Full Text Available Despite integration of advanced functions that enable Femto Access Points (FAPs to be deployed in a plug-and-play manner, the femtocell concept still cause several opened issues to be resolved. One of them represents an assignment of Physical Cell Identifiers (PCIs to FAPs. This paper analyses a random based assignment algorithm in LTE systems operating in diverse femtocell scenarios. The performance of the algorithm is evaluated by comparing the number of confusions for various femtocell densities, PCI ranges and knowledge of vicinity. Simulation results show that better knowledge of vicinity can significantly reduce the number of confusions events.
Paul, Gerald; Shao, Jia; Stanley, H. Eugene
The quadratic assignment problem, QAP, is one of the most difficult of all combinatorial optimization problems. Here, we use an abbreviated application of the statistical mechanics replica method to study the asymptotic behavior of instances in which the entries of at least one of the two matrices that specify the problem are chosen from a random distribution P. Surprisingly, the QAP has not been studied before using the replica method despite the fact that the QAP was first proposed over 50 years ago and the replica method was developed over 30 years ago. We find simple forms for C min and C max , the costs of the minimal and maximum solutions respectively. Notable features of our results are the symmetry of the results for C min and C max and their dependence on P only through its mean and standard deviation, independent of the details of P.
Landsheer, Johannes A; Smit, Johannes H; van Oppen, Patricia; van Balkom, Anton J L M
The effectiveness of Fluvoxamine was compared to that of Cognitive Therapy (CT) in a 12-week randomized controlled trial (RCT) in 48 patients with obsessive-compulsive disorder (OCD), who were treatment-resistant to a previous behavior therapy (BT). A considerable amount of patients did not comply with the assigned treatment and switched treatments. The aim of this study was to identify patient characteristics predictive of assignment compliance and to study whether these characteristics were related to outcome. A logistic model, based on psychological and social patient characteristics, in addition to or in interaction with the assignment, was used for the explanation of compliance with treatment assignment. Especially patients who have a higher score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) tend to comply with the effective Fluvoxamine treatment. The same set of variables was related to both compliance and outcome of therapy received. Therefore, the logistic model of compliance could be used to reduce the positive bias of As-Treated analysis (AT). The difference between the results of Fluvoxamine and Cognitive Therapy remained statistically significant after correcting for the positive bias as the result of assignment refusal and after applying the assumption that two drop-out patients needed imputation of lesser results. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Liu, Ying; Wang, Yuanjia; Zeng, Donglin
Sequential multiple assignment randomization trial (SMART) is a powerful design to study Dynamic Treatment Regimes (DTRs) and allows causal comparisons of DTRs. To handle practical challenges of SMART, we propose a SMART with Enrichment (SMARTER) design, which performs stage-wise enrichment for SMART. SMARTER can improve design efficiency, shorten the recruitment period, and partially reduce trial duration to make SMART more practical with limited time and resource. Specifically, at each subsequent stage of a SMART, we enrich the study sample with new patients who have received previous stages' treatments in a naturalistic fashion without randomization, and only randomize them among the current stage treatment options. One extreme case of the SMARTER is to synthesize separate independent single-stage randomized trials with patients who have received previous stage treatments. We show data from SMARTER allows for unbiased estimation of DTRs as SMART does under certain assumptions. Furthermore, we show analytically that the efficiency gain of the new design over SMART can be significant especially when the dropout rate is high. Lastly, extensive simulation studies are performed to demonstrate performance of SMARTER design, and sample size estimation in a scenario informed by real data from a SMART study is presented. © 2016, The International Biometric Society.
Landsheer, J.A.; Smit, J.H.; van Oppen, P.C.; van Balkom, A.J.L.M.
The effectiveness of Fluvoxamine was compared to that of Cognitive Therapy (CT) in a 12-week randomized controlled trial (RCT) in 48 patients with obsessive-compulsive disorder (OCD), who were treatment-resistant to a previous behavior therapy (BT). A considerable amount of patients did not comply
In a public school setting administrators are frequently under local pressure to make a new project service available to all eligible children. However, comparable control groups for project evaluation are often absent, and although random assignment to treatment groups remains the most systematic method of providing controls, this is not often…
Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.
Bonati, Leo H
In the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), early recurrent carotid stenosis was more common in patients assigned to endovascular treatment than it was in patients assigned to endarterectomy (CEA), raising concerns about the long-term effectiveness of endovascular treatment. We aimed to investigate the long-term risks of restenosis in patients included in CAVATAS.
NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel
Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.
Fang, Wenyi; Filos-Ratsikas, Aris; Frederiksen, Søren Kristoffer Stiil
often restrict the maximum allowed cycle-length of the exchange and for randomized algorithms, this imposes constraints of the cycle-length of every realized exchange in their decomposition. We prove that standard fairness properties such as envy-freeness or symmetry are incompatible with even...... the weakest notion of economic efficiency in this setting. On the plus side, we adapt some well-known matching mechanisms to incorporate the restricted cycle constraint and evaluate their performance experimentally on instances of the kidney exchange problem, showing tradeoffs between fairness and efficiency....
Fehm, Lydia; Mrose, Jana
Homework assignments are an indispensable part of cognitive-behavioural therapy. During the past two decades, a growing number of studies have shed light on its characteristics and effects. However, most studies primarily consider the therapists' view, and little is known about the use of supportive strategies to implement homework assignments in psychotherapy and about patients' attitudes towards regular assignments. To fill this gap, we assessed the attitudes towards homework assignments of 80 outpatients. In addition, those who had received a task during the past session (75%) were asked to report characteristics of their task as well as therapists' behaviour strategies during the assignment of the task. One week later, therapists rated the extent of completion of the task. Results showed that the patients generally had a positive attitude towards homework and that they accomplished most of the tasks. With regard to the therapists' behaviour during the assignment of the task, there seems to be room for improvement. Copyright (c) 2008 John Wiley & Sons, Ltd.
Full Text Available Method for generation pseudo-random series with arbitrarily assigned distribution law has been proposed. The praxis of using proposed method for generation pseudo-random series with anti-modal and approximate to Gaussian distribution law has been investigated.
Iimura, Ichiro; Yoshida, Kenji; Ishibashi, Ken; Nakayama, Shigeru
Ant Colony Optimization (ACO), which is a type of swarm intelligence inspired by ants' foraging behavior, has been studied extensively and its effectiveness has been shown by many researchers. The previous studies have reported that MAX-MIN Ant System (MMAS) is one of effective ACO algorithms. The MMAS maintains the balance of intensification and diversification concerning pheromone by limiting the quantity of pheromone to the range of minimum and maximum values. In this paper, we propose MAX-MIN Ant System with Random Selection (MMASRS) for improving the search performance even further. The MMASRS is a new ACO algorithm that is MMAS into which random selection was newly introduced. The random selection is one of the edgechoosing methods by agents (ants). In our experimental evaluation using ten quadratic assignment problems, we have proved that the proposed MMASRS with the random selection is superior to the conventional MMAS without the random selection in the viewpoint of the search performance.
Munro, Jane; Whyte, Fiona; Stewart, Jim; Letters, Andrew
The care of patients with inflammatory bowel disease (IBD) frequently falls short of the highest standards. This is noted in several publications, including national standards, despite nursing students being taught the importance of listening to and understanding patients. Teaching staff at the University of Glasgow primarily responsible for teaching third year undergraduate nursing students undertook a radical rethink of the planning, delivery and assessment of lectures on IBD. The subject had previously been delivered in a modified lecture format. Although the topic could be included in the end-of-year exams, there was little evidence to show whether this traditional teaching method had any effect on students' clinical practice. In a novel approach to learning and assessment, students were invited to research and produce an information leaflet for newly diagnosed patients with IBD. The leaflets were then assessed and grades awarded by an expert panel of patients and carers. Such enquiry based learning (EBL) intended to demonstrate in practice, the key role patients can play in both undergraduate nurse education and in service planning and delivery in the National Health Service (NHS). The panel found the exercise both interesting and insightful, while the students reported being invigorated and felt the expert assessment meant they were forced to achieve a higher level of work. Copyright © 2011 Elsevier Ltd. All rights reserved.
Full Text Available Fred Burbank Director, Salt Creek International Women's Health Foundation, San Clemente, CA, USA Purpose: Two parallel-design, randomized, sham-controlled clinical trials were conducted to study the safety and efficacy of vibratory stimulation (VS on restless legs syndrome (RLS patients (Part I of this series of articles. Pooled data from the two studies was retroactively analyzed to compare the relative effects of actual pad assignment with therapeutic pad assignment belief on sleep improvement for patients with RLS. Patients and methods: One hundred fifty-eight patients with at least moderately severe RLS, as measured by a score of 15 points or greater on the International Restless Legs Syndrome Study Group rating scale (IRLS, were enrolled in the study. Patients were randomly assigned to treatment (patient-controlled vibration or sham (patient-controlled sound or light-emitting pads. Patients and clinicians were blinded to pad assignment. The pad was placed under the patient's legs while in bed at night and activated during an RLS episode. Improvements in Medical Outcomes Study Sleep Problems Index II (MOS-II scores from baseline to week 4 were examined as a function of pad assignment (independent variable and therapeutic pad assignment belief held by each patient (mediator variable through mediation analysis. Results: Therapeutic pad assignment belief influenced change in MOS-II scores more than actual pad assignment. Patients who believed they had been assigned a therapeutic pad had substantially greater sleep improvement than those who concluded the opposite. When a patient believed that a therapeutic pad had been assigned, sleep improvement was comparable in magnitude, independent of the type of pad assigned (vibrating or sham. Patients assigned vibrating pads believed that they had been assigned a therapeutic pad 2.6 times more frequently than patients assigned sham pads. Consequently, vibrating pads were more efficient at improving
Ryum, Truls; Stiles, Tore C.; Svartberg, Martin; McCullough, Leigh
Therapist competence in assigning homework was used to predict mid- and posttreatment outcome for patients with Cluster C personality disorders in cognitive therapy (CT). Twenty-five patients that underwent 40 sessions of CT were taken from a randomized controlled trial (Svartberg, Stiles, & Seltzer, 2004). Therapist competence in assigning…
Kazantzis, Nikolaos; Shinkfield, Gregg
Nonadherence with homework assignments and, by implication, "barriers" to homework assignments are a frequent occurrence in the practice of standard cognitive therapy (Beck, A. T., Rush, A. J., Shaw, B. F., Emery, G. (1979). "Cognitive therapy of depression." New York: The Guilford Press). The clinical examples in this article illustrate some of…
Sir, Mustafa Y; Dundar, Bayram; Barker Steege, Linsey M; Pasupathy, Kalyan S
Patient classification systems (PCSs) are commonly used in nursing units to assess how many nursing care hours are needed to care for patients. These systems then provide staffing and nurse-patient assignment recommendations for a given patient census based on these acuity scores. Our hypothesis is that such systems do not accurately capture workload and we conduct an experiment to test this hypothesis. Specifically, we conducted a survey study to capture nurses' perception of workload in an inpatient unit. Forty five nurses from oncology and surgery units completed the survey and rated the impact of patient acuity indicators on their perceived workload using a six-point Likert scale. These ratings were used to calculate a workload score for an individual nurse given a set of patient acuity indicators. The approach offers optimization models (prescriptive analytics), which use patient acuity indicators from a commercial PCS as well as a survey-based nurse workload score. The models assign patients to nurses in a balanced manner by distributing acuity scores from the PCS and survey-based perceived workload. Numerical results suggest that the proposed nurse-patient assignment models achieve a balanced assignment and lower overall survey-based perceived workload compared to the assignment based solely on acuity scores from the PCS. This results in an improvement of perceived workload that is upwards of five percent. Copyright © 2015 Elsevier Inc. All rights reserved.
Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G
Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.
Park, Hyunjoon; Behrman, Jere R.; Choi, Jaesung
Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul—the random assignment of students into single-sex versus coeducational high schools—to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgroun...
Nikali, K.; Suomalainen, A.; Koskinen, T.; Peltonen, L. [Univ. of Helsinki (Finland); Terwilliger, J. [Univ. of Oxford (United Kingdom); Weissenbach, J. [Genethon, Evry (France)
Infantile-onset spinocerebellar ataxia (IOSCA) is an autosomal recessively inherited progressive neurological disorder of unknown etiology. This ataxia, identified so far only in the genetically isolated Finnish population, does not share gene locus with any of the previously identified hereditary ataxias, and a random mapping approach was adopted to assign the IOSCA locus. Based on the assumption of one founder mutation, a primary screening of the genome was performed using samples from just four affected individuals in two consanguineous pedigrees. The identification of a shared chromosomal region in these four patients provided the first evidence that the IOSCA gene locus is on chromosome 10q23.3-q24.1, which was confirmed by conventional linkage analysis in the complete family material. Strong linkage disequilibrium observed between IOSCA and the linked markers was utilized to define accurately the critical chromosomal region. The results showed the power of linkage disequilibrium in the locus assignment of diseases with very limited family materials. 30 refs., 3 figs., 2 tabs.
The validity of the Periodontal Treatment Need System and the Community Periodontal Index for Treatment Need as screening tests for allocation of patients to dental students was assessed and compared. Sixty-one patients reporting to the Department of Periodontology at the University of Oslo were studied. (MLW)
Pettigrew, Jonathan; Miller-Day, Michelle; Krieger, Janice L.; Zhou, Jiangxiu; Hecht, Michael L.
Random assignment to groups is the foundation for scientifically rigorous clinical trials. But assignment is challenging in group randomized trials when only a few units (schools) are assigned to each condition. In the DRSR project, we assigned 39 rural Pennsylvania and Ohio schools to three conditions (rural, classic, control). But even with 13 schools per condition, achieving pretest equivalence on important variables is not guaranteed. We collected data on six important school-level variables: rurality, number of grades in the school, enrollment per grade, percent white, percent receiving free/assisted lunch, and test scores. Key to our procedure was the inclusion of school-level drug use data, available for a subset of the schools. Also, key was that we handled the partial data with modern missing data techniques. We chose to create one composite stratifying variable based on the seven school-level variables available. Principal components analysis with the seven variables yielded two factors, which were averaged to form the composite inflate-suppress (CIS) score which was the basis of stratification. The CIS score was broken into three strata within each state; schools were assigned at random to the three program conditions from within each stratum, within each state. Results showed that program group membership was unrelated to the CIS score, the two factors making up the CIS score, and the seven items making up the factors. Program group membership was not significantly related to pretest measures of drug use (alcohol, cigarettes, marijuana, chewing tobacco; smallest p>.15), thus verifying that pretest equivalence was achieved. PMID:23722619
Zhang, Liang; Pu, Shi
We used housing assignment data from a college in China to investigate peer effects on college grades. Study results provided some evidence for peer effects in college housing units. First, peer effects through means occurred during both fall and spring semester of the first year in college, with estimated effect much larger than that in previous…
Yuan, Changzheng; Lv, Jun; VanderWeele, Tyler J
Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. Cross-sectional in-dormitory survey. Current students from Peking University Health Science Center from April to June, 2009. Self-reported questionnaire on health behaviors: physical activity (including bicycling), dietary intake and tobacco use. Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.
Park, Hyunjoon; Behrman, Jere R; Choi, Jaesung
Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul-the random assignment of students into single-sex versus coeducational high schools-to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgrounds and prior academic achievement of students attending single-sex schools and coeducational schools, which increases the credibility of our causal estimates of single-sex school effects. The three-level hierarchical model shows that attending all-boys schools or all-girls schools, rather than coeducational schools, is significantly associated with higher average scores on Korean and English test scores. Applying the school district fixed-effects models, we find that single-sex schools produce a higher percentage of graduates who attended four-year colleges and a lower percentage of graduates who attended two-year junior colleges than do coeducational schools. The positive effects of single-sex schools remain substantial, even after we take into account various school-level variables, such as teacher quality, the student-teacher ratio, the proportion of students receiving lunch support, and whether the schools are public or private.
Park, Hyunjoon; Behrman, Jere R.; Choi, Jaesung
Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul—the random assignment of students into single-sex versus coeducational high schools—to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgrounds and prior academic achievement of students attending single-sex schools and coeducational schools, which increases the credibility of our causal estimates of single-sex school effects. The three-level hierarchical model shows that attending all-boys schools or all-girls schools, rather than coeducational schools, is significantly associated with higher average scores on Korean and English test scores. Applying the school district fixed-effects models, we find that single-sex schools produce a higher percentage of graduates who attended four-year colleges and a lower percentage of graduates who attended two-year junior colleges than do coeducational schools. The positive effects of single-sex schools remain substantial, even after we take into account various school-level variables, such as teacher quality, the student-teacher ratio, the proportion of students receiving lunch support, and whether the schools are public or private. PMID:23073751
Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel
This study tested the effect of beginning treatment with a speech-generating device (SGD) in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. A total of 61 minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a SGD for 6 months with a 3-month follow-up. The intervention consisted of 2 stages. In stage 1, all children received 2 sessions per week for 3 months. Stage 2 intervention was adapted (by increased sessions or adding the SGD) based on the child's early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were the total number of novel words and total comments from a natural language sample. Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes. Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children's response to treatment. Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel
Objective This study tested the effect of beginning treatment with a speech-generating device in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. Method Sixty-one minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a speech-generating device (SGD) for 6 months with a 3-month follow-up. The intervention consisted of two stages. In Stage 1 all children received two sessions per week for 3 months. Stage 2 intervention was adapted (increased sessions or adding the SGD) based on the child’s early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were total number of novel words and total comments from a natural language sample. Results Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better post-treatment outcomes. Conclusion Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children’s response to treatment. Clinical trial registration information—Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. PMID:24839882
Li, Yi; Guo, Guang
Identifying casual peer influence is a long-standing challenge to social scientists. Using data from a natural experiment of randomly-assigned college roommates (N = 2,059), which removes the threat of friend selection, we investigate peer effects on aggressive behavior, smoking, and concurrent sexual partnering. The findings suggest that the magnitude and direction of peer influence depend on predisposition, gender, and the nature of the behavior. Peer effects on individuals predisposed toward a given behavior tend to be larger than peer effects on individuals without such a predisposition. We find that the influence of roommates on aggressive behavior is more pronounced among male students than among female students; roommate effects on smoking are negative among female students and male students who did not smoke before college. For concurrent sexual partnering, a highly private behavior, we find no evidence of peer effects. © American Sociological Association 2016.
Choi, Jaesung; Park, Hyunjoon; Behrman, Jere R
A growing body of research reports associations of school contexts with adolescents' weight and weight-related behaviors. One interesting, but under-researched, dimension of school context that potentially matters for adolescents' weight is the gender composition. If boys and girls are separated into single-sex schools, they might be less concerned about physical appearance, which may result in increased weight. Utilizing a unique setting in Seoul, Korea where students are randomly assigned to single-sex and coeducational schools within school districts, we estimate causal effects of single-sex schools on weight and weight-related behaviors. Our results show that students attending single-sex schools are more likely to be overweight, and that the effects are more pronounced for girls. We also find that girls in single-sex schools are less likely to engage in strenuous activities than their coeducational counterparts. Copyright © 2015 Elsevier Ltd. All rights reserved.
Full Text Available BACKGROUND: Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. METHODS: STUDY DESIGN: Cross-sectional in-dormitory survey. STUDY POPULATION: Current students from Peking University Health Science Center from April to June, 2009. MEASUREMENT: Self-reported questionnaire on health behaviors: physical activity (including bicycling, dietary intake and tobacco use. RESULTS: Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. CONCLUSION: Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.
NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel
Cluster-level dynamic treatment regimens can be used to guide sequential, intervention or treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level DTR, the intervention or treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including based on aggregate measures of the individuals or patients that comprise it. Cluster-randomized sequentia...
Mattila, Aino K; Fagerholm, Riitta; Santtila, Pekka; Miettinen, Päivi J; Taskinen, Seppo
Gender identity and gender role orientation were assessed in 24 female assigned patients with disorders of sex development. A total of 16 patients were prenatally exposed to androgens, of whom 15 had congenital adrenal hyperplasia and 1 was virilized due to maternal tumor. Eight patients had 46,XY karyotype, of whom 5 had partial and 3 had complete androgen insensitivity syndrome. Gender identity was measured by the 27-item Gender Identity/Gender Dysphoria Questionnaire for Adolescents and Adults with 167 female medical students as controls, and gender role was assessed by the femininity and masculinity subscales of the 30-item Bem Sex Role Inventory with 104 female and 64 male medical students as controls. No patient reached the cutoff for gender identity disorder on the Gender Identity/Gender Dysphoria Questionnaire for Adolescents and Adults. However, patients with 46,XY karyotype demonstrated a somewhat more conflicted gender identity, although the overall differences were relatively small. As to gender role orientation, patients with complete androgen insensitivity syndrome had high scores on the femininity and masculinity scales of the Bem Sex Role Inventory, which made them the most androgynous group. Our findings, although clinically not clear cut, suggest that patients with disorders of sex development are a heterogeneous group regarding gender identity and gender role outcomes, and that this issue should be discussed with the family when treatment plans are made. Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Full Text Available There is ample historical verification of 46,XX congenital adrenal hyperplasia (CAH patients being born with essentially male genitaliawhile outcome information is scant. Prior to glucocorticoid therapy, most patients died very young from adrenal insufficiency. Most available reports from laterchildhood, contain little information concerning sexual identity. Reports on older individuals lack adequate information about sexual identity and quality of life. The difficulty in assessing the relative impact of multiple dynamic environmental factors on the development of sexual identity, self- and body esteem and overall adjustment to life is clear. Nevertheless, it remains unclear whether those infants whose masculine genitalia at birth resulted in an initial male assignment would have enjoyed a better adult outcome had they been allowed to remain male rather than the female reassignment that most received. Further, one could ask whether a male sex of rearing should be considered in 46,XX CAH infants with male external genitalia. After reviewing available literature, we conclude that because those extremely virlized 46,XX CAH patients who were reared male with healthy social support demonstrated satisfactory levels of social and sexual function as adults a male sex assignment should be considered in these types of infants when social and cultural environment are supportive.
Ryan, Kimberley; Greenslade, Jaimi; Dalton, Emily; Chu, Kevin; Brown, Anthony F T; Cullen, Louise
The objective of this study was to explore factors associated with the triage category assigned by the triage nurse for patients ultimately diagnosed with acute myocardial infarction. This was a retrospective analysis of 12 months of data, on adult emergency department patients ultimately diagnosed with acute myocardial infarction. Data were obtained from hospital databases and included patient demographics, patient clinical characteristics and nurses' experience. Of the 153 patients, 20% (95% CI: 14-27%) were given a lower urgency triage category than recommended by international guidelines. Compared to patients who were triaged Australasian Triage Category 1 or 2, patients with an Australasian Triage Category 3-5 were older (mean age 76 versus 68 years), more likely to be female (63% versus 32%), more likely to present without chest pain (93% versus 35%) and less likely to have a cardiac history (3.3% versus 17.9%). A slightly higher proportion of patients Australasian Triage Category 3-5 were triaged by an experienced nurse (50%) compared to patients categorised Australasian Triage Category 1-2 (35.2%) but this finding did not reach statistical significance. One in five presentations was given a lower urgency triage category than recommended by international guidelines, potentially leading to delays in medical treatment. The absence of chest pain was the defining characteristic in this group of patients, along with other factors identified by previous research such as being of female sex and elderly. Copyright © 2015 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.
Kensinger, Clark D; Feurer, Irene D; Karp, Seth J
Current Model for End-Stage Liver Disease (MELD) exception points provided to patients with hepatocellular cancer (HCC) are not based on outcome data and advantage these patients compared to those listed based on laboratory values (LABMELD). We sought to develop a data-based assignment for exception points for patients with HCC that equalizes outcomes among HCC and LABMELD patients. We used Scientific Registry of Transplant Recipients data to compare patients listed with HCC who received exception points versus patients listed with LABMELD. Nation- and region-specific data were examined for (1) a composite outcome for adverse events of death, delisting, or becoming ineligible for transplant; and (2) transplant rate. We also determined MELD progression rates for LABMELD patients. Candidates listed with LABMELD scores were compared with those listed with 22 exception points for HCC (HCC22) to determine the LABMELD for which statistical parity was achieved for our composite outcome. HCC22 candidates time to adverse event were comparable to LABMELD scores of 16 (LABMELD16) candidates (range, 15-19), whereas time to transplant was comparable to LABMELD22 candidates (range, 21-23). LABMELD22 candidates had 2.1 times greater risk of adverse event compared with HCC22 (95% confidence interval, 1.9-2.4; range, 1.5-2.4). Progression among LABMELD16 candidates whose scores did not improve was similar across regions and averaged 0.94 points/month (95% confidence interval, 0.88-0.99, range 0.80-1.04). To equalize the occurrence of an adverse outcome, the proper listing MELD for patients with HCC is 16, with approximately 1 additional point/month. These results provide a data-driven algorithm to increase fairness in listing priority.
Weini Xin; Katherine Chiu Man Leung; Edward Chin Man Lo; Mo Yin Mok; Moon Ho Leung
.... Topical fluoride is commonly prescribed for caries prevention. Methods In this 24-month randomized, double-blind, placebo-controlled clinical trial, SS patients were randomly assigned to receive either fluoride varnish or placebo gel quarterly...
Barquero, Laura A; Sefcik, Angela M; Cutting, Laurie E; Rimrodt, Sheryl L
Neurofibromatosis type 1 (NF1) is a genetic disorder with a cognitive profile that includes visual-spatial perception deficits and a high incidence of reading disability. There is a paucity of information about how this cognitively complex population responds to mainstream reading interventions. The clinical trial goals were to determine whether children and adolescents with NF1 and reading deficits (NF+RD) benefit from mainstream remedial reading programs and whether responsiveness varies with differences in program-related visual-spatial demands. Forty-nine participants (28 males, 21 females; aged 8-14y) with either NF+RD (n=17, 11 males, six females) or idiopathic reading deficit (IRD) (n=32, 17 males, 15 females) were randomly assigned to intensive remedial teaching using one of two multisensory reading programs: one with greater kinesthetic demands and the other with greater visual-spatial demands. Two control groups - wait-list IRD (n=14, 11 males, three females) and typically developing readers (n=26, 13 males, 13 females) - received no treatment. Repeated measures and multivariate ANOVA analyses compared each group's growth in reading achievement from pre- to post-testing. Treated groups showed significant growth whereas untreated groups did not. Comparing treated groups, the IRD group responded equally well to both interventions, whereas the NF+RD group showed a better response to the more kinesthetic approach. Results suggest that multisensory remedial reading teaching that emphasizes kinesthetic demands more than visual-spatial demands is suitable for students with NF+RD. © 2015 Mac Keith Press.
Berntsen, David A.; Barr, Christopher D.; Mutti, Donald O.; Zadnik, Karla
Purpose. To determine the effect of progressive addition lenses (PALs) and single vision lenses (SVLs) on peripheral defocus in myopic children, and to compare the effect of myopic versus hyperopic peripheral defocus on foveal myopia progression. Methods. Eighty-four myopic children aged 6 to 11 years with spherical equivalent (SE) cycloplegic autorefraction between −0.75 diopters (D) and −4.50 D were randomly assigned to wear SVLs or PALs. Aberrometry measurements of the eye and spectacles were made centrally, 30° nasally, temporally, and superiorly, and 20° inferiorly on the retina using a Complete Ophthalmic Analysis System for Vision Research (COAS-VR). The association between peripheral defocus and the 1-year change in central myopia was investigated. Results. SVLs caused a hyperopic shift in peripheral defocus at all locations (all P ≤ 0.0003). PALs caused a myopic shift in peripheral defocus in three of four locations measured (all P ≤ 0.01) with the greatest shift superiorly due to the PAL addition (−1.04 ± 0.30 D). Superior retinal defocus when wearing either SVLs or PALs was associated with the 1-year change in central myopia. The adjusted 1-year change in central SE myopia was −0.38 D for children with absolute superior myopic defocus (n = 67) and −0.65 D for children with absolute superior hyperopic defocus (n = 17; difference = 0.27 D; P = 0.002). Conclusions. PALs caused a myopic shift in peripheral defocus. Superior myopic defocus was associated with less central myopia progression. These data support the continued investigation of optical designs that result in peripheral myopic defocus as a potential way to slow myopia progression. (ClinicalTrials.gov number, NCT00335049.) PMID:23838771
Fine Howard A
Full Text Available Abstract Background Advances in generating genome-wide gene expression data have accelerated the development of molecular-based tumor classification systems. Tools that allow the translation of such molecular classification schemas from research into clinical applications are still missing in the emerging era of personalized medicine. Results We developed GliomaPredict as a computational tool that allows the fast and reliable classification of glioma patients into one of six previously published stratified subtypes based on sets of extensively validated classifiers derived from hundreds of glioma transcriptomic profiles. Our tool utilizes a principle component analysis (PCA-based approach to generate a visual representation of the analyses, quantifies the confidence of the underlying subtype assessment and presents results as a printable PDF file. GliomaPredict tool is implemented as a plugin application for the widely-used GenePattern framework. Conclusions GliomaPredict provides a user-friendly, clinically applicable novel platform for instantly assigning gene expression-based subtype in patients with gliomas thereby aiding in clinical trial design and therapeutic decision-making. Implemented as a user-friendly diagnostic tool, we expect that in time GliomaPredict, and tools like it, will become routinely used in translational/clinical research and in the clinical care of patients with gliomas.
Rossen, Noortje G.; Fuentes, Susana; van der Spek, Mirjam J.; Tijssen, Jan G.; Hartman, Jorn H. A.; Duflou, Ann; Löwenberg, Mark; van den Brink, Gijs R.; Mathus-Vliegen, Elisabeth M. H.; de Vos, Willem M.; Zoetendal, Erwin G.; D'Haens, Geert R.; Ponsioen, Cyriel Y.
Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial. Patients with mild to moderately active UC (n = 50) were assigned to groups that
van Oostveen, Catharina J; Braaksma, Aleida; Vermeulen, Hester
Nurse-to-patient assignment is a frequently recurring, time-consuming, and complex process owing to the many considerations involved. Creating well-balanced, high-quality assignments is crucial to ensuring patient safety, quality of care, and job satisfaction for nurses. A computerized decision support system can assist (charge) nurses in the nurse-to-patient assignment process. In this two-phase multimethod study, a computerized decision support system was developed and evaluated. Three nursing wards in a 1000-bed Dutch university hospital participated. In the first phase of this study, considerations relevant to the assignment process--and their relative importance--were investigated in a literature review, focus group sessions with nurses, and a survey among nurses. Using information from the first phase, the computerized decision support system was developed based on an integer linear program. In the second phase, a before-and-after study was conducted to test and evaluate the computerized decision support system both quantitatively (duration of the assignment process) and qualitatively (survey on workload). Thirty-six measurements were performed to test the computerized decision support system. After implementation, a 30% time reduction was achieved in the nurse-to-patient assignments, and nurses (N = 138) experienced a lower workload. Therefore, the implementation of computerized decision support system would increase both the quality and safety of care as well as the nurses' job satisfaction and should be investigated rigorously in the coming years.
Stalpers, Lukas J. A.; da Costa, Hanna C.; Merbis, Merijn A. E.; Fortuin, Andries A.; Muller, Martin J.; van Dam, Frits S. A. M.
Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and Materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT
Leung, Ka Chun; Mui, Carlo; Chiu, Wing Yan; Ng, Yuk Yiu; Chen, Matthew H. Y.; Ho, Pui Hung; Kwok, Chun Pong; Lam, Suki S. M.; Wong, Chun Yip; Wong, Kit Yee; Pang, Herbert H.
This randomized controlled trial aimed to test the effectiveness of brief face-to-face patient education in increasing influenza vaccination rate among elderly in the community. Recruitment and intervention were conducted at two general outpatient clinics in Hong Kong. 529 eligible patients were randomly assigned to intervention or control group…
Scheurwegs, Elyne; Luyckx, Kim; Luyten, Léon; Daelemans, Walter; Van den Bulcke, Tim
Enormous amounts of healthcare data are becoming increasingly accessible through the large-scale adoption of electronic health records. In this work, structured and unstructured (textual) data are combined to assign clinical diagnostic and procedural codes (specifically ICD-9-CM) to patient stays. We investigate whether integrating these heterogeneous data types improves prediction strength compared to using the data types in isolation. Two separate data integration approaches were evaluated. Early data integration combines features of several sources within a single model, and late data integration learns a separate model per data source and combines these predictions with a meta-learner. This is evaluated on data sources and clinical codes from a broad set of medical specialties. When compared with the best individual prediction source, late data integration leads to improvements in predictive power (eg, overall F-measure increased from 30.6% to 38.3% for International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnostic codes), while early data integration is less consistent. The predictive strength strongly differs between medical specialties, both for ICD-9-CM diagnostic and procedural codes. Structured data provides complementary information to unstructured data (and vice versa) for predicting ICD-9-CM codes. This can be captured most effectively by the proposed late data integration approach. We demonstrated that models using multiple electronic health record data sources systematically outperform models using data sources in isolation in the task of predicting ICD-9-CM codes over a broad range of medical specialties. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: firstname.lastname@example.org.
The bag-of-features model is a distinctive and robust approach to detect human actions in videos. The discriminative power of this model relies heavily on the quantization of the video features into visual words. The quantization determines how well the visual words describe the human action. Random
Full Text Available Problem Statement: Studies have shown that language is used discriminatorily to women and men. Hence, there have been movements against gender biased language−the movements which are reported so successful especially in the West.Purpose of Study: This paper however argues that discrimination stems from speakers’ minds; and hence performing gender neutral language alone does not confirm gender neutrality of the performer. The reliable way of judging gender neutrality would then be studying the speakers’ minds.Method: The study applied psychoanalytic literary criticism as a gateway to the unconscious minds of American authors–to find out how gender neutral they were at cognitive level. Through psychoanalytic literary criticism, authors’ suppressed desires would find their way out onto their works in a distorted form. Along these lines, the study assessed the equality in assigning agentive and patient semantic roles between males and females in American fictions–to find out who between males and females were frequently assigned agentive and patient roles of the reciprocal verbs: kiss, hug, marry, and divorce.Findings: The study found out that males were assigned more agentive roles in kiss and hug, and females in divorce. Moreover, both were assigned almost equal roles in marry.Conclusion: The implication of the findings is that speakers’ unconscious mind is basically gender biased along gender stereotypes.
Stalpers, Lukas J A; da Costa, Hanna C; Merbis, Merijn A E; Fortuin, Andries A; Muller, Martin J; van Dam, Frits S A M
To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT plus hypnotherapy (33 patients). Patients in the hypnotherapy group received hypnotherapy at the intake, before RT simulation, before the first RT session, and halfway between the RT course. Anxiety was evaluated by the State-Trait Anxiety Inventory DY-1 form at six points. Quality of life was measured by the Rand Medical Outcomes Study 36-item Health Survey (SF-36) at five points. Additionally, patients answered a questionnaire to evaluate their experience and the possible benefits of this research project. No statistically significant difference was found in anxiety or quality of life between the hypnotherapy and control groups. However, significantly more patients in the hypnotherapy group indicated an improvement in mental (p Hypnotherapy did not reduce anxiety or improve the quality of life in cancer patients undergoing curative RT. The absence of statistically significant differences between the two groups contrasts with the hypnotherapy patients' own sense of mental and overall well-being, which was significantly greater after hypnotherapy. It cannot be excluded that the extra attention by the hypnotherapist was responsible for this beneficial effect in the hypnotherapy group. An attention-only control group would be necessary to control for this effect.
DEPARTMENT OF THE AIR FORCE 59TH MEDICAL W ING (AETC) JOINT BASE SAN ANTONIO - LACKLAND TEXAS MEMORANOUMFORSGVT ATTN: MAJ CARRIE LITKE-WAGER...Author Litke· Wager, Carrie 0-4/Major 959/CSPS/ 59MDW/SGVT b. Mu, Thornton 0-5/LTC MCH E-ZDP-N SA MMC c. Delaney, Heather 0-4/ MAJ MCHE-ZDP-N SA MMC d...78234-2715 15 June 2016 Maj Carrie Litke-Wager, MD Brooke Army Medical Center Institutional Review Board A Randomized Trial to Measure the
Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.
Michielsen, Marian E.; Selles, Ruud W.; van der Geest, Jos N.; Eckhardt, Martine; Yavuzer, Gunes; Stam, Henk J.; Smits, Marion; Ribbers, Gerard M.; Bussmann, Johannes B. J.
Objective. To evaluate for any clinical effects of home-based mirror therapy and subsequent cortical reorganization in patients with chronic stroke with moderate upper extremity paresis. Methods. A total of 40 chronic stroke patients (mean time post. onset, 3.9 years) were randomly assigned to the
Te-Wei Ho; Chun-Ta Huang; Herng-Chia Chiu; Sheng-Yuan Ruan; Yi-Ju Tsai; Chong-Jen Yu; Feipei Lai
Chronic obstructive pulmonary disease (COPD) is the leading cause of death worldwide, and poses a substantial economic and social burden. Telemonitoring has been proposed as a solution to this growing problem, but its impact on patient outcome is equivocal. This randomized controlled trial aimed to investigate effectiveness of telemonitoring in improving COPD patient outcome. In total, 106 subjects were randomly assigned to the telemonitoring (n?=?53) or usual care (n?=?53) group. During the ...
Talen, Mary R; Muller-Held, Christine F; Eshleman, Kate Grampp; Stephens, Lorraine
In research on doctor-patient communication, the patient role in the communication process has received little attention. The dynamic interactions of shared decision making and partnership styles which involve active patient communication are becoming a growing area of focus in doctor-patient communication. However, patients rarely know what makes "good communication" with medical providers and even fewer have received coaching in this type of communication. In this study, 180 patients were randomly assigned to either an intervention group using a written communication tool to facilitate doctor-patient communication or to standard care. The goal of this intervention was to assist patients in becoming more effective communicators with their physicians. The physicians and patients both rated the quality of the communication after the office visit based on the patients' knowledge of their health concerns, organizational skills and questions, and attitudes of ownership and partnership. The results supported that patients in the intervention group had significantly better communication with their doctors than patients in the standard care condition. Physicians also rated patients who were in the intervention group as having better overall communication and organizational skills, and a more positive attitude during the office visit. This study supports that helping patients structure their communication using a written format can facilitate doctor-patient communication. Patients can become more adept at describing their health concerns, organizing their needs and questions, and being proactive, which can have a positive effect on the quality of the doctor-patient communication during outpatient office visits. (PsycINFO Database Record (c) 2011 APA, all rights reserved).
Full Text Available Linguistic cues may be considered a potent tool for focusing attention on causes or effects. In this paper, we explore how different cues affect causal assignments in German and Tongan. From a larger screening study, two parts are reported here: Part 1 dealt with syntactic variations, including word order (agent vs. patient in first/subject position and case marking (e.g., as ergative vs. non-ergative in Tongan depending on verb type (transitive vs. intransitive. For two physical settings (wood floating on water and a man breaking a glass, participants assigned causality to the two entities involved. In the floating setting, speakers of the two languages were sensitive to syntactic variations, but differed in the entity regarded as causative. In the breaking setting, the human agent was uniformly regarded as causative. Part 2 dealt with implicit verb causality. Participants assigned causality to subject or object of 16 verbs presented in minimal social scenarios. In German, all verbs showed a subject (agent focus; in Tongan, the focus depended on the verb; and for nine verbs, the focus differed across languages. In conclusion, we discuss the question of domain-specificity of causal cognition, the role of the ergative as causal marker, and more general differences between languages.
Bender, Andrea; Beller, Sieghard
Linguistic cues may be considered a potent tool for focusing attention on causes or effects. In this paper, we explore how different cues affect causal assignments in German and Tongan. From a larger screening study, two parts are reported here: Part 1 dealt with syntactic variations, including word order (agent vs. patient in first/subject position) and case marking (e.g., as ergative vs. non-ergative in Tongan) depending on verb type (transitive vs. intransitive). For two physical settings (wood floating on water and a man breaking a glass), participants assigned causality to the two entities involved. In the floating setting, speakers of the two languages were sensitive to syntactic variations, but differed in the entity regarded as causative. In the breaking setting, the human agent was uniformly regarded as causative. Part 2 dealt with implicit verb causality. Participants assigned causality to subject or object of 16 verbs presented in minimal social scenarios. In German, all verbs showed a subject (agent) focus; in Tongan, the focus depended on the verb; and for nine verbs, the focus differed across languages. In conclusion, we discuss the question of domain-specificity of causal cognition, the role of the ergative as causal marker, and more general differences between languages.
Whalen, Scott [Department of Nuclear and Radiological Engineering, University of Florida, Gainesville, FL 32611 (United States); Lee, Choonsik [Department of Nuclear and Radiological Engineering, University of Florida, Gainesville, FL 32611 (United States); Williams, Jonathan L [Department of Radiology, University of Florida, Gainesville, FL 32611 (United States); Bolch, Wesley E [Departments of Nuclear and Radiological and Biomedical Engineering, University of Florida, Gainesville, FL 32611 (United States)
Current efforts to reconstruct organ doses in children undergoing diagnostic imaging or therapeutic interventions using ionizing radiation typically rely upon the use of reference anthropomorphic computational phantoms coupled to Monte Carlo radiation transport codes. These phantoms are generally matched to individual patients based upon nearest age or sometimes total body mass. In this study, we explore alternative methods of phantom-to-patient matching with the goal of identifying those methods which yield the lowest residual errors in internal organ volumes. Various thoracic and abdominal organs were segmented and organ volumes obtained from chest-abdominal-pelvic (CAP) computed tomography (CT) image sets from 38 pediatric patients ranging in age from 2 months to 15 years. The organs segmented included the skeleton, heart, kidneys, liver, lungs and spleen. For each organ, least-squared regression lines, 95th percentile confidence intervals and 95th percentile prediction intervals were established as a function of patient age, trunk volume, estimated trunk mass, trunk height, and three estimates of the ventral body cavity volume based on trunk height alone, or in combination with circumferential, width and/or breadth measurements in the mid-chest of the patient. When matching phantom to patient based upon age, residual uncertainties in organ volumes ranged from 53% (lungs) to 33% (kidneys), and when trunk mass was used (surrogate for total body mass as we did not have images of patient head, arms or legs), these uncertainties ranged from 56% (spleen) to 32% (liver). When trunk height is used as the matching parameter, residual uncertainties in organ volumes were reduced to between 21 and 29% for all organs except the spleen (40%). In the case of the lungs and skeleton, the two-fold reduction in organ volume uncertainties was seen in moving from patient age to trunk height-a parameter easily measured in the clinic. When ventral body cavity volumes were used
Whalen, Scott; Lee, Choonsik; Williams, Jonathan L.; Bolch, Wesley E.
Current efforts to reconstruct organ doses in children undergoing diagnostic imaging or therapeutic interventions using ionizing radiation typically rely upon the use of reference anthropomorphic computational phantoms coupled to Monte Carlo radiation transport codes. These phantoms are generally matched to individual patients based upon nearest age or sometimes total body mass. In this study, we explore alternative methods of phantom-to-patient matching with the goal of identifying those methods which yield the lowest residual errors in internal organ volumes. Various thoracic and abdominal organs were segmented and organ volumes obtained from chest-abdominal-pelvic (CAP) computed tomography (CT) image sets from 38 pediatric patients ranging in age from 2 months to 15 years. The organs segmented included the skeleton, heart, kidneys, liver, lungs and spleen. For each organ, least-squared regression lines, 95th percentile confidence intervals and 95th percentile prediction intervals were established as a function of patient age, trunk volume, estimated trunk mass, trunk height, and three estimates of the ventral body cavity volume based on trunk height alone, or in combination with circumferential, width and/or breadth measurements in the mid-chest of the patient. When matching phantom to patient based upon age, residual uncertainties in organ volumes ranged from 53% (lungs) to 33% (kidneys), and when trunk mass was used (surrogate for total body mass as we did not have images of patient head, arms or legs), these uncertainties ranged from 56% (spleen) to 32% (liver). When trunk height is used as the matching parameter, residual uncertainties in organ volumes were reduced to between 21 and 29% for all organs except the spleen (40%). In the case of the lungs and skeleton, the two-fold reduction in organ volume uncertainties was seen in moving from patient age to trunk height—a parameter easily measured in the clinic. When ventral body cavity volumes were used
Mei, H.; van Beijnum, Bernhard J.F.; Pawar, P.; Widya, I.A.; Hermens, Hermanus J.
Mobile Patient Monitoring System (MPMS) is positioned to provide high quality healthcare services in the near future. The gap between its application demands and resource supplies, however, still remains and may hinder this process. Dynamic context-aware adaptation mechanisms are required in order
Ferreira, Giovanni E; Stieven, Fábio F; Araújo, Francisco X; Wiebusch, Matheus; Rosa, Carolina G; Plentz, Rodrigo Della Méa; Silva, Marcelo F
To investigate if neurodynamic treatment is more effective than advice to remain active in patients with nerve-related leg pain. Parallel-group randomized controlled trial blinded to the outcome assessor conducted in Porto Alegre, Brazil. Sixty patients recruited from the community and private practices. Patients will be randomly assigned to receive four sessions of neurodynamic treatment over two weeks comprising passive lumbar foramen opening and neurodynamic sliders plus home exercises or advice to remain active. Leg pain intensity, disability, low back pain intensity, functional ability, symptoms distribution and global impression of recovery will be assessed at two and four weeks after randomization. A linear mixed model will be employed for each outcome following intention to treat principles. Copyright © 2016 Elsevier Ltd. All rights reserved.
Torres, V; Castro Sánchez, A Ma; Matarán Peñarocha, G A; Lara Palomo, I; Aguilar Ferrándiz, Ma E; Moreno Lorenzo, C
The purpose of this study was to analyze change of lifestyle in obese patients with cognitive behavior therapy and acupressure. An experimental study was performed with placebo control group. Forty patients were randomly assigned to intervention group (cognitive behaviour therapy + acupressure) and control group (information session). Outcome measure was a questionnaire for the assessment and quantification of obesity related lifestyles. Measures were performed at baseline and, after 3-months intervention. After 3 months of treatment, the intervention group showed significant differences (pobese patient, cognitive behavior therapy and acupressure, it has lost at least three kilograms over three months and has changed lifestyles related to obesity.
Maurice-Szamburski, A; Loundou, A; Auquier, P; Girard, N; Bruder, N
In this trial we sought to determine whether propofol-based patient-controlled sedation (PCS) during diagnostic cerebral angiography would result in improved patient satisfaction compared to placebo-based PCS. We randomly assigned 61 patients to receive propofol-based PCS (n=33, 15mg bolus in 9 s) or placebo-based PCS (n=28, bolus of 1.5mL of a 20% lipid emulsion in 9 s). We recorded the number of PCS bolus requirements, the need for rescue sedative drugs, and physiological variables. Prior to the procedure, the anxiety level of each patient was evaluated using the Anxiety State Traits Assessment (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The quality of patient conditioning was quoted by both the anesthetist and neuroradiologist using Visual Analog Scale (VAS). The day following the procedure, patients were given the EVAN questionnaire, a validated tool for assessing patient satisfaction. Both groups were similar in term of demographics, American Society of Anesthesiologist (ASA) physical status scores, STAI and APAIS scores, and procedure lengths. There were no differences between groups in EVAN scores 76.9±16.1 vs. 75.7±12.8; P=0.78. The number of PCS bolus requirements was significantly higher in the placebo group 3.96±9.5 vs. 3.13±3.1 (P=0.02). No adverse event was recorded. This prospective, double-blind, randomized study showed that sedation using propofol PCS did not improve patients' satisfaction during diagnostic cerebral angiography. Therefore, an anesthetist should be rapidly available on request but not necessarily present during the whole procedure. Copyright © 2013 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.
Kayser, Karen; Feldman, Barry N.; Borstelmann, Nancy A.; Daniels, Ann A.
The purpose of this study was to determine the effectiveness of a couple-based intervention on the quality of life (QOL) of early-stage breast cancer patients and their partners. A randomized controlled design was used to assign couples to either the hospital standard social work services (SSWS) or a couple-based intervention, the Partners in…
Moene, F.C.; Spinhoven, P.; Hoogduin, C.A.L.; Dyck, R. van
This study tested whether a hypnosis-based intervention showed promise as a treatment for patients with conversion disorder, motor type. Forty-four outpatients with conversion disorder, motor type, or somatization disorder with motor conversion symptoms, were randomly assigned to a hypnosis or a
Akıncı, Erhan; Öncü, Fatih; Ger, Can; Sabuncuoğlu, Mustafa; Kırmızı, Anıl; Eradamlar, Nezih
In this study, we aimed to evaluate the clinical and sociodemographic characteristics of patients with bipolar disorder who had been sent to the Forensic Psychiatry Unit by the court in order to determine factors that affected the decision to appoint a legal representative. The reports of health council, follow-up outpatient, and hospitalization files of a total of 78 patients with bipolar disorder who had been sent to the Department of Forensic Psychiatry Outpatient Clinic of Bakirköy Mental Health and Neurological Diseases Education and Research Hospital between 1st June 2009-31st December 2011 were examined. Patients had been sent by the court in order to determine whether a legal representative was required. Seventy patients meeting enough to sociodemographic and clinical form were separated as appointment group of legal representative or not and decision variables were compared statistically. Forty-six patients (66%) were recommended assignment of a legal representative. In the patients with bipolar disorder for whom a legal representative was recommended, the presence of other first axis comorbidity, the presence of psychotic episodes, delusions of persecution and reference, hallucinations, the total number of manic and mixed episodes, incidence of alcohol and substance abuse, lifetime total number of attacks, and the total number and duration of hospitalizations were found to be significantly higher. The probability of assignment of a legal representative was increased 11-fold by the presence of first axis comorbidity, 1.3-fold by the number of manic episodes, and 2.2-fold by the number of mixed episodes were specified. In the practice of forensic psychiatry, clinicians should focus on the course of the disease, especially the number and frequency of manic or mixed episodes, total number of episodes and hospitalizations, duration of hospitalizations, alcohol and substance use, the presence of episodes accompanied by psychosis with paranoid delusions and
Allen, Larry A.; Rogers, Joseph G.; Warnica, J. Wayne; DiSalvo, Thomas G.; Tasissa, Gudaye; Binanay, Cynthia; O’Connor, Christopher M.; Califf, Robert M.; Leier, Carl V.; Shah, Monica R.; Stevenson, Lynne W.
Background In ESCAPE, there was no difference in days alive and out of the hospital for patients with decompensated heart failure (HF) randomly assigned to therapy guided by pulmonary artery catheter (PAC) plus clinical assessment versus clinical assessment alone. The external validity of these findings is debated. Methods and Results ESCAPE sites enrolled 439 patients receiving PAC without randomization in a prospective registry. Baseline characteristics, pertinent trial exclusion criteria, reasons for PAC use, hemodynamics, and complications were collected. Survival was determined from the National Death Index and the Alberta Registry. On average, registry patients had lower blood pressure, worse renal function, less neurohormonal antagonist therapy, and higher use of intravenous inotropes as compared with trial patients. Although clinical assessment anticipated less volume overload and greater hypoperfusion among the registry population, measured filling pressures were similarly elevated in the registry and trial, while measured perfusion was slightly higher among registry patients. Registry patients had longer hospitalization (13 vs. 6 days, p <0.001) and higher 6-month mortality (34% vs. 20%, p < 0.001) than trial patients. Conclusions The decision to use PAC without randomization identified a population with higher disease severity and risk of mortality. This prospective registry highlights the complex context of patient selection for randomized trials. PMID:18926438
Greenberg, Steven; Murphy, Glenn S; Avram, Michael J; Shear, Torin; Benson, Jessica; Parikh, Kruti N; Patel, Aashka; Newmark, Rebecca; Patel, Vimal; Bailes, Julian; Szokol, Joseph W
To determine whether opioids during the first 24 postoperative hours were significantly altered when receiving intravenous (IV) acetaminophen during that time compared with those receiving placebo (normal saline). One hundred forty patients undergoing any type of craniotomy were randomly assigned to receive either 1 g of IV acetaminophen or placebo upon surgical closure, and every 6 hours thereafter, up to 18 hours postoperatively. Analgesic requirements for the first 24 postoperative hours were recorded. Time to rescue medications in the postanesthesia care unit (PACU)/intensive care unit (ICU), amount of rescue medication, ICU and hospital lengths of stay, number of successful neurological examinations, sedation, delirium, satisfaction, and visual analog scale pain scores were also recorded. Compared with the placebo group, more patients in the IV acetaminophen group (10/66 [15.2%] vs. 4/65 [6.2%] in the placebo group) did not require opioids within the first 24 postoperative hours, but this did not reach significance (odds ratio, -9.0%, 95% confidence interval -20.5% to 1.8%; P = 0.166). Both groups had similar times to rescue medications, amounts of rescue medications, ICU and hospital lengths of stay, numbers of successful neurological examinations, sedation, delirium, satisfaction scores, visual analog scale pain scores, and temperatures within the first 24 postoperative hours. The opioid requirements within the first 24 postoperative hours were similar in the placebo and acetaminophen groups. This study is informative for the design and planning of future studies investigating the management of postoperative pain in patients undergoing craniotomies. Copyright © 2017 Elsevier Inc. All rights reserved.
McIlvaine, Elizabeth; Borzabadi-Farahani, Ali; Lane, Christianne J; Azen, Stanley P; Yen, Stephen L-K
To assess the feasibility of randomizing treatment (surgical vs. non-surgical) for correction of a Class III malocclusion (underbite) resulting from an earlier repair of cleft lip and palate. Surveys about willingness to accept randomized treatment during adolescence were mailed to the parents of cleft lip and palate patients under the care of Children's Hospital Los Angeles between 2005 and 2010. The inclusion criteria were patients with cleft lip and palate, Class III malocclusion due to maxillary deficiency, and absence of medical and cognitive contraindications to treatment. Out of 287 surveys, 82 (28%) were completed and returned; 47% of the subjects held a strong treatment preference (95% CI, 35-58%), while 30% were willing to accept randomization (95% CI, 20-41%). Seventy-eight percent would drop out of a randomized trial if dissatisfied with the assigned treatment (95% CI, 67-86%). The three most commonly cited reasons for being unwilling to accept random treatment assignment were 1) the desire for doctors to choose the best treatment, 2) the desire for parents to have input on treatment, and 3) the desire to correct the underbite as early as possible. Based on this study, parents and patients would be unwilling to accept a randomly assigned treatment and would not remain in an assigned group if treatment did not meet expectations. This highlight the limitations associated with randomization trials involving surgical modalities and provide justification for other research models (e.g., cohort studies) to compare two treatment options when randomization is not feasible. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Najafi, Zahra; Taghadosi, Mohsen; Sharifi, Khadijeh; Farrokhian, Alireza; Tagharrobi, Zahra
Background: Anxiety is an important mental health problem in patients with cardiac disease. Anxiety reduces patients’ quality of life and increases the risk of different cardiac complications. Objectives: The aim of this study was to investigate the effects of inhalation aromatherapy on anxiety in patients with myocardial infarction. Patients and Methods: This was a randomized clinical trial conduced on 68 patients with myocardial infarction hospitalized in coronary care units of a large-scale teaching hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran in 2013. By using the block randomization technique, patients were randomly assigned to experimental (33 patients receiving inhalation aromatherapy with lavender aroma twice a day for two subsequent days) and control (35 patients receiving routine care of study setting including no aromatherapy) groups. At the beginning of study and twenty minutes after each aromatherapy session, anxiety state of patients was assessed using the Spielberger’s State Anxiety Inventory. Data was analyzed using SPSS v. 16.0. We used Chi-square, Fisher’s exact, independent-samples T-test and repeated measures analysis of variance to analyze the study data. Results: The study groups did not differ significantly regarding baseline anxiety mean and demographic characteristics. However, after the administration of aromatherapy, anxiety mean in the experimental group was significantly lower than the control group. Conclusions: Inhalation aromatherapy with lavender aroma can reduce anxiety in patients with myocardial infarction. Consequently, healthcare providers, particularly nurses, can use this strategy to improve postmyocardial infarction anxiety management. PMID:25389481
Nikrahan, Gholam Reza; Suarez, Laura; Asgari, Karim; Beach, Scott R; Celano, Christopher M; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Abbas, Rezaei; Huffman, Jeff C
Positive psychologic characteristics have been linked to superior cardiac outcomes. Accordingly, in this exploratory study, we assessed positive psychology interventions in patients who had recently undergone a procedure to treat cardiovascular disease. Participants were randomly assigned to receive 1 of 3 different 6-week face-to-face interventions or a wait-list control condition. We assessed intervention feasibility and compared changes in psychologic outcome measures postintervention (7wk) and at follow-up (15wk) between intervention and control participants. Across the interventions, 74% of assigned sessions were completed. When comparing outcomes between interventions and control participants (N = 55 total), there were no between-group differences post-intervention, but at follow-up intervention participants had greater improvements in happiness (β = 14.43, 95% CI: 8.66-20.2, p positive psychology intervention for cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.
Gorrell, Lindsay M; Engel, Roger M; Lystad, Reidar P; Brown, Benjamin T
Reporting of adverse events in randomized clinical trials (RCTs) is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT) statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT). During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1) they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2) they mentioned adverse events (or any related terms) in the title or abstract. Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078). Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of allocation of adverse event indexing terms in both databases. We
Lindsay M. Gorrell
Full Text Available Abstract Background Reporting of adverse events in randomized clinical trials (RCTs is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT. During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. Methods A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1 they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2 they mentioned adverse events (or any related terms in the title or abstract. Results Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078. Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. Conclusions While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of
I study strategy-proof assignment mechanisms where the agents reveal their preference rankings over the available objects. A stochastic mechanism returns lotteries over deterministic assignments, and mechanisms are compared according to first-order stochastic dominance. I show that non-wasteful strategy-proof mechanisms are not dominated by strategy-proof mechanisms, however nonwastefulness is highly restrictive when the mechanism involves randomization. In fact, the Random Priority mechanism...
Alireza Ostadrahimi; Akbar Taghizadeh; Majid Mobasseri; Nazila Farrin; Laleh Payahoo; Zahra Beyramalipoor Gheshlaghi; Morteza Vahedjabbari
Background: Diabetes is a global health problem in the world. Probiotic food has anti-diabetic property. The aim of this trial was to determine the effect of probiotic fermented milk (kefir) on glucose and lipid profile control in patients with type 2 diabetes mellitus. Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 60 diabetic patients aged 35 to 65 years.Patients were randomly and equally (n=30) assigned to consume either probiotic fermented milk (k...
Christensen, J F; Jones, L W; Tolver, A.; J?rgensen, L W; Andersen, J. L.; Adamsen, L; H?jman, P; Nielsen, R.H.; R?rth, M; Daugaard, G.
Background: Bleomycin?etoposid?cisplatin (BEP) chemotherapy is curative in most patients with disseminated germ cell cancer (GCC) but also associated with toxic actions and dysfunction in non-targeted tissues. We investigated changes in muscle function during BEP and the safety and efficacy of resistance training to modulate these changes. Methods: Thirty GCC patients were randomly assigned to resistance training (resistance training group (INT), n=15) or usual care (CON, n=15) during 9 weeks...
Martins, Cesario; Garly, May-Lill; Bale, Carlitos
The World Health Organization recommends administration of measles vaccine (MV) at age 9 months in low-income countries. We tested the measles virus antibody response at 4.5, 9, 18, and 24 months of age for children randomly assigned to receive standard-titer Edmonston-Zagreb MV at 4.5 and 9 months...
