmHg, and central venous oxygen saturation [ScvO2] ≥70%) within six hours after triage during early goal-directed therapy (EGDT) in the ED. Results Twenty five (48%) of 52 patients transported by ALS with severe sepsis received out-of-hospital fluid. Data for age, gender, source of sepsis, and presence of comorbidities were similar between patients who did and did not receive out-of-hospital fluid. Patients receiving out-of-hospital fluid had lower out-of-hospital mean (± standard deviation) systolic blood pressure (95 ± 40 mmHg vs. 117 ± 29 mmHg; p = 0.03) and higher median (interquartile range) Sequential Organ Failure Assessment (SOFA) scores in the ED (7 [5–8] vs. 4 [4–6]; p = 0.01) than patients not receiving out-of-hospital fluid. Despite greater severity of illness, patients receiving out-of-hospital fluid approached but did not attain a statistically significant increase in the likelihood of achieving MAP ≥65 mmHg within six hours after ED triage (70% vs. 44%, p = 0.09). On average, patients receiving out-of-hospital fluid received twice the fluid volume within one hour after ED triage (1.1 L [1.0–2.0 L] vs. 0.6 L [0.3–1.0 L]; p 0.01). No difference in achievement of goal CVP (72% vs. 60%; p = 0.6) or goal ScvO2 (54% vs. 36%; p = 0.25) was observed between groups. Conclusions Less than half of patients with severe sepsis transported by ALS received out-of-hospital fluid. Patients receiving out-of-hospital IV access and fluids approached but did not attain a statistically significant increase in the likelihood of achieving goal MAP during EGDT. These preliminary findings require additional investigation to evaluate the optimal role of out-of-hospital resuscitation in treating patients with severe sepsis. PMID:20199228

Real-world treatment patterns and costs in a US Medicare population with metastatic squamous non-small cell lung cancer.

PubMed

Davis, Keith L; Goyal, Ravi K; Able, Stephen L; Brown, Jacqueline; Li, Li; Kaye, James A

2015-02-01

Despite advances in the treatment of nonsquamous non-small cell lung cancer (NSCLC), therapeutic choices and overall disease course for squamous NSCLC have remained relatively unchanged over the past several years. We provide a detailed account of current treatment patterns, healthcare use, and survival in real-world clinical settings for metastatic squamous NSCLC. Patients aged ≥65 years with metastatic squamous NSCLC diagnosed 2001-2009 were identified and followed through 2010 using the Surveillance, Epidemiology and End Results-Medicare database. Treatment patterns were descriptively analyzed. Multivariate logistic regressions were estimated to identify predictors of treatment pattern events; generalized linear models were estimated for total all-cause and NSCLC-related costs to assess cost drivers. Of 17,133 patients, 72% received cancer-directed therapy (surgery, radiation, chemotherapy, or biologic therapy), whereas 28% received only supportive care. Median survival was significantly longer in patients receiving cancer-directed therapy (8 months) than in patients receiving supportive care only (2 months) (P<0.0001). An agent-specific first-line chemotherapy regimen was identified for 91% of the 7700 patients who received chemotherapy. Among these, the most common first-line regimen was carboplatin-paclitaxel combination therapy (46%). Common second-line regimens were gemcitabine monotherapy (16%) and pemetrexed monotherapy (11%). Factors associated with decreased odds of receiving cancer-directed treatment were black versus white race (OR, 0.72; 95% CI, 0.64-0.82), residence in the West versus South (OR, 0.73; 95% CI, 0.66-0.81), and metastatic disease at initial diagnosis versus progression to metastatic disease (OR, 0.77; 95% CI, 0.70-0.84). Our study shows that prognosis remains poor for patients with metastatic squamous NSCLC, even among those receiving treatment, but particularly for patients limited to supportive care only, highlighting the continuing unmet medical need in this population. Additionally, our analysis indicates that selections for second-line and third-line chemotherapies are not necessarily consistent with National Comprehensive Cancer Network guidelines. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Total Laryngectomy Versus Larynx Preservation for T4a Larynx Cancer: Patterns of Care and Survival Outcomes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grover, Surbhi; Swisher-McClure, Samuel; Mitra, Nandita

2015-07-01

Purpose: To examine practice patterns and compare survival outcomes between total laryngectomy (TL) and larynx preservation chemoradiation (LP-CRT) in the setting of T4a larynx cancer, using a large national cancer registry. Methods and Materials: Using the National Cancer Database, we identified 969 patients from 2003 to 2006 with T4a squamous cell larynx cancer receiving definitive treatment with either initial TL plus adjuvant therapy or LP-CRT. Univariate and multivariable logistic regression were used to assess predictors of undergoing surgery. Survival outcomes were compared using Kaplan-Meier and propensity score–adjusted and inverse probability of treatment–weighted Cox proportional hazards methods. Sensitivity analyses were performed tomore » account for unmeasured confounders. Results: A total of 616 patients (64%) received LP-CRT, and 353 (36%) received TL. On multivariable logistic regression, patients with advanced nodal disease were less likely to receive TL (N2 vs N0, 26.6% vs 43.4%, odds ratio [OR] 0.52, 95% confidence interval [CI] 0.37-0.73; N3 vs N0, 19.1% vs 43.4%, OR 0.23, 95% CI 0.07-0.77), whereas patients treated in high case-volume facilities were more likely to receive TL (46.1% vs 31.5%, OR 1.78, 95% CI 1.27-2.48). Median survival for TL versus LP was 61 versus 39 months (P<.001). After controlling for potential confounders, LP-CRT had inferior overall survival compared with TL (hazard ratio 1.31, 95% CI 1.10-1.57), and with the inverse probability of treatment–weighted model (hazard ratio 1.25, 95% CI 1.05-1.49). This survival difference was shown to be robust on additional sensitivity analyses. Conclusions: Most patients with T4a larynx cancer receive LP-CRT, despite guidelines suggesting TL as the preferred initial approach. Patients receiving LP-CRT had more advanced nodal disease and worse overall survival. Previous studies of (non-T4a) locally advanced larynx cancer showing no difference in survival between LP-CRT and TL may not apply to T4a disease, and patients should be counseled accordingly.« less

Review of thromboembolic prophylaxis in patients attending Cork University Hospital.

PubMed

Byrne, Stephen; Weaver, Daniel Timothy

2013-06-01

Although preventable, venous thromboembolism remains a common cause of hospital acquired morbidity and mortality. Guidelines, such as the one produced by the American College of Chest Physicians (ACCP), are aimed at reducing hospital associated venous thromboemboli. Unfortunately the majority of studies have revealed inadequate adherence to these guidelines. The objective of this study was to evaluate the use of venous thromboembolism prophylaxis at Cork University Hospital. Cork University Hospital, Wilton, Cork, Ireland. Data from the patient's chart, drug kardex and laboratory results were recorded during April 2010. A Caprini score, a venous thromboembolism risk factor assessment tool, was subsequently calculated for each patient based on data collected. Appropriate prophylaxis was determined after examining data collected, Caprini score and prophylactic regime according to the ACCP 8th edition guidelines. Primary outcome was to analyse adherence to VTE prophylaxis guidelines. A total of 394 patients met the inclusion criteria and were reviewed, of which, 60% (n = 236) were medical and 37% (n = 146) were surgical patients. In total 63% of patients received some form of venous thromboembolism prophylaxis. Furthermore, 54% of medical and 76% of surgical patients received prophylaxis. However only 37% of the patients studied received appropriate thromboprophylaxis according to the ACCP 8th edition guidelines (Geerts et al. in chest 133(6 Suppl):381S-453S, 2008). Additionally 51% of surgical and 27% of medical patients received appropriate prophylaxis. Data collected from Cork University Hospital revealed poor adherence to international venous thromboembolism prophylaxis guidelines. As stated in the ACCP 8th edition guidelines, every hospital should develop a formal strategy for venous thromboembolism prevention (Geerts et al. in chest 133(6 Suppl):381S-453S, 2008). In order to improve adherence to guidelines, Cork University Hospital should develop, implement and re-evaluate a specific protocol for venous thromboembolism prophylaxis.

Effects of a Brief Multimedia Psychoeducational Intervention on the Attitudes and Interest of Patients With Cancer Regarding Clinical Trial Participation: A Multicenter Randomized Controlled Trial

PubMed Central

Jacobsen, Paul B.; Wells, Kristen J.; Meade, Cathy D.; Quinn, Gwendolyn P.; Lee, Ji-Hyun; Fulp, William J.; Gray, Jhanelle E.; Baz, Rachid C.; Springett, Gregory M.; Levine, Richard M.; Markham, Merry-Jennifer; Schreiber, Fred J.; Cartwright, Thomas H.; Burke, James M.; Siegel, Robert D.; Malafa, Mokenge P.; Sullivan, Daniel

2012-01-01

Purpose The negative attitudes of patients with cancer regarding clinical trials are an important contributor to low participation rates. This study evaluated whether a brief psychoeducational intervention was effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials. Patients and Methods A total of 472 adults with cancer who had not been asked previously to participate in a clinical trial were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials. The primary (attitudes) and secondary outcomes (knowledge, self-efficacy, receptivity, and willingness) were assessed via patient self-report before random assignment and 7 to 28 days later. Results Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials (P = .016) and greater willingness to participate (P = .011) at follow-up than patients who received printed educational information. Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168; 95% CI, 0.088 to 0.248) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials. Conclusion A brief psychoeducational intervention can improve the attitudes of patients with cancer toward clinical trials and thereby increase their willingness to participate in clinical trials. Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials. PMID:22614993

Effects of resistance exercise training and nandrolone decanoate on body composition and muscle function among patients who receive hemodialysis: A randomized, controlled trial.

