Psychological effects of belonging to a Facebook weight management group in overweight and obese adults: Results of a randomised controlled trial.

Science.gov (United States)

Jane, Monica; Foster, Jonathan; Hagger, Martin; Ho, Suleen; Kane, Robert; Pal, Sebely

2018-05-18

This study was conducted to test whether the weight outcomes in an online social networking group were mediated by changes to psychological outcome measures in overweight and obese individuals, following a weight management programme delivered via Facebook. The data analysed in this study were collected during a three-armed, randomised, controlled clinical weight management trial conducted with overweight and obese adults over 24 weeks. Two intervention groups were given the same weight management programme: one within a Facebook group, along with peer support from other group members (the Facebook Group); the other group received the same programme in a pamphlet (the Pamphlet Group). A Control Group was given standard care. The primary outcome was weight; secondary outcomes included the following domains from self-reported questionnaires: energy intake and expenditure; psychological health, social relationships, physical health, quality of life, depression, anxiety, stress, health anxiety, happiness, as well as Facebook Group participants' opinion of this group. The Facebook Group experienced a reduction in their baseline weight measurement by week 24, significantly compared to the Control Group (p = .016). The Facebook Group recorded a significant increase in the psychological health domain during the trial (at week 12) relative to their baseline measurement, and significant compared to the Control Group (p = .022). Mediation analysis indicated a statistical trend, but not statistical significance, for psychological health as a mediator to weight loss in the Facebook Group. While both intervention groups showed significant changes in psychological outcome measures, the Facebook Group was the only group to experience statistically significant weight loss by the end of the 24 weeks. Therefore, an examination of other psychological and/or behavioural outcome measures undertaken in larger studies in the future may help to identify significant mediators to

Competition in human groups-Impact on group cohesion, perceived stress and outcome satisfaction.

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Boos, Margarete; Franiel, Xaver; Belz, Michael

2015-11-01

This study on competition in human groups was performed within the context of the competitive outcome interdependence concept: the degree to which personal outcomes among group members are affected by the consequences of task performance of others, e.g. when one group member gains a high reward for a task, this lowers the available reward for other group members. Our computer-based multi-participant game empirically assessed how competitive versus neutral conditions influenced the reward-maximising behaviour of 200 undergraduate students functioning in ten-person groups - each playing two games (1 neutral and 1 competitive), their perceived pay satisfaction as well as perceived stress levels and sense of calmness within the games' task to search for coins. Participants were represented by black dots moving on a virtual playground. Results showed that competition led to reward-maximising but fellow group member disadvantaging behaviour, and all participants experienced lower pay satisfaction, higher stress levels and less calmness. We conclude that short-term behavioural consequences of positive individual competitive behaviour were gained at the above-mentioned potential long-term negative costs for all group members. This implies group paradigms aimed at sustainability should avoid introducing competitive factors that at best result in short-lived gains and at worst cause widespread dissatisfaction, stress and a pervasive lack of calmness. Copyright © 2015. Published by Elsevier B.V.

CORE STABILIZATION EXERCISES AFTER ACL RECONSTRUCTION SURGERY PROVIDES BETTER OUTCOMES: A RANDOMIZED CONTROLLED TRIAL

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Dilpreet Kaur

2015-12-01

Full Text Available Background: Decreased core stability displaces center of gravity away from base of support reducing activity participation of athlete. Present study was conducted to study the effect of core stabilization exercises after reconstruction surgery of ACL on functional outcomes. Methods: 30 subjects following 5 months of ACL reconstruction were randomly assigned to either group that performed (study group or did not performed (control group additional core stabilization exercises in conjugation with standard rehabilitation protocol. Outcome measures were: activity level using Tegnar activity level scale and functional performance using triple hop test. Outcome measures were compared at day 1 and day 42 of the treatment. Result: Significant improvement was seen in the study group for Tegnar score with mean difference changing from 4.5 to 1.5 from day 1 to day 42 of treatment (p=0.039 while the control group showed improvement in mean difference changing from 3.8 to 1.4 (p=.045 from day 1 to day 42 of treatment. Highly significant improvement was seen in the study group for triple hop test with mean difference changing from 25 to 6.7 (p<.001 compared to the control group with mean difference changing from 15.2 to 9.7(p=.005 from day 1 to day 42 of treatment. Conclusions: Both the groups showed improvement for activity level and functional performance but highly significant improvement was seen in the study group for functional performance. Core stabilization exercises in conjugation with the standard ACL rehabilitation protocol results better improvement in the triple hop test.

Is There a Relation between ABO Blood Groups and Clinical Outcome in Patients with Pemphigoid? A Case-Control Study.

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Bakhtiari, Sedigheh; Toosi, Parviz; Azimi, Somayyeh; Esmaili, Nafiseh; Montazami, Ali; Rafieian, Nasrin

2016-01-01

Background. Relationship between blood groups and dermatologic diseases remains controversial and was not yet fully elucidated nor explained clearly. The aim of this study was to examine if any relation exists between different types of pemphigoid diseases and ABO blood group. Methods. In this case-control study, 159 pemphigoid patients and 152 healthy matched-controls were evaluated. All blood group (including Rh status) data for the study was obtained from the hospital medical records. Statistical comparisons were completed with chi-square test and logistic regression. Results. Blood group "O" was found in 32.9% of patients and 38.2% of control group. Blood group "A" was found among 30.8% of patients and 34.2% of control group, while group "B" was reported in 27.4% of cases and 21.1% of controls and "AB" was identified among 8.9% of patients and 6.6% of control group. 84.9% of patients were Rh positive, while in the control group 86.2% of patients were Rh positive. No significant differences were found regarding ABO blood groups (P = 0.46) or Rh (P = 0.76) between pemphigoid patients and control group. Also, older females had the higher risk of developing bullous pemphigoid. Conclusion. We found no relationship between ABO blood groups and pemphigoid disease.

Process Predictors of the Outcome of Group Drug Counseling

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Crits-Christoph, Paul; Johnson, Jennifer E.; Connolly Gibbons, Mary Beth; Gallop, Robert

2013-01-01

Objective: This study examined the relation of process variables to the outcome of group drug counseling, a commonly used community treatment, for cocaine dependence. Method: Videotaped group drug counseling sessions from 440 adult patients (23% female, 41% minority) were rated for member alliance, group cohesion, participation, self-disclosure,…

The International Dermatology Outcome Measures Group: formation of patient-centered outcome measures in dermatology.

Science.gov (United States)

Gottlieb, Alice B; Levin, Adriane A; Armstrong, April W; Abernethy, April; Duffin, Kristina Callis; Bhushan, Reva; Garg, Amit; Merola, Joseph F; Maccarone, Mara; Christensen, Robin

2015-02-01

As quality standards are increasingly in demand throughout medicine, dermatology needs to establish outcome measures to quantify the effectiveness of treatments and providers. The International Dermatology Outcome Measures Group was established to address this need. Beginning with psoriasis, the group aims to create a tool considerate of patients and providers using the input of all relevant stakeholders in assessment of disease severity and response to treatment. Herein, we delineate the procedures through which consensus is being reached and the future directions of the project. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Individual and group based parenting programmes for improving psychosocial outcomes for teenage parents and their children

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Barlow, Jane; Smailagic, Nadja; Bennett, Cathy; Huband, Nick; Jones, Hannah; Coren, Esther

2014-01-01

Background Parenting programmes are a potentially important means of supporting teenage parents and improving outcomes for their children, and parenting support is a priority across most Western countries. This review updates the previous version published in 2001. Objectives To examine the effectiveness of parenting programmes in improving psychosocial outcomes for teenage parents and developmental outcomes in their children. Search methods We searched to find new studies for this updated review in January 2008 and May 2010 in CENTRAL, MEDLINE, EMBASE, ASSIA, CINAHL, DARE, ERIC, PsycINFO, Sociological Abstracts and Social Science Citation Index. The National Research Register (NRR) was last searched in May 2005 and UK Clinical Research Network Portfolio Database in May 2010. Selection criteria Randomised controlled trials assessing short-term parenting interventions aimed specifically at teenage parents and a control group (no-treatment, waiting list or treatment-as-usual). Data collection and analysis We assessed the risk of bias in each study. We standardised the treatment effect for each outcome in each study by dividing the mean difference in post-intervention scores between the intervention and control groups by the pooled standard deviation. Main results We included eight studies with 513 participants, providing a total of 47 comparisons of outcome between intervention and control conditions. Nineteen comparisons were statistically significant, all favouring the intervention group. We conducted nine meta-analyses using data from four studies in total (each meta-analysis included data from two studies). Four meta-analyses showed statistically significant findings favouring the intervention group for the following outcomes: parent responsiveness to the child post-intervention (SMD −0.91, 95% CI −1.52 to −0.30, P = 0.04); infant responsiveness to mother at follow-up (SMD −0.65, 95% CI −1.25 to −0.06, P = 0.03); and an overall measure of parent

Study of the outcome of suicide attempts: characteristics of hospitalization in a psychiatric ward group, critical care center group, and non-hospitalized group

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Kemuyama Nobuo

2010-01-01

Full Text Available Abstract Background The allocation of outcome of suicide attempters is extremely important in emergency situations. Following categorization of suicidal attempters who visited the emergency room by outcome, we aimed to identify the characteristics and potential needs of each group. Methods The outcomes of 1348 individuals who attempted suicide and visited the critical care center or the psychiatry emergency department of the hospital were categorized into 3 groups, "hospitalization in the critical care center (HICCC", "hospitalization in the psychiatry ward (HIPW", or "non-hospitalization (NH", and the physical, mental, and social characteristics of these groups were compared. In addition, multiple logistic analysis was used to extract factors related to outcome. Results The male-to-female ratio was 1:2. The hospitalized groups, particularly the HICCC group, were found to have biopsychosocially serious findings with regard to disturbance of consciousness (JCS, general health performance (GAS, psychiatric symptoms (BPRS, and life events (LCU, while most subjects in the NH group were women who tended to repeat suicide-related behaviors induced by relatively light stress. The HIPW group had the highest number of cases, and their symptoms were psychologically serious but physically mild. On multiple logistic analysis, outcome was found to be closely correlated with physical severity, risk factor of suicide, assessment of emergent medical intervention, and overall care. Conclusion There are different potential needs for each group. The HICCC group needs psychiatrists on a full-time basis and also social workers and clinical psychotherapists to immediately initiate comprehensive care by a medical team composed of multiple professionals. The HIPW group needs psychological education to prevent repetition of suicide attempts, and high-quality physical treatment and management skill of the staff in the psychiatric ward. The NH group subjects need a

Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study.

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Vaughan, Elizabeth M; Johnston, Craig A; Cardenas, Victor J; Moreno, Jennette P; Foreyt, John P

2017-12-01

Purpose The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. Methods This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n = 50). Group visits met for 3 hours each month for a 6-month duration. Main measures included baseline and 6-month clinical outcomes (ie, A1C, lipids), concordance with 8 standard of care guidelines (ie, screens for cervical, breast, and colon cancer) from the US Preventive Task Force and American Diabetes Association, and participant acceptability. Results Compared to control participants, the intervention group resulted in significantly better clinical outcomes or guideline concordance for the following areas: target A1C levels, retinal eye exams, diabetes foot exams, mammograms, and urine microalbumin. Significantly more individuals in the control group gained weight, whereas a greater number of participants in the intervention group lost weight. Intervention participants found the group visits highly acceptable. Conclusions Integrating CHWs as part a comprehensive diabetes group visit program is a feasible and effective system-level intervention to improve glycemic control and achieve guideline concordance.

The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial.

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Miremberg, Hadas; Ben-Ari, Tal; Betzer, Tal; Raphaeli, Hagit; Gasnier, Rose; Barda, Giulia; Bar, Jacob; Weiner, Eran

2018-04-01

Patient compliance and tight glycemic control have been demonstrated to improve outcome in pregnancies complicated by gestational diabetes mellitus. The use of advanced technological tools, including smartphone-based platforms, to improve medical care and outcomes has been demonstrated in various fields of medicine, but only a few small studies were performed with gestational diabetes mellitus patients. We aimed to study the impact of introducing a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and their physicians, on patient compliance, glycemic control, pregnancy outcome, and patient satisfaction. This is a prospective, single-center, randomized controlled trial. Newly diagnosed gestational diabetes mellitus patients presenting to our multidisciplinary diabetes-in-pregnancy clinic were randomized to: (1) routine biweekly prenatal clinic care (control group); or (2) additional daily detailed feedback on their compliance and glycemic control from the clinic team via an application installed on their smartphone (smartphone group). The primary outcome was patient compliance defined as the actual blood glucose measurements/instructed measurements ×100. The secondary outcomes included diabetes-control parameters, pregnancy, and neonatal outcomes. The study was adequately powered to detect a 20% difference in patient compliance, based on a preliminary phase that demonstrated 70% baseline compliance to glucose measurements. A total of 120 newly diagnosed gestational diabetes mellitus patients were analyzed. The 2 groups did not differ in terms of age, parity, education, body mass index, family history, maternal comorbidities, oral glucose tolerance test values, and hemoglobin A1C at randomization. The smartphone group demonstrated higher level of compliance (84 ± 0.16% vs 66 ± 0.28%, P diabetes mellitus patients and the multidisciplinary diabetes-in-pregnancy clinic team improved patient compliance and

A waitlist control-group study of cognitive, mood, and quality of life outcome after posteroventral pallidotomy in Parkinson disease.

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Carr, Jason A R; Honey, Christopher R; Sinden, Marci; Phillips, Anthony G; Martzke, Jeffrey S

2003-07-01

The aim of this study was to examine neuropsychological outcome from unilateral posteroventral pallidotomy (PVP) in Parkinson disease while controlling for confounding factors such as test practice and disease progression. Participants underwent baseline and 2-month follow-up assessments of cognition, quality of life, mood, and motor functioning. The surgery group (22 patients) underwent PVP (15 left, seven right) after baseline assessment. The waitlist group (14 patients) underwent PVP after follow up. At follow up, the left PVP group exhibited a decline on verbal measures of learning, fluency, working memory, and speeded color naming. The incidence of significant decline on these measures after left PVP ranged from 50 to 86%. The right PVP group did not exhibit a significant cognitive decline, but fluency did decline in 71% of patients who underwent right PVP. Participants who underwent PVP reported better bodily pain and social functioning at follow up than participants in the waitlist group. Improved bodily pain was evident for 62% of the surgery group, and social functioning improved for 19%. Surgery did not alter reported physical functioning or mood. Dyskinesia improved after surgery, but there were no improvements in "on-state" manual dexterity or handwriting. Most patients who underwent left PVP exhibited declines in learning, fluency, working memory, and speeded color naming. Accounting for retesting effects altered the magnitude of these declines by up to one quarter of a standard deviation, but did not increase the breadth of postsurgical neuropsychological decline beyond that typically reported in the literature. It was found that PVP improved dyskinesia, bodily pain, and social functioning, but did not lead to improvement on other objective and self-reported measures of motor functioning.

Effect of endometrial biopsy on intrauterine insemination outcome in controlled ovarian stimulation cycle

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Wadhwa, Leena; Pritam, Amrita; Gupta, Taru; Gupta, Sangeeta; Arora, Sarika; Chandoke, Rajkumar

2015-01-01

OBJECTIVE: The objective was to evaluate the effect of endometrial biopsy (EB) on intrauterine insemination (IUI) outcome in controlled ovarian stimulation (COS) cycle. DESIGN: Prospective randomized control study. SETTING: Tertiary care center. MATERIALS AND METHODS: A total of 251 subjects were enrolled in the study. Subjects undergoing COS with IUI were randomly allocated into three groups. Group A: EB was taken between D19 and 24 of the spontaneous menstrual cycles that precedes the ferti...

Coasting, embryo development and outcomes of blastocyst transfer: a case-control study.

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Talebi Chahvar, Solmas; Zosmer, Ariel; Caragia, Alina; Balestrini, Simona; Sabatini, Luca; Tranquilli, Andrea Luigi; Al-Shawaf, Talha

2014-08-01

This study compared the effect on blastocyst development and clinical outcome of coasting in women at increased risk of moderate-severe ovarian hyperstimulation syndrome (OHSS; n=389) with a control group matched for age and basal FSH that did not undergo coasting (n=386) in IVF/intracytoplasmic sperm injection (ICSI) cycles. The main outcome measures were rate of blastocyst development and live birth. More cycles progressed to the blastocyst stage in the coasted group (n=169) compared with the control group (n=83; 43.4% versus 21.5%; P<0.001). The biochemical pregnancy, clinical pregnancy and live birth rates were similar (46.5% versus 42.0%; 40.6% versus 37.8%; 31.6% versus 30.1%). The duration of coasting up to 4 days did not affect progression to blastocyst stage. The multivariate model showed that coasting (OR 1.73, P=0.004) and the number of oocytes retrieved (OR 1.17, P=0.001) were positively correlated with blastocyst formation. Coasting, a measure to reduce the risk of OHSS, does not impair blastocyst development or clinical outcome. Coasting should remain an effective measure to prevent OHSS. Copyright © 2014 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

The impact of group composition and attitudes towards diversity on anticipated outcomes of diversity in groups

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van Oudenhoven-van der Zee, Karen; Paulus, Paul; Vos, Menno; Parthasarathy, Niveditha

In two studies, students evaluated group pictures of workgroups of varying ethnic and gender composition with respect to anticipated affective and productive outcomes. The impact of level of diversity, faultlines and individual differences in diversity attitudes on anticipated outcomes were

Group control of elevators

Energy Technology Data Exchange (ETDEWEB)

Umeda, Yasukazu; Hikita, Shiro; Tuji, Sintaro (Mitsubishi Electric Corp., Tokyo (Japan))

1988-09-05

Items to be evaluated in the group control of elevators, and a typical control system are described. A new system in which the fuzzy rule base is employed is introduced together with the configuration. The items to be evaluated are waiting time, riding time, accuracy of forecasting, energy saving, and ease of usage. The everage waiting time of less than 20 seconds with less than 3% waiting rate of more than 60 seconds is accepted as a satisfactory service condition. There are many conflicting matters in group-controlling, and the study for the controlling must deal with the optimization of multi-purpose problems. The standards for group-control evaluation differ according to building structures and the tastes of users, and an important problem is where to give emphasis of the evaluation. The TRAFFIC PATTERN LEARNING METHOD has been applied in the system for careful control to accommodate the traffic. No specific function is provided for the evaluation, but the call allocation is made by fuzzy rule-base. The configuration of a new group-control system is introduced. 7 references, 7 figures, 1 table.

Outcome of tight versus standard glycemic control in coronary artery bypass patients

International Nuclear Information System (INIS)

Subhani, H.

2012-01-01

Objectives: To compare the outcome of tight versus standard glycemic control and its impact on post operative morbidity and short term mortality in patients undergoing Coronary Artery Bypass Grafting (CA-BG). Patients and Methods: A prospective surveillance of 124 patients undergoing isolated CABG surgery (on pump) was included in the study, 62 patients in each group were randomly assigned to tight and standard glucose control group. The main exposure was insulin in respect to level of blood glucose and the primary outcome measures were Sternotomy wound infection, Leg wound infection and new Myocardial Infarction. Surgical Site infection was assessed on a daily basis during the patient's stay in the Department of Cardio-thoracic Surgery, Sheikh Zayed Hospital, Lahore or within 30 days of operation prompting the patient to return to the hospital. Chi-square test or test was used to identify the significance of various short term morbidities and mortality. Results: In this study, 12 patients in the standard group and 4 patients in the tightly controlled group developed Sternal wound infection (p value 0.046). Similarly, 9 versus 2 patients in the standard and tight group respectively developed Leg wound infection (p-value 0.035). Test of proportion was applied and it was found that there was significant difference in the pro-portion of infection in the two groups (p value 0.05). However, there were no significant differences in other morbidities and the short term mortality. Conclusion: Study confirmed that tight glucose con-trol post operatively in CABG patient's results in reduced sternal and leg wound infection rates; however, there was no effect on other morbidities and short term mortality. (author)

Home-based walking during pregnancy affects mood and birth outcomes among sedentary women: A randomized controlled trial.

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Taniguchi, Chie; Sato, Chifumi

2016-10-01

We examined the effects of home-based walking on sedentary Japanese women's pregnancy outcomes and mood. A randomized controlled trial was conducted, involving 118 women aged 22-36 years. Participants were randomly assigned to walking intervention (n = 60) or control (n = 58) groups. The walking group was instructed to walk briskly for 30 min, three times weekly from 30 weeks' gestation until delivery. Both groups counted their daily steps using pedometers. Pregnancy and delivery outcomes were assessed, participants completed the Profile of Mood States, and we used the intention-to-treat principle. Groups showed no differences regarding pregnancy or delivery outcomes. The walking group exhibited decreased scores on the depression-dejection and confusion subscales of the Profile of Mood States. Five of the 54 women in the intervention group who remained in the study (9.2%) completed 100% of the prescribed walking program; 32 (59.3%) women completed 80% or more. Unsupervised walking improves sedentary pregnant women's mood, indicating that regular walking during pregnancy should be promoted in this group. © 2016 John Wiley & Sons Australia, Ltd.

Assessing the variability of outcome for patients treated with localized prostate irradiation using different definitions of biochemical control

International Nuclear Information System (INIS)

Horwitz, Eric M.; Vicini, Frank A.; Ziaja, Ellen L.; Gonzalez, Jose; Dmuchowski, Carl F.; Stromberg, Jannifer S.; Brabbins, Donald S.; Hollander, Jay; Chen, Peter Y.; Martinez, Alvaro A.

1996-01-01

Purpose: Biochemical control using serial posttreatment serum prostate specific antigen (PSA) levels is being increasingly used to assess treatment efficacy for localized prostate cancer. However, no standardized definition of biochemical control has been established. We reviewed our experience treating patients with localized prostate cancer and applied three different commonly used definitions of biochemical control to determine if differences in therapeutic outcome would be observed. Methods and Materials: Between January 1987 and December 1991, 480 patients with clinically localized prostate cancer received external beam irradiation (RT) using localized prostate fields at William Beaumont Hospital. The median dose to the prostate was 66.6 Gy (range 58-70.4) using a four-field or arc technique. Pretreatment and posttreatment serum PSA levels were recorded. Over 86% (414 of 480) of patients had a pretreatment PSA level available. Three different definitions of biochemical control were used: (a) PSA nadir 20), and 5-year actuarial rates of biochemical control were calculated using the three biochemical control and one clinical local control definitions. For Group 1, 5-year actuarial rates of biochemical control were 84%, 90%, and 96% for Definitions 1-3 and clinical local control, respectively. For Group 2, 5-year actuarial control rates were 45%, 54%, 74%, and 92% for the four definitions, respectively. For Group 3, 5-year actuarial control rates were 26%, 31%, 63%, and 100% for the four definitions, respectively. For Group 4, 5-year actuarial control rates were 24%, 24%, 50%, and 100% for the four definitions, respectively. Finally, for Group 5, 5-year actuarial control rates were 5%, 14%, 15%, and 89% for the four definitions, respectively. Depending on the definition used, statistically significant differences overall in outcome rates were observed. Differences between all four definitions for all pairwise comparisons ranged from 5 to 53% (p < 0

A Binomial Test of Group Differences with Correlated Outcome Measures

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Onwuegbuzie, Anthony J.; Levin, Joel R.; Ferron, John M.