Adolescent Substance Use in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder (ADHD) (MTA) as a Function of Childhood ADHD, Random Assignment to Childhood Treatments, and Subsequent Medication
Molina, Brooke S. G.; Hinshaw, Stephen P.; Arnold, L. Eugene; Swanson, James M.; Pelham, William E.; Hechtman, Lily; Hoza, Betsy; Epstein, Jeffery N.; Wigal, Timothy; Abikoff, Howard B.; Greenhill, Laurence L.; Jensen, Peter S.; Wells, Karen C.; Vitiello, Benedetto; Gibbons, Robert D.; Howard, Andrea; Houck, Patricia R.; Hur, Kwan; Lu, Bo; Marcus, Sue
Objective: To determine long-term effects on substance use and substance use disorder (SUD), up to 8 years after childhood enrollment, of the randomly assigned 14-month treatments in the multisite Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder (MTA; n = 436); to test whether medication at follow-up, cumulative…
Salonen, Bradley R; Bonnes, Sara L; Vallumsetla, Nishanth; Varayil, Jithinraj Edakkanambeth; Mundi, Manpreet S; Hurt, Ryan T
Ethanol lock therapy (ELT) has been shown to reduce the rate of catheter-related bloodstream infection (CRBSI) in high-risk home parenteral nutrition (HPN) patients. The aim of this study was to determine whether ELT therapy for all patients newly started on HPN would reduce the incidence of CRBSI. This study was a prospective, double-blind, randomized controlled trial that was carried out from July 2014 to April 2016. The study participants were patients newly started on HPN, and they were randomly assigned to either treatment with ELT or our current standard of care with saline heparin locks. The primary outcome was occurrence of CRBSI. Thirty eight patients that were newly started on HPN were randomized to either treatment with ELT (n = 18) or to our current standard of care with heparin locks (n = 20). Four patients in the ELT group and one patient in the control arm had a CRBSI (p = 0.17). No significant adverse side effects were noted during the study. This study did not show improvement in the rate of CRBSI with ELT in all patients started on HPN. ELT therapy may be most helpful to reduce in CRBSI in high-risk HPN patients, but further studies with a randomized control trial design of high-risk patients are needed to further clarify this important issue in HPN patients. The study was registered at clinicaltrials.gov prior to patient enrollment (NCT02227329). Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
Brinkhaus, Benno; Roll, Stephanie; Jena, Susanne; Icke, Katja; Adam, Daniela; Binting, Sylvia; Lotz, Fabian; Willich, Stefan N; Witt, Claudia M
Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.
Full Text Available Abstract Background Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. Methods/Design The Rochester Patient Navigation Research Program (PNRP is a National Cancer Institute-sponsored, patient-level randomized trial (RCT of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. Discussion This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. Trials Registration clinicaltrials.gov identifier NCT
Full Text Available Background: Letrozole is an aromatase inhibitor which can decrease estrogen production inperipheral tissues and endometriosis. Danazol, as an androgen, inhibits estrogen production inovaries and recently has been introduced as an aromatase inhibitor. This study was designed tocompare the effects of Danazol with Letrozole on endometriosis symptom relief.Materials and Methods: This study was a randomized clinical trial in which 105 patients withconfirmed endometriosis were randomly assigned to one of three groups. Group 1 received Letrozoletablets (2.5 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 2 received Danazoltablets (600 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 3 (placebo groupwere assigned to take two calcium tablets daily (500 mg/tablet and vitamin D (800 IU/day. Pelvicpain, dysmenorrhea and dyspareunia were assessed in participants at baseline and monthly duringthe study for a total of six months. Data were analyzed via SPSS version 15 software with Freidmanand Wilcoxon tests.Results: Mean age in three groups has no significant difference. Of the 105 participants who wereenrolled in this study, 38 patients were assigned to group 1 (Letrozole group, 37 patients in group 2(Danazol group and 31 patients were placed in group 3 (placebo group. This study showed that themean scores for chronic pelvic pain, dysmenorrhea and dyspareunia for the Letrozole group wereless than the Danazol and placebo groups.Conclusion: This study showed that Letrozole can be more effective than Danazol for reducingchronic pelvic pain, dyspareunia and dysmenorrhea in patients suffering from recurrent endometriosis(Registeration Number: IRCT138812043414N1.
Less wound complications of a sinus tarsi approach compared to an extended lateral approach for the treatment of displaced intraarticular calcaneal fracture: A randomized clinical trial in 64 patients
Li, Lian-Hua; Guo, Yong-Zhi; Wang, Hao; Sang, Qing-Hua; Zhang, Jian-Zheng; Liu, Zhi; Sun, Tian-Sheng
... intraarticular calcaneal fractures. Between January 2009 and January 2014, patients with displaced intraarticular calcaneal fracture were randomly assigned to receive surgical treatment by the sinus tarsi approach or the extended...
Lokhorst, H.M.; Holt, B. van der; Zweegman, S.; Vellenga, E.; Croockewit, S.; Oers, M.H. van; Borne, P. von dem; Wijermans, P.; Schaafsma, R.; Weerdt, O. de; Wittebol, S.; Delforge, M.; Berenschot, H.; Bos, G.M.; Jie, K.S.; Sinnige, H.; Marwijk-Kooy, M. van; Joosten, P.; Minnema, M.C.; Ammerlaan, R. van; Sonneveld, P.
The phase 3 trial HOVON-50 was designed to evaluate the effect of thalidomide during induction treatment and as maintenance in patients with multiple myeloma who were transplant candidates. A total of 556 patients was randomly assigned to arm A: 3 cycles of vincristine, adriamycin, and
Lokhorst, Henk M.; van der Holt, Bronno; Zweegman, Sonja; Vellenga, Edo; Croockewit, Sandra; van Oers, Marinus H.; von dem Borne, Peter; Wijermans, Pierre; Schaafsma, Ron; de Weerdt, Okke; Wittebol, Shulamiet; Delforge, Michel; Berenschot, Henriëtte; Bos, Gerard M.; Jie, Kon-Siong G.; Sinnige, Harm; van Marwijk-Kooy, Marinus; Joosten, Peter; Minnema, Monique C.; van Ammerlaan, Rianne; Sonneveld, Pieter
The phase 3 trial HOVON-50 was designed to evaluate the effect of thalidomide during induction treatment and as maintenance in patients with multiple myeloma who were transplant candidates. A total of 556 patients was randomly assigned to arm A: 3 cycles of vincristine, adriamycin, and
H.M. Lokhorst (Henk); B. van der Holt (Bronno); S. Zweegman (Sonja); E. Vellenga (Edo); S. Croockewit (Sandra); M.H.J. van Oers (Marinus); P.A. von dem Borne (P. A.); P.W. Wijermans (Pierre); R. Schaafsma (Ron); O. de Weerdt (Okke); S. Wittebol (Shulamit); M. Delforge (Michel); H. Berenschot (Henriëtte); G.M. Bos (Gerard); K.S-G. Jie; H. Sinnige (Harm); M. van Marwijk Kooy (Marinus); P. Joosten (Peter); M.C. Minnema (Monique); R.A.H.M. Ammerlaan (Rianne); P. Sonneveld (Pieter)
textabstractThe phase 3 trial HOVON-50 was designed to evaluate the effect of thalidomide during induction treatment and as maintenance in patients with multiple myeloma who were transplant candidates. A total of 556 patients was randomly assigned to arm A: 3 cycles of vincristine, adriamycin, and
Park, So Yeon; Park, Jong Min; Choi, Chang Heon; Chun, MinSoo; Han, Ji Hye; Cho, Jin Dong; Kim, Jung In [Dept. of Radiation Oncology, Seoul National University Hospital, Seoul (Korea, Republic of)
The purpose of this study is to assign an appropriate density to virtual phantom for 2D diode array detector with different dose calculation algorithms to guarantee the accuracy of patient-specific QA. Ten VMAT plans with 6 MV photon beam and ten VMAT plans with 15 MV photon beam were selected retrospectively. The computed tomography (CT) images of MapCHECK2 with MapPHAN were acquired to design the virtual phantom images. For all plans, dose distributions were calculated for the virtual phantoms with four different materials by AAA and AXB algorithms. The four materials were polystyrene, 455 HU, Jursinic phantom, and PVC. Passing rates for several gamma criteria were calculated by comparing the measured dose distribution with calculated dose distributions of four materials. For validation of AXB modeling in clinic, the mean percentages of agreement in the cases of dose difference criteria of 1.0% and 2.0% for 6 MV were 97.2%±2.3%, and 99.4%±1.1%, respectively while those for 15 MV were 98.5%±0.85% and 99.8%±0.2%, respectively. In the case of 2%/2 mm, all mean passing rates were more than 96.0% and 97.2% for 6 MV and 15 MV, respectively, regardless of the virtual phantoms of different materials and dose calculation algorithms. The passing rates in all criteria slightly increased for AXB as well as AAA when using 455 HU rather than polystyrene. The virtual phantom which had a 455 HU values showed high passing rates for all gamma criteria. To guarantee the accuracy of patent-specific VMAT QA, each institution should fine-tune the mass density or HU values of this device.
Michalsen, Andreas; Bock, Silke; Lüdtke, Rainer; Rampp, Thomas; Baecker, Marcus; Bachmann, Jürgen; Langhorst, Jost; Musial, Frauke; Dobos, Gustav J
We investigated the effectiveness of cupping, a traditional method of treating musculoskeletal pain, in patients with carpal tunnel syndrome (CTS) in an open randomized trial. n = 52 outpatients (58.5 +/- 8.0 years) with neurologically confirmed CTS were randomly assigned to either a verum (n = 26) or a control group (n = 26). Verum patients were treated with a single application of wet cupping, and control patients with a single local application of heat within the region overlying the trapezius muscle. Patients were followed up on day 7 after treatment. The primary outcome, severity of CTS symptoms (VAS), was reduced from 61.5 +/- 20.5 to 24.6 +/- 22.7 mm at day 7 in the cupping group and from 67.1 +/- 20.2 to 51.7 +/- 23.9 mm in the control group [group difference -24.5mm (95%CI -36.1; -2.9, P cupping therapy may be effective in relieving the pain and other symptoms related to CTS. The efficacy of cupping in the long-term management of CTS and related mechanisms remains to be clarified. The results of a randomized trial on the clinical effects of traditional cupping therapy in patients with carpal tunnel syndrome are presented. Cupping of segmentally related shoulder zones appears to alleviate the symptoms of carpal tunnel syndrome.
Danhauer, Suzanne C; Vishnevsky, Tanya; Campbell, Cassie R; McCoy, Thomas P; Tooze, Janet A; Kanipe, Katherine N; Arrington, Sheila A; Holland, Elizabeth K; Lynch, Mary B; Hurd, David D; Cruz, Julia
To examine the impact of random assignment to music versus usual care on anxiety, perceived pain level and patient satisfaction in patients undergoing bone marrow biopsies. Patients were randomized to music or usual care after completing a baseline questionnaire. All patients completed a post-procedure questionnaire. Study participants (N=59) had a mean age of 50.9 years (SD = 13.9; range 22-78). Post-procedure state anxiety (STAI) and pain rating (VAS) were not significantly different between groups (STAI p=0.766; VAS p=0.771). However, patient satisfaction with music was high; 66% of these patients said they very much preferred to listen to music at a future biopsy. While there were no significant group differences for the music intervention compared to standard of care for anxiety or perceived pain, additional feedback indicated that patients found the music intervention beneficial and requested use of music during future procedures.
Ricard, Jean-Damien; Salomon, Laurence; Boyer, Alexandre; Thiery, Guillaume; Meybeck, Agnes; Roy, Carine; Pasquet, Blandine; Le Mière, Eric; Dreyfuss, Didier
The vast majority of ICU patients require some form of venous access. There are no evidenced-based guidelines concerning the use of either central or peripheral venous catheters, despite very different complications. It remains unknown which to insert in ICU patients. We investigated the rate of catheter-related insertion or maintenance complications in two strategies: one favoring the central venous catheters and the other peripheral venous catheters. Multicenter, controlled, parallel-group, open-label randomized trial. Three French ICUs. Adult ICU patients with equal central or peripheral venous access requirement. Patients were randomized to receive central venous catheters or peripheral venous catheters as initial venous access. The primary endpoint was the rate of major catheter-related complications within 28 days. Secondary endpoints were the rate of minor catheter-related complications and a composite score-assessing staff utilization and time spent to manage catheter insertions. Analysis was intention to treat. We randomly assigned 135 patients to receive a central venous catheter and 128 patients to receive a peripheral venous catheter. Major catheter-related complications were greater in the peripheral venous catheter than in the central venous catheter group (133 vs 87, respectively, p=0.02) although none of those was life threatening. Minor catheter-related complications were 201 with central venous catheters and 248 with peripheral venous catheters (p=0.06). 46% (60/128) patients were managed throughout their ICU stay with peripheral venous catheters only. There were significantly more peripheral venous catheter-related complications per patient in patients managed solely with peripheral venous catheter than in patients that received peripheral venous catheter and at least one central venous catheter: 1.92 (121/63) versus 1.13 (226/200), pcentral venous catheter-related complications per patient between patients initially randomized to peripheral
Chan, K Ming; Strohschein, Fay J; Rydz, David; Allidina, Amyn; Shuaib, Ashfaq; Westbury, Chris F
The purpose of this study was to test whether modafinil is effective in alleviating the symptoms of fatigue in postpolio patients, because it has been helpful for such symptoms in other neurologic disorders. Using a double-blind, randomized, placebo-controlled cross-over design, 14 postpolio patients with moderate to severe fatigue were assigned to receive modafinil or placebo first. Piper Fatigue Scale, Epworth Sleepiness Scale, digit span, and reaction time tests were done at baseline and then at weekly intervals. The Piper Fatigue Scale scores improved by 27 +/- 40% (mean +/- SD) following modafinil and by 43 +/- 36% following placebo. Scores for most of the other tests did not change during the study. Therefore, we conclude that modafinil was not effective in alleviating the symptoms of fatigue in postpolio patients.
Gilowski, L; Kondzielnik, P; Wiench, R; Płocica, I; Strojek, K; Krzemiński, T F
To investigate the effectiveness of short-term adjunctive subantimicrobial dose doxycycline (SDD) treatment in patients with diabetes mellitus type 2 and chronic periodontitis (CP). Thirty-four patients with CP and type 2 diabetes mellitus were included in the placebo-controlled, double-blind study. After scaling and root planing (SRP), patients were randomly assigned to two groups, receiving either SDD or placebo bid for 3 months. The probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), approximal plaque index, glycated hemoglobin (HbA1c) level were recorded and gingival crevicular fluid (GCF) samples were collected at baseline and after 3-month therapy for the estimation of matrix metalloproteinase-8 levels. Clinical attachment level, PD, and BOP improved significantly in both groups after therapy (P diabetes and CP. © 2012 John Wiley & Sons A/S.
Cai, Chunfeng; Yu, Liping; Rong, Lan; Zhong, Hanling
The primary aim of this pilot study was to evaluate the possible therapeutic effects of a 10-session humor intervention program in improving rehabilitative outcomes and the effects of the intervention on patients' sense of humor among patients with schizophrenia. Thirty subjects were randomly assigned into either the intervention (humor skill training) group (n = 15) or the control (doing handwork) group (n = 15). The results were analyzed using descriptive statistics, t-tests and ANOVA. Repeated measures analysis of variance (ANOVA) tests were conducted to examine the differences across conditions and time. A group by time interaction effect was observed on all of the outcomes, except positive symptoms of PANSS. The time main effect was also significant on the total score (p humor skill training in a mental health service can improve rehabilitative outcomes and sense of humor for schizophrenia patients who were in the rehabilitation stage. Copyright © 2014 Elsevier Ltd. All rights reserved.
Green, Heather J; Pakenham, Kenneth I; Headley, Betty C; Gardiner, Robert A
Prostatic carcinoma and its treatment have been associated with adverse effects on health-related quality of life (HRQoL). Individual differences in appraisal and coping have been suggested to mediate these HRQoL outcomes. A randomized trial of 65 men with non-localized prostate cancer compared several treatments and tested associations between appraisal, coping, and HRQoL. These patients, and 16 community volunteers matched for age and general health, undertook psychosocial assessments before treatment and after 6 months of treatment. Compared with baseline assessments, men on hormonal treatments reported impaired sexual function. Groups did not differ on emotional distress, existential satisfaction, subjective cognitive function, physical symptoms, or social and role functioning. For individuals, hormonal treatments were more frequently associated with decreased sexual, social and role functioning, but were also associated with improved physical symptoms. In hierarchical regression analysis, HRQoL was lower for men who had more comorbid illnesses, a history of neurological dysfunction, higher threat appraisals, or higher use of coping strategies at baseline. These results showed that pharmacological hormonal ablation for prostate cancer can improve or decrease HRQoL in different domains. HRQoL in men with prostate cancer was associated more strongly with appraisal and coping than with medical variables. Copyright 2002 John Wiley & Sons, Ltd.
Tabibi, Hadi; Imani, Hossein; Atabak, Shahnaz; Najafi, Iraj; Hedayati, Mehdi; Rahmani, Leila
♦ In peritoneal dialysis (PD) patients, one of the major risk factors for cardiovascular disease is lipid abnormalities. This study was designed to investigate the effects of ginger supplementation on serum lipids and lipoproteins in PD patients. ♦ In this randomized, double-blind, placebo-controlled trial, 36 PD patients were randomly assigned to either the ginger or the placebo group. The patients in the ginger group received 1,000 mg ginger daily for 10 weeks, while the placebo group received corresponding placebos. At baseline and at the end of week 10, 7 mL of blood were obtained from each patient after a 12- to 14-hour fast, and serum concentrations of triglyceride, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and lipoprotein (a) [Lp (a)] were measured. ♦ Serum triglyceride concentration decreased significantly up to 15% in the ginger group at the end of week 10 compared with baseline (p < 0.01), and the reduction was significant in comparison with the placebo group (p < 0.05). There were no significant differences between the 2 groups in mean changes of serum total cholesterol, LDL-C, HDL-C, and Lp (a). ♦ This study indicates that daily administration of 1,000 mg ginger reduces serum triglyceride concentration, which is a risk factor for cardiovascular disease, in PD patients. Copyright © 2016 International Society for Peritoneal Dialysis.
Full Text Available Background: Mizoribine (MZR is an immunosuppressive drug used in Japan for treating patients with lupus nephritis and nephrotic syndrome and has been also reportedly effective in patients with immunoglobulin A (IgA nephropathy. However, to date, few randomized control studies of MZR are performed in patients with IgA nephropathy. Therefore, this prospective, open-label, randomized, controlled trial aimed to investigate the efficacy and safety of adding MZR to standard treatment in these patients, and was conducted between April 1, 2009, and March 31, 2016, as a multicenter study. Methods: Patients were randomly assigned (1:1 to receiving standard treatment plus MZR (MZR group or standard treatment (control group. MZR was administered orally at a dose of 150 mg once daily for 12 months. Results: Primary outcomes were the percentage reduction in urinary protein excretion from baseline and the rate of patients with hematuria disappearance 36 months after study initiation. Secondary outcomes were the rate of patients with proteinuria disappearance, clinical remission rate, absolute changes in estimated glomerular filtration rate from baseline, and the change in daily dose of prednisolone. Forty-two patients were randomly assigned to MZR (n = 21 and control groups (n = 21. Nine patients in MZR group and 15 patients in the control group completed the study. No significant differences were observed between the two groups with respect to primary and secondary outcomes. Conclusion: The addition of MZR to standard treatment has no beneficial effect on reducing urinary protein excretion and hematuria when treating patients with IgA nephropathy.
Full Text Available Abstract Background The aim of this pilot randomized controlled trial (RCT was to evaluate the sagittal mandibular response induced by rapid maxillary expansion (RME therapy in mixed dentition patients with class II malocclusion, comparing the effects of bonded RME and banded RME with a matched untreated class II control group. Methods This RCT was designed in parallel with an allocation ratio of 1:1:1. The sample consisted of 30 children with a mean age of 8.1 ± 0.6 years who were randomly assigned to three groups: group 1 treated with bonded RME, group 2 treated with banded RME, and group 3 the untreated control group. All patients met the following inclusion criteria: early mixed dentition, class II molar relationship, transverse discrepancy ≥ 4 mm, overjet ≥ 5 mm, and prepubertal skeletal maturity stage (CS1–CS2. The expansion screw was activated one quarter of a turn per day (0.25 mm until overcorrection was reached. For each subject, lateral cephalograms and plaster casts were obtained before treatment (T1 and after 1 year (T2. A randomization list was created for the group assignment, with an allocation ratio of 1:1:1. The observer who performed all the measurements was blinded to group assignment. The study was single-blinded in regard to statistical analysis. Results RME was effective in the correction of maxillary deficiency. Class II patients treated with both types of RME showed no significant improvement of the anteroposterior relationship of the maxilla and the mandible at both skeletal and occlusal levels. The acrylic splint RME had significant effects on reducing the skeletal vertical dimension and the gonial angle. Conclusions The orthopedic expansion did not affect the sagittal relationship of class II patients treated in the early mixed dentition when compared with the untreated control group. Additional studies with a larger sample are warranted to elucidate individual variations in dento-skeletal mandibular
Lione, Roberta; Brunelli, Valerio; Franchi, Lorenzo; Pavoni, Chiara; Quiroga Souki, Bernardo; Cozza, Paola
The aim of this pilot randomized controlled trial (RCT) was to evaluate the sagittal mandibular response induced by rapid maxillary expansion (RME) therapy in mixed dentition patients with class II malocclusion, comparing the effects of bonded RME and banded RME with a matched untreated class II control group. This RCT was designed in parallel with an allocation ratio of 1:1:1. The sample consisted of 30 children with a mean age of 8.1 ± 0.6 years who were randomly assigned to three groups: group 1 treated with bonded RME, group 2 treated with banded RME, and group 3 the untreated control group. All patients met the following inclusion criteria: early mixed dentition, class II molar relationship, transverse discrepancy ≥ 4 mm, overjet ≥ 5 mm, and prepubertal skeletal maturity stage (CS1-CS2). The expansion screw was activated one quarter of a turn per day (0.25 mm) until overcorrection was reached. For each subject, lateral cephalograms and plaster casts were obtained before treatment (T1) and after 1 year (T2). A randomization list was created for the group assignment, with an allocation ratio of 1:1:1. The observer who performed all the measurements was blinded to group assignment. The study was single-blinded in regard to statistical analysis. RME was effective in the correction of maxillary deficiency. Class II patients treated with both types of RME showed no significant improvement of the anteroposterior relationship of the maxilla and the mandible at both skeletal and occlusal levels. The acrylic splint RME had significant effects on reducing the skeletal vertical dimension and the gonial angle. The orthopedic expansion did not affect the sagittal relationship of class II patients treated in the early mixed dentition when compared with the untreated control group. Additional studies with a larger sample are warranted to elucidate individual variations in dento-skeletal mandibular response to the maxillary expansion protocol in class
Hypospadias is a urogenital malformation, and it is a common inborn disorder in male individuals. The etiology of hypospadias is still unsolved. The present study is aimed to identify the genetic instability in hypospadias patients. Random amplified polymorphic DNA (RAPD), a polymerase chain reaction (PCR) based ...
Full Text Available Abstract Summary The aim of this prospective randomized single-center study was to investigate whether sling exercise therapy is superior to conventional exercises in osteoporosis patients. Background Patients with osteoporosis frequently experience fractures of the vertebral body, which may cause chronic back pain and other symptoms. These, in turn, may lead to immobilization, muscular atrophy, and restrictions in activities of daily living. The situation can be improved with specific medication and physiotherapy. We explored the effects of a variety of physical treatments on activities of daily living in patients with osteoporosis. Method Fifty patients were randomly allocated to two treatment groups. Group A received traditional physiotherapy (PT while group B underwent sling exercise therapy (ST. Both treatments were given twice a week for three months. The results of the treatment were registered on the quality of life questionnaire (Qualeffo-41 devised by the International Osteoporosis Foundation. After a further three months with no specific exercise treatment, we again tested all patients in order to draw conclusions about the long-term effects of both types of exercise. Results Forty-four patients (88% completed the study. Patients were assigned to small groups (a maximum of 5 patients in each group and thus received individual attention and motivation. Quality of life was improved in both groups; a significantly greater improvement was registered in patients who performed sling exercises (Global score Qualeffo: p = 0.002. Conclusion The test results confirm the known positive effects of physical therapy on the quality of life of osteoporosis patients, as well as the fact that sling exercises are a sound alternative treatment for this condition.
Miller-Spoto, Marcia; Gombatto, Sara P
A variety of diagnostic classification systems are used by physical therapists, but little information about how therapists assign diagnostic labels and how the labels are used to direct intervention is available. The purposes of this study were: (1) to examine the diagnostic labels assigned to patient problems by physical therapists who are board-certified Orthopaedic Clinical Specialists (OCSs) and (2) to determine whether the label influences selection of interventions. A cross-sectional survey was conducted. Two written cases were developed for patients with low back and shoulder pain. A survey was used to evaluate the diagnostic label assigned and the interventions considered important for each case. The cases and survey were sent to therapists who are board-certified OCSs. Respondents assigned a diagnostic label and rated the importance of intervention categories for each case. Each diagnostic label was coded based on the construct it represented. Percentage responses for each diagnostic label code and intervention category were calculated. Relative importance of intervention category based on diagnostic label was examined. For the low back pain and shoulder pain cases, respectively, "Combination" (48.5%, 34.9%) and "Pathology/Pathophysiology" (32.7%, 57.3%) diagnostic labels were most common. Strengthening (85.9%, 98.1%), stretching (86.8%, 84.9%), neuromuscular re-education (87.6%, 93.4%), functional training (91.4%, 88.6%), and mobilization/manipulation (85.1%, 86.8%) were considered the most important interventions. Relative importance of interventions did not differ based on diagnostic label (χ2=0.050-1.263, P=.261-.824). The low response rate may limit the generalizability of the findings. Also, examples provided for labels may have influenced responses, and some of the label codes may have represented overlapping constructs. There is little consistency with which OCS therapists assign diagnostic labels, and the label does not seem to influence
Dragsted, Ulrik Bak; Gerstoft, Jan; Pedersen, Court
This trial assessed the rate of virological failure at 48 weeks in adult human immunodeficiency virus (HIV) type 1-infected patients assigned indinavir/ritonavir (Idv/Rtv; 800/100 mg 2 times daily) or saquinavir/ritonavir (Sqv/Rtv; 1000/100 mg 2 times daily) in an open-label, randomized (1:1...
Rubbert-Roth, Andrea; Tak, Paul P.; Zerbini, Cristiano; Tremblay, Jean-Luc; Carreño, Luis; Armstrong, Gillian; Collinson, Neil; Shaw, Tim M.
Methods. Patients with active RA despite stable MTX (10-25 mg/week) were randomly assigned to one of the three treatment regimens comprising two courses of RTX given 24 weeks apart: 2 x 500 and 2 x 500 mg; 2 x 500 and 2 x 1000 mg (dose escalation); and 2 x 1000 and 2 x 1000 mg. The primary endpoint
Northouse, Laurel L.; Mood, Darlene W.; Schafenacker, Ann; Kalemkerian, Gregory; Zalupski, Mark; LoRusso, Patricia; Hayes, Daniel F.; Hussain, Maha; Ruckdeschel, John; Fendrick, A. Mark; Trask, Peter C.; Ronis, David L.; Kershaw, Trace
Objective Few intervention programs assist patients and their family caregivers to manage advanced cancer and maintain their quality of life (QOL). This study examined: 1) whether patient-caregiver dyads (i.e., pairs) randomly assigned to a Brief or Extensive dyadic intervention (the FOCUS Program) had better outcomes than dyads randomly assigned to usual care, and 2) if patients' risk for distress (RFD) and other factors moderated the effect of the Brief or Extensive Program on outcomes. Methods Advanced cancer patients and their caregivers (N=484 dyads) were stratified by patients' baseline risk for distress (high versus low), cancer type (lung, colorectal, breast, prostate), and research site, and then randomly assigned to a Brief (3-session) or Extensive (6-session) intervention or Control. The interventions offered dyads information and support. Intermediary outcomes were: appraisals (i.e., appraisal of illness/caregiving, uncertainty, hopelessness) and resources (i.e., coping, interpersonal relationships, and self-efficacy). The primary outcome was QOL. Data were collected prior to intervention and post-intervention (3 and 6 months from baseline). The final sample was 302 dyads. Repeated Measures MANOVA was used to evaluate outcomes. Results Significant Group by Time interactions showed there was improvement in dyads' coping (p<.05), self-efficacy (p<.05), and social QOL (p<.01), and in caregivers' emotional QOL (p<.05). Effects varied by intervention dose. Most effects were found at 3 months only. Risk for distress accounted for very few moderation effects. Conclusions Both Brief and Extensive programs had positive outcomes for patient-caregiver dyads, but few sustained effects. Patient-caregiver dyads benefit when viewed as the “unit of care.” PMID:22290823
Northouse, Laurel L; Mood, Darlene W; Schafenacker, Ann; Kalemkerian, Gregory; Zalupski, Mark; LoRusso, Patricia; Hayes, Daniel F; Hussain, Maha; Ruckdeschel, John; Fendrick, A Mark; Trask, Peter C; Ronis, David L; Kershaw, Trace
Few intervention programs assist patients and their family caregivers to manage advanced cancer and maintain their quality of life (QOL). This study examined (i) whether patient-caregiver dyads (i.e., pairs) randomly assigned to a brief or extensive dyadic intervention (the FOCUS Program) had better outcomes than dyads randomly assigned to usual care and (ii) whether patients' risk for distress and other factors moderated the effect of the brief or extensive program on outcomes. Advanced cancer patients and their caregivers (N = 484 dyads) were stratified by patients' baseline risk for distress (high versus low), cancer type (lung, colorectal, breast, or prostate), and research site and then randomly assigned to a brief (three-session) or extensive (six-session) intervention or control. The interventions offered dyads information and support. Intermediary outcomes were appraisals (i.e., appraisal of illness/caregiving, uncertainty, and hopelessness) and resources (i.e., coping, interpersonal relationships, and self-efficacy). The primary outcome was QOL. Data were collected prior to intervention and post-intervention (3 and 6 months from baseline). The final sample was 302 dyads. Repeated measures MANCOVA was used to evaluate outcomes. Significant group by time interactions showed that there was an improvement in dyads' coping (p < 0.05), self-efficacy (p < 0.05), and social QOL (p < 0.01) and in caregivers' emotional QOL (p < 0.05). Effects varied by intervention dose. Most effects were found at 3 months only. Risk for distress accounted for very few moderation effects. Both brief and extensive programs had positive outcomes for patient-caregiver dyads, but few sustained effects. Patient-caregiver dyads benefit when viewed as the 'unit of care'. Copyright © 2012 John Wiley & Sons, Ltd.
Boele, Florien W; Verdonck-de Leeuw, Irma M; Cuijpers, Pim; Reijneveld, Jaap C; Heimans, Jan J; Klein, Martin
Among glioma patients, depression is estimated to be more prevalent than in both the general population and the cancer patient population. This can have negative consequences for both patients and their primary informal caregivers (e.g., a spouse, family member or close friend). At present, there is no evidence from randomized controlled trials for the effectiveness of psychological treatment for depression in glioma patients. Furthermore, the possibility of delivering mental health care through the internet has not yet been explored in this population. Therefore, a randomized controlled trial is warranted to evaluate the effects of an internet-based, guided self-help intervention for depressive symptoms in glioma patients. The intervention is based on problem-solving therapy. An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms (Center for Epidemiology Studies Depression Scale score ≥12). Sample size calculations yield 126 glioma patients to be included, who are randomly assigned to either the intervention group or a waiting list control group. In addition, we aim to include 63 patients with haematological cancer in a non-central nervous system malignancy control group. Assessments take place at baseline, after 6 and 12 weeks, and after 6 and 12 months. Primary outcome measure is the change in depressive symptoms. Secondary outcome measures include health-related quality of life, fatigue, costs and patient satisfaction. In addition, all patients are asked to assign a primary informal caregiver, who does not participate in the intervention but who is asked to complete similar assessments. Their mood, health-related quality of life and fatigue is evaluated as well. This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients. If proven effective, this treatment will contribute to the mental health care of
Raghavendra Mohan Rao; Nagarathna Raghuram; H.R. Nagendra; M R Usharani; Gopinath, K. S.; Diwakar, Ravi B; Shekar Patil; Bilimagga, Ramesh S.; Nalini Rao
Aim: To compare the effects of yoga program with supportive therapy on self-reported symptoms of depression in breast cancer patients undergoing conventional treatment. Patients and Methods: Ninety-eight breast cancer patients with stage II and III disease from a cancer center were randomly assigned to receive yoga (n = 45) and supportive therapy (n = 53) over a 24-week period during which they underwent surgery followed by adjuvant radiotherapy (RT) or chemotherapy (CT) or both. The stud...
Hougaard, Jens Leth; Moreno-Ternero, Juan D.; Østerdal, Lars Peter Raahave
minimizing modification of the classic random priority method to solve this class of problems. We also provide some logical relations in our setting among standard axioms in the literature on assignment problems, and explore the robustness of our results to several extensions of our setting....
Liu, Li-Hong; Fan, Xin; An, Yu-Xi; Zhang, Jin; Wang, Cong-Min; Yang, Rong-Ya
Acne vulgaris is common in Asian populations. We compared three methods of phototherapy for the treatment of moderate to severe facial acne vulgaris in Chinese patients. Patients were randomly assigned to receive photodynamic therapy (PDT), intense pulsed light (IPL) or blue-red light-emitting diode (LED) phototherapy to the right side of the face until the inflammatory lesion count reduced by ≥ 90%. Patients were examined at 1 and 3 months after the final treatment. We enrolled 150 patients (92 males; mean age, 28 years). At 1 month, ≥90% clearance or moderate improvement occurred in 46/50 (92%), 29/50 (58%) and 22/50 (44%) patients in the PDT, IPL and LED groups, respectively (mean number of sessions required, PDT: 3 ± 1.52; IPL: 6 ± 2.15; LED: 9 ± 3.34). Forty-six (92%) patients experienced mild to moderate pain, erythema and edema after PDT, which resolved within 5-7 days. Slight erythema and stinging were reported immediately after IPL and LED, resolving within 2 h. After 3 months, minimal papules and pustules were observed in 4 patients in the PDT group, 7 in the IPL group and 12 in the LED group, but no nodular pustules recurred. Phototherapy is efficacious for moderate to severe facial acne vulgaris. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Chen, Jyun-Hong; Ou, Huang-Tz; Lin, Tzu-Chieh; Lai, Edward Chia-Cheng; Kao, Yea-Huei Yang
Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider. To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes. A 421-bed district hospital in Nantou City, Taiwan. We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann–Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups. The pharmacist intervention program provided pharmaceutical services that improved long-term, safe control of blood sugar levels for ambulatory elderly patients with diabetes and did not increase medical expenses.
Perl, Sabine; Niederl, Ella; Kos, Cornelia; Mrak, Peter; Ederer, Herbert; Rakovac, Ivo; Beck, Peter; Kraler, Elisabeth; Stoff, Ingrid; Klima, Gert; Pieske, Burkert M; Pieber, Thomas R; Zweiker, Robert
Adherence to medication and lifestyle interventions are essential keys for the management of hypertension. In this respect, a structured educational program for hypertensive patients has got remarkable merits (herz.leben). In order to determine the isolated effect of participation in the educational program, neglecting the possible impact of more intense care, this prospective multicenter randomized controlled study was designed (NCT00453037). A total of 256 patients in 13 centers were enrolled and randomly assigned to 2 groups (G). G-I (n = 137) underwent the educational program immediately (T-0), G-II (n = 119) after 6 months (T-6). Follow-up visits were done after 6 (T-6) and 12 (T-12) months. Primary endpoint was a difference in office blood pressure (BP) at T-6, when only G-I had undergone the educational program. Patients' baseline characteristics were comparable. At T-6, systolic office and home BP were significantly lower in G-I compared to G-II: office BP systolic 139 (134-150) mm Hg vs. 150 (135-165) mm Hg (P educational program differences in BP disappeared. The results of this multicenter randomized controlled study provide significant evidence for benefit by participation in a structured educational program. Positive effects seem to be mediated by better adherence and life style changes due to higher levels of information and patient empowerment. Therefore, educational strategies should be considered as standard of care for hypertensive patients. © American Journal of Hypertension, Ltd 2015. All rights reserved. For Permissions, please email: email@example.com.
Hege Gade; Jøran Hjelmesæth; Rosenvinge, Jan H.; Oddgeir Friborg
Objective. To examine whether cognitive behavioral therapy (CBT) alleviates dysfunctional eating (DE) patterns and symptoms of anxiety and depression in morbidly obese patients planned for bariatric surgery. Design and Methods. A total of 98 (68 females) patients with a mean (SD) age of 43 (10) years and BMI 43.5 (4.9) kg/m2 were randomly assigned to a CBT-group or a control group receiving usual care (i.e., nutritional support and education). The CBT-group received ten weekly intervention se...
Chun, Jin-Young; Seo, Jeong-Hwan; Park, Sung-Hee; Won, Yu Hui; Kim, Gi-Wook; Moon, Sung-Jun; Ko, Myoung-Hwan
Objective To investigate the effects of the newly developed Spine Balance 3D system on the balance and gait abilities of hemiplegic stroke patients. Methods Twenty-eight hemiplegic patients with chronic stroke were randomly assigned to an experimental (n=14) or control group (n=14). The experimental and control groups performed balance training by using the newly developed Spine Balance 3D system and the well-known Biodex Balance System 30 minutes per day, three times a week for 7 weeks. The ...
Using a partially randomized patient preference study design to evaluate the therapeutic effect of acupuncture and cupping therapy for fibromyalgia: study protocol for a partially randomized controlled trial.
Cao, Hui-Juan; Liu, Jian-Ping; Hu, Hui; Wang, Nissi S
Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality. The aim of this study is to investigate the feasibility of applying a partially randomized patient preference (PRPP) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies, acupuncture and cupping, for fibromyalgia while accounting for patients' preference of either therapeutic modality. This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital, Beijing University of Chinese Medicine (approval number: 2013052104-2). One hundred participants with fibromyalgia will be included in this study. Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria. Before treatment, participants will be interviewed for their preference toward acupuncture or cupping therapy. Fifty participants with no preference will be randomly assigned to one of the two groups and another 50 participants with strong preference to either acupuncture or cupping will receive what they choose. For acupuncture and cupping therapy, the main acupoints used will be tender points (Ashi). Treatment will be three times a week for 5 consecutive weeks with a follow-up period of 12 weeks. Outcome measures will be qualitative (patient expectation and satisfaction) and quantitative (pain intensity, quality of life, depression assessment). NCT01869712 (in clinicaltrials.gov, on 22nd May 2013).
Tamaki, Kentaro; Fukuyama, Akiko Komatsu; Terukina, Shigeharu; Kamada, Yoshihiko; Uehara, Kano; Arakaki, Miwa; Yamashiro, Kazuko; Miyashita, Minoru; Ishida, Takanori; McNamara, Keely May; Ohuchi, Noriaki; Tamaki, Nobumitsu; Sasano, Hironobu
Several studies focused on the effect of aromatherapy on mood, quality of life (QOL), and physical symptoms in patients with cancer. We compared the effects on QOL, vital signs, and sleep quality between aromatherapy and conventional therapy during perioperative periods of the breast cancer patients in this study. Patients were randomly assigned in a 2:1 ratio to receive aromatherapy or usual care. The primary endpoint was QOL, which was assessed using the quality of life questionnaire QLQ-C30, Version 3.0 of the European Organization for Research and Treatment of Cancer (EORTC) Study Group on quality of life. Secondary endpoints included the necessity of hypnotics, vital signs including blood pressure and heart rate and adverse events. In addition, we also summarized the patients' perception of the experience from a free description-type questionnaire. A total of 249 patients had breast cancer surgery and 162 patients gave physician consent and were recruited; 110 were randomly assigned to aromatherapy group (eight patients showed incomplete EORTC QLQ-C30) and 52 to control group (one patient showed incomplete EORTC QLQ-C30). There were no statistically significant differences between the aromatherapy group and control group in the EORTC QLQ-C30 at the surgery day. As for the results of the post-operation day 1, trends for differentiations of physical functioning and role functioning were detected between aromatherapy group and control group, but the differences did not reach statistical significance (p = 0.08 and 0.09). There were no significant differences of systolic and diastolic blood pressures between aromatherapy group and control group (p = 0.82 and 0.68). There was no statistically significant difference in heart rates between aromatherapy group (70.6 ± 11.0 bpm) and control group (71.2 ± 9.8 bpm) (p = 0.73). Likewise, the rate of hypnotic use was not statistically significant (p = 0.10). No adverse events were reported after aromatherapy
Müller, Mandy D; Ahlhelm, Frank J; von Hessling, Alexander; Doig, David; Nederkoorn, Paul J; Macdonald, Sumaira; Lyrer, Philippe A; van der Lugt, Aad; Hendrikse, Jeroen; Stippich, Christoph; van der Worp, H Bart; Richards, Toby; Brown, Martin M; Engelter, Stefan T; Bonati, Leo H
Complex vascular anatomy might increase the risk of procedural stroke during carotid artery stenting (CAS). Randomized controlled trial evidence that vascular anatomy should inform the choice between CAS and carotid endarterectomy (CEA) has been lacking. One-hundred eighty-four patients with symptomatic internal carotid artery stenosis who were randomly assigned to CAS or CEA in the ICSS (International Carotid Stenting Study) underwent magnetic resonance (n=126) or computed tomographic angiography (n=58) at baseline and brain magnetic resonance imaging before and after treatment. We investigated the association between aortic arch configuration, angles of supra-aortic arteries, degree, length of stenosis, and plaque ulceration with the presence of ≥1 new ischemic brain lesion on diffusion-weighted magnetic resonance imaging (DWI+) after treatment. Forty-nine of 97 patients in the CAS group (51%) and 14 of 87 in the CEA group (16%) were DWI+ (odds ratio [OR], 6.0; 95% confidence interval [CI], 2.9-12.4; Pcarotid artery angle (≥60° versus carotid artery angle was ≥60° (OR, 11.8; 95% CI, 4.1-34.1) than if it was carotid artery tortuosity increase the risk of cerebral ischemia during CAS, but not during CEA. Vascular anatomy should be taken into account when selecting patients for stenting. URL: http://www.isrctn.com/ISRCTN25337470. Unique identifier: ISRCTN25337470. © 2017 American Heart Association, Inc.
Manzano, Roberta Munhoz; Carvalho, Celso Ricardo Fernandes de; Saraiva-Romanholo, Beatriz Mangueira; Vieira, Joaquim Edson
Abdominal surgical procedures increase pulmonary complication risks. The aim of this study was to evaluate the effectiveness of chest physiotherapy during the immediate postoperative period among patients undergoing elective upper abdominal surgery. This randomized clinical trial was performed in the post-anesthesia care unit of a public university hospital. Thirty-one adults were randomly assigned to control (n = 16) and chest physiotherapy (n = 15) groups. Spirometry, pulse oximetry and anamneses were performed preoperatively and on the second postoperative day. A visual pain scale was applied on the second postoperative day, before and after chest physiotherapy. The chest physiotherapy group received treatment at the post-anesthesia care unit, while the controls did not. Surgery duration, length of hospital stay and postoperative pulmonary complications were gathered from patients' medical records. The control and chest physiotherapy groups presented decreased spirometry values after surgery but without any difference between them (forced vital capacity from 83.5 +/- 17.1% to 62.7 +/- 16.9% and from 95.7 +/- 18.9% to 79.0 +/- 26.9%, respectively). In contrast, the chest physiotherapy group presented improved oxygen-hemoglobin saturation after chest physiotherapy during the immediate postoperative period (p postoperative day. The medical record data were similar between groups. Chest physiotherapy during the immediate postoperative period following upper abdominal surgery was effective for improving oxygen-hemoglobin saturation without increased abdominal pain. Breathing exercises could be adopted at post-anesthesia care units with benefits for patients.
Moustafa, Ibrahim M; Diab, Aliaa A
To investigate the effects of lumbar extension traction in patients with unilateral lumbosacral radiculopathy due to L5-S1 disc herniation. A randomized controlled study with six-month follow-up. University research laboratory. Sixty-four patients with confirmed unilateral lumbosacral radiculopathy due to L5-S1 disc herniation and a lumbar lordotic angle less than 39°, randomly assigned to traction or control group. The control group (n = 32) received hot packs and interferential therapy, whereas the traction group (n = 32) received lumbar extension traction in addition to hot packs and interferential therapy. Absolute rotatory angle, back and leg pain rating scale, Oswestry Disability Index, Modified Schober test, H-reflex (latency and amplitude) and intervertebral movements were measured for all patients three times (before treatment, after 10 weeks of treatment and at six-month follow-up). There was a significant difference between the traction group and the control group adjusted to baseline values at 10 weeks post treatment with respect to: absolute rotatory angle (P traction group receiving lumbar extension traction in addition to hot packs and interferential therapy had better effects than the control group with regard to pain, disability, H-reflex parameters and segmental intervertebral movements.
Kangovi, Shreya; Mitra, Nandita; Grande, David; Huo, Hairong; Smith, Robyn A; Long, Judith A
To determine whether a community health worker (CHW) intervention improved outcomes in a low-income population with multiple chronic conditions. We conducted a single-blind, randomized clinical trial in Philadelphia, Pennsylvania (2013-2014). Participants (n = 302) were high-poverty neighborhood residents, uninsured or publicly insured, and diagnosed with 2 or more chronic diseases (diabetes, obesity, tobacco dependence, hypertension). All patients set a disease-management goal. Patients randomly assigned to CHWs also received 6 months of support tailored to their goals and preferences. Support from CHWs (vs goal-setting alone) led to improvements in several chronic diseases (changes in glycosylated hemoglobin: -0.4 vs 0.0; body mass index: -0.3 vs -0.1; cigarettes per day: -5.5 vs -1.3; systolic blood pressure: -1.8 vs -11.2; overall P = .08), self-rated mental health (12-item Short Form survey; 2.3 vs -0.2; P = .008), and quality of care (Consumer Assessment of Healthcare Providers and Systems; 62.9% vs 38%; P < .001), while reducing hospitalization at 1 year by 28% (P = .11). There were no differences in patient activation or self-rated physical health. A standardized CHW intervention improved chronic disease control, mental health, quality of care, and hospitalizations and could be a useful population health management tool for health care systems. clinicaltrials.gov identifier: NCT01900470.
Early, Frances; Everden, Angharad Jt; O'Brien, Cathy M; Fagan, Petrea L; Fuld, Jonathan P
Soliciting a patient's agenda (the reason for their visit, concerns and expectations) is fundamental to health care but if not done effectively outcomes can be adversely affected. Forms to help patients consider important issues prior to a consultation have been tested with mixed results. We hypothesized that using an agenda form would impact the extent to which patients felt their doctor discussed the issues that were important to them. Patients were randomized to receive an agenda form to complete whilst waiting or usual care. The primary outcome measure was the proportion of patients agreeing with the statement 'My doctor discussed the issues that were important to me' rated on a four-point scale. Secondary outcomes included other experience and satisfaction measures, consultation duration and patient confidence. There was no significant effect of agenda form use on primary or secondary outcomes. Post hoc exploratory analyses suggested possible differential effects for new compared to follow-up patients. There was no overall benefit from the form and a risk of detrimental impact on patient experience for some patients. There is a need for greater understanding of what works for whom in supporting patients to get the most from their consultation. © The Author(s) 2015.
Sapir-Weise, R; Berglund, M; Frank, A; Kristenson, H
Seventy-two alcoholics were treated with acupuncture to the ear in a randomized single-blind controlled design over 10 weeks. Orthodox points and incorrect points 3-5 mm from orthodox points were used. No initial differences were found regarding social characteristics, the responses to the Swedish version of the Alcohol Use Inventory and the Three-dimensional Personality Questionnaire, indicating a successful randomization. There were non-significant tendencies towards gender differential response after acupuncture treatment (P = 0.07). There was no difference in the number of drinking days or level of craving between treatment and control patients. Among females, those in the treatment group reported reduction of anxiety after 1 month, more often than those in the control group (P < 0.05). Response to acupuncture was not related to personality or drinking pattern. Patients' experience of needle placement was similar in the study and control groups. The effects of acupuncture were less pronounced than those previously reported.
Arving, Cecilia; Thormodsen, Inger; Brekke, Guri; Mella, Olav; Berntsen, Sveinung; Nordin, Karin
Faced with a life-threatening illness, such as cancer, many patients develop stress symptoms, i.e. avoidance behaviour, intrusive thoughts and worry. Stress management interventions have proven to be effective; however, they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses. Patients (≥ 18 years) with a recent diagnosis of breast cancer, colorectal cancer, lymphoma, prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment, will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach, patients will be randomized to control, treatment as usual, or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention, given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses, 300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level, sleep duration and quality recorded objectively, and anxiety, depression, quality of life, fatigue, stress in daily living, and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be evaluated through a cost-utility analysis. This RCT
Breitbart, William; Rosenfeld, Barry; Gibson, Christopher; Pessin, Hayley; Poppito, Shannon; Nelson, Christian; Tomarken, Alexis; Timm, Anne Kosinski; Berg, Amy; Jacobson, Colleen; Sorger, Brooke; Abbey, Jennifer; Olden, Megan
An increasingly important concern for clinicians who care for patients at the end of life is their spiritual well-being and sense of meaning and purpose in life. In response to the need for short-term interventions to address spiritual well-being, we developed Meaning Centered Group Psychotherapy (MCGP) to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives, even as they approach the end of life. Patients with advanced (stage III or IV) solid tumor cancers (N=90) were randomly assigned to either MCGP or a supportive group psychotherapy (SGP). Patients were assessed before and after completing the 8-week intervention, and again 2 months after completion. Outcome assessment included measures of spiritual well-being, meaning, hopelessness, desire for death, optimism/pessimism, anxiety, depression and overall quality of life. MCGP resulted in significantly greater improvements in spiritual well-being and a sense of meaning. Treatment gains were even more substantial (based on effect size estimates) at the second follow-up assessment. Improvements in anxiety and desire for death were also significant (and increased over time). There was no significant improvement on any of these variables for patients participating in SGP. MCGP appears to be a potentially beneficial intervention for patients' emotional and spiritual suffering at the end of life. Further research, with larger samples, is clearly needed to better understand the potential benefits of this novel intervention. (c) 2009 John Wiley & Sons, Ltd.
Full Text Available Abstract Background This study aimed to investigate the efficacy of prophylactic amifostine in reducing the risk of severe radiation colitis in cancer patients receiving radical radiotherapy to the pelvis. Methods Patients with pelvic tumours referred for radical radiotherapy who consented participation in this trial, were randomly assigned to receive daily amifostine (A (subcutaneously, 500 mg flat dose before radiotherapy or radiotherapy alone (R. Sigmoidoscopy and blinded biopsies were scheduled to conduct prior to initiation and following completion of radiotherapy and again 6 to 9 months later. Radiation colitis was assessed by clinical, endoscopic and histolopathological criteria. Results A total 44 patients were enrolled in this trial, the majority with rectal (20 patients and cervical cancer (12 patients and were assigned 23 in R arm and 21 in the A arm. In total 119 sigmoidoscopies were performed and 18 patients (18/44, 40.9% were diagnosed with radiation colitis (15 grade 1 and 2, and 3 grade 3 and 4. Of them, 6 patients belonged to the A group (6/21, 28.6% and 12 to the R group (12/23, 52.2%. Acute and grade IV radiation colitis was only developed in four patients (17.4% in the R group. Amifostine side effects were mild. Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury. Conclusions Amifostine given subcutaneously can lower the risk of acute severe radiation colitis in patients who receive radical radiotherapy to pelvic tumors.
Katsanos, Konstantinos H; Briasoulis, Evangelos; Tsekeris, Pericles; Batistatou, Anna; Bai, Maria; Tolis, Christos; Capizzello, Antonio; Panelos, Ioannis; Karavasilis, Vasileios; Christodoulou, Dimitrios; Tsianos, Epameinondas V
This study aimed to investigate the efficacy of prophylactic amifostine in reducing the risk of severe radiation colitis in cancer patients receiving radical radiotherapy to the pelvis. Patients with pelvic tumours referred for radical radiotherapy who consented participation in this trial, were randomly assigned to receive daily amifostine (A) (subcutaneously, 500 mg flat dose) before radiotherapy or radiotherapy alone (R). Sigmoidoscopy and blinded biopsies were scheduled to conduct prior to initiation and following completion of radiotherapy and again 6 to 9 months later. Radiation colitis was assessed by clinical, endoscopic and histolopathological criteria. A total 44 patients were enrolled in this trial, the majority with rectal (20 patients) and cervical cancer (12 patients) and were assigned 23 in R arm and 21 in the A arm. In total 119 sigmoidoscopies were performed and 18 patients (18/44, 40.9%) were diagnosed with radiation colitis (15 grade 1 and 2, and 3 grade 3 and 4). Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%). Acute and grade IV radiation colitis was only developed in four patients (17.4%) in the R group. Amifostine side effects were mild. Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury. Amifostine given subcutaneously can lower the risk of acute severe radiation colitis in patients who receive radical radiotherapy to pelvic tumors.
DeBusk, Robert Frank; Miller, Nancy Houston; Parker, Kathleen Marie; Bandura, Albert; Kraemer, Helena Chmura; Cher, Daniel Joseph; West, Jeffrey Alan; Fowler, Michael Bruce; Greenwald, George
Nurse care management programs for patients with chronic illness have been shown to be safe and effective. To determine whether a telephone-mediated nurse care management program for heart failure reduced the rate of rehospitalization for heart failure and for all causes over a 1-year period. Randomized, controlled trial of usual care with nurse management versus usual care alone in patients hospitalized for heart failure from May 1998 through October 2001. 5 northern California hospitals in a large health maintenance organization. Of 2786 patients screened, 462 met clinical criteria for heart failure and were randomly assigned (228 to intervention and 234 to usual care). Nurse care management provided structured telephone surveillance and treatment for heart failure and coordination of patients' care with primary care physicians. Time to first rehospitalization for heart failure or for any cause and time to a combined end point of first rehospitalization, emergency department visit, or death. At 1 year, half of the patients had been rehospitalized at least once and 11% had died. Only one third of rehospitalizations were for heart failure. The rate of first rehospitalization for heart failure was similar in both groups (proportional hazard, 0.85 [95% CI, 0.46 to 1.57]). The rate of all-cause rehospitalization was similar (proportional hazard, 0.98 [CI, 0.76 to 1.27]). The findings of this study, conducted in a single health care system, may not be generalizable to other health care systems. The overall effect of the intervention was minor. Among patients with heart failure at low risk on the basis of sociodemographic and medical attributes, nurse care management did not statistically significantly reduce rehospitalizations for heart failure or for any cause. Such programs may be less effective for patients at low risk than those at high risk.
Becker, David J; Gordon, Ram Y; Halbert, Steven C; French, Benjamin; Morris, Patti B; Rader, Daniel J
Red yeast rice is an herbal supplement that decreases low-density lipoprotein (LDL) cholesterol level. To evaluate the effectiveness and tolerability of red yeast rice and therapeutic lifestyle change to treat dyslipidemia in patients who cannot tolerate statin therapy. Randomized, controlled trial. Community-based cardiology practice. 62 patients with dyslipidemia and history of discontinuation of statin therapy due to myalgias. Patients were assigned by random allocation software to receive red yeast rice, 1800 mg (31 patients), or placebo (31 patients) twice daily for 24 weeks. All patients were concomitantly enrolled in a 12-week therapeutic lifestyle change program. Primary outcome was LDL cholesterol level, measured at baseline, week 12, and week 24. Secondary outcomes included total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride, liver enzyme, and creatinine phosphokinase (CPK) levels; weight; and Brief Pain Inventory score. In the red yeast rice group, LDL cholesterol decreased by 1.11 mmol/L (43 mg/dL) from baseline at week 12 and by 0.90 mmol/L (35 mg/dL) at week 24. In the placebo group, LDL cholesterol decreased by 0.28 mmol/L (11 mg/dL) at week 12 and by 0.39 mmol/L (15 mg/dL) at week 24. Low-density lipoprotein cholesterol level was significantly lower in the red yeast rice group than in the placebo group at both weeks 12 (P Red yeast rice and therapeutic lifestyle change decrease LDL cholesterol level without increasing CPK or pain levels and may be a treatment option for dyslipidemic patients who cannot tolerate statin therapy.
Jia, Jianping; Wei, Cuibai; Jia, Longfei; Tang, Yi; Liang, Junhua; Zhou, Aihong; Li, Fangyu; Shi, Lu; Doody, Rachelle S
Donepezil has been used worldwide for the treatment of severe Alzheimer's disease (AD). Whether it is also appropriate for severe AD in Chinese patients remains unknown. To determine whether donepezil is effective and tolerable for Chinese patients with severe AD. The present study was a 24-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group study conducted at 38 investigational hospitals in China. Patients with severe AD were enrolled in this trial. Patients were randomly assigned in a 1:1 ratio to receive either donepezil or placebo (5 mg for 6 weeks and10 mg for the remaining 18 weeks). The efficacy for donepezil were evaluated by the SIB, the Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-plus) and the MMSE. Safety parameters were monitored throughout. A total of 313 patients included the donepezil (n = 157) and the placebo groups (n = 156). Donepezil group improved more in SIB scores (least squares [LS] mean difference: 4.8, 95% CI 1.56 to 8.08, p = 0.004) and CIBIC-plus scores (drug-placebo difference: -0.4, 95% CI -0.66 to 0.03, p = 0.04) than placebo groups at Week 24. The MMSE scores between drug and placebo groups did not differ significantly. Twenty-nine patients with serious adverse events (SAEs) were reported in donepezil (n = 11) and placebo groups (n = 18) (p = 0.08). Most SAEs were not considered drug-related. Donepezil for 24 weeks was more effective than placebo and showed good safety and tolerability in Chinese patients with severe AD. This study supports utility of the drug in severe stages of AD in the Chinese population.
Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A; Arroyo-Morales, Manuel; Saavedra-Hernández, Manuel; Fernández-Sola, Cayetano; Moreno-Lorenzo, Carmen
To determine the effect of myofascial release techniques on pain symptoms, postural stability and physical function in fibromyalgia syndrome. A randomized, placebo-controlled trial was undertaken. Eighty-six patients with fibromyalgia syndrome were randomly assigned to an experimental group and a placebo group. Patients received treatments for 20 weeks. The experimental group underwent 10 myofascial release modalities and the placebo group received sham short-wave and ultrasound electrotherapy. Outcome variables were number of tender points, pain, postural stability, physical function, clinical severity and global clinical assessment of improvement. Outcome measures were assessed before and immediately after, at six months and one year after the last session of the corresponding intervention. After 20 weeks of myofascial therapy, the experimental group showed a significant improvement (P myofascial release techniques can be a complementary therapy for pain symptoms, physical function and clinical severity but do not improve postural stability in patients with fibromyalgia syndrome.
