Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report--Part I.

PubMed

Berger, Marc L; Mamdani, Muhammad; Atkins, David; Johnson, Michael L

2009-01-01

Health insurers, physicians, and patients worldwide need information on the comparative effectiveness and safety of prescription drugs in routine care. Nonrandomized studies of treatment effects using secondary databases may supplement the evidence based from randomized clinical trials and prospective observational studies. Recognizing the challenges to conducting valid retrospective epidemiologic and health services research studies, a Task Force was formed to develop a guidance document on state of the art approaches to frame research questions and report findings for these studies. The Task Force was commissioned and a Chair was selected by the International Society for Pharmacoeconomics and Outcomes Research Board of Directors in October 2007. This Report, the first of three reported in this issue of the journal, addressed issues of framing the research question and reporting and interpreting findings. The Task Force Report proposes four primary characteristics-relevance, specificity, novelty, and feasibility while defining the research question. Recommendations included: the practice of a priori specification of the research question; transparency of prespecified analytical plans, provision of justifications for any subsequent changes in analytical plan, and reporting the results of prespecified plans as well as results from significant modifications, structured abstracts to report findings with scientific neutrality; and reasoned interpretations of findings to help inform policy decisions. Comparative effectiveness research in the form of nonrandomized studies using secondary databases can be designed with rigorous elements and conducted with sophisticated statistical methods to improve causal inference of treatment effects. Standardized reporting and careful interpretation of results can aid policy and decision-making.

Systematic review and narrative summary: Treatments for and risk factors associated with respiratory tract secretions (death rattle) in the dying adult.

PubMed

Kolb, Hildegard; Snowden, Austyn; Stevens, Elaine

2018-03-01

To identify effective treatments and risk factors associated with death rattle in adults at the end of life. The presence of noisy, pooled respiratory tract secretions is among the most common symptoms in dying patients around the world. It is unknown if "death rattle" distresses patients, but it can distress relatives and clinicians. Treatments appear unsatisfactory, so prophylaxis would be ideal if possible. Quantitative systematic review and narrative summary following Cochrane Collaboration guidelines. CINAHL, MEDLINE, Health Source Nursing and Web of Science were searched for international literature in any language published from 1993 - 2016 using MeSH headings and iterative interchangeable terms for "death rattle". Randomized controlled trials were appraised using the Cochrane Collaboration's tool for assessing risk of bias. Non-randomized studies were assessed using ROBINS-I tool for assessing risk of bias in non-randomized studies of interventions. Instances of treatment and risk were extracted and relevant key findings extracted in line with Cochrane methods. Five randomized trials and 23 non-randomized studies were analysed. No pharmacological or non-pharmacological treatment was found superior to placebo. There was a weak association between lung or brain metastases and presence of death rattle, but otherwise inconsistent empirical support for a range of potential risk factors. Clinicians have no clear evidence to follow in either treating death rattle or preventing it occurring. However, several risk factors look promising candidates for prospective analysis, so this review concludes with clear recommendations for further research. © 2018 John Wiley & Sons Ltd.

Selected pharmacokinetic issues of the use of antiepileptic drugs and parenteral nutrition in critically ill patients

PubMed Central

2010-01-01

Objectives To conduct a systematic review for the evidence supporting or disproving the reality of parenteral nutrition- antiepileptic drugs interaction, especially with respect to the plasma protein-binding of the drug. Methods The articles related to the topic were identified through Medline and PubMed search (1968-Feburary 2010) for English language on the interaction between parenteral nutrition and antiepileptic drugs; the search terms used were anti-epileptic drugs, parenteral nutrition, and/or interaction, and/or in vitro. The search looked for prospective randomized and nonrandomized controlled studies; prospective nonrandomized uncontrolled studies; retrospective studies; case reports; and in vitro studies. Full text of the articles were then traced from the Universiti Sains Malaysia (USM) library subscribed databases, including Wiley-Blackwell Library, Cochrane Library, EBSCOHost, OVID, ScienceDirect, SAGE Premier, Scopus, SpringerLINK, and Wiley InterScience. The articles from journals not listed by USM library were traced through inter library loan. Results There were interactions between parenteral nutrition and drugs, including antiepileptics. Several guidelines were designed for the management of illnesses such as traumatic brain injuries or cancer patients, involving the use of parenteral nutrition and antiepileptics. Moreover, many studies demonstrated the in vitro and in vivo parenteral nutrition -drugs interactions, especially with antiepileptics. Conclusions There was no evidence supporting the existence of parenteral nutrition-antiepileptic drugs interaction. The issue has not been studied in formal researches, but several case reports and anecdotes demonstrate this drug-nutrition interaction. However, alteration in the drug-free fraction result from parenteral nutrition-drug (i.e. antiepileptics) interactions may necessitate scrupulous reassessment of drug dosages in patients receiving these therapies. This reassessment may be particularly imperative in certain clinical situations characterized by hypoalbuminemia (e.g., burn patients). PMID:21194458

Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies

PubMed Central

Papanikolaou, Panagiotis N.; Christidi, Georgia D.; Ioannidis, John P.A.

2006-01-01

Background Information on major harms of medical interventions comes primarily from epidemiologic studies performed after licensing and marketing. Comparison with data from large-scale randomized trials is occasionally feasible. We compared evidence from randomized trials with that from epidemiologic studies to determine whether they give different estimates of risk for important harms of medical interventions. Methods We targeted well-defined, specific harms of various medical interventions for which data were already available from large-scale randomized trials (> 4000 subjects). Nonrandomized studies involving at least 4000 subjects addressing these same harms were retrieved through a search of MEDLINE. We compared the relative risks and absolute risk differences for specific harms in the randomized and nonrandomized studies. Results Eligible nonrandomized studies were found for 15 harms for which data were available from randomized trials addressing the same harms. Comparisons of relative risks between the study types were feasible for 13 of the 15 topics, and of absolute risk differences for 8 topics. The estimated increase in relative risk differed more than 2-fold between the randomized and nonrandomized studies for 7 (54%) of the 13 topics; the estimated increase in absolute risk differed more than 2-fold for 5 (62%) of the 8 topics. There was no clear predilection for randomized or nonrandomized studies to estimate greater relative risks, but usually (75% [6/8]) the randomized trials estimated larger absolute excess risks of harm than the nonrandomized studies did. Interpretation Nonrandomized studies are often conservative in estimating absolute risks of harms. It would be useful to compare and scrutinize the evidence on harms obtained from both randomized and nonrandomized studies. PMID:16505459

Design and rationale of the ANALYZE ST study: a prospective, nonrandomized, multicenter ST monitoring study to detect acute coronary syndrome events in implantable cardioverter-defibrillator patients.

PubMed

Gibson, C Michael; Krucoff, Mitchell; Kirtane, Ajay J; Rao, Sunil V; Mackall, Judith A; Matthews, Ray; Saba, Samir; Waksman, Ron; Holmes, David

2014-10-01

In the setting of ST-segment elevation myocardial infarction, timely restoration of normal blood flow is associated with improved myocardial salvage and survival. Despite improvements in door-to-needle and door-to-balloon times, there remains an unmet need with respect to improved symptom-to-door times. A prior report of an implanted device to monitor ST-segment deviation demonstrated very short times to reperfusion among patients with an acute coronary syndrome (ACS) with documented thrombotic occlusion. The goal of the ANALYZE ST study is to evaluate the safety and effectiveness of a novel ST-segment monitoring feature using an existing implantable cardioverter-defibrillator (ICD) among patients with known coronary artery disease. The ANALYZE ST study is a prospective, nonrandomized, multicenter, pivotal Investigational Device Exemption study enrolling 5,228 patients with newly implanted ICD systems for standard clinical indications who also have a documented history of coronary artery disease. Patients will be monitored for 48 months, during which effectiveness of the device for the purpose of early detection of cardiac injury will be evaluated by analyzing the sensitivity of the ST monitoring feature to identify clinical ACS events. In addition, the safety of the ST monitoring feature will be evaluated through the assessment of the percentage of patients for which monitoring produces a false-positive event over the course of 12 months. The ANALYZE ST trial is testing the hypothesis that the ST monitoring feature in the Fortify ST ICD system (St. Jude Medical, Inc., St. Paul, MN) (or other ICD systems with the ST monitoring feature) will accurately identify patients with clinical ACS events. Copyright © 2014 Mosby, Inc. All rights reserved.

Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting

PubMed Central

Wang, Ruibin; Prasad, Vinay; Bates, Susan E.; Fojo, Tito

2016-01-01

Background. Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology). Materials and Methods. Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4−6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results. Results. A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11–1.36], p < .001; and 1.64 [1.15–2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38–1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61–1.29]; p = .532). Conclusion. This is the largest reported study examining why oncology trials are not published. The data show that 4−6 years after appearing as abstracts, 39% of oncology clinical trials remain unpublished. Larger sample size and advanced trial phase were associated with eventual publication; among randomized trials, an industry-affiliated author or a cooperative group increased likelihood of publication. Unfortunately, we found that, despite widespread recognition of the problem and the creation of central data repositories, timely publishing of oncology clinical trials results remains unsatisfactory. Implications for Practice: The Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects notes the ethical obligation to report clinical trial data, whether positive or negative. This obligation is listed alongside requirements for risk minimization, access, confidentiality, and informed consent, all bedrocks of the clinical trial system, yet clinical trials are often not published, particularly if negative or difficult to complete. This study found that among American Society for Clinical Oncology (ASCO) Annual Meeting abstracts, 2009–2011, only 61% were published 4–6 years later: 75% of randomized trials and 54% of nonrandomized trials. Clinicians need to insist that every study in which they participate is published. PMID:26888691

Assessing risk-adjustment approaches under non-random selection.

PubMed

Luft, Harold S; Dudley, R Adams

2004-01-01

Various approaches have been proposed to adjust for differences in enrollee risk in health plans. Because risk-selection strategies may have different effects on enrollment, we simulated three types of selection--dumping, skimming, and stinting. Concurrent diagnosis-based risk adjustment, and a hybrid using concurrent adjustment for about 8% of the cases and prospective adjustment for the rest, perform markedly better than prospective or demographic adjustments, both in terms of R2 and the extent to which plans experience unwarranted gains or losses. The simulation approach offers a valuable tool for analysts in assessing various risk-adjustment strategies under different selection situations.

Prospective Nonrandomized Comparative Study of Laparoscopic Versus Open Surgical Staging for Endometrial Cancer in India.

PubMed

Ansar P P; Ayyappan S; Mahajan, Vikash

2018-06-01

Laparoscopic procedures to treat endometrial cancer are currently emerging. At present, we have evidence to do laparoscopic oncologic resections for endometrial cancer as proven by many prospective studies from abroad such as LAP2 by GOG. So, we have decided to assess the safety and feasibility of such a study in our population with the following as our primary objectives: (1) to study whether laparoscopy is better compared to open approach in terms of duration of hospital stay, perioperative morbidity and early recovery from surgical trauma and (2) to study whether the laparoscopic approach is noninferior to the open approach in terms of number of lymph nodes harvested in lymphadenectomy and rate of conversion to open surgery. We did a prospective nonrandomized comparative study of open versus laparoscopy approach for surgical staging of endometrial cancer from 16th May 2013 to 15th May 2015. To prove a significant difference in the hospital stay, we needed 29 patients in each arm. Thirty patients in each arm were enrolled for the study. The median duration of stay in the open arm was 7 days and in the laparoscopy arm it was 5 days. The advantage of 2 days in the laparoscopic arm was statistically significant ( P value 0.006). Forty percent of patients in the open arm had to stay in the hospital for more than 7 days whereas only 3% of patients in the laparoscopy arm required to stay for more than 7 days ( P value 0.001). This difference was statistically significant. There was no significant difference between the early complication rates between the two arms (20% in open vs. 13% in laparoscopy; P value 0.730). There was a conversion rate of 10% in laparoscopy. The median number of nodes harvested in open arm was 16.50 and in the laparoscopy arm, it was 13.50. The difference was not statistically significant ( P value 0.086). Laparoscopy approach for endometrial cancer staging is feasible in Indian patients and the short-term advantages are replicable with same oncologic safety as proved by randomized controlled trials.

The effects of epidural analgesia on the course and outcome of labour.

PubMed

Finster, M; Santos, A C

1998-09-01

The potential effects of epidural analgesia on the progress and outcome of labour have been the subject of lasting controversy. Retrospective reviews indicate that epidurals are associated with longer labours and/or an increase in the incidence of instrumental or operative delivery. Similar results were obtained in non-randomized prospective studies. None of them established a causal relationship, because without randomization the selection bias cannot be ruled out. Other factors, such as premature rupture of membranes and maternal socioeconomic status, may affect the outcome of labour. It was also reported that introduction of the on-demand epidural service did not increase the primary caesarean section rate. The few prospective randomized studies are contradictory and not very reliable owing to small patient populations and high cross-over rates. There is, however, unanimity among the authors regarding the superiority of pain relief provided by epidural blocks over systemically administered opioids.

COMPUTERIZED EXPERT SYSTEM FOR EVALUATION OF AUTOMATED VISUAL FIELDS FROM THE ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL: METHODS, BASELINE FIELDS, AND SIX-MONTH LONGITUDINAL FOLLOW-UP

PubMed Central

Feldon, Steven E

2004-01-01

ABSTRACT Purpose To validate a computerized expert system evaluating visual fields in a prospective clinical trial, the Ischemic Optic Neuropathy Decompression Trial (IONDT). To identify the pattern and within-pattern severity of field defects for study eyes at baseline and 6-month follow-up. Design Humphrey visual field (HVF) change was used as the outcome measure for a prospective, randomized, multi-center trial to test the null hypothesis that optic nerve sheath decompression was ineffective in treating nonarteritic anterior ischemic optic neuropathy and to ascertain the natural history of the disease. Methods An expert panel established criteria for the type and severity of visual field defects. Using these criteria, a rule-based computerized expert system interpreted HVF from baseline and 6-month visits for patients randomized to surgery or careful follow-up and for patients who were not randomized. Results A computerized expert system was devised and validated. The system was then used to analyze HVFs. The pattern of defects found at baseline for patients randomized to surgery did not differ from that of patients randomized to careful follow-up. The most common pattern of defect was a superior and inferior arcuate with central scotoma for randomized eyes (19.2%) and a superior and inferior arcuate for nonrandomized eyes (30.6%). Field patterns at 6 months and baseline were not different. For randomized study eyes, the superior altitudinal defects improved (P = .03), as did the inferior altitudinal defects (P = .01). For nonrandomized study eyes, only the inferior altitudinal defects improved (P = .02). No treatment effect was noted. Conclusions A novel rule-based expert system successfully interpreted visual field defects at baseline of eyes enrolled in the IONDT. PMID:15747764

Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02).

PubMed

Christie, D; Le, T; Watling, K; Cornes, D; O'Brien, P; Hitchins, R

2009-04-01

A quality assurance (QA) audit of the Trans Tasman Radiation Oncology Group and Australasian Lymphoma and Leukaemia Group trial (TROG 99.04/ALLG LY02) began after accrual of 25 patients. The trial is a prospective non-randomized study of standard treatment for osteolymphoma. Data relating to informed consent, eligibility, chemotherapy and radiotherapy were reviewed. The audit showed a relatively low level of major variations from the protocol, with an overall rate of 3.6%. As this trial has accrued slowly over a long period, the concept of QA has also developed. Amendments were made to the protocol accordingly. In the future, QA procedures should be predetermined, conducted rapidly in real time, and appropriately funded in order to be relevant to the ongoing conduct of the trial.

Checklists of Methodological Issues for Review Authors to Consider When Including Non-Randomized Studies in Systematic Reviews

ERIC Educational Resources Information Center

Wells, George A.; Shea, Beverley; Higgins, Julian P. T.; Sterne, Jonathan; Tugwell, Peter; Reeves, Barnaby C.

2013-01-01

Background: There is increasing interest from review authors about including non-randomized studies (NRS) in their systematic reviews of health care interventions. This series from the Ottawa Non-Randomized Studies Workshop consists of six papers identifying methodological issues when doing this. Aim: To format the guidance from the preceding…

A Prospective, Nonrandomized, no Placebo-Controlled, Phase I/II Clinical Trial Assessing the Safety and Efficacy of Intramuscular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Patients With Severe Buerger’s Disease

PubMed Central

Ra, Jeong Chan; Jeong, Euicheol C.; Kang, Sung Keun; Lee, Seog Ju; Choi, Kyoung Ho

2017-01-01

Buerger’s disease is a rare and severe disease affecting the blood vessels of the limbs. Adipose tissue-derived mesenchymal stem cells (ADSCs) have the potential to cure Buerger’s disease when developed as a stem cell drug. In the present study, we conducted a prospective, nonrandomized, no placebo-controlled, phase I/II clinical trial with a 2-year follow-up questionnaire survey. A total of 17 patients were intramuscularly administered autologous ADSCs at a dose of 5 million cells/kg. The incidence of adverse events (AEs), adverse drug reaction (ADR), and serious adverse events (SAEs) was monitored. No ADRs and SAEs related to stem cell treatment occurred during the 6-month follow-up. In terms of efficacy, the primary endpoint was increase in total walking distance (TWD). The secondary endpoint was improvement in rest pain, increase in pain-free walking distance (PFWD), toe–brachial pressure index (TBPI), transcutaneous oxygen pressure (TcPO2), and arterial brachial pressure index (ABPI). ADSCs demonstrated significant functional improvement results including increased TWD, PFWD, and rest pain reduction. No amputations were reported during the 6-month clinical trial period and in the follow-up questionnaire survey more than 2 years after the ADSC injection. In conclusion, intramuscular injection of ADSCs is very safe and is shown to prompt functional improvement in patients with severe Buerger’s disease at a dosage of 300 million cells per 60 kg of body weight. However, the confirmatory therapeutic efficacy and angiogenesis need further study. PMID:28713639

Patient Acceptability of the Yorkshire Dialysis Decision Aid (YoDDA) Booklet: A Prospective Non-Randomized Comparison Study Across 6 Predialysis Services.

PubMed

Winterbottom, Anna E; Gavaruzzi, Teresa; Mooney, Andrew; Wilkie, Martin; Davies, Simon J; Crane, Dennis; Tupling, Ken; Baxter, Paul D; Meads, David M; Mathers, Nigel; Bekker, Hilary L

2016-01-01

♦ Patients are satisfied with their kidney care but want more support in making dialysis choices. Predialysis leaflets vary across services, with few being sufficient to enable patients' informed decision making. We describe the acceptability of a patient decision aid and feasibility of evaluating its effectiveness within usual predialysis practice. ♦ Prospective non-randomized comparison design, Usual Care or Usual Care Plus Yorkshire Dialysis Decision Aid Booklet (+YoDDA), in 6 referral centers (Yorkshire-Humber, UK) for patients with sustained deterioration of kidney function. Consenting (C) patients completed questionnaires after predialysis consultation (T1), and 6 weeks later (T2). Measures assessed YoDDA's utility to support patients' decisions and integration within usual care. ♦ Usual Care (n = 105) and +YoDDA (n = 84) participant characteristics were similar: male (62%), white (94%), age (mean = 62.6; standard deviation [SD] 14.4), kidney disease severity (glomerular filtration rate [eGFR] mean = 14.7; SD 3.7); decisional conflict was < 25; choice-preference for home versus hospital dialysis approximately 50:50. Patients valued receiving YoDDA, reading it on their own (96%), and sharing it with family (72%). The +YoDDA participants had higher scores for understanding kidney disease, reasoning about options, feeling in control, sharing their decision with family. Study engagement varied by center (estimated range 14 - 49%; mean 45%); participants varied in completion of decision quality measures. ♦ Receiving YoDDA as part of predialysis education was valued and useful to patients with worsening kidney disease. Integrating YoDDA actively within predialysis programs will meet clinical guidelines and patient need to support dialysis decision making in the context of patients' lifestyle. Copyright © 2016 International Society for Peritoneal Dialysis.

Three-dimensional vascular imaging of proliferative diabetic retinopathy by Doppler optical coherence tomography.

PubMed

Miura, Masahiro; Hong, Young-Joo; Yasuno, Yoshiaki; Muramatsu, Daisuke; Iwasaki, Takuya; Goto, Hiroshi

2015-03-01

To evaluate the 3-dimensional architecture of neovascularization in proliferative diabetic retinopathy using Doppler optical coherence tomography (OCT). Prospective, nonrandomized clinical trial. Seventeen eyes of 14 patients with proliferative diabetic retinopathy were prospectively studied. Prototype Doppler OCT was used to evaluate the 3-dimensional vascular architecture at vitreoretinal adhesions. Proliferative membranes were detected in all eyes with proliferative diabetic retinopathy by standard OCT images. Doppler OCT images detected blood flow by neovascularization of the disc in 12 eyes and neovascularization elsewhere in 11 eyes. Doppler OCT images showed the 3-dimensional extent of new vessels at various stages of neovascularization, and the extent of new vessels could be clearly confirmed at vitreoretinal adhesions. Doppler OCT is useful for the detection and evaluation of the 3-dimensional vascular structure of neovascularization, and can assist in the noninvasive assessment of proliferative diabetic retinopathy. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Innovative Discharge Process for Families with Pediatric Short Bowel Syndrome: A Prospective Nonrandomized Trial.

PubMed

Raphael, Bram P; Jorina, Maria; Gallotto, Mary; Grullon, Glendalis; Dalton, Meghan; Takvorian-Bené, Melissa; Tascione, Christina; Rosa, Carolyn; McClelland, Jennifer; Gray, Megan; Potemkin, Alexis K; Glavin, Courtney; Gura, Kathleen M; Murphy, Margaret K; Leger, Kierrah; Mahoney, Judith; Kerr, Jessica; Ozonoff, Al; Duggan, Christopher P

2018-03-30

Home parenteral nutrition (HPN) is a life-sustaining therapy for short bowel syndrome (SBS) and other severe digestive diseases, but complications are common. We evaluated a predischarge HPN hands-on training course to reduce complications in children with SBS, including hospital readmissions. We conducted a prospective, nonrandomized controlled research study between April 1, 2014, and April 30, 2017. Eligible participants were children aged <18 years old with SBS and anticipated HPN dependence duration ≥6 months. Excluded participants had a previous history of discharge with a central venous catheter (CVC), HPN, or intravenous fluids or strictly palliative goals of care. An intervention group practiced hands-on HPN within the hospital room for 24 hours using infusion equipment. The groups received standard teaching (CVC care, home infusion pump operation, HPN preparation and administration). Nine children were assigned to the intervention group and 12 served as controls. The median age was 8.4 months, and length of stay (LOS) was 82 days. All participants experienced ≥1 event, with a total of 47 issues related to HPN. There were no significant associations between group assignment and 30-day postdischarge events. Each additional week of LOS was associated with 11% increase in the odds of an emergency department visit (OR 1.11; 95% CI, 1.01-1.26) and 16% increase in the odds of readmission (OR 1.16; 95% CI, 1.04-1.37). Postdischarge events remained widespread despite HPN bedside interventions offered by this pilot intervention. With refinement of HPN discharge processes, quality benchmarks are needed. © 2018 American Society for Parenteral and Enteral Nutrition.

Pharyngocutaneous fistula after total laryngectomy: Less common with mechanical stapler closure.

PubMed

Calli, Caglar; Pinar, Ercan; Oncel, Semih

2011-05-01

The aim of the study was to compare the incidences of pharyngocutaneous fistula after total laryngectomy between patients who underwent manual and mechanical suturing for pharyngoesophageal closure. In a retrospective and prospective nonrandomized clinical study conducted at a single tertiary medical center between May 2002 and April 2009, we compared the incidence of pharyngocutaneous salivary fistula between two groups of patients after total laryngectomy. Sixty-one consecutive patients who underwent mechanical suturing with a 60-mm linear stapler (group A) were prospectively enrolled, and 121 patients who had undergone manual suturing (group B) were retrospectively reviewed. The groups were similar in terms of age, gender, comorbidities, TNM (tumor, node, metastasis) stage, and laryngeal tumor extension. The incidence of pharyngocutaneous salivary fistula was 4.9% in group A and 19.8% in group B (p = 0.014). Mechanical stapler closure of the pharynx after total laryngectomy was associated with a significant reduction in the incidence of pharyngocutaneous fistula compared with manual suture in selected cases.

Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions: The TREND Statement

PubMed Central

Des Jarlais, Don C.; Lyles, Cynthia; Crepaz, Nicole

2004-01-01

Developing an evidence base for making public health decisions will require using data from evaluation studies with randomized and nonrandomized designs. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study, with sufficient detail and clarity to readily see differences and similarities among studies in the same area. The Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for transparent reporting of randomized clinical trials. We present the initial version of the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement. These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions, research design, and methods of adjusting for possible biases in evaluation studies that use nonrandomized designs. PMID:14998794

Bayesian methods including nonrandomized study data increased the efficiency of postlaunch RCTs.

PubMed

Schmidt, Amand F; Klugkist, Irene; Klungel, Olaf H; Nielen, Mirjam; de Boer, Anthonius; Hoes, Arno W; Groenwold, Rolf H H

2015-04-01

Findings from nonrandomized studies on safety or efficacy of treatment in patient subgroups may trigger postlaunch randomized clinical trials (RCTs). In the analysis of such RCTs, results from nonrandomized studies are typically ignored. This study explores the trade-off between bias and power of Bayesian RCT analysis incorporating information from nonrandomized studies. A simulation study was conducted to compare frequentist with Bayesian analyses using noninformative and informative priors in their ability to detect interaction effects. In simulated subgroups, the effect of a hypothetical treatment differed between subgroups (odds ratio 1.00 vs. 2.33). Simulations varied in sample size, proportions of the subgroups, and specification of the priors. As expected, the results for the informative Bayesian analyses were more biased than those from the noninformative Bayesian analysis or frequentist analysis. However, because of a reduction in posterior variance, informative Bayesian analyses were generally more powerful to detect an effect. In scenarios where the informative priors were in the opposite direction of the RCT data, type 1 error rates could be 100% and power 0%. Bayesian methods incorporating data from nonrandomized studies can meaningfully increase power of interaction tests in postlaunch RCTs. Copyright © 2015 Elsevier Inc. All rights reserved.

Random Versus Nonrandom Peer Review: A Case for More Meaningful Peer Review.

PubMed

Itri, Jason N; Donithan, Adam; Patel, Sohil H

2018-05-10

Random peer review programs are not optimized to discover cases with diagnostic error and thus have inherent limitations with respect to educational and quality improvement value. Nonrandom peer review offers an alternative approach in which diagnostic error cases are targeted for collection during routine clinical practice. The objective of this study was to compare error cases identified through random and nonrandom peer review approaches at an academic center. During the 1-year study period, the number of discrepancy cases and score of discrepancy were determined from each approach. The nonrandom peer review process collected 190 cases, of which 60 were scored as 2 (minor discrepancy), 94 as 3 (significant discrepancy), and 36 as 4 (major discrepancy). In the random peer review process, 1,690 cases were reviewed, of which 1,646 were scored as 1 (no discrepancy), 44 were scored as 2 (minor discrepancy), and none were scored as 3 or 4. Several teaching lessons and quality improvement measures were developed as a result of analysis of error cases collected through the nonrandom peer review process. Our experience supports the implementation of nonrandom peer review as a replacement to random peer review, with nonrandom peer review serving as a more effective method for collecting diagnostic error cases with educational and quality improvement value. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of a porcine collagen sponge for cranial neurosurgery: a prospective case-control study.

PubMed

Brandão, Rafael Augusto Castro Santiago; Costa, Bruno Silva; Dellaretti, Marcos Antonio; de Carvalho, Gervásio Teles C; Faria, Marcello Penholate; de Sousa, Atos Alves

2013-01-01

The use of dural grafts is very useful when primary dural closure cannot be achieved. Our primary objective was to study the incidence of postoperative cerebrospinal fluid leak, including fistula and pseudomeningocele, and postoperative infection by comparing autologous material and a new collagen graft. A prospective nonrandomized study with a new collagen-based product derived from porcine cells (Peridry) was performed. It was used for dural replacement in 50 patients who underwent a variety of neurosurgical procedures requiring the use of a dural graft. These results were compared with a control group of 50 patients who were treated with autologous duraplasty material. The follow-up period was 3 months. Postoperative overall cerebrospinal fluid fistula occurred in 6% of both groups. No patient in the collagen group developed any sort of infection. One patient in the control developed osteomyelitis in the bone flap. The new collagen-based product derived from porcine cells (Peridry), compared with an autologous tissue, is safe, effective, easy to use, as well as time saving in cranial neurosurgery. Copyright © 2013 Elsevier Inc. All rights reserved.

Factors Influencing Functional Outcomes and Return-to-Work After Amputation: A Review of the Literature.

PubMed

Darter, Benjamin J; Hawley, Carolyn E; Armstrong, Amy J; Avellone, Lauren; Wehman, Paul

2018-02-03

Purpose Amputation is a life changing event that can significantly impact an individual's physical and mental well-being. Our objective was to review literature exploring the impact of amputation upon a person's functioning and inclusion in the workplace. Methods Medline, CINAHL, and PsycINFO were searched using keywords related to amputation, employment and community reintegration. Eligible studies were published since 2000 and one of the following study designs: randomized controlled trial, non-randomized controlled trial, retrospective study, prospective study, concurrent cohort study, or cross sectional study. Studies for civilians with amputation as well as service members and Veterans with amputation were considered for inclusion. Results The search identified 995 articles, 25 of which met inclusion/exclusion criteria and were included in the review. While strong evidence for correlations and predictors of outcomes after amputation were limited, multiple factors were identified as contributing to physical functioning and employment after amputation. Conclusions Outcomes after amputation can vary widely with many potentially inter-related factors contributing. The factors identified may also serve to inform the development of interventions aiming to improve functional performance and reintegration after amputation. Furthermore, the review highlights the need for more high quality prospective studies.

Nonoperative management in children with early acute appendicitis: A systematic review.

PubMed

Xu, Jane; Adams, Susan; Liu, Yingrui Cyril; Karpelowsky, Jonathan

2017-09-01

Appendectomy has remained the gold standard treatment of acute appendicitis for more than 100years. Nonoperative management (NOM) has been shown to be a valid treatment alternative for acute uncomplicated appendicitis in adults. A systematic review of available evidence comparing operative management (OM) and NOM in children with acute uncomplicated appendicitis was performed. Systematic searches of MedLine, Embase, and a clinical trial register (https://clinicaltrials.gov/) were performed in March 2016. Only articles that studied NOM for uncomplicated appendicitis in children were included. Data generation was performed independently by two authors, and quality was assessed using the rating schema by the Oxford Centre for Evidence-Based Medicine. 15 articles were selected: four retrospective analyses, four prospective cohort studies, four prospective nonrandomized comparative trials and one randomized controlled trial (RCT). Initial success of the NOM groups (a cure within two weeks of intervention) ranged from 58 to 100%, with 0.1-31.8% recurrence at one year. Although present literature is scarce, publications support the feasibility of further studies investigating NOM of acute uncomplicated appendicitis in children. Higher quality prospective RCTs with larger sample sizes and robust randomization methods, studying the noninferiority of NOM with antibiotics compared with OM are required to establish its utility. This manuscript is a systematic review and thus assigned the lowest evidence used from the manuscripts analyzed which is a Level IV. Copyright © 2017. Published by Elsevier Inc.

DNA asymmetry in stem cells - immortal or mortal?

PubMed

Yadlapalli, Swathi; Yamashita, Yukiko M

2013-09-15

The immortal strand hypothesis proposes that stem cells retain a template copy of genomic DNA (i.e. an 'immortal strand') to avoid replication-induced mutations. An alternative hypothesis suggests that certain cells segregate sister chromatids non-randomly to transmit distinct epigenetic information. However, this area of research has been highly controversial, with conflicting data even from the same cell types. Moreover, historically, the same term of 'non-random sister chromatid segregation' or 'biased sister chromatid segregation' has been used to indicate distinct biological processes, generating a confusion in the biological significance and potential mechanism of each phenomenon. Here, we discuss the models of non-random sister chromatid segregation, and we explore the strengths and limitations of the various techniques and experimental model systems used to study this question. We also describe our recent study on Drosophila male germline stem cells, where sister chromatids of X and Y chromosomes are segregated non-randomly during cell division. We aim to integrate the existing evidence to speculate on the underlying mechanisms and biological relevance of this long-standing observation on non-random sister chromatid segregation.

Pelvic floor muscle training for bowel dysfunction following colorectal cancer surgery: A systematic review.

PubMed

Lin, Kuan-Yin; Granger, Catherine L; Denehy, Linda; Frawley, Helena C

2015-11-01

To identify, evaluate and synthesize the evidence examining the effectiveness of pelvic floor muscle training (PFMT) on bowel dysfunction in patients who have undergone colorectal cancer surgery. Eight electronic databases (MEDLINE 1950-2014; CINAHL 1982-2014; EMBASE 1980-2014; Scopus 1823-2014; PsycINFO 1806-2014; Web of Science 1970-2014; Cochrane Library 2014; PEDro 1999-2014) were systematically searched in March 2014. Reference lists of identified articles were cross referenced and hand searched. Randomized controlled trials, cohort studies and case series were included if they investigated the effects of conservative treatments, including PFMT on bowel function in patients with colorectal cancer following surgery. Two reviewers independently assessed the risk of bias of studies using the Newcastle-Ottawa Scale (NOS). Six prospective non-randomized studies and two retrospective studies were included. The mean (SD) NOS risk of bias score was 4.9 (1.2) out of 9; studies were limited by a lack of non-exposed cohort, lack of independent blinded assessment, heterogeneous treatment protocols, and lack of long-term follow-up. The majority of studies reported significant improvements in stool frequency, incontinence episodes, severity of fecal incontinence, and health-related quality of life (HRQoL) after PFMT. Meta-analysis was not possible due to lack of randomized controlled trials. Pelvic floor muscle training for patients following surgery for colorectal cancer appears to be associated with improvements in bowel function and HRQoL. Results from non-randomized studies are promising but randomized controlled trials with sufficient power are needed to confirm the effectiveness of PFMT in this population. © 2014 Wiley Periodicals, Inc.

Duodenal Electric Stimulation: Results of a First-in-Man Study.

PubMed

Aberle, Jens; Busch, Philipp; Veigel, Jochen; Duprée, Anna; Roesch, Thomas; zu Eulenburg, Christine; Paschen, Björn; Scholz, Bernd M; Wolter, Stefan; Sauer, Nina; Ludwig, Kaja; Izbicki, Jakob; Mann, Oliver

2016-02-01

The aim of this study was to demonstrate feasibility and safety of a new electric duodenal stimulation system (EDS, BALANCE) in humans. Secondary objectives were to evaluate the effect on glycemic control and weight loss in patients with obesity and type 2 diabetes mellitus (T2DM). In an open-labeled, prospective, single-arm, non-randomized multicenter study, 12 obese T2DM patients with a mean HbA1c of 8.0% received laparoscopic implantation of the BALANCE duodenal stimulating device. Adverse events, changes in glycemic control, cardiovascular parameters, and weight were collected. The follow-up period after implantation was 12 months. Device related severe adverse events did not occur. Mean HbA1c decreased by 0.8% (p = 0.02) and mean fasting blood glucose level (FBG) was reduced by 19% (p = 0.038) after the 12 months. Mean HDL level increased from 44 to 48 mg/dl (p = 0.033). EDS is a feasible and safe procedure. Positive effects on T2DM and some cardiovascular parameters (HDL, weight) were seen. However, further prospective randomized blinded studies are needed in order to evaluate the potential of this new minimally invasive method.

The quality of control groups in nonrandomized studies published in the Journal of Hand Surgery.

PubMed

Johnson, Shepard P; Malay, Sunitha; Chung, Kevin C

2015-01-01

To evaluate control group selection in nonrandomized studies published in the Journal of Hand Surgery American (JHS). We reviewed all papers published in JHS in 2013 to identify studies that used nonrandomized control groups. Data collected included type of study design and control group characteristics. We then appraised studies to determine whether authors discussed confounding and selection bias and how they controlled for confounding. Thirty-seven nonrandomized studies were published in JHS in 2013. The source of control was either the same institution as the study group, a different institution, a database, or not provided in the manuscript. Twenty-nine (78%) studies statistically compared key characteristics between control and study group. Confounding was controlled with matching, exclusion criteria, or regression analysis. Twenty-two (59%) papers explicitly discussed the threat of confounding and 18 (49%) identified sources of selection bias. In our review of nonrandomized studies published in JHS, papers had well-defined controls that were similar to the study group, allowing for reasonable comparisons. However, we identified substantial confounding and bias that were not addressed as explicit limitations, which might lead the reader to overestimate the scientific validity of the data. Incorporating a brief discussion of control group selection in scientific manuscripts should help readers interpret the study more appropriately. Authors, reviewers, and editors should strive to address this component of clinical importance. Copyright © 2015 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Regional or general anesthesia for fast-track hip and knee replacement - what is the evidence?

PubMed Central

Kehlet, Henrik; Aasvang, Eske Kvanner

2015-01-01

Regional anesthesia for knee and hip arthroplasty may have favorable outcome effects compared with general anesthesia by effectively blocking afferent input, providing initial postoperative analgesia, reducing endocrine metabolic responses, and providing sympathetic blockade with reduced bleeding and less risk of thromboembolic complications but with undesirable effects on lower limb motor and urinary bladder function. Old randomized studies supported the use of regional anesthesia with fewer postoperative pulmonary and thromboembolic complications, and this has been supported by recent large non-randomized epidemiological database cohort studies. In contrast, the data from newer randomized trials are conflicting, and recent studies using modern general anesthetic techniques may potentially support the use of general versus spinal anesthesia. In summary, the lack of properly designed large randomized controlled trials comparing modern general anesthesia and spinal anesthesia for knee and hip arthroplasty prevents final recommendations and calls for prospective detailed studies in this clinically important field. PMID:26918127

Classroom-Based Narrative and Vocabulary Instruction: Results of an Early-Stage, Nonrandomized Comparison Study

ERIC Educational Resources Information Center

Gillam, Sandra Laing; Olszewski, Abbie; Fargo, Jamison; Gillam, Ronald B.

2014-01-01

Purpose: This nonrandomized feasibility study was designed to provide a preliminary assessment of the impact of a narrative and vocabulary instruction program provided by a speech-language pathologist (SLP) in a regular classroom setting. Method: Forty-three children attending 2 first-grade classrooms participated in the study. Children in each…

Efficacy and safety of a phytoestrogen preparation derived from Glycine max (L.) Merr in climacteric symptomatology: a multicentric, open, prospective and non-randomized trial.

PubMed

Albert, A; Altabre, C; Baró, F; Buendía, E; Cabero, A; Cancelo, M J; Castelo-Branco, C; Chantre, P; Duran, M; Haya, J; Imbert, P; Julía, D; Lanchares, J L; Llaneza, P; Manubens, M; Miñano, A; Quereda, F; Ribes, C; Vázquez, F

2002-03-01

A multicentric, open, prospective, observational and no-randomized clinical trial was carried out in Spain with 190 postmenopausal women receiving a soy preparation rich in isoflavones (PHYTO SOYA, capsules containing 17.5 mg isoflavones). The main object of the present study was to investigate its efficacy in alleviating the symptomatology derived from the lack of estrogen, mainly hot flushes, but also other symptoms such as sleep disorder, anxiety, depression, vaginal dryness, loss of libido and bone pain. Each patient received 35 mg isoflavones per day in two doses. During the four months' treatment, a statistically significant decrease in the number of hot flushes with PHYTO SOYA was experienced by 80.82% women; only 5,48% patients did not improve with the treatment. The average reduction was 47.8%, which is equivalent to 4 hot flushes. All the other studied parameters also showed a statistically significant decrease. No severe side-effects were reported and tolerance was excellent. Treatment with PHYTO SOYA resulted in a significant improvement of the symptomatology that accompanies the lack of estrogen during menopause.

Estimates of External Validity Bias When Impact Evaluations Select Sites Nonrandomly

ERIC Educational Resources Information Center

Bell, Stephen H.; Olsen, Robert B.; Orr, Larry L.; Stuart, Elizabeth A.

2016-01-01

Evaluations of educational programs or interventions are typically conducted in nonrandomly selected samples of schools or districts. Recent research has shown that nonrandom site selection can yield biased impact estimates. To estimate the external validity bias from nonrandom site selection, we combine lists of school districts that were…

Nitroglycerin can facilitate weaning of difficult-to-wean chronic obstructive pulmonary disease patients: a prospective interventional non-randomized study

PubMed Central

2010-01-01

Introduction Both experimental and clinical data give convincing evidence to acute cardiac dysfunction as the origin or a cofactor of weaning failure in patients with chronic obstructive pulmonary disease. Therefore, treatment targeting the cardiovascular system might help the heart to tolerate more effectively the critical period of weaning. This study aims to assess the hemodynamic, respiratory and clinical effects of nitroglycerin infusion in difficult-to-wean patients with severe chronic obstructive pulmonary disease. Methods Twelve difficult-to-wean (failed ≥ 3 consecutive trials) chronic obstructive pulmonary disease patients, who presented systemic arterial hypertension (systolic blood pressure ≥ 140mmHg) during weaning failure and had systemic and pulmonary artery catheters in place, participated in this prospective, interventional, non-randomized clinical trial. Patients were studied in two consecutive days, i.e., the first day without (Control day) and the second day with (Study day) nitroglycerin continuous intravenous infusion starting at the beginning of the spontaneous breathing trial, and titrated to maintain normal systolic blood pressure. Hemodynamic, oxygenation and respiratory measurements were performed on mechanical ventilation, and during a 2-hour T-piece spontaneous breathing trial. Primary endpoint was hemodynamic and respiratory effects of nitroglycerin infusion. Secondary endpoint was spontaneous breathing trial and extubation outcome. Results Compared to mechanical ventilation, mean systemic arterial pressure, rate-pressure product, mean pulmonary arterial pressure, and pulmonary artery occlusion pressure increased [from (mean ± SD) 94 ± 14, 13708 ± 3166, 29.9 ± 4.8, and 14.8 ± 3.8 to 109 ± 20mmHg, 19856 ± 4877mmHg b/min, 41.6 ± 5.8mmHg, and 23.4 ± 7.4 mmHg, respectively], and mixed venous oxygen saturation decreased (from 75.7 ± 3.5 to 69.3 ± 7.5%) during failing trials on Control day, whereas they did not change on Study day. Venous admixture increased throughout the trial on both Control day and Study day, but this increase was lower on Study day. Whereas weaning failed in all patients on Control day, nitroglycerin administration on Study day enabled a successful spontaneous breathing trial and extubation in 92% and 88% of patients, respectively. Conclusions In this clinical setting, nitroglycerin infusion can expedite the weaning by restoring weaning-induced cardiovascular compromise. PMID:21078149

Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review.

PubMed

Rossini, Gabriele; Parrini, Simone; Castroflorio, Tommaso; Deregibus, Andrea; Debernardi, Cesare L

2015-09-01

To assess the scientific evidence related to the efficacy of clear aligner treatment (CAT) in controlling orthodontic tooth movement. PubMed, PMC, NLM, Embase, Cochrane Central Register of Controlled Clinical Trials, Web of Knowledge, Scopus, Google Scholar, and LILACs were searched from January 2000 to June 2014 to identify all peer-reviewed articles potentially relevant to the review. Methodological shortcomings were highlighted and the quality of the studies was ranked using the Cochrane Tool for Risk of Bias Assessment. Eleven relevant articles were selected (two Randomized Clinical Trials (RCT), five prospective non-randomized, four retrospective non-randomized), and the risk of bias was moderate for six studies and unclear for the others. The amount of mean intrusion reported was 0.72 mm. Extrusion was the most difficult movement to control (30% of accuracy), followed by rotation. Upper molar distalization revealed the highest predictability (88%) when a bodily movement of at least 1.5 mm was prescribed. A decrease of the Little's Index (mandibular arch: 5 mm; maxillary arch: 4 mm) was observed in aligning arches. CAT aligns and levels the arches; it is effective in controlling anterior intrusion but not anterior extrusion; it is effective in controlling posterior buccolingual inclination but not anterior buccolingual inclination; it is effective in controlling upper molar bodily movements of about 1.5 mm; and it is not effective in controlling rotation of rounded teeth in particular. However, the results of this review should be interpreted with caution because of the number, quality, and heterogeneity of the studies.

GreenLight laser vs diode laser vaporization of the prostate: 3-year results of a prospective nonrandomized study.

PubMed

Guo, Sanwei; Müller, Georg; Bonkat, Gernot; Püschel, Heike; Gasser, Thomas; Bachmann, Alexander; Rieken, Malte

2015-04-01

Laser vaporization of the prostate is one of the alternatives to transurethral resection of the prostate. Short-term studies report a comparable outcome after laser vaporization with the 532 nm 120-W GreenLight high-performance system (HPS) laser and the 980 nm 200 W high-intensity diode (diode) laser. In this study, we analyzed the intermediate-term results of both techniques. From January 2007 to January 2008, 112 consecutive patients with symptomatic benign prostate enlargement were nonrandomly assigned to treatment with the GreenLight laser or the diode laser. Perioperative parameters, postoperative functional outcome, complications, and the reoperation rate at 3 years were analyzed. Improvement of voiding symptoms (International Prostate Symptom Score, quality-of-life) and micturition parameters (maximum flow rate, postvoid residual volume) showed no significant difference between the HPS group and the diode group. A significantly higher reoperation rate was observed in the diode group in comparison to the HPS group (37.5% vs 8.9%, p=0.0003) due to obstructive necrotic tissue (16.1% vs 0%, p=0.0018), bladder neck stricture (16.1% vs 1.8%, p=0.008), and persisting or recurrent adenoma (5.4% vs 7.1%, p=0.70), respectively. Both lasers lead to comparable improvement of voiding parameters and micturition symptoms. Treatment with the 200 W diode laser led to a significantly higher reoperation rate, which might be attributed to a higher degree of coagulation necrosis. Thus, a careful clinical application of this diode laser type is warranted.

A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis

PubMed Central

Chao, Ming; Wu, Hao; Jin, Kai; Li, Bin; Wu, Jianjun; Zhang, Guangqiang; Yang, Gong; Hu, Xun

2016-01-01

Study design: Previous works suggested that neutralizing intratumoral lactic acidosis combined with glucose deprivation may deliver an effective approach to control tumor. We did a pilot clinical investigation, including a nonrandomized (57 patients with large HCC) and a randomized controlled (20 patients with large HCC) studies. Methods: The patients were treated with transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor. Results: In the nonrandomized controlled study, geometric mean of viable tumor residues (VTR) in TACE with bicarbonate was 6.4-fold lower than that in TACE without bicarbonate (7.1% [95% CI: 4.6%–10.9%] vs 45.6% [28.9%–72.0%]; p<0.0001). This difference was recapitulated by a subsequent randomized controlled study. TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized). The survival data suggested that bicarbonate may bring survival benefit. Conclusion: Bicarbonate markedly enhances the anticancer activity of TACE. Clinical trail registration: ChiCTR-IOR-14005319. DOI: http://dx.doi.org/10.7554/eLife.15691.001 PMID:27481188

International clinical practice guidelines for the treatment and prophylaxis of thrombosis associated with central venous catheters in patients with cancer.

PubMed

Debourdeau, P; Farge, D; Beckers, M; Baglin, C; Bauersachs, R M; Brenner, B; Brilhante, D; Falanga, A; Gerotzafias, G T; Haim, N; Kakkar, A K; Khorana, A A; Lecumberri, R; Mandala, M; Marty, M; Monreal, M; Mousa, S A; Noble, S; Pabinger, I; Prandoni, P; Prins, M H; Qari, M H; Streiff, M B; Syrigos, K; Büller, H R; Bounameaux, H

2013-01-01

Although long-term indwelling central venous catheters (CVCs) may lead to pulmonary embolism (PE) and loss of the CVC, there is lack of consensus on management of CVC-related thrombosis (CRT) in cancer patients and heterogeneity in clinical practices worldwide. To establish common international Good Clinical Practices Guidelines (GCPG) for the management of CRT in cancer patients. An international working group of experts was set up to develop GCPG according to an evidence-based medicine approach, using the GRADE system. For the treatment of established CRT in cancer patients, we found no prospective randomized studies, two non-randomized prospective studies and one retrospective study examining the efficacy and safety of low-molecular-weight heparin (LMWH) plus vitamin K antagonists (VKAs). One retrospective study evaluated the benefit of CVC removal and two small retrospective studies were on thrombolytic drugs. For the treatment of symptomatic CRT, anticoagulant treatment (AC) is recommended for a minimum of 3 months; in this setting, LMWHs are suggested. VKAs can also be used, in the absence of direct comparisons of these two types of anticoagulants in this setting [Guidance]. The CVC can be kept in place if it is functional, well-positioned and non-infected and there is good resolution under close surveillance; whether the CVC is kept or removed, no standard approach in terms of AC duration has been established [Guidance]. For the prophylaxis of CRT in cancer patients, we found six randomized studies investigating the efficacy and safety of VKA vs. placebo or no treatment, one on the efficacy and safety of unfractionnated heparin, six on the value of LMWH, one double-blind randomized and one non randomized study on thrombolytic drugs and six meta-analyses of AC and CVC thromboprophylaxis. Type of catheter (open-ended like the Hickman(®) catheter vs. closed-ended catheter with a valve like the Groshong(®) catheter), its position (above, below or at the junction of the superior vena cava and the right atrium) and method of placement may influence the onset of CRT on the basis of six retrospective trials, four prospective non-randomized trials, three randomized trials and one meta-analysis. In light of these data: use of AC for routine prophylaxis of CRT is not recommended [1A]; a CVC should be inserted on the right side, in the jugular vein, and distal extremity of the CVC should be located at the junction of the superior vena cava and the right atrium [1A]. Dissemination and implementation of these international GCPG for the prevention and treatment of CRT in cancer patients at each national level is a major public health priority, needing worldwide collaboration. © 2012 International Society on Thrombosis and Haemostasis.

Identifying Baseline Covariates for Use in Propensity Scores: A Novel Approach Illustrated for a Nonrandomized Study of Recovery High Schools

ERIC Educational Resources Information Center

Tanner-Smith, Emily E.; Lipsey, Mark W.

2014-01-01

There are many situations where random assignment of participants to treatment and comparison conditions may be unethical or impractical. This article provides an overview of propensity score techniques that can be used for estimating treatment effects in nonrandomized quasi-experimental studies. After reviewing the logic of propensity score…

Mental Health Stress, Family Resources and Psychological Distress: A Longitudinal Mediation Analysis in African American Grandmothers Raising Grandchildren.

PubMed

Whitley, Deborah M; Lamis, Dorian A; Kelley, Susan J

2016-06-01

This study examines the effectiveness of a multidisciplinary intervention for African American grandmothers raising grandchildren on the relationship between dichotomized levels of mental health stress (low vs. high) and elevated levels of psychological distress, mediated by perceptions of family resources. A nonrandom sample of African American grandmothers (N = 679) was assessed to test the predictive relations among study constructs in the context of a prospective mediational model. Perception of family resources contributes to lower psychological distress among custodial grandmothers exhibiting low and high levels of mental health stress. There was no significant difference in the strength of the mediated effects between the 2 mental health stress groups. The findings suggest appropriate resource-focused interventions can enhance grandmothers' subjective assessments of family resources and reduce psychological distress. However, additional research is needed to ascertain the consistency and generalizability of findings. © 2016 Wiley Periodicals, Inc.

Mindfulness Meditation for Substance Use Disorders: A Systematic Review

PubMed Central

Zgierska, Aleksandra; Rabago, David; Chawla, Neharika; Kushner, Kenneth; Koehler, Robert; Marlatt, Allan

2009-01-01

Relapse is common in substance use disorders (SUDs), even among treated individuals. The goal of this article was to systematically review the existing evidence on mindfulness meditation-based interventions (MM) for SUDs. The comprehensive search for and review of literature found over 2,000 abstracts and resulted in 25 eligible manuscripts (22 published, 3 unpublished: 8 RCTs, 7 controlled non-randomized, 6 non-controlled prospective, 2 qualitative studies, 1 case report). When appropriate, methodological quality, absolute risk reduction, number needed to treat, and effect size (ES) were assessed. Overall, although preliminary evidence suggests MM efficacy and safety, conclusive data for MM as a treatment of SUDs are lacking. Significant methodological limitations exist in most studies. Further, it is unclear which persons with SUDs might benefit most from MM. Future trials must be of sufficient sample size to answer a specific clinical question and should target both assessment of effect size and mechanisms of action. PMID:19904664

Fissurectomy Combined with High-Dose Botulinum Toxin Is a Safe and Effective Treatment for Chronic Anal Fissure and a Promising Alternative to Surgical Sphincterotomy.

PubMed

Barnes, Thomas G; Zafrani, Zakhi; Abdelrazeq, Ayman S

2015-10-01

There is paucity of data on the long-term outcome of the combination of fissurectomy and botulinum toxin A injection for the management of chronic anal fissure. The aim of this study is to assess the safety, efficacy, and long-term outcome of the combination of fissurectomy and botulinum toxin A injection. This is a nonrandomized prospective cohort study. This study was conducted at a district general hospital in the United Kingdom. The cohort included all patients treated with fissurectomy and botulinum toxin A for chronic anal fissure between September 2008 and March 2012. The patients were treated with a combination of fissurectomy and botulinum toxin A injection. Symptomatic relief, fissure healing, complications, recurrence, and the need for further surgical intervention. One hundred and two patients received fissurectomy and botulinum toxin A injection for chronic anal fissure. At 12-week follow-up, 68 patients had resolution of symptoms and complete healing of chronic anal fissure, 29 patients had improvement of symptoms but incomplete healing and had further topical or botulinum toxin A treatment with subsequent complete healing. Ninety-five patients (93%) reported no postoperative complications. Seven patients reported a degree of incontinence in the immediate postoperative period. All reported normal continence at12-week follow-up. No local complications were observed or reported. At the mean follow-up of 33 months, there was no evidence of recurrence. Twelve-month follow-up was conducted via telephone interview only. This study is nonrandomized and did not examine the dose response of Botulinum Toxin A. Fissurectomy combined with high-dose botulinum toxin A is a safe, effective, and durable option for the management of chronic anal fissure and a promising alternative to surgical sphincterotomy.

The management of multidrug-resistant Enterobacteriaceae.

PubMed

Bassetti, Matteo; Peghin, Maddalena; Pecori, Davide

2016-12-01

Multidrug-resistant (MDR) Enterobacteriaceae are often related to the production of extended-spectrum b-lactamases (ESBLs) and carbapenemase-producing Enterobacteriaceae (CRE), and represent an increasing global threat. Recommendations for the therapeutic management of MDR-related infections, however, are mainly derived from retrospective and nonrandomized prospective studies. The aim of this review is to discuss the challenges in the treatment of patients with infections because of MDR Enterobacteriaceae and provide an expert opinion while awaiting for more definitive data. To avoid the selection of carbapenemase-producing Enterobacteriaceae, carbapenem-sparing strategies should be considered. B-lactams/b-lactamase inhibitors, mainly piperacillin-tazobactam, minimum inhibitory concentration (MIC) 16/4mg/ml or less represents the best alternative to carbapenems for the treatment of ESBL-producing strains. Overall, combination therapy may be preferred over monotherapy for CRE. The combination of a carbapenem-containing regimen with colistin or high-dose tigecycline or aminoglycoside can be administered at high-dose prolonged infusion with therapeutic drug monitoring for the treatment of CRE with MIC for meropenem 8-16 mg/l or less. For MIC higher than 8-16 mg/l, the use of meropenem should be avoided and various combination therapies based on the in-vitro susceptibility of antimicrobials (e.g., colistin, high-dose tigecycline, fosfomycin, and aminoglycosides) should be selected. Carbapenem-sparing strategies should be used, when feasible, for ESBL infections. The majority of available nonrandomized studies highlight that combination for CRE seem to offer some therapeutic advantage over monotherapy. Strict infection control measures toward MDR Gram-negative pathogens remain necessary while awaiting for new treatment options.

DNA asymmetry in stem cells – immortal or mortal?

PubMed Central

Yadlapalli, Swathi; Yamashita, Yukiko M.

2013-01-01

Summary The immortal strand hypothesis proposes that stem cells retain a template copy of genomic DNA (i.e. an ‘immortal strand’) to avoid replication-induced mutations. An alternative hypothesis suggests that certain cells segregate sister chromatids non-randomly to transmit distinct epigenetic information. However, this area of research has been highly controversial, with conflicting data even from the same cell types. Moreover, historically, the same term of ‘non-random sister chromatid segregation’ or ‘biased sister chromatid segregation’ has been used to indicate distinct biological processes, generating a confusion in the biological significance and potential mechanism of each phenomenon. Here, we discuss the models of non-random sister chromatid segregation, and we explore the strengths and limitations of the various techniques and experimental model systems used to study this question. We also describe our recent study on Drosophila male germline stem cells, where sister chromatids of X and Y chromosomes are segregated non-randomly during cell division. We aim to integrate the existing evidence to speculate on the underlying mechanisms and biological relevance of this long-standing observation on non-random sister chromatid segregation. PMID:23970416

Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Incidence Rate of Healthcare-Associated Clostridium difficile Infection: A Non-Randomized, Stepped Wedge, Single-Site, Observational Study.

PubMed

DiDiodato, Giulio; McArthur, Leslie

2016-01-01

The incidence rate of healthcare-associated Clostridium difficile infection (HA-CDI) is estimated at 1 in 100 patients. Antibiotic exposure is the most consistently reported risk factor for HA-CDI. Strategies to reduce the risk of HA-CDI have focused on reducing antibiotic utilization. Prospective audit and feedback is a commonly used antimicrobial stewardship intervention (ASi). The impact of this ASi on risk of HA-CDI is equivocal. This study examines the effectiveness of a prospective audit and feedback ASi on reducing the risk of HA-CDI. Single-site, 339 bed community-hospital in Barrie, Ontario, Canada. Primary outcome is HA-CDI incidence rate. Daily prospective and audit ASi is the exposure variable. ASi implemented across 6 wards in a non-randomized, stepped wedge design. Criteria for ASi; any intravenous antibiotic use for ≥ 48 hrs, any oral fluoroquinolone or oral second generation cephalosporin use for ≥ 48 hrs, or any antimicrobial use for ≥ 5 days. HA-CDI cases and model covariates were aggregated by ward, year and month starting September 2008 and ending February 2016. Multi-level mixed effect negative binomial regression analysis was used to model the primary outcome, with intercept and slope coefficients for ward-level random effects estimated. Other covariates tested for inclusion in the final model were derived from previously published risk factors. Deviance residuals were used to assess the model's goodness-of-fit. The dataset included 486 observation periods, of which 350 were control periods and 136 were intervention periods. After accounting for all other model covariates, the estimated overall ASi incidence rate ratio (IRR) was 0.48 (95% 0.30, 0.79). The ASi effect was independent of antimicrobial utilization. The ASi did not seem to reduce the risk of Clostridium difficile infection on the surgery wards (IRR 0.87, 95% CI 0.45, 1.69) compared to the medicine wards (IRR 0.42, 95% CI 0.28, 0.63). The ward-level burden of Clostridium difficile as measured by the ward's previous month's total CDI cases (CDI Lag) and the ward's current month's community-associated CDI cases (CA-CDI) was significantly associated with an increased risk of HA-CDI, with the estimated CDI Lag IRR of 1.21 (95% 1.15, 1.28) and the estimated CA-CDI IRR of 1.10 (95% CI 1.01, 1.20). The ward-level random intercept and slope coefficients were not significant. The final model demonstrated good fit. In this study, a daily prospective audit and feedback ASi resulted in a significant reduction in the risk of HA-CDI on the medicine wards, however, this effect was independent of an overall reduction in antibiotic utilization. In addition, the ward-level burden of Clostridium difficile was shown to significantly increase the risk of HA-CDI, reinforcing the importance of the environment as a source of HA-CDI.

Ovule positions within linear fruit are correlated with nonrandom mating in Robinia pseudoacacia

PubMed Central

Yuan, Cunquan; Sun, Yuhan; Sun, Peng; Li, Yunfei; Hu, Ruiyang; Zhao, Keqi; Wang, Jinxing; Li, Yun

2016-01-01

Post-pollination processes can lead to nonrandom mating among compatible pollen donors. Moreover, morphological patterns of ovule development within linear fruits are reportedly nonrandom and depend on ovule position. However, little is known about the relationship between nonrandom mating and ovule position within linear fruit. Here, we combined controlled pollen competition experiments and paternity analyses on R. pseudoacacia to better understand nonrandom mating and its connection with ovule position. Molecular determination of siring success showed a significant departure from the expected ratio based on each kind of pollen mixture, suggesting a nonrandom mating. Outcrossed pollen grains, which were strongly favored, produced significantly more progeny than other pollen grains. Paternity analyses further revealed that the distribution of offspring produced by one specific pollen source was also nonrandom within linear fruit. The stylar end, which has a higher probability of maturation, produced a significantly higher number of outcrossed offspring than other offspring, suggesting a correlation between pollen source and ovule position. Our results suggested that a superior ovule position exists within the linear fruit in R. pseudoacacia, and the pollen that was strongly favored often preferentially occupies the ovules that were situated in a superior position, which ensured siring success and facilitated nonrandom mating. PMID:27819357

Stapedotomy in osteogenesis imperfecta: a prospective study of 32 consecutive cases.

PubMed

Vincent, Robert; Wegner, Inge; Stegeman, Inge; Grolman, Wilko

2014-12-01

To prospectively evaluate hearing outcomes in patients with osteogenesis imperfecta undergoing primary stapes surgery and to isolate prognostic factors for success. A nonrandomized, open, prospective case series. A tertiary referral center. Twenty-five consecutive patients who underwent 32 primary stapedotomies for osteogenesis imperfecta with evidence of stapes fixation and available postoperative pure-tone audiometry. Primary stapedotomy with vein graft interposition and reconstruction with a regular Teflon piston or bucket handle-type piston. Preoperative and postoperative audiometric evaluation using conventional 4-frequency (0.5, 1, 2, and 4 kHz) audiometry. Air-conduction thresholds, bone-conduction thresholds, and air-bone gap were measured. The overall audiometric results as well as the results of audiometric evaluation at 3 months and at least 1 year after surgery were used. Overall, postoperative air-bone gap closure to within 10 dB was achieved in 88% of cases. Mean (standard deviation) gain in air-conduction threshold was 22 (9.4) dB for the entire case series, and mean (standard deviation) air-bone gap closure was 22 (9.0) dB. Backward multivariate logistic regression showed that a model with preoperative air-bone gap closure and intraoperatively established incus length accurately predicts success after primary stapes surgery. Stapes surgery is a feasible and safe treatment option in patients with osteogenesis imperfecta. Success is associated with preoperative air-bone gap and intraoperatively established incus length.

A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease.

PubMed

Friedman, Neil J; Butron, Karla; Robledo, Nora; Loudin, James; Baba, Stephanie N; Chayet, Arturo

2016-01-01

Dry eye disease (DED), a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED. This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed). Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE) rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations. Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related) were reported. Intraocular pressure remained stable and most subjects showed little or no change in visual acuity at days 30 and 180. No significant findings from other clinical examinations were noted. Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

The role of high-resolution endoscopy and narrow-band imaging in the evaluation of upper GI neoplasia in familial adenomatous polyposis.

PubMed

Lopez-Ceron, Maria; van den Broek, Frank J C; Mathus-Vliegen, Elisabeth M; Boparai, Karam S; van Eeden, Susanne; Fockens, Paul; Dekker, Evelien

2013-04-01

The Spigelman classification stratifies cancer risk in familial adenomatous polyposis (FAP) patients with duodenal adenomatosis. High-resolution endoscopy (HRE) and narrow-band imaging (NBI) may identify lesions at high risk. To compare HRE and NBI for the detection of duodenal and gastric polyps and to characterize duodenal adenomas harboring advanced histology with HRE and NBI. Prospective, nonrandomized, comparative study. Retrospective image evaluation study. Tertiary-care center. Thirty-seven FAP patients undergoing surveillance upper endoscopies. HRE endoscopy was followed by NBI. The number of gastric polyps and Spigelman staging were compared. Duodenal polyp images were systematically reviewed in a learning and validation phase. Number of gastric and duodenal polyps detected by HRE and NBI and prevalence of specific endoscopic features in duodenal adenomas with advanced histology. NBI did not identify additional gastric polyps but detected more duodenal adenomas in 16 examinations, resulting in upgrades of the Spigelman stage in 2 cases (4.4%). Pictures of 168 duodenal adenomas (44% advanced histology) were assessed. In the learning phase, 3 endoscopic features were associated with advanced histology: white color, enlarged villi, and size ≥1 cm. Only size ≥1 cm was confirmed in the validation phase (odds ratio 3.0; 95% confidence interval, 1.2-7.4). Nonrandomized study, scant number of high-grade dysplasia adenomas. Inspection with NBI did not lead to a clinically relevant upgrade in the Spigelman classification and did not improve the detection of gastric polyps in comparison with HRE. The only endoscopic feature that predicted advanced histology of a duodenal adenoma was size ≥1 cm. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Clinical impact of negative-pressure wound therapy: a 1,126-patient observational prospective study.

PubMed

Téot, Luc; Guillot-Masanovic, Margot; Miquel, Pierre; Truchetet, François; Meaume, Sylvie; Dompmartin, Anne; Charles Kerihuel, Jean; Trial, Chloé; Faure, Christine

2014-01-01

Negative-pressure wound therapy (NPWT) was developed in the early 1990s and reported in 1997 by Argenta and Morykwas. Ignored at first, this technique progressively came to be considered as an outstanding advancement in reconstructive surgery. Several randomized controlled studies produced evidence for the effect of NPWT on promotion of granulation tissue formation and prevention of tissue damage and amputation. However, no important longitudinal study has yet produced clinical and economic data on the consequences of integrating NPWT into practice in multiple institutions. This prospective, comparative longitudinal study of NPWT as a clinical-practice innovation was conducted in 1,126 patients between March 2006 and June 2009 in 30 university and nonuniversity public and private hospitals in France. NPWT was proposed in a nonrandomized fashion for various clinical indications, and the patients were divided into two groups, one using NPWT, the second using standard care. Efficacy criteria were spontaneous closure, closure after surgical coverage using skin grafts or flaps, or achievement of 40% wound area regression. The results, observed in a pragmatic but not randomized study, are suggestive of a favorable impact of NPWT in multiple clinical situations. The significance of differences between surgical patients who underwent NPWT and those who did not was unclear, as NPWT had already been adopted by most of the surgical wards. © 2014 by the Wound Healing Society.

Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus

PubMed Central

Hauptmann, Christian; Ströbel, Armin; Williams, Mark; Patel, Nitesh; Wurzer, Hannes; von Stackelberg, Tatjana; Brinkmann, Uwe; Langguth, Berthold; Tass, Peter A.

2015-01-01

Purpose. Primary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study “RESET Real Life” was commissioned by ANM GmbH. Herein we present the results of this study. Methods. In a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder). Results. Acoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy. Conclusion. The field study “RESET Real Life” provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting. PMID:26568958

Anal Cancer: An Examination of Radiotherapy Strategies

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

Glynne-Jones, Rob; Lim, Faye

2011-04-01

The Radiation Therapy Oncology Group 9811, ACCORD-03, and ACT II Phase III trials in anal cancer showed no benefit for cisplatin-based induction and maintenance chemotherapy, or radiation dose-escalation >59 Gy. This review examines the efficacy and toxicity of chemoradiation (CRT) in anal cancer, and discusses potential alternative radiotherapy strategies. The evidence for the review was compiled from randomized and nonrandomized trials of radiation therapy and CRT. A total of 103 retrospective/observational studies, 4 Phase I/II studies, 16 Phase II prospective studies, 2 randomized Phase II studies, and 6 Phase III trials of radiotherapy or chemoradiation were identified. There are nomore » meta-analyses based on individual patient data. A 'one-size-fits-all' approach for all stages of anal cancer is inappropriate. Early T1 tumors are probably currently overtreated, whereas T3/T4 lesions might merit escalation of treatment. Intensity-modulated radiotherapy or the integration of biological therapy may play a role in future.« less

Impact of specialist home-based palliative care services in a tertiary oncology set up: a prospective non-randomized observational study.

PubMed

Dhiliwal, Sunil R; Muckaden, Maryann

2015-01-01

Home-based specialist palliative care services are developed to meet the needs of the patients in advanced stage of cancer at home with physical symptoms and distress. Specialist home care services are intended to improve symptom control and quality of life, enable patients to stay at home, and avoid unnecessary hospital admission. Total 690 new cases registered under home-based palliative care service in the year 2012 were prospectively studied to assess the impact of specialist home-based services using Edmonton symptom assessment scale (ESAS) and other parameters. Out of the 690 registered cases, 506 patients received home-based palliative care. 50.98% patients were cared for at home, 28.85% patients needed hospice referral and 20.15% patients needed brief period of hospitalization. All patients receiving specialist home care had good relief of physical symptoms (P < 0.005). 83.2% patients received out of hours care (OOH) through liaising with local general practitioners; 42.68% received home based bereavement care and 91.66% had good bereavement outcomes. Specialist home-based palliative care improved symptom control, health-related communication and psychosocial support. It promoted increased number of home-based death, appropriate and early hospice referral, and averted needless hospitalization. It improved bereavement outcomes, and caregiver satisfaction.

The use of a virtual reality surgical simulator for cataract surgical skill assessment with 6 months of intervening operating room experience.

PubMed

Sikder, Shameema; Luo, Jia; Banerjee, P Pat; Luciano, Cristian; Kania, Patrick; Song, Jonathan C; Kahtani, Eman S; Edward, Deepak P; Towerki, Abdul-Elah Al

2015-01-01

To evaluate a haptic-based simulator, MicroVisTouch™, as an assessment tool for capsulorhexis performance in cataract surgery. The study is a prospective, unmasked, nonrandomized dual academic institution study conducted at the Wilmer Eye Institute at Johns Hopkins Medical Center (Baltimore, MD, USA) and King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). This prospective study evaluated capsulorhexis simulator performance in 78 ophthalmology residents in the US and Saudi Arabia in the first round of testing and 40 residents in a second round for follow-up. Four variables (circularity, accuracy, fluency, and overall) were tested by the simulator and graded on a 0-100 scale. Circularity (42%), accuracy (55%), and fluency (3%) were compiled to give an overall score. Capsulorhexis performance was retested in the original cohort 6 months after baseline assessment. Average scores in all measured metrics demonstrated statistically significant improvement (except for circularity, which trended toward improvement) after baseline assessment. A reduction in standard deviation and improvement in process capability indices over the 6-month period was also observed. An interval objective improvement in capsulorhexis skill on a haptic-enabled cataract surgery simulator was associated with intervening operating room experience. Further work investigating the role of formalized simulator training programs requiring independent simulator use must be studied to determine its usefulness as an evaluation tool.

Long-term results of a non-ramdomized prospective mono-centre study of 1000 laparoscopic totally extraperitoneal hernia repairs.

PubMed

Thill, V; Simoens, C; Smets, D; Ngongang, C; da Costa, P Mendes

2008-01-01

Information concerning short-term results for laparoscopic extraperitoneal hernia repair is available, but long-term results remain poorly documented. The purpose of this non-randomized prospective study was to evaluate recurrence and chronic pain after hernia repair over a period longer than 10 years. From 1995 to 2004, all patients aged 30 years or more, manifesting with inguinal hernia, were included in our study. Patients aged 20 to 30 years presenting with bilateral hernia, recurrent hernia, or who were heavy workers were also included. Patients who had pelvic irradiation, strangulated hernia, prostatic cancer resection, or a contra-indication to general anaesthesia were excluded. Of 1096 hernia repairs performed, 248 patients were excluded and underwent open repair and 848 patients (77.4%) were included in our prospective study, which corresponded to 1000 laparoscopic hernia repairs. The sex ratio (male : female) was 5:8, and the average age was 56 years. Seven hundred and fifty-three hernias (75.3%) were first repairs, 247 (24.7%) were recurrent hernias, and 161 were bilateral hernias. There were no mortalities. The conversion rate was 1.1%, and the global postoperative morbidity rate was 10.3%. Average follow-up was 39 months in 92.2% of the patients. Hernia recurrence rate was 1.5%. Chronic pain occurred in 2.9%. During this follow-up, 22 contra-lateral hernias appeared in those patients who initially had unilateral hernia repair (3.2%). All of these contra-lateral hernias could be successfully treated using a laparoscopic total extraperitoneal approach. The long-term results of this study demonstrate that preperitoneal laparoscopic hernia repair is a safe technique with a very low recurrence rate and low prevalence of chronic pain.

What is the effect of matrices on cartilage repair? A systematic review.

PubMed

Wylie, James D; Hartley, Melissa K; Kapron, Ashley L; Aoki, Stephen K; Maak, Travis G

2015-05-01

Articular cartilage has minimal endogenous ability to undergo repair. Multiple chondral restoration strategies have been attempted with varied results. The purpose of our review was to determine: (1) Does articular chondrocyte transplantation or matrix-assisted articular chondrocyte transplantation provide better patient-reported outcomes scores, MRI morphologic measurements, or histologic quality of repair tissue compared with microfracture in prospective comparative studies of articular cartilage repair; and (2) which available matrices for matrix-assisted articular chondrocyte transplantation show the best patient-reported outcomes scores, MRI morphologic measurements, or histologic quality of repair tissue? We conducted a systematic review of PubMed, CINAHL, and MEDLINE from March 2004 to February 2014 using keywords determined to be important for articular cartilage repair, including "cartilage", "chondral", "cell source", "chondrocyte", "matrix", "augment", "articular", "joint", "repair", "treatment", "regeneration", and "restoration" to find articles related to cell-based articular cartilage repair of the knee. The articles were reviewed by two authors (JDW, MKH), our study exclusion criteria were applied, and articles were determined to be relevant (or not) to the research questions. The Methodological Index for Nonrandomized Studies (MINORS) scale was used to judge the quality of nonrandomized manuscripts used in this review and the Jadad score was used to judge the quality of randomized trials. Seventeen articles were reviewed for the first research question and 83 articles were reviewed in the second research question from 301 articles identified in the original systematic search. The average MINORS score was 9.9 (62%) for noncomparative studies and 16.1 (67%) for comparative studies. The average Jadad score was 2.3 for the randomized studies. Articular chondrocyte transplantation shows better patient-reported outcomes at 5 years in patients without chronic symptoms preoperatively compared with microfracture (p = 0.026). Matrix-assisted articular chondrocyte transplantation consistently showed improved patient-reported functional outcomes compared with microfracture (p values ranging from < 0.001 to 0.029). Hyalograft C(®) (Anika Therapeutics Inc, Bedford, MA, USA) and Chondro-gide(®) (Genzyme Biosurgery, Kastrup, Denmark) are the matrices with the most published evidence in the literature, but no studies comparing different matrices met our inclusion criteria, because the literature consists only of uncontrolled case series. Matrix-assisted articular chondrocyte transplantation leads to better patient-reported outcomes in cartilage repair compared with microfracture; however, future prospective research is needed comparing different matrices to determine which products optimize cartilage repair. Level IV, therapeutic study.

Knowledge translation strategies for enhancing nurses' evidence-informed decision making: a scoping review.

PubMed

Yost, Jennifer; Thompson, David; Ganann, Rebecca; Aloweni, Fazila; Newman, Kristine; McKibbon, Ann; Dobbins, Maureen; Ciliska, Donna

2014-06-01

Nurses are increasingly expected to engage in evidence-informed decision making (EIDM); the use of research evidence with information about patient preferences, clinical context and resources, and their clinical expertise in decision making. Strategies for enhancing EIDM have been synthesized in high-quality systematic reviews, yet most relate to physicians or mixed disciplines. Existing reviews, specific to nursing, have not captured a broad range of strategies for promoting the knowledge and skills for EIDM, patient outcomes as a result of EIDM, or contextual information for why these strategies "work." To conduct a scoping review to identify and map the literature related to strategies implemented among nurses in tertiary care for promoting EIDM knowledge, skills, and behaviours, as well as patient outcomes and contextual implementation details. A search strategy was developed and executed to identify relevant research evidence. Participants included registered nurses, clinical nurse specialists, nurse practitioners, and advanced practice nurses. Strategies were those enhancing nurses' EIDM knowledge, skills, or behaviours, as well as patient outcomes. Relevant studies included systematic reviews, randomized controlled trials, cluster randomized controlled trials, non-randomized trials (including controlled before and after studies), cluster non-randomized trials, interrupted time series designs, prospective cohort studies, mixed-method studies, and qualitative studies. Two reviewers performed study selection and data extraction using standardized forms. Disagreements were resolved through discussion or third party adjudication. Using a narrative synthesis, the body of research was mapped by design, clinical areas, strategies, and provider and patient outcomes to determine areas appropriate for a systematic review. There are a sufficiently high number of studies to conduct a more focused systematic review by care settings, study design, implementation strategies, or outcomes. A focused review could assist in determining which strategies can be recommended for enhancing EIDM knowledge, skills, and behaviours among nurses in tertiary care. © 2014 The Authors. Worldviews on Evidence-Based Nursing published by Wiley Periodicals, Inc. on behalf of Sigma Theta Tau International.

Characterization of Foci and Breakthrough Sites During Persistent and Long-Standing Persistent Atrial Fibrillation in Patients: Studies Using High-Density (510-512 Electrodes) Biatrial Epicardial Mapping.

PubMed

Lee, Seungyup; Sahadevan, Jayakumar; Khrestian, Celeen M; Markowitz, Alan; Waldo, Albert L

2017-03-17

We previously demonstrated that persistent and long-standing persistent atrial fibrillation is maintained by activation emanating from foci and breakthrough sites of different cycle lengths (CLs). The purpose of this study was to characterize the behavior of focal and nonrandom breakthrough activation identified during high-density mapping of atrial fibrillation in these patients. During open heart surgery, we recorded activation from both atria simultaneously using 510 to 512 epicardial electrodes along with ECG lead II in 12 patients with persistent and long-standing persistent atrial fibrillation. For each patient, analysis of 32 consecutive seconds of activation from identified focal (sustained and/or intermittent) and nonrandom breakthrough sites was performed. Multiple foci (sustained and/or intermittent) of different CLs were present in both atria in 11 of 12 patients; 8 foci were sustained, and 22 were intermittent. Temporal CL behavior of sustained foci varied over time (≤20 ms of the mean CL). For intermittent foci, no activation periods were due to a spontaneous pause (18 of 22) or activation of the focus by another wave front (11 of 22). All patients had breakthrough activation. Seven patients had 12 nonrandom breakthrough sites. Periods of no breakthrough activation were caused by a spontaneous pause (6 of 12 patients) or activation from another wave front (4 of 12) or were uncertain (5 of 12). Focal and nonrandom breakthrough activation sometimes produced repetitive "wannabe" (incomplete) reentry in 6 of 12 patients. During persistent and long-standing persistent atrial fibrillation, sustained foci manifested variable CLs. Spontaneous pauses or activation from other wave fronts explained the intermittency of foci and nonrandom breakthrough. Focal and nonrandom breakthrough activation occasionally produced wannabe reentry. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Effects of ignition location models on the burn patterns of simulated wildfires

USGS Publications Warehouse

Bar-Massada, A.; Syphard, A.D.; Hawbaker, T.J.; Stewart, S.I.; Radeloff, V.C.

2011-01-01

Fire simulation studies that use models such as FARSITE often assume that ignition locations are distributed randomly, because spatially explicit information about actual ignition locations are difficult to obtain. However, many studies show that the spatial distribution of ignition locations, whether human-caused or natural, is non-random. Thus, predictions from fire simulations based on random ignitions may be unrealistic. However, the extent to which the assumption of ignition location affects the predictions of fire simulation models has never been systematically explored. Our goal was to assess the difference in fire simulations that are based on random versus non-random ignition location patterns. We conducted four sets of 6000 FARSITE simulations for the Santa Monica Mountains in California to quantify the influence of random and non-random ignition locations and normal and extreme weather conditions on fire size distributions and spatial patterns of burn probability. Under extreme weather conditions, fires were significantly larger for non-random ignitions compared to random ignitions (mean area of 344.5 ha and 230.1 ha, respectively), but burn probability maps were highly correlated (r = 0.83). Under normal weather, random ignitions produced significantly larger fires than non-random ignitions (17.5 ha and 13.3 ha, respectively), and the spatial correlations between burn probability maps were not high (r = 0.54), though the difference in the average burn probability was small. The results of the study suggest that the location of ignitions used in fire simulation models may substantially influence the spatial predictions of fire spread patterns. However, the spatial bias introduced by using a random ignition location model may be minimized if the fire simulations are conducted under extreme weather conditions when fire spread is greatest. ?? 2010 Elsevier Ltd.

Role of Internal Mammary Node Radiation as a Part of Modern Breast Cancer Radiation Therapy: A Systematic Review

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

Verma, Vivek; Vicini, Frank; Tendulkar, Rahul D.

Purpose: Despite data from multiple randomized trials, the role of internal mammary lymph node irradiation as a part of regional nodal irradiation (IMLN RT–RNI) remains unanswered. Recent noteworthy data and modern RT techniques might identify a subset of patients who will benefit from IMLN RT–RNI, lending insight into the balance between improved outcomes and acceptable toxicity. We evaluated the current role of IMLN RT–RNI by analyzing randomized, prospective, and retrospective data. Methods and Materials: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a review of the published data was performed using PubMed to evaluate publishedmore » studies from 1994 to 2015. The information evaluated included the number of patients, follow-up period, technical aspects of RT, and outcomes (clinical outcomes, complications/toxicity). Results: We included 16 studies (4 randomized, 4 nonrandomized, 7 retrospective, and 1 meta-analysis). Although older randomized trials failed to show differences in clinical outcomes or toxicity with IMLN RT–RNI, recent randomized data suggest the potential for improved outcomes, including overall survival, with IMLN RT–RNI. Furthermore, nonrandomized data have suggested a potential benefit for central tumors with IMLN RT–RNI. Although recent data have suggested a potential increase in pulmonary complications with IMLN RT–RNI with the use of advanced radiation techniques, toxicity rates remain low with limited cardiac toxicity data available. Conclusions: Increasing data from recent randomized trials support the use of IMLN RT–RNI. IMLN RT can be considered based on the inclusion of IMLN RT as a part of RNI in recent trials and the inclusion criteria from IMLN RT–RNI trials and for patients with central or medial tumors and axillary disease.« less

Reduced Suprathreshold Odor Identification in Patients with Pseudotumor Cerebri: A Non-Randomized Prospective Study.