2011-01-01

Building on previous arguments for why educational researchers should not provide effect-size estimates in the face of statistically nonsignificant outcomes (Robinson & Levin, 1997), Onwuegbuzie and Levin (2005) proposed a 3-step statistical approach for assessing group differences when multiple outcome measures are individually analyzed…

Group Music Intervention Reduces Aggression and Improves Self-esteem in Children with Highly Aggressive Behavior: A Pilot Controlled Trial

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Lee, Myeong Soo; Lee, Jung-Sook

2010-01-01

We investigated the effects of group music intervention on aggression and self-esteem in children with highly aggressive behavior. Forty-eight children were allocated to either a music intervention group or an untreated control group. The music intervention group received 50 min of music intervention twice weekly for 15 consecutive weeks. The outcome measures were Child Behavior Checklist Aggression Problems Scale (Parents), Child Aggression Assessment Inventory (Teachers) and Rosenberg Self-esteem Scale. After 15 weeks, the music intervention group showed significant reduction of aggression and improvement of self-esteem compared with the control group. All outcome measures were significantly lower in the music intervention group than prior to treatment, while there was no change in the control group. These findings suggest that music can reduce aggressive behavior and improve self-esteem in children with highly aggressive behavior. Music intervention is an easily accessible therapy for children and as such may be an effective intervention for aggressive behavior. Further more, objective and replicable measures are required from a randomized controlled trial with a larger sample size and active comparable control. PMID:18955314

Group Music Intervention Reduces Aggression and Improves Self-Esteem in Children with Highly Aggressive Behavior: A Pilot Controlled Trial

Directory of Open Access Journals (Sweden)

Ae-Na Choi

2010-01-01

Full Text Available We investigated the effects of group music intervention on aggression and self-esteem in children with highly aggressive behavior. Forty-eight children were allocated to either a music intervention group or an untreated control group. The music intervention group received 50 min of music intervention twice weekly for 15 consecutive weeks. The outcome measures were Child Behavior Checklist Aggression Problems Scale (Parents, Child Aggression Assessment Inventory (Teachers and Rosenberg Self-esteem Scale. After 15 weeks, the music intervention group showed significant reduction of aggression and improvement of self-esteem compared with the control group. All outcome measures were significantly lower in the music intervention group than prior to treatment, while there was no change in the control group. These findings suggest that music can reduce aggressive behavior and improve self-esteem in children with highly aggressive behavior. Music intervention is an easily accessible therapy for children and as such may be an effective intervention for aggressive behavior. Further more, objective and replicable measures are required from a randomized controlled trial with a larger sample size and active comparable control.

Intensive perioperative glucose control does not improve outcomes of patients submitted to open-heart surgery: a randomized controlled trial

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Raquel Pei Chen Chan

2009-01-01

Full Text Available BACKGROUND: The objective of this study was to investigate the relationship between different target levels of glucose and the clinical outcomes of patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: We designed a prospective study in a university hospital where 109 consecutive patients were enrolled during a six-month period. All patients were scheduled for open-heart surgery requiring cardiopulmonary bypass. Patients were randomly allocated into two groups. One group consisted of 55 patients and had a target glucose level of 80-130 mg/dl, while the other contained 54 patients and had a target glucose level of 160-200 mg/dl. These parameters were controlled during surgery and for 36 hours after surgery in the intensive care unit. Primary outcomes were clinical outcomes, including time of mechanical ventilation, length of stay in the intensive care unit, infection, hypoglycemia, renal or neurological dysfunction, blood transfusion and length of stay in the hospital. The secondary outcome was a combined end-point (mortality at 30 days, infection or length of stay in the intensive care unit of more than 3 days. A p-value of 0.05. CONCLUSIONS: In 109 patients undergoing cardiac surgery with cardiopulmonary bypass, both protocols of glycemic control in an intraoperative setting and in the intensive care unit were found to be safe, easily achieved and not to differentially affect clinical outcomes.

Personality disorder comorbidity and outcome: comparison of three age groups.

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Stevenson, Janine; Brodaty, Henry; Boyce, Philip; Byth, Karen

2011-09-01

Personality disorder comorbidity has been extensively studied in young adult populations, to a lesser extent in elderly populations, and not at all in an Australian population. This study examines PD comorbidity over the life span 18-100. The object of this study was to examine the interactions of comorbid personality disorder and age on outcome of Axis I disorders. A total of 238 consecutive consenting eligible psychiatric inpatients were assessed on admission, prior to discharge, and after 6 and 12 months as regards symptoms, function, well-being, relapse and readmission rates and social supports. Outcomes were compared for young (18-40 years old), middle-aged (41-64) and old (65+) patients. Patients improved over time symptomatically and functionally. Across all age groups patients with comorbid personality disorder had worse outcomes than those without, but improved though never to the same extent. Personality disorder was associated with increased rates of relapse and readmission in the whole sample and in the older group, but not increased length of stay. Severity of personality disorder was associated with poorer outcome. Personality disorder adversely affects outcomes, particularly for younger (and older) patients with psychiatric disorders independently of diagnosis and other factors.

Core outcome sets in dermatology: report from the second meeting of the International Cochrane Skin Group Core Outcome Set Initiative.

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Kottner, J; Jacobi, L; Hahnel, E; Alam, M; Balzer, K; Beeckman, D; Busard, C; Chalmers, J; Deckert, S; Eleftheriadou, V; Furlan, K; Horbach, S E R; Kirkham, J; Nast, A; Spuls, P; Thiboutot, D; Thorlacius, L; Weller, K; Williams, H C; Schmitt, J

2018-04-01

Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG-COUSIN) supports the development of core outcomes in dermatology. In the second CSG-COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers. © 2018 British Association of Dermatologists.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial

Directory of Open Access Journals (Sweden)

Mash Bob

2012-12-01

Full Text Available Abstract Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Methods Trial design: Pragmatic cluster randomized controlled trial Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. Objective: To evaluate the effectiveness of the group diabetes education programme Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life Randomisation: Computer generated random numbers Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation Numbers randomized: Seventeen health centres (34 in total will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. Discussion The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can

Linking implementation process to intervention outcomes in a middle school obesity prevention curriculum, ‘Choice, Control and Change’

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Gray, Heewon Lee; Contento, Isobel R.; Koch, Pamela A.

2015-01-01

This study investigates the link between process evaluation components and the outcomes of a school-based nutrition curriculum intervention, ‘Choice, Control and Change’. Ten New York City public middle schools were recruited and randomly assigned into intervention or control condition. The curriculum was to improve sixth to seventh grade students’ energy balance related behaviors, based on social cognitive and self-determination theories, and implemented during the 2006–2007 school year (n = 1136). Behaviors and psychosocial variables were measured by self-reported questionnaires. Process components were evaluated with classroom observations, teacher interviews, and a student questionnaire. Using ‘Teacher Implementation’ (dose delivered) and ‘Student Reception’ (dose received) process data; intervention group was further categorized into medium- and high-implementation groups. Analysis of covariance revealed that, compared with control group, only high-implementation group showed significant improvement in students’ behavior and psychosocial outcomes. Hierarchical linear models showed that ‘Teacher Implementation’ and ‘Student Reception’ significantly predicted students’ sweetened beverage outcomes (P < 0.05). ‘Student Satisfaction’ was also greater when these implementation components were higher, and significantly associated with behavior and psychosocial outcomes (P < 0.05). Implementation process influenced the effectiveness of the ‘Choice, Control and Change’ intervention study. It is important to take into account the process components when interpreting the results of such research. PMID:25700557

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

Directory of Open Access Journals (Sweden)

Patricia Bourgault

Full Text Available This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.A mixed-methods randomized controlled trial (intervention (INT vs. waitlist (WL was conducted with patients suffering from FMS. Data were collected at baseline (T0, at the end of the intervention (T1, and 3 months later (T2. The primary outcome was change in pain intensity (0-10. Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC, and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively than in the WL Group (8%, 12%, 20%. The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%. The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12% and 3 months post-intervention (33% vs 4%. Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.International Standard Randomized Controlled Trial Number

The Effect of Instructional Methods (Lecture-Discussion versus Group Discussion) and Teaching Talent on Teacher Trainees Student Learning Outcomes

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Mutrofin; Degeng, Nyoman Sudana; Ardhana, Wayan; Setyosari, Punaji

2017-01-01

The aim of this study is to examine difference in the effect of instructional methods (lecture-discussion versus group discussion) and teaching talent on teacher trainees student learning outcomes. It was conducted by a quasi-experimental design using the factorialized (2 x 2) version of the nonequivalent control group design. The subjects were…

Group Projects in Social Work Education: The Influence of Group Characteristics and Moderators on Undergraduate Student Outcomes

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Postlethwait, Ariana E.

2016-01-01

This study examined the impact of group size, group formation, group conflict, and division of labor on student outcomes in a group project for a sample of 112 BSW research seminar students at a large university in the Midwest. Students completed surveys on their experiences with the group project at the end of the semester. Multiple regression…

Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence.

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Lamb, S E; Pepper, J; Lall, R; Jørstad-Stein, E C; Clark, M D; Hill, L; Fereday-Smith, J

2009-09-14

The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. The majority of women expressed no preference (55%) or preference for individual treatment (36%). Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference 52.91 pounds 95%, confidence interval ( 25.82 pounds- 80.00 pounds)). Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. ISRCTN 16772662.

Best practices: increased attendance in inpatient group psychotherapy improves patient outcomes.

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Page, Andrew C; Hooke, Geoffrey R

2009-04-01

This column describes an initiative that promoted increased attendance in group psychotherapy and its effect on patient outcomes. Information on patient- and staff-rated outcomes, readmission rates, and patient satisfaction was gathered for 2,782 inpatients in a private psychiatric facility in Australia. On average, after the initiative was implemented, patients went from attending one session per day to two sessions. Inpatients admitted after implementation had better patient- and staff-rated outcomes and lower rates of readmission within one month of discharge. However, patients' treatment satisfaction ratings declined. These findings indicate that increasing attendance in group psychotherapy can be a useful adjunct to hospital treatment.

CHILE: Outcomes of a group randomized controlled trial of an intervention to prevent obesity in preschool Hispanic and American Indian children.

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Davis, Sally M; Myers, Orrin B; Cruz, Theresa H; Morshed, Alexandra B; Canaca, Glenda F; Keane, Patricia C; O'Donald, Elena R

2016-08-01

We examined the outcomes of the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, a group randomized controlled trial to design, implement, and test the efficacy of a trans-community intervention to prevent obesity in children enrolled in Head Start centers in rural American Indian and Hispanic communities in New Mexico. CHILE was a 5-year evidence-based intervention that used a socioecological approach to improving dietary intake and increasing physical activity of 1898 children. The intervention included a classroom curriculum, teacher and food service training, family engagement, grocery store participation, and healthcare provider support. Height and weight measurements were obtained four times (fall of 2008, spring and fall of 2009, and spring of 2010), and body mass index (BMI) z-scores in the intervention and comparison groups were compared. At baseline, demographic characteristics in the comparison and intervention groups were similar, and 33% of all the children assessed were obese or overweight. At the end of the intervention, there was no significant difference between the two groups in BMI z-scores. Obesity prevention research among Hispanic and AI preschool children in rural communities is challenging and complex. Although the CHILE intervention was implemented successfully, changes in overweight and obesity may take longer than 2years to achieve. Copyright © 2016 Elsevier Inc. All rights reserved.

Outcomes of glycemic control in Hispanic geriatric diabetic patients admitted to a general ward community hospital in Puerto Rico.

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Maldonado-Rodríguez, Miguel; Pérez-López, Shirley; Torres-Torres, Nancy; Torres-Semprit, Erick; Millán-Aponte, Ismenio

2012-01-01

Diabetes mellitus is one of the most prevalent medical conditions among the Hispanic population. Although studies with patients in intensive care units have shown poor outcomes among those with uncontrolled glucose, more recent data have shown increased mortality associated with a tighter inpatient glucose control. In view of the lack of information regarding geriatric Hispanic patients with diabetes this study evaluated the effect of glucose control in the outcomes of this population in a community hospital in Puerto Rico. Through analysis of data from a previous study we evaluated 502 admissions of Hispanic geriatric patients with diabetes as comorbidity, for glucose control, management of diabetes and outcome. Data was stratified by age groups (65-74 years, 75-84 years and > or = 85 years) and outcomes were compared between the groups using chi-square and odds ratio. The most common admission diagnosis was pneumonia. Hypoglycemia was the most common complication and was associated with tighter glucose control in the age group of 75-84 years. An increased risk of having an acute coronary syndrome/acute myocardial infarction among uncontrolled patients was observed in the 75-84 year old group. Finally, although we found a high prevalence of uncontrolled blood glucose, only 54% of the patients received interventions for their glucose control. Poor glucose control seems to be associated with a tendency for decreased risk of hypoglycemia and higher risk of acute coronary syndrome/acute myocardial infarction as complications among geriatric patients with diabetes admitted to a general ward.

P3-10: Crossmodal Perceptual Grouping Modulates Subjective Causality between Action and Outcome

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Takahiro Kawabe

2012-10-01

Full Text Available Agents have to determine which external events their action has causally produced. A sensation of causal relation between action and outcome is called subjective causality. Subjective causality has been linked to the comparator model. This model assumes that the brain compares an internal prediction for action outcome with an actual sensory outcome, distinguishing between self and externally produced outcomes depending on spatiotemporal congruency. However, recent studies have expressed some doubt about the idea that subjective causality arises depending solely on the spatiotemporal congruency, suggesting instead that other perceptual/cognitive factors play a critical role in determining subjective causality. We hypothesized that crossmodal grouping between action and outcome contributed to subjective causality. Crossmodal temporal grouping is an essential factor for crossmodal simultaneity judgments with ungrouped crossmodal signals likely to be judged as non-simultaneous. We predicted that subjective causality would decrease when an agent's action was not temporally grouped with action outcome. In the experiment, observers were asked to press a key in order to trigger a display change with some temporal delay. To disrupt temporal grouping between action and outcome, a task-irrelevant visual flash or tone was sometimes presented synchronously with the button press and/or the display change. Subjective causality was decreased when the flash or the tone was coincided with the button press. This demonstrates that perceptual grouping has a key role in determination of subjective causality, a result that is not accounted for by the standard comparator model.

Collaboration of chemistry instructional games and group investigation (Gi) model to improve learning outcome in high school students

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Puspita, Ita; Sugiyarto, Kristian H.; Ikhsan, Jaslin

2017-05-01

The aims of this research are to: (1) develop chemistry instructional games on reaction rate matter; and (2) reveal the collaboration of chemistry instructional games and group investigation model to improvement learning outcome in high school student. This study is research and development (R&D). The procedure of developing product was adapted from Borg & Gall that modified into three principal steps: product planning, product developing, and product evaluating. The product planning step consist of field study, literature study, and manufacturing product. Product developing was developed product using Adobe Flash Professional CS 6 program. The last, product evaluating was performed by year XI of high school students, uses experimental methods nonequivalent control-group design by control class and experiment class. The results of this research show that: (1) a software of chemistry instructional games successfully developed using Adobe Flash Professional CS 6 and can be run on Android device; and (2) the test results of students showed that the collaboration of instructional games and group investigation model able to improvement learning outcome of hight school student.

Initiating statistical process control to improve quality outcomes in colorectal surgery.

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Keller, Deborah S; Stulberg, Jonah J; Lawrence, Justin K; Samia, Hoda; Delaney, Conor P

2015-12-01

Unexpected variations in postoperative length of stay (LOS) negatively impact resources and patient outcomes. Statistical process control (SPC) measures performance, evaluates productivity, and modifies processes for optimal performance. The goal of this study was to initiate SPC to identify LOS outliers and evaluate its feasibility to improve outcomes in colorectal surgery. Review of a prospective database identified colorectal procedures performed by a single surgeon. Patients were grouped into elective and emergent categories and then stratified by laparoscopic and open approaches. All followed a standardized enhanced recovery protocol. SPC was applied to identify outliers and evaluate causes within each group. A total of 1294 cases were analyzed--83% elective (n = 1074) and 17% emergent (n = 220). Emergent cases were 70.5% open and 29.5% laparoscopic; elective cases were 36.8% open and 63.2% laparoscopic. All groups had a wide range in LOS. LOS outliers ranged from 8.6% (elective laparoscopic) to 10.8% (emergent laparoscopic). Evaluation of outliers demonstrated patient characteristics of higher ASA scores, longer operating times, ICU requirement, and temporary nursing at discharge. Outliers had higher postoperative complication rates in elective open (57.1 vs. 20.0%) and elective lap groups (77.6 vs. 26.1%). Outliers also had higher readmission rates for emergent open (11.4 vs. 5.4%), emergent lap (14.3 vs. 9.2%), and elective lap (32.8 vs. 6.9%). Elective open outliers did not follow trends of longer LOS or higher reoperation rates. SPC is feasible and promising for improving colorectal surgery outcomes. SPC identified patient and process characteristics associated with increased LOS. SPC may allow real-time outlier identification, during quality improvement efforts, and reevaluation of outcomes after introducing process change. SPC has clinical implications for improving patient outcomes and resource utilization.

Group performance and group learning at dynamic system control tasks

International Nuclear Information System (INIS)

Drewes, Sylvana

2013-01-01

Proper management of dynamic systems (e.g. cooling systems of nuclear power plants or production and warehousing) is important to ensure public safety and economic success. So far, research has provided broad evidence for systematic shortcomings in individuals' control performance of dynamic systems. This research aims to investigate whether groups manifest synergy (Larson, 2010) and outperform individuals and if so, what processes lead to these performance advantages. In three experiments - including simulations of a nuclear power plant and a business setting - I compare the control performance of three-person-groups to the average individual performance and to nominal groups (N = 105 groups per experiment). The nominal group condition captures the statistical advantage of aggregated group judgements not due to social interaction. First, results show a superior performance of groups compared to individuals. Second, a meta-analysis across all three experiments shows interaction-based process gains in dynamic control tasks: Interacting groups outperform the average individual performance as well as the nominal group performance. Third, group interaction leads to stable individual improvements of group members that exceed practice effects. In sum, these results provide the first unequivocal evidence for interaction-based performance gains of groups in dynamic control tasks and imply that employers should rely on groups to provide opportunities for individual learning and to foster dynamic system control at its best.

[The influence of patient-controlled epidural analgesia on labor progress and neonatal outcome].

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Rzepka, Rafał; Zukowski, Maciej; Michalczyk, Michał; Nikodemski, Tomasz; Torbé, Andrzej; Kwiatkowski, Sebastian; Mikołajek-Bedner, Wioletta; Czajka, Ryszard

2012-02-01

The aim of the study was to check the influence of patient control epidural analgesia on labor progress and neonatal outcome. 144 parturients were included into the clinical trial. In 73 cases patient control epidural analgesia was used and in 71 cases pethidine (meperidine) solution was given intravenously. Apgar score, umbilical artery pH, pain intensity the time of the first, second and third stage of labor the rate of episiotomy and uterine postpartum abrasions and the rate of caesarean sections and vaginal operative delivery were compared. The time of the second stage of labor was significantly longer in the study group (40.99 vs 26.49 min, p- neonatal outcome was comparable in both groups. There were no differences in the time of the first and the second stage of labor in primiparas and multiparas analyzed separately. Visual Analogue Score was lower in the study group (Ch(2)-12,48, p-0.25), especially in the subgroups of primiparas and multiparas. Patient control epidural analgesia does not affect the time of the first and second stage of labor, oxytocin augmentation of labor may be the reason of that. This method is a more effective way of relieving labor pain. An increase of operative delivery is not observed after patient control epidural analgesia on condition that low doses and concentrations of analgesic drugs are used.

Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

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Clark MD

2009-09-01

Full Text Available Abstract Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. Results The majority of women expressed no preference (55% or preference for individual treatment (36%. Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference £52.91 95%, confidence interval (£25.82 - £80.00. Conclusion Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. Trial Registration Trial Registration number: ISRCTN 16772662

Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial.

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Evelyn Korkor Ansah

2009-01-01

Full Text Available Delays in accessing care for malaria and other diseases can lead to disease progression, and user fees are a known barrier to accessing health care. Governments are introducing free health care to improve health outcomes. Free health care affects treatment seeking, and it is therefore assumed to lead to improved health outcomes, but there is no direct trial evidence of the impact of removing out-of-pocket payments on health outcomes in developing countries. This trial was designed to test the impact of free health care on health outcomes directly.2,194 households containing 2,592 Ghanaian children under 5 y old were randomised into a prepayment scheme allowing free primary care including drugs, or to a control group whose families paid user fees for health care (normal practice; 165 children whose families had previously paid to enrol in the prepayment scheme formed an observational arm. The primary outcome was moderate anaemia (haemoglobin [Hb] < 8 g/dl; major secondary outcomes were health care utilisation, severe anaemia, and mortality. At baseline the randomised groups were similar. Introducing free primary health care altered the health care seeking behaviour of households; those randomised to the intervention arm used formal health care more and nonformal care less than the control group. Introducing free primary health care did not lead to any measurable difference in any health outcome. The primary outcome of moderate anaemia was detected in 37 (3.1% children in the control and 36 children (3.2% in the intervention arm (adjusted odds ratio 1.05, 95% confidence interval 0.66-1.67. There were four deaths in the control and five in the intervention group. Mean Hb concentration, severe anaemia, parasite prevalence, and anthropometric measurements were similar in each group. Families who previously self-enrolled in the prepayment scheme were significantly less poor, had better health measures, and used services more frequently than those in

Intervention for children with word-finding difficulties: a parallel group randomised control trial.

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Best, Wendy; Hughes, Lucy Mari; Masterson, Jackie; Thomas, Michael; Fedor, Anna; Roncoli, Silvia; Fern-Pollak, Liory; Shepherd, Donna-Lynn; Howard, David; Shobbrook, Kate; Kapikian, Anna

2017-07-31

The study investigated the outcome of a word-web intervention for children diagnosed with word-finding difficulties (WFDs). Twenty children age 6-8 years with WFDs confirmed by a discrepancy between comprehension and production on the Test of Word Finding-2, were randomly assigned to intervention (n = 11) and waiting control (n = 9) groups. The intervention group had six sessions of intervention which used word-webs and targeted children's meta-cognitive awareness and word-retrieval. On the treated experimental set (n = 25 items) the intervention group gained on average four times as many items as the waiting control group (d = 2.30). There were also gains on personally chosen items for the intervention group. There was little change on untreated items for either group. The study is the first randomised control trial to demonstrate an effect of word-finding therapy with children with language difficulties in mainstream school. The improvement in word-finding for treated items was obtained following a clinically realistic intervention in terms of approach, intensity and duration.

United States Air Force Academy Educational Outcomes Assessment Working Group. Phase 2

National Research Council Canada - National Science Library

Porter, David

1997-01-01

This publication provides an account of educational outcomes assessment activity undertaken by seven assessment teams under the Phase II Charter of the Dean of the Faculty's Educational Outcomes Assessment Working Group...

Glycemic control, compliance, and satisfaction for diabetic gravidas in centering group care.

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Parikh, Laura I; Jelin, Angie C; Iqbal, Sara N; Belna, Sarah L; Fries, Melissa H; Patel, Misbah; Desale, Sameer; Ramsey, Patrick S

2017-05-01

To determine if diabetic gravidas enrolled in Centering® group care have improved glycemic control compared to those attending standard prenatal care. To compare compliance and patient satisfaction between the groups. We conducted a prospective cohort study of diabetics enrolled in centering group care from October 2013 to December 2015. Glycemic control, compliance and patient satisfaction (five-point Likert scale) were evaluated. Student's t-test, Chi-Square and mixed effects model were used to compare outcomes. We compared 20 patients in centering to 28 standard prenatal care controls. Mean fasting blood sugar was lower with centering group care (91.0 versus 105.5 mg/dL, p =0.017). There was no difference in change in fasting blood sugar over time between the two groups (p = 0.458). The percentage of time patients brought their blood glucose logs did not differ between the centering group and standard prenatal care (70.7 versus 73.9%, p = 0.973). Women in centering group care had better patient satisfaction scores for "ability to be seen by a physician" (5 versus 4, p = 0.041) and "time in waiting room" (5 versus 4, p =0.001). Fasting blood sugar was lower for patients in centering group care. Change in blood sugar over time did not differ between groups. Diabetic gravidas enrolled in centering group care report improved patient satisfaction.