Pestka, Jan M; Schmal, Hagen; Salzmann, Gian; Hecky, Jochen; Südkamp, Norbert P; Niemeyer, Philipp
Autologous chondrocyte implantation (ACI) is a well-established therapeutic option for the treatment of cartilage defects of the knee joint. Since information concerning the cellular aspects of ACI is still limited, the aim of the present study was to investigate relevant differences between chondrocyte quality after in vitro cultivation and possible correlations with patient-specific factors. Cell quality of 252 consecutive ACI patients was assessed after chondrocyte in vitro expansion by determination of the expression of cartilage relevant surface marker CD44 and cartilage-specific differentiation markers (aggrecan and collagen type II). All cell quality parameters were correlated with patient-specific parameters, such as age, size and defect location, number of defects and grade of joint degeneration according to the Kellgren-Lawrence classification. Neither the expression of CD44, aggrecan or collagen type II nor cell density or viability after proliferation seemed to correlate with the grade of joint degeneration, defect aetiology or patient gender. However, chondrocytes harvested from the knee joints of patients at less than 20 years of age showed significantly higher expression rates of cartilage-specific markers when compared to older patients' chondrocytes. The present study identifies relevant differences concerning chondrocyte quality after in vitro expansion in a highly preselected study population of 252 patients that from a surgical point of view were eligible for ACI. With the exception of patients aged 20 years or younger, no patient-specific parameters could be identified which might allow anticipation of cell quality in individual patients.
Manfredini, Fabio; Mallamaci, Francesca; D'Arrigo, Graziella; Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Lamberti, Nicola; Bertoli, Silvio; Ciurlino, Daniele; Rocca-Rey, Lisa; Barillà, Antonio; Battaglia, Yuri; Rapanà, Renato Mario; Zuccalà, Alessandro; Bonanno, Graziella; Fatuzzo, Pasquale; Rapisarda, Francesco; Rastelli, Stefania; Fabrizi, Fabrizio; Messa, Piergiorgio; De Paola, Luciano; Lombardi, Luigi; Cupisti, Adamasco; Fuiano, Giorgio; Lucisano, Gaetano; Summaria, Chiara; Felisatti, Michele; Pozzato, Enrico; Malagoni, Anna Maria; Castellino, Pietro; Aucella, Filippo; Abd ElHafeez, Samar; Provenzano, Pasquale Fabio; Tripepi, Giovanni; Catizone, Luigi; Zoccali, Carmine
Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n=145) or walking exercise (n=151); 227 patients (exercise n=104; control n=123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; Pquality of social interaction score (P=0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis. Copyright © 2017 by the American Society of Nephrology.
Kelsen, David P; Winter, Katryn A; Gunderson, Leonard L; Mortimer, Joanne; Estes, Norman C; Haller, Daniel G; Ajani, Jaffer A; Kocha, Walter; Minsky, Bruce D; Roth, Jack A; Willett, Christopher G
We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed. The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated. Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival. For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients.
Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.
Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan
Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress
Using a partially randomized patient preference study design to evaluate the therapeutic effect of acupuncture and cupping therapy for fibromyalgia: study protocol for a partially randomized controlled trial
Background Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality. The aim of this study is to investigate the feasibility of applying a partially randomized patient preference (PRPP) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies, acupuncture and cupping, for fibromyalgia while accounting for patients’ preference of either therapeutic modality. Methods This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital, Beijing University of Chinese Medicine (approval number: 2013052104-2). One hundred participants with fibromyalgia will be included in this study. Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria. Before treatment, participants will be interviewed for their preference toward acupuncture or cupping therapy. Fifty participants with no preference will be randomly assigned to one of the two groups and another 50 participants with strong preference to either acupuncture or cupping will receive what they choose. For acupuncture and cupping therapy, the main acupoints used will be tender points (Ashi). Treatment will be three times a week for 5 consecutive weeks with a follow-up period of 12 weeks. Outcome measures will be qualitative (patient expectation and satisfaction) and quantitative (pain intensity, quality of life, depression assessment). Trial registration number NCT01869712 (in clinicaltrials.gov, on 22nd May 2013). PMID:25012121
Full Text Available Background: Rotator cuff tendinopathy is a significant problem among diabetics that frequently restricts patient’s activity in terms of pain and disability. The purpose of this study was to compare between the effect of Astym therapy and kinesiotaping in treating diabetic patients with chronic rotator cuff tendinopathy. Methods: 56 diabetic patients diagnosed with chronic rotator cuff tendinopathy were randomly assigned into Astym therapy group (n=28 or kinesiotaping group (n= 28. All patients received conventional program in addition to Astym treatment or Kinesiotaping for 24 sessions (2times/week. Patients were assessed at baseline and at the end of corresponding intervention with visual analogy scale (VAS for pain intensity, shoulder disability questioner (SDQ for shoulder disability, and electrogoniometer for shoulder range of motion. Results: For the 56 study participants (21 males and 35 females; mean age=41.9±6.9 years there were significant differences in all measuring outcomes in both group when compared to baseline measurements (p 0.05. Conclusion: kinesiotaping appears to be more effective than Astym therapy in reducing pain for diabetic patients with chronic rotator cuff tendinopathy.
Poulsen, Grith M; Pedersen, Louise L; Østerlind, Kell; Bæksgaard, Lene; Andersen, Jens R
Cancer-related malnutrition is multifactorial and related to a bad prognosis. The aim of this study was to investigate the effect of intensive, individual dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic-, gastric-, or esophageal cancer. 61 outpatients were stratified by diagnoses and randomly assigned to one of two groups (G1; n = 32 and G2; n = 29). The basic regimen, applied to both groups, included measurement of body weight, 24-h dietary recall interview, micronutrient status and quality of life. In addition G1 received intensive, individual dietary counseling one hour per week and, if the patient accepted, a daily oral nutritional supplement containing 2531 kJ, 33.8 g protein and 2.2 g EPA. At the end of the treatment period, significantly fewer patients had lost weight in the intervention group (mean: 44% vs. 72%, p requirements was better during treatment (mean: 107% vs. 95%, p requirement, both during the treatment period (mean: 92% vs. 71%, p cancer patients, intensive, individual dietary counseling was associated with a better weight maintenance and a higher provision of adequate amounts of protein and energy. The intervention had no significant effects on patients' quality of life, incidence of treatment-related side effects or appearance of micronutrient deficiencies. Copyright © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
Roh, Jong-Lyel; Park, Chan Il
A high rate of facial nerve paralysis (FNP) develops after parotid surgery, but there have been few clinical trials on treatments to improve recovery times. This study evaluated the efficacy of prednisolone in these patients. A total of 123 patients who underwent parotidectomy without injury to the facial nerve were assessed prospectively for postoperative FNP. These patients were assigned randomly to treatment with prednisolone or placebo for 10 days. FNP was evaluated by House-Brackmann grades. Recovery rates and adverse effects were monitored regularly for 6 months after surgery. Of the 123 patients, 45 had postoperative FNP. All FNPs were grades II to IV, mostly on 1 or 2 facial areas. The incidence of FNP was increased significantly with malignant pathology, increased parotidectomy extent, and neck dissection (P FNP after 6 months, whereas 1 patient had permanent FNP. Recovery rates were equal in both groups, and there was no evidence of major adverse effects. Prednisolone was ineffective in early recovery from postparotidectomy FNP.
Falcón-González, Juan C; Borkoski-Barreiro, Silvia; Limiñana-Cañal, José María; Ramos-Macías, Angel
Music is a universal, cross-cultural phenomenon. Perception and enjoyment of music are still not solved with current technological objectives of cochlear implants. The objective of this article was to advance the development and validation of a method of programming of cochlear implants that implements a frequency allocation strategy. We compared standard programming vs frequency programming in every subject. We studied a total of 40 patients with cochlear implants. Each patient was programmed with a optimal version of the standard program, using the Custom Sound Suite 3.2 cochlear platform. Speech tests in quiet were performed using syllable word lists from the protocol for the assessment of hearing in the Spanish language. Patients implanted bilaterally were tested in both ears at the same time. For assessing music listening habits we used the Munich Music Questionnaire and «MACarena»(minimum auditory capability) software. All patients achieved better results in recognition, instrument tests and tonal scales with frequency programming (P<.005). Likewise, there were better results with frequency programming in recognising harmonics and pitch test (P<.005). Frequency programming achieves better perception and recognition results in patients in comparison with standard programming. Bilateral stimulation patients have better perception of musical patterns and better performance in recognition of tonal scales, harmonics and musical instruments compared with patients with unilateral stimulation. Modification and frequency allocation during programming allows decreased levels of current intensity and increase the dynamic range, which allows mapping of each audio band less obtrusively and improves the quality of representation of the signal. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.
Huang, Shih-Tzu; Good, Marion; Zauszniewski, Jaclene A
To examine effects of sedative music on cancer pain. A randomized controlled trial. Two large medical centers in Kaoshiung City, in southern Taiwan. 126 hospitalized persons with cancer pain. Participants were randomly assigned to an experimental (n=62) or a control group (n=64), with computerized minimization, stratifying on gender, pain, and hospital unit. Music choices included folk songs, Buddhist hymns (Taiwanese music), plus harp, and piano (American). The experimental group listened to music for 30 min; the control group rested in bed. Sensation and distress of pain were rated on 100mm VAS before and after the 30-min test. Using MANCOVA, there was significantly less posttest pain in the music versus the control group, pmusic was very helpful for pain. Thirty minutes of music provided 50% relief in 42% of the music group compared to 8% of the controls. The number needed to treat (NNT) to find one with 50% sensation relief was three patients. More patients chose Taiwanese music (71%) than American music (29%), but both were liked and effective. Offering a choice of familiar, culturally appropriate music was a key element of the intervention. Findings extend the Good and Moore theory (1996) to cancer pain. Soft music was safe, effective, and liked by participants. It provided greater relief of cancer pain than analgesics alone. Thus nurses should offer calming, familiar music to supplement analgesic medication for persons with cancer pain. Copyright 2010 Elsevier Ltd. All rights reserved.
Doenst, Torsten; Cleland, John G F; Rouleau, Jean L; She, Lilin; Wos, Stanislaw; Ohman, E Magnus; Krzeminska-Pakula, Maria; Airan, Balram; Jones, Robert H; Siepe, Matthias; Sopko, George; Velazquez, Eric J; Racine, Normand; Gullestad, Lars; Filgueira, Jose Luis; Lee, Kerry L
To assess the influence of therapy crossovers on treatment comparisons and mortality at 5 years in patients with ischemic heart disease and heart failure randomly assigned to medical therapy alone (MED) or to MED and coronary artery bypass graft (CABG) surgery in the Surgical Treatment for Ischemic Heart Failure (STICH) trial. The influence of early crossover (within the first year after randomization) on 5-year mortality was assessed using time-dependent multivariable Cox models. CABG was performed in 65/602 patients (10.8%) assigned to MED, and 55/610 patients (9.0%) assigned to CABG received MED only. Common reasons for crossover from MED to CABG were progressive symptoms or acute decompensation. MED-assigned patients who underwent CABG had lower 5-year mortality than those who received MED only (25% vs 42%; hazard ratio, 0.50; 95% confidence interval, 0.30-0.85; P=0.008).The main reason for crossover from CABG to MED was patient/family decision. Five patients did not undergo their assigned CABG within a year but died before receiving surgery without status change. They were deemed crossover to MED. The CABG-to-MED crossover population had higher 5-year mortality compared with those treated with CABG per-protocol (59% vs 33%; hazard ratio, 2.01; 95% confidence interval, 1.36-2.96; P<0.001). CABG was associated with lower mortality compared with MED in per-protocol and several time-dependent analyses (all P<0.05). CABG reduced mortality in both the per-protocol and crossover STICH patient populations. Crossover from assigned therapy, therefore, diminished the impact of CABG on survival in STICH when analyzed by intention to treat. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00023595.
Fukuda, Takuya; Fukui, Michiaki; Tanaka, Muhei; Senmaru, Takafumi; Iwase, Hiroya; Yamazaki, Masahiro; Aoi, Wataru; Inui, Toshio; Nakamura, Naoto; Marunaka, Yoshinori
Propolis contains a variety of chemical compounds, including polyphenols, flavonoids, phenolic aldehydes, amino acids and vitamins, and presents numerous biological and pharmacological properties. The aim of the present study was to evaluate the effect of propolis on blood examination data in patients with type 2 diabetes. In the double-blind, 8-week randomized controlled study, 80 patients with type 2 diabetes were enrolled. Patients were randomly assigned to receive Brazilian green propolis (226.8 mg/day for 8 weeks) (n=41) or the placebo (n=39). The primary endpoint was to detect changes in blood examination data associated with metabolic disorders in patients suffering from diabetes mellitus, including the homeostasis model assessment of insulin resistance (HOMA-IR), uric acid and estimated glomerular filtration rate (eGFR) from baseline to the end of this study. The value of HOMA-IR was not significantly changed by the 8-week administration of propolis or placebo from the baseline data. Values of blood uric acid and eGFR in patients taking the placebo became worse at 8 weeks compared to the baseline, whereas this did not occur in patients consuming Brazilian green propolis. However, HOMA-IR was not improved by propolis intake. A randomized, controlled 8-week trial suggests that Brazilian green propolis (226.8 mg/day) prevents patients with type 2 diabetes from developing worse blood uric acid and eGFR.
Martino, Steve; Carroll, Kathleen M; Nich, Charla; Rounsaville, Bruce J
This pilot study examined the efficacy of a two-session motivational interview adapted for dually diagnosed psychotic and drug-related disordered patients (DDMI) in comparison to a two-session standard psychiatric interview (SI). The study used a randomized controlled trial design. Participants received either DDMI or SI and were assessed at baseline, 4-, 8- and 12-week follow-up points. The principal analysis for examination of treatment effects across time was a random effects regression model. Both DDMI and SI interviews served as pre-admission intake interventions to an ambulatory specialty dual diagnosis intensive out-patient and partial hospital program. Forty-four treatment-seeking participants (DDMI = 24; SI = 20) who had co-occurring psychotic and drug-related disorders were assigned randomly to the treatment conditions. Measurements Primary outcomes were days of primary drug use, secondary drug use, alcohol use and psychotropic medication adherence, proportion of participants admitted into the program and days of attendance. DDMI and SI resulted in improved treatment outcomes, but there were no main effects for the sample as a whole. Separate examination of primary cocaine and primary marijuana using subsamples, however, suggested that DDMI resulted in significantly better primary drug treatment outcomes for the cocaine-using group, whereas SI resulted in significantly better primary drug treatment outcomes for the marijuana-using group. These findings indicate that MI may not work equally well for all types of psychotic disordered dually diagnosed patients and that alternative approaches may be as effective in fostering improved substance use treatment outcomes for subgroups of these individuals.
Ravaud, Alain; Hawkins, Robert; Gardner, Jason P
of metastatic sites--were randomly assigned to lapatinib 1,250 mg daily or HT. The primary end point was time to progression (TTP); secondary end points included overall survival (OS), safety, and biomarker analyses. RESULTS: Four hundred sixteen patients were enrolled onto the study. Median TTP was 15.3 weeks......PURPOSE: Lapatinib is an orally reversible inhibitor of epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER-2) tyrosine kinases with demonstrated activity in patients with HER-2-positive breast cancer. In the current phase III open-label trial, lapatinib...... was compared with hormone therapy (HT) in patients with advanced renal cell carcinoma (RCC) that express EGFR and/or HER-2. PATIENTS AND METHODS: Patients with advanced RCC who had experienced disease progression through first-line cytokine therapy--stratified by Karnofsky performance status and number...
Volpe, Umberto; Torre, Fabiana; De Santis, Valeria; Perris, Francesco; Catapano, Francesco
Group reading activities are often reported to be helpful in a variety of psychiatric conditions. However, data on the effects of structured reading rehabilitation activities, in both hospital and community settings for patients with psychosis, are still scarce. Our aim was to investigate the effects on clinical status, disability, psychosocial functioning and cognitive functioning of a structured group reading activity, in a sample of hospitalized patients with psychosis. We enrolled 41 consecutive patients with psychosis and randomly assigned them to a structured group reading programme. For all included patients, we psychometrically evaluated clinical symptomatology, psychosocial functioning and disability, as well as cognitive functioning. All evaluations were repeated at a 6-month follow-up. Repeated-measure multiple analyses of variance were used to test the effect of the group reading activities on the clinical, psychosocial and cognitive measures. We found that, after 6 months from discharge, structured group reading activities induced a statistically significant improvement of cognitive (p < 0.007) and psychosocial (p < 0.008) functioning in patients with psychosis and reduced their disability (p < 0.005), with respect to the control group. Furthermore, such programmes are easy to implement and were perceived as extremely 'interesting' and 'useful' by patients with psychosis. Rehabilitation programmes focusing on group reading activities should be regarded as a valid psychosocial rehabilitation tool for psychotic patients with severe mental disability. A structured group reading programme induced a significant symptomatological cognitive and psychosocial amelioration in hospitalized patients with psychosis. The improvement was sustained also at the 6-month follow-up, with respect to the control group. Structured group reading activities are perceived, by severely ill psychiatric patients, as highly useful, interesting and pleasant, while they are
Morales, Carlos H; Mejía, Camila; Roldan, Luis Alberto; Saldarriaga, Maria Fernanda; Duque, Andres Felipe
The study aimed to establish the benefits of using chest tubes with negative pleural suction against trapped water in patients with penetrating or blunt chest trauma who underwent tube thoracostomy, in terms of the incidence of complications, such as persistent air leak, clotted hemothorax, empyema, and duration of stay. Patients who underwent tube thoracostomy because of traumatic pneumothorax, hemothorax, or hemopneumothorax were randomly assigned into one of two groups: in Group 1, the three-bottle drainage system was connected to a negative suction; in Group 2, no suction was given. Patients who required mechanical ventilation or emergency surgery (thoracotomy or thoracoscopy) either at the time of admission to the institution or immediately after the tube thoracostomy, patients who had histories of thoracic procedures or chronic pulmonary diseases (chronic obstructive pulmonary disease, diffuse interstitial lung disease), and patients with multiple injuries with severe traumatic brain injury and a Glasgow Coma Scale (GCS) score less than 8 of 15 were excluded from the study. Hospital stay, duration of tube thoracostomy, prolonged fistula, and other clinical variables were compared. One hundred ten patients were included, 56 in the group with suction and 54 in the group without suction. There were no differences in the demographic characteristics of each group. There were no differences between the groups in terms of hospital stay (p = 0.22), duration of tube thoracostomy (p = 0.35) (3 days in each group), or complications. However, the probability of air leak presence in time was greater for the Group 1 patients with negative suction versus the Group 2 patients (p = 0.023). The use of negative pleural suction did not demonstrate advantages over the three-bottle chest drainage system without suction in patients with uncomplicated traumatic pneumothorax, hemothorax, or hemopneumothorax. Therapeutic study, level II.
Miklowitz, David J.; Otto, Michael W.; Frank, Ellen; Reilly-Harrington, Noreen A.; Kogan, Jane N.; Sachs, Gary S.; Thase, Michael E.; Calabrese, Joseph R.; Marangell, Lauren B.; Ostacher, Michael J.; Patel, Jayendra; Thomas, Marshall R.; Araga, Mako; Gonzalez, Jodi M.; Wisniewski, Stephen R.
Objective Psychosocial interventions are effective adjuncts to pharmacotherapy in delaying recurrences of bipolar disorder; however, to date their effects on life functioning have been given little attention. In a randomized trial, the authors examined the impact of intensive psychosocial treatment plus pharmacotherapy on the functional outcomes of patients with bipolar disorder over the 9 months following a depressive episode. Method Participants were 152 depressed outpatients with bipolar I or bipolar II disorder in the multisite Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study. All patients received pharmacotherapy. Eighty-four patients were randomly assigned to intensive psychosocial intervention (30 sessions over 9 months of interpersonal and social rhythm therapy, cognitive behavior therapy [CBT], or family-focused therapy), and 68 patients were randomly assigned to collaborative care (a 3-session psychoeducational treatment). Independent evaluators rated the four subscales of the Longitudinal Interval Follow-Up Evaluation–Range of Impaired Functioning Tool (LIFE-RIFT) (relationships, satisfaction with activities, work/role functioning, and recreational activities) through structured interviews given at baseline and every 3 months over a 9-month period. Results Patients in intensive psychotherapy had better total functioning, relationship functioning, and life satisfaction scores over 9 months than patients in collaborative care, even after pretreatment functioning and concurrent depression scores were covaried. No effects of psychosocial intervention were observed on work/role functioning or recreation scores during this 9-month period. Conclusions Intensive psychosocial treatment enhances relationship functioning and life satisfaction among patients with bipolar disorder. Alternate interventions focused on the specific cognitive deficits of individuals with bipolar disorder may be necessary to enhance vocational functioning
Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin
The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.
Milbury, Kathrin; Spelman, Amy; Wood, Christopher; Matin, Surena F; Tannir, Nizar; Jonasch, Eric; Pisters, Louis; Wei, Qi; Cohen, Lorenzo
This randomized controlled trial examined the quality-of-life benefits of an expressive writing (EW) intervention for patients with renal cell carcinoma (RCC) and identified a potential underlying mechanism of intervention efficacy. Patients (N = 277) with stage I to IV RCC were randomly assigned to write about their deepest thoughts and feelings regarding their cancer (EW) or about neutral topics (neutral writing [NW]) on four separate occasions. Patients completed the Center for Epidemiologic Studies Depression Scale (CES-D), MD Anderson Symptom Inventory (MDASI), Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form-36 (SF-36), and Impact of Event Scale (IES) at baseline and 1, 4, and 10 months after the intervention. The mean age of participants (28% stage IV; 41% female) was 58 years. Multilevel modeling analyses, using a Bonferroni-corrected α = .021 for six outcomes adjusted for the correlation among outcomes, revealed that, relative to the NW group, patients in the EW group reported significantly lower MDASI scores (P = .003) and higher physical component summary scores on the SF-36 (P = .019) at 10 months after the intervention. Mediation analyses revealed that significant group differences for MDASI scores at 10 months were mediated by lower IES scores at 1 month after the intervention in the EW group (P = .042). No significant group differences were observed in the BFI, CES-D, PSQI, and mental component summary of the SF-36. EW may reduce cancer-related symptoms and improve physical functioning in patients with RCC. Evidence suggests that this effect may occur through short-term improvements in cognitive processing.
Julião, Miguel; Oliveira, Fátima; Nunes, Baltazar; Vaz Carneiro, António; Barbosa, António
Dignity therapy is a brief psychotherapy developed for patients living with a life-limiting illness. To determine the influence of dignity therapy on depression and anxiety in inpatients with a terminal illness and experiencing a high level of distress in a palliative care unit. A nonblinded phase II randomized controlled trial of 80 patients who were randomly assigned to one of two groups: intervention group (dignity therapy+standard palliative care [SPC]) or control group (SPC alone). The main outcomes were depression and anxiety scores, as measured with the Hospital Anxiety and Depression Scale, and assessed at baseline (T1), day 4 (T2), day 15 (T3), and day 30 (T4) of follow-up. This study is registered with www.controlled-trials.com/ISRCTN34354086. Of the final 80 participants, 41 were randomly assigned to SPC and 39 to dignity therapy. Baseline characteristics were similar between the two groups. Dignity therapy was associated with a decrease in depression scores (median, 95% confidence interval [CI]: -4.00, -6.00 to -2.00, pdepression and anxiety symptoms in end-of-life care. The therapeutic benefit of dignity therapy was sustained over a 30-day period. Having established its efficacy, future trials of dignity therapy may now begin, comparing it with other psychotherapeutic approaches within the context of terminal illness.
Gutgsell, Kathy Jo; Schluchter, Mark; Margevicius, Seunghee; DeGolia, Peter A; McLaughlin, Beth; Harris, Mariel; Mecklenburg, Janice; Wiencek, Clareen
Treatment of pain in palliative care patients is challenging. Adjunctive methods of pain management are desirable. Music therapy offers a nonpharmacologic and safe alternative. To determine the efficacy of a single music therapy session to reduce pain in palliative care patients. Two hundred inpatients at University Hospitals Case Medical Center were enrolled in the study from 2009 to 2011. Patients were randomly assigned to one of two groups: standard care alone (medical and nursing care that included scheduled analgesics) or standard care with music therapy. A clinical nurse specialist administered pre- and post-tests to assess the level of pain using a numeric rating scale as the primary outcome, and the Face, Legs, Activity, Cry, Consolability Scale and the Functional Pain Scale as secondary outcomes. The intervention incorporated music therapist-guided autogenic relaxation and live music. A significantly greater decrease in numeric rating scale pain scores was seen in the music therapy group (difference in means [95% CI] -1.4 [-2.0, -0.8]; P0.05). Mean change in Functional Pain Scale scores was significantly greater in the music therapy group (difference in means -0.5 [95% CI] -0.8, 0.3; Pmusic therapy intervention incorporating therapist-guided autogenic relaxation and live music was effective in lowering pain in palliative care patients. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
Black, David S; Peng, Cheng; Sleight, Alix G; Nguyen, Nathalie; Lenz, Heinz-Josef; Figueiredo, Jane C
The objective of this randomized clinical experiment was to test the influence of a mindfulness meditation practice, when delivered during 1 session of active chemotherapy administration, on the acute salivary cortisol response as a marker of neuroendocrine system activity in cancer patients. A mindfulness, attention-control, or resting exposure was assigned to 57 English- or Spanish-speaking colorectal cancer patients at 1 county oncology clinic and 1 university oncology clinic at the start of chemotherapy. Saliva samples were collected at the start of chemotherapy and at subsequent 20-minute intervals during the first 60 minutes of chemotherapy (4 samples in all). Self-reporting on biobehavioral assessments after chemotherapy included distress, fatigue, and mindfulness. An area-under-the-curve analysis (AUC) showed a relative increase in cortisol reactivity in the mindfulness group after adjustments for biological and clinical measures (β = 123.21; P = .03). More than twice as many patients in the mindfulness group versus the controls displayed a cortisol rise from the baseline to 20 minutes (69% vs 34%; P = .02). AUC values were uncorrelated with biobehavioral measure scores, although mindfulness scores were inversely correlated with fatigue (r = -0.46; P mindfulness practice during chemotherapy can reduce the blunting of neuroendocrine profiles typically observed in cancer patients. Implications include support for the use of mindfulness practice in integrative oncology. Cancer 2017;123:3088-96. © 2017 American Cancer Society. © 2017 American Cancer Society.
Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z
To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.
Effects and cost of glycyrrhizin in the treatment of upper respiratory tract infections in members of the Japanese maritime self-defense force: Preliminary report of a prospective, randomized, double-blind, controlled, parallel-group, alternate-day treatment assignment clinical trial.
Yanagawa, Youichi; Ogura, Masatsune; Fujimoto, Eita; Shono, Satoshi; Okuda, Eriya
Upper respiratory tract infections (URTIs) account for at least half of all acute illnesses. Specific antiviral therapy has not been developed against most respiratory viruses thought to cause URTIs. The pharmacologic action of glycyrrhizin has been shown to produce anti-inflammatory activity, modulation of the immune system, inhibition of virus growth, and inactivation of viruses. The aim of this study was to assess the tolerability, efficacy, and cost of glycyrrhizin in improving the severity and duration of signs and symptoms of URTIs. The primary end point was tolerability, and the secondary and points included improvement in signs and symptoms of URTI and cost. Members of the Japanese Maritime Self-Defense Force (SDF) treated for URTIs from January 2002 to May 2002 in the SDF Etajima Hospital (Hiroshima, Japan) were eligible for this prospective, randomized, double-blind, controlled, parallel-group, alternate-day treatment assignment study. All patients in this study fulfilled the following enrollment criteria: admitted to the hospital on the first arrival day as an outpatient; fever (body temperature women; mean [SD] age, 25.2 [1.5] years) were assigned to the glycyrrhizin group and 269 patients (24 men, 2 women; mean [SD] age, 22.6 [0.9] years) were assigned to the control group. The 2 groups were similar in terms of baseline characteristics. The mean duration of hospitalization was shorter (P = 0.01), the mean maximum body temperature 24 to 48 hours after admission was less (P = 0.05), and the cost of therapy (P = 0.03) was less in the glycyrrhizin group than the control group. No AEs were reported. In this study of hospitalized patients with URTIs, glycyrrhizin therapy was associated with a shorter hospitalization, lower-grade fever, and lower cost of therapy compared with controls, showing that it may be beneficial to patients with URTIs without acute bacterial infections.
Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis
The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.
Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis
The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.
Trouillet, Jean-Louis; Luyt, Charles-Edouard; Guiguet, Marguerite; Ouattara, Alexandre; Vaissier, Elisabeth; Makri, Ralouka; Nieszkowska, Ania; Leprince, Pascal; Pavie, Alain; Chastre, Jean; Combes, Alain
Whether early percutaneous tracheotomy in patients who require prolonged mechanical ventilation can shorten mechanical ventilation duration and lower mortality remains controversial. To compare the outcomes of severely ill patients who require prolonged mechanical ventilation randomly assigned to early percutaneous tracheotomy or prolonged intubation. Prospective, randomized, controlled, single-center trial (ClinicalTrials.gov registration number: NCT00347321). Academic center. 216 adults requiring mechanical ventilation 4 or more days after cardiac surgery. Immediate early percutaneous tracheotomy or prolonged intubation with tracheotomy 15 days after randomization. The primary end point was the number of ventilator-free days during the first 60 days after randomization. Secondary outcomes included 28-, 60-, or 90-day mortality rates; durations of mechanical ventilation, intensive care unit stay, and hospitalization; sedative, analgesic, and neuroleptic use; ventilator-associated pneumonia rate; unscheduled extubations; comfort and ease of care; and long-term health-related quality of life (HRQoL) and psychosocial evaluations. There was no difference in ventilator-free days during the first 60 days after randomization between early percutaneous tracheotomy and prolonged intubation groups (mean, 30.4 days [SD, 22.4] vs. 28.3 days [SD, 23.7], respectively; absolute difference, 2.1 days [95% CI, -4.1 to 8.3 days]) nor in 28-, 60-, or 90-day mortality rates (16% vs. 21%, 26% vs. 28%, and 30% vs. 30%, respectively). The durations of mechanical ventilation and hospitalization, as well as frequencies of ventilator-associated pneumonia and other severe infections, were also similar. However, early percutaneous tracheotomy was associated with less intravenous sedation; less time of heavy sedation; less haloperidol use for agitation, delirium, or both; fewer unscheduled extubations; better comfort and ease of care; and earlier resumption of oral nutrition. After a median
Yki-Järvinen, H; Ryysy, L; Nikkilä, K; Tulokas, T; Vanamo, R; Heikkilä, M
Compared with other insulin regimens, combination therapy with oral hypoglycemic agents and bedtime insulin produces similar improvement in glycemic control but induces less weight gain. To determine whether bedtime insulin regimens differ with respect to their effects on weight gain in patients with type 2 diabetes. Randomized, controlled trial. Four outpatient clinics at central hospitals. 96 patients (mean age, 58 +/- 1 years; mean body mass index, 29 +/- 1 kg/m2) whose type 2 diabetes was poorly controlled with sulfonylurea therapy (mean glycosylated hemoglobin value, 9.9% +/- 0.2%; mean fasting plasma glucose level, 11.9 +/- 0.3 mmol/L [214 +/- 5 mg/dL]). Random assignment to 1 year of treatment with bedtime intermediate-acting insulin plus glyburide (10.5 mg) and placebo, metformin (2 g) and placebo, glyburide and metformin, or a second injection of intermediate-acting insulin in the morning. Patients were taught to adjust the bedtime insulin dose on the basis of fasting glucose measurements. Body weight, biochemical and symptomatic hypoglycemias, and indices of glycemic control. At 1 year, body weight remained unchanged in patients receiving bedtime insulin plus metformin (mean change, 0.9 +/- 1.2 kg; P bedtime insulin plus glyburide, those receiving bedtime insulin plus both oral drugs, and those receiving bedtime and morning insulin, respectively. The greatest decrease in the glycosylated hemoglobin value was observed in the bedtime insulin and metformin group (from 9.7% +/- 0.4% to 7.2% +/- 0.2% [difference, -2.5 +/- 0.4 percentage points] at 1 year; P bedtime insulin plus metformin prevents weight gain. This regimen also seems superior to other bedtime insulin regimens with respect to improvement in glycemic control and frequency of hypoglycemia.
Knoop, J; Dekker, J; van der Leeden, M; van der Esch, M; Thorstensson, C A; Gerritsen, M; Voorneman, R E; Peter, W F; de Rooij, M; Romviel, S; Lems, W F; Roorda, L D; Steultjens, M P M
To investigate whether an exercise program, initially focusing on knee stabilization and subsequently on muscle strength and performance of daily activities is more effective than an exercise program focusing on muscle strength and performance of daily activities only, in reducing activity limitations in patients with knee osteoarthritis (OA) and instability of the knee joint. A single-blind, randomized, controlled trial involving 159 knee OA patients with self-reported and/or biomechanically assessed knee instability, randomly assigned to two treatment groups. Both groups received a supervised exercise program for 12 weeks, consisting of muscle strengthening exercises and training of daily activities, but only in the experimental group specific knee joint stabilization training was provided. Outcome measures included activity limitations (Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC physical function, primary outcome), pain, global perceived effect and knee stability. Both treatment groups demonstrated large (∼20-40%) and clinically relevant reductions in activity limitations, pain and knee instability, which were sustained 6 months post-treatment. No differences in effectiveness between experimental and control treatment were found on WOMAC physical function (B (95% confidence interval - CI) = -0.01 (-2.58 to 2.57)) or secondary outcome measures, except for a higher global perceived effect in the experimental group (P = 0.04). Both exercise programs were highly effective in reducing activity limitations and pain and restoring knee stability in knee OA patients with instability of the knee. In knee OA patients suffering from knee instability, specific knee joint stabilization training, in addition to muscle strengthening and functional exercises, does not seem to have any additional value. Dutch Trial Register (NTR) registration number: NTR1475. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier
Nyklicek, I.; Dijksman, S.C.; Lenders, P.J.; Fonteijn, W.A.; Koolen, J.J.
In this study effects of a brief mindfulness-based stress reduction intervention were examined in cardiac patients who had a percutaneous coronary intervention (PCI). One-hundred-and-fourteen patients (mean age 55 ± 7 years, 18 % women) were randomly assigned to a 4-session mindfulness group
Heideman, W.H.; de Wit, M.; Middelkoop, B.J.C.; Nierkens, V.; Stronks, K.; Verhoeff, A.P.; Snoek, F.J.
Objectives To test the efficacy of a low-intensive lifestyle education program (DiAlert) for overweight first degree relatives of type 2 diabetes patients aimed at reducing diabetes risk. Methods Overweight first degree relatives of type 2 diabetes patients were randomly assigned to the DiAlert
Ural, Fatma Gülçin; Öztürk, Gökhan Tuna; Bölük, Hüma; Akkuş, Selami
To explore the effect of acupuncture on common extensor tendon (CET) thickness in patients with lateral epicondylitis (LE). Additionally, to identify whether clinical and ultrasonographic changes showed any correlation. Forty-one patients were randomly assigned to acupuncture and control groups. Conventional treatment (rest, NSAİİ, bracing, exercise) methods for LE were applied to all patients. In addition to this, the acupuncture treatment was applied to the acupuncture group. The visual analog scale (VAS) for pain, the Duruoz Hand Index (DHI) for functioning of the affected limb, the pressure pain threshold, and CET thickness (via ultrasound imaging) were assessed before and end of the treatment in both groups. The VAS and DHI scores in both groups decreased. The pressure pain threshold and CET thickness only demonstrated improvement in the acupuncture group. These findings show that the CET thickness was reduced after 10 sessions of acupuncture treatment in LE patients.
Thaler, Christian; Faizy, Tobias D; Sedlacik, Jan; Bester, Maxim; Stellmann, Jan-Patrick; Heesen, Christoph; Fiehler, Jens; Siemonsen, Susanne
In multiple sclerosis (MS), inflammatory lesions present a broad spectrum of histopathologic processes. For a better discrimination, lesions are visually defined into different lesion groups according to their appearance on conventional magnetic resonance imaging (MRI). The aim of this study was to investigate the properties of different MS lesion groups using multiparametric quantitative MRI. 35 patients diagnosed with relapsing-remitting MS received 3 Tesla MRI including magnetization-prepared 2 rapid acquisition gradient echo, diffusion tensor imaging and magnetization transfer imaging. Lesion segmentation was performed for T2 lesions, black holes and contrast-enhancing lesions. A subtraction mask was created including only T2 lesions that did not correspond to a black hole or contrast-enhancing lesion. T1 relaxation time (T1-RT), magnetization transfer ratio (MTR), mean diffusivity (MD) and fractional anisotropy (FA) were determined for every lesion and in normal-appearing white matter. Only MD differed significantly between all lesion groups and NAWM (p lesion groups but not NAWM. T1-RT and MTR were not useful imaging biomarkers to distinguish between lesion groups. A lack of sensitivity and specificity and unproportional alterations of quantitative MRI measures, due to heterogenous histopathologic processes within lesions, may be a possible explanation for missing discrimination. Thus, not only interpretation of visually defined MS lesion but also interpretation of quantitative MRI measures remains challenging and should be conducted carefully.
Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene Z
Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused. To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes. Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740). Department of Veterans Affairs Medical Center in Durham, North Carolina. 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record. The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes. At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ. The study was conducted in a single Veterans Affairs medical center. The combined patient and provider intervention resulted in
Schadé, Annemiek; Marquenie, Loes A; van Balkom, Anton J L M; Koeter, Maarten W J; de Beurs, Edwin; van den Brink, Wim; van Dyck, Richard
Evidence has emerged which indicates that the post-treatment relapse rate for alcohol-dependent patients with a comorbid anxiety disorder is higher than for alcohol-dependent patients without a comorbid anxiety disorder. The question raised by this evidence is whether the relapse rate in these dually diagnosed patients could be reduced if they were given additional treatment for the comorbid anxiety disorder. We attempted to answer this question by conducting a trial among patients with a double diagnosis of alcohol dependence and agoraphobia or social phobia. We conducted a 32-week randomized controlled trial among 96 abstinent patients with a primary diagnosis of alcohol dependence and a comorbid anxiety disorder involving agoraphobia or social phobia. The patients were randomly assigned to an intensive psychosocial relapse-prevention program on its own (n = 49) or in combination with an anxiety treatment program comprising cognitive behavioral therapy (CBT) and optional pharmacotherapy consisting of an SSRI (n = 47). The primary outcome measure was the percentage of patients who suffered an alcohol relapse during a 32-week period. The secondary outcome measures were total abstinence, a reduction in the days of heavy drinking, and less severe anxiety symptoms. Although the additional therapy clearly reduced the anxiety symptoms, it had no significant effect on the alcohol relapse rates. Anxiety treatment for alcohol-dependent patients with a comorbid anxiety disorder can alleviate anxiety symptoms, but it has no significant effect on the outcome of alcohol treatment programs.
Zheng, Kai; Shen, Hong; Jia, Jia; Lu, Yuelin; Zhu, Lei; Zhang, Lu; Shen, Zhaofeng
Approximately 20% of patients with ulcerative colitis become steroid dependent. Azathioprine is recommended in steroid-dependent ulcerative colitis, but its side effects limit its use. Chinese herbal medicine has been widely used to treat ulcerative colitis in China. However, its effectiveness in steroid-dependent patients has not been evaluated. This study aims to investigate the efficacy of traditional Chinese medicine combination therapy with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. This is a parallel, multicenter, randomized controlled trial. One hundred and twenty eligible patients will be randomly assigned to a traditional Chinese medicine group or azathioprine group. All patients will be given basic treatment, which includes steroids and 5-aminosalicylic acid. Patients allocated to the traditional Chinese medicine group will receive basic treatment plus Chinese herbal medicine granules, while patients in the azathioprine group will receive basic treatment plus azathioprine. The whole study will last 24 weeks. The primary outcome measure is the steroid-free remission rate. Secondary outcome measures are health-related quality of life, efficacy of endoscopic response, degree of mucosal healing, and inflammation indicators. Results from this study may provide evidence for the effectiveness of traditional Chinese medicine combined with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. The findings will provide a basis for further confirmatory studies. Chinese Clinical Trial Register, ChiCTR-IPR-15005760 . Registered on 2 January 2015.
Hess, Erik P; Hollander, Judd E; Schaffer, Jason T; Kline, Jeffrey A; Torres, Carlos A; Diercks, Deborah B; Jones, Russell; Owen, Kelly P; Meisel, Zachary F; Demers, Michel; Leblanc, Annie; Shah, Nilay D; Inselman, Jonathan; Herrin, Jeph; Castaneda-Guarderas, Ana; Montori, Victor M
To compare the effectiveness of shared decision making with usual care in choice of admission for observation and further cardiac testing or for referral for outpatient evaluation in patients with possible acute coronary syndrome. Multicenter pragmatic parallel randomized controlled trial. Six emergency departments in the United States. 898 adults (aged >17 years) with a primary complaint of chest pain who were being considered for admission to an observation unit for cardiac testing (451 were allocated to the decision aid and 447 to usual care), and 361 emergency clinicians (emergency physicians, nurse practitioners, and physician assistants) caring for patients with chest pain. Patients were randomly assigned (1:1) by an electronic, web based system to shared decision making facilitated by a decision aid or to usual care. The primary outcome, selected by patient and caregiver advisers, was patient knowledge of their risk for acute coronary syndrome and options for care; secondary outcomes were involvement in the decision to be admitted, proportion of patients admitted for cardiac testing, and the 30 day rate of major adverse cardiac events. Compared with the usual care arm, patients in the decision aid arm had greater knowledge of their risk for acute coronary syndrome and options for care (questions correct: decision aid, 4.2 v usual care, 3.6; mean difference 0.66, 95% confidence interval 0.46 to 0.86), were more involved in the decision (observing patient involvement scores: decision aid, 18.3 v usual care, 7.9; 10.3, 9.1 to 11.5), and less frequently decided with their clinician to be admitted for cardiac testing (decision aid, 37% v usual care, 52%; absolute difference 15%; Ppatients at low risk for acute coronary syndrome increased patient knowledge about their risk, increased engagement, and safely decreased the rate of admission to an observation unit for cardiac testing.Trial registration ClinicalTrials.gov NCT01969240. Published by the BMJ
Shulman, Lisa M; Katzel, Leslie I; Ivey, Frederick M; Sorkin, John D; Favors, Knachelle; Anderson, Karen E; Smith, Barbara A; Reich, Stephen G; Weiner, William J; Macko, Richard F
To compare the efficacy of treadmill exercises and stretching and resistance exercises in improving gait speed, strength, and fitness for patients with Parkinson disease. A comparative, prospective, randomized, single-blinded clinical trial of 3 types of physical exercise. The Parkinson's Disease and Movement Disorders Center at the University of Maryland and the Baltimore Veterans Affairs Medical Center, Geriatric Research Education and Clinical Center. A total of 67 patients with Parkinson disease who had gait impairment were randomly assigned to 1 of 3 arms of the trial. INTERVENTIONS; (1) A higher-intensity treadmill exercise (30 minutes at 70%-80% of heart rate reserve), (2) a lower-intensity treadmill exercise (50 minutes at 40%-50% of heart rate reserve), and (3) stretching and resistance exercises (2 sets of 10 repetitions on each leg on 3 resistance machines [leg press, leg extension, and curl]). These exercises were performed 3 times a week for 3 months. The primary outcome measures were gait speed (6-minute walk), cardiovascular fitness (peak oxygen consumption per unit time [$$ VO2], and muscle strength (1-repetition maximum strength). All 3 types of physical exercise improved distance on the 6-minute walk: lower-intensity treadmill exercise (12% increase; P=.001), stretching and resistance exercises (9% increase; Pexercise (6% increase; P=.07), with no between-group differences. Both treadmill exercises improved peak $$ VO2 (7%-8% increase; Pexercises. Only stretching and resistance improved muscle strength (16% increase; Pexercise were seen across all 3 exercise groups. The lower-intensity treadmill exercise resulted in the greatest improvement in gait speed. Both the higher- and lower-intensity treadmill exercises improved cardiovascular fitness. Only the stretching and resistance exercises improved muscle strength. Therefore, exercise can improve gait speed, muscle strength, and fitness for patients with Parkinson disease. The combination of
Full Text Available Abstract Background The large clinical trials proved that Basal-Bolus (BB insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. Methods In PROBE (Prospective, Randomized, Open, Blinded-Endpoint design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range age: 64.5(56.8~71.0years with secondary failure of sulfonylurea (SU were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group, and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. Results After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3 → 7.4(6.9~8.7%, p Conclusion Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. Trial registration Current Controlled Trials number, NCT00348231
Vas, Jorge; Modesto, Manuela; Aguilar, Inmaculada; Santos-Rey, Koldo; Benítez-Parejo, Nicolás; Rivas-Ruiz, Francisco
Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. ISRCTN trial number ISRCTN60217348 (19 October 2010).
Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number
Dwi R Helianthi
Full Text Available Aim: to compare the effectiveness of active laser acupuncture with placebo on reducing pain intensity and improving functional outcome in geriatric patients with knee osteoarthritis (OA. Methods: a double-blind randomized controlled trial was conducted in geriatrics with knee OA at Medical Acupuncture Outpatient Clinic, Integrated Geriatric Outpatient Clinic, Rheumatology Outpatient Clinic of Cipto Mangunkusumo Hospital, Jakarta, during May to October 2015. Sixty two patients with knee OA were randomly assigned into two groups: active laser acupuncture group or placebo laser acupuncture group. Interventions were carried out using a gallium aluminum arsenide laser device at the ST35 Dubi, ST36 Zusanli, SP9 Yinlingquan, GB34 Yanglingquan and EX - LE - 4 Neixiyan acupuncture points on the affected knee for ten sessions of treatment, i.e. twice a week. Patients were assessed using a visual analogue scale (VAS and Lequesne index at baseline, after four sessions, after nine sessions and at 2 weeks after the treatment had been stopped. Results: the VAS scores were significantly improved in the active laser acupuncture group compared to the placebo group. The evaluation of VAS scores was carried out after four treatment sessions (mean difference: 0.39; p<0.001, after nine treatment sessions (mean difference: 37.48; p<0.001 and at 2 weeks post intervention (mean difference: 39.15; p<0.001. The evaluation also showed significant improvement of Lequesne index after four treatment sessions (mean difference: 4.68; p<0.001, after nine treatment sessions (mean difference: 5.90; p<0.001 and at 2 weeks post intervention (mean difference: 6.48; p<0.001. Conclusion: active laser acupuncture is effective in reducing pain.
Adelaida María Castro-Sánchez
Full Text Available The objective of this study was to evaluate the efficacy of connective tissue massage to improve blood circulation and intermittent claudication symptoms in type 2 diabetic patients. A randomized, placebo-controlled trial was undertaken. Ninety-eight type 2 diabetes patients with stage I or II-a peripheral arterial disease (PAD (Leriche-Fontaine classification were randomly assigned to a massage group or to a placebo group treated using disconnected magnetotherapy equipment. Peripheral arterial circulation was determined by measuring differential segmental arterial pressure, heart rate, skin temperature, oxygen saturation and skin blood flow. Measurements were taken before and at 30 min, 6 months and 1 year after the 15-week treatment. After the 15-week program, the groups differed (P<.05 in differential segmental arterial pressure in right lower limb (lower one-third of thigh, upper and lower one-third of leg and left lower limb (lower one-third of thigh and upper and lower one-third of leg. A significant difference (P<.05 was also observed in skin blood flow in digits 1 and 4 of right foot and digits 2, 4 and 5 of left foot. ANOVA results were significant (P<.05 for right and left foot oxygen saturation but not for heart rate and temperature. At 6 months and 1 year, the groups differed in differential segmental arterial pressure in upper third of left and right legs. Connective tissue massage improves blood circulation in the lower limbs of type 2 diabetic patients at stage I or II-a and may be useful to slow the progression of PAD.
Fernández García, Rubén; Sánchez Sánchez, Laura de Carmen; López Rodríguez, María Del Mar; Sánchez Granados, Gema
Spondyloarthritis is a general term referring to a group of chronic rheumatic illnesses that share clinical, genetic, radiological and epidemiological features. The clinical presentation of spondyloarthritis is characterized by the compromise of both the axial and peripheral articular skeleton. We aimed to evaluate the efficacy of an aquatic exercise plus relaxation program in patients with spondyloarthritis. This was a randomized single blind study including 30 patients with spondylitis who were randomly assigned to an experimental or control group. For 2 months, the experimental group underwent an aquatic fitness plus relaxation program (3 sessions per week). Evaluations were also performed in the control group the same days as the experimental group but they did not participate in any supervised exercise program. The following data were obtained at baseline and immediately after application of the last session: Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Disease Activity Index, Health Questionnaire SF-12 and Sigma PC3(®) (Sigma-Elektro GmbH, Neustadt, Germany) Heart Rate Monitor. The Mann-Whitney test showed statistically significant differences in the quality of life (physical function [P=.05]), Bath Ankylosing Spondylitis Functional Index (P=.015), Bath Ankylosing Spondylitis Disease Activity Index (fatigue [P=.032], neck pain, back and hips [P=.045], pain or swelling in other joints [P=.032] and in waking morning stiffness [P=.019]). The results of the present study suggest that therapy with physical exercise plus relaxation provides benefits to spondyloarthritis patients and these are advised as a part of their usual treatment. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.
Fernandes, Giovana; Jennings, Fabio; Nery Cabral, Michele Vieira; Pirozzi Buosi, Ana Letícia; Natour, Jamil
To evaluate the effect of swimming on pain, functional capacity, aerobic capacity, and quality of life in patients with fibromyalgia (FM). Randomized controlled trial. Rheumatology outpatient clinics of a university hospital. Women with FM (N=75; age range, 18-60y) randomly assigned to a swimming group (SG) (n=39) or a walking group (WG) (n=36). The SG performed 50 minutes of swimming 3 times a week for 12 weeks, with a heart rate at 11 beats under the anaerobic threshold. The WG performed walking with a heart rate at the anaerobic threshold, with the same duration and frequency as the SG. Participants were evaluated before the exercise protocols (t0), at 6 weeks (t6), and at 12 weeks (t12) after the onset of the protocols. The primary outcome measure was the visual analog scale for pain. The secondary measurements were the Fibromyalgia Impact Questionnaire and the Medical Outcomes Study 36-Item Short-Form Health Survey for quality of life; a spiroergometric test for cardiorespiratory variables; and the timed Up & Go test for functional performance. Patients in both groups experienced improvement in pain after the 12-week program, with no difference between groups (P=.658). The same results were found regarding functional capacity and quality of life. Moreover, no statistical difference between groups was found regarding aerobic capacity over time. Swimming, like walking, is an effective method for reducing pain and improving both functional capacity and quality of life in patients with FM. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Huang, Wei-Chang; Wu, Pi-Chu; Chen, Chao-Jung; Cheng, Ya-Hua; Shih, Sou-Jen; Chen, Hui-Chen; Wu, Chieh-Liang
Patients with prolonged mechanical ventilation (PMV) often retain airway secretions, which may be cleared with the assistance of high-frequency chest wall oscillation (HFCWO). This study aimed to determine the effectiveness, safety and tolerance/comfort of HFCWO after extubation in PMV patients. This parallel-designed, randomized controlled trial enrolled subjects with both intra-tracheal intubation and mechanical ventilator support continuously for at least 21 days between January 2011 and December 2012. Upon extubation, the participants were randomly assigned to either receive HFCWO for 5 days or not. The effectiveness [based on weaning success rates, daily clearance volume of sputum, serial changes in sputum coloration and chest X-ray (CXR) improvement rates], safety (by physiologic parameters) and tolerance/comfort [using the Modified Borg Scale (MBS) and Hamilton Anxiety Scale (HAS)] of HFCWO were investigated. There were 43 PMV subjects, including 23 in the HFCWO group and 20 in the non-HFCWO group. The weaning success rates were 82.6% (19/23) and 85% (17/20) in the HFCWO and non-HFCWO groups, respectively (P = 1.000). The HFCWO group had persistently greater numbers of daily sputum suctions and higher CXR improvement rates compared with the non-HFCWO group. There was significant sputum coloration lightening in the HFCWO group only. There was no significant difference in the MBS and HAS between the two groups and between pre- and post-HFCWO physiologic parameters. In PMV patients, HFCWO was safe, comfortable and effective in facilitating airway hygiene after removal of endotracheal tubes, but had no positive impact on weaning success. © 2014 John Wiley & Sons Ltd.
Kuck, K H; Cappato, R; Siebels, J; Rüppel, R
We conducted a prospective, multicenter, randomized comparison of implantable cardioverter-defibrillator (ICD) versus antiarrhythmic drug therapy in survivors of cardiac arrest secondary to documented ventricular arrhythmias. From 1987, eligible patients were randomized to an ICD, amiodarone, propafenone, or metoprolol (ICD versus antiarrhythmic agents randomization ratio 1:3). Assignment to propafenone was discontinued in March 1992, after an interim analysis conducted in 58 patients showed a 61% higher all-cause mortality rate than in 61 ICD patients during a follow-up of 11.3 months. The study continued to recruit 288 patients in the remaining 3 study groups; of these, 99 were assigned to ICDs, 92 to amiodarone, and 97 to metoprolol. The primary end point was all-cause mortality. The study was terminated in March 1998, when all patients had concluded a minimum 2-year follow-up. Over a mean follow-up of 57+/-34 months, the crude death rates were 36.4% (95% CI 26.9% to 46.6%) in the ICD and 44.4% (95% CI 37.2% to 51.8%) in the amiodarone/metoprolol arm. Overall survival was higher, though not significantly, in patients assigned to ICD than in those assigned to drug therapy (1-sided P=0.081, hazard ratio 0.766, [97.5% CI upper bound 1.112]). In ICD patients, the percent reductions in all-cause mortality were 41.9%, 39.3%, 28. 4%, 27.7%, 22.8%, 11.4%, 9.1%, 10.6%, and 24.7% at years 1 to 9 of follow-up. During long-term follow-up of cardiac arrest survivors, therapy with an ICD is associated with a 23% (nonsignificant) reduction of all-cause mortality rates when compared with treatment with amiodarone/metoprolol. The benefit of ICD therapy is more evident during the first 5 years after the index event.
Silva, Paula Simplício da; Mediano, Mauro Felippe Felix; Silva, Gilberto Marcelo Sperandio da; Brito, Patricia Dias de; Cardoso, Claudia Santos de Aguiar; Almeida, Cristiane Fonseca de; Sangenis, Luiz Henrique Conde; Pinheiro, Roberta Olmo; Hasslocher-Moreno, Alejandro Marcel; Brasil, Pedro Emmanuel Alvarenga Americano do; Sousa, Andrea Silvestre de
Several studies have been focusing on the effect of omega-3 polyunsaturated fatty acids on modulation of inflammatory markers in several cardiopathies. Although immunoregulatory dysfunction has been associated to the chronic cardiac involvement in Chagas disease, there is no study examining the effects of omega-3 supplementation in these patients. We investigated the effects of omega-3 PUFAs on markers of inflammation and lipid profile in chronic Chagas cardiomyopathy patients. The present study was a single-center double-blind clinical trial including patients with chronic Chagas cardiomyopathy. Patients were randomly assigned to receive omega-3 PUFAs capsules (1.8g EPA and 1.2g DHA) or placebo (corn oil) during an 8-week period. Cytokines, fasting glucose, lipid, and anthropometric profiles were evaluated. Forty-two patients (23 women and 19 men) were included in the study and there were only two losses to follow-up during the 8-week period. Most of sociodemographic and clinical characteristics were similar between the groups at baseline, except for the cytokines IL-1β, IL-6, IL-8, IL-10, IL-17α, and IFNγ. The omega-3 PUFAs group demonstrated greater improvements in serum triglycerides (-21.1 vs. -4.1; p = 0.05) and IL-10 levels (-10.6 vs. -35.7; p = 0.01) in comparison to controls after 8 weeks of intervention. No further differences were observed between groups. Omega-3 PUFAs supplementation may favorably affect lipid and inflammatory profile in chronic Chagas cardiomyopathy patients, demonstrated by a decrease in triglycerides and improvements on IL-10 concentration. Further studies examining the clinical effects of omega-3 fatty acids supplementation in chronic Chagas cardiomyopathy are necessary. NCT01863576.
Full Text Available The modern approach to the care of the mentally retarded in institutional settings is no longer to provide only custiodial care, but to train and rehabilitate each patient to be able to function at his maximal potential. This requires that each resident must have his abilities assessed and a programme implemented for his training, according to his particular needs and capabilities. Residents requiring similar training programmes are therefore grouped together under the care of one nurse, the number of residents in each group depending upon their selfcare skills. The nurse is assigned the responsibility of carrying out the training programme under the supervision of the Ward Sister and with the guidance of the multidisciplinary team under the leadership of the psychiatrist.
Full Text Available Background. Postoperative pain management remains a significant challenge for all healthcare providers. A randomized controlled trial was conducted to examine the adjuvant effects of auricular acupressure on relieving postoperative pain and improving the passive range of motion in patients with total knee replacement (TKR. Method. Sixty-two patients who had undergone a TKR were randomly assigned to the acupressure group and the sham control group. The intervention was delivered three times a day for 3 days. A visual analog scale (VAS and the Short-Form McGill Pain Questionnaire were used to assess pain intensity. Pain medication consumption was recorded, and the knee motion was measured using a goniometer. Results. The patients experienced a moderately severe level of pain postoperatively (VAS 58.66 ± 20.35 while being on the routine PCA. No differences were found in pain scores between the groups at all points. However, analgesic drug usage in the acupressure group patients was significantly lower than in the sham control group (<0.05, controlling for BMI, age, and pain score. On the 3rd day after surgery, the passive knee motion in the acupressure group patients was significantly better than in the sham control group patients (<0.05, controlling for BMI. Conclusion. The application of auricular acupressure at specific therapeutic points significantly reduces the opioid analgesia requirement and improves the knee motion in patients with TKR.
Quadrel, M; Lavery, R F; Jaker, M; Atkin, S; Tortella, B J; Cody, R P
To compare the effectiveness and incidence of adverse reactions with three treatment regimens for asthma in adults in the prehospital setting. Prospective, randomized clinical study. Inner-city emergency medical service system providing basic and advanced life support and transport to 14 urban area hospital emergency departments. One hundred fifty-four adult asthmatic patients, 18 to 50 years old, who presented to paramedics with shortness of breath and wheezing. Eligible patients were randomly assigned by the base station physician to one of three treatment groups: subcutaneous epinephrine, nebulized metaproterenol, or subcutaneous epinephrine and nebulized metaproterenol. Peak expiratory flow rate (PEFR), blood pressure, heart rate, and respiratory rate were measured before and after treatment in each patient. During a 9-month period (October 1992 through June 1993), 154 patients were enrolled in the study; 53 (34%) received epinephrine, 49 (32%) received metaproterenol, and 52 (34%) received both. There were no significant differences in patient demographics, initial vital signs, or pretreatment PEFR among the three groups. The mean difference between pretreatment and posttreatment PEFR was 73 L/min and did not significantly differ among the treatment groups. Significant changes in vital signs were seen in no treatment group. Nebulized metaproterenol is as effective as subcutaneous epinephrine in the prehospital treatment of adult patients with acute asthma. The combination of these two treatments offered no additional clinical benefit in the patients we studied.