PubMed

Johansen, Kirsten L; Painter, Patricia L; Sakkas, Giorgos K; Gordon, Patricia; Doyle, Julie; Shubert, Tiffany

2006-08-01

Patients who are on hemodialysis commonly experience muscle wasting and weakness, which have a negative effect on physical functioning and quality of life. The objective of this study was to determine whether anabolic steroid administration and resistance exercise training induce anabolic effects among patients who receive maintenance hemodialysis. A randomized 2 x 2 factorial trial of anabolic steroid administration and resistance exercise training was conducted in 79 patients who were receiving maintenance hemodialysis at University of California, San Francisco-affiliated dialysis units. Interventions included double-blinded weekly nandrolone decanoate (100 mg for women; 200 mg for men) or placebo injections and lower extremity resistance exercise training for 12 wk during hemodialysis sessions three times per week using ankle weights. Primary outcomes included change in lean body mass (LBM) measured by dual-energy x-ray absorptiometry, quadriceps muscle cross-sectional area measured by magnetic resonance imaging, and knee extensor muscle strength. Secondary outcomes included changes in physical performance, self-reported physical functioning, and physical activity. Sixty-eight patients completed the study. Patients who received nandrolone decanoate increased their LBM by 3.1 +/- 2.2 kg (P < 0.0001). Exercise did not result in a significant increase in LBM. Quadriceps muscle cross-sectional area increased in patients who were assigned to exercise (P = 0.01) and to nandrolone (P < 0.0001) in an additive manner. Patients who exercised increased their strength in a training-specific fashion, and exercise was associated with an improvement in self-reported physical functioning (P = 0.04 compared with nonexercising groups). Nandrolone decanoate and resistance exercise produced anabolic effects among patients who were on hemodialysis. Further studies are needed to determine whether these interventions improve survival.

The Effect of Ramelteon on Heartburn Symptoms of Patients With Gastroesophageal Reflux Disease and Chronic Insomnia: A Pilot Study.

PubMed

Jha, Lokesh K; Fass, Ronnie; Gadam, Rakshith; Maradey-Romero, Carla; Nasrollah, Laya; Hershcovici, Tiberiu; Quan, Stuart F; Dickman, Ram

2016-02-01

There is a bidirectional relationship between gastroesophageal reflux disease (GERD) and sleep. It has been demonstrated that antireflux treatment can improve sleep quality in GERD patients with nighttime reflux. Patients with heartburn and/or regurgitation ≥3 times/week and insomnia for ≥3 months were included. Patients were assessed at baseline with the demographic, GERD symptom assessment scale, Epworth sleepiness scale, Berlin sleep apnea, Pittsburgh sleep quality index, and the Insomnia severity index questionnaires. Subjects underwent an upper endoscopy followed by pH testing. Subsequently, subjects were randomized, in a double-blind, placebo-controlled trial, to receive either ramelteon 8 mg or placebo before bedtime for 4 weeks. During the last week of treatment, subjects completed a daily GERD symptom and sleep diary and underwent actigraphy. Sixteen patients completed the study, 8 in each arm (mean age and M/F were 48.5 vs. 57.8 y, and 8/0 vs. 6/2, respectively). Patients who received ramelteon demonstrated a statistically significant decrease in symptom score as compared with those who received placebo for daytime heartburn (-42% vs. -29%), nighttime heartburn (-42% vs. 78%), 24-hour heartburn (-42% vs. -3%), and 24-hour acid regurgitation (-26% vs. 19%) (all P<0.05). Insomnia severity index score was significantly reduced in patients receiving ramelteon as compared with placebo (-46% vs. -5%, P<0.05). Ramelteon group also demonstrated a significant improvement in sleep efficiency and sleep latency, as compared with placebo, P<0.05). No significant adverse events were observed with ramelteon. Ramelteon significantly improved symptoms in patients with GERD. In addition, ramelteon significantly improved patients' sleep experience. Further studies are needed in the future (NCT01128582).

Dabigatran affects thrombin-dependent platelet aggregation after a week-long therapy.

PubMed

Sokol, Juraj; Nehaj, Frantisek; Ivankova, Jela; Mokan, Michal; Mokan, Marian; Stasko, Jan

2018-05-29

Dabigatran is a direct thrombin inhibitor. As the main adverse event is bleeding, it is relevant whether dabigatran has additional effects on platelet function. If so, it could affect the bleeding risk. We aimed to assess in vitro aggregation in patients with atrial fibrillation (AF) receiving dabigatran. We evaluated 32 AF patients treated with dabigatran (study group) and 18 non-anticoagulated non-AF blood donors (control group). We assessed light transmittance platelet aggregation (LTA) with 100 nmol/L γ-thrombin in both groups. The LTA was performed at two time-points in our dabigatran group of patients. The thrombin-induced platelet aggregation was significantly lower two hours after dabigatran was taken compared to baseline measurement (9% ± 6% vs. 29% ± 21%) in our study group. Moreover, we observed that the baseline value of platelet aggregation in patients on dabigatran treatment was significantly lower compared to healthy volunteers (29% ± 21% vs. 89 ± 8). However, one subanalysis showed that this significant reduction in platelet aggregation at baseline was only observed in patients who received dabigatran for over a week. The thrombin-induced platelet aggregation is reduced in non-valvular AF patients receiving dabigatran after a week-long therapy.

Renoprotective effects of thiazides combined with loop diuretics in patients with type 2 diabetic kidney disease.

PubMed

Hoshino, Taro; Ookawara, Susumu; Miyazawa, Haruhisa; Ito, Kiyonori; Ueda, Yuichiro; Kaku, Yoshio; Hirai, Keiji; Mori, Honami; Yoshida, Izumi; Tabei, Kaoru

2015-04-01

Type 2 diabetic kidney disease (DKD) is frequently accompanied by uncontrollable hypertension due to the sodium sensitivity inherent in DKD and to diuretic-resistant edema. In general, diuretics are effective in treating this condition, but thiazide diuretics are thought to be innocuous in advanced chronic kidney disease (CKD). We examined the renoprotective effects of combination therapy with thiazides and loop diuretics in type 2 DKD patients with CKD stage G4 or G5. This study included 11 patients with type 2 DKD and an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m(2) who were suffering from severe edema even with loop diuretics. Each patient received additional hydrochlorothiazide (HCTZ) therapy, which was continued for more than 12 months. We examined clinical parameters including blood pressure (BP), proteinuria, and eGFR before and after the addition of HCTZ. Patients received a 13.6 ± 3.8 mg/day dose of HCTZ in addition to loop diuretics (azosemide: 120 mg/day in 6 cases, 60 mg/day in 3 cases and furosemide: 80 mg/day in 1 case, 120 mg/day in 1 case). Side effects of HCTZ were not observed in all patients. After the addition of HCTZ therapy, systolic and diastolic blood pressures (S-BP, D-BP) as well as proteinuria significantly decreased (S-BP: at 6 months, p < 0.05 and 12 months, p < 0.01 vs. 0 month, D-BP: at 12 months, p < 0.05 vs. 0 month, proteinuria: at 6 months, p < 0.05 and 12 months, p < 0.01 vs. 0 month). The annual decline in eGFR was not significantly different before and after HCTZ therapy (-7.7 ± 8.5 and -8.4 ± 4.8 mL/min/1.73 m(2)/year, respectively). Our findings suggest that the combination of HCTZ and loop diuretics improves BP levels, and decreases proteinuria even in advanced stage type 2 DKD patients with severe edema. The addition of HCTZ therapy was not found to negatively affect the change in eGFR in the present study.