Neonatal outcome and congenital malformations in children born after ICSI with testicular or epididymal sperm: a controlled national cohort study.

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Fedder, J; Loft, A; Parner, E T; Rasmussen, S; Pinborg, A

2013-01-01

Does neonatal outcome including congenital malformations in children born after ICSI with epididymal and testicular sperm [testicular sperm extraction (TESE)/percutaneous epididymal sperm aspiration (PESA)/testicular sperm aspiration (TESA) (TPT)] differ from neonatal outcome in children born after ICSI with ejaculated sperm, IVF and natural conception (NC)? Children born after TPT have similar neonatal outcome, including total malformation rates, as have children born after ICSI and IVF with ejaculated sperm. Testing for variance over the four groups may indicate smaller differences in specific malformation rates with TPT as the highest risk group. Regarding neonatal outcome as well as congenital malformations in children born after TPT, studies are few, with limited sample size, heterogeneous and often performed without relevant control groups. Population-based cohort study including all Danish children born after TPT and fresh embryo transfer in Denmark from 1995 to 2009. Children born after transfer of frozen-thawed embryos were excluded. Control groups of children conceived by ICSI with ejaculated sperm, IVF and NC were identified by cross-linkage of the Danish IVF Register, Medical Birth Register (MBR) and National Hospital Discharge Register (HDR). The study group consisted of 466 children born after TPT, while the control groups consisted of 8967 (ICSI with ejaculated sperm), 17 592 (IVF) and 63 854 (NC) children. Neonatal outcomes and congenital malformations were analysed for singletons and twins separately. Risk estimates for low birthweight (LBW, congenital malformations in the TPT group was 7.7% and did not differ significantly from any of the control groups. However, singleton TPT boys showed an increased rate of cardiac malformations (3.6%) compared with singleton boys after IVF (1.4%; P = 0.04) and NC (1.1%; P = 0.02). Considering the level of male infertility as a continuum over the four groups, tests for variance in the rate of cardiac

Delay and probability discounting of sexual and monetary outcomes in individuals with cocaine use disorders and matched controls.

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Johnson, Matthew W; Johnson, Patrick S; Herrmann, Evan S; Sweeney, Mary M

2015-01-01

Individuals with cocaine use disorders are disproportionately affected by HIV/AIDS, partly due to higher rates of unprotected sex. Recent research suggests delay discounting of condom use is a factor in sexual HIV risk. Delay discounting is a behavioral economic concept describing how delaying an event reduces that event's value or impact on behavior. Probability discounting is a related concept describing how the uncertainty of an event decreases its impact on behavior. Individuals with cocaine use disorders (n = 23) and matched non-cocaine-using controls (n = 24) were compared in decision-making tasks involving hypothetical outcomes: delay discounting of condom-protected sex (Sexual Delay Discounting Task), delay discounting of money, the effect of sexually transmitted infection (STI) risk on likelihood of condom use (Sexual Probability Discounting Task), and probability discounting of money. The Cocaine group discounted delayed condom-protected sex (i.e., were more likely to have unprotected sex vs. wait for a condom) significantly more than controls in two of four Sexual Delay Discounting Task partner conditions. The Cocaine group also discounted delayed money (i.e., preferred smaller immediate amounts over larger delayed amounts) significantly more than controls. In the Sexual Probability Discounting Task, both groups showed sensitivity to STI risk, however the groups did not differ. The Cocaine group did not consistently discount probabilistic money more or less than controls. Steeper discounting of delayed, but not probabilistic, sexual outcomes may contribute to greater rates of sexual HIV risk among individuals with cocaine use disorders. Probability discounting of sexual outcomes may contribute to risk of unprotected sex in both groups. Correlations showed sexual and monetary results were unrelated, for both delay and probability discounting. The results highlight the importance of studying specific behavioral processes (e.g., delay and probability

Delay and probability discounting of sexual and monetary outcomes in individuals with cocaine use disorders and matched controls.

Directory of Open Access Journals (Sweden)

Matthew W Johnson

Full Text Available Individuals with cocaine use disorders are disproportionately affected by HIV/AIDS, partly due to higher rates of unprotected sex. Recent research suggests delay discounting of condom use is a factor in sexual HIV risk. Delay discounting is a behavioral economic concept describing how delaying an event reduces that event's value or impact on behavior. Probability discounting is a related concept describing how the uncertainty of an event decreases its impact on behavior. Individuals with cocaine use disorders (n = 23 and matched non-cocaine-using controls (n = 24 were compared in decision-making tasks involving hypothetical outcomes: delay discounting of condom-protected sex (Sexual Delay Discounting Task, delay discounting of money, the effect of sexually transmitted infection (STI risk on likelihood of condom use (Sexual Probability Discounting Task, and probability discounting of money. The Cocaine group discounted delayed condom-protected sex (i.e., were more likely to have unprotected sex vs. wait for a condom significantly more than controls in two of four Sexual Delay Discounting Task partner conditions. The Cocaine group also discounted delayed money (i.e., preferred smaller immediate amounts over larger delayed amounts significantly more than controls. In the Sexual Probability Discounting Task, both groups showed sensitivity to STI risk, however the groups did not differ. The Cocaine group did not consistently discount probabilistic money more or less than controls. Steeper discounting of delayed, but not probabilistic, sexual outcomes may contribute to greater rates of sexual HIV risk among individuals with cocaine use disorders. Probability discounting of sexual outcomes may contribute to risk of unprotected sex in both groups. Correlations showed sexual and monetary results were unrelated, for both delay and probability discounting. The results highlight the importance of studying specific behavioral processes (e.g., delay and

Effect of endometrial biopsy on intrauterine insemination outcome in controlled ovarian stimulation cycle.

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Wadhwa, Leena; Pritam, Amrita; Gupta, Taru; Gupta, Sangeeta; Arora, Sarika; Chandoke, Rajkumar

2015-01-01

The objective was to evaluate the effect of endometrial biopsy (EB) on intrauterine insemination (IUI) outcome in controlled ovarian stimulation (COS) cycle. Prospective randomized control study. Tertiary care center. A total of 251 subjects were enrolled in the study. Subjects undergoing COS with IUI were randomly allocated into three groups. Group A: EB was taken between D19 and 24 of the spontaneous menstrual cycles that precedes the fertility treatment and IUI, which was done in next cycle (n = 86). Group B: EB was taken before D6 of the menstrual cycle, and fertility treatment and IUI was done in the same cycle (n = 90). Group C: (control group) no EB in previous 3 cycle (n = 75). Clinical pregnancy rate (CPR). Clinical pregnancy rate was 19.77%, 31.11%, and 9.3% for Group A, Group B, and Group C, respectively. The results show a highly significant value for the paired t-test of intervention Group B and control Group C of the cases (P = 0.000957). CPR was maximum after first cycle of ovulation induction and IUI following EB scratch in both Groups A and in Group B (P Endometrial biopsy done in early follicular phase in the same cycle of stimulation with IUI gives better CPR as compared with EB done in the luteal phase of the previous cycle.

Outpatient psychodynamic group psychotherapy - outcomes related to personality disorder, severity, age and gender.

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Kvarstein, Elfrida Hartveit; Nordviste, Ola; Dragland, Lone; Wilberg, Theresa

2017-02-01

Outpatient group psychotherapy is frequent within specialist services, recruits a mixed population, but effects are poorly documented. This study investigates long-term outcomes for patients with personality disorder (PD) treated in outpatient, psychodynamic groups within secondary mental health service. A naturalistic study (N = 103) with repeated assessments of process and clinical outcomes. Longitudinal statistics are linear mixed models. The main PDs were avoidant, borderline and NOS PD, mean number of PDs 1.4(SD0.7), 60% females and mean initial age 38(SD10) years. Mean treatment duration was 1.5(SD 0.9) years. Therapist alliance and experienced group climate was satisfactory and stable. Improvements were significant (symptom distress, interpersonal problems, occupational functioning and additional mental health services), irrespective of general PD-severity, but not of PD-type, age or gender. The study demonstrates PD NOS benefits across all outcomes, occupational improvements for avoidant PD, despite prevailing symptoms, but generally poorer outcomes for males and age >38 years. For borderline PD, experienced conflict was stronger, treatment duration shorter and outcomes poor for early drop-outs (28%). Psychodynamic group psychotherapy is a recommendable treatment for moderate PDs, which may address avoidant strategies, but may not meet clinical challenges of borderline PD. The outcome differences related to gender and age are noteworthy. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

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Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

Effectiveness of group reminiscence for improving wellbeing of institutionalized elderly adults: study protocol for a randomized controlled trial.

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Gaggioli, Andrea; Scaratti, Chiara; Morganti, Luca; Stramba-Badiale, Marco; Agostoni, Monica; Spatola, Chiara A M; Molinari, Enrico; Cipresso, Pietro; Riva, Giuseppe

2014-10-25

Group reminiscence therapy is a brief and structured intervention in which participants share personal past events with peers. This approach has been shown to be promising for improving wellbeing and reducing depressive symptoms among institutionalized older adults. However, despite the considerable interest in reminiscence group therapy, controlled studies to determine its specific benefits as compared to generic social interactions with peers (group conversations about everyday subjects) are still lacking. We have designed a randomized controlled trial aimed at comparing the effects of group reminiscence therapy with those of group recreational activity on the psychological wellbeing of an institutionalized sample of older adults. The study includes two groups of 20 hospitalized elderly participants: the experimental group and the control group. Participants included in the experimental group will receive six sessions of group reminiscence therapy, while the control group will participate in a recreational group discussion. A repeated-measures design will be used post-intervention and three months post-intervention to evaluate changes in self-reported outcome measures of depressive symptoms, self-esteem, life satisfaction, and quality of life from baseline. The protocol of a study aimed at examining the specific effects of group reminiscence therapy on psychological wellbeing, depression, and quality of life among institutionalized elderly people is described. It is expected that the outcomes of this trial will contribute to our knowledge about the process of group reminiscence, evaluate its effectiveness in improving psychological wellbeing of institutionalized individuals, and identify the best conditions for optimizing this approach. This trial was registered with ClinicalTrials.gov (registration number: NCT02077153) on 31 January 2014.

Volunteer Macroinvertebrate Monitoring: Tensions Among Group Goals, Data Quality, and Outcomes

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Nerbonne, Julia Frost; Nelson, Kristen C.

2008-09-01

Volunteer monitoring of natural resources is promoted for its ability to increase public awareness, to provide valuable knowledge, and to encourage policy change that promotes ecosystem health. We used the case of volunteer macroinvertebrate monitoring (VMM) in streams to investigate whether the quality of data collected is correlated with data use and organizers’ perception of whether they have achieved these outcomes. We examined the relation between site and group characteristics, data quality, data use, and perceived outcomes (education, social capital, and policy change). We found that group size and the degree to which citizen groups perform tasks on their own (rather than aided by professionals) positively correlated with the quality of data collected. Group size and number of years monitoring positively influenced whether a group used their data. While one might expect that groups committed to collecting good-quality data would be more likely to use it, there was no relation between data quality and data use, and no relation between data quality and perceived outcomes. More data use was, however, correlated with a group’s feeling of connection to a network of engaged citizens and professionals. While VMM may hold promise for bringing citizens and scientists together to work on joint conservation agendas, our data illustrate that data quality does not correlate with a volunteer group’s desire to use their data to promote regulatory change. Therefore, we encourage scientists and citizens alike to recognize this potential disconnect and strive to be explicit about the role of data in conservation efforts.

Outcomes of Video-Assisted Teaching for Latching in Postpartum Women: A Randomized Controlled Trial.

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Sroiwatana, Suttikamon; Puapornpong, Pawin

2018-04-25

Latching is an important process of breastfeeding and should be taught and practiced by the postpartum mother. The objective is to compare latching outcomes between video-assisted and routine teaching methods among postpartum women. A randomized controlled trial was conducted. Postpartum women who had deliveries without complications were randomized into two groups: 14 cases in the video-assisted teaching group and 14 cases in a routine teaching group. In the first group, the mothers were taught breastfeeding benefits, latching methods, and breastfeeding positions and practiced breastfeeding in a controlled setting for a 30-minute period and watched a 6-minute video with consistent content. In the second group, the mothers were taught a normal 30-minute period and then practiced breastfeeding. In both groups, Latching on, Audible swallowing, the Type of nipples, Comfort, and Help (LATCH) scores were assessed at 24-32 and 48-56 hours after the breastfeeding teaching modals. Demographic data and LATCH scores were collected and analyzed. There were no statistically significant differences in the mothers' ages, occupations, marital status, religion, education, income, infants' gestational age, body mass index, nipple length, route of delivery, and time to first latching between the video-assisted and routine breastfeeding teaching groups. First and second LATCH score assessments had shown no significant differences between both breastfeeding teaching groups. The video-assisted breastfeeding teaching did not improve latching outcomes when it was compared with routine teaching.

A Randomized Controlled Trial of a Mindfulness and Acceptance Group Therapy for Residential Substance Use Patients.

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Shorey, Ryan C; Elmquist, Joanna; Gawrysiak, Michael J; Strauss, Catherine; Haynes, Ellen; Anderson, Scott; Stuart, Gregory L

2017-09-19

Substance use disorders are understood as a chronically relapsing condition that is difficult to treat. However, in recent years there have been promising developments in the treatment of substance use disorders, specifically with interventions based on mindfulness and acceptance and commitment therapy. Little research has examined whether these types of interventions may positively impact residential substance use treatment outcomes. Thus, in the current study we developed and examined, in a randomized controlled trial, a 4-week, eight-session, adjunctive mindfulness and acceptance group therapy for patients in residential substance use treatment. Our primary outcomes were substance use cravings, psychological flexibility, and dispositional mindfulness at treatment discharge. Patients (N = 117) from a private residential substance use facility were randomized to receive the adjunctive mindfulness and acceptance group or treatment-as-usual. Patients were assessed at treatment intake and at discharge from a 28-30-day residential program. Although treatment groups did not statistically differ at discharge on any primary outcome, small effect sizes favored the mindfulness and acceptance group on cravings and psychological flexibility. Conclusions/Importance: Continued research is needed to determine whether the addition of mindfulness and acceptance-based interventions improve outcomes long term following residential substance use treatment.

Risk factors for adverse driving outcomes in Dutch adults with ADHD and controls.

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Bron, Tannetje I; Bijlenga, Denise; Breuk, Minda; Michielsen, Marieke; Beekman, Aartjan T F; Kooij, J J Sandra

2018-02-01

To identify risk factors for adverse driving outcomes and unsafe driving among adults with and without ADHD in a Dutch sample. In this cross-sectional study, validated self-report questionnaires were used to compare driving history and current driving behavior between 330 adults diagnosed with ADHD and 330 controls. Adults with ADHD had significantly more adverse driving outcomes when compared to controls. Having an ADHD diagnosis significantly increased the odds for having had 3 or more vehicular crashes (OR = 2.72; p = .001). Driving frequency, male gender, age, high anxiety levels, high hostility levels, and alcohol use all significantly influenced the odds for unsafe driving behavior, for having had 12 or more traffic citations, and/or for having had 3 or more vehicular crashes. Alcohol use, and high levels of anxiety and hostility are highly prevalent among adults with ADHD, and they mediate the risk for negative driving outcomes in this group. Copyright © 2017 Elsevier Ltd. All rights reserved.

Comparison of two psycho-educational family group interventions for improving psycho-social outcomes in persons with spinal cord injury and their caregivers: a randomized-controlled trial of multi-family group intervention versus an active education control condition.

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Dyck, Dennis G; Weeks, Douglas L; Gross, Sarah; Lederhos Smith, Crystal; Lott, Hilary A; Wallace, Aimee J; Wood, Sonya M

2016-07-26

Over 12,000 individuals suffer a spinal cord injury (SCI) annually in the United States, necessitating long-term, complex adjustments and responsibilities for patients and their caregivers. Despite growing evidence that family education and support improves the management of chronic conditions for care recipients as well as caregiver outcomes, few systematic efforts have been made to involve caregivers in psycho-educational interventions for SCI. As a result, a serious gap exists in accumulated knowledge regarding effective, family-based treatment strategies for improving outcomes for individuals with SCI and their caregivers. The proposed research aims to fill this gap by evaluating the efficacy of a structured adaptation of an evidence-based psychosocial group treatment called Multi-Family Group (MFG) intervention. The objective of this study is to test, in a randomized-controlled design, an MFG intervention for the treatment of individuals with SCI and their primary caregivers. Our central hypothesis is that by providing support in an MFG format, we will improve coping skills of persons with SCI and their caregivers as well as supportive strategies employed by caregivers. We will recruit 32 individuals with SCI who have been discharged from inpatient rehabilitation within the previous 3 years and their primary caregivers. Patient/caregiver pairs will be randomized to the MFG intervention or an active SCI education control (SCIEC) condition in a two-armed randomized trial design. Participants will be assessed pre- and post-program and 6 months post-program. Intent to treat analyses will test two a priori hypotheses: (1) MFG-SCI will be superior to SCIEC for SCI patient activation, health status, and emotion regulation, caregiver burden and health status, and relationship functioning, and (2) MFG will be more effective for individuals with SCI and their caregivers when the person with SCI is within 18 months of discharge from inpatient rehabilitation compared

Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators.

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Craske, Michelle G; Niles, Andrea N; Burklund, Lisa J; Wolitzky-Taylor, Kate B; Vilardaga, Jennifer C Plumb; Arch, Joanna J; Saxbe, Darby E; Lieberman, Matthew D

2014-12-01

Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. The current study (N = 87) was a 3-arm randomized clinical trial comparing CBT, acceptance and commitment therapy (ACT), and a wait-list control group (WL) in participants with a diagnosis of social phobia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994). Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and posttreatment, and participants assigned to CBT and ACT also completed assessments 6 and 12 months following baseline. Assessments consisted of self-report measures, a public-speaking task, and clinician ratings. Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public-speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-month follow-up in CBT compared with ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Implications for clinical practice and future research are discussed.

Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators

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Craske, Michelle G; Niles, Andrea N.; Burklund, Lisa J.; Wolitzky-Taylor, Kate B.; Vilardaga, Jennifer C. Plumb; Arch, Joanna J.; Saxbe, Darby E.; Lieberman, Matthew D.

2014-01-01

Objective Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. Method The current study (N=87) was a 3-arm randomized clinical trial comparing CBT, Acceptance and Commitment therapy (ACT), and a waitlist control group (WL) in participants with a DSM-IV diagnosis of social phobia. Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and post-treatment, and participants assigned to CBT and ACT also completed assessments at 6 and 12 months following baseline. Assessments consisted of self-report measures, a public speaking task, and clinician ratings. Results Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-mo follow-up in CBT compared to ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control, and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Conclusions Implications for clinical practice and future research are discussed. PMID:24999670

Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial.

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Dickson-Spillmann, Maria; Haug, Severin; Schaub, Michael P

2013-12-23

Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Current Controlled Trials ISRCTN72839675.

Local endometrial scratching under ultrasound-guidance after failed intrauterine insemination and cycle outcome: A randomized controlled trial

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Badeea S. Soliman

2017-03-01

Full Text Available Background: Interaction between the embryo and endometrium plus endometrial receptivity is considered as two strong issues affecting the implantation outcome. Purpose: To investigate the effect of local endometrial scratching on pregnancy rate after failed previous intra uterine insemination. Study design: A prospective, randomized, control trial. Setting: At Cytogenetic and Endoscopy Unit, Zagazig University Hospital. Patients and methods: A total of 226 women either with unexplained or with mild male factor infertility were divided randomly into approximately two groups: in study group, 114 women and in control group, 112 women. For both groups, folliculometry was started at cycle day 7 additionally and at the same setting; endometrial scratching was done only for the study group. Outcome results: Biochemical and clinical pregnancy rates. Results: The biochemical and clinical pregnancy rates were significantly higher in the endometrial scratching group compared to the control group [27/106 (25.5% vs. 15/106 (14.1% p = 0.03 and 24/106 (22.6% vs. 12/106 (11.3%; p = 0.02] respectively. Also, ongoing pregnancy rate was statistically significantly different between both groups [22/106 (20.7% vs. 11/106 (10.4%; p = 0.03]. Conclusion: Endometrial scratching is useful in increasing pregnancy rates after failed previous intra uterine insemination trials when it is performed in the mid proliferative phase.

A Multicenter, Randomized, Open-Labeled, Parallel Group Trial of Sildenafil in Alcohol-Associated Erectile Dysfunction: The Impact on Psychosocial Outcomes

Directory of Open Access Journals (Sweden)

Alexander Grinshpoon

2009-09-01

Full Text Available To examine the effect of sildenafil on erectile dysfunction (ED and psychosocial outcomes in alcohol-dependent (AD men, 108 men with these diagnoses were randomly assigned to either take sildenafil (50 mg as add-on to standard treatment for AD, or the same treatment without sildenafil, for 12 weeks. Only 50 patients in sildenafil group and 51 in control group twice completed the International Index of Erectile Function (IIEF and a battery of self-report questionnaires. IIEF scores and psychosocial functioning, self-esteem and support from friends improved only for sildenafil-treated patients (P < 0.001. The high effect sizes suggest that the observed benefits are unlikely to be a placebo effect, although their unspecific nature could not be ruled out. In men with ED associated with AD, sildenafil improves both ED and psychosocial outcomes. Further placebo-controlled clinical trial is warranted.

Effect of Metabolic Syndrome on the Functional Outcome of Corticosteroid Injection for Lateral Epicondylitis: Retrospective Matched Case-Control Study.

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Roh, Young Hak; Oh, Minjoon; Noh, Jung Ho; Gong, Hyun Sik; Baek, Goo Hyun

2017-09-07

Both obesity and diabetes mellitus are well-known risk factors for tendinopathies. We retrospectively compared the efficacy of single corticosteroid injections in treating lateral epicondylitis in patients with and without metabolic syndrome (MetS). Fifty-one patients with lateral epicondylitis and MetS were age- and sex-matched with 51 controls without MetS. Pain severity, Disability of the Arm, Shoulder, and Hand score, and grip strength were assessed at base line and at 6, 12 and 24 weeks post-injection. The pain scores in the MetS group were greater than those in the control group at 6 and 12 weeks. The disability scores and grip strength in the MetS group were significantly worse than those of the control group at 6 weeks. However, there were no significant differences at 24 weeks between the groups in terms of pain, disability scores and grip strengths. After 24 weeks, three patients (6%) in the control group and five patients (10%) in the MetS group had surgical decompression (p = 0.46). Patients with MetS are at risk for poor functional outcome after corticosteroid injection for lateral epicondylitis in the short term, but in the long term there was no difference in outcomes of steroid injection in patients with and without MetS.

A case-control study of the effectiveness of tissue plasminogen activator on 6 month patients--reported outcomes and health care utilization.