ALINE TABORDA FLESCH
Full Text Available ABSTRACT Objective: to evaluate the effect of perioperative administration of symbiotics on the incidence of surgical wound infection in patients undergoing surgery for colorectal cancer. Methods: We conducted a randomized clinical trial with colorectal cancer patients undergoing elective surgery, randomly assigned to receive symbiotics or placebo for five days prior to the surgical procedure and for 14 days after surgery. We studied 91 patients, 49 in the symbiotics group (Lactobacillus acidophilus 108 to 109 CFU, Lactobacillus rhamnosus 108 to 109 CFU, Lactobacillus casei 108 to 109 CFU, Bifi dobacterium 108 to 109 CFU and fructo-oligosaccharide (FOS 6g and 42 in the placebo group. Results: surgical site infection occurred in one (2% patient in the symbiotics group and in nine (21.4% patients in the control group (p=0.002. There were three cases of intraabdominal abscess and four cases of pneumonia in the control group, whereas we observed no infections in patients receiving symbiotics (p=0.001. Conclusion: the perioperative administration of symbiotics significantly reduced postoperative infection rates in patients with colorectal cancer. Additional studies are needed to confirm the role of symbiotics in the surgical treatment of colorectal cancer.
Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.
Casals, C; García-Agua-Soler, N; Vázquez-Sánchez, M Á; Requena-Toro, M V; Padilla-Romero, L; Casals-Sánchez, J L
Malnutrition is associated with an increased risk of mortality and morbidity, longer hospital stays and general loss of quality of life. The aim of this study is to assess the impact of dietary counseling for malnourished hospital patients. Prospective, randomized, open-label study of 106 hospital patients with malnutrition (54 in the control group and 52 in the intervention group). The intervention group received dietary counseling, and the control group underwent standard treatment. We determined the patients' nutritional state (body mass index, laboratory parameters, malnutrition universal screening tool), degree of dependence (Barthel index), quality of life (SF-12), degree of satisfaction (CSQ-8), the number and length of readmissions and mortality. The patients who underwent the "intervention" increased their weight at 6 months, while the controls lost weight (difference in body mass index, 2.14kg/m(2); p<.001). The intervention group had better results when compared with the control group in the Malnutrition Universal Screening Tool scores (difference, -1.29; p<.001), Barthel index (difference, 7.49; p=.025), SF-12 (difference, 13.72; p<.001) and CSQ-8 (difference, 4.34, p<.001) and required fewer readmissions (difference, -0.37; p=.04) and shorter stays for readmissions (difference, -6.75; p=.035). Mortality and laboratory parameters were similar for the 2 groups. Nutritional counseling improved the patients' nutritional state, quality of life and degree of dependence and decreased the number of hospital readmissions. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.
Slot, Marie Falkesgaard
This article discusses scaffolding in typical student assignments in mother tongue learning materials in upper secondary education in Denmark and the United Kingdom. It has been determined that assignments do not have sufficient scaffolding end features to help pupils understand concepts and build...
Araujo, Amanda Costa; do Carmo Silva Parreira, Patrícia; Junior, Luiz Carlos Hespanhol; da Silva, Tatiane Mota; da Luz Junior, Maurício Antônio; da Cunha Menezes Costa, Lucíola; Pena Costa, Leonardo Oliveira
Kinesio taping is a commonly used intervention for patients with chronic low back pain. However, the medium term effects of kinesio taping in these patients are unknown. To investigate the effectiveness of kinesio taping in patients with chronic low back pain after 6 months from randomization. This was a randomized controlled trial with a 6 months follow up. One hundred and forty eight participants were randomly assigned to the experimental (kinesio taping with skin convolutions) or control (kinesio taping without convolutions-Sham Taping) group. Participants from both groups had the tape reapplied twice a week for four weeks. The outcomes were pain, disability and global impression of recovery after 6 months. One participant was lost to follow up in the experimental group (n=73, response rate 99%) and two in the control group (n=72, response rate 97%). After 6 months there were no statistically significant between-group differences in pain intensity (between-group difference -0.8 points, 95% CI -1.7 to 0.2), global impression of recovery (0.4, -0.7 to 1.5), or disability (-1.1, -3.0 to 0.7). Four weeks of kinesio taping treatment was no better than sham taping for patients with chronic low back pain, at 6 months follow-up. Trial Registration Number (http://www.ensaiosclinicos.gov.br/): RBR-7ggfkv (Brazilian Registry of Clinical Trials). Copyright © 2017 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J
A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). 10 Duke University Health System community-based primary care clinics. 537 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. The study involved 1 health care network. Data on provider referrals were not collected. Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically
2O0O;9Ot3):706-712. 20. Bertrand P, Maye J. A description of the indices of heart rate variabil- ity in orofacial pain paticnis. Bcihcsda, MD: National...neck proce- dures were randomly assigned into 2 groups for this single-blind investigation. Anxiety and baseline pain levels were documented...control group patients received no intervention. Data were collected on pain and nar- cotic consumption at 7- and 2-hour postoperative inter- vals. In
Mu-Lien Lin; Jih-Huah Wu; Chi-Wan Lin; Chuan-Tsung Su; Hung-Chien Wu; Yong-Sheng Shih; I-Ting Chiu; Chao-Yi Chen; Wen-Dien Chang
Objectives. Chronic nonspecific lower back pain (LBP) is a common disease. Insufficient data is currently available to conclusively confirm the analgesic effects of laser acupuncture on LBP. This study evaluated the effectiveness of laser acupuncture plus Chinese cupping in LBP treatment. Methods. Patients with chronic nonspecific LBP were enrolled for a randomized controlled trial and assigned to the laser acupuncture group (laser acupuncture plus Chinese cupping) and control group (sham las...
Lapid, Maria I; Rummans, Teresa A; Brown, Paul D; Frost, Marlene H; Johnson, Mary E; Huschka, Mashele M; Sloan, Jeff A; Richardson, Jarrett W; Hanson, Jean M; Clark, Matthew M
To examine the potential impact of elderly age on response to participation in a structured, multidisciplinary quality-of-life (QOL) intervention for patients with advanced cancer undergoing radiation therapy. Study design was a randomized stratified, two group, controlled clinical trial in the setting of a tertiary care comprehensive cancer center. Subjects with newly diagnosed cancer and an estimated 5-year survival rate of 0%-50% who required radiation therapy were recruited and randomly assigned to either an intervention group or a standard care group. The intervention consisted of eight 90-min sessions designed to address the five QOL domains of cognitive, physical, emotional, spiritual, and social functioning. QOL was measured using Spitzer uniscale and linear analogue self-assessment (LASA) at baseline and weeks 4, 8, and 27. Of the 103 study participants, 33 were geriatric (65 years or older), of which 16 (mean age 72.4 years) received the intervention and 17 (mean age 71.4 years) were assigned to the standard medical care. The geriatric participants who completed the intervention had higher QOL scores at baseline, at week 4 and at week 8, compared to the control participants. Our results demonstrate that geriatric patients with advanced cancer undergoing radiation therapy will benefit from participation in a structured multidisciplinary QOL intervention. Therefore, geriatric individuals should not be excluded from participating in a cancer QOL intervention, and, in fact, elderly age may be an indicator of strong response to a QOL intervention. Future research should further explore this finding.
Sehn, L. H.; Goy, A.; Offner, F. C.
Purpose Obinutuzumab (GA101), a novel glycoengineered type II anti-CD20 monoclonal antibody, demonstrated responses in single-arm studies of patients with relapsed/refractory non-Hodgkin lymphoma. This is the first prospective, randomized study comparing safety and efficacy of obinutuzumab...... with rituximab in relapsed indolent lymphoma. The primary end point of this study was the overall response rate (ORR) in patients with follicular lymphoma after induction and safety in patients with indolent lymphoma. Patients and Methods A total of 175 patients with relapsed CD20(+) indolent lymphoma requiring...... therapy and with previous response to a rituximab-containing regimen were randomly assigned (1:1) to four once-per-week infusions of either obinutuzumab (1,000 mg) or rituximab (375 mg/m(2)). Patients without evidence of disease progression after induction therapy received obinutuzumab or rituximab...
Ahmed, Anthony O; Hunter, Kristin M; Goodrum, Nada M; Batten, Nancy-Jane; Birgenheir, Denis; Hardison, Erik; Dixon, Thaddeus; Buckley, Peter F
Cognitive remediation has proven efficacy for improving neurocognition in people with schizophrenia. The current study evaluated the benefits of cognitive remediation on neurocognition, functioning, psychotic symptoms, and aggression in a sample of forensic and mental health patients. Care recipients with schizophrenia or schizoaffective disorder (N = 78) receiving services in the forensic and mental health units of a state hospital were randomized to participate in cognitive remediation versus computer games control activities. Participants' neurocognition, functional capacity, experiential recovery, psychotic symptoms, and aggression incidents were assessed at baseline and posttreatment. Cognitive remediation was associated with improvements in several neurocognitive domains and circumscribed domains of functional capacity. People assigned to cognitive remediation experiences greater reductions in negative symptoms, agitation/excitement, and verbal and physical aggression. In addition to improving neurocognition in long-term hospitalized forensic and mental health patients, cognitive remediation may enhance efforts at reducing negative symptoms, emotion dysregulation, and aggression incidents. Forensic settings may represent a new frontier for the clinical dissemination of cognitive remediation. Copyright © 2015 Elsevier Ltd. All rights reserved.
Martinsen, Unni; Bentzen, Hege; Holter, Morag Kelly; Nilsen, Tove; Skullerud, Hallvard; Mowinckel, Petter; Kjeken, Ingvild
Aim The main aim of this study was to evaluate the effect of individualized occupational therapy in patients with chronic obstructive pulmonary disease (COPD). Additionally, the authors wanted to explore the occupational problems experienced in daily life by individuals with COPD. Methods A total of 52 patients were randomly assigned to the intervention group (occupational therapy) or control group (treatment as usual). The primary outcome was assessed using the Canadian Occupational Performance Measure (COPM), and participants were assessed at baseline and after four and 12 months. Results There were no treatment effects on occupational performance or satisfaction with performance, as measured by the COPM. However, we found a significant effect in favour of the intervention group at exertion when performing an individually chosen activity, and in the activity dimension of St George's Respiratory Questionnaire. A total of 595 occupational problems were reported, most frequently within mobility, active recreation, and household management. Conclusions The results show that, compared with the usual care, individualized occupational therapy did not improve occupational performance or satisfaction with performance. Small but significant changes in activity performance in favour of the intervention group were found in some of the secondary outcomes.
Full Text Available Abstract Background The purpose of this study was to assess whether planning and problem-solving training is more effective in improving functional capacity in patients with schizophrenia than a training program addressing basic cognitive functions. Methods Eighty-nine patients with schizophrenia were randomly assigned either to a computer assisted training of planning and problem-solving or a training of basic cognition. Outcome variables included planning and problem-solving ability as well as functional capacity, which represents a proxy measure for functional outcome. Results Planning and problem-solving training improved one measure of planning and problem-solving more strongly than basic cognition training, while two other measures of planning did not show a differential effect. Participants in both groups improved over time in functional capacity. There was no differential effect of the interventions on functional capacity. Conclusion A differential effect of targeting specific cognitive functions on functional capacity could not be established. Small differences on cognitive outcome variables indicate a potential for differential effects. This will have to be addressed in further research including longer treatment programs and other settings. Trial registration ClinicalTrials.gov NCT00507988
Full Text Available Background: Although evidences emphasize on the importance of aftercare programs to achieve continuity of care, different studies have revealed controversial results about the outcome. The objective of this study was to investigate the effect of aftercare program on outcome measures of patients with severe mental disorders. Materials and Methods: Of a total 123 eligible patients with severe mental disorders, 61 patients were randomly assigned to the intervention group and 62 patients to the control group. The interventions included follow-up phone calls, home visits, and psychoeducation for families. Assessments were performed on hospital admission, discharge and the following 3 rd , 6 th and 12 th month. Young Mania Rating Scale (YMRS, Hamilton Depression Rating Scale (HDRS, Positive and Negative Syndrome Scale (PANSS, Global Assessment of Functioning (GAF, Clinical Global Impression (CGI, and the World Health Organization Quality of Life Questionnaire (WHO-QOL were used. Data were analyzed through Chi square, t-test, Mann-Whitney-U, and Repeated Measures Analysis of Co-Variance. Results: Mean of the HDRS scores revealed significant difference between the two groups when HDRS scores on the admission day were controlled (P = 0.028. The level of functioning was significantly different between the two groups based on the sequential assessments of GAF (P = 0.040. One year after the onset of trial, the number of psychiatric readmissions were significantly different between the two groups (P = 0.036. Conclusion: Readmission rates could be reduced by aftercare services, through the first year, after discharge of patients with severe mental disorders. On the other hand, higher levels of functioning would be expected after one year.
Sugano, Nobuhiro; Aoyama, Toru; Sato, Tsutomu; Kamiya, Mariko; Amano, Shinya; Yamamoto, Naoto; Nagashima, Takuya; Ishikawa, Yoshihiro; Masudo, Katsuhiko; Taguri, Masataka; Yamanaka, Takeharu; Yamamoto, Yuji; Matsukawa, Hiroshi; Shiraisi, Ryuji; Oshima, Takashi; Yukawa, Norio; Rino, Yasushi; Masuda, Munetaka
The present study evaluated the efficacy and safety of TJ-54 (Yokukansan; a traditional Japanese medicine) for the prevention and/or treatment of postoperative delirium in a randomized phase II trial of patients receiving surgery for gastrointestinal and lung malignancies. Patients ≥70 years of age who underwent surgery for gastrointestinal or lung malignancy were eligible for participation in the study. The 186 eligible patients were randomly assigned at a 1:1 ratio to receive TJ-54 or control during their peri-operative care (between 7 days prior to surgery and 4 days following surgery, except for the operation day). The signs and symptoms of delirium were assessed using the Diagnostic and Statistical Manual of Mental Disorders-IV by the investigator during the peri-operative period. A total of 186 eligible gastrointestinal or lung malignancy patients were analyzed (93, TJ-54; 93, control). There were no marked differences between the two randomized groups. The incidence of delirium was 6.5% (6 patients) in the TJ-54 group and 9.7% (9 patients) in the control group, with no significant difference (P=0.419). However, of the patients categorized with a mini-mental state examination (MMSE) score of ≤26, the incidence of postoperative delirium was 9.1% in the TJ-54 group and 26.9% in the control group [risk ratio, 0.338; 95% confidence interval (0.078-1.462), P=0.115]. Treatment with TJ-54 reduced the incidence of postoperative delirium compared with the control group. Although TJ-54 did not demonstrate any contribution to preventing or treating postoperative delirium in patients following surgery for gastrointestinal or lung malignancy, TJ-54 reduced the risk of postoperative delirium in the patients who were classified as MMSE ≤26. Further phase III studies with a larger sample size are required in order to clarify the effects of TJ-54 against postoperative delirium.
Ho, Te-Wei; Huang, Chun-Ta; Chiu, Herng-Chia; Ruan, Sheng-Yuan; Tsai, Yi-Ju; Yu, Chong-Jen; Lai, Feipei
Chronic obstructive pulmonary disease (COPD) is the leading cause of death worldwide, and poses a substantial economic and social burden. Telemonitoring has been proposed as a solution to this growing problem, but its impact on patient outcome is equivocal. This randomized controlled trial aimed to investigate effectiveness of telemonitoring in improving COPD patient outcome. In total, 106 subjects were randomly assigned to the telemonitoring (n = 53) or usual care (n = 53) group. During the two months following discharge, telemonitoring group patients had to report their symptoms daily using an electronic diary. The primary outcome measure was time to first re-admission for COPD exacerbation within six months of discharge. During the follow-up period, time to first re-admission for COPD exacerbation was significantly increased in the telemonitoring group than in the usual care group (p = 0.026). Telemonitoring was also associated with a reduced number of all-cause re-admissions (0.23 vs. 0.68/patient; p = 0.002) and emergency room visits (0.36 vs. 0.91/patient; p = 0.006). In conclusion, telemonitoring intervention was associated with improved outcomes among COPD patients admitted for exacerbation in a country characterized by a small territory and high accessibility to medical services. The findings are encouraging and add further support to implementation of telemonitoring as part of COPD care.
Hasanpour Dehkordi, Ali
Multiple sclerosis (MS) is an autoimmune disease involving brain and spinal cord. Weakness, cognitive impairment, pain, depression and fatigue, as common symptoms of MS, may significantly affect on general health of MS patients. This study aimed to investigate the influence of yoga and aerobic exercise on fatigue, pain, and psychosocial status among these patients. In a randomized clinical trial study on 90 patients whom were randomly assigned to three equal groups of yoga exercises, aerobics exercises, and control group. The exercise program was performed as three sessions per week for 12 weeks. The exercise program included 40 minutes, including 5-10 minutes for warm-up, 25-30 minutes of exercise (walking), and 5 minutes for cooling down. Yoga exercises were scheduled three sessions a week for 12 weeks as well. There was no significant difference in fatigue, pain severity and psychological status among three groups prior to the study, but after the study, in yoga and exercise groups, fatigue physical function, physical and emotional role which patients play throughout daily life, social function, energy, mental status and overall hygiene increased, and the pain and fatigue were relieved in the patients. Yoga and aerobics exercise could decrease some of the MS symptoms, therapeutic costs, hospital stay, and days lost from work as well as increasing the patients' efficiency.
Rouzé, Anahita; Loridant, Séverine; Poissy, Julien; Dervaux, Benoit; Sendid, Boualem; Cornu, Marjorie; Nseir, Saad
The aim of this study was to determine the impact of a biomarker-based strategy on early discontinuation of empirical antifungal treatment. Prospective randomized controlled single-center unblinded study, performed in a mixed ICU. A total of 110 patients were randomly assigned to a strategy in which empirical antifungal treatment duration was determined by (1,3)-β-D-glucan, mannan, and anti-mannan serum assays, performed on day 0 and day 4; or to a routine care strategy, based on international guidelines, which recommend 14 days of treatment. In the biomarker group, early stop recommendation was determined using an algorithm based on the results of biomarkers. The primary outcome was the percentage of survivors discontinuing empirical antifungal treatment early, defined as a discontinuation strictly before day 7. A total of 109 patients were analyzed (one patient withdraw consent). Empirical antifungal treatment was discontinued early in 29 out of 54 patients in the biomarker strategy group, compared with one patient out of 55 in the routine strategy group [54% vs 2%, p empirical antifungal treatment among critically ill patients with suspected invasive Candida infection. These results confirm previous findings suggesting that early discontinuation of empirical antifungal treatment had no negative impact on outcome. However, further studies are needed to confirm the safety of this strategy. This trial was registered at ClinicalTrials.gov, NCT02154178.
National Oceanic and Atmospheric Administration, Department of Commerce — 4"x6" index cards represent the first written assignments of Weather Bureau Army Navy (WBAN) station identifier numbers by the National Climatic Data Center....
Post, Robert E.; Johnson, Jack E.
Presents two assignments that show (1) how George Orwell's "Politics and the English Language" can be applied to business writing and (2) how structured student-teacher conferences can generate enthusiasm for oral expression in a business communication course. (AEA)
Aline Bassoli Gomiero
Full Text Available ABSTRACT BACKGROUND: Osteoarthritis of the knee is defined as a progressive disease of the synovial joints and is characterized by failure of joint damage repair. The objective here was to compare the effectiveness of sensory-motor training versus resistance training among patients with knee osteoarthritis. DESIGN AND SETTING: Randomized, single-blinded controlled trial conducted at the outpatient service of the University of Santo Amaro. METHODS: A total of 64 patients were randomly assigned to sensory-motor training or resistance training. The evaluations were performed at baseline and 16 weeks after the intervention and included pain evaluation on a visual analogue scale, isometric quadriceps femoris force measurement using a dynamometer, Timed Up and Go test, Tinetti balance scale, Western Ontario and McMaster Universities osteoarthritis index, and the SF-36 quality-of-life questionnaire. Data analysis was performed using analysis of variance with repeated measurements and Cohen’s effect size. RESULTS: Sensory-motor training may be a plausible alternative and showed a small effect on pain and a medium effect on maximal voluntary isometric contraction. Resistance training showed a small effect on balance and a medium effect on mobility. CONCLUSION: Resistance training and sensory motor training for the lower limbs among patients with knee osteoarthritis seemed to present similar effects on pain and function. However, because there was a considerable risk of type 2 error, further randomized clinical trials are still needed to provide a sound conclusion.
Kotooka, Norihiko; Kitakaze, Masafumi; Nagashima, Kengo; Asaka, Machiko; Kinugasa, Yoshiharu; Nochioka, Kotaro; Mizuno, Atsushi; Nagatomo, Daisuke; Mine, Daigo; Yamada, Yoko; Kuratomi, Akiko; Okada, Norihiro; Fujimatsu, Daisuke; Kuwahata, So; Toyoda, Shigeru; Hirotani, Shin-Ichi; Komori, Takahiro; Eguchi, Kazuo; Kario, Kazuomi; Inomata, Takayuki; Sugi, Kaoru; Yamamoto, Kazuhiro; Tsutsui, Hiroyuki; Masuyama, Tohru; Shimokawa, Hiroaki; Momomura, Shin-Ichi; Seino, Yoshihiko; Sato, Yasunori; Inoue, Teruo; Node, Koichi
Home telemonitoring is becoming more important to home medical care for patients with heart failure. Since there are no data on home telemonitoring for Japanese patients with heart failure, we investigated its effect on cardiovascular outcomes. The HOMES-HF study was the first multicenter, open-label, randomized, controlled trial (RCT) to elucidate the effectiveness of home telemonitoring of physiological data, such as body weight, blood pressure, and pulse rate, for Japanese patients with heart failure (UMIN Clinical Trials Registry 000006839). The primary end-point was a composite of all-cause death or rehospitalization due to worsening heart failure. We analyzed 181 recently hospitalized patients with heart failure who were randomly assigned to a telemonitoring group (n = 90) or a usual care group (n = 91). The mean follow-up period was 15 (range 0-31) months. There was no statistically significant difference in the primary end-point between groups [hazard ratio (HR), 0.95; 95% confidence interval (CI), 0.548-1.648; p = 0.572]. Home telemonitoring for Japanese patients with heart failure was feasible; however, beneficial effects in addition to those of usual care were not demonstrated. Further investigation of more patients with severe heart failure, participation of home medical care providers, and use of a more integrated home telemonitoring system emphasizing communication as well as monitoring of symptoms and physiological data are required.
Kooistra, Bauke W; Dijkman, Bernadette G; Guyatt, Gordon H; Sprague, Sheila; Tornetta, Paul; Bhandari, Mohit
To compare the accuracy of estimates of potential recruitment from a prospective 8-week screening study compared with a retrospective chart review across sites participating in two fracture management trials. During the planning phase of two large, multicenter, randomized controlled fracture management trials, 74 clinical sites provided estimates of the annual recruitment rate both retrospectively (based on chart reviews) and prospectively. The prospective estimate was generated by screening, for 8 weeks, all incoming patients for eligibility in the concerning trial, without actually enrolling any patient. We compared these prospective and retrospective estimates with one another (for 74 sites in the two trials) and with actual 1-year recruitment rates in the definitive trial (for nine sites in one trial). There was a median difference of four patients (interquartile range: -14 to 18 patients; P=0.89) between a center's prospective estimate and its retrospective estimate. Both predictions were overestimations of recruitment in the definitive trial; only 31% (95% confidence interval [CI]: 28, 35) of retrospectively estimated patients, and 31% (95% CI: 27, 35) of prospectively estimated patients were recruited in the definitive trials. Compared with relatively simple chart reviews, prospectively screening for eligible patients at clinical sites, which is associated with substantial costs, did not result in more accurate predictions of accrual in large, multicenter, randomized controlled trials. Copyright © 2011 Elsevier Inc. All rights reserved.
Akkurt, Halil; Karapolat, Hale U; Kirazli, Yesim; Kose, Timur
Immobility and secondary complications, including cardiopulmonary disease, pressure ulcers, and pain, occur in patients with spinal cord injury (SCI). These patients also have difficulty coping with the strain of daily activities. Thus, it is important for SCI patients to engage in aerobic exercise in order to be able to cope adequately with the strain of activities and SCI-related complications. The aim of this study was to investigate the effects of arm aerobic exercise on the parameters of cardiopulmonary function, quality of life, degree of disability, psychological state, and metabolic syndrome. This study was a single blind, randomized, controlled trial. This study was conducted in a university hospital. SCI patients were randomly assigned to an intervention group (N.=17) or a control group (N.=16). Arm ergometer exercises (three days/week; 1.5 hours/week 50-70% pVO2) and general exercises (two sessions/day; 5 days/week), were assigned to the intervention group for 12 weeks. The control group was assigned general exercises only during this trial. Before the rehabilitation (Week 0), after six weeks, and after the rehabilitation (Week 12), all patients were evaluated for functional status (maximal oxygen uptake [pVO2], power output [PO], and Functional Independence Measurement), pulmonary function (FEV1%, FVC%, FEV1/FVC%), quality of life (World Health Organization Measure of Quality of Life, short form, Turkish version), metabolic syndrome parameters (triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, fasting blood sugar, waist circumference, and systolic and diastolic blood pressure), degree of disability (Craig Handicap Assessment and Reporting Technique, short form), and psychological status (Center for Epidemiologic Studies Depression Scale and Hospital Anxiety and Depression Scale). At the end of the study, increases of 39.6% and 45.4% in the pVO2 and PO levels, respectively, were found
Román, Miguel; Larraz, Concepción; Gómez, Amalia; Ripoll, Joana; Mir, Isabel; Miranda, Eduardo Z; Macho, Ana; Thomas, Vicenç; Esteva, Magdalena
Pulmonary Rehabilitation for moderate Chronic Obstructive Pulmonary Disease in primary care could improve patients' quality of life. This study aimed to assess the efficacy of a 3-month Pulmonary Rehabilitation (PR) program with a further 9 months of maintenance (RHBM group) compared with both PR for 3 months without further maintenance (RHB group) and usual care in improving the quality of life of patients with moderate COPD.We conducted a parallel-group, randomized clinical trial in Majorca primary health care in which 97 patients with moderate COPD were assigned to the 3 groups. Health outcomes were quality of life, exercise capacity, pulmonary function and exacerbations. We found statistically and clinically significant differences in the three groups at 3 months in the emotion dimension (0.53; 95%CI0.06-1.01) in the usual care group, (0.72; 95%CI0.26-1.18) the RHB group (0.87; 95%CI 0.44-1.30) and the RHBM group as well as in fatigue (0.47; 95%CI 0.17-0.78) in the RHBM group. After 1 year, these differences favored the long-term rehabilitation group in the domains of fatigue (0.56; 95%CI 0.22-0.91), mastery (0.79; 95%CI 0.03-1.55) and emotion (0.75; 95%CI 0.17-1.33). Between-group analysis only showed statistically and clinically significant differences between the RHB group and control group in the dyspnea dimension (0.79 95%CI 0.05-1.52). No differences were found for exacerbations, pulmonary function or exercise capacity. We found that patients with moderate COPD and low level of impairment did not show meaningful changes in QoL, exercise tolerance, pulmonary function or exacerbation after a one-year, community based rehabilitation program. However, long-term improvements in the emotional, fatigue and mastery dimensions (within intervention groups) were identified. ISRCTN94514482.
Rahmani, Farnaz; Ebrahimi, Hossein; Ranjbar, Fatemeh; Razavi, Seyed Sajjad; Asghari, Elnaz
Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS) before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.
Natour, Jamil; Cazotti, Luciana de Araujo; Ribeiro, Luiza Helena; Baptista, Andréia Salvador; Jones, Anamaria
To assess the effectiveness of pilates method on patients with chronic non-specific low back pain (LBP). A randomized controlled trial was carried out in sixty patients with a diagnosis of chronic non-specific LBP. Patients were randomly assigned to one of two groups: Experimental Group (EG) that maintained medication treatment with use of NSAID and underwent treatment with the pilates method and Control Group (CG) that continue medication treatment with use of NSAID and did not undergo any other intervention. A blinded assessor performed all evaluations at baseline (T0), after 45, 90, and 180 days (T45, T90 and T180) for: pain (VAS), function (Roland Morris questionnaire), quality of life (SF-36), satisfaction with treatment (Likert scale), flexibility (sit and reach test) and NSAID intake. The groups were homogeneous at baseline. Statistical differences favoring the EG were found with regard to pain (P pain (P pain medication at T45, T90 and T180 (P pilates method can be used by patients with LBP to improve pain, function and aspects related to quality of life (functional capacity, pain and vitality). Moreover, this method has no harmful effects on such patients. © The Author(s) 2014.
Hashemi, Sayyed Hossein; Hajbagheri, Ali; Aghajani, Mohammad
Restless leg syndrome (RLS) is a common problem in patients with chronic renal failure. It can reduce the quality of life and sleep disturbances. This disorder is usually treated pharmacologically. Recently, complementary medicine methods have been suggested because of chemical drugs adverse effects. There is not enough evidence about the effect of aromatherapy on RLS. The aim of this study was to determine the effects of massage with lavender oil on RLS symptoms in hemodialysis patients. This randomized clinical trial study included 70 hemodialysis patients with RLS that were randomly assigned into two groups in 2014. The experimental group received effleurage massage using lavender oil and control group received routine care for three weeks. Data was collected with RLS questionnaire and analyzed using independent and paired t-test and Chi-square test. The mean RLS scores were not significantly different in the two groups at the start of study (22.41 ± 7.67 vs. 22.90 ± 4.38, P = 0.76). At the end of study, the mean RLS score significantly decreased in the intervention group, while this score remained relatively un-changed in the control group (12.41 ± 5.49 vs. 23.23 ± 4.52, P < 0.0001). Lavender oil massage was effective to improve RLS in hemodialysis patients. It has no adverse effects, is practical and cost-effective. It is suggested to be used along with routine treatment of RLS in hemodialysis patients.
Liao, Juan; Wu, Yu; Zhao, Yang; Zhao, Yuan-Chen; Zhang, Xu; Zhao, Nan; Lee, Chun-Ging; Yang, Yu-Fei
To evaluate the effects of progressive muscle relaxation training (PMRT) combined with fifive elements music therapy of Chinese medicine (CM) for improving anxiety and depression of cancer patients. From June 2015 to March 2016, 60 cancer patients were included into the study. The patients were randomly assigned to a control group and a treatment group by envelope randomization, receiving PMRT and PMRT plus CM five elements music therapy, respectively, for 8 weeks. Hospital Anxiety and Depression Scale (HADS), Benefit Finding Scales (BFS), Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp), and Intervention Expectations Questionnaire (IEQU) were adopted to assess the depression of the two groups before and after the treatment. Four cases dropped out during the study, and 29 cases in the treatment group and 27 in the control group were included in the fifinal analysis. Prior to the treatments, the baselines of the 4 questionnaires in the two groups showed no difference. After the 8-week treatment, the treatment group presented better levels of HADS, BFS and FACIT-Sp scores compared with the control group (Pmusic therapy mitigated anxiety and depression of cancer patients. Cancer patients have been found to respond well to psychological intervention in areas regarding stabilisation of emotions, disease awareness, and therapeutic compliance. This brings about a great difference in improving their quality of life and psychological state, offers an effective approach to better self-management in cancer treatment.
Full Text Available Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.
Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid
This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P scores of physiologic measures between groups before and after music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach.
Full Text Available An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53±12 years were included. General stress level (measured using Perceived Stress Scale (PSS, burnout (Shirom-Melamed Burnout Questionnaire (SMBQ, anxiety and depression (Hospital Anxiety and Depression Scale (HADS, insomnia severity (Insomnia Severity Index (ISI, pain (visual analogue scale (VAS, and overall health status (Euro Quality of Life VAS (EQ-VAS were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P<0.000, anxiety (P<0.019, and overall health status (P<0.018 compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care.
Kalter-Leibovici, Ofra; Freimark, Dov; Freedman, Laurence S; Kaufman, Galit; Ziv, Arnona; Murad, Havi; Benderly, Michal; Silverman, Barbara G; Friedman, Nurit; Cukierman-Yaffe, Tali; Asher, Elad; Grupper, Avishay; Goldman, Dorit; Amitai, Miriam; Matetzky, Shlomi; Shani, Mordechai; Silber, Haim
The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems. This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies. In this multicenter open-label trial, 1,360 patients recruited after hospitalization for heart failure exacerbation (38%) or from the community (62%) were randomly assigned to either disease management or usual care. Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists. The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause. Secondary endpoints included the number of all hospital admissions, health-related quality of life and depression during follow-up. Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center. During the follow-up, 388 (56.9%) patients assigned to disease management and 387 (57.1%) assigned to usual care had a primary endpoint event. The median (range) time elapsed until the primary endpoint event or end of study was 2.0 (0-5.0) years among patients assigned to disease management, and 1.8 (0-5.0) years among patients assigned to usual care (adjusted hazard ratio, 0.908; 95% confidence interval, 0.788 to 1.047). Hospital admissions were mostly (70%) unrelated to heart failure. Patients assigned to disease management had a better
Mouthaan, Joanne; Sijbrandij, Marit; de Vries, Giel-Jan; Reitsma, Johannes B; van de Schoot, Rens; Goslings, J Carel; Luitse, Jan S K; Bakker, Fred C; Gersons, Berthold P R; Olff, Miranda
Posttraumatic stress disorder (PTSD) develops in 10-20% of injury patients. We developed a novel, self-guided Internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT) to prevent the onset of PTSD symptoms. To determine whether Trauma TIPS is effective in preventing the onset of PTSD symptoms in injury patients. Adult, level 1 trauma center patients were randomly assigned to receive the fully automated Trauma TIPS Internet intervention (n=151) or to receive no early intervention (n=149). Trauma TIPS consisted of psychoeducation, in vivo exposure, and stress management techniques. Both groups were free to use care as usual (nonprotocolized talks with hospital staff). PTSD symptom severity was assessed at 1, 3, 6, and 12 months post injury with a clinical interview (Clinician-Administered PTSD Scale) by blinded trained interviewers and self-report instrument (Impact of Event Scale-Revised). Secondary outcomes were acute anxiety and arousal (assessed online), self-reported depressive and anxiety symptoms (Hospital Anxiety and Depression Scale), and mental health care utilization. Intervention usage was documented. The mean number of intervention logins was 1.7, SD 2.5, median 1, interquartile range (IQR) 1-2. Thirty-four patients in the intervention group did not log in (22.5%), 63 (41.7%) logged in once, and 54 (35.8%) logged in multiple times (mean 3.6, SD 3.5, median 3, IQR 2-4). On clinician-assessed and self-reported PTSD symptoms, both the intervention and control group showed a significant decrease over time (PTrauma TIPS Internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Moreover, uptake was relatively low since one-fifth of individuals did not log in to the intervention. Future research should therefore focus on innovative strategies to increase intervention usage, for example, adding gameplay, embedding it in a blended care context, and
Full Text Available We report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure.This was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment, or no hemoperfusion (control. Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7.97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15. Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7% compared to the control group (26.0%; p = 0.039. The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9% when compared to the control group (16.3%. After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19.In this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation.
Schädler, Dirk; Pausch, Christine; Heise, Daniel; Meier-Hellmann, Andreas; Brederlau, Jörg; Weiler, Norbert; Marx, Gernot; Putensen, Christian; Spies, Claudia; Jörres, Achim; Quintel, Michael; Engel, Christoph; Kellum, John A; Kuhlmann, Martin K
We report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure. This was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment), or no hemoperfusion (control). Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7. 97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15). Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7%) compared to the control group (26.0%; p = 0.039). The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9%) when compared to the control group (16.3%). After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19). In this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation.
Obling, Sine Roelsgaard; Wilson, Benedicte Vibjerg; Pfeiffer, Per
Objective: Preventing loss of muscle mass and function is an enduring challenge in malnourished patients with incurable cancer. The benefit of supplemental home parenteral nutrition has not been firmly established. Our aim was to evaluate the effects of supplemental home parenteral nutrition......, the primary endpoint being fat free mass (FFM) and secondary: muscle function, quality of life and overall survival. Design and methods: In a single centre open-label randomised controlled trial, patients with incurable gastrointestinal cancer, nutritionally at risk, were randomly assigned to either; a) best...... practice nutritional care and dietetic counselling (non-sHPN) or b) dietetic counselling and supplemental home parenteral nutrition (sHPN group). Treatment duration was 24 weeks with visits every six weeks for five scheduled visits.Main outcome was gain in bioelectrical impedance analyses (BIA) estimated...
Ali Hassanpour Dehkordi
Full Text Available Background: Multiple sclerosis (MS is a common disease of central nervous system (CNS that causes sensorimotor complications through demyelination of CNS neurons. This study was aimed to evaluate the effects of aerobic exercise and yoga on the fatigue and general health of patients with multiple sclerosis. Methods: In this clinical trial, the samples were randomly assigned to three groups of yoga (n: 30, aerobics exercises (n: 30, and control group (n: 30. The data were analyzed by SPSS software using descriptive statistics (mean and standard deviation, ANOVA and independent and pair t-test. Results: The results indicated no significant difference in fatigue and general health among the three groups prior to the study, but after the study, the results showed a significant difference in general health and fatigue in yoga and aerobic exercise groups. Conclusion: Yoga and aerobics exercise decreased the fatigue, promoted the general health, and improved the psychological performance and efficiency of MS patients.
Tramontano, Marco; Shofany, Jacob; Iemma, Antonella; Musicco, Massimo; Paolucci, Stefano; Caltagirone, Carlo
The video game-based therapy emerged as a potential valid tool in improving balance in several neurological conditions with controversial results, whereas little information is available regarding the use of this therapy in subacute stroke patients. The aim of this study was to investigate the efficacy of balance training using video game-based intervention on functional balance and disability in individuals with hemiparesis due to stroke in subacute phase. Fifty adult stroke patients participated to the study: 25 subjects were randomly assigned to balance training with Wii Fit, and the other 25 subjects were assigned to usual balance therapy. Both groups were also treated with conventional physical therapy (40 min 2 times/day). The main outcome was functional balance (Berg Balance Scale-BBS), and secondary outcomes were disability (Barthel Index-BI), walking ability (Functional Ambulation Category), and walking speed (10-meters walking test). Wii Fit training was more effective than usual balance therapy in improving balance (BBS: 53 versus 48, P = 0.004) and independency in activity of daily living (BI: 98 versus 93, P = 0.021). A balance training performed with a Wii Fit as an add on to the conventional therapy was found to be more effective than conventional therapy alone in improving balance and reducing disability in patients with subacute stroke. PMID:24877116
Zortea, Karine; Franco, Viviane C; Guimarães, Paula; Belmonte-de-Abreu, Paulo S
Schizophrenia (SZ) is associated with psychotic experiences and cognitive deficits. Therefore, cognitive function is one of the most critical determinants of quality of life in this pathology. Resveratrol has been related to neuroprotective action, but there are no studies evaluating resveratrol in SZ. The objective of this study was to determine the efficacy of resveratrol supplementation on cognition in individuals with SZ. This is a 1-month randomized, double-blind, and controlled trial (NCT 02062190), in which 19 men with diagnosis of SZ, aged 18-65 years, were assigned to a resveratrol supplementation group (200 mg) or placebo group (200 mg), with a 1-month follow-up. Applying a series of cognitive tests assessed neuropsychology performance (Hopkins Verbal Learning Test, Stroop Color and Word Test, and Weschler Adult Intelligence Scale) and Brief Psychiatric Rating Scale assessed psychopathology severity. There were no significant improvement in neuropsychology performance (episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention, and mental flexibility) and psychopathology severity after 1 month of resveratrol supplementation (P > 0.05). In conclusion, we have shown that 1 month of a resveratrol supplementation (200 mg/day) did not improve episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention, and mental flexibility as compared with placebo in patients with SZ.
Full Text Available Background: Schizophrenia is associated with psychotic experiences and cognitive deficits. Therefore, cognitive function is one of the most critical determinants of quality of life in this pathology. Resveratrol has been related with neuroprotective action but there are no studies evaluating resveratrol in schizophrenia. The objective of this study was to determine the efficacy of resveratrol supplementation on cognition in individuals with schizophrenia. Methods: This is a 1-month randomized, double-blind controlled trial (NCT 02062190, in which 19 men with diagnosis of schizophrenia, aged 18 to 65 years, were assigned to a resveratrol supplement group (200mg or placebo group (200mg, with a 1-month follow-up. Applying a series of cognitive tests assessed neuropsychology performance (Hopkins Verbal Learning Test, Stroop Color and Word Test, Weschler Adult Intelligence Scale and Brief Psychiatric Rating Scale assessed psychopathology severity. Results: There were no significant improvement in neuropsychology performance (episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention and mental flexibility and psychopathology severity after 1-month of resveratrol supplementation (p>0.05. Conclusion: In conclusion, we have shown that 1-month of a resveratrol supplementation (200 mg/day did not improve episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention and mental flexibility as compared with placebo in patients with schizophrenia.
Lones, Carrie E; Bond, Gary R; McGovern, Mark P; Carr, Kathryn; Leckron-Myers, Teresa; Hartnett, Tim; Becker, Deborah R
Individual Placement and Support (IPS) is an evidence-based employment model for people with severe mental illness, but it has not been evaluated for clients enrolled in substance abuse treatment programs. This study evaluated the effectiveness of IPS for people with opioid use disorders enrolled in an opioid treatment program. Within a randomized controlled experiment, 45 patients receiving methadone maintenance therapy were assigned to either IPS or a 6-month waitlist. The waitlist group received IPS after 6 months. The primary outcome assessed over 1 year compared the attainment of a job for the IPS condition to the waitlist comparison group. During the first 6 months after enrollment, 11 (50%) active IPS participants gained competitive employment compared to 1 (5%) waitlist participant (Χ (2) = 12.0, p IPS participants gained competitive employment compared to 5 (22%) waitlist participants (Χ (2) = 3.92, p = 0.07). We conclude that IPS holds promise as an employment intervention for people with opioid use disorders in methadone maintenance treatment, but larger trials with longer follow-up are needed.
Bucci, Paola; Piegari, Giuseppe; Mucci, Armida; Merlotti, Eleonora; Chieffi, Marcello; De Riso, Francesco; De Angelis, Maria; Di Munzio, Walter; Galderisi, Silvana
Rehabilitation programs integrating cognitive remediation (CR) and psychosocial rehabilitation are often implemented as they seem to yield greater improvements in functional outcome than stand alone treatment approaches. Mechanisms underlying synergistic effects of combining CR with psychosocial interventions are not fully understood. Disentangling the relative contribution of each component of integrated programs might improve understanding of underlying mechanisms. In the present study we compared the efficacy of two components of our rehabilitation program [the Neurocognitive Individualized Training (NIT) and the Social Skills Individualized Training (SSIT)]. Seventy-two patients with schizophrenia or schizoaffective disorder were randomly assigned to one of two treatment groups. Changes in cognitive, psychopathological and real-world functioning indices after 6 and 12 months were compared between the two groups. After both 6 and 12 months, NIT produced an improvement of attention, verbal memory and perseverative aspects of executive functioning, while SSIT produced a worsening of visuo-spatial memory and attention and no significant effect on the other cognitive domains. As to the real-world functioning, NIT produced a significant improvement of interpersonal relationships, while SSIT yielded a significant improvement of QLS instrumental role subscale. According to our findings, cognitive training is more effective than social skills training on several cognitive domains and indices of real-world functioning relevant to subject's relationships with other people. Integrated approaches might target different areas of functional impairment but should be planned carefully and individually to fully exploit the synergistic potential. © 2013.
Mittal, N; Goyal, A; Gauba, K; Kapur, A; Jain, K
To find out the safe and efficient sedative agent for primary molar pulpectomy in uncooperative pediatric patients. This double blind randomized trial enrolled 40 anxious and healthy 2-6 year olds. All subjects received IV propofol (1-1.5 mg/kg) or ketofol (1-1.5 mg/kg propofol with 0.25 mg/kg ketamine) as per group assignment after oral midazolam premedication (0.5 mg/kg). Sedation maintenance was done with propofol infusion at 25-75 microg/kg/min titrated to a predefined Worse level as per Houpt's sedation rating scale. Additional bolus/es was/were administered in the dosage similar to induction dose in case of inadequate sedation. Primary outcomes were intraoperative and postoperative adverse events. Secondary outcomes were vital signs, success of procedure, operator satisfaction, sedation quality, treatment time, recovery time and total propofol dose. Significantly greater incidence of respiratory depression was reported for ketofol group (11/20; 55%) when compared to propofol group (3/20; 15%) (p = 0.008). Desaturation was the most common adverse respiratory event with significantly greater incidence in ketofol group (9/20; 45%) when compared to propofol only group (3/20; 15%) (p = 0.033). No significant differences regarding secondary outcomes were reported in two groups. Both the regimen exhibited similar sedation profile while propofol alone emerged as a safer option.
Snyder, Brad; Wilson, Erik; Wilson, Todd; Mehta, Sheilendra; Bajwa, Kulvinder; Klein, Conniw
The effect of laparoscopic sleeve gastrectomy (SG) on reflux symptoms is unclear. Many surgeons offer SG only to patients with minor or no reflux symptoms, fearing that patients with severe reflux symptoms will experience worsening of their condition after SG. Many also advocate crural repair at the time of SG to prevent de novo or worsening reflux symptoms. These decisions are made without suitable data to form such conclusions. To determine the effect of SG with or without hiatal hernia repair on reflux symptoms. University of Texas Health Sciences Center in Houston. The Gastrointestinal Symptom Rating Scale (GSRS) was administered to 100 consecutive, preoperative SG patients who were then randomly assigned into a crural repair group or nonrepair group in a parallel design. The patients were subsequently followed-up every 3 months for 1 year. We compared reflux symptoms of the 2 groups on the basis of demographic characteristics, body mass index, weight loss, presence and size of hiatal hernia, and GSRS for 12 months. At 1 year, with 78% follow-up, the data demonstrated a significant decrease in the GSRS for both groups (Phiatal hernia size did not correlate with change in the GSRS score. The only variable that affected outcome was the preoperative GSRS. At 12 months, 38% of patients with a preoperative GSRS score less than the median score of the study population experienced worsening of their symptoms compared with only 2% of patients who had a preoperative GSRS score greater than the median. Overall, 19% experienced worsening reflux (5% de novo), 14% had no change, and 66% reported an improvement in symptoms. These data suggest that a crural repair at the time of SG does not significantly reduce reflux symptoms compared with SG alone. Preoperative patients with significant reflux symptoms experienced a more significant improvement in symptoms after surgery compared with those who did not report significant reflux symptoms before surgery. The high incidence of
Full Text Available The article is devoted to the airline scheduling process and methods of its modeling. This article describes the main stages of airline scheduling process (scheduling, fleet assignment, revenue management, operations, their features and interactions. The main part of scheduling process is fleet assignment. The optimal solution of the fleet assignment problem enables airlines to increase their incomes up to 3 % due to quality improving of connections and execution of the planned number of flights operated by less number of aircraft than usual or planned earlier. Fleet assignment of scheduling process is examined and Conventional Leg-Based Fleet Assignment Model is analyzed. Finally strong and weak aspects of the model (SWOT are released and applied. The article gives a critical analysis of FAM model, with the purpose of identi- fying possible options and constraints of its use (for example, in cases of short-term and long-term planning, changing the schedule or replacing the aircraft, as well as possible ways to improve the model.
Schmidt, Maren; Eckardt, Rahel; Scholtz, Kathrin; Neuner, Bruno; von Dossow-Hanfstingl, Vera; Sehouli, Jalid; Stief, Christian G; Wernecke, Klaus-Dieter; Spies, Claudia D
This randomized controlled, clinical prospective interventional trial was aimed at exploring the effect of patient empowerment on short- and long-term outcomes after major oncologic surgery in elderly cancer patients...
de Jong, Kim; Segaar, Jaap; Ingenhoven, Theo; van Busschbach, Jan; Timman, Reinier
This study aimed to evaluate the differential effect of outcome monitoring feedback to therapists and to patients on outcomes in cluster B, cluster C, and personality disorder not otherwise specified (PD-NOS) patients. Day treatment patients (n = 112) and inpatients (n = 94) were randomly assigned to a feedback to therapist (FbT), feedback to therapist and patient (FbTP), or no feedback (NFb) condition. Feedback was based on weekly administrations of the Outcome Questionnaire-45 (OQ-45). In cluster B and PD-NOS patients FbTP resulted in increased OQ-45 scores during the first 6 months of therapy for not on track (NOT) patients. In cluster C patients, no adverse effects of feedback were found. These results suggest that for certain personality disorder patient groups, providing feedback during treatment may not always be beneficial, although more research is needed to further assess these effects.
Davy, Jean-Marc; Hoffmann, Ellen; Frey, Axel; Jocham, Kurt; Rossi, Stefano; Dupuis, Jean-Marc; Frabetti, Lorenzo; Ducloux, Pascale; Prades, Emmanuel; Jauvert, Gaël
SafeR performance versus DDD/automatic mode conversion (DDD/AMC) and DDD with a 250-ms atrioventricular (AV) delay (DDD/LD) modes was assessed toward ventricular pacing (Vp) reduction. After a 1-month run-in phase, recipients of dual-chamber pacemakers without persistent AV block and persistent atrial fibrillation (AF) were randomly assigned to SafeR, DDD/AMC, or DDD/LD in a 1:1:1 design. The main endpoint was the percentage of Vp (%Vp) at 2 months and 1 year after randomization, ascertained from device memories. Secondary endpoints include %Vp at 1 year according to pacing indication and 1-year AF incidence based on automatic mode switch device stored episodes. Among 422 randomized patients (73.2±10.6 years, 50% men, sinus node dysfunction 47.4%, paroxysmal AV block 30.3%, bradycardia-tachycardia syndrome 21.8%), 141 were assigned to SafeR versus 146 to DDD/AMC and 135 to DDD/LD modes. Mean %Vp at 2 months was 3.4±12.6% in SafeR versus 33.6±34.7% and 14.0±26.0% in DDD/AMC and DDD/LD modes, respectively (PDDD/AMC and DDD/LD modes, respectively (PDDD/AMC (15%) and DDD/LD (45%) modes (P30% of the time was 5.4% lower in SafeR than in the DDD pacing group (ns). In this selected patient population, SafeR markedly suppressed unnecessary Vp compared with DDD modes. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.
Mei, Lijuan; Miao, Xing; Chen, Haiying; Huang, Xiufang; Zheng, Guohua
Anxiety is the most common negative emotion among the patients awaiting coronary angiography. The increased anxiety may exacerbate coronary heart disease symptoms and possibly contribute to complications during the procedure. Chinese hand massage is a nonpharmaceutical intervention that has been used in several clinical situations in China and might have beneficial effects on reducing anxiety before coronary angiography. The aim of this study was to evaluate the effectiveness and safety of Chinese hand massage care on anxiety among patients awaiting coronary angiography. One hundred eighty-five subjects awaiting coronary angiography in a single hospital in Fuzhou, China, between May 2012 and September 2012 were screened. One hundred eligible participants were recruited and randomly assigned into the control or Chinese hand massage group. The control group received the conventional therapies and care according to the guidelines, and those in the Chinese hand massage group received additional Chinese hand massage care in conjunction with the same conventional therapies and care as the control group. The anxiety scores (evaluated by using the Hamilton Anxiety Rating Scale), heart rate, blood pressure, quality of life (Short-Form Health Survey), and the adverse events were recorded at the baseline and after coronary angiography, respectively. The scores of Hamilton Anxiety Rating Scale in the Chinese hand massage group (11.78 [SD, 2.9]) had a statistically significant decrease compared with those in the control group (15.96 [SD, 3.4]) at post-procedure (P anxiety without any adverse effects among patients awaiting coronary angiography. Therefore, it might be recommended as a nonpharmacological nursing intervention. However, future study with a larger sample size is needed to further confirm the efficacy of Chinese hand massage intervention.
Ebrahimi, Hossein; Sadeghi, Mahdi; Amanpour, Farzaneh; Vahedi, Hamid
Diabetes education is a major subject in achieving optimal glycemic control. Effective empowerment approach can be beneficial for improving patients' health. The aim of this study was to evaluate the effect of empowerment model on indicators of metabolic control in patients with type 2 diabetes. a randomized controlled trial of 103 patients with type 2 diabetes were randomly assigned to either the intervention (empowerment approach training) or the control group (conventional training) 2014. Empowerment approach training were performed for the experimental group for eight weeks. Data collection tool included demographic information form and indicators of metabolic control checklist. Analysis was performed by one-way analysis of variance, chi-square test, paired t-test, independent t-test and multiple linear regression. Before the intervention, two groups were homogeneous in terms of demographic variables, glycosylated hemoglobin (HbA1C), and other indicators of metabolic control. After the intervention, average HbA1C and other metabolic indicators except for LDL showed significant differences in the experimental group compared to the control group. study results indicated the positive effects of applying the empowerment model on the metabolic control indicators. Therefore, applying this model is recommended to nurses and the relevant authorities in order to improve clinical outcomes in diabetic patients. Copyright © 2015 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
Yang, Wei; Zhou, Yu Jie; Fu, Yan; Qin, Jian; Qin, Shu; Chen, Xiao Min; Guo, Jin Cheng; Wang, De Zhao; Zhan, Hong; Li, Jing; He, Jing Yu; Hua, Qi
Urapidil is putatively effective for patients with hypertension and acute heart failure, although randomized controlled trials thereon are lacking. We investigated the efficacy and safety of intravenous urapidil relative to that of nitroglycerin in older patients with hypertension and heart failure in a randomized controlled trial. Patients (>60 y) with hypertension and heart failure were randomly assigned to receive intravenous urapidil (n=89) or nitroglycerin (n=91) for 7 days. Hemodynamic parameters, cardiac function, and safety outcomes were compared. Patients in the urapidil group had significantly lower mean systolic blood pressure (110.1±6.5 mm Hg) than those given nitroglycerin (126.4±8.1 mm Hg, p=0.022), without changes in heart rate. Urapidil was associated with improved cardiac function as reflected by lower N terminal-pro B type natriuretic peptide after 7 days (3311.4±546.1 ng/mL vs. 4879.1±325.7 ng/mL, p=0.027) and improved left ventricular ejection fraction (62.2±3.4% vs. 51.0±2.4%, p=0.032). Patients given urapidil had fewer associated adverse events, specifically headache (p=0.025) and tachycardia (p=0.004). The one-month rehospitalization and all-cause mortality rates were similar. Intravenous administration of urapidil, compared with nitroglycerin, was associated with better control of blood pressure and preserved cardiac function, as well as fewer adverse events, for elderly patients with hypertension and acute heart failure.
Abdulsalim, Suhaj; Unnikrishnan, Mazhuvancherry Kesavan; Manu, Mohan K; Alrasheedy, Alian A; Godman, Brian; Morisky, Donald E
COPD is characterised by a progressive airflow limitation in the lungs. However, adherence to therapy improves management of symptoms and delays disease progression. Therefore, patients' knowledge and awareness about the disease are important. Hence, pharmacist-led educational interventions could achieve this and improve medication adherence. This study evaluated the effectiveness of a clinical pharmacist-led intervention on medication adherence in COPD patients in a teaching hospital. In an open-labelled randomized controlled study at Kasturba Medical College Hospital, Manipal, India, patients were randomly assigned to two groups (Intervention group [IG] and Control group [CG]), and were matched for socio-demographics and clinical characteristics. Medication adherence was assessed by the Morisky, Green and Levine Medication Adherence Questionnaire (MAQ). In IG, pharmacist intervention placed emphasis on (1) compliance, (2) smoking cessation, (3) exercise, (4) inhaler use and (5) need for timely follow up. The MAQ assessment was repeated at 6, 12, 18 and 24 months. Data were analysed statistically by SPSS version 20.0. Out of 328 patients screened during March 2012 to June 2013, 260 were recruited. Of these, 206 completed the follow-up (98 in CG and 104 in IG). Medication adherence improved significantly after pharmacist intervention in IG at all follow-up time points (P adherence in COPD patients, but was effectively reduced by the intervention. This is the first randomized controlled trial in India that demonstrates the pivotal role of pharmacist-led educational intervention in improving medication adherence in COPD. Involving non-physician health professionals could be the best strategy, for resource-poor nations like India, because the current physician-centric healthcare has no emphasis on patient education and counselling. Copyright © 2017 Elsevier Inc. All rights reserved.
Diéras, Véronique; Fumoleau, Pierre; Romieu, Gilles; Tubiana-Hulin, Michèle; Namer, Moïse; Mauriac, Louis; Guastalla, Jean-Paul; Pujade-Lauraine, Eric; Kerbrat, Pierre; Maillart, Philippe; Pénault-Llorca, Frédérique; Buyse, Marc; Pouillart, Pierre
This randomized, noncomparative, parallel-group study was designed to evaluate the pathologic complete response (pCR) rate of combined doxorubicin plus paclitaxel (AP) and doxorubicin plus cyclophosphamide (AC) as neoadjuvant chemotherapy in patients with previously untreated breast cancer who were unsuitable for conservative surgery. A total of 200 patients with T2-3, N0-1, M0 disease were randomly assigned in a 2:1 ratio to receive preoperative chemotherapy with either doxorubicin 60 mg/m(2) plus paclitaxel 200 mg/m(2) as a 3-hour infusion (AP) or doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) (AC) every 3 weeks for 4 courses followed by surgery. A pCR (eradication of invasive carcinoma in tumor and in axillary lymph nodes) was found in 16% and 10% of patients in the AP and AC arms, respectively, by study center pathologists, and in 8% and 6% of patients, respectively, by independent pathologists. Patients with pCRs tended to have unifocal disease, tumors with negative hormonal receptor status, and less differentiation (Scarff, Bloom, and Richardson scale grade 3). Breast-conserving surgery was performed in 58% and 45% of patients in the AP and AC arms, respectively. An objective clinical response was achieved in 89% of patients in the AP arm and 70% in the AC arm. At a median follow-up of 31 months, disease-free survival (DFS) was higher in patients who reached pCR versus those without pCR (91% v 70%). The encouraging pathologic and clinical responses of patients with breast cancer after neoadjuvant chemotherapy with doxorubicin plus paclitaxel warrant additional investigation of paclitaxel in the neoadjuvant setting of breast cancer management.