Usual Course of Treatment and Predictors of Treatment Utilization for Patients with Posttraumatic Stress Disorder

PubMed Central

Nobles, Carrie J.; Valentine, Sarah E.; Zepeda, E. David; Ahles, Emily M.; Shtasel, Derri L.; Marques, Luana

2017-01-01

Objective Posttraumatic stress disorder (PTSD) is a debilitating psychiatric illness that frequently remains undiagnosed and untreated. While extensive research has been conducted among veterans, little research has evaluated course of treatment for PTSD in a general hospital setting. Method We utilized data from the Partners Healthcare Research Patient Database Registry to evaluate mental health treatment utilization, including psychotherapy and pharmacotherapy, by patients with recently diagnosed primary PTSD following Diagnostic and Statistical Manual IV criteria between January 1, 2002 and June 30, 2011. We additionally evaluated predictors of treatment utilization 6 months post-diagnosis. Results Among 2,475 patients with recently diagnosed prim ary PTSD, approximately half (55.7%) had any therapy visit and 10% at least 12 therapy visits in the 6 months following diagnosis. Approximately half (47.0%) received a psychiatric prescription, with 29.3% receiving a selective serotonin reuptake inhibitor (SSRI), 11.8% an atypical antipsychotic and 24.4% a benzodiazepine. Latinos were 25% more likely to have an SSRI prescription, 35% more likely to have an atypical antipsychotic prescription and 28% more likely to have any psychotherapy. Men were 96% more likely to have an atypical antipsychotic prescription. Patients with Medicare were 20% less likely to have any psychotherapy, and patients with Medicaid were 35% less likely to have 12 or more therapy visits. Conclusion Many patients with a primary diagnosis of PTSD do not receive psychotherapy, and psychiatric prescriptions, including atypical antipsychotics and benzodiazepines, are common. Future research is needed to determine quality of care received and explore sub-population specific barriers limiting access to care. PMID:28570794

Is immediate adjunctive CBT more beneficial than delayed CBT in treating depression?: A Pilot Study.

PubMed

Rizvi, Sakina J; Zaretsky, Ari; Schaffer, Ayal; Levitt, Anthony

2015-03-01

Cognitive-behavioral therapy (CBT) is an efficacious first-line therapy for patients with major depressive disorder (MDD). Due to the limited accessibility of CBT, long wait lists result in delayed treatment, which may affect treatment outcomes. The goal of this pilot study was to obtain preliminary data from a randomized controlled trial to determine whether delayed CBT reduces the effectiveness of the therapy compared to immediate CBT in patients with MDD receiving pharmacotherapy. Patients were randomized to receive immediate CBT (n=18) or to begin CBT after 6 months (n=20) and received 14 weekly sessions, followed by two additional booster sessions. During the active treatment months, patients in the immediate group demonstrated reductions in scores on the Beck Depression Inventory II (BDI-II) that were similar to those in the delayed CBT group. However, when the analysis was performed using only data from patients in the delayed group who were still in a depressive episode, there was an overall greater decrease in BDI-II scores in the immediate group vs. the delayed group over the active treatment months, but not specifically at the 6-month endpoint. These findings suggest delays in depression treatment, similar to what occurs with real-world wait list times, may not have a significant impact on the effectiveness of CBT in patients who are already receiving treatment as usual. However, such delays may affect the effectiveness of CBT in those patients who remain depressed during the time delay. A larger trial is necessary to confirm these findings. (Journal of Psychiatric Practice 2015;21:107-113).

Breast Milk Feeding Rates in Patients With Cleft Lip and Palate at a North American Craniofacial Center.

PubMed

Alperovich, Michael; Frey, Jordan D; Shetye, Pradip R; Grayson, Barry H; Vyas, Raj M

2017-05-01

  Our study goal was to evaluate the rates of breast milk feeding among patients with oral clefts at a large North American Craniofacial Center.   Parents of patients with oral clefts born from 2000 to 2012 and treated at our center were interviewed regarding cleft diagnosis, counseling received for feeding, and feeding habits.   Data were obtained from parents of 110 patients with oral clefts. Eighty-four percent of parents received counseling for feeding a child with a cleft. Sixty-seven percent of patients received breast milk for some period of time with a mean duration of 5.3 months (range 0.25 to 18 months). When used, breast milk constituted the majority of the diet with a mean percentage of 75%. Breast milk feeding rates increased successively over the 13-year study period. The most common method of providing breast milk was the Haberman feeder at 75% with other specialty cleft bottles composing an additional 11%. Parents who received counseling were more likely to give breast milk to their infant (P = .02). Duration of NasoAlveolar Molding prior to cleft lip repair did not affect breast milk feeding length (P = .72). Relative to patients with cleft lip and palate, patients with isolated cleft lip had a breast milk feeding odds ratio of 1.71.   We present breast milk feeding in the North American cleft population. Although still lower than the noncleft population, breast milk feeding with regards to initiation rate, length of time, and proportion of total diet is significantly higher than previously reported.

Acquired von Willebrand Syndrome Associated to Secondary IgM MGUS Emerging after Autologous Stem Cell Transplantation for AL Amyloidosis

PubMed Central

Qamar, Hina; Lee, Adrienne; Valentine, Karen; Skeith, Leslie; Jimenez-Zepeda, Victor H

2017-01-01

Acquired von Willebrand syndrome (AVWS) is a rare hemorrhagic disorder that occurs in patients with no prior personal or family history of bleeding. Here, we describe a case of AVWS occurring after autologous stem cell transplantation (ASCT). Interestingly, AVWS developed after bortezomib-based induction and conditioning regimens. Recent evidence suggests that the proximity of the bortezomib therapy to the collection of stem cells with consequent depletion of regulatory T cells after the conditioning regimen could explain some of the unusual autoimmune complications reported in patients receiving bortezomib prior to ASCT. In addition, this patient developed a secondary MGUS post-ASCT, which may have also contributed to the AVWS. To the best of our knowledge, this is the first case of post-ASCT AVWS reported. Prospective data is needed to better elucidate the mechanisms by which these unusual complications occur in patients receiving bortezomib prior to ASCT. PMID:28512563

Acquired von Willebrand Syndrome Associated to Secondary IgM MGUS Emerging after Autologous Stem Cell Transplantation for AL Amyloidosis.

PubMed

Qamar, Hina; Lee, Adrienne; Valentine, Karen; Skeith, Leslie; Jimenez-Zepeda, Victor H

2017-01-01

Acquired von Willebrand syndrome (AVWS) is a rare hemorrhagic disorder that occurs in patients with no prior personal or family history of bleeding. Here, we describe a case of AVWS occurring after autologous stem cell transplantation (ASCT). Interestingly, AVWS developed after bortezomib-based induction and conditioning regimens. Recent evidence suggests that the proximity of the bortezomib therapy to the collection of stem cells with consequent depletion of regulatory T cells after the conditioning regimen could explain some of the unusual autoimmune complications reported in patients receiving bortezomib prior to ASCT. In addition, this patient developed a secondary MGUS post-ASCT, which may have also contributed to the AVWS. To the best of our knowledge, this is the first case of post-ASCT AVWS reported. Prospective data is needed to better elucidate the mechanisms by which these unusual complications occur in patients receiving bortezomib prior to ASCT.

The Effect of Underwater Gait Training on Balance Ability of Stroke Patients

PubMed Central

Park, Seok Woo; Lee, Kyoung Jin; Shin, Doo Chul; Shin, Seung Ho; Lee, Myung Mo; Song, Chang Ho

2014-01-01

[Purpose] The purpose of this study was to investigate the effects of underwater treadmill gait training on the balance ability of stroke patients. [Subjects] Twenty-two patients with stroke were randomly assigned to an underwater treadmill group (n =11) or a control group (n =11). [Methods] Both groups received general rehabilitation for 30 min per session, 5 times per week, over a 4-week period. The underwater treadmill group received additional underwater gait training for 30 min per session, 5 times per week, over the same 4-week period. Static and dynamic balances were evaluated before and after the intervention. [Results] The means of static and dynamic balance ability increased significantly in both groups, but there was no significant difference between the two groups. [Conclusion] Compared to the general rehabilitation program, underwater treadmill gait training was not more effective at improving the balance ability of stroke patients than land-based training. PMID:25013292

Calcium oxalate crystal related kidney injury in a patient receiving Roux-en Y hepaticojejunostomy due to gall bladder cancer.

PubMed

Tsai, Jun-Li; Tsai, Shang-Feng

2017-03-29

Calcium oxalate nephropathy is rare in current practice. It was a common complication during jejunoileal bypass, but much less seen in modern gastric bypass surgery for morbid obesity. The major cause of it is enteric hyperoxaluria. We report on a patient here with acute kidney disease due to calcium oxalate nephropathy, rather than the conditions mentioned above. The male patient received a Roux-en Y hepaticojejunostomy and common bile duct drainage. In addition to enteric hyperoxaluria, chronic kidney disease related metabolic acidosis, chronic diarrhea related volume depletion, a high oxalate and low potassium diet, long term ascorbic acid intake and long term exposure to antibiotics, all predisposed him to having oxalate nephropathy. This is the first case with such conditions and we recommend that similarly diagnosed patients avoid all these predisposing factors, in order to avoid this rare disease and its undesired outcome.

Management of Hyperglycemia During Enteral and Parenteral Nutrition Therapy

PubMed Central

Umpierrez, Guillermo E.