PubMed

Dotan, Gad; Cohen, Eyal; Klein, Ainat; Kesler, Anat

2018-01-01

Recent evidence suggests that olfaction is impaired in patients with pseudotumor cerebri (PTC). To measure suprathreshold olfactory function by using the University of Pennsylvania Smell Identification Test (UPSIT), assessing its usefulness for routine clinical use. Forty PTC patients underwent USPIT olfactory testing. Twenty-nine out of 40 (73%) PTC patients (36 women, 4 men; mean age 34 years) had reduced suprathreshold smell sensation according to UPSIT scores: 19 (47%) had mild microsmia, 9 (23%) had moderate microsmia, and one (3%) was classified as having severe microsmia. The mean UPSIT score of all patients was 32.4 (95% confidence interval 31.4-33.4). Multivariate regression analysis found that UPSIT scores were not related to disease activity, disease duration, initial intracranial pressure (ICP), or visual function. Many PTC patients have reduced suprathreshold olfactory dysfunction that can be discovered by UPSIT, a rapidly administered smell test, which is suitable for clinical office use.

Treatment of lymphangiomas in children: an update of Picibanil (OK-432) sclerotherapy.

PubMed

Greinwald, J H; Burke, D K; Sato, Y; Poust, R I; Kimura, K; Bauman, N M; Smith, R J

1999-10-01

Picibanil (OK-432) is a sclerosing agent derived from a low-virulence strain of Streptococcus pyogenes that induces regression of macrocystic lymphangiomas. This report describes a prospective, nonrandomized trial to evaluate the efficacy of Picibanil in the treatment of 13 affected children ranging in age from 1 to 94 months. On average, 4.1 fluoroscopically guided intracystic injections were performed per child, with an average total dose of 0.56 mg of Picibanil. As judged by physical examination and radiographic studies, 5 children (42%) showed a complete or substantial response, and 2 children (16%) showed an intermediate response. No response was seen in 5 children (42%), 2 of whom had massive craniofacial lymphangioma. Factors that contribute to failure with Picibanil sclerotherapy are the presence of a significant microcystic component to the lesion, massive craniofacial involvement, and previous surgical resection. Macrocystic lymphangiomas of the infratemporal fossa or cervical area have the best response to therapy.

Pharyngocutaneous fistulae following total laryngectomy comparison between manual and mechanical sutures.

PubMed

Gonçalves, Antonio José; de Souza, J A L; Menezes, M B; Kavabata, N K; Suehara, A B; Lehn, C N

2009-11-01

The extension of the surgery and closure type of the pharynx can be the determinants in the pharyngocutaneous fistula development. The objective of the study is to evaluate the incidence of pharingocutaneous salivary fistulae after total laryngectomies comparing manual and mechanical sutures. The study is designed as non-randomized, prospective clinical study. Sixty patients with squamous cell carcinoma were submitted to total laryngectomies. In 30 cases, the linear stapler (75 mm) closure (surgical technique described in details) and in other 30 cases manual suture was used. The cases of mechanical suture were prospective and consecutive and the cases of manual suture were a review series of patients who underwent a manual suture of pharynx, in the same period of time. The statistical analysis between the two groups concluded that both were comparable. Fistulae incidence was 6.7% (2/30) in the group with the mechanical suture and 36.7% (11/30) in the group with manual suture closure, presenting a significant difference (p = 0.0047). The total laryngectomy with mechanical closure is an easy and fast learning technique, allowing watertight closure of the pharynx with a low risk of contamination of the surgical field. It is an assured method, even in previously irradiated patients, since we respect the limits of its indication regarding the extension of primary tumor that must be confirmed by previous suspension laryngectomy performed in the operating room.

Iodine and mental development of children 5 years old and under: a systematic review and meta-analysis.

PubMed

Bougma, Karim; Aboud, Frances E; Harding, Kimberly B; Marquis, Grace S

2013-04-22

Several reviews and meta-analyses have examined the effects of iodine on mental development. None focused on young children, so they were incomplete in summarizing the effects on this important age group. The current systematic review therefore examined the relationship between iodine and mental development of children 5 years old and under. A systematic review of articles using Medline (1980-November 2011) was carried out. We organized studies according to four designs: (1) randomized controlled trial with iodine supplementation of mothers; (2) non-randomized trial with iodine supplementation of mothers and/or infants; (3) prospective cohort study stratified by pregnant women's iodine status; (4) prospective cohort study stratified by newborn iodine status. Average effect sizes for these four designs were 0.68 (2 RCT studies), 0.46 (8 non-RCT studies), 0.52 (9 cohort stratified by mothers' iodine status), and 0.54 (4 cohort stratified by infants' iodine status). This translates into 6.9 to 10.2 IQ points lower in iodine deficient children compared with iodine replete children. Thus, regardless of study design, iodine deficiency had a substantial impact on mental development. Methodological concerns included weak study designs, the omission of important confounders, small sample sizes, the lack of cluster analyses, and the lack of separate analyses of verbal and non-verbal subtests. Quantifying more precisely the contribution of iodine deficiency to delayed mental development in young children requires more well-designed randomized controlled trials, including ones on the role of iodized salt.

Non-random loss of chromosome 3 during transition of Helicobacter pylori-associated gastric MALT to B-cell MALT lymphoma revealed by fluorescence in situ hybridization.

PubMed

Banerjee, S K; Weston, A P; Persons, D L; Campbell, D R

1997-12-16

Acquired gastric mucosa-associated lymphoid tissue (MALT) accumulates as a result of long-standing Helicobacter pylori (H. pylori) infection and from this acquired MALT, low-grade B-cell MALT lymphoma may develop. Carcinogenesis is a multistep, multifactorial process involving the progressive accumulation of genetic changes. To determine whether numerical chromosomal alterations are involved in the transition of H. pylori-associated human gastric MALT to low-grade B-cell MALT lymphoma, frozen biopsy specimens prospectively obtained from H. pylori positive gastric MALT and gastric MALT lymphoma patients, as well as normal control patients (normal gastroscopy/gastric mucosal histology/H. pylori negative), were analyzed by fluorescence in situ hybridization (FISH). Fluorescent, directly labeled alpha-satellite DNA probes, specific for the centromeres of chromosomes 1, 3, 4, 11, 17 and Y were used in this study. The non-random loss of chromosome 3 was detected in two MALT patients and in all five MALT lymphoma patients. Trisomy 17 was detected in one MALT patient and one MALT lymphoma patient. Trisomy 1 was detected in a single MALT lymphoma patient as was trisomy 3. None of the MALT patients had trisomy 3 or trisomy 1. Monosomy 17 was noted in one MALT lymphoma patient. Clonal aneusomy was not observed in any patient for chromosomes Y, 4 or 11. These results suggest that the consistent loss of chromosome 3 may be an important genetic alteration in the transformation of H. pylori-associated gastric MALT into low-grade B-cell gastric MALT lymphoma.

Importance of anticoagulation and postablation silent cerebral lesions: Subanalyses of REVOLUTION and reMARQable studies.

PubMed

Grimaldi, Massimo; Swarup, Vijay; DeVille, Brian; Sussman, Jonathan; Jaïs, Pierre; Gaita, Fiorenzo; Duytschaever, Mattias; Ng, G Andre; Daoud, Emile; Lakkireddy, Dhanunjaya Dj; Horton, Rodney; Wickliffe, Andrew; Ellis, Christopher; Geller, Laszlo

2017-12-01

Silent cerebral lesions (SCLs) are a potential complication of left atrial radiofrequency ablation (RFA) procedures for paroxysmal atrial fibrillation (PAF). We aimed to compare the incidence of SCLs in patients treated with irrigated RFA multielectrode catheters (nMARQ ® Catheter group) and irrigated focal RFA catheters (NAVISTAR ® THERMOCOOL ® Catheter; TC group) after PAF ablation from subpopulation neurological assessment (SNA) cohorts of the REVOLUTION and reMARQable studies. Data from SNA cohorts in the prospective, nonrandomized REVOLUTION study (March 2011-September 2013) and the prospective, randomized, controlled reMARQable study (October 2013-November 2015) were included. The incidence of SCLs was assessed pre- and postablation using magnetic resonance imaging. Neurological deficits were assessed using the National Institutes of Health Stroke Scale, modified Rankin Scale, and Montreal Cognitive Assessment. A total of 37 patients from REVOLUTION and 76 patients from reMARQable were included in the SNA cohort of each study. In the REVOLUTION SNA cohort, the incidence of SCLs was 21.1% (4/19) in the nMARQ ® Catheter group and 5.9% (1/17) in the TC group. Findings from REVOLUTION helped inform the reMARQable study protocol's stringent anticoagulation regimen. SCL incidence was subsequently reduced in both groups (nMARQ ® Catheter, 7.9%; TC, 3.3%). No permanent neurological deficits were observed. Adherence to a stringent anticoagulation regimen prior to and during ablation procedures appears to be an important factor in minimizing the risk of SCL. © 2017 Wiley Periodicals, Inc.

Run charts revisited: a simulation study of run chart rules for detection of non-random variation in health care processes.

PubMed

Anhøj, Jacob; Olesen, Anne Vingaard

2014-01-01

A run chart is a line graph of a measure plotted over time with the median as a horizontal line. The main purpose of the run chart is to identify process improvement or degradation, which may be detected by statistical tests for non-random patterns in the data sequence. We studied the sensitivity to shifts and linear drifts in simulated processes using the shift, crossings and trend rules for detecting non-random variation in run charts. The shift and crossings rules are effective in detecting shifts and drifts in process centre over time while keeping the false signal rate constant around 5% and independent of the number of data points in the chart. The trend rule is virtually useless for detection of linear drift over time, the purpose it was intended for.

A sexy spin on nonrandom chromosome segregation.

PubMed

Charville, Gregory W; Rando, Thomas A

2013-06-06

Nonrandom chromosome segregation is an intriguing phenomenon linked to certain asymmetric stem cell divisions. In a recent report in Nature, Yadlapalli and Yamashita (2013) observe nonrandom segregation of X and Y chromosomes in Drosophila germline stem cells and shed light on the complex mechanisms of this fascinating process. Copyright © 2013 Elsevier Inc. All rights reserved.

A systematic review of nonrandomized controlled trials on the curative effects of aquatic exercise

PubMed Central

Kamioka, Hiroharu; Tsutani, Kiichiro; Mutoh, Yoshiteru; Okuizum, Hiroyasu; Ohta, Miho; Handa, Shuichi; Okada, Shinpei; Kitayuguchi, Jun; Kamada, Masamitsu; Shiozawa, Nobuyoshi; Park, Sang-Jun; Honda, Takuya; Moriyama, Shoko

2011-01-01

Background: The objectives of this review were to integrate the evidence of curative effects through aquatic exercise and assess the quality of studies based on a review of nonrandomized controlled trials (nRCTs). Methods: Study design was a systematic review of nonrandomized controlled trials. Trials were eligible if they were nonrandomized clinical trials. Studies included one treatment group in which aquatic exercise was applied. We searched the following databases from 2000 up to July 20, 2009: MEDLINE via PubMed, CINAHL, and Ichushi-Web. Results: Twenty-one trials met all inclusion criteria. Languages included were English (N = 9), Japanese (N = 11), and Korean (N = 1). Target diseases were knee and/or hip osteoarthritis, poliomyelitis, chronic kidney disease, discomforts of pregnancy, cardiovascular diseases, and rotator cuff tears. Many studies on nonspecific disease (healthy participants) were included. All studies reported significant effectiveness in at least one or more outcomes. However results of evaluations with the TREND and CLEAR-NPT checklists generally showed a remarkable lack of description in the studies. Furthermore, there was the problem of heterogeneity, and we were therefore not able to perform a meta-analysis. Conclusion: Because there was insufficient evidence on aquatic exercise due to poor methodological and reporting quality and heterogeneity of nRCTs, we were unable to offer any conclusions about the effects of this intervention. However, we were able to identify problems with current nRCTs of aquatic exercise, and propose a strategy of strengthening study quality, stressing the importance of study feasibility as a future research agenda objective. PMID:21556311

Prospective Measurement of Daily Health Behaviors: Modeling Temporal Patterns in Missing Data, Sexual Behavior, and Substance Use in an Online Daily Diary Study of Gay and Bisexual Men.

PubMed

Rendina, H Jonathon; Ventuneac, Ana; Mustanski, Brian; Grov, Christian; Parsons, Jeffrey T

2016-08-01

Daily diary and other intensive longitudinal methods are increasingly being used to investigate fluctuations in psychological and behavioral processes. To inform the development of this methodology, we sought to explore predictors of and patterns in diary compliance and behavioral reports. We used multilevel modeling to analyze data from an online daily diary study of 371 gay and bisexual men focused on sexual behavior and substance use. We found that greater education and older age as well as lower frequency of substance use were associated with higher compliance. Using polynomial and trigonometric functions, we found evidence for circaseptan patterns in compliance, sexual behavior, and substance use, as well as linear declines in compliance and behavior over time. The results suggest potential sources of non-random patterns of missing data and suggest that trigonometric terms provide a similar but more parsimonious investigation of circaseptan rhythms than do third-order polynomial terms.

Prospective Measurement of Daily Health Behaviors: Modeling Temporal Patterns in Missing Data, Sexual Behavior, and Substance Use in an Online Daily Diary Study of Gay and Bisexual Men

PubMed Central

Rendina, H. Jonathon; Ventuneac, Ana; Mustanski, Brian; Grov, Christian; Parsons, Jeffrey T.

2016-01-01

Daily diary and other intensive longitudinal methods are increasingly being used to investigate fluctuations in psychological and behavioral processes. To inform the development of this methodology, we sought to explore predictors of and patterns in diary compliance and behavioral reports. We used multilevel modeling to analyze data from an online daily diary study of 371 gay and bisexual men focused on sexual behavior and substance use. We found that greater education and older age as well as lower frequency of substance use were associated with higher compliance. Using polynomial and trigonometric functions, we found evidence for circaseptan patterns in compliance, sexual behavior, and substance use, as well as linear declines in compliance and behavior over time. The results suggest potential sources of non-random patterns of missing data and suggest that trigonometric terms provide a similar but more parsimonious investigation of circaseptan rhythms than do third-order polynomial terms. PMID:26992392

Use of prophylactic Saccharomyces boulardii to prevent Clostridium difficile infection in hospitalized patients: a controlled prospective intervention study.

PubMed

Carstensen, Jeppe West; Chehri, Mahtab; Schønning, Kristian; Rasmussen, Steen Christian; Anhøj, Jacob; Godtfredsen, Nina Skavlan; Andersen, Christian Østergaard; Petersen, Andreas Munk

2018-05-03

Clostridium difficile infection (CDI) is a common complication to antibiotic use. Saccharomyces boulardii has shown effect as a prophylactic agent. We aimed to evaluate the efficacy of S. boulardii in preventing CDI in unselected hospitalized patients treated with antibiotics. We conducted a 1 year controlled prospective intervention study aiming to prescribe Sacchaflor (S. boulardii 5 × 10 9 , Pharmaforce ApS) twice daily to hospitalized patients treated with antibiotics. Comparable departments from three other hospitals in our region were included as controls. All occurrences of CDI in patients receiving antibiotics were reported and compared to a baseline period defined as 2 years prior to intervention. Results were analyzed using run chart tests for non-random variation in CDI rates. In addition, odds ratios for CDI were calculated. S. boulardii compliance reached 44% at the intervention hospital, and 1389 patients were treated with Sacchaflor. Monthly CDI rates dropped from a median of 3.6% in the baseline period to 1.5% in the intervention period. S. boulardii treatment was associated with a reduced risk of CDI at the intervention hospital: OR = 0.06 (95% CI 0.02-0.16). At two control hospitals, CDI rates did not change. At one control hospital, the median CDI rate dropped from 3.5 to 2.4%, possibly reflecting the effects of simultaneous multifaceted intervention against CDI at that hospital. The results from this controlled prospective interventional study indicate that S. boulardii is effective for the prevention of CDI in an unselected cohort of mainly elderly patients from departments of internal medicine.

Systematic Review and Meta-Analysis: Infliximab or Cyclosporine as Rescue Therapy in Patients With Severe Ulcerative Colitis Refractory to Steroids.

PubMed

Narula, Neeraj; Marshall, John K; Colombel, Jean-Frederic; Leontiadis, Grigorios I; Williams, John G; Muqtadir, Zack; Reinisch, Walter

2016-04-01

Acute severe steroid-refractory ulcerative colitis (UC) carries a poor prognosis and requires optimal management. A systematic review and meta-analysis were conducted to assess cyclosporine and infliximab (IFX) as rescue agents in patients with steroid-refractory UC. A literature search identified studies that investigated IFX and cyclosporine in steroid-refractory UC patients. The primary outcome was short-term response to treatment. Secondary outcomes included the rates of colectomy at 3 months and 12 months, adverse drug reactions, post-operative complications in those who received rescue therapy but underwent colectomy subsequently, and mortality. Odds ratios (ORs) with 95% confidence intervals (CIs) are reported. Overall, 16 studies with 1,473 participants were eligible for inclusion. Among three randomized controlled trials, no significant difference was seen with IFX compared with cyclosporine with regard to treatment response and 3- or 12-month colectomy. Among 13 non-randomized studies, IFX was associated with significantly higher rates of treatment response (OR 2.96 (95% CI 2.12-4.14, χ(2)=6.50, I(2)=0%)) and a lower 12-month colectomy rate (OR 0.42 (95% CI 0.22-0.83, χ(2)=30.94, I(2)=71%)), with no significant difference seen in the 3-month colectomy rate (OR 0.53 (95% CI 0.22-1.28, χ(2)=22.73, I(2)=69%)) compared with cyclosporine. There were no significant differences between IFX and cyclosporine in adverse drug-related events, post-operative complications, or mortality. In the management of steroid-refractory severe UC, no definitive difference between IFX and cyclosporine is demonstrated by randomized trials, but non-randomized studies suggest that IFX is associated with better treatment response and lower risk of colectomy at 12 months. Prospective studies comparing dose-optimized IFX with cyclosporine are needed.

Correction of confounding bias in non-randomized studies by appropriate weighting.

PubMed

Schmoor, Claudia; Gall, Christine; Stampf, Susanne; Graf, Erika

2011-03-01

In non-randomized studies, the assessment of a causal effect of treatment or exposure on outcome is hampered by possible confounding. Applying multiple regression models including the effects of treatment and covariates on outcome is the well-known classical approach to adjust for confounding. In recent years other approaches have been promoted. One of them is based on the propensity score and considers the effect of possible confounders on treatment as a relevant criterion for adjustment. Another proposal is based on using an instrumental variable. Here inference relies on a factor, the instrument, which affects treatment but is thought to be otherwise unrelated to outcome, so that it mimics randomization. Each of these approaches can basically be interpreted as a simple reweighting scheme, designed to address confounding. The procedures will be compared with respect to their fundamental properties, namely, which bias they aim to eliminate, which effect they aim to estimate, and which parameter is modelled. We will expand our overview of methods for analysis of non-randomized studies to methods for analysis of randomized controlled trials and show that analyses of both study types may target different effects and different parameters. The considerations will be illustrated using a breast cancer study with a so-called Comprehensive Cohort Study design, including a randomized controlled trial and a non-randomized study in the same patient population as sub-cohorts. This design offers ideal opportunities to discuss and illustrate the properties of the different approaches. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Are Locking Constructs in Distal Femoral Fractures Always Best? A Prospective Multicenter Randomized Controlled Trial Comparing the Less Invasive Stabilization System With the Minimally Invasive Dynamic Condylar Screw System.

PubMed

2016-01-01

The purpose of this clinical study is to determine whether the rate of fracture healing and fracture union, repaired with a locked device, will be as good as or better than standard nonlocking bicortical fixation in distal femoral fractures. Institutional review board-approved, multicenter prospective randomized controlled trial. Seven level 1 trauma centers across Canada. Fifty-two patients with distal femoral fractures (AO/OTA 33A1 to 33C2) were enrolled in the randomized trial. Twelve AO/OTA 33C3 fractures were excluded from the randomized trial but followed up as a nonrandomized cohort. Patients were treated through a standardized minimally invasive approach. Fractures were randomized 1:1 to treatment with the locked Less Invasive Stabilization System (LISS; Synthes, Paoli, PA) or the dynamic condylar screw (DCS). The nonrandomized cohort was treated at the surgeon's discretion. Primary outcomes were time to radiological union and number of delayed/nonunions at 12 months. Secondary outcomes were postoperative function and complications. Fifty-two patients were randomized including 34 women and 18 men. The mean age was 59 years. Twenty-eight patients were treated with the LISS and 24 with the DCS. There was no statistically significant difference between the LISS and the DCS in terms of the number of fractures healed, time to union, or functional scores. Complications and revisions were more common in the LISS group. There were 7 reoperations in the LISS group and one in the DCS group. Only 52% of the LISS group healed without intervention by 12 months compared with 91% in the DCS group. There was no advantage to the locking plate design in the management of distal femoral fractures in this study. The higher cost of the locking plates, challenges in technique, and lack of superiority have led the authors to discontinue the use of this lateral unicortical locking device in favor of other devices that allow locked or nonlocked bicortical fixation, articular compression, and bridging of the comminuted fracture segments. The cost-effective treatment for a subgroup or periarticular fractures may be a fixed-angle nonlocked device in patients with reasonable bone quality. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

International, prospective haemovigilance study on methylene blue-treated plasma.

PubMed

Noens, L; Vilariño, Ma D; Megalou, A; Qureshi, H

2017-05-01

Methylene blue is a phenothiazine dye, which in combination with visible light has virucidal and bactericidal properties, disrupting the replication of a broad range of enveloped viruses and some non-enveloped viruses. The study objective was to collect data on adverse reactions occurring with methylene blue plasma administered in a routine clinical practice environment and document their characteristics and severity. This was an open label, multicentre, non-controlled, non-randomized, non-interventional study. Patients who receive a methylene blue plasma transfusion were observed for any signs and symptoms (adverse reactions) within 24 h safter the start of the transfusion, in different hospitals for a study duration of at least 1 year. A total of 19 315 methylene blue plasma units were transfused. There were eight patients with adverse reactions recorded during the study, one of them serious. Two had more than one reaction (two and four, respectively). Three patients had previous transfusions with methylene blue plasma only. Methylene blue plasma has a very acceptable safety profile with a rate of serious adverse reactions of 0·5/10 000 units. © 2017 International Society of Blood Transfusion.

BeGraft Peripheral PMCF Study: 12-month results.

PubMed

Deloose, Koen; Bosiers, Marc; Callaert, Joren; Peeters, Patrick; Verbist, Jurgen; van den Eynde, Wouter; Maene, Lieven; Beelen, Roel; Keirse, Koen

2017-05-26

The Begraft Peripheral PMCF study is a prospective, non-randomized study, conducted at the vascular departments of 4 hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months. Between June 2014 and March 2015, 70 patients with TASC II Class A (77.1%), B (14.3%), C (5.7%) or D (2.9%) aortoiliac lesions were included. The mean lesion length was 34.3mm with a mean degree of stenosis of 83.16%. Primary patency rate for the total patient population was 94.4% at 12-month follow-up. Freedom from TLR at 12-month was 96.7%. These results confirm the already existing enthusiasm of the use of covered stents in the aorto-iliac field. Longer follow-up and more complex lesions have to be studies in the upcoming future.

A study to compare the efficacy of corticosteroid therapy with platelet-rich plasma therapy in recalcitrant plantar fasciitis: a preliminary report.

PubMed

Shetty, Vijay D; Dhillon, Mandeep; Hegde, Chintan; Jagtap, Prajyot; Shetty, Suvin

2014-03-01

Plantar fasciitis is one of the commonest, and most frustrating, foot ailments seen in a regular orthopaedic clinic. There are a number of modalities available to treat this condition, of which corticosteroid injection is, perhaps, the most popular. However, recent years have seen an increased interest in the use of platelet-rich plasma (PRP) injections in various clinical situations such as plantar fasciitis. We undertook a prospective non-randomized study to compare the efficacy of traditional corticosteroid injection (Steroid group) to PRP injection (PRP group), in a cohort of patients. We studied both groups of patients before and after the injections using Visual Analogue Score (VAS), the Foot & Ankle Disability Index (FADI) and American Foot and Ankle Score (AFAS). Our study confirms that there is significant clinical improvement in PRP group at three months after the injection. The use of PRP injection can be an attractive alternative in the treatment of disabling, recalcitrant plantar fasciitis. Cohort study. Level 3. Copyright © 2013 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

Prospective cohort studies of newly marketed medications: using covariate data to inform the design of large-scale studies.

PubMed

Franklin, Jessica M; Rassen, Jeremy A; Bartels, Dorothee B; Schneeweiss, Sebastian

2014-01-01

Nonrandomized safety and effectiveness studies are often initiated immediately after the approval of a new medication, but patients prescribed the new medication during this period may be substantially different from those receiving an existing comparator treatment. Restricting the study to comparable patients after data have been collected is inefficient in prospective studies with primary collection of outcomes. We discuss design and methods for evaluating covariate data to assess the comparability of treatment groups, identify patient subgroups that are not comparable, and decide when to transition to a large-scale comparative study. We demonstrate methods in an example study comparing Cox-2 inhibitors during their postmarketing period (1999-2005) with nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). Graphical checks of propensity score distributions in each treatment group showed substantial problems with overlap in the initial cohorts. In the first half of 1999, >40% of patients were in the region of nonoverlap on the propensity score, and across the study period this fraction never dropped below 10% (the a priori decision threshold for transitioning to the large-scale study). After restricting to patients with no prior NSAID use, <1% of patients were in the region of nonoverlap, indicating that a large-scale study could be initiated in this subgroup and few patients would need to be trimmed from analysis. A sequential study design that uses pilot data to evaluate treatment selection can guide the efficient design of large-scale outcome studies with primary data collection by focusing on comparable patients.

Albumin in Burn Shock Resuscitation: A Meta-Analysis of Controlled Clinical Studies.

PubMed

Navickis, Roberta J; Greenhalgh, David G; Wilkes, Mahlon M

2016-01-01

Critical appraisal of outcomes after burn shock resuscitation with albumin has previously been restricted to small relatively old randomized trials, some with high risk of bias. Extensive recent data from nonrandomized studies assessing the use of albumin can potentially reduce bias and add precision. The objective of this meta-analysis was to determine the effect of burn shock resuscitation with albumin on mortality and morbidity in adult patients. Randomized and nonrandomized controlled clinical studies evaluating mortality and morbidity in adult patients receiving albumin for burn shock resuscitation were identified by multiple methods, including computer database searches and examination of journal contents and reference lists. Extracted data were quantitatively combined by random-effects meta-analysis. Four randomized and four nonrandomized studies with 688 total adult patients were included. Treatment effects did not differ significantly between the included randomized and nonrandomized studies. Albumin infusion during the first 24 hours showed no significant overall effect on mortality. However, significant statistical heterogeneity was present, which could be abolished by excluding two studies at high risk of bias. After those exclusions, albumin infusion was associated with reduced mortality. The pooled odds ratio was 0.34 with a 95% confidence interval of 0.19 to 0.58 (P < .001). Albumin administration was also accompanied by decreased occurrence of compartment syndrome (pooled odds ratio, 0.19; 95% confidence interval, 0.07-0.50; P < .001). This meta-analysis suggests that albumin can improve outcomes of burn shock resuscitation. However, the scope and quality of current evidence are limited, and additional trials are needed.

A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study.

PubMed

Ielasi, Alfonso; Varricchio, Attilio; Campo, Gianluca; Leoncini, Massimo; Cortese, Bernardo; Vicinelli, Paolo; Brugaletta, Salvatore; di Uccio, Fortunato Scotto; Latib, Azeem; Tespili, Maurizio

2017-06-01

To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients. Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events. This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781. The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up. This will be the first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Per-Oral Endoscopic Myotomy Versus Laparoscopic Heller Myotomy for Achalasia: A Meta-Analysis of Nonrandomized Comparative Studies.

PubMed

Zhang, Yuan; Wang, Hongjuan; Chen, Xingdong; Liu, Lan; Wang, Hongbo; Liu, Bin; Guo, Jianqiang; Jia, Hongying

2016-02-01

We aimed to assess the short-term outcomes of per-oral endoscopic myotomy (POEM) compared with laparoscopic Heller myotomy (LHM) for achalasia through a meta-analysis of nonrandomized comparative studies.We searched PubMed, Embase, Medline, Cochrane Library, and Google Scholar for studies that compared POEM and LHM for achalasia and were published between January 1, 2008 and December 31, 2014. The Methodological Index for Nonrandomized Studies (MINORS) was used to evaluate the quality of the studies. Random- and fixed-effects meta-analytical models were used, and between-study heterogeneity was assessed.Four nonrandomized comparative studies that included 317 patients (125 in the POEM group and 192 in the LHM group) met our research criteria and were assessed. There were no differences between the POEM and LHM groups in terms of sex, preoperative Eckhart score, length of myotomy, operation time, length of hospital stay, and complications. The patients in the POEM group were older than those in the LHM group (MD =2.81, 95% CI 0.27-5.35; P = 0.03) with high between-study homogeneity (χ = 1.96, df = 2, I = 0%; P = 0.38). The patients in the POEM group had a lower Eckardt score after surgery compared with those in the LHM group (MD = -0.30, 95% CI -0.42 to -0.18; P < 0.001) with high between-study homogeneity (χ = 0.00, df = 1, I = 0%; P = 1.00).The efficacy and safety of POEM appear to be comparable to those of LHM. Multicenter and randomized trials with larger sample size are needed to further compare the efficacy and safety of POEM and LHM for the treatment of achalasia.

Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: design and rationale of the ROADMAP clinical trial.

PubMed

Rogers, Joseph G; Boyle, Andrew J; O'Connell, John B; Horstmanshof, Douglas A; Haas, Donald C; Slaughter, Mark S; Park, Soon J; Farrar, David J; Starling, Randall C

2015-02-01

Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy. Copyright © 2014 Elsevier Inc. All rights reserved.

Nurse-physician collaboration impacts job satisfaction and turnover among nurses: A hospital-based cross-sectional study in Beijing.

PubMed

Zhang, Lin; Huang, Lei; Liu, Meng; Yan, Hong; Li, Xiue

2016-06-01

This study aims to explore the impact of physician-nurse collaboration on nurse job satisfaction and turnover in a dental hospital. Physician-nurse collaboration is important for the stability of the entire nursing team. Few studies have shown the impact on job satisfaction and turnover among nurses working in Chinese dental hospitals. This was a prospective, cross-sectional study and investigated nurses from a tertiary dental hospital in Beijing using convenience non-randomized sampling. A structured questionnaire was used to collect data, which included general information, the Index of Work Satisfaction, the Nurse-Physician Collaboration Scale and the Turnover Intention Scale. The scores of physician-nurse collaboration correlated positively with those for job satisfaction and negatively with the stated likelihood of turnover intention. Physician-nurse collaboration scores positively predicted job satisfaction and negatively predicted the likelihood of quitting the current job. In conclusion, improving the level of physician-nurse collaboration is helpful to enhance job satisfaction and reduce turnover among nurses in a dental hospital. © 2016 John Wiley & Sons Australia, Ltd.

Implications of nonrandom seed abscission and global stilling for migration of wind-dispersed plant species.

PubMed

Thompson, Sally E; Katul, Gabriel G

2013-06-01

Migration of plant populations is a potential survival response to climate change that depends critically on seed dispersal. Biological and physical factors determine dispersal and migration of wind-dispersed species. Recent field and wind tunnel studies demonstrate biological adaptations that bias seed release toward conditions of higher wind velocity, promoting longer dispersal distances and faster migration. However, another suite of international studies also recently highlighted a global decrease in near-surface wind speeds, or 'global stilling'. This study assessed the implications of both factors on potential plant population migration rates, using a mechanistic modeling framework. Nonrandom abscission was investigated using models of three seed release mechanisms: (i) a simple drag model; (ii) a seed deflection model; and (iii) a 'wear and tear' model. The models generated a single functional relationship between the frequency of seed release and statistics of the near-surface wind environment, independent of the abscission mechanism. An Inertial-Particle, Coupled Eulerian-Lagrangian Closure model (IP-CELC) was used to investigate abscission effects on seed dispersal kernels and plant population migration rates under contemporary and potential future wind conditions (based on reported global stilling trends). The results confirm that nonrandom seed abscission increased dispersal distances, particularly for light seeds. The increases were mitigated by two physical feedbacks: (i) although nonrandom abscission increased the initial acceleration of seeds from rest, the sensitivity of the seed dispersal to this initial condition declined as the wind speed increased; and (ii) while nonrandom abscission increased the mean dispersal length, it reduced the kurtosis of seasonal dispersal kernels, and thus the chance of long-distance dispersal. Wind stilling greatly reduced the modeled migration rates under biased seed release conditions. Thus, species that require high wind velocities for seed abscission could experience threshold-like reductions in dispersal and migration potential if near-surface wind speeds continue to decline. © 2013 Blackwell Publishing Ltd.

Assessing the Status of Wild Felids in a Highly-Disturbed Commercial Forest Reserve in Borneo and the Implications for Camera Trap Survey Design

PubMed Central

Wearn, Oliver R.; Rowcliffe, J. Marcus; Carbone, Chris; Bernard, Henry; Ewers, Robert M.

2013-01-01

The proliferation of camera-trapping studies has led to a spate of extensions in the known distributions of many wild cat species, not least in Borneo. However, we still do not have a clear picture of the spatial patterns of felid abundance in Southeast Asia, particularly with respect to the large areas of highly-disturbed habitat. An important obstacle to increasing the usefulness of camera trap data is the widespread practice of setting cameras at non-random locations. Non-random deployment interacts with non-random space-use by animals, causing biases in our inferences about relative abundance from detection frequencies alone. This may be a particular problem if surveys do not adequately sample the full range of habitat features present in a study region. Using camera-trapping records and incidental sightings from the Kalabakan Forest Reserve, Sabah, Malaysian Borneo, we aimed to assess the relative abundance of felid species in highly-disturbed forest, as well as investigate felid space-use and the potential for biases resulting from non-random sampling. Although the area has been intensively logged over three decades, it was found to still retain the full complement of Bornean felids, including the bay cat Pardofelis badia, a poorly known Bornean endemic. Camera-trapping using strictly random locations detected four of the five Bornean felid species and revealed inter- and intra-specific differences in space-use. We compare our results with an extensive dataset of >1,200 felid records from previous camera-trapping studies and show that the relative abundance of the bay cat, in particular, may have previously been underestimated due to the use of non-random survey locations. Further surveys for this species using random locations will be crucial in determining its conservation status. We advocate the more wide-spread use of random survey locations in future camera-trapping surveys in order to increase the robustness and generality of inferences that can be made. PMID:24223717

Nutritional Recovery after Open and Laparoscopic Distal Gastrectomy for Early Gastric Cancer: A Prospective Multicenter Comparative Trial (CCOG1204).

PubMed

Matsushita, Hidenobu; Tanaka, Chie; Murotani, Kenta; Misawa, Kazunari; Ito, Seiji; Ito, Yuichi; Kanda, Mitsuro; Mochizuki, Yoshinari; Ishigure, Kiyoshi; Yaguchi, Toyohisa; Teramoto, Jin; Nakayama, Hiroshi; Kawase, Yoshihisa; Fujiwara, Michitaka; Kodera, Yasuhiro

2018-01-01

Little information from prospective clinical trials is available on the influences of surgical approaches on postoperative body compositions and nutritional status. We designed a prospective non-randomized trial to compare postoperative chronological changes in body composition and nutritional status between laparoscopic and open distal gastrectomy for stage I gastric cancer (GC). Body compositions and nutritional indicators in blood tests were measured at the baseline and at the 1st, 3rd, 6th, and 12th postoperative months (POM). The primary end point was the decrease relative to the baseline in the body muscle mass at POM 6. Ninety-six patients for the laparoscopic group and 52 for the open group were eligible for data analysis. No significant differences were found in any baseline demographics, body compositions, and nutritional indicators between the groups. The changes of body muscle mass at POM 6 were similar in both groups. Overall, no significant differences between the groups were observed in any of the body composition and nutritional indicators during the first year after surgery. Postoperative body compositions and nutritional status were not affected by surgical approaches during the first 12 months after surgery in patients who underwent distal gastrectomy for stage I GC. © 2017 S. Karger AG, Basel.

Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: new directions and interventions.

PubMed

Wetzel, F Todd; McNally, Thomas A; Phillips, Frank M

2002-11-15

Retrospective literature review. To review the data on the clinical efficacy of intradiscal electrothermal annuloplasty found at this writing in the peer-reviewed literature to date, to discuss the methodologic strengths and flaws of the studies, to discuss the pitfalls of clinical study designs, to emphasize the need for prospective randomized studies and for increased basic science investigation. Studies published or presented at peer-reviewed societies concerning the clinical efficacy of intradiscal electrothermal annuloplasty are reviewed, including background studies on deafferentation and application of thermal energy to alter biomechanical and structural properties. A proposal for future investigations is presented. Background data from intracapsular annuloplasty highlighting the safety and efficacy of intradiscal electrothermal annuloplasty are presented. Current studies on this procedure, including those in the National Registry are reviewed. All the studies share a common study design: prospective cohort with historical or noninterventional groups used as controls. The patients reviewed are similar. All have nonradicular low back pain of at least 3 months duration, failed conservative care, normal neurologic examination, and MRI showing only nondegenerative disc disease and positive concordant discography. All the patients underwent intradiscal electrothermal annuloplasty lesion at one or two levels according to standard protocols. Follow-up evaluation was performed at various intervals up to 2 years. All the studies used data from a visual analog scale, with most using the Short Form 36 (SF-36) as outcome instruments. The reported follow-up periods for the studies ranged from 6 months to 2 years. Three published studies, one with a 6-month follow-up period and two with a 1-year follow-up period, were published in the peer-reviewed literature. Two recent reports presented to the North American Spine Society were reviewed: a study of patients on a manufacturer-sponsored registry with a 1-year follow-up period and a multicenter prospective cohort study of 75 patients in an intent-to-treat group, with a 1-year follow-up period. Using the 7-point criteria of Deyo et al, all the studies suggested a positive effect of treatment, with a decrease in visual analog scale ratings and improvement in SF-36 scales, particularly those for physical function and bodily pain. The studies published so far suggest that the pain resulting from lumbar disc disease may be diminished by intradiscal electrothermal annuloplasty. All these studies project a positive therapeutic effect. However, all the studies suffer from the same methodologic flaws. A prospective cohort design or a nonrandomized prospective design is used with a biased control. The scientific validity of various study designs is discussed, and a randomized prospective study is recommended. Additionally, more investigation into the basic science of the action of intradiscal electrothermal annuloplasty is required.

A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis.

PubMed

Glaser, Dee Anna; Pariser, David M; Hebert, Adelaide A; Landells, Ian; Somogyi, Chris; Weng, Emily; Brin, Mitchell F; Beddingfield, Frederick

2015-01-01

To evaluate the efficacy and safety of onabotulinumtoxinA in adolescents with primary axillary hyperhidrosis. This 52-week, multicenter, nonrandomized, open-label study was conducted in 141 adolescents ages 12 to 17 years with severe primary axillary hyperhidrosis. Patients could receive up to six treatments with onabotulinumtoxinA (50 U per axilla), with re-treatment occurring no sooner than 8 weeks after the prior treatment cycle and no later than 44 weeks after the initial treatment cycle. The primary efficacy measure was treatment response, based on self-assessed hyperhidrosis severity following the first two treatments using the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Other efficacy measures included spontaneous resting sweat production and health outcomes. Fifty-six (38.9%) participants underwent one treatment, 59 (41.0%) underwent two, 20 (13.9%) underwent three, 6 (4.2%) underwent four, and 3 (2.1%) underwent five. OnabotulinumtoxinA significantly improved HDSS scores and decreased sweat production compared with treatment cycle baselines. Seventy-nine patients (54.9%) responded to treatment based on HDSS criteria. From 56.6% to 72.3% of patients experienced a two-grade or more improvement at 4 and 8 weeks after each of the first two treatments. The majority (79.4%-93.2%) had a 75% or greater reduction in sweat production at week 4 (treatments 1-3). The median duration of effect for responders ranged from 134 to 152 days. Using quality of life measures, health outcomes improved markedly. Eight patients (5.6%) had mild or moderate treatment-related adverse events. No unexpected safety signals were observed in this study. Neutralizing antibodies to onabotulinumtoxinA did not develop. OnabotulinumtoxinA injections provided beneficial effects in adolescents with primary axillary hyperhidrosis. © 2015 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.

A nonrandomized comparison of the thulium laser and the CO2 laser in primary stapedotomy for otosclerosis.

PubMed

Kamalski, Digna M A; Vincent, Robert; Wegner, Inge; Bittermann, Arnold J N; Grolman, Wilko

2014-12-01

Comparing hearing results in patients with otosclerosis treated with laser-assisted stapedotomy using the 2-μm thulium laser or the CO2 laser. Prospective nonrandomized clinical study. In a tertiary referral center in France (Jean Causse Ear Clinic, Béziers), 208 primary stapedotomies were performed in 204 patients between March 2008 and November 2009. Sufficient follow-up data were available for 194 procedures. The fenestration in the footplate was made with the thulium laser in 98 procedures and with a flexible CO2 laser in 96 procedures. Preoperative and postoperative audiometric results were compared. Side effects, such as vertigo and tinnitus, were scored. Patients treated with the CO2 laser had better hearing outcome compared with those treated with the thulium laser at both 3 and 12 months of follow-up. At 3 months, the success of the surgery, defined as closure of the air-bone gap to within 10 dB, was 90.0% in the thulium group compared with 96.8% in the CO2 group. Bone conduction shift showed an overall deterioration of 1.6 dB (standard deviation, 6.9 dB) in the thulium group compared with an improvement of 1.3 dB (standard deviation, 4 dB) in the CO2 group. In the thulium group, there were four patients with sensorineural hearing loss (4.4%) and three with tinnitus (3.1%) compared with none in the CO2 group. Stapedotomy surgery performed with a fiber-delivered thulium laser resulted in a higher chance of inner ear damage measured by bone conduction shift compared with the use of a fiber-delivered CO2 laser. We advise not to use the thulium laser for stapedotomy.

[Non-palpable testicular tumors in adults: A management based on imaging? Issue from the French Urologic Association Genital Cancer committee's edit].

PubMed

Rocher, L; Feretti, L; Camparo, P; Savoie, P H; Morel-Journel, N; Murez, T; Sebe, P; Flechon, A; Méjean, A; Durand, X

2018-04-09

Help in management of non-palpable testicular tumors. French Urologic Association Genital cancer committee's Edit. To review their characterization at imaging findings of non-palpable testicular tumors. Literature review (PubMed, Medline) of urological and radiological studies dealing with testicular tumors using keywords: non-palpable/incidental testicular tumors; color Doppler ultrasound; US elastography; magnetic resonance imaging; contrast enhanced sonography; partial surgery. Color Doppler is the basic exam. The size, the presence of microlithts/microlithiasis/macrocalcifications, the vascular architecture are major semiological findings to suggest the benign or the malignant nature of the lesion. Other techniques like multiparametric MRI, contrast-enhanced sonography, sonographic elastography are still in evaluation. The frequency of benign tumors such as Leydig cell tumors lead to preservation management, through improved characterization, monitoring or tumorectomy. Non-randomized study - a very few prospective studies. The era of total orchiectomy for any uncertain testicular lesion is over. We try the challenge of characterization, and define management's algorithms based on the suspected nature of the tumors. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

A systematic review of yoga for state anxiety: considerations for occupational therapy.

PubMed

Chugh-Gupta, Neha; Baldassarre, Fulvia G; Vrkljan, Brenda H

2013-06-01

State anxiety can result from a variety of life situations. This type of anxiety can disrupt occupational engagement and performance, thereby affecting rehabilitation and recovery. Occupational therapists need to address the connection between mind-body-spirit and its relationship to performance and engagement in meaningful occupations. Yoga, when used as an adjunct to therapy, has the potential to address state anxiety. The aim was to systematically review the evidence concerning the effectiveness of yoga as a treatment approach for state anxiety. Six electronic databases, the authors' own files, and the references of included studies from 1990 to July 2011 were searched. A total of 25 unique studies represented by 26 publications made up the sample: two systematic reviews; 16 randomized controlled trials, and seven prospective, controlled, non-randomized studies. Evidence suggests yoga can be a viable therapeutic option for reducing state anxiety in certain situations. In making the determination to recommend yoga as an intervention, occupational therapists should consider the client's circumstances and values as well as the type and intensity of the yoga program.

The usefulness of lean six sigma to the development of a clinical pathway for hip fractures.

PubMed

Niemeijer, Gerard C; Flikweert, Elvira; Trip, Albert; Does, Ronald J M M; Ahaus, Kees T B; Boot, Anja F; Wendt, Klaus W

2013-10-01

The objective of this study was to show the usefulness of lean six sigma (LSS) for the development of a multidisciplinary clinical pathway. A single centre, both retrospective and prospective, non-randomized controlled study design was used to identify the variables of a prolonged length of stay (LOS) for hip fractures in the elderly and to measure the effect of the process improvements--with the aim of improving efficiency of care and reducing the LOS. The project identified several variables influencing LOS, and interventions were designed to improve the process of care. Significant results were achieved by reducing both the average LOS by 4.2 days (-31%) and the average duration of surgery by 57 minutes (-36%). The average LOS of patients discharged to a nursing home reduced by 4.4 days. The findings of this study show a successful application of LSS methodology within the development of a clinical pathway. Further research is needed to explore the effect of the use of LSS methodology at clinical outcome and quality of life. © 2012 John Wiley & Sons Ltd.

Systematic Review and Meta-Analysis of Extraperitoneal Versus Transperitoneal Colostomy for Preventing Parastomal Hernia.

PubMed

Kroese, Leonard F; de Smet, Gijs H J; Jeekel, Johannes; Kleinrensink, Gert-Jan; Lange, Johan F

2016-07-01

Parastomal hernia remains a frequent problem after constructing a colostomy. Current research mainly focuses on prophylactic mesh placement as an addition to transperitoneal colostomies. However, for constructing a colostomy, either an extraperitoneal or transperitoneal route can be chosen. The aim of this meta-analysis was to investigate which technique results in lower parastomal hernia rates in patients undergoing end colostomy. A meta-analysis was conducted according to Preferred Items for Reporting of Systematic Reviews and Meta-Analyses and Meta-Analysis of Observational Studies in Epidemiology guidelines. Embase, MEDLINE, Web of Science, Scopus, Cumulative Index to Nursing and Allied Health Literature, Cochrane, PubMed, and Google Scholar databases were searched. The study protocol was registered in the International Prospective Register of Systematic Reviews database. Studies comparing extraperitoneal and transperitoneal colostomies were included. Only studies written in English were included. The quality of studies and risk of bias were assessed using the Cochrane risk-of-bias tool. The quality of nonrandomized studies was assessed using the Newcastle-Ottawa Scale. The intervention was colostomy formation. The main outcome measure was parastomal hernia incidence. Secondary outcome measures were stoma prolapse, stoma necrosis, and operating time. Of 401 articles found, a meta-analysis was conducted of 10 studies (2 randomized controlled trials and 8 retrospective studies) composed of 1048 patients (347 extraperitoneal and 701 transperitoneal). Extraperitoneal colostomy led to significantly lower parastomal hernia rates (22 of 347 (6.3%) for extraperitoneal versus 125 of 701 (17.8%) for transperitoneal; risk ratio = 0.36 (95% CI, 0.21-0.62); I = 26%; p < 0.001) and significantly lower stoma prolapse rates (2 of 185 (1.1%) for extraperitoneal versus 13 of 179 (7.3%) for transperitoneal; risk ratio = 0.21 (95% CI, 0.06-0.73); I = 0%; p = 0.01). Differences in stoma necrosis were not significant. Operating time data were insufficient to analyze. Most of the studies were nonrandomized, and some were not recent publications. Although the majority of studies included were retrospective, extraperitoneal colostomy was observed to lead to a lower rate of parastomal hernia and stoma prolapse.

A comparison of the in vivo neoendothelialization and wound healing processes of three atrial septal defect occluders used during childhood in a nonrandomized prospective trial

PubMed Central

Şahin, Derya Aydın; Başpınar, Osman; Sülü, Ayşe; Karslıgil, Tekin; Kul, Seval

2017-01-01

Objective: We prospectively investigated the neoendothelialization of transcatheter secundum atrial septal defect (ASD) closure in children receiving one of three different occluders. Methods: Transcatheter ASD closure was performed for 44 children. The patients were divided into three groups: group I: Amplatzer, group II: Lifetech CeraFlex, and group III: Occlutech Figulla Flex II septal occluder. The data were prospectively analyzed. Markers of the three phases of wound healing were studied in all patients before and on the 1st and 10th days and 1st month post intervention. Results: The mean age of children was 7.08±3.51 years, and the mean weight was 26.07±15.07 kg. The mean ASD diameter was 12.65±3.50 mm. Groups I, II, and III comprised 34.1%, 31.8%, and 34.1% patients, respectively. No significant differences were observed between the groups regarding patient number, age, defect size, device diameter, or total septum/device ratio (p>0.05). Inflammatory and proliferative phase marker levels increased following the procedure (p<0.05). However, scar formation markers did not change after 1 month. No significant differences in neoendothelializaton were observed among the different occluders (p>0.05). Conclusion: All three devices were composed of nitinol with different surface coating techniques. Although the different manufacturing features were claimed to facilitate of neoendothelialization, no differences were observed among the three devices 1 month following the procedure. PMID:28761023

The role of the therapeutic alliance on pain relief in musculoskeletal rehabilitation: A systematic review.

PubMed

Taccolini Manzoni, Ana Carolina; Bastos de Oliveira, Naiane Teixeira; Nunes Cabral, Cristina Maria; Aquaroni Ricci, Natalia

2018-02-05

The aim of this systematic review was to investigate the role of therapeutic alliance in pain relief in patients with musculoskeletal disorders treated by physiotherapy. Manual and database searches (Medline, Embase, ISI Web of Knowledge, CINAHL, PEDro, Lilacs, Cochrane Library, and PsycINFO) were performed with no restrictions of language and publication date. We included prospective studies with samples of patients undergoing physiotherapy for musculoskeletal conditions, with one measure of therapeutic alliance and the outcome pain. Methodological quality was assessed by the Methodological Index for Nonrandomized Studies and the Cochrane tool for risk of bias. Six articles from four studies were included out of the 936 manuscripts identified. All studies used samples composed of patients with chronic low back pain. Two studies applied therapeutic alliance incentive measures during treatment and reported significant improvement in pain. The remaining studies, without alliance incentives, showed divergence regarding the relationship between the therapeutic alliance and pain. Methodological quality analysis determined low risk of bias of the studies. A lack of studies on the therapeutic alliance regarding musculoskeletal physiotherapy was verified. Existing studies fail to provide evidence of a strong relationship between the therapeutic alliance and pain relief.

It is important to note that RWD will never replace the more traditional and more robust RCT data; however, the emerging trend is to incorporate data that are more generalizable. Introduction.

PubMed

Mullins, C Daniel; Sanchez, Robert J

2011-01-01

The Patient Protection and Affordable Care Act brought considerable attention to comparative effectiveness research (CER).   To (a) suggest best practices for conducting and reporting CER using "real-world data" (RWD), (b) describe some of the data and infrastructure requirements for conducting CER using RWD, (c) identify statistical challenges with the analysis of nonrandomized studies and suggest appropriate techniques to address those challenges, (d) recognize the value of patient-reported outcomes in CER, (e) encourage the incorporation of observational data into randomized controlled studies, and (f) highlight the importance of incorporating payers in industry-sponsored research.  The first article in this supplement, "Something old, something new…" provides a policy perspective on the recent evolution of CER. It reviews the historical context, discusses the "promise and fear" of CER, and then describes the new role of the Patient-Centered Outcomes Research Institute (PCORI) in defining and sponsoring CER. The second paper, "Ten Commandments," proposes a series of tenets for planning, conducting, and reporting CER done with RWD. Oriented for basic-to-intermediate researchers, it combines standard scientific research principles with considerations specific to nonrandomized, RWD studies. The third article, "Infrastructure Requirements," points out that effective use of secondary data requires addressing major methodological and infrastructural issues, including development of analytical tools to readily access and analyze data, formulation of guidelines to enhance quality and transparency, establishment of data standards, and creation of data warehouses that respect the privacy and confidentiality of patients. It identifies gaps that must be filled to address the underlying issues, with emphasis on data standards, data quality assurance, data warehouses, computing environment, and protection of privacy and confidentiality. The fourth paper, "Statistical Issues," discusses how the validity of analytic results from observational studies is adversely impacted by biases that may be introduced due to lack of randomization. It reviews some of the methodological challenges that arise in the analysis of data from nonrandomized studies, with particular emphasis on the limitations of traditional approaches and potential solutions from recent methodological developments. The fifth paper, "Considerations on the Use of Patient Reported Outcomes (PROs)," describes how PRO data can play a critical role in guiding patients, health care providers, payers, and policy makers in making informed decisions regarding patient-centered treatment from among alternative options and technologies and have been noted as such by PCORI. However, collection and interpretation of such data within the context of CER have not yet been fully established. It discusses some challenges with including PROs in CER initiatives, provides a framework for their effective use, and proposes several areas for future research. Lastly, "Developing a Collaborative Study Protocol…" indicates that there is the potential, the desire, and the capability for payers to be involved in CER studies, combining elements of their own observational data with prospective studies. It describes a case example of a payer, a pharmaceutical company, and a research organization collaborating on a prospective study to examine the effect of prior authorization for pregabalin on health care costs to the payer.   Researchers at Pfizer routinely conduct CER-type studies. In this supplement, we have proposed some approaches that we believe are useful in developing certain kinds of evidence and have described some of our experiences. Our experiences also make us acutely aware of the limitations of approaches and data sources that have been used for CER studies and suggest that there is a need to further develop methods that are most useful for answering CER questions.

Renormalization-group study of superfluidity and phase separation of helium mixtures immersed in a nonrandom aerogel

NASA Astrophysics Data System (ADS)

Lopatnikova, Anna; Nihat Berker, A.

1997-02-01

Superfluidity and phase separation in 3-4He mixtures immersed in a jungle-gym (nonrandom) aerogel are studied by renormalization-group theory. Phase diagrams are calculated for a variety of aerogel concentrations. Superfluidity at very low 4He concentrations and a depressed tricritical temperature are found at the onset of superfluidity. A superfluid-superfluid phase separation, terminating at an isolated critical point, is found entirely within the superfluid phase. These phenomena and trends with respect to aerogel concentration are explained by the connectivity and tenuousness of a jungle-gym aerogel.

Hysterectomy for complications after uterine artery embolization for leiomyoma: results of a Canadian multicenter clinical trial.

PubMed

Pron, Gaylene; Mocarski, Eva; Cohen, Marsha; Colgan, Terence; Bennett, John; Common, Andrew; Vilos, George; Kung, Rose

2003-02-01

To determine the complication-related hysterectomy rate after uterine artery embolization (UAE) for symptomatic uterine leiomyomas. Prospective, multicenter, nonrandomized, single-arm clinical trial (Canadian Task Force classification II-2). Eight Ontario University-affiliated teaching and community hospitals. Five hundred fifty-five women. Polyvinyl alcohol particles were delivered through a catheter into uterine arteries under fluoroscopic guidance. Prospective follow-up investigations consisted of telephone interviews, ultrasound examinations, and reviews of pathology and surgery reports. Median follow-up was 8.1 months, and all but five patients had complete 3-month follow-up. At 3 months, eight women (1.5%, 95% CI 0.6-2.8) underwent complication-related hysterectomy. Half of the surgeries were performed at institutions other than where UAE had been performed. Indications for hysterectomies were infections (2), postembolization pain (4), vaginal bleeding (1), and prolapsed leiomyoma (1). The 3-month complication rate resulting in hysterectomy after UAE in a large cohort of women was low. Hysterectomy after UAE is an important measure of safety and a key outcome measure of this new therapy.

Complex Atheromatosis of the Aortic Arch in Cerebral Infarction

PubMed Central

Capmany, Ramón Pujadas; Ibañez, Montserrat Oliveras; Pesquer, Xavier Jané

2010-01-01

In many stroke patients it is not possible to establish the etiology of stroke. However, in the last two decades, the use of transesophageal echocardiography in patients with stroke of uncertain etiology reveals atherosclerotic plaques in the aortic arch, which often protrude into the lumen and have mobile components in a high percentage of cases. Several autopsy series and retrospective studies of cases and controls have shown an association between aortic arch atheroma and arterial embolism, which was later confirmed by prospectively designed studies. The association with ischemic stroke was particularly strong when atheromas were located proximal to the ostium of the left subclavian artery, when the plaque was ≥ 4 mm thick and particularly when mobile components are present. In these cases, aspirin might not prevent adequately new arterial ischemic events especially stroke. Here we review the evidence of aortic arch atheroma as an independent risk factor for stroke and arterial embolism, including clinical and pathological data on atherosclerosis of the thoracic aorta as an embolic source. In addition, the impact of complex plaques (≥ 4 mm thick, or with mobile components) on increasing the risk of stroke is also reviewed. In non-randomized retrospective studies anticoagulation was superior to antiplatelet therapy in patients with stroke and aortic arch plaques with mobile components. In a retrospective case-control study, statins significantly reduced the relative risk of new vascular events. However, given the limited data available and its retrospective nature, randomized prospective studies are needed to establish the optimal secondary prevention therapeutic regimens in these high risk patients. PMID:21804777

Complex atheromatosis of the aortic arch in cerebral infarction.

PubMed

Capmany, Ramón Pujadas; Ibañez, Montserrat Oliveras; Pesquer, Xavier Jané

2010-08-01

In many stroke patients it is not possible to establish the etiology of stroke. However, in the last two decades, the use of transesophageal echocardiography in patients with stroke of uncertain etiology reveals atherosclerotic plaques in the aortic arch, which often protrude into the lumen and have mobile components in a high percentage of cases. Several autopsy series and retrospective studies of cases and controls have shown an association between aortic arch atheroma and arterial embolism, which was later confirmed by prospectively designed studies. The association with ischemic stroke was particularly strong when atheromas were located proximal to the ostium of the left subclavian artery, when the plaque was ≥ 4 mm thick and particularly when mobile components are present. In these cases, aspirin might not prevent adequately new arterial ischemic events especially stroke. Here we review the evidence of aortic arch atheroma as an independent risk factor for stroke and arterial embolism, including clinical and pathological data on atherosclerosis of the thoracic aorta as an embolic source. In addition, the impact of complex plaques (≥ 4 mm thick, or with mobile components) on increasing the risk of stroke is also reviewed. In non-randomized retrospective studies anticoagulation was superior to antiplatelet therapy in patients with stroke and aortic arch plaques with mobile components. In a retrospective case-control study, statins significantly reduced the relative risk of new vascular events. However, given the limited data available and its retrospective nature, randomized prospective studies are needed to establish the optimal secondary prevention therapeutic regimens in these high risk patients.

Novel robotic catheter manipulation system integrated with remote magnetic navigation for fully remote ablation of atrial tachyarrhythmias: a two-centre evaluation.

PubMed

Nölker, Georg; Gutleben, Klaus-Jürgen; Muntean, Bogdan; Vogt, Jürgen; Horstkotte, Dieter; Dabiri Abkenari, Lara; Akca, Ferdi; Szili-Torok, Tamas

2012-12-01

Studies have shown that remote magnetic navigation is safe and effective for ablation of atrial arrhythmias, although optimal outcomes often require frequent manual manipulation of a circular mapping catheter. The Vdrive robotic system ('Vdrive') was designed for remote navigation of circular mapping catheters to enable a fully remote procedure. This study details the first human clinical experience with remote circular catheter manipulation in the left atrium. This was a prospective, multi-centre, non-randomized consecutive case series that included patients presenting for catheter ablation of left atrial arrhythmias. Remote systems were used exclusively to manipulate both the circular mapping catheter and the ablation catheter. Patients were followed through hospital discharge. Ninety-four patients were included in the study, including 23 with paroxysmal atrial fibrillation (AF), 48 with persistent AF, and 15 suffering from atrial tachycardias. The population was predominately male (77%) with a mean age of 60.5 ± 11.7 years. The Vdrive was used for remote navigation between veins, creation of chamber maps, and gap identification with segmental isolation. The intended acute clinical endpoints were achieved in 100% of patients. Mean case time was 225.9 ± 70.5 min. Three patients (3.2%) crossed over to manual circular mapping catheter navigation. There were no adverse events related to the use of the remote manipulation system. The results of this study demonstrate that remote manipulation of a circular mapping catheter in the ablation of atrial arrhythmias is feasible and safe. Prospective randomized studies are needed to prove efficiency improvements over manual techniques.

Evaluation of orthodontically induced external root resorption following orthodontic treatment using cone beam computed tomography (CBCT): a systematic review and meta-analysis.

PubMed

Samandara, Aikaterini; Papageorgiou, Spyridon N; Ioannidou-Marathiotou, Ioulia; Kavvadia-Tsatala, Smaragda; Papadopoulos, Moschos A

2018-05-15

Orthodontically induced external root resorption (OIRR) is a pathologic consequence of orthodontic tooth movement. However, the limitations of two-dimensional radiography suggest that cone beam computed tomography (CBCT) with its three-dimensional capabilities might be more suitable to assess OIRR. The aim of this study was to assess in an evidence-based manner data on linear or volumetric OIRR measurements of permanent teeth by means of CBCT, during and/or after the end of orthodontic treatment. Unrestricted electronic and hand searches were performed up to January 2017 in 15 databases. Randomized clinical trials, prospective, and retrospective non-randomized studies assessing OIRR during and/or after orthodontic treatment using CBCT in human patients were included. After duplicate study selection, data extraction, and risk-of-bias assessment according to the Cochrane guidelines, random-effects meta-analyses, followed by subgroup, meta-regression, and sensitivity analyses were also performed in order to evaluate factors that affect OIRR. A total of 33 studies (30 datasets) were included in the qualitative analysis while data from 27 of them were included in the quantitative analysis. Direct comparisons from randomized trials found little to no influence of appliance-related factors on OIRR. Explorative analyses including non-randomized studies found a pooled OIRR of 0.79 mm based on all included studies and 0.86 mm when OIRR was assessed at the end of orthodontic treatment. Statistically significant differences in OIRR were found according to tooth type or jaw, inclusion of extractions, treatment duration, and diagnostic accuracy of the CBCT. Based on the results of this study, CBCT seems to be a reliable tool to examine OIRR during or at the end of orthodontic treatment. Although the average OIRR measured with CBCT seems to lack clinical relevance, there are certain factors that may affect OIRR following orthodontic treatment. Nevertheless, due to data heterogeneity and low quality of the included studies, the corresponding results should be interpreted with some caution. PROSPERO (CRD42016030131).

Genetic View on the Phenomenon of Combined Diseases in Man

PubMed Central

Freidin, M.B.

2009-01-01

In clinical medicine, the phenomenon of polypathy, as a particular object of investigation, was first put forth by French clinicians at the end of the 19th century through the "arthritismus" doctrine. In the first half of the 20th century, German paediatricians singled out "syntropias," which are combinations of diseases with common pathophysiological mechanisms, and "dystropias," which are diseases that rarely co-occur in one individual. In the present paper, syntropy/dystropy is defined as a natural generic nonrandom phenomenon with an evolutionary-genetic basis. The genes involved in the development of syntropy are called "syntropic genes," whereas the genes that co-participate in pathophysiological mechanisms and prevent the co-occurrence of particular phenotypes are called "dystropic genes." Prospects for studying the genetic basis of this phenomenon are highlighted. The publicly available database HuGENet can be used in order to identify syntropic genes, as will be shown as examples in an analysis of cardiovascular diseases. PMID:22649614

Early crisis nontechnical skill teaching in residency leads to long-term skill retention and improved performance during crises: A prospective, nonrandomized controlled study.

PubMed

Doumouras, Aristithes G; Engels, Paul T

2017-07-01

Medical error is common in crises, and the majority of observed errors are nontechnical in nature. The long-term impact of teaching crisis nontechnical skills to residents has not been evaluated. The objective of this study was to determine the effect of simulation-based teaching of crisis nontechnical skills compared to controls one year after initial teaching. This was a prospective study using both historical controls and a before-and-after methodology to evaluate the effect of a high-fidelity simulation curriculum that used crisis resource management principles to teach nontechnical skills. Postgraduate year 2 and 3 residents were invited to take part in a prospective training course over 2 years. The primary outcome was leader performance evaluated by expert raters using the previously validated 7-point Ottawa Global Rating Scale. Overall, 23 residents performed 30 simulations over the 2 years with the intervention group of 7 residents being assessed in both years. After adjustment, the postgraduate year 3 intervention group who received training the previous year had significantly higher overall performance scores than all postgraduate year 2 scores (1.09 95% confidence interval 0.70-1.47, P < .001) and the historical postgraduate year 3 cohort who received no prior training (1.20, 95% confidence interval 0.37-2.03, P = .005). There was no decay of skills noted over the course of the study. Postgraduate year 3 residents who had prior training had significantly improved crisis performance compared to historical postgraduate year 3 controls and untrained postgraduate year 2 residents. There were no significant differences between the crisis performance of postgraduate year 2 residents and the untrained postgraduate year 3 controls. This confirms the beneficial effect and long-term retention after crisis nontechnical skill training. Copyright © 2016 Elsevier Inc. All rights reserved.

Prospective, Controlled Study of Invasiveness and Post-Aggression Metabolism in Patients Undergoing Robotic-Assisted Radical Prostatectomy.

PubMed

Martinschek, Andreas; Stumm, Lisa; Ritter, Manuel; Heinrich, Elmar; Bolenz, Christian; Trojan, Lutz

2017-01-01

To evaluate in a prospective, controlled, nonrandomized study the surgical stress and acute-phase systemic response in robotic-assisted laparoscopic prostatectomy (RALP) compared to open radical retro-pubic prostatectomy (ORRP) by measuring humoral mediators. Forty consecutive patients undergoing either RALP or ORRP were prospectively included to assess the extent of systemic response. Blood samples were collected before surgery (T1), at the time of prostatectomy (T2), at the time of wound closure (T3), and 12 h (T4), 24 h (T5), and 48 h (T6) after surgery, and assayed for interleukins (IL-6 and IL-10), C-reactive protein (CRP), and hemoglobin. A 2-sided p < 0.05 was considered to indicate significance. Baseline levels of IL-6, IL-10, and CRP were comparable in both arms of the study. IL-6 and IL-10 increased in both groups during surgery and reached maximum levels at 12 and 24 h after surgery. The RALP and RRP groups differed significantly at T2 (p = 0.009), T3 (p = 0.046), T5 (p = 0.05) and T6 (p = 0.0007) for IL-6, and at T3 (p = 0.05) and T4 (p = 0.05) for IL-10. CRP levels differed significantly at 48 h postoperative (p = 0.0053). The maximum levels of all 3 mediators in the RALP group were significantly lower than those in the open surgery group. Patients in the RALP group experienced less pain from day 2 to 4 according to the Visual Analog Scale (p < 0.05). The study suggests that IL-6 and IL-10 are useful objective markers for surgical stress and that tissue trauma and activation of post-aggression metabolism seem to be less in RALP compared to ORRP. © 2017 S. Karger AG, Basel.

Factors affecting interest in orthopedics among female medical students: a prospective analysis.

PubMed

Baldwin, Keith; Namdari, Surena; Bowers, Andrea; Keenan, Mary Ann; Levin, L Scott; Ahn, Jaimo

2011-12-06

The field of orthopedics has a limited ability to recruit high-quality female applicants. The purpose of this study was to determine whether early exposure to the field affects a woman's decision to pursue orthopedics. We performed a prospective, nonrandomized cohort study between academic years 2005 and 2009 and compared interest in orthopedic surgery among female (n=271) and male (n=71) medical students at 2 urban teaching institutions. Elective lectures and orthopedic literature were distributed via e-mail to the study participants. These materials included articles published in the medical literature, materials produced and distributed by the American Academy of Orthopaedic Surgeons, and Web sites providing educational materials. The primary outcome was the likelihood of application for orthopedic residency. We studied the influence of demographics, exposure, and attitudes on interest in pursuing an orthopedic career. Men had a significantly higher baseline level of interest in orthopedic surgery than women (P=.005). Younger age (P<.001) and personal (P<.001), independent (P<.001), and school (P=.023) exposures to orthopedics were significantly related to interest among women. At final follow-up, total personal exposures (P=.003) and total independent exposures (P<.001) in the form of our literature and lectures were correlated with final interest in women. Female interest was decreased by the long hours, physical demands, and predominantly male nature of the field. Early exposure to orthopedic educational resources may be useful in generating female interest. Perceptions and attitudes regarding orthopedic surgery must to be changed to attract the best and brightest minds, regardless of sex. Copyright © 2011, SLACK Incorporated.

5-year results comparing mineral trioxide aggregate and adhesive resin composite for root-end sealing in apical surgery.

PubMed

von Arx, Thomas; Hänni, Stefan; Jensen, Simon Storgård

2014-08-01

Recent meta-analyses of the outcome of apical surgery using modern techniques including microsurgical principles and high-power magnification have yielded higher rates of healing. However, the information is mainly based on 1- to 2-year follow-up data. The present prospective study was designed to re-examine a large sample of teeth treated with apical surgery after 5 years. Patients were recalled 5 years after apical surgery, and treated teeth were classified as healed or not healed based on clinical and radiographic examination. (The latter was performed independently by 3 observers). Two different methods of root-end preparation and filling (primary study parameters) were to be compared (mineral trioxide aggregate [MTA] vs adhesive resin composite [COMP]) without randomization. A total of 271 patients and teeth from a 1-year follow-up sample of 339 could be re-examined after 5 years (dropout rate = 20.1%). The overall rate of healed cases was 84.5% with a significant difference (P = .0003) when comparing MTA (92.5%) and COMP (76.6%). The evaluation of secondary study parameters yielded no significant difference for healing outcome when comparing subcategories (ie, sex, age, type of tooth treated, post/screw, type of surgery). The results from this prospective nonrandomized clinical study with a 5-year follow-up of 271 teeth indicate that MTA exhibited a higher healing rate than COMP in the longitudinal prognosis of root-end sealing. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

PubMed

Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

2017-09-01

Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

Ribavirin for treating Crimean Congo haemorrhagic fever.

PubMed

Johnson, Samuel; Henschke, Nicholas; Maayan, Nicola; Mills, Inga; Buckley, Brian S; Kakourou, Artemisia; Marshall, Rachel

2018-06-05

Crimean Congo haemorrhagic fever (CCHF) is a tick-borne disease that occurs in parts of Asia, Europe and Africa. Since 2000 the infection has caused epidemics in Turkey, Iran, Russia, Uganda and Pakistan. Good-quality general supportive medical care helps reduce mortality. There is uncertainty and controversy about treating CCHF with the antiviral drug ribavirin. To assess the effects of ribavirin for treating people with Crimean Congo haemorrhagic fever. We searched the Cochrane Infectious Diseases Group Specialized Register; the Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (OVID); Science Citation Index-Expanded, Social Sciences Citation index, conference proceedings (Web of Science); and CINAHL (EBSCOHost). We also searched the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for trials in progress. We conducted all searches up to 16 October 2017. We also contacted experts in the field and obtained further studies from these sources. We evaluated studies assessing the use of ribavirin in people with suspected or confirmed Crimean Congo haemorrhagic fever. We included randomised control trials (RCTs); non-randomised studies (NRSs) that included more than 10 participants designed as cohort studies with comparators; and case-control studies. Two review authors assessed eligibility, risk of bias, and extracted data. For non-randomized studies we used the ROBINS-I tool to assess risk of bias. The main effects analysis included all studies where we judged the risk of bias to be low, moderate or high. We summarized dichotomous outcomes using risk ratios (RRs) and continuous outcomes using mean differences (MDs), and used meta-analyses where appropriate. We carried out a subsidiary appraisal and analysis of studies with critical risk of bias for the primary outcome, as these are often cited to support using ribavirin. For the main effects analysis, five studies met our inclusion criteria: one RCT with 136 participants and four non-randomized studies with 612 participants. We excluded 18 non-randomized studies with critical risk of bias, where none had attempted to control for confounding.We do not know if ribavirin reduces mortality (1 RCT; RR 1.13, 95% confidence interval (CI) 0.29 to 4.32; 136 participants; very low-certainty evidence; 3 non-randomized studies; RR 0.72, 95% CI 0.41 to 1.28; 549 participants; very low-certainty evidence). We do not know if ribavirin reduces the length of stay in hospital (1 RCT: mean difference (MD) 0.70 days, 95% CI -0.39 to 1.79; 136 participants; and 1 non-randomized study: MD -0.80, 95% CI -2.70 to 1.10; 50 participants; very low-certainty evidence). We do not know if it reduces the risk of patients needing platelet transfusions (1 RCT: RR 1.23, 95% CI 0.77 to 1.96; 136 participants; very low-certainty evidence). For adverse effects (including haemolytic anaemia and a need to discontinue treatment), we do not know whether there is an increased risk with ribavirin in people with CCHF as data are insufficient.We do not know if adding ribavirin to early supportive care improves outcomes. One non-randomized study assessed mortality in people receiving ribavirin and supportive care within four days or less from symptom onset compared to after four days since symptom onset: mortality was lower in the group receiving early supportive care and ribavirin, but it is not possible to distinguish between the effects of ribavirin and early supportive medical care alone.In the subsidiary analysis, 18 studies compared people receiving ribavirin with those not receiving ribavirin. All had a critical risk of bias due to confounding, reflected in the mortality point estimates favouring ribavirin. We do not know if ribavirin is effective for treating Crimean Congo haemorrhagic fever. Non-randomized studies are often cited as evidence of an effect, but the risk of bias in these studies is high.

Hybrid natural orifice transluminal endoscopic cholecystectomy: prospective human series.

PubMed

Cuadrado-Garcia, Angel; Noguera, Jose F; Olea-Martinez, Jose M; Morales, Rafael; Dolz, Carlos; Lozano, Luis; Vicens, Jose-Carlos; Pujol, Juan José

2011-01-01

Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. Currently, it is not possible to perform these interventions without the help of abdominal wall entryways, so these procedures are hybrids fusing minilaparoscopy and transluminal endoscopic surgery. This report presents a prospective clinical series of 25 patients who underwent transvaginal hybrid cholecystectomy for cholelithiasis. The study comprised a clinical series of 25 consecutive nonrandomized women who underwent a fusion transvaginal NOTES and minilaparoscopy procedure with two trocars for cholelithiasis: one 5-mm umbilical trocar and one 3-mm trocar in the upper left quadrant. The study had no control group. The scheduled surgical intervention was performed for all 25 women. No intraoperative complications occurred. One patient had mild hematuria that resolved in less than 12 h, but no other complications occurred during an average follow-up period of 140 days. Of the 25 women, 20 were discharged in 24 h, and 5 were discharged less than 12 h after the procedure. Hybrid transvaginal cholecystectomy, combining NOTES and minilaparoscopy, is a good surgical model for minimally invasive surgery. It can be performed in surgical settings where laparoscopy is practiced regularly using the instruments normally used for endoscopy and laparoscopic surgery. Due to the reproducibility of the intervention and the ease of vaginal closure, hybrid transvaginal cholecystectomy will permit further development of NOTES in the future.

A 12-month, open-label, comparative study of quetiapine and risperidone in the acute and long-term treatment of schizophrenia.

PubMed

Perez, Victor; Cañas, Fernando; Tafalla, Monica

2008-05-01

This multicentre, observational, prospective, nonrandomized study compared the effectiveness and tolerability of quetiapine and risperidone in the acute and long-term treatment of schizophrenia in a clinical setting. Patients admitted to an acute unit with schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV), who were prescribed quetiapine or risperidone (3 : 1 ratio) within the first week of treatment, according to the physician's usual practice, were recruited. In total, 492 patients (quetiapine: 367; risperidone: 125) were followed up at weeks 1 and 2, discharge and 6 and 12 months thereafter. Mean doses at 12 months were: quetiapine 718.5 mg/day and risperidone 7.0 mg/day. Efficacy measures (Brief Psychiatric Rating Scale, Clinical Global Impression Severity of Illness and Improvement) indicated similar results for both agents. No difference was found in rehospitalization rate with either drug. In terms of tolerability, orthostatic hypotension was more frequent with quetiapine, but extrapyramidal symptoms and male sexual dysfunction were more frequent with risperidone. In conclusion, quetiapine and risperidone had comparable effectiveness, but there were differences between treatments in their side effect profile.

Open source posturography.

PubMed

Rey-Martinez, Jorge; Pérez-Fernández, Nicolás

2016-12-01

The proposed validation goal of 0.9 in intra-class correlation coefficient was reached with the results of this study. With the obtained results we consider that the developed software (RombergLab) is a validated balance assessment software. The reliability of this software is dependent of the used force platform technical specifications. Develop and validate a posturography software and share its source code in open source terms. Prospective non-randomized validation study: 20 consecutive adults underwent two balance assessment tests, six condition posturography was performed using a clinical approved software and force platform and the same conditions were measured using the new developed open source software using a low cost force platform. Intra-class correlation index of the sway area obtained from the center of pressure variations in both devices for the six conditions was the main variable used for validation. Excellent concordance between RombergLab and clinical approved force platform was obtained (intra-class correlation coefficient =0.94). A Bland and Altman graphic concordance plot was also obtained. The source code used to develop RombergLab was published in open source terms.

Laparoscopic anterior resection and total mesorectal excision for rectal cancer: a prospective nonrandomized study.

PubMed

Palanivelu, C; Sendhilkumar, K; Jani, Kalpesh; Rajan, P S; Maheshkumar, G S; Shetty, Roshan; Parthasarthi, R

2007-04-01

The purpose of this study was to present our experience of laparoscopic total mesorectal resection, including ultralow resection and coloanal anastomosis. Between 1993 and 2005, patients fit for general anesthesia, with resectable cancers, and with lower edge of tumor beyond 5 cm of the anal verge were subjected to laparoscopic anterior resection with sphincter preservation. Double stapling technique is used to establish bowel continuity. A total of 170 patients, 88 males and 82 females, were subjected to successful laparoscopic anterior resection, which included high anterior resection (n=90), low anterior resection (n=52), ultralow anterior resection (n=20), and coloanal anastomosis (n=8). The average age of patients was 58.4 years (12-90 years). Mean operating time was 130 min and mean hospital stay was 7 days. The morbidity was 13.5% with nil mortality. With an average follow-up of 49 months (range 9 years to 3 months), 9 patients developed local recurrence and 45 patients developed distant metastasis. In selected cases, laparoscopic anterior resection is possible for all levels of rectal tumors, allowing sphincter preservation and maintaining oncological safety.

Some design issues of strata-matched non-randomized studies with survival outcomes.

PubMed

Mazumdar, Madhu; Tu, Donsheng; Zhou, Xi Kathy

2006-12-15

Non-randomized studies for the evaluation of a medical intervention are useful for quantitative hypothesis generation before the initiation of a randomized trial and also when randomized clinical trials are difficult to conduct. A strata-matched non-randomized design is often utilized where subjects treated by a test intervention are matched to a fixed number of subjects treated by a standard intervention within covariate based strata. In this paper, we consider the issue of sample size calculation for this design. Based on the asymptotic formula for the power of a stratified log-rank test, we derive a formula to calculate the minimum number of subjects in the test intervention group that is required to detect a given relative risk between the test and standard interventions. When this minimum number of subjects in the test intervention group is available, an equation is also derived to find the multiple that determines the number of subjects in the standard intervention group within each stratum. The methodology developed is applied to two illustrative examples in gastric cancer and sarcoma.

Low-Impact Flooring: Does It Reduce Fall-Related Injuries?

PubMed

Hanger, H Carl

2017-07-01

To compare fall rates and injuries from falls on low-impact flooring (LIF) compared with a standard vinyl flooring. Prospective, observational, nonrandomized controlled study. Subacute Older Persons Health ward (N = 20 beds). Older inpatients. Three different types of LIF. All falls in the ward were prospectively monitored using incident reporting, noting location and consequences of each fall. Fall rates (per 1000 bed days) and injuries, were compared between bedroom falls on LIF against those occurring on standard vinyl flooring (controls). Over 31 months, there were 278 bedroom falls (from 178 fallers). The bedroom fall rate (falls per 1000 bed days occupied) did not differ between the LIF and control groups (median 15 [IQR 8-18] versus 17 [IQR 9-23], respectively; P = .47). However, fall-related injuries were significantly less frequent when they occurred on LIFs (22% of falls versus 34% of falls on control flooring; P = .02). Fractures occurred in 0.7% of falls in the LIF cohort versus 2.3% in the control cohort. Rolling resistance when moving heavier equipment, such as beds or hoists, was an issue for staff on LIF. LIF significantly reduced fall-related injuries compared with a standard vinyl flooring, whereas they did not alter the overall risk of falling. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Vitamin status after gastric bypass and lifestyle intervention: a comparative prospective study.

PubMed

Aasheim, Erlend Tuseth; Johnson, Line Kristin; Hofsø, Dag; Bøhmer, Thomas; Hjelmesæth, Jøran

2012-01-01

Bariatric surgery can lead to vitamin deficiencies. We aimed to assess the changes in blood vitamin concentrations in patients who were taking predefined supplements after gastric bypass surgery. A total of 29 patients underwent gastric bypass and 24 unmatched controls underwent lifestyle intervention in a prospective, nonrandomized trial. The patients in the surgical group received multivitamin, iron, calcium, vitamin D, and vitamin B(12) supplements. No supplements were prescribed to the lifestyle group. The median body mass index decreased from 46 to 32 kg/m(2) after surgery and from 40 to 39 kg/m(2) after lifestyle intervention. Of the 53 included patients, 50 completed the 1-year follow-up examination (94%). Compared with the lifestyle patients, the surgical patients had increased vitamin B(6), folic acid, vitamin B(12), and lipid-adjusted vitamin E (P <.02 for each) concentrations but decreased vitamin A concentrations (P <.01) during follow-up. No significant difference between the 2 groups was found for vitamin B(1), vitamin C, or 25-hydroxyvitamin D. Most surgical patients reported taking their supplements. Gastric bypass patients adhering to a set of dietary supplements had mostly stable or increased vitamin concentrations compared with both their baseline values and the changes in a nonsurgical control group. Copyright © 2012 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Renormalization-group study of superfluidity and phase separation of helium mixtures immersed in a nonrandom aerogel

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

Lopatnikova, A.; Berker, A.N.