Tibaldi, V; Aimonino, N; Ponzetto, M; Stasi, M F; Amati, D; Raspo, S; Roglia, D; Molaschi, M; Fabris, F
A Geriatric Home Hospitalization Service (GHHS) has been operating in Torino at S. Giovanni Battista Hospital since 1985. GHHS allows us to perform diagnostic and therapeutic interventions, which are usually made in hospital, also at home. GHHS team includes geriatricians, nurses, physiotherapists, social workers and counselors. Between February 1999 and April 2002, the GHH Service conducted a randomized controlled trial on 109 elderly, demented patients requiring admission to the Hospital Emergency Department (ED)for acute illnesses. Objective of the study was to identify the benefits of the care in a GHHScompared to a general medical ward (GMW) in reducing behavioral disturbances in elderly patients with advanced dementia and in lowering caregiver's stress. Patients were randomly assigned to GHHS (56 patients) or to GMW (53 patients). Both groups were examined using the same protocol and were evaluated on admission and on discharge. All patients had a severe form of dementia as shown by the clinical dementia rating (CDR) scale mean value (3.7 +/- 0.9) with an important functional impairment and a relevant degree of comorbidity.The main reasons for hospitalization were infections, cerebrovascular accidents and malnutrition. Mortality of total sample was 19.3 %, without significant differences in the two settings of care. On discharge, in GHHS patients there was a significant reduction of behavioral disturbances. The use of anti-psychotic drugs was significantly lower in GHHS patients compared to the GMW group (p < 0.001). The stress of caregivers on discharge was reduced only in GHHS group and not in the control ones. In conclusion, we can say that a GHHS continuous support allows us to reduce the family caregiver's stress. When treated at home, demented patients do not have to change their environment or routine and it is possible to have a better control on behavioral disturbances.
Meuleman, Yvette; Hoekstra, Tiny; Dekker, Friedo W.; Navis, Gerjan; Vogt, Liffert; van der Boog, Paul J. M.; Bos, Willem Jan W.; van Montfrans, Gert A.; van Dijk, Sandra
Background: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. Study Design: Open randomized controlled trial. Setting & Participants: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.
Kjaersgaard, Annette; Nielsen, Lars Hedemann; Sjölund, Bengt H.
OBJECTIVE: To examine whether patients assessed for initiation of oral intake only by Facial-Oral Tract Therapy had a greater risk of developing aspiration pneumonia during neurorehabilitation than patients assessed by Fibreoptic Endoscopic Evaluation of Swallowing. DESIGN: Randomized controlled ...
Xue, Yangjing; Tao, Luyuan; Wu, Shaoze; Wang, Guoqiang; Qian, Lu; Li, Jiwu; Liao, Lianming; Tang, Jifei; Ji, Kangting
About 10-15% patients who take statins experience skeletal muscle problems. Red yeast rice has a good safety profile could provide a compromise therapeutic strategy. Therefore, the aim of this study was to evaluate the effects of red yeast rice, when compared to simvastatin, on the muscle fatigue symptom and the serum lipid level in dyslipidemic patients with low to moderate cardiovascular risk. A total of 60 dyslipidemic patients with low to moderate cardiovascular risk were recruited and randomly assigned to receive either simvastatin (n = 33) or red yeast rice (n = 27) for 4 weeks. The muscle fatigue score, the physical activity, the serum lipid profile and the safety profile were then evaluated. At the end of study, the fatigue score was significantly increased in patients treated with simvastatin, whereas no significant change was observed in patients receiving red yeast rice. In addition, the physical activity level was significantly decreased in patients from simvastatin group when compared to those from red yeast rice group. Similar lipid-lowering effects were observed in two groups. The safety profile was not affected after the treatments. Among dyslipidemic patients with low to moderate cardiovascular risk, red yeast rice induced less fatigue side effect and exerted comparable lipid-lowering effects when compared to simvastatin in this pilot primary prevention study. NCT01686451 .
Korrelboom, Kees; Maarsingh, Maaike; Huijbrechts, Irma
Self-esteem is a major concern in mood disorders. Low self-esteem is a symptom of depressive disorders and is considered by some to be a predictor for relapse, whereas high self-esteem seems to buffer against depression. Recently, Competitive Memory Training (COMET) has shown to be effective for the enhancement of self-esteem in several psychopathological conditions. The current study assesses whether COMET is also an effective intervention for patients with depressive disorders. Sixty-one patients with depressive disorders who were already in therapy in an outpatient mental health institution were randomly assigned to either eight group sessions of COMET in addition to their regular therapy (COMET + therapy as usual [TAU]: the experimental group) or to 8 weeks of ongoing regular therapy (TAU only: the control group). These latter (control) patients received COMET after their TAU only period. All patients in both groups that completed COMET were contacted 3 and 6 months later to assess whether the effects of COMET had remained stable. Compared to the patients who received TAU only, patients in the COMET + TAU condition showed significant improvement with large effect sizes on indices of self-esteem, depression, and depressive rumination. The therapeutic effects of COMET + TAU remained stable after 3 and 6 months on all outcome measures or improved even further. COMET for low self-esteem seems to be an efficacious trans-diagnostic intervention that can relatively easily be added to the regular treatment of patients with depressive disorders. © 2012 Wiley Periodicals, Inc.
Vallance Jeffrey K
Full Text Available Abstract Background Patient preference for group assignment may affect outcomes in unblinded trials but few studies have attempted to understand such preferences. The purpose of the present study was to examine factors associated with breast cancer patients' preference for two types of exercise training during chemotherapy. Methods Breast cancer patients (N = 242 completed a battery of tests including a questionnaire that assessed patient preference and the theory of planned behavior (TPB prior to being randomized to usual care, resistance exercise training (RET, or aerobic exercise training (AET. Results 99 (40.9% participants preferred RET, 88 (36.4% preferred AET, and 55 (22.7% reported no preference. Past exercisers (p = 0.023, smokers (p = 0.004, and aerobically fitter participants (p = 0.005 were more likely to prefer RET. As hypothesized, participants that preferred AET had more favorable TPB beliefs about AET whereas participants that preferred RET had more favorable TPB beliefs about RET. In multivariate modeling, patient preference for RET versus AET was explained (R2 = .46; p 2 = .48; p Conclusion Breast cancer patients' preference for RET versus AET during chemotherapy was predicted largely by a difference in motivation for each type of exercise which, in turn, was based on differences in their beliefs about the anticipated benefits, enjoyment, and difficulty of performing each type of exercise during chemotherapy. These findings may help explain patient preference effects in unblinded behavioral trials. Trial Registration ClinicalTrials.gov Identifier NCT00115713.
Eckhouse, Diane R; Hurd, Mary; Cotter-Schaufele, Susan; Sulo, Suela; Sokolowski, Malgorzata; Barbour, Laurel
Nonpharmacological interventions, including combinations of music, education, coping skills, and relaxation techniques, have been found to have a positive effect on patients' perceived anxiety in many settings. However, few research studies have assessed and compared the effectiveness of music and relaxation interventions in reducing the anxiety levels of orthopaedic and oncology patients. We conducted a prospective, randomized, controlled study to examine the effectiveness of music and relaxation interventions on perceived anxiety during initial hospitalization for patients receiving orthopaedic or cancer care treatment at a Midwestern teaching hospital. This was a pre-test/post-test study design utilizing the State-Trait Anxiety Inventory. One hundred twelve patients were randomized into 3 study groups. Thirty-eight subjects (34%) were randomized in the music-focused relaxation group, 35 subjects (31%) in the music and video group, and 39 (35%) subjects in the control group. Fifty-seven (51%) were orthopaedic patients and 55 (49%) were oncology patients. Comparison of the 3 study groups showed no statistically significant differences with regard to patients' demographics. Although reduced anxiety levels were reported for all 3 groups postintervention, the differences were not statistically significant (p > .05). Also, there was no significant difference found between the perceived anxiety levels of patients admitted to the orthopaedic and oncology care units (p > .05). Finally, the results of the intragroup comparisons (regardless of the group assignment) showed a significant decrease in anxiety levels reported by all patients postintervention (p management of patient anxiety during hospitalization.
An important task of a manager is to motivate her subordinates. One way in which a manager can give incentives to junior employees is through the assignment of tasks. How a manager allocates tasks in an organization, provides information to the junior employees about his ability. Without coaching
Ponce, D; Berbel, M N; Abrão, J M G; Goes, C R; Balbi, A L
Acute kidney injury (AKI) requiring dialysis in critically ill patients is associated with an in-hospital mortality rate of 50-80 %. Extended daily hemodialysis (EHD) and high volume peritoneal dialysis (HVPD) have emerged as alternative modalities. A double-center, randomized, controlled trial was conducted comparing EHD versus HVPD for the treatment for AKI in the intensive care unit (ICU). Four hundred and seven patients were randomized and 143 patients were analyzed. Principal outcome measure was hospital mortality, and secondary end points were recovery of renal function and metabolic and fluid control. There was no difference between the two groups in relation to median ICU stay [11 (5.7-20) vs. 9 (5.7-19)], recovery of kidney function (26.9 vs. 29.6 %, p = 0.11), need for chronic dialysis (9.7 vs. 6.5 %, p = 0.23), and hospital mortality (63.4 vs. 63.9 %, p = 0.94). The groups were different in metabolic and fluid control. Blood urea nitrogen (BUN), creatinine, and bicarbonate levels were stabilized faster in EHD group than in HVPD group. Delivered Kt/V and ultrafiltration were higher in EHD group. Despite randomization, there were significant differences between the groups in some covariates, including age, pre-dialysis BUN, and creatinine levels, biased in favor of the EHD. Using logistic regression to adjust for the imbalances in group assignment, the odds of death associated with HVPD was 1.4 (95 % CI 0.7-2.4, p = 0.19). A detailed investigation of the randomization process failed to explain the marked differences in patient assignment. Despite faster metabolic control and higher dialysis dose and ultrafiltration with EHD, this study provides no evidence of a survival benefit of EHD compared with HVPD. The limitations of this study were that the results were not presented according to the intention to treat and it did not control other supportive management strategies as nutrition support and timing of dialysis initiation that might influence outcomes in
Guedes de Castro, Douglas; Matiello, Juliana; Roa, Wilson; Ghosh, Sunita; Kepka, Lucyna; Kumar, Narendra; Sinaika, Valery; Lomidze, Darejan; Hentati, Dalenda; Rosenblatt, Eduardo; Fidarova, Elena
To perform a subset analysis of survival outcomes in elderly patients with glioblastoma from a randomized phase 3 trial comparing 2 short-course radiation therapy (RT) regimens in elderly and/or frail patients. The original trial population included elderly and/or frail patients with a diagnosis of glioblastoma. Patients joined the phase 3, randomized, multicenter, prospective, noninferiority trial; were assigned to 1 of 2 groups in a 1:1 ratio, either short-course RT (25 Gy in 5 fractions, arm 1) or commonly used RT (40 Gy in 15 fractions, arm 2); and were stratified by age (elderly and frail patients were defined as patients aged ≥65 years with KPS of 50%-70%; elderly and non-frail patients were defined as patients aged ≥65 years with KPS of 80%-100%); 61 of the 98 initial patients comprised the patient population, with 26 patients randomized to arm 1 and 35 to arm 2. In this unplanned analysis, the short-course RT results were not statistically significantly different from the results of commonly used RT in elderly patients. The median overall survival time was 6.8 months (95% confidence interval [CI], 4.5-9.1 months) in arm 1 and 6.2 months (95% CI, 4.7-7.7 months) in arm 2 (P=.936). The median progression-free survival time was 4.3 months (95% CI, 2.6-5.9 months) in arm 1 and 3.2 months (95% CI, 0.1-6.3 months) in arm 2 (P=.706). A short-course RT regimen of 25 Gy in 5 fractions is an acceptable treatment option for patients aged ≥65 years, mainly those with a poor performance status or contraindication to chemotherapy, which would be indicated in cases of methylated O6 methylguanine-DNA-methyltransferase promoter tumors. Copyright © 2017 Elsevier Inc. All rights reserved.
Mourad, Ghassan; Strömberg, Anna; Jonsbu, Egil; Gustafsson, Mikael; Johansson, Peter; Jaarsma, Tiny
Patients with recurrent episodes of non-cardiac chest pain may experience cardiac anxiety and avoidance behavior, leading to increased healthcare utilization. These patients might benefit from help and support to evaluate the perception and management of their chest pain. The purpose of this study was to test the feasibility of a short guided Internet-delivered cognitive behavioural therapy (CBT) program and explore the effects on cardiac anxiety, fear of body sensations, depressive symptoms, and chest pain in patients with non-cardiac chest pain, compared with usual care. A pilot randomized controlled study was conducted. Fifteen patients with non-cardiac chest pain with cardiac anxiety or fear of body sensations, aged 22-76 years, were randomized to intervention (n = 7) or control (n = 8) groups. The four-session CBT program contained psychoeducation, physical activity, and relaxation. The control group received usual care. Data were collected before and after intervention. Five of seven patients in the intervention group completed the program, which was perceived as user-friendly with comprehensible language, adequate and varied content, and manageable homework assignments. Being guided and supported, patients were empowered and motivated to be active and complete the program. Patients in both intervention and control groups improved with regard to cardiac anxiety, fear of body sensations, and depressive symptoms, but no significant differences were found between the groups. The Internet-delivered CBT program seems feasible for patients with non-cardiac chest pain, but needs to be evaluated in larger groups and with a longer follow-up period. Clinicaltrials.gov NCT02336880 . Registered on 8 January 2015.
Cheng, Steven C; Young, Daniel O; Huang, Yihung; Delmez, James A; Coyne, Daniel W
Niacinamide inhibits intestinal sodium/phosphorus transporters and reduces serum phosphorus in open-label studies. A prospective, randomized, double-blind, placebo-controlled crossover trial was performed for assessment of the safety and efficacy of niacinamide. Hemodialysis patients with phosphorus levels > or =5.0 mg/dl were randomly assigned to 8 wk of niacinamide or placebo, titrated from 500 to 1500 mg/d. After a 2-wk washout period, patients switched to 8 wk of the alternative therapy. Vitamin D analogs and calcimimetics were held constant; phosphorus binders were not changed unless safety criteria were met. Thirty-three patients successfully completed the trial. Serum phosphorus fell significantly from 6.26 to 5.47 mg/dl with niacinamide but not with placebo (5.85 to 5.98 mg/dl). A concurrent fall in calcium-phosphorus product was seen with niacinamide, whereas serum calcium, intact parathyroid hormone, uric acid, platelet, triglyceride, LDL, and total cholesterol levels remained stable in both arms. Serum HDL levels rose with niacinamide (50 to 61 mg/dl but not with placebo. Adverse effects were similar between both groups. Among patients who were > or =80% compliant, results were similar, although the decrease in serum phosphorus with niacinamide was more pronounced (6.45 to 5.28 mg/dl) and the increase in HDL approached significance (49 to 58 mg/dl). In hemodialysis patients, niacinamide effectively reduces serum phosphorus when co-administered with binders and results in a potentially advantageous increase in HDL cholesterol. Further study in larger randomized trials and other chronic kidney disease populations is indicated.
van der Helm, Jannie J; Koekenbier, Rik H; van Rooijen, Martijn S; Schim van der Loeff, Maarten F; de Vries, Henry J C
Chlamydia trachomatis is a common, often recurring sexually transmitted infection, with serious adverse outcomes in women. Current guidelines recommend retesting after a chlamydia infection, but the optimum timing is unknown. We assessed the optimal retest interval after urogenital chlamydia treatment. A randomized controlled trial among urogenital chlamydia nucleic acid amplification test positive heterosexual clients of the Amsterdam sexually transmitted infection clinic. After treatment, patients were randomly assigned for retesting 8, 16, or 26 weeks later. Patients could choose to do this at home (and send a self-collected sample by mail) or at the clinic. Retest uptake and chlamydia positivity at follow-up were calculated. Between May 2012 and March 2013, 2253 patients were included (45% men; median age, 23 years; interquartile range, 21-26). The overall uptake proportion within 35 weeks after the initial visit was significantly higher in the 8-week group (77%) compared with the 16- and 26-week groups (67% and 64%, respectively, P < 0.001), and the positivity proportions among those retested were comparable (P = 0.169). The proportion of people with a diagnosed recurrent chlamydia infection among all randomized was similar between the groups (n = 69 [8.6%], n = 52 [7.4%], and n = 69 [9.3%]; P = 0.4). Patients with a recent urogenital chlamydia are at high risk of recurrence of chlamydia and retesting them is an effective way of detecting chlamydia cases. We recommend inviting patients for a re-test 8 weeks after the initial diagnosis and treatment.
Chang, Hui-Kuan; Peng, Tai-Chu; Wang, Ji-Hung; Lai, Hui-Ling
Cardiovascular diseases are the number 1 cause of death globally. Cardiac catheterization is a key step in the diagnosis and management of cardiovascular diseases. Decreasing the stress of cardiac catheterization is a key factor in improving patients' well-being. The aim of the study was to explore the effect of music on psychophysiological indices in patients awaiting cardiac catheterization examination. Using a 2-group repeated-measures design, 54 subjects aged 47 to 70 years and scheduled for cardiac catheterization examination were recruited. The subjects were randomly assigned to either the music group (27 subjects) or the usual-care group (27 subjects). Subjects in the music group listened to 30 minutes of music, whereas the usual-care group rested quietly, as in routine care. The heart rate (HR), HR variability, and skin temperature (ST) were measured at 7 time points and were recorded by the MP150 recording system (BIOPAC Systems, Inc, Goleta, California). Heart rate variability was analyzed by power spectral analysis: low frequency, high frequency, and ratio of low frequency to high frequency. The state of anxiety was measured at baseline and at time 7. At the end of the study, the subjects' music preference was evaluated using a visual analog scale. Listening to music resulted in a significantly reduced state of anxiety (P = .003). Both the music and quiet rest groups noted the beneficial effects of decreased HR and increased ST (all P music preference, the lower the subjects' perceived anxiety level (P = .05). Our findings provide the necessary scientific support for the use of sedative music and quiet rest as safe and effective interventions against anxiety, as manifested in the subjects' anxiety state, HR, and ST.
Tahririan, Dana; Kaviani, Naser; Nourbakhsh, Nosrat
This study was planned to determine the relationship between bispectoral index (BIS) during dental treatment and recovery conditions in children undergoing two regimes of anesthesia of propofol and isoflurane. In this single-blind clinical trial study, 57 4-7-year-old healthy children who had been referred for dental treatment under general anesthesia between 60 and 90 min were selected by convenience sampling and assigned to two groups, after obtaining their parents' written consent. The anesthesia was induced by inhalation. For the first group, the anesthesia was preserved by a mixture of oxygen (50%), nitrous oxide (50%), and isoflurane (1%). For the second group, the anesthesia was preserved by a mixture of oxygen (50%), nitrous oxide (50%), and propofol was administered intravenously at a dose of 100 Ng/kg/min. The patients' vital signs, BIS, and agitation scores were recorded every 10 min. The data were analyzed by repeated measure ANOVA and t-tests at a significance level of α = 0.05 using SPSS version 20. The results of independent t-test for anesthesia time showed no statistically significant difference between isoflurane and propofol (P = 0.87). Controlling age, the BIS difference between the two anesthetic agents was not significant (P > 0.05); however, it was negatively correlated with the duration of anesthesia and the discharge time (P = 0.001, r = -0.308) and (P < 0.001, r = -0.55). The same depth of anesthesia is produced by propofol and isoflurane, but lower recovery complications from anesthesia are observed with isoflurane.
Kjellman, Görel; Oberg, Birgitta
Seventy-seven patients with neck pain in the primary health care were included in a prospective, randomized clinical trial and randomly assigned to general exercise, McKenzie treatment, or a control group. Seventy patients completed the treatment; response rate 93% at 12-month follow-up. All three groups showed significant improvement regarding the main outcomes, pain intensity and Neck Disability Index, even at 12-month follow-up, but there was no significant difference between the groups. In all, 79% reported that they were better or completely restored after treatment, although 51% reported constant/daily pain. In the McKenzie group compared with the control group, a tendency toward greater improvement was noted for pain intensity at 3 weeks and at 6-month follow-up, and for post-treatment Neck Disability Index. Significant improvement in Distress and Risk Assessment Method scores was shown in the McKenzie group only. The three groups had similar recurrence rates, although after 12 months the McKenzie group showed a tendency toward fewer visits for additional health care. The study did not provide a definite evidence of treatment efficacy in patients with neck pain, however, there was a tendency toward a better outcome with the two active alternatives compared with the control group.
Gerage, Aline Mendes; Benedetti, Tânia Rosane Bertoldo; Ritti-Dias, Raphael Mendes; Dos Santos, Ana Célia Oliveira; de Souza, Bruna Cadengue Coêlho; Almeida, Fábio Araujo
This study aimed to analyze the effect of a behavior change program, called Vida Ativa Melhorando a Saúde (VAMOS), on physical activity, eating habits, and quality of life in patients with hypertension. A randomized controlled trial was carried out in 90 patients with hypertension (57.8 ± 9.9 y). They were randomly assigned to 2 groups: VAMOS group (n = 45) and control group (n = 45). The VAMOS group participated in a behavioral change program aimed at motivating changes in physical activity and nutrition behavior for 12 weeks. Physical activity, eating habits, quality of life, self-efficacy, and social support were evaluated at preintervention and postintervention. The control group increased sedentary time (407 ± 87 vs 303 ± 100 min/d; P eating habits score (36.9 ± 6.6 vs 43.4 ± 5.8; P eating habits and quality of life in patients with hypertension.
[Usefulness of TIMI Risk Score in assessing the prognosis in patients with acute coronary syndromes without ST elevation assigned to early percutaneous coronary intervention. Comparison of the high-risk and the moderate-risk patients].
Szyguła-Jurkiewicz, Bozena; Wilczek, Krzysztof; Trzeciak, Przemysław; Poloński, Lech
Risk stratification in acute coronary syndromes (ACS) without ST segment elevation plays an important role in choosing treatment strategy and making further prognosis. We aimed at 1) assessing the usefulness of TIMI Risk Score in risk stratification and prognosis in unselected patients with ACS without ST elevation who underwent early percutaneous revascularization, 2) comparing the frequency of adverse events (death, MI, repeat revascularization in high-risk and moderate-risk patients during 14 days from revascularization, 3) comparing the efficacy of percutaneous revascularization in the high-risk and in the moderate-risk group. High-risk (TIMI Risk Score > or = 5 points) and moderate-risk (TIMI Risk Score 3-4 points) group comprised 324 and 240 patients respectively. High-risk group comprised older patients, fewer men, more diabetics and hypertensive patients. Peripheral vessel disease and prior MI was also more frequent in the high-risk group. More high-risk patients had initial TIMI flow TIMI 3 flow after revascularization was achieved in fewer high-risk patients. During 14-day follow-up the frequency of combined end-point (death, MI, repeat revascularization) was more frequent in the high-risk group (8.95% vs 1.67%). TIMI Risk Score is an easy to use and useful method in risk stratification and prediction of adverse events in patients with ACS without ST segment elevation assigned to early percutaneous intervention in the early post-procedure period.
Tamara J. Somers
Full Text Available Psychosocial pain management interventions are efficacious for cancer pain but are underutilized. Recent advances in mobile health (mHealth technologies provide new opportunities to decrease barriers to access psychosocial pain management interventions. The objective of this study was to gain information about the accessibility and efficacy of mobile pain coping skills training (mPCST intervention delivered to cancer patients with pain compared to traditional in-person pain coping skills training intervention. This study randomly assigned participants (N=30 to receive either mobile health pain coping skills training intervention delivered via Skype or traditional pain coping skills training delivered face-to-face (PCST-trad. This pilot trial suggests that mPCST is feasible, presents low burden to patients, may lead to high patient engagement, and appears to be acceptable to patients. Cancer patients with pain in the mPCST group reported decreases in pain severity and physical symptoms as well as increases in self-efficacy for pain management that were comparable to changes in the PCST-trad group (p’s < 0.05. These findings suggest that mPCST, which is a highly accessible intervention, may provide benefits similar to an in-person intervention and shows promise for being feasible, acceptable, and engaging to cancer patients with pain.
Qian, Qingwen; Qian, Shuhong; Fan, Ping; Huo, Dongxia; Wang, Shijin
To investigate whether Salvia miltiorrhiza hydrophilic extract (SMHE) has the ability to ameliorate oxidative stress in diabetic patients with chronic heart disease (CHD), 62 patients with CHD were recruited. These patients were assigned randomly into two groups: (1) placebo group receiving hypoglycemic therapy; (2) treatment group receiving hypoglycemic therapy plus SMHE. The biological markers related to oxidative stress were measured to determine the effect of treatment. Thirty patients in the placebo group and 24 patients in the treatment group were followed to completion in this study. Overall, the malondialdehyde (MDA) level at day 30 in the treatment group was significantly lower than in the placebo group. However, no significant difference in the serum antioxidant enzymes activities was observed between the groups. At day 60, the serum glutathione (GSH) level, superoxide dismutase (SOD), Paraoxonase (PONase) and glutathione reductase (GSSG-R) activities increased markedly in the treatment group compared with the placebo group. There was no significant difference in the level of lipid profile between the two groups. This study indicated that SMHE clearly reduced oxidative stress in diabetic patients with CHD. Copyright © 2011 John Wiley & Sons, Ltd.
Jang, Seung-Ho; Kang, Seung-Yeon; Lee, Hye-Jin; Lee, Sang-Yeol
Mindfulness-based art therapy (MBAT) induces emotional relaxation in cancer patients and is a treatment known to improve psychological stability. The objective of this research was to evaluate the treatment effects of MBAT for breast cancer patients. Overall, 24 breast cancer patients were selected as subjects of the study. Two groups, the MBAT group and control group with 12 patients each, were randomly assigned. The patients in the MBAT group were given 12 sessions of treatments. To measure depression and anxiety, low scales of the personality assessment inventory (PAI) was used. Health-related quality of life was evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30). The treatment results were analyzed using analysis of covariance (ANCOVA) and two-way repeated measures analysis of variance (ANOVA). The results showed that depression and anxiety decreased significantly and health-related quality of life improved significantly in the MBAT group. In the control group, however, there was no significant change. MBAT can be seen as an effective treatment method that improves breast cancer patients׳ psychological stability and quality of life. Evaluation of treatment effects using program development and large-scale research for future clinical application is needed. Copyright © 2016 Elsevier Inc. All rights reserved.
Full Text Available Abstract Background Several studies have recently demonstrated that a post-treatment communication to explain the importance of an oral hygiene can improve the orthodontic patients’ compliance over a period of 66 days. The main goal of this study is to evaluate the effects of a structured follow-up communication after orthodontic appliance application on oral hygiene compliance after 30–40 days. Methods Eighty-four orthodontic participants enrolled from patients who were beginning fixed orthodontic treatment at the Orthodontic Department, Gaslini Hospital, Genova, between July and October 2014 were randomly assigned to one of three trial arms. Before the bonding, all patients underwent a session of oral hygiene aimed at obtaining an plaque index of “zero.” At the following orthodontic appointment, the plaque index was calculated for each patient in order to assess oral hygiene compliance. The first group served as control and did not receive any post-procedure communication, the second group received a structured text message giving reassurance, and the third group received a structured telephone call. Participants were blinded to group assignment and were not made aware that the text message or the telephone call was part of the study. (The research protocol was approved by the Italian Comitato Etico Regionale della Liguria-sezione 3^ c/o IRCCS-Istituto G. Gaslini 845/2014, and it is not registered in the trial’s register. Results Thirty patients were randomly assigned to the control group, 28 participants to the text message group, and 26 to the telephone group. Participants who received a post-treatment communication reported higher level of oral hygiene compliance than participants in the control group. The plaque index was 0.3 (interquartile range (Iqr, 0.60 and 0.75 (Iqr, 1.30, respectively, with a significant difference (P = 0.0205. Conclusions A follow-up procedure after orthodontic treatment may be an effective tool to
Su, Mei-Yin; Lin, Shi-Quan; zhou, Ye-Wen; Zhou, Ye-Wen; Liu, Si-Ya; Lin, Ai; Lin, Xi-Rong
Elderly patients with acute neurological impairment are prone to severe disability, fecal incontinence (FI), and resultant complications. A suspension positioning system (SPS), based on the orthopedic suspension traction system commonly used for conservative treatment of pediatric femoral fracture and uncomplicated adult pelvic fracture, was developed to facilitate FI management in patients immobilized secondary to an acute neurological condition. To evaluate the effectiveness and safety of the system, a prospective, randomized, controlled study was conducted between October 2009 and July 2012. Two hundred (200) elderly, bedridden, hospitalized patients with acute, nonchronic neurological impairment were randomly assigned to receive routine FI nursing care (ie, individualized dietary modification, psychological support, health education, and social support for caregivers and family members [control group]) or routine incontinence care plus the SPS (experimental group) during the day. Rates of perianal fecal contamination, skin breakdown, incontinence associated dermatitis, pressure ulcer development, and lower urinary tract infection (LUTI) were significantly lower in the SPS than in the control group (P care were also lower in the SPS group (P <0.05). Patient quality-of-life (QoL) and FI QoL scores were similar at baseline but significantly higher (better) at the 6-month follow-up interview in the SPS than in the control group (P <0.05). In this study, the rate of FI-associated morbidities was lower and 6-month patient QoL scores were higher in the SPS than in the control group. No adverse events were observed, and all patients completed the study. Further clinical studies are needed to examine the long-term effects of SPS use among neurologically impaired FI patients.
Testa, A; Iannace, C; Di Libero, L
In the immediate postoperative period surgical breast cancer patients can face many problems including functional limitation of the shoulder, edema, pain and depression. Although those symptoms can alleviate during the stages of the therapeutic route, most of the time concur significantly to the everyday life discomforts decreasing sharply the quality of life. Therefore, is essential to pay attention to the functional problems of breast cancer patients in order to ensure a quick and complete physical and psychosocial recovery. Aim of this study, comparing 2 groups of patients, one that underwent to early physical rehabilitation program (EPRP) and one as a control group, is to evaluate: functional improvements of the glenohumeral joint mobility, antalgic effect of EPRP, improvements and/or worsening of quality of life. Randomized controlled study. Inpatient and outpatient clinic, Breast Unit, "San Giuseppe Moscati" Hospital, Avellino, Italy. Seventy women planned for Madden's modified radical mastectomy or for segmental mastectomy with axillary dissection in the period from March 2010 to February 2011. Patients were randomly assigned to treated and control group. All participants were evaluated before surgery and postoperatively at fifth day, first, sixth and twelfth month. Patients of the treated group, underwent first, to assisted cautious mobilization of hand, wrist and elbow and after drainage removal, to twenty physiotherapy sessions under the guide of a physiotherapist. Within group statistical analysis evidenced that TG regained normal function at 1 year after surgery while CG was unable to do so for flexion, abduction and internal rotation movements. TG manifested general and statistically significative improvements in QoL. Improvements in the grade of pain perceived were observed starting from the first postoperative month. Postoperative early physical rehabilitation programme in surgical breast cancer patients surgically treated significantly improves
Filaire, Marc; Tardy, Marie M; Richard, Ruddy; Naamee, Adel; Chadeyras, Jean Baptiste; Da Costa, Valence; Bailly, Patrick; Eisenmann, Nathanaël; Pereira, Bruno; Merle, Patrick; Galvaing, Géraud
Whether prophylactic tracheotomy can shorten the duration of mechanical ventilation (MV) in high risk patients eligible for lung cancer resection. The objective was to compare duration of MV and outcome in 39 patients randomly assigned to prophylactic tracheotomy or control. Prospective randomized controlled, single-center trial (ClinicalTrials.gov Identifier: NCT01053624). The primary outcome measure was the cumulative number of MV days after operation until discharge. The secondary outcome measures were the 60 days mortality rate, the ICU and the hospital length of stay, the incidence of postoperative respiratory, cardiac and general complications, the reventilation rate, the need of noninvasive ventilation (NIV), the need of a tracheotomy in control group and the tracheal complications. The duration of MV was not significantly different between the tracheotomy group (3.5±6 days) and the control group (4.7±9.3 days) (P=0.54). Among patients needing prolonged MV >4 days, tracheotomy patients had a shortened duration of MV than control patients (respectively 11.4±7.1 and 20.4±9.6 days, P=0.04). The rate of respiratory complications were significantly lower in the tracheotomy group than in the control group (28% vs. 51%, P=0.03). Six patients (15%) needed a postoperative tracheotomy in the control group because of a prolonged MV >7 days. Tracheotomy was associated with a reduced need of NIV (P=0.04). There was no difference in 60-day mortality rate, cardiac complications, intensive care unit and hospital length of stay. No death was related with the tracheotomy. Prophylactic tracheotomy in patients with ppo FEV1 <50% who underwent thoracotomy for lung cancer resection provided benefits in terms of duration of prolonged MV and respiratory complications but was not associated with a decreased mortality rate, ICU and hospital length of stay and non-respiratory complications.
Bauer, Brent A; Cutshall, Susanne A; Anderson, Patricia G; Prinsen, Sharon K; Wentworth, Laura J; Olney, Tammy J; Messner, Penny K; Brekke, Karen M; Li, Zhuo; Sundt, Thoralf M; Kelly, Ryan F; Bauer, Brent A
Postoperative pain and anxiety are common in cardiac surgery patients. Studies have suggested that music can decrease anxiety in hospitalized patients. Primary Study Objective This study focused on the efficacy and feasibility of special music, which included nature sounds, for pain and anxiety. In this randomized controlled trial, postoperative cardiovascular surgery patients were randomly assigned to a music group to receive 20 minutes of standard postoperative care and music twice daily on postoperative days 2 through 4 or to a control group to receive 20 minutes of standard care with a quiet resting period twice daily on postoperative days 2 through 4. Cardiovascular surgical unit of Saint Marys Hospital, Rochester, Minnesota. One hundred patients completed the study (music group, n = 49; control group, n = 51). Intervention The music was delivered through CD players in the patients' rooms. Pain, anxiety, satisfaction, and relaxation were evaluated from visual analog scales. Data showed a significant decrease in mean (SD) pain scores after the second session of day 2 for the music group (change, ?1.4 [1.4]) compared with the control group (change, ?0.4 [1.4]) (P = .001). Mean relaxation scores improved more at the first session of day 2 for the music group (change, 1.9 [2.7]) compared with the control group (change, 0.3 [2.9]) (P = .03). The music group also showed lower anxiety and increased satisfaction overall, but these differences were not statistically significant. No major barriers to using the therapy were identified. Recorded music and nature sounds can be integrated into the postoperative care of cardiovascular surgery patients. The recordings may provide an additional means for addressing common symptoms of pain and anxiety while providing a means of relaxation for these patients.
Macedo, Luciana Gazzi; Latimer, Jane; Maher, Christopher G; Hodges, Paul W; McAuley, James H; Nicholas, Michael K; Tonkin, Lois; Stanton, Chris J; Stanton, Tasha R; Stafford, Ryan
Motor control exercises to improve control and coordination of trunk muscles and graded activity under the principles of cognitive-behavioral therapy are 2 commonly used exercise therapies, yet there is little evidence to support the use of one intervention over the other. The objective of this study was to compare the effectiveness of motor control exercises and graded activity for patients with chronic nonspecific low back pain. This study was a prospectively registered randomized controlled trial with outcome assessment and statistical analyses conducted blind to group. The study was conducted in primary care settings. The participants were 172 patients with chronic (>12 weeks) nonspecific low back pain. Patients were randomly assigned to receive either motor control exercises or graded activity. There was no attempt to subclassify patients to match them to a treatment. Patients in both groups received 14 sessions of individualized, supervised exercise therapy. Primary outcomes were average pain over the previous week (numeric rating scale) and function (Patient-Specific Functional Scale); secondary outcomes were disability (24-item Roland-Morris Disability Questionnaire), global impression of change (Global Perceived Effect Scale), and quality of life (36-Item Short-Form Health Survey questionnaire [SF-36]). Outcome measures were collected at baseline and at 2, 6, and 12 months after intervention. A linear mixed models analysis showed that there were no significant differences between treatment groups at any of the time points for any of the outcomes studied. For example, the effect for pain at 2 months was 0.0 (-0.7 to 0.8). Clinicians could not be blinded to the interventions. results of this study suggest that motor control exercises and graded activity have similar effects for patients with chronic nonspecific low back pain.
Kiser, Katie; Jonas, Daniel; Warner, Zachary; Scanlon, Kelli; Shilliday, Betsy Bryant; DeWalt, Darren A
Low literacy skills are common and associated with a variety of poor health outcomes. This may be particularly important in patients with chronic illnesses such as chronic obstructive pulmonary disease (COPD) that require appropriate inhaler technique to maintain quality of life and avoid exacerbations. To explore the impact of a literacy-sensitive self-management intervention on inhaler technique scores in COPD patients and to determine if effects differ by literacy. Randomized controlled trial. Ninety-nine patients with COPD. Patients were randomly assigned to a one-on-one self-management educational intervention or usual care. The intervention focused on inhaler technique, smoking cessation, and using a COPD action plan. At baseline, an inhaler technique assessment, literacy assessment, health-related quality of life questionnaires, and pulmonary function tests were completed. Inhaler technique was re-evaluated after two to eight weeks. Mean age 63, 65% female, 69% Caucasian, moderate COPD severity on average, 36% with low literacy, moderately impaired health-related quality of life, and similar baseline metered dose inhaler technique scores. Patients in the intervention group had greater mean improvement from baseline in metered dose inhaler technique score compared to those in the usual care group (difference in mean change 2.1, 95% CI 1.1, 3.0). The patients in the intervention group also had greater mean improvements in metered dose inhaler technique score than those in the usual care group whether they had low health literacy (difference in mean change 2.8, 95% CI 0.6, 4.9) or higher health literacy (1.8, 95% CI 0.7, 2.9). A literacy-sensitive self-management intervention can lead to improvements in inhaler technique, with benefits for patients with both low and higher health literacy.
Davidson, John B.; Andrisani, Dominick, II
This report presents the development of the gain weighted eigenspace assignment methodology. This provides a designer with a systematic methodology for trading off eigenvector placement versus gain magnitudes, while still maintaining desired closed-loop eigenvalue locations. This is accomplished by forming a cost function composed of a scalar measure of error between desired and achievable eigenvectors and a scalar measure of gain magnitude, determining analytical expressions for the gradients, and solving for the optimal solution by numerical iteration. For this development the scalar measure of gain magnitude is chosen to be a weighted sum of the squares of all the individual elements of the feedback gain matrix. An example is presented to demonstrate the method. In this example, solutions yielding achievable eigenvectors close to the desired eigenvectors are obtained with significant reductions in gain magnitude compared to a solution obtained using a previously developed eigenspace (eigenstructure) assignment method.
González-Formoso, Clara; Martín-Miguel, María Victoria; Fernández-Domínguez, Ma José; Rial, Antonio; Lago-Deibe, Fernando Isidro; Ramil-Hermida, Luis; Pérez-García, Margarita; Clavería, Ana
Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience. Our study aims to achieve the following:--Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia.--Find and analyze educational tools to improve patient safety culture in primary care.--Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care. Experimental unifactorial study of two groups, control and intervention. Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain. From the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned. Residents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group--either intervention or control--through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent feedback, after receiving instruction on the process. No action will be taken in the control group. After
S Delevatti, Rodrigo; Schuch, Felipe Barreto; Kanitz, Ana Carolina; Alberton, Cristine L; Marson, Elisa Corrêa; Lisboa, Salime Chedid; Pinho, Carolina Dertzbocher Feil; Bregagnol, Luciana Peruchena; Becker, Maríndia Teixeira; Kruel, Luiz Fernando M
To compare the effects of two aerobic training models in water and on dry-land on quality of life, depressive symptoms and sleep quality in patients with type 2 diabetes. Randomized clinical trial. Thirty-five patients with type 2 diabetes were randomly assigned to aquatic aerobic training group (n=17) or dry-land aerobic training group (n=18). Exercise training length was of 12 weeks, performed in three weekly sessions (45min/session), with intensity progressing from 85% to 100% of heart rate of anaerobic threshold during interventions. All outcomes were evaluated at baseline and 12 weeks later. In per protocol analysis, physical and psychological domains of quality of life improved in both groups (pland environment on quality of life, depressive symptoms and sleep quality in patients with type 2 diabetes. Clinical trial reg. no. NCT01956357, clinicaltrials.gov. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.
Full Text Available Maria Rasmussen,1 Morten Smærup Olsen,2 Lone Sunde,1,3 Lars Pedersen,2 Olav Bjørn Petersen4 1Department of Clinical Genetics, Aarhus University Hospital, Skejby, 2Department of Clinical Epidemiology, Aarhus University Hospital, Skejby, 3Department of Biomedicine, Aarhus University, Aarhus, 4Department of Gynecology and Obstetrics, Aarhus University Hospital, Skejby, Denmark Objective: Restricting studies of severe congenital malformations to live-born children may introduce substantial bias. In this study, we estimated the attendance to the second-trimester fetal malformation screening program. We also estimated the positive predictive value (PPV of prenatally assigned International Classification of Disease-10 diagnoses recorded in the Danish National Patient Registry (DNPR and the completeness of case registration. We used kidney anomalies as an example. Methods: We identified the proportion of all Danish live-born children from January 1, 2007 to December 31, 2012, who were scanned during the second trimester using the DNPR and the Civil Registration System. Details of all fetuses with specific kidney anomaly diagnoses according to the DNPR were retrieved. The PPV was estimated using the nationwide Astraia database of pregnancy medical charts or traditional medical charts, as gold standard. The completeness was assessed using the total number of cases estimated by the capture–recapture method. Results: Of 372,263 live born infants, 97.3% were scanned during the second trimester. We identified 172 fetuses in the DNPR. Of these, 149 had kidney anomalies according to Astraia or medical chart review, corresponding to a PPV of 87% (95% CI: 81%–91%. The estimated completeness was 43% (95% CI: 38%–49% for the DNPR and 75% (95% CI: 70%–79% for Astraia. Conclusion: Almost all live-born children were scanned during the second trimester in Denmark. However, low completeness may hamper the use of the DNPR for studies of prenatally detected
Akanni, Feranmi Timothy
One of the common ways of checking that knowledge is impacted into students at every level of education is by giving various tasks to students and part of the responsibilities of the teacher is to give assignments to students and check the solution provided by the students. Increase in technology development involves a number of mobile applications that are being developed and released on a daily basis, out of which Android operating application is one of the dominant mobile application. T...
An important task of a manager is to motivate her subordinates. One way in which a manager can give incentives to junior employees is through the assignment of tasks. How a manager allocates tasks in an organization, provides information to the junior employees about his ability. Without coaching from a manager, the junior employee only has information about his past performance. Based on his past performance, a talented junior who has performed a difficult task sometimes decides to leave the...
Yeh, Mei-Ling; Chung, Yu-Chu
This study aimed to evaluate the effects of Chan-Chuang qigong exercise in non-Hodgkin's lymphoma patients who were undergoing chemotherapy on fatigue intensity and sleep quality. The study was a single-centre, controlled randomized study. One hundred and eight subjects were randomly assigned to the qigong group (n = 54) or control group (n = 54). The qigong group received Chan-Chuang qigong exercise 20-min twice daily for 21 days in the course of the chemotherapy treatment, whereas the control group without special exercise intervention. Outcome measures included fatigue and sleep quality. After the three-week intervention, participants who were in the qigong group had lower fatigue intensity scores than those in the control group. The results of generalized estimating equations (GEE) analyses showed a significant group-by-time interaction effect in average fatigue, worse fatigue, and overall sleep quality (p sleep quality significantly decreased over time in the qigong group. Chan-Chuang qigong exercise could be regarded as an adjunct measure in clinical practice. This study cannot completely discount the possible influence of placebo effects, and more objective clinical outcome measures are needed to produce our findings with long-term follow-up in a randomized controlled study. Copyright © 2016 Elsevier Ltd. All rights reserved.
Løppenthin, Katrine; Esbensen, Bente Appel; Jennum, Poul; Østergaard, Mikkel; Christensen, Jesper Frank; Thomsen, Tanja; Bech, Julie Schjerbech; Midtgaard, Julie
Poor sleep is prevalent in patients with systemic inflammatory disorders, including rheumatoid arthritis, and, in addition to fatigue, pain, depression and inflammation, is associated with an increased risk of co-morbidity and all-cause mortality. Whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue, no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis. The aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep, assessed both objectively and subjectively in patients with rheumatoid arthritis. A randomized controlled trial including 44 patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group. The intervention consists of 18 session intermittent aerobic exercise training on a bicycle ergometer three times a week. Patients are evaluated according to objective changes in sleep as measured by polysomnography (primary outcome). Secondary outcomes include changes in subjective sleep quality and sleep disturbances, fatigue, pain, depressive symptoms, physical function, health-related quality of life and cardiorespiratory fitness. This trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis, which is considered important in promotion of health and well-being. As such, the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis. ClinicalTrials.gov Identifier: NCT01966835.
A Randomized Controlled Trial for the Effectiveness of Progressive Muscle Relaxation and Guided Imagery as Anxiety Reducing Interventions in Breast and Prostate Cancer Patients Undergoing Chemotherapy
Full Text Available Objective. To test the effectiveness of guided imagery (GI and progressive muscle relaxation (PMR as stress reducing interventions in patients with prostate and breast cancer who undergo chemotherapy. Methods. Patients were randomly assigned to either the control group or the intervention group (PMR and GI. Patients were observed for a total duration of 3 weeks and assessed with the SAS and BECK-II questionnaires for anxiety and depression, respectively, in addiotion to two biological markers (saliva cortisol and saliva amylase (trial registration number: NCT01275872. Results. 256 patients were registered and 236 were randomly assigned. In total 104 were randomised to the control group and 104 to the intervention group. Intervention’s mean anxiety score and depression score changes were significantly different compared to the control’s (b=-29.4, p<0.001; b=-29.4, p<0.001, resp.. Intervention group’s cortisol levels before the intervention (0.30±0.25 gradually decreased up to week 3 (0.16±0.18, whilst the control group’s cortisol levels before the intervention (0.21±0.22 gradually increased up to week 3 (0.44±0.35. The same interaction appears for the Amylase levels (p<0.001. Conclusions. The findings showed that patients with prostate and breast cancer undergoing chemotherapy treatment can benefit from PMR and GI sessions to reduce their anxiety and depression.
A Randomized Controlled Trial for the Effectiveness of Progressive Muscle Relaxation and Guided Imagery as Anxiety Reducing Interventions in Breast and Prostate Cancer Patients Undergoing Chemotherapy.
Charalambous, Andreas; Giannakopoulou, Margarita; Bozas, Evangelos; Paikousis, Lefkios
Objective. To test the effectiveness of guided imagery (GI) and progressive muscle relaxation (PMR) as stress reducing interventions in patients with prostate and breast cancer who undergo chemotherapy. Methods. Patients were randomly assigned to either the control group or the intervention group (PMR and GI). Patients were observed for a total duration of 3 weeks and assessed with the SAS and BECK-II questionnaires for anxiety and depression, respectively, in addiotion to two biological markers (saliva cortisol and saliva amylase) (trial registration number: NCT01275872). Results. 256 patients were registered and 236 were randomly assigned. In total 104 were randomised to the control group and 104 to the intervention group. Intervention's mean anxiety score and depression score changes were significantly different compared to the control's (b = -29.4, p < 0.001; b = -29.4, p < 0.001, resp.). Intervention group's cortisol levels before the intervention (0.30 ± 0.25) gradually decreased up to week 3 (0.16 ± 0.18), whilst the control group's cortisol levels before the intervention (0.21 ± 0.22) gradually increased up to week 3 (0.44 ± 0.35). The same interaction appears for the Amylase levels (p < 0.001). Conclusions. The findings showed that patients with prostate and breast cancer undergoing chemotherapy treatment can benefit from PMR and GI sessions to reduce their anxiety and depression.
Gregersen, Merete; Borris, Lars C; Damsgaard, Else Marie
Hip fracture (HF) in frail elderly patients is associated with poor physical recovery and death. There is often postoperative blood loss and the hemoglobin (Hb) threshold for red blood cell (RBC) transfusions in these patients is unknown. We investigated whether RBC transfusion strategies were associated with the degree of physical recovery or with reduced mortality after HF surgery. We enrolled 284 consecutive post-surgical HF patients (aged ≥ 65 years) with Hb levels nursing homes or sheltered housing. Allocation was stratified by residence. The patients were randomly assigned to either restrictive (Hb nursing home residents in the restrictive transfusion group (36%) than for those in the liberal group (20%) (HR = 2.0, 95% CI: 1.1-3.6; p = 0.01). According to our Hb thresholds, recovery from physical disabilities in frail elderly hip fracture patients was similar after a restrictive RBC transfusion strategy and after a liberal strategy. Implementation of a liberal RBC transfusion strategy in nursing home residents has the potential to increase survival.
von Piekartz, Harry; Lüdtke, Kerstin
The present study was comprised of 43 patients (16 men) with cervicogenic headaches for over three months, diagnosed according to the International Classification of Diagnostic Criteria of Headaches (ICDH-II). The patients were randomly assigned to receive either manual therapy for the cervical region (usual care group) or additional manual therapy techniques to the temporomandibular region to additionally influence temporomandibular disorders (TMD). All patients were assessed prior to treatment, after six sessions of treatment, and at a six-month follow-up. The outcome criteria were: intensity of headaches measured on a colored analog scale, the Neck Disability Index (Dutch version), the Conti Anamnestic Questionnaire, noise registration at the mandibular joint using a stethoscope, the Graded Chronic Pain Status (Dutch version), mandibular deviation, range of mouth opening, and pressure/pain threshold of the masticatory muscles. The results indicate in the studied sample of cervicogenic headache patients, 44.1% had TMD. The group that received additional temporomandibular manual therapy techniques showed significantly decreased headache intensities and increased neck function after the treatment period. These improvements persisted during the treatment-free period (follow-up) and were not observed in the usual care group. This trend was also reflected on the questionnaires and the clinical temporomandibular signs. Based on these observations, we strongly believe that treatment of the temporomandibular region has beneficial effects for patients with cervicogenic headaches, even in the long-term.
Farahmand, Syed Kazem; Gang, Li Zhi; Saghebi, Seyed Ahmad; Mohammadi, Maryam; Mohammadi, Shabnam; Mohammadi, Ghazaleh; Ferns, Gordan A; Zadeh, Majid Ghanbar; Razmgah, Gholamreza Ghayour; Ramazani, Zahra; Ghayour-Mobarhan, Majid; Azizi, Hoda
High serum cholesterol is an important risk factor for cardiovascular events. It has been reported that regular blood donation is associated with a reduction in serum cholesterol. This study aimed to determine the effects of wet cupping on lipid profiles and anthropometric characteristics of patients with metabolic syndrome. One hundred and thirty-six patients aged 18-65 years with metabolic syndrome were recruited to participate in this trial. Ten patients were excluded due to exclusion criteria. Patients (n = 126) were randomly assigned into the control (n = 63) and experimental (n = 63) groups. Patients in the experimental group were treated with wet cupping combined with dietary advice. The controls were given dietary advice only. Anthropometric and biochemical parameters were assessed at baseline and at six and 12 weeks after treatment. The significance of the data was analyzed using a repeated measure ANOVA. The lipid profile status did not differ significantly between the two groups (p > 0.05) whereas there was a significant difference between the two time points within each group (p Wet cupping does not have a significant effect on anthropometric or biochemical indices compared to the effect of dietary advice alone.
Full Text Available Background. Osteosarcoma is a highly malignant bone tumour. After the second relapse, the 12-month postrelapse disease-free survival (PRDFS rate decreases below 20%. Oral Etoposide is often used in clinical practice after surgery as an “adjuvant” outside any protocol and with only limited evidence of improved survival. Viscum album fermentatum Pini (Viscum is an extract of mistletoe plants grown on pine trees for subcutaneous (sc injection with immunomodulatory activity. Methods. Encouraged by preliminary findings, we conducted a study where osteosarcoma patients free from disease after second metastatic relapse were randomly assigned to Viscum sc or Oral Etoposide. Our goal was to compare 12-month PRDFS rates with an equivalent historical control group. Results. Twenty patients have been enrolled, with a median age of 34 years (range 11–65 and a median follow-up time of 38.5 months (3–73. The median PRDSF is currently 4 months (1–47 in the Etoposide and 39 months (2–73 in the Viscum group. Patients getting Viscum reported a higher quality of life due to lower toxicity. Conclusion. Viscum shows promise as adjuvant treatment in prolonging PRDFS after second relapse in osteosarcoma patients. A larger study is required to conclusively determine efficacy and immunomodulatory mechanisms of Viscum therapy in osteosarcoma patients.
Longhi, Alessandra; Reif, Marcus; Mariani, Erminia; Ferrari, Stefano
Background. Osteosarcoma is a highly malignant bone tumour. After the second relapse, the 12-month postrelapse disease-free survival (PRDFS) rate decreases below 20%. Oral Etoposide is often used in clinical practice after surgery as an "adjuvant" outside any protocol and with only limited evidence of improved survival. Viscum album fermentatum Pini (Viscum) is an extract of mistletoe plants grown on pine trees for subcutaneous (sc) injection with immunomodulatory activity. Methods. Encouraged by preliminary findings, we conducted a study where osteosarcoma patients free from disease after second metastatic relapse were randomly assigned to Viscum sc or Oral Etoposide. Our goal was to compare 12-month PRDFS rates with an equivalent historical control group. Results. Twenty patients have been enrolled, with a median age of 34 years (range 11-65) and a median follow-up time of 38.5 months (3-73). The median PRDSF is currently 4 months (1-47) in the Etoposide and 39 months (2-73) in the Viscum group. Patients getting Viscum reported a higher quality of life due to lower toxicity. Conclusion. Viscum shows promise as adjuvant treatment in prolonging PRDFS after second relapse in osteosarcoma patients. A larger study is required to conclusively determine efficacy and immunomodulatory mechanisms of Viscum therapy in osteosarcoma patients.
Xu, Mao; Li, Xiao-Xi; Guo, Xiang-Yang; Wang, Jun
Airway management is critical in patients with cervical spondylosis, a population with a high incidence of difficult airway. Intubation with Shikani Optical Stylet (SOS) has become increasingly popular in difficult airway. We compared the effects of intubation with SOS versus Macintosh laryngoscope (MLS) in patients undergoing surgery for cervical spondylosis. A total of 270 patients scheduled for elective surgery for cervical spondylosis of spinal cord and nerve root type from August 2012 to January 2016 were enrolled and randomly allocated to the MLS or SOS group by random numbers. Patients were evaluated for difficult airway preoperatively, and Cormack-Lehane laryngoscopy classification was determined during anesthesia induction. Difficult airway was defined as Cormack-Lehane Grades III-IV. Patients were intubated with the randomly assigned intubation device. The success rate, intubation time, required assistance, immediate complications, and postoperative complaints were recorded. Categorical variables were analyzed by Chi-square test, and continuous variables were analyzed by independent samples t-test or rank sum test. The success rate of intubation among normal airways was 100% in both groups. In patients with difficult airway, the success rates in the MLS and SOS groups were 84.2% and 94.1%, respectively (P = 0.605). Intubation with SOS took longer compared with MLS (normal airway: 25.1 ± 5.8 s vs. 24.5 ± 5.7 s, P = 0.426; difficult airway: 38.5 ± 8.5 s vs. 36.1 ± 8.2 s, P = 0.389). Intubation with SOS required less assistance in patients with difficult airway (5.9% vs. 100%, P< 0.001). The frequency of postoperative sore throat was lower in SOS group versus MLS group in patients with normal airway (22.0% vs. 34.5%, P = 0.034). SOS is a safe and effective airway management device in patients undergoing surgery for cervical spondylosis. Compared with MLS, SOS appears clinically beneficial for intubation, especially in patients with difficult airway
Rodriguez-Cristobal, Juan Jose; Alonso-Villaverde, Carlos; Panisello, Jose Ma; Travé-Mercade, Pere; Rodriguez-Cortés, Francisca; Marsal, Josep Ramon; Peña, Esther
Overweight and obesity are common health problems which increase the risk of developing several serious health conditions. The main difficulty in the management of weight-loss lies in its maintenance, once it is achieved. The aim of this study was to investigate whether a motivational intervention, together with current clinical practice, was more efficient than a traditional intervention, in the treatment of overweight and obesity and whether this intervention reduces cardiovascular risk factors associated with overweight and obesity. Multi-centre cluster randomized trial with a 24-month follow-up included 864 overweight/obese patients randomly assigned. Motivational intervention group (400 patients), delivered by a nurse trained by an expert psychologist, in 32 sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard programmed diet and exercise. The control group (446 patients), received the usual follow-up. Weight reduction was statistically significant in the second year with a mean reduction of 1.0 Kg in the control group and 2.5 Kg in the intervention group (p = 0. 02). While 18.1% of patients in the control group reduced their weight by more than 5%, this percentage rose to 26.9% in the intervention group, which is statistically significant (p = 0.04). Patients in the motivational intervention group had significantly greater improvements in triglycerides and APOB/APOA1ratio. The results highlight the importance of the group motivational interview in the treatment of overweight /obese patients in primary care, and in the improvement of their associated cardiovascular risks factors. ClinicalTrials.gov Identifier: NCT01006213 October 30, 2009.
May 16, 2011 ... based technique, was adopted using ten random primers in twelve cases and twelve controls. The primer detectability on .... control sample was used as a criterion of genomic instability. RESULTS AND DISCUSSION .... Fingerprinting and assessment of genetic variability of Varroa destructor in Egypt.