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Lang, Catherine E; Bland, Marghuretta D; Cheng, Nuo; Corbetta, Maurizio; Lee, Jin-Moo

2014-01-01

We examined the benefit of tissue plasminogen activator (tPA), delivered as part of usual stroke management, on patient-reported outcomes and health care utilization. Using a case control design, patients who received tPA as part of usual stroke management were compared with patients who would have received tPA had they arrived to the hospital within the therapeutic time window. Data were collected from surveys 6 months after stroke using standardized patient-reported outcome measures and questions about health care utilization. Demographic and medical data were acquired from hospital records. Patients were matched on stroke severity, age, race, and gender. Matching was done with 1:2 ratio of tPA to controls. Results were compared between groups with 1-tailed tests because of a directionally specific hypothesis in favor of the tPA group. The tPA (n = 78) and control (n = 156) groups were matched across variables, except for stroke severity, which was better in the control group; subsequent analyses controlled for this mismatch. The tPA group reported better physical function, communication, cognitive ability, depressive symptomatology, and quality of life/participation compared with the control group. Fewer people in the tPA group reported skilled nursing facility stays, emergency department visits, and rehospitalizations after their stroke compared with controls. Reports of other postacute services were not different between groups. Although it is known that tPA reduces disability, this is the first study to demonstrate the effectiveness of tPA in improving meaningful, patient-reported outcomes. Thus, use of tPA provides a large benefit to the daily lives of people with ischemic stroke. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Outcomes and Costs of Community Living: Semi-Independent Living and Fully Staffed Group Homes

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Felce, David; Perry, Jonathan; Romeo, Renee; Robertson, Janet; Meek, Andrea; Emerson, Eric; Knapp, Martin

2008-01-01

In a matched-groups design, costs and quality of life outcomes for adults with intellectual disabilities with relatively low support needs were compared between those in fully staffed group homes (n = 35) and in semi-independent living (n = 35). Data were collected on participant characteristics, setting organization, various lifestyle outcomes,…

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

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Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John; Keyhani, Salomeh

2017-01-17

 To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.  Cross sectional study of randomized controlled trials (RCTs).  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.  Random sample of RCTs focused on drug efficacy.  Association between financial ties of principal investigators and study outcome.  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1

The Examination of Patient-Reported Outcomes and Postural Control Measures in Patients With and Without a History of ACL Reconstruction: A Case Control Study.

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Hoch, Johanna M; Sinnott, Cori W; Robinson, Kendall P; Perkins, William O; Hartman, Jonathan W

2018-03-01

There is a lack of literature to support the diagnostic accuracy and cut-off scores of commonly used patient-reported outcome measures (PROMs) and clinician-oriented outcomes such as postural-control assessments (PCAs) when treating post-ACL reconstruction (ACLR) patients. These scores could help tailor treatments, enhance patient-centered care and may identify individuals in need of additional rehabilitation. To determine if differences in 4-PROMs and 3-PCAs exist between post-ACLR and healthy participants, and to determine the diagnostic accuracy and cut-off scores of these outcomes. Case control. Laboratory. A total of 20 post-ACLR and 40 healthy control participants. The participants completed 4-PROMs (the Disablement in the Physically Active Scale [DPA], The Fear-Avoidance Belief Questionnaire [FABQ], the Knee Osteoarthritis Outcomes Score [KOOS] subscales, and the Tampa Scale of Kinesiophobia [TSK-11]) and 3-PCAs (the Balance Error Scoring System [BESS], the modified Star Excursion Balance Test [SEBT], and static balance on an instrumented force plate). Mann-Whitney U tests examined differences between groups. Receiver operating characteristic (ROC) curves were employed to determine sensitivity and specificity. The Area Under the Curve (AUC) was calculated to determine the diagnostic accuracy of each instrument. The Youdin Index was used to determine cut-off scores. Alpha was set a priori at P < 0.05. There were significant differences between groups for all PROMs (P < 0.05). There were no differences in PCAs between groups. The cut-off scores should be interpreted with caution for some instruments, as the scores may not be clinically applicable. Post-ACLR participants have decreased self-reported function and health-related quality of life. The PROMs are capable of discriminating between groups. Clinicians should consider using the cut-off scores in clinical practice. Further use of the instruments to examine detriments after completion of standard

Evaluation of support group interventions for children in troubled families: study protocol for a quasi-experimental control group study.

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Skerfving, Annemi; Johansson, Fredrik; Elgán, Tobias H

2014-01-24

Support groups for children in troubled families are available in a majority of Swedish municipalities. They are used as a preventive effort for children in families with different parental problems such as addiction to alcohol/other drugs, mental illness, domestic violence, divorce situations, or even imprisonment. Children from families with these problems are a well-known at-risk group for various mental health and social problems. Support groups aim at strengthening children's coping behaviour, to improve their mental health and to prevent a negative psycho-social development. To date, evaluations using a control-group study design are scarce. The aim of the current study is to evaluate the effects of support groups. This paper describes the design of an effectiveness study, initially intended as a randomized controlled trial, but instead is pursued as a quasi-experimental study using a non-randomized control group. The aim is to include 116 children, aged 7-13 years and one parent/another closely related adult, in the study. Participants are recruited via existing support groups in the Stockholm county district and are allocated either into an intervention group or a waiting list control group, representing care as usual. The assessment consists of questionnaires that are to be filled in at baseline and at four months following the baseline. Additionally, the intervention group completes a 12-month follow-up. The outcomes include the Strength and Difficulties Questionnaire (SDQ S11-16), the Kids Coping Scale, the "Ladder of life" which measures overall life satisfaction, and "Jag tycker jag är" (I think I am) which measures self-perception and self-esteem. The parents complete the SDQ P4-16 (parent-report version) and the Swedish scale "Familjeklimat" (Family Climate), which measures the emotional climate in the family. There is a need for evaluating the effects of support groups targeted to children from troubled families. This quasi-experimental study

Outcome and process differences between professional and nonprofessional therapists in time-limited group psychotherapy.

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Burlingame, G M; Barlow, S H

1996-10-01

The outcome of clients who saw one of four "expert" professional group therapists selected by peer nomination or four "natural helper" nonprofessional nominated by students is contrasted in a 15-session psychotherapy group. Process measures tapping specific group and "common factors" were drawn from sessions 3, 8, and 14; outcome was assessed at pre, mid, posttreatment, and a 6-month follow-up. Results were examined by leader condition (professional vs. nonprofessional therapists) and time (group development). Virtually no reliable differences were found on measures of outcome primarily because of a floor effect on several measures. Therapist differences on the process measures tapping the "common factors" of therapeutic alliance, client expectancy, and perception of therapists were either nonsignificant or disappeared by the end of treatment. A complex picture of differences on one therapeutic factor (insight), common factor measures and subtle variation in the outcome data suggests a distinct pattern of change, however. Methodological limitations are also addressed including problems inherent in large-scale clinical-trial studies, ethical concerns raised by using nonprofessional leaders, and problems with generalizability, given the absence of significant psychopathology in group members.

Preventing patient-to-worker violence in hospitals: outcome of a randomized controlled intervention

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Arnetz, Judith E.; Hamblin, Lydia; Russell, Jim; Upfal, Mark J.; Luborsky, Mark; Janisse, James; Essenmacher, Lynnette

2016-01-01

Objective To evaluate the effects of a randomized controlled intervention on the incidence of patient-to-worker (Type II) violence and related injury in hospitals. Methods Forty-one units across 7 hospitals were randomized into intervention (n=21) and control (n=20) groups. Intervention units received unit-level violence data to facilitate development of an action plan for violence prevention; no data were presented to control units. Main outcomes were rates of violent events and injuries across study groups over time. Results Six months post-intervention, incident rate ratios of violent events were significantly lower on intervention units compared to controls (IRR 0.48, 95% CI 0.29-0.80). At 24 months, the risk for violence-related injury was lower on intervention units, compared to controls (IRR 0.37, 95% CI 0.17-0.83). Conclusion This data-driven, worksite-based intervention was effective in decreasing risks of patient-to-worker violence and related injury. PMID:28045793

The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial.

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Lee, Gun Woo; Yang, Han Seok; Yeom, Jin S; Ahn, Myun-Whan

2017-09-01

Vitamin C has critical features relavant to postoperative pain management and functional improvement; however, no study has yet evaluated the effectiveness of vitamin C on improving the surgical outcomes for spine pathologies. Thus, this study aimed to explore the impact of vitamin C on postoperative outcomes after single-level posterior lumbar interbody fusion (PLIF) for lumbar spinal stenosis in prospectively randomized design. We conducted a 1-year prospective, randomized, placebo-controlled, double-blind study to evaluate the impact of vitamin C on the postoperative outcomes after PLIF surgery. A total of 123 eligible patients were randomly assigned to either group A (62 patients with vitamin C) or group B (61 patients with placebo). Patient follow-up was continued for at least 1 year after surgery. The primary outcome measure was pain intensity in the lower back using a visual analogue scale. The secondary outcome measures were: (1) the clinical outcome assessed using the Oswestry Disability Index (ODI); (2) the fusion rate assessed using dynamic radiographs and computed tomography scans; and (3) complications. Pain intensity in the lower back was significantly improved in both groups compared with preoperative pain intensity, but no significant difference was observed between the 2 groups over the follow-up period. The ODI score of group A at the third postoperative month was significantly higher than the score of group B. After the sixth postoperative month, the ODI score of group A was slightly higher than the score of group B; however, this difference was not significant. The fusion rates at 1 year after surgery and the complication rates were not significantly different between the 2 groups. Postoperative pain intensity, the primary outcome measure, was not significantly different at 1 year after surgery between the 2 groups. However, vitamin C may be associated with improving functional status after PLIF surgery, especially during the first 3

The comparative effects of group prenatal care on psychosocial outcomes.

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Heberlein, Emily C; Picklesimer, Amy H; Billings, Deborah L; Covington-Kolb, Sarah; Farber, Naomi; Frongillo, Edward A

2016-04-01

To compare the psychosocial outcomes of the CenteringPregnancy (CP) model of group prenatal care to individual prenatal care, we conducted a prospective cohort study of women who chose CP group (N = 124) or individual prenatal care (N = 124). Study participants completed the first survey at study recruitment (mean gestational age 12.5 weeks), with 89% completing the second survey (mean gestational age 32.7 weeks) and 84% completing the third survey (6 weeks' postpartum). Multiple linear regression models compared changes by prenatal care model in pregnancy-specific distress, prenatal planning-preparation and avoidance coping, perceived stress, affect and depressive symptoms, pregnancy-related empowerment, and postpartum maternal-infant attachment and maternal functioning. Using intention-to-treat models, group prenatal care participants demonstrated a 3.2 point greater increase (p prenatal planning-preparation coping strategies. While group participants did not demonstrate significantly greater positive outcomes in other measures, women who were at greater psychosocial risk benefitted from participation in group prenatal care. Among women reporting inadequate social support in early pregnancy, group participants demonstrated a 2.9 point greater decrease (p = 0.03) in pregnancy-specific distress in late pregnancy and 5.6 point higher mean maternal functioning scores postpartum (p = 0.03). Among women with high pregnancy-specific distress in early pregnancy, group participants had an 8.3 point greater increase (p prenatal planning-preparation coping strategies in late pregnancy and a 4.9 point greater decrease (p = 0.02) in postpartum depressive symptom scores. This study provides further evidence that group prenatal care positively impacts the psychosocial well-being of women with greater stress or lower personal coping resources. Large randomized studies are needed to establish conclusively the biological and psychosocial benefits of group

Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide--a randomised controlled trial.

Science.gov (United States)

George, Anne; Mathews, Jiji E; Sam, Dibu; Beck, Manisha; Benjamin, Santosh J; Abraham, Anuja; Antonisamy, Balevendra; Jana, Atanu K; Thomas, Nihal

2015-02-01

Two oral hypoglycaemic agents, metformin and glibenclamide, have been compared with insulin in separate large randomised controlled trials and have been found to be as effective as insulin in gestational diabetes. However, very few trials have compared metformin with glibenclamide. Of 159 South Indian women with fasting glucose ≥5.5 mmol/l and ≤7.2 mmol/l and/or 2-h post-prandial value ≥6.7 mmol/l and ≤13.9 mmol/l after medical nutritional therapy consented to be randomised to receive either glibenclamide or metformin. 80 women received glibenclamide and 79 received metformin. Neonatal outcomes were assessed by neonatologists who were unaware that the mother was part of a study and were recorded by assessors blinded to the medication the mother was given. The primary outcome was a composite of neonatal outcomes namely macrosomia, hypoglycaemia, need for phototherapy, respiratory distress, stillbirth or neonatal death and birth trauma. Secondary outcomes were birthweight, maternal glycaemic control, pregnancy induced hypertension, preterm birth, need for induction of labour, mode of delivery and complications of delivery. Baseline characteristics were similar but for the higher fasting triglyceride levels in women on metformin. The primary outcome was seen in 35% of the glibenclamide group and 18.9% of the metformin group [95% CI 16.1 (2.5, 29.7); P = 0.02]. The difference in outcome related to a higher rate of neonatal hypoglycaemia in the glibenclamide group (12.5%) versus none in the metformin group [95% CI 12.5(5.3, 19.7); P = 0.001]. Secondary outcomes in both groups were similar. In a south Indian population with gestational diabetes, metformin was associated with better neonatal outcomes than glibenclamide. © 2015 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial

Science.gov (United States)

2013-01-01

Background Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. Methods This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. Results At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). Conclusions A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Trial registration Current Controlled Trials ISRCTN72839675. PMID:24365274

Randomized Control Trial of COMPASS for Improving Transition Outcomes of Students with Autism Spectrum Disorder.

Science.gov (United States)

Ruble, Lisa A; McGrew, John H; Toland, Michael; Dalrymple, Nancy; Adams, Medina; Snell-Rood, Claire

2018-06-01

The postsecondary outcomes of individuals with autism spectrum disorder (ASD) are significantly worse than peers with other disabilities. One problem is the lack of empirically-supported transition planning interventions to guide services and help produce better outcomes. We applied an implementation science approach to adapt and modify an evidence-based consultation intervention originally tested with young children called the Collaborative Model for Promoting Competence and Success (COMPASS; Ruble et al., The collaborative model for promoting competence and success for students with ASD. Springer, New York, 2012a) and evaluate it for efficacy in a randomized controlled trial for transition-age youth. Results replicated findings with younger students with ASD that IEP outcomes were higher for COMPASS compared to the placebo control group (d = 2.1). Consultant fidelity was high and teacher adherence improved over time, replicating the importance of ongoing teacher coaching.

Impact of Tight Glycemic Control on Neurodevelopmental Outcomes at 1 Year of Age for Children with Congenital Heart Disease: A Randomized Controlled Trial

Science.gov (United States)

Sadhwani, Anjali; Asaro, Lisa A.; Goldberg, Caren; Ware, Janice; Butcher, Jennifer; Gaies, Michael; Smith, Cynthia; Alexander, Jamin L.; Wypij, David; Agus, Michael S. D.

2016-01-01

Objective To assess the association of postoperative tight glycemic control and hypoglycemia in children undergoing cardiac surgery with neurodevelopmental outcomes at 1 year of age. Study design A 2-center, prospective, randomized trial of postoperative tight glycemic control vs standard care was conducted in 980 children undergoing cardiac surgery. Neurodevelopmental outcomes were assessed at nine to 18 months using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Adaptive Behavior Assessment System, Second Edition, the Ages and Stages Questionnaire, Third Edition, and the Brief Infant Toddler Social-Emotional Assessment. Results Neurodevelopmental follow-up was performed on 237 patients with a mean age of 13 months. No significant treatment group differences were found in the Bayley-III and Adaptive Behavior Assessment System, Second Edition composite scores or percentage at risk based on the Ages and Stages Questionnaire, Third Edition and the Brief Infant Toddler Social-Emotional Assessment. Patients who experienced moderate to severe hypoglycemia (n = 8) had lower Bayley-III composite scores compared with patients with no to mild hypoglycemia, even after controlling for factors known to be associated with poorer neurodevelopmental outcomes. Conclusion For infants undergoing cardiac surgery, tight glycemic control did not impact neurodevelopmental outcomes compared with standard care. These data suggest a possible association between moderate to severe hypoglycemia and poorer neurodevelopmental outcomes at 1 year of age. PMID:27112038

The effects of Internet-based exercise compared with supervised group exercise in people with type 2 diabetes: a randomized controlled study.

Science.gov (United States)

Akinci, Buket; Yeldan, Ipek; Satman, Ilhan; Dirican, Ahmet; Ozdincler, Arzu Razak

2018-06-01

To compare the effects of Internet-based exercise on glycaemic control, blood lipids, body composition, physical activity level, functional capacity, and quality of life with supervised group exercise in patients with type 2 diabetes. Single-blind, randomized controlled study. A Faculty of Health Sciences. A total of 65 patients with type 2 diabetes (47 women, 18 men). Group A ( n = 22), control group - physical activity counselling once with a brochure. Group B ( n = 22), supervised group-based exercise, three days per week for eight weeks. Group C ( n = 21), Internet-based exercise following the same programme via a website. Primary outcomes - glycosylated haemoglobin, fasting blood glucose, high-density and low-density lipoprotein, triglyceride, and cholesterol. Secondary outcomes - waist and hip circumferences, body mass index, number of steps, six-minute walking test, and Euro-Quality of Life-5 Dimension. After treatment, glycaemic control (mean change for Group B; Group C; -0.80%, -0.91%, P = 0.003), waist circumference (-4.23 cm, 5.64 cm, P = 0.006), and quality of life (0.26, 0.15, P = 0.013) significantly improved in both training groups compared with the control group. Fasting blood glucose (-46.86 mg/dL, P = 0.009) and hip circumference (-2.7 cm, P = 0.011) were significantly decreased in Group B and total cholesterol (-16.4 mg/dL, P = 0.028), six-minute walking distance (30.5 m, P = 0.01), and number of steps (1258.05, P = 0.023) significantly improved in Group C compared with control group. Group B and Group C changed with equal magnitude. In type 2 diabetes, supervised group-based and Internet-based exercise can improve equally glycaemic control, waist circumference, and quality of life, and both are better than simply counselling.

A randomized controlled trial of pre-conception treatment for periodontal disease to improve periodontal status during pregnancy and birth outcomes.

Science.gov (United States)

Jiang, Hong; Xiong, Xu; Su, Yi; Zhang, Yiming; Wu, Hongqiao; Jiang, Zhijun; Qian, Xu

2013-12-09

Evidence has suggested that periodontal disease is associated with an increased risk of various adverse pregnancy and birth outcomes. However, several large clinical randomized controlled trials failed to demonstrate periodontal therapy during pregnancy reduced the incidence of adverse pregnancy and birth outcomes. It has been suggested that the pre-conception period may be an optimal period for periodontal disease treatment rather than during pregnancy. To date, no randomized controlled trial (RCT) has examined if treating periodontal disease before pregnancy reduces adverse birth outcomes. This study aims to examine if the pre-conception treatment of periodontal disease will lead to improved periodontal status during late pregnancy and subsequent birth outcomes. A sample of 470 (235 in each arm of the study) pre-conception women who plan to conceive within one year and with periodontal disease will be recruited for the study. All participants will be randomly allocated to the intervention or control group. The intervention group will receive free therapy including dental scaling and root planning (the standard therapy), supragingival prophylaxis, and oral hygiene education. The control group will only receive supragingival prophylaxis and oral hygiene education. Women will be followed throughout their pregnancy and then to childbirth. The main outcomes include periodontal disease status in late pregnancy and birth outcomes measured such as mean birth weight (grams), and mean gestational age (weeks). Periodontal disease will be diagnosed through a dental examination by measuring probing depth, clinical attachment loss and percentage of bleeding on probing (BOP) between gestational age of 32 and 36 weeks. Local and systemic inflammatory mediators are also included as main outcomes. This will be the first RCT to test whether treating periodontal disease among pre-conception women reduces periodontal disease during pregnancy and prevents adverse birth outcomes. If

Pregnancy outcome in hyperthyroidism: a case control study.

Science.gov (United States)

Aggarawal, Neelam; Suri, Vanita; Singla, Rimpi; Chopra, Seema; Sikka, Pooja; Shah, Viral N; Bhansali, Anil

2014-01-01

Data comparing pregnancy outcome in hyperthyroid women with euthyroid women are scarce. Hence, this study was carried out to assess the maternal and fetal outcome in pregnant women with hyperthyroidism to ascertain the effect of disease on pregnancy. This retrospective study was conducted over a period of 28 years. We compared the maternal and fetal outcomes of 208 hyperthyroid women with 403 healthy controls, between women with well-controlled and uncontrolled disease and amongst women diagnosed with hyperthyroidism before and during pregnancy. Maternal outcome: women with hyperthyroidism were at increased risk for preeclampsia (OR = 3.94), intrauterine growth restriction (OR = 2.16), spontaneous preterm labor (OR = 1.73), preterm birth (OR = 1.7), gestational diabetes mellitus (OR = 1.8), and cesarean delivery (OR = 1.47). Hyperthyroid women required induction of labor more frequently (OR = 3.61). Fetal outcome: newborns of hyperthyroid mothers had lower birth weight than normal ones (p = 0.0001). Women with uncontrolled disease had higher odds for still birth (OR = 8.42; 95% CI: 2.01-35.2) and lower birth weight (p = 0.0001). Obstetrical complications were higher in women with hyperthyroidism than normal women. Outcome was worsened by uncontrolled disease. Women with pregestational hyperthyroidism had better outcomes than those diagnosed with it during pregnancy. © 2014 S. Karger AG, Basel.

Striving for Group Agency: Threat to Personal Control Increases the Attractiveness of Agentic Groups

Directory of Open Access Journals (Sweden)

Janine eStollberg

2015-05-01

Full Text Available When their sense of personal control is threatened people try to restore perceived control through the social self. We propose that it is the perceived agency of ingroups that provides the self with a sense of control. In three experiments, we for the first time tested the hypothesis that threat to personal control increases the attractiveness of being part or joining those groups that are perceived as coherent entities engaging in coordinated group goal pursuit (agentic groups but not of those groups whose agency is perceived to be low. Consistent with this hypothesis we found in Study 1 (N = 93 that threat to personal control increased ingroup identification only with task groups, but not with less agentic types of ingroups that were made salient simultaneously. Furthermore, personal control threat increased a sense of collective control and support within the task group, mediated through task-group identification (indirect effects. Turning to groups people are not (yet part of, Study 2 (N = 47 showed that personal control threat increased relative attractiveness ratings of small groups as possible future ingroups only when the relative agency of small groups was perceived to be high. Perceived group homogeneity or social power did not moderate the effect. Study 3 (N = 78 replicated the moderating role of perceived group agency for attractiveness ratings of entitative groups, whereas perceived group status did not moderate the effect. These findings extend previous research on group-based control, showing that perceived agency accounts for group-based responses to threatened control.

Group Facial Width-to-Height Ratio Predicts Intergroup Negotiation Outcomes.

Science.gov (United States)

Yang, Yu; Tang, Chen; Qu, Xiaofei; Wang, Chao; Denson, Thomas F

2018-01-01

Past studies have found that the facial width-to-height ratio (FWHR) is associated with a range of traits and behaviors that are possibly important to dyadic negotiations. However, it is unknown whether the FWHR would have an impact on intergroup negotiations, which happen frequently and often have higher stakes in the real world. To examine this question, in the current study, we randomly assigned 1,337 Chinese business executives into 288 groups and they completed a multi-issue negotiation exercise against each other. Results showed that groups with larger maximum individual FWHRs achieved objectively better negotiation outcomes. We conclude that groups containing individuals with relatively large FWHRs can claim more value in negotiations between groups.

Expressive writing intervention and self-reported physical health out-comes - Results from a nationwide randomized controlled trial with breast cancer patients

DEFF Research Database (Denmark)

Jensen-Johansen, Mikael B; O'Toole, Mia S; Christensen, Søren

2018-01-01

or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints......The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related......, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about...