1997-02-01

Superfluidity and phase separation in {sup 3}He-{sup 4}He mixtures immersed in a jungle-gym (nonrandom) aerogel are studied by renormalization-group theory. Phase diagrams are calculated for a variety of aerogel concentrations. Superfluidity at very low {sup 4}He concentrations and a depressed tricritical temperature are found at the onset of superfluidity. A superfluid-superfluid phase separation, terminating at an isolated critical point, is found entirely within the superfluid phase. These phenomena and trends with respect to aerogel concentration are explained by the connectivity and tenuousness of a jungle-gym aerogel. {copyright} {ital 1997} {ital The American Physical Society}

Continuous subcutaneous infusion of insulin lispro in children and adolescents with type 1 diabetes mellitus.

PubMed

Kaiserman, Kevin; Rodriguez, Henry; Stephenson, Amanda; Wolka, Linda; Fahrbach, Jessie L

2012-01-01

To provide a comprehensive review of insulin lispro administered by continuous subcutaneous insulin infusion (CSII) in children and adolescents. We performed PubMed literature searches to identify clinical studies of insulin lispro administered via CSII within pediatric and adolescent populations. Twenty-six studies involving 2521 pediatric patients with type 1 diabetes mellitus met inclusion criteria. Of these, 10 were randomized controlled trials (RCTs), 6 of which compared insulin lispro CSII with multiple daily injection (MDI) therapy. We identified 7 additional prospective, nonrandomized studies and 9 retrospective studies. Within the RCTs, endpoint hemoglobin A1c levels ranged from 6.3% to 8.5% for insulin lispro CSII therapy and from 6.2% to 8.7% for those trials with MDI comparator arms. In those trials that compared insulin lispro CSII with MDI, the endpoint hemoglobin A1c achieved with insulin lispro was similar or improved compared with observations in the MDI treatment arm. In the RCTs, severe hypoglycemia rates of 0.1 to 0.3 episodes/patient per year were reported for insulin lispro CSII therapy; those trials with MDI comparator arms reported relatively similar severe hypoglycemia rates (0.1 to 0.5 episodes/patient per year). Events of diabetic ketoacidosis (DKA) were rare. Where reported, insulin lispro CSII and MDI therapy demonstrated a similar occurrence of DKA and incidence of severe hypoglycemia. Prospective and retrospective studies demonstrated results similar to the RCT findings. In 26 studies of more than 2500 pediatric and adolescent patients with type 1 diabetes, with more than 1000 patients specifically receiving insulin lispro CSII, insulin lispro CSII therapy consistently demonstrated similar or improved efficacy and safety vs studied comparators.

Non-randomized response model for sensitive survey with noncompliance.

PubMed

Wu, Qin; Tang, Man-Lai

2016-12-01

Collecting representative data on sensitive issues has long been problematic and challenging in public health prevalence investigation (e.g. non-suicidal self-injury), medical research (e.g. drug habits), social issue studies (e.g. history of child abuse), and their interdisciplinary studies (e.g. premarital sexual intercourse). Alternative data collection techniques that can be adopted to study sensitive questions validly become more important and necessary. As an alternative to the famous Warner randomized response model, non-randomized response triangular model has recently been developed to encourage participants to provide truthful responses in surveys involving sensitive questions. Unfortunately, both randomized and non-randomized response models could underestimate the proportion of subjects with the sensitive characteristic as some respondents do not believe that these techniques can protect their anonymity. As a result, some authors hypothesized that lack of trust and noncompliance should be highest among those who have the most to lose and the least to use for the anonymity provided by using these techniques. Some researchers noticed the existence of noncompliance and proposed new models to measure noncompliance in order to get reliable information. However, all proposed methods were based on randomized response models which require randomizing devices, restrict the survey to only face-to-face interview and are lack of reproductivity. Taking the noncompliance into consideration, we introduce new non-randomized response techniques in which no covariate is required. Asymptotic properties of the proposed estimates for sensitive characteristic as well as noncompliance probabilities are developed. Our proposed techniques are empirically shown to yield accurate estimates for both sensitive and noncompliance probabilities. A real example about premarital sex among university students is used to demonstrate our methodologies. © The Author(s) 2014.

Does Pharmacogenomic Testing Improve Clinical Outcomes for Major Depressive Disorder? A Systematic Review of Clinical Trials and Cost-Effectiveness Studies.

PubMed

Rosenblat, Joshua D; Lee, Yena; McIntyre, Roger S

2017-06-01

Pharmacogenomic testing has become scalable and available to the general public. Pharmacogenomics has shown promise for predicting antidepressant response and tolerability in the treatment of major depressive disorder (MDD). In theory, pharmacogenomics can improve clinical outcomes by guiding antidepressant selection and dosing. The current systematic review examines the extant literature to determine the impact of pharmacogenomic testing on clinical outcomes in MDD and assesses its cost-effectiveness. The MEDLINE/PubMed and Google Scholar databases were systematically searched for relevant articles published prior to October 2015. Search terms included various combinations of the following: major depressive disorder (MDD), depression, mental illness, mood disorder, antidepressant, response, remission, outcome, pharmacogenetic, pharmacogenomics, pharmacodynamics, pharmacokinetic, genetic testing, genome wide association study (GWAS), CYP450, personalized medicine, cost-effectiveness, and pharmacoeconomics. Of the 66 records identified from the initial search, relevant clinical studies, written in English, assessing the cost-effectiveness and/or efficacy of pharmacogenomic testing for MDD were included. Each publication was critically examined for relevant data. Two nonrandomized, open-label, 8-week, prospective studies reported overall greater improvement in depressive symptom severity in the group of MDD subjects receiving psychiatric care guided by results of combinatorial pharmacogenomic testing (GeneSight) when compared to the unguided group. One industry-sponsored, randomized, double-blind, 10-week prospective study reported a trend for improved outcomes for the GeneSight-guided group; however, the trend did not reach statistical significance. Another industry-sponsored, randomized, double-blind, 12-week prospective study reported a 2.5-fold increase in remission rates in the CNSDose-guided group (P < .0001). One naturalistic, unblinded, industry-sponsored study showed clinical improvement when pharmacogenomics testing guided prescribing; however, this study lacked a control group. A single cost-effectiveness study concluded that single gene testing was not cost-effective. Conversely, a separate study reported that combinatorial pharmacogenomic testing is cost-effective. A limited number of studies have shown promise for the clinical utility of pharmacogenomic testing; however, cost-effectiveness of pharmacogenomics, as well as demonstration of improved health outcomes, is not yet supported with replicated evidence. © Copyright 2017 Physicians Postgraduate Press, Inc.

A pilot study of audiovisual family meetings in the intensive care unit.

PubMed

de Havenon, Adam; Petersen, Casey; Tanana, Michael; Wold, Jana; Hoesch, Robert

2015-10-01

We hypothesized that virtual family meetings in the intensive care unit with conference calling or Skype videoconferencing would result in increased family member satisfaction and more efficient decision making. This is a prospective, nonblinded, nonrandomized pilot study. A 6-question survey was completed by family members after family meetings, some of which used conference calling or Skype by choice. Overall, 29 (33%) of the completed surveys came from audiovisual family meetings vs 59 (67%) from control meetings. The survey data were analyzed using hierarchical linear modeling, which did not find any significant group differences between satisfaction with the audiovisual meetings vs controls. There was no association between the audiovisual intervention and withdrawal of care (P = .682) or overall hospital length of stay (z = 0.885, P = .376). Although we do not report benefit from an audiovisual intervention, these results are preliminary and heavily influenced by notable limitations to the study. Given that the intervention was feasible in this pilot study, audiovisual and social media intervention strategies warrant additional investigation given their unique ability to facilitate communication among family members in the intensive care unit. Copyright © 2015 Elsevier Inc. All rights reserved.

ILM peeling in nontractional diabetic macular edema: review and metanalysis.

PubMed

Rinaldi, M; dell'Omo, R; Morescalchi, F; Semeraro, F; Gambicorti, E; Cacciatore, F; Chiosi, F; Costagliola, C

2017-10-31

To evaluate the effect of internal limiting membrane (ILM) peeling during vitrectomy for nontractional diabetic macular edema. PUBMED, MEDLINE and CENTRAL were reviewed using the following terms (or combination of terms): diabetic macular edema, nontractional diabetic macular edema, internal limiting membrane peeling, vitrectomy, Müller cells. Randomized and nonrandomized studies were included. The eligible studies compared anatomical and functional outcomes of vitrectomy with or without ILM peeling for tractional and nontractional diabetic macular edema. Postoperative best-corrected visual acuity and central macular thickness were considered, respectively, the primary and secondary outcomes. Meta-analysis on mean differences between vitrectomy with and without ILM peeling was performed using inverse variance method in random effects. Four studies with 672 patients were eligible for analysis. No significant difference was found between postoperative best-corrected visual acuity or best-corrected visual acuity change of ILM peeling group compared with nonpeeling group. There was no significant difference in postoperative central macular thickness and central macular thickness reduction between the two groups. The visual acuity outcomes in patients affected by nontractional diabetic macular edema using pars plana vitrectomy with ILM peeling versus no ILM peeling were not significantly different. A larger prospective and randomized study would be necessary.

Smoking behavior and motivation to quit among chronic pain patients initiating multidisciplinary pain treatment: a prospective study.

PubMed

Unrod, Marina; Gironda, Ronald J; Clark, Michael E; White, Kristi E; Simmons, Vani N; Sutton, Steven K; Brandon, Thomas H

2014-08-01

The primary aim of this study was to assess smoking characteristics and cessation motivation prior to and after initiation of multidisciplinary chronic pain treatment. A secondary aim was to identify predictors of cessation motivation among smokers initiating treatment for chronic pain. We used a prospective, nonrandomized, repeated measures design. The study was conducted in a multidisciplinary specialty pain treatment program at a veterans hospital. Smokers (N = 90) referred to a multidisciplinary pain program for the treatment of chronic pain. Patients completed questionnaires assessing pain-related and smoking-related factors prior to (baseline) and 8 weeks post (follow-up) specialty pain treatment initiation. Primary outcome measures were the Contemplation Ladder and the Stages of Change (SOC) algorithm. At baseline, patients reported moderate levels of cessation motivation, and 69% were in the contemplation stage or higher on the SOC. Motivation to quit smoking was higher at follow-up compared with baseline on both continuous, t(89) = 2.11, P < 0.05, and stage-based, z = 3.69, P < 0.01, measures. At follow-up, participants reported greater interest in receiving cessation interventions, and 7.8% of patients had quit smoking. Pain-related predictors of motivation (e.g., pain intensity) were subsumed by more general predictors (e.g., nicotine dependence). Patients in this sample were more motivated to quit smoking a few weeks after, as compared with before initiating specialty pain treatment. Future research into pain-specific predictors of cessation motivation is warranted to inform the development of interventions that address pain patients' unique needs. Wiley Periodicals, Inc.

A fully covered self-expandable metal stent with antimigration features for benign biliary strictures: a prospective, multicenter cohort study.

PubMed

Walter, Daisy; Laleman, Wim; Jansen, Jeroen M; van Milligen de Wit, A W M; Weusten, Bas L; van Boeckel, Petra G; Hirdes, Meike M; Vleggaar, Frank P; Siersema, Peter D

2015-05-01

Self-expandable metal stents (SEMSs) are increasingly used for the treatment of benign biliary strictures (BBSs). A new fully covered SEMS (FCSEMS) with flared ends and high conformability was designed to prevent migration of the stent. To evaluate the efficacy of a novel FCSEMS with antimigration features. Prospective cohort study. Five hospitals in the Netherlands and Belgium. Consecutive patients with BBS. FCSEMS placement for 3 months. Initial and long term clinical success, stent migration rate and safety. Thirty-eight patients (24 men; mean age, 53 ± 16 years) were included. Stent placement was technically successful in 37 patients (97%). Two patients died of an unrelated cause before stent removal, and no data on these patients were available on stricture resolution. Initial clinical success was achieved in 28 of 35 patients (80%). During follow-up after stent removal, a symptomatic recurrent stricture developed in 6 of 28 patients (21%). Overall, the long-term clinical success rate was 63% (22 of 35 patients). Stent migration occurred in 11 of 35 patients (31%), including 5 symptomatic (14%) and 6 asymptomatic (17%) migrations. In total, 11 serious adverse events occurred in 10 patients (29%), with cholangitis (n = 5) being most common. Nonrandomized study design. Good initial clinical success was achieved after placement of this novel FCSEMS, but stricture recurrence was in the upper range compared with other FCSEMSs. The antimigration design could not prevent migration in a significant number of patients with a persisting stricture. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Seven deadly sins in trauma outcomes research: an epidemiologic post mortem for major causes of bias.

PubMed

del Junco, Deborah J; Fox, Erin E; Camp, Elizabeth A; Rahbar, Mohammad H; Holcomb, John B

2013-07-01

Because randomized clinical trials in trauma outcomes research are expensive and complex, they have rarely been the basis for the clinical care of trauma patients. Most published findings are derived from retrospective and occasionally prospective observational studies that may be particularly susceptible to bias. The sources of bias include some common to other clinical domains, such as heterogeneous patient populations with competing and interdependent short- and long-term outcomes. Other sources of bias are unique to trauma, such as rapidly changing multisystem responses to injury that necessitate highly dynamic treatment regimens such as blood product transfusion. The standard research design and analysis strategies applied in published observational studies are often inadequate to address these biases. Drawing on recent experience in the design, data collection, monitoring, and analysis of the 10-site observational PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, 7 common and sometimes overlapping biases are described through examples and resolution strategies. Sources of bias in trauma research include ignoring (1) variation in patients' indications for treatment (indication bias), (2) the dependency of intervention delivery on patient survival (survival bias), (3) time-varying treatment, (4) time-dependent confounding, (5) nonuniform intervention effects over time, (6) nonrandom missing data mechanisms, and (7) imperfectly defined variables. This list is not exhaustive. The mitigation strategies to overcome these threats to validity require epidemiologic and statistical vigilance. Minimizing the highlighted types of bias in trauma research will facilitate clinical translation of more accurate and reproducible findings and improve the evidence-base that clinicians apply in their care of injured patients.

Topical glycopyrrolate reduces axillary hyperhidrosis.

PubMed

Baker, D M

2016-12-01

Oral anti-cholinergic medications reduce generalized hyperhidrosis, but the effectiveness of topical anticholinergic solutions on axillary hyperhidrosis is unclear. This study determines the initial effectiveness of 1% and 2% topical glycopyrrolate spray and compares this with Botulinum toxin type A injections for the management of axillary hyperhidrosis. In a non-randomized, consecutive patient, prospective questionnaire, treatment comparison study, 40 patients with axillary hyperhidrosis were allocated to one of four study groups (10 patients to each group): (a) 1% glycopyrrolate spray, (b) 2% glycopyrrolate spray, (c) subcutaneous Botulinum toxin type A injections, (d) no treatment. Clinical outcomes were measured by comparing a prospectively administered questionnaire, completed both pre-treatment and 6 weeks after starting treatment. Forty healthy volunteers without axillary hyperhidrosis completed the same questionnaire. The three treatment groups showed a significant (P < 0.05) improvement in their hyperhidrosis scores following treatment. The degree of improvement was less for the 1% glycopyrrolate group when compared with the Botulinum toxin type A group (P < 0.05), but there was no difference in treatment outcomes between the 2% glycopyrrolate and Botulinum toxin type A groups. No treatment group experienced reduced hyperhidrosis to a level similar to those without hyperhidrosis. Patients in both, the 2% glycopyrrolate and Botulinum toxin type A groups reported a significant improvement in axillary hyperhidrosis symptoms. These included reduction in psychologically precipitating factors (e.g. public speaking) and axillary hyperhidrosis-specific physical effects (e.g. limitation of clothing choice). Topical glycopyrrolate spray could provide a further treatment modality to manage axillary hyperhidrosis. © 2016 European Academy of Dermatology and Venereology.

Optimal preparation-to-colonoscopy interval in split-dose PEG bowel preparation determines satisfactory bowel preparation quality: an observational prospective study.

PubMed

Seo, Eun Hee; Kim, Tae Oh; Park, Min Jae; Joo, Hee Rin; Heo, Nae Yun; Park, Jongha; Park, Seung Ha; Yang, Sung Yeon; Moon, Young Soo

2012-03-01

Several factors influence bowel preparation quality. Recent studies have indicated that the time interval between bowel preparation and the start of colonoscopy is also important in determining bowel preparation quality. To evaluate the influence of the preparation-to-colonoscopy (PC) interval (the interval of time between the last polyethylene glycol dose ingestion and the start of the colonoscopy) on bowel preparation quality in the split-dose method for colonoscopy. Prospective observational study. University medical center. A total of 366 consecutive outpatients undergoing colonoscopy. Split-dose bowel preparation and colonoscopy. The quality of bowel preparation was assessed by using the Ottawa Bowel Preparation Scale according to the PC interval, and other factors that might influence bowel preparation quality were analyzed. Colonoscopies with a PC interval of 3 to 5 hours had the best bowel preparation quality score in the whole, right, mid, and rectosigmoid colon according to the Ottawa Bowel Preparation Scale. In multivariate analysis, the PC interval (odds ratio [OR] 1.85; 95% CI, 1.18-2.86), the amount of PEG ingested (OR 4.34; 95% CI, 1.08-16.66), and compliance with diet instructions (OR 2.22l 95% CI, 1.33-3.70) were significant contributors to satisfactory bowel preparation. Nonrandomized controlled, single-center trial. The optimal time interval between the last dose of the agent and the start of colonoscopy is one of the important factors to determine satisfactory bowel preparation quality in split-dose polyethylene glycol bowel preparation. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Skin-to-skin contact with an umbilical venous catheter: prospective evaluation in a level 3 unit.

PubMed

Catherine, Zaoui-Grattepanche; Béatrice, Pindi; Fabrice, Lapeyre; Claire, Huart; Alain, Duhamel

2016-04-01

The aim was to assess the incidence of complications related to skin-to-skin contact (SSC) in newborns with an umbilical venous catheter (UVC). We carried out a prospective follow-up study of all UVCs in a level 3 unit where SSC is systematic. A total of 333 babies were included (mean gestational age of 31.3 weeks (24-41), mean birth weight of 1618 g (454-4900). Two hundred sixty-three babies (78.9 %) had SSC, at a mean postnatal age of 24 h (3-144 h). Two babies presented with a significant umbilical bleeding, all in the first 3 h, before SSC. In 17 cases of UVC leaking, this necessitated an unwanted withdrawal of the UVC; of these, 14 UVCs (82 %) were in sub-hepatic position. In five cases of UVC displacement, babies had no SSC. The overall incidence (3 % [95 % CI = 1.4-5.4]) and incidence density (6.2/1000 UVC-day [95 % CI = 3-11.4]) of catheter-associated infections are similar to those identified by the French multicenter network NEOCAT in 2012 (5 % [95 % CI = 4.1-5.9] and 11.3/1000 UVC-day [95 % CI = 9.3-13.2]). In this prospective, non-randomized study in a level unit, routine practice of SSC with a UVC does not seem to influence the incidence of mechanical and infectious complications. What is known? • SSC is beneficial for pretem infants. • Fear of mechanical problems and/or infections with a UVC is an obstacle to early use of SSC. What is New: • In this study, SSC for preterm infants with a UVC is associated with low risks of mechanical complications, and does not seem to be associated with any higher risk of catheter-related infections.

Frugivores bias seed-adult tree associations through nonrandom seed dispersal: a phylogenetic approach.

PubMed

Razafindratsima, Onja H; Dunham, Amy E

2016-08-01

Frugivores are the main seed dispersers in many ecosystems, such that behaviorally driven, nonrandom patterns of seed dispersal are a common process; but patterns are poorly understood. Characterizing these patterns may be essential for understanding spatial organization of fruiting trees and drivers of seed-dispersal limitation in biodiverse forests. To address this, we studied resulting spatial associations between dispersed seeds and adult tree neighbors in a diverse rainforest in Madagascar, using a temporal and phylogenetic approach. Data show that by using fruiting trees as seed-dispersal foci, frugivores bias seed dispersal under conspecific adults and under heterospecific trees that share dispersers and fruiting time with the dispersed species. Frugivore-mediated seed dispersal also resulted in nonrandom phylogenetic associations of dispersed seeds with their nearest adult neighbors, in nine out of the 16 months of our study. However, these nonrandom phylogenetic associations fluctuated unpredictably over time, ranging from clustered to overdispersed. The spatial and phylogenetic template of seed dispersal did not translate to similar patterns of association in adult tree neighborhoods, suggesting the importance of post-dispersal processes in structuring plant communities. Results suggest that frugivore-mediated seed dispersal is important for structuring early stages of plant-plant associations, setting the template for post-dispersal processes that influence ultimate patterns of plant recruitment. Importantly, if biased patterns of dispersal are common in other systems, frugivores may promote tree coexistence in biodiverse forests by limiting the frequency and diversity of heterospecific interactions of seeds they disperse. © 2016 by the Ecological Society of America.

Nonrandom network connectivity comes in pairs.

PubMed

Hoffmann, Felix Z; Triesch, Jochen

2017-01-01

Overrepresentation of bidirectional connections in local cortical networks has been repeatedly reported and is a focus of the ongoing discussion of nonrandom connectivity. Here we show in a brief mathematical analysis that in a network in which connection probabilities are symmetric in pairs, P ij = P ji , the occurrences of bidirectional connections and nonrandom structures are inherently linked; an overabundance of reciprocally connected pairs emerges necessarily when some pairs of neurons are more likely to be connected than others. Our numerical results imply that such overrepresentation can also be sustained when connection probabilities are only approximately symmetric.

Mechanisms Leading to Nonrandom, Nonhomologous Chromosomal Translocations in Leukemia

PubMed Central

Gollin, Susanne M.

2007-01-01

Nonrandom, reciprocal translocations between nonhomologous chromosomes are critical cellular events that lead to malignant transformation. Therefore, understanding the mechanisms involved in these chromosomal rearrangements is essential for understanding the process of carcinogenesis. There has been substantial discussion in the literature over the past ten years about mechanisms involved in constitutional chromosomal rearrangements, including deletions, duplications, and translocations. Yet our understanding of the mechanisms of chromosomal rearrangements in cancer is still developing. This review presents what is known about the mechanisms involved in selected nonrandom chromosomal translocations in leukemia. PMID:17157028

Quantitative studies on the mating system of jute (Corchorus olitorius L.).

PubMed

Basak, S L; Gupta, S

1972-01-01

More than 100,000 individuals of C. olitorius were scored for selfing versus outcrossing in various populations, at several locations, over a number of years and seasons. Different marker loci, such as A (d) /a (0), Sh/sh, Cr/cr and Pl/pl, were used to determine the male gametes which had effected fertilization. The results showed that the frequency of outcrossing was extremely variable among loci, crosses and samples within a single locus. The outcrossing parameter, α, was found to differ with years, locations and seasons within years. It was also found that outcrossing, in general, was nonrandom. Nonrandomness was also independent of flowering dates. The amount of outcrossing was directly associated with the frequency of F 2 plants flowering at different dates. A recalculated outcrossing parameter from different authors' reported data, representing different years and locations, has been found to be nonrandom. It was observed that the propensity to outcross was not a simple function of changing gene frequency but was associated with the genotype of individual selected.

Strand-seq: a unifying tool for studies of chromosome segregation

PubMed Central

Falconer, Ester; Lansdorp, Peter M.

2013-01-01

Non random segregation of sister chromatids has been implicated to help specify daughter cell fate (the Silent Sister Hypothesis [1]) or to protect the genome of long-lived stem cells (the Immortal Strand Hypothesis [2]). The idea that sister chromatids are non-randomly segregated into specific daughter cells is only marginally supported by data in sporadic and often contradictory studies. As a result, the field has moved forward rather slowly. The advent of being able to directly label and differentiate sister chromatids in vivo using fluorescence in situ hybridization [3] was a significant advance for such studies. However, this approach is limited by the need for large tracks of unidirectional repeats on chromosomes and the reliance on quantitative imaging of fluorescent probes and rigorous statistical analysis to discern between the two competing hypotheses. A novel method called Strand-seq which uses next-generation sequencing to assay sister chromatid inheritance patterns independently for each chromosome [4] offers a comprehensive approach to test for non-random segregation. In addition Strand-seq enables studies on the deposition of chromatin marks in relation to DNA replication. This method is expected to help unify the field by testing previous claims of non-random segregation in an unbiased way in many model systems in vitro and in vivo. PMID:23665005

Long-term follow-up of DDD and VDD pacing: a prospective non-randomized single-centre comparison of patients with symptomatic atrioventricular block.

PubMed

Marchandise, Sébastien; Scavée, Christophe; le Polain de Waroux, Jean-Benoit; de Meester, Christophe; Vanoverschelde, Jean-Louis; Debbas, Nadia

2012-04-01

This prospective non-randomized single-centre registry compared clinical outcome, pacing parameters, and long-term survival in patients receiving VDD or DDD pacemaker (PMs) for symptomatic atrioventricular (AV) block. Single-lead VDD (n= 166) and DDD (n= 254) PMs were implanted in 420 successive patients with isolated AV block between January 2001 and December 2009. At the end of the follow-up period [median 25 (1-141) months], there was no difference in the incidence of atrial fibrillation [11.2% in the VDD group; 11.4% in the DDD group (P= 0.95)], myocardial infarction [31.1% in the VDD group; 25.2% in the DDD group (P= 0.20)], or dilated cardiomyopathy [9.9% in the VDD group; 8.9% in the DDD group (P= 0.74)]. At last follow-up, 65.9% of the VDD PMs and 89.3% of the DDD PMs were still programmed in their original mode with good atrial sensing. Due to permanent atrial fibrillation, 7.9% patients out of the VDD group had been switched to VVIR mode and 8.7% patients out of the DDD group to VVIR or DDIR mode. The P-wave amplitude was poor (sensed P-wave <0.5 mV) in 19.1% of the VDD PM and 1.6% of the DDD PM (P< 0.001) and 7.1% of the VDD patients and 0.4% of the DDD patients had been switched to VVIR pacing mode due to P-wave undersensing and AV dissociation (P= 0.003). Symptomatic atrial undersensing requiring upgrading was similar in both groups. The overall survival, adjusted for age, was not significantly different in the VDD and the DDD group (log rank: 0.26). Moreover, Cox survival analysis excluded the pacing mode as a significant predictor of mortality [hazard ratio (HR) = 0.79, confidence interval (CI) (0.46-1.35), P= 0.39]. Comparing VDD and DDD pacing, a significantly larger number of VDD-paced patients developed poor atrial signal detection without clinical impact. However, atrial under sensing did not influence the incidence of atrial fibrillation, myocardial infarction, dilated cardiomyopathy, or mortality.

Use of a transanal drainage tube for prevention of anastomotic leakage and bleeding after anterior resection for rectal cancer.

PubMed

Zhao, Wen-Tao; Hu, Feng-Liang; Li, Yu-Ying; Li, Hong-Jie; Luo, Wei-Ming; Sun, Feng

2013-01-01

The aim of the present study was to investigate the usefulness of the transanal drainage tube for prevention of anastomotic leakage and bleeding after anterior resection for rectal cancer. Between January 2007 and May 2011 a nonrandomized prospective study of patients undergoing anterior resection for rectal cancer was done. The patients were divided into the transanal drainage tube (TDT) and non-transanal drainage tube (NTDT) groups according to whether the transanal drainage tube was used in the operation. Clinical characteristics and postoperative complications were compared between the TDT and NTDT groups. The study included 81 patients in the TDT group and 77 patients in the NTDT group. In the TDT group, anastomotic leakage occurred in 2 patients and no anastomotic bleeding occurred. In the NTDT group, anastomotic leakage occurred in 7 patients and anastomotic bleeding occurred in 2 patients. The TDT group had significantly fewer anastomotic complications compared with the NTDT group (2.5 vs 11.7 %; P = 0.029). Furthermore, the TDT group showed an obvious reduction in the rate of anastomotic leakage and anastomotic bleeding compared with the NTDT group (2.5 vs 7.8 % and 0.0 vs 2.6 %), but because the number of cases is relatively small, the difference did not reach statistical significance (P = 0.160 and P = 0.236). The use of a transanal drainage tube in anterior resection for rectal cancer may be a simple, safe, and effective means of preventing or reducing the occurrence of anastomotic leakage and bleeding. A larger-scale single or multi-center prospective randomized study or a meta-analysis including similar studies is necessary for further elucidation of this issue.

Higher 5-hydroxymethylcytosine identifies immortal DNA strand chromosomes in asymmetrically self-renewing distributed stem cells.

PubMed

Huh, Yang Hoon; Cohen, Justin; Sherley, James L

2013-10-15

Immortal strands are the targeted chromosomal DNA strands of nonrandom sister chromatid segregation, a mitotic chromosome segregation pattern unique to asymmetrically self-renewing distributed stem cells (DSCs). By nonrandom segregation, immortal DNA strands become the oldest DNA strands in asymmetrically self-renewing DSCs. Nonrandom segregation of immortal DNA strands may limit DSC mutagenesis, preserve DSC fate, and contribute to DSC aging. The mechanisms responsible for specification and maintenance of immortal DNA strands are unknown. To discover clues to these mechanisms, we investigated the 5-methylcytosine and 5-hydroxymethylcytosine (5hmC) content on chromosomes in mouse hair follicle DSCs during nonrandom segregation. Although 5-methylcytosine content did not differ significantly, the relative content of 5hmC was significantly higher in chromosomes containing immortal DNA strands than in opposed mitotic chromosomes containing younger mortal DNA strands. The difference in relative 5hmC content was caused by the loss of 5hmC from mortal chromosomes. These findings implicate higher 5hmC as a specific molecular determinant of immortal DNA strand chromosomes. Because 5hmC is an intermediate during DNA demethylation, we propose a ten-eleven translocase enzyme mechanism for both the specification and maintenance of nonrandomly segregated immortal DNA strands. The proposed mechanism reveals a means by which DSCs "know" the generational age of immortal DNA strands. The mechanism is supported by molecular expression data and accounts for the selection of newly replicated DNA strands when nonrandom segregation is initiated. These mechanistic insights also provide a possible basis for another characteristic property of immortal DNA strands, their guanine ribonucleotide dependency.

Risk factors for bowel dysfunction after sphincter-preserving rectal cancer surgery: a prospective study using the Memorial Sloan Kettering Cancer Center bowel function instrument.

PubMed

Ihn, Myong Hoon; Kang, Sung-Bum; Kim, Duck-Woo; Oh, Heung-Kwon; Lee, Soo Young; Hong, Sa Min

2014-08-01

Until recently, no studies have prospectively evaluated bowel function after sphincter-preserving surgery for rectal cancer with the use of a validated bowel function scoring system. The aim of this study was to investigate possible risk factors for altered bowel function after sphincter-preserving surgery. This was a prospective study. The study was conducted between January 2006 and May 2012 at the authors' institution. Patients who underwent sphincter-preserving rectal cancer surgery were recruited. Bowel function was assessed 1 day before (baseline) and at 1 year after sphincter-preserving surgery or temporary ileostomy takedown with the use of the Memorial Sloan Kettering Cancer Center questionnaire. Multivariable analysis was performed to identify the factors associated with altered bowel function after surgery. Overall, 266 patients were eligible for the analysis. The tumor was located in the upper, middle, and lower rectum in 68 (25.5%), 113 (42.5%), and 85 (32.0%) patients. Intersphincteric resection and temporary ileostomy were performed in 18 (6.8%) and 129 (48.5%) patients. The mean Memorial Sloan Kettering Cancer Center score was 64.5 ± 7.6 at 1 year after sphincter-preserving surgery or temporary ileostomy takedown. The Memorial Sloan Kettering Cancer Center score decreased in 163/266 patients (61.3%) between baseline and 1 year after surgery. Tumor location (p = 0.01), operative method (p = 0.03), anastomotic type (p = 0.01), and temporary ileostomy (p = 0.01) were associated with altered bowel function after sphincter-preserving surgery in univariate analyses. In multivariable analysis, only tumor location was independently associated with impaired bowel function after sphincter-preserving rectal cancer surgery. This study was limited by its nonrandomized design and the lack of measurement before preoperative chemoradiotherapy. We suggest that preoperative counseling should be implemented to inform patients of the risk of bowel dysfunction, especially in patients with lower rectal cancer, although this study cannot exclude the effect of chemoradiotherapy owing to the limitation of study.

Chromosome and cell wall segregation in Streptococcus faecium ATCC 9790

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

Higgins, M.L.; Glaser, D.; Dicker, D.T.

1989-01-01

Segregation was studied by measuring the positions of autoradiographic grain clusters in chains formed from single cells containing on average less than one radiolabeled chromosome strand. The degree to which chromosomal and cell wall material cosegregated was quantified by using the methods of S. Cooper and M. Weinberger, dividing the number of chains labeled at the middle. This analysis indicated that in contrast to chromosomal segregation in Escherichia coli and, in some studies, to that in gram-positive rods, chromosomal segregation in Streptococcus faecium was slightly nonrandom and did not vary with growth rate. Results were not significantly affected by strandmore » exchange. In contrast, labeled cell wall segregated predominantly nonrandomly.« less

Soft tissue infection after missile injuries to the extremities--a non-randomized, prospective study in Gaza City.

PubMed

Hamouda, Hazem M; Witsø, Eivind; Moghani, Nedal K E; Shahwan, Ahmed; Nygaard, Oystein P

2007-01-01

Patients with soft tissue injuries caused by missile attacks during wartime have been treated with radical debridement and delayed closure. In a study in Gaza City, the rate of infection of missile injuries to the extremities when treated with minimal surgical intervention, was measured. Patients with severe soft tissue damage, compound fractures, and injuries to major blood vessels and/or nerves were excluded from the study. One hundred fourteen patients were treated according to a standardized regime that included a superficial, minor surgery revision of the inlet and the outlet opening, and antibiotic treatment. Local soft tissue infection was defined as the presence of at least two signs of local infection. A total of 109 out of 114 patients attended the first follow-up visit. Eleven (10%) of these patients had an infected wound. A total of 105 of the patients (92%) attended a second follow-up. None of these patients had an infected wound. Under conditions with a high number of casualties, minimal surgical treatment followed by the administration of antibiotics is a safe procedure for patients with penetrating missile injuries and less severe soft tissue damage.

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly.

PubMed

Tamber, Mandeep S; Nikas, Dimitrios; Beier, Alexandra; Baird, Lissa C; Bauer, David F; Durham, Susan; Klimo, Paul; Lin, Alexander Y; Mazzola, Catherine; McClung-Smith, Catherine; Mitchell, Laura; Tyagi, Rachana; Flannery, Ann Marie

2016-11-01

No evidence-based guidelines exist on the role of cranial-molding orthosis (helmet) therapy for patients with positional plagiocephaly. To address the clinical question: "Does helmet therapy provide effective treatment for positional plagiocephaly?" and to make treatment recommendations based on the available evidence. The US National Library of Medicine Medline database and the Cochrane Library were queried by using MeSH headings and key words relevant to the objective of this systematic review. Abstracts were reviewed, after which studies meeting the inclusion criteria were selected and graded according to their quality of evidence (Classes I-III). Evidentiary tables were constructed that summarized pertinent study results, and, based on the quality of the literature, recommendations were made (Levels I-III). Fifteen articles met criteria for inclusion into the evidence tables. There was 1 prospective randomized controlled trial (Class II), 5 prospective comparative studies (Class II), and 9 retrospective comparative studies (Class II). There is a fairly substantive body of nonrandomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy. Specific criteria regarding the measurement and quantification of deformity and the most appropriate time window in infancy for treatment of positional plagiocephaly with a helmet remains elusive. In general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shape. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_5.

Guidelines: Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly.

PubMed

Tamber, Mandeep S; Nikas, Dimitrios; Beier, Alexandra; Baird, Lissa C; Bauer, David F; Durham, Susan; Klimo, Paul; Lin, Alexander Y; Mazzola, Catherine; McClung-Smith, Catherine; Mitchell, Laura; Tyagi, Rachana; Flannery, Ann Marie

2016-11-01

No evidence-based guidelines exist on the role of cranial-molding orthosis (helmet) therapy for patients with positional plagiocephaly. To address the clinical question: "Does helmet therapy provide effective treatment for positional plagiocephaly?" and to make treatment recommendations based on the available evidence. The US National Library of Medicine Medline database and the Cochrane Library were queried by using MeSH headings and key words relevant to the objective of this systematic review. Abstracts were reviewed, after which studies meeting the inclusion criteria were selected and graded according to their quality of evidence (Classes I-III). Evidentiary tables were constructed that summarized pertinent study results, and, based on the quality of the literature, recommendations were made (Levels I-III). Fifteen articles met criteria for inclusion into the evidence tables. There was 1 prospective randomized controlled trial (Class II), 5 prospective comparative studies (Class II), and 9 retrospective comparative studies (Class II). There is a fairly substantive body of nonrandomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy. Specific criteria regarding the measurement and quantification of deformity and the most appropriate time window in infancy for treatment of positional plagiocephaly with a helmet remains elusive. In general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shape. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_5.

Role of antibiotic prophylaxis in antenatal hydronephrosis: A systematic review from the European Association of Urology/European Society for Paediatric Urology Guidelines Panel.

PubMed

Silay, Mesrur Selcuk; Undre, Shabnam; Nambiar, Arjun K; Dogan, Hasan Serkan; Kocvara, Radim; Nijman, Rien J M; Stein, Raimund; Tekgul, Serdar; Radmayr, Christian

2017-06-01

The benefits and harms of continuous antibiotic prophylaxis (CAP) versus observation in patients with antenatal hydronephrosis (ANH) are controversial. The aim was to determine the effectiveness of CAP for ANH, and if beneficial to determine the best type and regimen of antibiotic and the most harmful to provide guidance for clinical practice. A systematic literature search was performed in databases including Medline, Embase, and Cochrane in June 2015. The protocol was prospectively registered to PROSPERO (CRD42015024775). The search started from 1980, when maternal ultrasound was first introduced into clinical practice. Eligible studies were critically evaluated for risk of bias using Revman software. The outcomes included reduction in urinary tract infections (UTI), drug-related adverse events and kidney functions. Of 797 articles identified, 57 full text articles and six abstracts were eligible for inclusion (2 randomized controlled trials, 11 non-randomized comparative studies, and 50 case series). It remains unclear whether CAP is superior to observation in decreasing UTIs. No conclusion could be drawn for drug-related adverse events and kidney function because of lack of data. Children who were not circumcised, with ureteral dilatation, and high-grade hydronephrosis may be more likely to develop UTI, and CAP may be warranted for these subgroups of patients. A majority of the studies had low-to-moderate quality of evidence and with high risk of bias. The benefits of CAP in a heterogeneous group of children with ANH involving different etiologies remains unproven. However, the evidence in the form of prospective and retrospective observational studies has shown that it reduces febrile UTI in particular subgroups. Copyright © 2017 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF).

PubMed

Angermann, Christiane E; Assmus, Birgit; Anker, Stefan D; Brachmann, Johannes; Ertl, Georg; Köhler, Friedrich; Rosenkranz, Stephan; Tschöpe, Carsten; Adamson, Philip B; Böhm, Michael

2018-05-19

Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States. MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland. After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject's 12-month visit. The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems. ClinicalTrials.gov; NCT02693691.

Comparison of inflammatory responses following robotic and open colorectal surgery: a prospective study.

PubMed

Zawadzki, Marek; Krzystek-Korpacka, Malgorzata; Gamian, Andrzej; Witkiewicz, Wojciech

2017-03-01

Robotic colorectal surgery continues to rise in popularity, but there remains little evidence on the stress response following the procedure. The aim of this study was to evaluate the inflammatory response to robotic colorectal surgery and compare it with the response generated by open colorectal surgery. This was a prospective nonrandomized comparative study involving 61 patients with colorectal cancer. The evaluation of inflammatory response to either robotic or open colorectal surgery was expressed as changes in interleukin-1β, interleukin-1 receptor antagonist, interleukin-6, tumor necrosis factor-α, C-reactive protein, and procalcitonin during the first three postoperative days. Of the 61 patients, 33 underwent robotic colorectal surgery while 28 had open colorectal surgery. Groups were comparable with respect to age, sex, BMI, cancer stage, and type of resection. The relative increase of interleukin-1 receptor antagonist at 8 h postoperative, compared to baseline, was higher in the open group (P = 0.006). The decrease of interleukin-1 receptor antagonist on postoperative days 1 and 3, compared to the maximum at 8 h, was more pronounced in the open group than in the robotic group (P = 0.008, P = 0.006, respectively), and the relative increase of interleukin-6 at 8 h after incision was higher in the open group (P = 0.007). The relative increase of procalcitonin on postoperative days 1 and 3 was higher in the open group than the robotic group (P < 0.001, P = 0.004, respectively). This study shows that when compared with open colorectal surgery, robotic colorectal surgery results in a less pronounced inflammatory response and more pronounced anti-inflammatory action.

A new partially covered metal stent for palliation of malignant dysphagia: a prospective follow-up study.

PubMed

van Boeckel, Petra G; Siersema, Peter D; Sturgess, Richard; Dwyer, Laura; Raijman, Isaac; Hirdes, Meike M; Vleggaar, Frank P

2010-12-01

Metal stents are frequently used for palliation of malignant dysphagia. Recently, a new stent design, the partially covered Wallflex stent (Boston Scientific, Natick, Mass), has been introduced. To determine clinical effectiveness and safety of the esophageal Wallflex stent for the palliation of dysphagia. A prospective follow-up study evaluating a new stent design. Three tertiary-care referral centers. This study involved 37 patients with cancer of the esophagus or gastric cardia. Stent placement. Data were collected regarding technical and clinical outcome, complications, recurrent dysphagia, and survival. A total of 37 patients (median age, 67 years; range, 48-84 years; 22 men [59%]) had a Wallflex stent placed. Stent placement was technically successful in all but 1 patient. Dysphagia improved from a median dysphagia score of 3 (ability to swallow liquids only) to 1 (ability to eat some solid foods) 4 weeks after stent placement. Major complications occurred in 3 patients (8%; pneumonia in 1, severe pain in 2), and 1 patient (3%) died from a complication (pneumonia). Minor complications included mild retrosternal pain in 10 patients (27%) and regurgitation in 7 patients (19%). In total, 8 patients (22%) developed recurrent dysphagia because of stent migration (n = 2 [6%]), food impaction (n = 2 [6%]), or tissue ingrowth or overgrowth (n = 4 [10%]). Nonrandomized study design. Placement of a partially covered Wallflex stent is safe and effective for the palliation of malignant dysphagia, with migration and tissue in- and overgrowth rates comparable to those of similarly designed stents. Retrosternal pain may occur more often with this stent than with other stent designs. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study.

PubMed

Lefevre, N; Klouche, S; de Pamphilis, O; Herman, S; Gerometta, A; Bohu, Y

2016-11-01

Femoral nerve block (FNB) is considered as a major advance in anterior cruciate ligament (ACL) reconstruction as it reduces the need for parenteral opioids. However, the incidence of transient or even permanent neurological deficits due to the FNB is estimated at 1.94% after knee surgery. The primary objective of this study was to compare local infiltration analgesia (LIA) to FNB during ACL reconstruction procedures. The study hypothesis was that LIA was not less effective than FNB on early postoperative pain. A retrospective analysis of data collected prospectively in the FAST cohort included a series of continuous patients who underwent primary repair for isolated ACL with a hamstring graft in 2013-2014. Changes in our anesthesia practices over time allowed us to form three successive groups: Group 1 - FNB, Group 2 - FNB+LIA, Group 3 - LIA only. Ultrasound-guided FNB was done pre-operatively. The LIA was done at the end of the procedure by the surgeon with systematic infiltration of all skin incisions and the hamstring donor site; no intra-articular injections were performed. The primary endpoint was the average early postoperative pain (Days 0-3) described by the patient on a visual analogue scale (0-10). Sample size calculation pointed to 36 subjects being needed per group for a non-inferiority study. The study involved 126 patients: G1=42, G2=38, G3=46. The patients were comparable at enrolment. The average early postoperative pain levels were 3.1±2.4, 2.8±2.0 and 2.5±2.2, respectively (P=0.66). A trend toward higher intake of tramadol was noted in the LIA group on D0 to D3, with a significant trend test on Day 1 (P=0.03) and Day 2 (P=0.02). After reconstruction of isolated ACL tears with a hamstring graft, FNB is not more effective than LIA on patients' early postoperative pain. Patients who received a FNB consumed significantly less opioid-like analgesics. III - Prospective, comparative, non-randomized study. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Assessing the Quality of a Nonrandomized Pragmatic Trial for Primary Prevention of Falls among Older Adults

PubMed Central

Albert, Steven M.; Edelstein, Offer; King, Jennifer; Flatt, Jason; Lin, Chyongchiou J.; Boudreau, Robert; Newman, Anne B.

2014-01-01

Background Current approaches to falls prevention mostly rely on secondary and tertiary prevention and target individuals at high risk of falls. An alternative is primary prevention, in which all seniors are screened, referred as appropriate, and educated regarding falls risk. Little information is available on research designs that allow investigation of this approach in the setting of aging services delivery, where randomization may not be possible. Methods Healthy Steps for Older Adults, a statewide program of the Pennsylvania (PA) Department of Aging, involves a combination of education about falls and screening for balance problems, with referral to personal physicians and home safety assessments. We developed a nonrandomized statewide trial, Falls Free PA, to assess its effectiveness in reducing falls incidence over 12 months. We recruited 814 seniors who completed the program (503 first time participants, 311 people repeating the program) and 1020 who did not participate in the program, from the same sites. We assessed the quality of this nonrandomized design by examining recruitment, follow-up across study groups, and comparability at baseline. Results Of older adults approached in senior centers, 90.5% (n=2219) signed informed consent, and 1834 (82.4%) completed baseline assessments and were eligible for follow-up. Attrition in the three groups over 12 months was low and non-differential (<10% for withdrawal and <2% for other loss to follow-up). Median follow-up, which involved standardized monthly assessment of falls, was 10 months in all study groups. At baseline the groups did not differ in measures of health or falls risk factors. Conclusions Comparable status at baseline, recruitment from common sites, and similar experience with retention suggest that the nonrandomized design will be effective for assessment of this approach to primary prevention of falls. PMID:24488533

Assessing the quality of a non-randomized pragmatic trial for primary prevention of falls among older adults.

PubMed

Albert, Steven M; Edelstein, Offer; King, Jennifer; Flatt, Jason; Lin, Chyongchiou J; Boudreau, Robert; Newman, Anne B

2015-01-01

Current approaches to falls prevention mostly rely on secondary and tertiary prevention and target individuals at high risk of falls. An alternative is primary prevention, in which all seniors are screened, referred as appropriate, and educated regarding falls risk. Little information is available on research designs that allow investigation of this approach in the setting of aging services delivery, where randomization may not be possible. Healthy Steps for Older Adults, a statewide program of the Pennsylvania (PA) Department of Aging, involves a combination of education about falls and screening for balance problems, with referral to personal physicians and home safety assessments. We developed a non-randomized statewide trial, Falls Free PA, to assess its effectiveness in reducing falls incidence over 12 months. We recruited 814 seniors who completed the program (503 first-time participants, 311 people repeating the program) and 1,020 who did not participate in the program, from the same sites. We assessed the quality of this non-randomized design by examining recruitment, follow-up across study groups, and comparability at baseline. Of older adults approached in senior centers, 90.5 % (n = 2,219) signed informed consent, and 1,834 (82.4 %) completed baseline assessments and were eligible for follow-up. Attrition in the three groups over 12 months was low and non-differential (<10 % for withdrawal and <2 % for other loss to follow-up). Median follow-up, which involved standardized monthly assessment of falls, was 10 months in all study groups. At baseline, the groups did not differ in measures of health or falls risk factors. Comparable status at baseline, recruitment from common sites, and similar experience with retention suggest that the non-randomized design will be effective for assessment of this approach to primary prevention of falls.

Higher 5-hydroxymethylcytosine identifies immortal DNA strand chromosomes in asymmetrically self-renewing distributed stem cells

PubMed Central

Huh, Yang Hoon; Cohen, Justin; Sherley, James L.

2013-01-01

Immortal strands are the targeted chromosomal DNA strands of nonrandom sister chromatid segregation, a mitotic chromosome segregation pattern unique to asymmetrically self-renewing distributed stem cells (DSCs). By nonrandom segregation, immortal DNA strands become the oldest DNA strands in asymmetrically self-renewing DSCs. Nonrandom segregation of immortal DNA strands may limit DSC mutagenesis, preserve DSC fate, and contribute to DSC aging. The mechanisms responsible for specification and maintenance of immortal DNA strands are unknown. To discover clues to these mechanisms, we investigated the 5-methylcytosine and 5-hydroxymethylcytosine (5hmC) content on chromosomes in mouse hair follicle DSCs during nonrandom segregation. Although 5-methylcytosine content did not differ significantly, the relative content of 5hmC was significantly higher in chromosomes containing immortal DNA strands than in opposed mitotic chromosomes containing younger mortal DNA strands. The difference in relative 5hmC content was caused by the loss of 5hmC from mortal chromosomes. These findings implicate higher 5hmC as a specific molecular determinant of immortal DNA strand chromosomes. Because 5hmC is an intermediate during DNA demethylation, we propose a ten-eleven translocase enzyme mechanism for both the specification and maintenance of nonrandomly segregated immortal DNA strands. The proposed mechanism reveals a means by which DSCs “know” the generational age of immortal DNA strands. The mechanism is supported by molecular expression data and accounts for the selection of newly replicated DNA strands when nonrandom segregation is initiated. These mechanistic insights also provide a possible basis for another characteristic property of immortal DNA strands, their guanine ribonucleotide dependency. PMID:24082118

Epoetin alfa improves survival after chemoradiation for Stage III esophageal cancer: Final results of a prospective observational study

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

Rades, Dirk; Tribius, Silke; Yekebas, Emre F.

Purpose: This prospective, nonrandomized study evaluates the effectiveness of epoetin alfa to maintain the hemoglobin levels at 12 to14 g/dL (optimal range for tumor oxygenation) during chemoradiation for Stage III esophageal cancer and its impact on overall survival (OS), metastatic-free survival (MFS), and locoregional control (LC). Methods and Materials: Ninety-six patients were included. Forty-two patients received epoetin alfa (150 IU/kg, 3 times a week) during radiotherapy, which was started at hemoglobin less than 13 g/dL and stopped at 14 g/dL or higher. Hemoglobin levels were measured weekly during RT. Results: Both groups were balanced for age, sex, performance status, tumormore » length/location, histology, grading, T-stage/N-stage, chemotherapy, treatment schedule, and hemoglobin before RT. Median change of hemoglobin was +0.3 g/dL/wk with epoetin alfa and -0.5 g/dL/wk without epoetin alfa. At least 60% of hemoglobin levels were 12 to 14 g/dL in 64% and 17% of the patients, respectively (p < 0.001). Patients who received epoetin alfa had better OS (32% vs. 8% at 2 years, p = 0.009) and LC (67% vs. 15% at 2 years, p = 0.001). MFS was not significantly different (42% vs. 18% at 2 years, p = 0.09). Conclusions: The findings suggest that epoetin alfa when used to maintain the hemoglobin levels at 12 to 14 g/dL can improve OS and LC of Stage III esophageal cancer patients.« less

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

PubMed

Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

2015-10-07

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos).

PubMed

Canena, Jorge; Liberato, Manuel; Meireles, Liliane; Marques, Inês; Romão, Carlos; Coutinho, António Pereira; Neves, Beatriz Costa; Veiga, Pedro Mota

2015-07-01

Endoscopic management of postcholecystectomy biliary leaks is widely accepted as the treatment of choice. However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for this situation is unclear. To compare the clinical effectiveness of the use of a fully covered self-expandable metal stent (FCSEMS) with the placement of multiple plastic stents (MPS) for the treatment of postcholecystectomy refractory biliary leaks. Prospective study. Two tertiary-care referral academic centers and one general district hospital. Forty consecutive patients with refractory biliary leaks who underwent endoscopic management. Temporary placement of MPS (n = 20) or FCSEMSs (n = 20). Clinical outcomes of endotherapy as well as the technical success, adverse events, need for reinterventions, and prognostic factors for clinical success. Endotherapy was possible in all patients. After endotherapy, closure of the leak was accomplished in 13 patients (65%) who received MPS and in 20 patients (100%) who received FCSEMSs (P = .004). The Kaplan-Meier (log-rank) leak-free survival analysis showed a statistically significant difference between the 2 patient populations (χ(2) [1] = 8.30; P < .01) in favor of the FCSEMS group. Use of <3 plastic stents (P = .024), a plastic stent diameter <20F (P = .006), and a high-grade biliary leak (P = .015) were shown to be significant predictors of treatment failure with MPS. The 7 patients in whom placement of MPS failed were retreated with FCSEMSs, resulting in closure of the leaks in all cases. Non-randomized design. In our series, the results of the temporary placement of FCSEMSs for postcholecystectomy refractory biliary leaks were superior to those from the use of MPS. A randomized study is needed to confirm our results before further recommendations. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Strand-seq: a unifying tool for studies of chromosome segregation.

PubMed

Falconer, Ester; Lansdorp, Peter M

2013-01-01

Non random segregation of sister chromatids has been implicated to help specify daughter cell fate (the Silent Sister Hypothesis [1]) or to protect the genome of long-lived stem cells (the Immortal Strand Hypothesis [2]). The idea that sister chromatids are non-randomly segregated into specific daughter cells is only marginally supported by data in sporadic and often contradictory studies. As a result, the field has moved forward rather slowly. The advent of being able to directly label and differentiate sister chromatids in vivo using fluorescence in situ hybridization [3] was a significant advance for such studies. However, this approach is limited by the need for large tracks of unidirectional repeats on chromosomes and the reliance on quantitative imaging of fluorescent probes and rigorous statistical analysis to discern between the two competing hypotheses. A novel method called Strand-seq which uses next-generation sequencing to assay sister chromatid inheritance patterns independently for each chromosome [4] offers a comprehensive approach to test for non-random segregation. In addition Strand-seq enables studies on the deposition of chromatin marks in relation to DNA replication. This method is expected to help unify the field by testing previous claims of non-random segregation in an unbiased way in many model systems in vitro and in vivo. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

Ivabradine, a novel heart rate slower: is it a sword of double blades in patients with idiopathic dilated cardiomyopathy?

PubMed

Rayan, Mona; Tawfik, Mazen; Alabd, Ali; Gamal, Amr

2011-08-01

To prospectively assess the safety and efficacy of ivabradine in patients with idiopathic dilated cardiomyopathy. We included 35 patients with idiopathic dilated cardiomyopathy with an ejection fraction (EF) <40% and heart rate >70 beats/min despite optimal medical therapy, according to the international guidelines in this prospective, non-randomized, single-arm, open-label safety study. Ivabradine was used as an add-on therapy to the maximally tolerated b-blocker in an increasing titrated dose till a target dose of 15 mg/day or resting heart rate of 60 beats/min for 3 months. During follow-up period the safety, patient tolerance and efficacy of this drug were assessed. All patients underwent 12-lead resting electrocardiography and Holter monitoring at inclusion and after 3 months. Statistical analysis was accomplished using paired t-test and Pearson correlation analysis. We found a significant reduction in the resting heart rate by a mean of 25.9 ± 9.4%, without a significant change of blood pressure. There was no prolongation of PR, QTc or QRS durations. Ventricular ectopic activity showed significant reduction (p<0.001). There was a significant correlation between the resting heart rate, NYHA and left ventricular ejection fraction (p<0.001 for both). One patient developed photopsia and decompensation was observed in another patient. Ivabradine is a safe and effective drug in reducing resting heart rate, improving NYHA functional class without undesirable effects on conduction parameters or ectopic activity.

Gastric emptying evaluation by ultrasound prior colonoscopy: An easy tool following bowel preparation

PubMed Central

Coriat, Romain; Polin, Vanessa; Oudjit, Ammar; Henri, Franck; Dhooge, Marion; Leblanc, Sarah; Delchambre, Chantal; Esch, Anouk; Tabouret, Tessa; Barret, Maximilien; Prat, Frédéric; Chaussade, Stanislas

2014-01-01

AIM: To investigate the gastric emptying after bowel preparation to allow general anaesthesia. METHODS: A prospective, non-comparative, and non-randomized trial was performed and registered on Eudra CT database (2011-002953-80) and on www.trial.gov (NCT01398098). All patients had a validated indication for colonoscopy and a preparation using sodium phosphate (NaP) tablets. The day of the procedure, patients took 4 tablets with 250 mL of water every 15 min, three times. The gastric volume was estimated every 15 min from computed antral surfaces and weight according to the formula of Perlas et al (Anesthesiology, 2009). Colonoscopy was performed within the 6 h following the last intake. RESULTS: Thirty patients were prospectively included in the study from November 2011 to May 2012. The maximum volume of the antrum was 212 mL, achieved 15 min after the last intake. 24%, 67% and 92% of subjects had an antral volume below 20 mL at 60, 120 and 150 min, respectively. 81% of patients had a Boston score equal to 2 or 3 in each colonic segment. No adverse events leading to treatment discontinuation were reported. CONCLUSION: Gastric volume evaluation appeared to be a simple and reliable method for the assessment of gastric emptying. Data allow considering the NaP tablets bowel preparation in the morning of the procedure and confirming that gastric emptying is achieved after two hours, allowing general anaesthesia. PMID:25309090

Efficacy of Distortion Product Oto-Acoustic Emission (OAE)/Auditory Brainstem Evoked Response (ABR) Protocols in Universal Neonatal Hearing Screening and Detecting Hearing Loss in Children <2 Years of Age.

PubMed

Mishra, Girish; Sharma, Yojana; Mehta, Kanishk; Patel, Gunjan

2013-04-01

Deafness is commonest curable childhood handicap. Most remedies and programmes don't address this issue at childhood level leading to detrimental impact on development of newborns. Aims and objectives are (A) screen all newborns for deafness and detect prevalence of deafness in children less than 2 years of age. and (B) assess efficacy of multi-staged OAE/ABR protocol for hearing screening. Non-randomized, prospective study from August 2008 to August 2011. All infants underwent a series of oto-acoustic emission (OAE) and final confirmatory auditory brainstem evoked response (ABR) audiometry. Finally, out of 1,101 children, 1,069 children passed the test while 12 children had impaired hearing after final testing, confirmed by ABR. Positive predictive value of OAE after multiple test increased to 100 %. OAE-ABR test series is effective in screening neonates and multiple tests reduce economic burden. High risk screening will miss nearly 50 % deaf children, thus universal screening is indispensable in picking early deafness.

The Role of Unilateral Balloon Kyphoplasty for the Treatment of Patients with OVCFS: A Systematic Review and Meta-Analysis.

PubMed

Xiang, Guang-Heng; Tong, Min-Ji; Lou, Chao; Zhu, Si-Pin; Guo, Wei Jun; Ke, Chen Rong

2018-05-01

An increasing number of studies have been conducted to apply unilateral balloon kyphoplasty in the treatment of ostroporotic vertebral compression fractures (OVCFs). However, the efficacy and safety of unilateral kyphoplasty and whether a unilateral or a bilateral approach is superior is controversial. The purpose of this study was to evaluate the role of unilateral balloon kyphoplasty and use meta-analysis to compare the efficacy and safety of unilateral and bilateral kyphoplasty in patients with OVCFs. A systematic literature search was conducted from 1970 to April 2017 using Medline database and the Cochrane Central Register of Controlled Trials. Articles were limited to those published in English. Randomized controlled trials and nonrandomized comparative studies were also included. The following search terms were used: "osteoporotic vertebral compression fractures," or "OVCF," and "unilateral kyphoplasty," or "unipedicular approach," or "single balloon kyphoplasty," or "one balloon kyphoplasty." A comprehensive search of reference lists of retrieved articles and previous published reviews was also performed to ensure inclusion of all possible studies. All potential articles were independently reviewed by 2 investigators for inclusion into the final analysis. MINORS score was used for nonrandomized studies, and Detsky quality index was applied for prospective randomized controlled trials. Systematic review and meta-analysis was performed for the included studies. After unilateral balloon kyphoplasty the mean postoperative visual analog score (VAS) was from 1.74 to 4.77, mean postoperative kyphotic angle was from 5.9º to 11.22º, and complications involving cement leaks was from 6.8 to 21.9% or adjacent level fractures was from 0 to 5.6%). Unilateral kyphoplasty had significantly lower operative time, and less bone cement volume; however, the postoperative VAS, Oswestry Disability Index (ODI), vertebral height restoration rate, and cement leakage and adjacent vertebral fracture rate, were similar to bilateral kyphoplasty. Only 6 randomized controlled trials and 3 retrospective comparative studies were selected for analysis. Heterogeneity was detected among the studies when we pooled the outcomes. Based on the available evidence, the clinical and radiological results of unilateral balloon kyphoplasty were as good as those of bilateral balloon kyphoplasty for the treatment of OVCFs. And unilateral kyphoplasty had advantages in terms of operation time, radiation exposure, and cost. Unilateral balloon kyphoplasty, bilateral balloon kyphoplasty, osteoporotic vertebral compression fractures, complications of balloon kyphoplasty, meta-analysis.

The Nonrandom Distribution of Interior Landforms for 100-km Diameter Craters on Mercury Suggests Regional Variations in Near-Surface Mechanical Properties

NASA Astrophysics Data System (ADS)

Herrick, R. R.

2018-05-01

There is great diversity of appearance in the interiors of 100-km diameter craters. The spatial distribution of interior landforms is clustered and nonrandom, but does not clearly correlate with Mercury's surface geology patterns.

Weight distributions for turbo codes using random and nonrandom permutations

NASA Technical Reports Server (NTRS)

Dolinar, S.; Divsalar, D.

1995-01-01

This article takes a preliminary look at the weight distributions achievable for turbo codes using random, nonrandom, and semirandom permutations. Due to the recursiveness of the encoders, it is important to distinguish between self-terminating and non-self-terminating input sequences. The non-self-terminating sequences have little effect on decoder performance, because they accumulate high encoded weight until they are artificially terminated at the end of the block. From probabilistic arguments based on selecting the permutations randomly, it is concluded that the self-terminating weight-2 data sequences are the most important consideration in the design of constituent codes; higher-weight self-terminating sequences have successively decreasing importance. Also, increasing the number of codes and, correspondingly, the number of permutations makes it more and more likely that the bad input sequences will be broken up by one or more of the permuters. It is possible to design nonrandom permutations that ensure that the minimum distance due to weight-2 input sequences grows roughly as the square root of (2N), where N is the block length. However, these nonrandom permutations amplify the bad effects of higher-weight inputs, and as a result they are inferior in performance to randomly selected permutations. But there are 'semirandom' permutations that perform nearly as well as the designed nonrandom permutations with respect to weight-2 input sequences and are not as susceptible to being foiled by higher-weight inputs.

No evidence for MHC class II-based non-random mating at the gametic haplotype in Atlantic salmon.

PubMed

Promerová, M; Alavioon, G; Tusso, S; Burri, R; Immler, S

2017-06-01

Genes of the major histocompatibility complex (MHC) are a likely target of mate choice because of their role in inbreeding avoidance and potential benefits for offspring immunocompetence. Evidence for female choice for complementary MHC alleles among competing males exists both for the pre- and the postmating stages. However, it remains unclear whether the latter may involve non-random fusion of gametes depending on gametic haplotypes resulting in transmission ratio distortion or non-random sequence divergence among fused gametes. We tested whether non-random gametic fusion of MHC-II haplotypes occurs in Atlantic salmon Salmo salar. We performed in vitro fertilizations that excluded interindividual sperm competition using a split family design with large clutch sample sizes to test for a possible role of the gametic haplotype in mate choice. We sequenced two MHC-II loci in 50 embryos per clutch to assess allelic frequencies and sequence divergence. We found no evidence for transmission ratio distortion at two linked MHC-II loci, nor for non-random gamete fusion with respect to MHC-II alleles. Our findings suggest that the gametic MHC-II haplotypes play no role in gamete association in Atlantic salmon and that earlier findings of MHC-based mate choice most likely reflect choice among diploid genotypes. We discuss possible explanations for these findings and how they differ from findings in mammals.

Stem cells in sepsis and acute lung injury.

PubMed

Cribbs, Sushma K; Matthay, Michael A; Martin, Greg S

2010-12-01

Sepsis and acute lung injury continue to be major causes of morbidity and mortality worldwide despite advances in our understanding of pathophysiology and the discovery of new management strategies. Recent investigations show that stem cells may be beneficial as prognostic biomarkers and novel therapeutic strategies in these syndromes. This article reviews the potential use of endogenous adult tissue-derived stem cells in sepsis and acute lung injury as prognostic markers and also as exogenous cell-based therapy. A directed systematic search of the medical literature using PubMed and OVID, with particular emphasis on the time period after 2002, was done to evaluate topics related to 1) the epidemiology and pathophysiology of sepsis and acute lung injury; and 2) the definition, characterization, and potential use of stem cells in these diseases. DATA SYNTHESIS AND FINDINGS: When available, preferential consideration was given to prospective nonrandomized clinical and preclinical studies. Stem cells have shown significant promise in the field of critical care both for 1) prognostic value and 2) treatment strategies. Although several recent studies have identified the potential benefit of stem cells in sepsis and acute lung injury, further investigations are needed to more completely understand stem cells and their potential prognostic and therapeutic value.

Evaluation of some essential element levels in thalassemia major patients in Mosul district, Iraq.

PubMed

Al-Samarrai, Abdulmunaim H; Adaay, Mohaisen H; Al-Tikriti, Khudhair A; Al-Anzy, Muayed M

2008-01-01

To evaluate the levels of some essential elements in thalassemic patients in Mosul, Iraq. One hundred and five thalassemic blood transfusion dependent children, 2.5-18 years of age attending Ibn-Al-Atheer teaching hospital in Mosul City, Iraq, during 2005, were used in this study. Fifty-four healthy subjects served as a control group. Patients were allocated in a non-randomized prospective cross-sectional hospital based study. Essential elements levels were estimated. The mean, standard deviation, correlation coefficient, and z-test were used. P-values <0.05 were considered statistically significant. Low serum zinc, and magnesium, and high serum copper, and potassium levels were found among the 105 thalassemic patients compared to the 54 controls. Levels of calcium, phosphate, and sodium were within normal limits. Fluctuations in the essential elements levels seem to be related to the different complications associated with the disease. Zinc deficiency may be attributed to hyperzincuria resulted from the release of Zn from hemolyzed red cells. Hypercupremia occurs in acute and chronic infections and hemochromatosis, which is a principal complication of thalassemia. Increased Na levels may be due to renal damage. Hypomagnesemia may occur due to hypoparathyroidism.

Buprenorphine Treatment of Opioid-Dependent Pregnant Women: A Comprehensive Review

PubMed Central

Jones, Hendrée E.; Arria, Amelia M.; Baewert, Andjela; Heil, Sarah H.; Kaltenbach, Karol; Martin, Peter R.; Coyle, Mara G.; Selby, Peter; Stine, Susan M.; Fischer, Gabriele

2015-01-01

Aims This paper reviews the published literature regarding outcomes following maternal treatment with buprenorphine in five areas: maternal efficacy, fetal effects, neonatal effects, effects on breast milk, and longer-term developmental effects. Methods Within each outcome area, findings are summarized first for the 3 randomized controlled trials and then for the 44 non-randomized studies (i.e., prospective studies, case reports and series, and retrospective chart reviews), only 28 of which involve independent samples. Results Results indicate that maternal treatment with buprenorphine has comparable efficacy to methadone, although difficulties may exist with current buprenorphine induction methods. The available fetal data suggest buprenorphine results in less physiologic suppression of fetal heart rate and movements than methadone. Regarding neonatal effects, perhaps the single definitive conclusion is that prenatal buprenorphine treatment results in a clinically significant less severe neonatal abstinence syndrome (NAS) than treatment with methadone. The limited research suggests that, like methadone, buprenorphine is compatible with breastfeeding. Data available thus far suggest that there are no deleterious effects of in utero buprenorphine exposure on infant development. Conclusions Buprenorphine produces a less severe neonatal abstinence syndrome than methadone, but there is still a role for methadone in the treatment of opioid dependence during pregnancy. PMID:23106923

Round window electrode insertion potentiates retention in the scala tympani.

PubMed

Connor, Stephen E J; Holland, N Julian; Agger, Andreas; Leong, Annabelle C; Varghese, Re Ajay; Jiang, Dan; Fitzgerald O'Connor, Alec

2012-09-01

The round window membrane (RWM)-intentioned approach is superior to the traditional bony cochleostomy (BC) approach in obtaining electrode placement within the scala tympani (ST). Cochlear implant outcome is influenced by several factors, including optimal placement and retention of the electrode array within the ST. The present study aimed to assess whether the RWM route is superior to a traditional BC for placement and retention of the electrode array in the ST. This was a prospective consecutive non-randomized comparison study. All patients were implanted with the Advanced Bionics 1J electrode array. The RWM approach (n = 32) was compared with a traditional BC group (n = 33). The outcome measure was the electrode position as judged within the scalar chambers at four points along the basal turn using postoperative computed tomography (CT). When the mean position scores were compared, the RWM-intentioned group had significantly more electrodes directed towards the ST compartment than the BC group (p < 0.001). The RWM electrodes achieved 94% ST retention compared with 64% for the BC group (p < 0.05). All electrodes stayed in the ST in the RWM group, whereas in the BC group 9% crossed from the ST to the scala vestibuli.

Development and evaluation of an audiology app for iPhone/iPad mobile devices.

PubMed

Larrosa, Francisco; Rama-Lopez, Julio; Benitez, Jesus; Morales, Jose M; Martinez, Asuncion; Alañon, Miguel A; Arancibia-Tagle, Diego; Batuecas-Caletrio, Angel; Martinez-Lopez, Marta; Perez-Fernandez, Nicolas; Gimeno, Carlos; Ispizua, Angel; Urrutikoetxea, Alberto; Rey-Martinez, Jorge

2015-01-01

The application described in this study appears to be accurate and valid, thus allowing calculation of a hearing handicap and assessment of the pure-tone air conduction threshold with iPhone/iPad devices. To develop and evaluate a newly developed professional, computer-based hearing handicap calculator and a manual hearing sensitivity assessment test for the iPhone and iPad (AudCal). Multi-center prospective non-randomized validation study. One hundred and ten consecutive adult participants underwent two hearing evaluations, a standard audiometry and a pure-tone air conduction test using AudCal with an iOS device. The hearing handicap calculation accuracy was evaluated comparing AudCal vs a web-based calculator. Hearing loss was found in 83 and 84 out of 220 standard audiometries and AudCal hearing tests (Cohen's Kappa = 0.89). The mean difference between AudCal and standard audiogram thresholds was -0.21 ± 6.38 dB HL. Excellent reliability and concordance between standard audiometry and the application's hearing loss assessment test were obtained (Cronbach's alpha = 0.96; intra-class correlation coefficient = 0.93). AudCal vs a web-based calculator were perfectly correlated (Pearson's r = 1).

Enhanced recovery pathways in pancreatic surgery: State of the art

PubMed Central

Pecorelli, Nicolò; Nobile, Sara; Partelli, Stefano; Cardinali, Luca; Crippa, Stefano; Balzano, Gianpaolo; Beretta, Luigi; Falconi, Massimo

2016-01-01

Pancreatic surgery is being offered to an increasing number of patients every year. Although postoperative outcomes have significantly improved in the last decades, even in high-volume centers patients still experience significant postoperative morbidity and full recovery after surgery takes longer than we think. In recent years, enhanced recovery pathways incorporating a large number of evidence-based perioperative interventions have proved to be beneficial in terms of improved postoperative outcomes, and accelerated patient recovery in the context of gastrointestinal, genitourinary and orthopedic surgery. The role of these pathways for pancreatic surgery is still unclear as high-quality randomized controlled trials are lacking. To date, non-randomized studies have shown that care pathways for pancreaticoduodenectomy and distal pancreatectomy are safe with no difference in postoperative morbidity, leading to early discharge and no increase in hospital readmissions. Hospital costs are reduced due to better organization of care and resource utilization. However, further research is needed to clarify the effect of enhanced recovery pathways on patient recovery and post-discharge outcomes following pancreatic resection. Future studies should be prospective and follow recent recommendations for the design and reporting of enhanced recovery pathways. PMID:27605881

A new fully covered metal stent for the treatment of benign and malignant dysphagia: a prospective follow-up study.

PubMed

Hirdes, Meike M C; Siersema, Peter D; Vleggaar, Frank P

2012-04-01

Fully covered self-expandable metal stents (FCSEMSs) are increasingly being used for malignant and benign strictures. Particularly in the latter, FCSEMSs are known for their high migration rates. A new FCSEMS with a dog-bone shape and internal covering was developed to reduce migration risk. To evaluate recurrent dysphagia and safety of the new FC stent in benign and malignant esophageal disorders. Prospective follow-up study. Tertiary referral center. Between November 2009 and February 2011, 48 consecutive patients (mean age 61 years, range 28-81 years) underwent FC stent placement for malignant (n = 33) or benign (n = 15) dysphagia. FC stent placement. Recurrent dysphagia and complications. Indications for FC stent placement included esophageal cancer (n = 28), extrinsic malignant compression (n = 4), recurrent malignancy after esophagectomy (n = 1), and refractory benign esophageal stricture (n = 15). In malignant strictures, recurrent dysphagia occurred in 5 patients (15%) because of stent migration (n = 3), tissue overgrowth (n = 1), and acute edema (n = 1). In benign strictures, stents were prematurely removed in 9 (60%) patients because of stent migration (n = 5), tissue overgrowth (n = 3), and pain (n = 1). Recurrent dysphagia occurred in all patients after stent removal. Major complications occurred in 10 patients (30%) with malignant strictures and in 3 patients (20%) with benign strictures and included severe pain and/or vomiting (n = 8), fistula formation (n = 2), bleeding (n = 2), and aspiration pneumonia (n = 1). Nonrandomized study design. Although the new FC stent effectively treats malignant dysphagia, it is associated with substantial major complications. In patients with refractory benign esophageal strictures, recurrent dysphagia occurs rapidly after removal of the new FC stent. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms.

PubMed

Spiotta, Alejandro M; Derdeyn, Colin P; Tateshima, Satoshi; Mocco, Jay; Crowley, R Webster; Liu, Kenneth C; Jensen, Lee; Ebersole, Koji; Reeves, Alan; Lopes, Demetrius K; Hanel, Ricardo A; Sauvageau, Eric; Duckwiler, Gary; Siddiqui, Adnan; Levy, Elad; Puri, Ajit; Pride, Lee; Novakovic, Roberta; Chaudry, M Imran; Turner, Raymond D; Turk, Aquilla S

2017-07-01

The safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial-the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial. To present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial. Aneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study. Thirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). Mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range 2.3-11.6 mm). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months. The results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist. Copyright © 2017 by the Congress of Neurological Surgeons

Metabolic effects of the contraceptive skin patch and subdermal contraceptive implant in Mexican women: A prospective study

PubMed Central

2014-01-01

Background The contraceptive skin patch (CSP) accepted by the U.S. FDA in 2001 includes ethinylestradiol and norelgestromine, whereas the subdermal contraceptive implant (SCI) has etonogestrel and is also approved by the FDA. In Mexico, both are now widely used for contraception but their effects on Mexican population are unknown. The objective of the study was to evaluate if these treatments induce metabolic changes in a sample of indigenous and mestizo Mexican women. Methods An observational, prospective, longitudinal, non-randomized study of women between 18 and 35 years of age assigned to CSP or SCI. We performed several laboratory tests: clinical chemistry, lipid profile, and liver and thyroid function tests. Also, serum levels of insulin, C-peptide, IGF-1, leptin, adiponectin, and C reactive protein were assayed. Results Sixty-two women were enrolled, 25 used CSP (0 indigenous; 25 mestizos) and 37 used SCI (18 indigenous; 19 mestizos). Clinical symptoms were relatively more frequent in the SCI group. Thirty-four contraceptive users gained weight without other clinical significant changes. After 4 months of treatment, significant changes were found in some biochemical parameters in both treatment groups. Most were clinically irrelevant. Interestingly, the percentage of users with an abnormal atherogenic index diminished from 75% to 41.6% after follow-up. Conclusions The CSP slightly modified the metabolic variables. Most changes were nonsignificant, whereas for SCI users changes were more evident and perhaps beneficial. Results of this attempt to evaluate the effects of contraceptives in mestizo and native-American populations show that clinical symptoms are frequent in Mexican users of CSP and SCI. Although these medications may affect some metabolic variables, these changes seem clinically irrelevant. Induction of abnormalities in other physiological pathways cannot be ruled out. PMID:24767248

Clinic teaching made easy: a prospective study of the American Academy of Dermatology core curriculum in primary care learners.

PubMed

McCleskey, Patrick E

2013-08-01

Dermatology instruction for primary care learners is limited, and the American Academy of Dermatology (AAD) has developed a new core curriculum for dermatology. This study sought to prospectively evaluate short-term knowledge acquisition and long-term knowledge retention after using the AAD core curriculum during a clinical dermatology clerkship. Resident physicians and physician assistant students performing clerkships at military dermatology clinics were given access to the AAD core curriculum teaching modules before their public availability. Knowledge acquisition was measured with pretests and posttests, and a follow-up quiz was given up to a year after the dermatology rotation to assess knowledge retention. In all, 82 primary care learners met inclusion criteria. Knowledge improved significantly from pretest to posttest (60.1 vs 77.4, P < .01). Of the 10 factors evaluated, only high use of the World Wide Web site was significantly associated with improved posttest scores (70.8 vs 82.2, P = .003). Long-term follow-up scores available from 38 participants were only slightly lower than their posttest scores (70.5 vs 78.9, P < .01) at a median time of 6.8 months after the clerkship. Students found the online modules clear, engaging, and worth their time and preferred them to other teaching methods such as textbook reading and lectures. The nonrandomized study was voluntary, so individual performance may be influenced by selection bias. The more learners used the online curriculum, the better they scored on the posttest. This demonstrates the efficacy of the AAD core curriculum in teaching its goals and objectives for primary care learners performing a dermatology clerkship. Copyright © 2012 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.

PubMed

Ciudad, Antonio; Gutiérrez, Miguel; Cañas, Fernando; Gibert, Juan; Gascón, Josep; Carrasco, José-Luis; Bobes, Julio; Gómez, Juan-Carlos; Alvarez, Enrique

2005-07-01

This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia. This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy. 339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (p<0.0001). Response rate was significantly higher in the OGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS. In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.

Use of Antegrade Continence Enema for the Treatment of Fecal Incontinence and Functional Constipation in Adults: A Systematic Review.

PubMed

Patel, Abhilasha S; Saratzis, Athanasios; Arasaradnam, Ramesh; Harmston, Christopher

2015-10-01

Antegrade continence enema is a proximal colonic stoma that allows antegrade lavage of the colon for the treatment of fecal incontinence and functional constipation. Its role in the treatment of these conditions in adults has not been established. This review aimed to evaluate the clinical response and complications of antegrade continence enema in the adult population. A systematic literature search of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases from January 1980 to October 2013 was conducted. Studies reporting clinical outcomes of antegrade continence enema in adult patients were considered. Only studies with participants aged 16 years and older were selected. Use of the antegrade continence enema for the treatment of constipation and incontinence in adults was investigated. The primary outcome was the number of patients irrigating their stoma. Secondary outcomes included the incidence of stoma stenosis, assessment of functional outcome, and evaluation of quality of life. Overall, 15 studies were selected, describing outcomes in 374 patients. All of the reports were observational cross-sectional studies, and 4 were prospective. The number of participants still using their stoma ranged from 47% to 100% over a follow-up period of 6 to 55 months. Eleven studies reported achievement of full continence in 33% to 100% of patients. Four studies described functional outcomes, and 7 studies reported a wide range of patient satisfaction. The rate of stoma stenosis varied from 8% to 50%. There were considerable heterogeneities within and across studies. Most studies were of poor quality, as reflected in the Methodological Index for Nonrandomized Studies score. Antegrade continence enema has been reported as an acceptable treatment of both functional constipation and fecal incontinence in adults across several analyses. There is wide variation regarding outcome measures. Larger prospective studies are required to assess the role of antegrade continence enema in the adult population.

An algorithmic programming approach for back pain symptoms in failed back surgery syndrome using spinal cord stimulation with a multicolumn surgically implanted epidural lead: a multicenter international prospective study.

PubMed

Rigoard, Philippe; Jacques, Line; Delmotte, Alexandre; Poon, Katherine; Munson, Russell; Monlezun, Olivier; Roulaud, Manuel; Prevost, Audrey; Guetarni, Farid; Bataille, Benoit; Kumar, Krishna

2015-03-01

Many studies have demonstrated the efficacy and the medical/economic value of epidural spinal cord stimulation for the treatment of "failed back surgery syndrome" (FBSS). However, the back pain component of FBSS has been recalcitrant. Recent clinical trials have suggested that multicolumn surgically implanted leads combined with enhanced programming capabilities in the newer implantable pulse generators demonstrate the ability to treat the back pain component of FBSS. The objective of our present international multicentre study is to prospectively evaluate these findings in a larger population. We conducted a prospective, nonrandomized, observational study on 76 patients with refractory FBSS, consecutively implanted with multicolumn spinal cord stimulation (SCS) between 2008 and 2011 in three neurosurgical pain management centers (Poitiers, France; Montréal, Canada; and Regina, Canada). The primary objective of this study was to prospectively analyze the effect of multicolumn lead programming on paresthesia coverage for the back pain region in these patients. The secondary objective was to assess the analgesic efficacy of this technique on the global and back pain components. Paresthesia could be induced in the lower extremities in the majority of patients with at least one of the configurations tested. Bilateral low back paresthesia was induced in 53.5% of patients, while unilateral low back paresthesia was induced in 78.9% of patients. Multicolumn configurations were statistically more effective than monocolumn configurations for all anatomic regions studied. At 6 months, 75.4% of patients receiving multicolumn stimulation (n = 57) obtained at least a 30% improvement of the back pain VAS score, while 42.1% of patients obtained at least a 50% improvement of the back pain VAS score. This study confirms the hypothesis that multicolumn SCS should be considered as an important tool in the treatment of radicular and axial pain in FBSS patients. The efficacy of this modality is based on a rigorous patient selection process, access to new generation lead technologies, but most importantly an algorithmic programming approach for optimal stimulation and electrical field shaping. With over 40 million potential programming combinations associated with 16 contact leads to achieve paresthesia coverage, optimal stimulation is often missed as either the patient or the clinician become exhausted or overwhelmed during the course of therapy programming and optimization session. © 2014 World Institute of Pain.