Kumada, Hiromitsu; Suzuki, Fumitaka; Suzuki, Yoshiyuki; Toyota, Joji; Karino, Yoshiyasu; Chayama, Kazuaki; Kawakami, Yoshiiku; Fujiyama, Shigetoshi; Ito, Takayoshi; Itoh, Yoshito; Tamura, Etsuko; Ueki, Tomoko; Ishikawa, Hiroki; Hu, Wenhua; McPhee, Fiona; Linaberry, Misti; Hughes, Eric
Daclatasvir combined with asunaprevir is the first all-oral, ribavirin-free treatment of hepatitis C virus genotype 1b infection in Japan. This study compared the efficacy and safety of daclatasvir plus asunaprevir versus telaprevir plus peginterferon/ribavirin in Japanese treatment-naive patients infected with hepatitis C virus genotype 1b. Treatment-naive patients (20-70 years; baseline viral load, ≥ 100,000 IU/mL) were randomly assigned (stratified by IL28B rs8099917 TT/non-TT status) to receive either daclatasvir 60 mg tablets once daily and asunaprevir 100 mg softgel capsules twice daily for 24 weeks or telaprevir 750 mg (3 × 250 mg tablets) three times daily for 12 weeks and peginterferon/ribavirin per Japanese prescribing information for 24 weeks. A cohort of prior relapsers to peginterferon/ribavirin (20-75 years; baseline viral load, ≥ 100,000 IU/mL) received daclatasvir plus asunaprevir. In treatment-naive patients, sustained virologic response at post-treatment week 12 in daclatasvir plus asunaprevir recipients was non-inferior (treatment difference, +25.8% in favor of daclatasvir plus asunaprevir) and higher (89.1%, 106/119) than telaprevir plus peginterferon/ribavirin recipients (62.2%, 69/111); sustained viral response was achieved in 95.5% (n = 21/22) of relapsers. Numerically, fewer patients receiving daclatasvir plus asunaprevir compared with telaprevir plus peginterferon/ribavirin experienced serious adverse events (4.2% vs. 5.4%), adverse events leading to discontinuation of any drug (5.0% vs. 62.2%), grade 3/4 treatment-related adverse events (14.3% vs. 72.1%), rash-related events (0% vs. 13.5%), or anemia (0% vs. 47.7%). Marked differences were observed in the efficacy and safety profile of daclatasvir in combination with asunaprevir, compared with telaprevir plus peginterferon/ribavirin. © 2015 Bristol-Myers Squibb. Journal of Gastroenterology and Hepatology published by Wiley Publishing Asia Pty Ltd. and Journal of Gastroenterology and
Bidabadi, Elham; Mashouf, Mehryar
Migraine is the most common of the paroxysmal disorders to affect the brain in the pediatric population. Both propranolol and sodium valproate (valproic acid) have been advocated as prophylactic agents for childhood migraine. To compare the efficacy and tolerability of propranolol and sodium valproate in the prevention of migraine in the pediatric population. Sixty-three children (aged 5-15 years) with migraine without aura, as defined by the 2004 International Headache Society (IHS) criteria, were included in this prospective, double-blind clinical trial and were randomly assigned to two groups. Group A (n = 32 patients) received propranolol 3 mg/kg/day and group B (n = 31 patients) received sodium valproate 30 mg/kg/day, with at least 6 months of follow up. The propranolol dosage was adjusted to 2 mg/kg/day and the sodium valproate dosage to 15 mg/kg/day, after the first follow-up visit. Participants were evaluated by using a detailed questionnaire that asked about the features of headaches and general health characteristics. The study endpoints were successful treatment for a 4- to 6-month period; 3 months of a persistent unsuccessful or incomplete response to treatment; intolerable side effects; and/or patient non-adherence. All data were analyzed longitudinally by comparing baseline data with data from each follow-up. A total of 60 patients completed the full headache prophylaxis period. The baseline headache frequency was reduced by more than 50% in 83% of propranolol recipients and in 63% of sodium valproate recipients (statistically not significant); the overall reduction of baseline headache frequency per month was better in group A (p = 0.044). The mean headache frequency per month was reduced from 13.86 +/- 2.11 to 4.23 +/- 3.24 in group A, and from 13.23 +/- 2.43 to 5.83 +/- 4.04 in group B; the difference between the two groups was statistically significant (p sodium valproate, headache duration was markedly improved with each drug (p sodium valproate
Full Text Available Sulfonamides are drugs extensively used in the management of AIDS patients. However, the use of sulfonamides is often associated with the development of allergic reactions, provoking the substitution of the drug (by another that may be less effective; alternatively attempts are made to desensitize the patient. OBJECTIVE: Compare two drug regimens (full vs. escalating doses for the oral desensitization of AIDS patients allergic to sulfonamides. MATERIAL AND METHODS: AIDS patients with previous allergic reactions to sulfonamides and requiring prophylaxis against Pneumocistis carinii, central nervous system toxoplasmosis and diarrhea caused by Isospora belli were randomly assigned to a group receiving a routine dose of cothrimoxazole, or another that received escalating doses of an oral suspension of the same drug, initiating with 75mg/day of sulfamethoxazole that was doubled every 48 hours till the full dose was reached, if no allergic reaction occurred. Patients were monitored for at least 6 months after enrollment in the trial. The major end-point was the ability to maintain prophylactic treatment after that period of time. Plasma viral load (PVL and CD4/CD8 counts were measured at baseline. Liver enzymes and hematological parameters were measured at baseline and after 1, 3 and 6 months. RESULTS: Eighteen patients were enrolled in the study (15 men and 3 women, with ages ranging from 30 to 57 years (mean 39.9. The mean CD4 counts were slightly higher for patients receiving a full dose; there was also a trend towards higher baseline CD8 counts among patients developing new reactions. The mean PVL was similar among the patients in both desensitization groups. The incidence of new allergic reactions was identical (40% in the two groups. All adverse reactions were mild and no significant increase in liver enzymes were observed. CONCLUSON: Dose regimen is not a predictor of the development of new allergic reactions amongst patients challenged with
Full Text Available Sulfonamides are drugs extensively used in the management of AIDS patients. However, the use of sulfonamides is often associated with the development of allergic reactions, provoking the substitution of the drug (by another that may be less effective; alternatively attempts are made to desensitize the patient. OBJECTIVE: Compare two drug regimens (full vs. escalating doses for the oral desensitization of AIDS patients allergic to sulfonamides. MATERIAL AND METHODS: AIDS patients with previous allergic reactions to sulfonamides and requiring prophylaxis against Pneumocistis carinii, central nervous system toxoplasmosis and diarrhea caused by Isospora belli were randomly assigned to a group receiving a routine dose of cothrimoxazole, or another that received escalating doses of an oral suspension of the same drug, initiating with 75mg/day of sulfamethoxazole that was doubled every 48 hours till the full dose was reached, if no allergic reaction occurred. Patients were monitored for at least 6 months after enrollment in the trial. The major end-point was the ability to maintain prophylactic treatment after that period of time. Plasma viral load (PVL and CD4/CD8 counts were measured at baseline. Liver enzymes and hematological parameters were measured at baseline and after 1, 3 and 6 months. RESULTS: Eighteen patients were enrolled in the study (15 men and 3 women, with ages ranging from 30 to 57 years (mean 39.9. The mean CD4 counts were slightly higher for patients receiving a full dose; there was also a trend towards higher baseline CD8 counts among patients developing new reactions. The mean PVL was similar among the patients in both desensitization groups. The incidence of new allergic reactions was identical (40% in the two groups. All adverse reactions were mild and no significant increase in liver enzymes were observed. CONCLUSON: Dose regimen is not a predictor of the development of new allergic reactions amongst patients challenged with
Full Text Available This study compared the efficacy and safety of azelnidipine with that of trichlormethiazide in Japanese type 2 diabetic patients with hypertension.In a multicenter, open-label trial, 240 patients with adequately controlled diabetes (HbA1c ≤ 7.0% under lifestyle modification and/or administration of hypoglycemic agents and inadequately controlled hypertension (systolic blood pressure [sBP] ≥ 130 mmHg or diastolic blood pressure [dBP] ≥ 80 mmHg who were being treated with olmesartan were enrolled. Participants were randomly assigned to an azelnidipine group or a trichlormethiazide group and were followed up for 48 weeks. Main outcome measure was the difference in the change in HbA1c levels from the baseline values at 48 weeks between these two groups.Of the 240 subjects that were enrolled, 209 subjects (azelnidipine group: 103 patients, trichlormethiazide group: 106 patients completed this trial. At 48 weeks, the following changes were observed in the azelnidipine and trichlormethiazide groups, respectively: HbA1c levels, 0.19 ± 0.52% and 0.19 ± 0.54%; sBP/dBP, -10.7 ± 9.6/-6.6 ± 6.6 mmHg and -7.1 ± 7.7/-3.3 ± 6.1 mmHg (P < 0.001 for both sBP and dBP. In both groups, dizziness (12 patients [11.7%] and 16 patients [15.1%] and edema (16 patients [15.5%] and 7 patients [6.6%], P = 0.047 were observed during the 48-week follow-up period.Azelnidipine was more effective for controlling blood pressure than trichlormethiazide in Japanese type 2 diabetes patients, whereas trichlormethiazide was more effective for reducing albuminuria than azelnidipine. Both of these agents, however, similarly exacerbated glycemic control in type 2 diabetic patients with hypertension.UMIN 000006081.
Korrelboom, Kees; Marissen, Marlies; van Assendelft, Tanja
Self-esteem is a major concern in the treatment of patients with personality disorders in general. In patients with borderline personality disorder, low self-esteem is associated with factors contributing to suicidal and self-injurious behaviour. At the moment there are no well-proven interventions that specifically target low self-esteem. Recently, a new approach, Competitive Memory Training or COMET, aimed at the enhancement of retrieving beneficial information from memory, appeared to be successful in addressing low self-esteem in different patient populations. To assess whether COMET for low self-esteem is also an effective intervention for patients with personality disorders. 91 patients with personality disorders who were already in therapy in a regular mental health institution were randomly assigned to either 7 group sessions of COMET in addition to their regular therapy or to 7 weeks of ongoing regular therapy. These latter patients received COMET after their “7 weeks waiting period for COMET”. All patients that completed COMET were contacted 3 months later to assess whether the effects of COMET had remained stable. Compared to the patients who received regular therapy only, patients in the COMET + regular therapy condition improved significantly and with large effect sizes on indices of self-esteem and depression. Significant differential improvements on measures of autonomy and social optimism were also in favour of COMET, but had small to intermediate effect sizes. The therapeutic effects of COMET remained stable after 3 months on three out of the four outcome measures. COMET for low self-esteem seems to be an efficacious trans-diagnostic approach that can rather easily be implemented in the treatment of patients with personality disorders.
Rachel L. Rosenthal
Full Text Available The objective of the present study is to determine the likelihood of injured or poisoned patients in special populations, such as those patients that are elderly and self-injurious, being seen within an emergency department’s triage nurse assigned urgency. Data from the National Hospital Ambulatory Medical Care Survey (2007 was utilized in this study. Multi-level models and multivariate linear regression models were used; patient age, sex, reported pain levels, wait time, and injury type were examined as potential predictors of being seen within assigned urgency. From a random sample across all US Emergency Departments, 5616 patients nested in 312 hospital emergency departments were included into the study. Typically, approximately 1 in 5 emergency department patients were not seen within their triage nurse assigned urgencies. The typical patient in the average hospital had an 81% likelihood of being seen within their assigned urgency. P atients who were oldest [odds ratio (OR=0.0990] and had self-inflicted injuries (vs assault OR=1.246 and OR=1.596 had the least likelihood to be seen within their assigned urgencies. As actual wait-time increased for patients, they were less likely to be seen within their assigned urgencies. The most powerful predictors of the study’s outcome were injury type and age, indicating that patients from special populations such as the elderly or those with injuries resulting from deliberate self-harm are less likely to be actually priority patients independent of triage nurse assigned urgencies.
Moustafa, Ibrahim M; Diab, Aliaa A
The aim of this study was to investigate the immediate and long-term effects of a one-year multimodal program, with the addition of upper cervical manipulative therapy, on fibromyalgia management outcomes in addition to three-dimensional (3D) postural measures. This randomized clinical trial with one-year follow-up was completed at the research laboratory of our university. A total of 120 (52 female) patients with fibromyalgia syndrome (FMS) and definite C1-2 joint dysfunction were randomly assigned to the control or an experimental group. Both groups received a multimodal program; additionally, the experimental group received upper cervical manipulative therapy. Primary outcomes were the Fibromyalgia Impact Questionnaire (FIQ), whereas secondary outcomes included Pain Catastrophizing Scale (PCS), algometric score, Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and 3D postural measures. Measures were assessed at three time intervals: baseline, 12 weeks, and 1 year after the 12-week follow-up. The general linear model with repeated measures indicated a significant group × time effect in favor of the experimental group on the measures of 3D postural parameters (P manipulative therapy to a multimodal program is beneficial in treating patients with FMS.
Full Text Available Objectives: This study compares the effects of an integrated yoga program with brief supportive therapy on distressful symptoms in breast cancer outpatients undergoing adjuvant radiotherapy. Materials and Methods: Eighty-eight stage II and III breast cancer outpatients were randomly assigned to receive yoga (n = 44 or brief supportive therapy (n = 44 prior to their radiotherapy treatment. Intervention consisted of yoga sessions lasting 60 min daily while the control group was imparted supportive therapy once in 10 days during the course of their adjuvant radiotherapy. Assessments included Rotterdam Symptom Check List and European Organization for Research in the Treatment of Cancer-Quality of Life (EORTC QoL C30 symptom scale. Assessments were done at baseline and after 6 weeks of radiotherapy treatment. Results: A GLM repeated-measures ANOVA showed a significant decrease in psychological distress (P = 0.01, fatigue (P = 0.007, insomnia (P = 0.001, and appetite loss (P = 0.002 over time in the yoga group as compared to controls. There was significant improvement in the activity level (P = 0.02 in the yoga group as compared to controls. There was a significant positive correlation between physical and psychological distress and fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, and constipation. There was a significant negative correlation between the activity level and fatigue, nausea and vomiting, pain, dyspnea, insomnia, and appetite loss. Conclusion: The results suggest beneficial effects with yoga intervention in managing cancer- and treatment-related symptoms in breast cancer patients.
Bryk, Flavio Fernandes; Dos Reis, Amir Curcio; Fingerhut, Deborah; Araujo, Thomas; Schutzer, Marcela; Cury, Ricardo de Paula Leite; Duarte, Aires; Fukuda, Thiago Yukio
The objective of this study was to evaluate whether women with knee osteoarthritis performing a rehabilitation programme consisting of low-load exercises combined with PVO exhibited the same results in changes in quadriceps strength, pain relief, and functional improvement when compared to women receiving a programme consisting of high-load exercises without PVO. Thirty-four women (mean age, 61 years) with a diagnosis of knee osteoarthritis were randomly assigned to a conventional or occlusion group. The women in the conventional group (n = 17) performed a 6-week quadriceps strengthening and stretching programme using a load around 70 % of the 1-repetition maximum (RM). The women in the occlusion group (n = 17) performed the same programme, however, only using a load around 30 % of the 1-RM, while PVO was induced. The PVO was achieved using a pressure cuff applied to the upper third of the thigh and inflated to 200 mmHg during the quadriceps exercise. An 11-point Numerical Pain Rating Scale (NPRS), the Lequesne questionnaire, the Timed-Up and Go (TUG) test, and muscle strength measurement using a hand-held dynamometer were used as outcome measures at baseline (pretreatment) and at the end of the 6-week of treatment. Pain, using the NPRS, was also assessed when performing the quadriceps exercises during the exercise sessions. At baseline, demographic, strength, pain, and functional assessment data were similar between groups. Patients from both the conventional and occlusion groups had a higher level of function (Lequesne and TUG test), less pain (NPRS), and higher quadriceps strength at the 6-week evaluation when compared to baseline (all P knee discomfort during the treatment sessions than those in the high-load exercise group (P knee osteoarthritis. However, the use of PVO combined with low-load exercise resulted in less anterior knee pain during the training sessions. I.
Liao, Juan; Yang, Yu-fei; Cohen, Lorenzo; Zhao, Yuan-chen; Xu, Yun
To evaluate the effects of the Chinese medicine (CM) five-element music on quality of life for senior and non-senior advanced cancer patients. With a randomized controlled trial, 170 advanced cancer patients were randomly assigned to three groups: the CM five-element music group (68 patients), the Western music therapy group (68 cases), and the no music therapy group (34 cases). All patients of 70 years old or older were considered seniors and the remaining patients younger than 70 years were considered nonseniors. Patients in the CM five-element music group listened to CM five-element music, the patients in the Western music group listened to Western music, and the patients in the no music group did not listen to music. A course of treatment was 3 weeks, with 30 min each day, 5 days a week. The Hospice Quality of Life Index-Revised (HQOLI-R) and Karnofsky performance score (KPS) were measured in the three groups before and after treatment. The symptom diary score was measured in the three groups every 3 days, 7 times in total. CM five-element music group showed a significant difference of HQOLI-R, KPS and symptom diary score with other groups (all Pmusic group and other groups in the non-senior subgroup (Pmusic therapy could improve the quality of life and KPS for senior and non senior advanced cancer patients, and it could improve subjective symptoms for non-senior advanced cancer patients.
Prinsen, Hetty; Heerschap, Arend; Bleijenberg, Gijs; Zwarts, Machiel J.; Leer, Jan Willem H.; van Asten, Jack J.; van der Graaf, Marinette; Rijpkema, Mark; van Laarhoven, Hanneke W. M.
Background Postcancer fatigue is a frequently occurring problem, impairing quality of life. Until now, little is known about (neuro) physiological factors determining postcancer fatigue. For non-cancer patients with chronic fatigue syndrome, certain characteristics of brain morphology and metabolism have been identified in previous studies. We investigated whether these volumetric and metabolic traits are a reflection of fatigue in general and thus also of importance for postcancer fatigue. Methods Fatigued patients were randomly assigned to either the intervention condition (cognitive behavior therapy) or the waiting list condition. Twenty-five patients in the intervention condition and fourteen patients in the waiting list condition were assessed twice, at baseline and six months later. Baseline measurements of 20 fatigued patients were compared with 20 matched non-fatigued controls. All participants had completed treatment of a malignant, solid tumor minimal one year earlier. Global brain volumes, subcortical brain volumes, metabolite tissue concentrations, and metabolite ratios were primary outcome measures. Results Volumetric and metabolic parameters were not significantly different between fatigued and non-fatigued patients. Change scores of volumetric and metabolic parameters from baseline to follow-up were not significantly different between patients in the therapy and the waiting list group. Patients in the therapy group reported a significant larger decrease in fatigue scores than patients in the waiting list group. Conclusions No relation was found between postcancer fatigue and the studied volumetric and metabolic markers. This may suggest that, although postcancer fatigue and chronic fatigue syndrome show strong resemblances as a clinical syndrome, the underlying physiology is different. Trial Registration ClinicalTrials.gov NCT01096641 PMID:24040301
Full Text Available BACKGROUND: Postcancer fatigue is a frequently occurring problem, impairing quality of life. Until now, little is known about (neuro physiological factors determining postcancer fatigue. For non-cancer patients with chronic fatigue syndrome, certain characteristics of brain morphology and metabolism have been identified in previous studies. We investigated whether these volumetric and metabolic traits are a reflection of fatigue in general and thus also of importance for postcancer fatigue. METHODS: Fatigued patients were randomly assigned to either the intervention condition (cognitive behavior therapy or the waiting list condition. Twenty-five patients in the intervention condition and fourteen patients in the waiting list condition were assessed twice, at baseline and six months later. Baseline measurements of 20 fatigued patients were compared with 20 matched non-fatigued controls. All participants had completed treatment of a malignant, solid tumor minimal one year earlier. Global brain volumes, subcortical brain volumes, metabolite tissue concentrations, and metabolite ratios were primary outcome measures. RESULTS: Volumetric and metabolic parameters were not significantly different between fatigued and non-fatigued patients. Change scores of volumetric and metabolic parameters from baseline to follow-up were not significantly different between patients in the therapy and the waiting list group. Patients in the therapy group reported a significant larger decrease in fatigue scores than patients in the waiting list group. CONCLUSIONS: No relation was found between postcancer fatigue and the studied volumetric and metabolic markers. This may suggest that, although postcancer fatigue and chronic fatigue syndrome show strong resemblances as a clinical syndrome, the underlying physiology is different. TRIAL REGISTRATION: ClinicalTrials.gov NCT01096641.
Vos-Vromans, D C W M; Smeets, R J E M; Huijnen, I P J; Köke, A J A; Hitters, W M G C; Rijnders, L J M; Pont, M; Winkens, B; Knottnerus, J A
The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS). Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT. Four rehabilitation centres in the Netherlands. A total of 122 patients participated in the trial. Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation. A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant. This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial. © 2015 The Association for the Publication of the Journal of Internal Medicine.
Jun, Byoung Yeon; Choi, Myung-Gyu; Lee, Jong Yul; Baeg, Myong-Ki; Moon, Sung Jin; Lim, Chul-Hyun; Kim, Jin Su; Cho, Yu Kyung; Lee, In Seok; Kim, Sang Woo; Choi, Kyu Yong
Food residue in the remnant stomach after subtotal gastrectomy (STG) interferes with endoscopic observation. We investigated whether intravenous erythromycin improves gastric mucosa visualization in patients with STG. This study was conducted from April 2012 to October 2012 as a double-blinded, placebo-controlled, randomized trial. Patients who received STG with complete resection (stage T1-2N0M0) were included. Exclusion criteria were diabetes mellitus, neurologic disease, myopathy, recent viral enteritis history, concomitant therapy influencing gastrointestinal motility and severe comorbidity. Patients were instructed to consume a soft diet for dinner between 1800 and 2000 h, and endoscopies were performed between 0900 and 1200 h. Patients were assigned randomly to receive either erythromycin (125 mg in normal saline 50 cc) or placebo saline. The endoscopy was performed 15 min after infusion. Grade of residual food was rated as follows: G0, no residual food; G1, a small amount of residual food; G2, a moderate amount of residual food; G3, a moderate amount of residual food that hinders observation of the entire surface, even with body rolling; G4, a great amount of residual food such that endoscopic observation is impossible. When good visibility was defined as G0+G1, visibility was significantly better in the erythromycin group (61 + 19 %) than in the placebo group (38 + 12 %, p erythromycin response in the erythromycin group (n = 56) was elapsed time since surgery. Adverse effects included nausea [11 (19.7 %)] and vomiting [1 (1.8 %)] in the erythromycin group and vomiting [3 (5.2 %)] in the placebo group. However, they were transient and tolerable. Premedication with erythromycin improves mucosal visualization during endoscopy in patients with STG. ( NCT01659619).
Lee, Peisan; Liu, Ju-Chi; Hsieh, Ming-Hsiung; Hao, Wen-Rui; Tseng, Yuan-Teng; Liu, Shuen-Hsin; Lin, Yung-Kuo; Sung, Li-Chin; Huang, Jen-Hung; Yang, Hung-Yu; Ye, Jong-Shiuan; Zheng, He-Shun; Hsu, Min-Huei; Syed-Abdul, Shabbir; Lu, Richard; Nguyen, Phung-Anh; Iqbal, Usman; Huang, Chih-Wei; Jian, Wen-Shan; Li, Yu-Chuan Jack
Less than 50% of patients with hypertensive disease manage to maintain their blood pressure (BP) within normal levels. The aim of this study is to evaluate whether cloud BP system integrated with computerized physician order entry (CPOE) can improve BP management as compared with traditional care. A randomized controlled trial done on a random sample of 382 adults recruited from 786 patients who had been diagnosed with hypertension and receiving treatment for hypertension in two district hospitals in the north of Taiwan. Physicians had access to cloud BP data from CPOE. Neither patients nor physicians were blinded to group assignment. The study was conducted over a period of seven months. At baseline, the enrollees were 50% male with a mean (SD) age of 58.18 (10.83) years. The mean sitting BP of both arms was no different. The proportion of patients with BP control at two, four and six months was significantly greater in the intervention group than in the control group. The average capture rates of blood pressure in the intervention group were also significantly higher than the control group in all three check-points. Cloud-based BP system integrated with CPOE at the point of care achieved better BP control compared to traditional care. This system does not require any technical skills and is therefore suitable for every age group. The praise and assurance to the patients from the physicians after reviewing the Cloud BP records positively reinforced both BP measuring and medication adherence behaviors. Copyright © 2016. Published by Elsevier Ireland Ltd.
Full Text Available Intracutaneous sterile water injection (ISWI is used for relief of low back pain during labor, acute attacks of urolithiasis, chronic neck and shoulder pain following whiplash injuries, and chronic myofascial pain syndrome. We conducted a randomized, double-blinded, placebo-controlled trial to evaluate the effect of ISWI for relief of acute low back pain (aLBP. A total of 68 patients (41 females and 27 males between 18 and 55 years old experiencing aLBP with moderate to severe pain (scores ≥5 on an 11-point visual analogue scale [VAS] were recruited and randomly assigned to receive either ISWIs (n=34 or intracutaneous isotonic saline injections (placebo treatment; n=34. The primary outcome was improvement in pain intensity using the VAS at 10, 45, and 90 min and 1 day after treatment. The secondary outcome was functional improvement, which was assessed using the Patient-Specific Functional Scale (PSFS 1 day after treatment. The mean VAS score was significantly lower in the ISWI group than in the control group at 10, 45, and 90 min, and 1 day after injection (P<0.05, t-test. The mean increment in PSFS score of the ISWI group was 2.9±2.2 1 day after treatment, while that in the control group was 0.9±2.2. Our study showed that ISWI was effective for relieving pain and improving function in aLBP patients at short-term follow-up. ISWI might be an alternative treatment for aLBP patients, especially in areas where medications are not available, as well as in specific patients (e.g., those who are pregnant or have asthma, who are unable to receive medications or other forms of analgesia because of side effects.
Full Text Available Background: Diabetes causes the increased concentration of circulatory cytokines as a result of inflammation. Considering that pomegranate juice (PJ is known to have antioxidant and anti-inflammatory properties, the purpose of this study was to determine the effects of PJ consumption on markers of inflammation in patients with type 2 diabetes (T2D. Materials and Methods: In a randomized, double-blind clinical trial study, 50 patients with T2D (40-65 years old were randomly assigned to one of two groups. Participants in each group received either 250 mL/day PJ or a control beverage for 12 weeks. Biochemical markers including fasting plasma glucose (FPG, insulin and inflammatory markers were assayed on the baseline and follow-up blood samples. Results: In all, 44 patients in two groups were included in the analysis: PJ (n = 22 and placebo (n = 22. After 12 weeks of intervention, in the PJ group, there were 32% and 30% significant decreases in plasma C-reactive protein (hs-CRP and Interlukin-6, respectively (P < 0.05. The mean ± SD plasma interlukin-6 (7.1 ± 5.6 vs. 11.9 ± 14.4 mg/L and hs-CRP (1791 ± 1657 and 1953 ± 1561 ng/mL concentrations in the PJ group were significantly lower than the placebo group after intervention (P < 0.05. Conclusion: PJ consumption by patients with T2D does not affect FPG or the insulin resistance index (HOMA-IR, whereas it does reduce Interlukin-6 and hs-CRP concentrations in plasma. Therefore, PJ consumption may have an anti-inflammatory effect in patients with T2D.
Pecos-Martín, Daniel; Montañez-Aguilera, F Javier; Gallego-Izquierdo, Tomás; Urraca-Gesto, Alicia; Gómez-Conesa, Antonia; Romero-Franco, Natalia; Plaza-Manzano, Gustavo
To evaluate the effect of dry needling into a myofascial trigger point (MTrP) in the lower trapezius muscle of patients with mechanical idiopathic neck pain. A single-center, randomized, double-blinded controlled study. Patients were recruited from the student population of a local hospital by advertisement in the university clinic from January 2010 to December 2011. Patients (N=72) with unilateral neck pain, neck pain for ≥3 months, and active trigger points in the lower trapezius muscle were randomly assigned to 1 of 2 treatment groups. All the patients completed the study. Dry needling in an MTrP in the lower trapezius muscle, or dry needling in the lower trapezius muscle but not at an MTrP. The visual analog scale (VAS), Neck Pain Questionnaire (NPQ), and pressure-pain threshold (PPT) were assessed before the intervention and 1 week and 1 month postintervention. Treatment with dry needling of the lower trapezius muscle close to the MTrP showed decreases in pain and PPT as well as an improvement in the degree of disability (Pdry-needling technique performed in the MTrP showed more significant therapeutic effects (Pdry needling into an active MTrP of the lower trapezius muscle induces significant changes in the VAS, NPQ, and PPT levels compared with the application of dry needling in other locations of the same muscle in patients with mechanical neck pain. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Geng, Ying-Jie; Wu, Qing-Hua; Zhang, Rui-Qin
To compare the incidence of postoperative cognitive dysfunction (POCD) in elderly surgical patients (>60years) receiving different anesthetics (propofol, sevoflurane, or isoflurane) and to identify potential biomarkers of POCD in this patient population. Prospective, randomized, double-blind clinical trial. University-affiliated teaching hospital. One hundred and fifty elderly patients scheduled for laparoscopic cholecystectomy. Elderly patients undergoing laparoscopic cholecystectomy were randomly assigned to receive propofol, sevoflurane, or isoflurane anesthesia. Cognitive function was assessed using neuropsychological tests at baseline (1day before surgery [D0]), and on postoperative day 1 (D1) and day 3 (D3). Plasma S-100β and Aβ1-40 protein, IL-1β, IL-6 and TNF-α concentrations were assessed before induction of anesthesia (T0), after extubation (T1), and 1h (T2) and 24h (T3) postoperatively. The incidence of POCD was significantly lower in the propofol group compared to the isoflurane group and the sevoflurane group at D1 and D3 (propofol vs. isoflurane: D1 and D3, Ppropofol vs. sevoflurane: D1, P=0.012; D3, P=0.013). The incidence of POCD was significantly lower in the sevoflurane group compared to the isoflurane group at D1 (P=0.041), but not at D3. Postoperatively, plasma S-100β and Aβ1-40 protein, IL-1β, IL-6, and TNF-α concentrations were significantly decreased in the propofol group compared to the isoflurane group. Propofol anesthesia may be an option for elderly surgical patients. Copyright © 2017 Elsevier Inc. All rights reserved.
Holtzer-Goor, Kim M.; van Vliet, Ellen J.; van Sprundel, Esther; Plochg, Thomas; Koopmanschap, Marc A.; Klazinga, Niek S.; Lemij, Hans G.
Comparing the quality of care provided by a hospital-based shared care glaucoma follow-up unit with care as usual. This randomized controlled trial included stable glaucoma patients and patients at risk for developing glaucoma. Patients in the Usual Care group (n=410) were seen by glaucoma
Full Text Available Abstract Background Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The primary objective of this randomized-controlled trial (RCT is to study the effect of an exercise program (in- and outpatient on immune cell recovery in patients undergoing an autologous stem cell transplantation. The secondary objective is to determine if an exercise intervention diminishes the usual deterioration in quality of life, physical fitness, and the acquisition of a sedentary lifestyle. Methods This RCT has received approval from The Conjoint Health Research Ethics Board (CHREB of the University of Calgary (Ethics ID # E-24476. Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years in the Alberta Children’s Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in- and outpatient from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system
Full Text Available Abstract Background Pulmonary Rehabilitation for moderate Chronic Obstructive Pulmonary Disease in primary care could improve patients’ quality of life. Methods This study aimed to assess the efficacy of a 3-month Pulmonary Rehabilitation (PR program with a further 9 months of maintenance (RHBM group compared with both PR for 3 months without further maintenance (RHB group and usual care in improving the quality of life of patients with moderate COPD. We conducted a parallel-group, randomized clinical trial in Majorca primary health care in which 97 patients with moderate COPD were assigned to the 3 groups. Health outcomes were quality of life, exercise capacity, pulmonary function and exacerbations. Results We found statistically and clinically significant differences in the three groups at 3 months in the emotion dimension (0.53; 95%CI0.06-1.01 in the usual care group, (0.72; 95%CI0.26-1.18 the RHB group (0.87; 95%CI 0.44-1.30 and the RHBM group as well as in fatigue (0.47; 95%CI 0.17-0.78 in the RHBM group. After 1 year, these differences favored the long-term rehabilitation group in the domains of fatigue (0.56; 95%CI 0.22-0.91, mastery (0.79; 95%CI 0.03-1.55 and emotion (0.75; 95%CI 0.17-1.33. Between-group analysis only showed statistically and clinically significant differences between the RHB group and control group in the dyspnea dimension (0.79 95%CI 0.05-1.52. No differences were found for exacerbations, pulmonary function or exercise capacity. Conclusions We found that patients with moderate COPD and low level of impairment did not show meaningful changes in QoL, exercise tolerance, pulmonary function or exacerbation after a one-year, community based rehabilitation program. However, long-term improvements in the emotional, fatigue and mastery dimensions (within intervention groups were identified. Trial registration ISRCTN94514482
Richard, Edo; Kuiper, Roy; Dijkgraaf, Marcel G. W.; van Gool, Willem A.
OBJECTIVES: To investigate whether vascular care slows dementia progression in patients with Alzheimer's disease with cerebrovascular lesions on neuroimaging. DESIGN: Multicenter randomized controlled clinical trial with 2-year follow-up. SETTING: Neurological and geriatric outpatient clinics in 10
Jochems, E.C.; van der Feltz-Cornelis, C.M.; van Dam, A.; Duivenvoorden, H.J.; Mulder, C.L.
Objective: To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness. Methods: Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968).
Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M
Purpose: To compare the treatment complications for patients with Stage I endometrial cancer treated with surgery and pelvic radiotherapy (RT) or surgery alone in a multicenter randomized trial. Methods and Materials: The Postoperative Radiation Therapy in Endometrial Carcinoma (PORTEC) trial
Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van
Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40
Sivalingam, Varun P; Panneerselvam, Elavenil; Raja, Krishnakumar V B; Gopi, Gayathri
To assess the influence of topical ozone administration on patient comfort after third molar surgery. A single-blinded randomized controlled clinical trial was designed involving patients who required removal of bilateral impacted mandibular third molars. The predictor variable was the postoperative medication used after third molar surgery. Using the split-mouth design, the study group received topical ozone without postoperative systemic antibiotics, whereas the control group did not receive ozone but only systemic antibiotics. The 2 groups were prescribed analgesics for 2 days. The assessing surgeon was blinded to treatment assignment. The primary outcome variables were postoperative mouth opening, pain, and swelling. The secondary outcome variable was the number of analgesic doses required by each group on postoperative days 3 to 5. Data analysis involved descriptive statistics, paired t tests, and 2-way analysis of variance with repeated measures (P ozone gel were observed in any patient. Ozone gel was found to be an effective topical agent that considerably improves patient comfort postoperatively and can be considered a substitute of postoperative systemic antibiotics. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.
Gade, Hege; Hjelmesæth, Jøran; Rosenvinge, Jan H; Friborg, Oddgeir
To examine whether cognitive behavioral therapy (CBT) alleviates dysfunctional eating (DE) patterns and symptoms of anxiety and depression in morbidly obese patients planned for bariatric surgery. A total of 98 (68 females) patients with a mean (SD) age of 43 (10) years and BMI 43.5 (4.9) kg/m(2) were randomly assigned to a CBT-group or a control group receiving usual care (i.e., nutritional support and education). The CBT-group received ten weekly intervention sessions. DE, anxiety, and depression were assessed by the TFEQ R-21 and HADS, respectively. Compared with controls, the CBT-patients showed significantly less DE, affective symptoms, and a larger weight loss at follow-up. The effect sizes were large (DE-cognitive restraint, g = -.92, P ≤ .001; DE-uncontrolled eating, g = -.90, P ≤ .001), moderate (HADS-depression, g = -.73, P ≤ .001; DE-emotional eating, g = -.67, P ≤ .001; HADS-anxiety, g = -.62, P = .003), and low (BMI, g = -.24, P = .004). This study supports the use of CBT in helping patients preparing for bariatric surgery to reduce DE and to improve mental health. This clinical trial is registered with NCT01403558.
Mobini-Bidgoli, Maryam; Taghadosi, Mohsen; Gilasi, Hamidreza; Farokhian, Alireza
This study aimed to evaluate effects of hand reflexology on anxiety level in coronary angiography patients. This clinical trial recruited 80 eligible patients >6 months. The patients were randomly assigned to receive routine care plus either hand reflexology or a simple hand massage. Data were collected using the Spielberger State-Trait Anxiety Inventory. Both groups' anxiety levels were measured before (T0) and 30 min (T1) and 1 h after the intervention (T2). The mean anxiety level in the intervention group decreased from 57.54 at baseline to 55.47 after the intervention (P = 0.0001). The values in the control group were 54.27 and 51.4, respectively. The two groups had statistically significant differences in the mean scores of anxiety at T0 and T1 (P = 0.003), T1 and T2, and T0 and T2 (P = 0.0001). Hand reflexology could effectively decrease anxiety in coronary angiography patients. Copyright © 2017 Elsevier Ltd. All rights reserved.
Knapp, Sebastian; Briest, Juliane; Bethge, Matthias
There is evidence that rehabilitation with a multidisciplinary focus on work-related demands effectively improves work ability and quickens return to work in patients with musculoskeletal disorders. There could be benefits to the transfer of work-related components into rehabilitation aftercare. We examined the effectiveness of an intensified work-related rehabilitation aftercare program compared with standard intensified rehabilitation aftercare in Germany on work ability. We randomly assigned 307 patients with musculoskeletal disorders from 11 rehabilitation centers to an aftercare program with work-related functional capacity training, work-related psychosocial groups, social counseling, relaxation training and exercise therapy (intervention group), or the usual aftercare program consisting of only exercise therapy (control group). The 6-month follow-up questionnaire was completed by 78.5% of patients. There was no statistically relevant between-group difference in follow-up primary (work ability) and secondary outcomes (e.g. health-related quality of life, sick leave duration). Significant improvements were observed within both the intervention and the control groups. Severely disabled participants in the intervention group had better physical functioning and shorter sick leave duration after 6 months compared with severely disabled patients in the control group. A partial replacement of standard exercise therapy by a more work-related therapy does not seem to improve work ability superiorly. Improved aftercare treatment may require a focus on employer participation and involvement within the actual work environment.
Chatchawan, Uraiwan; Eungpinichpong, Wichai; Plandee, Piyawan; Yamauchi, Junichiro
BACKGROUND Peripheral neuropathy is the most common complications of diabetic patients and leads to loss of plantar cutaneous sensation, movement perception, and body balance. Thai foot massage is an alternative therapy to improve balance. Therefore, the purpose of this study was to investigate the effects of Thai foot massage on balance performance in diabetic patients with peripheral neuropathy. MATERIAL AND METHODS Sixty patients with type-2 diabetes were recruited and randomly assigned into either the Thai foot massage or control groups. The Thai foot massage group received a modified Thai traditional foot massage for 30 min, 3 days per week for 2 weeks. We measured timed up and go (TUG), one leg stance: OLS), the range of motion (ROM) of the foot, and foot sensation (SWMT) before treatment, after the first single session, and after the 2-week treatment. RESULTS After the single treatment session, only the Thai foot massage group showed a significant improvement in TUG. After the 2-week treatment, both Thai foot massage and control groups showed a significant improvement of TUG and OLS (Pfoot massage group showed better improvement in TUG than the control group (pfoot massage group also showed significant improvements in ROM and SWMT after the 2-week treatment. CONCLUSIONS The results of this study suggest that Thai foot massage is a viable alternative treatment for balance performance, ROM of the foot, and the foot sensation in diabetic patients with peripheral neuropathy.
Chatchawan, Uraiwan; Eungpinichpong, Wichai; Plandee, Piyawan; Yamauchi, Junichiro
Background Peripheral neuropathy is the most common complications of diabetic patients and leads to loss of plantar cutaneous sensation, movement perception, and body balance. Thai foot massage is an alternative therapy to improve balance. Therefore, the purpose of this study was to investigate the effects of Thai foot massage on balance performance in diabetic patients with peripheral neuropathy. Material/Methods Sixty patients with type-2 diabetes were recruited and randomly assigned into either the Thai foot massage or control groups. The Thai foot massage group received a modified Thai traditional foot massage for 30 min, 3 days per week for 2 weeks. We measured timed up and go (TUG), one leg stance: OLS), the range of motion (ROM) of the foot, and foot sensation (SWMT) before treatment, after the first single session, and after the 2-week treatment. Results After the single treatment session, only the Thai foot massage group showed a significant improvement in TUG. After the 2-week treatment, both Thai foot massage and control groups showed a significant improvement of TUG and OLS (Pmassage group showed better improvement in TUG than the control group (pmassage group also showed significant improvements in ROM and SWMT after the 2-week treatment. Conclusions The results of this study suggest that Thai foot massage is a viable alternative treatment for balance performance, ROM of the foot, and the foot sensation in diabetic patients with peripheral neuropathy. PMID:25892354
Full Text Available Objective. To examine whether cognitive behavioral therapy (CBT alleviates dysfunctional eating (DE patterns and symptoms of anxiety and depression in morbidly obese patients planned for bariatric surgery. Design and Methods. A total of 98 (68 females patients with a mean (SD age of 43 (10 years and BMI 43.5 (4.9 kg/m2 were randomly assigned to a CBT-group or a control group receiving usual care (i.e., nutritional support and education. The CBT-group received ten weekly intervention sessions. DE, anxiety, and depression were assessed by the TFEQ R-21 and HADS, respectively. Results. Compared with controls, the CBT-patients showed significantly less DE, affective symptoms, and a larger weight loss at follow-up. The effect sizes were large (DE-cognitive restraint, g=-.92, P≤.001; DE-uncontrolled eating, g=-.90, P≤.001, moderate (HADS-depression, g=-.73, P≤.001; DE-emotional eating, g=-.67, P≤.001; HADS-anxiety, g=-.62, P=.003, and low (BMI, g=-.24, P=.004. Conclusion. This study supports the use of CBT in helping patients preparing for bariatric surgery to reduce DE and to improve mental health. This clinical trial is registered with NCT01403558.
Baria, Flavia; Kamimura, Maria Ayako; Aoike, Danilo Takashi; Ammirati, Adriano; Rocha, Mariana Leister; de Mello, Marco Túlio; Cuppari, Lilian
The prevalence of obesity has markedly increased in patients with chronic kidney disease (CKD). Studies on the impact of exercise focusing on obese CKD patients are scarce. Therefore, we aimed to investigate the effect of aerobic exercise performed either in an exercise centre or at home on visceral fat in overweight non-dialysed CKD patients. Twenty-seven sedentary men (52.1 ± 9.5 years, body mass index 30.4 ± 3.8 kg/m(2), estimated glomerular filtration rate (eGFR) 27.5 ± 11.6 mL/min) were randomly assigned to a centre-based exercise group (n = 10), home-based exercise group (n = 8) or control group (n = 9). The aerobic training was prescribed according to ventilatory threshold and performed three times per week during 12 weeks. Body composition was assessed by dual energy X-ray absorptiometry (DEXA) and the distribution of abdominal fat by computed tomography. In the centre-based group, visceral fat and waist circumference decreased 6.4 ± 6.4 mm (P exercise groups and for leg lean mass for the centre-based group. Mean blood pressure decreased in both exercise groups (centre-based 13%, P aerobic exercise is an effective approach to reduce visceral fat besides promoting relevant clinical benefits in male overweight CKD patients.
Mateusz Wojciech Romanowski
Full Text Available Objectives. This study aims to compare the effectiveness of deep tissue massage (DTM and therapeutic massage (TM in the management of ankylosing spondylitis (AS patients. Materials and Methods. This was a small, randomized clinical pilot study. Subjects were 27 men with diagnosed AS, randomly assigned to DTM group or TM group. Subjects in each group had 10 sessions of massage. Outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI, Modified Schober Test, Finger to Floor Test, chest expansion, and pain intensity of lower back. Results. There are no statistical significant differences between groups, except for BASDAI and pain intensity of lower back. Conclusions. This study suggests that massage may have clinical benefits for treating ankylosing spondylitis patients. Additional scientific research in this area is warranted.
Ferreira,Giovanni E.; Barreto,Rodrigo G. P.; Caroline C. Robinson; Rodrigo D. M. Plentz; Silva, Marcelo F.
ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Ri...
Hosokawa, Koji; Nishimura, Masaji; Egi, Moritoki; Vincent, Jean-Louis
Introduction The optimal timing of tracheotomy in critically ill patients remains a topic of debate. We performed a systematic review to clarify the potential benefits of early versus late tracheotomy. Methods We searched PubMed and CENTRAL for randomized controlled trials that compared outcomes in patients managed with early and late tracheotomy. A random-effects meta-analysis, combining data from three a priori-defined categories of timing of tracheotomy (within 4 versus after 10?days, with...
Lim, Siew Hoon; Chan, Sally Wai-Chi; Lai, Jiunn Herng; He, Hong-Gu
To report a study protocol that evaluates the effects of a psychosocial intervention on patients with a newly formed stoma. With the loss of a significant body function and distorted body image, stoma patients experience physical, psychological and social challenges. Nurses have an important role in helping patients' make a smooth transition to living with their stoma. Limited studies have examined the effects of psychosocial interventions on improving stoma-related health outcomes. A randomized controlled trial is planned. Eighty-four patients with newly formed stoma in a tertiary hospital in Singapore (Research Ethics Committee approval obtained in January 2013) will be recruited. Participants will be randomly assigned to either a control group who receive routine care or an intervention group who receive STOMA psychosocial intervention besides routine care. Outcome variables include stoma care self-efficacy, days to stoma proficiency, length of hospital stay, acceptance of stoma, anxiety and depression and quality of life. Data will be collected at four time points: before randomization and intervention (baseline), on the day of discharge (mid-intervention), at 4 weeks after discharge (postintervention 1) and at 4 months after discharge (postintervention 2). This study will develop a psychosocial intervention programme, which may improve patients' stoma-related outcomes. The findings will provide direction to health professionals about education and the type of support that could be offered to patients concerning stoma care in the hospital setting, which will eventually improve their quality of life. © 2014 John Wiley & Sons Ltd.
Telles, Shirley; Bhardwaj, Abhishek K.; Gupta, Ram K.; Sharma, Sachin K.; Monro, Robin; Balkrishna, Acharya
Background The present study aimed at determining whether 12 weeks of yoga practice in patients with chronic LBP and MRI-based degenerative changes would result in differences in: (i) self-reported pain, anxiety, and spinal flexibility; and (ii) the structure of the discs or vertebrae. Material/Methods Sixty-two persons with MRI-proven degenerative intervertebral discs (group mean ?S.D., 36.2?6.4 years; 30 females) were randomly assigned to yoga and control groups. However, testing was conduc...
Krebber Anne-Marie H
Full Text Available Abstract Background Psychological distress is common in cancer survivors. Although there is some evidence on effectiveness of psychosocial care in distressed cancer patients, referral rate is low. Lack of adequate screening instruments in oncology settings and insufficient availability of traditional models of psychosocial care are the main barriers. A stepped care approach has the potential to improve the efficiency of psychosocial care. The aim of the study described herein is to evaluate efficacy of a stepped care strategy targeting psychological distress in cancer survivors. Methods/design The study is designed as a randomized clinical trial with 2 treatment arms: a stepped care intervention programme versus care as usual. Patients treated for head and neck cancer (HNC or lung cancer (LC are screened for distress using OncoQuest, a computerized touchscreen system. After stratification for tumour (HNC vs. LC and stage (stage I/II vs. III/IV, 176 distressed patients are randomly assigned to the intervention or control group. Patients in the intervention group will follow a stepped care model with 4 evidence based steps: 1. Watchful waiting, 2. Guided self-help via Internet or a booklet, 3. Problem Solving Treatment administered by a specialized nurse, and 4. Specialized psychological intervention or antidepressant medication. In the control group, patients receive care as usual which most often is a single interview or referral to specialized intervention. Primary outcome is the Hospital Anxiety and Depression Scale (HADS. Secondary outcome measures are a clinical level of depression or anxiety (CIDI, quality of life (EQ-5D, EORTC QLQ-C30, QLQ-HN35, QLQ-LC13, patient satisfaction with care (EORTC QLQ-PATSAT, and costs (health care utilization and work loss (TIC-P and PRODISQ modules. Outcomes are evaluated before and after intervention and at 3, 6, 9 and 12 months after intervention. Discussion Stepped care is a system of delivering and
Tahririan, Dana; Kaviani, Naser; Nourbakhsh, Nosrat
Background: This study was planned to determine the relationship between bispectoral index (BIS) during dental treatment and recovery conditions in children undergoing two regimes of anesthesia of propofol and isoflurane. Materials and Methods: In this single-blind clinical trial study, 57 4-7-year-old healthy children who had been referred for dental treatment under general anesthesia between 60 and 90 min were selected by convenience sampling and assigned to two groups, after obtaining ...
Full Text Available Total knee arthroplasty (TKA is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA.
ter Huurne, Elke D; de Haan, Hein A; Postel, Marloes G; van der Palen, Job; VanDerNagel, Joanne E L; DeJong, Cornelis A J
Many patients with eating disorders do not receive help for their symptoms, even though these disorders have severe morbidity. The Internet may offer alternative low-threshold treatment interventions. This study evaluated the effects of a Web-based cognitive behavioral therapy (CBT) intervention using intensive asynchronous therapeutic support to improve eating disorder psychopathology, and to reduce body dissatisfaction and related health problems among patients with eating disorders. A two-arm open randomized controlled trial comparing a Web-based CBT intervention to a waiting list control condition (WL) was carried out among female patients with bulimia nervosa (BN), binge eating disorder (BED), and eating disorders not otherwise specified (EDNOS). The eating disorder diagnosis was in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and was established based on participants' self-report. Participants were recruited from an open-access website, and the intervention consisted of a structured two-part program within a secure Web-based application. The aim of the first part was to analyze participant's eating attitudes and behaviors, while the second part focused on behavioral change. Participants had asynchronous contact with a personal therapist twice a week, solely via the Internet. Self-report measures of eating disorder psychopathology (primary outcome), body dissatisfaction, physical health, mental health, self-esteem, quality of life, and social functioning were completed at baseline and posttest. A total of 214 participants were randomized to either the Web-based CBT group (n=108) or to the WL group (n=106) stratified by type of eating disorder (BN: n=44; BED: n=85; EDNOS: n=85). Study attrition was low with 94% of the participants completing the posttest assignment. Overall, Web-based CBT showed a significant improvement over time for eating disorder psychopathology (F97=63.07, Peating disorder psychopathology (F201
Ajani, Jaffer A.; Winter, Kathryn; Komaki, Ritsuko; Kelsen, David P.; Minsky, Bruce D.; Liao, Zhongxing; Bradley, Jeffrey; Fromm, Mitchel; Hornback, David; Willett, Christopher G.
Purpose Two nonoperative approaches (one without fluorouracil) using induction chemotherapy and then definitive chemoradiotherapy developed at two centers were compared in patients with localized esophageal cancer (LEC). The primary end point was to assess whether any approach would achieve a ≥ 77.5% 1-year survival rate, surpassing the historical 66% rate from the Radiation Therapy Oncology Group (RTOG) protocol 9405. Patients and Methods In a multi-institutional cooperative group setting, patients with LEC who had unresectable cancer, were unwilling to undergo surgery, or were medically unfit for surgery were randomly assigned to receive either induction with fluorouracil, cisplatin, and paclitaxel and then fluorouracil plus paclitaxel with 50.4 Gy of radiation (arm A) or induction with paclitaxel plus cisplatin and then the same chemotherapy with 50.4 Gy of radiation (arm B). Safety and survival rates were assessed. Results A total of 84 patients were randomly assigned (arm A, n = 41; arm B, n = 43), and 72 were assessable (arm A, n = 37; arm B, n = 35). The median survival time was 28.7 months for patients in arm A and 14.9 months for patients in arm B (18.8 months for patients in RTOG 9405). The 1-year survival rate of 75.7% in arm A was close to, but did not meet or surpass, the 77.5% goal. The 2-year survival rate was 56% for arm A and 37% for arm B. Grade 3 (arm A = 54%, arm B = 43%) and grade 4 toxicities (arm A = 27%, arm B = 40%) were frequent. Treatment-related death occurred in 3% of patients in arm A and 6% of patients in arm B. Conclusion Both arms of RTOG 0113 were associated with high morbidity, and the study did not meet its 1-year survival end point. PMID:18574157
Gok Metin, Zehra; Ozdemir, Leyla
Nonpharmacologic interventions for symptom management in patients with rheumatoid arthritis are underinvestigated. Limited data suggest that aromatherapy massage and reflexology may help to reduce pain and fatigue in patients with rheumatoid arthritis. The aim of this study was to examine and compare the effects of aromatherapy massage and reflexology on pain and fatigue in patients with rheumatoid arthritis. The study sample was randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in the first intervention group for 30 minutes. Reflexology was administered to both feet of subjects in the second intervention group for 40 minutes during weekly home visits. Control group subjects received no intervention. Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this randomized controlled trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks. Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p aromatherapy massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p Aromatherapy massage and reflexology are simple and effective nonpharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis. Copyright © 2016 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.
Yang, Jaewon; Bahk, Won-Myong; Cho, Hyun-Sang; Jeon, Yang-Whan; Jon, Duk-In; Jung, Hee-Yeon; Kim, Chan-Hyung; Kim, Hee-Cheol; Kim, Yong-Ku; Kim, Young-Hoon; Kwon, Jun-Soo; Lee, Sang-Yeol; Lee, Seung-Hwan; Yi, Jung-Seo; Yoon, Bo-Hyun; Kim, Seung-Hyun
The objective of this study was to evaluate the efficacy and tolerability of blonanserin for the treatment of Korean patients with schizophrenia using a double-blind risperidone-compared design. Patients aged 18 to 65 years with schizophrenia were randomly assigned to blonanserin or risperidone treatment for 8 weeks. The efficacy was assessed using the mean change in Positive and Negative Syndrome Scale score total scores from baseline to week 8. Safety assessments included monitoring of vital signs, a physical examination, laboratory tests, and adverse events. Of 206 randomly enrolled patients, 103 receiving blonanserin and 103 receiving risperidone were included in the analysis. In this study, noninferiority between blonanserin and risperidone was demonstrated. The mean change in the Positive and Negative Syndrome Scale total score at the final evaluation time point was -23.48 +/- 19.73 for the blonanserin group and -25.40 +/- 18.38 for the risperidone group. Adverse events, which occurred less frequently in the blonanserin than in the risperidone group, included dysarthria (P = 0.0288), dizziness (P = 0.0139), increased alanine aminotransferase and aspartate aminotransferase (P = 0.0095 and P = 0.0032, respectively), and increased level blood prolactin (P = 0.0012). On the other hand, the adverse events that occurred more frequently in the blonanserin than in the risperidone group was hand tremor (P = 0.0006). Blonanserin was effective in the treatment of Korean patients with schizophrenia compared with risperidone and was more tolerable with a better safety profile, particularly with respect to prolactin elevation. These findings suggest that blonanserin is useful in the treatment of schizophrenia.
Zhao, Ming-xing; Dong, Zhen-hua; Yu, Zhong-hai; Xiao, Shi-yuan; Li, Ya-ming
Mild cognitive impairment is a transitional stage between normal aging and dementia. It is important in terms of recognizing memory loss in older people as well as identifying a group of individuals at high risk of developing dementia and who may benefit from preventive strategies. Ginkgo biloba extract has been shown to possess polyvalent properties, such as anti-oxidation, anti-apoptosis and anti-inflammation. Ginkgo biloba extract appears to have a neuroprotective effect against neurodegenerative diseases. To observe the efficacy of Ginkgo biloba leaf tablet in improving episodic memory of mild cognitive impairment. This is a multicenter, randomized, controlled trial. The authors enrolled generally healthy, ambulatory or ambulatory-aided amnestic subjects with MCI, 60 to 85 years old, who expressed a memory complaint from Huadong Hospital, seven Community Health Centers in Shanghai, and Shanghai First Welfare Institution. A total of 120 MCI patients were randomly assigned to the Ginkgo biloba leaf tablet group (treatment group, 60 cases) and control group (60 cases). The patients in the treatment group took Ginkgo biloba leaf tablets 3 times a day, 19.2 mg each dose. The control group did not receive any intelligence-promoting or vasodilator reflex treatment except some health care. The patients were tested with nonsense picture recognition of the clinical memory scale and the logical memory test based on the Wechsler memory scale before and after treatment. After 6 months of treatment, the scores of the logical memory test and nonsense picture recognition were increased significantly in the treatment group (P0.05). After treatment, the positive rate of nonsense picture recognition was 55.17% in the treatment group, which was significantly higher than that of the control group at 32.73% (PGinkgo biloba leaf tablet showed good efficacy in promoting episodic memory function in MCI patients.
González-Islas, Dulce; Orea-Tejeda, Arturo; Castillo-Martínez, Lilia; Olvera-Mayorga, Gabriela; Rodríguez-García, Wendy Daniella; Santillán-Díaz, Cira; Keirnes-Davis, Candace; Vaquero-Barbosa, Nayeli
Nutritional therapy in heart failure (HF) patients has been focused on fluid and sodium restriction with the aim of decreasing volume overload. However, these recommendations are not well established and sometimes controversial. To evaluate the effect of the consumption of a low-carbohydrate diet on oxygen saturation, body composition and clinical variables during two months of follow-up in chronic, stable heart failure patients. In a parallel group randomized controlled clinical trial, 88 ambulatory patients were randomly assigned to a low-carbohydrate diet group (40% carbohydrates, 20% protein and 40% fats [12% saturated, 18% monounsaturated and 10% polyunsaturated]) or a standard diet group (50% carbohydrates, 20% protein and 30% fats [10% saturated, 10% monounsaturated and 10% polyunsaturated]) for two months. Diets were normocaloric in both groups. At baseline and at two months of follow-up, the variables evaluated were: oxygen saturation, dietary intake, body composition and handgrip strength. After two months of follow-up, the low-carbohydrate diet group decreased the carbohydrate consumption and had improved oxygen saturation (93.0 ±4.4 to 94.6 ± 3.2, p = 0.02), while the standard diet group had decreased (94.90 ± 2.4 to 94.0 ± 2.9, p = 0.03). There were also differences between the groups at the end of the study (p = 0.04). No significant differences showed in handgrip strength in both groups, low-carbohydrate diet group (26.4 ± 8.3 to 27.2 ± 8.3 kg, p = 0.07) and standard diet group (25.4 ± 8.9 to 26.1 ± 9.5 kg, p = 0.14). Low-carbohydrate diet may improve the oxygen saturation in patients with chronic stable heart failure.
Asakura, Satoshi; Hayano, Taiji; Hagino, Atsushi; Koyama, Tsukasa
This randomized, double-blind placebo-controlled study compared the efficacy and tolerability of escitalopram (10 and 20 mg/day) in Japanese patients with social anxiety disorder (SAD). Patients aged 18-64 years with a primary diagnosis of DSM-IV-TR defined SAD, a Liebowitz Social Anxiety Scale Japanese version (LSAS-J) total score ≥60 and a Clinical Global Impression-Severity (CGI-S) score ≥4 at baseline were randomly assigned (1:1:1) to placebo, escitalopram 10 mg or escitalopram 20 mg. The primary endpoint was change from baseline to Week 12 in the LSAS-J total score for both escitalopram 10 mg and 20 mg versus placebo (ANCOVA, FAS, LOCF), using a hierarchical testing procedure. Pre-specified secondary endpoints included LSAS-J sensitivity analyses. This study has the www.japic.or.jp identifier: JapicCTI-121842. For the primary efficacy endpoint, the difference from placebo in the LSAS-J was -3.9 (p = 0.089) for escitalopram 10 mg. Since the superiority of escitalopram 10 mg over placebo was not confirmed, an analysis without multiplicity adjustment was made, which showed a difference for escitalopram 20 mg versus placebo of -9.8 (p escitalopram 10 mg) and -10.1 (p escitalopram 20 mg). Common adverse events (incidence ≥5% and significantly different from placebo) were somnolence, nausea and ejaculation disorder. Escitalopram was efficacious, safe and well tolerated by patients with SAD in Japan. Study limitations are discussed including patient characteristics.