2013-01-01

Hyperglycemia is a frequent complication of enteral and parenteral nutrition in hospitalized patients. Extensive evidence from observational studies indicates that the development of hyperglycemia during parenteral and enteral nutrition is associated with an increased risk of death and infectious complications. There are no specific guidelines recommending glycemic targets and effective strategies for the management of hyperglycemia during specialized nutritional support. Managing hyperglycemia in these patients should include optimization of carbohydrate content and administration of intravenous or subcutaneous insulin therapy. The administration of continuous insulin infusion and insulin addition to nutrition bag are efficient approaches to control hyperglycemia during parenteral nutrition. Subcutaneous administration of long-acting insulin with scheduled or corrective doses of short-acting insulin is superior to the sliding scale insulin strategy in patients receiving enteral feedings. Randomized controlled studies are needed to evaluate safe and effective therapeutic strategies for the management of hyperglycemia in patients receiving nutritional support. PMID:23065369

Telephone reminder call in addition to mailing notification improved the acceptance rate of colonoscopy in patients with a positive fecal immunochemical test.

PubMed

Cha, Jae Myung; Lee, Joung Il; Joo, Kwang Ro; Shin, Hyun Phil; Park, Jae Jun

2011-11-01

Colorectal cancer (CRC) screening with a fecal immunochemical test (FIT) reduces CRC mortality; however, the acceptance rate of a colonoscopy in patients with a positive FIT was not high. The aim of this study was therefore to determine whether a telephone reminder call could increase the acceptance rate of colonoscopy in patients with a positive FIT. We performed FITs for asymptomatic participants aged 50 years or older. For patients with a positive FIT, a colonoscopy was recommended via mailing notification only (control group) or via a telephone reminder call after mailing notification (intervention group). The calls informed patients about the significance of a positive FIT and encouraged a colonoscopy following positive FITs. The FIT results were positive in 90 of 8,318 patients who received FITs. Fifty patients were advised to receive colonoscopy via mailing notification only, and 40 patients were advised via both a telephone reminder call and a mailing notification. The acceptance rate of colonoscopy was significantly higher in the intervention group than in the control group (p = 0.038). The lesion-detection rate for an advanced neoplasia was also significantly higher in the intervention group than in the control group (p = 0.046). According to multivariate logistic regression analysis, a telephone reminder was a significant determinant of colonoscopy acceptance in patients with a positive FIT (OR 4.33; 95% CI, 1.19-15.75; p = 0.026). Telephone reminder calls in addition to mailing notification improved the acceptance rate of colonoscopy in patients with a positive FIT.

Molecular Solutions to Low Injuries Resulting from Battlefield Injuries. Addendum

DTIC Science & Technology

2008-05-01

regeneration; (5) dry eye by determining how to minimize dry eye after LASIK refractive surgery by developing new tests to predict pre-disposition to...been enrolled and treated. Of these 12 have received LASIK and 10 PRK. Six additional patients have been scheduled for enrollment/preop/treatment in...the next two weeks. Of these individuals 1 will receive LASIK and 5 PRK. There have been no adverse events to report to date. KEY RESEARCH

Decisions about Renal Replacement Therapy in Patients with Advanced Kidney Disease in the US Department of Veterans Affairs, 2000-2011.

PubMed

Wong, Susan P Y; Hebert, Paul L; Laundry, Ryan J; Hammond, Kenric W; Liu, Chuan-Fen; Burrows, Nilka R; O'Hare, Ann M

2016-10-07

It is not known what proportion of United States patients with advanced CKD go on to receive RRT. In other developed countries, receipt of RRT is highly age dependent and the exception rather than the rule at older ages. We conducted a retrospective study of a national cohort of 28,568 adults who were receiving care within the US Department of Veteran Affairs and had a sustained eGFR <15 ml/min per 1.73 m 2 between January 1, 2000 to December 31, 2009. We used linked administrative data from the US Renal Data System, US Department of Veteran Affairs, and Medicare to identify cohort members who received RRT during follow-up through October 1, 2011 ( n =19,165). For a random 25% sample of the remaining 9403 patients, we performed an in-depth review of their VA-wide electronic medical records to determine the treatment status of their CKD. Two thirds (67.1%) of cohort members received RRT on the basis of administrative data. On the basis of the results of chart review, we estimate that an additional 7.5% (95% confidence interval, 7.2% to 7.8%) of cohort members had, in fact, received dialysis, that 10.9% (95% confidence interval, 10.6% to 11.3%) were preparing for and/or discussing dialysis but had not started dialysis at most recent follow-up, and that a decision had been made not to pursue dialysis in 14.5% (95% confidence interval, 14.1% to 14.9%). The percentage of cohort members who received or were preparing to receive RRT ranged from 96.2% (95% confidence interval, 94.4% to 97.4%) for those <45 years old to 53.3% (95% confidence interval, 50.7% to 55.9%) for those aged ≥85 years old. Results were similar after stratification by tertile of Gagne comorbidity score. In this large United States cohort of patients with advanced CKD, the majority received or were preparing to receive RRT. This was true even among the oldest patients with the highest burden of comorbidity. Copyright © 2016 by the American Society of Nephrology.

Decisions about Renal Replacement Therapy in Patients with Advanced Kidney Disease in the US Department of Veterans Affairs, 2000–2011

PubMed Central

Hebert, Paul L.; Laundry, Ryan J.; Hammond, Kenric W.; Liu, Chuan-Fen; Burrows, Nilka R.; O’Hare, Ann M.

2016-01-01

Background and objectives It is not known what proportion of United States patients with advanced CKD go on to receive RRT. In other developed countries, receipt of RRT is highly age dependent and the exception rather than the rule at older ages. Design, setting, participants, & measurements We conducted a retrospective study of a national cohort of 28,568 adults who were receiving care within the US Department of Veteran Affairs and had a sustained eGFR <15 ml/min per 1.73 m2 between January 1, 2000 to December 31, 2009. We used linked administrative data from the US Renal Data System, US Department of Veteran Affairs, and Medicare to identify cohort members who received RRT during follow-up through October 1, 2011 (n=19,165). For a random 25% sample of the remaining 9403 patients, we performed an in-depth review of their VA–wide electronic medical records to determine the treatment status of their CKD. Results Two thirds (67.1%) of cohort members received RRT on the basis of administrative data. On the basis of the results of chart review, we estimate that an additional 7.5% (95% confidence interval, 7.2% to 7.8%) of cohort members had, in fact, received dialysis, that 10.9% (95% confidence interval, 10.6% to 11.3%) were preparing for and/or discussing dialysis but had not started dialysis at most recent follow-up, and that a decision had been made not to pursue dialysis in 14.5% (95% confidence interval, 14.1% to 14.9%). The percentage of cohort members who received or were preparing to receive RRT ranged from 96.2% (95% confidence interval, 94.4% to 97.4%) for those <45 years old to 53.3% (95% confidence interval, 50.7% to 55.9%) for those aged ≥85 years old. Results were similar after stratification by tertile of Gagne comorbidity score. Conclusions In this large United States cohort of patients with advanced CKD, the majority received or were preparing to receive RRT. This was true even among the oldest patients with the highest burden of comorbidity. PMID:27660306

Preemptive Analgesia in Hip Arthroscopy: A Randomized Controlled Trial of Preemptive Periacetabular or Intra-articular Bupivacaine in Addition to Postoperative Intra-articular Bupivacaine.

PubMed

Shlaifer, Amir; Sharfman, Zachary Tuvya; Martin, Hal David; Amar, Eyal; Kazum, Efi; Warschawski, Yaniv; Paret, Matan; Brill, Silviu; Drexler, Michael; Rath, Ehud

2017-01-01

To evaluate and compare the efficacy of intra-articular and periacetabular blocks for postoperative pain control after hip arthroscopy. Forty-two consecutive patients scheduled for hip arthroscopy were randomized into 2 postoperative pain control groups. One group received preemptive intra-articular 20 mL of bupivacaine 0.5% injection, and the second group received preemptive periacetabular 20 mL of bupivacaine 0.5% injection. Before closure all patients received an additional dose of 20 mL of bupivacaine 0.5% intra-articularly. Data were compared with respect to postoperative pain with visual analog scale (VAS) and analgesic consumption, documented in a pain diary for 2 weeks after surgery. Twenty-one patients were treated with intra-articular injection, and 21 patients with peri-acetabular injection. There were no significant differences with regards to patient demographics or surgical procedures. VAS scores recorded during the first 30 minutes postoperatively and 18 hours after surgery were significantly lower in the periacetabular group compared with in the intra-articular group (0.667 ± 1.49 vs 2.11 ± 2.29; P < .045 and 2.62 ± 2.2 vs 4.79 ± 2.6; P < .009). There were no differences between the groups with regard to analgesic consumption. Periacetabular injection of bupivacaine 0.5% was superior to intra-articular injection in pain reduction after hip arthroscopy at 30 minutes and 18 hours postoperatively. However, total analgesic consumption over the first 2 postoperative weeks and VAS pain measurements were not significantly affected. Level I, randomized controlled trial. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.