42 CFR 421.505 - Termination and extension of non-random prepayment complex medical review.

Code of Federal Regulations, 2010 CFR

2010-10-01

... prepayment complex medical review for that provider or supplier may be extended. However, if the number of... complex medical review. 421.505 Section 421.505 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... § 421.505 Termination and extension of non-random prepayment complex medical review. (a) Timeframe that...

Variation of mutational burden in healthy human tissues suggests non-random strand segregation and allows measuring somatic mutation rates.

PubMed

Werner, Benjamin; Sottoriva, Andrea

2018-06-01

The immortal strand hypothesis poses that stem cells could produce differentiated progeny while conserving the original template strand, thus avoiding accumulating somatic mutations. However, quantitating the extent of non-random DNA strand segregation in human stem cells remains difficult in vivo. Here we show that the change of the mean and variance of the mutational burden with age in healthy human tissues allows estimating strand segregation probabilities and somatic mutation rates. We analysed deep sequencing data from healthy human colon, small intestine, liver, skin and brain. We found highly effective non-random DNA strand segregation in all adult tissues (mean strand segregation probability: 0.98, standard error bounds (0.97,0.99)). In contrast, non-random strand segregation efficiency is reduced to 0.87 (0.78,0.88) in neural tissue during early development, suggesting stem cell pool expansions due to symmetric self-renewal. Healthy somatic mutation rates differed across tissue types, ranging from 3.5 × 10-9/bp/division in small intestine to 1.6 × 10-7/bp/division in skin.

Plasticity-Driven Self-Organization under Topological Constraints Accounts for Non-random Features of Cortical Synaptic Wiring

PubMed Central

Miner, Daniel; Triesch, Jochen

2016-01-01

Understanding the structure and dynamics of cortical connectivity is vital to understanding cortical function. Experimental data strongly suggest that local recurrent connectivity in the cortex is significantly non-random, exhibiting, for example, above-chance bidirectionality and an overrepresentation of certain triangular motifs. Additional evidence suggests a significant distance dependency to connectivity over a local scale of a few hundred microns, and particular patterns of synaptic turnover dynamics, including a heavy-tailed distribution of synaptic efficacies, a power law distribution of synaptic lifetimes, and a tendency for stronger synapses to be more stable over time. Understanding how many of these non-random features simultaneously arise would provide valuable insights into the development and function of the cortex. While previous work has modeled some of the individual features of local cortical wiring, there is no model that begins to comprehensively account for all of them. We present a spiking network model of a rodent Layer 5 cortical slice which, via the interactions of a few simple biologically motivated intrinsic, synaptic, and structural plasticity mechanisms, qualitatively reproduces these non-random effects when combined with simple topological constraints. Our model suggests that mechanisms of self-organization arising from a small number of plasticity rules provide a parsimonious explanation for numerous experimentally observed non-random features of recurrent cortical wiring. Interestingly, similar mechanisms have been shown to endow recurrent networks with powerful learning abilities, suggesting that these mechanism are central to understanding both structure and function of cortical synaptic wiring. PMID:26866369

Does a diet low in FODMAPs reduce symptoms associated with functional gastrointestinal disorders? A comprehensive systematic review and meta-analysis.

PubMed

Marsh, Abigail; Eslick, Enid M; Eslick, Guy D

2016-04-01

Functional gastrointestinal symptoms such as abdominal pain, bloating, distension, constipation, diarrhea and flatulence have been noted in patients with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD). The diversity of symptoms has meant that finding an effective treatment has been challenging with most treatments alleviating only the primary symptom. A novel treatment option for IBS and IBD currently generating much excitement is the low fermentable, oligo-, di-, mono-saccharides and polyol (FODMAP) diet. The aim of this meta-analysis was to determine the evidence of the efficacy of such a diet in the treatment of functional gastrointestinal symptoms. Electronic databases were searched through to March 2015 to identify relevant studies. Pooled odds ratios (ORs) and 95 % confidence intervals were calculated for the effect of a low FODMAP diet on the reduction in IBS [Symptoms Severity Score (SSS)] score and increase in IBS quality of life (QOL) score for both randomized clinical trials (RCTs) and non-randomized interventions using a random-effects model. Six RCTs and 16 non-randomized interventions were included in the analysis. There was a significant decrease in IBS SSS scores for those individuals on a low FODMAP diet in both the RCTs (OR 0.44, 95 % CI 0.25-0.76; I (2) = 35.52, p = 0.00) and non-randomized interventions (OR 0.03, 95 % CI 0.01-0.2; I (2) = 69.1, p = 0.02). In addition, there was a significant improvement in the IBS-QOL score for RCTs (OR 1.84, 95 % CI 1.12-3.03; I (2) = 0.00, p = 0.39) and for non-randomized interventions (OR 3.18, 95 % CI 1.60-6.31; I (2) = 0.00, p = 0.89). Further, following a low FODMAP diet was found to significantly reduce symptom severity for abdominal pain (OR 1.81, 95 % CI 1.13-2.88; I (2) = 0.00, p = 0.56), bloating (OR 1.75, 95 % CI 1.07-2.87; I (2) = 0.00, p = 0.45) and overall symptoms (OR 1.81, 95 % CI 1.11-2.95; I (2) = 0.00, p = 0.4) in the RCTs. In the non-randomized interventions similar findings were observed. The present meta-analysis supports the efficacy of a low FODMAP diet in the treatment of functional gastrointestinal symptoms. Further research should ensure studies include dietary adherence, and more studies looking at greater number of patients and long-term adherence to a low FODMAP diet need to be conducted.

[Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

PubMed

Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

2018-02-01

To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

Complications of fluoroscopically directed facet joint nerve blocks: a prospective evaluation of 7,500 episodes with 43,000 nerve blocks.

PubMed

Manchikanti, Laxmaiah; Malla, Yogesh; Wargo, Bradley W; Cash, Kimberly A; Pampati, Vidyasagar; Fellows, Bert

2012-01-01

Chronic spinal pain is common along with numerous modalities of diagnostic and therapeutic interventions utilized, creating a health care crisis. Facet joint injections and epidural injections are the 2 most commonly utilized interventions in managing chronic spinal pain. While the literature addressing the effectiveness of facet joint nerve blocks is variable and emerging, there is paucity of literature on adverse effects of facet joint nerve blocks. A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009. A private interventional pain management practice, a specialty referral center in the United States. Investigation of the incidence in characteristics of adverse effects and complications of facet joint nerve blocks. The study was carried out over a period of 20 months including almost 7,500 episodes of 43,000 facet joint nerve blocks with 3,370 episodes in the cervical region, 3,162 in the lumbar region, and 950 in the thoracic region. All facet joint nerve blocks were performed under fluoroscopic guidance in an ambulatory surgery center by 3 physicians. The complications encountered during the procedure and postoperatively were evaluated prospectively. This study was carried out over a period of 20 months and included over 7,500 episodes or 43,000 facet joint nerve blocks. All of the interventions were performed under fluoroscopic guidance in an ambulatory surgery center by one of 3 physicians. The complications encountered during the procedure and postoperatively were prospectively evaluated. Measurable outcomes employed were intravascular entry of the needle, profuse bleeding, local hematoma, dural puncture and headache, nerve root or spinal cord irritation with resultant injury, and infectious complications. There were no major complications. Multiple side effects and complications observed included overall intravascular penetration in 11.4% of episodes with 20% in cervical region, 4% in lumbar region, and 6% in thoracic region; local bleeding in 76.3% of episodes with highest in thoracic region and lowest in cervical region; oozing with 19.6% encounters with highest in cervical region and lowest in lumbar region; with local hematoma seen only in 1.2% of the patients with profuse bleeding, bruising, soreness, nerve root irritation, and all other effects such as vasovagal reactions observed in 1% or less of the episodes. Limitations of this study include lack of contrast injection, use of intermittent fluoroscopy and also an observational nature of the study. This study illustrate that major complications are extremely rare and minor side effects are common.

Update on bispectral index monitoring.

PubMed

Johansen, Jay W

2006-03-01

Since 1997, bispectral index (BIS; Aspect Medical Systems Inc., Natick, MA) has been in clinical practice and a wealth of experimental research has accumulated on its use. Originally, the device was approved only for monitoring hypnosis and has now received an indication for reducing the incidence of intraoperative awareness during anesthesia. Numerous studies have documented the ability of BIS to reduce intermediate outcomes such as hypnotic drug administration, extubation time, postoperative nausea and shortened recovery room discharge. Two recent large-scale outcome studies using BIS (one randomized controlled trial and one prospective, nonrandomized historical cohort study) identified an approximately 80% reduction in the incidence of recall after anesthesia. BIS provides clinicians with unique information that can be used to tailor hypnotic drug doses to individual patient requirements. BIS does not predict movement or hemodynamic response to stimulation, nor will it predict the exact moment consciousness returns. This review will also discuss other BIS applications including use in pediatrics, intensive care and for procedural sedation. Some limitations exist to the use of BIS and it is not useful for some individual hypnotic agents (ketamine, dexmedetomidine, nitrous oxide, xenon, opioids). BIS technology is moving out of the operating room and into diverse environments where conscious and deep sedation are provided. Anesthesiologists need to be actively involved in promoting patient safety and helping transition this technology into broader use.

Robotic versus Open Thyroidectomy for Differentiated Thyroid Cancer: An Evidence-Based Review.

PubMed

Liu, Shirley Yuk Wah; Ng, Enders Kwok Wai

2016-01-01

While open thyroidectomy (OT) is advocated as the gold standard treatment for differentiated thyroid cancer, the contemporary use of robotic thyroidectomy (RT) is often controversial. Although RT combines the unique benefits of the surgical robot and remote access thyroidectomy, its applicability on cancer patients is challenged by the questionable oncological benefits and safety. This review aims to analyze the current literature evidence in comparing RT to OT on thyroid cancers for their perioperative and oncological outcomes. To date, no randomized controlled trial is available in comparing RT to OT. All published studies are nonrandomized or retrospective comparisons. Current data suggests that RT compares less favorably than OT for longer operative time, higher cost, and possibly inferior oncological control with lower number of central lymph nodes retrieved. In terms of morbidity, quality of life outcomes, and short-term recurrence rates, RT and OT are comparable. While conventional OT continues to be appropriate for most thyroid cancers, RT should better be continued by expert surgeons on selected patients who have low-risk thyroid cancers and have high expectations on cosmetic outcomes. Future research should embark on prospective randomized studies for unbiased comparisons. Long-term follow-up studies are also needed to evaluate outcomes on recurrence and survival.

Yoga for Adults with Type 2 Diabetes: A Systematic Review of Controlled Trials

PubMed Central

Innes, Kim E.; Selfe, Terry Kit

2016-01-01

A growing body of evidence suggests yogic practices may benefit adults with type 2 diabetes (DM2). In this systematic review, we evaluate available evidence from prospective controlled trials regarding the effects of yoga-based programs on specific health outcomes pertinent to DM2 management. To identify qualifying studies, we searched nine databases and scanned bibliographies of relevant review papers and all identified articles. Controlled trials that did not target adults with diabetes, included only adults with type 1 diabetes, were under two-week duration, or did not include quantitative outcome data were excluded. Study quality was evaluated using the PEDro scale. Thirty-three papers reporting findings from 25 controlled trials (13 nonrandomized, 12 randomized) met our inclusion criteria (N = 2170 participants). Collectively, findings suggest that yogic practices may promote significant improvements in several indices of importance in DM2 management, including glycemic control, lipid levels, and body composition. More limited data suggest that yoga may also lower oxidative stress and blood pressure; enhance pulmonary and autonomic function, mood, sleep, and quality of life; and reduce medication use in adults with DM2. However, given the methodological limitations of existing studies, additional high-quality investigations are required to confirm and further elucidate the potential benefits of yoga programs in populations with DM2. PMID:26788520

Measurement of carotid pulse wave velocity using ultrafast ultrasound imaging in hypertensive patients.

PubMed

Li, Xiaopeng; Jiang, Jue; Zhang, Hong; Wang, Hua; Han, Donggang; Zhou, Qi; Gao, Ya; Yu, Shanshan; Qi, Yanhua

2017-04-01

The study aimed to assess the utility of ultrafast ultrasound imaging for evaluation of carotid pulse wave velocity (PWV) in newly diagnosed hypertension patients. This prospective non-randomized study enrolled 90 hypertensive patients in our hospital from September to December 2013 as a hypertension group. An age- and sex-matched cohort of 50 healthy adults in our hospital from September to December 2013 was also included in the study as a control group. Carotid PWV at the beginning and at the end of systole (PWV-BS and PWV-ES, respectively) and intima-media thickness (IMT) were measured by ultrafast ultrasound imaging technology. The associations of PWV-BS, PWV-ES, and IMT with hypertension stage were evaluated by Spearman correlation analysis. PWV-BS and PWV-ES in the hypertension group were significantly elevated compared with those in control group. Different hypertension stages significantly differed in PWV-BS and PWV-ES. PWV-BS and PWV-ES appeared to increase with the hypertension stage. Moreover, IMT, PWV-BS, and PWV-ES were positively correlated with the hypertension stage in hypertensive patients. Ultrafast ultrasound imaging was a valid and convenient method for the measurement of carotid PWV in hypertensive patients. Ultrafast ultrasound imaging might be recommended as a promising alternative method for early detection of arterial abnormality in clinical practice.

Is there any relationship between proinflammatory mediator levels in disc material and myelopathy with cervical disc herniation and spondylosis? A non-randomized, prospective clinical study

PubMed Central

Asir, Alparslan; Cetinkal, Ahmet; Gedik, Nursal; Kutlay, Ahmet Murat; Çolak, Ahmet; Kurtar, Sedat; Simsek, Hakan

2007-01-01

The proinflammatory mediator (PIM) levels were assessed in surgically removed samples of herniated cervical intervertebral discs. The objective of this study was to investigate if there is a correlation between the levels of PIMs in disc material and myelopathy associated with cervical intervertebral disc herniation and spondylosis. The role of proinflammatory mediators in the degeneration of intervertebral disc and the inflammatory effects of disc herniations on radicular pain has been previously published. However, the possible relationship between PIMs and myelopathy related to cervical disc herniation and spondylosis has not been investigated before. Thirty-two patients undergoing surgery for cervical disc herniation and spondylosis were investigated. Surgically obtained disc materials, stored at 70°C, were classified into two groups: cervical disc herniation alone or with myelopathy. Biochemical preparation and solid phase enzyme amplified sensitivity immunoassay (ELISIA) analysis of the samples were performed to assess the concentration of mediators in the samples. Very similar values of interleukin-6 were found in both groups whereas the concentrations of mediators were significantly higher in myelopathy group. This study has demonstrated that PIMs are involved in cervical intervertebral disc degeneration with higher concentrations in the samples associated with myelopathy. PMID:17476536

Non-random mate choice in humans: insights from a genome scan.

PubMed

Laurent, R; Toupance, B; Chaix, R

2012-02-01

Little is known about the genetic factors influencing mate choice in humans. Still, there is evidence for non-random mate choice with respect to physical traits. In addition, some studies suggest that the Major Histocompatibility Complex may affect pair formation. Nowadays, the availability of high density genomic data sets gives the opportunity to scan the genome for signatures of non-random mate choice without prior assumptions on which genes may be involved, while taking into account socio-demographic factors. Here, we performed a genome scan to detect extreme patterns of similarity or dissimilarity among spouses throughout the genome in three populations of African, European American, and Mexican origins from the HapMap 3 database. Our analyses identified genes and biological functions that may affect pair formation in humans, including genes involved in skin appearance, morphogenesis, immunity and behaviour. We found little overlap between the three populations, suggesting that the biological functions potentially influencing mate choice are population specific, in other words are culturally driven. Moreover, whenever the same functional category of genes showed a significant signal in two populations, different genes were actually involved, which suggests the possibility of evolutionary convergences. © 2011 Blackwell Publishing Ltd.

Detecting Random, Partially Random, and Nonrandom Minnesota Multiphasic Personality Inventory-2 Protocols

ERIC Educational Resources Information Center

Pinsoneault, Terry B.

2007-01-01

The ability of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2; J. N. Butcher et al., 2001) validity scales to detect random, partially random, and nonrandom MMPI-2 protocols was investigated. Investigations included the Variable Response Inconsistency scale (VRIN), F, several potentially useful new F and VRIN subscales, and F-sub(b) - F…

Non-random species loss in a forest herbaceous layer following nitrogen addition

Treesearch

Christopher A. ​Walter; Mary Beth Adams; Frank S. Gilliam; William T. Peterjohn

2017-01-01

Nitrogen (N) additions have decreased species richness (S) in hardwood forest herbaceous layers, yet the functional mechanisms for these decreases have not been explicitly evaluated.We tested two hypothesized mechanisms, random species loss (RSL) and non-random species loss (NRSL), in the hardwood forest herbaceous layer of a long-term, plot-scale...

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.

PubMed

Christiansen, Mark P; Klaff, Leslie J; Brazg, Ronald; Chang, Anna R; Levy, Carol J; Lam, David; Denham, Douglas S; Atiee, George; Bode, Bruce W; Walters, Steven J; Kelley, Lynne; Bailey, Timothy S

2018-03-01

Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D (NCT02647905). The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days postinsertion for reference glucose values from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days postinsertion. Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%-9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three percent of CGM values were within 20/20% of reference values over the total glucose range of 40-400 mg/dL. Clarke Error Grid analysis showed 99.3% of samples in the clinically acceptable error zones A (92.8%) and B (6.5%). Ninety-one percent of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor. The PRECISE II trial demonstrated that the Eversense CGM system provided accurate glucose readings through the intended 90-day sensor life with a favorable safety profile.

PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study.

PubMed

Maltais, Simon; Kilic, Ahmet; Nathan, Sriram; Keebler, Mary; Emani, Sitaramesh; Ransom, John; Katz, Jason N; Sheridan, Brett; Brieke, Andreas; Egnaczyk, Gregory; Entwistle, John W; Adamson, Robert; Stulak, John; Uriel, Nir; O'Connell, John B; Farrar, David J; Sundareswaran, Kartik S; Gregoric, Igor

2017-01-01

Recommended structured clinical practices including implant technique, anti-coagulation strategy, and pump speed management (PREVENT [PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management] recommendations) were developed to address risk of early (<3 months) pump thrombosis (PT) risk with HeartMate II (HMII; St. Jude Medical, Inc. [Thoratec Corporation], Pleasanton, CA). We prospectively assessed the HMII PT rate in the current era when participating centers adhered to the PREVENT recommendations. PREVENT was a prospective, multi-center, single-arm, non-randomized study of 300 patients implanted with HMII at 24 participating sites. Confirmed PT (any suspected PT confirmed visually and/or adjudicated by an independent assessor) was evaluated at 3 months (primary end-point) and at 6 months after implantation. The population included 83% men (age 57 years ± 13), 78% destination therapy, and 83% Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1-3. Primary end-point analysis showed a confirmed PT of 2.9% at 3 months and 4.8% at 6 months. Adherence to key recommendations included 78% to surgical recommendations, 95% to heparin bridging, and 79% to pump speeds ≥9,000 RPMs (92% >8,600 RPMs). Full adherence to implant techniques, heparin bridging, and pump speeds ≥9,000 RPMs resulted in a significantly lower risk of PT (1.9% vs 8.9%; p < 0.01) and lower composite risk of suspected thrombosis, hemolysis, and ischemic stroke (5.7% vs 17.7%; p < 0.01) at 6 months. Adoption of all components of a structured surgical implant technique and clinical management strategy (PREVENT recommendations) is associated with low rates of confirmed PT. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up.

PubMed

Yin, Way; Pauza, Kevin; Olan, Wayne J; Doerzbacher, Jeff F; Thorne, Kevin J

2014-01-01

Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain. Prospective, nonrandomized Food and Drug Administration approved pilot study. Three centers in the United States. Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography. Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX(®) Fibrin Sealant with the Biostat(®) Delivery Device into symptomatic lumbar disc(s). Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ). Safety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product. Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6-80.3) at baseline to 31.7 (17.4-46.1), 35.4 (17.7-53.1), and 33.0 (16.3-49.6); mean RMDQ score improved from 15.2 (12.7-17.7) at baseline to 8.9 (5.3-12.5), 6.2 (3.4-9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively. Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain. Wiley Periodicals, Inc.

Photobiomodulation with non-thermal lasers: Mechanisms of action and therapeutic uses in dermatology and aesthetic medicine.

PubMed

Nestor, Mark; Andriessen, Anneke; Berman, Brian; Katz, Bruce E; Gilbert, Dore; Goldberg, David J; Gold, Michael H; Kirsner, Robert S; Lorenc, Paul Z

2017-08-01

Non-thermal laser therapy in dermatology, is a growing field in medical technology by which therapeutic effects are achieved by exposing tissues to specific wavelengths of light. The purpose of this review was to gain a better understanding of the science behind non-thermal laser and the evidence supporting its use in dermatology. A group of dermatologists and surgeons recently convened to review the evidence supporting the use of non-thermal laser for body sculpting, improving the appearance of cellulite, and treating onychomycosis. The use of non-thermal laser for body sculpting is supported by three randomized, double-blind, sham-controlled studies (N = 161), one prospective open-label study (N = 54), and two retrospective studies (N = 775). Non-thermal laser application for improving the appearance of cellulite is supported by one randomized, double-blind, sham-controlled study (N = 38). The use of non-thermal laser for the treatment of onychomycosis is supported by an analysis of three non-randomized, open-label studies demonstrating clinical improvement of nails (N = 292). Non-thermal laser is steadily moving into mainstream medical practice, such as dermatology. Although present studies have demonstrated the safety and efficacy of non-thermal laser for body sculpting, cellulite reduction and onychomycosis treatment, studies demonstrating the efficacy of non-thermal laser as a stand-alone procedure are still inadequate.

Impact of nursing interventions on adherence to treatment with antituberculosis drugs in children and young people: A non-randomized controlled trial.

PubMed

Guix-Comellas, Eva Maria; Rozas-Quesada, Librada; Velasco-Arnaiz, Eneritz; Ferres-Canals, Ariadna; Estrada-Masllorens, Joan Maria; Force-Sanmartín, Enriqueta; Noguera-Julian, Antoni

2018-05-03

To evaluate the association of a new nursing intervention on the adherence to antituberculosis treatment in a pediatric cohort (<18 years). Tuberculosis remains a public health problem worldwide. The risk of developing tuberculosis after primary infection and its severity are higher in children. Proper adherence to antituberculosis treatment is critical for disease control. Non-randomized controlled trial; Phase 1, retrospective (2011-2013), compared with Phase 2, prospective with intervention (2015-2016), in a referral center for pediatric tuberculosis in Spain (NCT03230409). A total of 359 patients who received antituberculosis drugs after close contact with a smear-positive patient (primary chemoprophylaxis) or were treated for latent tuberculosis infection or tuberculosis disease were included, 261 in Phase 1 and 98 in Phase 2. In phase 2, a new nurse-led intervention was implemented in all patients and included two educational steps (written information in the child's native language and follow-up telephone calls) and two monitoring steps (Eidus-Hamilton test and follow-up questionnaire) that were exclusively carried out by nurses. Adherence to antituberculosis treatment increased from 74.7% in Phase 1 to 87.8% in Phase 2 (p=0.014; Chi-square test), after the implementation of the nurse-led intervention. In Phase 2, non-adherence was only associated with being born abroad (28.6% versus 7.8%; p=0.019; Chi-square test) and with foreign origin families (27.3% versus 0%; p<0.0001; Chi-square test). The nurse-led intervention was associated to an increase in adherence to antituberculosis treatment. Immigrant-related variables remained major risk factors for sub-optimal adherence in a low-endemic setting. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Functional and phylogenetic structure of island bird communities.

PubMed

Si, Xingfeng; Cadotte, Marc W; Zeng, Di; Baselga, Andrés; Zhao, Yuhao; Li, Jiaqi; Wu, Yiru; Wang, Siyu; Ding, Ping

2017-05-01

Biodiversity change in anthropogenically transformed habitats is often nonrandom, yet the nature and importance of the different mechanisms shaping community structure are unclear. Here, we extend the classic Theory of Island Biogeography (TIB) to account for nonrandom processes by incorporating species traits and phylogenetic relationships into a study of faunal relaxation following habitat loss and fragmentation. Two possible mechanisms can create nonrandom community patterns on fragment islands. First, small and isolated islands might consist of similar or closely related species because they are environmentally homogeneous or select for certain shared traits, such as dispersal ability. Alternatively, communities on small islands might contain more dissimilar or distantly related species than on large islands because limited space and resource availability result in greater competitive exclusion among species with high niche overlap. Breeding birds were surveyed on 36 islands and two mainland sites annually from 2010 to 2014 in the Thousand Island Lake region, China. We assessed community structure of breeding birds on these subtropical land-bridge islands by integrating species' trait and evolutionary distances. We additionally analysed habitat heterogeneity and variance in size ratios to distinguish biotic and abiotic processes of community assembly. Results showed that functional-phylogenetic diversity increased with island area, and decreased with isolation. Bird communities on the mainland were more diverse and generally less clustered than island bird communities and not different than randomly assembled communities. Bird communities on islands tend to be functionally similar and phylogenetically clustered, especially on small and isolated islands. The nonrandom decline in species diversity and change in bird community structure with island area and isolation, along with the relatively homogeneous habitats on small islands, support the environmental filtering hypothesis. Our study demonstrates the importance of integrating multiple forms of diversity for understanding the effects of habitat loss and fragmentation, and further reveals that TIB could be extended to community measures by moving beyond assumptions of species equivalency in colonisation rates and extinction susceptibilities. © 2017 The Authors. Journal of Animal Ecology © 2017 British Ecological Society.

Self-administered foot reflexology for the management of chronic health conditions: a systematic review.

PubMed

Song, Hyun Jin; Choi, Sun Mi; Seo, Hyun-Ju; Lee, Heeyoung; Son, Heejeong; Lee, Sanghun

2015-02-01

To systematically review the effect of self-administered foot reflexology in patients with chronic health conditions. Electronic databases were searched for literature published from 1948 to January 2014. The databases included MEDLINE, EMBASE, the Cochrane Library, CINAHL, CNKI, J-STAGE, Koreamed, Kmbase, KISS, NDSL, KISTI, and OASIS. Key search terms were "exp/relaxation therapy," "foot," "reflexology," "zone therapy," and "self." All study designs were included. Two raters independently extracted data and assessed study quality by using the Cochrane risk of bias tool (for randomized controlled trials) and the risk of bias assessment tool for nonrandomized studies (for nonrandomized and before-and-after studies). A qualitative and descriptive analysis was performed because of the clinical diversity associated with chronic health conditions. Of the 224 records assessed, 4 trials met the inclusion criteria: 3 nonrandomized controlled trials and 1 before-and-after study without comparison. Self-administered foot reflexology might have a positive effect in type 2 diabetes, but the low quality of the included study and the lack of adequately reported clinical outcomes obscure the results. Two studies of hypertensive patients and 1 study of patients with urinary incontinence showed that self-performed foot reflexology may exert a beneficial effect on lowering blood pressure and urinary incontinence; however, given the small sample size and the lack of any description of medications and other cointerventions, there was insufficient evidence to conclusively determine whether foot reflexology had any effect. The included studies on self-administered foot reflexology in patients with type 2 diabetes, hypertension, or urinary incontinence provided insufficient evidence to determine a treatment effect. Therefore, a well-designed, large-scale, and randomized controlled trial is needed to confirm the effect of self-administered foot reflexology for chronic conditions.

Rationale and design of a prospective study of the clinical significance of atrial arrhythmias detected by implanted device diagnostics: the TRENDS study.

PubMed

Glotzer, Taya V; Daoud, Emile G; Wyse, D George; Singer, Daniel E; Holbrook, Reece; Pruett, Khadeeja; Smith, Kenneth; Hilker, Christopher E

2006-01-01

Sustained atrial fibrillation (AF) is a common risk factor for stroke. While intermittent AF also appears to pose a substantial stroke risk, the quantitative relationship between the percentage of time spent in AF and stroke risk is poorly specified and "intermittent" AF is not the same as paroxysmal AF. Improved assessment of the impact of AF burden on stroke risk will allow more targeted and safer use of antithrombotic therapy. The primary objective of this study is to determine if AT/AF (all device detected atrial tachyarrhythmias, including atrial flutter, atrial fibrillation, and atrial tachycardia) burden over a 30 day period is an independent predictor of the occurrence of ischemic stroke, transient ischemic attack (TIA) and/or systemic embolism in subjects not receiving anticoagulation therapy. TRENDS is a prospective, post-market, non-randomized, multicenter study designed to enroll 3100 subjects who have an independent Class I/II indication for cardiac rhythm device implantation and who have demographic features suggestive of an increased risk for thromboembolic complications related to AT/AF. All implanted devices will have the ability to collect long-term AT/AF burden trending data and will be equivalently programmed to ensure consistent data collection. All subjects will be followed with device interrogations every 3 months and clinic visits every 6 months for 1 year. Subjects with a documented history of AT/AF prior to enrollment and those who develop AT/AF during the 12-month follow-up will be followed until the last subject enrolled in the study has completed their 24-month follow-up. The results of the TRENDS study should help clarify the implications of data retrieved from an implantable device with regard to the risk for thromboembolic complications from atrial arrhythmias, even in the absence of symptoms.

Per-Oral Endoscopic Myotomy Versus Laparoscopic Heller Myotomy for Achalasia

PubMed Central

Zhang, Yuan; Wang, Hongjuan; Chen, Xingdong; Liu, Lan; Wang, Hongbo; Liu, Bin; Guo, Jianqiang; Jia, Hongying

2016-01-01

Abstract We aimed to assess the short-term outcomes of per-oral endoscopic myotomy (POEM) compared with laparoscopic Heller myotomy (LHM) for achalasia through a meta-analysis of nonrandomized comparative studies. We searched PubMed, Embase, Medline, Cochrane Library, and Google Scholar for studies that compared POEM and LHM for achalasia and were published between January 1, 2008 and December 31, 2014. The Methodological Index for Nonrandomized Studies (MINORS) was used to evaluate the quality of the studies. Random- and fixed-effects meta-analytical models were used, and between-study heterogeneity was assessed. Four nonrandomized comparative studies that included 317 patients (125 in the POEM group and 192 in the LHM group) met our research criteria and were assessed. There were no differences between the POEM and LHM groups in terms of sex, preoperative Eckhart score, length of myotomy, operation time, length of hospital stay, and complications. The patients in the POEM group were older than those in the LHM group (MD =2.81, 95% CI 0.27–5.35; P = 0.03) with high between-study homogeneity (χ2 = 1.96, df = 2, I2 = 0%; P = 0.38). The patients in the POEM group had a lower Eckardt score after surgery compared with those in the LHM group (MD = −0.30, 95% CI −0.42 to −0.18; P < 0.001) with high between-study homogeneity (χ2 = 0.00, df = 1, I2 = 0%; P = 1.00). The efficacy and safety of POEM appear to be comparable to those of LHM. Multicenter and randomized trials with larger sample size are needed to further compare the efficacy and safety of POEM and LHM for the treatment of achalasia. PMID:26871816

Diagnostic Value of Run Chart Analysis: Using Likelihood Ratios to Compare Run Chart Rules on Simulated Data Series

PubMed Central

Anhøj, Jacob

2015-01-01

Run charts are widely used in healthcare improvement, but there is little consensus on how to interpret them. The primary aim of this study was to evaluate and compare the diagnostic properties of different sets of run chart rules. A run chart is a line graph of a quality measure over time. The main purpose of the run chart is to detect process improvement or process degradation, which will turn up as non-random patterns in the distribution of data points around the median. Non-random variation may be identified by simple statistical tests including the presence of unusually long runs of data points on one side of the median or if the graph crosses the median unusually few times. However, there is no general agreement on what defines “unusually long” or “unusually few”. Other tests of questionable value are frequently used as well. Three sets of run chart rules (Anhoej, Perla, and Carey rules) have been published in peer reviewed healthcare journals, but these sets differ significantly in their sensitivity and specificity to non-random variation. In this study I investigate the diagnostic values expressed by likelihood ratios of three sets of run chart rules for detection of shifts in process performance using random data series. The study concludes that the Anhoej rules have good diagnostic properties and are superior to the Perla and the Carey rules. PMID:25799549

A prospective development study of software-guided radio-frequency ablation of primary and secondary liver tumors: Clinical intervention modelling, planning and proof for ablation cancer treatment (ClinicIMPPACT).

PubMed

Reinhardt, Martin; Brandmaier, Philipp; Seider, Daniel; Kolesnik, Marina; Jenniskens, Sjoerd; Sequeiros, Roberto Blanco; Eibisberger, Martin; Voglreiter, Philip; Flanagan, Ronan; Mariappan, Panchatcharam; Busse, Harald; Moche, Michael

2017-12-01

Radio-frequency ablation (RFA) is a promising minimal-invasive treatment option for early liver cancer, however monitoring or predicting the size of the resulting tissue necrosis during the RFA-procedure is a challenging task, potentially resulting in a significant rate of under- or over treatments. Currently there is no reliable lesion size prediction method commercially available. ClinicIMPPACT is designed as multicenter-, prospective-, non-randomized clinical trial to evaluate the accuracy and efficiency of innovative planning and simulation software. 60 patients with early liver cancer will be included at four European clinical institutions and treated with the same RFA system. The preinterventional imaging datasets will be used for computational planning of the RFA treatment. All ablations will be simulated simultaneously to the actual RFA procedure, using the software environment developed in this project. The primary outcome measure is the comparison of the simulated ablation zones with the true lesions shown in follow-up imaging after one month, to assess accuracy of the lesion prediction. This unique multicenter clinical trial aims at the clinical integration of a dedicated software solution to accurately predict lesion size and shape after radiofrequency ablation of liver tumors. Accelerated and optimized workflow integration, and real-time intraoperative image processing, as well as inclusion of patient specific information, e.g. organ perfusion and registration of the real RFA needle position might make the introduced software a powerful tool for interventional radiologists to optimize patient outcomes.

Cross-Sectional and Panel Data Analyses of an Incompletely Observed Variable Derived from the Nonrandomized Method for Surveying Sensitive Questions

ERIC Educational Resources Information Center

Yamaguchi, Kazuo

2016-01-01

This article describes (1) the survey methodological and statistical characteristics of the nonrandomized method for surveying sensitive questions for both cross-sectional and panel survey data and (2) the way to use the incompletely observed variable obtained from this survey method in logistic regression and in loglinear and log-multiplicative…

Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study.

PubMed

Davis, Thomas; Ramaiah, Venkatesh; Niazi, Khusrow; Martin Gissler, Hans; Crabtree, Tami

2017-12-01

Objectives To evaluate the novel Phoenix Atherectomy System as percutaneous treatment of de novo and restenotic infrainguinal arterial lesions. Methods This prospective, multicenter, nonrandomized investigational device exemption trial was conducted across 16 US and German centers between August 2010 and April 2013. Intention-to-treat enrollment was 128 patients (mean age: 71.8 years, 59% male) with 149 lesions (mean length: 34 mm, mean diameter stenosis: 89.5%), and the primary analysis per-protocol population consisted of 105 patients with 123 lesions. The primary efficacy endpoint, technical success, was the achievement of acute debulking with a post-atherectomy residual diameter stenosis ≤50% (before adjunctive therapy). The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Results For the primary analysis per-protocol population, the rate of lesion technical success was 95.1% (117/123), with the lower limit of the 95% CI 90.6%, meeting the prospectively established target performance goal of ≥86%. After post-atherectomy adjunctive therapy, residual stenosis was ≤30% for 99.2% (122/123) of lesions (mean final diameter stenosis 10.5%). Improvement of ≥1 Rutherford class occurred for 74.5% of patients through 30 days and for 80% through six months. MAEs were experienced by 5.7% (6/105) of patients through 30 days (with the upper limit of the 95% CI 11.0%, meeting the target performance goal of <20%), and 16.8% through six months. Six-month freedom from TLR and TVR was 88.0% and 86.1%, respectively. Conclusions Based on the high rate of technical success and the low rates of MAEs through six months, the Phoenix Atherectomy System is safe and effective for the debulking of lower-extremity arterial lesions. ClinicalTrials.gov identifier NCT01541774.

Effective Size of Nonrandom Mating Populations

PubMed Central

Caballero, A.; Hill, W. G.

1992-01-01

Nonrandom mating whereby parents are related is expected to cause a reduction in effective population size because their gene frequencies are correlated and this will increase the genetic drift. The published equation for the variance effective size, N(e), which includes the possibility of nonrandom mating, does not take into account such a correlation, however. Further, previous equations to predict effective sizes in populations with partial sib mating are shown to be different, but also incorrect. In this paper, a corrected form of these equations is derived and checked by stochastic simulation. For the case of stable census number, N, and equal progeny distributions for each sex, the equation is & where S(k)(2) is the variance of family size and α is the departure from Hardy-Weinberg proportions. For a Poisson distribution of family size (S(k)(2) = 2), it reduces to N(e) = N/(1 + α), as when inbreeding is due to selfing. When nonrandom mating occurs because there is a specified system of partial inbreeding every generation, α can be substituted by Wright's F(IS) statistic, to give the effective size as a function of the proportion of inbred mates. PMID:1582565

Statistical issues on the analysis of change in follow-up studies in dental research.

PubMed

Blance, Andrew; Tu, Yu-Kang; Baelum, Vibeke; Gilthorpe, Mark S

2007-12-01

To provide an overview to the problems in study design and associated analyses of follow-up studies in dental research, particularly addressing three issues: treatment-baselineinteractions; statistical power; and nonrandomization. Our previous work has shown that many studies purport an interacion between change (from baseline) and baseline values, which is often based on inappropriate statistical analyses. A priori power calculations are essential for randomized controlled trials (RCTs), but in the pre-test/post-test RCT design it is not well known to dental researchers that the choice of statistical method affects power, and that power is affected by treatment-baseline interactions. A common (good) practice in the analysis of RCT data is to adjust for baseline outcome values using ancova, thereby increasing statistical power. However, an important requirement for ancova is there to be no interaction between the groups and baseline outcome (i.e. effective randomization); the patient-selection process should not cause differences in mean baseline values across groups. This assumption is often violated for nonrandomized (observational) studies and the use of ancova is thus problematic, potentially giving biased estimates, invoking Lord's paradox and leading to difficulties in the interpretation of results. Baseline interaction issues can be overcome by use of statistical methods; not widely practiced in dental research: Oldham's method and multilevel modelling; the latter is preferred for its greater flexibility to deal with more than one follow-up occasion as well as additional covariates To illustrate these three key issues, hypothetical examples are considered from the fields of periodontology, orthodontics, and oral implantology. Caution needs to be exercised when considering the design and analysis of follow-up studies. ancova is generally inappropriate for nonrandomized studies and causal inferences from observational data should be avoided.

Systematic Review of the Impact of Cancer Survivorship Care Plans on Health Outcomes and Health Care Delivery.

PubMed

Jacobsen, Paul B; DeRosa, Antonio P; Henderson, Tara O; Mayer, Deborah K; Moskowitz, Chaya S; Paskett, Electra D; Rowland, Julia H

2018-05-18

Purpose Numerous organizations recommend that patients with cancer receive a survivorship care plan (SCP) comprising a treatment summary and follow-up care plans. Among current barriers to implementation are providers' concerns about the strength of evidence that SCPs improve outcomes. This systematic review evaluates whether delivery of SCPs has a positive impact on health outcomes and health care delivery for cancer survivors. Methods Randomized and nonrandomized studies evaluating patient-reported outcomes, health care use, and disease outcomes after delivery of SCPs were identified by searching MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library. Data extracted by independent raters were summarized on the basis of qualitative synthesis. Results Eleven nonrandomized and 13 randomized studies met inclusion criteria. Variability was evident across studies in cancer types, SCP delivery timing and method, SCP recipients and content, SCP-related counseling, and outcomes assessed. Nonrandomized study findings yielded descriptive information on satisfaction with care and reactions to SCPs. Randomized study findings were generally negative for the most commonly assessed outcomes (ie, physical, functional, and psychological well-being); findings were positive in single studies for other outcomes, including amount of information received, satisfaction with care, and physician implementation of recommended care. Conclusion Existing research provides little evidence that SCPs improve health outcomes and health care delivery. Possible explanations include heterogeneity in study designs and the low likelihood that SCP delivery alone would influence distal outcomes. Findings are limited but more positive for proximal outcomes (eg, information received) and for care delivery, particularly when SCPs are accompanied by counseling to prepare survivors for future clinical encounters. Recommendations for future research include focusing to a greater extent on evaluating ways to ensure SCP recommendations are subsequently acted on as part of ongoing care.

Tubal anastomosis after previous sterilization: a systematic review.

PubMed

van Seeters, Jacoba A H; Chua, Su Jen; Mol, Ben W J; Koks, Carolien A M

2017-05-01

Female sterilization is one of the most common contraceptive methods. A small number of women, however, opt for reversal of sterilization procedures after they experience regret. Procedures can be performed by laparotomy or laparoscopy, with or without robotic assistance. Another commonly utilized alternative is IVF. The choice between surgery and IVF is often influenced by reimbursement politics for that particular geographic location. We evaluated the fertility outcomes of different surgical methods available for the reversal of female sterilization, compared these to IVF and assessed the prognostic factors for success. Two search strategies were employed. Firstly, we searched for randomized and non-randomized clinical studies presenting fertility outcomes of sterilization reversal up to July 2016. Data on the following outcomes were collected: pregnancy rate, ectopic pregnancy rate, cost of the procedure and operative time. Eligible study designs included prospective or retrospective studies, randomized controlled trials, cohort studies, case-control studies and case series. No age restriction was applied. Exclusion criteria were patients suffering from tubal infertility from any other reason (e.g. infection, endometriosis and adhesions from previous surgery) and studies including <10 participants. The following factors likely to influence the success of sterilization reversal procedures were then evaluated: female age, BMI and duration and method of sterilization. Secondly, we searched for randomized and non-randomized clinical studies that compared reversal of sterilization to IVF and evaluated them for pregnancy outcomes and cost effectiveness. We included 37 studies that investigated a total of 10 689 women. No randomized controlled trials were found. Most studies were retrospective cohort studies of a moderate quality. The pooled pregnancy rate after sterilization reversal was 42-69%, with heterogeneity seen from the different methods utilized. The reported ectopic pregnancy rate was 4-8%. The only prognostic factor affecting the chance of conception was female age. The surgical approach (i.e. laparotomy [microscopic], laparoscopy or robotic) had no impact on the outcome, with the exception of the macroscopic laparotomic technique, which had inferior results and is not currently utilized. For older women, IVF could be a more cost-effective alternative for the reversal of sterilization. However, direct comparative data are lacking and a cut-off age cannot be stated. In sterilized women who suffer regret, surgical tubal re-anastomosis is an effective treatment, especially in younger women. However, there is a need for randomized controlled trials comparing the success rates and costs of surgical reversal with IVF. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: the BEST (Biodegradable Esophageal Stent) study.

PubMed

Repici, Alessandro; Vleggaar, Frank P; Hassan, Cesare; van Boeckel, Petra G; Romeo, Fabio; Pagano, Nicola; Malesci, Alberto; Siersema, Peter D

2010-11-01

Benign esophageal strictures refractory to standard dilation therapy present a challenging problem. Temporary plastic and metal stents have been proposed with inconclusive results. To evaluate the efficacy and safety of a new biodegradable stent for the treatment of refractory benign esophageal strictures (RBESs). Prospective study from 2 European endoscopy centers. Twenty-one patients (11 men/10 women, mean age 60.2 ± 17.6 years) with RBESs defined according to the Kochman criteria treated by placement of a biodegradable stent (Ella stent). Clinical and endoscopic follow-up was scheduled at 1, 2, 3, and 6 months and later only in case of dysphagia recurrence. Pre- and poststenting dysphagia status was graded according to a 5-point scale. Minor and major complication rates were prospectively assessed. Stent insertion was technically successful in all of the patients. At 4 and 7 weeks, stent migration occurred in 2 patients (9.5%). At 3-month endoscopy, the stent appeared to be almost completely fragmented in all remaining patients. The median pre- and poststenting dysphagia scores were 3 (range 3-4) and 1 (range 0-2), respectively (P < .01), with a median follow-up of 53 weeks (range 25-88 weeks). In detail, 9 of 20 patients (45%) were dysphagia free at the end of the follow-up. No major complications occurred. Severe poststenting pain requiring analgesics developed in 3 patients, and minor bleeding was observed in 1 patient. Limited follow-up; nonrandomized study. In this preliminary study, the biodegradable stent showed a favorable risk/benefit ratio, achieving complete relief of dysphagia in nearly 50% of RBES patients without the occurrence of major complications. The use of this stent may be a valuable alternative to repeat endoscopic dilation. Larger studies with longer follow-up are needed. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

A prospective comparative study on neovascular glaucoma and non-neovascular refractory glaucoma following Ahmed glaucoma valve implantation.

PubMed

Li, Zheng; Zhou, Minwen; Wang, Wei; Huang, Wenbin; Chen, Shida; Li, Xingyi; Gao, Xinbo; Zhang, Xiulan

2014-01-01

Neovascular glaucoma is a refractory disease, and difficult to manage. The aim of this study was to evaluate the clinical outcomes of Ahmed glaucoma valve implantation (AGVI) in neovascular glaucoma (NVG) and non-NVG patients. This prospective, non-randomized study included 55 eyes of 55 patients with refractory glaucoma; 27 had NVG (NVG group) and 28 had non-NVG (non-NVG group). All of the patients underwent AGVI. The NVG group was adjunctively injected with intravitreal ranibizumab/bevacizumab (IVR/IVB) before AGVI. Intraocular pressure (IOP) was the primary outcome measure in this study. Surgical success rate, number of antiglaucoma medications used, best corrected visual acuity (BCVA), and postoperative complications were analyzed between the groups. All of the patients completed the study (follow-up of 12 months). Kaplan-Meier survival curve analysis indicated that the qualified success rates in the NVG and non-NVG groups at 12 months were 70.5% and 92.9%, respectively; this difference was significant (P = 0.036). The complete success rates in the NVG and non-NVG groups at 12 months were 66.7% and 89.3%, respectively (P = 0.049). Compared with preoperative examinations, the postoperative mean IOP and use of medications were significantly lower at all follow-up time points in both groups (all P < 0.05). There were significant differences in BCVA between the two groups at the 12-month follow-up (χ(2) = 9.86, P = 0.020). Cox proportional hazards regression showed NVG as a risk factor for surgical failure (RR = 15.08, P = 0.033). Postoperative complications were similar between the two groups. AGVI is a safe and effective procedure in refractory glaucoma, but the success rate of surgery was related to the type of refractory glaucoma. The complete and qualified success rates of NVG patient adjunctive anti-vascular endothelial growth factor treatment are still lower than those of non-NVG patients.

Psychosocial impact of prognostic genetic testing in the care of uveal melanoma patients: protocol of a controlled prospective clinical observational study.

PubMed

Erim, Yesim; Scheel, Jennifer; Breidenstein, Anja; Metz, Claudia Hd; Lohmann, Dietmar; Friederich, Hans-Christoph; Tagay, Sefik

2016-07-07

Uveal melanoma patients with a poor prognosis can be detected through genetic analysis of the tumor, which has a very high sensitivity. A large number of patients with uveal melanoma decide to receive information about their individual risk and therefore routine prognostic genetic testing is being carried out on a growing number of patients. It is obvious that a positive prediction for recidivism in the future will emotionally burden the respective patients, but research on the psychosocial impact of this innovative method is lacking. The aim of the current study is therefore to investigate the psychosocial impact (psychological distress and quality of life) of prognostic genetic testing in patients with uveal melanoma. This study is a non-randomized controlled prospective clinical observational trial. Subjects are patients with uveal melanoma, in whom genetic testing is possible. Patients who consent to genetic testing are allocated to the intervention group and patients who refuse genetic testing form the observational group. Both groups receive cancer therapy and psycho-oncological intervention when needed. The psychosocial impact of prognostic testing is investigated with the following variables: resilience, social support, fear of tumor progression, depression, general distress, cancer-specific and general health-related quality of life, attitude towards genetic testing, estimation of the perceived risk of metastasis, utilization and satisfaction with psycho-oncological crisis intervention, and sociodemographic data. Data are assessed preoperatively (at initial admission in the clinic) and postoperatively (at discharge from hospital after surgery, 6-12 weeks, 6 and 12 months after initial admission). Genetic test results are communicated 6-12 weeks after initial admission to the clinic. We created optimal conditions for investigation of the psychosocial impact of prognostic genetic testing. This study will provide information on the course of disease and psychosocial outcomes after prognostic genetic testing. We expect that empirical data from our study will give a scientific basis for medico-ethical considerations.

Three-month treatment with triptorelin, letrozole and ulipristal acetate before hysteroscopic resection of uterine myomas: prospective comparative pilot study.

PubMed

Bizzarri, Nicolò; Ghirardi, Valentina; Remorgida, Valentino; Venturini, Pier Luigi; Ferrero, Simone

2015-09-01

To compare the usefulness of preoperative treatment with triptorelin, letrozole or ulipristal acetate or no treatment before hysteroscopic removal of uterine submucosal myomas. Single center prospective non-randomized comparative pilot study. The study included consecutive premenopausal patients undergoing hysteroscopic resection of myomas graded as type 0, type 1 or type 2 according to the FIGO classification with diameter between 20 and 35 mm. Exclusion criteria were: associated polyps, associated non-hysteroscopic surgical procedures, >2 myomas requiring hysteroscopic resection. This study enrolled patients who underwent either direct surgery (group S; n=23) or 3-month preoperative treatment with triptorelin (3.75 mg every 28 days; group T; n=20), letrozole (2.5 mg/day; group L; n=11) or ulipristal acetate (5 mg/day; group U; n=7). Patients underwent hysteroscopic resection of the myomas. All medical treatments caused a significant decrease in the volume of myomas (group T, p<.001; group L, p<.001; group U, p=.006); however, the percentage decrease in myoma volume was lower in group U than in group T (p=.001) and in group L (p=.010). The hysteroscopy time was higher in group S than in group T (p<.001) and in group L (p=.001); there was no significant difference in the hysteroscopy time between group S and group U (p=.206). Fluid absorption was lower in group T than in group S (p=.002) and in group L than in group S (p=.048); fluid absorption was similar in group S and group U (p=.110). Intra- and postoperative complications, postoperative pain, and patient satisfaction were similar in the four study groups. Surgeon's evaluation of operative difficulty was better in group T than in group S (p<.005). Preoperative treatment with triptorelin and letrozole decreases the hysteroscopy time and the volume of fluid absorbed during hysteroscopic resection of uterine submucosal myomas. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Dietary Magnesium Intake and Metabolic Syndrome in the Adult Population: Dose-Response Meta-Analysis and Meta-Regression

PubMed Central

Ju, Sang-Yhun; Choi, Whan-Seok; Ock, Sun-Myeong; Kim, Chul-Min; Kim, Do-Hoon

2014-01-01

Increasing evidence has suggested an association between dietary magnesium intake and metabolic syndrome. However, previous research examining dietary magnesium intake and metabolic syndrome has produced mixed results. Our objective was to determine the relationship between dietary magnesium intake and metabolic syndrome in the adult population using a dose-response meta-analysis. We searched the PubMed, Embase and the Cochrane Library databases from August, 1965, to May, 2014. Observational studies reporting risk ratios with 95% confidence intervals (CIs) for metabolic syndrome in ≥3 categories of dietary magnesium intake levels were selected. The data extraction was performed independently by two authors, and the quality of the studies was evaluated using the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS). Based on eight cross-sectional studies and two prospective cohort studies, the pooled relative risks of metabolic syndrome per 150 mg/day increment in magnesium intake was 0.88 (95% CI, 0.84–0.93; I2 = 36.3%). The meta-regression model showed a generally linear, inverse relationship between magnesium intake (mg/day) and metabolic syndrome. This dose-response meta-analysis indicates that dietary magnesium intake is significantly and inversely associated with the risk of metabolic syndrome. However, randomized clinical trials will be necessary to address the issue of causality and to determine whether magnesium supplementation is effective for the prevention of metabolic syndrome. PMID:25533010

Vitamin D status and weight loss: a systematic review and meta-analysis of randomized and nonrandomized controlled weight-loss trials.

PubMed

Mallard, Simonette R; Howe, Anna S; Houghton, Lisa A

2016-10-01

Obesity is associated with lower concentrations of serum 25-hydroxyvitamin D; however, uncertainty exists as to the direction of causation. To date, meta-analyses of randomized controlled vitamin D-supplementation trials have shown no effect of raising circulating vitamin D on body weight, although several weight-loss-intervention trials have reported an increase in circulating vitamin D after weight reduction. We undertook a systematic review and meta-analysis of randomized and nonrandomized controlled trials to determine whether weight loss compared with weight maintenance leads to an increase in serum 25-hydroxyvitamin D. A systematic search for controlled weight-loss-intervention studies published up to 31 March 2016 was performed. Studies that included participants of any age with changes in adiposity and serum 25-hydroxyvitamin D as primary or secondary outcomes were considered eligible. We identified 4 randomized controlled trials (n = 2554) and 11 nonrandomized controlled trials (n = 917) for inclusion in the meta-analysis. Random assignment to weight loss compared with weight maintenance resulted in a greater increase in serum 25-hydroxyvitamin D with a mean difference of 3.11 nmol/L (95% CI: 1.38, 4.84 nmol/L) between groups, whereas a mean difference of 4.85 nmol/L (95% CI: 2.59, 7.12 nmol/L) was observed in nonrandomized trials. No evidence for a dose-response effect of weight loss on the change in serum 25-hydroxyvitamin D was shown overall. Our results indicate that vitamin D status may be marginally improved with weight loss in comparison with weight maintenance under similar conditions of supplemental vitamin D intake. Although additional studies in unsupplemented individuals are needed to confirm these findings, our results support the view that the association between obesity and lower serum 25-hydroxyvitamin D may be due to reversed causation with increased adiposity leading to suboptimal concentrations of circulating vitamin D. This trial was registered at www.crd.york.ac.uk/PROSPERO/ as CRD42015023836. © 2016 American Society for Nutrition.

Intravenous paracetamol as an antipyretic and analgesic medication: the significance of drug metabolism.

PubMed

Giamarellos-Bourboulis, Evangelos J; Spyridaki, Aikaterini; Savva, Athina; Georgitsi, Marianna; Tsaganos, Thomas; Mouktaroudi, Maria; Raftogiannis, Maria; Antonopoulou, Anastasia; Papaziogas, Vassilios; Baziaka, Fotini; Sereti, Kalliopi; Christopoulos, Petros; Marioli, Androniki; Kanni, Theodora; Maravitsa, Panagiota; Pantelidou, Ilianna; Leventogiannis, Konstantinos; Tsiaoussis, Panagiotis; Lymberopoulou, Korina; Koutelidakis, Ioannis M

2014-01-01

One prospective, open-label, non-randomized study was conducted in 100 patients to define the antipyretic and analgesic effect of a new intravenous formulation of 1 g of paracetamol; 71 received paracetamol for the management of fever and 29 received paracetamol for pain relief after abdominal surgery or for neoplastic pain. Serial follow-up measurements of core temperature and of pain intensity were done for 6 h. Additional rescue medications were recorded for 5 days. Blood was sampled for the measurement of free paracetamol (APAP) and of glucuronide-APAP and N-sulfate-APAP by an HPLC assay. Defervescence, defined as core temperature below or equal to 37.1°C, was achieved in 52 patients (73.2%) within a median time of 3 h. Patients failing to become afebrile with the first dose of paracetamol became afebrile when administered other agents as rescue medications. Analgesia was achieved in 25 patients (86.4%) within a median time of 2 h. Serum levels of glucuronide-APAP were greater among non-responders to paracetamol. The presented results suggest that the intravenous formulation of paracetamol is clinically effective depending on drug metabolism.

Clinical Outcomes after Binocular Implantation of a New Trifocal Diffractive Intraocular Lens

PubMed Central

Kretz, Florian T. A.; Breyer, Detlev; Diakonis, Vasilios F.; Klabe, Karsten; Henke, Franziska; Auffarth, Gerd U.; Kaymak, Hakan

2015-01-01

Purpose. To evaluate visual, refractive, and contrast sensitivity outcomes, as well as the incidence of pseudophakic photic phenomena and patient satisfaction after bilateral diffractive trifocal intraocular lens (IOL) implantation. Methods. This prospective nonrandomized study included consecutive patients undergoing cataract surgery with bilateral implantation of a diffractive trifocal IOL (AT LISA tri 839MP, Carl Zeiss Meditec). Distance, intermediate, and near visual outcomes were evaluated as well as the defocus curve and the refractive outcomes 3 months after surgery. Photopic and mesopic contrast sensitivity, patient satisfaction, and halo perception were also evaluated. Results. Seventy-six eyes of 38 patients were included; 90% of eyes showed a spherical equivalent within ±0.50 diopters 3 months after surgery. All patients had a binocular uncorrected distance visual acuity of 0.00 LogMAR or better and a binocular uncorrected intermediate visual acuity of 0.10 LogMAR or better, 3 months after surgery. Furthermore, 85% of patients achieved a binocular uncorrected near visual acuity of 0.10 LogMAR or better. Conclusions. Trifocal diffractive IOL implantation seems to provide an effective restoration of visual function for far, intermediate, and near distances, providing high levels of visual quality and patient satisfaction. PMID:26301104

Fluoroscopic Placement of Double-Pigtail Ureteral Stents

PubMed Central

Chen, Gregory L.

2001-01-01

Purpose: Double-pigtail ureteral stent is placed cystoscopically after ureteroscopy. We describe a technique for fluoroscopic placement of ureteral stents and demonstrate its use in a non-randomized prospective study. Materials and methods: Double-pigtail stents were placed either fluoroscopically or cystoscopically in 121 consecutive patients. In the fluoroscopic method, the stent was placed over a guide wire using a stent pusher without the use of cystoscopy. Conversely, stents were placed through the working channel of the cystoscope under vision. The procedure, stent length, width, type, method, ureteral dilation, and use of a retrieval string were noted. Results: A wide range of stent sizes were used. The success with fluoroscopic placement of double-pigtail ureteral stents was 100% (89 of 89 cases). No stents migrated or required replacement. Stents were placed after ureteroscopic laser lithotripsy (53/89) and ureteroscopic tumor treatment (22/89). Cystoscopic visualization was used in 32 additional procedures requiring precise control (15 ureteral strictures and nine retrograde endopyelotomy). Conclusions: The fluoroscopic placement of ureteral stents is a safe and simple technique with a very high success rate. We have used cystoscopic placement only after incisional procedures such as retrograde endopyelotomy, stricture or ureterotomy. PMID:18493562

Tomographic Structural Changes of Retinal Layers after Internal Limiting Membrane Peeling for Macular Hole Surgery.

PubMed

Faria, Mun Yueh; Ferreira, Nuno P; Cristóvao, Diana M; Mano, Sofia; Sousa, David Cordeiro; Monteiro-Grillo, Manuel

2018-01-01

To highlight tomographic structural changes of retinal layers after internal limiting membrane (ILM) peeling in macular hole surgery. Nonrandomized prospective, interventional study in 38 eyes (34 patients) subjected to pars plana vitrectomy and ILM peeling for idiopathic macular hole. Retinal layers were assessed in nasal and temporal regions before and 6 months after surgery using spectral domain optical coherence tomography. Total retinal thickness increased in the nasal region and decreased in the temporal region. The retinal nerve fiber layer (RNFL), ganglion cell layer (GCL), and inner plexiform layer (IPL) showed thinning on both nasal and temporal sides of the fovea. The thickness of the outer plexiform layer (OPL) increased. The outer nuclear layer (ONL) and outer retinal layers (ORL) increased in thickness after surgery in both nasal and temporal regions. ILM peeling is associated with important alterations in the inner retinal layer architecture, with thinning of the RNFL-GCL-IPL complex and thickening of OPL, ONL, and ORL. These structural alterations can help explain functional outcome and could give indications regarding the extent of ILM peeling, even though peeling seems important for higher rate of hole closure. © 2017 S. Karger AG, Basel.

Balloon catheter dilation and nasolacrimal duct intubation for treatment of nasolacrimal duct obstruction after failed probing.

PubMed

Repka, Michael X; Chandler, Danielle L; Holmes, Jonathan M; Hoover, Darren L; Morse, Christine L; Schloff, Susan; Silbert, David I; Tien, D Robbins

2009-05-01

To compare the outcomes of balloon catheter dilation and nasolacrimal intubation as treatment for congenital nasolacrimal duct obstruction after failed probing in children younger than 4 years. We conducted a prospective, nonrandomized, multicenter study that enrolled 159 children aged 6 months to younger than 48 months who had a history of a single failed nasolacrimal duct probing and at least 1 of the following clinical signs of nasolacrimal duct obstruction: epiphora, mucous discharge, or increased tear lake. One hundred ninety-nine eyes underwent either balloon catheter nasolacrimal duct dilation or nasolacrimal duct intubation. Treatment success was defined as absence of epiphora, mucous discharge, or increased tear lake at the outcome visit 6 months after surgery. Treatment success was reported in 65 of 84 eyes (77%; 95% confidence interval, 65%-85%) in the balloon catheter dilation group compared with 72 of 88 eyes (84% after adjustment for intereye correlation; 74%-91%) in the nasolacrimal intubation group (risk ratio for success for intubation vs balloon dilation, 1.08; 0.95-1.22). Both balloon catheter dilation and nasolacrimal duct intubation alleviate the clinical signs of persistent nasolacrimal duct obstruction in a similar percentage of patients.

Variability of disease activity in patients treated with ranibizumab for neovascular age-related macular degeneration.

PubMed

Enders, P; Scholz, P; Muether, P S; Fauser, S

2016-08-01

PurposeTo analyze choroidal neovasularization (CNV) activity and recurrence patterns in patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab, and the correlation with individual intraocular vascular endothelial growth factor (VEGF) suppression time (VST).MethodsPost-hoc analysis of data from a prospective, non-randomized clinical study. Patients with nAMD treated with ranibizumab on a pro re nata regimen. Disease activity was analyzed monthly by spectral-domain optical coherence tomography and correlated with VSTs.ResultsOverall, 73 eyes of 73 patients were included in the study with a mean follow-up of 717 days (range: 412-1239 days). Overall, the mean CNV-activity-free interval was 76.5 days (range: 0-829 days). The individual range of the length of dry intervals was high. A total of 42% of patients had a range of more than 90 days. Overall, 16% of patients showed persistent activity. And 12% stayed dry after the initial ranibizumab treatment. No significant correlation was found between the CNV-recurrence pattern and VST (P=0.12).ConclusionsCNV activity in nAMD is irregular, which is reflected in the range of the duration of dry intervals and late recurrences. The biomarker VST solely seems not to be sufficient to explain recurrence pattern of CNV in all AMD patients.

Concurrent ganirelix and follitropin beta therapy is an effective and safe regimen for ovulation induction in women with polycystic ovary syndrome.

PubMed

Elkind-Hirsch, Karen E; Webster, Bobby W; Brown, Crystal P; Vernon, Michael W

2003-03-01

To evaluate controlled ovarian stimulation cycles using the GnRH antagonist ganirelix in combination with the recombinant FSH, follitropin-beta, in women with polycystic ovary syndrome (PCOS). Prospective, nonrandomized clinical study. Hospital-based infertility practice. Twenty women with PCOS planning to undergo ovarian stimulation. Fasting glucose and insulin levels were used to calculate insulin resistance ratios (FG/I). After pretreatment with oral contraceptives, serum LH levels were determined, and 250 microg ganirelix was administered on cycle day 2. Upon suppression of LH, concurrent ganirelix and follitropin-beta therapy (morning ganirelix and evening follitropin-beta) was started and continued until the day of hCG. Days of stimulation, dose of follitropin-beta, pregnancy, and ongoing pregnancy were compared based on FG/I ratios. One dose of ganirelix effectively suppressed LH levels in all patients. All patients ovulated as documented by a rise in progesterone. Significant differences were observed between the insulin-resistant and non-insulin-resistant groups for both days of stimulation and dose of follitropin-beta. The overall clinical pregnancy rate was 44.4%, with an ongoing pregnancy rate of 27.8%. In this preliminary study, we demonstrate the effectiveness of a concurrent ganirelix and follitropin-beta therapy for ovarian stimulation in women with PCOS.

Implementation of a Nutrition Program Reduced Post-Discharge Growth Restriction in Thai Very Low Birth Weight Preterm Infants.

PubMed

Japakasetr, Suchada; Sirikulchayanonta, Chutima; Suthutvoravut, Umaporn; Chindavijak, Busba; Kagawa, Masaharu; Nokdee, Somjai

2016-12-17

Very low birth weight (VLBW) preterm infants are vulnerable to growth restriction after discharge due to cumulative protein and energy deficits during their hospital stay and early post-discharge period. The current study evaluated the effectiveness of the preterm infant, post-discharge nutrition (PIN) program to reduce post-discharge growth restriction in Thai VLBW preterm infants. A prospective, non-randomized interventional cohort study was undertaken to assess the growth of 22 VLBW preterm infants who received the PIN program and compared them with 22 VLBW preterm infants who received conventional nutrition services. Infant's growth was recorded monthly until the infants reached six months' corrected age (6-moCA). Intervention infants had significantly greater body weights ( p = 0.013) and head circumferences ( p = 0.009). Also, a greater proportion of the intervention group recovered their weight to the standard weight at 4-moCA ( p = 0.027) and at 6-moCA ( p = 0.007) and their head circumference to the standard head circumference at 6-moCA ( p = 0.004) compared to their historical comparison counterparts. Enlistment in the PIN program thus resulted in significantly reduced post-discharge growth restriction in VLBW preterm infants. Further research on longer term effects of the program on infant's growth and development is warranted.

The Relationship between Emotional and Esteem Social Support Messages and Health.

PubMed

Robinson, James D; Turner, Jeanine W; Tian, Yan; Neustadtl, Alan; Mun, Seong Ki; Levine, Betty

2017-11-28

The purpose of this investigation is to determine the relative contribution of five types of social support to improved patient health. This analysis suggests that emotional and esteem social support messages are associated with improved patient health as measured by a decrease in average blood glucose levels among diabetic patients. In addition, when two system feature variables, two system use variables, two measures of learning, one measure of self-efficacy, and one measure of affect toward their HCP were added to the baseline model, a third significant factor emerged. Perceptions about learning about diabetes from reading the digital messages sent by their HCP also predicted improved patient health. Cognitive-Emotional Theory of Esteem Support Messages suggests a combination of esteem social support and emotional social support messages enhanced our ability to predict improved patient health by change in patient hemoglobin A1c (HbA1c) scores. While a nonrandomized prospective study, this investigation provides support for the notion that provider-patient interaction is related to improved patient health and that both emotional and esteem social support messages play a role in that process. Finally, the study suggests some types of social support are and other types are not associated with improved patient health; this is consistent with the optimal matching hypothesis.

Effects of low-dose combined drospirenone-ethinylestradiol on perimenstrual symptoms experienced by women with endometriosis.

PubMed

Tanaka, Yukiko; Mori, Taisuke; Ito, Fumitake; Koshiba, Akemi; Kusuki, Izumi; Kitawaki, Jo

2016-11-01

To determine the effectiveness of a 24/4-day regimen of a low-dose combination drospirenone-ethinylestradiol oral contraceptive in alleviating perimenstrual symptoms among Japanese women with endometriosis. The present prospective, non-randomized study enrolled women diagnosed with endometriosis radiographically or surgically at the Kyoto Prefectural University of Medicine hospital, Japan, between December 1, 2010 and August 31, 2013. Patients received treatment with oral drospirenone-ethinylestradiol for six treatment cycles. Dysmenorrhea, chronic pelvic pain, and dyspareunia severity were assessed using visual analog scale scores after three and six treatment cycles, and changes in perimenstrual symptoms were assessed using the menstrual distress questionnaire (MDQ) scores. In total, 46 patients were recruited for the study. Dysmenorrhea, chronic pelvic pain, and dyspareunia were all significantly reduced after both three and six treatment cycles in comparison with baseline (P<0.001 for all comparisons). After six treatment cycles, significant reductions were observed for all menstrual MDQ measures and for the premenstrual water retention and negative-effect MDQ measures (all P<0.05). Combination drospirenone-ethinylestradiol was effective in the treatment of dysmenorrhea, chronic pelvic pain, dyspareunia, and somatic/psychological symptoms in Japanese women with endometriosis. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Nonrandom Intrafraction Target Motions and General Strategy for Correction of Spine Stereotactic Body Radiotherapy

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

Ma Lijun, E-mail: lijunma@radonc.ucsf.ed; Sahgal, Arjun; Hossain, Sabbir

2009-11-15

Purpose: To characterize nonrandom intrafraction target motions for spine stereotactic body radiotherapy and to develop a method of correction via image guidance. The dependence of target motions, as well as the effectiveness of the correction strategy for lesions of different locations within the spine, was analyzed. Methods and Materials: Intrafraction target motions for 64 targets in 64 patients treated with a total of 233 fractions were analyzed. Based on the target location, the cases were divided into three groups, i.e., cervical (n = 20 patients), thoracic (n = 20 patients), or lumbar-sacrum (n = 24 patients) lesions. For each case,more » time-lag autocorrelation analysis was performed for each degree of freedom of motion that included both translations (x, y, and z shifts) and rotations (roll, yaw, and pitch). A general correction strategy based on periodic interventions was derived to determine the time interval required between two adjacent interventions, to overcome the patient-specific target motions. Results: Nonrandom target motions were detected for 100% of cases regardless of target locations. Cervical spine targets were found to possess the highest incidence of nonrandom target motion compared with thoracic and lumbar-sacral lesions (p < 0.001). The average time needed to maintain the target motion to within 1 mm of translation or 1 deg. of rotational deviation was 5.5 min, 5.9 min, and 7.1 min for cervical, thoracic, and lumbar-sacrum locations, respectively (at 95% confidence level). Conclusions: A high incidence of nonrandom intrafraction target motions was found for spine stereotactic body radiotherapy treatments. Periodic interventions at approximately every 5 minutes or less were needed to overcome such motions.« less

Commentary: The Challenge of Nonexperimental Interventions Studies in Social Work

ERIC Educational Resources Information Center

Schilling, Robert

2010-01-01

The challenging context of social work interventions require that most intervention studies will be derived from nonexperimental research designs. Two evaluation studies in this special issue employed nonrandomized designs to examine the efficacy of two programs--a police crisis intervention team designed to enhance officers' responses to mental…

Randomized Controlled Studies and Alternative Designs in Outcome Studies: Challenges and Opportunities

ERIC Educational Resources Information Center

Shadish, William R.

2011-01-01

This article reviews several decades of the author's meta-analytic and experimental research on the conditions under which nonrandomized experiments can approximate the results from randomized experiments (REs). Several studies make clear that we can expect accurate effect estimates from the regression discontinuity design, though its statistical…

Quasi-experimental study designs series-paper 6: risk of bias assessment.

PubMed

Waddington, Hugh; Aloe, Ariel M; Becker, Betsy Jane; Djimeu, Eric W; Hombrados, Jorge Garcia; Tugwell, Peter; Wells, George; Reeves, Barney

2017-09-01

Rigorous and transparent bias assessment is a core component of high-quality systematic reviews. We assess modifications to existing risk of bias approaches to incorporate rigorous quasi-experimental approaches with selection on unobservables. These are nonrandomized studies using design-based approaches to control for unobservable sources of confounding such as difference studies, instrumental variables, interrupted time series, natural experiments, and regression-discontinuity designs. We review existing risk of bias tools. Drawing on these tools, we present domains of bias and suggest directions for evaluation questions. The review suggests that existing risk of bias tools provide, to different degrees, incomplete transparent criteria to assess the validity of these designs. The paper then presents an approach to evaluating the internal validity of quasi-experiments with selection on unobservables. We conclude that tools for nonrandomized studies of interventions need to be further developed to incorporate evaluation questions for quasi-experiments with selection on unobservables. Copyright © 2017 Elsevier Inc. All rights reserved.

Severe traumatic brain injury management and clinical outcome using the Lund concept.

PubMed

Koskinen, L-O D; Olivecrona, M; Grände, P O

2014-12-26

This review covers the main principles of the Lund concept for treatment of severe traumatic brain injury. This is followed by a description of results of clinical studies in which this therapy or a modified version of the therapy has been used. Unlike other guidelines, which are based on meta-analytical approaches, important components of the Lund concept are based on physiological mechanisms for regulation of brain volume and brain perfusion and to reduce transcapillary plasma leakage and the need for plasma volume expanders. There have been nine non-randomized and two randomized outcome studies with the Lund concept or modified versions of the concept. The non-randomized studies indicated that the Lund concept is beneficial for outcome. The two randomized studies were small but showed better outcome in the groups of patients treated according to the modified principles of the Lund concept than in the groups given a more conventional treatment. Copyright © 2014 IBRO. Published by Elsevier Ltd. All rights reserved.

Chemotherapy-induced nausea and vomiting in routine practice: a European perspective.

PubMed

Glaus, Agnes; Knipping, Cornelia; Morant, Rudolf; Böhme, Christel; Lebert, Burkhard; Beldermann, Frank; Glawogger, Bernhard; Ortega, Paz Fernandez; Hüsler, André; Deuson, Robert

2004-10-01

The aim of this study was to evaluate the occurrence of chemotherapy-induced nausea and vomiting (CINV) and its effect on patients' ability to carry out daily life activities following moderately to highly emetogenic, first-cycle chemotherapy in routine practice in cancer centers of four different European countries. This was a prospective, cross-sectional, nonrandomized, self-assessment study in 249 patients enrolled from cancer centers in Spain, Austria, Germany, and Switzerland. The study population consisted of 78% women, with a mean age of 54. Breast, lung, and ovarian cancers made up 75% of all cancers in the study. Patients received a mean of 2.0 chemotherapy agents and 2.5 antiemetic drugs. A total of 450 emetic episodes experienced by 243 patients was recorded over 5 days following chemotherapy, with an average of 1.8 episodes per patient (range: 0-28). A higher percentage of patients (38%) suffered from delayed compared to acute emesis (13%). Between 42% and 52% of all patients suffered from nausea (visual analogue scale > or = 5 mm) on any one day, peaking at day 3. Using the Functional Living Index for Emesis (FLIE) questionnaire, 75% of patients with nausea and 50% with vomiting reported a negative impact of these conditions on performance of daily living. CINV remains a significant problem in routine practice, particularly in the delayed phase posttreatment. Overall, CINV had a negative impact on patients' daily life.

EFFECT OF INTERNAL LIMITING MEMBRANE PEELING DURING VITRECTOMY FOR DIABETIC MACULAR EDEMA: Systematic Review and Meta-analysis.

PubMed

Nakajima, Takuya; Roggia, Murilo F; Noda, Yasuo; Ueta, Takashi

2015-09-01

To evaluate the effect of internal limiting membrane (ILM) peeling during vitrectomy for diabetic macular edema. MEDLINE, EMBASE, and CENTRAL were systematically reviewed. Eligible studies included randomized or nonrandomized studies that compared surgical outcomes of vitrectomy with or without ILM peeling for diabetic macular edema. The primary and secondary outcome measures were postoperative best-corrected visual acuity and central macular thickness. Meta-analysis on mean differences between vitrectomy with and without ILM peeling was performed using inverse variance method in random effects. Five studies (7 articles) with 741 patients were eligible for analysis. Superiority (95% confidence interval) in postoperative best-corrected visual acuity in ILM peeling group compared with nonpeeling group was 0.04 (-0.05 to 0.13) logMAR (equivalent to 2.0 ETDRS letters, P = 0.37), and superiority in best-corrected visual acuity change in ILM peeling group was 0.04 (-0.02 to 0.09) logMAR (equivalent to 2.0 ETDRS letters, P = 0.16). There was no significant difference in postoperative central macular thickness and central macular thickness reduction between the two groups. The visual acuity outcomes using pars plana vitrectomy with ILM peeling versus no ILM peeling were not significantly different. A larger randomized prospective study would be necessary to adequately address the effectiveness of ILM peeling on visual acuity outcomes.

The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED).

PubMed

Gold, Michael R; Knops, Reinoud; Burke, Martin C; Lambiase, Pier D; Russo, Andrea M; Bongiorni, Maria Grazia; Deharo, Jean-Claude; Aasbo, Johan; El Chami, Mikhael F; Husby, Michael; Carter, Nathan; Boersma, Lucas

2017-01-01

The UNTOUCHED study will assess the safety and efficacy of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the most common cohort of patients receiving ICDs. The primary goal is to evaluate the inappropriate shock (IAS)-free rate in primary prevention patients with a reduced ejection fraction (EF) and compare with a historical control of transvenous ICD patients with similar programming. The UNTOUCHED study is a global, multicenter, prospective, nonrandomized study of patients undergoing de novo S-ICD implantation for primary prevention of sudden cardiac death with a left ventricular EF ≤35%. The primary end point of this trial is freedom from IAS at 18 months. The lower 95% confidence bound of the observed incidence will be compared to a performance goal of 91.6%, which was derived from the IAS rate in MADIT-RIT. The secondary end points are all-cause shock-free rate at 18 months, and system- and procedure-related complication-free rate at 1 month and 6 months. Enrollment of a minimum of 1,100 subjects from up to 200 centers worldwide is planned based on power calculations of the primary and principal secondary end points. This trial will provide important data regarding the rates of inappropriate and appropriate shock therapy in real-world use of the S-ICD in the most common group of patients receiving ICDs. © 2016 Wiley Periodicals, Inc.

Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504).

PubMed

Palacios, S; Espadaler, J; Fernández-Moya, J M; Prieto, C; Salas, N

2016-10-01

The purpose of this study was to prospectively evaluate the impact of the use of L. plantarum I1001 applied vaginally on Vulvovaginal Candidiasis (VVC) time-until-recurrence after treatment with single-dose vaginal clotrimazole. This was a clinical open-label, prospective study of two non-randomized parallel cohorts with symptomatic acute VVC: (1) 33 sexually active women 18-50 years old, prescribed a standard single-dose 500 mg vaginal tablet of clotrimazole followed by vaginal tablets with L. plantarum I1001 as adjuvant therapy, and (2) 22 women of similar characteristics but prescribed single-dose clotrimazole only. Use of the probiotic and factors that might influence recurrence risk (age, recurrent VVC within previous year, antibiotic prior to study enrolment, diaphragm or IUD contraception, among others) were included in a multivariate Cox regression model to adjust for potential between-cohort differences. Probiotic use was associated with a three-fold reduction in the adjusted risk of recurrence (HR [95 %CI]: 0.30 [0.10-0.91]; P = 0.033). Adjusted free-survival recurrence was 72.83 % and 34.88 % for the probiotic and control groups, respectively. A higher cumulative recurrence was also observed in cases with use of antibiotics prior to enrolment (HR [95 %CI]: 10.46 [2.18-50.12]; P = 0.003). Similar findings were found at six months after azole treatment in women with RVVC. Overall, good compliance with the probiotic was reported for 91.3 % of women. The study suggests that follow-up therapy with vaginal tablets with L. plantarum I1001 could increase the effectiveness of single-dose 500 mg clotrimazole at preventing recurrence of VVC, an effect that was also observed in women with recurrent vulvovaginal candidiasis (RVVC) after six months of azole treatment.

Phrenic nerve stimulation for the treatment of central sleep apnea.

PubMed

Abraham, William T; Jagielski, Dariusz; Oldenburg, Olaf; Augostini, Ralph; Krueger, Steven; Kolodziej, Adam; Gutleben, Klaus-Jürgen; Khayat, Rami; Merliss, Andrew; Harsch, Manya R; Holcomb, Richard G; Javaheri, Shahrokh; Ponikowski, Piotr

2015-05-01

The aim of this study was to evaluate chronic, transvenous, unilateral phrenic nerve stimulation to treat central sleep apnea (CSA) in a prospective, multicenter, nonrandomized study. CSA occurs predominantly in patients with heart failure and increases the risk for morbidity and mortality. Established therapies for CSA are lacking, and those available are limited by poor patient adherence. Fifty-seven patients with CSA underwent baseline polysomnography followed by transvenous phrenic nerve stimulation system implantation and follow-up. Feasibility was assessed by implantation success rate and therapy delivery. Safety was evaluated by monitoring of device- and procedure-related adverse events. Efficacy was evaluated by changes in the apnea-hypopnea index at 3 months. Quality of life at 6 months was evaluated using a sleepiness questionnaire, patient global assessment, and, in patients with heart failure at baseline, the Minnesota Living With Heart Failure Questionnaire. The study met its primary end point, demonstrating a 55% reduction in apnea-hypopnea index from baseline to 3 months (49.5 ± 14.6 episodes/h vs. 22.4 ± 13.6 episodes/h of sleep; p < 0.0001; 95% confidence interval for change: -32.3 to -21.9). Central apnea index, oxygenation, and arousals significantly improved. Favorable effects on quality of life and sleepiness were noted. In patients with heart failure, the Minnesota Living With Heart Failure Questionnaire score significantly improved. Device- or procedure-related serious adverse events occurred in 26% of patients through 6 months post therapy initiation, predominantly due to lead repositioning early in the study. Therapy was well tolerated. Efficacy was maintained at 6 months. Transvenous, unilateral phrenic nerve stimulation appears safe and effective for treating CSA. These findings should be confirmed in a prospective, randomized, controlled trial. (Chronic Evaluation of Respicardia Therapy; NCT01124370). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Pulsed electromagnetic fields dosing impacts postoperative pain in breast reduction patients.