Effect of an office worksite-based yoga program on heart rate variability: outcomes of a randomized controlled trial

Science.gov (United States)

2013-01-01

Background Chronic work-related stress is an independent risk factor for cardiometabolic diseases and associated mortality, particularly when compounded by a sedentary work environment. The purpose of this study was to determine if an office worksite-based hatha yoga program could improve physiological stress, evaluated via heart rate variability (HRV), and associated health-related outcomes in a cohort of office workers. Methods Thirty-seven adults employed in university-based office positions were randomized upon the completion of baseline testing to an experimental or control group. The experimental group completed a 10-week yoga program prescribed three sessions per week during lunch hour (50 min per session). An experienced instructor led the sessions, which emphasized asanas (postures) and vinyasa (exercises). The primary outcome was the high frequency (HF) power component of HRV. Secondary outcomes included additional HRV parameters, musculoskeletal fitness (i.e. push-up, side-bridge, and sit & reach tests) and psychological indices (i.e. state and trait anxiety, quality of life and job satisfaction). Results All measures of HRV failed to change in the experimental group versus the control group, except that the experimental group significantly increased LF:HF (p = 0.04) and reduced pNN50 (p = 0.04) versus control, contrary to our hypotheses. Flexibility, evaluated via sit & reach test increased in the experimental group versus the control group (p yoga sessions (n = 11) to control (n = 19) yielded the same findings, except that the high adherers also reduced state anxiety (p = 0.02) and RMSSD (p = 0.05), and tended to improve the push-up test (p = 0.07) versus control. Conclusions A 10-week hatha yoga intervention delivered at the office worksite during lunch hour did not improve HF power or other HRV parameters. However, improvements in flexibility, state anxiety and musculoskeletal fitness were noted with high adherence

How Does Group Affiliation Affect The Diversification Performance Of Family-Controlled Firms In Malaysia? – A Governance Perspective

OpenAIRE

Ng Sin Huei

2014-01-01

This paper examines the roles of business group affiliations and whether the size and ownership structure of business groups influence the performance outcomes of diversification among family-controlled firms in Malaysia. It presents evidence that agency-driven and thus performance-diminishing firm diversification is more likely to take place in firms affiliated with a family-controlled business group than in independent firms. The findings support the hypothesis that if the benefits of diver...

Variations in depression care and outcomes among high-risk mothers from different racial/ethnic groups.

Science.gov (United States)

Huang, Hsiang; Chan, Ya-Fen; Katon, Wayne; Tabb, Karen; Sieu, Nida; Bauer, Amy M; Wasse, Jessica Knaster; Unützer, Jürgen

2012-08-01

PURPOSE. To examine variations in depression care and outcomes among high-risk pregnant and parenting women from different racial/ethnic groups served in community health centres. As part of a collaborative care programme that provides depression treatment in primary care clinics for high-risk mothers, 661 women with probable depression (Patient Health Questionnaire-9 ≥ 10), who self-reported race/ethnicity as Latina (n = 393), White (n = 126), Black (n = 75) or Asian (n = 67), were included in the study. Primary outcomes include quality of depression care and improvement in depression. A Cox proportional hazard model adjusting for sociodemographic and clinical characteristics was used to examine time to treatment response. We observed significant differences in both depression processes and outcomes across ethnic groups. After adjusting for other variables, Blacks were found to be significantly less likely to improve than Latinas [hazard ratio (HR): 0.53, 95% confidence interval (CI): 0.44-0.65]. Other factors significantly associated with depression improvement were pregnancy (HR: 1.52, 95% CI: 1.27-1.82), number of clinic visits (HR: 1.26, 95% CI: 1.17-1.36) and phone contacts (HR: 1.45, 95% CI: 1.32-1.60) by the care manager in the first month of treatment. After controlling for depression severity, having suicidal thoughts at baseline was significantly associated with a decreased likelihood of depression improvement (HR: 0.75, 95% CI: 0.67-0.83). In this racially and ethnically diverse sample of pregnant and parenting women treated for depression in primary care, the intensity of care management was positively associated with improved depression. There was also appreciable variation in depression outcomes between Latina and Black patients.

Outcomes after autologous SCT in lymphoma patients grouped by weight.

Science.gov (United States)

Lau, J E; Weber, C; Earl, M; Rybicki, L A; Carlstrom, K D; Wenzell, C M; Hill, B T; Majhail, N S; Kalaycio, M

2015-05-01

Obesity continues to be an increasing global health issue contributing to the complexity of chemotherapy dosing in the field of SCT. Investigation into the optimal dosing weight used to calculate chemotherapy doses in obese patients undergoing SCT is limited and inconclusive. Our single-center, retrospective study compared safety and efficacy outcomes by body mass index (BMI) for 476 adult lymphoma patients who underwent auto-SCT with a myeloablative chemotherapeutic regimen of BU, CY and etoposide dosed using adjusted body weight. Three weight groups categorized based on BMI were defined: normal/underweight ⩽24.9 kg/m(2), overweight 25-29.9 kg/m(2) and obese ⩾30 kg/m(2). Severity of mucositis, incidence of secondary malignancy, incidence of bacteremia and median hospital length of stay did not differ among the groups. The median times to absolute neutrophil count and platelet recovery were 10 days (P=0.75) and 14 days (P=0.17), respectively. Obese patients had a lower 100-day mortality compared with other weight groups, although this did not translate into an OS benefit. OS and disease relapse were similar among the groups. Our study demonstrates that use of adjusted body weight to calculate chemotherapy doses does not negatively have an impact on outcomes in obese patients undergoing auto-SCT with BU, CY and etoposide.

Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; Okamoto, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio

2014-12-29

Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of depression and insomnia after cataract surgery, randomized controlled trials are lacking. We will conduct a parallel-group, assessor-blinded, simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms, sleep quality, body mass regulation, and glucose and lipid metabolism. We will recruit patients who are aged 60 years and over, scheduled to receive their first cataract surgery, and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III. Exclusion criteria will be patients with major depression, severe corneal opacity, severe glaucoma, vitreous haemorrhage, proliferative diabetic retinopathy, macular oedema, age-related macular degeneration, and patients needing immediate or combined cataract surgery. After baseline participants will be randomized to two groups. Outcomes will be measured at three months after surgery among the intervention group, and three months after baseline among the control group. We will assess depressive symptoms as a primary outcome, using the short version geriatric depression scale (GDS-15). Secondary outcomes will be subjective and actigraph-measured sleep quality, sleepiness, glycated haemoglobin, fasting plasma glucose and triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, body mass index, abdominal circumference, circadian rhythms of physical

Group treatments for sensitive health care problems : a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

OpenAIRE

Lamb, S. E. (Sallie E.); Pepper, Jo; Lall, Ranjit; Jørstad-Stein , Ellen C.; Clark, M. D. (Michael D.); Hill, Lesley; Fereday Smith, Jan

2009-01-01

Abstract Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in ...

Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial.

Science.gov (United States)

Pinxsterhuis, Irma; Sandvik, Leiv; Strand, Elin Bolle; Bautz-Holter, Erik; Sveen, Unni

2017-01-01

To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. A randomized controlled trial. Four mid-sized towns in southern Norway and two suburbs of Oslo. A total of 137 adults with chronic fatigue syndrome. A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale). Assessments were performed at baseline, and at six-month and one-year follow-ups. At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity ( p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group ( p = 0.039). These significant differences were not sustained at the one-year follow-up. No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points. The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight). The evaluated self-management program did not have any sustained effect, as compared with receiving usual care.

The Challenge of Recruiting Control Groups

DEFF Research Database (Denmark)

O'Connor, Maja

2011-01-01

. This study was a direct reaction to the first recruitment attempt that had a 10% response rate. This study consisted of four groups of randomly selected elderly married people (65-81 years) receiving a postal questionnaire measuring depression, social support, coping style, adult attachment, life......  Recruitment of a large and reliable control group is a challenge in psychological survey based research. The effect of recruitment styles and age on response-rate, data quality, and individual differences were investigated in a control group for a postal survey of elderly bereaved people...... incentive had the highest response-rate (51%), good data quality, and no sampling bias in individual differences. This method can be highly recommended in future control group recruitment....

Loss of control eating and weight outcomes after bariatric surgery: a study with a Portuguese sample

OpenAIRE

Conceição, Eva Martins; Silva, Ana Isabel Pinto Bastos Leite; Brandão, Isabel; Vaz, Ana Rita Rendeiro Ribeiro; Ramalho, Sofia Marlene Marques; Arrojado, Filipa; Costa, José; Machado, Paulo P. P.

2014-01-01

The present study aim is to investigate the frequency of loss of control eating (LOC) episodes in three groups with different assessment times: one before, one at short and one at long-term after bariatric surgery; as well as to explore the association of postoperative problematic eating behaviors and weight outcomes and psychological characteristics. This cross-sectional study compared a group of preoperative bariatric surgery patients (n = 176) and two postoperative groups, one at short-ter...

The Weight Management Dietetics Practice Group collecting outcomes mentoring program

Science.gov (United States)

The is a newsletter article for the Academy of Nutrition and Dietetics (AND), Weight Management Dietetics Practice Group (WM DPG). The article presents the ‘Collecting Outcomes Mentoring Program’ for 2017 that is managed by the Research Section of the WM DPG. Dietitians in the WM DGP are provided wi...

Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder

Directory of Open Access Journals (Sweden)

Roberts Christopher

2011-07-01

Full Text Available Abstract Background Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years, and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. Methods/design Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. Discussion The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement. Trial Registration ISRCTN62761948 Funding National Institute for Health Research, England.

Coordinated Control of Vehicle Groups

National Research Council Canada - National Science Library

Kumar, Vijay

2004-01-01

.... There are three main objectives: (1) to develop a theoretical paradigm for formalizing the concepts of a group, a team, and control of groups, with specified tasks such as exploring, mapping, searching, and transporting objects; (2...

Risk group dependence of dose-response for biopsy outcome after three-dimensional conformal radiation therapy of prostate cancer

International Nuclear Information System (INIS)

Levegruen, Sabine; Jackson, Andrew; Zelefsky, Michael J.; Venkatraman, Ennapadam S.; Skwarchuk, Mark W.; Schlegel, Wolfgang; Fuks, Zvi; Leibel, Steven A.; Ling, C. Clifton

2002-01-01

Background and purpose: We fit phenomenological tumor control probability (TCP) models to biopsy outcome after three-dimensional conformal radiation therapy (3D-CRT) of prostate cancer patients to quantify the local dose-response of prostate cancer. Materials and methods: We analyzed the outcome after photon beam 3D-CRT of 103 patients with stage T1c-T3 prostate cancer treated at Memorial Sloan-Kettering Cancer Center (MSKCC) (prescribed target doses between 64.8 and 81 Gy) who had a prostate biopsy performed ≥2.5 years after end of treatment. A univariate logistic regression model based on D mean (mean dose in the planning target volume of each patient) was fit to the whole data set and separately to subgroups characterized by low and high values of tumor-related prognostic factors T-stage ( 6), and pre-treatment prostate-specific antigen (PSA) (≤10 ng/ml vs. >10 ng/ml). In addition, we evaluated five different classifications of the patients into three risk groups, based on all possible combinations of two or three prognostic factors, and fit bivariate logistic regression models with D mean and the risk group category to all patients. Dose-response curves were characterized by TCD 50 , the dose to control 50% of the tumors, and γ 50 , the normalized slope of the dose-response curve at TCD 50 . Results: D mean correlates significantly with biopsy outcome in all patient subgroups and larger values of TCD 50 are observed for patients with unfavorable compared to favorable prognostic factors. For example, TCD 50 for high T-stage patients is 7 Gy higher than for low T-stage patients. For all evaluated risk group definitions, D mean and the risk group category are independent predictors of biopsy outcome in bivariate analysis. The fit values of TCD 50 show a clear separation of 9-10.6 Gy between low and high risk patients. The corresponding dose-response curves are steeper (γ 50 =3.4-5.2) than those obtained when all patients are analyzed together (γ 50 =2

78 FR 46851 - Controlled Group Regulation Examples

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2013-08-02

...) to require the presence of two levels of controlled entities for a controlled group to exist, and... changes would add a new example to illustrate both the mechanics of the controlled group rules as applied...

Improving of the Drones Group Control System

Directory of Open Access Journals (Sweden)

Tatiana Yurievna Morozova

2015-05-01

Full Text Available The article deals with the problem of drone group control, in particular, the problem of formation damage drone ensure safe movement of the group. To solve this problem is proposed to use multi-agent approach to the implementation of the overall strategy of management and metric routing algorithm for communication and the formation of the group. In general, the action of the control algorithms are shown and controlled drones in the formation of groups and roles. The conditions for the safe distance of the drone relative to each other in the group. It is shown that the combined use of these mechanisms can improve the efficiency of group management drone resistance groups to failures and failures, resulting in an increased probability of the assignment.

Importance of hemodialysis-related outcomes: comparison of ratings by a self-help group, clinicians, and health technology assessment authors with those by a large reference group of patients

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Janssen IM

2016-12-01

Full Text Available Inger M Janssen,1 Fueloep Scheibler,2 Ansgar Gerhardus3,4 1Department of Epidemiology and International Public Health, University of Bielefeld, Bielefeld, 2Department of Non-Drug Interventions, Institute for Quality and Efficiency in Health Care, Cologne, 3Department for Health Services Research, Institute for Public Health and Nursing Research, University of Bremen, 4Health Sciences Bremen, University of Bremen, Bremen, Germany Background: The selection of important outcomes is a crucial decision for clinical research and health technology assessment (HTA, and there is ongoing debate about which stakeholders should be involved. Hemodialysis is a complex treatment for chronic kidney disease (CKD and affects many outcomes. Apart from obvious outcomes, such as mortality, morbidity and health-related quality of life (HRQoL, others such as, concerning daily living or health care provision, may also be important. The aim of our study was to analyze to what extent the preferences for patient-relevant outcomes differed between various stakeholders. We compared preferences of stakeholders normally or occasionally involved in outcome prioritization (patients from a self-help group, clinicians and HTA authors with those of a large reference group of patients. Participants and methods: The reference group consisted of 4,518 CKD patients investigated previously. We additionally recruited CKD patients via a regional self-help group, nephrologists via an online search and HTA authors via an expert database or personal contacts. All groups assessed the relative importance of the 23 outcomes by means of a discrete visual analog scale. We used descriptive statistics to rank outcomes and compare the results between groups. Results: We received completed questionnaires from 49 self-help group patients, 19 nephrologists and 18 HTA authors. Only the following 3 outcomes were ranked within the top 7 outcomes by all 4 groups: safety, HRQoL and emotional state. The

Outcomes of Osteochondral Allograft Transplantation With and Without Concomitant Meniscus Allograft Transplantation: A Comparative Matched Group Analysis.

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Frank, Rachel M; Lee, Simon; Cotter, Eric J; Hannon, Charles P; Leroux, Timothy; Cole, Brian J

2018-03-01

Osteochondral allograft transplantation (OCA) is often performed with concomitant meniscus allograft transplantation (MAT) as a strategy for knee joint preservation, although to date, the effect of concomitant MAT on outcomes and failure rates after OCA has not been assessed. To determine clinical outcomes for patients undergoing OCA with MAT as compared with a matched cohort of patients undergoing isolated OCA. Control study; Level of evidence, 3. Patients who underwent OCA of the medial or lateral femoral condyle without concomitant MAT by a single surgeon were compared with a matched group of patients who underwent OCA with concomitant MAT (ipsilateral compartment). The patients were matched per age, sex, body mass index, and number of previous ipsilateral knee operations ±1. Patient-reported outcomes, complications, reoperations, and survival rates were compared between groups. One hundred patients undergoing OCA (50 isolated, 50 with MAT) with a mean ± SD follow-up of 4.9 ± 2.7 years (minimum, 2 years) were included (age, 31.7 ± 9.8 years; 52% male). Significantly more patients underwent OCA to the medial femoral condyle (n = 59) than the lateral femoral condyle (n = 41, P OCA. There were no significant differences between the groups regarding reoperation rate (n = 18 for OCA with MAT, n = 17 for OCA without MAT, P = .834), time to reoperation (2.2 ± 2.4 years for OCA with MAT, 3.4 ± 2.7 years for OCA without MAT, P = .149), or failure rates (n = 7 [14%] for OCA with MAT, n = 7 [14%] for OCA without MAT, P > .999). There were no significant differences in patient-reported clinical outcome scores between the groups at final follow-up. There was no significant difference in failure rates between patients undergoing medial femoral condyle OCA (n = 12, 15.3%) and lateral femoral condyle OCA (n = 5, 12.2%, P = .665). These results imply that with appropriate surgical indications to address meniscus deficiency in patients otherwise indicated for OCA and

Predictors of outcome of group and internet-based cognitive behaviour therapy.

NARCIS (Netherlands)

Spek, V.; Nyklicek, I.; Cuijpers, P.; Pop, V.

2008-01-01

Background: Little is known about which participant characteristics determine the effectiveness of various types of cognitive behavior therapy for sub-threshold depression. The aim of this study was to investigate which characteristics predict treatment outcome of group and internet-based

Predicting the outcome of a cognitive-behavioral group training for patients with unexplained physical symptoms: a one-year follow-up study

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Zonneveld Lyonne NL

2012-10-01

Full Text Available Abstract Background Although Cognitive-Behavioral Therapy (CBT is effective for Unexplained Physical Symptoms (UPS, some therapists in clinical practice seem to believe that CBT outcome will diminish if psychiatric comorbidity is present. The result is that patients with a psychiatric comorbidity are redirected from treatment for UPS into treatment for mental health problems. To explore whether this selection and allocation are appropriate, we explored whether CBT outcomes in UPS could be predicted by variables assessed at baseline and used in routine-practice assessments. Methods Patients (n=162 with UPS classified as undifferentiated somatoform disorder or chronic pain disorder were followed up until one year after they had attended a CBT group training. The time-points of the follow-up were at the end of CBT (immediate outcome, three months after CBT (short-term outcome, and one year after CBT (long-term outcome. CBT outcome was measured using the Physical Component Summary of the SF-36, which was the primary outcome measure in the randomized controlled trial that studied effectiveness of the CBT group training. Predictors were: 1. psychological symptoms (global severity score of SCL-90, 2. personality-disorder characteristics (sum of DSM-IV axis II criteria confirmed, 3. psychiatric history (past presence of DSM-IV axis I disorders, and 4. health-related quality of life in the mental domain (mental component summary of SF-36. The effect of this predictor set was explored using hierarchical multiple regression analyses into which these predictors had been entered simultaneously, after control for: a. pretreatment primary outcome scores, b. age, c. gender, d. marital status, and e. employment. Results The predictor set was significant only for short-term CBT outcome, where it explained 15% of the variance. A better outcome was predicted by more psychological symptoms, fewer personality-disorder characteristics, the presence of a psychiatric

The relationship between interpersonal problems, therapeutic alliance, and outcomes following group and individual cognitive behaviour therapy.

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McEvoy, Peter M; Burgess, Melissa M; Nathan, Paula

2014-03-01

Cognitive behavioural therapy (CBT) is efficacious, but there remains individual variability in outcomes. Patient's interpersonal problems may affect treatment outcomes, either directly or through a relationship mediated by helping alliance. Interpersonal problems may affect alliance and outcomes differentially in individual and group (CBGT) treatments. The main aim of this study was to investigate the relationship between interpersonal problems, alliance, dropout and outcomes for a clinical sample receiving either individual or group CBT for anxiety or depression in a community clinic. Patients receiving individual CBT (N=84) or CBGT (N=115) completed measures of interpersonal problems, alliance, and disorder specific symptoms at the commencement and completion of CBT. In CBGT higher pre-treatment interpersonal problems were associated with increased risk of dropout and poorer outcomes. This relationship was not mediated by alliance. In individual CBT those who reported higher alliance were more likely to complete treatment, although alliance was not associated with symptom change, and interpersonal problems were not related to attrition or outcome. Allocation to group and individual therapy was non-random, so selection bias may have influenced these results. Some analyses were only powered to detect large effects. Helping alliance ratings were high, so range restriction may have obscured the relationship between helping alliance, attrition and outcomes. Pre-treatment interpersonal problems increase risk of dropout and predict poorer outcomes in CBGT, but not in individual CBT, and this relationship is not mediated by helping alliance. Stronger alliance is associated with treatment completion in individual, but not group CBT. Copyright © 2014 Elsevier B.V. All rights reserved.

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

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Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

2017-12-01

Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

Assessing the children's views on foods and consumption of selected food groups: outcome from focus group approach.

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Sharif Ishak, Sharifah Intan Zainun; Shohaimi, Shamarina; Kandiah, Mirnalini

2013-04-01

The food choices in childhood have high a probability of being carried through into their adulthood life, which then contributes to the risk of many non-communicable diseases. Therefore, there is a need to gather some information about children's views on foods which may influence their food choices for planning a related dietary intervention or programme. This paper aimed to explore the views of children on foods and the types of foods which are usually consumed by children under four food groups (snacks, fast foods, cereals and cereal products; and milk and dairy products) by using focus group discussions. A total of 33 school children aged 7-9 years old from Selangor and Kuala Lumpur participated in the focus groups. Focus groups were audio-taped, transcribed and analyzed according to the listed themes. The outcomes show that the children usually consumed snacks such as white bread with spread or as a sandwich, local cakes, fruits such as papaya, mango and watermelon, biscuits or cookies, tea, chocolate drink and instant noodles. Their choices of fast foods included pizza, burgers, French fries and fried chicken. For cereal products, they usually consumed rice, bread and ready-to-eat cereals. Finally, their choices of dairy products included milk, cheese and yogurt. The reasons for the food liking were taste, nutritional value and the characteristics of food. The outcome of this study may provide additional information on the food choices among Malaysian children, especially in urban areas with regard to the food groups which have shown to have a relationship with the risk of childhood obesity.

Assessing the children's views on foods and consumption of selected food groups: outcome from focus group approach

Science.gov (United States)

Sharif Ishak, Sharifah Intan Zainun; Kandiah, Mirnalini

2013-01-01

The food choices in childhood have high a probability of being carried through into their adulthood life, which then contributes to the risk of many non-communicable diseases. Therefore, there is a need to gather some information about children's views on foods which may influence their food choices for planning a related dietary intervention or programme. This paper aimed to explore the views of children on foods and the types of foods which are usually consumed by children under four food groups (snacks, fast foods, cereals and cereal products; and milk and dairy products) by using focus group discussions. A total of 33 school children aged 7-9 years old from Selangor and Kuala Lumpur participated in the focus groups. Focus groups were audio-taped, transcribed and analyzed according to the listed themes. The outcomes show that the children usually consumed snacks such as white bread with spread or as a sandwich, local cakes, fruits such as papaya, mango and watermelon, biscuits or cookies, tea, chocolate drink and instant noodles. Their choices of fast foods included pizza, burgers, French fries and fried chicken. For cereal products, they usually consumed rice, bread and ready-to-eat cereals. Finally, their choices of dairy products included milk, cheese and yogurt. The reasons for the food liking were taste, nutritional value and the characteristics of food. The outcome of this study may provide additional information on the food choices among Malaysian children, especially in urban areas with regard to the food groups which have shown to have a relationship with the risk of childhood obesity. PMID:23610606

Mobile-Based Video Learning Outcomes in Clinical Nursing Skill Education: A Randomized Controlled Trial.

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Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun

2016-01-01

Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes.

Perinatal outcomes of unplanned out-of-hospital deliveries: a case-control study.

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Pasternak, Yael; Wintner, Eliana Muskin; Shechter-Maor, Gil; Pasternak, Yehonatan; Miller, Netanella; Biron-Shental, Tal

2018-04-01

To compare the pregnancy and perinatal outcomes of unplanned home or car births vs. in-hospital deliveries. A retrospective, case-control study of women who underwent unplanned out-of-hospital deliveries vs. in-hospital deliveries from 2004 through 2014. Matching was based on gestational age and parity in a ratio of 2:1. There were no significant differences between the groups regarding demographic criteria, prenatal care and delivery complications. Women who delivered out of hospital (n = 90) had significantly fewer cesarean deliveries (1.1 vs. 10.6%; p = 0.05) and operative deliveries (2.2 vs. 13.3%; p = 0.004) in their obstetrical history than did the control group (n = 180). Significantly more newborns delivered out of the hospital had polycythemia (25.6 vs. 1.7%; p unplanned out-of-hospital deliveries tend to have fewer complications in their previous deliveries. Higher rates of polycythemia and hypothermia require attention for neonates born out of the hospital.

Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study

Directory of Open Access Journals (Sweden)

Sachin A Narvekar

2010-01-01

Full Text Available Background: Management of repeated implantation failure despite transfer of good-quality embryos still remains a dilemma for ART specialists. Scrapping of endometrium in the nontransfer cycle has been shown to improve the pregnancy rate in the subsequent IVF/ET cycle in recent studies. Aim: The objective of this randomized controlled trial (RCT was to determine whether endometrial injury caused by Pipelle sampling in the nontransfer cycle could improve the probability of pregnancy in the subsequent IVF cycle in patients who had previous failed IVF outcome. Setting: Tertiary assisted conception center. Design: Randomized controlled study. Materials and Methods: 100 eligible patients with previous failed IVF despite transfer of good-quality embryos were randomly allocated to the intervention group and control groups. In the intervention group, Pipelle endometrial sampling was done twice: One in the follicular phase and again in the luteal phase in the cycle preceding the embryo transfer cycle. Outcome Measure: The primary outcome measure was live birth rate. The secondary outcome measures were implantation and clinical pregnancy rates. Results: The live birth rate was significantly higher in the intervention group compared to control group (22.4% and 9.8% P = 0.04. The clinical pregnancy rate in the intervention group was 32.7%, while that in the control group was 13.7%, which was also statistically significant ( P = 0.01. The implantation rate was significantly higher in the intervention group as compared to controls (13.07% vs 7.1% P = 0.04. Conclusions: Endometrial injury in nontransfer cycle improves the live birth rate,clinical pregnancy and implantation rates in the subsequent IVF-ET cycle in patients with previous unsuccessful IVF cycles.

Social cognitive markers of short-term clinical outcome in first-episode psychosis.

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Montreuil, Tina; Bodnar, Michael; Bertrand, Marie-Claude; Malla, Ashok K; Joober, Ridha; Lepage, Martin

2010-07-01

In psychotic disorders, impairments in cognition have been associated with both clinical and functional outcome, while deficits in social cognition have been associated with functional outcome. As an extension to a recent report on neurocognition and short-term clinical outcome in first-episode psychosis (FEP), the current study explored whether social cognitive deficits could also identify poor short-term clinical outcome among FEP patients. We defined the social-cognition domain based on the scores from the Hinting Task and the Four Factor Tests of Social Intelligence. Data were collected in 45 FEP patients and 26 healthy controls. The patients were divided into good- and poor-outcome groups based on clinical data at six months following initiation of treatment. Social cognition was compared among 27 poor-outcome, 18 good-outcome, and 26 healthy-control participants. Outcome groups significantly differed in the social cognition domain (z-scores: poor outcome=-2.0 [SD=1.4]; good outcome=-1.0 [SD=1.0]; p=0.005), with both groups scoring significantly lower than the control group (psocial cognition appears to be compromised in all FEP patients compared to healthy controls. More interestingly, significant differences in social cognitive impairments exist between good and poor short-term clinical outcome groups, with the largest effect found in the Cartoon Predictions subtest.

Comparative effectiveness of Pilates and yoga group exercise interventions for chronic mechanical neck pain: quasi-randomised parallel controlled study.

Science.gov (United States)

Dunleavy, K; Kava, K; Goldberg, A; Malek, M H; Talley, S A; Tutag-Lehr, V; Hildreth, J

2016-09-01

To determine the effectiveness of Pilates and yoga group exercise interventions for individuals with chronic neck pain (CNP). Quasi-randomised parallel controlled study. Community, university and private practice settings in four locations. Fifty-six individuals with CNP scoring ≥3/10 on the numeric pain rating scale for >3 months (controls n=17, Pilates n=20, yoga n=19). Exercise participants completed 12 small-group sessions with modifications and progressions supervised by a physiotherapist. The primary outcome measure was the Neck Disability Index (NDI). Secondary outcomes were pain ratings, range of movement and postural measurements collected at baseline, 6 weeks and 12 weeks. Follow-up was performed 6 weeks after completion of the exercise classes (Week 18). NDI decreased significantly in the Pilates {baseline: 11.1 [standard deviation (SD) 4.3] vs Week 12: 6.8 (SD 4.3); mean difference -4.3 (95% confidence interval -1.64 to -6.7); PPilates and yoga group exercise interventions with appropriate modifications and supervision were safe and equally effective for decreasing disability and pain compared with the control group for individuals with mild-to-moderate CNP. Physiotherapists may consider including these approaches in a plan of care. ClinicalTrials.gov NCT01999283. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Intact goal-directed control in treatment-seeking drug users indexed by outcome-devaluation and Pavlovian to instrumental transfer: Critique of habit theory.

Science.gov (United States)

Hogarth, Lee; Lam-Cassettari, Christa; Pacitti, Helena; Currah, Tara; Mahlberg, Justin; Hartley, Lucie; Moustafa, Ahmed

2018-05-22

Animal studies have demonstrated that chronic exposure to drugs of abuse impairs goal-directed control over action selection indexed by the outcome-devaluation and specific Pavlovian to instrumental transfer procedures, suggesting this impairment might underpin addiction. However, there is currently only weak evidence for impaired goal-directed control in human drug users. Two experiments were undertaken in which treatment-seeking drug users and non-matched normative reference samples (controls) completed outcome-devaluation and specific Pavlovian to instrumental transfer procedures notionally translatable to animal procedures (Experiment 2 used a more challenging biconditional schedule). The two experiments found significant outcome-devaluation and specific Pavlovian to instrumental transfer effects overall and there was no significant difference between groups in the magnitude of these effects. Moreover, Bayes factor supported the null hypothesis for these group comparisons. Although limited by non-matched group comparisons and small sample sizes, the two studies suggest that treatment-seeking drug users have intact goal-directed control over action selection, adding uncertainty to already mixed evidence concerning the role of habit learning in human drug dependence. Neuro-interventions might seek to tackle goal-directed drug-seeking rather than habit formation in drug users. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Surgical outcomes in two different age groups with Focal Cortical Dysplasia type II: Any real difference?

Science.gov (United States)

Ramírez-Molina, Jorge Luis; Di Giacomo, Roberta; Mariani, Valeria; Deleo, Francesco; Cardinale, Francesco; Uscátegui-Daccarett, Angélica María; Lorenzana, Pablo; Tassi, Laura

2017-05-01

Focal Cortical Dysplasias (FCDs) represent a common architectural cortical disorder underlying drug-resistant focal epilepsy. So far, studies aimed at evaluating whether age at surgery is a factor influencing surgical outcome are lacking, so that data on the comparison between patients harboring Type II FCD operated at younger age and those operated at adult age are still scarce. We compared presurgical clinical features and surgical outcomes of patients with histopathologically diagnosed Type II FCD undergoing surgery at an earlier age with those operated after 20 years of age. We retrospectively analyzed 1660 consecutive patients operated at the "Claudio Munari" Epilepsy Surgery Centre. There were 289 patients (17.4%) with a neuropathological diagnosis of Type II FCD. We included two different groups of patients, the first one including patients operated on at less than 6years, the second sharing the same seizure onset age but with delayed surgery, carried out after the age of 20. Seizure characteristics and, neuropsychological and postoperative seizure outcomes were evaluated by study group. Forty patients underwent surgery before the age of 6 and 66 patients after the age of 20. Surgical outcome was favorable in the whole population (72.6% were classified in Engel's Class Ia+Ic), independently from age at surgery. In the children group, 32 patients were classified in Class I, including 30 (75%) children in classes Ia and Ic. In the adult group, 53 belonged to Class I of whom 47 (71%) were in classes Ia and Ic. The percentage of permanent complications, the surgical outcomes, and AED withdrawal did not significantly differ by study group. Our results indicate that there is no difference between the groups, suggesting that outcome depends mainly on the histological findings and not on timing of surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

Self-declared stock ownership and association with positive trial outcome in randomized controlled trials with binary outcomes published in general medical journals: a cross-sectional study.

Science.gov (United States)

Falk Delgado, Alberto; Falk Delgado, Anna

2017-07-26

Describe the prevalence and types of conflicts of interest (COI) in published randomized controlled trials (RCTs) in general medical journals with a binary primary outcome and assess the association between conflicts of interest and favorable outcome. Parallel-group RCTs with a binary primary outcome published in three general medical journals during 2013-2015 were identified. COI type, funding source, and outcome were extracted. Binomial logistic regression model was performed to assess association between COI and funding source with outcome. A total of 509 consecutive parallel-group RCTs were included in the study. COI was reported in 74% in mixed funded RCTs and in 99% in for-profit funded RCTs. Stock ownership was reported in none of the non-profit RCTs, in 7% of mixed funded RCTs, and in 50% of for-profit funded RCTs. Mixed-funded RCTs had employees from the funding company in 11% and for-profit RCTs in 76%. Multivariable logistic regression revealed that stock ownership in the funding company among any of the authors was associated with a favorable outcome (odds ratio = 3.53; 95% confidence interval = 1.59-7.86; p < 0.01). COI in for-profit funded RCTs is extensive, because the factors related to COI are not fully independent, a multivariable analysis should be cautiously interpreted. However, after multivariable adjustment only stock ownership from the funding company among authors is associated with a favorable outcome.

Rape-related symptoms in adolescents: short- and long-term outcome after cognitive behavior group therapy.

Science.gov (United States)

Bicanic, Iva; de Roos, Carlijn; van Wesel, Floryt; Sinnema, Gerben; van de Putte, Elise

2014-01-01

Efficacy studies on treatment in adolescent victims of single rape are lacking, even though sexual victimization is most likely to occur during adolescence and despite the fact that adolescents are at risk to develop subsequent posttraumatic stress disorder. The aim of this prospective observational study was to evaluate the short- and long-term outcomes of a nine-session cognitive behavior group therapy (STEPS), including a parallel six-session parents' group on rape-related symptomatology in female adolescents (13-18 years). STEPS includes psychoeducation, exposure in sensu as well as in vivo, cognitive restructuring, and relapse prevention. Fifty-five female adolescents with mental health problems due to single rape, but without prior sexual trauma, received STEPS while their parents participated in a support group. Subjects were assessed on posttraumatic stress (PTS) and comorbid symptoms using self-report questionnaires prior to and directly after treatment, and at 6 and 12 months follow-up. Repeated measures analysis showed a significant and large decrease in symptoms of PTS, anxiety, depression, anger, dissociation, sexual concerns, and behavior problems directly after treatment, which maintained at 12 months follow-up. Time since trauma did not influence the results. Dropout during STEPS was 1.8%. The results potentially suggest that the positive treatment outcomes at short- and long-term may be caused by STEPS. The encouraging findings need confirmation in future controlled studies on the effectiveness of STEPS because it may be possible that the treatment works especially well for more chronic symptoms, while the less chronic part of the sample showed considerable improvement on its own.

What is the effect of regular group exercise on maternal psychological outcomes and common pregnancy complaints? An assessor blinded RCT.

Science.gov (United States)

Haakstad, Lene A H; Torset, Beate; Bø, Kari

2016-01-01

to examine the effects of supervised group exercise on maternal psychological outcomes and commonly reported pregnancy complaints. an observer-blinded randomized controlled trial. Norwegian School of Sport Sciences, Oslo, Norway. 105 sedentary, nulliparous pregnant women, mean age 30.7(± 4.0) years, pre-pregnancy BMI 23.8 (± 4.3), were assigned to either exercise (n=52) or control group (n= 53) at mean gestation week 17.7 (± 4.2). the exercise intervention followed ACOG guidelines and included a 60 minutes general fitness class, with 40 minutes of endurance training/aerobic and 20 minutes of strength training and stretching/relaxation, performed at least twice per week for a minimum of 12 weeks. outcome measures were assessed through standardized interviews pre- and post-intervention (gestation week 36.6, ± 0.9), and included psychological variables related to quality of life, well-being, body image and pregnancy depression, as well as assessment of 13 commonly reported pregnancy complaints. post-intervention, using intention to treat (ITT) analysis, women randomized to exercise rated their health significantly better compared to women in the control group (p=0.02) and reported less fatigue related to everyday activities (p=0.04). Women with complete exercise adherence (≥ 24 sessions) had significantly better scores on measurements of feelings related to sadness, hopelessness and anxiety (pbenefits. A qualitative study exploring the barriers of women in achieving recommended amount of activity may be necessary to understand this population and developing better clinical practice educational tools. Copyright © 2015 Elsevier Ltd. All rights reserved.

The effect of the presence and characteristics of an outlying group on exposure-outcome associations.

Science.gov (United States)

Coenen, Pieter; Mathiassen, Svend Erik; Kingma, Idsart; Boot, Cécile R L; Bongers, Paulien M; van Dieën, Jaap H

2015-01-01

Physical exposures (eg, lifting or bending) are believed to be risk factors for low-back pain (LBP), but the literature is inconsistent. Exposure and LBP prevalence differ considerably between occupations, and exposure-outcome associations could be severely modified by the presence of particular occupational groups. We aimed to investigate the influence of such outlying groups on the properties of associations between exposure and LBP. Lifting and trunk flexion were observed for 371 of 1131 workers within 19 groups. LBP was obtained from all workers during three follow-up years. Both exposure variables were associated with LBP (Pexposures and LBP prevalence substantially affected the exposure-outcome association in the total population. In order to further examine this phenomenon, we assessed, by simulation, the influence of realistic sizes (n=4, 8, 16, 32, 64, 128), mean exposures (e=2000, 3000, 4000 lifts and e=30, 40, 50% trunk flexion time) and LBP prevalences (p=70, 80, 90, 100%) of the outlying group on the strength and certainty of the eventual relationship between exposure and LBP. For each combination of n, e and p, 3000 virtual studies were constructed, including the simulated group together with the other 18 original groups from the parent data-set. Average odds ratios (OR), 95% confidence limits, and power (Pexposure. The size and characteristics of a single group with high exposure and outcome prevalence can strongly influence both the OR point estimate and the likelihood of obtaining significant exposure-outcome associations in studies of large populations. These findings can guide interpretations of prior epidemiological studies and support informed design of future studies.

A multilevel analysis of the demands-control model: Is stress at work determined by factors at the group level or the individual level?

NARCIS (Netherlands)

Van Yperen, N.W.; Snijders, T.A.B.

2000-01-01

This study explored the extent to which negative health-related outcomes are associated with differences between work groups and with differences between individuals within work groups using R. A. Karasek's (1979) demands-control model. The sample consisted of 260 employees in 31 working groups of a

Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial.

Science.gov (United States)

Schaefert, R; Kaufmann, C; Wild, B; Schellberg, D; Boelter, R; Faber, R; Szecsenyi, J; Sauer, N; Guthrie, E; Herzog, W

2013-01-01

Patients with medically unexplained symptoms (MUS) are frequent in primary care and substantially impaired in their quality of life (QoL). Specific training of general practitioners (GPs) alone did not demonstrate sustained improvement at later follow-up in current reviews. We evaluated a collaborative group intervention. We conducted a cluster randomized controlled trial. Thirty-five GPs recruited 304 MUS patients (intervention group: 170; control group: 134). All GPs were trained in diagnosis and management of MUS (control condition). Eighteen randomly selected intervention GPs participated in training for a specific collaborative group intervention. They conducted 10 weekly group sessions and 2 booster meetings in their practices, together with a psychosomatic specialist. Six and 12 months after baseline, QoL was assessed with the Short-Form 36. The primary outcome was the physical composite score (PCS), and the secondary outcome was the mental composite score (MCS). At 12 months, intention-to-treat analyses showed a significant between-group effect for the MCS (p = 0.023) but not for the PCS (p = 0.674). This effect was preceded by a significant reduction of somatic symptom severity (15-item somatic symptom severity scale of the Patient Health Questionnaire, PHQ-15) at 6 months (p = 0.008) that lacked significance at 12 months (p = 0.078). As additional between-group effects at 12 months, per-protocol analyses showed less health anxiety (Whiteley-7; p = 0.038) and less psychosocial distress (PHQ; p = 0.024); GP visits were significantly (p = 0.042) reduced in the intervention group. Compared to pure GP training, collaborative group intervention achieved a progressive, clinically meaningful improvement in mental but not physical QoL. It could bridge gaps between general practice and mental health care. Copyright © 2012 S. Karger AG, Basel.

Export Control in the AREVA Group

International Nuclear Information System (INIS)

Zero, S.

2013-01-01

After the Second World War the nuclear technology was mostly considered inappropriate for the export. It remains strictly regulated today, but the development of the civil applications urged states to facilitate the peaceful uses while establishing a strict control in the domains of the internal security and the nuclear proliferation. AREVA decided to set up an Export Control program applied to all the products and in all the countries where the group operates. AREVA can export products or make transfer of technology considered as sensitive for the non-proliferation and the risks linked to the terrorism. This sensitiveness results from the nature of the products or from the country of destination and in certain cases both of them. AREVA has set up an Export Control program and an interactive e-learning training within the Group to make exports of sensitive products, raw materials and technologies more secure. The subject is rather complex, the regulations are constantly evolving, and becoming familiar with them is necessarily a gradual process, but it must be made in-depth, hence the idea of regular training sessions. The implementation of the Export Control in the AREVA Group declines in four fundamental stages: -) Policy and procedure; -) Appointment of Export Control Officers (ECO); -) Training; and -) Audit and Self Assessment. The training program is composed by the following elements: Ethics (Value Charter) of the Group, Non-proliferation, international regulations and more particularly those that are applicable in Europe (Germany and France) and in the United States. Particular attention is devoted to the Export Control practice in China, Japan and India. (A.C.)

A randomized, controlled trial of group cognitive-behavioral therapy for compulsive buying disorder: posttreatment and 6-month follow-up results.

Science.gov (United States)

Mueller, Astrid; Mueller, Ulrike; Silbermann, Andrea; Reinecker, Hans; Bleich, Stefan; Mitchell, James E; de Zwaan, Martina

2008-07-01

The purpose of this study was to conduct a randomized trial comparing the efficacy of a group cognitive-behavioral therapy (CBT) intervention designed for the treatment of compulsive buying disorder to a waiting list control (WLC) group. Thirty-one patients with compulsive buying problems according to the criteria developed by McElroy et al. were assigned to receive active treatment (12 weekly sessions and 6-month follow-up) and 29 to the WLC group. The treatment was specifically aimed at interrupting and controlling the problematic buying behavior, establishing healthy purchasing patterns, restructuring maladaptive thoughts and negative feelings associated with shopping and buying, and developing healthy coping skills. Primary outcome measures were the Compulsive Buying Scale (CBS), the Yale-Brown Obsessive Compulsive Scale-Shopping Version (YBOCS-SV), and the German Compulsive Buying Scale (G-CBS). Secondary outcome measures were the Symptom Checklist-90-Revised (SCL-90-R), the Barratt Impulsiveness Scale (BIS-11), and the Saving Inventory-Revised (SI-R). The study was completed between November 2003 and May 2007 at the University Hospital of Erlangen, Bavaria, Germany. Multivariate analysis revealed significant differences between the CBT and the WLC groups on the primary outcome variables (outcome-by-time-by-group effect, Pillai's trace, F = 6.960, df = 1, p = .002). The improvement was maintained during the 6-month follow-up. The treatment did not affect other psychopathology, e.g., compulsive hoarding, impulsivity, or SCL-90-R scores. We found that lower numbers of visited group therapy sessions and higher pretreatment hoarding traits as measured with the SI-R total score were significant predictors for nonresponse. The results suggest that a disorder-specific cognitive-behavioral intervention can significantly impact compulsive buying behavior.

The Emotional Resources Group: Provisional outcome data for a pilot six-session emotion regulation programme for secondary care.

Science.gov (United States)

Bacon, Thomas; Doughty, Caitriona; Summers, Andrew; Wiffen, Benjamin; Stanley, Zoe; McAlpine, Susan

2018-06-01

To examine the effectiveness of a new, six-session emotion regulation group intervention designed for the secondary care setting: The Emotional Resources Group (ERG). In this pilot study, participants were recruited by referral from secondary care mental health services. Forty-seven individuals participated in the study. Participants who attended the ERG were compared on measures of emotion regulation, well-being, and self-efficacy, pre- and post-intervention. Intent-to-treat analyses indicated highly statistically significant improvements in measures of emotion regulation, well-being, and self-efficacy, accompanied by large effect sizes. In addition, improvements in emotion regulation produced good rates of both reliable and clinically significant change. The ERG may be an effective, brief intervention to improve emotion regulation in the secondary care setting, worthy of further evaluation. Clinical implications Emotion regulation may be an appropriate treatment target to improve well-being and self-efficacy in a transdiagnostic population. The ERG may be effective as a brief emotion regulation intervention for secondary care mental health settings. Outcomes of the ERG appear to be equivalent to other more intensive group-based emotion regulation interventions. The ERG's tailored design may be responsible for positive outcomes. Limitations There was a small sample size. There was no control group. There was no follow-up data. © 2018 The British Psychological Society.

Mindfulness training in a heterogeneous psychiatric sample : Outcome evaluation and comparison of different diagnostic groups

NARCIS (Netherlands)

Bos, Elisabeth H.; Merea, Ria; van den Brink, Erik; Sanderman, Robbert; Bartels-Velthuis, Agna A.

ObjectivesTo examine outcome after mindfulness training in a heterogeneous psychiatric outpatient population and to compare outcome in different diagnostic groups. MethodOne hundred and forty-three patients in 5 diagnostic categories completed questionnaires about psychological symptoms, quality of

Outcomes in registered, ongoing randomized controlled trials of patient education.

Directory of Open Access Journals (Sweden)

Cécile Pino

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.

The relationship between interpersonal problems, negative cognitions, and outcomes from cognitive behavioral group therapy for depression.

Science.gov (United States)

McEvoy, Peter M; Burgess, Melissa M; Nathan, Paula

2013-09-05

Interpersonal functioning is a key determinant of psychological well-being, and interpersonal problems (IPs) are common among individuals with psychiatric disorders. However, IPs are rarely formally assessed in clinical practice or within cognitive behavior therapy research trials as predictors of treatment attrition and outcome. The main aim of this study was to investigate the relationship between IPs, depressogenic cognitions, and treatment outcome in a large clinical sample receiving cognitive behavioral group therapy (CBGT) for depression in a community clinic. Patients (N=144) referred for treatment completed measures of IPs, negative cognitions, depression symptoms, and quality of life (QoL) before and at the completion of a 12-week manualized CBGT protocol. Two IPs at pre-treatment, 'finding it hard to be supportive of others' and 'not being open about problems,' were associated with higher attrition. Pre-treatment IPs also predicted higher post-treatment depression symptoms (but not QoL) after controlling for pre-treatment symptoms, negative cognitions, demographics, and comorbidity. In particular, 'difficulty being assertive' and a 'tendency to subjugate one's needs' were associated with higher post-treatment depression symptoms. Changes in IPs did not predict post-treatment depression symptoms or QoL when controlling for changes in negative cognitions, pre-treatment symptoms, demographics, and comorbidity. In contrast, changes in negative cognitions predicted both post-treatment depression and QoL, even after controlling for changes in IPs and the other covariates. Correlational design, potential attrition bias, generalizability to other disorders and treatments needs to be evaluated. Pre-treatment IPs may increase risk of dropout and predict poorer outcomes, but changes in negative cognitions during treatment were most strongly associated with improvement in symptoms and QoL during CBGT. Copyright © 2013 Elsevier B.V. All rights reserved.

Group therapy task training versus individual task training during inpatient stroke rehabilitation: a randomised controlled trial.