PubMed

Bourlière, Marc; Gordon, Stuart C; Flamm, Steven L; Cooper, Curtis L; Ramji, Alnoor; Tong, Myron; Ravendhran, Natarajan; Vierling, John M; Tran, Tram T; Pianko, Stephen; Bansal, Meena B; de Lédinghen, Victor; Hyland, Robert H; Stamm, Luisa M; Dvory-Sobol, Hadas; Svarovskaia, Evguenia; Zhang, Jie; Huang, K C; Subramanian, G Mani; Brainard, Diana M; McHutchison, John G; Verna, Elizabeth C; Buggisch, Peter; Landis, Charles S; Younes, Ziad H; Curry, Michael P; Strasser, Simone I; Schiff, Eugene R; Reddy, K Rajender; Manns, Michael P; Kowdley, Kris V; Zeuzem, Stefan

2017-06-01

Patients who are chronically infected with hepatitis C virus (HCV) and who do not have a sustained virologic response after treatment with regimens containing direct-acting antiviral agents (DAAs) have limited retreatment options. We conducted two phase 3 trials involving patients who had been previously treated with a DAA-containing regimen. In POLARIS-1, patients with HCV genotype 1 infection who had previously received a regimen containing an NS5A inhibitor were randomly assigned in a 1:1 ratio to receive either the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the protease inhibitor voxilaprevir (150 patients) or matching placebo (150 patients) once daily for 12 weeks. Patients who were infected with HCV of other genotypes (114 patients) were enrolled in the sofosbuvir-velpatasvir-voxilaprevir group. In POLARIS-4, patients with HCV genotype 1, 2, or 3 infection who had previously received a DAA regimen but not an NS5A inhibitor were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir-voxilaprevir (163 patients) or sofosbuvir-velpatasvir (151 patients) for 12 weeks. An additional 19 patients with HCV genotype 4 infection were enrolled in the sofosbuvir-velpatasvir-voxilaprevir group. In the three active-treatment groups, 46% of the patients had compensated cirrhosis. In POLARIS-1, the rate of sustained virologic response was 96% with sofosbuvir-velpatasvir-voxilaprevir, as compared with 0% with placebo. In POLARIS-4, the rate of response was 98% with sofosbuvir-velpatasvir-voxilaprevir and 90% with sofosbuvir-velpatasvir. The most common adverse events were headache, fatigue, diarrhea, and nausea. In the active-treatment groups in both trials, the percentage of patients who discontinued treatment owing to adverse events was 1% or lower. Sofosbuvir-velpatasvir-voxilaprevir taken for 12 weeks provided high rates of sustained virologic response among patients across HCV genotypes in whom treatment with a DAA regimen had previously failed. (Funded by Gilead Sciences; POLARIS-1 and POLARIS-4 ClinicalTrials.gov numbers, NCT02607735 and NCT02639247 .).

Three year naturalistic outcome study of panic disorder patients treated with paroxetine

PubMed Central

Dannon, Pinhas N; Iancu, Iulian; Cohen, Ami; Lowengrub, Katherine; Grunhaus, Leon; Kotler, Moshe

2004-01-01

Background This naturalistic open label follow-up study had three objectives: 1) To observe the course of illness in Panic Disorder patients receiving long-term versus intermediate-term paroxetine treatment 2) To compare the relapse rates and side-effect profile after long-term paroxetine treatment between patients with Panic Disorder and Panic Disorder with Agoraphobia. 3) To observe paroxetine's tolerability over a 24 month period. Methods 143 patients with panic disorder (PD), with or without agoraphobia, successfully finished a short-term (ie 12 week) trial of paroxetine treatment. All patients then continued to receive paroxetine maintenance therapy for a total of 12 months. At the end of this period, 72 of the patients chose to discontinue paroxetine pharmacotherapy and agreed to be monitored throughout a one year discontinuation follow-up phase. The remaining 71 patients continued on paroxetine for an additional 12 months and then were monitored, as in the first group, for another year while medication-free. The primary limitation of our study is that the subgroups of patients receiving 12 versus 24 months of maintenance paroxetine therapy were selected according to individual patient preference and therefore were not assigned in a randomized manner. Results Only 21 of 143 patients (14%) relapsed during the one year medication discontinuation follow-up phase. There were no significant differences in relapse rates between the patients who received intermediate-term (up to 12 months) paroxetine and those who chose the long-term course (24 month paroxetine treatment). 43 patients (30.1%) reported sexual dysfunction. The patients exhibited an average weight gain of 5.06 kg. All patients who eventually relapsed demonstrated significantly greater weight increase (7.3 kg) during the treatment phase. Conclusions The extension of paroxetine maintenance treatment from 12 to 24 months did not seem to further decrease the risk of relapse after medication discontinuation. Twenty-four month paroxetine treatment is accompanied by sexual side effects and weight gain similar to those observed in twelve month treatment. PMID:15191617

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial.

PubMed

Grunfeld, Eva; Manca, Donna; Moineddin, Rahim; Thorpe, Kevin E; Hoch, Jeffrey S; Campbell-Scherer, Denise; Meaney, Christopher; Rogers, Jess; Beca, Jaclyn; Krueger, Paul; Mamdani, Muhammad

2013-11-20

Primary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system. However, there remains a gap between recommended preventive services and actual practice. This trial (the BETTER Trial) aimed to improve preventive care of heart disease, diabetes, colorectal, breast and cervical cancers, and relevant lifestyle factors through a practice facilitation intervention set in primary care. Pragmatic two-way factorial cluster RCT with Primary Care Physicians' practices as the unit of allocation and individual patients as the unit of analysis. The setting was urban Primary Care Team practices in two Canadian provinces. Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control; 4 physicians in each team (32 physicians) were randomly assigned to receive the patient-level intervention or wait-list control. Patients randomly selected from physicians' rosters were stratified into two groups: 1) general and 2) moderate mental illness. The interventions involved a multifaceted, evidence-based, tailored practice-level intervention with a Practice Facilitator, and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored 'prevention prescription'. The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets, expressed as the ratio of eligible actions at baseline that were met at follow-up. A cost-effectiveness analysis was conducted. 789 of 1,260 (63%) eligible patients participated. On average, patients were eligible for 8.96 (SD 3.2) actions at baseline. In the adjusted analysis, control patients met 23.1% (95% CI: 19.2% to 27.1%) of target actions, compared to 28.5% (95% CI: 20.9% to 36.0%) receiving the practice-level intervention, 55.6% (95% CI: 49.0% to 62.1%) receiving the patient-level intervention, and 58.9% (95% CI: 54.7% to 63.1%) receiving both practice- and patient-level interventions (patient-level intervention versus control, P < 0.001). The benefit of the patient-level intervention was seen in both strata. The extra cost of the intervention was $26.43CAN (95% CI: $16 to $44) per additional action met. A Prevention Practitioner can improve the implementation of clinically important prevention and screening for chronic diseases in a cost-effective manner.

Chemotherapy Toxicity Risk Score for Treatment Decisions in Older Adults with Advanced Solid Tumors.

PubMed

Nishijima, Tomohiro F; Deal, Allison M; Williams, Grant R; Sanoff, Hanna K; Nyrop, Kirsten A; Muss, Hyman B

2018-05-01

The decision whether to treat older adults with advanced cancer with standard therapy (ST) or reduced therapy (RT) is complicated by heterogeneity in aging. We assessed the potential utility of the chemotherapy toxicity risk score (CTRS) [J Clin Oncol 2011;29:3457-3465] for treatment decisions in older adults. This was a prospective observational study of patients aged ≥65 years receiving first-line chemotherapy for advanced cancer for which combination chemotherapy is the standard of care. Patients were categorized as high risk (CTRS ≥10), for whom RT (dose-reduced combination or single-agent chemotherapy) is deemed appropriate, or nonhigh risk (CTRS <10), for whom ST is deemed appropriate for toxicity. The primary objective was to estimate the agreement in chemotherapy choice (ST vs. RT) between the treating physician and the CTRS using a κ statistic. Fifty-eight patients (median age, 71 years) were enrolled. Thirty-eight patients received ST (21 had CTRS <10, and 17 had CTRS ≥10), and 20 patients received RT (12 had CTRS ≥10, and 8 had CTRS <10), with minimal agreement in chemotherapy choice (κ = 0.14; 95% CI, -0.10 to 0.38). Grade 3-4 toxicity and hospitalization occurred in 60% and 27% of 55 patients with follow-up data, respectively. Among patients receiving ST, patients with CTRS ≥10 had a higher incidence of toxicity (88% vs. 40%, p  = .006) and hospitalization (50% vs. 15%, p  = .03) than those with CTRS <10. Older patients with cancer with a high CTRS who receive combination chemotherapy have an exceedingly high rate of severe toxicity and hospitalization. The potential utility of the chemotherapy toxicity risk score (CTRS) in old adults with advanced solid tumors receiving first-line chemotherapy was assessed. Little agreement was found between chemotherapy treatment decisions based on the clinical impression versus what was recommended based on the CTRS. Among patients treated with standard-dose combination chemotherapy, patients with CTRS ≥10 had a very high incidence of grade 3-4 toxicities and hospitalization, which was significantly greater than that of patients with a low CTRS (<10). These findings suggest that the addition of CTRS to the clinical impression has a potential to improve treatment decisions. © AlphaMed Press 2018.