PubMed

Taylor, Erin M; Hardy, Krista L; Alonso, Amanda; Pilla, Arthur A; Rohde, Christine H

2015-01-01

Pulsed electromagnetic fields (PEMF) reduce postoperative pain and narcotic requirements in breast augmentation, reduction, and reconstruction patients. PEMF enhances both calmodulin-dependent nitric oxide and/or cyclic guanosine monophosphate signaling and phosphodiesterase activity, which blocks cyclic guanosine monophosphate. The clinical effect of these competing responses on PEMF dosing is not known. Two prospective, nonrandomized, active cohorts of breast reduction patients, with 15 min PEMF per 2 h; "Q2 (active)", and 5 min PEMF per 20 min; "5/20 (active)", dosing regimens were added to a previously reported double-blind clinical study wherein 20 min PEMF per 4 h, "Q4 (active)", dosing significantly accelerated postoperative pain reduction compared with Q4 shams. Postoperative visual analog scale pain scores and narcotic use were compared with results from the previous study. Visual analog scale scores at 24 h were 43% and 35% of pain at 1 h in the Q4 (active) and Q2 (active) cohorts, respectively (P < 0.01). Pain at 24 h in the 5/20 (active) cohort was 87% of pain at 1 h, compared with 74% in the Q4 (sham) cohort (P = 0.451). Concomitantly, narcotic usage in the 5/20 (active) and Q4 (sham) cohorts was not different (P = 0.478), and 2-fold higher than the Q4 (active) and Q2 (active) cohorts (P < 0.02). This prospective study shows Q4/Q2, but not 5/20 PEMF dosing, accelerated postoperative pain reduction compared with historical shams. The 5/20 (active) regimen increases NO 4-fold faster than the Q4 (active) regimen, possibly accelerating phosphodiesterase inhibition of cyclic guanosine monophosphate sufficiently to block the PEMF effect. This study helps define the dosing limits of clinically useful PEMF signals. Copyright © 2015 Elsevier Inc. All rights reserved.

A Systematic Review of Antimicrobial Stewardship Interventions in the Emergency Department.

PubMed

Losier, Mia; Ramsey, Tasha D; Wilby, Kyle John; Black, Emily K

2017-09-01

To improve antimicrobial utilization, development and implementation of antimicrobial stewardship programs in the emergency department (ED) has been recommended. The primary objective of this review was to characterize antimicrobial stewardship (AMS) in the ED and to identify interventions that improve patient outcomes or process of care and/or reduce consequences of antimicrobial use. This study was completed as a systematic review. The following databases were searched from inception through November, 2016: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Scopus, and Web of Science. Randomized controlled trials, nonrandomized controlled trials, controlled and uncontrolled before-and-after studies, interrupted time series studies, and repeated-measures studies evaluating AMS interventions in the ED were included in the review. Studies published in languages other than English were excluded. A total of 43 studies meeting inclusion criteria were identified from our search. Patient or provider education and guideline or clinical pathway implementation were the most commonly reported interventions. Few studies reported on audit and feedback, and no study evaluated preauthorization. Impact of interventions showed variable results. Where identified, benefits of AMS interventions primarily included improvement in delivery of care or a decrease in antimicrobial utilization; however, most studies were rated as having unclear or high risk of bias. AMS interventions in the ED may improve patient care. However, the optimal combination of interventions is unclear. Additional studies with more rigorous design evaluating core components of AMS programs, including prospective audit and feedback are needed.

Is caffeine intake a risk factor leading to infertility? A protocol of an epidemiological systematic review of controlled clinical studies.

PubMed

Cao, Huijuan; Ren, Jun; Feng, Xue; Yang, Guoyan; Liu, Jianping

2016-03-15

Previous studies showed that high dose of caffeine intake may induce some specific human reproductive system diseases, even lead to infertility. In consideration of the high consumption of caffeine according to the latest population-based survey, this review is aimed to systematically review the evidence from all controlled clinical studies of caffeine intake for infertility. Relevant randomized/quasi-randomized controlled trials, non-randomized clinical studies, cohort studies, and case-control studies will be included in this review. Participants will be either those without a history of infertility who are willing to have a baby (for prospective studies) or infertile patients with confirmed diagnosis (for retrospective studies). Caffeine or caffeine-containing beverage will be observed as the exposure factor. The key outcome will be the diagnosis of infertility in participants. All relevant published/unpublished or ongoing studies will be searched from seven databases and four online systems until December 2015. Two authors will screen the literatures and extract the data independently. Methodological quality of the included studies will be assessed by two authors according to either Risk of Bias Assessment or Newcastle-Ottawa Scale. We will use R software to analyze the data. Dose of caffeine will be quantified on a daily basis, and relative risk with their 95 % confidence interval will be measured. If data permit, meta-analysis and dose-response analysis will be conducted. Summary of findings tables will be generated using Guideline Development Tool online. PROSPERO CRD42015015714.

Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study.

PubMed

Carlson, Mike; Vigen, Cheryl Lp; Rubayi, Salah; Blanche, Erna Imperatore; Blanchard, Jeanine; Atkins, Michal; Bates-Jensen, Barbara; Garber, Susan L; Pyatak, Elizabeth A; Diaz, Jesus; Florindez, Lucia I; Hay, Joel W; Mallinson, Trudy; Unger, Jennifer B; Azen, Stanley Paul; Scott, Michael; Cogan, Alison; Clark, Florence

2017-04-17

Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI. A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group. Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County. Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group. The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts. Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures. Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were .56 for intervention recipients, .48 for randomized controls, and .65 for nonrandomized controls. At follow-up, rates were .44 and .39 respectively for randomized intervention and control participants. Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect. ClinicalTrials.gov NCT01999816.

Outcome of Large to Massive Rotator Cuff Tears Repaired With and Without Extracellular Matrix Augmentation: A Prospective Comparative Study.

PubMed

Gilot, Gregory J; Alvarez-Pinzon, Andres M; Barcksdale, Leticia; Westerdahl, David; Krill, Michael; Peck, Evan

2015-08-01

To compare the results of arthroscopic repair of large to massive rotator cuff tears (RCTs) with or without augmentation using an extracellular matrix (ECM) graft and to present ECM graft augmentation as a valuable surgical alternative used for biomechanical reinforcement in any RCT repair. We performed a prospective, blinded, single-center, comparative study of patients who underwent arthroscopic repair of a large to massive RCT with or without augmentation with ECM graft. The primary outcome was assessed by the presence or absence of a retear of the previously repaired rotator cuff, as noted on ultrasound examination. The secondary outcomes were patient satisfaction evaluated preoperatively and postoperatively using the 12-item Short Form Health Survey, the American Shoulder and Elbow Surgeons shoulder outcome score, a visual analog scale score, the Western Ontario Rotator Cuff index, and a shoulder activity level survey. We enrolled 35 patients in the study: 20 in the ECM-augmented rotator cuff repair group and 15 in the control group. The follow-up period ranged from 22 to 26 months, with a mean of 24.9 months. There was a significant difference between the groups in terms of the incidence of retears: 26% (4 retears) in the control group and 10% (2 retears) in the ECM graft group (P = .0483). The mean pain level decreased from 6.9 to 4.1 in the control group and from 6.8 to 0.9 in the ECM graft group (P = .024). The American Shoulder and Elbow Surgeons score improved from 62.1 to 72.6 points in the control group and from 63.8 to 88.9 points (P = .02) in the treatment group. The mean Short Form 12 scores improved in the 2 groups, with a statistically significant difference favoring graft augmentation (P = .031), and correspondingly, the Western Ontario Rotator Cuff index scores improved in both arms, favoring the treatment group (P = .0412). The use of ECM for augmentation of arthroscopic repairs of large to massive RCTs reduces the incidence of retears, improves patient outcome scores, and is a viable option during complicated cases in which a significant failure rate is anticipated. Level III, prospective, blinded, nonrandomized, comparative study. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Unbiased Causal Inference from an Observational Study: Results of a Within-Study Comparison

ERIC Educational Resources Information Center

Pohl, Steffi; Steiner, Peter M.; Eisermann, Jens; Soellner, Renate; Cook, Thomas D.

2009-01-01

Adjustment methods such as propensity scores and analysis of covariance are often used for estimating treatment effects in nonexperimental data. Shadish, Clark, and Steiner used a within-study comparison to test how well these adjustments work in practice. They randomly assigned participating students to a randomized or nonrandomized experiment.…

Story immersion may be effective in promoting diet and physical activity in Chinese children

USDA-ARS?s Scientific Manuscript database

This study evaluated the effect of playing a health video game embedded with story immersion, Escape from Diab (Diab), on children's diet and physical activity (PA), and also explored whether children immersed in Diab had greater positive outcomes. The study design employed two groups, nonrandomized...

Burn, freeze, or photo-ablate?: comparative symptom profile in Barrett's dysplasia patients undergoing endoscopic ablation

NASA Astrophysics Data System (ADS)

Gill, Kanwar Rupinder S.; Gross, Seth A.; Greenwald, Bruce D.; Hemminger, Lois L.; Wolfsen, Herbert C.

2009-06-01

Background: There are few data available comparing endoscopic ablation methods for Barrett's esophagus with high-grade dysplasia (BE-HGD). Objective: To determine differences in symptoms and complications associated with endoscopic ablation. Design: Prospective observational study. Setting: Two tertiary care centers in USA. Patients: Consecutive patients with BE-HGD Interventions: In this pilot study, symptoms profile data were collected for BE-HGD patients among 3 endoscopic ablation methods: porfimer sodium photodynamic therapy, radiofrequency ablation and low-pressure liquid nitrogen spray cryotherapy. Main Outcome Measurements: Symptom profiles and complications from the procedures were assessed 1-8 weeks after treatment. Results: Ten BE-HGD patients were treated with each ablation modality (30 patients total; 25 men, median age: 69 years (range 53-81). All procedures were performed in the clinic setting and none required subsequent hospitalization. The most common symptoms among all therapies were chest pain, dysphagia and odynophagia. More patients (n=8) in the porfimer sodium photodynamic therapy group reported weight loss compared to radio-frequency ablactation (n=2) and cryotherapy (n=0). Four patients in the porfimer sodium photodynamic therapy group developed phototoxicity requiring medical treatment. Strictures, each requiring a single dilation, were found in radiofrequency ablactation (n=1) and porfimer sodium photodynamic therapy (n=2) patients. Limitations: Small sample size, non-randomized study. Conclusions: These three endoscopic therapies are associated with different types and severity of post-ablation symptoms and complications.

Prevalence and comorbidity of eating disorders among a community sample of adolescents: 2-year follow-up.

PubMed

Rojo-Moreno, Luis; Arribas, Pilar; Plumed, Javier; Gimeno, Natalia; García-Blanco, Ana; Vaz-Leal, Francisco; Luisa Vila, María; Livianos, Lorenzo

2015-05-30

The previous literature about comorbidity between eating disorders (ED) and other DSM-IV psychiatric disorders in adolescence has employed cross-sectional studies with clinical samples, where the comorbid disorders were diagnosed retrospectively. The present study aims to overcome these limitations by the analysis of comorbidity in a community population during 2-year follow-up. A semi-structured interview was applied to a teenager sample. Firstly, a cross-sectional and non-randomized study on psychiatric morbidity was conducted with 993 teenagers between the ages of 12 and 16 from five schools. Secondly, 326 students between 14 and 17 years old of one school were reassessed 2 years later in order to detect ED new cases and find associations with previous psychiatric disorders. The ED prevalence was 3.6%. Cross-sectional analysis revealed that 62.9% of individuals with an ED had comorbid disorders: anxiety disorders (51.4%), Attention Deficit Hyperactivity Disorder (31.4%), oppositional defiant disorder (11.4%), and obsessive compulsive disorder (8.6%). Prospective longitudinal analysis showed an ED incidence rate of 2.76% over the course of 2 years. 22.2% of new cases had received previous psychiatric diagnoses, of which all were anxiety disorders. Thus, ED exhibited a high comorbidity rate among adolescent populations and anxiety disorders were the most common comorbid diagnosis. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A.

PubMed

Welzel, Grit; Boch, Angela; Sperk, Elena; Hofmann, Frank; Kraus-Tiefenbacher, Uta; Gerhardt, Axel; Suetterlin, Marc; Wenz, Frederik

2013-01-07

Intraoperative radiotherapy (IORT) is a new treatment approach for early stage breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters. Two hundred and thirty women with stage I-III breast cancer (age, 31 to 84 years) were entered into the study. A single-center subgroup of 87 women from the two arms of the randomized phase III trial TARGIT-A (TARGeted Intra-operative radioTherapy versus whole breast radiotherapy for breast cancer) was analyzed. Furthermore, results were compared to non-randomized control groups: n = 90 receiving IORT as a tumor bed boost followed by external beam whole breast radiotherapy (EBRT) outside of TARGIT-A (IORT-boost), and n = 53 treated with EBRT followed by an external-beam boost (EBRT-boost). QoL was collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 (QLQ-C30) and BR23 (QLQ-BR23). The mean follow-up period in the TARGIT-A groups was 32 versus 39 months in the non-randomized control groups. Patients receiving IORT alone reported less general pain (21.3 points), breast (7.0 points) and arm (15.1 points) symptoms, and better role functioning (78.7 points) as patients receiving EBRT (40.9; 19.0; 32.8; and 60.5 points, respectively, P < 0.01). Patients receiving IORT alone also had fewer breast symptoms than TARGIT-A patients receiving IORT followed by EBRT for high risk features on final pathology (IORT-EBRT; 7.0 versus 29.7 points, P < 0.01). There were no significant differences between TARGIT-A patients receiving IORT-EBRT compared to non-randomized IORT-boost or EBRT-boost patients and patients receiving EBRT without a boost. In the randomized setting, important radiation-related QoL parameters after IORT were superior to EBRT. Non-randomized comparisons showed equivalent parameters in the IORT-EBRT group and the control groups.

Is thoracoscopic patent ductus arteriosus closure superior to conventional surgery?

PubMed

Stankowski, Tomasz; Aboul-Hassan, Sleiman Sebastian; Marczak, Jakub; Cichon, Romuald

2015-10-01

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether thoracoscopic patent ductus arteriosus (PDA) closure is superior to conventional surgery. Altogether 821 papers were found using the reported search, 11 of which represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Eleven studies included in the analysis consisted of two prospective and three retrospective, non-randomized studies and six case series. Four included studies focused only on preterm infants, three studies enrolled neonates and the other four analysed all age groups from neonates to older children or young adults. There were no differences in mortality between video-assisted thoracoscopic surgery (VATS) and conventional surgery. Two studies suggested that VATS offers shorter operative times. Two papers observed shorter hospital stay, although the other two noted no significant difference. A large prospective trial found VATS to be associated with a lower number of postoperative complications in neonates and infants, whereas other studies suggested no significant differences in short-term postoperative complications. There is little evidence to suggest better musculoskeletal status and cosmesis in neonates following VATS. Conversion from thoracoscopy to thoracotomy described in six papers was seldom and it did not lead to any additional complications. All observational studies confirmed that both techniques are free from major adverse cardiovascular complications and these two techniques can be safely used in all patients qualified for surgical PDA closure. Two studies compared cost-effectiveness between the two techniques; one of them described VATS as significantly more cost-efficient, whereas the other study observed no difference. However, it should be noted that data were provided from different countries and time periods. The results presented suggest that there are no significant differences in early clinical outcomes between VATS and thoracotomy in all age groups. However, where differences have been shown, such as pain, postoperative complications, length of hospital and ICU stay and cost, these favour the VATS approach. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Robotic Radical Hysterectomy After Concomitant Chemoradiation in Locally Advanced Cervical Cancer: A Prospective Phase II Study.

PubMed

Gallotta, Valerio; Chiantera, Vito; Conte, Carmine; Vizzielli, Giuseppe; Fagotti, Anna; Nero, Camilla; Costantini, Barbara; Lucidi, Alessandro; Cicero, Carla; Scambia, Giovanni; Ferrandina, Gabriella

2017-01-01

To assess the feasibility of total robotic radical surgery (TRRS) in patients with locally advanced cervical cancer (LACC) who receive chemoradiation therapy (CT/RT). A prospective (preplanned) study of a nonrandomized controlled trial (Canadian Task Force classification level 2). Catholic University of the Sacred Hearth, Rome, Italy. Between September 2013 and January 2016, a total of 40 patients with LACC (Fédération Internationale de Gynécologie et d'Obstétrique stage IB2-III) were enrolled in the study. Robotic radical hysterectomy (RRH) plus pelvic and/or aortic lymphadenectomy was attempted within 6 weeks after CT/RT. The feasibility of TRRS as well as the rate, pattern, and severity of early and late postoperative complications were analyzed. After CT/RT, 29 patients (72.5%) underwent type B2 RRH, and 11 (27.5%) underwent type C1 RRH. Pelvic lymphadenectomy was performed in all cases. TRRS was successful in 39 of 40 cases (feasibility rate = 97.5%). In patients successfully completing TRRS, the median operating time was 185 minutes (range, 100-330 minutes), and the median blood loss was 100 mL (range, 50-300 mL). The median time of hospitalization counted from the first postoperative day was 2 days (range, 1-4 days). No intraoperative complications were recorded. During the observation period (median = 18 months; range, 4-28 months), 9 of 40 (22.5%) experienced postoperative complications, for a total number of 12 complications. As of April 2016, recurrence of disease was documented in 5 cases (12.5%). TRRS is feasible in LACC patients administered preoperative CT/RT, providing perioperative outcomes comparable with those registered in early-stage disease, and LACC patients receiving neoadjuvant chemotherapy. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

A prospective comparison of cold snare polypectomy using traditional or dedicated cold snares for the resection of small sessile colorectal polyps

PubMed Central

Dwyer, Jeremy P.; Tan, Jonathan Y. C.; Urquhart, Paul; Secomb, Robyn; Bunn, Catherine; Reynolds, John; La Nauze, Richard; Kemp, William; Roberts, Stuart; Brown, Gregor

2017-01-01

Background and study aims  The evidence for efficacy and safety of cold snare polypectomy is limited. The aim of this study was to assess the completeness of resection and safety of cold snare polypectomy, using either traditional or dedicated cold snares. Patients and methods  This was a prospective, non-randomized study performed at a single tertiary hospital. Adult patients with at least one colorectal polyp (size ≤ 10 mm) removed by cold snare were included. In the first phase, all patients had polyps removed by traditional snare without diathermy. In the second phase, all patients had polyps removed by dedicated cold snare. Complete endoscopic resection was determined from histological examination of quadrantic polypectomy margin biopsies. Immediate or delayed bleeding within 2 weeks was recorded. Results  In total, 181 patients with 299 eligible polyps (n = 93 (173 polyps) traditional snare group, n = 88 (126 polyps) dedicated cold snare group) were included. Patient demographics and procedure indications were similar between groups. Mean polyp size was 6 mm in both groups ( P  = 0.25). Complete polyp resection was 165 /173 (95.4 %; 95 %CI 90.5 – 97.6 %) in the traditional snare group and 124/126 (98.4 %; 95 %CI 93.7 – 99.6 %) in the dedicated cold snare group ( P  = 0.16). Serrated polyps, compared with adenomatous polyps, had a higher rate of incomplete resection (7 % vs. 2 %, P  = 0.03). There was no statistically significant difference in the rate of immediate bleeding (3 % vs. 1 %, P  = 0.41) and there were no delayed hemorrhages or perforations. Conclusions  Cold snare polypectomy is effective and safe for the complete endoscopic resection of small (≤ 10 mm) colorectal polyps with either traditional or dedicated cold snares. PMID:29250580

Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes.

PubMed

Ferro, Matteo; Bottero, Danilo; D'Elia, Carolina; Matei, Deliu Victor; Cioffi, Antonio; Cozzi, Gabriele; Serino, Alessandro; Cordima, Giovanni; Bianchi, Roberto; Incarbone, Piero Giacomo; Brescia, Antonio; Musi, Gennaro; Fusco, Ferdinando; Detti, Serena; Mirone, Vincenzo; de Cobelli, Ottavio

2017-03-01

To evaluate the efficacy and safety of the Virtue ® male sling (Coloplast, Humlebaek, Denmark) in a cohort of patients affected by post-prostatectomy stress urinary incontinence (SUI). All 29 consecutive patients treated with a Virtue male sling at our Institution between July 2012 and October 2013 were included in the present prospective, non-randomized study. Patients were evaluated preoperatively and at 1, 3, 6, 12, 24 and 36 months after surgery using a 24-h pad weight test, the International Consultation on Incontinence short-form questionnaire (ICIQ-SF), Urinary Symptom Profile (USP) questionnaire, a bladder diary, uroflowmetry and the Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity questionnaires. The mean patient age was 65.5 years. A total of 72.4% of patients had preoperative mild incontinence (1-2 pads/day), while nine patients used 3-5 pads/day. There were a total of 17 complications, which occurred in 29 patients (58.6%); all were Clavien-Dindo grade I. At 12-month follow-up patients showed a significant improvement in 24-h pad test (128.6 vs 2.5 g), number of pads per day (2 vs 0), ICIQ-SF score (14.3 vs 0.9) and USP score for SUI (4 vs 0), and outcomes remained stable at 36 months. At last follow-up, the median score on the PGI-I questionnaire was 1 (very much better). The Virtue male sling is an effective treatment option for low to moderate post-prostatectomy incontinence. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

E-mail communication in pain practice: The importance of being earnest.

PubMed

Ruiz, Irene Solera; García, Guadalupe Población; Riquelme, Irene

2014-07-01

Information technology can play a vital role in meeting patient needs and reinforcing the relationship among patients and their pain physicians. However, strong resistance remains on the medical side to this type of non-frontal care. The primary objective of this study was to assess the effectiveness of an E-mail intervention on customers' satisfaction. The secondary goals were to analyze the messages from patients to their clinician (not only the volume but also the content) and the impact on client, professional and health services outcomes. A prospective, non-randomized evaluation of patients undergoing treatment for chronic pain from September 2011 to May 2012. A private, specialty referral center in Spain. Participants were users visiting the Pain Management Unit evaluated by one physician. The E-mail address of the facility was written in every medical report provided. Patient satisfaction at the end of the 8-month trial period was assessed and outcomes recorded. Patients reported better communication with their therapist and greater satisfaction with overall care. 780 E-mails were read. Specialists received an average of 5 messages per day (standard deviation 0,3). None of them was unsuitable. This is a prospective, single center evaluation performed by one doctor. There was no control group due to ethical considerations. Electronic communication is a cheap, easy and feasible way to address a wide range of concerns, thus enhancing patients' satisfaction. More efforts are needed to implement routinely usage of this tool. If used appropriately, E-mail can facilitate physician-dependent interactions, promote access to care, save time and reduce costs. Concerns about billing, improper utilization, privacy and confidentiality might complicate its introduction and acceptance. Internet access remains a significant barrier to online patient-provider transference.

The use of a weaning and extubation protocol to facilitate effective weaning and extubation from mechanical ventilation in patients suffering from traumatic injuries: a non-randomized experimental trial comparing a prospective to retrospective cohort.

PubMed

Plani, Natascha; Becker, Piet; van Aswegen, Helena

2013-04-01

Many patients who have suffered traumatic injuries require mechanical ventilation (MV). Weaning is the transition from ventilatory support to spontaneous breathing. The purpose of this study was to determine whether the use of a nurse and a physiotherapist-driven protocol to wean and extubate patients from MV resulted in decreased MV days and intensive care unit (ICU) length of stay (LOS). A prospective cohort of 28 patients (Phase I), weaned according to the protocol developed for the Union Hospital Trauma Unit, was matched retrospectively with a historical cohort of 28 patients (Phase II), weaned according to physician preference. Pairs in the two groups were matched for gender, age, type, and severity of injury. For mean MV days, the groups did not differ statistically significantly (p 0.3; 14.4 days vs. 16.3 days), although the reduction in MV is clinically significant in view of the complications of additional MV days. The difference of 0.2 days for ICU LOS was not statistically significant (p = 0.9; 20.8 days vs. 21.0 days) demonstrating that the reduction in MV days may not result in the reduction of ICU LOS. The rate of re-intubation was similar between the groups (Phase I = 3/28 vs. Phase II = 4/24). The use of a weaning and extubation protocol led by nursing staff and physiotherapists resulted in a clinically significant reduction in MV time, reducing risk of ventilator-associated complications. The role of physiotherapists and nursing staff in weaning and extubation from MV could be greatly expanded in South African ICUs.

Impact of the transparent reporting of evaluations with nonrandomized designs reporting guideline: ten years on.

PubMed

Fuller, Thomas; Peters, Jaime; Pearson, Mark; Anderson, Rob

2014-11-01

We assessed how the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) reporting guideline was used by authors and journal editors in journals' instructions to authors. We also evaluated its impact on reporting completeness and study quality. We extracted data from publications that cited TREND on how TREND was used in those reports; we also extracted information on journals' instructions to authors. We then undertook a case-control study of relevant publications to evaluate the impact of using TREND. Between 2004 and 2013, TREND was cited 412 times, but it was only evidently applied to study reports 47 times. TREND was specifically mentioned 14 times in the sample of 61 instructions to authors. Some evidence suggested that use of TREND was associated with more comprehensive reporting and higher study quality ratings. TREND appeared to be underutilized by authors and journal editors despite its potential application and benefits. We found evidence that suggested that using TREND could contribute to more transparent and complete study reports. Even when authors reported using TREND, reporting completeness was still suboptimal.

Impact of the Transparent Reporting of Evaluations With Nonrandomized Designs Reporting Guideline: Ten Years On

PubMed Central

Peters, Jaime; Pearson, Mark; Anderson, Rob

2014-01-01

Objectives. We assessed how the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) reporting guideline was used by authors and journal editors in journals’ instructions to authors. We also evaluated its impact on reporting completeness and study quality. Methods. We extracted data from publications that cited TREND on how TREND was used in those reports; we also extracted information on journals’ instructions to authors. We then undertook a case–control study of relevant publications to evaluate the impact of using TREND. Results. Between 2004 and 2013, TREND was cited 412 times, but it was only evidently applied to study reports 47 times. TREND was specifically mentioned 14 times in the sample of 61 instructions to authors. Some evidence suggested that use of TREND was associated with more comprehensive reporting and higher study quality ratings. Conclusions. TREND appeared to be underutilized by authors and journal editors despite its potential application and benefits. We found evidence that suggested that using TREND could contribute to more transparent and complete study reports. Even when authors reported using TREND, reporting completeness was still suboptimal. PMID:25211744

A New Method for Synthesizing Radiation Dose-Response Data From Multiple Trials Applied to Prostate Cancer

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

Diez, Patricia; Vogelius, Ivan S.; Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792

2010-07-15

Purpose: A new method is presented for synthesizing dose-response data for biochemical control of prostate cancer according to study design (randomized vs. nonrandomized) and risk group (low vs. intermediate-high). Methods and Materials: Nine published prostate cancer dose escalation studies including 6,539 patients were identified in the MEDLINE and CINAHL databases and reviewed to assess the relationship between dose and biochemical control. A novel method of analysis is presented in which the normalized dose-response gradient, {gamma}{sub 50}, is estimated for each study and subsequently synthesized across studies. Our method does not assume that biochemical control rates are directly comparable between studies.more » Results: Nonrandomized studies produced a statistically significantly higher {gamma}{sub 50} than randomized studies for intermediate- to high-risk patients ({gamma}{sub 50} = 1.63 vs. {gamma}{sub 50} = 0.93, p = 0.03) and a borderline significantly higher ({gamma}{sub 50} = 1.78 vs. {gamma}{sub 50} = 0.56, p = 0.08) for low-risk patients. No statistically significant difference in {gamma}{sub 50} was found between low- and intermediate- to high-risk patients (p = 0.31). From the pooled data of low and intermediate- to high-risk patients in randomized trials, we obtain the overall best estimate of {gamma}{sub 50} = 0.84 with 95% confidence interval 0.54-1.15. Conclusions: Nonrandomized studies overestimate the steepness of the dose-response curve as compared with randomized trials. This is probably the result of stage migration, improved treatment techniques, and a shorter follow-up in higher dose patients that were typically entered more recently. This overestimation leads to inflated expectations regarding the benefit from dose-escalation and could lead to underpowered clinical trials. There is no evidence of a steeper dose response for intermediate- to high-risk compared with low-risk patients.« less

Influence of site and operator characteristics on carotid artery stent outcomes: analysis of the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) clinical study.

PubMed

Gray, William A; Rosenfield, Kenneth A; Jaff, Michael R; Chaturvedi, Seemant; Peng, Lei; Verta, Patrick

2011-02-01

The aim of this study was to analyze the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) study for physician- or site-related variables associated with differential outcomes for carotid artery stenting (CAS). The CAPTURE 2 trial is an ongoing, prospective, nonrandomized, independently adjudicated, multicenter clinical study enrolling high-surgical-risk patients undergoing CAS. In this assessment of the CAPTURE 2 study, the American Heart Association carotid endarterectomy guideline limits were used to define acceptable site and physician CAS outcomes; therefore, the resulting population of nonoctogenarian, asymptomatic subjects in this analysis is confined to 3,388 (of the total 5,297) subjects treated at 180 U.S. hospitals by 459 operators between March 2006 and January 2009. The rates of death, stroke, and myocardial infarction and death and stroke (DS) at 30 days were 3.5% and 3.3%, respectively, for the full CAPTURE 2 study cohort and 2.9% and 2.7%, respectively, for the asymptomatic, nonoctogenarian subgroup. In this subgroup, two-thirds of sites (118 of 180, 66%) had no DS events. Within the remaining sites, an inverse relationship between event rates and hospital patient volume as well as between event rates and individual operator volume was observed. The DS rates trended lower for interventional cardiologists compared with other specialties. Outcomes from the largest prospectively gathered, independently adjudicated, multicenter CAS study indicate that CAS can be safely performed in a variety of hospital settings by physicians with various specialties. The most important determinant of perioperative CAS outcomes was both site and operator CAS volume. A threshold of 72 cases was found to be necessary for consistently achieving a DS rate below 3% in this later-phase single arm study; background era and non-study operator experience will affect this determination. (Second Phase of "Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events"; NCT00302237). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Colonic stem cell data are consistent with the immortal model of stem cell division under non-random strand segregation.

PubMed

Walters, K

2009-06-01

Colonic stem cells are thought to reside towards the base of crypts of the colon, but their numbers and proliferation mechanisms are not well characterized. A defining property of stem cells is that they are able to divide asymmetrically, but it is not known whether they always divide asymmetrically (immortal model) or whether there are occasional symmetrical divisions (stochastic model). By measuring diversity of methylation patterns in colon crypt samples, a recent study found evidence in favour of the stochastic model, assuming random segregation of stem cell DNA strands during cell division. Here, the effect of preferential segregation of the template strand is considered to be consistent with the 'immortal strand hypothesis', and explore the effect on conclusions of previously published results. For a sample of crypts, it is shown how, under the immortal model, to calculate mean and variance of the number of unique methylation patterns allowing for non-random strand segregation and compare them with those observed. The calculated mean and variance are consistent with an immortal model that incorporates non-random strand segregation for a range of stem cell numbers and levels of preferential strand segregation. Allowing for preferential strand segregation considerably alters previously published conclusions relating to stem cell numbers and turnover mechanisms. Evidence in favour of the stochastic model may not be as strong as previously thought.

Gravitropic moss cells default to spiral growth on the clinostat and in microgravity during spaceflight

NASA Technical Reports Server (NTRS)

Kern, Volker D.; Schwuchow, Jochen M.; Reed, David W.; Nadeau, Jeanette A.; Lucas, Jessica; Skripnikov, Alexander; Sack, Fred D.

2005-01-01

In addition to shoots and roots, the gravity (g)-vector orients the growth of specialized cells such as the apical cell of dark-grown moss protonemata. Each apical cell of the moss Ceratodon purpureus senses the g-vector and adjusts polar growth accordingly producing entire cultures of upright protonemata (negative gravitropism). The effect of withdrawing a constant gravity stimulus on moss growth was studied on two NASA Space Shuttle (STS) missions as well as during clinostat rotation on earth. Cultures grown in microgravity (spaceflight) on the STS-87 mission exhibited two successive phases of non-random growth and patterning, a radial outgrowth followed by the formation of net clockwise spiral growth. Also, cultures pre-aligned by unilateral light developed clockwise hooks during the subsequent dark period. The second spaceflight experiment flew on STS-107 which disintegrated during its descent on 1 February 2003. However, most of the moss experimental hardware was recovered on the ground, and most cultures, which had been chemically fixed during spaceflight, were retrieved. Almost all intact STS-107 cultures displayed strong spiral growth. Non-random culture growth including clockwise spiral growth was also observed after clinostat rotation. Together these data demonstrate the existence of default non-random growth patterns that develop at a population level in microgravity, a response that must normally be overridden and masked by a constant g-vector on earth.

The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up.

PubMed

Hagatun, Susanne; Vedaa, Øystein; Nordgreen, Tine; Smith, Otto R F; Pallesen, Ståle; Havik, Odd E; Bjorvatn, Bjørn; Thorndike, Frances P; Ritterband, Lee M; Sivertsen, Børge

2017-03-27

Insomnia is a major health problem, and the need for effective and accessible treatment is urgent. The aim of the current study was to evaluate the short-term efficacy of an unguided Internet-based cognitive-behavioral treatment program for insomnia (CBTi), called SHUTi (Sleep Healthy Using the Internet). This study used a parallel arm randomized controlled trial in Norway. Participants were randomly allocated to the SHUTi condition or a Web-based patient education condition. Both groups were assessed before and after the nine-week intervention period (online sleep diaries and questionnaires). The SHUTi participants were reassessed in a six-month nonrandomized follow-up. Primary outcome measures were the Insomnia Severity Index (ISI) and the Bergen Insomnia Scale (BIS). A total of 181 participants were included in the study; SHUTi condition (n = 95), patient education condition (n = 86). Intention-to-treat mixed-model repeated-measures analysis revealed that the SHUTi group had better short-term outcomes compared with the patient education group on most sleep measures. The SHUTi group showed a significant decrease on the primary outcomes, the ISI (d between = -1.77, 95% CI = -2.23, -1.31) and the BIS (d between = -1.00, 95% CI = -1.32, -.68). Improvements were maintained among the completing SHUTi participants at the six-month nonrandomized follow-up. However, dropout attrition was high. Unguided Internet-based CBTi produced significant short-term improvements in sleep in patients with chronic insomnia. This highlights the benefits of making Internet-delivered CBTi programs available as a standard first-line treatment option in public health services. Nevertheless, the rate of dropout attrition (participants not completing post-assessment) in this trial limits the generalizability of the findings.

Effectiveness and safety of wheelchair skills training program in improving the wheelchair skills capacity: a systematic review.

PubMed

Tu, Chun-Jing; Liu, Lin; Wang, Wei; Du, He-Ping; Wang, Yu-Ming; Xu, Yan-Bing; Li, Ping

2017-12-01

To comprehensively assess the effectiveness and safety of wheelchair skills training program in improving wheelchair skills capacity. PubMed, OVID, EBSCO, ScienceDirect, Web of Science, CINAHL, Cochrane Library, Google Scholar, and China Knowledge Resource Integrated Database were searched up to March 2017. Controlled clinical trials that compared a wheelchair skills training program with a control group that received other interventions and used the wheelchair skills test scores to evaluate wheelchair skills capacity were included. Two authors independently screened articles, extracted data, and assessed the methodological quality using the Cochrane risk-of-bias tool in randomized controlled trial (RCT) and methodological index for non-randomized studies. The data results of wheelchair skills test scores were extracted. Data from 455 individuals in 10 RCTs and from 140 participants in seven non-randomized studies were included for meta-analysis using Stata version 12.0 (Stata Corporation, College Station, TX, USA). In the short term (immediately to one week) post-intervention, relative to a control group, manual wheelchair skills training could increase the total wheelchair skills test scores by 13.26% in RCTs (95% confidence interval (CI), 6.19%-20.34%; P < 0.001) and by 23.44% in non-randomized studies (95% CI, 13.98%-32.90%; P < 0.001). Few adverse events occurred during training; however, compared with a control group, evidence was insufficient to support the effectiveness of powered wheelchair skills training and the long-term (3-12 months) advantage of manual wheelchair skills training ( P = 0.755). The limited evidence suggests that wheelchair skills training program is beneficial in the short term, but its long-term effects remain unclear.

Nasal vs Oronasal CPAP for OSA Treatment: A Meta-Analysis.

PubMed

Andrade, Rafaela G S; Viana, Fernanda M; Nascimento, Juliana A; Drager, Luciano F; Moffa, Adriano; Brunoni, André R; Genta, Pedro R; Lorenzi-Filho, Geraldo

2018-03-01

Nasal CPAP is the "gold standard" treatment for OSA. However, oronasal masks are frequently used in clinical practice. The aim of this study was to perform a meta-analysis of all randomized and nonrandomized trials that compared nasal vs oronasal masks on CPAP level, residual apnea-hypopnea index (AHI), and CPAP adherence to treat OSA. The Cochrane Central Register of Controlled Trials, Medline, and Web of Science were searched for relevant studies in any language with the following terms: "sleep apnea" and "CPAP" or "sleep apnea" and "oronasal mask" or "OSA" and "oronasal CPAP" or "oronasal mask" and "adherence." Studies on CPAP treatment for OSA were included, based on the following criteria: (1) original article; (2) randomized or nonrandomized trials; and (3) comparison between nasal and oronasal CPAP including pressure level, and/or residual AHI, and/or CPAP adherence. We identified five randomized and eight nonrandomized trials (4,563 patients) that reported CPAP level and/or residual AHI and/or CPAP adherence. Overall, the random-effects meta-analysis revealed that as compared with nasal, oronasal masks were associated with a significantly higher CPAP level (Hedges' g, -0.59; 95% CI, -0.82 to -0.37; P < .001) (on average, +1.5 cm H 2 O), higher residual AHI (Hedges' g, -0.34; 95% CI, -0.52 to -0.17; P < .001) (+2.8 events/h), and a poorer adherence (Hedges' g, 0.50; 95% CI, 0.21-0.79; P = .001) (-48 min/night). Oronasal masks are associated with a higher CPAP level, higher residual AHI, and poorer adherence than nasal masks. PROSPERO database; No.: CRD42017064584; URL: https://www.crd.york.ac.uk/prospero/. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Short-term intake of a Japanese-style healthy lunch menu contributes to prevention and/or improvement in metabolic syndrome among middle-aged men: a non-randomized controlled trial

PubMed Central

2014-01-01

Background Metabolic syndrome is now widely appreciated as a cluster of metabolic abnormalities such as visceral obesity, hypertension, hyperglycemia and dyslipidemia. To date, incidence of metabolic syndrome is continuously increasing worldwide. In addition, low vegetable consumption has recently become a serious issue in Japan. Furthermore, Japan is facing a shortfall in places offering food that can help prevent metabolic syndrome in the first place. Our study is designed to influence these developments. We conducted a non-randomized controlled trial by offering a Japanese-style healthy lunch menu to middle-aged men in a workplace cafeteria. This menu was designed to prevent and reduce metabolic syndrome. Methods This intervention study took the form of a non-randomized controlled trial. Participants chose the control or intervention group. The control group consumed their habitual lunches without restriction and only nutrient contents were assessed. The intervention group received a Japanese-style healthy lunch at a workplace cafeteria for 3 months. The participants worked in offices at a city hall and mostly had low levels of physical activity. Data of 35 males (control group: 7 males, intervention group: 28 males, mean age: 47.2 ± 7.9 years) were collected and analyzed. Results We obtained an effective outcome by demonstrating that ongoing intake of a Japanese-style healthy lunch decreased blood pressure and serum lipids and increased plasma ghrelin levels. The results grew more pronounced as intake of Japanese-style healthy lunches increased in frequency. Conclusions This study presents new empirical data as a result of an original intervention program undertaken in Japan. A Japanese-style healthy lunch menu containing many vegetables consumed can help prevent and/or improve metabolic syndrome. PMID:24673894

Does increased exercise or physical activity alter ad-libitum daily energy intake or macronutrient composition in healthy adults? A systematic review.

PubMed

Donnelly, Joseph E; Herrmann, Stephen D; Lambourne, Kate; Szabo, Amanda N; Honas, Jeffery J; Washburn, Richard A

2014-01-01

The magnitude of the negative energy balance induced by exercise may be reduced due to compensatory increases in energy intake. TO ADDRESS THE QUESTION: Does increased exercise or physical activity alter ad-libitum daily energy intake or macronutrient composition in healthy adults? PubMed and Embase were searched (January 1990-January 2013) for studies that presented data on energy and/or macronutrient intake by level of exercise, physical activity or change in response to exercise. Ninety-nine articles (103 studies) were included. Primary source articles published in English in peer-reviewed journals. Articles that presented data on energy and/or macronutrient intake by level of exercise or physical activity or changes in energy or macronutrient intake in response to acute exercise or exercise training in healthy (non-athlete) adults (mean age 18-64 years). Articles were grouped by study design: cross-sectional, acute/short term, non-randomized, and randomized trials. Considerable heterogeneity existed within study groups for several important study parameters, therefore a meta-analysis was considered inappropriate. Results were synthesized and presented by study design. No effect of physical activity, exercise or exercise training on energy intake was shown in 59% of cross-sectional studies (n = 17), 69% of acute (n = 40), 50% of short-term (n = 10), 92% of non-randomized (n = 12) and 75% of randomized trials (n = 24). Ninety-four percent of acute, 57% of short-term, 100% of non-randomized and 74% of randomized trials found no effect of exercise on macronutrient intake. Forty-six percent of cross-sectional trials found lower fat intake with increased physical activity. The literature is limited by the lack of adequately powered trials of sufficient duration, which have prescribed and measured exercise energy expenditure, or employed adequate assessment methods for energy and macronutrient intake. We found no consistent evidence that increased physical activity or exercise effects energy or macronutrient intake.

The Misconception of Case-Control Studies in the Plastic Surgery Literature: A Literature Audit.

PubMed

Hatchell, Alexandra C; Farrokhyar, Forough; Choi, Matthew

2017-06-01

Case-control study designs are commonly used. However, many published case-control studies are not true case-controls and are in fact mislabeled. The purpose of this study was to identify all case-control studies published in the top three plastic surgery journals over the past 10 years, assess which were truly case-control studies, clarify the actual design of the articles, and address common misconceptions. MEDLINE, Embase, and Web of Science databases were searched for case-control studies in the three highest-impact factor plastic surgery journals (2005 to 2015). Two independent reviewers screened the resulting titles, abstracts, and methods, if applicable, to identify articles labeled as case-control studies. These articles were appraised and classified as true case-control studies or non-case-control studies. The authors found 28 articles labeled as case-control studies. However, only six of these articles (21 percent) were truly case-control designs. Of the 22 incorrectly labeled studies, one (5 percent) was a randomized controlled trial, three (14 percent) were nonrandomized trials, two (9 percent) were prospective comparative cohort designs, 14 (64 percent) were retrospective comparative cohort designs, and two (9 percent) were cross-sectional designs. The mislabeling was worse in recent years, despite increases in evidence-based medicine awareness. The majority of published case-control studies are not in fact case-control studies. This misunderstanding is worsening with time. Most of these studies are actually comparative cohort designs. However, some studies are truly clinical trials and thus a higher level of evidence than originally proposed.

Enhancing Transfer of Knowledge in Physics through Effective Teaching Strategies

ERIC Educational Resources Information Center

Akinbobola, Akinyemi Olufunminiyi

2015-01-01

The study assessed the enhancement of transfer of knowledge in physics through the use of effective teaching strategies in Nigerian senior secondary schools. Non-randomized pretest-posttest control group design was adopted for the study. A total of 278 physics students took part in the study. Transfer of Knowledge Test in Physics (TKTP) with the…

The Effect of Chin-cup Therapy in Class III Malocclusion: A Systematic Review

PubMed Central

Mousoulea, Sophia; Tsolakis, Ioannis; Ferdianakis, Efstratios; Tsolakis, Apostolos I.

2016-01-01

Background: The treatment of Class III malocclusion has been challenging for orthodontists. Among a plethora of treatment modalities, the chin-cup is considered a traditional appliance for early orthopedic intervention. Objective: The present study aims to investigate the current scientific evidence regarding the effectiveness of chin-cup therapy in Class III malocclusion of prognathic growing patients. Method: A systematic review of the literature was conducted using PubMed/Medline and the Cochrane Central Register of Controlled Trials from January 1954 to October 2015. Articles were selected based on established inclusion/ exclusion criteria. Results: The search strategy resulted in 3285 articles.14 studies were selected for the final analysis. They were all CCTs, 13 of retrospective and 1 of prospective design. Methodological quality was evaluated by a risk of bias assessment, as suggested by the Cochrane Risk of Bias Assessment Tool for Non-Randomized Studies on Interventions. The reported evidence presented favorable short-term outcomes both in hard and soft tissues improving the Class III profile, as well as desirable dento-alveolar changes, positively affecting the Class III malocclusion. Conclusion: There is considerable agreement between studies that chin-cup therapy can be considered for the short-term treatment of growing patients with Class III malocclusion, as indicated by favorable changes both in the hard and soft tissues. The existence of considerable risk of bias in all selected studies and the unclear long-term effectiveness of chin-cup therapy highlight the need for further investigation to draw reliable conclusions. PMID:28077971

Treatment results in localized primary gastric lymphoma: data of patients registered within the German multicenter study (GIT NHL 02/96).

PubMed

Koch, Peter; Probst, Andreas; Berdel, Wolfgang E; Willich, Normann A; Reinartz, Gabriele; Brockmann, Jens; Liersch, Rüdiger; del Valle, Francisco; Clasen, Hermann; Hirt, Carsten; Breitsprecher, Regine; Schmits, Rudolf; Freund, Mathias; Fietkau, Rainer; Ketterer, Peter; Freitag, Eva-Maria; Hinkelbein, Margit; Heinecke, Achim; Parwaresch, Reza; Tiemann, Markus

2005-10-01

In the prospective study 02/96 on primary GI lymphoma, we have collected data on histology, clinical features, and treatment results. In particular, in stages I and II localized primary gastric lymphoma (PGL), our objectives were to reduce treatment intensity and to confirm our hypothesis from study 01/92, which maintained that an organ-preserving approach is not inferior to primary surgery. Patients receiving radiotherapy and/or chemotherapy were stratified for histologic grade, stage, and whether surgery had been carried out or not (as decided by each participating center). Patients with aggressive PGL received six cycles of CHOP-14 (cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by involved-field radiotherapy (40 Gy). Patients with indolent PGL (including patients experiencing treatment failure with antibiotic therapy for Helicobacter pylori) were treated with extended-field radiotherapy. The volume depended on stage. The irradiation dose was 30 Gy, followed by a boost of 10 Gy (the latter omitted after complete resection) to the tumor region. Seven hundred forty-seven patients were accrued. Of these patients, 393 with localized PGL were treated with radiotherapy and/or chemotherapy only or additional surgery between December 1996 and December 2003. The survival rate at 42 months for patients treated with surgery was 86% compared with 91.0% for patients without surgery. In this nonrandomized study (02/96), we reproduced the previous results of study 01/92 showing no disadvantage for an organ-preserving treatment. Therefore, primary stomach resection should be questioned.

Robertsonian translocations

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

NONE

1993-12-31

Chapter 27, describes the occurrence of Robertsonian translocations (RTs), which refer to the recombination of whole chromosome arms, in both monocentric and dicentric chromosomes. The nonrandom participation of acrocentric chromosomes in RTs is documented by various methods, including unbiased ascertainment and ascertainment through trisomy, infertility, unspecified mental retardation, and Prader-Willi syndrome. Causes of nonrandom participation of chromosomes in RTs is presented, as are the following topics: segregation in carriers of RTs and segregation in sperm cells of RT carriers, interchromosomal effects and conclusions. 48 refs., 3 figs., 2 tabs.

Does school-based physical activity decrease overweight and obesity in children aged 6-9 years? A two-year non-randomized longitudinal intervention study in the Czech Republic.

PubMed

Sigmund, Erik; El Ansari, Walid; Sigmundová, Dagmar

2012-07-29

Globally, efforts aimed at the prevention of childhood obesity have led to the implementation of a range of school-based interventions. This study assessed whether augmenting physical activity (PA) within the school setting resulted in increased daily PA and decreased overweight/obesity levels in 6-9-year-old children. Across the first to third primary school years, PA of 84 girls and 92 boys was objectively monitored five times (each for seven successive days) using Yamax pedometer (step counts) and Caltrac accelerometer (activity energy expenditure AEE - kcal/kg per day). Four schools were selected to participate in the research (2 intervention, 2 controls), comprising intervention (43 girls, 45 boys) and control children (41 girls, 47 boys). The study was non-randomized and the intervention schools were selected on the basis of existing PA-conducive environment. Analyses of variance (ANOVA) for repeated measures examined the PA programme and gender effects on the step counts and AEE. Logistic regression (Enter method) determined the obesity and overweight occurrence prospect over the course of implementation of the PA intervention. There was a significant increase of school-based PA during schooldays in intervention children (from ≈ 1718 to ≈ 3247 steps per day; and from 2.1 to ≈ 3.6 Kcal/Kg per day) in comparison with the control children. Increased school-based PA of intervention children during schooldays contributed to them achieving >10,500 steps and >10.5 Kcal/Kg per school day across the 2 years of the study, and resulted in a stop of the decline in PA levels that is known to be associated with the increasing age of children. Increased school-based PA had also positive impact on leisure time PA of schooldays and on PA at weekends of intervention children. One year after the start of the PA intervention, the odds of being overweight or obese in the intervention children was almost three times lower than that of control children (p < 0.005), and these odds steadily decreased with the duration of the intervention. The findings suggest that school-based PA (Physical Education lessons, PA during short breaks and longer recesses, PA at after-school nursery) in compatible active environments (child-friendly gym and school playground, corridors with movement and playing around corners and for games) has a vital role in obesity and overweight reduction among younger pupils.

Does school-based physical activity decrease overweight and obesity in children aged 6–9 years? A two-year non-randomized longitudinal intervention study in the Czech Republic

PubMed Central

2012-01-01

Background Globally, efforts aimed at the prevention of childhood obesity have led to the implementation of a range of school-based interventions. This study assessed whether augmenting physical activity (PA) within the school setting resulted in increased daily PA and decreased overweight/obesity levels in 6-9-year-old children. Methods Across the first to third primary school years, PA of 84 girls and 92 boys was objectively monitored five times (each for seven successive days) using Yamax pedometer (step counts) and Caltrac accelerometer (activity energy expenditure AEE - kcal/kg per day). Four schools were selected to participate in the research (2 intervention, 2 controls), comprising intervention (43 girls, 45 boys) and control children (41 girls, 47 boys). The study was non-randomized and the intervention schools were selected on the basis of existing PA-conducive environment. Analyses of variance (ANOVA) for repeated measures examined the PA programme and gender effects on the step counts and AEE. Logistic regression (Enter method) determined the obesity and overweight occurrence prospect over the course of implementation of the PA intervention. Results There was a significant increase of school-based PA during schooldays in intervention children (from ≈ 1718 to ≈ 3247 steps per day; and from 2.1 to ≈ 3.6 Kcal/Kg per day) in comparison with the control children. Increased school-based PA of intervention children during schooldays contributed to them achieving >10,500 steps and >10.5 Kcal/Kg per school day across the 2 years of the study, and resulted in a stop of the decline in PA levels that is known to be associated with the increasing age of children. Increased school-based PA had also positive impact on leisure time PA of schooldays and on PA at weekends of intervention children. One year after the start of the PA intervention, the odds of being overweight or obese in the intervention children was almost three times lower than that of control children (p < 0.005), and these odds steadily decreased with the duration of the intervention. Conclusions The findings suggest that school-based PA (Physical Education lessons, PA during short breaks and longer recesses, PA at after-school nursery) in compatible active environments (child-friendly gym and school playground, corridors with movement and playing around corners and for games) has a vital role in obesity and overweight reduction among younger pupils. PMID:22892226

Application of a nonrandomized stepped wedge design to evaluate an evidence-based quality improvement intervention: a proof of concept using simulated data on patient-centered medical homes.

PubMed

Huynh, Alexis K; Lee, Martin L; Farmer, Melissa M; Rubenstein, Lisa V

2016-10-21

Stepped wedge designs have gained recognition as a method for rigorously assessing implementation of evidence-based quality improvement interventions (QIIs) across multiple healthcare sites. In theory, this design uses random assignment of sites to successive QII implementation start dates based on a timeline determined by evaluators. However, in practice, QII timing is often controlled more by site readiness. We propose an alternate version of the stepped wedge design that does not assume the randomized timing of implementation while retaining the method's analytic advantages and applying to a broader set of evaluations. To test the feasibility of a nonrandomized stepped wedge design, we developed simulated data on patient care experiences and on QII implementation that had the structures and features of the expected data from a planned QII. We then applied the design in anticipation of performing an actual QII evaluation. We used simulated data on 108,000 patients to model nonrandomized stepped wedge results from QII implementation across nine primary care sites over 12 quarters. The outcome we simulated was change in a single self-administered question on access to care used by Veterans Health Administration (VA), based in the United States, as part of its quarterly patient ratings of quality of care. Our main predictors were QII exposure and time. Based on study hypotheses, we assigned values of 4 to 11 % for improvement in access when sites were first exposed to implementation and 1 to 3 % improvement in each ensuing time period thereafter when sites continued with implementation. We included site-level (practice size) and respondent-level (gender, race/ethnicity) characteristics that might account for nonrandomized timing in site implementation of the QII. We analyzed the resulting data as a repeated cross-sectional model using HLM 7 with a three-level hierarchical data structure and an ordinal outcome. Levels in the data structure included patient ratings, timing of adoption of the QII, and primary care site. We were able to demonstrate a statistically significant improvement in adoption of the QII, as postulated in our simulation. The linear time trend while sites were in the control state was not significant, also as expected in the real life scenario of the example QII. We concluded that the nonrandomized stepped wedge design was feasible within the parameters of our planned QII with its data structure and content. Our statistical approach may be applicable to similar evaluations.

A systematic comparison of the closed shoulder reduction techniques.

PubMed

Alkaduhimi, H; van der Linde, J A; Willigenburg, N W; van Deurzen, D F P; van den Bekerom, M P J

2017-05-01

To identify the optimal technique for closed reduction for shoulder instability, based on success rates, reduction time, complication risks, and pain level. A PubMed and EMBASE query was performed, screening all relevant literature of closed reduction techniques mentioning the success rate written in English, Dutch, German, and Arabic. Studies with a fracture dislocation or lacking information on success rates for closed reduction techniques were excluded. We used the modified Coleman Methodology Score (CMS) to assess the quality of included studies and excluded studies with a poor methodological quality (CMS < 50). Finally, a meta-analysis was performed on the data from all studies combined. 2099 studies were screened for their title and abstract, of which 217 studies were screened full-text and finally 13 studies were included. These studies included 9 randomized controlled trials, 2 retrospective comparative studies, and 2 prospective non-randomized comparative studies. A combined analysis revealed that the scapular manipulation is the most successful (97%), fastest (1.75 min), and least painful reduction technique (VAS 1,47); the "Fast, Reliable, and Safe" (FARES) method also scores high in terms of successful reduction (92%), reduction time (2.24 min), and intra-reduction pain (VAS 1.59); the traction-countertraction technique is highly successful (95%), but slower (6.05 min) and more painful (VAS 4.75). For closed reduction of anterior shoulder dislocations, the combined data from the selected studies indicate that scapular manipulation is the most successful and fastest technique, with the shortest mean hospital stay and least pain during reduction. The FARES method seems the best alternative.

Twenty-Year Systematic Review of the Hip Pathology, Risk Factors, Treatment, and Clinical Outcomes in Artistic Athletes-Dancers, Figure Skaters, and Gymnasts.

PubMed

Bolia, Ioanna; Utsunomiya, Hajime; Locks, Renato; Briggs, Karen; Philippon, Marc J

2018-01-01

To identify (1) the predominant level of evidence of the clinical studies regarding the hip pathology, risk factors, treatment, and clinical outcomes in artistic athletes (dancers, figure skaters, and gymnasts) (2) the most commonly reported hip pathology, risk factors, treatments, and clinical outcomes in dancers, figure skaters, and gymnasts. To conduct this systematic review PubMed, EMBASE, and Scopus databases were searched for relevant studies and pertinent data were collected from the eligible articles. Included were studies which reported hip injuries in artistic athletes, the risk factors, treatment, and/or the clinical outcomes. We excluded case reports or irrelevant studies. No meta-analysis was performed because of study heterogeneity. The methodical index for nonrandomized studies (MINORS) criteria were used for quality control. Thirty-eight studies were included in the analysis. The mean MINORS score was 13.6 ± 4.6 points indicating fair quality of evidence of the included articles. The predominant level of evidence was level IV. Chondrolabral pathology and muscle injuries were the most commonly reported pathologies. We found only 2 risk factor analysis studies; however, many studies reported risk correlation between artistic sports or imaging findings and hip pathology. Treatment strategies were reported in only 7 studies, clinical outcomes are significantly underreported. Chondrolabral pathology was the most commonly reported hip pathology in artistic athletes, however, prospective cohort studies are necessary to really understand these injuries and their associated risk factors. The lack of clinical outcomes is significant and future data collection is required to assess the effectiveness of the various treatments.

Variability of disease activity in patients treated with ranibizumab for neovascular age-related macular degeneration

PubMed Central

Enders, P; Scholz, P; Muether, P S; Fauser, S

2016-01-01

Purpose To analyze choroidal neovasularization (CNV) activity and recurrence patterns in patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab, and the correlation with individual intraocular vascular endothelial growth factor (VEGF) suppression time (VST). Methods Post-hoc analysis of data from a prospective, non-randomized clinical study. Patients with nAMD treated with ranibizumab on a pro re nata regimen. Disease activity was analyzed monthly by spectral-domain optical coherence tomography and correlated with VSTs. Results Overall, 73 eyes of 73 patients were included in the study with a mean follow-up of 717 days (range: 412–1239 days). Overall, the mean CNV-activity-free interval was 76.5 days (range: 0–829 days). The individual range of the length of dry intervals was high. A total of 42% of patients had a range of more than 90 days. Overall, 16% of patients showed persistent activity. And 12% stayed dry after the initial ranibizumab treatment. No significant correlation was found between the CNV-recurrence pattern and VST (P=0.12). Conclusions CNV activity in nAMD is irregular, which is reflected in the range of the duration of dry intervals and late recurrences. The biomarker VST solely seems not to be sufficient to explain recurrence pattern of CNV in all AMD patients. PMID:27197870

Holding Area LINQ Trial (HALT).

PubMed

Lee, John J; Weitz, Daniel; Anand, Rishi

Recent studies have shown that insertable cardiac monitors (ICMs) can be implanted out of the traditional hospital setting and efforts are being made to explore the feasibility of implanting these devices in a specific standardized location other than the operating room or a cardiac catherization/electrophysiology lab. This was a prospective, non-randomized, single center post-market clinical trial designed to occur in the holding area of a hospital operating room or cardiac catheterization/electrophysiology laboratory. The Medtronic Reveal LINQ ICM was implanted and patients were followed for 90 days post implant. This study was designed to observe any procedure related adverse events stemming from the holding area implantation. Twenty patients were implanted at our hospital in a holding room not traditionally associated with the electrophysiology/cardiac/operatory labs. One patient was lost to the 90-day follow up. In one case, ICM implantation led to diagnosis requiring removal of ICM before the 90 day follow up and insertion of a biventricular implantable cardioverter defibrillator (ICD). In the remaining 18 patients, there were no serious complications such as minor skin infections, systemic infections or procedure-related adverse events requiring device explant. When following a standardized protocol with attention to sterile technique, it is feasible to implant ICMs in a holding area with no procedure related adverse events (AE). Copyright © 2017 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.

Hematologic improvement in dogs with parvovirus infection treated with recombinant canine granulocyte-colony stimulating factor.

PubMed

Duffy, A; Dow, S; Ogilvie, G; Rao, S; Hackett, T

2010-08-01

Previously, dogs with canine parvovirus-induced neutropenia have not responded to treatment with recombinant human granulocyte-colony stimulating factor (rhG-CSF). However, recombinant canine G-CSF (rcG-CSF) has not been previously evaluated for treatment of parvovirus-induced neutropenia in dogs. We assessed the effectiveness of rcG-CSF in dogs with parvovirus-induced neutropenia with a prospective, open-label, nonrandomized clinical trial. Endpoints of our study were time to recovery of WBC and neutrophil counts, and duration of hospitalization. 28 dogs with parvovirus and neutropenia were treated with rcG-CSF and outcomes were compared to those of 34 dogs with parvovirus and neutropenia not treated with rcG-CSF. We found that mean WBC and neutrophil counts were significantly higher (P < 0.05) in the 28 dogs treated with rcG-CSF compared to disease-matched dogs not treated with rcG-CSF. In addition, the mean duration of hospitalization was reduced (P = 0.01) in rcG-CSF treated dogs compared to untreated dogs. However, survival times were decreased in dogs treated with rcG-CSF compared to untreated dogs. These results suggest that treatment with rcG-CSF was effective in stimulating neutrophil recovery and shortening the duration of hospitalization in dogs with parvovirus infection, but indicate the need for additional studies to evaluate overall safety of the treatment.

Multimodal treatment with primary single-agent epirubicin in operable breast cancer: 5-year experience of the Michelangelo Cooperative Group.

PubMed

Bonadonna, G; Zambetti, M; Bumma, C; Donadio, M; Bolognesi, A; Robustelli Della Cuna, G; Ambrosini, G; Lelli, G; Mansutti, M; Verderio, P; Valagussa, P

2002-07-01

To assess the efficacy of primary single-agent epirubicin (120 mg/m(2) every 3 weeks for three cycles) in reducing tumor burden in operable breast cancer >or=2.5 cm in largest diameter at diagnosis and its effect on the rate of conservative surgery. A total of 319 eligible patients, who were all candidates for mastectomy, were enrolled on to a multicenter prospective non-randomized study. Tumor response was assessed clinically and pathologically. Relapse-free and overall survival were assessed on major prognostic variables. After primary epirubicin, complete disappearance of invasive neoplastic cells accounted for only 2.6% of patients, but 40% of patients had their primary tumor downstaged to

Effects of pitavastatin on walking capacity and CD34+/133+ cell number in patients with peripheral artery disease.

PubMed

Arao, Kenshiro; Yasu, Takanori; Endo, Yasuhiro; Funazaki, Toshikazu; Ota, Yoshimi; Shimada, Kazunori; Tokutake, Eiichi; Naito, Naoki; Takase, Bonpei; Wake, Minoru; Ikeda, Nahoko; Horie, Yasuto; Sugimura, Hiroyuki; Momomura, Shin-Ichi; Kawakami, Masanobu

2017-10-01

This multi-center prospective non-randomized comparative study investigated the effects of pitavastatin in patients with peripheral artery disease (PAD) in terms of exercise tolerance capacities and peripheral CD34 + /133 + cell numbers. At baseline, a peripheral blood test was administered to 75 patients with PAD, along with a treadmill exercise test using the Skinner-Gardner protocol to measure asymptomatic walking distance (AWD) and maximum walking distance (MWD). Each patient was assigned to a 6-month pitavastatin treatment group (n = 53) or a control group (n = 22), according to the patient's preference. The tests were repeated in both groups at 3 and 6 months. Baseline AWD and MWD correlated positively with the ankle-brachial pressure index (r = 0.342, p = 0.0032 and r = 0.324, p = 0.0054, respectively). Both AWD and MWD values improved at 3 and 6 months compared with baseline, and the degrees of their improvement were higher in the pitavastatin treatment group. CD34 + /133 + cell numbers did not change over time or between groups. Eighty-seven percent of patients in the treatment group attained low-density lipoprotein cholesterol levels below 100 mg/dL after 3 months. The study shows that pitavastatin may be effective in increasing exercise tolerance capacity in patients with PAD.

Effectiveness of a nonsteroidal anti-inflammatory drug for nocturia on patients with benign prostatic hyperplasia: a prospective non-randomized study of loxoprofen sodium 60 mg once daily before sleeping.

PubMed

Araki, Tohru; Yokoyama, Teruhiko; Kumon, Hiromi

2004-02-01

We explored the effectiveness of loxoprofen sodium (loxoprofen), which is the most common non-steroidal anti-inflammatory drug (NSAID) in Japan, for patients with benign prostatic hyperplasia (BPH) complaining of nocturia. A total of 93 BPH patients aged 49-84 years were enrolled in the study. These patients had received standard drug therapy with alpha1-blocker for BPH, followed by anticholinergic drugs, hypnotics, tricyclic antidepressants, and/or antiduretic hormone, but they still complained about 2 or more episodes of nocturia. They each took a single 60-mg tablet of loxoprofen prior to sleeping at night for 14 days in addition to their BPH treatments. The effects were assessed by questionnaire before and after treatment as excellent (nocturia disappeared or decreased by 2 or more voids/night), improved (nocturia decreased by 1 void/night), unchanged, or worsened (nocturia increased). Nocturia improved or disappeared in 74.2% of patients: excellent, improved, unchanged, and worsened results were obtained in 37.6%, 36.6%, 21.5%, and 4.3% of patients, respectively. The effects were better in patients whose baseline nocturia was > 2 times than in those with a lesser frequency at enrollment (P = 0.04). Loxoprofen can be an effective and useful treatment option for patients with BPH complaining of refractory nocturia.

Reliability of automatic biometric iris recognition after phacoemulsification or drug-induced pupil dilation.

PubMed

Seyeddain, Orang; Kraker, Hannes; Redlberger, Andreas; Dexl, Alois K; Grabner, Günther; Emesz, Martin

2014-01-01

To investigate the reliability of a biometric iris recognition system for personal authentication after cataract surgery or iatrogenic pupil dilation. This was a prospective, nonrandomized, single-center, cohort study for evaluating the performance of an iris recognition system 2-24 hours after phacoemulsification and intraocular lens implantation (group 1) and before and after iatrogenic pupil dilation (group 2). Of the 173 eyes that could be enrolled before cataract surgery, 164 (94.8%) were easily recognized postoperatively, whereas in 9 (5.2%) this was not possible. However, these 9 eyes could be reenrolled and afterwards recognized successfully. In group 2, of a total of 184 eyes that were enrolled in miosis, a total of 22 (11.9%) could not be recognized in mydriasis and therefore needed reenrollment. No single case of false-positive acceptance occurred in either group. The results of this trial indicate that standard cataract surgery seems not to be a limiting factor for iris recognition in the large majority of cases. Some patients (5.2% in this study) might need "reenrollment" after cataract surgery. Iris recognition was primarily successful in eyes with medically dilated pupils in nearly 9 out of 10 eyes. No single case of false-positive acceptance occurred in either group in this trial. It seems therefore that iris recognition is a valid biometric method in the majority of cases after cataract surgery or after pupil dilation.

Ultrathin Silicon Sheet in the Management of Unilateral Post-traumatic Temporo-Mandibuar Joint Ankylosis in Children: A Good Alternative to Conventional Techniques.

PubMed

Aggarwal, Sushil Kumar; Ankur, Bhatnagar; Jain, R K

2015-09-01

We have described a new technique of using ultra-thin silicon sheet (0.2 mm) between two transected bony ends for temporo-mandibular joint (TMJ) ankylosis in children with advantages of short operative time, minimal foreign material insertion and faster recovery time post-operatively which makes our technique a good alternative to conventional techniques. Our study is a non-randomized prospective study conducted on 10 children aged between 4 and 15 years who presented to our tertiary care institute with severe trismus after traumatic injury and were willing to undergo this new technique. The main outcome measure taken into consideration was difference between pre-operative, intra-operative (on table) and post-operative mouth opening (minimum 2 years follow-up). The pre-operative mouth opening in our cases varied from 1 to 5 mm. The intra-operative mouth opening achieved ranged from 2.8 to 3.2 cm. The mouth opening was about more than 2.7 cm in all our cases at 2 years of follow-up. Our technique is a good alternative to conventional techniques used for TMJ ankylosis in children but few more randomized controlled trials are required to assess its effectiveness in comparison to conventional techniques and for universal adoption of this technique.

Cutaneous tolerability to tretinoin shows little variation with Fitzpatrick skin type.

PubMed

Webster, Guy F

2014-06-01

Determinants of skin irritability are poorly understood. This study aims to assess differences in cutaneous safety/irritation based on Fitzpatrick skin type among patients with acne treated with tretinoin gel microsphere (TGM). This was a phase 4, 12-week, prospective, nonrandomized, open-label, multicenter study. Approximately 500 patients with mild to moderate acne were treated with TGM 0.04% or 0.1% and assessed for cutaneous irritation at baseline and weeks 3, 6, and 12. In this post hoc analysis of patients with Fitzpatrick skin type I-III vs Fitzpatrick skin type IV-VI, there was a general trend toward initial worsening of cutaneous adverse events (AEs) by week 3 across all variables and groups. This was followed by a trend toward improvement and resolution of skin-related AEs from week 3 to week 12 regardless of Fitzpatrick skin type, with a few exceptions. Erythema was the only cutaneous AE that consistently decreased among patients with darker skin. Results from a subsequent 3-group analysis (Fitzpatrick I-II vs Fitzpatrick III-IV vs Fitzpatrick V-VI) generally mirrored those from the 2-group study. Study limitations include patient nonadherence, lack of a placebo arm, and lack of data regarding the impact of concurrent medications on outcomes. There was no correlation between irritation and Fitzpatrick skin type. ABBREVIATIONS USED: adverse event (AE), analysis of variance (ANOVA), benzoyl peroxide (BP), case report form (CRF), modified Global Acne Grading Score (mGAGS), tretinoin gel microsphere (TGM).

Effect of sleeve gastrectomy on type 2 diabetes as an alternative treatment modality to Roux-en-Y gastric bypass: systemic review and meta-analysis.

PubMed

Cho, Jun-Min; Kim, Hyun Jung; Lo Menzo, Emanuele; Park, Sungsoo; Szomstein, Samuel; Rosenthal, Raul J

2015-01-01

Until recently, Roux-en-Y gastric bypass (RYGB) was the most frequently performed procedure in bariatric surgery. In the last decade, sleeve gastrectomy (SG) has emerged as a more popular, simpler, and less morbid form of bariatric surgery. This study compares the efficacy of SG and RYGB for the treatment of type 2 diabetes mellitus (T2D). Systemic review and meta-analysis. MEDLINE, EMBASE, and the Cochrane Library were searched for entries up to December 2013. Search terms included "Sleeve gastrectomy," "Gastric bypass," and "Type 2 diabetes mellitus." The chosen articles described both "Sleeve gastrectomy" and "Gastric bypass" and included over 1 year of follow-up data. Data analysis was performed with Review Manager 5.2 and SPSS version 20. The data set is comprised of 3 retrospective clinical studies, 6 prospective clinical studies, and 2 randomized controlled trials (RCTs), which involved 429 patients in the SG group and 428 patients in the RYGB group. In nonrandomized clinical studies, SG displayed similar efficacy in remission of T2D compared with the standard RYGB. In the RCTs, SG had a lower effect than that of RYGB. T2D remission was not correlated with the percent of excess weight loss for either procedure. Based on the current evidence, SG has a similar effect on T2D remission as RYGB. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Nephrogenic Systemic Fibrosis Risk After Liver Magnetic Resonance Imaging With Gadoxetate Disodium in Patients With Moderate to Severe Renal Impairment

PubMed Central

Lauenstein, Thomas; Ramirez-Garrido, Francisco; Kim, Young Hoon; Rha, Sung Eun; Ricke, Jens; Phongkitkarun, Sith; Boettcher, Joachim; Gupta, Rajan T.; Korpraphong, Pornpim; Tanomkiat, Wiwatana; Furtner, Julia; Liu, Peter S.; Henry, Maren; Endrikat, Jan

2015-01-01

Objective The objective of this study was to assess the risk of gadoxetate disodium in liver imaging for the development of nephrogenic systemic fibrosis (NSF) in patients with moderate to severe renal impairment. Materials and Methods We performed a prospective, multicenter, nonrandomized, open-label phase 4 study in 35 centers from May 2009 to July 2013. The study population consisted of patients with moderate to severe renal impairment scheduled for liver imaging with gadoxetate disodium. All patients received a single intravenous bolus injection of 0.025-mmol/kg body weight of liver-specific gadoxetate disodium. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period. Results A total of 357 patients were included, with 85 patients with severe and 193 patients with moderate renal impairment, which were the clinically most relevant groups. The mean time period from diagnosis of renal disease to liver magnetic resonance imaging (MRI) was 1.53 and 5.46 years in the moderate and severe renal impairment cohort, respectively. Overall, 101 patients (28%) underwent additional contrast-enhanced MRI with other gadolinium-based MRI contrast agents within 12 months before the start of the study or in the follow-up. No patient developed symptoms conclusive of NSF within the 2-year follow-up. Conclusions Gadoxetate disodium in patients with moderate to severe renal impairment did not raise any clinically significant safety concern. No NSF cases were observed. PMID:25756684

Lingual vs. labial fixed orthodontic appliances: systematic review and meta-analysis of treatment effects.

PubMed

Papageorgiou, Spyridon N; Gölz, Lina; Jäger, Andreas; Eliades, Theodore; Bourauel, Christoph

2016-04-01

The aim of this systematic review was to compare the therapeutic and adverse effects of lingual and labial orthodontic fixed appliances from clinical trials on human patients in an evidence-based manner. Randomized and prospective non-randomized clinical trials comparing lingual and labial appliances were included. Risk of bias within and across studies was assessed using the Cochrane tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Random-effects meta-analyses were conducted, followed by subgroup and sensitivity analyses. Six electronic databases were searched from inception to July 2015, without limitations. A total of 13 papers pertaining to 11 clinical trials were included with a total of 407 (34% male/66% female) patients. Compared with labial appliances, lingual appliances were associated with increased overall oral discomfort, increased speech impediment (measured using auditory analysis), worse speech performance assessed by laypersons, increased eating difficulty, and decreased intermolar width. On the other hand, lingual appliances were associated with increased intercanine width and significantly decreased anchorage loss of the maxillary first molar during space closure. Based on existing trials, there is insufficient evidence to make robust recommendations for lingual fixed orthodontic appliances regarding their therapeutic or adverse effects, as the quality of evidence was low. © 2016 Eur J Oral Sci.

Diaphragm pacing improves sleep in patients with amyotrophic lateral sclerosis.

PubMed

Gonzalez-Bermejo, Jesus; Morélot-Panzini, Capucine; Salachas, François; Redolfi, Stefania; Straus, Christian; Becquemin, Marie-Hélène; Arnulf, Isabelle; Pradat, Pierre-François; Bruneteau, Gaëlle; Ignagni, Anthony R; Diop, Moustapha; Onders, Raymond; Nelson, Teresa; Menegaux, Fabrice; Meininger, Vincent; Similowski, Thomas

2012-01-01

In amyotrophic lateral sclerosis (ALS) patients, respiratory insufficiency is a major burden. Diaphragm conditioning by electrical stimulation could interfere with lung function decline by promoting the development of type 1 muscle fibres. We describe an ancillary study to a prospective, non-randomized trial (NCT00420719) assessing the effects of diaphragm pacing on forced vital capacity (FVC). Sleep-related disturbances being early clues to diaphragmatic dysfunction, we postulated that they would provide a sensitive marker. Stimulators were implanted laparoscopically in the diaphragm close to the phrenic motor point in 18 ALS patients for daily conditioning. ALS functioning score (ALSFRS), FVC, sniff nasal inspiratory pressure (SNIP), and polysomnographic recordings (PSG, performed with the stimulator turned off) were assessed before implantation and after four months of conditioning (n = 14). Sleep efficiency improved (69 ± 15% to 75 ± 11%, p = 0.0394) with fewer arousals and micro-arousals. This occurred against a background of deterioration as ALSFRS-R, FVC, and SNIP declined. There was, however, no change in NIV status or the ALSFRS respiratory subscore, and the FVC decline was mostly due to impaired expiration. Supporting a better diaphragm function, apnoeas and hypopnoeas during REM sleep decreased. In conclusion, in these severe patients not expected to experience spontaneous improvements, diaphragm conditioning improved sleep and there were hints at diaphragm function changes.

[Hand burns in children and Aquacel(®) Burn gloves, an alternative to prolonged hospital stays].

PubMed

Ridel, P; Perrot, P; Truffandier, M V; Bellier-Waast, F; Duteille, F

2015-04-01

Occlusive dressings for second-degree hand burns in children must prevent infection and promote healing. For good management of analgesia, these treatments often require children to be hospitalized. Our goal was to find an alternative to conventional care protocol that would reduce the number of dressings and therefore the length of hospitalization. We report our experience with the use of Aquacel(®) Burn. Non-randomized monocentric prospective study was conducted from 2012 to 2014. The glove was used in the operating room within 72hours after the burn in children younger than 15 years old with isolated superficial to deep 2nd degree hand burns. Once the glove was perfectly stuck to the burn, the children could go back home. We saw them 10 to 12 days after the accident to be sure there was no indication of skin graft. Twenty gloves were used in 16 children aged from 16 months to 13 years. The average length of stay (ALOS) was five days to put the glove on and one day to remove it. Four hands were grafted. Once we get used to the product, Aquacel(®) Burn gloves have reduced the ALOS before skin graft in cases of isolated hand burns in children. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Effects of Bobath-based therapy on depression, shoulder pain and health-related quality of life in patients after stroke.

PubMed

Hafsteinsdóttir, Thóra B; Kappelle, Jaap; Grypdonck, Maria H F; Algra, Ale

2007-10-01

To measure the effects of Bobath-based (BB) therapy on depression, shoulder pain and health-related quality of life (HRQoL) of patients during one year after stroke. In a prospective, non-randomized design, the use of BB therapy was compared with a more task-oriented therapy and no BB therapy. A total of 324 patients in 12 hospitals. Patients in the intervention group received BB therapy, whereas patients in the control group received no BB therapy and a more task-oriented therapy. HRQoL was measured using the SF-36; depression was measured with the Center of Epidemiological Studies Depression Scale and shoulder pain was measured with the Visual Analogue Scale at discharge, 6 and 12 months. Linear and logistic regression analyses were performed. No effects of BB therapy on HRQoL or shoulder pain were found. After one year fewer patients were depressed in the BB group (30%) than in the non-BB group (43%); the adjusted odds ratio was 0.6 (95% confidence interval 0.3-1.0). BB therapy did not have any effect on HRQoL or shoulder pain in stroke patients. Healthcare professionals should reconsider the use of BB therapy in the care of stroke patients.

Use of a fibrin adhesive for conjunctival closure in trabeculectomy.

PubMed

Martinez-de-la-Casa, José M; Rayward, Omar; Saenz-Frances, Federico; Mendez, Carmen; Bueso, Enrique Santos; Garcia-Feijoo, Julián

2013-08-01

To assess the safety and efficacy of a fibrin tissue adhesive (Tissucol Duo(®) ) used to close the conjunctiva in trabeculectomy. A nonrandomized prospective study including 57 patients with chronic simple glaucoma who underwent trabeculectomy surgery. All the trabeculectomies were conducted by the same surgeon using the same surgical technique with the exception that conjunctival closure was achieved by either running Nylon 10/0 suture (n = 29) or using the fibrin glue (n = 28). Preoperative and postoperative data were obtained on intraocular pressure (IOP), number of hypotensive medications used, self-reported discomfort and complications arising during and after surgery. No differences were detected between the two patient groups regarding the intraocular pressure reduction achieved during follow-up. In the first 2 weeks of follow-up, reported discomfort assessed using a visual analogue scale was significantly lower in the Tissucol Duo(®) group. Two patients in the Tissucol Duo(®) group suffered conjunctival dehiscence and suturing was required at 24 hours postsurgery. Remaining complications were similar in the two groups. The use of Tissucol Duo(®) seems to be a safe and efficient option for conjunctival closure in trabeculectomy that simplifies the surgical procedure and reduces patient discomfort in the immediate postoperative period. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

Laparoscopic distal pancreatectomy: results of a prospective non-randomized study from a tertiary center.

PubMed

Palanivelu, C; Shetty, R; Jani, K; Sendhilkumar, K; Rajan, P S; Maheshkumar, G S

2007-03-01

Though laparoscopic distal pancreatectomy for benign conditions was first described in the early 1990s, it has not become as popular as other laparoscopic surgeries. Published literature on this topic consists of several case reports and a handful of small series. We present our experience, which, to the best of our knowledge, is the largest series reported to date. Since 1998, 22 patients have undergone distal pancreatectomy at our institute. The technique of distal pancreatosplenectomy, as well as spleen-preserving distal pancreatectomy, is described. Four males and 18 females in the age range of 12-69 years underwent operation. Splenic preservation was possible in 7 patients. The tumor diameter ranged from 2.1 cm to 7.4 cm. The mean operating time was 215 min. The mean length of incision required for specimen retrieval was 3.4 cm. All patients were started on a liquid diet on the first postoperative day. The median hospital stay was 4 days. One patient developed a pancreatic fistula that was managed conservatively. At the end of an average follow-up of 4.6 years, no recurrence has been reported. Laparoscopic distal pancreatectomy is a safe procedure, with minimal morbidity, rapid recovery, and short hospital stay. In appropriate cases, splenic preservation is feasible.

Double-Labeled Metabolic Maps of Memory.

ERIC Educational Resources Information Center

John, E. R.; And Others

1986-01-01

Reviews a study which sought to obtain a quantitative metabolic map of the neurons mediating a specific memory. Research results support notions of cooperative processes in which nonrandom behavior of high ensembles of neural elements mediates the integration and processing of information and the retrieval of memory. (ML)

Part-Time Employment by Secondary Agricultural Education Teachers

ERIC Educational Resources Information Center

Boone, Harry N., Jr.; Scarbrough, Connie; Gartin, Stacy A.; Boone, Deborah A.