Mendes, Fernanda de Souza Nogueira Sardinha; Sousa, Andréa Silvestre; Souza, Fernando Cesar de Castro Cesar; Pinto, Vivian Liane Mattos; Silva, Paula Simplicio; Saraiva, Roberto Magalhães; Xavier, Sergio Salles; Veloso, Henrique Horta; Holanda, Marcelo Teixeira; Costa, Andréa Rodrigues; Carneiro, Fernanda Martins; Silva, Gilberto Marcelo Sperandio; Borges, Juliana Pereira; Tibirica, Eduardo; Pinheiro, Roberta Olmo; Lara, Flávio Alves; Hasslocher-Moreno, Alejandro Marcel; Brasil, Pedro Emmanuel Alvarenga Americano; Mediano, Mauro Felippe Felix
The effects of exercise training on Chagas heart disease are still unclear. This study aimed to evaluate the effect of exercise training over functional capacity, cardiac function, quality of life, and biomarkers in Chagas heart disease. The PEACH study is a superiority randomized clinical trial which will include subjects who meet the following criteria: Chagas heart disease with a left ventricular ejection fraction below 45 % with or without heart failure symptoms; clinical stability in the last 3 months; adherence to clinical treatment; and age above 18 years. The exclusion criteria are: pregnancy; neuromuscular limitations; smoking; evidence of non-chagasic heart disease; systemic conditions that limit exercise practice or cardiopulmonary exercise test; unavailability to attend the center three times a week during the intervention period; and practitioners of regular exercise. The intervention group will perform an exercise training intervention three times per week during 6 months and will be compared to the control group without exercise. Both groups will undergo the same monthly pharmaceutical and nutritional counseling as well as standard medical treatment according to the Brazilian consensus on Chagas disease. The primary outcome is functional capacity based on peak exercise oxygen consumption during cardiopulmonary exercise testing. Secondary outcomes are: cardiac function; body composition; muscle respiratory strength; microvascular reactivity; cardiac rhythm abnormalities; autonomic function; biochemical; oxidative stress and inflammatory biomarkers; and quality of life. Subjects will be evaluated at baseline, and at 3 and 6 months after randomization. Thirty patients will be randomly assigned into exercise or control groups at a ratio of 1:1. Findings of the present study will be useful to determine if physical exercise programs should be included as an important additional therapy in the treatment of patients with Chagas heart disease. Clinical
Herschtal, A.; te Marvelde, L.; Mengersen, K.; Hosseinifard, Z.; Foroudi, F.; Devereux, T.; Pham, D.; Ball, D.; Greer, P. B.; Pichler, P.; Eade, T.; Kneebone, A.; Bell, L.; Caine, H.; Hindson, B.; Kron, T.
Collected real-life clinical target volume (CTV) displacement data show that some patients undergoing external beam radiotherapy (EBRT) demonstrate significantly more fraction-to-fraction variability in their displacement (‘random error’) than others. This contrasts with the common assumption made by historical recipes for margin estimation for EBRT, that the random error is constant across patients. In this work we present statistical models of CTV displacements in which random errors are characterised by an inverse gamma (IG) distribution in order to assess the impact of random error variability on CTV-to-PTV margin widths, for eight real world patient cohorts from four institutions, and for different sites of malignancy. We considered a variety of clinical treatment requirements and penumbral widths. The eight cohorts consisted of a total of 874 patients and 27 391 treatment sessions. Compared to a traditional margin recipe that assumes constant random errors across patients, for a typical 4 mm penumbral width, the IG based margin model mandates that in order to satisfy the common clinical requirement that 90% of patients receive at least 95% of prescribed RT dose to the entire CTV, margins be increased by a median of 10% (range over the eight cohorts -19% to +35%). This substantially reduces the proportion of patients for whom margins are too small to satisfy clinical requirements.
Sleep improvement for restless legs syndrome patients. Part I: pooled analysis of two prospective, double-blind, sham-controlled, multi-center, randomized clinical studies of the effects of vibrating pads on RLS symptoms
Full Text Available Fred Burbank,1 Mark J Buchfuhrer,2 Branko Kopjar31Salt Creek International Women’s Health Foundation, San Clemente, CA, USA; 2Stanford University Center for Sleep Sciences, Downey, CA, USA; 3Department of Health Services, University of Washington, Seattle, WA, USAPurpose: Pooled data from two randomized, double-blind, prospective clinical trials were analyzed (i to determine if vibratory stimulation can safely treat patients with moderately severe restless legs syndrome and (ii to compare two types of shams.Patients and methods: One hundred and fifty-eight patients with at least moderately severe primary restless legs syndrome (a score of 15 or greater on the International Restless Legs Syndrome Study Group rating scale were enrolled at five investigational sites, between April 20, 2009 and February 12, 2010. Patients were randomly assigned to treatment with a vibrating pad or control (sound-producing or light-emitting sham pad. Patients and investigators were blinded to pad assignment type (treatment pad or sham pad. Efficacy was measured as a change in score from baseline to week 4, on the Medical Outcomes Study Sleep Problems Index II, the Johns Hopkins Restless Legs Syndrome Quality of Life summary scale, and the International Restless Legs Syndrome Study Group rating scale. Clinicians were asked to evaluate the effectiveness of the pad assignment and to guess whether treatment or sham therapy had been assigned. Adverse events related to vibrating pad assignment were tabulated.Results: The Medical Outcomes Study Sleep Problems Index II scores improved significantly more for patients receiving a vibrating pad over those receiving a sham pad (P ≤ 0.02 even when corrected for multiplicity (P ≤ 0.04. Clinician evaluation favored patients assigned vibrating pads, and neither patients nor clinicians accurately guessed which pad was assigned. No significant difference in adverse event rates was observed between the vibrating and sham pad
Full Text Available Background/Aims: This study explores the effective outcomes of a structured cognitive stimulation treatment to improve cognition and behavioral symptoms in people with dementia (PWDs, using a randomized controlled clinical trial. Methods: Thirty PWDs were divided into three groups: experimental (treated with cognitive stimulation, placebo (treated with occupational therapy, and control (continuing with the usual activities of the nursing home. Assessment, at baseline and after a period of 8 weeks, was performed using the Clinical Dementia Rating Scale, activities of daily living, Mini-Mental State Examination, Esame Neuropsicologico Breve 2, Geriatric Depression Scale and Behavioral Pathology in Alzheimer's Disease Scale. Results: Only the experimental group improved its performance in cognitive tests (p Conclusions: The results suggest that a cognitive stimulation treatment for PWDs would improve not only their cognition, but also behavioral symptoms.
El-Sadr, W M; Grund, B; Neuhaus, J; Babiker, A; Cohen, C J; Darbyshire, J; Emery, S; Lundgren, J D; Phillips, A; Neaton, J D
Episodic use of antiretroviral therapy guided by CD4+ cell counts is inferior to continuous antiretroviral therapy. To determine whether reinitiating continuous antiretroviral therapy in patients who received episodic treatment reduces excess risk for opportunistic disease or death. Randomized, controlled trial. Sites in 33 countries. 5472 HIV-infected individuals with CD4(+) cell counts greater than 0.350 x 10(9) cells/L enrolled from January 2002 to January 2006. Episodic or continuous antiretroviral therapy initially, followed by continuous therapy in participants previously assigned to episodic treatment. Opportunistic disease or death was the primary outcome. Eighteen months after the recommendation to reinitiate continuous therapy, mean CD4+ cell counts were 0.152 x 10(9) cells/L (95% CI, 0.136 to 0.167 x 10(9) cells/L) less in participants previously assigned to episodic treatment (P HIV RNA levels of 400 copies/mL or less was 29% for participants initially assigned to episodic therapy and 66% for those assigned to continuous therapy. Participants who reinitiated continuous therapy experienced rapid suppression of HIV RNA levels (89.7% with HIV RNA levels disease or death decreased after the recommendation to reinitiate continuous therapy (from 2.5 [CI, 1.8 to 3.5] to 1.4 [CI, 1.0 to 2.0]; P = 0.033 for difference). The residual excess risk was attributable to failure to reinitiate therapy by some participants and slow recovery of CD4+ cell counts for those who reinitiated therapy. Follow-up was too short to assess the full effect of switching from episodic to continuous antiretroviral therapy. Reinitiating continuous antiretroviral therapy in patients previously assigned to episodic treatment reduced excess risk for opportunistic disease or death, but excess risk remained. Episodic antiretroviral therapy, as used in the SMART study, should be avoided.
Mozaffari-Khosravi, Hassan; Naderi, Zahra; Dehghan, Ali; Nadjarzadeh, Azadeh; Fallah Huseini, Hassan
There is limited evidence that ginger powder consumption can relieve pain and inflammation due to specific anti-inflammatory phytochemical constitutents. This study investigates the effect of ginger supplementation on proinflammatory factors in participants (n = 120) of a randomized double-blind placebo-controlled 3-month clinical trial investigating knee osteoarthritis. Patients were randomly assigned to one of two groups: the ginger group (GG) or the placebo group (PG). Administered daily for 3 months, participants in the GG intervention received capsules containing 500 mg of ginger powder, while PG participants received capsules filled with 500 mg starch. Serum samples collected at baseline and 3 months were analyzed for serum levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β). At baseline, proinflammatory cytokine concentrations did not differ by group. However, at 3 months, both cytokines decreased in the GG relative to the PG. The results of this study indicate that ginger supplementation may have a promising benefits for knee osteoarthritis and may, therefore, may warrant further study.
Taveggia, Giovanni; Borboni, Alberto; Mulé, Chiara; Negrini, Stefano
Robot gait training has the potential to increase the effectiveness of walking therapy. Clinical outcomes after robotic training are often not superior to conventional therapy. We evaluated the effectiveness of a robot training compared with a usual gait training physiotherapy during a standardized rehabilitation protocol in inpatient participants with poststroke hemiparesis. This was a randomized double-blind clinical trial in a postacute physical and rehabilitation medicine hospital. Twenty-eight patients, 39.3% women (72±6 years), with hemiparesis (Bobath approach were assigned randomly to an experimental or a control intervention of robot gait training to improve walking (five sessions a week for 5 weeks). Outcome measures included the 6-min walk test, the 10 m walk test, Functional Independence Measure, SF-36 physical functioning and the Tinetti scale. Outcomes were collected at baseline, immediately following the intervention period and 3 months following the end of the intervention. The experimental group showed a significant increase in functional independence and gait speed (10 m walk test) at the end of the treatment and follow-up, higher than the minimal detectable change. The control group showed a significant increase in the gait endurance (6-min walk test) at the follow-up, higher than the minimal detectable change. Both treatments were effective in the improvement of gait performances, although the statistical analysis of functional independence showed a significant improvement in the experimental group, indicating possible advantages during generic activities of daily living compared with overground treatment. PMID:26512928
Taveggia, Giovanni; Borboni, Alberto; Mulé, Chiara; Villafañe, Jorge H; Negrini, Stefano
Robot gait training has the potential to increase the effectiveness of walking therapy. Clinical outcomes after robotic training are often not superior to conventional therapy. We evaluated the effectiveness of a robot training compared with a usual gait training physiotherapy during a standardized rehabilitation protocol in inpatient participants with poststroke hemiparesis. This was a randomized double-blind clinical trial in a postacute physical and rehabilitation medicine hospital. Twenty-eight patients, 39.3% women (72±6 years), with hemiparesis (treatment according to the Bobath approach were assigned randomly to an experimental or a control intervention of robot gait training to improve walking (five sessions a week for 5 weeks). Outcome measures included the 6-min walk test, the 10 m walk test, Functional Independence Measure, SF-36 physical functioning and the Tinetti scale. Outcomes were collected at baseline, immediately following the intervention period and 3 months following the end of the intervention. The experimental group showed a significant increase in functional independence and gait speed (10 m walk test) at the end of the treatment and follow-up, higher than the minimal detectable change. The control group showed a significant increase in the gait endurance (6-min walk test) at the follow-up, higher than the minimal detectable change. Both treatments were effective in the improvement of gait performances, although the statistical analysis of functional independence showed a significant improvement in the experimental group, indicating possible advantages during generic activities of daily living compared with overground treatment.
Ford, Jessica; Rosman, Lindsey; Wuensch, Karl; Irvine, Jane; Sears, Samuel F
Approximately 20% of patients with implantable cardioverter defibrillators (ICDs) suffer from posttraumatic stress disorder (PTSD) due to a history of cardiac arrest, device implantation, and ICD shock. There has been very little examination of treatment of PTSD symptoms in these patients. This study evaluated the effect of a specific cognitive-behavioral therapy (CBT) intervention for ICD patients with high levels of PTSD symptoms: a manualized program consisting of 8 telephone sessions with a trained counselor, a patient education book, and a stress management procedure on compact disc. Participants were 193 ICD patients, who were randomized to CBT or usual cardiac care (UCC) who completed self-report surveys at the time of recruitment and 6 and 12 months after initial measurement. Previous publication on the primary research evaluation questions reported that the CBT condition resulted in greater improvement on PTSD and depression symptoms than the UCC for the general population of ICD patients, but did not evaluate the effect on those with elevated symptoms of PTSD. The authors conducted secondary analyses of the effect of treatment on high and low PTSD symptom groups based on a cutoff for the Impact of Event Scale-Revised (Weiss & Marmar, 1997). Participants in the CBT group who had high symptoms experienced significantly greater symptom reduction from baseline to 12 months (d = 2.44, p = .021) than the UCC group (d = 1.12). Participants with low symptoms had small reductions regardless of group assignment (d = 0.16, p = .031). ICD-focused CBT was sufficient to produce a large, statistically significant reduction in PTSD symptoms in ICD patients with indications for treatment. Copyright © 2016 International Society for Traumatic Stress Studies.
Kamiya, Takeshi; Shikano, Michiko; Kubota, Eiji; Mizoshita, Tsutomu; Wada, Tsuneya; Tanida, Satoshi; Kataoka, Hiromi; Adachi, Hiroshi; Hirako, Makoto; Okuda, Noriaki; Joh, Takashi
The aims of this study were to compare the therapeutic effects of a proton pump inhibitor (PPI), rabeprazole (RPZ), and a prokinetic agent, itopride (ITO), and to investigate the role of PPI in the treatment strategy for Japanese functional dyspepsia (FD) patients. We randomly assigned 134 patients diagnosed by Rome III criteria to 4 weeks treatment with RPZ 10 mg/day (n = 69) or ITO 150 mg/day (n = 65). Dyspeptic symptoms were evaluated using FD scores at baseline and after 1, 2 and 4 weeks of treatment. We also divided subjects into predominantly epigastric pain syndrome (EPS) or postprandial distress syndrome (PDS), and evaluated the efficacy of RPZ and ITO respectively. RPZ showed a significant decrease in the Rate of Change (RC) in FD score within 1 week, which was maintained until after 4 weeks, with RPZ a significant effect compared with ITO at all evaluation points. In addition, RPZ showed a significant decrease in FD score in subjects with both EPS and PDS, whereas a significant decrease in the RC with ITO was only shown in those with predominant PDS. Acid-suppressive therapy with RPZ is useful for PDS as well EPS in Japanese FD patients (UMIN Clinical Trials Registry number: UMIN 000013962).
Foster, Gary D.; Borradaile, Kelley E.; Sanders, Mark H.; Millman, Richard; Zammit, Gary; Newman, Anne B.; Wadden, Thomas A.; Kelley, David; Wing, Rena R.; Pi-Sunyer, F. Xavier; Reboussin, David; Kuna, Samuel T.
Background The belief that weight loss improves obstructive sleep apnea (OSA) has limited empirical support. The purpose of this 4-center study was to assess the effects of weight loss on OSA over a 1-year period. Methods The study included 264 participants with type 2 diabetes and a mean (SD) age of 61.2 (6.5) years, weight of 102.4 (18.3) kg, body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) of 36.7 (5.7), and an apnea-hypopnea index (AHI) of 23.2 (16.5) events per hour. The participants were randomly assigned to either a behavioral weight loss program developed specifically for obese patients with type 2 diabetes (intensive lifestyle intervention [ILI]) or 3 group sessions related to effective diabetes management (diabetes support and education [DSE]). Results The ILI participants lost more weight at 1 year than did DSE participants (10.8 kg vs 0.6 kg; P weight loss were the strongest predictors of changes in AHI at 1 year (Pweight loss of 10 kg or more had the greatest reductions in AHI. Conclusions Physicians and their patients can expect that weight loss will result in significant and clinically relevant improvements in OSA among obese patients with type 2 diabetes. Trial Registration clinicaltrials.gov Identifier: NCT00194259 PMID:19786682
Vijayakumar, Maniyal; Vasudevan, D M; Sundaram, K R; Krishnan, Sajitha; Vaidyanathan, Kannan; Nandakumar, Sandya; Chandrasekhar, Rajiv; Mathew, Navin
Coronary artery disease (CAD) and its pathological atherosclerotic process are closely related to lipids. Lipids levels are in turn influenced by dietary oils and fats. Saturated fatty acids increase the risk for atherosclerosis by increasing the cholesterol level. This study was conducted to investigate the impact of cooking oil media (coconut oil and sunflower oil) on lipid profile, antioxidant mechanism, and endothelial function in patients with established CAD. In a single center randomized study in India, patients with stable CAD on standard medical care were assigned to receive coconut oil (Group I) or sunflower oil (Group II) as cooking media for 2 years. Anthropometric measurements, serum, lipids, Lipoprotein a, apo B/A-1 ratio, antioxidants, flow-mediated vasodilation, and cardiovascular events were assessed at 3 months, 6 months, 1 year, and 2 years. Hundred patients in each arm completed 2 years with 98% follow-up. There was no statistically significant difference in the anthropometric, biochemical, vascular function, and in cardiovascular events after 2 years. Coconut oil even though rich in saturated fatty acids in comparison to sunflower oil when used as cooking oil media over a period of 2 years did not change the lipid-related cardiovascular risk factors and events in those receiving standard medical care. Copyright © 2015 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.
Koch, Alexander; Nafziger, Julia
Inefficient job assignments are usually explained with incomplete information about employees' abilities or contractual imperfections. We show that inefficient assignments arise even without uncertainty about the employee's ability and with complete contracts. Building on this result we provide...
Cruciani, Ricardo A.; Zhang, Jenny J.; Manola, Judith; Cella, David; Ansari, Bilal; Fisch, Michael J.
Purpose L-carnitine, a popular complementary and alternative medicine product, is used by patients with cancer for the treatment of fatigue, the most commonly reported symptom in this patient population. The purpose of this study was to determine the efficacy of L-carnitine supplementation as a treatment for fatigue in patients with cancer. Patients and Methods In this double-blind, placebo-controlled trial, patients with invasive malignancies and fatigue were randomly assigned to either 2 g/d of L-carnitine oral supplementation or matching placebo. The primary end point was the change in average daily fatigue from baseline to week 4 using the Brief Fatigue Inventory (BFI). Results Three hundred seventy-six patients were randomly assigned to treatment with L-carnitine supplementation or placebo. L-carnitine supplementation resulted in significant carnitine plasma level increase by week 4. The primary outcome, fatigue, measured using the BFI, improved in both arms compared with baseline (L-carnitine: −0.96, 95% CI, −1.32 to −0.60; placebo: −1.11, 95% CI −1.44 to −0.78). There were no statistically significant differences between arms (P = .57). Secondary outcomes, including fatigue measured by the Functional Assessment of Chronic Illness Therapy–Fatigue instrument, depression, and pain, did not show significant difference between arms. A separate analysis of patients who were carnitine-deficient at baseline did not show statistically significant improvement in fatigue or other outcomes after L-carnitine supplementation. Conclusion Four weeks of 2 g of L-carnitine supplementation did not improve fatigue in patients with invasive malignancies and good performance status. PMID:22987089
Huang, Huawei; Jiang, Li; Shen, Ling; Zhang, Guobin; Zhu, Bo; Cheng, Jiajia; Xi, Xiuming
Sleep deprivation is common in critically ill patients in intensive care units (ICU). It can result in delirium, difficulty weaning, repeated nosocomial infections, prolonged ICU length of stay and increased ICU mortality. Melatonin, a physiological sleep regulator, is well known to benefit sleep quality in certain people, but evidence for the effectiveness in ICU sleep disturbance is limited. This study has a prospective, randomized, double-blind, controlled, parallel-group design. Eligible patients are randomly assigned to one of the two treatment study groups, labelled the 'melatonin group' or the 'placebo group'. A dose of 3 mg of oral melatonin or placebo is administered at 9:00 pm on four consecutive days. Earplugs and eye masks are made available to every participant. We plan to enrol 198 patients. The primary outcome is the objective sleep quality measured by the 24-hour polysomnography. The secondary outcomes are the subjective sleep quality assessed by the Richards Campbell Sleep Questionnaire, the anxiety level evaluated by the Visual Analogue Scale-Anxiety, the number of delirium-free days in 8 and 28 days, the number of ventilation-free days in 28 days, the number of antibiotic-free days, ICU length of stay, the overall ICU mortality in 28 days and the incidence and severity of the side effects of melatonin in ICU patients. Additionally, the body stress levels, oxidative stress levels and inflammation levels are obtained via measuring the plasma melatonin, cortisone, norepinephrine, malonaldehyde(MDA), superoxide dismutase(SOD), interleukin-6 (IL-6) and interleukin-8 (IL-8)concentrations. The proposed study will be the first randomized controlled study to use the polysomnography, which is the gold standard of assessing sleep quality, to evaluate the effect of melatonin on the sleep quality and circadian rhythms of ICU patients. The results may recommend a new treatment for ICU patients with sleep deprivation that is safe, effective and easily
Staats, Peter S; Yearwood, Thomas; Charapata, Steven G; Presley, Robert W; Wallace, Mark S; Byas-Smith, Michael; Fisher, Robert; Bryce, David A; Mangieri, Eugene A; Luther, Robert R; Mayo, Martha; McGuire, Dawn; Ellis, David
Ziconotide (formerly SNX-111) selectively blocks N-type voltage-sensitive calcium channels and may be effective in patients with pain that is refractory to opioid therapy or those with intolerable opioid-related adverse effects. To assess the safety and efficacy of intrathecal ziconotide in patients with pain that is refractory to conventional treatment. Double-blind, placebo-controlled, randomized trial conducted from March 12, 1996, to July 11, 1998, at 32 study centers in the United States, Australia, and the Netherlands. Patients were 111 individuals ages 24 to 85 years with cancer or AIDS and a mean Visual Analog Scale of Pain Intensity (VASPI) score of 50 mm or greater. Patients were randomly assigned in a 2:1 ratio to receive ziconotide or placebo treatment. Intrathecal ziconotide was titrated over 5 to 6 days, followed by a 5-day maintenance phase for responders and crossover of nonresponders to the opposite treatment group. Mean percentage change in VASPI score from baseline to the end of the initial titration period. Of the evaluable population, 67 (98.5%) of 68 patients receiving ziconotide and 38 (95%) of 40 patients receiving placebo were taking opioids at baseline (median morphine equivalent dosage of 300 mg/d for the ziconotide group and 600 mg/d for the placebo group; P =.63, based on mean values), and 36 had used intrathecal morphine. Mean (SD) VASPI scores were 73.6 (1.8) mm in the ziconotide group and 77.9 (2.3) mm in the placebo group (P =.18). Mean VASPI scores improved 53.1% (95% confidence interval [CI], 44.0%-62.2%) in the ziconotide group and 18.1% (95% CI, 4.8%-31.4%) in the placebo group (Pziconotide in the maintenance phase. Pain relief was moderate to complete in 52.9% of patients in the ziconotide group compared with 17.5% in the placebo group (Pziconotide achieved complete pain relief, and 50.0% of patients receiving ziconotide responded to therapy compared with 17.5% of those receiving placebo (P =.001). Intrathecal ziconotide
Spies, C D; Dubisz, N; Neumann, T; Blum, S; Müller, C; Rommelspacher, H; Brummer, G; Specht, M; Sanft, C; Hannemann, L; Striebel, H W; Schaffartzik, W
To assess the effect of three different alcohol withdrawal therapy regimens in traumatized chronic alcoholic patients with respect to the duration of mechanical ventilation and the frequency of pneumonia and cardiac disorders during their intensive care unit (ICU) stay. A prospective, randomized, blinded, controlled clinical trial. A university hospital ICU. Multiple-injured alcohol-dependent patients (n=180) transferred to the ICU after admission to the emergency room and operative management. A total of 180 patients were included in the study; however, 21 patients were excluded from the study after assignment. Patients who developed actual alcohol withdrawal syndrome were randomized to one of the following treatment regimens: flunitrazepam/clonidine (n=54); chlormethiazole/haloperidol (n=50); or flunitrazepam/haloperidol (n=55). The need for administration of medication was determined, using a validated measure of the severity of alcohol withdrawal (Revised Clinical Institute Withdrawal Assessment for Alcohol Scale). The duration of mechanical ventilation and major intercurrent complications, such as pneumonia, sepsis, cardiac disorders, bleeding disorders, and death, were documented. Patients did not differ significantly between groups regarding age, Revised Trauma and Injury Severity Score and Acute Physiology and Chronic Health Evaluation II score on admission. In all except four patients in the flunitrazepam/clonidine group, who continued to hallucinate, the Revised Clinical Institute Withdrawal Assessment for Alcohol Scale decreased to <20 after initiation of therapy. ICU stay did not significantly differ between groups (p=.1669). However, mechanical ventilation was significantly prolonged in the chlormethiazole/haloperidol group (p=.0315) due to an increased frequency of pneumonia (p=.0414). Cardiac complications were significantly (p=.0047) increased in the flunitrazepam/clonidine group. There was some advantage in the flunitrazepam/clonidine regimen with
Bielka, Kateryna; Kuchyn, Iurii; Glumcher, Felix
Dexmedetomidine (DEX) is a centrally acting alpha-2-adrenoceptor agonist that has potential in the management of alcohol withdrawal syndrome (AWS) owing to its ability to produce arousable sedation and to inhibit the adrenergic system without respiratory depression. The objective of this randomized controlled study was to evaluate whether addition of DEX to benzodiazepine (BZD) therapy is effective and safe for AWS patients in the intensive care unit (ICU). Eligible participants were randomly assigned to intervention (Group D; n = 36) or control (Group C; n = 36). In Group D, DEX infusion was started at a dose of 0.2-1.4 μg/kg/h and titrated to achieve the target sedation level (-2 to 0 on the Richmond Agitation Sedation Scale (RASS)) with symptom-triggered BZD (10 mg diazepam bolus) was used as needed. Patients in Group C received only symptom-triggered 10 mg boluses of diazepam. The primary efficacy outcomes were 24-h diazepam consumption and cumulative diazepam dose required over the course of the ICU stay; secondary outcomes included length of ICU stay, sedation and communication quality and haloperidol requirements. Median 24-h diazepam consumption during the study was significantly lower in Group D (20 vs. 40 mg, p < 0.001), as well as median cumulative diazepam dose during the ICU stay (60 vs. 90 mg, p < 0.001). The median percentage of time in the target sedation range was higher in Group D (median 90 % (90-95) vs. 64.5 % (60-72.5; p < 0.001). DEX infusion was also associated with better nurse-assessed patient communication (<0.001) and fewer patients requiring haloperidol treatment (2 vs. 10 p = 0.02). One patient in Group D and four in Group C were excluded owing to insufficient control of AWS symptoms and use of additional sedatives (p = 0.36). There were no severe adverse events in either group. Spontaneous breathing remained normal in all patients. Bradycardia was a common adverse event in Group D (10 vs. 2; p = 0.03). DEX
Takamoto, K; Bito, I; Urakawa, S; Sakai, S; Kigawa, M; Ono, T; Nishijo, H
Although there is some evidence that massage therapy, especially compression at myofascial trigger points (MTrPs), is effective for sub-acute and chronic low back pain, the effectiveness of massage therapy with compression at MTrPs for acute low back pain has not been studied. To evaluate the effectiveness of compression at MTrPs for acute low back pain, 63 patients with acute low back pain were randomly assigned to one of three groups: the MTrP group who received compression at MTrPs (N = 23), the non-MTrP group who received compression at non-trigger points (N = 21), and the effleurage massage group who received superficial massage (N = 19). The patients received the assigned treatment 3 times/week for 2 weeks. The subjective pain intensity in static and dynamic conditions and disability caused by low back pain were measured by the visual analogue scale (VAS) and Roland-Morris questionnaire (RMQ), respectively; along with the range of motion (ROM) at the lumbar region and pressure pain threshold (PPT) at trigger points before treatment (baseline), 1 week after the start of treatment, and 1 month after the end of treatment (follow-up). Static and dynamic VAS score, PPT and ROM were significantly improved in the MTrP group compared with those in the non-MTrP and effleurage groups. These results indicate that compression at MTrPs is effective to treat acute low back pain compared with compression at non-MTrPs and superficial massage. For this article, a commentary is available at the Wiley Online Library. © 2015 European Pain Federation - EFIC®
Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E
To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.
Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.
Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677
van Santen, Marijke; Bolwijn, Paulien; Verstappen, Frans; Bakker, Carla; Hidding, Alita; Houben, Harry; van der Heijde, Desiree; Landewé, Robert; van der Linden, Sjef
To compare the therapeutic effects of physical fitness training or biofeedback training with the results of usual care in patients with fibromyalgia (FM). One hundred forty-three female patients with FM (American College of Rheumatology criteria) were randomized into 3 groups: a fitness program (n =
van Tubergen, A.; Landewé, R.; van der Heijde, D.; Hidding, A.; Wolter, N.; Asscher, M.; Falkenbach, A.; Genth, E.; Thè, H. G.; van der Linden, S.
To determine the efficacy of combined spa-exercise therapy in addition to standard treatment with drugs and weekly group physical therapy in patients with ankylosing spondylitis (AS). A total of 120 Dutch outpatients with AS were randomly allocated into 3 groups of 40 patients each. Group 1 (mean
Rossen, N.G.; Fuentes Enriquez de Salamanca, S.; Spek, van der M.J.; Tijssen, J.; Hartman, J.H.A.; Duflou, A.; Löwenberg, M.; Brink, van den G.R.; Mathus-Vliegen, E.M.; Vos, de W.M.; Zoetendal, E.G.; Haens, D' G.R.; Ponsioen, C.Y.
BACKGROUND: & Aims: Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial. METHODS: Patients with mild to moderately active UC (n=50)
Miraghajani, Maryam; Zaghian, Nafiseh; Dehkohneh, Abolfazl; Mirlohi, Maryam; Ghiasvand, Reza
Diabetic nephropathy (DN) is one the most important complications of diabetes leading to end-stage renal disease. Dietary approaches have been considered to control of the kidney function deterioration among these patients. The aim of the present study was to determine the effects of fortified soy milk with Lactobacillus plantarum A7 on renal function biomarkers in type 2 DN patients. Forty-eight DN subjects were attended to this parallel randomized trial study. Participants were randomly assigned to consume a diet containing 200 mL/day probiotic soy milk in intervention group or soy milk in the control condition for 8 weeks. An inflammatory adipokine-Progranulin (PGRN), a cytokine receptor-soluble tumor necrosis factor receptor 1 (sTNFR1), and serum levels of Neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C (Cys-C) as the new renal function biomarkers were measured after 8 weeks of intervention according to the standard protocol. Our analysis showed that consumption of probiotic soy milk resulted in a significant reduction in the Cys-C and PGRN levels compared with the soy milk (P = 0.01) in the final adjusted model. In addition, after adjustment for age, weight, and energy intake, a marginally significant in the NGAL level was seen between two groups (P = 0.05). However, there was no significant differences on the sTNFR1concenteration between two groups (P = 0.06). Overall, intake of probiotic soy milk may have a beneficial effect on the renal function in patients with DN.
Chun, Jin-Young; Seo, Jeong-Hwan; Park, Sung-Hee; Won, Yu Hui; Kim, Gi-Wook; Moon, Sung-Jun; Ko, Myoung-Hwan
To investigate the effects of the newly developed Spine Balance 3D system on the balance and gait abilities of hemiplegic stroke patients. Twenty-eight hemiplegic patients with chronic stroke were randomly assigned to an experimental (n=14) or control group (n=14). The experimental and control groups performed balance training by using the newly developed Spine Balance 3D system and the well-known Biodex Balance System 30 minutes per day, three times a week for 7 weeks. The Berg Balance Scale (BBS), 10-m walking test (10mWT), Timed Up and Go Test (TUG), Functional Reach Test (FRT), the Korean version of the Fall Efficacy Scale-International (KFES-I), trunk muscle strength and stability were evaluated before and after 7 weeks of intervention. The 10mWT improved significantly (p=0.001) in the experimental group (using the Spine Balance 3D system) but not in the control group, and core muscle strength, which we checked using Spine Balance 3D system evaluation program, improved more in the experimental group as well. The results of the BBS, FRT, TUG, KFES-I, and Biodex Balance System evaluation program improved in both groups after 7 weeks of balance training. We suggest that the newly-developed Spine Balance 3D system can be a more useful therapeutic tool for gait and dynamic balance rehabilitation in hemiplegic patients than a conventional 2D-based balance training system. A large-scale randomized controlled study is needed to prove the effect of this system.
Peluso, Rosario; Caso, Francesco; Costa, Luisa; Sorbo, Dario; Carraturo, Nello; Di Minno, Matteo Nicola Dario; Carraturo, Federica; Oriente, Alfonso; Balestrieri, Umberto; Minicucci, Annamaria; Del Puente, Antonio; Scarpa, Raffaele
To evaluate the efficacy and safety of combined treatment of mud-bath therapy and glucosamine crystalline sulfate (GlcN-S) in patients with knee osteoarthritis (OA). This study was a randomised, controlled, crossover investigation. Patients were randomly assigned (1:1) by the investigators to two groups, named group 1 and 2. Group 1 included twenty-three patients receiving oral GlcN-S treatment from the beginning of the study (T0) to the end of the 3rd month of treatment (T3) and a combined treatment of both mud-bath therapy and GlcN-S from T3 to the end of the study at six months (T6). Group 2 included twenty-two patients receiving a combined treatment of both mud-bath therapy and GlcN-S from T0 to T3 and that discontinued mud-bath therapy, receiving GlcN-S treatment alone, from T3 to T6. Primary endpoints of the study consisted of evaluating OA severity and activity at baseline and at follow-up visits. All 45 patients, eligible for the study, completed the period of the crossover. In group 1, no significant difference was shown in the comparison from T0 to T3, while from T3 to T6 most variables were significantly improved. In group 2, instead, the comparison between T0 and T3 showed a significant difference in different parameters. When comparing T3 and T6, despite an improvement of all the variables, no significant difference was shown. The association of GlcN-S and mud-bath therapy has a positive and safe role in improving pain, function and quality of life in knee OA patients.
Neumann, Helmut; Vieth, Michael; Günther, Claudia; Neufert, Clemens; Kiesslich, Ralf; Grauer, Martin; Atreya, Raja; Neurath, Markus F
Increased vascular permeability and angiogenesis play a crucial role in the pathogenesis of inflammatory bowel disease (IBD). Aim was to determine whether computed virtual chromoendoscopy has the potential to enhance assessment of disease severity and extent in patients with mild or inactive IBD in comparison to high-definition white-light endoscopy. Consecutive patients with IBD were randomly assigned at a 1:1 ratio to undergo colonoscopy with high-definition white light (group A) or computed virtual chromoendoscopy (group B). The mucosal vascular pattern and any mucosal abnormalities were recorded. Subsequent to endoscopic characterization targeted, biopsies were obtained from every segment for subsequent histopathological analysis of disease activity. Overall, 100 patients were screened to participate in this study of whom 78 patients (high-definition white light, n = 39; computed virtual chromoendoscopy, n = 39) completed the study protocol thereby matching the previously calculated sample size. Average duration of the examination was 18 minutes in group A and 20.5 minutes in group B that was not statistically significant. When comparing the endoscopic prediction of inflammatory extent and activity with the histological results, an overall agreement of 48.71% and 53.85% (group A) and 92.31% and 89.74% (group B) was found, respectively. These differences were statistically significant (P = 0.0009 and P = 0.066). This study indicates that computed virtual chromoendoscopy significantly improves the diagnosis of the severity and extent of mucosal inflammation in patients with IBD. This newly developed imaging technique may therefore have important implications for therapeutic interventions in patients with IBD.
Tuinmann, Gert; Preissler, Pia; Böhmer, Hauke; Suling, Anna; Bokemeyer, Carsten
Patients with high dose chemotherapy (HDC) with autologous stem cell transplantation (ASCT) are highly distressed. Psycho-oncological support might be beneficial but is not routinely provided. Our aim was to investigate whether music therapy (MT) in addition to standard supportive treatment had any effect on quality of life, depression, anxiety, side effects of therapy, medication, and immunological changes during and within three months after HDC plus ASCT. Patients (n = 66) with HDC plus ASCT were randomly assigned to either MT (Intervention Group = IG) or standard supportive treatment (Control Group = CG). Quality of life was measured by EORTC QLQ-C30. Depression and anxiety were measured by the HADS-D before transplantation, during and after the inpatient stay. In addition, adverse events (AE), medication, and immunological parameters were observed. There was no improvement of global quality of life for patients receiving additional MT, but their perception of pain significantly changed (p = 0.027). Patients were neither depressed nor anxious on admission, therefore no improvements were found. IG patients had less 3-4° toxicities (e.g., mucositis). Aprepitant for antiemetic therapy was administered significantly more often in the CG (p = 0.040). The IgA decline and T4 count was less in IG, T8, and NK count decreased most in IG. These findings failed significance. MT may improve pain perception in patients receiving HDC plus ASCT. Additionally positive effects on toxicities, use of antiemetic medication, and immunological changes were observed. As some of these findings failed significance, studies with larger sample sizes are needed. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
Randomized Trial of the Effect of Mindfulness-Based Stress Reduction on Pain-Related Disability, Pain Intensity, Health-Related Quality of Life, and A1C in Patients With Painful Diabetic Peripheral Neuropathy.
Nathan, Howard J; Poulin, Patricia; Wozny, Denise; Taljaard, Monica; Smyth, Cathy; Gilron, Ian; Sorisky, Alexander; Lochnan, Heather; Shergill, Yaad
IN BRIEF Painful diabetic peripheral neuropathy (PDPN) has a large negative impact on patients' physical and mental functioning, and pharmacological therapies rarely provide more than partial relief. Mindfulness-based stress reduction (MBSR) is a group psychosocial intervention that was developed for patients with chronic illness who were not responding to existing medical treatments. This study tested the effects of community-based MBSR courses for patients with PDPN. Among patients whose PDPN pharmacotherapy had been optimized in a chronic pain clinic, those randomly assigned to treatment with MBSR experienced improved function, better health-related quality of life, and reduced pain intensity, pain catastrophizing, and depression compared to those receiving usual care.
Jacobson, Ira M; Lawitz, Eric; Gane, Edward J; Willems, Bernard E; Ruane, Peter J; Nahass, Ronald G; Borgia, Sergio M; Shafran, Stephen D; Workowski, Kimberly A; Pearlman, Brian; Hyland, Robert H; Stamm, Luisa M; Svarovskaia, Evguenia; Dvory-Sobol, Hadas; Zhu, Yanni; Subramanian, G Mani; Brainard, Diana M; McHutchison, John G; Bräu, Norbert; Berg, Thomas; Agarwal, Kosh; Bhandari, Bal Raj; Davis, Mitchell; Feld, Jordan J; Dore, Gregory J; Stedman, Catherine A M; Thompson, Alexander J; Asselah, Tarik; Roberts, Stuart K; Foster, Graham R
Patients with chronic hepatitis C virus (HCV) infection have high rates of sustained virologic response (SVR) after 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir. We assessed the efficacy of 8 weeks of treatment with sofosbuvir and velpatasvir plus the pangenotypic NS3/4A protease inhibitor voxilaprevir (sofosbuvir-velpatasvir-voxilaprevir). In 2 phase 3, open-label trials, patients with HCV infection who had not been treated previously with a direct-acting antiviral agent were assigned randomly to groups given sofosbuvir-velpatasvir-voxilaprevir for 8 weeks or sofosbuvir-velpatasvir for 12 weeks. POLARIS-2, which enrolled patients infected with all HCV genotypes with or without cirrhosis, except patients with genotype 3 and cirrhosis, was designed to test the noninferiority of 8 weeks of sofosbuvir-velpatasvir-voxilaprevir to 12 weeks of sofosbuvir-velpatasvir using a noninferiority margin of 5%. POLARIS-3, which enrolled patients infected with HCV genotype 3 who had cirrhosis, compared rates of SVR in both groups with a performance goal of 83%. In POLARIS-2, 95% (95% confidence interval [CI], 93%-97%) of patients had an SVR to 8 weeks of sofosbuvir-velpatasvir-voxilaprevir; this did not meet the criterion to establish noninferiority to 12 weeks of sofosbuvir-velpatasvir, which produced an SVR in 98% of patients (95% CI, 96%-99%; difference in the stratum-adjusted Mantel-Haenszel proportions of -3.2%; 95% CI, -6.0% to -0.4%). The difference in the efficacy was owing primarily to a lower rate of SVR (92%) among patients with HCV genotype 1a infection receiving 8 weeks of sofosbuvir-velpatasvir-voxilaprevir. In POLARIS-3, 96% of patients (95% CI, 91%-99%) achieved an SVR in both treatment groups, which was significantly superior to the performance goal. Overall, the most common adverse events were headache, fatigue, diarrhea, and nausea; diarrhea and nausea were reported more frequently by
Full Text Available Students can experience first hand through interactive assignments what is involved in teaching an online course. Most students develop a whole new appreciation for the student learning process. Faculty are beginning to realize that online instruction is more than a series of readings posted to a course management system. This paper summarizes the faculty member's instructional strategies involved when creating student interaction assignments. The paper also summarizes the assignments, discussion board, and trends in education from the student's perspective. In summary, it concludes with the faculty's overall perspective concerning these assignments and how the assignments could be more effective for the student.
Edinger, Jack D; Olsen, Maren K; Stechuchak, Karen M; Means, Melanie K; Lineberger, Margaret D; Kirby, Angela; Carney, Colleen E
This study was conducted to evaluate the efficacy of cognitive behavioral therapy (CBT) against a sleep hygiene education control therapy in patients with primary or comorbid insomnia. Randomized, parallel-group, clinical trial conducted at a single Veterans Affairs medical center, with recruitment from March 2001 to June 2005. Eighty-one adults (n = 11 women; mean age, 54.2 years) with chronic primary (n = 40) or comorbid insomnia associated predominantly with mixed psychiatric disorders (n = 41). Patients, screened via structured interviews and diagnostic polysomnography, were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions; 20 patients with primary and 21 with comorbid insomnia), or sleep hygiene (SH: education about aspects of lifestyle and the bedroom environment that affect sleep; 20 patients with primary and 20 with comorbid insomnia). Outpatient treatment included 4 biweekly sessions with a posttreatment assessment and a follow-up conducted at 6 months. Participants completed actigraphy and sleep diaries for 2 weeks prior to therapy, during a 2-week posttreatment assessment, and during 2 weeks at follow-up. They also completed questionnaires measuring global insomnia symptoms, general sleep quality, and sleep-disruptive beliefs before treatment, immediately following treatment, and at the follow-up time point. Consistent with previous studies, CBT outperformed sleep hygiene across several study outcome measures for the sample as a whole. Statistical analyses showed no significant 3-way interaction of treatment group, time, and insomnia type for any of the sleep or questionnaire measures, suggesting the benefits of CBT over sleep hygiene were comparable for patients with primary insomnia and comorbid insomnia. Moreover, only 1 of several indexes of clinically notable improvement suggested a significantly better response to CBT by patients with primary insomnia, as compared with those with comorbid insomnia. A
Soltani, Rasool; Soheilipour, Saeed; Hajhashemi, Valiollah; Asghari, Gholamreza; Bagheri, Mahdi; Molavi, Mahdi
To evaluate the effect of aromatherapy with Lavandula angustifolia essential oil on post-tonsillectomy pain in pediatric patients. This was a randomized controlled prospective clinical trial. In this study, 48 post-tonsillectomy patients aged 6-12 years were randomly assigned to two groups (24 patients in each group). After tonsillectomy surgery, all patients received acetaminophen (10-15 mg/kg/dose, PO) every 6h as necessary to relieve pain. The patients of the case group also inhaled lavender essential oil. The frequencies of daily use of acetaminophen and nocturnal awakening due to pain, and pain intensity (evaluated using visual analog scale [VAS]) were recorded for each patient for 3 days after surgery. Finally, the mean values of variables were compared between two groups separately for each post-operative day. The use of lavender essential oil caused statistically significant reduction in daily use of acetaminophen in all three post-operative days but had not significant effects on pain intensity and frequency of nocturnal awakening. Aromatherapy with lavender essential oil decreases the number of required analgesics following tonsillectomy in pediatric patients. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
Abbasi, Behnood; Ghiasvand, Reza; Mirlohi, Maryam
Even with the ultimate medical management, more than one-third of diabetic patients develop diabetic nephropathy. To our knowledge, there is no study that has examined the effect of probiotic soy milk on kidney function in type 2 diabetic patients with nephropathy. This clinical trial aimed to assess the effects of consumption of probiotic soy milk, compared with conventional soy milk, on kidney-related indexes in patients with diabetic nephropathy. In a randomized double-blinded placebo-controlled trial, 44 patients were randomly assigned to receive 200 mL/d of either soy milk containing Lactobacillus plantarum A7 or conventional soy milk for 8 weeks. Primary endpoints included urinary albumin excretion, estimated glomerular filtration rate, interlukin-18, serum sialic acid, and serum creatinine. Fasting blood samples and morning fasting spot urine samples were collected at the beginning and after 8 weeks for evaluation of biochemical parameters. Forty patients completed the study. Administration of probiotic soymilk resulted in a significant reduction in albuminuria (P = .03), serum creatinine (P soy milk. Probiotic soymilk supplementation also led to a significant improvement in estimated glomerular filtration rate (15.9 ± 10.8 mL/min versus 3.2 ± 8.4 mL/min, P soy milk was safe and well-tolerated by patients with diabetic nephropathy for 8 weeks. Probiotic soy milk also improved indexes of kidney function in type 2 diabetic patients with nephropathy.
Mosher, Catherine E; Secinti, Ekin; Johns, Shelley A; O'Neil, Bert H; Helft, Paul R; Shahda, Safi; Jalal, Shadia I; Champion, Victoria L
At the end of life, spiritual well-being is a central aspect of quality of life for many patients and their family caregivers. A prevalent spiritual value in advanced cancer patients is the need to actively give. To address this need, the current randomized trial examined whether adding a peer helping component to a coping skills intervention leads to improved meaning in life and peace for advanced gastrointestinal cancer patients and their caregivers. Feasibility and acceptability outcomes were also assessed. Advanced gastrointestinal cancer patients and caregivers (n = 50 dyads) were randomly assigned to a 5-session, telephone-based coping skills intervention or a peer helping + coping skills intervention. One or both dyad members had moderate-severe distress. Peer helping involved contributing to handouts on coping skills for other families coping with cancer. Patients and caregivers completed measures of meaning in life/peace, fatigue, psychological symptoms, coping self-efficacy, and emotional support. Patient pain and caregiver burden were also assessed. Small effects in favor of the coping skills group were found regarding meaning in life/peace at 1 and 5 weeks post-intervention. Other outcomes did not vary as a function of group assignment, with both groups showing small decreases in patient and caregiver fatigue and caregiver distress and burden. High recruitment and retention rates supported feasibility, and high participant satisfaction ratings supported acceptability. Although a telephone-based intervention is feasible and acceptable for this population, peer helping in the context of a coping skills intervention does not enhance spiritual well-being relative to coping skills alone.
Pedersen, J L; Pedersen, P U; Damsgaard, E M
To compare the effects of two nutritional follow-up interventions with regard to preventing short-term deterioration in ADL, and to compare their effects on physical function, emotional health, and health-related quality of life. Randomized clinical trial with two intervention groups and one control group, and a follow-up period of eight weeks. Intervention in the participants' homes after discharge from hospital. Inclusion: Malnourished geriatric patients and patients at risk of malnutrition (MNApatients with terminal illnesses or cognitive impairment. Randomization: At discharge, the patients were assigned to one of three groups: 'home visit', 'telephone consultation', or 'control' group. Individually tailored nutritional counselling of the patient and the patient's daily home carer by a clinical dietician one, two, and four weeks after discharge from hospital. The counselling was either in-person at the patients' homes, or by telephone. The control group received no follow-up after discharge. Primary outcome: Change in ADL (Barthel-100 score) at discharge and eight weeks later. Change in physical performance (handgrip strength, 30-sec. chair stand test, CAS), quality of life and depression measurements (SF-36, Depression List, Geriatric Depression Score), and Avlund mobility-tiredness score (Mob-T). Two-hundred and eight participants were randomized, 73 to home visits and 68 to telephone consultations. The control group comprised 67 patients. The mean age of the participants was 86.1 years. At eight weeks after discharge, 157 completed the follow-up (home visit 52, telephone consultation 51, and control group 54). The mean age of these patients was 85.8 years. More patients in the home visit group improved or maintained their ADL (96%), compared to the telephone (75%) and control groups (72%), pquality of life, and emotional health. Early nutritional follow-up after discharge, performed as home visits, prevents deterioration of ADL in malnourished, independent
Ros, Mirco; Casciaro, Rosaria; Lucca, Francesca; Troiani, Patrizia; Salonini, Elena; Favilli, Federica; Quattrucci, Serena; Sher, Daniel; Assael, Baroukh Maurice
TRIAL DESIGN AND METHODS: Between December 2009 and July 2011, four cystic fibrosis (CF) centers in Italy participated in a randomized, double-blind, controlled clinical trial to test whether 7% hypertonic saline (HS) administered together with 0.1% hyaluronic acid (HA) was better tolerated by patients who previously did not tolerate HS well on its own. Participants were CF patients at least 8 years old, in clinically stable conditions, with forced expiratory volume in 1 sec (FEV1) at least 50% predicted. Forty patients were recruited and randomized to receive either HS or HS plus HA (5 mL to be inhaled over 15 min, twice daily for 28 days). Primary endpoints were cough, throat irritation, salty taste, and overall acceptability, as assessed by each patient on a semiquantitative scale on a diary card. Secondary endpoint was FEV1 change at the end of treatment. Patients were randomized into randomly permuted blocks. The first and last doses were administered in hospital. In between, patients were treated at home. Patients, all caregivers, and the statistician who conducted the analysis (different from the one who generated the random list) were blinded to group assignment. Severity of cough, throat irritation, and saltiness were more severe in patients treated with HS alone, both after the first inhalation and over the entire treatment period. Overall pleasantness was rated higher by patients treated with the combination product. All differences were highly significant. There were no changes in FEV1 between the first and last administrations. Five patients did not complete the study. Four patients (two from each group) withdrew because of cough or throat irritation. One more patient from the HS group withdrew because of a respiratory exacerbation at week 3. HS is currently a cornerstone in the treatment of CF patients. The addition of HA to HS reduces the prevalence and severity of cough, throat irritation, and saltiness and may improve compliance in patients
Schjerning, Ole; Damkier, Per; Lykkegaard, Signe Engelhardt
INTRODUCTION: Anxiety is frequent in patients with schizophrenia and poses a major impact on patients perceived quality of life, daily functioning and risk of suicide. Pregabalin has shown effective in the treatment of generalized anxiety disorder and has been suggested for the treatment of anxiety...... in patients with schizophrenia. As evidence is sparse regarding treatment of anxiety in this patient group, we aimed to investigate the use of pregabalin for anxiety in patients with schizophrenia. METHODS: A randomized, double-blind placebo controlled study was used. Patients were randomized to either...... placebo or pregabalin (≤600mg/d) as add-on treatment. Primary analyses were intention-to-treat based with change in Hamilton Anxiety Scale after 4 and 8weeks of treatment as primary outcome. Secondary outcomes were change in psychopathology, quality-of-life, cognitive functioning and sleep. The study used...
Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen
Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.
Moody, Karen M; Baker, Rebecca A; Santizo, Ruth O; Olmez, Inan; Spies, Jeanie M; Buthmann, Amanda; Granowetter, Linda; Dulman, Robin Y; Ayyanar, Kanyalakshmi; Gill, Jonathan B; Carroll, Aaron E
The neutropenic diet (ND) is prescribed to avoid introduction of bacteria into a host's gastrointestinal tract and reduce infection. Due to a lack of evidence to support the ND, there continues to be debate among pediatric oncologists regarding its usefulness. This prospective randomized controlled trial evaluated the difference in neutropenic infection rates in pediatric oncology patients randomized to Food and Drug Administration approved food safety guidelines (FSGs) versus the ND plus FSGs during one cycle of chemotherapy. Pediatric patients receiving cancer treatment with myelosuppressive chemotherapy were eligible. Neutropenic infection was the primary outcome and defined as (i) fever with neutropenia or (ii) hospital admission and treatment for clinical infection and neutropenia. The rate of neutropenic infection was compared with Student's t-test for independent samples. Documented infections were identified by comprehensive chart review and compared between groups using a χ 2 test. One hundred fifty patients were randomly assigned to FSGs (n = 73) or ND + FSGs (n = 77). The most common diagnoses were acute lymphoblastic leukemia (32%) and sarcoma (32%). There was no significant difference between the groups in the percentage of patients who developed neutropenic infection: FSGs 33% versus ND + FSGs 35% (P = 0.78). Patients randomized to ND + FSGs reported that following the diet required more effort than those on FSGs alone. The ND offers no benefit over FSGs in the prevention of infection in pediatric oncology patients undergoing myelosuppressive chemotherapy and adherence requires more effort for patients and families. Institutions caring for children with cancer should consider replacing ND guidelines with FSGs. © 2017 Wiley Periodicals, Inc.
An, Ming-Wen; Mandrekar, Sumithra J; Edelman, Martin J; Sargent, Daniel J
The primary goal of Phase II clinical trials is to understand better a treatment's safety and efficacy to inform a Phase III go/no-go decision. Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection. The Phase II design with an option for direct assignment (i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis (IA) at 50% accrual) was recently proposed [An et al., 2012]. We discuss this design in the context of existing designs, and extend it from a single-IA to a two-IA design. We compared the statistical properties and clinical relevance of the direct assignment design with two IA (DAD-2) versus a balanced randomized design with two IA (BRD-2) and a direct assignment design with one IA (DAD-1), over a range of response rate ratios (2.0-3.0). The DAD-2 has minimal loss in power (designs, the direct assignment design, especially with two IA, provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients. Copyright © 2014 Elsevier Inc. All rights reserved.
Cook, Deborah; De Jonghe, Bernard; Heyland, Daren
Objective To review the effect of enteral nutrition on nosocomial pneumonia in critically ill patients as summarized in randomized clinical trials. Study identification and selection Studies were identified through MEDLINE, SCISEARCH, EMBASE, the Cochrane Library, bibliographies of primary and review articles, and personal files. Through duplicate independent review, we selected randomized trials evaluating approaches to nutrition and their relation to nosocomial pneumonia. Data abstraction I...
Oshakbayev, Kuat; Dukenbayeva, Bibazhar; Otarbayev, Nurzhan; Togizbayeva, Gulnar; Tabynbayev, Nariman; Gazaliyeva, Meruyert; Idrisov, Alisher; Oshakbayev, Pernekul
Background The prevalence and burden of atherosclerotic (AS) diseases are increasing during the last twenty years. Some studies show a close relationship between overweight and AS, but influence on AS diseases of different weight loss methods are still studying. The purpose of the research was to study the effectiveness of a weight loss program in AS patients in randomized controlled trial, and to develop a conception of evolution of AS. Methods A randomized controlled prospective clinical tr...
Tekur Padmini; Chametcha Singphow; Hongasandra Ramarao; Raghuram Nagarathna
Context: In two of the earlier Randomized Control Trials on yoga for chronic lower back pain (CLBP), 12 to 16 weeks of intervention were found effective in reducing pain and disability. Aim: To study the efficacy of a residential short term intensive yoga program on quality of life in CLBP. Materials and Methods: About 80 patients with CLBP (females 37) registered for a week long treatment at SVYASA Holistic Health Centre in Bengaluru, India. They were randomized into two groups (40 each). T...
Figueiras, Maria João; Maroco, João; Monteiro,Rita; Caeiro, Raúl; Neto, David Dias
There is converging evidence that changing beliefs about an illness leads to positive recovery outcomes. However, cardiac misconceptions interventions have been investigated mainly in Angina or Coronary Heart Disease patients, and less in patients following Myocardial Infarction (MI). In these patients, cardiac misconceptions may play a role in the adjustment or lifestyle changes. This article reports a randomized controlled trial of an intervention designed to reduce the strength of misconce...
Jafarpour-Sadegh, Farnaz; Montazeri, Vahid; Adili, Ali; Esfehani, Ali; Rashidi, Mohammad-Reza; Mesgari, Mehran; Pirouzpanah, Saeed
Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (Ponion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy.
Bignami, E; Cattaneo, M; Crescenzi, G; Ranucci, M; Guarracino, F; Cariello, C; Baldassarri, R; Isgrò, G; Baryshnikova, E; Fano, G; Franco, A; Gerli, C; Crivellari, M; Zangrillo, A; Landoni, G
Previous studies showed that desmopressin decreases post-operative blood loss in patients undergoing cardiac surgery. These studies were small and never studied the effect of desmopressin in patients with active bleeding. Objective of the study was to determine whether desmopressin reduces red blood cells transfusion requirements in patients with active bleeding after cardiac surgery who had been pre-treated with tranexamic acid. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study randomized elective patients with bleeding after cardiac surgery despite pre-treatment with tranexamic acid, to receive placebo (saline solution) or a single administration of desmopressin (0.3 μg/kg in saline solution). The primary endpoint was the number of patients requiring red blood cells transfusion after randomization and during hospital stay. Secondary end points were: blood loss from chest tubes during the first 24 h after study drug administration, hours of mechanical ventilation, intensive care unit stay, and in-hospital mortality. The study was interrupted after inclusion of 67% of the planned patients for futility. The number of patients requiring red blood cells transfusion after randomization was 37/68 (54%) in desmopressin group and 33/67 (49%) in placebo group (P = 0.34) with no difference in blood loss: 575 (interquartile 422-770) ml in desmopressin group and 590 (476-1013) ml in placebo group (P = 0.42), mechanical ventilation, intensive care unit stay or mortality. This multicenter randomized trial demonstrated that, in patients pre-treated with tranexamic acid, desmopressin should not be expected to improve treatment of patients who experience bleeding after cardiac surgery. © 2016 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.
Cassin, Stephanie E.; Sockalingam, Sanjeev; Du, Chau; Wnuk, Susan; Hawa, Raed; Parikh, Sagar V.
Background Psychosocial interventions can improve eating behaviours and psychosocial functioning in bariatric surgery candidates. However, those that involve face-to-face sessions are problematic for individuals with severe obesity due to mobility issues and practical barriers. Objective To examine the efficacy of a pre-operative telephone-based cognitive behavioural therapy (Tele-CBT) intervention versus standard pre-operative care for improving eating psychopathology and psychosocial functioning. Methods Preoperative bariatric surgery patients (N = 47) were randomly assigned to receive standard preoperative care (n = 24) or 6 sessions of Tele-CBT (n = 23). Results Retention was 74.5% at post-intervention. Intent-to-treat analyses indicated that the Tele-CBT group reported significant improvements on the Binge Eating Scale (BES), t (22) = 2.81, p = .01, Emotional Eating Scale (EES), t (22) = 3.44, p = .002, and Patient Health Questionnaire-9 (PHQ-9), t (22) = 2.71, p = .01, whereas the standard care control group actually reported significant increases on the EES, t (23) = 4.86, p bariatric surgery candidates. PMID:26990279
Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907
Hu, Ruiming; Xu, Feng; Sheng, Youyu; Qi, Sisi; Han, Yumei; Miao, Ying; Rui, Wenlong; Yang, Qinping
Finasteride at 1 mg/day and 5% topical minoxidil are effective in male androgenetic alopecia (MAGA). However, studies describing their effects in Chinese individuals are scarce. 450 Chinese MAGA patients were randomly assigned to receive finasteride (n = 160), minoxidil (n = 130) and combined medication (n = 160) for 12 months. The patients returned to the clinic every 3 months for efficacy evaluation. And efficacy was evaluated in 428 men at treatment end, including 154, 122, and 152 in the finasteride, 5% minoxidil, and combination groups, respectively. All groups showed similar baseline characteristics, including age at enrollment, and duration and severity of alopecia (p > 0.05). At 12 months, 80.5, 59, and 94.1% men treated with finasteride, 5% minoxidil and the combination therapy showed improvement, respectively. Adverse reactions were rare (finasteride, 1.8%; minoxidil, 6.1%), and disappeared right after drug withdrawal. In conclusion, finasteride is superior to 5% minoxidil, while the combined medication showed the best efficacy. © 2015 Wiley Periodicals, Inc.