Science.gov (United States)

Renner, Caroline Ie; Outermans, Jacqueline; Ludwig, Ricarda; Brendel, Christiane; Kwakkel, Gert; Hummelsheim, Horst

2016-07-01

To compare the efficacy of intensive daily applied progressive group therapy task training with equally dosed individual progressive task training on self-reported mobility for patients with moderate to severe stroke during inpatient rehabilitation. Randomized controlled clinical trial. In-patient rehabilitation center. A total of 73 subacute patients with stroke who were not able to walk without physical assistance at randomisation. Patients were allocated to group therapy task training (GT) or individual task training (IT). Both interventions were intended to improve walking competency and comprised 30 sessions of 90 minutes over six weeks. Primary outcome was the mobility domain of the Stroke Impact Scale (SIS-3.0). Secondary outcomes were the other domains of SIS-3.0, standing balance, gait speed, walking distance, stair climbing, fatigue, anxiety and depression. No adverse events were reported in either arm of the trial. There were no significant differences between groups for the SIS mobility domain at the end of the intervention (Z= -0.26, P = 0.79). No significant differences between groups were found in gait speed improvements (GT:0.38 ±0.23; IT:0.26±0.35), any other gait related parameters, or in non-physical outcomes such as depression and fatigue. Inpatient group therapy task training for patients with moderate to severe stroke is safe and equally effective as a dose-matched individual task training therapy. Group therapy task training may be delivered as an alternative to individual therapy or as valuable adjunct to increase time spent in gait-related activities. © The Author(s) 2015.

Social capital and adverse treatment outcomes of tuberculosis: a case-control study.

Science.gov (United States)

Deshmukh, P R; Mundra, A; Dawale, A

2017-08-01

'Social capital' refers to social norms, relationships, networks and values that affect the functioning and development of society. Social capital influences health positively, but its role in the treatment outcomes of tuberculosis (TB) is not known. To study the role of social capital in determining adverse TB treatment outcomes. Of 516 patients registered under the Revised National Tuberculosis Control Programme in 2014 in Wardha Tuberculosis Unit, Wardha, India, we included 88 patients with adverse treatment outcomes as cases and 187 controls from among those without adverse outcomes. Multiple logistic regression was used to compare standardised Z-scores. A greater proportion of controls than cases belonged to higher quartiles of social capital and its domains than cases, and the mean standardised Z-score was also consistently higher among controls than cases. Respectively 47% and 15% of cases and controls were in the poorest quartile of social capital, whereas respectively 10% and 33% of cases and controls were in the richest quartile. Each unit increase in Z-score of overall social capital reduced the odds of adverse treatment outcomes by 63.1%. Appropriate interventions for building social capital for TB patients and linking them with the programme would improve programme performance.

Effect of self-hypnosis on duration of labor and maternal and neonatal outcomes: a randomized controlled trial.

Science.gov (United States)

Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Nohr, Ellen A

2013-07-01

To examine the effect of a brief course in self-hypnosis for childbirth on duration of the labor and other birth outcomes. A randomized, controlled, single-blind trial. Aarhus University Hospital Skejby, Denmark. A total of 1222 healthy nulliparous women. A hypnosis group receiving three 1-h lessons in self-hypnosis with additional audio-recordings to ease childbirth, a relaxation group receiving three 1-h lessons in various relaxation methods and mindfulness with audio-recordings for additional training, and a usual-care group receiving only the usual antenatal care were compared. Duration of labor, birth complications, lactation success, caring for the child, and preferred future mode of delivery. No differences were found across the three groups on duration from arriving at the birth department until the expulsive phase of second stage of labor, the duration of the expulsive phase, or other birth outcomes. Fewer emergency and more elective cesarean sections occurred in the hypnosis group. No difference was seen across the groups for lactation success or caring for the child but fewer women in the hypnosis group preferred a cesarean section in future pregnancies because of fear of childbirth and negative birth experiences. Learning self-hypnosis to ease childbirth taught as a brief course failed to show any effects on duration of childbirth and other birth outcomes. © 2013 The Authors Acta Obstetricia et Gynecologica Scandinavica © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

Ultrasound as an Outcome Measure in Gout. A Validation Process by the OMERACT Ultrasound Working Group

DEFF Research Database (Denmark)

Terslev, Lene; Gutierrez, Marwin; Schmidt, Wolfgang A

2015-01-01

OBJECTIVE: To summarize the work performed by the Outcome Measures in Rheumatology (OMERACT) Ultrasound (US) Working Group on the validation of US as a potential outcome measure in gout. METHODS: Based on the lack of definitions, highlighted in a recent literature review on US as an outcome tool...

Use of the scoliosis research society outcomes instrument to evaluate patient outcome in untreated idiopathic scoliosis patients in Japan: part I: comparison with nonscoliosis group: preliminary/limited review in a Japanese population.

Science.gov (United States)

Watanabe, Kei; Hasegawa, Kazuhiro; Hirano, Toru; Uchiyama, Seiji; Endo, Naoto

2005-05-15

This preliminary study evaluates untreated Japanese patients with idiopathic scoliosis using the Scoliosis Research Society Outcomes Instrument (SRS-24). To determine the baseline patient outcome score using the SRS-24 for untreated Japanese scoliosis patients compared with a nonscoliosis group. The SRS instrument with 24 questions was developed to help evaluate patient-perceived outcomes of idiopathic scoliosis treatment. Evaluation of untreated Japanese idiopathic scoliosis patients using the SRS instrument has not been reported. Japanese idiopathic scoliosis patients (n = 141) (mean age, 13.6 years; range, 10-17 years) with a Cobb angle of more than 20 degrees who were not treated with a brace or surgery, were evaluated in comparison with a nonscoliosis group (healthy junior high school students; n = 72) using the SRS-24. The scoliosis group was categorized as mild deformity group with a major curve Cobb angle of less than 30 degrees, moderate deformity group with 30 degrees to 49 degrees, and severe deformity group with more than 50 degrees. The patients were evaluated using section 1 (15 questions) of the SRS-24, which was divided into four domains: total pain, general self-image, general function, and activity. Reliability, as determined by internal consistency, was validated using Cronbach's alpha for these domain scales. The severe deformity group had the lowest scores compared with the other deformity groups and the nonscoliosis group in pain (P self-image (P self-image of back appearance, were significantly lower in the scoliosis group than those in the nonscoliosis group. This tendency was more significant in the patients with greater curve magnitude. Scores for questions 14 and 15, evaluation of general self-image, in the scoliosis group were, however, higher than those in the nonscoliosis group. Internal consistency using Cronbach's alpha was 0.57 (pain), 0.27 (general self-image), -0.08 (general function), and 0.15 (overall level of activity

26 CFR 1.382-8 - Controlled groups.

Science.gov (United States)

2010-04-01

... 26 Internal Revenue 4 2010-04-01 2010-04-01 false Controlled groups. 1.382-8 Section 1.382-8 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Insolvency Reorganizations § 1.382-8 Controlled groups. (a) Introduction. This section...

Characteristics, stability and outcomes of the 2011 GOLD COPD groups in the ECLIPSE cohort

DEFF Research Database (Denmark)

Agusti, Alvar; Edwards, Lisa D; Celli, Bartolomé

2013-01-01

The 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifies patients with chronic obstructive pulmonary disease (COPD) into four groups (A to D). We explored the characteristics, stability and relationship to outcomes of these groups within the ECLIPSE study (Evaluation of C...

A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China.

Science.gov (United States)

Zhang, Hongyu; Huang, Shurong; Guo, Xiaolan; Zhao, Ningning; Lu, Yujing; Chen, Min; Li, Yingxia; Wu, Junqin; Huang, Lihua; Ma, Fenglan; Yang, Yuhong; Zhang, Xiaoli; Zhou, Xiaoyu; Guo, Renfei; Cai, Wenzhi

2017-07-01

the supine position is the most frequently offered for birth delivery in China and many other countries, but the hands-and-knees position is now gaining prominence with doctors in China. This study aims to examine the differences in maternal and neonatal outcomes among low-risk women who gave birth either in the hands-and-knees position or the supine position. a randomised controlled trial was conducted in 11 hospitals in China from May to December in 2012. In total, 1400 women were recruited and randomly allocated to either the experimental group (n=700, 446 completed the protocol) who delivered in hands-and-knees position and the control group (n=700, 440 completed the protocol) who delivered in supine position. Women who could not maintain the randomised position during the second stage of labour were allowed to withdraw from the study. The primary maternal outcome measured was rate of episiotomy. Secondary outcomes included degree of perineum laceration, rate of emergency caesarean section, rate of shoulder dystocia, and duration of labour, postpartum bleeding, neonatal Apgar score, and the rate of neonatal asphyxia. Because outcome data were only collected for women who gave birth in the randomised position, per-protocol analyses were used to compare groups. The primary outcome, episiotomy, was also compared between groups using logistic regression adjusting for maternal age，gestational age at birth, whether the woman was primiparous, the process of second stage of labour and birthweight. as compared with the control group, the experimental group had lower rates of episiotomy and second-degree perineum laceration (including episiotomy), and higher rates of intact perineum and first-degree perineum laceration, with a longer duration of second stage of labour. No significant differences were found in the amount of postpartum bleeding, shoulder dystocia, neonatal asphyxia and neonatal Apgar scores at 1minute and 5minutes. Adjusted for maternal age, gestational

Using Student Learning and Development Outcomes to Evaluate a First-Year Undergraduate Group Video Project

Science.gov (United States)

Jensen, Murray; Mattheis, Allison; Johnson, Brady

2012-01-01

Students in an interdisciplinary undergraduate introductory course were required to complete a group video project focused on nutrition and healthy eating. A mixed-methods approach to data collection involved observing and rating video footage of group work sessions and individual and focus group interviews. These data were analyzed and used to evaluate the effectiveness of the assignment in light of two student learning outcomes and two student development outcomes at the University of Minnesota. Positive results support the continued inclusion of the project within the course, and recommend the assignment to other programs as a viable means of promoting both content learning and affective behavioral objectives. PMID:22383619

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

Science.gov (United States)

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial.

Science.gov (United States)

Schuster, Corina; Maunz, Gerd; Lutz, Karin; Kischka, Udo; Sturzenegger, Rolf; Ettlin, Thierry

2011-10-01

For early inpatient stroke rehabilitation, the effectiveness of amphetamine combined with physiotherapy varies across studies. To investigate whether the recovery of activities of daily living (ADL, primary outcome) and motor function (secondary outcome) can be improved by dexamphetamine added to physiotherapy. In a double-blind, placebo-controlled trial, 16 patients, from 918 who were screened, were randomized to the experimental group (EG, dexamphetamine + physiotherapy) or control group (CG, placebo + physiotherapy). Both groups received multidisciplinary inpatient rehabilitation. Dexamphetamine (10 mg oral) or placebo was administered 2 days per week before physiotherapy. ADL and motor function were measured using the Chedoke-McMaster Stroke Assessment (CMSA) twice during baseline, every week during the 5-week treatment period, and at follow-up 1 week, 6 months, and 12 months after intervention. The majority of ineligible patients had too little paresis, were on anticoagulants, or had a stroke >60 days prior to entry. Participants (EG, n = 7, age 70.3 ± 10 years, 5 women, 37.9 ± 9 days after stroke; CG, n = 9, age 65.2 ± 17 years, 3 women, 40.3 ± 9 days after stroke) did not differ at baseline except for the leg subscale. Analysis of variance from baseline to 1 week follow-up revealed significant improvements in favor of EG for subscales ADL (P = .023) and arm function (P = .020) at end of treatment. No adverse events were detected. In this small trial that was based on prior positive trials, significant gains in ADL and arm function suggest that the dose and timing of dexamphetamine can augment physiotherapy. Effect size calculation suggests inclusion of at least 25 patients per group in future studies.

Heterogenic control groups in randomized, controlled, analgesic trials of total hip and knee arthroplasty.

Science.gov (United States)

Karlsen, Anders P; Mathiesen, Ole; Dahl, Jørgen B

2018-03-01

Postoperative analgesic interventions are often tested adjunct to basic non-opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and possible assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities vary between different control groups in analgesic trials. Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0 to 24 hours postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where a non-steroidal anti-inflammatory drug (NSAID) was administered as an intervention with trial where NSAID was administered in a control group. We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligible for subgroup comparisons. These subgroups received "opioid" alone, "NSAID + opioid", "acetaminophen + opioid", or "NSAID + acetaminophen + opioid", respectively. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Additionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group. Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.

'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.

Science.gov (United States)

Mountain, Gail A; Hind, Daniel; Gossage-Worrall, Rebecca; Walters, Stephen J; Duncan, Rosie; Newbould, Louise; Rex, Saleema; Jones, Carys; Bowling, Ann; Cattan, Mima; Cairns, Angela; Cooper, Cindy; Edwards, Rhiannon Tudor; Goyder, Elizabeth C

2014-04-24

Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For

Outcomes of 847 childhood-onset systemic lupus erythematosus patients in three age groups.

Science.gov (United States)

Lopes, S R M; Gormezano, N W S; Gomes, R C; Aikawa, N E; Pereira, R M R; Terreri, M T; Magalhães, C S; Ferreira, J C; Okuda, E M; Sakamoto, A P; Sallum, A M E; Appenzeller, S; Ferriani, V P L; Barbosa, C M; Lotufo, S; Jesus, A A; Andrade, L E C; Campos, L M A; Bonfá, E; Silva, C A

2017-08-01

Objective The objective of this study was to assess outcomes of childhood systemic lupus erythematosus (cSLE) in three different age groups evaluated at last visit: group A early-onset disease (Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR-DI) (0 (0-9) vs 0 (0-6) vs 0 (0-7), p = 0.065) was comparable in the three groups. Further analysis of organ/system damage revealed that frequencies of neuropsychiatric (21% vs 10% vs 7%, p = 0.007), skin (10% vs 1% vs 3%, p = 0.002) and peripheral vascular involvements (5% vs 3% vs 0.3%, p = 0.008) were more often observed in group A compared to groups B and C. Frequencies of severe cumulative lupus manifestations such as nephritis, thrombocytopenia, and autoimmune hemolytic anemia were similar in all groups ( p > 0.05). Mortality rate was significantly higher in group A compared to groups B and C (15% vs 10% vs 6%, p = 0.028). Out of 69 deaths, 33/69 (48%) occurred within the first two years after diagnosis. Infections accounted for 54/69 (78%) of the deaths and 38/54 (70%) had concomitant disease activity. Conclusions This large multicenter study provided evidence that early-onset cSLE group had distinct outcomes. This group was characterized by higher mortality rate and neuropsychiatric/vascular/skin organ damage in spite of comparable frequencies of severe cumulative lupus manifestations. We also identified that overall death in cSLE patients was an early event mainly attributed to infection associated with disease activity.

Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial.

Science.gov (United States)

O'Brien, Claire; Bray, Emma P; Bryan, Stirling; Greenfield, Sheila M; Haque, M Sayeed; Hobbs, F D Richard; Jones, Miren I; Jowett, Sue; Kaambwa, Billingsley; Little, Paul; Mant, Jonathan; Penaloza, Cristina; Schwartz, Claire; Shackleford, Helen; Varghese, Jinu; Williams, Bryan; McManus, Richard J

2013-03-23

Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care. The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes. The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond. ISRCTN87171227.

The Impact of Teenage Pregnancy on Maternal and Perinatal Outcome

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Chaitra Ramachandra

2016-05-01

Full Text Available To study the impact of teenage pregnancy on maternal and perinatal outcome. This is a randomized prospective clinical study carried out in the Obstetrics and Gynaecology department, BGS Global Medical College, over a period of one year from January 2015 to December 2015. In study group (Group A included a total of 200 primigravid teenage mothers(age <20 years and the control group included 200 primigavid adult mothers (20- 30years of age . The maternal status, labour progress, delivery characteristics and neonatal outcomes were reviewed and analysed. Proportion of mothers in the study group who delivered vaginally was 61.5% compared to 80.5% in the control group. Instrumental delivery rate, emergency LSCS and elective LSCS rates were higher in the study group (teenage pregnancy compared to the control group. (9.5% Vs 5%, 17% Vs 9.5%, 12% Vs 5% respectively. Anaemia, Premature Rupture of Membranes, Oligohydraminos, Post partum Haemorrhage was found to be higher among teenage mothers when compared to adult mothers. PIH, polyhydraminos were found to be higher in control group than in the study group. In regard to adverse perinatal outcomes, higher risks of intra uterine growth restriction, preterm births, stillbirths, low APGAR scores, NICU admission were higher were higher in the study group compared to the control group. In this study, we found that women with teenage pregnancies were at increased risk for adverse pregnancy outcomes in regard to maternal, foetal and neonatal complications as compared with adult control mothers.

Information Problem-Solving Skills in Small Virtual Groups and Learning Outcomes

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Garcia, Consuelo; Badia, Antoni

2017-01-01

This study investigated the frequency of use of information problem-solving (IPS) skills and its relationship with learning outcomes. During the course of the study, 40 teachers carried out a collaborative IPS task in small virtual groups in a 4-week online training course. The status of IPS skills was collected through self-reports handed in over…

Adaptive control of human action: The role of outcome representations and reward signals

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Hans eMarien

2013-09-01

Full Text Available The present paper aims to advance the understanding of the control of human behavior by integrating two lines of literature that so far have led separate lives. First, one line of literature is concerned with the ideomotor principle of human behavior, according to which actions are represented in terms of their outcomes. The second line of literature mainly considers the role of reward signals in adaptive control. Here, we offer a combined perspective on how outcome representations and reward signals work together to modulate adaptive control processes. We propose that reward signals signify the value of outcome representations and facilitate the recruitment of control resources in situations where behavior needs to be maintained or adapted to attain the represented outcome. We discuss recent research demonstrating how adaptive control of goal-directed behavior may emerge when outcome representations are co-activated with positive reward signals.

Social support and education groups for single mothers: a randomized controlled trial of a community-based program.

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Lipman, Ellen L; Boyle, Michael H

2005-12-06

Members of families headed by single mothers are at increased risk of psychosocial disadvantage and mental health problems. We assessed the effect of a community-based program of social support and education groups for single mothers of young children on maternal well-being and parenting. We recruited 116 single mothers of children 3 to 9 years old through community advertisements. Eligible mothers were randomly assigned either to participate in a 10-week program of group sessions (1.5 hours per week) offering social support and education, with a parallel children's activity group, or to receive a standard list of community resources and the option to participate in group sessions at the end of the follow-up period. Interviewers blinded to the randomization collected assessment data from all mothers at baseline and at 3 follow-up visits (immediately after the intervention and at 3 and 6 months after the intervention). Outcome measures were self-reported mood, self-esteem, social support and parenting. Between February 2000 and April 2003, the program was offered to 9 groups of single mothers. Most of the mothers in the trial reported high levels of financial and mental health problems. In the short term (after the intervention), mothers in the intervention group had improved scores for mood (p effect = 0.55) and self-esteem (p effect = 0.29) compared with mothers in the control group; scores for the other 2 measures did not differ between the groups. Growth curve analysis of program effects over the follow-up period showed improvement in all 4 outcomes, with no significant difference between the intervention and control groups. This community-based program of group sessions offering social support and education to low-income single mothers had positive short-term effects on mood and self-esteem but not on social support and parenting. Longer follow-up showed attenuation of these effects.

Diabetes Support Groups Improve Patient’s Compliance and Control Blood Glucose Levels

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Zamrotul Izzah

2013-09-01

Full Text Available Providing information is not enough to improve diabetic patient’s compliance and achieve goals of therapy. Patient’s good awareness as well as emotional and social supports from family and community may play an important role to improve their compliance and clinical outcomes. Therefore, diabetes support groups were developed and each support group consisted of two pharmacists, two nurses, diabetic patients and their family members. A total of 70 type 2 diabetic patient’s were enrolled and randomized into support group 1 and support group 2. Patients in the group 1 received information leaflets only, while patient in the group 2 received pharmacist counselling and information leaflets at each meeting. Patient’s awareness of diabetes and compliance with medications were assessed by a short questionnaire at baseline and final follow-up. Blood glucose and cholesterol levels were also evaluated in both groups. At the end of study, the overall patient’s awareness and compliance improved by 61.5%. The random and fasting blood glucose levels decreased over than 30% in the group 2 and around 14% in the group 1. This study reveals that collaboration between health care professionals and community in the diabetes support group might help diabetic patients to increase their knowledge and compliance with the diabetes therapy as well as glycaemic control.

Rape-related symptoms in adolescents: short- and long-term outcome after cognitive behavior group therapy

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Iva Bicanic

2014-06-01

Full Text Available Background: Efficacy studies on treatment in adolescent victims of single rape are lacking, even though sexual victimization is most likely to occur during adolescence and despite the fact that adolescents are at risk to develop subsequent posttraumatic stress disorder. Aim: The aim of this prospective observational study was to evaluate the short- and long-term outcomes of a nine-session cognitive behavior group therapy (STEPS, including a parallel six-session parents’ group on rape-related symptomatology in female adolescents (13–18 years. STEPS includes psychoeducation, exposure in sensu as well as in vivo, cognitive restructuring, and relapse prevention. Methods: Fifty-five female adolescents with mental health problems due to single rape, but without prior sexual trauma, received STEPS while their parents participated in a support group. Subjects were assessed on posttraumatic stress (PTS and comorbid symptoms using self-report questionnaires prior to and directly after treatment, and at 6 and 12 months follow-up. Results: Repeated measures analysis showed a significant and large decrease in symptoms of PTS, anxiety, depression, anger, dissociation, sexual concerns, and behavior problems directly after treatment, which maintained at 12 months follow-up. Time since trauma did not influence the results. Dropout during STEPS was 1.8%. Conclusions: The results potentially suggest that the positive treatment outcomes at short- and long-term may be caused by STEPS. The encouraging findings need confirmation in future controlled studies on the effectiveness of STEPS because it may be possible that the treatment works especially well for more chronic symptoms, while the less chronic part of the sample showed considerable improvement on its own.

Managing mobility outcomes in vulnerable seniors ( MMOVeS): a randomized controlled pilot study.

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Figueiredo, Sabrina; Morais, Jose A; Mayo, Nancy

2017-12-01

To estimate feasibility and potential for efficacy of an individualized, exercise-focused, self-management program (i.e. Managing Mobility Outcomes In Vulnerable Seniors ( MMOVeS)), in comparison to exercise information in improving mobility after six months among seniors recently discharged from hospital. Randomized pilot study. Two McGill University-teaching hospitals. Community dwelling seniors, aged 70 years and older, recently discharged from either participating hospitals. The physiotherapy-facilitated intervention consisted of (1) evaluation of mobility capacity, (2) setting short- and long-term goals, (3) delineation of an exercise treatment plan, (4) an educational booklet to enhance mobility self-management skills, and (5) six monthly telephone calls. Control group received a booklet with information on exercises targeting mobility limitations in seniors. Mobility, pain, and health status were assessed at baseline and at six months using multiple indicators drawn from Disabilities of the Arm, Shoulder, and Hand (DASH) Score, Lower Extremity Functional Scale (LEFS) and Short-Form (SF)-36. In all, 26 people were randomized to the intervention (mean age: 81 ± 8; 39% women), and 23 were randomized to the control (mean age: 79 ± 7; 33% women). The odds ratio for the mobility outcomes combined was 3.08 and the 95% confidence interval excluded 1 (1.65-5.77). The odds ratio for pain and health perception favored the MMOVeS group, but the 95% confidence interval included the null value. This feasibility study highlights the potential for efficacy of an individualized, exercise-focused, self-management program in comparison to exercise information in improving mobility outcome for seniors. Furthermore, a home-program combining self-management skills and exercise taught with minimal supervision prove to be feasible. Finally, data from this study can be used to estimate sample size for a confirmatory trial.

Comparison of group-based outpatient physiotherapy with usual care after total knee replacement: a feasibility study for a randomized controlled trial.

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Artz, Neil; Dixon, Samantha; Wylde, Vikki; Marques, Elsa; Beswick, Andrew D; Lenguerrand, Erik; Blom, Ashley W; Gooberman-Hill, Rachael

2017-04-01

To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. A feasibility study for a randomized controlled trial. One secondary-care hospital orthopaedic centre, Bristol, UK. A total of 46 participants undergoing primary total knee replacement. The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial.