2006-01-01

The purpose of this study was to compare secondary agricultural educators' perceptions of the benefits and problems associated with teaching agricultural education and being involved in other part-time employment activities. The sample consisted of 107 agricultural educators nonrandomly selected from three states. Sixty-nine usable questionnaires…

School-Based Intervention for Test Anxiety

ERIC Educational Resources Information Center

Yeo, Lay See; Goh, Valerie Grace; Liem, Gregory Arief D.

2016-01-01

Background: With children today being tested at younger ages, test anxiety has an earlier onset age. There is relatively limited research on test anxiety management programs with elementary school children. The theoretical basis for this nonrandomized pre-post intervention study is grounded in cognitive and behavioral interventions for test…

A phylogenetic perspective on the individual species-area relationship in temperate and tropical tree communities.

PubMed

Yang, Jie; Swenson, Nathan G; Cao, Min; Chuyong, George B; Ewango, Corneille E N; Howe, Robert; Kenfack, David; Thomas, Duncan; Wolf, Amy; Lin, Luxiang

2013-01-01

Ecologists have historically used species-area relationships (SARs) as a tool to understand the spatial distribution of species. Recent work has extended SARs to focus on individual-level distributions to generate individual species area relationships (ISARs). The ISAR approach quantifies whether individuals of a species tend have more or less species richness surrounding them than expected by chance. By identifying richness 'accumulators' and 'repellers', respectively, the ISAR approach has been used to infer the relative importance of abiotic and biotic interactions and neutrality. A clear limitation of the SAR and ISAR approaches is that all species are treated as evolutionarily independent and that a large amount of work has now shown that local tree neighborhoods exhibit non-random phylogenetic structure given the species richness. Here, we use nine tropical and temperate forest dynamics plots to ask: (i) do ISARs change predictably across latitude?; (ii) is the phylogenetic diversity in the neighborhood of species accumulators and repellers higher or lower than that expected given the observed species richness?; and (iii) do species accumulators, repellers distributed non-randomly on the community phylogenetic tree? The results indicate no clear trend in ISARs from the temperate zone to the tropics and that the phylogenetic diversity surrounding the individuals of species is generally only non-random on very local scales. Interestingly the distribution of species accumulators and repellers was non-random on the community phylogenies suggesting the presence of phylogenetic signal in the ISAR across latitude.

A phase II single institution single arm prospective study with paclitaxel, ifosfamide and cisplatin (TIP) as first-line chemotherapy in high-risk germ cell tumor patients with more than ten years follow-up and retrospective correlation with ERCC1, Topoisomerase 1, 2A, p53 and HER-2 expression.

PubMed

Ligia Cebotaru, Cristina; Zenovia Antone, Nicoleta; Diana Olteanu, Elena; Bejinariu, Nona; Buiga, Rares; Todor, Nicolae; Ioana Iancu, Dana; Eliade Ciuleanu, Tudor; Nagy, Viorica

2016-01-01

One half of high-risk germ cell tumor (HRGCT) patients relapse after standard chemotherapy. This phase II study evaluated prospectively the toxicity and efficacy in first-line of the paclitaxel-ifosfamide-cisplatin combination (TIP) in HRGCT patients and tried to identify biomarkers that may allow patient-tailored treatments. Between October 1997- September 2000, 28 chemo-naive HRGCT patients were enrolled. Patients received 4 cycles of TIP (paclitaxel 175 mg/m(2) day 1/; ifosfamide 1.2 g/m(2)/day, days 1-5; Mesna 1.2 g/m(2)/day, days 1-5; and cisplatin 20 mg/m(2)/day, days 1-5 every 3 weeks). A non-randomized comparison was made between HRGCT patients treated in the same period with first-line TIP and bleomycin-etoposide-cisplatin (BEP) (28 patients vs 20). In 17 HRGCT patients treated between 1998-2006, ERCC1, Topoisomerase 1 and 2A, p53 and HER-2 expression was retrospectively analysed by immunohistochemistry (IHC) (7 patients with TIP, 10 with BEP), and correlations were made with response to chemotherapy and survival. With a median follow-up of 72 months [range 48+...89+], 5-year disease free survival (DFS) was 55%, with 95% CI 36-72, and the overall survival (OS) was 63%, with 95% CI 44-78. In June 2015, with a median follow-up of 196.47 months (range 177.30-209.27) (>15 years), 12 [%?] patients were alive and disease-free, and 16 [%?] had died (12 specific causes). There was no significant correlation between the expression of ERCC1, Topoisomerase 1 and 2A, HER-2 and p53 and response to treatment. Long-term follow-up showed no difference in OS between TIP vs BEP as first-line therapy. Both regimens had mild toxicity.

A prospective, multicenter study of a double stent system for palliative treatment of malignant extrahepatic biliary obstructions.

PubMed

Kim, Jong Woo; Gwon, Dong Il; Han, Young-Min; Won, Je Hwan; Hong, Hyun Pyo; Ko, Gi-Young; Yoon, Hyun-Ki; Sung, Kyu-Bo

2015-10-01

A double stent system (covered stent in uncovered stent) was designed to provide long-term patency without tumor ingrowth or stent-related complications, such as stent migration, cholecystitis, or pancreatitis. To investigate the safety and efficacy of double stents in patients with malignant extrahepatic biliary obstructions. This prospective, nonrandomized, multicenter study enrolled 160 consecutive patients (102 men; mean age, 64 years; range, 33-91 years) with malignant extrahepatic biliary obstructions treated with a double stent system from January 2010 to March 2012. The technical success rate of the double stent placement was 100%. No stent migration was observed. Procedure-related minor (self-limiting hemobilia [n = 6] and cholangitis [n = 2]) and major (pancreatitis [n = 16], cholecystitis [n = 3], and hepatic abscess [n = 2]) complications occurred in a total of 29 patients. The mean serum bilirubin level, which was 8.9 ± 5.6 mg/dL before drainage, decreased to 2.2 ± 4.6 mg/dL 1 month after stent placement (P < 0.001). Successful internal drainage was achieved in 148 patients (92.5%). During the mean follow-up period of 205 days, acute cholecystitis (n = 3) and hepatic abscess (n = 2) occurred in five patients. The median patient survival and stent patency time were 135 days (95% confidence interval [CI], 96-160 days) and 114 days (95% CI, 83-131 days), respectively. Of 153 patients, 22 (14.4%) presented with stent dysfunction due to sludge incrustation (n = 17), tumor overgrowth (n = 4), or blood clot (n = 1), and required repeat intervention. Tumor ingrowth was not observed in any of these patients. Percutaneous treatment of malignant extrahepatic biliary obstruction using a double stent safely and effectively achieves internal biliary drainage. © The Foundation Acta Radiologica 2014.

A prospective comparison of phakic collamer lenses and wavefront-optimized laser-assisted in situ keratomileusis for correction of myopia

PubMed Central

Parkhurst, Gregory D

2016-01-01

Purpose The aim of this study was to evaluate and compare night vision and low-luminance contrast sensitivity (CS) in patients undergoing implantation of phakic collamer lenses or wavefront-optimized laser-assisted in situ keratomileusis (LASIK). Patients and methods This is a nonrandomized, prospective study, in which 48 military personnel were recruited. Rabin Super Vision Test was used to compare the visual acuity and CS of Visian implantable collamer lens (ICL) and LASIK groups under normal and low light conditions, using a filter for simulated vision through night vision goggles. Results Preoperative mean spherical equivalent was −6.10 D in the ICL group and −6.04 D in the LASIK group (P=0.863). Three months postoperatively, super vision acuity (SVa), super vision acuity with (low-luminance) goggles (SVaG), super vision contrast (SVc), and super vision contrast with (low luminance) goggles (SVcG) significantly improved in the ICL and LASIK groups (P<0.001). Mean improvement in SVaG at 3 months postoperatively was statistically significantly greater in the ICL group than in the LASIK group (mean change [logarithm of the minimum angle of resolution, LogMAR]: ICL =−0.134, LASIK =−0.085; P=0.032). Mean improvements in SVc and SVcG were also statistically significantly greater in the ICL group than in the LASIK group (SVc mean change [logarithm of the CS, LogCS]: ICL =0.356, LASIK =0.209; P=0.018 and SVcG mean change [LogCS]: ICL =0.390, LASIK =0.259; P=0.024). Mean improvement in SVa at 3 months was comparable in both groups (P=0.154). Conclusion Simulated night vision improved with both ICL implantation and wavefront-optimized LASIK, but improvements were significantly greater with ICLs. These differences may be important in a military setting and may also affect satisfaction with civilian vision correction. PMID:27418804

A prospective comparison of phakic collamer lenses and wavefront-optimized laser-assisted in situ keratomileusis for correction of myopia.

PubMed

Parkhurst, Gregory D

2016-01-01

The aim of this study was to evaluate and compare night vision and low-luminance contrast sensitivity (CS) in patients undergoing implantation of phakic collamer lenses or wavefront-optimized laser-assisted in situ keratomileusis (LASIK). This is a nonrandomized, prospective study, in which 48 military personnel were recruited. Rabin Super Vision Test was used to compare the visual acuity and CS of Visian implantable collamer lens (ICL) and LASIK groups under normal and low light conditions, using a filter for simulated vision through night vision goggles. Preoperative mean spherical equivalent was -6.10 D in the ICL group and -6.04 D in the LASIK group (P=0.863). Three months postoperatively, super vision acuity (SVa), super vision acuity with (low-luminance) goggles (SVaG), super vision contrast (SVc), and super vision contrast with (low luminance) goggles (SVcG) significantly improved in the ICL and LASIK groups (P<0.001). Mean improvement in SVaG at 3 months postoperatively was statistically significantly greater in the ICL group than in the LASIK group (mean change [logarithm of the minimum angle of resolution, LogMAR]: ICL =-0.134, LASIK =-0.085; P=0.032). Mean improvements in SVc and SVcG were also statistically significantly greater in the ICL group than in the LASIK group (SVc mean change [logarithm of the CS, LogCS]: ICL =0.356, LASIK =0.209; P=0.018 and SVcG mean change [LogCS]: ICL =0.390, LASIK =0.259; P=0.024). Mean improvement in SVa at 3 months was comparable in both groups (P=0.154). Simulated night vision improved with both ICL implantation and wavefront-optimized LASIK, but improvements were significantly greater with ICLs. These differences may be important in a military setting and may also affect satisfaction with civilian vision correction.

Preservative-free 0.9% sodium chloride for flushing and locking peripheral intravenous access device: a prospective controlled trial.

PubMed

Wang, Rui; Luo, Ou; He, Liu; Li, Jia-Xin; Zhang, Ming-Guang

2012-11-01

In Mainland China, heparin saline solution is commonly used for flushing and locking peripheral intravenous access devices in clinical practice for a long time. We conducted a prospective controlled trial to compare the effectiveness and safety of preservative-free 0.9% sodium chloride solution versus heparin saline solution as flushing and locking solution for peripheral intravenous access devices. Patients with gastroenterological or hepatic diseases were enrolled for this study from August 2011 to October 2011. After non-randomized allocation, preservative-free 0.9% sodium chloride was used as flushing and locking solution in the sodium chloride solution group, while hepatic solution (10 U/mL) was given in the heparin saline solution group. The device related complications and its maintenance duration were compared between two groups. One-way ANOVA, Chi(2), or Mantel-Haenszel test were performed using SPSS 13.0 and RevMan 5.0. Totally, 181 and 178 peripheral intravenous access devices in the sodium chloride solution and heparin saline solution groups were included and analyzed. Results indicated than sodium chloride solution did not increase the risks of occlusion (7.7% vs. 7.9%) and other adverse events of peripheral intravenous access devices (P = 0.163). Sodium chloride solution neither shortened the duration of peripheral intravenous access devices maintenance (3.6 ± 1.1 days vs. 3.7 ± 1.2 days, P = 0.651), nor increased the proportion of abnormal withdrawal (29.3% vs. 31.5%, P = 0.654). Sodium chloride solution is as effective and safe as conventional heparin saline solution for flushing and locking peripheral intravenous access devices, which results from our evidence-based study and should be transferred to other nurses in China. © 2012 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

Prospective evaluation of the feasibility, safety, and efficacy of Cocoon Duct Occluder for transcatheter closure of large patent ductus arteriosus: A single-center study with short- and medium-term follow-up results

PubMed Central

Sinha, Santosh Kumar; Razi, Mahmadula; Pandey, Rama Niwas; Kumar, Prakash; Krishna, Vinay; Jha, Mukesh Jitendra; Mishra, Vikas; Asif, Mohammad; Abdali, Nasar; Tewari, Pradyot; Thakur, Ramesh; Pandey, Umeshwar; Varma, Chandra Mohan

2017-01-01

Objective: To evaluate the feasibility, safety, and efficacy of a novel Cocoon Duct Occluder device for the transcatheter closure (TCC) of large patent ductus arteriosus (PDA). Methods: In this prospective, non-randomized study, consecutive patients with large PDA (narrowest diameter: ≥3.5/4.0 mm in symptomatic/asymptomatic patients, respectively), who underwent TCC with Cocoon Duct Occluder at our institute between November, 2012 and June, 2016 were examined. TCC was performed using the standard technique, and devices were antegradely delivered via 6–10F delivery sheaths. Device embolization, residual shunt, hemolysis, left pulmonary artery (LPA) stenosis, procedural and fluoroscopy time, and mortality were assessed. Patients were followed-up by transthoracic echocardiography with color Doppler imaging at 24 h (D1), 1 month (D30), and 6 months (D180) after implantation. Results: A total of 57 patients (age: 11.7±2.8 years; weight: 22.3±3.5 kg) were enrolled. The mean narrowest diameter was 7.4±0.7 mm. The PDA closure was successfully performed in each patient. Fluoroscopy and procedural time was 6.7±3.2 min and 23.9±2.7 min, respectively. Postprocedural angiography revealed that 49 (85.9%) patients had immediate and complete closure, whereas 8 (14.1%) had residual shunt. Color Doppler imaging at D1 revealed complete closure in 52 (91.3%) patients. At D30, complete closure was reported in all patients and was maintained at D180. Hemolysis, embolization, obstruction of LPA or descending aorta, and death were not reported till D180. Conclusion: TCC using Cocoon Duct Occluder is feasible, safe, and effective in the management of patients with large PDA, with excellent results on short- and medium-term follow-up. PMID:29145233

The BraveNet prospective observational study on integrative medicine treatment approaches for pain

PubMed Central

2013-01-01

Background Chronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures. Methods Our prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks. Results Of 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (−23%) and interference (−28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12. Conclusions Among participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures. Trial Registration ClinicalTrials.gov, NCT01186341 PMID:23800144

The BraveNet prospective observational study on integrative medicine treatment approaches for pain.

PubMed

Abrams, Donald I; Dolor, Rowena; Roberts, Rhonda; Pechura, Constance; Dusek, Jeffery; Amoils, Sandi; Amoils, Steven; Barrows, Kevin; Edman, Joel S; Frye, Joyce; Guarneri, Erminia; Kligler, Ben; Monti, Daniel; Spar, Myles; Wolever, Ruth Q

2013-06-24

Chronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures. Our prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks. Of 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (-23%) and interference (-28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12. Among participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures. ClinicalTrials.gov, NCT01186341.

Effect of Self-Instruction Strategy on the Achievement in Algebra of Students with Learning Difficulty in Mathematics

ERIC Educational Resources Information Center

Adani, Anthony; Eskay, Michael; Onu, Victoria

2012-01-01

This quasi-experimental study examined the effect of self-instruction strategy on the achievement in algebra of students with learning difficulty in mathematics. Two research questions and one null hypothesis were formulated to guide the study. The study adopted a non-randomized pre-test and post-test control group design with one experimental…

Consequences of non-random species loss for decomposition dynamics: Experimental evidence for additive and non-additive effects

Treesearch

Becky A. Ball; Mark D. Hunter; John S. Kominoski; Christopher M. Swan; Mark A. Bradford

2008-01-01

Although litter decomposition is a fundamental ecological process, most of our understanding comes from studies of single-species decay. Recently, litter-mixing studies have tested whether monoculture data can be applied to mixed-litter systems. These studies have mainly attempted to detect non-additive effects of litter mixing, which address potential consequences of...

Prognostic factors associated with the success rates of posterior orthodontic miniscrew implants: A subgroup meta-analysis.

PubMed

Hong, Sung-Bin; Kusnoto, Budi; Kim, Eun-Jeong; BeGole, Ellen A; Hwang, Hyeon-Shik; Lim, Hoi-Jeong

2016-03-01

To systematically review previous studies and to assess, via a subgroup meta-analysis, the combined odds ratio (OR) of prognostic factors affecting the success of miniscrew implants (MIs) inserted into the buccal posterior region. Three electronic searches that were limited to articles on clinical human studies using MIs that were published in English prior to March 2015 were conducted. The outcome measure was the success of MIs. Patient factors included age, sex, and jaw of insertion (maxilla vs. mandible), while the MI factors included length and diameter. A meta-analysis was performed on 17 individual studies. The quality of each study was assessed for non-randomized studies and quantified using the Newcastle-Ottawa Scale. The meta-analysis outcome was a combined OR. Subgroup and sensitivity analyses based on the study design, study quality, and sample size of miniscrews implanted were performed. Significantly higher success rates were revealed for MIs inserted in the maxilla, for patients ≥ 20 years of age, and for long MIs (≥ 8 mm) and MIs with a large diameter (> 1.4 mm). All subgroups acquired homogeneity, and the combined OR of the prospective studies (OR, 3.67; 95% confidence interval [CI], 2.10-6.44) was significantly higher in the maxilla than that in the retrospective studies (OR, 2.10; 95% CI, 1.60-2.74). When a treatment plan is made, these risk factors, i.e. jaw of insertion, age, MI length, and MI diameter, should be taken into account, while sex is not critical to the success of MIs.

A robust TDT-type association test under informative parental missingness.

PubMed

Chen, J H; Cheng, K F

2011-02-10

Many family-based association tests rely on the random transmission of alleles from parents to offspring. Among them, the transmission/disequilibrium test (TDT) may be considered to be the most popular statistical test. The TDT statistic and its variations were proposed to evaluate nonrandom transmission of alleles from parents to the diseased children. However, in family studies, parental genotypes may be missing due to parental death, loss, divorce, or other reasons. Under some missingness conditions, nonrandom transmission of alleles may still occur even when the gene and disease are not associated. As a consequence, the usual TDT-type tests would produce excessive false positive conclusions in association studies. In this paper, we propose a novel TDT-type association test which is not only simple in computation but also robust to the joint effect of population stratification and informative parental missingness. Our test is model-free and allows for different mechanisms of parental missingness across subpopulations. We use a simulation study to compare the performance of the new test with TDT and point out the advantage of the new method. Copyright © 2010 John Wiley & Sons, Ltd.

Two Universality Classes for the Many-Body Localization Transition

NASA Astrophysics Data System (ADS)

Khemani, Vedika; Sheng, D. N.; Huse, David A.

2017-08-01

We provide a systematic comparison of the many-body localization (MBL) transition in spin chains with nonrandom quasiperiodic versus random fields. We find evidence suggesting that these belong to two separate universality classes: the first dominated by "intrinsic" intrasample randomness, and the second dominated by external intersample quenched randomness. We show that the effects of intersample quenched randomness are strongly growing, but not yet dominant, at the system sizes probed by exact-diagonalization studies on random models. Thus, the observed finite-size critical scaling collapses in such studies appear to be in a preasymptotic regime near the nonrandom universality class, but showing signs of the initial crossover towards the external-randomness-dominated universality class. Our results provide an explanation for why exact-diagonalization studies on random models see an apparent scaling near the transition while also obtaining finite-size scaling exponents that strongly violate Harris-Chayes bounds that apply to disorder-driven transitions. We also show that the MBL phase is more stable for the quasiperiodic model as compared to the random one, and the transition in the quasiperiodic model suffers less from certain finite-size effects.

The Hard but Necessary Task of Gathering Order-One Effect Size Indices in Meta-Analysis

ERIC Educational Resources Information Center

Ortego, Carmen; Botella, Juan

2010-01-01

Meta-analysis of studies with two groups and two measurement occasions must employ order-one effect size indices to represent study outcomes. Especially with non-random assignment, non-equivalent control group designs, a statistical analysis restricted to post-treatment scores can lead to severely biased conclusions. The 109 primary studies…

The Discrimination of Fully Randomized and Partially Randomized Responding from Nonrandomized Responding on the Sixteen Personality Factor Questionnaire-Fifth Edition

ERIC Educational Resources Information Center

Pietrzak, Dale; Korcuska, James S.

2007-01-01

This study examines the detection of various rates of noncontent responding on the Sixteen Personality Factor Questionnaire-Fifth Edition (R. Cattell, H. Eber, & M. Tatsuoka, 1970). The study used a sample of 237 adult volunteers. New scales were developed and tested. (Contains 3 tables.)

An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies

ERIC Educational Resources Information Center

Austin, Peter C.

2011-01-01

The propensity score is the probability of treatment assignment conditional on observed baseline characteristics. The propensity score allows one to design and analyze an observational (nonrandomized) study so that it mimics some of the particular characteristics of a randomized controlled trial. In particular, the propensity score is a balancing…

Effects of a School-Based Sexuality Education Program on Peer Educators: The Teen PEP Model

ERIC Educational Resources Information Center

Jennings, J. M.; Howard, S.; Perotte, C. L.

2014-01-01

This study evaluated the impact of the Teen Prevention Education Program (Teen PEP), a peer-led sexuality education program designed to prevent unintended pregnancy and sexually transmitted infections (STIs) including HIV among high school students. The study design was a quasi-experimental, nonrandomized design conducted from May 2007 to May…

Protocol of a prospective study for the combination treatment of Shu-Gan-jian-Pi decoction and steroid standard therapy in autoimmune hepatitis patients.

PubMed

Chi, Xiao-Ling; Xiao, Huan-Ming; Xie, Yu-Bao; Cai, Gao-Shu; Jiang, Jun-Min; Tian, Guang-Jun; Shi, Mei-Jie; Wu, Shu-Duo; Zhao, Peng-Tao; Chen, Hui-Jun

2016-12-07

Prednisone plus azathioprine is considered the mainstay of therapy in the current recommendations for autoimmune hepatitis (AIH). However, it does not provide good benefits for AIH patients because of its serious side effects. Therefore, more and more AIH patients prefer to seek for traditional Chinese medicine (TCM) to manage their symptoms and reduce the side effects of steroids in China. Shu-Gan-Jian-Pi Decoction is a popular used Chinese herbal formula in Guangdong province of China, which has demonstrated the effect of improving efficacy and reducing side effects of corticosteroids in AIH patients. The aim of this study is to evaluate the effects of Shu-Gan-Jian-Pi Decoction combined with steroid in AIH patients. So, this study aims to explore whether the combination treatment of Shu-Gan-Jian-Pi Decoction and steroid standard therapy could improve the clinical management of AIH. A prospective non-randomized study on AIH will be conducted between October 2015 and June 2017 in Guangdong Provincial hospital of Chinese medicine. Eligible AIH patients will be classified as the case group (n = 66) and the control group (n = 66) based on the interventions. Patients taking Shu-Gan-Jian-Pi Decoction combined with prednisone and azathioprine will be in the case group and those taking prednisone and azathioprine will be in the control group. The whole study will last 48 weeks, including a 24-week observation period and a 24-week follow-up period. The primary outcome was complete response to therapy, defined as complete biochemical remission at the patient's last visit of observation period and the absence of predefined steroid-specific side effects throughout treatment. This trial will evaluate the efficacy and safety of Shu-Gan-Jian-Pi Decoction combined with prednisone and azathioprine on AIH patients. The achievement of this trial will provide evidence-based data for Shu-Gan-Jian-Pi Decoction, which could provide good benefits for AIH patients. Chinese Clinical Trial Registry: ChiCTR-OOC-15006155 . Registration date: 28 March 2015.

Pre-Enrollment Reimbursement Patterns of Medicare Beneficiaries Enrolled in “At-Risk” HMOs

PubMed Central

Eggers, Paul W.; Prihoda, Ronald

1982-01-01

The Health Care Financing Administration (HCFA) has initiated several demonstration projects to encourage HMOs to participate in the Medicare program under a risk mechanism. These demonstrations are designed to test innovative marketing techniques, benefit packages, and reimbursement levels. HCFA's current method for prospective payments to HMOs is based on the Adjusted Average Per Capita Cost (AAPCC). An important issue in prospective reimbursement is the extent to which the AAPCC adequately reflects the risk factors which arise out of the selection process of Medicare beneficiaries into HMOs. This study examines the pre-enrollment reimbursement experience of Medicare beneficiaries who enrolled in the demonstration HMOs to determine whether or not a non-random selection process took place. The three demonstration HMOs included in the study are the Fallon Community Health Plan, the Greater Marshfield Community Health Plan, and the Kaiser-Permanente medical program of Portland, Oregon. The study includes 18,085 aged Medicare beneficiaries who had enrolled in the three plans as of April, 1981. We included comparison groups consisting of a 5 percent random sample of aged Medicare beneficiaries (N = 11,240) living in the same geographic areas as the control groups. The study compares the groups by total Medicare reimbursements for the years 1976 through 1979. Adjustments were made for AAPCC factor differences in the groups (age, sex, institutional status, and welfare status). In two of the HMO areas there was evidence of a selection process among the HMOs enrollees. Enrollees in the Fallon and Kaiser health plans were found to have had 20 percent lower Medicare reimbursements than their respective comparison groups in the four years prior to enrollment. This effect was strongest for inpatient services, but a significant difference also existed for use of physician and outpatient services. In the Marshfield HMO there was no statistically significant difference in pre-enrollment Medicare total reimbursements between the enrollee and comparison groups. However, outpatient and physician reimbursements were significantly higher (22 percent) among the enrollee group. The results of this study suggest that the AAPCC may not be an adequate mechanism for setting prospective reimbursement rates. The Marshfield results further suggest that the type of HMO may have an influence on the selection process among Medicare beneficiaries. If Medicare beneficiaries do not have to change providers to join an HMO, as in an IPA model or a staff model which includes most of the providers in an area, the selection process may be more likely to result in an unbiased risk group. PMID:10309720

Motivation and Student Success in Developmental Education

ERIC Educational Resources Information Center

Livingston, Shannon

2017-01-01

Using self-determination theory (Deci & Ryan, 1985) as the theoretical framework, this study explored how high-school GPA and motivation contributed to academic performance and persistence among students enrolled in developmental-education courses during the fall of 2016 at a two-year technical college in the Midwest. A non-random purposive…

Empirically Driven Variable Selection for the Estimation of Causal Effects with Observational Data

ERIC Educational Resources Information Center

Keller, Bryan; Chen, Jianshen

2016-01-01

Observational studies are common in educational research, where subjects self-select or are otherwise non-randomly assigned to different interventions (e.g., educational programs, grade retention, special education). Unbiased estimation of a causal effect with observational data depends crucially on the assumption of ignorability, which specifies…

Treatment of Adolescent Panic Disorder: A Nonrandomized Comparison of Intensive versus Weekly CBT

ERIC Educational Resources Information Center

Chase, Rhea M.; Whitton, Sarah W.; Pincus, Donna B.

2012-01-01

This study compared the relative efficacy of intensive versus weekly panic control treatment (PCT) for adolescent panic disorder with agoraphobia (PDA). Twenty-six adolescents participated in weekly sessions and 25 received intensive treatment involving daily sessions. Both groups demonstrated significant and comparable reductions in panic…

Therapeutic Nursery Programs: A Survey of Alternative Preschools.

ERIC Educational Resources Information Center

Marsh, Pamela T.

Noting that therapeutic nursery programs (TNPs) offer one alternative to mainstream daycare or preschool settings for young children experiencing severe emotional and behavioral difficulties, this study gathered information about TNPs and their services. Response rate to a survey mailed to a nonrandom nationwide sample of 40 programs was 50…

Randomly and Non-Randomly Missing Renal Function Data in the Strong Heart Study: A Comparison of Imputation Methods

PubMed Central

Shara, Nawar; Yassin, Sayf A.; Valaitis, Eduardas; Wang, Hong; Howard, Barbara V.; Wang, Wenyu; Lee, Elisa T.; Umans, Jason G.

2015-01-01

Kidney and cardiovascular disease are widespread among populations with high prevalence of diabetes, such as American Indians participating in the Strong Heart Study (SHS). Studying these conditions simultaneously in longitudinal studies is challenging, because the morbidity and mortality associated with these diseases result in missing data, and these data are likely not missing at random. When such data are merely excluded, study findings may be compromised. In this article, a subset of 2264 participants with complete renal function data from Strong Heart Exams 1 (1989–1991), 2 (1993–1995), and 3 (1998–1999) was used to examine the performance of five methods used to impute missing data: listwise deletion, mean of serial measures, adjacent value, multiple imputation, and pattern-mixture. Three missing at random models and one non-missing at random model were used to compare the performance of the imputation techniques on randomly and non-randomly missing data. The pattern-mixture method was found to perform best for imputing renal function data that were not missing at random. Determining whether data are missing at random or not can help in choosing the imputation method that will provide the most accurate results. PMID:26414328

Randomly and Non-Randomly Missing Renal Function Data in the Strong Heart Study: A Comparison of Imputation Methods.

PubMed

Shara, Nawar; Yassin, Sayf A; Valaitis, Eduardas; Wang, Hong; Howard, Barbara V; Wang, Wenyu; Lee, Elisa T; Umans, Jason G

2015-01-01

Kidney and cardiovascular disease are widespread among populations with high prevalence of diabetes, such as American Indians participating in the Strong Heart Study (SHS). Studying these conditions simultaneously in longitudinal studies is challenging, because the morbidity and mortality associated with these diseases result in missing data, and these data are likely not missing at random. When such data are merely excluded, study findings may be compromised. In this article, a subset of 2264 participants with complete renal function data from Strong Heart Exams 1 (1989-1991), 2 (1993-1995), and 3 (1998-1999) was used to examine the performance of five methods used to impute missing data: listwise deletion, mean of serial measures, adjacent value, multiple imputation, and pattern-mixture. Three missing at random models and one non-missing at random model were used to compare the performance of the imputation techniques on randomly and non-randomly missing data. The pattern-mixture method was found to perform best for imputing renal function data that were not missing at random. Determining whether data are missing at random or not can help in choosing the imputation method that will provide the most accurate results.

Utilizing bi-spectral index (BIS) for the monitoring of sedated adult ICU patients: a systematic review.

PubMed

Bilgili, Beliz; Montoya, Juan C; Layon, A J; Berger, Andrea L; Kirchner, H L; Gupta, Leena K; Gloss, David S

2017-03-01

The ideal level of sedation in the ICU is an ongoing source of scrutiny. At higher levels of sedation, the current scoring systems are not ideal. BIS may be able to improve both. We evaluated literature on effectiveness of BIS monitoring in sedated mechanically ventilated (MV) ICU patients compared to clinical sedation scores (CSS). For this systematic review, full text articles were searched in OVID, MEDLINE, EMBASE, and Cochrane databases from 1986 - 2014. Additional studies were identified searching bibliographies/abstracts from national/international Critical Care Medicine conferences and references from searched articles retrieved. Search terms were: 'Clinical sedation scale, Bi-spectral Index, Mechanical ventilation, Intensive care Unit'. Included were prospective, randomized and non-randomized studies comparing BIS monitoring with any CSS in MV adult (>18 yr old) ICU patients. Studies were graded for quality of evidence based on bias as established by the GRADE guidelines. Additional sources of bias were examined. There were five studies which met inclusion criteria. All five studies were either unclear or high risk for blinding of participants and blinding of outcome assessment. All papers had at least one source of additional high risk, or unclear/unstated. BIS monitoring in the mechanically ventilated ICU patient may decrease sedative drug dose, recall, and time to wake-up. The studies suggesting this are severely limited methodologically. BIS, when compared to subjective CSSs, is not, at this time, clearly indicated. An appropriately powered randomized, controlled study is needed to determine if this monitoring modality is of use on the ICU.

Blood pressure variability of two ambulatory blood pressure monitors.

PubMed

Kallem, Radhakrishna R; Meyers, Kevin E C; Cucchiara, Andrew J; Sawinski, Deirdre L; Townsend, Raymond R

2014-04-01

There are no data on the evaluation of blood pressure (BP) variability comparing two ambulatory blood pressure monitoring monitors worn at the same time. Hence, this study was carried out to compare variability of BP in healthy untreated adults using two ambulatory BP monitors worn at the same time over an 8-h period. An Accutorr device was used to measure office BP in the dominant and nondominant arms of 24 participants.Simultaneous 8-h BP and heart rate data were measured in 24 untreated adult volunteers by Mobil-O-Graph (worn for an additional 16 h after removing the Spacelabs monitor) and Spacelabs with both random (N=12) and nonrandom (N=12) assignment of each device to the dominant arm. Average real variability (ARV), SD, coefficient of variation, and variation independent of mean were calculated for systolic blood pressure, diastolic blood pressure, mean arterial pressure, and pulse pressure (PP). Whether the Mobil-O-Graph was applied to the dominant or the nondominant arm, the ARV of mean systolic (P=0.003 nonrandomized; P=0.010 randomized) and PP (P=0.009 nonrandomized; P=0.005 randomized) remained significantly higher than the Spacelabs device, whereas the ARV of the mean arterial pressure was not significantly different. The average BP readings and ARVs for systolic blood pressure and PP obtained by the Mobil-O-Graph were considerably higher for the daytime than the night-time. Given the emerging interest in the effect of BP variability on health outcomes, the accuracy of its measurement is important. Our study raises concerns about the accuracy of pooling international ambulatory blood pressure monitoring variability data using different devices.

Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance.

PubMed

Walter, Jessica R; Ghobadi, Comeron W; Hayman, Emily; Xu, Shuai

2017-01-01

In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.

Impact of chest radiography for children with lower respiratory tract infection: a propensity score approach.

PubMed

Ecochard-Dugelay, Emmanuelle; Beliah, Muriel; Boisson, Caroline; Perreaux, Francis; de Laveaucoupet, Jocelyne; Labrune, Philippe; Epaud, Ralph; Ducou-Lepointe, Hubert; Bouyer, Jean; Gajdos, Vincent

2014-01-01

Management of acute respiratory tract infection varies substantially despite this being a condition frequently encountered in pediatric emergency departments. Previous studies have suggested that the use of antibiotics was higher when chest radiography was performed. However none of these analyses had considered the inherent indication bias of observational studies. The aim of this work was to assess the relationship between performing chest radiography and prescribing antibiotics using a propensity score analysis to address the indication bias due to non-random radiography assignment. We conducted a prospective study of 697 children younger than 2 years of age who presented during the winter months of 2006-2007 for suspicion of respiratory tract infection at the Pediatric Emergency Department of an urban general hospital in France (Paris suburb). We first determined the individual propensity score (probability of having a chest radiography according to baseline characteristics). Then we assessed the relation between radiography and antibiotic prescription using two methods: adjustment and matching on the propensity score. We found that performing a chest radiography lead to more frequent antibiotic prescription that may be expressed as OR = 2.3, CI [1.3-4.1], or as an increased use of antibiotics of 18.6% [0.08-0.29] in the group undergoing chest radiography. Chest radiography has a significant impact on the management of infants admitted for suspicion of respiratory tract infection in a pediatric emergency department and may lead to unnecessary administration of antibiotics.

Circular instead of hierarchical: methodological principles for the evaluation of complex interventions

PubMed Central

Walach, Harald; Falkenberg, Torkel; Fønnebø, Vinjar; Lewith, George; Jonas, Wayne B

2006-01-01

Background The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery). Discussion The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability). Summary Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform. PMID:16796762

Conjunctival autografting combined with low-dose mitomycin C for prevention of primary pterygium recurrence.

PubMed

Frucht-Pery, Joseph; Raiskup, Frederic; Ilsar, Michael; Landau, David; Orucov, Faik; Solomon, Abraham

2006-06-01

To compare the clinical outcome of pterygium surgery combining intraoperative mitomycin C (MMC) with a free conjunctival autograft, with three other methods of pterygium surgery, including intraoperative MMC alone, conjunctival autograft alone, and bare sclera without adjunctive treatment. Interventional, randomized and in part nonrandomized, prospective, comparative study. setting: A university medical center department of ophthalmology. One hundred and twenty patients underwent pterygium excision surgery. These patients were divided into four treatment groups. In group 1 (30 patients), MMC, 0.2 mg/ml, was applied for three minutes. In group 2 (30 patients), conjunctival autografting was performed. Group 3 (30 patients) received sodium chloride 0.9% only, and group 4 (30 patients) underwent conjunctival autografting combined with one minute application of MMC, 0.2 mg/ml. Recurrence rates and complications. Pterygium recurred in two patients (6.6%) in group 1, in four patients (13.3%) in group 2, in 14 patients (46.6%) in group 3, and in none of the patients in group 4. chi(2) analysis revealed a significantly lower recurrence rate in group 4 compared with group 2 (P = .038) and with group 3 (P < .0001). Epithelialization of the wounds was complete within 14 days of surgery. No complications were demonstrated in any of the study groups except for one case of minor melting of the flap in group 4. This study indicates that pterygium excision with a free conjunctival autograft combined with intraoperative low-dose MMC is a safe and effective technique in pterygium surgery.

Evaluation of sleep quality in subjects with chronic nononcologic pain.

PubMed

Covarrubias-Gomez, Alfredo; Mendoza-Reyes, Jonathan J

2013-08-01

A survey conducted by the National Sleep Foundation found that 20% of Americans have sleep disorders and 45% experience chronic pain. Several authors evaluated the interrelationship between these functions using various instruments such the Pittsburgh Sleep Quality Index (PSQI) and identified that 34% of subjects in the general population have a poor quality of sleep, but there are few studies that assess the quality of sleep in patients with chronic pain of nonmalignant origin. We undertook this study to evaluate the quality of sleep using the PSQI in patients with chronic pain unrelated to cancer. We conducted a clinical, nonrandomized, uncontrolled, descriptive, and prospective study, applying the PSQI through a direct one-time interview to 311 subjects with chronic pain unrelated to cancer. According to the categorization of the PSQI between good and poor sleepers, 89% of the subjects were poor sleepers (n = 276). There are significant differences in pain intensity according to the categorization of the PSQI, with a higher intensity shown in the "poor sleepers" (analysis of variance [ANOVA], P = .030). Using a linear regression model to estimate the curve, a higher score is rated on the PSQI global score (ANOVA, P = .000, R(2) = .46) with the increase of the intensity of the pain. We conclude that "poor sleepers" or those who considered their sleep as "poor quality" have significantly higher pain intensity. This suggests that intensity of pain plays a role in evaluating the quality of sleep in the subjective perception of sleep and instruments that assess quality.

Feasibility and Efficacy of Nurse-Driven Acute Stroke Care.

PubMed

Mainali, Shraddha; Stutzman, Sonja; Sengupta, Samarpita; Dirickson, Amanda; Riise, Laura; Jones, Donald; Yang, Julian; Olson, DaiWai M

2017-05-01

Acute stroke care requires rapid assessment and intervention. Replacing traditional sequential algorithms in stroke care with parallel processing using telestroke consultation could be useful in the management of acute stroke patients. The purpose of this study was to assess the feasibility of a nurse-driven acute stroke protocol using a parallel processing model. This is a prospective, nonrandomized, feasibility study of a quality improvement initiative. Stroke team members had a 1-month training phase, and then the protocol was implemented for 6 months and data were collected on a "run-sheet." The primary outcome of this study was to determine if a nurse-driven acute stroke protocol is feasible and assists in decreasing door to needle (intravenous tissue plasminogen activator [IV-tPA]) times. Of the 153 stroke patients seen during the protocol implementation phase, 57 were designated as "level 1" (symptom onset <4.5 hours) strokes requiring acute stroke management. Among these strokes, 78% were nurse-driven, and 75% of the telestroke encounters were also nurse-driven. The average door to computerized tomography time was significantly reduced in nurse-driven codes (38.9 minutes versus 24.4 minutes; P < .04). The use of a nurse-driven protocol is feasible and effective. When used in conjunction with a telestroke specialist, it may be of value in improving patient outcomes by decreasing the time for door to decision for IV-tPA. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Utility of inverse probability weighting in molecular pathological epidemiology.

PubMed

Liu, Li; Nevo, Daniel; Nishihara, Reiko; Cao, Yin; Song, Mingyang; Twombly, Tyler S; Chan, Andrew T; Giovannucci, Edward L; VanderWeele, Tyler J; Wang, Molin; Ogino, Shuji

2018-04-01

As one of causal inference methodologies, the inverse probability weighting (IPW) method has been utilized to address confounding and account for missing data when subjects with missing data cannot be included in a primary analysis. The transdisciplinary field of molecular pathological epidemiology (MPE) integrates molecular pathological and epidemiological methods, and takes advantages of improved understanding of pathogenesis to generate stronger biological evidence of causality and optimize strategies for precision medicine and prevention. Disease subtyping based on biomarker analysis of biospecimens is essential in MPE research. However, there are nearly always cases that lack subtype information due to the unavailability or insufficiency of biospecimens. To address this missing subtype data issue, we incorporated inverse probability weights into Cox proportional cause-specific hazards regression. The weight was inverse of the probability of biomarker data availability estimated based on a model for biomarker data availability status. The strategy was illustrated in two example studies; each assessed alcohol intake or family history of colorectal cancer in relation to the risk of developing colorectal carcinoma subtypes classified by tumor microsatellite instability (MSI) status, using a prospective cohort study, the Nurses' Health Study. Logistic regression was used to estimate the probability of MSI data availability for each cancer case with covariates of clinical features and family history of colorectal cancer. This application of IPW can reduce selection bias caused by nonrandom variation in biospecimen data availability. The integration of causal inference methods into the MPE approach will likely have substantial potentials to advance the field of epidemiology.

Sentinel Node Biopsy for the Head and Neck Using Contrast-Enhanced Ultrasonography Combined with Indocyanine Green Fluorescence in Animal Models: A Feasibility Study.

PubMed

Kogashiwa, Yasunao; Sakurai, Hiroyuki; Akimoto, Yoshihiro; Sato, Dai; Ikeda, Tetsuya; Matsumoto, Yoshifumi; Moro, Yorihisa; Kimura, Toru; Hamanoue, Yasuhiro; Nakamura, Takehiro; Yamauchi, Koichi; Saito, Koichiro; Sugasawa, Masashi; Kohno, Naoyuki

2015-01-01

Sentinel node navigation surgery is gaining popularity in oral cancer. We assessed application of sentinel lymph node navigation surgery to pharyngeal and laryngeal cancers by evaluating the combination of contrast-enhanced ultrasonography and indocyanine green fluorescence in animal models. This was a prospective, nonrandomized, experimental study in rabbit and swine animal models. A mixture of indocyanine green and Sonazoid was used as the tracer. The tracer mixture was injected into the tongue, larynx, or pharynx. The sentinel lymph nodes were identified transcutaneously by infra-red camera and contrast-enhanced ultrasonography. Detection time and extraction time of the sentinel lymph nodes were measured. The safety of the tracer mixture in terms of mucosal reaction was evaluated macroscopically and microscopically. Sentinel lymph nodes were detected transcutaneously by contrast-enhanced ultrasonography alone. The number of sentinel lymph nodes detected was one or two. Despite observation of contrast enhancement of Sonazoid for at least 90 minutes, the number of sentinel lymph nodes detected did not change. The average extraction time of sentinel lymph nodes was 4.8 minutes. Indocyanine green fluorescence offered visual information during lymph node biopsy. The safety of the tracer was confirmed by absence of laryngeal edema both macro and microscopically. The combination method of indocyanine green fluorescence and contrast-enhanced ultrasonography for detecting sentinel lymph nodes during surgery for head and neck cancer seems promising, especially for pharyngeal and laryngeal cancer. Further clinical studies to confirm this are warranted.

Balneotherapy for chronic plaque psoriasis at Comano spa in Trentino, Italy.

PubMed

Peroni, Anna; Gisondi, Paolo; Zanoni, Mauro; Girolomoni, Giampiero

2008-07-01

Thermal therapy is used worldwide in the treatment of psoriasis but few controlled studies have evaluated its efficacy and safety. We studied the efficacy and safety of balneotherapy compared to photobalneotherapy performed at Comano spa in Trentino, Italy, in chronic plaque psoriasis in a prospective, nonrandomized, open study. Three hundred adult patients with mild to severe chronic plaque psoriasis were assigned to either balneotherapy or photobalneotherapy with daily narrow-band ultraviolet B for a mean period of 1 or 2 weeks, reflecting the times that most patients can dedicate to thermal therapy. Patients were evaluated at baseline and end of treatment for psoriasis area and severity index (PASI) and body surface area; self-administered PASI (SAPASI) and Skindex-29 were evaluated at the same times, and also at 4 months by a mailed questionnaire. One-week balneotherapy or photobalneotherapy resulted in a significant reduction in PASI score (11.54% +/- 2.76 and 12.76% +/- 3.79, respectively; mean +/- standard deviation; p < 0.001). Two-week therapy induced a greater response with photobalneotherapy than with balneotherapy alone, with PASI reduction of 19.8% +/- 24.5 and 13.5% +/- 23.1 (p < 0.005), respectively. These results were confirmed by SAPASI and Skindex-29 evaluation. The therapy was well tolerated. Skin improvement was mostly lost after 4 months. Short-term balneotherapy and photobalneotherapy could thus be offered to patients willing to temporarily discontinue pharmacologic therapy or as adjuvant therapy.

[Nerve sparing techniques in deep endometriosis surgery to prevent urinary or digestive functional disorders: Techniques and results: CNGOF-HAS Endometriosis Guidelines].

PubMed

Rabischong, B; Botchorishvili, R; Bourdel, N; Curinier, S; Campagne-Loiseau, S; Pouly, J L; Canis, M

2018-03-01

To evaluate the feasibility and functional urinary and digestive results of nerve sparing techniques in endometriosis surgery. A research on the medline/pubmed database using specific keywords (nerve sparing, endometriosis, pelvic nerves) identified 7 publications among about 50 whose purpose was to describe the feasibility, the techniques and the functional results of nerve preservation in this indication. Among them there are: 2 uncontrolled retrospective studies, 3 prospective non-randomized studies, a meta-analysis and a review of the literature. Nerve preservation requires a perfect knowledge of the anatomy of the pelvic autonomic system. The laparoscopic approach is preferred by the different authors due to its anatomical advantage. The feasibility of this technique seems to be demonstrated despite certain limitations in the different studies and depending of the retroperitoneal extension of the lesions. When feasible, it is likely to significantly improve postoperative urinary function (urinary retention) compared to a conventional technique. It is observed no difference regarding digestive function. Nerve sparing in this indication is a technique the feasibility of which has been demonstrated and is subject to the topography and extent of the disease. In the absence of invasion or entrapment of pelvic autonomic nerves by endometriosis, this technique improves postoperative voiding function (NP3). During pelvic surgery for endometriosis, it is recommended to identify and preserve autonomic pelvic nerves whenever possible (GradeC). Copyright © 2018. Published by Elsevier Masson SAS.

Benzodiazepine use in seizure emergencies: A systematic review.

PubMed

Haut, Sheryl R; Seinfeld, Syndi; Pellock, John

2016-10-01

The aim of this review was to systematically examine safety and efficacy outcomes, as well as patient/caregiver satisfaction, from clinical studies in pediatric and adult patients treated with benzodiazepines (BZDs) through various administration routes in response to seizure emergencies. A literature search was conducted to identify articles describing the use of various routes of administration (RoAs) of BZDs for the treatment of seizure emergencies through April 21, 2015, using Embase™ and PubMed®. Eligible studies included (a) randomized controlled trials or (b) controlled nonrandomized clinical trials, either retrospective or prospective. Outcome assessments reviewed were 1) time to administration, 2) time to seizure termination, 3) rate of treatment failure, 4) prevention of seizure recurrence, 5) patient and caregiver treatment satisfaction, 6) adverse events related to BDZ treatment or RoA, and 7) respiratory adverse events. Seventy-five studies evaluated safety and efficacy using individual or comparator BDZs of various RoAs for treating seizure emergencies in all-aged patients with epilepsy. Buccal, intranasal (IN), or intramuscular (IM) BZDs were often more rapidly administered compared with rectal and intravenous (IV) formulations. Time to seizure termination, seizure recurrence rates, and adverse events were generally similar among RoAs, whereas nonrectal RoAs resulted in greater patient and caregiver satisfaction compared with rectal RoA. Results of this systematic literature review suggest that nonrectal and non-IV BZD formulations provide equal or improved efficacy and safety outcomes compared with rectal and IV formulations for the treatment of seizure emergencies. Copyright © 2016. Published by Elsevier Inc.

Do moderate aerobic exercise and strength training influence electromyographic biofeedback of the pelvic floor muscles in female non-athletes?

PubMed Central

Gonçalves, Maria Lucia Campos; Fernandes, Samantha; Batista de Sousa, João

2018-01-01

[Purpose] To assess the influence of moderate physical exercise on pelvic floor muscle electromyographic (EMG) biofeedback signal in female non-athletes. [Subjects and Methods] A prospective, non-randomized study of 90 adult females (age ≥18 years) divided into three groups: Intervention (I), which began physical exercise upon study enrollment; Moderate Exercise (ME), comprising those who already engaged in physical activity; and Sedentary (S), comprising those who had a sedentary lifestyle. All participants underwent EMG biofeedback of the pelvic floor muscles upon study enrollment (T1) and at the end of the third subsequent month (T2). [Results] Mean age was 35.7 (SD: 7.5) years, with no significant difference between groups. T1 values in groups I and S were significantly lower than in group ME. There was no statistically significant difference between groups S and I. On comparison between groups at T2, values were highest in group I (18.5 µV vs. 15.3 µV in group S, vs. 16.1 µV in group ME). There was no significant difference between groups S and ME. On age-adjusted analysis, group I exhibited the greatest change between T1 and T2 (I, 4.7 µV; ME, 2.1 µV; S, 1.5 µV). [Conclusion] Females who exercise exhibit better pelvic floor muscle function than those who do not engage in physical activity. PMID:29545703

The effects of biome and spatial scale on the Co-occurrence patterns of a group of Namibian beetles

NASA Astrophysics Data System (ADS)

Pitzalis, Monica; Montalto, Francesca; Amore, Valentina; Luiselli, Luca; Bologna, Marco A.

2017-08-01

Co-occurrence patterns (studied by C-score, number of checkerboard units, number of species combinations, and V-ratio, and by an empirical Bayes approach developed by Gotelli and Ulrich, 2010) are crucial elements in order to understand assembly rules in ecological communities at both local and spatial scales. In order to explore general assembly rules and the effects of biome and spatial scale on such rules, here we studied a group of beetles (Coleoptera, Meloidae), using Namibia as a case of study. Data were gathered from 186 sampling sites, which allowed collection of 74 different species. We analyzed data at the level of (i) all sampled sites, (ii) all sites stratified by biome (Savannah, Succulent Karoo, Nama Karoo, Desert), and (iii) three randomly selected nested areas with three spatial scales each. Three competing algorithms were used for all analyses: (i) Fixed-Equiprobable, (ii) Fixed-Fixed, and (iii) Fixed-Proportional. In most of the null models we created, co-occurrence indicators revealed a non-random structure in meloid beetle assemblages at the global scale and at the scale of biomes, with species aggregation being much more important than species segregation in determining this non-randomness. At the level of biome, the same non-random organization was uncovered in assemblages from Savannah (where the aggregation pattern was particularly strong) and Succulent Karoo, but not in Desert and Nama Karoo. We conclude that species facilitation and similar niche in endemic species pairs may be particularly important as community drivers in our case of study. This pattern is also consistent with the evidence of a higher species diversity (normalized according to biome surface area) in the two former biomes. Historical patterns were perhaps also important for Succulent Karoo assemblages. Spatial scale had a reduced effect on patterning our data. This is consistent with the general homogeneity of environmental conditions over wide areas in Namibia.

Propofol and non-propofol based sedation for outpatient colonoscopy-prospective comparison of depth of sedation using an EEG based SEDLine monitor.

PubMed

Goudra, Basavana; Singh, Preet Mohinder; Gouda, Gowri; Borle, Anuradha; Carlin, Augustus; Yadwad, Avantika

2016-10-01

Propofol is a popular anesthetic sedative employed in colonoscopy. It is known to increase the patient satisfaction and improve throughput. However, there are concerns among the clinicians with regard to the depth of sedation, as a deeper degree of sedation is known to increase the incidence of aspiration and other adverse events. So we planned to compare the depth of sedation between propofol and non-propofol based sedation in patients undergoing outpatient colonoscopy, as measured by an electroencephalogram (EEG) based monitor SEDLine monitor (SedlineInc., San Diego, CA). The non-randomized prospective observational study was performed in the outpatient gastroenterology suite of the Hospital of the University of Pennsylvania, Philadelphia. Patients included ASA class I-III aged more than 18 years scheduled for colonoscopy under Propofol or non-propofol based sedation. After an institutional review board approval, a written consent was obtained from prospective patients. Sedation (propofol or non-propofol based) was administered by either a certified nurse anesthetist under the supervision of an anesthesiologist (propofol) or a registered endoscopy nurse under the guidance of the endoscopist performing the procedure (non-propofol sedation). Depth of sedation was measured with an EEG based SEDLine monitor. The sedation providers were blinded to the patient state index-the indicator of depth of sedation. PSI (patient state index-SEDLine reading) was documented at colonoscope insertion, removal and at the return of verbal responsiveness after colonoscope withdrawal. Sedation spectrum was retrieved from the data stored on the SEDLine monitor. Patients sedated with propofol experience significantly deeper degrees of sedation at all times during the procedure. Additionally, during significant part of the procedure, they are at PSI levels associated with deep general anesthesia. The group that received propofol was more deeply sedated and had lower PSI values. Lighter propofol titration protocols may lead to improved patient care such as lowering risk of aspiration and hypotension. The role of processed EEG monitors such as the SEDLine monitor to improve sedation protocols remains to be determined. Trial registration We obtained an ethical clearance from the Institute. No trial registration was mandated, as no interventional drug or investigational device were used during the study.

Does Increased Exercise or Physical Activity Alter Ad-Libitum Daily Energy Intake or Macronutrient Composition in Healthy Adults? A Systematic Review

PubMed Central

Donnelly, Joseph E.; Herrmann, Stephen D.; Lambourne, Kate; Szabo, Amanda N.; Honas, Jeffery J.; Washburn, Richard A.

2014-01-01

Background The magnitude of the negative energy balance induced by exercise may be reduced due to compensatory increases in energy intake. Objective To address the question: Does increased exercise or physical activity alter ad-libitum daily energy intake or macronutrient composition in healthy adults? Data Sources PubMed and Embase were searched (January 1990–January 2013) for studies that presented data on energy and/or macronutrient intake by level of exercise, physical activity or change in response to exercise. Ninety-nine articles (103 studies) were included. Study Eligibility Criteria Primary source articles published in English in peer-reviewed journals. Articles that presented data on energy and/or macronutrient intake by level of exercise or physical activity or changes in energy or macronutrient intake in response to acute exercise or exercise training in healthy (non-athlete) adults (mean age 18–64 years). Study Appraisal and Synthesis Methods Articles were grouped by study design: cross-sectional, acute/short term, non-randomized, and randomized trials. Considerable heterogeneity existed within study groups for several important study parameters, therefore a meta-analysis was considered inappropriate. Results were synthesized and presented by study design. Results No effect of physical activity, exercise or exercise training on energy intake was shown in 59% of cross-sectional studies (n = 17), 69% of acute (n = 40), 50% of short-term (n = 10), 92% of non-randomized (n = 12) and 75% of randomized trials (n = 24). Ninety-four percent of acute, 57% of short-term, 100% of non-randomized and 74% of randomized trials found no effect of exercise on macronutrient intake. Forty-six percent of cross-sectional trials found lower fat intake with increased physical activity. Limitations The literature is limited by the lack of adequately powered trials of sufficient duration, which have prescribed and measured exercise energy expenditure, or employed adequate assessment methods for energy and macronutrient intake. Conclusions We found no consistent evidence that increased physical activity or exercise effects energy or macronutrient intake. PMID:24454704

A systematic review and meta-analysis of pneumonia associated with thin liquid vs. thickened liquid intake in patients who aspirate.

PubMed

Kaneoka, Asako; Pisegna, Jessica M; Saito, Hiroki; Lo, Melody; Felling, Katey; Haga, Nobuhiko; LaValley, Michael P; Langmore, Susan E

2017-08-01

To investigate whether drinking thin liquids with safety strategies increases the risk for pneumonia as compared with thickened liquids in patients who have demonstrated aspiration of thin liquids. Seven electronic databases, one clinical register, and three conference archives were searched. No language or publication date restrictions were imposed. Reference lists were scanned and authors and experts in the field were contacted. A blind review was performed by two reviewers for published or unpublished randomized controlled trials and prospective non-randomized trials comparing the incidence of pneumonia with intake of thin liquids plus safety strategies vs. thickened liquids in adult patients who aspirated on thin liquids. The data were extracted from included studies. Odds ratios (OR) for pneumonia were calculated from the extracted data. Risk of bias was also assessed with the included published trials. Seven studies out of 2465 studies including 650 patients met the inclusion criteria. All of the seven studies excluded patients with more than one known risk factor for pneumonia. Six studies compared thin water protocols to thickened liquids for pneumonia prevention. A meta-analysis was done on the six studies, showing no significant difference for pneumonia risk (OR = 0.82; 95% CI = 0.05-13.42; p = 0.89). There was no significant difference in the risk of pneumonia in aspirating patients who took thin liquids with safety strategies compared with those who took thickened liquids only. This result, however, is generalizable only for patients with low risk of pneumonia.

Effects of Teaching Gardening on Science Students' Attitudes toward Entrepreneurial Skills Acquisition in Jos South, Plateau State, Nigeria

ERIC Educational Resources Information Center

Charity, Dimlong; Ozoji, Bernadette Ebele; Osasebor, Florence Osaze; Ibn Umar, Suleiman

2017-01-01

This study investigated the effects of teaching gardening on science students' attitudes toward entrepreneurial skills acquisition in Jos South, Plateau State, Nigeria. The study employed the non-randomized pre-test post-test non-equivalent control group design. A sample of 75 senior secondary school students from two intact classes, randomly…

Effects of a Target-Task Problem-Solving Model on Senior Secondary School Students' Performance in Physics

ERIC Educational Resources Information Center

Olaniyan, A. O.; Omosewo, E. O.

2015-01-01

The study investigated the Effects of a Target-Task Problem-Solving Model on Senior Secondary School Students' Performance in Physics. The research design was a quasi-experimental, non-randomized, non-equivalent pretest, post-test using a control group. The study was conducted in two schools purposively selected and involved a total of 120 Senior…

Reducing Test Anxiety among 12th Grade Students: Iraqi Kurdistan Region/Soran City as an Example

ERIC Educational Resources Information Center

Faqe, Chiayee Khorshid; Moheddin, Kurdistan Rafiq; Kakamad, Karwan Kakabra

2016-01-01

This study aims at reducing test anxiety among twelfth grade students at Soran city high schools. Throughout the study both quantitative and qualitative methods used to collect data. The participants were 450 twelfth grade students in five schools at Soran City-Kurdistan region of Iraq. Non-random purposive sampling because the students needed…

Effectiveness of and Dropout from Outpatient Cognitive Behavioral Therapy for Adult Unipolar Depression: A Meta-Analysis of Nonrandomized Effectiveness Studies

ERIC Educational Resources Information Center

Hans, Eva; Hiller, Wolfgang

2013-01-01

Objective: The primary aim of this study was to assess the overall effectiveness of and dropout from individual and group outpatient cognitive behavioral therapy (CBT) for adults with a primary diagnosis of unipolar depressive disorder in routine clinical practice. Method: We conducted a random effects meta-analysis of 34 nonrandomized…

Choosing an Appropriate Physical Exercise to Reduce Stereotypic Behavior in Children with Autism Spectrum Disorders: A Non-Randomized Crossover Study

ERIC Educational Resources Information Center

Tse, C. Y. Andy; Pang, C. L.; Lee, Paul H.

2018-01-01

Considerable evidence has shown that physical exercise could be an effective treatment in reducing stereotypical autism spectrum disorder (ASD) behaviors in children. The present study seeks to examine the underlying mechanism by considering the theoretical operant nature of stereotypy. Children with ASD (n = 30) who exhibited hand-flapping and…

L2 Reading Strategies Used by Iranian EFL Learners: A Think-Aloud Study

ERIC Educational Resources Information Center

Ghavamnia, Maedeh; Ketabi, Saeed; Tavakoli, Mansoor

2013-01-01

This study investigated the differences in the type and frequency of strategy use by four proficient and four less-proficient readers. Thirty female senior undergraduates majoring in TEFL at a university in Iran were given a reading comprehension test. Based on the results of their reading test, eight were chosen based on a nonrandom purposive…

Non-random cratering flux in recent time

NASA Technical Reports Server (NTRS)

Schultz, P. H.

1988-01-01

Proposed periodic cycles of mass mortality have been linked to periodic changes in the impact flux on Earth. Such changes in the impact flux, however, also should be recorded on the Moon. Previous studies have concluded that the impact flux on the Moon over the last 1 to 2 billion years has been reasonably constant, but sudden changes in the impact flux over time intervals as short as 30 my could not be detected in these studies unless the added crater population greatly exceeded the cumulative cratering record. Consequently this study focuses only on bright-rayed craters larger than 1 km thereby not only limiting the study to recent craters but also largely eliminating contamination by secondary craters. Preservation of ray patterns and other fine-scale surface textures in the ejecta provides first-order culling of craters younger than Tycho, i.e., about 100 my. Although a periodic change in the impact flux in the Earth-Moon system cannot yet be confirmed from the data, a non-random component appears to exist with an increased flux around 7 and 15 my. The concentrations in different quadrants of the lunar hemisphere would be consistent with a shower of debris generally smaller than 0.5 km.

Tackling inequalities in obesity: a protocol for a systematic review of the effectiveness of public health interventions at reducing socioeconomic inequalities in obesity among adults.

PubMed

Bambra, Clare L; Hillier, Frances C; Moore, Helen J; Cairns-Nagi, Joanne-Marie; Summerbell, Carolyn D

2013-05-10

Socioeconomic inequalities in obesity and associated risk factors for obesity are widening throughout developed countries worldwide. Tackling obesity is high on the public health agenda both in the United Kingdom and internationally. However, what works in terms of interventions that are able to reduce inequalities in obesity is lacking. The review will examine public health interventions at the individual, community and societal level that might reduce inequalities in obesity among adults aged 18 years and over, in any setting and in any country. The following electronic databases will be searched: MEDLINE, EMBASE, CINAHL, PsycINFO, Social Science Citation Index, ASSIA, IBSS, Sociological Abstracts, and the NHS Economic Evaluation Database. Database searches will be supplemented with website and gray literature searches. No studies will be excluded based on language, country or publication date. Randomized and non-randomized controlled trials, prospective and retrospective cohort studies (with/without control groups) and prospective repeat cross-sectional studies (with/without control groups) that have a primary outcome that is a proxy for body fatness and have examined differential effects with regard to socioeconomic status (education, income, occupation, social class, deprivation, poverty) or where the intervention has been targeted specifically at disadvantaged groups or deprived areas will be included. Study inclusion, data extraction and quality appraisal will be conducted by two reviewers. Meta-analysis and narrative synthesis will be conducted. The main analysis will examine the effects of 1) individual, 2) community and 3) societal level public health interventions on socioeconomic inequalities in adult obesity. Interventions will be characterized by their level of action and their approach to tackling inequalities. Contextual information on how such public health interventions are organized, implemented and delivered will also be examined. The review will provide evidence, and reveal any gaps in the evidence base, of public health strategies which reduce and prevent inequalities in the prevalence of obesity in adults and provide information on the organization, implementation and delivery of such interventions. PROSPERO registration number: CRD42013003612.

Successful management of benign biliary strictures with fully covered self-expanding metal stents.

PubMed

Devière, Jacques; Nageshwar Reddy, D; Püspök, Andreas; Ponchon, Thierry; Bruno, Marco J; Bourke, Michael J; Neuhaus, Horst; Roy, André; González-Huix Lladó, Ferrán; Barkun, Alan N; Kortan, Paul P; Navarrete, Claudio; Peetermans, Joyce; Blero, Daniel; Lakhtakia, Sundeep; Dolak, Werner; Lepilliez, Vincent; Poley, Jan W; Tringali, Andrea; Costamagna, Guido

2014-08-01

Fully covered self-expanding metal stents (FCSEMS) are gaining acceptance for the treatment of benign biliary strictures. We performed a large prospective multinational study to study the ability to remove these stents after extended indwell and the frequency and durability of stricture resolution. In a nonrandomized study at 13 centers in 11 countries, 187 patients with benign biliary strictures received FCSEMS. Removal was scheduled at 10-12 months for patients with chronic pancreatitis or cholecystectomy and at 4-6 months for patients who received liver transplants. The primary outcome measure was removal success, defined as either scheduled endoscopic removal of the stent with no removal-related serious adverse events or spontaneous stent passage without the need for immediate restenting. Endoscopic removal of FCSEMS was not performed for 10 patients because of death (from unrelated causes), withdrawal of consent, or switch to palliative treatment. For the remaining 177 patients, removal success was accomplished in 74.6% (95% confidence interval [CI], 67.5%-80.8%). Removal success was more frequent in the chronic pancreatitis group (80.5%) than in the liver transplantation (63.4%) or cholecystectomy (61.1%) groups (P = .017). FCSEMS were removed by endoscopy from all patients in whom this procedure was attempted. Stricture resolution without restenting upon FCSEMS removal occurred in 76.3% of patients (95% CI, 69.3%-82.3%). The rate of resolution was lower in patients with FCSEMS migration (odds ratio, 0.22; 95% CI, 0.11-0.46). Over a median follow-up period of 20.3 months (interquartile range, 12.9-24.3 mo), the rate of stricture recurrence was 14.8% (95% CI, 8.2%-20.9%). Stent- or removal-related serious adverse events, most often cholangitis, occurred in 27.3% of patients. There was no stent- or removal-related mortality. In a large prospective multinational study, removal success of FCSEMS after extended indwell and stricture resolution were achieved for approximately 75% of patients. ClincialTrials.gov number, NCT01014390. Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.

Mindfulness and reduced cognitive reactivity to sad mood: evidence from a correlational study and a non-randomized waiting list controlled study.

PubMed

Raes, Filip; Dewulf, David; Van Heeringen, Cees; Williams, J Mark G

2009-07-01

Cognitive Reactivity (CR) refers to the degree to which a mild dysphoric state reactivates negative thinking patterns, and it has been found to play a key causal role in depressive relapse. Although Mindfulness-Based Cognitive Therapy (MBCT) directly aims to address this mechanism of CR, the relationship between mindfulness and CR has not been tested to date. Using a cross-sectional design (Study 1; n = 164) and a non-randomized waiting list controlled design (Study 2; MBCT [n = 18] vs. waiting list [n = 21]), the authors examined the relationship between naturally occurring levels of mindfulness (Study 1) and MBCT (Study 2) on the one hand, and CR on the other hand. In line with predictions, it was found that (a) trait mindfulness is significantly negatively correlated with CR, even when controlled for current depressive symptoms and prior history of depression (Study 1), and that (b) MBCT, compared to a matched control group, significantly reduces CR, and that this effect of MBCT on reduction of CR is mediated by a positive change in mindfulness skills (Study 2). Results provide first evidence for the claim that mindfulness practices in MBCT are designed to address the process of CR.

Transport of oxygen ions in Er doped La2Mo2O9 oxide ion conductors: Correlation with microscopic length scales

NASA Astrophysics Data System (ADS)

Paul, T.; Ghosh, A.

2018-01-01

We report oxygen ion transport in La2-xErxMo2O9 (0.05 ≤ x ≤ 0.25) oxide ion conductors. We have measured conductivity and dielectric spectra at different temperatures in a wide frequency range. The mean square displacement and spatial extent of non-random sub-diffusive regions are estimated from the conductivity spectra and dielectric spectra, respectively, using linear response theory. The composition dependence of the conductivity is observed to be similar to that of the spatial extent of non-random sub-diffusive regions. The behavior of the composition dependence of the mean square displacement of oxygen ions is opposite to that of the conductivity. The attempt frequency estimated from the analysis of the electric modulus agrees well with that obtained from the Raman spectra analysis. The full Rietveld refinement of X-ray diffraction data of the samples is performed to estimate the distance between different oxygen lattice sites. The results obtained from such analysis confirm the ion hopping within the spatial extent of non-random sub-diffusive regions.

College Students and AIDS: AIDS Communication and Involvement Effects on Sexual Behavior.

ERIC Educational Resources Information Center

Jacobs, Randy; McCain, Thomas

The purpose of this study was to describe college students' AIDS communication and explore the relationships between AIDS communication, involvement, and sexual behavior. A non-random sample of 334 college students was surveyed. AIDS message discrimination and multiple indicators of involvement were tested for associations with sexual behavior…

Divergence of Scientific Heuristic Method and Direct Algebraic Instruction

ERIC Educational Resources Information Center

Calucag, Lina S.

2016-01-01

This is an experimental study, made used of the non-randomized experimental and control groups, pretest-posttest designs. The experimental and control groups were two separate intact classes in Algebra. For a period of twelve sessions, the experimental group was subjected to the scientific heuristic method, but the control group instead was given…

Primary School Teachers' Understanding of Environmental Issues: An Interview Study.

ERIC Educational Resources Information Center

Summers, Mike; Kruger, Colin; Childs, Ann; Mant, Jenny

2000-01-01

Uses in-depth interviews to explore the understanding of a non-random sample of 12 practicing primary school teachers in four areas: (1) biodiversity; (2) the carbon cycle; (3) ozone; and (4) global warming. Identifies those underpinning science concepts that were well understood, and those which were not so well understood. (Author/SAH)

The Relationship between Critical Thinking Abilities and Classroom Management Skills of High School Teachers

ERIC Educational Resources Information Center

Demirdag, Seyithan

2015-01-01

High school teachers experience difficulties while providing effective teaching approaches in their classrooms. Some of the difficulties are associated with the lack of classroom management skills and critical thinking abilities. This quantitative study includes non-random selection of the participants and aims to examine critical thinking…

Assessing Student Achievement in Large-Scale Educational Programs Using Hierarchical Propensity Scores

ERIC Educational Resources Information Center

Vaughan, Angela L.; Lalonde, Trent L.; Jenkins-Guarnieri, Michael A.

2014-01-01

Many researchers assessing the efficacy of educational programs face challenges due to issues with non-randomization and the likelihood of dependence between nested subjects. The purpose of the study was to demonstrate a rigorous research methodology using a hierarchical propensity score matching method that can be utilized in contexts where…

NON-RANDOM CELL KILLING IN CRYOPRESERVATION: IMPLICATIONS FOR PERFORMANCE OF THE BATTERY OF LEUKOCYTE TESTS (BLT) - I. TOXIC AND IMMUNOTOXIC EFFECTS

EPA Science Inventory

To eliminate between-tests error in longitudinal studies, for specimen sharing, convenient scheduling, etc., it is necessary to freeze freshly separated leukocytes as well as non-transformed, continuous T lymphocyte (CTL) lines. o test the efficacy of a programmable reezer (tempe...

Translating the use of an enriched environment poststroke from bench to bedside: study design and protocol used to test the feasibility of environmental enrichment on stroke patients in rehabilitation.

PubMed

Janssen, H; Ada, L; Karayanidis, F; Drysdale, K; McElduff, P; Pollack, M; White, J; Nilsson, M; Bernhardt, J; Spratt, N J

2012-08-01

Environmental enrichment, a paradigm investigated extensively in animal models, is an intervention, which by design facilitates motor, sensory, social, and cognitive activity. It has been shown to improve poststroke motor and cognitive function in animal models of stroke. This is the first study to attempt to translate this intervention from the laboratory to the clinical setting. The overall aim of this pilot study is to test the feasibility of using environmental enrichment with stroke patients in a rehabilitation setting. The aim is to enrich the environment of stroke survivors in a rehabilitation ward and measure changes in their activity (physical, cognitive, and social activity). Prospective nonrandomized block design intervention study. In the control phase we will determine the change in activity levels of patients treated in a usual rehabilitation environment over time. In the intervention phase structured observational techniques (behavioural mapping) will be used to quantify the change in activity levels of patients exposed to environmental enrichment. The primary outcome is change in activity level. Additional data collected on entry to and exit from the study will include: cognitive function using a battery of cognitive tests, general function using the Functional Independence Measure, mood using the Patient Health Questionnaire 9 and boredom using the Stroke Rehabilitation Boredom Survey. Quality of life will be assessed using the Assessment of Quality of Life 1 month postdischarge from rehabilitation. Australian New Zealand Clinical Trials Registry# ACTRN12611000629932. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

Safety and feasibility of chronic transvenous phrenic nerve stimulation for treatment of central sleep apnea in heart failure patients.

PubMed

Zhang, Xilong; Ding, Ning; Ni, Buqing; Yang, Bing; Wang, Hong; Zhang, Shi-Jiang

2017-03-01

Central sleep apnea (CSA) is common in patients with heart failure (HF) and is associated with poor quality of life and prognosis. Early acute studies using transvenous phrenic nerve stimulation (PNS) to treat CSA in HF have shown a significantly reduction of CSA and improvement of key polysomnographic parameters. In this study, we evaluated the safety of and efficiency chronic transvenous PNS with an implanted neurostimulator in HF patients with CSA. This study was a prospective, nonrandomized evaluation of unilateral transvenous PNS in eight HF patients with CSA. The stimulation lead, which connected to a proprietary neurostimulator, was positioned in either the left pericardiophrenic or right brachiocephalic vein. Monitoring during implantation and 6-monthly follow-ups were performed. Six of the implanted eight patients completed the study (one was lost to follow-up; one died from pneumonia). Neither side effects nor adverse events related to stimulation occurred. During the 6-monthly follow-ups, one patient had a lead dislodgement in the first month and the lead was subsequently repositioned. No additional lead dislodgements occurred. There were no significant changes in sleep habits, appetite, bleeding or infections. Compared with the parameters before stimulator implantation, there were significant improvement in apnea-hypopnea index, central apnea index, left ventricular ejection fraction and 6-min walk distance (all P < 0.01). Use of chronic transvenous PNS appears to be safe and feasible in HF patients with CSA. Large multicenter studies are needed to confirm safety and efficacy in this population. © 2015 John Wiley & Sons Ltd.

Boosting restraint norms: a community-delivered campaign to promote booster seat use.

PubMed

Bryant-Stephens, Tyra; Garcia-Espana, J Felipe; Winston, Flaura K

2013-01-01

The objective of this study was to evaluate the effectiveness of a theoretically grounded community-delivered marketing campaign to promote belt-positioning booster seat (BPB) use among vulnerable populations when disseminated by community members. A prospective, nonrandomized community intervention trial was conducted to evaluate the "Boosting Restraint Norms" social marketing campaign delivered by community partners in Norristown, Pennsylvania (intervention community), between October 2008 and November 2008. York, Pennsylvania, served as the comparison community. In total, 800 vehicles with 822 children aged 4 to 7 years were observed for BPB use, the primary outcome of interest, at baseline (September 2008) and at 6 months after intervention (April 2009). During the study period, a 28 percent increase in the prevalence of BPB use at 6 months was observed in the intervention community with no change in the prevalence of BPB use in the comparison community. After adjustment for child age and gender, vehicle type, driver gender, and driver level, BPB use increased from 39 to 50 percent in the intervention community. The "Boosting Restraint Norms" social marketing campaign, distributed through community organizations combined with caregiver education and a one-time free distribution of BPBs, was effective in increasing BPB use. This study demonstrates the feasibility of utilizing community organizations with established audiences to spread the "No Regrets" messaging of the campaign in the community. This study also indicates that spreading evidence-based messages in this manner may effectively change behavior in populations that are often hard to reach. Future studies are needed in which this methodology is tested in additional communities and rural settings.

The Impact of WIC on Birth Outcomes: New Evidence from South Carolina.

PubMed

Sonchak, Lyudmyla

2016-07-01

Objectives To investigate the impact of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) on a variety of infant health outcomes using recent South Carolina Vital Statistics data (2004-2012). Methods To account for non-random WIC participation, the study relies on a maternal fixed effects estimation, due to the availability of unique maternally linked data. Results The results indicate that WIC participation is associated with an increase in birth weight and length of gestation, decrease in the probability of low birth weight, prematurity, and Neonatal Intensive Care Unit admission. Additionally, addressing gestational bias and accounting for the length of gestation, WIC participation is associated with a decrease in the probability of delivering a low weight infant and a small for gestational age infant among black mothers. Conclusions for Practice Accounting for non-random program participation, the study documents a large improvement in birth outcomes among infants of WIC participating mothers. Even in the context of somewhat restrictive gestation-adjusted specification, the positive impact of WIC remains within the subsample of black mothers.

Behavior of nucleolus in the tobacco male meiocytes involved in cytomixis.

PubMed

Mursalimov, Sergey; Sidorchuk, Yuriy; Deineko, Elena

2017-03-01

Behavior of nucleolus during the nuclear migration between plant cells (cytomixis) is studied for the first time in the tobacco male meiosis. As is shown, the nucleolus is located in a nonrandom manner in the migrating nuclei. In the majority of cases, the nucleolus resides on the nuclear pole strictly opposite to the cytomictic channel. Owing to this localization, the nucleolus extremely rare enters the recipient cell, so that the nucleolar material is in most cases undetectable in the micronuclei formed after cytomixis. When a whole nucleus migrates from a donor cell to recipient, the nucleolus can leave the nucleus and remain in the donor cells either alone or with a small amount of chromatin. The causes underlying a nonrandom location of the nucleolus in cytomictic cells are discussed. It is assumed that the nucleolar material contacts the cytoplasmic cytoskeleton, which prevents migration of the nucleolus into another cell within the nucleus. The potential use of cytomixis as a model for studying the nuclear motion is discussed. © 2017 International Federation for Cell Biology.

Offender and offense characteristics of a nonrandom sample of mass murderers.

PubMed

Hempel, A G; Meloy, J R; Richards, T C

1999-01-01

A nonrandom sample (N = 30) of mass murderers in the United States and Canada during the past 50 years was studied. Data suggest that such individuals are single or divorced males in their fourth decade of life with various Axis I paranoid and/or depressive conditions and Axis II personality traits and disorders, usually Clusters A and B. The mass murder is precipitated by a major loss related to employment or relationship. A warrior mentality suffuses the planning and attack behavior of the subject, and greater deaths and higher casualty rates are significantly more likely if the perpetrator is psychotic at the time of the offense. Alcohol plays a very minor role. A large proportion of subjects will convey their central motivation in a psychological abstract, a phrase or sentence yelled with great emotion at the beginning of the mass murder; but in our study sample, only 20 percent directly threatened their victims before the offense. Death by suicide or at the hands of others is the usual outcome for the mass murderer.

A comparison of the test-negative and the traditional case-control study designs for estimation of influenza vaccine effectiveness under nonrandom vaccination.

PubMed

Shi, Meng; An, Qian; Ainslie, Kylie E C; Haber, Michael; Orenstein, Walter A

2017-12-08

As annual influenza vaccination is recommended for all U.S. persons aged 6 months or older, it is unethical to conduct randomized clinical trials to estimate influenza vaccine effectiveness (VE). Observational studies are being increasingly used to estimate VE. We developed a probability model for comparing the bias and the precision of VE estimates from two case-control designs: the traditional case-control (TCC) design and the test-negative (TN) design. In both study designs, acute respiratory illness (ARI) patients seeking medical care testing positive for influenza infection are considered cases. In the TN design, ARI patients seeking medical care who test negative serve as controls, while in the TCC design, controls are randomly selected individuals from the community who did not contract an ARI. Our model assigns each study participant a covariate corresponding to the person's health status. The probabilities of vaccination and of contracting influenza and non-influenza ARI depend on health status. Hence, our model allows non-random vaccination and confounding. In addition, the probability of seeking care for ARI may depend on vaccination and health status. We consider two outcomes of interest: symptomatic influenza (SI) and medically-attended influenza (MAI). If vaccination does not affect the probability of non-influenza ARI, then VE estimates from TN studies usually have smaller bias than estimates from TCC studies. We also found that if vaccinated influenza ARI patients are less likely to seek medical care than unvaccinated patients because the vaccine reduces symptoms' severity, then estimates of VE from both types of studies may be severely biased when the outcome of interest is SI. The bias is not present when the outcome of interest is MAI. The TN design produces valid estimates of VE if (a) vaccination does not affect the probabilities of non-influenza ARI and of seeking care against influenza ARI, and (b) the confounding effects resulting from non-random vaccination are similar for influenza and non-influenza ARI. Since the bias of VE estimates depends on the outcome against which the vaccine is supposed to protect, it is important to specify the outcome of interest when evaluating the bias.

Systematic Review of Interventions to Improve the Provision of Information for Adults with Primary Brain Tumors and Their Caregivers

PubMed Central

Langbecker, Danette; Janda, Monika

2014-01-01

Background: Adults with primary brain tumors and their caregivers have significant information needs. This review assessed the effect of interventions to improve information provision for adult primary brain tumor patients and/or their caregivers. Methods: We included randomized or non-randomized trials testing educational interventions that had outcomes of information provision, knowledge, understanding, recall, or satisfaction with the intervention, for adults diagnosed with primary brain tumors and/or their family or caregivers. PubMed, MEDLINE, EMBASE, and Cochrane Reviews databases were searched for studies published between 1980 and June 2014. Results: Two randomized controlled, 1 non-randomized controlled, and 10 single group pre–post trials enrolled more than 411 participants. Five group, four practice/process change, and four individual interventions assessed satisfaction (12 studies), knowledge (4 studies), and information provision (2 studies). Nine studies reported high rates of satisfaction. Three studies showed statistically significant improvements over time in knowledge and two showed greater information was provided to intervention than control group participants, although statistical testing was not performed. Discussion: The trials assessed intermediate outcomes such as satisfaction, and only 4/13 reported on knowledge improvements. Few trials had a randomized controlled design and risk of bias was either evident or could not be assessed in most domains. PMID:25667919

Evaluating Effect of Students' Academic Achievement on Identified Difficult Concepts in Senior Secondary School Biology in Delta State

ERIC Educational Resources Information Center

Agboghoroma, Tim E.; Oyovwi, E. O.