Improving cancer patients' pain: the impact of the hospital specialist palliative care team.

PubMed

Jack, B; Hillier, V; Williams, A; Oldham, J

2006-12-01

Pain is reported to occur in the majority of patients with advanced cancer and is one of the main reasons for referral to a hospital specialist palliative care team. Yet despite this, there is a paucity of research into the impact the hospital specialist palliative care team has on pain control in patients. A non-equivalent control group design using a quota sample investigated 100 cancer patients who had been admitted to hospital for symptom control. Fifty patients received specialist hospital palliative care team intervention compared with 50 patients receiving traditional care. Outcome was assessed using the Palliative Care Assessment (PACA) tool on three occasions. There was no difference between the groups on the initial assessment and the results indicated that all cancer patients admitted to hospital had a significant improvement in their pain control. However, the patients who had the additional input of the palliative care team demonstrated a statistically significant greater improvement than the control group (P<0.001). Potential explanations are made for the results including the enhanced knowledge and skills of the hospital specialist palliative care team.

Information perception, wishes, and satisfaction in ambulatory cancer patients under active treatment: patient-reported outcomes with QLQ-INFO25

PubMed Central

Pinto, Ana Catarina; Ferreira-Santos, Fernando; Lago, Lissandra Dal; de Azambuja, Evandro; Pimentel, Francisco Luís; Piccart-Gebhart, Martine; Razavi, Darius

2014-01-01

Background Information is vital to cancer patients. Physician–patient communication in oncology presents specific challenges. The aim of this study was to evaluate self-reported information of cancer patients in ambulatory care at a comprehensive cancer centre and examine its possible association with patients’ demographic and clinical characteristics. Patients and methods This study included adult patients with solid tumours undergoing chemotherapy at the Institute Jules Bordet’s Day Hospital over a ten-day period. EORTC QLQ-C30 and QLQ-INFO25 questionnaires were administered. Demographic and clinical data were collected. Descriptive and inferential statistics were used. Results 101 (99%) fully completed the questionnaires. They were mostly Belgian (74.3%), female (78.2%), with a mean age of 56.9 ± 12.8 years. The most frequent tumour was breast cancer (58.4%). Patients were well-informed about the disease and treatments, but presented unmet information domains. The Jules Bordet patients desired more information on treatment side effects, long-term outcome, nutrition, and recurrence symptoms. Patients on clinical trials reported having received less information about their disease and less written information than patients outside clinical trials. Higher information levels were associated with higher quality of life (QoL) scores and higher patient satisfaction. Conclusion Patients were satisfied with the information they received and this correlated with higher QoL, but they still expressed unmet information wishes. Additional studies are required to investigate the quality of the information received by patients enrolled in clinical trials. PMID:24834120

Multidisciplinary decision-making on chemotherapy for colorectal cancer: an age-based comparison.

PubMed

Hamaker, Marije E; van Rixtel, Bert; Thunnissen, Peter; Oberndorff, Ardi H; Smakman, Niels; Ten Bokkel Huinink, Daan

2015-05-01

With the ageing of society, optimising decision-making for older patients with cancer becomes increasingly important. A first step is awareness of current clinical practice. We analysed how treatment decisions regarding chemotherapy for older and younger patients with colorectal cancer are currently being made by the multidisciplinary team, the oncologist and the patient. A total of 316 patients with colorectal cancer (median age 68.3 years), discussed at the multidisciplinary gastrointestinal oncology team meetings between 2010 and 2013, were reviewed to select patients for whom guidelines recommended chemotherapy. Multidisciplinary decision-making and subsequent clinical course were extracted from medical files. The multidisciplinary team recommended chemotherapy in 97% of younger patients treated with curative intent, compared to 65% of older patients; 86% of younger patients and 42% of older patients subsequently received chemotherapy. In a palliative setting, the multidisciplinary team recommended chemotherapy in 98% of younger and 69% of older patients and 81% and 45%, respectively, subsequently received this treatment. In addition to comorbidity and the patient's physical condition, chronological age was an important reason for withholding chemotherapy. When older patients did receive chemotherapy, reduced intensity regimens were often effectuated. Multidisciplinary decision-making regarding chemotherapy for older patients with colorectal cancer is still frequently based on clinical impressions, preconceptions or chronological age alone. Rather, treatment decisions should be made after thorough evaluation of the patient's health status across multiple domains, either by a geriatrician or within the oncology team itself. Given the preference-sensitive nature of chemotherapy decisions in the elderly, shared decision-making should be strived for whenever possible. Copyright © 2015 Elsevier Inc. All rights reserved.

Contrasting Sleeve Gastrectomy with Lifestyle Modification Therapy in the Treatment of Polycystic Ovary Syndrome.

PubMed

Wang, Kaijing; Jiang, Qixin; Zhi, Yunqing; Zhu, Zhe; Zhou, Zhuqing; Xie, Yanting; Yin, Xiaoqi; Lu, Aiguo

2015-06-01

To explore the feasibility of sleeve gastrectomy (SG) as a treatment for polycystic ovary syndrome (PCOS) and its potential to improve clinical efficacy in PCOS patients with symptoms of oligomenorrhea. Twenty-four obese patients with PCOS underwent laparoscopic SG. Simultaneously, 24 obese patients with PCOS received lifestyle modification therapy (LMT). Follow-ups were conducted at 3-6 months. Weight loss, menstruation, and improvements in hirsutism and metabolic symptoms were compared. In the SG group, 20 patients were restored to normal menstrual cycles and ovulation at 3-6 months after surgery. Their average androgen levels decreased significantly following surgery (P=.012). Conversely, only 6 patients in the LMT group were restored to normal menstrual cycles and ovulation after receiving 3 months of treatment. Their average preoperative and postoperative androgen levels showed a nonstatistically significant decrease (P>.05). Compared with the LMT group, the SG group showed more pronounced improvements in menstruation. Additionally, body mass and body mass index were significantly reduced in patients in the SG group 3 months after the surgeries, with maximum weight loss observed at approximately 6 months after surgery. Patients who received LMT showed a gradual weight reduction such that body mass decreased significantly after 3 months (P<. 001). Compared with patients in the LMT group, patients in the SG group showed greater weight loss results (P<.0001). In patients with PCOS, SG resulted in more marked weight loss and better improvements in clinical symptoms compared with LMT.

An official American Thoracic Society Clinical Practice guideline: the diagnosis of intensive care unit-acquired weakness in adults.

PubMed

Fan, Eddy; Cheek, Fern; Chlan, Linda; Gosselink, Rik; Hart, Nicholas; Herridge, Margaret S; Hopkins, Ramona O; Hough, Catherine L; Kress, John P; Latronico, Nicola; Moss, Marc; Needham, Dale M; Rich, Mark M; Stevens, Robert D; Wilson, Kevin C; Winkelman, Chris; Zochodne, Doug W; Ali, Naeem A

2014-12-15

Profound muscle weakness during and after critical illness is termed intensive care unit-acquired weakness (ICUAW). To develop diagnostic recommendations for ICUAW. A multidisciplinary expert committee generated diagnostic questions. A systematic review was performed, and recommendations were developed using the Grading, Recommendations, Assessment, Development, and Evaluation (GRADE) approach. Severe sepsis, difficult ventilator liberation, and prolonged mechanical ventilation are associated with ICUAW. Physical rehabilitation improves outcomes in heterogeneous populations of ICU patients. Because it may not be feasible to provide universal physical rehabilitation, an alternative approach is to identify patients most likely to benefit. Patients with ICUAW may be such a group. Our review identified only one case series of patients with ICUAW who received physical therapy. When compared with a case series of patients with ICUAW who did not receive structured physical therapy, evidence suggested those who receive physical rehabilitation were more frequently discharged home rather than to a rehabilitative facility, although confidence intervals included no difference. Other interventions show promise, but fewer data proving patient benefit existed, thus precluding specific comment. Additionally, prior comorbidity was insufficiently defined to determine its influence on outcome, treatment response, or patient preferences for diagnostic efforts. We recommend controlled clinical trials in patients with ICUAW that compare physical rehabilitation with usual care and further research in understanding risk and patient preferences. Research that identifies treatments that benefit patients with ICUAW is necessary to determine whether the benefits of diagnostic testing for ICUAW outweigh its burdens.

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis.