Silverman, Michael J
The purpose of this study was to determine the effects of a songwriting intervention on psychiatric patients' knowledge of coping skills and working alliance. Participants were randomly assigned to scripted and manualized experimental (n=48) or control (n=41) conditions. The experimental condition was a group psychoeducational music therapy songwriting session concerning coping skills while the control condition was a group psychoeducational session concerning coping skills. Both conditions were single-session therapy with patients on an acute adult psychiatric unit. Results indicated no significant between group differences in measures of knowledge of coping skills, consumer working alliance, or perception of enjoyment (p>.05), although the experimental condition tended to have slightly higher mean scores than the control group for these measures. There was a significant between group difference in measures of therapist working alliance (pcoping skills can be as effective a psychosocial intervention as traditional talk-based psychoeducation to teach psychiatric inpatients how to proactively manage their illness. Additionally, music therapy can be as effective as talk-based psychoeducation in establishing working alliance. Implications for clinical practice, limitations, and suggestions for future research are provided.
Full Text Available Background. Recent reports suggest that a proportion of tinnitus patients suffer from mental illness. Autonomic nervous system plays a useful role in tinnitus therapy since electrical vagal nerve stimulation (VNS has been frequently used to alleviate tinnitus-induced depression in clinic. heart rate variability (HRV, which is reflective of autonomic nervous system function, has been proved to be modulated by acupuncture. In the present study, we aim to compare the effect of deqi sensation on heart rate variability in adult tinnitus patients. Methods. Thirty participants are randomly assigned to verum acupuncture (creating deqi or shallow acupuncture (not creating deqi at Baihui (Du-20, Shenting (Du-24, Tinghui (GB-2, Waiguan (SJ-5, and Zulinqi (GB-41 for 3 weeks. The primary outcome measure is heart rate variability, which is measured at the first acupuncture, as well as the last acupuncture. Discussion. Completion of this trial will help to identify the role of deqi sensation in acupuncture effect for tinnitus and reveal an autonomic modulation mechanism for acupuncture effect. Trial Registration. This trial is registered with International Standard Randomised Controlled Trial Number ISRCTN58013563.
Cassin, Stephanie E; Sockalingam, Sanjeev; Du, Chau; Wnuk, Susan; Hawa, Raed; Parikh, Sagar V
Psychosocial interventions can improve eating behaviours and psychosocial functioning in bariatric surgery candidates. However, those that involve face-to-face sessions are problematic for individuals with severe obesity due to mobility issues and practical barriers. To examine the efficacy of a pre-operative telephone-based cognitive behavioural therapy (Tele-CBT) intervention versus standard pre-operative care for improving eating psychopathology and psychosocial functioning. Preoperative bariatric surgery patients (N = 47) were randomly assigned to receive standard preoperative care (n = 24) or 6 sessions of Tele-CBT (n = 23). Retention was 74.5% at post-intervention. Intent-to-treat analyses indicated that the Tele-CBT group reported significant improvements on the Binge Eating Scale (BES), t (22) = 2.81, p = .01, Emotional Eating Scale (EES), t (22) = 3.44, p = .002, and Patient Health Questionnaire-9 (PHQ-9), t (22) = 2.71, p = .01, whereas the standard care control group actually reported significant increases on the EES, t (23) = 4.86, p bariatric surgery candidates. Copyright © 2016 Elsevier Ltd. All rights reserved.
Gonik, Nathan; Tassler, Andrew; Ow, Thomas J; Smith, Richard V; Shuaib, Stefan; Cohen, Hillel W; Sarta, Catherine; Schiff, Bradley A
American Society of Anesthesiology guidelines recommend preoperative fasts of 6 hours after light snacks and 8 hours after large meals. These guidelines were designed for healthy patients undergoing elective procedures but are often applied to intubated intensive care unit (ICU) patients. ICU patients undergoing routine procedures may be subjected to unnecessary prolonged fasts. This study tests whether shorter fasts allow for better nutrition delivery and patient outcomes without increasing the risk. Randomized blinded controlled trial. Tertiary academic medical center. ICU patients undergoing bedside tracheotomy. Intubated ICU patients who were receiving enteral feeding and for whom bedside tracheotomy was indicated were enrolled prospectively and randomly allocated to 2 parallel preoperative fasting regimens: a 6-hour fast (control) and a 45-minute fast (intervention). Patients were assessed for aspiration, caloric delivery, metabolic markers, and infectious and noninfectious complications. Twenty-four patients were enrolled and randomized. There were no complications related to the procedure. There were no cases of intraoperative aspiration identified. There was a single postoperative pneumonia in the control group. Median (interquartile range) length of fast and caloric delivery were significantly different between the control group and the shortened fast group: 22 hours (18, 34) vs 14 hours (5, 25; P < .001) and 429 kcal (57, 1125) vs 1050 kcal (825, 1410; P = .01), respectively. Shortening preoperative fasts in intubated ICU patients allowed for better caloric delivery in the preoperative period. © American Academy of Otolaryngology-Head and Neck Surgery Foundation 2015.
Clayton, Josephine M; Butow, Phyllis N; Tattersall, Martin H N; Devine, Rhonda J; Simpson, Judy M; Aggarwal, Ghauri; Clark, Katherine J; Currow, David C; Elliott, Louise M; Lacey, Judith; Lee, Philip G; Noel, Michael A
To determine whether provision of a question prompt list (QPL) influences advanced cancer patients'/caregivers' questions and discussion of topics relevant to end-of-life care during consultations with a palliative care (PC) physician. This randomized controlled trial included patients randomly assigned to standard consultation or provision of QPL before consultation, with endorsement of the QPL by the physician during the consultation. Consecutive eligible patients with advanced cancer referred to 15 PC physicians from nine Australian PC services were invited to participate. Consultations were audiotaped, transcribed, and analyzed by blinded coders; patients completed questionnaires before, within 24 hours, and 3 weeks after the consultation. A total of 174 patients participated (92 QPL, 82 control). Compared with controls, QPL patients and caregivers asked twice as many questions (for patients, ratio, 2.3; 95% CI, 1.7 to 3.2; P < .0001), and patients discussed 23% more issues covered by the QPL (95% CI, 11% to 37%; P < .0001). QPL patients asked more prognostic questions (ratio, 2.3; 95% CI, 1.3 to 4.0; P = .004) and discussed more prognostic (ratio, 1.43; 95% CI, 1.1 to 1.8, P = .003) and end-of-life issues (30% v 10%; P = .001). Fewer QPL patients had unmet information needs about the future (21 = 4.14; P = .04), which was the area of greatest unmet information need. QPL consultations (average, 38 minutes) were longer (P = .002) than controls (average, 31 minutes). No differences between groups were observed in anxiety or patient/physician satisfaction. Providing a QPL and physician endorsement of its use assists terminally ill cancer patients and their caregivers to ask questions and promotes discussion about prognosis and end-of-life issues, without creating patient anxiety or impairing satisfaction.
Kang, Kyusik; Lee, Se-Jin; Kim, Hee-Jin; Koh, Seong-Ho; Kim, Byung Kun
Clopidogrel napadisilate has better chemical stability than clopidogrel bisulfate. Our trial's objective was to compare the efficacy and safety of clopidogrel napadisilate with clopidogrel bisulfate in participants with ischemic stroke. The study was a phase 4, 4 week, randomized, parallel-group, non-inferiority trial. Patients with ischemic stroke were randomized to receive either clopidogrel napadisilate 75 mg or clopidogrel bisulfate 75 mg. The primary study endpoint was change from baseline in P2Y12 percentage inhibition at week 4. The primary analysis was conducted in the per-protocol population. Non-inferiority was confirmed if the lower limit of the 95% confidence interval (CI) of the treatment difference was greater than or equal to -9.0% points. Sixty-one participants were randomly assigned clopidogrel napadisilate and 60 were randomly assigned clopidogrel bisulfate. Thirty-nine participants in the clopidogrel napadisilate group and 39 in the clopidogrel bisulfate group were analyzed for the primary endpoint. At 4 weeks, mean P2Y12 percentage inhibition had increased in both treatment groups. The estimated mean change from baseline was 22.3% with clopidogrel napadisilate and 21.4% with clopidogrel bisulfate; the estimated treatment difference of 0.9% (95% CI, -8.6 to 10.4) confirmed the non-inferiority of clopidogrel napadisilate to clopidogrel bisulfate. Clopidogrel napadisilate was non-inferior to clopidogrel bisulfate as assessed by change in P2Y12 percentage inhibition. Rates of adverse events were similar between the two groups. Therefore, clopidogrel napadisilate is a useful alternative option for the dosing of ischemic stroke patient populations.
van Oenen, Flip Jan; Schipper, Suzy; Van, Rien; Schoevers, Robert; Visch, Irene; Peen, Jaap; Dekker, Jack
This study looks at the effect of immediate session-by-session feedback using short questionnaires for evaluating outcome of and alliance in the therapy. Research data strongly suggests that using this feedback informed treatment improves the outcome of therapy. However, until now, this method of Miller and Duncan has only been examined in clients (generally students) with mild problems and in partner counselling. The question addressed by this study is whether immediate feedback is also effective when applied during crisis intervention and subsequent brief therapy in a psychiatric patient population in emergency situations. It also looks at whether 'feedback-informed treatment' affects the quality of the alliance. To test the hypotheses, all patients seeking help from the Crisis Intervention & Brief Therapy Team over a two-year period will be followed throughout their treatment up to a maximum of six months and a follow-up period of three months after ending the treatment. Patients are randomly assigned to two conditions: treatment without feedback and treatment with immediate feedback for each session. The therapists all operate in both conditions and so they deliver both treatments. An estimated total of 180 patients, aged 18 years and over, will be included in the study. The aim of this study is to make clear whether, and to what extent, systematic feedback from the patient in this target group during therapy determines the course and outcomes of therapy. We also look at whether, and to what extent, the quality of the alliance and the motivation of the person delivering treatment with respect to the instruments play a role. NTR3168.
Full Text Available Objectives: This study was conducted to determine the efficacy of mindfulness-based cognitive therapy (MBCT on psychological symptoms and quality of life (QoL in patients with systemic lupus erythematosus (SLE. Methods: We conducted a randomized single-blind clinical trial in patients with SLE referred from the Imam Ali Clinic in Shahrekord, southwest Iran. The patients (46 in total in two groups of 23 each were randomly assigned into the experimental and control groups. Both groups underwent routine medical care, and the experimental group underwent eight group sessions of MBCT in addition to routine care. The patient,s QoL was assessed using the General Health Questionnaire-28 and 36-Item Short Form Health Survey before, after, and six months after intervention (follow-up. Results: A significant difference was seen in psychological symptoms and QoL between MBCT and control groups immediately after the intervention and at follow-up (p ≤ 0.050. However, the difference was not significant for the physical components of QoL (p ≥ 0.050. Conclusions: MBCT contributed to decreased psychological symptoms and improved QoL in patients with SLE with a stable effect on psychological symptoms and psychological components of QoL, but an unstable effect on physical components.
Molassiotis, Alex; Brearley, Sarah; Saunders, Mark; Craven, Olive; Wardley, Andrew; Farrell, Carole; Swindell, Ric; Todd, Chris; Luker, Karen
To assess the effectiveness of a symptom-focused home care program in patients with cancer who were receiving oral chemotherapy in relation to toxicity levels, anxiety, depression, quality of life, and service utilization. A randomized, controlled trial was carried out with 164 patients with a diagnosis of colorectal (n = 110) and breast (n = 54) cancers who were receiving oral capecitabine. Patients were randomly assigned to receive either a home care program by a nurse or standard care for 18 weeks (ie, six cycles of chemotherapy). Toxicity assessments were carried out weekly for the duration of the patients' participation in the trial, and validated self-report tools assessed anxiety, depression, and quality of life. Significant improvements were observed in the home care group in relation to the symptoms of oral mucositis, diarrhea, constipation, nausea, pain, fatigue (first four cycles), and insomnia (all P < .05). This improvement was most significant during the initial two cycles. Unplanned service utilization, particularly the number of inpatient days (57 v 167 days; P = .02), also was lower in the home care group. A symptom-focused home care program was able to assist patients to manage their treatment adverse effects more effectively than standard care. It is imperative that patients receiving oral chemotherapy are supported with such programs, particularly during initial treatment cycles, to improve their treatment and symptom experiences.
Soltani, Rasool; Hashemi, Mohammad; Farazmand, Alimohammad; Asghari, Gholamreza; Heshmat-Ghahdarijani, Kiyan; Kharazmkia, Ali; Ghanadian, Syed Mustafa
Hyperlipidemia is associated with increased risk of atherosclerosis; therefore, control of this risk factor is very important in preventing atherosclerosis. Cucumber (Cucumis sativus) seed is used traditionally as a lipid-lowering nutritional supplement. The aim of this study was to evaluate the effect of cucumber seed extract on serum lipid profile in adult patients with mild hyperlipidemia. In a randomized double-blind placebo-controlled clinical trial, hyperlipidemic patients with inclusion criteria were randomly and equally assigned to either Cucumis or placebo groups and used one medicinal or placebo capsule, respectively, once daily with food for 6 wk. Body mass index (BMI) as well as fasting serum levels of total cholesterol, triglycerides (TG), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) were measured for all patients pre- and post-intervention and finally the changes were compared between the groups. Twenty-four patients in Cucumis group and 23 patients in placebo group completed the study. Cucumis seed extract resulted in significant reduction of total cholesterol (P = 0.016), LDL-C (P effects on serum lipid profile in adult hyperlipidemic patients. Therefore, cucumber seed could be considered as a food supplement for treatment of dyslipidemia. © 2016 Institute of Food Technologists®.
Hong, Paul; Makdessian, Ara Samuel; Ellis, David A F; Taylor, S Mark
To determine the effectiveness of providing written information in enhancing patient understanding and retention. A multicentre prospective randomized study was conducted in university-affiliated ambulatory surgical centres. One hundred consecutive patients seen for rhinoplasty consultation were included. Patients were randomly assigned to (1) those receiving traditional oral dialogue of the surgical risks or (2) those receiving an oral discussion and a written pamphlet outlining the risks of the procedure. Fourteen to 18 days after the consultation, each patient was contacted for an assessment of risk recall. Overall risk recall was higher in the group that received written information (2.3 vs 1.3 of 5 risks; p group that received a pamphlet, patients with university and postgraduate levels of education had a better rate of recall (p groups reported higher risk recall (p < .01). Patient risk recall of rhinoplasty is improved with the addition of written information during the informed consent process. As the process of informed consent plays a very decisive role in facial plastic surgery, enhanced postoperative satisfaction may result from the use of supplemental educational materials.
Shibly, Othman; Patel, Nishith; Albandar, Jasim M; Kutkut, Ahmad
This 2-year randomized clinical trial compared bone regeneration and esthetic outcome between immediate and conventional loading of dental implants placed immediately after extraction in patients with a history of periodontal disease. Patients were randomly assigned to receive immediate implants with either immediate loading or conventional loading after 3 months. Both groups received a periodontal flap, tooth extraction, implant placement, allograft bone, and membrane placement. The immediate loading group received a temporary crown. In the conventional loading group primary closure was achieved. All patients were followed up at 3, 6, 12, and 24 months. Evaluation included radiographic bone changes, papillary esthetic outcome, and implant survival rate. Seventy-two patients were recruited into the study. However, 60 patients received immediate implant placement after extraction: 30 with conventional loading and 30 with immediate loading. In the immediate loading group the implant survival rate at 2 years was 96.7%, and the mean bone gain was 1.19 mm. The corresponding figures in the conventional loading group were 93.3% and 1 mm. The gain in bone level occurred mainly from baseline to 1 year postoperatively in both groups (P Immediate loading of a single implant placed in a fresh extraction site in periodontally compromised patients resulted in similar bone gain and soft tissue esthetic outcomes compared to delayed loading. Primary closure and delayed loading to ensure bone regeneration around implants were not critical in this study.
Zheng, Zhen; Guo, Runxiang J; Helme, Robert D; Muir, Andrew; Da Costa, Cliff; Xue, Charlie C L
Opioid-like medications (OLM) are commonly used by patients with various types of chronic pain, but their long-term benefit is questionable. Electroacupuncture (EA) has been previously shown beneficial in reducing post-operative acute OLM consumption. In this pilot randomized controlled trial, the effect of EA on OLM usage and associated side effects in chronic pain patients was evaluated. After a two-week baseline assessment, participants using OLM for their non-malignant chronic pain were randomly assigned to receive either real EA (REA, n=17) or sham EA (SEA, n=18) treatment twice weekly for 6 weeks before entering a 12-week follow-up. Pain, OLM consumption and their side effects were recorded daily. Participants also completed the McGill Pain Questionnaire (MPQ), SF-36 and Beck Depression Inventory (BDI) at baseline, and at the 5th, 8th, 12th, 16th and 20th week. Nine participants withdrew during the treatment period with another three during the follow-up period. Intention to treat analysis was applied. At the end of treatment period, reductions of OLM consumption in REA and SEA were 39% and 25%, respectively (p=0.056), but this effect did not last more than 8 weeks after treatment. There was no difference between the two groups with respect to reduction of side effects and pain and the improvement of depression and quality of life. In conclusion, REA demonstrates promising short-term reduction of OLM for participants with chronic non-malignant pain, but such effect needs to be confirmed by trials with adequate sample sizes.
Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Piemontese, Matteo; Nieri, Michele
To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 3-year, parallel group, randomized clinical trial. The study was conducted in a private dental clinic between July 2005 and July 2010. Patients 18 years or older were randomized to receive implants for fixed partial dentures in cases of partial edentulism. The test group was represented by immediate non-occlusal implant loading, whereas the control group was represented by early non-occlusal implant loading. The outcome variables were implant failure, complications and radiographic bone level at implant sites 3 years after loading, measured from the implant-abutment junction to the most coronal point of bone-to-implant contact. Randomization was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes, and the measurer was blinded to group assignment. Sixty patients were randomized: 30 to the immediately loaded group and 30 to the early loaded group. Four patients dropped out; however, the data of all patients were included in the analysis. No implant failure occurred. Two complications occurred in the control group and one in the test group. The mean bone level at 3 years was 1.91 mm for test group and 1.59 mm for control group. The adjusted difference in bone level was 0.26 mm (CI 95% -0.08 to 0.59, p = 0.1232). The null hypothesis of no difference in failure rates, complications and bone level between implants that were loaded immediately or early at 3 years cannot be rejected in this randomized clinical trial. © 2011 John Wiley & Sons A/S.
Pedreira da Fonseca, Erika; Ribeiro da Silva, Nildo Manoel; Pinto, Elen Beatriz
The study aimed to check the therapeutic effect of virtual reality associated with conventional physiotherapy on gait balance and the occurrence of falls after a stroke. This was a randomized, blinded clinical trial conducted with post-stroke patients, randomized into two groups-treatment group and control group-and subjected to balance assessments by the Dynamic Gait Index and investigation of falls before and after 20 intervention sessions. Statistically significant difference was considered at P rehabilitation in post-stroke patients, with repercussions on the reduction of falls. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.
Full Text Available Abstract Background Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience. Our study aims to achieve the following: - Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia. - Find and analyze educational tools to improve patient safety culture in primary care. - Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care. Design and methods Design Experimental unifactorial study of two groups, control and intervention. Study population Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain. Sample From the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned. Intervention Residents and their respective tutor (tutor-resident pair in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group-either intervention or control-through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent
Pedersen, Christian Roed; Nielsen, Lars Relund; Andersen, Kim Allan
We consider the bicriterion multimodal assignment problem, which is a new generalization of the classical linear assignment problem. A two-phase solution method using an effective ranking scheme is presented. The algorithm is valid for generating all nondominated criterion points or an approximat......We consider the bicriterion multimodal assignment problem, which is a new generalization of the classical linear assignment problem. A two-phase solution method using an effective ranking scheme is presented. The algorithm is valid for generating all nondominated criterion points...
Background Poor sleep is prevalent in patients with systemic inflammatory disorders, including rheumatoid arthritis, and, in addition to fatigue, pain, depression and inflammation, is associated with an increased risk of co-morbidity and all-cause mortality. Whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue, no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis. The aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep, assessed both objectively and subjectively in patients with rheumatoid arthritis. Methods/design A randomized controlled trial including 44 patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group. The intervention consists of 18 session intermittent aerobic exercise training on a bicycle ergometer three times a week. Patients are evaluated according to objective changes in sleep as measured by polysomnography (primary outcome). Secondary outcomes include changes in subjective sleep quality and sleep disturbances, fatigue, pain, depressive symptoms, physical function, health-related quality of life and cardiorespiratory fitness. Discussion This trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis, which is considered important in promotion of health and well-being. As such, the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis. Trial registration ClinicalTrials.gov Identifier: NCT01966835 PMID:24559487
Pérula de Torres, Luis Angel; Pulido Ortega, Laura; Pérula de Torres, Carlos; González Lama, Jesús; Olaya Caro, Inmaculada; Ruiz Moral, Roger
To evaluate the effectiveness of an intervention based on motivational interviewing to reduce medication errors in chronic patients over 65 with polypharmacy. Cluster randomized trial that included doctors and nurses of 16 Primary Care centers and chronic patients with polypharmacy over 65 years. The professionals were assigned to the experimental or the control group using stratified randomization. Interventions consisted of training of professionals and revision of patient treatments, application of motivational interviewing in the experimental group and also the usual approach in the control group. The primary endpoint (medication error) was analyzed at individual level, and was estimated with the absolute risk reduction (ARR), relative risk reduction (RRR), number of subjects to treat (NNT) and by multiple logistic regression analysis. Thirty-two professionals were randomized (19 doctors and 13 nurses), 27 of them recruited 154 patients consecutively (13 professionals in the experimental group recruited 70 patients and 14 professionals recruited 84 patients in the control group) and completed 6 months of follow-up. The mean age of patients was 76 years (68.8% women). A decrease in the average of medication errors was observed along the period. The reduction was greater in the experimental than in the control group (F=5.109, P=.035). RRA 29% (95% confidence interval [95% CI] 15.0-43.0%), RRR 0.59 (95% CI:0.31-0.76), and NNT 3.5 (95% CI 2.3-6.8). Motivational interviewing is more efficient than the usual approach to reduce medication errors in patients over 65 with polypharmacy. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.
Najafi, Seyed Saeed; Shaabani, Maryam; Momennassab, Marzieh; Aghasadeghi, Kamran
Adherence to dietary and medication regimen plays an important role in successful treatment and reduces the negative complications and severity of the disease. Therefore, the present study aimed to investigate the effect of nurse-led telephone follow-up on the level of adherence to dietary and medication regimen among patients after Myocardial Infarction (MI). This non-blinded randomized controlled clinical trial was conducted on 100 elderly patients with MI who had referred to the cardiovascular clinics in Shiraz. Participants were selected and randomly assigned to intervention and control groups using balanced block randomization method. The intervention group received a nurse-led telephone follow-up. The data were collected using a demographic questionnaire, Morisky's 8-item medication adherence questionnaire, and dietary adherence questionnaire before and three months after the intervention. Data analysis was done by the SPSS statistical software (version 21), using paired t-test for intra-group and Chi-square and t-test for between groups comparisons. Significance level was set at0.05). However, a statistically significant difference was found between the two groups in this regard after the intervention (Ptele-nursing on improvement of adherence to dietary and medication regimen in the patients with MI. IRCT201409148505N8.
Naumann, Johannes; Grebe, Julian; Kaifel, Sonja; Weinert, Tomas; Sadaghiani, Catharina; Huber, Roman
Despite advances in the treatment of depression, one-third of depressed patients fail to respond to conventional antidepressant medication. There is a need for more effective treatments with fewer side effects. The primary aim of this study was to determine whether hyperthermic baths reduce depressive symptoms in adults with depressive disorder. Randomized, two-arm placebo-controlled, 8-week pilot trial. Medically stable outpatients with confirmed depressive disorder (ICD-10: F32/F33) who were moderately depressed as determined by the 17-item Hamilton Scale for Depression (HAM-D) score ≥18 were randomly assigned to 2 hyperthermic baths (40 °C) per week for 4 weeks or a sham intervention with green light and follow-up after 4 weeks. Main outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). A total of 36 patients were randomized (hyperthermic baths, n = 17; sham condition, n = 19). The intention-to-treat analysis showed a significant (P = .037) difference in the change in HAM-D total score with 3.14 points after 4 interventions (T1) in favour of the hyperthermic bath group compared to the placebo group. This pilot study suggests that hyperthermic baths do have generalized efficacy in depressed patients. DRKS00004803 at drks-neu.uniklinik-freiburg.de, German Clinical Trials Register (registration date 2016-02-02), retrospectively registered.
Breugom, A J; van Gijn, W; Muller, E W; Berglund, Å; van den Broek, C B M; Fokstuen, T; Gelderblom, H; Kapiteijn, E; Leer, J W H; Marijnen, C A M; Martijn, H; Meershoek-Klein Kranenbarg, E; Nagtegaal, I D; Påhlman, L; Punt, C J A; Putter, H; Roodvoets, A G H; Rutten, H J T; Steup, W H; Glimelius, B; van de Velde, C J H
The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomized phase III trial, PROCTOR-SCRIPT, was conducted to compare adjuvant chemotherapy with observation for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision (TME). The PROCTOR-SCRIPT trial recruited patients from 52 hospitals. Patients with histologically proven stage II or III rectal adenocarcinoma were randomly assigned (1:1) to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME. Radiotherapy consisted of 5 × 5 Gy. Chemoradiotherapy consisted of 25 × 1.8-2 Gy combined with 5-FU-based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT). Randomization was based on permuted blocks of six, stratified according to centre, residual tumour, time between last irradiation and surgery, and preoperative treatment. The primary end point was overall survival. Of 470 enrolled patients, 437 were eligible. The trial closed prematurely because of slow patient accrual. Patients were randomly assigned to observation (n = 221) or adjuvant chemotherapy (n = 216). After a median follow-up of 5.0 years, 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.62-1.39; P = 0.73]. The HR for disease-free survival was 0.80 (95% CI 0.60-1.07; P = 0.13). Five-year cumulative incidence for locoregional recurrences was 7.8% in both groups. Five-year cumulative incidence for distant recurrences was 38.5% and 34.7%, respectively (P = 0.39). The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and TME on overall survival, disease-free survival, and recurrence rate. However, this trial did not complete
Full Text Available Airport gate assignment is core task for airport ground operations. Due to the fact that the departure and arrival time of flights may be influenced by many random factors, the airport gate assignment scheme may encounter gate conflict and many other problems. This paper aims at finding a robust solution for airport gate assignment problem. A mixed integer model is proposed to formulate the problem, and colony algorithm is designed to solve this model. Simulation result shows that, in consideration of robustness, the ability of antidisturbance for airport gate assignment scheme has much improved.
Failure of a patient-centered intervention to substantially increase the identification and referral for-treatment of ambulatory emergency department patients with occult psychiatric conditions: a randomized trial [ISRCTN61514736
Nezami Wais A
Full Text Available Abstract Background We previously demonstrated that a computerized psychiatric screening interview (the PRIME-MD can be used in the Emergency Department (ED waiting room to identify patients with mental illness. In that trial, however, informing the ED physician of the PRIME-MD results did not increase the frequency of psychiatric diagnosis, consultation or referral. We conducted this study to determine whether telling the patient and physician the PRIME-MD result would result in the majority of PRIME-MD-diagnosed patients being directed toward treatment for their mental illness. Methods In this single-site RCT, consenting patients with non-specific somatic chief complaints (e.g., fatigue, back pain, etc. completed the computerized PRIME-MD in the waiting room and were randomly assigned to one of three groups: patient and physician told PRIME-MD results, patient told PRIME-MD results, and neither told PRIME-MD results. The main outcome measure was the percentage of patients with a PRIME-MD diagnosis who received a psychiatric consultation or referral from the ED. Results 183 (5% of all ED patients were approached. 123 eligible patients consented to participate, completed the PRIME-MD and were randomized. 95 patients had outcomes recorded. 51 (54% had a PRIME-MD diagnosis and 8 (16% of them were given a psychiatric consultation or referral in the ED. While the frequency of consultation or referral increased as the intervention's intensity increased (tell neither = 11% (1/9, tell patient 15% (3/20, tell patient and physician 18% (4/22, no group came close to the 50% threshold we sought. For this reason, we stopped the trial after an interim analysis. Conclusion Patients willingly completed the PRIME-MD and 54% had a PRIME-MD diagnosis. Unfortunately, at our institution, informing the patient (and physician of the PRIME-MD results infrequently led to the patient being directed toward care for their psychiatric condition.
Zegarra, Luis; Vaisberg, Abraham; Loza, Cesar; Aguirre, Roxana L; Campos, Miguel; Fernandez, Irma; Talla, Oscar; Villegas, Leon
To determine the efficacy of Bixa Orellana (BO) in patients with benign prostatic hyperplasia (BPH) presenting moderate lower urinary tract symptoms (LUTS). It is a prospective double-blind randomized placebo-controlled study. One thousand four hundred and seventy eight patients presenting moderate LUTS associated to BPH were interviewed, from whom we selected 136 to fulfill the criteria of inclusion and exclusion. Assignation was performed at random in blocks of four to receive B0 at a dose of 250 mg 3 times a day or placebo (Pbo) for 12 months, 68 patients were assigned to each group. From the patients in the study we obtained data of demographic, epidemiologic, symptom score, uroflowmetry and post void residual urine variables. Basically both groups were compared clinically, demographically and biochemically. Throughout the study variations of symptom score, mean delta symptom score during each visit and the final average delta were similar for both groups (BO - 0.79 +/- 1.87 and Pbo - 1.07 +/- 1.49) (p = 0.33). Similarly variations of Qmax mean, Qmax average delta and final average delta were similar (BO 0.44 +/- 1.07 and Pbo 0.47 +/- 1.32) (p = 0.88). Variations of post void residual urine mean, post void residual urine average delta in each visit and the final average delta were similar for both groups (BO 4.24 +/- 11.69 and Pbo 9.01 +/- 18.66) (p = 0.07). No differences were found in the answers of clinically significant improvement assessed with relative risk and risk differences, even though the proportion of adverse effects was similar for both groups. Patients with BPH that present moderate LUTS did not show any benefit receiving BO when compared to placebo.
Full Text Available OBJECTIVE: To determine the efficacy of Bixa Orellana (BO in patients with benign prostatic hyperplasia (BPH presenting moderate lower urinary tract symptoms (LUTS. MATERIALS AND METHODS: It is a prospective double-blind randomized placebo-controlled study. One thousand four hundred and seventy eight patients presenting moderate LUTS associated to BPH were interviewed, from whom we selected 136 to fulfill the criteria of inclusion and exclusion. Assignation was performed at random in blocks of four to receive B0 at a dose of 250 mg 3 times a day or placebo (Pbo for 12 months, 68 patients were assigned to each group. From the patients in the study we obtained data of demographic, epidemiologic, symptom score, uroflowmetry and post void residual urine variables. RESULTS: Basically both groups were compared clinically, demographically and biochemically. Throughout the study variations of symptom score, mean delta symptom score during each visit and the final average delta were similar for both groups (BO - 0.79 ± 1.87 and Pbo - 1.07 ± 1.49 (p = 0.33. Similarly variations of Qmax mean, Qmax average delta and final average delta were similar (BO 0.44 ± 1.07 and Pbo 0.47 ± 1.32 (p = 0.88. Variations of post void residual urine mean, post void residual urine average delta in each visit and the final average delta were similar for both groups (BO 4.24 ± 11.69 and Pbo 9.01 ± 18.66 (p = 0.07. No differences were found in the answers of clinically significant improvement assessed with relative risk and risk differences, even though the proportion of adverse effects was similar for both groups. CONCLUSION: Patients with BPH that present moderate LUTS did not show any benefit receiving BO when compared to placebo.
Mohamadshahi, Majid; Veissi, Masoud; Haidari, Fatemeh; Javid, Ahmad Zare; Mohammadi, Fatemeh; Shirbeigi, Esmat
Alteration in plasma lipid and lipoprotein profile has been documented in diabetic patients. The purpose of this study was to compare the effect of probiotic and conventional yogurt on lipid profile in type 2 diabetes mellitus patients. A total of 44 patients with type 2 diabetes aged 30-60 years old who had low density lipoprotein cholesterol (LDL-c) ≥100 mg/dl enrolled in this randomized, double - blind controlled trial and were assigned to two intervention and control groups. The subjects in the intervention group consumed 300 g/d probiotic yogurt containing Lactobacillus acidophilus La-5 and Bifidobacterium lactis Bb-12 and subjects in the control group consumed 300 g/d conventional yogurt for 8 weeks. Anthropometric indices, dietary intake, and serum lipid profile were evaluated at the beginning and end of the intervention. Independent-sample t-test, paired sample t-test, ANCOVA, and repeated measures were used for statistical analysis. The consumption of probiotic yogurt caused significant decrease in LDL-c/high density lipoprotein cholesterol (HDL-c) ratio (3.13 ± 1.00-2.07 ± 0.71, P = 0.016). The levels of HDL-c were increased significantly (43.66 ± 6.80-50.42 ± 6.64, P = 0.023) in the intervention group postintervention. However, there were no significant differences in triglyceride and total cholesterol levels between two groups postintervention (P yogurt consumption may be used as an alternative prevention approach and treatment method to improve dyslipidemia in patients with type 2 diabetes.
Full Text Available Background: Alteration in plasma lipid and lipoprotein profile has been documented in diabetic patients. The purpose of this study was to compare the effect of probiotic and conventional yogurt on lipid profile in type 2 diabetes mellitus patients. Materials and Methods: A total of 44 patients with type 2 diabetes aged 30-60 years old who had low density lipoprotein cholesterol (LDL-c ≥100 mg/dl enrolled in this randomized, double - blind controlled trial and were assigned to two intervention and control groups. The subjects in the intervention group consumed 300 g/d probiotic yogurt containing Lactobacillus acidophilus La-5 and Bifidobacterium lactis Bb-12 and subjects in the control group consumed 300 g/d conventional yogurt for 8 weeks. Anthropometric indices, dietary intake, and serum lipid profile were evaluated at the beginning and end of the intervention. Independent-sample t-test, paired sample t-test, ANCOVA, and repeated measures were used for statistical analysis. Results: The consumption of probiotic yogurt caused significant decrease in LDL-c/high density lipoprotein cholesterol (HDL-c ratio (3.13 ± 1.00-2.07 ± 0.71, P = 0.016. The levels of HDL-c were increased significantly (43.66 ± 6.80-50.42 ± 6.64, P = 0.023 in the intervention group postintervention. However, there were no significant differences in triglyceride and total cholesterol levels between two groups postintervention (P < 0.05. Conclusion: It is suggested that probiotic yogurt consumption may be used as an alternative prevention approach and treatment method to improve dyslipidemia in patients with type 2 diabetes.
Ökmen, Burcu Metin; Eröksüz, Rıza; Altan, Lale; Aksoy, Meliha Kasapoğlu
The aim of this study was to assess the effect of peloid on pain, functionality, daily life activities, and quality of life of lateral epicondylitis (LE) patients. In this randomized, controlled, single-blind study, 75 patients who were diagnosed with chronic LE were enrolled to the study. Patients were randomized into two groups using the random number table. The patients in the first group (group 1) (n = 33), were given lateral epicondylitis band (LEB) (during the day for 6 weeks) + peloid therapy (five consecutive days a week for 2 weeks), and the second group (group 2) (n = 32), received LEB treatment alone. The patients were assessed by using Patient Rated Tennis Elbow Evaluation (PRTEE) and Nottingham Health Profile (NHP). The data were obtained before treatment (W0), immediately after treatment (W2), and 1 month after treatment (W6). In analysis of the collected data, the Wilcoxon signed rank test for intra-group comparisons and Mann-Whitney U test for comparisons between groups were used. Both in groups 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0 (p 0.05), a statistically significant difference was found in favor of group 1 for all the evaluation parameters at W6 (p patients.
Toth, Maria; Marcantonio, Edward R.; Davis, Roger B.; Walton, Tracy; Kahn, Janet R.
Abstract Objectives The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. Design This was a randomized controlled trial. Settings/location Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects Subjects were patients with metastatic cancer. Interventions There were three interventions: massage therapy, no-touch intervention, and usual care. Outcome measures Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. Results In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. Conclusions The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings. PMID:23368724
Murphy, Glenn S; Szokol, Joseph W; Avram, Michael J; Greenberg, Steven B; Shear, Torin D; Deshur, Mark A; Vender, Jeffery S; Benson, Jessica; Newmark, Rebecca L
Patients undergoing spinal fusion surgery often experience severe pain during the first three postoperative days. The aim of this parallel-group randomized trial was to assess the effect of the long-duration opioid methadone on postoperative analgesic requirements, pain scores, and patient satisfaction after complex spine surgery. One hundred twenty patients were randomized to receive either methadone 0.2 mg/kg at the start of surgery or hydromorphone 2 mg at surgical closure. Anesthetic care was standardized, and clinicians were blinded to group assignment. The primary outcome was intravenous hydromorphone consumption on postoperative day 1. Pain scores and satisfaction with pain management were measured at postanesthesia care unit admission, 1 and 2 h postadmission, and on the mornings and afternoons of postoperative days 1 to 3. One hundred fifteen patients were included in the analysis. Median hydromorphone use was reduced in the methadone group not only on postoperative day 1 (4.56 vs. 9.90 mg) but also on postoperative days 2 (0.60 vs. 3.15 mg) and 3 (0 vs. 0.4 mg; all Pmethadone group at 21 of 27 assessments (all P = 0.001 to methadone group than in the hydromorphone group until the morning of postoperative day 3 (all P = 0.001 to methadone administration reduced postoperative opioid requirements, decreased pain scores, and improved patient satisfaction with pain management.
Adachi, Sen; Miura, Shin-Ichiro; Shiga, Yuhei; Arimura, Tadaaki; Kuwano, Takashi; Kitajima, Ken; Ike, Amane; Sugihara, Makoto; Iwata, Atsushi; Nishikawa, Hiroaki; Morito, Natsumi; Saku, Keijiro
We compared the efficacy and safety of azilsartan to those of olmesartan in a prospective, randomized clinical trial. Forty-four hypertensive patients who had coronary artery disease (CAD) were enrolled. We randomly assigned patients to changeover from their prior angiotensin II receptor blockers (ARBs) to either azilsartan or olmesartan, and followed the patients for 12 weeks. Office systolic blood pressure (SBP) in the azilsartan group was significantly decreased after 12 weeks. SBP and diastolic blood pressure (DBP) after 12 weeks in the azilsartan group were significantly lower than those in the olmesartan group. The percentage of patients who reached the target BP at 12 weeks (78%) in the azilsartan group was significantly higher than that at 12 weeks (45%) in the olmesartan group. There were no significant changes in pentraxin-3, high-sensitively C-reactive protein or adiponectin in blood after 12 weeks in either group. Although serum levels of creatinine (Cr) in the azilsartan group significantly increased, these changes were within the respective normal range. In conclusion, the ability of azilsartan to reduce BP may be superior to that of prior ARBs with equivalent safety in hypertensive patients with CAD.
Nasiri, Ahmad; Mahmodi, Mohammad Azim; Nobakht, Zohre
Osteoarthritis of the knee is the most common chronic joint disease that involves middle aged and elderly people. The purpose of this study was to investigate the effect of aromatherapy massage with lavender essential oil on pain in patients with osteoarthritis of the knee. In this single-blinded, randomized clinical trial, 90 patients with osteoarthritis of the knee who referred to the outpatient rheumatology clinics affiliated with Birjand University of Medical Sciences were selected through convenience sampling method. They were randomly assigned to three groups: intervention (aromatherapy massage with lavender essential oil), placebo (massage with almond oil) and control (without massage). The patients were evaluated at baseline, immediately after the intervention, 1 week, and 4 weeks after the intervention in terms of pain via visual analogue scale. The data were analyzed in SPSS (version 16) using the repeated measure ANOVA, one-way ANOVA, and chi-squared test. Pain severity of the patients in the intervention group was significantly different immediately and 1 week after the intervention compared with their initial status (p Aromatherapy massage with lavender essential oil was found effective in relieving pain in patients with knee osteoarthritis. However, further studies are needed to confirm findings of this study. Copyright © 2016 Elsevier Ltd. All rights reserved.
Yeh, Tsui-Yun; Lin, Jen-Chien; Liu, Chi-Feng
To investigate the effects of transcutaneous electrical nerve stimulation (TENS) through acupoints on the intraocular pressure (IOP) in patients with glaucoma. A single-blinded, randomized experimental design study was conducted. Patients from the North of Taipei Ophthalmology outpatient department diagnosed with intraocular hypertension were selected and were further enrolled if they met the research subject criteria. The patients who met all criteria, and who met no exclusion criteria became the participants. Participants were randomly assigned into the treated group, wherein the TENS electrodes (Qing Ming Medical Device Co., Ltd., New Taipei City, China) were applied with direct current (DC) on the acupoints Pucan (BL 61) and Shenmai (BL 62) for 20 min. The control group received no TENS electrode treatments. Measurements of IOP were taken four times using a pneumotonometer (Clinico Co., Ltd., New Taipei City, China), before, immediately after, 30 min after, and 60 min after TENS electrode treatments. Eighty-two participants completed the experiment. IOP decreased more in the group treated with DC (P IOPs were not affected by the age of the patients and their usage of medications. TENS of acupoints of Pucan (BL 61) and Shenmai (BL 62) could significantly reduce the IOP in patients with glaucoma.
Hogg, William; Lemelin, Jacques; Dahrouge, Simone; Liddy, Clare; Armstrong, Catherine Deri; Legault, Frances; Dalziel, Bill; Zhang, Wei
T o examine whether quality of care (QOC) improves when nurse practitioners and pharmacists work with family physicians in community practice and focus their work on patients who are 50 years of age and older and considered to be at risk of experiencing adverse health outcomes. Randomized controlled trial. A family health network with 8 family physicians, 5 nurses, and 11 administrative personnel serving 10 000 patients in a rural area near Ottawa, Ont. Patients 50 years of age and older at risk of experiencing adverse health outcomes (N = 241). At-risk patients were randomly assigned to receive usual care from their family physicians or Anticipatory and Preventive Team Care (APTCare) from a collaborative team composed of their physicians, 1 of 3 nurse practitioners, and a pharmacist. Quality of care for chronic disease management (CDM) for diabetes, coronary artery disease, congestive heart failure, and chronic obstructive pulmonary disease. Controlling for baseline demographic characteristics, the APTCare approach improved CDM QOC by 9.2% (P multidisciplinary care teams with intensive interventions in primary care can improve QOC for CDM in a population of older at-risk patients. The appropriateness of this intervention will depend on its cost-effectiveness. TRIAL REGISTRATION NUMBER NCT00238836 (CONSORT).
Ishiki, Hiroto; Iwase, Satoru; Gyoda, Yasuaki; Kanai, Yoshiaki; Ariyoshi, Keisuke; Miyaji, Tempei; Tahara, Yukiko; Kawaguchi, Takashi; Chinzei, Mieko; Yamaguchi, Takuhiro
Tube feeding or hydration is often considered for end-of-life cancer patients despite the negative effects on quality of life. The efficacy of oral nutritional support in this setting is unknown. We conducted a randomized trial to compare the efficacies of an amino acid jelly, Inner Power® (IP), and a liquid enteral product, Ensure Liquid® (EL), in terminally ill cancer patients. We randomly assigned patients to 3 arms: EL, IP, and EL+IP. The primary endpoint was drip infusion in vein (DIV)-free survival, which was defined as the duration from nutritional support initiation to administration of parenteral hydration. Twenty-seven patients were enrolled in the study, of whom 21 were included in the intention-to-treat analysis. The median age of the subjects was 69 yr. There were significant differences between the arms with regard to the median DIV-free survival (0.5, 6.0, and 4.5 days in the EL, IP, and EL + IP arms, respectively; P = 0.05). The median overall survival was 7, 9, and 8 days in the EL, IP, and EL + IP arms, respectively. IP may shorten the duration of parenteral hydration in terminally ill cancer patients and does not affect their survival.
Chiu, Hui-Chuan; Hung, Hsin-Yuan; Lin, Hsiu-Chen; Chen, Shu-Ching
Our purpose was to evaluate the effects of a health education and telephone counseling program on knowledge and attitudes about colorectal cancer and screening and the psychological impact of positive screening results. A randomized controlled trial was conducted with 2 groups using a pretest and posttest measures design. Patients with positive colorectal cancer screening results were selected and randomly assigned to an experimental (n = 51) or control (n = 51) group. Subjects in the experimental group received a health education and telephone counseling program, while the control group received routine care only. Patients were assessed pretest before intervention (first visit to the outpatient) and posttest at 4 weeks after intervention (4 weeks after first visit to the outpatient). Patients in the experimental group had a significantly better level of knowledge about colorectal cancer and the psychological impact of a positive screening result than did the control group. Analysis of covariance revealed that the health education and telephone counseling program had a significant main effect on colorectal cancer knowledge. A health education and telephone counseling program can improve knowledge about colorectal cancer and about the psychological impact in patients with positive colorectal cancer screening results. The health education and telephone counseling program is an easy, simple, and convenient method of improving knowledge, improving attitudes, and alleviating psychological distress in patients with positive colorectal cancer screening results, and this program can be expanded to other types of cancer screening. Copyright © 2016 John Wiley & Sons, Ltd.
Pfirrmann, Daniel; Tug, Suzan; Brosteanu, Oana; Mehdorn, Matthias; Busse, Martin; Grimminger, Peter P; Lordick, Florian; Glatz, Torben; Hoeppner, Jens; Lang, Hauke; Simon, Perikles; Gockel, Ines
Patients undergoing surgery for esophageal cancer have a high risk for postoperative deterioration of lung function and pulmonary complications. This is partly due to one-lung ventilation during thoracotomy. This often accounts for prolonged stay on intensive care units, delayed postoperative reconvalescence and reduced quality of life. Socioeconomic disadvantages can result from these problems. Physical preconditioning has become a crucial leverage to optimize fitness and lung function in patients scheduled for esophagectomy, in particular during the time period of neoadjuvant therapy. We designed a prospective multicenter randomized-controlled trial. The objective is to evaluate the impact of an internet-based exercise program on postoperative respiratory parameters and pneumonia rates in patients with Barrett's carcinoma scheduled for esophagectomy. Patients are randomly assigned to either execute internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training or treatment as usual (TAU). During neoadjuvant therapy and recovery, patients in the intervention group receive an individually designed intensive exercise program based on functional measurements at baseline. Personal feedback of the supervisor with customized training programs is provided in weekly intervals. This study will evaluate if an intensive individually adapted training program via online supervision during neoadjuvant therapy will improve cardiorespiratory fitness and reduce pulmonary complications following esophagectomy for Barrett's cancer. NCT02478996 , registered 26 May 2015.
Lu, Lingyun; Zheng, Hui; Zheng, Qianhua; Hao, Xinyu; Zhou, Siyuan; Zhang, Shusen; Wei, Tao; Gao, Tao; Duan, Duoxi; Zhao, Ling; Li, Ning; Li, Ying
The effectiveness of acupuncture for patients with chronic tension-type headache (CTTH) is controversial. In this article, we report the protocol for a randomized controlled trial aiming to evaluate the long-term effect of acupuncture for CTTH, in comparison with superficial acupuncture. A two-armed, parallel-design, patient-assessor blind, randomized controlled trial is underway in China. A total of 218 participants with CTTH will be randomly assigned to the treatment group or the control group in a 1:1 ratio. Participants in the treatment group and control group will receive acupuncture or superficial acupuncture treatments in a fixed prescription of acupoints respectively, for a total of 20 sessions over 8 weeks. The posttreatment follow-up period will be 24 weeks. The primary outcome will be the proportion of responders assessed at week 16 after randomization. The secondary outcomes will include the number of headache days, the mean intensity of headache, the reduction of medication intake, results from the 36-item short form health survey, the Hamilton Depression Scale and the Hamilton Anxiety Scale, the number of participants with adverse events, the expectation value of acupuncture treatment, and the intensity of deqi sensation. The first five secondary outcomes will be assessed or calculated at baseline, and at 4, 8, 12, 16, 20, 24, 28, and 32 weeks after randomization. Moreover, the expectation value will be collected at baseline and at week 8 after randomization, the intensity of deqi sensation will be assessed at 5 minutes after each treatment and adverse events will be summarized at the end of the follow-up period. Results from this trial will provide evidence for the long-term effect of acupuncture for CTTH with a long follow-up period. ClinicalTrial.gov NCT03133884 . Registered on 25 April 2017.
Vilmar, A C; Santoni-Rugiu, E; Sørensen, Jens Benn
Platinum-based doublets (PBDs) remain the cornerstone of treatment in non-small-cell lung cancer (NSCLC) and may include gemcitabine. A biomarker predicting sensitivity to this antimetabolite would represent a major step forward. Accordingly, we explored the predictive role of ribonucleotide...
Tønnesen, Louise Lindhardt; Meteran, Howraman; Hostrup, Morten
the effects of an 8-week intervention of either exercise (high-intensity interval training), diet (high protein/low glycemic index), or a combination of the 2, on asthma control and clinical outcomes in nonobese patients with asthma. METHODS: Nonobese adult patients with asthma (n = 149) were randomized to 1......BACKGROUND: Behavioral interventions focusing on exercise and healthy diet improve asthma control in obese patients with asthma, but whether these interventions can lead to improvements in nonobese patients remains unclear. OBJECTIVES: In a randomized, controlled parallel-group design, we studied...... of 4 groups: an exercise group, a diet group, an exercise + diet group, or a control group. Outcomes included Asthma Control Questionnaire (ACQ) score, asthma-related quality-of-life (Asthma-Related Quality-of-Life Questionnaire [AQLQ]) score, inflammatory cell counts in induced sputum, FEV1...
Full Text Available Background: This study was planned to determine the relationship between bispectoral index (BIS during dental treatment and recovery conditions in children undergoing two regimes of anesthesia of propofol and isoflurane. Materials and Methods: In this single-blind clinical trial study, 57 4-7-year-old healthy children who had been referred for dental treatment under general anesthesia between 60 and 90 min were selected by convenience sampling and assigned to two groups, after obtaining their parents′ written consent. The anesthesia was induced by inhalation. For the first group, the anesthesia was preserved by a mixture of oxygen (50%, nitrous oxide (50%, and isoflurane (1%. For the second group, the anesthesia was preserved by a mixture of oxygen (50%, nitrous oxide (50%, and propofol was administered intravenously at a dose of 100 Ng/kg/min. The patients′ vital signs, BIS, and agitation scores were recorded every 10 min. The data were analyzed by repeated measure ANOVA and t-tests at a significance level of α = 0.05 using SPSS version 20. Results: The results of independent t-test for anesthesia time showed no statistically significant difference between isoflurane and propofol (P = 0.87. Controlling age, the BIS difference between the two anesthetic agents was not significant (P > 0.05; however, it was negatively correlated with the duration of anesthesia and the discharge time (P = 0.001, r = -0.308 and (P < 0.001, r = -0.55. Conclusion: The same depth of anesthesia is produced by propofol and isoflurane, but lower recovery complications from anesthesia are observed with isoflurane.
Molina-Torres, Guadalupe; Rodríguez-Archilla, Alberto; Matarán-Peñarrocha, Guillermo; Albornoz-Cabello, Manuel; Aguilar-Ferrándiz, María Encarnación; Castro-Sánchez, Adelaida María
Context • Patients with fibromyalgia syndrome (FMS) report frequent and severe symptoms from temporomandibular disorders (TMDs). The appropriate treatment of TMDs remains controversial. No studies have occurred on the efficacy of therapy with a laser or an occlusal stabilization splint in the treatment of TMDs in patients with FMS. Objective • The study intended to investigate the therapeutic effects of laser therapy and of an occlusal stabilization splint for reducing pain and dysfunction and improving the quality of sleep in patients with TMDs and FMS. Design • The research team designed a single-blinded, randomized clinical trial. Setting • The study took place in the research laboratory at the University of Granada (Granada, Spain). Participants • Participants were 58 women and men who had been diagnosed with FMS and TMDs and who were referred from the clinical setting. Intervention • Participants were randomly assigned to the occlusal-splint or the laser group. The laser group received a treatment protocol in which laser therapy was applied to the participant's tender points, and the occlusal-splint group underwent a treatment protocol in which an occlusal stabilization splint was used. Both groups underwent treatment for 12 wk. Outcomes Measures • Pain intensity, widespread pain, quality of sleep, severity of symptoms, active and passive mouth opening, and joint sounds were assessed in both groups at baseline and after the last intervention. The measurements used were (1) a visual analogue scale (VAS), (2) the Widespread Pain Index (WPI), (3) the Symptom Severity Scale (SSS), (4) the Patient's Global Impression of Change (PGIC), (5) the Pittsburgh Quality of Sleep Questionnaire Index (PSQI), (6) an assessment of the number of tender points, (7) a measurement of the active mouth opening, (8) a measurement of the vertical overlap of the incisors, and (9) the measurement of joint sounds during mouth opening and closing. Results • The group X time
Yumul, Roya; Elvir-Lazo, Ofelia L; White, Paul F; Sloninsky, Alejandro; Kaplan, Marshal; Kariger, Robert; Naruse, Robert; Parker, Nathaniel; Pham, Christine; Zhang, Xiao; Wender, Ronald H
To compare three different video laryngoscope devices (VL) to standard direct laryngoscopy (DL) for tracheal intubation of obese patients undergoing bariatric surgery. VL (vs DL) would reduce the time required to achieve successful tracheal intubation and improve the glottic view. Prospective, randomized and controlled. Preoperative/operating rooms and postanesthesia care unit. One hundred twenty-one obese patients (ASA physical status I-III), aged 18 to 80 years, body mass index (BMI) >30 kg/m(2) undergoing elective bariatric surgery. Patients were prospectively randomized assigned to one of 4 different airway devices for tracheal intubation: standard Macintosh (Mac) blade (DL); Video-Mac VL; Glide Scope VL; or McGrath VL. After performing a preoperative airway evaluation, patients underwent a standardized induction sequence. The glottic view was graded using the Cormack Lehane and percentage of glottic opening (POGO) scoring systems at the time of tracheal intubation. Times from the blade entering the patient's mouth to obtaining a glottic view, placement of the tracheal tube, and confirmation of an end-tidal CO2 waveform were recorded. In addition, intubation attempts, adjuvant airway devices, hemodynamic changes, adverse events, and any airway-related trauma were recorded. All three VL devices provided improved glottic views compared to standard DL (p < 0.05). Video-Mac VL and McGrath also significantly reduced the time required to obtain the glottic view. Video-Mac VL significantly reduced the time required for successful placement of the tracheal tube (vs DL and the others VL device groups). The Video-Mac and GlideScope required fewer intubation attempts (P< .05) and less frequent use of ancillary intubating devices compared to DL and the McGrath VL. Video-Mac and GlideScope required fewer intubation attempts than standard DL and the McGrath device. The Video-Mac also significantly reduced the time needed to secure the airway and improved the glottic view
Alfadda, Sara Abdulaziz
A 1-year blinded two-arm parallel randomized controlled clinical trial was conducted to test the null hypothesis that immediate loading of four dental implants between the mental foramina with a fixed prosthesis has no benefits compared with the conventional loading technique in terms of implant success and clinical function. Forty-five patients, completely edentulous in the mandibles seeking implant-supported prostheses at the Faculty of Dentistry, University of Toronto, were recruited. Four TiUnite dental implants (NobelBiocare®, Göteborg, Sweden) were placed following the one-stage surgical protocol. Immediately after surgery, the patients were randomly assigned to either study arms by a third independent party. In the experimental arm (EA), existing mandibular denture was converted into an interim implant-supported fixed bridge (ISFB) on the same day of surgery. In the control arm (CA), the mandibular denture was hollowed out and relined with a soft tissue reline. The implants were loaded with the permanent ISFB at least 3 months postsurgery. Patients were assessed by a calibrated independent investigator at 2, 6, and 12 months following completion of treatment. A total of one hundred sixty implants were placed. Due to anatomical limitations, one patient was excluded from the study. Four patients in the EA did not receive intervention as allocated and were transferred to the CA. Implant success rate was comparable between the two arms and exceeded 96%. Marginal bone loss was statistically significantly more in the immediate loading arm, -0.296 mm versus -0.037 mm (intention to treat: p = .002; per protocol: p = .021). The relatively early intervention and insertion of the final prosthesis in the immediate arm, when bone healing and remodeling process had not yet been completed, might explain the difference in the amount of bone loss. Immediate loading of four dental implants with a fixed prosthesis in the edentulous mandible is a feasible treatment option
Stegenga Boudewijn; Dommerholt Jan; de Gast Arthur; Bron Carel; Wensing Michel; Oostendorp Rob AB
Abstract Background Shoulder pain is a common musculoskeletal problem that is often chronic or recurrent. Myofascial trigger points (MTrPs) cause shoulder pain and are prevalent in patients with shoulder pain. However, few studies have focused on MTrP therapy. The aim of this study was to assess the effectiveness of multimodal treatment of MTrPs in patients with chronic shoulder pain. Methods A single-assessor, blinded, randomized, controlled trial was conducted. The intervention group receiv...
Andersson, M; Kolodziej, B; Andersson, R E
The role of imaging in the diagnosis of appendicitis is controversial. This prospective interventional study and nested randomized trial analysed the impact of implementing a risk stratification algorithm based on the Appendicitis Inflammatory Response (AIR) score, and compared routine imaging with selective imaging after clinical reassessment. Patients presenting with suspicion of appendicitis between September 2009 and January 2012 from age 10 years were included at 21 emergency surgical centres and from age 5 years at three university paediatric centres. Registration of clinical characteristics, treatments and outcomes started during the baseline period. The AIR score-based algorithm was implemented during the intervention period. Intermediate-risk patients were randomized to routine imaging or selective imaging after clinical reassessment. The baseline period included 1152 patients, and the intervention period 2639, of whom 1068 intermediate-risk patients were randomized. In low-risk patients, use of the AIR score-based algorithm resulted in less imaging (19·2 versus 34·5 per cent; P appendicitis (6·8 versus 9·7 per cent; P = 0·034). Intermediate-risk patients randomized to the imaging and observation groups had the same proportion of negative appendicectomies (6·4 versus 6·7 per cent respectively; P = 0·884), number of admissions, number of perforations and length of hospital stay, but routine imaging was associated with an increased proportion of patients treated for appendicitis (53·4 versus 46·3 per cent; P = 0·020). AIR score-based risk classification can safely reduce the use of diagnostic imaging and hospital admissions in patients with suspicion of appendicitis. Registration number: NCT00971438 ( http://www.clinicaltrials.gov). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.