2015-01-01

This study evaluated the effect of students' academic achievement on identified difficult concepts or topics in Senior Secondary School Biology in Delta State, Nigeria. The study was quasi-experimental and the design was a 2X2 factorial non-randomized pretest-posttest control group design. The sample was drawn from intact classes from four…

Arthroscopic management of suprascapular neuropathy of the shoulder improves pain and functional outcomes with minimal complication rates.

PubMed

Memon, M; Kay, J; Ginsberg, L; Simunovic, N; Bak, K; Lapner, P; Ayeni, O R

2018-01-01

The purpose of this study was to systematically assess the arthroscopic management of suprascapular neuropathy, including the aetiology, surgical decision-making, clinical outcomes, and complications associated with the procedure. Three databases [PubMed, Ovid (Medline), and Embase] were searched. Systematic literature screening and data abstraction was performed in duplicate to present a review of studies reporting on arthroscopic management of suprascapular neuropathy. The quality of the included studies was assessed using level of evidence and the MINORS (Methodological Index for Nonrandomized Studies) checklist. In total, 40 studies (17 case reports, 20 case series, 2 retrospective comparative studies, and 1 prospective comparative study) were identified, including 259 patients (261 shoulders) treated arthroscopically for suprascapular neuropathy. The most common aetiology of suprascapular neuropathy was suprascapular nerve compression by a cyst at the spinoglenoid notch (42%), and the decision to pursue arthroscopic surgery was most commonly based on the results of clinical findings and investigations (47%). Overall, 97% of patients reported significant improvement in or complete resolution of their pre-operative symptoms (including pain, strength, and subjective function of the shoulder) over a mean follow-up period of 23.7 months. Further, there was a low overall complication rate (4%) associated with the arthroscopic procedures. While most studies evaluating arthroscopic management of suprascapular neuropathy are uncontrolled studies with lower levels of evidence, results indicate that such management provides patients with significant improvements in pain, strength, and subjective function of the shoulder, and has a low incidence of complications. Patients managed arthroscopically for suprascapular neuropathy may expect significant improvements in pain, strength, and subjective function of the shoulder. Level IV, systematic review of level II to IV studies.

Thymectomy in Myasthenia Gravis

PubMed Central

Aydin, Yener; Ulas, Ali Bilal; Mutlu, Vahit; Colak, Abdurrahim; Eroglu, Atilla

2017-01-01

In recent years, thymectomy has become a widespread procedure in the treatment of myasthenia gravis (MG). Likelihood of remission was highest in preoperative mild disease classification (Osserman classification 1, 2A). In absence of thymoma or hyperplasia, there was no relationship between age and gender in remission with thymectomy. In MG treatment, randomized trials that compare conservative treatment with thymectomy have started, recently. As with non-randomized trials, remission with thymectomy in MG treatment was better than conservative treatment with only medication. There are four major methods for the surgical approach: transcervical, minimally invasive, transsternal, and combined transcervical transsternal thymectomy. Transsternal approach with thymectomy is the accepted standard surgical approach for many years. In recent years, the incidence of thymectomy has been increasing with minimally invasive techniques using thoracoscopic and robotic methods. There are not any randomized, controlled studies which are comparing surgical techniques. However, when comparing non-randomized trials, it is seen that minimally invasive thymectomy approaches give similar results to more aggressive approaches. PMID:28416933

Infracommunity dynamics of chiggers (Trombiculidae) parasitic on a rodent.

PubMed

Barnard, Karlien; Krasnov, Boris R; Goff, Lee; Matthee, Sonja

2015-11-01

We studied the structure of chigger mite (Trombiculidae) communities parasitic on a South African rodent, Rhabdomys pumilio. We aimed to determine whether: (a) different chigger species differ in preferences for certain body areas of a host and (b) chigger assemblages among body areas of the same host individual, are structured and if so, whether the structure of these assemblages is aggregative or segregative. Rhabdomys pumilio is parasitized by seven chigger species belonging to six genera. The three most abundant species (Leptotrombidium sp. nr. muridium, Schoutedenichia sp. and Neoschoengastia sp. A) displayed a non-random distribution across the host body, with the two most abundant species (L. sp. nr. muridium and Schoutedenichia sp.) significantly associated with the tail area. In addition, whenever non-randomness of chigger co-occurrence in the same body area was recorded, it indicated positive but not negative co-occurrences of different species. This might be due to similarity of chigger species in resource needs and strategies to avoid host defence efforts.

Non-random Mis-segregation of Human Chromosomes.

PubMed

Worrall, Joseph Thomas; Tamura, Naoka; Mazzagatti, Alice; Shaikh, Nadeem; van Lingen, Tineke; Bakker, Bjorn; Spierings, Diana Carolina Johanna; Vladimirou, Elina; Foijer, Floris; McClelland, Sarah Elizabeth

2018-06-12

A common assumption is that human chromosomes carry equal chances of mis-segregation during compromised cell division. Human chromosomes vary in multiple parameters that might generate bias, but technological limitations have precluded a comprehensive analysis of chromosome-specific aneuploidy. Here, by imaging specific centromeres coupled with high-throughput single-cell analysis as well as single-cell sequencing, we show that aneuploidy occurs non-randomly following common treatments to elevate chromosome mis-segregation. Temporary spindle disruption leads to elevated mis-segregation and aneuploidy of a subset of chromosomes, particularly affecting chromosomes 1 and 2. Unexpectedly, we find that a period of mitotic delay weakens centromeric cohesion and promotes chromosome mis-segregation and that chromosomes 1 and 2 are particularly prone to suffer cohesion fatigue. Our findings demonstrate that inherent properties of individual chromosomes can bias chromosome mis-segregation and aneuploidy rates, with implications for studies on aneuploidy in human disease. Copyright © 2018 The Author(s). Published by Elsevier Inc. All rights reserved.

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

PubMed

Baumhauer, Judith F; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; De Vries, Gwyneth; Le, Ian L D; Nielsen, Dominic; Pedersen, M Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair S E; Daniels, Timothy

2016-05-01

Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were nonrandomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. VAS pain scores decreased significantly in both the implant and arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6.2 degrees (27.3%) after implant placement and was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2%) implant patients (17 procedures) and 6 (12.0%) arthrodesis patients (7 procedures). Fourteen (9.2%) implants were removed and converted to arthrodesis, and 6 (12.0%) arthrodesis patients (7 procedures [14%]) had isolated screws or plate and screw removal. There were no cases of implant fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical equivalence between the implant and arthrodesis groups. A prospective, randomized (2:1), controlled, noninferiority clinical trial was performed to compare the safety and efficacy of a small synthetic cartilage bone implant to first MTP arthrodesis in patients with advanced-stage hallux rigidus. This study showed equivalent pain relief and functional outcomes. The synthetic implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP motion. The percentage of secondary surgical procedures was similar between groups. Less than 10% of the implant group required revision to arthrodesis at 2 years. Level I, prospective randomized study. © The Author(s) 2016.

Effects of diquafosol sodium eye drops on tear film stability in short BUT type of dry eye.

PubMed

Shimazaki-Den, Seika; Iseda, Hiroyuki; Dogru, Murat; Shimazaki, Jun

2013-08-01

To investigate the effects of diquafosol sodium (DQS) eye drops, a purinergic P2Y2 receptor agonist, on tear film stability in patients with unstable tear film (UTF). Two prospective studies were conducted. One was an exploratory nonrandomized trial on 39 eyes with dry eye symptoms and short tear film break-up time (BUT), but without epithelial damage. Changes in symptoms, BUT, Schirmer value, and ocular surface fluorescein staining (FS) scores were studied for 3 months. The other was a randomized clinical trial of DQS and artificial tears (AT) in 17 eyes with short BUT. Eyes with decreased Schirmer values (≤ 5 mm) were excluded. Changes in symptoms, BUT, FS scores, and tear film stability using continuous corneal topographic analysis were studied for 4 weeks. In the exploratory study, while Schirmer values were not significantly increased, significant improvements in symptoms and BUT were noted at both 1 and 3 months. In the randomized clinical trial, significant improvements in symptoms were noted in the DQS group, but not in the AT group, at 2 weeks. BUT was significantly prolonged in the DQS group at 4 weeks but not in the AT group. No significant changes were noted in FS scores or tear film stability. DQS improved subjective symptoms and prolonged BUT in eyes with UTF not associated with low tear secretion and ocular surface epithelial damage. Because many patients who have UTF are refractory to conventional treatments, DQS may offer benefits in the treatment of dry eyes.

Effects of electroconvulsive therapy on amygdala function in major depression - a longitudinal functional magnetic resonance imaging study.

PubMed

Redlich, R; Bürger, C; Dohm, K; Grotegerd, D; Opel, N; Zaremba, D; Meinert, S; Förster, K; Repple, J; Schnelle, R; Wagenknecht, C; Zavorotnyy, M; Heindel, W; Kugel, H; Gerbaulet, M; Alferink, J; Arolt, V; Zwanzger, P; Dannlowski, U

2017-09-01

Electroconvulsive therapy (ECT) is one of the most effective treatments for severe depression. However, little is known regarding brain functional processes mediating ECT effects. In a non-randomized prospective study, functional magnetic resonance imaging data during the automatic processing of subliminally presented emotional faces were obtained twice, about 6 weeks apart, in patients with major depressive disorder (MDD) before and after treatment with ECT (ECT, n = 24). Additionally, a control sample of MDD patients treated solely with pharmacotherapy (MED, n = 23) and a healthy control sample (HC, n = 22) were obtained. Before therapy, both patient groups equally showed elevated amygdala reactivity to sad faces compared with HC. After treatment, a decrease in amygdala activity to negative stimuli was discerned in both patient samples indicating a normalization of amygdala function, suggesting mechanisms potentially unspecific for ECT. Moreover, a decrease in amygdala activity to sad faces was associated with symptomatic improvements in the ECT sample (r spearman = -0.48, p = 0.044), and by tendency also for the MED sample (r spearman = -0.38, p = 0.098). However, we did not find any significant association between pre-treatment amygdala function to emotional stimuli and individual symptom improvement, neither for the ECT sample, nor for the MED sample. In sum, the present study provides first results regarding functional changes in emotion processing due to ECT treatment using a longitudinal design, thus validating and extending our knowledge gained from previous treatment studies. A limitation was that ECT patients received concurrent medication treatment.

Prehospital cardiac arrest survival and neurologic recovery.

PubMed

Hillis, M; Sinclair, D; Butler, G; Cain, E

1993-01-01

Many studies of prehospital defibrillation have been conducted but the effects of airway intervention are unknown and neurologic follow-up has been incomplete. A non-randomized cohort prospective study was conducted to determine the effectiveness of defibrillation in prehospital cardiac arrest. Two ambulance companies in the study area developed a defibrillation protocol and they formed the experimental group. A subgroup of these patients received airway management with an esophageal obturator airway (EOA) or endotracheal intubation (ETT). The control group was composed of patients who suffered a prehospital cardiac arrest and did not receive prehospital defibrillation. All survivors were assessed for residual deficits using the Sickness Impact Profile (SIP) and the Dementia Rating Scale (DRS). A total of 221 patients were studied over a 32-month period. Both the experimental group (N = 161) and the control group (N = 60) were comparable with respect to age, sex distribution, and ambulance response time. Survival to hospital discharge was 2/60 (3.3%) in the control group and 12/161 (6.3%) in the experimental group. This difference is not statistically significant. Survival in the experimental group by airway management technique was basic airway support (3/76 3.9%), EOA (3/67 4.5%), and ETT (6/48 12.5%). The improved effect on survival by ETT management was statistically significant. Survivors had minor differences in memory, work, and recreation as compared to ischemic heart disease patients as measured by the SIP and DRS. No effect of defibrillation was found on survival to hospital discharge. However, endotracheal intubation improved survival in defibrillated patients. Survivors had a good functional outcome.

Does balneotherapy with low radon concentration in water influence the endocrine system? A controlled non-randomized pilot study.

PubMed

Nagy, Katalin; Berhés, István; Kovács, Tibor; Kávási, Norbert; Somlai, János; Bender, Tamás

2009-08-01

Radon bath is a well-established modality of balneotherapy for the management of degenerative musculoskeletal disorders. The present study was conducted to ascertain whether baths of relatively low (80 Bq/l) radon concentration have any influence on the functioning of the endocrine system. In the study, a non-randomized pilot study, 27 patients with degenerative musculoskeletal disorders received 30-min radon baths (of 31-32 degrees C temperature and 80 Bq/l average radon concentration) daily, for 15 days. Twenty-five patients with matching pathologies were subjected to balneotherapy according to the same protocol, using thermal water with negligible radon content (6 Bq/l). Serum thyroid stimulating hormone, prolactin, cortisol, adrenocorticotropic hormone, and dehydroepiandrosterone levels were measured before and after a balneotherapy course of 15 sessions. Comparison of the accumulated data using the Wilcoxon test did not reveal any significant difference between pre- and post-treatment values or between the two patient groups. It is noted that while the beneficial effects of balneotherapy with radon-containing water on degenerative disorders is widely known, only few data have been published in the literature on its effect on endocrine functions. The present study failed to demonstrate any substantial effect of thermal water with relatively low radon content on the functioning of the endocrine system.

Inbreeding avoidance in an isolated indigenous Zapotec community in the valley of Oaxaca, southern Mexico.

PubMed

Little, Bertis B; Malina, Robert M

2005-06-01

We analyzed inbreeding using surname isonymy in an indigenous genetic isolate. The subjects were residents of a rural Zapotec-speaking community in the valley of Oaxaca, southern Mexico. The community can be classified as a genetic isolate with an average gene flow of < or = 3% per generation. Surnames were collected for individuals in each household in pedigree form using the culturally traditional patronym-matronym naming. Estimation of inbreeding from surname isonymy is facilitated by the traditional patronym-matronym name assignment among indigenous Mexican populations. A total of 2,149 individuals had valid surname patronym-matronym pairings, including 484 deceased ancestors. Surname isonymy analysis methods were used to estimate total inbreeding and to segregate it into random and nonrandom components. The surname isonymy coefficient computed from 119 isonymous surname pairings (119/2,149) was 0.0554. The estimated inbreeding coefficient from surname isonymy was 0.0138 (0.0554/4). The random and nonrandom components of inbreeding were F(r) = 0.0221 and F(n) = -0.0091, respectively. The results suggest that consanguinity is culturally avoided. Nonrandom inbreeding decreased total inbreeding by about 41%. Total estimated inbreeding by surname isonymy was 0.0138, which is similar to inbreeding estimated from a sample of pedigrees, 0.01. Socially prescribed inbreeding avoidance substantially lowered total F through negative nonrandom inbreeding. Even in the situation of genetic isolation and small effective population size (N(e)), estimated inbreeding is lower than may have otherwise occurred if inbreeding were only random. However, among the poorest individuals, socially prescribed jural rules for inbreeding avoidance failed to operate. Thus the preponderance of inbreeding appears to occur among the poor, economically disadvantaged in the community.

Giving blood and enrolling on the stem cell donor registry: ranking of obstacles and motives in Switzerland.

PubMed

Bart, Thomas; Volken, Thomas; Fischer, Yvonne; Taleghani, Behrouz Mansouri

2014-07-01

To obtain a better understanding of factors affecting blood and blood stem cell donation behavior in Switzerland, a series of studies has been performed. In the recent study of this series, which is described here, motivators and barriers in the field of blood and blood stem cell donation were identified. Web-based survey data from a non-random sample of the Swiss population 2012/2013 (n = 3,153) were used to describe and compare the ranking of motives and obstacles to donate blood and to enroll on the Swiss blood stem cell registry. Wilcoxon rank-sum test and Spearman's rank correlations were used to assess differences and associations between ranks and groups. The prospect of saving lives and solidarity were the top two motives to donate blood or to enroll on the blood stem cell registry. The top two obstacles to enroll on the blood stem cell registry were lack of general information on blood stem cell donation and on its risks, whereas the top two obstacles to donate blood were the lack of information where and when to donate and deferral of or exclusion from blood donation. Classical altruistic motives are top drivers for giving blood as well as registering for blood stem cell donation. Recruitment campaigns should focus on these motivators. Similarities in motivational factors as well as in obstacles regarding blood and blood stem cell donation can be found.

Effect of glatiramer acetate on disease reactivation in MS patients discontinuing natalizumab.

PubMed

Rossi, S; Motta, C; Studer, V; De Chiara, V; Barbieri, F; Monteleone, F; Fornasiero, A; Coarelli, G; Bernardi, G; Cutter, G; Stüve, O; Salvetti, M; Centonze, D

2013-01-01

Multiple sclerosis (MS) patients discontinuing natalizumab are at risk of rebound of disease activity. In the present multi-center, open-label, non-randomized, prospective, pilot study, we tested whether treatment with glatiramer acetate (GA) is safe and effective after natalizumab in MS patients. The study was performed at academic tertiary medical centers. Forty active relapsing-remitting MS patients who never failed GA therapy and who discontinued natalizumab after 12-18 months of therapy were enrolled. GA was initiated 4 weeks after the last dose of natalizumab. 62.5% of patients were relapse-free 12 months after GA initiation. Annualized relapse rate and time to relapse were significantly lower than before natalizumab. Notably, the frequency of relapses was significantly lower amongst those patients who had experienced ≤2 relapses the year before initiation of natalizumab therapy, compared with patients who had had three or more relapses. No evidence of rebound was observed in magnetic resonance imaging scans. Furthermore, Expanded Disability Status Scale and Multiple Sclerosis Functional Composite were stable in our patients, again suggesting that 12 months of post-natalizumab-GA therapy is not associated with clinical deterioration. Following discontinuation of natalizumab, 12 months of therapy with GA is safe and well tolerated in MS patients. GA can reduce the risk of early reactivation/rebound of disease activity in this setting. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

Sternotomy or bilateral thoracoscopy: pain and postoperative complications after lung-volume reduction surgery

PubMed Central

Boley, Theresa M.; Reid, Adam J.; Manning, Blaine T.; Markwell, Stephen J.; Vassileva, Christina M.; Hazelrigg, Stephen R.

2012-01-01

OBJECTIVES Video-assisted thoracoscopic surgery (VATS) and median sternotomy (MS) are two approaches in lung-volume reduction surgery (LVRS). This study focused on the two surgical approaches with regard to postoperative pain. METHODS In this prospective, non-randomized study, pain was measured preoperatively and postoperatively using the visual analog scale (VAS) and the brief pain inventory (BPI). Incentive spirometry (IS) assessed restriction of the thoracic cage due to pain. Factors associated with treatment complications, medication usage, hospital stay, operating times, and chest-tube duration differences were examined between groups. RESULTS Of 85 patients undergoing LVRS, 23 patients underwent reduction via MS and 62 patients via bilateral VATS. VAS scores revealed no difference in postoperative pain except for VAS scores on days 6 (PM) and 7 (PM). BPI scores yielded higher scores in the VATS group on postoperative day (POD) 1 in the reactive dimension, but no other overall differences. MS patients receiving tramadol consumed a higher mean amount than VATS patients on POD 5 and POD 6. IS change from baseline to postoperative were similar between groups, and increased pain correlated with decreased IS scores on POD 1. Chest-tube duration, complications, and pain medication were similar between groups. CONCLUSIONS Bilateral VATS and MS offer similar outcomes with regard to postoperative pain and complications. These results suggest that the choice of LVRS operative approach should be dependent on disease presentation, surgeon expertise, and patient preference, not based upon differences in perceived postoperative pain between MS and bilateral VATS. PMID:21601469

Median nerve fascicle transfer versus ulnar nerve fascicle transfer to the biceps motor branch in C5-C6 and C5-C7 brachial plexus injuries: nonrandomized prospective study of 23 consecutive patients.

PubMed

Cho, Alvaro Baik; Paulos, Renata Gregorio; de Resende, Marcelo Rosa; Kiyohara, Leandro Yoshinobu; Sorrenti, Luiz; Wei, Teng Hsiang; Bolliger Neto, Raul; Mattar Júnior, Rames

2014-10-01

The purpose of this study was to observe whether the results of the median nerve fascicle transfer to the biceps are equivalent to the classical ulnar nerve fascicle transfer, in terms of elbow flexion strength and donor nerve morbidity. Twenty-five consecutive patients were operated between March 2007 and July 2013. The patients were divided into two groups. In Group 1 (n = 8), the patients received an ulnar nerve fascicle transfer to the biceps motor branch. In Group 2 (n = 15), the patients received a median nerve fascicle transfer to the biceps motor branch. Two patients with follow-up less than six months were excluded. Both groups were similar regarding age (P = 0.070), interval of injury (P = 0.185), and follow-up period (P = 0.477). Elbow flexion against gravity was achieved in 7 of 8 (87.5%) patients in Group 1, versus 14 of 15 (93.3%) patients in Group 2 (P = 1.000). The level of injury (C5-C6 or C5-C7) did not affect anti-gravity elbow flexion recovery in both the groups (P = 1.000). It was concluded that the median nerve fascicle transfer to the biceps is as good as the ulnar nerve fascicle transfer, even in C5-C7 injuries. © 2014 Wiley Periodicals, Inc.

Ultrastructural effects of silicone oil on the clear crystalline lens of the human eye.

PubMed

Soliman, Wael; Sharaf, Mohamed; Abdelazeem, Khaled; El-Gamal, Dalia; Nafady, Allam

2018-03-01

To evaluate light and electron microscopic changes of the anterior capsule and its epithelium after clear lens extraction of vitrectomized myopic eyes with silicone oil tamponade. This prospective, controlled, non-randomized, interventional study included 20 anterior lens capsular specimens that were excised during combined clear lens extraction and silicone oil removal from previously vitrectomized highly myopic patients with silicone oil tamponade for previous retinal detachment surgeries. The specimens were examined via light microscopy and electron microscopy and compared with 20 anterior capsule specimens removed during clear lens extraction of non-vitrectomized highly myopic eyes. Light microscopic examination of clear lens anterior capsule specimens of vitrectomized myopic eyes filled with silicone oil showed relatively more flat cells with irregular outline of lens' epithelial cells with wide intercellular spaces, deeply stained nuclei, and multiple intracytoplasmic vacuoles. Scanning electron microscopy revealed collagenous surfaces filled with multiple pits, depressions, and abnormal deposits. Transmission electron microscopy revealed lens epithelial cells with apoptotic changes, many cytoplasmic vacuoles, and filopodia-like protrusions between lens epithelial cells and the capsule. Epithelial proliferation and multilayering were also observed. silicone oil may play a role in the development of apoptotic and histopathological changes in clear lens epithelial cells. Clarity of the lens at the time of silicone oil removal does not indicate an absence of cataractous changes. We found justification of combined clear lens extraction and silicone oil removal or combined phacovitrectomy when silicone oil injection is planned, but further long-term studies with larger patient groups are required.

Interest of submucosal dissection knife for endoscopic treatment of Zenker's diverticulum.

PubMed

Laquière, A; Grandval, P; Arpurt, J P; Boulant, J; Belon, S; Aboukheir, S; Laugier, R; Penaranda, G; Curel, L; Boustière, C

2015-09-01

Dual-Knife(®) (Olympus) and Hydride-Knife(®) are new needle knives frequently used for submucosal dissection because of their safety and precision. In this study we aimed to evaluate the efficacy and safety of such devices in the diverticulopexy by flexible endoscopy. From February 2009 to March 2013, 42 patients (25 men), mean age 74.5, with symptomatic Zenker's diverticulum, were included in a non-randomized prospective multicenter study. The symptoms described by all patients include dysphagia, regurgitation and/or swallowing disorders. The diverticulopexy was performed with the Dual-Knife(®) or Hydrid-Knife(®), after septum exposure with the diverticuloscope, and terminated with distal tip clips positioning. All complications were noted. Patients' symptoms were regularly assessed during follow-up visits or telephone interviews. The first endoscopy treatment was successful for all patients. Thirty-seven patients (88%) had symptoms improvement after the first treatment. The recurrence rate was 14% (6 patients); a second endoscopic treatment was required 12 months on average after the first treatment, with 100% efficiency. Mid-term (16 months) efficiency was 91.67% after 1 to 3 endoscopic treatments. A total of 55 procedures were performed without perforation or significant bleeding and 3 patients underwent surgery. In multivariate analysis, the diverticulum size and the type of dissection knife were not risks factors for recurrence. Endoscopic diverticuloscope-assisted diverticulotomy with submucosal dissection knives is a safe and effective alternative treatment for patients with a symptomatic Zenker's diverticulum measuring between 2 and 10 cm.

Evaluation of an educational, theater-based intervention on attitudes toward organ donation in Risaralda, Colombia

PubMed Central

Buitrago, Juliana; Gómez, Sandra; Guerra, Alvaro; Lucumí, Leidy; Romero, César

2013-01-01

Introduction: The shortage of organs for transplantation is a worldwide problem and the main cause is the refusal of family members to donate. Consent to donate is influenced by many factors and educational interventions are strongly recommended. Objective: To evaluate the impact of an educational, theaterbased strategy on the attitudes toward organ donation. Methods: This study employed an intervention using theater as the central tool. The impact of this intervention on the intention to donate was assessed through a controlled, prospective, nonrandomized designed study. The sample consisted of 1,038 people. All the participants answered a survey that asked about sex, age and intent to donate. Afterward, one portion of the sample was exposed to the play, The Gift of Life, and a subsequent discussion forum that was guided by experts. The same survey was administered again after the intervention. Results: Before the intervention, donation attitudes were positive in 68.3% of the responses, negative in 6.8% and uncertain in 24.9%. Females showed a greater intent to donate while age had no apparent influence on the donation decision. Those exposed to the intervention were found to be more likely to donate and show a favorable change in attitude toward donation than those who were not exposed to the intervention. Conclusion: An educational intervention using theater is an effective tool to generate a short-term change in the intent to donate. Educational strategies should be employed to increase the rates of organ donation. PMID:24892320

Adjustable tongue advancement for obstructive sleep apnea: a pilot study.

PubMed

Hamans, Evert; Boudewyns, An; Stuck, Boris A; Baisch, Alexander; Willemen, Marc; Verbraecken, Johan; Van de Heyning, Paul

2008-11-01

Surgical treatment of obstructive sleep apnea (OSA) caused by hypopharyngeal collapse of the upper airway can be considered in patients who are intolerant to continuous positive airway pressure (CPAP). The present procedures addressing the hypopharynx are invasive and have substantial morbidity and limited efficacy. Ten patients (mean age, 44 years) with moderate to severe OSA, ie, an apnea-hypopnea index (AHI) between 15 and 50, with CPAP intolerance were included in a prospective, nonrandomized, multicenter study to evaluate the feasibility, safety, and efficacy of a novel tongue advancement procedure. The procedure consists of the implantation of a tissue anchor in the tongue base and an adjustment spool at the mandible. Titration of this tissue anchor results in advancement of the tongue and a patent upper airway. The mean AHI decreased from 22.8 at baseline to 11.8 at the 6-month follow-up (p = 0.007). The Epworth Sleepiness Scale score decreased from 11.4 at baseline to 7.7 at the 6-month follow-up (p = 0.094), and the snoring score decreased from 7.5 at baseline to 3.9 at the 6-month follow-up (p = 0.005). Four technical adverse events were noted, and 1 clinical adverse event occurred. Adjustable tongue advancement is a feasible and relatively safe way to reduce the AHI and snoring in selected patients with moderate to severe OSA and CPAP intolerance. Technical improvements and refinements to the procedure are ongoing.

Clinical review: Helmet and non-invasive mechanical ventilation in critically ill patients.

PubMed

Esquinas Rodriguez, Antonio M; Papadakos, Peter J; Carron, Michele; Cosentini, Roberto; Chiumello, Davide

2013-04-25

Non-invasive mechanical ventilation (NIV) has proved to be an excellent technique in selected critically ill patients with different forms of acute respiratory failure. However, NIV can fail on account of the severity of the disease and technical problems, particularly at the interface. The helmet could be an alternative interface compared to face mask to improve NIV success. We performed a clinical review to investigate the main physiological and clinical studies assessing the efficacy and related issues of NIV delivered with a helmet. A computerized search strategy of MEDLINE/PubMed (January 2000 to May 2012) and EMBASE (January 2000 to May 2012) was conducted limiting the search to retrospective, prospective, nonrandomized and randomized trials. We analyzed 152 studies from which 33 were selected, 12 physiological and 21 clinical (879 patients). The physiological studies showed that NIV with helmet could predispose to CO₂ rebreathing and increase the patients' ventilator asynchrony. The main indications for NIV were acute cardiogenic pulmonary edema, hypoxemic acute respiratory failure (community-acquired pneumonia, postoperative and immunocompromised patients) and hypercapnic acute respiratory failure. In 9 of the 21 studies the helmet was compared to a face mask during either continous positive airway pressure or pressure support ventilation. In eight studies oxygenation was similar in the two groups, while the intubation rate was similar in four and lower in three studies for the helmet group compared to face mask group. The outcome was similar in six studies. The tolerance was better with the helmet in six of the studies. Although these data are limited, NIV delivered by helmet could be a safe alternative to the face mask in patients with acute respiratory failure.

Systematic review of β blocker, aspirin, and statin in critically ill patients: importance of severity of illness and cardiac troponin.

PubMed

Rothenberg, Florence G; Clay, Michael B; Jamali, Hina; Vandivier-Pletsch, Robin H

2017-04-01

Non-cardiac critically ill patients with type II myocardial infarction (MI) have a high risk of mortality. There are no evidence-based interventions to mitigate this risk. We systematically reviewed the literature regarding the use of medications known to reduce mortality in patients with cardiac troponin (cTn) elevation due to type I MI (β blockers, statin, and aspirin) in studies of critically ill patients without Type I MI. All PubMed publications between 1976-2/19/16 were reviewed. Search terms included: β blocker or aspirin or statin and intensive care unit (ICU) or critically ill or sepsis; 497 primary references were obtained. Inclusion criteria were as follows: (1) study population consisted of critically ill patients in the ICU with non-cardiovascular illnesses, (2) mortality end point, (3) severity of illness (or injury) was measured, and (4) the antiplatelet agent was primarily aspirin. Retrospective investigations, prospective observational studies, meta-analysis, systematic review, and randomized controlled trials were included; case reports were excluded. 25 primary references were obtained. The data were extracted and tabulated using data collection headings as follows: article title, first author/year/reference number, study type/design, population studied, outcome and intervention, and study question addressed. Evidence was not graded as the majority of studies were non-randomized (low-to-moderate quality). 11 studies were found through bibliography reviews for a total of 36 references. In conclusion, β blockers, statins, and aspirin may play a role in reducing mortality in non-cardiac critically ill patients. Benefit appears to be related to severity of illness, for which cTn may be a marker. Copyright © 2017 American Federation for Medical Research.

Using Ensemble-Based Methods for Directly Estimating Causal Effects: An Investigation of Tree-Based G-Computation

ERIC Educational Resources Information Center

Austin, Peter C.

2012-01-01

Researchers are increasingly using observational or nonrandomized data to estimate causal treatment effects. Essential to the production of high-quality evidence is the ability to reduce or minimize the confounding that frequently occurs in observational studies. When using the potential outcome framework to define causal treatment effects, one…

Class Attendance and Students' Evaluations of Teaching: Do No-Shows Bias Course Ratings and Rankings?

ERIC Educational Resources Information Center

Wolbring, Tobias

2012-01-01

Background: Many university departments use students' evaluations of teaching (SET) to compare and rank courses. However, absenteeism from class is often nonrandom and, therefore, SET for different courses might not be comparable. Objective: The present study aims to answer two questions. Are SET positively biased due to absenteeism? Do…

Triple A: Alternative for At-Risk Adolescents?

ERIC Educational Resources Information Center

Mills-Walker, Shelly

2011-01-01

The purpose of this quantitative, causal comparative study was to examine the extent to which attending an alternative educational program at some point during high school could likely influence the graduation rate of at-risk students in an urban school district in the state of Missouri. Four years of nonrandom samples of graduation data from 2006…

Does Cognitive Behavioral Therapy for Youth Anxiety Outperform Usual Care in Community Clinics? An Initial Effectiveness Test

ERIC Educational Resources Information Center

Southam-Gerow, Michael A.; Weisz, John R.; Chu, Brian C.; McLeod, Bryce D.; Gordis, Elana B.; Connor-Smith, Jennifer K.

2010-01-01

Objective: Most tests of cognitive behavioral therapy (CBT) for youth anxiety disorders have shown beneficial effects, but these have been efficacy trials with recruited youths treated by researcher-employed therapists. One previous (nonrandomized) trial in community clinics found that CBT did not outperform usual care (UC). The present study used…

A Meta-Analysis of the Effects of Classroom Management Strategies and Classroom Management Programs on Students' Academic, Behavioral, Emotional, and Motivational Outcomes

ERIC Educational Resources Information Center

Korpershoek, Hanke; Harms, Truus; de Boer, Hester; van Kuijk, Mechteld; Doolaard, Simone

2016-01-01

This meta-analysis examined which classroom management strategies and programs enhanced students' academic, behavioral, social-emotional, and motivational outcomes in primary education. The analysis included 54 random and nonrandom controlled intervention studies published in the past decade (2003-2013). Results showed small but significant…

Day Hospital and Residential Addiction Treatment: Randomized and Nonrandomized Managed Care Clients

ERIC Educational Resources Information Center

Witbrodt, Jane; Bond, Jason; Kaskutas, Lee Ann; Weisner, Constance; Jaeger, Gary; Pating, David; Moore, Charles

2007-01-01

Male and female managed care clients randomized to day hospital (n=154) or community residential treatment (n=139) were compared on substance use outcomes at 6 and 12 months. To address possible bias in naturalistic studies, outcomes were also examined for clients who self-selected day hospital (n=321) and for clients excluded from randomization…

Effects of an Art-Based Curriculum on Clinical Trials Attitudes and Breast Cancer Prevention Knowledge

ERIC Educational Resources Information Center

Herman, Patricia M.; Larkey, Linda K.

2006-01-01

Although Latinos now comprise the largest minority in the U.S. population, they continue to be seriously underrepresented in clinical trials. A nonrandomized controlled study of an innovative community-developed clinical trial and breast cancer education program targeting Latinas tested whether use of an art-based curriculum could increase…

The Effect of Art Therapy on Cognitive Performance of Hispanic/Latino Older Adults

ERIC Educational Resources Information Center

Alders, Amanda; Levine-Madori, Linda

2010-01-01

This article presents the results of a pilot study investigating the efficacy of art therapy to enhance cognitive performance in a sample of 24 elderly Hispanic/Latino members of a community center who participated in a weekly structured thematic therapeutic arts program. A 12-week, quasi-experimental, pretest/posttest, nonrandomized, controlled…

Effectiveness of Virtual Worlds in Public Health Preparedness Training

ERIC Educational Resources Information Center

Earley, Elvia A.

2012-01-01

In emergency response training, it is essential that the learners are able to apply their classroom knowledge and implement the practical and critical thinking skills they learned. A quasi-experimental methodology with a non-randomized control group and a pretest-posttest was used in this study to evaluate the training level of satisfaction as a…

School Counselor Advocacy for Lesbian, Gay, and Bisexual Students: Intentions and Practice

ERIC Educational Resources Information Center

Simons, Jack D.; Hutchison, Brian; Bahr, Michael W.

2017-01-01

This study sought to understand school counselor advocacy for lesbian, gay, and bisexual (LGB) students using the theory of planned behavior (Ajzen, 2015). The authors analyzed data from a non-random sample of 398 school counselors in the United States. Participants completed demographic items and the Attitudes subscale of the Sexual Orientation…

Effectiveness of a Therapeutic Summer Camp for Children with ADHD: Phase I Clinical Intervention Trial

ERIC Educational Resources Information Center

Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie

2012-01-01

Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…

Brief Report: Non-Random X Chromosome Inactivation in Females with Autism

ERIC Educational Resources Information Center

Talebizadeh, Z.; Bittel, D. C.; Veatch, O. J.; Kibiryeva, N.; Butler, M. G.

2005-01-01

Autism is a heterogeneous neurodevelopmental disorder with a 3-4 times higher sex ratio in males than females. X chromosome genes may contribute to this higher sex ratio through unusual skewing of X chromosome inactivation. We studied X chromosome skewness in 30 females with classical autism and 35 similarly aged unaffected female siblings as…

Measurement of Physical Performance and Objective Fatigability in People with Mild-to-Moderate Traumatic Brain Injury

ERIC Educational Resources Information Center

Merritta, Catherine; Cherian, Binu; Macaden, Ashish S.; John, Judy Ann

2010-01-01

The aims of this study were to objectively measure the physical performance and physical endurance of patients with traumatic brain injury with minimization of cognitive and psychological fatigue, and to compare the physical performance of brain injured patients with that of healthy controls. This was a nonrandomized partially blinded controlled…

A simulation study of hardwood rootstock populations in young loblolly pine plantations

Treesearch

David R. Weise; Glenn R. Glover

1988-01-01

A computer program to simulate spatial distribution of hardwood rootstock populations is presented. Nineteen 3 to 6 yearold loblolly pine (Pinus taeda L.) plantations in Alabama and Georgia were measured to provide information for the simulator. Spatial pattern, expressed as Pielou's nonrandomness index (PNI), ranged from 0.47 to 2.45. Scatterplots illustrated no...

Three-year Follow up of GMCSF/bi-shRNA(furin) DNA-transfected Autologous Tumor Immunotherapy (Vigil) in Metastatic Advanced Ewing's Sarcoma.

PubMed

Ghisoli, Maurizio; Barve, Minal; Mennel, Robert; Lenarsky, Carl; Horvath, Staci; Wallraven, Gladice; Pappen, Beena O; Whiting, Sam; Rao, Donald; Senzer, Neil; Nemunaitis, John

2016-08-01

Ewing's sarcoma is a devastating rare pediatric cancer of the bone. Intense chemotherapy temporarily controls disease in most patients at presentation but has limited effect in patients with progressive or recurrent disease. We previously described preliminary results of a novel immunotherapy, FANG (Vigil) vaccine, in which 12 advanced stage Ewing's patients were safely treated and went on to achieve a predicted immune response (IFNγ ELISPOT). We describe follow-up through year 3 of a prospective, nonrandomized study comparing an expanded group of Vigil-treated advanced disease Ewing's sarcoma patients (n = 16) with a contemporaneous group of Ewing's sarcoma patients (n = 14) not treated with Vigil. Long-term follow-up results show a survival benefit without evidence of significant toxicity (no ≥ grade 3) to Vigil when administered once monthly by intradermal injection (1 × 10e(6) cells/injection to 1 × 10e(7) cells/injection). Specifically, we report a 1-year actual survival of 73% for Vigil-treated patients compared to 23% in those not treated with Vigil. In addition, there was a 17.2-month difference in overall survival (OS; Kaplan-Meier) between the Vigil (median OS 731 days) and no Vigil patient groups (median OS 207 days). In conclusion, these results supply the rational for further testing of Vigil in advanced stage Ewing's sarcoma.

Reduced availability of sugar-sweetened beverages and diet soda has a limited impact on beverage consumption patterns in Maine high school youth.

PubMed

Blum, Janet E Whatley; Davee, Anne-Marie; Beaudoin, Christina M; Jenkins, Paul L; Kaley, Lori A; Wigand, Debra A

2008-01-01

To examine change in high school students' beverage consumption patterns pre- and post-intervention of reduced availability of sugar-sweetened beverages (SSB) and diet soda in school food venues. A prospective, quasi-experimental, nonrandomized study design. Public high schools. A convenience sample from control (n = 221) and intervention (n = 235) high schools. Schools aimed to reduce (n = 4) or not change (n = 3) availability of SSB and diet soda in food venues for 1 school year. Subjects' beverage servings/day was determined from a food frequency questionnaire pre- and post-intervention. Two-by-two mixed analysis of variance model compared pre- to post-intervention servings/day between control and intervention subjects, stratified by gender. Consumption of SSB decreased in both intervention and control boys (F = 53.69, P < .05) and girls (F = 22.87, P < .05). Intervention girls decreased diet soda consumption as compared to control girls (F = 6.57, P < .05). Reducing availability of SSB in schools did not result in a greater decrease in SSB consumption by intervention as compared to control subjects. The impact of reducing availability of SSB at school may be limited. A better understanding of beverage consumption patterns may be needed to determine the efficacy of school food policies on those youth susceptible to obesity.

Comparative evaluation of the content and structure of communication using two handoff tools: implications for patient safety.

PubMed

Abraham, Joanna; Kannampallil, Thomas G; Almoosa, Khalid F; Patel, Bela; Patel, Vimla L

2014-04-01

Handoffs vary in their structure and content, raising concerns regarding standardization. We conducted a comparative evaluation of the nature and patterns of communication on 2 functionally similar but conceptually different handoff tools: Subjective, Objective, Assessment and Plan, based on a patient problem-based format, and Handoff Intervention Tool (HAND-IT), based on a body system-based format. A nonrandomized pre-post prospective intervention study supported by audio recordings and observations of 82 resident handoffs was conducted in a medical intensive care unit. Qualitative analysis was complemented with exploratory sequential pattern analysis techniques to capture the characteristics and types of communication events (CEs) and breakdowns. Use of HAND-IT led to fewer communication breakdowns (F1,80 = 45.66: P < .0001), greater number of CEs (t40 = 4.56; P < .001), with more ideal CEs than Subjective, Objective, Assessment and Plan (t40 = 9.27; P < .001). In addition, the use of HAND-IT was characterized by more request-response CE transitions. The HAND-IT's body system-based structure afforded physicians the ability to better organize and comprehend patient information and led to an interactive and streamlined communication, with limited external input. Our results also emphasize the importance of information organization using a medical knowledge hierarchical format for fostering effective communication. Copyright © 2014 Elsevier Inc. All rights reserved.

Adolescents' experiences using the contraceptive patch versus pills.

PubMed

Sucato, Gina S; Land, Stephanie R; Murray, Pamela J; Cecchini, Reena; Gold, Melanie A

2011-08-01

To compare use of the weekly transdermal contraceptive patch (patch) with daily combined hormonal contraceptive pills (pills) in adolescents. Prospective longitudinal study of adolescents' self-selected (non-randomized) use of the patch or pills. Urban, university hospital-affiliated, adolescent outpatient clinic. 13-22-year-old female adolescents seeking hormonal contraception, 40 who chose the patch and 40 who chose pills. Data were collected via self-report on paper questionnaires at three-cycle intervals for a total of up to nine cycles. Method continuation, perfect use, method satisfaction, quality of life, and side effects, including menstrual changes and perceived mood changes. After nine cycles, 38% of patch users and 60% of pill users were still using the method they had chosen at enrollment. There were no significant differences between the groups in self-reported perfect use. No differences were found in quality of life or side effects. Both patch and pill users noted menses became lighter and more predictable and reported decreased depression prior to their menses; only the pill group reported improvement in premenstrual anger. Method satisfaction was similar in both groups except patch users were more likely to report that their contraceptive method improved normal daily activities. Despite apparent advantages of the patch over the pill, adolescents using both methods continue to face challenges achieving perfect and sustained contraceptive use. 2011 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Comparison between bilateral implantation of a trifocal intraocular lens and blended implantation of two bifocal intraocular lenses

PubMed Central

Vilar, César; Hida, Wilson Takashi; de Medeiros, André Lins; Magalhães, Klayny Rafaella Pereira; de Moraes Tzelikis, Patrick Frensel; Chaves, Mario Augusto Pereira Dias; Motta, Antônio Francisco Pimenta; Carricondo, Pedro Carlos; Alves, Milton Ruiz; Nosé, Walton

2017-01-01

Purpose To compare visual outcomes and performance between bilateral implantation of a diffractive trifocal intraocular lens (IOL) Acrysof®PanOptix® TFNT00 and blended implantation of two different near add power bifocal IOLs: Acrysof® Restor® SV25T0 in dominant eye and Acrysof® Restor® SN6AD1 in the nondominant eye. Methods This prospective, nonrandomized, consecutive and comparative study assessed 20 patients (40 eyes) who had bilateral cataract surgery performed using the IOLs described. Patients were divided into groups, bilateral trifocal implant and blended implant. Evaluation included measurement of binocular uncorrected and corrected distance visual acuity at 4 m (UDVA, CDVA) and uncorrected intermediate (60 cm) and near (at 40 cm) visual acuity; contrast sensitivity (CS) and visual defocus curve. Results Postoperative CDVA comparison showed no statistical significance between groups. UDVA was significantly better in the trifocal groups. Under photopic conditions, the trifocal group had better CS in higher frequencies with and without glare. The binocular defocus curve demonstrated a trifocal behavior in both groups, with the bilateral trifocal group exhibiting better performance for intermediate vision. Conclusion Both lens combinations were able to provide good near, intermediate and distance vision, with the trifocal group showing significantly better performance at intermediate distances and better CS under photopic conditions. PMID:28814826

Distal femoral osteotomy in genovalgum: internal fixation with blade plate versus casting.

PubMed

Makhmalbaf, Hadi; Moradi, Ali; Ganji, Saeid

2014-10-01

To compare the results of two different ways of distal femoral osteotomy stabilization in patients suffering from genuvalgum: internal fixation with plate, and casting. In a non-randomized prospective study, after distal femoral osteotomy with the zigzag method, patients were divided into two groups: long leg casting, and internal fixation with blade plate. For all patients, questionnaires were filled to obtain data. Information such as range of motion, tibiofemoral anatomical angle and complications were recorded. 38 knees with valgus deformity underwent distal femoral supracondylar osteotomy. (8 with plaster cast and 30 with internal fixation using a blade plate). Preoperative range of motion was 129±6° and six months later it was 120±14°. The preoperative tibiofemoral angle was 32±6°; postoperative tibiofemoral angles were 3±3°, 6±2°, and 7±3° just after operation, six months, and two years later, respectively. Although this angle was greater among the group stabilized with a cast, this difference was not statistically significant. In postoperative complications, over-correction was found in five, recorvatom deformity in one, knee stiffness in three and superficial wound infection was recorded in three knees. There is no prominent difference in final range of motion and alignment whether fixation is done with casting or internal fixation. However, the complication rate seems higher in the casting method.

Evaluation of Optical Quality: Ocular Scattering and Aberrations in Eyes Implanted with Diffractive Multifocal or Monofocal Intraocular Lenses.

PubMed

Liao, Xuan; Lin, Jia; Tian, Jing; Wen, BaiWei; Tan, QingQing; Lan, ChangJun

2018-06-01

To compare objective optical quality, ocular scattering and aberrations of eyes implanted with an aspheric monofocal intraocular lens (IOL) or an aspheric apodized diffractive multifocal IOL three months after surgery. Prospective consecutive nonrandomized comparative cohort study. A total of 80 eyes from 57 cataract patients were bilaterally or unilaterally implanted with monofocal (AcrySof IQ SN60WF) or multifocal (AcrySof IQ ReSTOR SN6AD1) IOLs. Respectively, 40 eyes of 27 patients were implanted with monofocal IOLs, and 40 eyes of 30 patients were implanted with multifocal IOLs. Ocular high-order aberration (HOA) values were obtained using Hartmann-Shack aberrometer; objective scatter index (OSI), modulation transfer function (MTF) cutoff, Strehl ratio (SR), and contrast visual acuity OV at 100%, 20%, and 9% were measured using Objective Quality Analysis System II (OQAS II). Ocular aberrations performed similar in both groups (p > 0.05). However, significantly higher values of OSI and lower values of MTF cutoff, SR and OV were found in the SN6AD1 group (p < 0.05). Both ocular scattering and wave-front aberrations play essential role in retinal image quality, which may be overestimated when only aberrations were taken into account. Combining the effect of ocular scattering with HOA will result in a more accurate assessment of the visual and optical quality.

Infiltration of Local Anesthesia at Wound Site after Single-Incision Laparoscopic Colectomy Reduces Postoperative Pain and Analgesic Usage.

PubMed

Lee, Ko-Chao; Lu, Chien-Chang; Lin, Shung-Eing; Chang, Chia-Lo; Chen, Hong-Hwa

2015-06-01

Minimally invasive laparoscopy provides faster recovery, less pain, fewer complications, and better cosmesis than laparotomy. We aimed to evaluate outcomes of postoperative local anesthesia infiltration at the single-incision laparoscopic surgery (SILS) wound. This prospective, non-randomized controlled study evaluated outcomes of 58 colorectal cancer cases receiving SILS from May 2010 to December 2010. Twenty-nine patients received postoperative infiltration of local anesthesia at the wound site; another 29 patients did not. Demographic, intra- and postoperative data were compared. Postoperative pain was assessed by visual analogue scale and analgesic usage. Local anesthesia group included 16 males, 13 females (mean age, 62.0 ± 15.1 years); no local anesthesia group included 14 males, 15 females (mean age, 58.1 ± 12.7 years). There were no significant differences between groups at baseline (i.e., age, gender, disease stage, tumor location or size) except BMI (25.2 ± 2.8 vs. 23.5 ± 3.4, p = 0.041) was significantly higher. Postoperative pain scores were significantly lower in local anesthesia group than in no local anesthesia group (median VAS score 2.0, IQR 2.0-3.0 vs. VAS score 3.0, IQR 3.0-4.0, respectively, P = 0.024). Our results provide further evidence of SILS safety. Local anesthesia infiltration at SILS wounds decreases postoperative wound pain and analgesic usage.

Reduction in postnatal cumulative nutritional deficit and improvement of growth in extremely preterm infants.

PubMed

Senterre, Thibault; Rigo, Jacques

2012-02-01

To evaluate the influence of gestational age (GA) on cumulative nutritional deficit and postnatal growth in extremely preterm (EPT) infants after optimizing nutritional protocol as recently recommended. A prospective, nonrandomized, observational study in extremely preterm (EPT, <28 weeks) and very preterm (VPT, 28-30 weeks) infants. Eighty-four infants were included (BW: 978 ± 156 g, GA: 27.8 ± 1.3 weeks). Cumulative nutritional deficit increased during first week of life to -290 ± 84 and -285 ± 117 kcal/kg and -4.2 ± 3.1 and -4.8 ± 3.9 g/kg of protein in EPT and VPT groups, respectively. After 6 weeks, only cumulative energy deficit in EPT group remained significant (p < 0.05) even when 96% of theoretical energy intakes were provided. Weight z score decreased during first 3 days in average with initial weight loss, and then, the z score increased during the first 6 weeks of life in the majority (75%) of infants. Cumulative protein deficit during the first week of life was the major determinant of the postnatal growth during the first 6 weeks of life. Cumulative nutritional deficit may be drastically reduced in both EPT and VPT infants after optimizing nutritional policy during the first weeks of life, and the postnatal growth restriction could even be prevented. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

Effectiveness of yoga program in the management of diabetes using community health workers in the urban slums of Bangalore city: A non-randomized controlled trial

PubMed Central

Dasappa, Hemavathi; Fathima, Farah Naaz; Prabhakar, Rugmani

2016-01-01

Trial Design: Nonrandomized controlled trial. Methods: Nonrandomized controlled trial. This was an interventional study that was conducted in 4 slums of Bengaluru. Of the 256 diabetes participants, only 109 people agreed to participate in the program. Of 109 people, 52 people agreed to participate in the intervention (agreed to learn and practice Yoga) while the remaining 57 people were assigned to nonintervention group. Randomization and blinding could not be done. Objective and Outcome: The study was conducted with objective of assessing the effectiveness of Yoga, Pranayama, and Sudarshan Kriya in the community-based management of diabetes mellitus. The primary outcome variable was Hb1Ac and secondary outcome variables were systolic blood pressure (SBP), diastolic blood pressure (DBP), adherence to medication, and changes in lifestyle. Results: The study was conducted for 40 days. Community health workers made a total of 6 visits during the study. All the 109 participants were available for weekly follow-up. There were no drop outs among the study population. Statistically significant change was seen in the consumption of vegetable (χ2 = 15.326, P < 0.005), fruits (χ2 = 16.207, P < 0.005), salty food (χ2 = 14.823, P < 0.005), bakery food (χ2 = 10.429, P < 0.005) and fried food (χ2 = 15.470, P < 0.005), adherence to metformin (χ2 = 41.780, P < 0.005) and other medication(χ2 = 21.871, P < 0.005) and proportion of patients with DBP under control (χ2 = 9.396, P < 0.005) and proportion of people with glucose random blood sugar under control (χ2 = 29.693, P < 0.005) between the two groups following the intervention. Statistically significant change was also seen in the proportion of people with SBP/DBP ≤140/90 (χ2 = 10.635, P < 0.005) between the two groups. Conclusion: The Yoga program was successful in improving dietary practices and medication adherence and in increasing the proportion of diabetics and hypertensive patients under control. PMID:28217594

Palliative radiation therapy for bone metastases: Update of an ASTRO Evidence-Based Guideline.

PubMed

Lutz, Stephen; Balboni, Tracy; Jones, Joshua; Lo, Simon; Petit, Joshua; Rich, Shayna E; Wong, Rebecca; Hahn, Carol

The purpose is to provide an update the Bone Metastases Guideline published in 2011 based on evidence complemented by expert opinion. The update will discuss new high-quality literature for the 8 key questions from the original guideline and implications for practice. A systematic PubMed search from the last date included in the original Guideline yielded 414 relevant articles. Ultimately, 20 randomized controlled trials, 32 prospective nonrandomized studies, and 4 meta-analyses/pooled analyses were selected and abstracted into evidence tables. The authors synthesized the evidence and reached consensus on the included recommendations. Available literature continues to support pain relief equivalency between single and multiple fraction regimens for bone metastases. High-quality data confirm single fraction radiation therapy may be delivered to spine lesions with acceptable late toxicity. One prospective, randomized trial confirms both peripheral and spine-based painful metastases can be successfully and safely palliated with retreatment for recurrence pain with adherence to published dosing constraints. Advanced radiation therapy techniques such as stereotactic body radiation therapy lack high-quality data, leading the panel to favor its use on a clinical trial or when results will be collected in a registry. The panel's conclusion remains that surgery, radionuclides, bisphosphonates, and kyphoplasty/vertebroplasty do not obviate the need for external beam radiation therapy. Updated data analysis confirms that radiation therapy provides excellent palliation for painful bone metastases and that retreatment is safe and effective. Although adherence to evidence-based medicine is critical, thorough expert radiation oncology physician judgment and discretion regarding number of fractions and advanced techniques are also essential to optimize outcomes when considering the patient's overall health, life expectancy, comorbidities, tumor biology, anatomy, previous treatment including prior radiation at or near current site of treatment, tumor and normal tissue response history to local and systemic therapies, and other factors related to the patient, tumor characteristics, or treatment. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Teaching residents to use asthma devices. Assessing family residents' skills and a brief intervention.

PubMed Central

Kelcher, S.; Brownoff, R.

1994-01-01

OBJECTIVE: To evaluate an educational program for family medicine residents on using selected inhaler devices for delivery of asthma medications. DESIGN: A prospective analysis using pretests and posttests of a nonrandomized study group and control group. The study group of residents was given an instructional manual and a set of devices for home study, followed by a 1-hour tutorial session with a clinical instructor that included a video and hands-on practice. SETTING: Family medicine centres in Edmonton hospitals. PARTICIPANTS: The study group consisted of a convenience sample of 23 first- and second-year family medicine residents at the Misericordia Hospital Family Medicine Centre. The control group consisted of a convenience sample of 22 first- and second-year family medicine residents at the Royal Alexandra Hospital Family Medicine Centre. Nine residents did not take the posttest; one was absent because of injury, one missed the in-service, and seven had left the city on other rotations, had completed their program, or declined to participate. MAIN OUTCOME MEASURES: Improvements in scores on a multiple-choice test and in techniques of using the devices. RESULTS: Using an average of scores on seven different devices, only 36% of residents showed adequate knowledge of how to use the devices on the pretest. Posttest scores improved for both the control (P < 0.001) and study (P < 0.001) groups, but improvement was significantly greater for the study group (P < 0.001). CONCLUSIONS: Residents lacked adequate knowledge of asthma devices. More study is needed to confirm the long-term effectiveness of formal teaching about the devices. Images Figure 1 PMID:7888821

Fibrin Sealants in Dura Sealing: A Systematic Literature Review

PubMed Central

2016-01-01

Background Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. Methods A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. Results A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. Conclusions A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety. PMID:27119993

Fibrin Sealants in Dura Sealing: A Systematic Literature Review.

PubMed

Esposito, Felice; Angileri, Filippo Flavio; Kruse, Peter; Cavallo, Luigi Maria; Solari, Domenico; Esposito, Vincenzo; Tomasello, Francesco; Cappabianca, Paolo

2016-01-01

Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.

Discovering non-random segregation of sister chromatids: the naïve treatment of a premature discovery

PubMed Central

Lark, Karl G.

2013-01-01

The discovery of non-random chromosome segregation (Figure 1) is discussed from the perspective of what was known in 1965 and 1966. The distinction between daughter, parent, or grandparent strands of DNA was developed in a bacterial system and led to the discovery that multiple copies of DNA elements of bacteria are not distributed randomly with respect to the age of the template strand. Experiments with higher eukaryotic cells demonstrated that during mitosis Mendel’s laws were violated; and the initial serendipitous choice of eukaryotic cell system led to the striking example of non-random segregation of parent and grandparent DNA template strands in primary cultures of cells derived from mouse embryos. Attempts to extrapolate these findings to established tissue culture lines demonstrated that the property could be lost. Experiments using plant root tips demonstrated that the phenomenon exists in plants and that it was, at some level, under genetic control. Despite publication in major journals and symposia (Lark et al., 1966, 1967; Lark, 1967, 1969a,b,c) the potential implications of these findings were ignored for several decades. Here we explore possible reasons for the pre-maturity (Stent, 1972) of this discovery. PMID:23378946

Using Empowering Processes to Create Empowered Outcomes through the Family Development Credential Program: An Empirical Study of Change in Human Service Workers

ERIC Educational Resources Information Center

Hewitt, Nicole M.

2010-01-01

This study employed a quasi-experimental non-equivalent control group design with pretest and posttest. Two waves of data were collected from a non-random sample of 180 human service professionals in Western and Central Pennsylvania using two research instruments: the Social Work Empowerment Scale and the Conditions of Work Effectiveness-II Scale.…

Issues Relating to Selective Reporting When Including Non-Randomized Studies in Systematic Reviews on the Effects of Healthcare Interventions

ERIC Educational Resources Information Center

Norris, Susan L.; Moher, David; Reeves, Barnaby C.; Shea, Beverley; Loke, Yoon; Garner, Sarah; Anderson, Laurie; Tugwell, Peter; Wells, George

2013-01-01

Background: Selective outcome and analysis reporting (SOR and SAR) occur when only a subset of outcomes measured and analyzed in a study is fully reported, and are an important source of potential bias. Key methodological issues: We describe what is known about the prevalence and effects of SOR and SAR in both randomized controlled trials (RCTs)…

Bias reduction in repeated-measures observational studies by the use of propensity score: the case of enteral sedation for critically ill patients.

PubMed

Umbrello, Michele; Mistraletti, Giovanni; Corbella, Davide; Cigada, Marco; Salini, Silvia; Morabito, Alberto; Iapichino, Gaetano

2012-12-01

Within the evidence-based medicine paradigm, randomized controlled trials represent the "gold standard" to produce reliable evidence. Indeed, planning and implementing randomized controlled trials in critical care medicine presents limitations because of intrinsic and structural problems. As a consequence, observational studies still occur frequently. In these cases, propensity score (PS) (probability of receiving a treatment conditional on observed covariates) is an increasingly used technique to adjust the results. Few studies addressed the specific issue of a PS correction of repeated-measures designs. Three techniques for correcting the analysis of nonrandomized designs (matching, stratification, regression adjustment) are presented in a tutorial form and applied to a real case study: the comparison between intravenous and enteral sedative therapy in the intensive care unit setting. After showing the results before and after the use of PS, we suggest that such a tool allows to partially overcoming the bias associated with the observational nature of the study. It permits to correct the estimates for any observed covariate, while unobserved confounders cannot be controlled for. Propensity score represents a useful additional tool to estimate the effects of treatments in nonrandomized studies. In the case study, an enteral sedation approach was equally effective to an intravenous regime, allowing for a lower level of sedation and spare of resources. Copyright © 2012 Elsevier Inc. All rights reserved.

Seven Deadly Sins in Trauma Outcomes Research: An Epidemiologic Post-Mortem for Major Causes of Bias

PubMed Central

del Junco, Deborah J.; Fox, Erin E.; Camp, Elizabeth A.; Rahbar, Mohammad H.; Holcomb, John B.

2013-01-01

Background Because randomized clinical trials (RCTs) in trauma outcomes research are expensive and complex, they have rarely been the basis for the clinical care of trauma patients. Most published findings are derived from retrospective and occasionally prospective observational studies that may be particularly susceptible to bias. The sources of bias include some common to other clinical domains, such as heterogeneous patient populations with competing and interdependent short- and long-term outcomes. Other sources of bias are unique to trauma, such as rapidly changing multi-system responses to injury that necessitate highly dynamic treatment regimes like blood product transfusion. The standard research design and analysis strategies applied in published observational studies are often inadequate to address these biases. Methods Drawing on recent experience in the design, data collection, monitoring and analysis of the 10-site observational PROMMTT study, seven common and sometimes overlapping biases are described through examples and resolution strategies. Results Sources of bias in trauma research include ignoring 1) variation in patients’ indications for treatment (indication bias), 2) the dependency of intervention delivery on patient survival (survival bias), 3) time-varying treatment, 4) time-dependent confounding, 5) non-uniform intervention effects over time, 6) non-random missing data mechanisms, and 7) imperfectly defined variables. This list is not exhaustive. Conclusion The mitigation strategies to overcome these threats to validity require epidemiologic and statistical vigilance. Minimizing the highlighted types of bias in trauma research will facilitate clinical translation of more accurate and reproducible findings and improve the evidence-base that clinicians apply in their care of injured patients. PMID:23778519

Tissue adhesive skills study: the physician learning curve.

PubMed

Lin, Michelle; Coates, Wendy C; Lewis, Roger J

2004-04-01

To compare 2 educational approaches (structured group session vs. individual instruction) of learning application techniques of 2-octylcyanoacrylate (OCA) on wounds repaired in the emergency department. This prospective, nonrandomized, observational study was conducted in an urban hospital emergency department. Medical students, residents, and faculty were trained in the use of OCA either in a standardized group session or individually, based on their availability to attend the group session. Physicians completed a data collection form that included wound characteristics, type of instruction, and number of lacerations previously repaired with OCA. Impressions of time required, difficulty, and postrepair cosmesis were each recorded on a 5-point Likert scale. The 3 scales were totaled to yield a 15-point summary outcome measure. Univariate nonparametric comparisons of measures were performed between physicians with and without group instruction and between those with and without prior OCA experience. Using 35 subjects in each group, this study had a power of 0.95 to detect a difference of 1.5 points in the 15-point summary score, using alpha = 0.05. Eighty-one subjects were enrolled; the median summary score was 13 (IQR 12 to 15). There was no statistically significant difference in the summary score, nor any of its 3 components (time saved, difficulty, cosmesis), when comparing physicians with and without group instruction, nor when comparing first-time users to those with prior experience. OCA application is an easily acquired skill. Physicians were satisfied with their proficiency in OCA application, regardless of type of instruction received or number of previous lacerations repaired with OCA.

Clinical feasibility study of protrach dualcare a new speaking valve with heat and moisture exchanger for tracheotomized patients.

PubMed

de Kleijn, B J; van As-Brooks, C J; Wedman, J; van der Laan, B F A M

2017-12-01

The aim of this study was to evaluate the clinical feasibility of the ProTrach DualCare (Atos Medical, Hörby, Sweden), a device combining a hands-free speaking valve and a Heat and Moisture Exchanger (HME) for tracheotomized patients. A non-randomized, prospective single center feasibility study. Sixteen adult tracheotomized patients were included. Participants were asked to test the DualCare for two weeks while continuing their normal activities. After these two weeks, participants could choose whether or not to take part in the long-term evaluation. The EuroQOL-5D, Borg scale and questionnaires on speaking, pulmonary function and patient preference were used. During the long-term evaluation, a minor redesign was implemented and all participants were asked to test the new device again for one week, with a potential long-term evaluation. Eleven decided to participate. The device was well-tolerated. Speaking noise was reduced ( p  = 0.020) and speech was considered to sound more natural compared to previously used devices according to the users ( p  = 0.020). Overall 11 participants preferred the DualCare to their standard device. No serious adverse events were reported. Overall, 11 of 16 participants preferred the DualCare to their standard speaking valve or HME. Users of the DualCare were able to use hands free speech with the benefits of an HME and the device was considered clinically feasible and has the potential to improve quality of life of tracheotomized patients. 2b.

Primary anorectoplasty in females with common anorectal malformations without colostomy.

PubMed

Menon, Prema; Rao, Katragadda Lakshmi Narashima

2007-06-01

The objective of this study is to assess the feasibility of primary posterior sagittal anorectoplasty in vestibular fistula without a covering colostomy. Girls presenting from July 1997 to July 2005 with vestibular fistula were included prospectively in the study, in a nonrandomized manner, after excluding those with megarectosigmoid and pouch colon. All underwent primary posterior sagittal anorectoplasty after total gut irrigation with normal saline. They were kept nil per oral until the fifth postoperative day. No patient was started on anal dilatation. Patients were assessed for immediate and delayed complications as well as voluntary bowel movements and continence. A total of 72 patients with an age range of 1.5 months to 8 years (median, 9 months) were studied after excluding 7 with pouch colon and 3 with megarectosigmoid. Of the 72, 3 had undergone previous surgery. Follow-up ranged from 7 months to 8 years. No wound dehiscence or recurrence of fistula was noted. There were 5 mild wound infections. At 1 month postoperative, all patients had 1 to 3 stools per day with no episodes of soiling. None required anal dilatations, laxatives, or enemas. Primary posterior sagittal anorectoplasty in vestibular fistula can be performed without a covering colostomy provided fecal contamination of the wound can be kept to the minimum in the first postoperative week. We achieve this by thorough total gut irrigation preoperatively and keeping the child nil per oral for the first 5 postoperative days. Continence rates are excellent and postoperative constipation is unlikely if megarectosigmoid and pouch colon are ruled out before surgery. Anal dilatation is not required after surgery.

Effect of intravitreal bevacizumab on diabetic macular edema with hard exudates

PubMed Central

Jeon, Sohee; Lee, Won Ki

2014-01-01

Background We evaluated the efficacy of intravitreal bevacizumab on diabetic macular edema with subfoveal and perifoveal hard exudates. Materials and methods Eleven eyes (11 patients) exhibiting diabetic macular edema with subfoveal and perifoveal hard exudates were included in this prospective, nonrandomized interventional pilot study. All patients were treated with monthly scheduled intravitreal bevacizumab injections for 6 months. Changes in the Early Treatment Diabetic Retinopathy Study best corrected visual acuity, amount of hard exudates on fundus photography, and macular edema detected by central subfield thickness on spectral domain optical coherence tomography after six serial injections, were assessed. The amount of hard exudates at each visit was evaluated as pixels in fundus photography, using an Adobe Photoshop program. Results Ten of 11 patients completed follow-up. The mean Early Treatment Diabetic Retinopathy Study best corrected visual acuity was 59.9±5.7 letters (Snellen equivalent, 20/63) at baseline evaluation. The best corrected visual acuity exhibited no significant difference at month 6 compared with at baseline (57.9±6.0 letters or 20/70 at month 6; P=0.085). At month 6, mean central subfield thickness decreased from 370.4±56.5 to 334.6±65.0 μm (P=0.009). The mean amount of hard exudates increased from 4467.1±2736.1 to 6592.4±2498.3 pixels at month 6 (P=0.022). No serious adverse events occurred. Conclusion Continuous intravitreal bevacizumab was found to have no benefit in visual acuity and amount of hard exudates, despite the improvement of macular edema at 6 months. PMID:25143708

Safety and efficacy of simultaneous corneal collagen cross-linking with topography-guided PRK in managing low-grade keratoconus: 1-year follow-up.

PubMed

Tuwairqi, Waleed S; Sinjab, Mazen M

2012-05-01

To evaluate 1-year visual and topographic outcomes and safety and efficacy of corneal collagen cross-linking (CXL) combined with topography-guided photorefractive keratectomy (TG-PRK) to achieve near emmetropia in eyes with low-grade keratoconus. Twenty-two eyes from 15 patients (11 women, 4 men) were included in a prospective, nonrandomized, noncontrolled clinical study. Mean patient age was 26.6±6.07 years (range: 19 to 40 years). Inclusion criteria were low-grade keratoconus with evidence of progression, transparent cornea, corrected distance visual acuity (CDVA) 0.8 (decimal) or better, corneal thickness >440 μm, and maximum keratometry readings (K-max) <51.00 diopters (D). All patients underwent simultaneous TG-PRK with CXL. Study parameters were uncorrected distance visual acuity, CDVA, manifest refractive error, manifest and topographic (corneal) astigmatism, patient satisfaction, and efficacy and safety of the treatment. Follow-up was 1 year. After 1 year, statistically significant improvement was noted in all study parameters (P<.01). The safety and efficacy indices were 1.6 and 0.4, respectively. Patient satisfaction questionnaire showed that 91% were satisfied, 9% were not completely satisfied but believed they improved, and none were dissatisfied. Corneal topography demonstrated significant improvement in 55%, improvement in 36%, and minor improvement in 9% of cases. No cases progressed as evidenced by keratometry readings. Simultaneous TG-PRK with CXL is an effective and safe treatment with remarkable visual and topographic outcomes in patients with low-grade keratoconus who meet the recommended inclusion criteria. Copyright 2012, SLACK Incorporated.

The Effect of Intra-articular Injection of Autologous Microfragmented Fat Tissue on Proteoglycan Synthesis in Patients with Knee Osteoarthritis

PubMed Central

Borić, Igor; Rod, Eduard; Jeleč, Željko; Radić, Andrej; Vrdoljak, Trpimir; Skelin, Andrea; Trbojević-Akmačić, Irena; Plečko, Mihovil; Primorac, Dragan

2017-01-01

Osteoarthritis (OA) is one of the leading musculoskeletal disorders in the adult population. It is associated with cartilage damage triggered by the deterioration of the extracellular matrix tissue. The present study explores the effect of intra-articular injection of autologous microfragmented adipose tissue to host chondrocytes and cartilage proteoglycans in patients with knee OA. A prospective, non-randomized, interventional, single-center, open-label clinical trial was conducted from January 2016 to April 2017. A total of 17 patients were enrolled in the study, and 32 knees with osteoarthritis were assessed. Surgical intervention (lipoaspiration) followed by tissue processing and intra-articular injection of the final microfragmented adipose tissue product into the affected knee(s) was performed in all patients. Patients were assessed for visual analogue scale (VAS), delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) and immunoglobulin G (IgG) glycans at the baseline, three, six and 12 months after the treatment. Magnetic resonance sequence in dGEMRIC due to infiltration of the anionic, negatively charged contrast gadopentetate dimeglumine (Gd-DTPA2−) into the cartilage indicated that the contents of cartilage glycosaminoglycans significantly increased in specific areas of the treated knee joint. In addition, dGEMRIC consequently reflected subsequent changes in the mechanical axis of the lower extremities. The results of our study indicate that the use of autologous and microfragmented adipose tissue in patients with knee OA (measured by dGEMRIC MRI) increased glycosaminoglycan (GAG) content in hyaline cartilage, which is in line with observed VAS and clinical results. PMID:29027984

Activity of IPI-504, a Novel Heat-Shock Protein 90 Inhibitor, in Patients With Molecularly Defined Non–Small-Cell Lung Cancer

PubMed Central

Sequist, Lecia V.; Gettinger, Scott; Senzer, Neil N.; Martins, Renato G.; Jänne, Pasi A.; Lilenbaum, Rogerio; Gray, Jhanelle E.; Iafrate, A. John; Katayama, Ryohei; Hafeez, Nafeeza; Sweeney, Jennifer; Walker, John R.; Fritz, Christian; Ross, Robert W.; Grayzel, David; Engelman, Jeffrey A.; Borger, Darrell R.; Paez, Guillermo; Natale, Ronald

2010-01-01

Purpose IPI-504 is a novel, water-soluble, potent inhibitor of heat-shock protein 90 (Hsp90). Its potential anticancer activity has been validated in preclinical in vitro and in vivo models. We studied the activity of IPI-504 after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy in patients with advanced, molecularly defined non–small-cell lung cancer (NSCLC). Patients and Methods Patients with advanced NSCLC, prior treatment with EGFR TKIs, and tumor tissue available for molecular genotyping were enrolled in this prospective, nonrandomized, multicenter, phase II study of IPI-504 monotherapy. The primary outcome was objective response rate (ORR). Secondary aims included safety, progression-free survival (PFS), and analysis of activity by molecular subtypes. Results Seventy-six patients were enrolled between December 2007 and May 2009 from 10 United States cancer centers. An ORR of 7% (five of 76) was observed in the overall study population, 10% (four of 40) in patients who were EGFR wild-type, and 4% (one of 28) in those with EGFR mutations. Although both EGFR groups were below the target ORR of 20%, among the three patients with an ALK gene rearrangement, two had partial responses and the third had prolonged stable disease (7.2 months, 24% reduction in tumor size). The most common adverse events included grades 1 and 2 fatigue, nausea, and diarrhea. Grade 3 or higher liver function abnormalities were observed in nine patients (11.8%). Conclusion IPI-504 has clinical activity in patients with NSCLC, particularly among patients with ALK rearrangements. PMID:20940188

Intra-Arterial Immunoselected CD34+ Stem Cells for Acute Ischemic Stroke

PubMed Central

Bentley, Paul; Hamady, Mohammad; Marley, Stephen; Davis, John; Shlebak, Abdul; Nicholls, Joanna; Williamson, Deborah A.; Jensen, Steen L.; Gordon, Myrtle; Habib, Nagy; Chataway, Jeremy

2014-01-01

Treatment with CD34+ hematopoietic stem/progenitor cells has been shown to improve functional recovery in nonhuman models of ischemic stroke via promotion of angiogenesis and neurogenesis. We aimed to determine the safety and feasibility of treatment with CD34+ cells delivered intra-arterially in patients with acute ischemic stroke. This was the first study in human subjects. We performed a prospective, nonrandomized, open-label, phase I study of autologous, immunoselected CD34+ stem/progenitor cell therapy in patients presenting within 7 days of onset with severe anterior circulation ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score ≥8). CD34+ cells were collected from the bone marrow of the subjects before being delivered by catheter angiography into the ipsilesional middle cerebral artery. Eighty-two patients with severe anterior circulation ischemic stroke were screened, of whom five proceeded to treatment. The common reasons for exclusion were age >80 years (n = 19); medical instability (n = 17), and significant carotid stenosis (n = 13). The procedure was well tolerated in all patients, and no significant treatment-related adverse effects occurred. All patients showed improvements in clinical functional scores (Modified Rankin Score and NIHSS score) and reductions in lesion volume during a 6-month follow-up period. Autologous CD34+ selected stem/progenitor cell therapy delivered intra-arterially into the infarct territory can be achieved safely in patients with acute ischemic stroke. Future studies that address eligibility criteria, dosage, delivery site, and timing and that use surrogate imaging markers of outcome are desirable before larger scale clinical trials. PMID:25107583

Palliative sedation in end-of-life care and survival: a systematic review.

PubMed

Maltoni, Marco; Scarpi, Emanuela; Rosati, Marta; Derni, Stefania; Fabbri, Laura; Martini, Francesca; Amadori, Dino; Nanni, Oriana

2012-04-20

Palliative sedation is a clinical procedure aimed at relieving refractory symptoms in patients with advanced cancer. It has been suggested that sedative drugs may shorten life, but few studies exist comparing the survival of sedated and nonsedated patients. We present a systematic review of literature on the clinical practice of palliative sedation to assess the effect, if any, on survival. A systematic review of literature published between January 1980 and December 2010 was performed using MEDLINE and EMBASE databases. Search terms included palliative sedation, terminal sedation, refractory symptoms, cancer, neoplasm, palliative care, terminally ill, end-of-life care, and survival. A manual search of the bibliographies of electronically identified articles was also performed. Eleven published articles were identified describing 1,807 consecutive patients in 10 retrospective or prospective nonrandomized studies, 621 (34.4%) of whom were sedated. One case-control study was excluded from prevalence analysis. The most frequent reason for sedation was delirium in the terminal stages of illness (median, 57.1%; range, 13.8% to 91.3%). Benzodiazepines were the most common drug category prescribed. Comparing survival of sedated and nonsedated patients, the sedation approach was not shown to be associated with worse survival. Even if there is no direct evidence from randomized clinical trials, palliative sedation, when appropriately indicated and correctly used to relieve unbearable suffering, does not seem to have any detrimental effect on survival of patients with terminal cancer. In this setting, palliative sedation is a medical intervention that must be considered as part of a continuum of palliative care.

Influenza vaccination in healthy working adults in Russia: observational study of effectiveness and return on investment for the employer.

PubMed

At'kov, O Yu; Azarov, A V; Zhukov, D A; Nicoloyannis, N; Durand, L

2011-03-01

All age groups are affected by influenza infection, resulting in significant medical and economic burden. Influenza infection of healthy working adults can have a marked effect on companies due to lost work days and reduced productivity. Studies in corporate settings have shown that vaccination programmes reduce this burden, although there is a lack of data in Eastern European countries. To determine the effectiveness of influenza vaccination in healthy working adults in Russia and the economic benefits of such a programme from an employer's perspective. In a prospective, non-randomized, non-placebo-controlled, observational study, healthy vaccinated and unvaccinated adults employed at the Russian Railways Public Corporation were followed for 8 months during the 2005-6 influenza season using questionnaires. A first questionnaire was administered at inclusion to collect general employee information; a second questionnaire was administered to collect data on post-vaccination adverse events; and monthly questionnaires were used to gather data on influenza-like illness (ILI). Effectiveness calculations and cost analyses were performed to evaluate the impact of the influenza vaccination programme on employee productivity and costs for the employer. The study vaccine used was the trivalent, inactivated, split vaccine Vaxigrip® (sanofi pasteur, France). A total of 1331 employees volunteered for the study: 701 were vaccinated and 630 were not. The vaccine effectiveness was 70.4% against ILI events and 80.8% against sick leave days. Assuming that employees working with ILI symptoms had a reduced level of productivity (30-70% of normal), cost savings per vaccinated employee ranged from &U20AC;2.13 to &U20AC;5.43. This study showed that an influenza vaccination programme significantly reduced ILI episodes and absenteeism, and may provide a positive return on investment for the employer.

Location of prosthodontic treatment and oral health-related quality of life--an exploratory study.

PubMed

Sukumar, Smitha; John, Mike T; Schierz, Oliver; Aarabi, Ghazal; Reissmann, Daniel R

2015-01-01

Prosthodontic treatment has a positive effect on oral health-related quality of life (OHRQoL); however, there is a paucity of studies assessing the impact of OHRQoL based on where in the mouth ("location") the treatment is performed. This exploratory study investigated the association of the location (anterior, posterior region) of prosthodontic treatment with magnitude and nature of OHRQoL changes. In this non-randomized prospective clinical study, 190 adult patients (17-83 years) were recruited at baseline and 104 were available for the follow-up analyses. Of those, 50 patients received treatment only in the posterior segment and 54 patients in both anterior and posterior regions. Treatment included conventional fixed partial prostheses, removable prostheses or a combination of both. OHRQoL was assessed with the German language version of the 49-item Oral Health Impact Profile (OHIP) at baseline and the questionnaire was repeated 4-6 weeks post-treatment. Magnitude and effect size of changes in summary and sub-scale scores were calculated and data analyzed. Patients experienced a substantially impaired OHRQoL (mean OHIP score: 32.3 points) at baseline and an improvement in OHRQoL of 6.8 OHIP points following treatment. This study showed a greater improvement in OHRQoL in patients treated in both regions compared to those treated in the posterior region alone, especially in the function and aesthetic domains. This explorative study suggests that OHRQoL improvement is affected by where prosthodontic treatment is performed in the mouth. Greater understanding of qualitative aspects of reconstructive therapies is needed for improved treatment planning and patient consent. Copyright © 2014 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

Use of letrozole in assisted reproduction: a systematic review and meta-analysis

PubMed Central

Requena, Antonio; Herrero, Julio; Landeras, José; Navarro, Esperanza; Neyro, José L.; Salvador, Cristina; Tur, Rosa; Callejo, Justo; Checa, Miguel A.; Farré, Magí; Espinós, Juan J.; Fábregues, Francesc; Graña-Barcia, María

2008-01-01

BACKGROUND Letrozole is the third-generation aromatase inhibitor (AI) most widely used in assisted reproduction. AIs induce ovulation by inhibiting estrogen production; the consequent hypoestrogenic state increases GnRH release and pituitary follicle-stimulating hormone (FSH) synthesis. METHODS A systematic search of the literature was performed for both prospective and retrospective studies. Meta-analyses of randomized clinical trials (RCTs) were performed for three comparisons: letrozole versus clomiphene citrate (CC), letrozole + FSH versus FSH in intrauterine insemination (IUI) and letrozole + FSH versus FSH in IVF. In the absence of RCTs, non-randomized studies were pooled. RESULTS Nine studies were included in the meta-analysis. Four RCTs compared the overall effect of letrozole with CC in patients with polycystic ovary syndrome. The pooled result was not significant for ovulatory cycles (OR = 1.17; 95% CI 0.66–2.09), or for pregnancy rate per cycle (OR = 1.47; 95% CI 0.73–2.96) or for pregnancy rate per patient (OR = 1.37; 95% CI 0.70–2.71). In three retrospective studies which compared L + FSH with FSH in ovarian stimulation for IUI, the pooled OR was 1.15 (95% CI 0.78−1.71). A final meta-analysis included one RCT and one cohort study that compared letrozole + gonadotrophin versus gonadotrophin alone: the pooled pregnancy rate per patient was not significantly different (OR = 1.40; 95% CI 0.67–2.91). CONCLUSIONS Letrozole is as effective as other methods of ovulation induction. Further randomized-controlled studies are warranted to define more clearly the efficacy and safety of letrozole in human reproduction. PMID:18812422

Unattended Sleep Studies in a VA Population: Initial Evaluation by Chart Review Versus Clinic Visit by a Midlevel Provider.