PubMed

Simpson, Eric L; Bieber, Thomas; Guttman-Yassky, Emma; Beck, Lisa A; Blauvelt, Andrew; Cork, Michael J; Silverberg, Jonathan I; Deleuran, Mette; Kataoka, Yoko; Lacour, Jean-Philippe; Kingo, Külli; Worm, Margitta; Poulin, Yves; Wollenberg, Andreas; Soo, Yuhwen; Graham, Neil M H; Pirozzi, Gianluca; Akinlade, Bolanle; Staudinger, Heribert; Mastey, Vera; Eckert, Laurent; Gadkari, Abhijit; Stahl, Neil; Yancopoulos, George D; Ardeleanu, Marius

2016-12-15

Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important drivers of atopic or allergic diseases such as atopic dermatitis. In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1 and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment. Patients were randomly assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg) or placebo weekly or the same dose of dupilumab every other week alternating with placebo. The primary outcome was the proportion of patients who had both a score of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment and a reduction of 2 points or more in that score from baseline at week 16. We enrolled 671 patients in SOLO 1 and 708 in SOLO 2. In SOLO 1, the primary outcome occurred in 85 patients (38%) who received dupilumab every other week and in 83 (37%) who received dupilumab weekly, as compared with 23 (10%) who received placebo (P<0.001 for both comparisons with placebo). The results were similar in SOLO 2, with the primary outcome occurring in 84 patients (36%) who received dupilumab every other week and in 87 (36%) who received dupilumab weekly, as compared with 20 (8%) who received placebo (P<0.001 for both comparisons). In addition, in the two trials, an improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo (P<0.001 for all comparisons). Dupilumab was also associated with improvement in other clinical end points, including reduction in pruritus and symptoms of anxiety or depression and improvement in quality of life. Injection-site reactions and conjunctivitis were more frequent in the dupilumab groups than in the placebo groups. In two phase 3 trials of identical design involving patients with atopic dermatitis, dupilumab improved the signs and symptoms of atopic dermatitis, including pruritus, symptoms of anxiety and depression, and quality of life, as compared with placebo. Trials of longer duration are needed to assess the long-term effectiveness and safety of dupilumab. (Funded by Sanofi and Regeneron Pharmaceuticals; SOLO 1 ClinicalTrials.gov number, NCT02277743 ; SOLO 2 ClinicalTrials.gov number, NCT02277769 .).

Bone health and adherence to vitamin D and calcium therapy in early breast cancer patients on endocrine therapy with aromatase inhibitors.

PubMed

Bošković, Lidija; Gašparić, Maja; Petković, Marija; Gugić, Damir; Lovasić, Ingrid Belac; Soldić, Željko; Miše, Branka Petrić; Dabelić, Nina; Vazdar, Ljubica; Vrdoljak, Eduard

2017-02-01

Randomized trials involving aromatase inhibitors (AIs) in the adjuvant treatment of breast cancer patients have reported increased osteoporosis risk. Bone loss can be reduced with appropriate life style, vitamin D and calcium supplements, and with bisphosphonate therapy. The aim of this analysis was to investigate adherence to vitamin D and calcium in postmenopausal breast cancer patients receiving adjuvant non-steroidal AIs, and oncologists' adherence to the bone health guidelines. This prospective study included 438 newly diagnosed patients and those who have already been receiving non-steroidal AIs for up to 3.5 years. Median endocrine therapy duration before recruitment in the study was 10.5 months (interquartile 4.8-26.6). Densitometry was performed on 142 patients (32.4%) before initiation of endocrine therapy, and on additional 38 (8.6%) patients at second study visit. Densitometry was not performed on 258 (59%) patients. Vitamin D and calcium were prescribed to 329/438 (75.1%) patients at some point during the study. Patients who took more than 80% of the prescribed dose were considered adherent. Self-reported adherence was 88.4%. Osteoporosis was diagnosed in 24 patients (5.5%) of the total study population, bearing in mind that 258/438 (59%) patients did not have densitometry. Bisphosphonates were prescribed to 54/438 (12.3%) patients, whilst only 19 (35.2%) of those had osteoporosis. In this analysis, lack of oncologists' adherence to the bone health guidelines was observed. In addition, a significant proportion of the patients did not adhere to the vitamin D and calcium. Copyright © 2016 Elsevier Ltd. All rights reserved.

Significant savings with a stepped care model for treatment of patients with intermittent claudication.

PubMed

Fokkenrood, H J P; Scheltinga, M R M; Koelemay, M J W; Breek, J C; Hasaart, F; Vahl, A C; Teijink, J A W

2014-10-01

International guidelines recommend supervised exercise therapy (SET) as primary treatment for intermittent claudication (IC). The aim of this study was to calculate treatment costs in patients with IC and to estimate nationwide annual savings if a stepped care model (SCM, primary SET treatment followed by revascularization in case of SET failure) was followed. Invoice data of all patients with IC in 2009 were obtained from a Dutch health insurance company (3.4 million members). Patients were divided into three groups based on initial treatment after diagnosis (t0). The SET group received SET initiated at any time between 12 months before and up to 3 months after t0. The intervention group (INT) underwent endovascular or open revascularization between t0 and t+3 months. The third group (REST) received neither SET nor any intervention. All peripheral arterial disease related invoices were recorded during 2 years and average costs per patient were calculated. Savings following use of a SCM were calculated for three scenarios. Data on 4954 patients were analyzed. Initial treatment was SET (n = 701, 14.1%), INT (n = 1363, 27.5%), or REST (n = 2890, 58.3%). Within 2 years from t0, invasive revascularization in the SET group was performed in 45 patients (6.4%). Additional interventions (primary at other location and/or re-interventions) were performed in 480 INT patients (35.2%). Some 431 REST patients received additional SET (n = 299, 10.3%) or an intervention (n = 132, 4.5%). Mean total IC related costs per patient were €2,191, €9851 and €824 for SET, INT, and REST, respectively. Based on a hypothetical worst, moderate, and best case scenario, some 3.8, 20.6, or 33.0 million euros would have been saved per annum if SCM was implemented in the Dutch healthcare system. Implementation of a SCM treatment for patients with IC may lead to significant savings of health care resources. Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

A randomized controlled trial of preprocedure administration of parecoxib for therapeutic endoscopic retrograde cholangiopancreatography.

PubMed

Amornyotin, Somchai; Chalayonnawin, Wiyada; Kongphlay, Siriporn

2012-01-01

Parecoxib is occasionally used for analgesia in postprocedural patients. The clinical efficacy of parecoxib used for endoscopic retrograde cholangiopancreatography (ERCP) is controversial. The aim of the study was to determine the clinical efficacy of preprocedure administration of parecoxib for therapeutic ERCP patients. Eighty-five patients who underwent therapeutic ERCP in a single year were randomly assigned to normal saline group (C, n = 43) and parecoxib group (P, n = 42). Patients in group C received normal saline and those in group P received 40 mg of parecoxib intravenously in equivalent volume. Patients in both groups received the saline or parecoxib 60 seconds before administration of the sedative agents. All patients were monitored for the depth of sedation by using the Narcotrend(TM) monitor, maintaining stage D0-E0 during ERCP. All patients were oxygenated with 100% O(2) via nasal cannula and sedated with 0.03 mg/kg of intravenous midazolam and 1 μg/kg of intravenous fentanyl as well as the titration of intravenous propofol. After the ERCP procedure, pethidine in an intramuscular dose of 0.5-1.0 mg/kg was used as rescue medication. The pain scores (visual analog scale [VAS], 0-10) at 2, 12, and 24 hours post-ERCP, the total number of doses of pethidine used, the dose volume of pethidine used, patient satisfaction, endoscopist satisfaction, and complications were recorded. There were no significant differences in sedative and analgesic agents used during the procedure, pain at 24 hours post-ERCP, endoscopist satisfaction, and complications in both groups. The total number of doses of pethidine used post-ERCP in group C was significantly higher than in group P. Additionally, the mean pain score at 2 and 12 hours post-ERCP in group C was significantly greater than in group P. Patient satisfaction in group P was higher than in group C. Preprocedure administration of parecoxib for therapeutic ERCP patients was clinically effective. The analgesic efficacy of a standard dose of parecoxib was clearly demonstrated during the first 12 hours postprocedure. Additionally, patient satisfaction in the parecoxib group was also higher than in the control group.

Diabetic foot ulcer management in clinical practice in the UK: costs and outcomes.