PubMed

Alsharif, Abdelhamid M; Potts, Michelle; Laws, Regina; Freire, Amado X; Sultan-Ali, Ibrahim

2016-10-01

Obstructive sleep apnea (OSA) is a prevalent disorder that is associated with multiple medical consequences. Although in-laboratory polysomnography is the gold standard for the diagnosis of OSA, portable monitors have been developed and studied to help increase efficiency and ease of diagnosis. We aimed to assess the adequacy of a midlevel provider specializing in sleep medicine to risk-stratify patients for OSA based on a chart review versus a comprehensive clinic evaluation before scheduling an unattended sleep study. This study was an observational, nonrandomized, retrospective data collection by chart review of patients accrued prospectively who underwent an unattended sleep study at the Sleep Health Center at the Memphis Veterans Affairs Medical Center during the first 13 months of the program (May 1, 2011-May 31, 2012). A total of 205 patients were included in the data analysis. Analysis showed no statistically significant differences between chart review and clinic visit groups ( P = 0.54) in terms of OSA diagnosis. Although not statistically significant, the analysis shows a trend toward higher mean age (50.3 vs 47.4 years; P = 0.10) and lower mean body mass index (34.4 vs 36.0; P = 0.08) in individuals who were evaluated during a comprehensive clinic visit. A statistically significant difference is seen in terms of the pretest clinical probability of OSA being moderate or high in 62.2% of patients in the clinic visit group and 95.7% in the chart review group, with a χ 2 P ≤ 0.0001. In the Veterans Health Administration's system, the assessment of pretest probability may be determined by a midlevel provider using chart review with equal efficacy to a comprehensive face-to-face evaluation in terms of OSA diagnosis via unattended sleep studies.

Complete Surgical Resection Is Curative for Children With Hepatoblastoma With Pure Fetal Histology: A Report From the Children's Oncology Group

PubMed Central

Malogolowkin, Marcio H.; Katzenstein, Howard M.; Meyers, Rebecka L.; Krailo, Mark D.; Rowland, Jon M.; Haas, Joel; Finegold, Milton J.

2011-01-01

Purpose Children with pure fetal histology (PFH) hepatoblastoma treated with complete surgical resection and minimal adjuvant therapy have been shown to have excellent outcomes when compared with other patients with hepatoblastoma. We prospectively studied the safety and efficacy of reducing therapy in all children with stage I PFH enrolled onto two consecutive studies. Patients and Methods From August 1989 to December 1992, 9 children with stage I PFH were treated on the Intergroup Hepatoblastoma study INT-0098 and were nonrandomly assigned to receive chemotherapy after surgical resection with single-agent bolus doxorubicin for 3 consecutive days. From March 1999 to November 2006, 16 children with stage I PFH enrolled onto Children's Oncology Group Study P9645 were treated with observation after resection. Central confirmation of the histologic diagnosis by a study group pathologist was mandated. The extent of liver disease was assigned retrospectively according to the pretreatment extent of disease (PRETEXT) system and is designated “retro-PRETEXT” to clarify the retrospective group assignment. Results Five-year event-free and overall survival for the 9 patients treated on INT-0098 were 100%. All 16 patients enrolled onto the P9645 study were alive and free of disease at the time of last contact, with a median follow-up of 4.9 years. Retro-PRETEXT for the 21 patients with available data revealed seven patients with stage I disease, 10 patients with stage II disease, and four patients with stage III disease. Conclusion Children with completely resected PFH hepatoblastoma can achieve long-term survival without additional chemotherapy. When feasible, surgical resection of hepatoblastoma at diagnosis, without chemotherapy, can identify children for whom no additional therapy is necessary. PMID:21768450

Effects of prey abundance, distribution, visual contrast and morphology on selection by a pelagic piscivore

USGS Publications Warehouse

Hansen, Adam G.; Beauchamp, David A.

2014-01-01

Most predators eat only a subset of possible prey. However, studies evaluating diet selection rarely measure prey availability in a manner that accounts for temporal–spatial overlap with predators, the sensory mechanisms employed to detect prey, and constraints on prey capture.We evaluated the diet selection of cutthroat trout (Oncorhynchus clarkii) feeding on a diverse planktivore assemblage in Lake Washington to test the hypothesis that the diet selection of piscivores would reflect random (opportunistic) as opposed to non-random (targeted) feeding, after accounting for predator–prey overlap, visual detection and capture constraints.Diets of cutthroat trout were sampled in autumn 2005, when the abundance of transparent, age-0 longfin smelt (Spirinchus thaleichthys) was low, and 2006, when the abundance of smelt was nearly seven times higher. Diet selection was evaluated separately using depth-integrated and depth-specific (accounted for predator–prey overlap) prey abundance. The abundance of different prey was then adjusted for differences in detectability and vulnerability to predation to see whether these factors could explain diet selection.In 2005, cutthroat trout fed non-randomly by selecting against the smaller, transparent age-0 longfin smelt, but for the larger age-1 longfin smelt. After adjusting prey abundance for visual detection and capture, cutthroat trout fed randomly. In 2006, depth-integrated and depth-specific abundance explained the diets of cutthroat trout well, indicating random feeding. Feeding became non-random after adjusting for visual detection and capture. Cutthroat trout selected strongly for age-0 longfin smelt, but against similar sized threespine stickleback (Gasterosteus aculeatus) and larger age-1 longfin smelt in 2006. Overlap with juvenile sockeye salmon (O. nerka) was minimal in both years, and sockeye salmon were rare in the diets of cutthroat trout.The direction of the shift between random and non-random selection depended on the presence of a weak versus a strong year class of age-0 longfin smelt. These fish were easy to catch, but hard to see. When their density was low, poor detection could explain their rarity in the diet. When their density was high, poor detection was compensated by higher encounter rates with cutthroat trout, sufficient to elicit a targeted feeding response. The nature of the feeding selectivity of a predator can be highly dependent on fluctuations in the abundance and suitability of key prey.

A robust and efficient statistical method for genetic association studies using case and control samples from multiple cohorts

PubMed Central

2013-01-01

Background The theoretical basis of genome-wide association studies (GWAS) is statistical inference of linkage disequilibrium (LD) between any polymorphic marker and a putative disease locus. Most methods widely implemented for such analyses are vulnerable to several key demographic factors and deliver a poor statistical power for detecting genuine associations and also a high false positive rate. Here, we present a likelihood-based statistical approach that accounts properly for non-random nature of case–control samples in regard of genotypic distribution at the loci in populations under study and confers flexibility to test for genetic association in presence of different confounding factors such as population structure, non-randomness of samples etc. Results We implemented this novel method together with several popular methods in the literature of GWAS, to re-analyze recently published Parkinson’s disease (PD) case–control samples. The real data analysis and computer simulation show that the new method confers not only significantly improved statistical power for detecting the associations but also robustness to the difficulties stemmed from non-randomly sampling and genetic structures when compared to its rivals. In particular, the new method detected 44 significant SNPs within 25 chromosomal regions of size < 1 Mb but only 6 SNPs in two of these regions were previously detected by the trend test based methods. It discovered two SNPs located 1.18 Mb and 0.18 Mb from the PD candidates, FGF20 and PARK8, without invoking false positive risk. Conclusions We developed a novel likelihood-based method which provides adequate estimation of LD and other population model parameters by using case and control samples, the ease in integration of these samples from multiple genetically divergent populations and thus confers statistically robust and powerful analyses of GWAS. On basis of simulation studies and analysis of real datasets, we demonstrated significant improvement of the new method over the non-parametric trend test, which is the most popularly implemented in the literature of GWAS. PMID:23394771

Curtailing the high rate of late-stage attrition of investigational therapeutics against unprecedented targets in patients with lung and other malignancies.

PubMed

Rowinsky, Eric K

2004-06-15

A greater understanding of the pathogenesis and biology of cancer coupled with major advances in biotechnology has resulted in the identification of rationally designed, target-based (RDTB) anticancer therapeutics, ushering in new therapeutic opportunities and high expectations for the future as well as developmental challenges. Because these agents appear to principally target malignant cells, it is expected that they will produce less toxicity at clinically effective doses than nonspecific cytotoxic agents, but their target requirements are likely to be much more stringent. The innate complexity of the networks that contain elements targeted by these agents also decreases the probability that any single therapeutic manipulation will result in robust clinical activity and success when used alone, particularly in patients with solid malignancies that have multiple relevant signaling aberrations. In contrast, proof of principle and robust antitumor activity may be most efficiently demonstrated in nonrandomized evaluations involving tumors that are principally driven by aberrations of the specific target. The predominant therapeutic manifestation of RDTB agents in preclinical studies is due to decreased tumor growth rates and will likely be similar in the clinic; however, such manifestations are not readily detectable and quantifiable using nonrandomized clinical evaluations. To curtail the increasing rate of late-stage attrition of RDTB agents, which, if maintained, will stymie progress in cancer therapy, the design of initial nonrandomized evaluations, particularly the selection of tumors and patients, must be guided by the principal biological features of the agents. Next, evaluations, some of which must be randomized, can be performed in a wide range of tumor types, depending on the presence and relevance of the target. To validate the concept of RDTB therapeutics and to realize their full potential, radically different development, evaluation, and regulatory paradigms must be adopted.

Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients: An Open-Label Nonrandomized Trial.

PubMed

Durand, Christine M; Bowring, Mary G; Brown, Diane M; Chattergoon, Michael A; Massaccesi, Guido; Bair, Nichole; Wesson, Russell; Reyad, Ashraf; Naqvi, Fizza F; Ostrander, Darin; Sugarman, Jeremy; Segev, Dorry L; Sulkowski, Mark; Desai, Niraj M

2018-04-17

Given the high mortality rate for patients with end-stage kidney disease receiving dialysis and the efficacy and safety of hepatitis C virus (HCV) treatments, discarded kidneys from HCV-infected donors may be a neglected public health resource. To determine the tolerability and feasibility of using direct-acting antivirals (DAAs) as prophylaxis before and after kidney transplantation from HCV-infected donors to non-HCV-infected recipients (that is, HCV D+/R- transplantation). Open-label nonrandomized trial. (ClinicalTrials.gov: NCT02781649). Single center. 10 HCV D+/R- kidney transplant candidates older than 50 years with no available living donors. Transplantation of kidneys from deceased donors aged 13 to 50 years with positive HCV RNA and HCV antibody test results. All recipients received a dose of grazoprevir (GZR), 100 mg, and elbasvir (EBR), 50 mg, immediately before transplantation. Recipients of kidneys from donors with genotype 1 infection continued receiving GZR-EBR for 12 weeks after transplantation; those receiving organs from donors with genotype 2 or 3 infection had sofosbuvir, 400 mg, added to GZR-EBR for 12 weeks of triple therapy. The primary safety outcome was the incidence of adverse events related to GZR-EBR treatment. The primary efficacy outcome was the proportion of recipients with an HCV RNA level below the lower limit of quantification 12 weeks after prophylaxis. Among 10 HCV D+/R- transplant recipients, no treatment-related adverse events occurred, and HCV RNA was not detected in any recipient 12 weeks after treatment. Nonrandomized study design and a small number of patients. Pre- and posttransplantation HCV treatment was safe and prevented chronic HCV infection in HCV D+/R- kidney transplant recipients. If confirmed in larger studies, this strategy should markedly expand organ options and reduce mortality for kidney transplant candidates without HCV infection. Merck Sharp & Dohme.

Studies in Ambulatory Care Quality Assessment in the Indian Health Service. Volume II: Appraisal of System Performance.

ERIC Educational Resources Information Center

Nutting, Paul A.; And Others

Six Indian Health Service (IHS) units, chosen in a non-random manner, were evaluated via a quality assessment methodology currently under development by the IHS Office of Research and Development. A set of seven health problems (tracers) was selected to represent major health problems, and clinical algorithms (process maps) were constructed for…

Effect of Programmed Instruction on Students' Attitude towards Structure of the Atom and the Periodic Table among Kenyan Secondary Schools

ERIC Educational Resources Information Center

Wangila, M. J.; Martin, W.; Ronald, M.

2015-01-01

This study examined the effect of Programmed Instruction on students' attitude towards Structure of the Atom and the Periodic Table (SAPT) among mixed (co-educational) secondary schools of Butere district, Kakamega county, Kenya. The quasi-experimental research design was adopted, using the nonrandomized Solomon four-group as a model. The sample…

Mind the Teachers! The Impact of Mindfulness Training on Self-Regulation and Classroom Performance in a Sample of German School Teachers

ERIC Educational Resources Information Center

Rupprecht, Silke; Paulus, Peter; Walach, Harald

2017-01-01

Teacher wellbeing and performance is affected by their ability to cope with the demands of the profession. This pilot nonrandomized, waitlist-controlled study investigated the impact of a mindfulness intervention (Mindfulness-Based Stress Reduction) on teachers' wellbeing, self-regulation ability and classroom performance applying a mixed-method…

Mind the Teachers! The Impact of Mindfulness Training on Self-Regulation and Classroom Performance in a Sample of German School Teachers

ERIC Educational Resources Information Center

Rupprecht, Silke; Paulu, Peter; Walach, Harald

2017-01-01

Teacher wellbeing and performance is affected by their ability to cope with the demands of the profession. This pilot non-randomized, waitlist-controlled study investigated the impact of a mindfulness intervention (Mindfulness-Based Stress Reduction) on teachers' wellbeing, self-regulation ability and classroom performance applying a mixed-method…

Investigating the Relationship between Critical Thinking Skills and the Quality of Iranian Intermediate TEFL Students' Writing

ERIC Educational Resources Information Center

Nikou, Farahnaz Rimani; Bonyadi, Alireza; Amirikar, Negin

2015-01-01

The current study intended to find out the relationship between critical thinking skills and the quality of Iranian TEFL (Teaching English as a Foreign Language) students' writing. One-hundred forty students who were homogeneous in their language proficiency were selected non-randomly. The researcher asked students to take part in a proficiency…

Using the Cognitive Structure of Knowledge of Female Retirees To Assess Speed and Content of Information Processing.

ERIC Educational Resources Information Center

Middlestead, Charles G.

A study examined how a stratified nonrandom sample of 112 female retirees cognitively structure their knowledge about retirement. The women, who were selected from two rural communities in two Mid-Atlantic states, were asked to complete brief questionnaires about their background and satisfaction with retirement and to sort 13 cards imprinted with…

Suicide Prevention among High School Students: Evaluation of a Nonrandomized Trial of a Multi-Stage Suicide Screening Program

ERIC Educational Resources Information Center

Torcasso, Gina; Hilt, Lori M.

2017-01-01

Background: Suicide is a leading cause of death among youth. Suicide screening programs aim to identify mental health issues and prevent death by suicide. Objective: The present study evaluated outcomes of a multi-stage screening program implemented over 3 school years in a moderately-sized Midwestern high school. Methods: One hundred ninety-three…

Agreement on Child Maltreatment Decisions: A Nonrandomized Study on the Effects of Structured Decision-Making

ERIC Educational Resources Information Center

Bartelink, C.; van Yperen, T. A.; ten Berge, I. J.; de Kwaadsteniet, L.; Witteman, C. L. M.

2014-01-01

Background: Practitioners investigating cases of suspected child maltreatment often disagree whether a child is subject to or at risk of abuse or neglect in the family and, if so, what to do about such abuse or neglect. Structured decision-making is considered to be a solution to the problem of subjective judgments and decisions. Objective: This…

Non-Randomized Studies as a Source of Complementary, Sequential or Replacement Evidence for Randomized Controlled Trials in Systematic Reviews on the Effects of Interventions

ERIC Educational Resources Information Center

Schünemann, Holger J.; Tugwell, Peter; Reeves, Barnaby C.; Akl, Elie A.; Santesso, Nancy; Spencer, Frederick A.; Shea, Beverley; Wells, George; Helfand, Mark

2013-01-01

The terms applicability, generalizability, external validity and transferability are related, sometimes used interchangeably and have in common that they lack a clear and consistent definition in the classic epidemiological literature. However, all of these terms generally describe one overarching theme: whether or not available research evidence…

Going to Scale: A Nonrandomized Nationwide Trial of the KiVa Antibullying Program for Grades 1-9

ERIC Educational Resources Information Center

Karna, Antti; Voeten, Marinus; Little, Todd D.; Poskiparta, Elisa; Alanen, Erkki; Salmivalli, Christina

2011-01-01

Objective: The effects of school-based antibullying programs have typically been examined on small samples, with number of schools ranging from 1 to 78 (Farrington & Ttofi, 2009). This study investigated the effectiveness of the KiVa antibullying program in the beginning of its nationwide implementation in Finland. Method: At each time point,…

The Relationship between Faculty's Pedagogical Content Knowledge and Students' Knowledge about Diversity in Online Courses

ERIC Educational Resources Information Center

Chaudhery, Mitali

2012-01-01

The purpose of this proposed study will be to examine the relationship between faculty's pedagogical content knowledge and the design of online curriculum to teach students about diversity in a higher education environment. One hundred twenty-seven faculty teaching online courses at a Midwestern state will be selected on non-random sampling to…

Combining Randomized and Non-Randomized Evidence in Clinical Research: A Review of Methods and Applications

ERIC Educational Resources Information Center

Verde, Pablo E.; Ohmann, Christian

2015-01-01

Researchers may have multiple motivations for combining disparate pieces of evidence in a meta-analysis, such as generalizing experimental results or increasing the power to detect an effect that a single study is not able to detect. However, while in meta-analysis, the main question may be simple, the structure of evidence available to answer it…

Testing for Non-Random Mating: Evidence for Ancestry-Related Assortative Mating in the Framingham Heart Study

PubMed Central

Sebro, Ronnie; Hoffman, Thomas J.; Lange, Christoph; Rogus, John J.; Risch, Neil J.

2013-01-01

Population stratification leads to a predictable phenomenon—a reduction in the number of heterozygotes compared to that calculated assuming Hardy-Weinberg Equilibrium (HWE). We show that population stratification results in another phenomenon—an excess in the proportion of spouse-pairs with the same genotypes at all ancestrally informative markers, resulting in ancestrally related positive assortative mating. We use principal components analysis to show that there is evidence of population stratification within the Framingham Heart Study, and show that the first principal component correlates with a North-South European cline. We then show that the first principal component is highly correlated between spouses (r=0.58, p=0.0013), demonstrating that there is ancestrally related positive assortative mating among the Framingham Caucasian population. We also show that the single nucleotide polymorphisms loading most heavily on the first principal component show an excess of homozygotes within the spouses, consistent with similar ancestry-related assortative mating in the previous generation. This nonrandom mating likely affects genetic structure seen more generally in the North American population of European descent today, and decreases the rate of decay of linkage disequilibrium for ancestrally informative markers. PMID:20842694

Genetic effects on mating success and partner choice in a social mammal

PubMed Central

Tung, Jenny; Charpentier, Marie JE; Mukherjee, Sayan; Altmann, Jeanne; Alberts, Susan C

2012-01-01

Mating behavior has profound consequences for two phenomena – individual reproductive success and the maintenance of species boundaries – that contribute to evolutionary processes. Studies of mating behavior in relation to individual reproductive success are common in many species, but studies of mating behavior in relation to genetic variation and species boundaries are less commonly conducted in socially complex species. Here, we leveraged extensive observations of a wild yellow baboon (Papio cynocephalus) population that has experienced recent gene flow from a close sister taxon, the anubis baboon (Papio anubis), to examine how admixture-related genetic background affects mating behavior. We identified novel effects of genetic background on mating patterns, including an advantage accruing to anubis-like males and assortative mating among both yellow-like and anubis-like pairs. These genetic effects acted alongside social dominance rank, inbreeding avoidance, and age to produce highly nonrandom mating patterns. Our results suggest that this population may be undergoing admixture-related evolutionary change, driven in part by nonrandom mating. However, the strength of the genetic effects is mediated by behavioral plasticity and social interactions, emphasizing the strong influence of social context on mating behavior in socially complex species. PMID:22673655

Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion

PubMed Central

2007-01-01

Background The US Food and Drug Administration approved the Charité artificial disc on October 26, 2004. This approval was based on an extensive analysis and review process; 20 years of disc usage worldwide; and the results of a prospective, randomized, controlled clinical trial that compared lumbar artificial disc replacement to fusion. The results of the investigational device exemption (IDE) study led to a conclusion that clinical outcomes following lumbar arthroplasty were at least as good as outcomes from fusion. Methods The author performed a new analysis of the Visual Analog Scale pain scores and the Oswestry Disability Index scores from the Charité artificial disc IDE study and used a nonparametric statistical test, because observed data distributions were not normal. The analysis included all of the enrolled subjects in both the nonrandomized and randomized phases of the study. Results Subjects from both the treatment and control groups improved from the baseline situation (P < .001) at all follow-up times (6 weeks to 24 months). Additionally, these pain and disability levels with artificial disc replacement were superior (P < .05) to the fusion treatment at all follow-up times including 2 years. Conclusions The a priori statistical plan for an IDE study may not adequately address the final distribution of the data. Therefore, statistical analyses more appropriate to the distribution may be necessary to develop meaningful statistical conclusions from the study. A nonparametric statistical analysis of the Charité artificial disc IDE outcomes scores demonstrates superiority for lumbar arthroplasty versus fusion at all follow-up time points to 24 months. PMID:25802574

Survival Benefit of Japanese Extended Lymphadenectomy for Clinically Node-Negative and Node-Positive Colorectal Cancers.

PubMed

Ouchi, Akira; Komori, Koji; Kimura, Kenya; Kinoshita, Takashi; Shimizu, Yasuhiro; Nagino, Masato

2018-02-01

The impact of extended lymphadenectomy for colorectal cancer is still not sufficiently clear. The aim of the present study was to evaluate the survival benefit of extended lymphadenectomy compared with nonextended lymphadenectomy for clinically node-negative and node-positive colorectal cancers. The present study was a retrospective cohort study that used prospectively collected data and a propensity score matching method. The present study was conducted at a single specialized colorectal surgery department. Of the 1314 patients who underwent radical resection with nonextended or extended lymphadenectomy between 1988 and 2007, we included 711 and 603 patients in the cN0 and cN1/2 series. Propensity score matching was applied, and 141 and 63 pairs were extracted from the cN0 and cN1/2 series. Disease-free survival, cancer-specific survival, and overall survival of the 2 groups were calculated and compared. In the cN0 series, no differences were observed in the long-term outcomes between the nonextended and extended groups. In the cN1/2 series, the disease-free survival, cancer-specific survival and overall survival were significantly higher (log rank, p = 0.04, p = 0.02, and p = 0.01, respectively), and the frequency of local recurrence was significantly lower (p = 0.04) in the extended group. The present study was limited by its nonrandomized retrospective design. Extended lymphadenectomy demonstrated a good inhibitory effect on the local recurrence rate and led to improved disease-free survival, cancer-specific survival, and overall survival of patients in the cN1/2 series. See Video Abstract at http://links.lww.com/DCR/A517.

Psychosocial stimulation interventions for children with severe acute malnutrition: a systematic review.

PubMed

Daniel, Allison I; Bandsma, Robert H; Lytvyn, Lyubov; Voskuijl, Wieger P; Potani, Isabel; van den Heuvel, Meta

2017-06-01

The WHO Guidelines for the inpatient treatment of severely malnourished children include a recommendation to provide sensory stimulation or play therapy for children with severe acute malnutrition (SAM). This systematic review was performed to synthesize evidence around this recommendation. Specifically, the objective was to answer the question: "In children with severe acute malnutrition, does psychosocial stimulation improve child developmental, nutritional, or other outcomes?" A review protocol was registered on the International Prospective Register of Systematic Reviews (PROSPERO 2016: CRD42016036403). MEDLINE, Embase, CINAHL, and PsycINFO were searched with terms related to SAM and psychosocial stimulation. Studies were selected if they applied a stimulation intervention in children with SAM and child developmental and nutritional outcomes were assessed. Findings were presented within a narrative synthesis and a summary of findings table. Quality of the evidence was evaluated using the Cochrane risk of bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Only two studies, both non-randomized controlled trials, met the selection criteria for this review. One was conducted in Jamaica (1975) with a follow-up period of 14 years; the other was done in Bangladesh (2002) with a six-month follow-up. At the individual study level, each of the included studies demonstrated significant differences in child development outcomes between intervention and control groups. Only the study conducted in Bangladesh demonstrated a clinically significant increase in weight-for-age z-scores in the intervention group compared to the control group. The evidence supporting the recommendation of psychosocial stimulation for children with SAM is not only sparse, but also of very low quality across important outcomes. High-quality trials are needed to determine the effects of psychosocial stimulation interventions on outcomes in children with SAM.

Pros and Cons of 3D Image Fusion in Endovascular Aortic Repair: A Systematic Review and Meta-analysis.

PubMed

Goudeketting, Seline R; Heinen, Stefan G H; Ünlü, Çağdaş; van den Heuvel, Daniel A F; de Vries, Jean-Paul P M; van Strijen, Marco J; Sailer, Anna M

2017-08-01

To systematically review and meta-analyze the added value of 3-dimensional (3D) image fusion technology in endovascular aortic repair for its potential to reduce contrast media volume, radiation dose, procedure time, and fluoroscopy time. Electronic databases were systematically searched for studies published between January 2010 and March 2016 that included a control group describing 3D fusion imaging in endovascular aortic procedures. Two independent reviewers assessed the methodological quality of the included studies and extracted data on iodinated contrast volume, radiation dose, procedure time, and fluoroscopy time. The contrast use for standard and complex endovascular aortic repairs (fenestrated, branched, and chimney) were pooled using a random-effects model; outcomes are reported as the mean difference with 95% confidence intervals (CIs). Seven studies, 5 retrospective and 2 prospective, involving 921 patients were selected for analysis. The methodological quality of the studies was moderate (median 17, range 15-18). The use of fusion imaging led to an estimated mean reduction in iodinated contrast of 40.1 mL (95% CI 16.4 to 63.7, p=0.002) for standard procedures and a mean 70.7 mL (95% CI 44.8 to 96.6, p<0.001) for complex repairs. Secondary outcome measures were not pooled because of potential bias in nonrandomized data, but radiation doses, procedure times, and fluoroscopy times were lower, although not always significantly, in the fusion group in 6 of the 7 studies. Compared with the control group, 3D fusion imaging is associated with a significant reduction in the volume of contrast employed for standard and complex endovascular aortic procedures, which can be particularly important in patients with renal failure. Radiation doses, procedure times, and fluoroscopy times were reduced when 3D fusion was used.

Prevention of esophageal stricture after endoscopic submucosal dissection: a systematic review and meta-analysis.

PubMed

Oliveira, J F; Moura, E G H; Bernardo, W M; Ide, E; Cheng, S; Sulbaran, M; Santos, C M L; Sakai, P

2016-07-01

Endoscopic submucosal dissection (ESD) of extensive superficial cancers of the esophagus may progress with high rates of postoperative stenosis, resulting in significantly decreased quality of life. Several therapies are performed to prevent this, but have not yet been compared in a systematic review. A systematic review of the literature and meta-analysis were performed using the MEDLINE, Embase, Cochrane, LILACS, Scopus, and CINAHL databases. Clinical trials and observational studies were searched from March 2014 to February 2015. Search terms included: endoscopy, ESD, esophageal stenosis, and esophageal stricture. Three retrospective and four prospective (three randomized) cohort studies were selected and involved 249 patients with superficial esophageal neoplasia who underwent ESD, at least two-thirds of the circumference. We grouped trials comparing different techniques to prevent esophagus stenosis post-ESD. We conducted different meta-analyses on randomized clinical trials (RCT), non-RCT, and global analysis. In RCT (three studies, n = 85), the preventive therapy decreased the risk of stenosis (risk difference = -0.36, 95 % CI -0.55 to -0.18, P = 0.0001). Two studies (one randomized and one non-randomized, n = 55) showed that preventative therapy lowered the average number of endoscopy dilatations (mean difference = -8.57, 95 % CI -13.88 to -3.25, P < 0.002). There were no significant differences in the three RCT studies (n = 85) in complication rates between patients with preventative therapy and those without (risk difference = 0.02, 95 % CI -0.09 to 0.14, P = 0.68). The use of preventive therapy after extensive ESD of the esophagus reduces the risk of stenosis and the number of endoscopic dilatations for resolution of stenosis without increasing the number of complications.

Development and pilot testing of a mobile health solution for asthma self-management: asthma action plan smartphone application pilot study.

PubMed

Licskai, Christopher; Sands, Todd W; Ferrone, Madonna

2013-01-01

Collaborative self-management is a core recommendation of national asthma guidelines; the written action plan is the knowledge tool that supports this objective. Mobile health technologies have the potential to enhance the effectiveness of the action plan as a knowledge translation tool. To design, develop and pilot a mobile health system to support asthma self-management. The present study was a prospective, single-centre, nonrandomized, pilot preintervention-postintervention analysis. System design and development were guided by an expert steering committee. The network included an agnostic web browser-based asthma action plan smartphone application (SPA). Subjects securely transmitted symptoms and peak flow data daily, and received automated control assessment, treatment advice and environmental alerts. Twenty-two adult subjects (mean age 47 years, 82% women) completed the study. Biophysical data were received on 84% of subject days (subject day = 1 subject × 1 day). Subjects viewed their action plan current zone of control on 54% and current air quality on 61% of subject days, 86% followed self-management advice and 50% acted to reduce exposure risks. A large majority affirmed ease of use, clarity and timeliness, and 95% desired SPA use after the study. At baseline, 91% had at least one symptom criterion for uncontrolled asthma and 64% had ≥2, compared with 45% (P=0.006) and 27% (P=0.022) at study close. Mean Asthma Quality of Life Questionnaire score improved from 4.3 to 4.8 (P=0.047). A dynamic, real-time, interactive, mobile health system with an integrated asthma action plan SPA can support knowledge translation at the patient and provider levels.

A comparison of two ambulatory blood pressure monitors worn at the same time.

PubMed

Kallem, Radhakrishna R; Meyers, Kevin E C; Sawinski, Deirdre L; Townsend, Raymond R

2013-05-01

There are limited data in the literature comparing two simultaneously worn ambulatory blood pressure (BP) monitoring (ABPM) devices. The authors compared BPs from two monitors (Mobil-O-Graph [I.E.M., Stolberg, Germany] and Spacelabs 90207 [Spacelabs Medical, Issequah, WA]). In the nonrandomized component of the study, simultaneous 8-hour BP and heart rate data were measured by Mobil-O-Graph, consistently applied to the nondominant arm, and Spacelabs to the dominant arm on 12 untreated adults. Simultaneous 8-hour BP and heart data were obtained by the same monitors randomly assigned to a dominant or nondominant arm on 12 other untreated adults. Oscillometric BP profiles were obtained in the dominant and nondominant arms of the above 24 patients using an Accutorr (Datascope, Mahwah, NJ) device. The Spacelabs monitor recorded a 10.2-mm Hg higher systolic pressure in the nonrandomized (P=.0016) and a 7.9-mm Hg higher systolic pressure in the randomized studies (P=.00008) compared with the Mobil-O-Graph. The mean arterial pressures were 1 mm Hg to 2 mm Hg different between monitors in the two studies, and heart rates were nearly identical. Our observations, if confirmed in larger cohorts, support the concern that ABPM device manufacturers consider developing normative databases for their devices. ©2013 Wiley Periodicals, Inc.

The Effect of Acupressure on Pain in Cancer Patients With Bone Metastasis: A Nonrandomized Controlled Trial.

PubMed

Serçe, Sibel; Ovayolu, Özlem; Pirbudak, Lütfiye; Ovayolu, Nimet

2018-04-01

Pain is a serious and common problem in bone metastases. For this purpose, complementary and supportive practices are also applied along with medical treatment. This study was conducted for the purpose of evaluating the effect of acupressure on pain in cancer patients with bone metastasis. The study was conducted in a nonrandomized controlled trial with patients who applied to the radiotherapy unit of an oncology hospital. The data of the study were collected by using a questionnaire and the Visual Analog Scale. A total of 8 acupressure sessions, which lasted for approximately 10 minutes each (with warming and acupressure periods), was applied to the intervention group. The data were analyzed by using χ 2 test, paired t test, and Pearson's correlation coefficient. It was determined that the pain mean score of the intervention group was 7.6 ± 1.9 before the acupressure and decreased to 6.8 ± 1.9 after the acupressure and this result was statistically significant. On the other hand, no significant difference was determined in the pain mean score of the control group. Acupressure is applicable for cancer patients with bone metastasis by nursing staff after receiving brief training and may make a difference in relieving pain of the patients. Further well-designed trials should be conducted.

The role of anaerobes in patients with ventilator-associated pneumonia and aspiration pneumonia: a prospective study.

PubMed

Marik, P E; Careau, P

1999-01-01

Aspiration of oropharyngeal material, with its high concentration of anaerobic bacteria, has been implicated in the pathogenesis of both ventilator-associated pneumonia (VAP) and aspiration pneumonitis (AP). Consequently, patients with these disorders are usually treated with antimicrobial agents with anaerobic activity. To determine the incidence of anaerobic bacteria in patients with VAP and AP. Prospective, nonrandomized, interventional study. University-affiliated community teaching hospital. We performed sequential blind protected specimen brush (PSB) sampling and mini-BAL in 143 patients with 185 episodes of suspected VAP and 25 patients with AP who required mechanical ventilation. Quantitative aerobic and anaerobic cultures were performed on all specimens. Pneumonia was considered to be present when either > 500 cfu/mL cultured from blind PSB sampling or > 5,000 cfu/mL cultured from mini-BAL were present. Using the predefined criteria, bacterial pneumonia was diagnosed in 63 of 185 suspected VAP episodes (34%) and 12 of 25 patients with AP (48%). At least one dose of an antibiotic was given in the 24 h prior to bacteriologic sampling in 106 suspected VAP episodes (57%) and in 12 patients with AP (48%). More than one pathogen was isolated from 11 VAP and four AP patients. Pseudomonas aeruginosa, Staphylococcus aureus, and enteric Gram-negative organisms were isolated most frequently from patients with VAP. In the patients with AP, enteric Gram-negative organisms were isolated in patients with GI disorders and Streptococcus pneumoniae and Haemophilus influenzae predominated in patients with "community-acquired" aspiration. Only one anaerobic organism was isolated from the entire group of patients; Veillonella paravula was isolated from a blind PSB specimen in a patient with suspected aspiration pneumonia. Despite painstaking effort, we were able to isolate only one anaerobic organism (nonpathogenic) from this group of patients. The spectrum of aerobes in patients with VAP was similar to that reported in the literature. The organisms found in patients with AP was a reflection of the organisms likely to colonize the oropharynx. The use of antibiotics with anaerobic coverage may not be necessary in patients with suspected VAP and AP. Furthermore, penicillin G and clindamycin may not be the antibiotics of choice in patients with AP.

Nutritional support for patients sustaining traumatic brain injury: a systematic review and meta-analysis of prospective studies.

PubMed

Wang, Xiang; Dong, Yan; Han, Xi; Qi, Xiang-Qian; Huang, Cheng-Guang; Hou, Li-Jun

2013-01-01

In traumatic brain injury (TBI), the appropriate timing and route of feeding, and the efficacy of immune-enhancing formulae have not been well established. We performed this meta-analysis aiming to compare the effects of different nutritional support modalities on clinical outcomes of TBI patients. We systematically searched Pubmed, Embase, and the Cochrane Library until October, 2012. All randomized controlled trials (RCTs) and non-randomized prospective studies (NPSs) that compared the effects of different routes, timings, or formulae of feeding on outcomes in TBI patients were selected. The primary outcomes included mortality and poor outcome. The secondary outcomes included the length of hospital stay, the length of ventilation days, and the rate of infectious or feeding-related complications. 13 RCTs and 3 NPSs were included. The pooled data demonstrated that, compared with delayed feeding, early feeding was associated with a significant reduction in the rate of mortality (relative risk [RR] = 0.35; 95% CI, 0.24-0.50), poor outcome (RR = 0.70; 95% CI, 0.54-0.91), and infectious complications (RR = 0.77; 95% CI, 0.59-0.99). Compared with enteral nutrition, parenteral nutrition showed a slight trend of reduction in the rate of mortality (RR = 0.61; 95% CI, 0.34-1.09), poor outcome (RR = 0.73; 95% CI, 0.51-1.04), and infectious complications (RR = 0.89; 95% CI, 0.66-1.22), whereas without statistical significances. The immune-enhancing formula was associated with a significant reduction in infection rate compared with the standard formula (RR = 0.54; 95% CI, 0.35-0.82). Small-bowel feeding was found to be with a decreasing rate of pneumonia compared with nasogastric feeding (RR = 0.41; 95% CI, 0.22-0.76). After TBI, early initiation of nutrition is recommended. It appears that parenteral nutrition is superior to enteral nutrition in improving outcomes. Our results lend support to the use of small-bowel feeding and immune-enhancing formulae in reducing infectious complications.

Nutritional Support for Patients Sustaining Traumatic Brain Injury: A Systematic Review and Meta-Analysis of Prospective Studies

PubMed Central

Han, Xi; Qi, Xiang-Qian; Huang, Cheng-Guang; Hou, Li-Jun

2013-01-01

Background In traumatic brain injury (TBI), the appropriate timing and route of feeding, and the efficacy of immune-enhancing formulae have not been well established. We performed this meta-analysis aiming to compare the effects of different nutritional support modalities on clinical outcomes of TBI patients. Methods We systematically searched Pubmed, Embase, and the Cochrane Library until October, 2012. All randomized controlled trials (RCTs) and non-randomized prospective studies (NPSs) that compared the effects of different routes, timings, or formulae of feeding on outcomes in TBI patients were selected. The primary outcomes included mortality and poor outcome. The secondary outcomes included the length of hospital stay, the length of ventilation days, and the rate of infectious or feeding-related complications. Findings 13 RCTs and 3 NPSs were included. The pooled data demonstrated that, compared with delayed feeding, early feeding was associated with a significant reduction in the rate of mortality (relative risk [RR] = 0.35; 95% CI, 0.24–0.50), poor outcome (RR = 0.70; 95% CI, 0.54–0.91), and infectious complications (RR = 0.77; 95% CI, 0.59–0.99). Compared with enteral nutrition, parenteral nutrition showed a slight trend of reduction in the rate of mortality (RR = 0.61; 95% CI, 0.34–1.09), poor outcome (RR = 0.73; 95% CI, 0.51–1.04), and infectious complications (RR = 0.89; 95% CI, 0.66–1.22), whereas without statistical significances. The immune-enhancing formula was associated with a significant reduction in infection rate compared with the standard formula (RR = 0.54; 95% CI, 0.35–0.82). Small-bowel feeding was found to be with a decreasing rate of pneumonia compared with nasogastric feeding (RR = 0.41; 95% CI, 0.22–0.76). Conclusion After TBI, early initiation of nutrition is recommended. It appears that parenteral nutrition is superior to enteral nutrition in improving outcomes. Our results lend support to the use of small-bowel feeding and immune-enhancing formulae in reducing infectious complications. PMID:23527035

A comparison of continuous video-EEG monitoring and 30-minute EEG in an ICU.

PubMed

Khan, Omar I; Azevedo, Christina J; Hartshorn, Alendia L; Montanye, Justin T; Gonzalez, Juan C; Natola, Mark A; Surgenor, Stephen D; Morse, Richard P; Nordgren, Richard E; Bujarski, Krzysztof A; Holmes, Gregory L; Jobst, Barbara C; Scott, Rod C; Thadani, Vijay M

2014-12-01

To determine whether there is added benefit in detecting electrographic abnormalities from 16-24 hours of continuous video-EEG in adult medical/surgical ICU patients, compared to a 30-minute EEG. This was a prospectively enroled non-randomized study of 130 consecutive ICU patients for whom EEG was requested. For 117 patients, a 30-minute EEG was requested for altered mental state and/or suspected seizures; 83 patients continued with continuous video-EEG for 16-24 hours and 34 patients had only the 30-minute EEG. For 13 patients with prior seizures, continuous video-EEG was requested and was carried out for 16-24 hours. We gathered EEG data prospectively, and reviewed the medical records retrospectively to assess the impact of continuous video-EEG. A total of 83 continuous video-EEG recordings were performed for 16-24 hours beyond 30 minutes of routine EEG. All were slow, and 34% showed epileptiform findings in the first 30 minutes, including 2% with seizures. Over 16-24 hours, 14% developed new or additional epileptiform abnormalities, including 6% with seizures. In 8%, treatment was changed based on continuous video-EEG. Among the 34 EEGs limited to 30 minutes, almost all were slow and 18% showed epileptiform activity, including 3% with seizures. Among the 13 patients with known seizures, continuous video-EEG was slow in all and 69% had epileptiform abnormalities in the first 30 minutes, including 31% with seizures. An additional 8% developed epileptiform abnormalities over 16-24 hours. In 46%, treatment was changed based on continuous video-EEG. This study indicates that if continuous video-EEG is not available, a 30-minute EEG in the ICU has a substantial diagnostic yield and will lead to the detection of the majority of epileptiform abnormalities. In a small percentage of patients, continuous video-EEG will lead to the detection of additional epileptiform abnormalities. In a sub-population, with a history of seizures prior to the initiation of EEG recording, the benefits of continuous video-EEG in monitoring seizure activity and influencing treatment may be greater.

Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study.

PubMed

Smith, Timothy L; Kern, Robert C; Palmer, James N; Schlosser, Rodney J; Chandra, Rakesh K; Chiu, Alexander G; Conley, David; Mace, Jess C; Fu, Rongwei F; Stankiewicz, James A

2011-01-01

Evidence evaluating the comparative effectiveness of various treatments for chronic rhinosinusitis (CRS) is insufficient. This study evaluates outcomes in patients who failed initial medical management and elect a subsequent treatment option, either continued medical management or endoscopic sinus surgery (ESS) coupled with continued medical management. Adult subjects were prospectively enrolled into a nonrandomized, multi-institutional cohort. Baseline characteristics and objective clinical findings were collected. Primary outcome measures included 2 disease-specific quality-of-life (QOL) instruments: the Rhinosinusitis Disability Index (RSDI) and Chronic Sinusitis Survey (CSS). Bivariate and multivariate analyses compared QOL improvement by treatment type, as well as differences in antibiotic and oral steroid utilization and work/school productivity. Subjects (n = 180) were enrolled between March 2009 and April 2010. Patients electing medical management (n = 55) reported significantly better baseline QOL on 1 instrument relative to surgery patients (CSS symptom [p = 0.019] and total scores [p = 0.010]). Surgical patients (n = 75) reported significantly more improvement than medically managed patients (RSDI, p = 0.015; CSS, p < 0.001). Surgical patients reported significantly fewer oral antibiotics (p = 0.002), oral steroids (p = 0.042), and missed days of work/school (p < 0.001) following ESS. After adjustment, more frequent improvement was found within the surgical cohort as measured by the RSDI physical (78.7% vs 56.4%; odds ratio [OR], 3.36; 95% confidence interval [CI], 1.15-9.87; p = 0.027), CSS symptom (80.6% vs 57.4%; OR, 2.65; 95% CI, 1.06-6.66; p = 0.038), medication (49.3% vs 29.6%; OR, 2.33; 95% CI, 0.96-5.64; p = 0.060), and total scores (76.4% vs 53.7%; OR, 2.20; 95% CI, 0.86-5.59; p = 0.099). Patients electing ESS experienced significantly higher levels of improvement in several outcomes. Further investigation with a larger cohort is warranted as treatment selection bias may confound the magnitude of improvement experienced with each treatment. Copyright © 2011 American Rhinologic Society-American Academy of Otolaryngic Allergy, LLC.

Lacrimal Gland Radiosensitivity in Uveal Melanoma Patients

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

Muller, Karin; Nowak, Peter J.C.M.; Naus, Nicole

2009-06-01

Purpose: To find a dose-volume effect for inhomogeneous irradiated lacrimal glands. Methods and Materials: Between 1999 and 2006, 72 patients (42 men and 30 women) were treated with fractionated stereotactic radiotherapy in a prospective, nonrandomized clinical trial (median follow-up, 32 months). A total dose of 50 Gy was given on 5 consecutive days. The mean of all Schirmer test results obtained {>=}6 months after treatment was correlated with the radiation dose delivered to the lacrimal gland. Also, the appearance of dry eye syndrome (DES) was related to the lacrimal gland dose distribution. Results: Of the 72 patients, 17 developed amore » late Schirmer value <10 mm; 9 patients developed DES. A statistically significant relationship was found between the received median dose in the lacrimal gland vs. reduced tear production (p = 0.000) and vs. the appearance of DES (p = 0.003), respectively. A median dose of 7 Gy/fraction to the lacrimal gland caused a 50% risk of low Schirmer results. A median dose of 10 Gy resulted in a 50% probability of DES. Conclusion: We found a clear dose-volume relationship for irradiated lacrimal glands with regard to reduced tear production and the appearance of DES.« less

Patient-based outcomes in patients with primary tinnitus undergoing tinnitus retraining therapy.

PubMed

Berry, Julie A; Gold, Susan L; Frederick, Ellen Alvarez; Gray, William C; Staecker, Hinrich

2002-10-01

To determine whether the Tinnitus Handicap Inventory (THI), a validated patient-based outcomes measure, may improve our ability to quantify impact and assess therapy for patients with tinnitus. Nonrandomized, prospective analysis of 32 patients undergoing tinnitus retraining therapy (TRT). Assessment tools included comprehensive audiology, a subjective self-assessment survey of tinnitus characteristics, and the THI. Tinnitus Handicap Inventory scores were assessed at baseline and 6 months following TRT. Baseline analysis revealed significant correlation between the subjective presence of hyperacusis and higher total, emotional, and catastrophic THI scores. Tinnitus Handicap Inventory scores correlated with subjective perception of overall tinnitus effect (P<.001). Mean pure-tone threshold average was 17.4 dB, and mean speech discrimination was 97.0%. There were no consistent correlations between baseline audiologic parameters and THI scores. Following 6 months of TRT, the total, emotional, functional, and catastrophic THI scores significantly improved (P<.001). Loudness discomfort levels also significantly improved (P< or =.02). There is significant improvement in self-perceived disability following TRT as measured by the THI. The results confirm the utility of the THI as a patient-based outcomes measure for quantifying treatment status in patients with primary tinnitus.

Non-random nectar unloading interactions between foragers and their receivers in the honeybee hive

NASA Astrophysics Data System (ADS)

Goyret, Joaquín; Farina, Walter M.

2005-09-01

Nectar acquisition in the honeybee Apis mellifera is a partitioned task in which foragers gather nectar and bring it to the hive, where nest mates unload via trophallaxis (i.e. mouth-to-mouth transfer) the collected food for further storage. Because forager mates exploit different feeding places simultaneously, this study addresses the question of whether nectar unloading interactions between foragers and hive-bees are established randomly, as it is commonly assumed. Two groups of foragers were trained to exploit a different scented food source for 5 days. We recorded their trophallaxes with hive-mates, marking the latter ones according to the forager group they were unloading. We found non-random probabilities for the occurrence of trophallaxes between experimental foragers and hive-bees, instead, we found that trophallactic interactions were more likely to involve groups of individuals which had formerly interacted orally. We propose that olfactory cues present in the transferred nectar promoted the observed bias, and we discuss this bias in the context of the organization of nectar acquisition: a partitioned task carried out in a decentralized insect society.

Selecting for extinction: nonrandom disease-associated extinction homogenizes amphibian biotas.

PubMed

Smith, Kevin G; Lips, Karen R; Chase, Jonathan M

2009-10-01

Studying the patterns in which local extinctions occur is critical to understanding how extinctions affect biodiversity at local, regional and global spatial scales. To understand the importance of patterns of extinction at a regional spatial scale, we use data from extirpations associated with a widespread pathogenic agent of amphibian decline, Batrachochytrium dendrobatidis (Bd) as a model system. We apply novel null model analyses to these data to determine whether recent extirpations associated with Bd have resulted in selective extinction and homogenization of diverse tropical American amphibian biotas. We find that Bd-associated extinctions in this region were nonrandom and disproportionately, but not exclusively, affected low-occupancy and endemic species, resulting in homogenization of the remnant amphibian fauna. The pattern of extirpations also resulted in phylogenetic homogenization at the family level and ecological homogenization of reproductive mode and habitat association. Additionally, many more species were extirpated from the region than would be expected if extirpations occurred randomly. Our results indicate that amphibian declines in this region are an extinction filter, reducing regional amphibian biodiversity to highly similar relict assemblages and ultimately causing amplified biodiversity loss at regional and global scales.

Intraoperative radiotherapy for patients with carcinoma of the pancreas. The Howard University Hospital experience, 1978-1986.

PubMed

Tuckson, W B; Goldson, A L; Ashayeri, E; Halyard-Richardson, M; DeWitty, R L; Leffall, L D

1988-06-01

During the period from 1978 to 1986, 106 patients were diagnosed with carcinoma of the pancreas; 30 of these patients were excluded from this study. Of the remaining 76 patients, 40 did not receive intraoperative radiotherapy (IORT) and were used as the nonrandomized control group for the 36 patients who did receive IORT after histologic confirmation of carcinoma of the pancreas. The records of 35 patients were available for review. The group receiving IORT ranged in ages from 43 to 89 years (20 males and 15 females). Seventeen patients had distant metastatic disease. The primary was located in the head of the pancreas in 32 and the body in three. No patient in this group had a curative resection. All patients were treated by a combination of biliary and gastric bypass prior to or concurrent with IORT. IORT was begun only after obtaining a histologic diagnosis and prior to the completion of any anastomosis. Necrotizing pancreatitis occurred in the treated group. There was no statistically significant difference in the survival of the nonrandomized control and treated groups.

Systematic review of physiotherapy interventions to improve gross motor capacity and performance in children and adolescents with an acquired brain injury.

PubMed

Baque, Emmah; Sakzewski, Leanne; Barber, Lee; Boyd, Roslyn N

2016-01-01

To systematically review the efficacy of physiotherapy interventions to improve gross motor capacity, performance and societal participation in children aged 5-17 years with an acquired brain injury (ABI). Randomized and non-randomized controlled trials, cohort, case series, case-control and case studies were included and classified according to grades of evidence. Methodological quality of studies was assessed using the Downs and Black (D&B) scale and quantitative data was analysed using effect sizes. Two home-based studies investigated functional strength training (one randomized controlled trial, n = 20, level 2b, D&B = 16/32 and one non-randomized self-control study, n = 19, level 4, D&B = 15/32). Four studies evaluated virtual reality including: one pilot study, n = 50, level 4, D&B = 22/32; one single-subject, non-concurrent, randomized multiple baseline study, n = 3, level 4, D&B = 15/32; one case series study, n = 2, level 4, D&B = 15/32; one case study, n = 1, level 4, D&B = 15/32. Effect sizes for the randomized controlled trial ranged between 0.30-1.29 for the Functional Reach and Timed Up and Go outcome measures. There is preliminary evidence to support the efficacy of physiotherapy interventions to improve gross motor outcomes in children with an ABI. Both functional strength training and virtual-reality based therapy are potential treatment options for clinicians to prescribe in either home or clinical settings.

Chromatin position in human HepG2 cells: although being non-random, significantly changed in daughter cells.

PubMed

Cvacková, Zuzana; Masata, Martin; Stanĕk, David; Fidlerová, Helena; Raska, Ivan

2009-02-01

Mammalian chromosomes occupy chromosome territories within nuclear space the positions of which are generally accepted as non-random. However, it is still controversial whether position of chromosome territories/chromatin is maintained in daughter cells. We addressed this issue and investigated maintenance of various chromatin regions of unknown composition as well as nucleolus-associated chromatin, a significant part of which is composed of nucleolus organizer region-bearing chromosomes. The photoconvertible histone H4-Dendra2 was used to label such regions in transfected HepG2 cells, and its position was followed up to next interphase. The distribution of labeled chromatin in daughter cells exhibited a non-random character. However, its distribution in a vast majority of daughter cells extensively differed from the original ones and the labeled nucleolus-associated chromatin differently located into the vicinity of different nucleoli. Therefore, our results were not consistent with a concept of preservation chromatin position. This conclusion was supported by the finding that the numbers of nucleoli significantly differed between the two daughter cells. Our results support a view that while the transfected daughter HepG2 cells maintain some features of the parental cell chromosome organization, there is also a significant stochastic component associated with reassortment of chromosome territories/chromatin that results in their positional rearrangements.

Nonrandom patterns of roost emergence in big brown bats, Eptesicus fuscus

USGS Publications Warehouse

Gillam, E.H.; O'Shea, T.J.; Brigham, R.M.

2011-01-01

In most colonial species of bats individuals emerge en masse from day roosts each evening to begin foraging. Although some aspects of emergence behavior are understood, one previously unexplored area is the specific order in which individuals emerge. The goal of our research was to determine if big brown bats, Eptesicus fuscus, fitted with passive integrated transponder tags emerge from roosts in buildings each evening in a nonrandom order. We assessed relative and absolute order of emergence to determine if order is concordant across nights and whether individuals consistently emerge in close association with specific roost mates. We found significant concordance in rank order among nights at all roosts. At 5 roosts concordance decreased as time between dates increased. Association rates between individuals were low, and temporal analyses revealed that associations rapidly degraded over time, indicating that bats do not emerge each evening consistently with the same group of roost mates. We discuss how social structure, information transfer, and/or individual energetic needs could be responsible for the observed nonrandom patterns of emergence. Our results suggest that emergence order represents behavioral information that traditionally has been overlooked and that might be useful for characterizing aspects of the ecology and social behavior of bats and other species with cryptic behavior. ?? 2011 American Society of Mammalogists.

Higher-order genome organization in platypus and chicken sperm and repositioning of sex chromosomes during mammalian evolution.

PubMed

Tsend-Ayush, Enkhjargal; Dodge, Natasha; Mohr, Julia; Casey, Aaron; Himmelbauer, Heinz; Kremitzki, Colin L; Schatzkamer, Kyriena; Graves, Tina; Warren, Wesley C; Grützner, Frank

2009-02-01

In mammals, chromosomes occupy defined positions in sperm, whereas previous work in chicken showed random chromosome distribution. Monotremes (platypus and echidnas) are the most basal group of living mammals. They have elongated sperm like chicken and a complex sex chromosome system with homology to chicken sex chromosomes. We used platypus and chicken genomic clones to investigate genome organization in sperm. In chicken sperm, about half of the chromosomes investigated are organized non-randomly, whereas in platypus chromosome organization in sperm is almost entirely non-random. The use of genomic clones allowed us to determine chromosome orientation and chromatin compaction in sperm. We found that in both species chromosomes maintain orientation of chromosomes in sperm independent of random or non-random positioning along the sperm nucleus. The distance of loci correlated with the total length of sperm nuclei, suggesting that chromatin extension depends on sperm elongation. In platypus, most sex chromosomes cluster in the posterior region of the sperm nucleus, presumably the result of postmeiotic association of sex chromosomes. Chicken and platypus autosomes sharing homology with the human X chromosome located centrally in both species suggesting that this is the ancestral position. This suggests that in some therian mammals a more anterior position of the X chromosome has evolved independently.

Higher-order genome organization in platypus and chicken sperm and repositioning of sex chromosomes during mammalian evolution

PubMed Central

Tsend-Ayush, Enkhjargal; Dodge, Natasha; Mohr, Julia; Casey, Aaron; Himmelbauer, Heinz; Kremitzki, Colin L.; Schatzkamer, Kyriena; Graves, Tina; Warren, Wesley C.

2013-01-01

In mammals, chromosomes occupy defined positions in sperm, whereas previous work in chicken showed random chromosome distribution. Monotremes (platypus and echidnas) are the most basal group of living mammals. They have elongated sperm like chicken and a complex sex chromosome system with homology to chicken sex chromosomes. We used platypus and chicken genomic clones to investigate genome organization in sperm. In chicken sperm, about half of the chromosomes investigated are organized non-randomly, whereas in platypus chromosome organization in sperm is almost entirely non-random. The use of genomic clones allowed us to determine chromosome orientation and chromatin compaction in sperm. We found that in both species chromosomes maintain orientation of chromosomes in sperm independent of random or non-random positioning along the sperm nucleus. The distance of loci correlated with the total length of sperm nuclei, suggesting that chromatin extension depends on sperm elongation. In platypus, most sex chromosomes cluster in the posterior region of the sperm nucleus, presumably the result of postmeiotic association of sex chromosomes. Chicken and platypus autosomes sharing homology with the human X chromosome located centrally in both species suggesting that this is the ancestral position. This suggests that in some therian mammals a more anterior position of the X chromosome has evolved independently. PMID:18726609

The Pharmacogenomics of Bipolar Disorder study (PGBD): identification of genes for lithium response in a prospective sample.

PubMed

Oedegaard, Ketil J; Alda, Martin; Anand, Anit; Andreassen, Ole A; Balaraman, Yokesh; Berrettini, Wade H; Bhattacharjee, Abesh; Brennand, Kristen J; Burdick, Katherine E; Calabrese, Joseph R; Calkin, Cynthia V; Claasen, Ana; Coryell, William H; Craig, David; DeModena, Anna; Frye, Mark; Gage, Fred H; Gao, Keming; Garnham, Julie; Gershon, Elliot; Jakobsen, Petter; Leckband, Susan G; McCarthy, Michael J; McInnis, Melvin G; Maihofer, Adam X; Mertens, Jerome; Morken, Gunnar; Nievergelt, Caroline M; Nurnberger, John; Pham, Son; Schoeyen, Helle; Shekhtman, Tatyana; Shilling, Paul D; Szelinger, Szabolcs; Tarwater, Bruce; Yao, Jun; Zandi, Peter P; Kelsoe, John R

2016-05-05

Bipolar disorder is a serious and common psychiatric disorder characterized by manic and depressive mood switches and a relapsing and remitting course. The cornerstone of clinical management is stabilization and prophylaxis using mood-stabilizing medications to reduce both manic and depressive symptoms. Lithium remains the gold standard of treatment with the strongest data for both efficacy and suicide prevention. However, many patients do not respond to this medication, and clinically there is a great need for tools to aid the clinician in selecting the correct treatment. Large genome wide association studies (GWAS) investigating retrospectively the effect of lithium response are in the pipeline; however, few large prospective studies on genetic predictors to of lithium response have yet been conducted. The purpose of this project is to identify genes that are associated with lithium response in a large prospective cohort of bipolar patients and to better understand the mechanism of action of lithium and the variation in the genome that influences clinical response. This study is an 11-site prospective non-randomized open trial of lithium designed to ascertain a cohort of 700 subjects with bipolar I disorder who experience protocol-defined relapse prevention as a result of treatment with lithium monotherapy. All patients will be diagnosed using the Diagnostic Interview for Genetic Studies (DIGS) and will then enter a 2-year follow-up period on lithium monotherapy if and when they exhibit a score of 1 (normal, not ill), 2 (minimally ill) or 3 (mildly ill) on the Clinical Global Impressions of Severity Scale for Bipolar Disorder (CGI-S-BP Overall Bipolar Illness) for 4 of the 5 preceding weeks. Lithium will be titrated as clinically appropriate, not to exceed serum levels of 1.2 mEq/L. The sample will be evaluated longitudinally using a wide range of clinical scales, cognitive assessments and laboratory tests. On relapse, patients will be discontinued or crossed-over to treatment with valproic acid (VPA) or treatment as usual (TAU). Relapse is defined as a DSM-IV manic, major depressive or mixed episode or if the treating physician decides a change in medication is clinically necessary. The sample will be genotyped for GWAS. The outcome for lithium response will be analyzed as a time to event, where the event is defined as clinical relapse, using a Cox Proportional Hazards model. Positive single nucleotide polymorphisms (SNPs) from past genetic retrospective studies of lithium response, the Consortium on Lithium Genetics (ConLiGen), will be tested in this prospective study sample; a meta-analysis of these samples will then be performed. Finally, neurons will be derived from pluripotent stem cells from lithium responders and non-responders and tested in vivo for response to lithium by gene expression studies. SNPs in genes identified in these cellular studies will also be tested for association to response. Lithium is an extraordinarily important therapeutic drug in the clinical management of patients suffering from bipolar disorder. However, a significant proportion of patients, 30-40 %, fail to respond, and there is currently no method to identify the good lithium responders before initiation of treatment. Converging evidence suggests that genetic factors play a strong role in the variation of response to lithium, but only a few genes have been tested and the samples have largely been retrospective or quite small. The current study will collect an entirely unique sample of 700 patients with bipolar disorder to be stabilized on lithium monotherapy and followed for up to 2 years. This study will produce useful information to improve the understanding of the mechanism of action of lithium and will add to the development of a method to predict individual response to lithium, thereby accelerating recovery and reducing suffering and cost. ClinicalTrials.gov Identifier: NCT01272531 Registered: January 6, 2011.

A Preliminary Investigation into the Potential Role of Waist Hip Ratio (WHR) Preference within the Assortative Mating Hypothesis of Autistic Spectrum Disorders

ERIC Educational Resources Information Center

Brosnan, Mark; Walker, Ian

2009-01-01

Of particular interest to studying the etiology of Autistic Spectrum Disorders (ASDs) is the potential for multiple risk factors to combine through non-random mechanisms--assortative mating. Both genetic influences and a high-testosterone prenatal environment have been implicated in the etiology of ASDs, and given that waist-hip ratio (WHR) is…

What Can We Learn about Effective Early Mathematics Teaching? A Framework for Estimating Causal Effects Using Longitudinal Survey Data

ERIC Educational Resources Information Center

Guarino, Cassandra; Dieterle, Steven G.; Bargagliotti, Anna E.; Mason, William M.

2013-01-01

This study investigates the impact of teacher characteristics and instructional strategies on the mathematics achievement of students in kindergarten and first grade and tackles the question of how best to use longitudinal survey data to elicit causal inference in the face of potential threats to validity due to nonrandom assignment to treatment.…

"At Risk of Harm"? An Exploratory Survey of School Counsellors in the UK, Their Perceptions of Confidentiality, Information Sharing and Risk Management

ERIC Educational Resources Information Center

Jenkins, Peter; Palmer, Joanne

2012-01-01

The primary objective of this study was to explore perceptions of UK school counsellors of confidentiality and information sharing in therapeutic work with children and young people, using qualitative methods. The research design employed a two-stage process, using questionnaires and follow-up interviews, with a small, non-random sample of school…

The origin of biological macromolecules on the earth. The hypothesis of inorganic template

NASA Technical Reports Server (NTRS)

Lu, T. S.

1977-01-01

Studies about the origin of life are reviewed. The nonrandom organization of organelles is discussed from a structural and functional point of view. After postulating that the origin of biomacromolecules was not a random event, the paper develops the hypothesis that polypeptides and polynucleotides were formed on an inorganic template. Only information-containing structures can pass natural selection and develop through evolution.

Can we prevent hip dislocation in children with cerebral palsy? Effects of postural management.

PubMed

Picciolini, Odoardo; LE Métayer, Michel; Consonni, Dario; Cozzaglio, Massimo; Porro, Matteo; Gasparroni, Verusca; Panou, Artemisia; Mosca, Fabio; Portinaro, Nicola M

2016-10-01

Hip dislocation is common in children with cerebral palsy (CP). At birth they do not have musculoskeletal deformities but they develop over time due to the combined effects of the movement disorder and impaired gross motor function. Early detection and treatment of a hip at risk is needed to modify the natural of hip development in CP. The aim of this study was to determine the effect of postural management treatment on hip displacement's progression in children CP. Prospective comparative non-randomized study. Rehabilitative outpatient unit. Fifty-one children with CP were studied; the treated group (N.=30) was compared to a control group (N.=21). The treated group followed a two year's long combined treatment program consisting a neurodevelopment treatment (NDT) two times a week and a 5 hours daily siège moulé postural program. The control group underwent only NDT twice a week for two years. Hip radiographs were measured with the migration percentage (MP) method at baseline, at 1 and 2 years of follow-up. A significant difference has been observed in the MP (%) trend (P<0.001) between treatment and control groups. At 2 years, there was a marked worsening (MP from 23.0 to 37.7) in the control group, compared to the stability (from 28.8 to 26.8) in the treatment group. This study supports the evidence that conservative postural management of hip deformity is useful to prevent the natural progression of hip dislocation. Hip radiographic follow up program together with NDT and postural management program is useful to modify the natural progression of hip dislocation in children with CP.

Initial experience with ketamine-based analgesia in patients undergoing robotic radical cystectomy and diversion.

PubMed

Jacobsohn, Kenneth; Davis, Tanya D; El-Arabi, Ahmad M; Tlachac, Jonathan; Langenstroer, Peter; O'Connor, R Corey; Guralnick, Michael L; See, William A; Schlosser, Robert

2015-01-01

We instituted a ketamine-predominant analgesic regimen in the peri- and postoperative periods to limit the effects of narcotic analgesia on bowel function in patients undergoing radical cystectomy. The primary end points of interest were time to return of bowel function, time to discharge, and efficacy of the analgesic regimen. We performed a retrospective chart review of patients undergoing robotic-assisted laparoscopic cystectomy (RARC) with urinary diversion by a single surgeon at our institution from January 1, 2011 to June 30, 2012. Patients receiving the opioid-minimizing ketamine protocol were compared to a cohort of patients undergoing RARC with an opioid-predominant analgesic regimen. In total, 15 patients (Group A) were included in the ketamine-predominant regimen and 25 patients (Group B) in the opioid-predominant control group. Three patients (19%) in Group A discontinued the protocol due to ketamine side effects. The mean time to bowel movement and length of stay in Group A versus Group B was 3 versus 6 days (p < 0.001), and 4 versus 8 days, respectively (p < 0.001). Group A patients received an average of 13.0 mg of morphine versus 97.5 mg in Group B (p < 0.001). Patients who received our ketamine pain control regimen had a shorter time to return of bowel function and length of hospitalization after RARC. Our study has its limitations as a retrospective, single surgeon, single institution study and the non-randomization of patients. Notwithstanding these limitations, this study was not designed to show inferiority of one approach, but instead to show that our protocol is safe and efficacious, warranting further study in a prospective fashion.

Validation of STA-Liatest D-Di assay for exclusion of pulmonary embolism according to the latest Clinical and Laboratory Standard Institute/Food and Drug Administration guideline. Results of a multicenter management study.

PubMed

Pernod, Gilles; Wu, Haifeng; de Maistre, Emmanuel; Lazarchick, John; Kassis, Jeannine; Aguilar, Carlos; Vera, Pascual M; Palareti, Gualtiero; D'Angelo, Armando

2017-04-01

: Combined clinical pretest probability (PTP) and D-dimer testing have great diagnostic value for pulmonary embolism exclusion. To harmonize performance levels of D-dimer assays available on the market, the Clinical and Laboratory Standard Institute (CLSI) has published a guideline, endorsed by the US Food and Drug Administration (FDA). Such guideline specifies the ideal D-dimer assay characteristic and target population. This study was conducted following the CLSI guideline to upgrade the assay-intended use and obtain FDA clearance of STA-Liatest D-Di assay for pulmonary embolism exclusion in patient with low/moderate PTP. This was an international, multicenter, prospective nonrandomized, noninterventional clinical outcome management study conducted in a standard of care setting. D-dimer assay was performed in consecutive, ambulatory outpatients suspected of pulmonary embolism, with low/moderate PTP, and without medical conditions or in clinical settings known to alter default D-dimer values regardless of the presence of thrombosis using a threshold of 0.5 μg/ml (fibrinogen equivalent units) for venous thromboembolism exclusion. Results were used to determine test performance. Of 1141 patients who underwent D-dimer testing, 1060 had valid results and completed study as planned. STA-Liatest D-Di assay performance has exceeded the CLSI/FDA guidance requirements, with a sensitivity of 97.6% (95% confidence interval: 91.7-99.7%) and a negative predictive value of 99.7% (95% confidence interval: 99.0-100%). STA-Liatest D-Di assay has an excellent performance when used in combination with a PTP score in relevant patients and has the potential to minimize the economic healthcare burden avoiding unnecessary and expensive imaging tests.

Correlation of Radiological and Endoscopic Findings in Patients Presenting with Dysphagia.

PubMed

Sachdeva, Kavita; Kaul, Vineet

2017-03-01

Dysphagia is a common symptom with diverse etiology in otolaryngology. In the present study clinicopathological, radiological and endoscopic evaluation of patients was done in a tertiary care hospital in patients presenting with dysphagia. A prospective nonrandomized observational study was carried out on total of 80 cases having dysphagia during March 2015 to August 2016. In the present study, out of 80 patients, youngest case was a three years old child while oldest case was an 85 years old female. The mean age was 48.3 ± 20.3 years. The majority of cases were in age group 41-59 years (35%). Male to female ratio was 2.33:1. The mean duration of illness was 15.44 weeks. 15% of patients had absolute dysphagia. For detecting the lesion, Barium swallow study (BSS) showed a total sensitivity of 49.05% (n = 53), Computerised Tomography (CT) showed a total sensitivity of 85.70% (n = 49), plain skiagram neck & chest showed a total sensitivity of 88.88% (n = 9) and endoscopy was the most sensitive test overall as it showed a total sensitivity of 98.75% (n = 80). No complications were reported with either rigid or flexible endoscopy. Dysphagia is a common presenting complaint in otolaryngology with cases coming directly or being referred from other specialities. Males are more commonly affected than females and incidence of malignancy increases with age. Endoscopy can become the first screening test in dysphagia due to its high sensitivity and low risk of complications, with radiological tests being done in an adjunct manner.

A Novel Technique for Clinical Assessment of Laryngeal Nerve Conduction: Normal and Abnormal Results

PubMed Central

Sulica, Lucian; Carey, Bridget; Branski, Ryan C.

2014-01-01

Objectives/Hypothesis To describe a novel conduction study of the laryngeal nerves, including normal values and abnormal findings. Study Design Prospective nonrandomized. Methods Seventeen healthy adult volunteers, as well as three patients with clinically identified laryngeal neuropathy, underwent low-level brief electrical stimulation of the laryngeal mucosa by means of a wire inserted via a transnasal flexible laryngoscope. Bilateral hookwire electrodes recorded the result in the laryngeal adductor muscles. Results This study yields an early response ipsilateral to the side of stimulation (LR1), which is uniform and consistent (right 5 13.2 6 0.80 msec; left 5 15.2 6 1.20 msec), and late bilateral responses (ipsilateral LR2 [LR2i] and contralateral LR2 [LR2c]), which exhibit greater variation in latency and morphology (right LR2i 5 50.5 6 3.38 msec; left LR2i 5 52.2 msec; right LR2c 5 50.7 6 4.26; left LR2c 5 50.6 6 4.07). Findings in abnormal patients differ significantly from normal, consistent with the distribution of neuropathy. Conclusions We describe a novel, clinically applicable conduction study of laryngeal nerves. Normative electrodiagnostic values and variations of the reflex responses of the laryngeal adductor muscles in response to irritative stimulation of the laryngeal mucosa (Laryngeal Closure Reflex) are proposed. By enabling the determination of electrophysiological parameters of the superior laryngeal and recurrent laryngeal branches of cranial nerve X (CN X), this procedure, which is used as an adjunct to laryngeal electromyography, may provide earlier and more accurate information regarding the extent and grade of nerve injury. Because injury grade relates directly to prognosis, the information derived from this test may have clinical relevance in determining optimal treatment. Level of Evidence 4. PMID:23835889

Quality of life and side effects in patients with actinic keratosis treated with ingenol mebutate: a pilot study.

PubMed

Jubert-Esteve, E; Del Pozo-Hernando, L J; Izquierdo-Herce, N; Bauzá-Alonso, A; Martín-Santiago, A; Jones-Caballero, M

2015-10-01

Actinic keratosis (AK) lesions are in situ squamous cell carcinoma. These lesions have a low risk of progressing to invasive disease but significant impact on patients' quality of life (QoL). The aim of this study was to assess QoL and side effects in patients with AK receiving treatment with ingenol mebutate. This was a prospective, non-randomized pilot study carried out in Spain. The target population was adults with a clinical diagnosis of AK affecting any part of the body. Outcomes were assessed on the basis of a QoL questionnaire (Skindex-29), local skin response, the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4), and clinical response. A total of 19 patients were studied. Most of the participants were men (89.5%) and mean age was 76.2 years. After treatment with ingenol mebutate, significant improvement was observed in the Skindex-29 subscales relating to symptom severity (P=.041), the patients' emotional state (P=.026), and in the overall score (P=.014). Erythema, crusting, and flaking or scaling were the local skin responses with highest median score (2.0 in all 3 cases). Imiquimod 5% and ingenol mebutate achieved higher median scores for effectiveness and global satisfaction than any other previous treatments (as measured by TSQM 1.4). In the patients' assessment of convenience, ingenol mebutate had a higher median score than previous treatments. Over half of the patients (52.6%) had an improvement of at least 75% at month 3. QoL in patients with AK improves after treatment with ingenol mebutate. The presence of side effects did not affect QoL or patient satisfaction with treatment. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

Evidence for the use of Levomepromazine for symptom control in the palliative care setting: a systematic review

PubMed Central

2013-01-01

Background Levomepromazine is an antipsychotic drug that is used clinically for a variety of distressing symptoms in palliative and end-of-life care. We undertook a systematic review based on the question “What is the published evidence for the use of levomepromazine in palliative symptom control?”. Methods To determine the level of evidence for the use of levomepromazine in palliative symptom control, and to discover gaps in evidence, relevant studies were identified using a detailed, multi-step search strategy. Emerging data was then scrutinized using appropriate assessment tools, and the strength of evidence systematically graded in accordance with the Oxford Centre for Evidence-Based Medicine’s ‘levels of evidence’ tool. The electronic databases Medline, Embase, Cochrane, PsychInfo and Ovid Nursing, together with hand-searching and cross-referencing provided the full research platform on which the review is based. Results 33 articles including 9 systematic reviews met the inclusion criteria: 15 on palliative sedation, 8 regarding nausea and three on delirium and restlessness, one on pain and six with other foci. The studies varied greatly in both design and sample size. Levels of evidence ranged from level 2b to level 5, with the majority being level 3 (non-randomized, non-consecutive or cohort studies n = 22), with the quality of reporting for the included studies being only low to medium. Conclusion Levomepromazine is widely used in palliative care as antipsychotic, anxiolytic, antiemetic and sedative drug. However, the supporting evidence is limited to open series and case reports. Thus prospective randomized trials are needed to support evidence-based guidelines. PMID:23331515

Local hemostatic matrix for endoscope-assisted removal of intracerebral hemorrhage is safe and effective.

PubMed

Luh, Hui-Tzung; Huang, Abel Po-Hao; Yang, Shih-Hung; Chen, Chien-Ming; Cho, Der-Yang; Chen, Chun-Chung; Kuo, Lu-Ting; Li, Chieh-Hsun; Wang, Kuo-Chuan; Tseng, Wei-Lung; Hsing, Ming-Tai; Yang, Bing-Shiang; Lai, Dar-Ming; Tsai, Jui-Chang

2018-01-01

Minimally invasive endoscope-assisted (MIE) evacuation of spontaneous intracerebral hemorrhage (ICH) is simple and effective, but the limited working space may hinder meticulous hemostasis and might lead to rebleeding. Management of intraoperative hemorrhage is therefore a critical issue of this study. This study presents experience in the treatment of patients with various types of ICH by MIE evacuation followed by direct local injection of FloSeal Hemostatic Matrix (Baxter Healthcare Corp, Fremont, CA, USA) for hemostasis. The retrospective nonrandomized clinical and radiology-based analysis enrolled 42 patients treated with MIE evacuation of ICH followed by direct local injection of FloSeal Hemostatic Matrix. Rebleeding, morbidity, and mortality were the primary endpoints. The percentage of hematoma evacuated was calculated from the pre- and postoperative brain computed tomography (CT) scans. Extended Glasgow Outcome Scale (GOSE) was evaluated at 6 months postoperatively. Forty-two ICH patients were included in this study, among these, 23 patients were putaminal hemorrhage, 16 were thalamic ICH, and the other three were subcortical type. Surgery-related mortality was 2.4%. The average percentage of hematoma evacuated was 80.8%, and the rebleeding rate was 4.8%. The mean operative time was 102.7 minutes and the average blood loss was 84.9 mL. The mean postoperative GOSE score was 4.55 at 6-months' follow-up. This study shows that local application of FloSeal Hemostatic Matrix is safe and effective for hemostasis during MIE evacuation of ICH. In our experience, this shortens the operation time, especially in cases with intraoperative bleeding. A large, prospective, randomized trial is needed to confirm the findings. Copyright © 2017. Published by Elsevier B.V.

The ABCs of diabetes: diabetes self-management education program for African Americans affects A1C, lipid-lowering agent prescriptions, and emergency department visits.

PubMed

Magee, Michelle; Bowling, Andrea; Copeland, James; Fokar, Ali; Pasquale, Patricia; Youssef, Gretchen

2011-01-01

The purpose of the study was to examine the feasibility and impact of a concise community-based program on diabetes self-management education (DSME), according to frequency of emergency department visits and knowledge of, prescriptions for, and control of A1C, blood pressure, and low-density lipoprotein (LDL) cholesterol. A free community-based DSME program was placed in a public library. Adults with diabetes (N, 360) consented to participate in this prospective nonrandomized cohort study with preintervention-postintervention design. The small-group interactive DSME (two 2.5-hour classes) focused on improving cardiovascular disease risk factors and facilitating communication with the primary care physician. An increase in knowledge of American Diabetes Association-recommended targets for A1C, blood pressure, and LDL cholesterol from baseline to postintervention was seen among participants. Significant clinical outcomes included reduction in self-reported emergency department visits and reduction in mean A1C. However, despite an increase in prescriptions written for lipid-lowering drugs, blood pressure and LDL cholesterol did not change. Participants who started on insulin were more likely to achieve or maintain A1C < 7% compared to those who either did not take or stopped taking insulin during the study. Offering DSME classes for African Americans at a public library was feasible and significantly affected 6-month clinical outcomes, including a reduction in A1C, an increased likelihood of attaining a target A1C of < 7% if insulin was started during the study period, and a two-thirds reduction in emergency department visits for uncontrolled diabetes. Observed results suggest that partnering with community-based organizations such as public libraries offers an accessible and well-received location for offering DSME programs.

Pilot study evaluating the effect of massage therapy on stress, anxiety and aggression in a young adult psychiatric inpatient unit.

PubMed

Garner, Belinda; Phillips, Lisa J; Schmidt, Hans-Martin; Markulev, Connie; O'Connor, Jenny; Wood, Stephen J; Berger, Gregor E; Burnett, Peter; McGorry, Patrick D

2008-05-01

The aim of the present pilot study was to examine the effectiveness of a relaxation massage therapy programme in reducing stress, anxiety and aggression on a young adult psychiatric inpatient unit. This was a prospective, non-randomized intervention study comparing treatment as usual (TAU) with TAU plus massage therapy intervention (MT) over consecutive 7 week blocks (May-August 2006). MT consisted of a 20 min massage therapy session offered daily to patients during their period of hospitalization. The Kennedy Nurses' Observational Scale for Inpatient Evaluation (NOSIE), the Symptom Checklist-90-Revised (SCL-90-R), the State-Trait Anxiety Inventory (STAI) and stress hormone (saliva cortisol) levels were used to measure patient outcomes at admission and discharge from the unit. The Staff Observation Aggression Scale-Revised (SOAS-R) was used to monitor the frequency and severity of aggressive incidents on the unit. There was a significant reduction in self-reported anxiety (p < 0.001), resting heart rate (p < 0.05) and cortisol levels (p < 0.05) immediately following the initial and final massage therapy sessions. Significant improvements in hostility (p = 0.007) and depression scores (p < 0.001) on the SCL-90-R were observed in both treatment groups. There was no group x time interaction on any of the measures. Poor reliability of staff-reported incidents on the SOAS-R limited the validity of results in this domain. Massage therapy had immediate beneficial effects on anxiety-related measures and may be a useful de-escalating tool for reducing stress and anxiety in acutely hospitalized psychiatric patients. Study limitations preclude any definite conclusions on the effect of massage therapy on aggressive incidents in an acute psychiatric setting. Randomized controlled trials are warranted.

Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study.

PubMed

Isayama, Hiroyuki; Mukai, Tsuyoshi; Itoi, Takao; Maetani, Iruru; Nakai, Yousuke; Kawakami, Hiroshi; Yasuda, Ichiro; Maguchi, Hiroyuki; Ryozawa, Shomei; Hanada, Keiji; Hasebe, Osamu; Ito, Kei; Kawamoto, Hirofumi; Mochizuki, Hitoshi; Igarashi, Yoshinori; Irisawa, Atsushi; Sasaki, Tamito; Togawa, Osamu; Hara, Taro; Kamada, Hideki; Toda, Nobuo; Kogure, Hirofumi

2012-07-01

Covered self-expandable metal stents (CSEMSs) were developed to prevent tumor ingrowth, but stent migration is one of the problems with CSEMSs. To evaluate a new, commercially available CSEMS with flared ends and low axial force compared with a commercially available CSEMS without the anti-migration system and high axial force. Multicenter, prospective study with a historical cohort. Twenty Japanese referral centers. This study involved patients with unresectable distal malignant biliary obstruction. Placement of a new, commercially available, partially covered SEMS. Recurrent biliary obstruction rate, time to recurrent biliary obstruction, stent-related complications, survival. Between April 2009 and March 2010, 141 patients underwent partially covered nitinol stent placement, and between May 2001 and January 2007, 138 patients underwent placement of partially covered stainless stents as a historical control. The silicone cover of the partially covered nitinol stents prevented tumor ingrowth. There were no significant differences in survival (229 vs 219 days; P = .250) or the rate of recurrent biliary obstruction (33% vs 38%; P = .385) between partially covered nitinol stents and partially covered stainless stents. Stent migration was less frequent (8% vs 17%; P = .019), and time to recurrent biliary obstruction was significantly longer (373 vs 285 days; P = .007) with partially covered nitinol stents. Stent removal was successful in 26 of 27 patients (96%). Nonrandomized, controlled trial. Partially covered nitinol stents with an anti-migration system and less axial force demonstrated longer time to recurrent biliary obstruction with no tumor ingrowth and less stent migration. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.