PubMed

Guest, Julian F; Fuller, Graham W; Vowden, Peter

2018-02-01

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing diabetic foot ulcers (DFUs) in clinical practice by the UK's National Health Service (NHS), and the associated costs of patient management. This was a retrospective cohort analysis of the records of 130 patients with a newly diagnosed DFU in The Health Improvement Network (THIN) database. Patients' characteristics, wound-related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015-2016 prices. Patients were predominantly managed in the community by nurses, with minimal clinical involvement of specialist physicians. 5% of patients saw a podiatrist, and 5% received a pressure-offloading device. Additionally, 17% of patients had at least one amputation within the first 12 months from initial presentation of their DFU. 14% of DFUs were documented as being clinically infected at initial presentation, although an additional 31% of patients were prescribed an antimicrobial dressing at the time of presentation. Of all the DFUs, 35% healed within 12 months, and the mean time to healing was 4·4 months. Over the study period, 48% of all patients received at least one prescription for a compression system, but significantly more patients healed if they never received compression (67% versus 16%; P < 0·001). The mean NHS cost of wound care over 12 months was an estimated £7800 per DFU (of which 13% was attributable to amputations), ranging from £2140 to £8800 per healed and unhealed DFU, respectively, and £16 900 per amputated wound. Consolidated medical records from a primary care held database provided 'real-world evidence' highlighting the consequences of inefficient and inadequate management of DFUs in clinical practice in the UK. Clinical and economic benefits to both patients and the NHS could accrue from strategies that focus on (i) wound prevention, (ii) improving wound-healing rates and (iii) reducing infection and amputation rates. © 2017 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Involvement of a Case Manager in Palliative Care Reduces Hospitalisations at the End of Life in Cancer Patients; A Mortality Follow-Back Study in Primary Care.

PubMed

van der Plas, Annicka G M; Vissers, Kris C; Francke, Anneke L; Donker, Gé A; Jansen, Wim J J; Deliens, Luc; Onwuteaka-Philipsen, Bregje D

2015-01-01

Case managers have been introduced in primary palliative care in the Netherlands; these are nurses with expertise in palliative care who offer support to patients and informal carers in addition to the care provided by the general practitioner (GP) and home-care nurse. To compare cancer patients with and without additional support from a case manager on: 1) the patients' general characteristics, 2) characteristics of care and support given by the GP, 3) palliative care outcomes. This article is based on questionnaire data provided by GPs participating in two different studies: the Sentimelc study (280 cancer patients) and the Capalca study (167 cancer patients). The Sentimelc study is a mortality follow-back study amongst a representative sample of GPs that monitors the care provided via GPs to a general population of end-of-life patients. Data from 2011 and 2012 were analysed. The Capalca study is a prospective study investigating the implementation and outcome of the support provided by case managers in primary palliative care. Data were gathered between March 2011 and December 2013. The GP is more likely to know the preferred place of death (OR 7.06; CI 3.47-14.36), the place of death is more likely to be at the home (OR 2.16; CI 1.33-3.51) and less likely to be the hospital (OR 0.26; CI 0.13-0.52), and there are fewer hospitalisations in the last 30 days of life (none: OR 1.99; CI 1.12-3.56 and one: OR 0.54; CI 0.30-0.96), when cancer patients receive additional support from a case manager compared with patients receiving the standard GP care. Involvement of a case manager has added value in addition to palliative care provided by the GP, even though the role of the case manager is 'only' advisory and he or she does not provide hands-on care or prescribe medication.

Work-related medical rehabilitation in patients with musculoskeletal disorders: the protocol of a propensity score matched effectiveness study (EVA-WMR, DRKS00009780).

PubMed

Neuderth, Silke; Schwarz, Betje; Gerlich, Christian; Schuler, Michael; Markus, Miriam; Bethge, Matthias

2016-08-17

Musculoskeletal disorders are one of the most important causes of work disability. Various rehabilitation services and return-to-work programs have been developed in order to reduce sickness absence and increase sustainable return-to-work. As the effects of conventional medical rehabilitation programs on sickness absence duration were shown to be slight, work-related medical rehabilitation programs have been developed and tested. While such studies proved the efficacy of work-related medical rehabilitation compared with conventional medical rehabilitation in well-conducted randomized controlled trials, its effectiveness under real-life conditions has yet to be proved. The cohort study will be performed under real-life conditions with two parallel groups. Participants will receive either a conventional or a work-related medical rehabilitation program. Propensity score matching will be used to identify controls that are comparable to treated work-related medical rehabilitation patients. Over a period of three months, about 18,000 insured patients with permission to undergo a musculoskeletal rehabilitation program will be contacted. Of these, 15,000 will receive a conventional and 3,000 a work-related medical rehabilitation. We expect a participation rate of 40 % at baseline. Patients will be aged 18 to 65 years and have chronic musculoskeletal disorders, usually back pain. The control group will receive a conventional medical rehabilitation program without any explicit focus on work, work ability and return to work in diagnostics and therapy. The intervention group will receive a work-related medical rehabilitation program that in addition to common rehabilitation treatments contains 11 to 25 h of work-related treatment modules. Follow-up data will be assessed three and ten months after patients' discharge from the rehabilitation center. Additionally, department characteristics will be assessed and administrative data records used. The primary outcomes are sick leave duration, stable return to work and subjective work ability. Secondary outcomes cover several dimensions of health, functioning and coping strategies. This study will determine the relative effectiveness of a complex, newly implemented work-related rehabilitation strategy for patients with musculoskeletal disorders. German Clinical Trials Register ( DRKS00009780 , February 10, 2016).

Impact of stress-induced diabetes on outcomes in severely burned children.

PubMed

Finnerty, Celeste C; Ali, Arham; McLean, Josef; Benjamin, Nicole; Clayton, Robert P; Andersen, Clark R; Mlcak, Ronald P; Suman, Oscar E; Meyer, Walter; Herndon, David N

2014-04-01

Post-burn hyperglycemia leads to graft failure, multiple organ failure, and death. A hyperinsulinemic-euglycemic clamp is used to keep serum glucose between 60 and 110 mg/dL. Because of frequent hypoglycemic episodes, a less-stringent sliding scale insulin protocol is used to maintain serum glucose levels between 80 and 160 mg/dL after elevations >180 mg/dL. We randomized pediatric patients with massive burns into 2 groups, patients receiving sliding scale insulin to lower blood glucose levels (n = 145) and those receiving no insulin (n = 98), to determine the differences in morbidity and mortality. Patients 0 to 18 years old with burns covering ≥ 30% of the total body surface area and not randomized to receive anabolic agents were included in this study. End points included glucose levels, infections, resting energy expenditure, lean body mass, bone mineral content, fat mass, muscle strength, and serum inflammatory cytokines, hormones, and liver enzymes. Maximal glucose levels occurred within 6 days of burn injury. Blood glucose levels were age dependent, with older children requiring more insulin (p < 0.05). Daily maximum and daily minimum, but not 6 am, glucose levels were significantly different based on treatment group (p < 0.05). Insulin significantly increased resting energy expenditure and improved bone mineral content (p < 0.05). Each additional wound infection increased incidence of hyperglycemia (p = 0.004). There was no mortality in patients not receiving insulin, only in patients who received insulin (p < 0.004). Muscle strength was increased in patients receiving insulin (p < 0.05). Burn-induced hyperglycemia develops in a subset of severely burned children. Length of stay was reduced in the no insulin group, and there were no deaths in this group. Administration of insulin positively impacted bone mineral content and muscle strength, but increased resting energy expenditure, hypoglycemic episodes, and mortality. New glucose-lowering strategies might be needed. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Genetic and Non-genetic Factors Associated With Constipation in Cancer Patients Receiving Opioids

PubMed Central

Laugsand, Eivor A; Skorpen, Frank; Kaasa, Stein; Sabatowski, Rainer; Strasser, Florian; Fayers, Peter; Klepstad, Pål

2015-01-01

Objectives: To examine whether the inter-individual variation in constipation among patients receiving opioids for cancer pain is associated with genetic or non-genetic factors. Methods: Cancer patients receiving opioids were included from 17 centers in 11 European countries. Intensity of constipation was reported by 1,568 patients on a four-point categorical scale. Non-genetic factors were included as covariates in stratified regression analyses on the association between constipation and 75 single-nucleotide polymorphisms (SNPs) within 15 candidate genes related to opioid- or constipation-signaling pathways (HTR3E, HTR4, HTR2A, TPH1, ADRA2A, CHRM3, TACR1, CCKAR, KIT, ARRB2, GHRL, ABCB1, COMT, OPRM1, and OPRD1). Results: The non-genetic factors significantly associated with constipation were type of laxative, mobility and place of care among patients receiving laxatives (N=806), in addition to Karnofsky performance status and presence of metastases among patients not receiving laxatives (N=762) (P<0.01). Age, gender, body mass index, cancer diagnosis, time on opioids, opioid dose, and type of opioid did not contribute to the inter-individual differences in constipation. Five SNPs, rs1800532 in TPH1, rs1799971 in OPRM1, rs4437575 in ABCB1, rs10802789 in CHRM3, and rs2020917 in COMT were associated with constipation (P<0.01). Only rs2020917 in COMT passed the Benjamini–Hochberg criterion for a 10% false discovery rate. Conclusions: Type of laxative, mobility, hospitalization, Karnofsky performance status, presence of metastases, and five SNPs within TPH1, OPRM1, ABCB1, CHRM3, and COMT may contribute to the variability in constipation among cancer patients treated with opioids. Knowledge of these factors may help to develop new therapies and to identify patients needing a more individualized approach to treatment. PMID:26087058