Outcomes for Women with Gestational Diabetes Treated with Metformin: A Retrospective, Case-Control Study

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Rachel T. McGrath

2018-03-01

Full Text Available Metformin is increasingly being used a therapeutic option for the management of gestational diabetes mellitus (GDM. The aim of this study was to compare the maternal characteristics and perinatal outcomes of women with GDM treated with metformin (with or without supplemental insulin with those receiving other management approaches. A retrospective, case-control study was carried out and 83 women taking metformin were matched 1:1 with women receiving insulin or diet and lifestyle modification alone. Women managed with diet and lifestyle modification had a significantly lower fasting plasma glucose (p < 0.001 and HbA1c (p < 0.01 at diagnosis of GDM. Furthermore, women managed with metformin had a higher early pregnancy body mass index (BMI compared to those receiving insulin or diet and lifestyle modification (p < 0.001. There was no difference in mode of delivery, birth weight or incidence of large- or small-for-gestational-age neonates between groups. Women receiving glucose lowering therapies had a higher rate of neonatal hypoglycaemia (p < 0.05. The incidence of other adverse perinatal outcomes was similar between groups. Despite their greater BMI, women with metformin-treated GDM did not have an increased risk of adverse perinatal outcomes. Metformin is a useful alternative to insulin in the management of GDM.

A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

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Schuengel Carlo

2011-07-01

Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

Prehospital rapid sequence intubation improves functional outcome for patients with severe traumatic brain injury: a randomized controlled trial.

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Bernard, Stephen A; Nguyen, Vina; Cameron, Peter; Masci, Kevin; Fitzgerald, Mark; Cooper, David J; Walker, Tony; Std, B Paramed; Myles, Paul; Murray, Lynne; David; Taylor; Smith, Karen; Patrick, Ian; Edington, John; Bacon, Andrew; Rosenfeld, Jeffrey V; Judson, Rodney

2010-12-01

To determine whether paramedic rapid sequence intubation in patients with severe traumatic brain injury (TBI) improves neurologic outcomes at 6 months compared with intubation in the hospital. Severe TBI is associated with a high rate of mortality and long-term morbidity. Comatose patients with TBI routinely undergo endo-tracheal intubation to protect the airway, prevent hypoxia, and control ventilation. In many places, paramedics perform intubation prior to hospital arrival. However, it is unknown whether this approach improves outcomes. In a prospective, randomized, controlled trial, we assigned adults with severe TBI in an urban setting to either prehospital rapid sequence intubation by paramedics or transport to a hospital emergency department for intubation by physicians. The primary outcome measure was the median extended Glasgow Outcome Scale (GOSe) score at 6 months. Secondary end-points were favorable versus unfavorable outcome at 6 months, length of intensive care and hospital stay, and survival to hospital discharge. A total of 312 patients with severe TBI were randomly assigned to paramedic rapid sequence intubation or hospital intubation. The success rate for paramedic intubation was 97%. At 6 months, the median GOSe score was 5 (interquartile range, 1-6) in patients intubated by paramedics compared with 3 (interquartile range, 1-6) in the patients intubated at hospital (P = 0.28).The proportion of patients with favorable outcome (GOSe, 5-8) was 80 of 157 patients (51%) in the paramedic intubation group compared with 56 of 142 patients (39%) in the hospital intubation group (risk ratio, 1.28; 95% confidence interval, 1.00-1.64; P = 0.046). There were no differences in intensive care or hospital length of stay, or in survival to hospital discharge. In adults with severe TBI, prehospital rapid sequence intubation by paramedics increases the rate of favorable neurologic outcome at 6 months compared with intubation in the hospital.

Improved Outcomes for Hispanic Women with Gestational Diabetes Using the Centering Pregnancy© Group Prenatal Care Model.

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Schellinger, Megan M; Abernathy, Mary Pell; Amerman, Barbara; May, Carissa; Foxlow, Leslie A; Carter, Amy L; Barbour, Kelli; Luebbehusen, Erin; Ayo, Katherine; Bastawros, Dina; Rose, Rebecca S; Haas, David M

2017-02-01

Objective To determine the impact of Centering Pregnancy © -based group prenatal care for Hispanic gravid diabetics on pregnancy outcomes and postpartum follow-up care compared to those receiving traditional prenatal care. Methods A cohort study was performed including 460 women diagnosed with gestational diabetes mellitus (GDM) who received traditional or Centering Pregnancy © prenatal care. The primary outcome measured was completion of postpartum glucose tolerance testing. Secondary outcomes included postpartum visit attendance, birth outcomes, breastfeeding, and initiation of a family planning method. Results 203 women received Centering Pregnancy © group prenatal care and 257 received traditional individual prenatal care. Women receiving Centering Pregnancy © prenatal care were more likely to complete postpartum glucose tolerance testing than those receiving traditional prenatal care, (83.6 vs. 60.7 %, respectively; p prenatal care (30.2 vs. 42.1 %; p = 0.009), and were less likely to undergo inductions of labor (34.5 vs. 46.2 %; p = 0.014). When only Hispanic women were compared, women in the Centering group continued to have higher rates of breastfeeding and completion of postpartum diabetes screening. Conclusion for Practice Hispanic women with GDM who participate in Centering Pregnancy © group prenatal care may have improved outcomes.

Outcomes of hip arthroscopy in patients aged 50 years or older compared with a matched-pair control of patients aged 30 years or younger.

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Domb, Benjamin G; Linder, Dror; Finley, Zachary; Botser, Itamar B; Chen, Austin; Williamson, Joseph; Gupta, Asheesh

2015-02-01

Age has been suggested as a negative prognostic factor for hip arthroscopy. The purpose of this study was to compare patient characteristics and outcomes after hip arthroscopy in patients aged 50 years or older with a matched control group of patients aged 30 years or younger at a minimum postoperative follow-up of 2 years. Between September 2008 and March 2010, data were prospectively collected on all patients aged 50 years or older undergoing primary hip arthroscopy. Fifty-two patients met our inclusion and matching criteria, of whom all 52 (100%) were available for follow-up at a minimum of 2 years. This cohort was compared with a matched-pair control group of patients aged 30 years or younger who underwent similar procedures. The mean age of the study group was 54.8 years (range, 50 to 69 years), and that of the control group was 20.3 years (range, 13 to 30 years). The groups were matched at a 1:1 ratio, including 18 male patients (34.6%) and 34 female patients (65.4%) in each group, with a mean follow-up period of 32 months (range, 24 to 54 months). In the younger control group, the score improvement from preoperatively to 2 years' follow-up was 62.9 to 84.2 for the modified Harris Hip Score, 60.5 to 84.2 for the Non-Arthritic Hip Score, 63.1 to 86.5 for the Hip Outcome Score-Activities of Daily Living, and 42.2 to 72.7 for the Hip Outcome Score-Sport-Specific Subscale. In the older study group, the score improvement from preoperatively to 2 years' follow-up was 61.2 to 82.2 for the modified Harris Hip Score, 59.9 to 80.4 for the Non-Arthritic Hip Score, 63.9 to 83 for the Hip Outcome Score-Activities of Daily Living, and 41.2 to 64.6 for the Hip Outcome Score-Sport-Specific Subscale. All improvements in both groups were statistically significant at the 2-year postoperative follow-up (P arthroscopy should be considered a valid treatment option when treating hip pain in patients aged 50 years or older with a Tönnis arthritic grade of 0 or 1. Older patients

Is the Belief in Meritocracy Palliative for Members of Low Status Groups? Evidence for a Benefit for Self-Esteem and Physical Health via Perceived Control

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McCoy, Shannon K.; Wellman, Joseph D.; Cosley, Brandon; Saslow, Laura; Epel, Elissa

2013-01-01

Consensually held ideologies may serve as the cultural “glue” that justifies hierarchical status differences in society (e.g. Augustinos, 1998). Yet to be effective these beliefs need to be embraced by low-status groups. Why would members of low-status groups endorse beliefs that justify their relative disadvantage? We propose that members of low-status groups in the United States may benefit from some system-justifying beliefs (such as the belief in meritocracy) to the extent that these beliefs emphasize the perception of control over future outcomes. In 2 studies, among women, lower-SES women, and women of color, we found a positive relationship between the belief in meritocracy and well-being (self-esteem and physical health) that was mediated by perceived control. Members of low-status groups may benefit from some system-justifying beliefs to the extent that these beliefs, like the belief in meritocracy, emphasize the perception of control over future outcomes. PMID:24039310

Control of complex physically simulated robot groups

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Brogan, David C.

2001-10-01

Actuated systems such as robots take many forms and sizes but each requires solving the difficult task of utilizing available control inputs to accomplish desired system performance. Coordinated groups of robots provide the opportunity to accomplish more complex tasks, to adapt to changing environmental conditions, and to survive individual failures. Similarly, groups of simulated robots, represented as graphical characters, can test the design of experimental scenarios and provide autonomous interactive counterparts for video games. The complexity of writing control algorithms for these groups currently hinders their use. A combination of biologically inspired heuristics, search strategies, and optimization techniques serve to reduce the complexity of controlling these real and simulated characters and to provide computationally feasible solutions.

Memories of early attachment: the use of PBI as a predictor of outcome in Pesso-Boyden System Psychomotor (PBSP) group therapy, Cognitive-Behavioural Group Therapy (CBGT), Individual Cognitive-Behavioural Therapy (CBT) and Individual Treatment As Usual (TAU) with adult out-patients.

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Ryum, Truls; Vogel, Patrick A; Hagen, Roger; Stiles, Tore C

2008-01-01

To examine the predictive validity of the Parental Bonding Instrument (PBI) for outcome in individual and group psychotherapy. Data from four different clinical trials were combined, yielding a total of 105 patients. After controlling for gender, age and initial symptomatic distress, the predictive validity of the PBI subscales was investigated using the symptom checklist-90-revised (SCL-90-R) and inventory of interpersonal problems-64 (IIP-64) at termination as dependent measures in each treatment condition using separate hierarchical multiple regression analyses. Using the SCL-90-R at termination as dependent measure, reports of higher paternal and maternal care were related to a worse outcome in the Pesso-Boyden System Psychomotor condition, whereas reports of higher paternal care were related to a better outcome in the Cognitive-Behavioural Therapy condition. Also, higher maternal protection was related to a better outcome in the Cognitive-Behavioral Group condition. Using the IIP-64 at termination as dependent measure, reports of higher paternal protection were related to a better outcome in the Treatment As Usual condition. The study shows that the PBI may function as a clinical predictor for treatment response, although the results were somewhat contrary to previous reportings. Future studies should contrast and investigate possible differences between individual and group treatments further, as well as more clearly defined diagnostic groups. Clinical implications are presented. Copyright (c) 2008 John Wiley & Sons, Ltd.

Shamba Maisha: randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes.

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Weiser, Sheri D; Bukusi, Elizabeth A; Steinfeld, Rachel L; Frongillo, Edward A; Weke, Elly; Dworkin, Shari L; Pusateri, Kyle; Shiboski, Stephen; Scow, Kate; Butler, Lisa M; Cohen, Craig R

2015-09-10

Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. This is a pilot cluster randomized controlled trial. The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/μl, P security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.

Clinical characteristics and pregnancy outcomes of Syrian refugees: a case-control study in a tertiary care hospital in Istanbul, Turkey.

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Erenel, Hakan; Aydogan Mathyk, Begum; Sal, Veysel; Ayhan, Isil; Karatas, Suat; Koc Bebek, Arzu

2017-01-01

We aimed to compare the clinical characteristics and pregnancy outcomes in women who are Syrian refugees and Turkish women who are non-refugees at a maternity center in Istanbul, Turkey. A total of 600 singleton pregnancies who delivered at Sisli Hamidiye Etfal Training and Research Hospital were included in the study. Demographic data, obstetrical history, clinical findings, obstetrical and neonatal outcomes were compared between 300 Syrian refugees and 300 control patients. The Syrian refugee patients were significantly younger than Turkish patients. The percentage of adolescents aged 12-19 years were significantly higher in the Syrian patients (14.3 vs. 5.3 %, p refugee patients had no antenatal care. However, this ratio was only 7.7 % for the control group (p refugee control patients, refugee women in our study had poor antenatal care but no adverse perinatal outcomes were observed. Further larger multicenter studies may provide more convincing data about obstetric outcomes in the Syrian refugee population as well as adolescent pregnancies in this population.

Risks and Outcomes Associated with Disorganized/Controlling Patterns of Attachment at Age Three in the NICHD Study of Early Child Care and Youth Development.

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O'Connor, Erin; Bureau, Jean-Francois; McCartney, Kathleen; Lyons-Ruth, Karlen

2011-07-01

Disorganized/controlling attachment in preschool has been found to be associated with maternal and child maladjustment, making it of keen interest in the study of psychopathology. Additional work is needed, however, to better understand disorganized/controlling attachment occurring as early as age three. The primary aims of this study were to evaluate risk factors and outcomes associated with disorganized/controlling behavior at age three and to evaluate the risk factors and outcomes differentiating the four subtypes of disorganized/controlling attachment. Analyses were conducted with the first two phases of the NICHD Study of Early Child Care and Youth Development, a prospective study of 1,364 children from birth. At 36 months of age, across the attachment-relevant domains of maternal well-being, mother-child interactions, and child social adaptation, the disorganized/controlling group evidenced the most maladaptive patterns in comparison to both secure and insecure-organized groups. At 54 months of age, the disorganized/controlling group displayed the highest levels of internalizing and externalizing behavior problems, as rated by mothers and teachers, and the lowest quality relationships with teachers. Significant differences found among the disorganized/controlling subtypes indicated that the behaviorally disorganized and controlling-punitive subtypes had more maladaptive patterns across variables than did the controlling-caregiving and controlling-mixed subtypes.

Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness.

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Santer, Miriam; Ridd, Matthew J; Francis, Nick A; Stuart, Beth; Rumsby, Kate; Chorozoglou, Maria; Becque, Taeko; Roberts, Amanda; Liddiard, Lyn; Nollett, Claire; Hooper, Julie; Prude, Martina; Wood, Wendy; Thomas, Kim S; Thomas-Jones, Emma; Williams, Hywel C; Little, Paul

2018-05-03

To determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children. Pragmatic randomised open label superiority trial with two parallel groups. 96 general practices in Wales and western and southern England. 483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded. Participants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants. The primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed. 483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean baseline POEM score was 9.5 (SD 5.7) in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. The mean POEM score

Growth and Neurodevelopmental Outcomes of Early, High-Dose Parenteral Amino Acid Intake in Very Low Birth Weight Infants: A Randomized Controlled Trial.

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Balakrishnan, Maya; Jennings, Alishia; Przystac, Lynn; Phornphutkul, Chanika; Tucker, Richard; Vohr, Betty; Stephens, Bonnie E; Bliss, Joseph M

2017-03-01

Administration of high-dose parenteral amino acids (AAs) to premature infants within hours of delivery is currently recommended. This study compared the effect of lower and higher AA administration starting close to birth on short-term growth and neurodevelopmental outcomes at 18-24 months corrected gestational age (CGA). Infants Toddler Development, Third Edition at 18-24 months CGA. Secondary outcomes were growth parameters at 36 weeks CGA among infants surviving to hospital discharge, serum bicarbonate, serum urea nitrogen, creatinine, AA profiles in the first week of life, and incidence of major morbidities and mortality. No differences in neurodevelopmental outcome were detected between the high and low AA groups. Infants in the high AA group had significantly lower mean weight, length, and head circumference percentiles than those in the standard AA group at 36 weeks CGA and at hospital discharge. These differences did not persist after controlling for birth growth parameters, except for head circumference. Infants in the high AA group had higher mean serum urea nitrogen than the standard group on each day throughout the first week. Current recommendations for high-dose AA starting at birth are not associated with improved growth or neurodevelopmental outcomes.

Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial.

Science.gov (United States)

Suszek, Hubert; Holas, Paweł; Wyrzykowski, Tomasz; Lorentzen, Steinar; Kokoszka, Andrzej

2015-07-29

Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals for the treatment of anxiety disorders and comorbid depressive or personality disorders in Poland and other Eastern European countries. Yet there is not enough evidence as to their effectiveness in this environment; this study addresses this gap. The aim of the study is to determine the effectiveness of these two kinds of day treatment care consisting of intensive, short-term group psychodynamic and cognitive-behavioral therapy, for patients with anxiety disorders and/or comorbid depressive or personality disorders. Our objectives are to: 1) show the effectiveness of each treatment in a day-care setting relative to the wait-list control group; 2) demonstrate the relative short- and long-term effectiveness of the two active treatments; 3) carry out a preliminary examination of the predictors and moderators of treatment response; 4) carry out a preliminary examination of the mediators of therapeutic change; and 5) compare the impact of both methods of treatment on the outcome of the measures used in this study. In this randomized controlled trial, a total of 199 patients with anxiety disorders and comorbid depressive and/or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; or 3) wait-list control group. The therapy will last 12 weeks. Both treatments will be manualized (the manuals will address comorbidity). Primary outcome measures will include self-reported symptoms of anxiety, observer-rated symptoms of anxiety, global improvement, and recovery rate. Secondary outcome measures will include the number of pathological personality traits, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, and quality of life. Measures will be taken at baseline, post-treatment, and at six months following

Pregnancy associated nasopharyngeal carcinoma: A retrospective case-control analysis of maternal survival outcomes

International Nuclear Information System (INIS)

Cheng, Yi-Kan; Zhang, Fan; Tang, Ling-Long; Chen, Lei; Zhou, Guan-Qun; Zeng, Mu-Sheng; Kang, Tie-Bang; Jia, Wei-Hua; Shao, Jian-Yong; Mai, Hai-Qiang; Guo, Ying; Ma, Jun

2015-01-01

Background: Pregnancy-associated nasopharyngeal carcinoma (PANPC) has been associated with poor survival. Recent advances in radiation technology and imaging techniques, and the introduction of chemotherapy have improved survival in nasopharyngeal carcinoma (NPC); however, it is not clear whether these changes have improved survival in PANPC. Therefore, the purpose of this study was to compare five-year maternal survival in patients with PANPC and non-pregnant patients with NPC. Methods: After adjusting for age, stage and chemotherapy mode, we conducted a retrospective case-control study among 36 non-metastatic PANPC patients and 36 non-pregnant NPC patients (control group) who were treated at our institution between 2000 and 2010. Results: The median age of both groups was 30 years (range, 23–35 years); median follow-up for all patients was 70 months. Locoregionally-advanced disease accounted for 83.3% of all patients with PANPC and 92.9% of patients who developed NPC during pregnancy. In both the PANPC and control groups, 31 patients (86.1%) received chemotherapy and all patients received definitive radiotherapy. The five-year rates for overall survival (70% vs. 78%, p = 0.72), distant metastasis-free survival (79% vs. 76%, p = 0.77), loco-regional relapse-free survival (97% vs. 91%, p = 0.69) and disease-free survival (69% vs. 74%, p = 0.98) were not significantly different between the PANPC and control groups. Multivariate analysis using a Cox proportional hazards model revealed that only N-classification was significantly associated with five-year OS. Conclusion: This study demonstrates that, in the modern treatment era, pregnancy itself may not negatively influence survival outcomes in patients with NPC; however, pregnancy may delay the diagnosis of NPC

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.

Science.gov (United States)

Bul, Kim C M; Kato, Pamela M; Van der Oord, Saskia; Danckaerts, Marina; Vreeke, Leonie J; Willems, Annik; van Oers, Helga J J; Van Den Heuvel, Ria; Birnie, Derk; Van Amelsvoort, Thérèse A M J; Franken, Ingmar H A; Maras, Athanasios

2016-02-16

The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called "Plan-It Commander") as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

Science.gov (United States)

2016-01-01

Background The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called “Plan-It Commander”) as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). Objective The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Methods Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. Results After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the

Expressive writing intervention and self-reported physical health out-comes - Results from a nationwide randomized controlled trial with breast cancer patients.

Science.gov (United States)

Jensen-Johansen, Mikael B; O'Toole, Mia S; Christensen, Søren; Valdimarsdottir, Heiddis; Zakowski, Sandra; Bovbjerg, Dana H; Jensen, Anders B; Zachariae, Robert

2018-01-01

The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related to emotion regulation as possible moderators of the effect. Women who had recently completed treatment for primary breast cancer (n = 507) were randomly assigned to three 20 min. home-based writing exercises, one week apart, focusing on emotional disclosure (EWI) of a distressing experience (their cancer or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about their own cancer, but not women writing about other topics, showed a larger decrease than controls. The results from this large randomized trial are concordant with previous findings showing that EWI is unlikely to be a generally applicable intervention to improve health-related outcomes in cancer patients and cancer survivors. However, written disclosure might have a beneficial impact for individuals who write about their own cancer, as well as for those low in alexithymia.

Group cognitive behavioral therapy for patients with generalized social anxiety disorder in Japan: outcomes at 1-year follow up and outcome predictors

Science.gov (United States)

Kawaguchi, Akiko; Watanabe, Norio; Nakano, Yumi; Ogawa, Sei; Suzuki, Masako; Kondo, Masaki; Furukawa, Toshi A; Akechi, Tatsuo

2013-01-01

Background Social anxiety disorder (SAD) is one of the most common psychiatric disorders worldwide. Cognitive behavioral therapy (CBT) is an effective treatment option for patients with SAD. In the present study, we examined the efficacy of group CBT for patients with generalized SAD in Japan at 1-year follow-up and investigated predictors with regard to outcomes. Methods This study was conducted as a single-arm, naturalistic, follow-up study in a routine Japanese clinical setting. A total of 113 outpatients with generalized SAD participated in group CBT from July 2003 to August 2010 and were assessed at follow-ups for up to 1 year. Primary outcome was the total score on the Social Phobia Scale/Social Interaction Anxiety Scale (SPS/SIAS) at 1 year. Possible baseline predictors were investigated using mixed-model analyses. Results Among the 113 patients, 70 completed the assessment at the 1-year follow-up. The SPS/SIAS scores showed significant improvement throughout the follow-ups for up to 1 year. The effect sizes of SPS/SIAS at the 1-year follow-up were 0.68 (95% confidence interval 0.41–0.95)/0.76 (0.49–1.03) in the intention-to-treat group and 0.77 (0.42–1.10)/0.84 (0.49–1.18) in completers. Older age at baseline, late onset, and lower severity of SAD were significantly associated with good outcomes as a result of mixed-model analyses. Conclusions CBT for patients with generalized SAD in Japan is effective for up to 1 year after treatment. The effect sizes were as large as those in previous studies conducted in Western countries. Older age at baseline, late onset, and lower severity of SAD were predictors for a good outcome from group CBT. PMID:23450841

Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder: Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial.

Science.gov (United States)

Arnfred, Sidse M; Aharoni, Ruth; Hvenegaard, Morten; Poulsen, Stig; Bach, Bo; Arendt, Mikkel; Rosenberg, Nicole K; Reinholt, Nina

2017-01-23

Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence. The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in

The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial.

Science.gov (United States)

Cannell, John; Jovic, Emelyn; Rathjen, Amy; Lane, Kylie; Tyson, Anna M; Callisaya, Michele L; Smith, Stuart T; Ahuja, Kiran Dk; Bird, Marie-Louise

2018-02-01

To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Randomized controlled clinical trial. Two subacute hospital rehabilitation units in Australia. In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. Both groups received functional retraining and individualized programs for up to an hour, on weekdays for 8-40 sessions (dose matched). For the intervention group, this individualized program used motivating virtual reality rehabilitation and novel gesture controlled interactive motion capture software. For usual care, the individualized program was delivered in a group class on one unit and by rehabilitation assistant 1:1 on the other. Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. Participants (mean 22 days post-stroke) attended mean 14 sessions. Both groups improved (mean (95% confidence interval)) on primary outcome functional reach (usual care 3.3 (0.6 to 5.9), intervention 4.1 (-3.0 to 5.0) cm) with no difference between groups ( P = 0.69) on this or any secondary measures. No differences between the rehabilitation units were seen except in lateral reach (less affected side) ( P = 0.04). No adverse events were recorded during therapy. Interactive, motion capture rehabilitation for inpatients post stroke produced functional improvements that were similar to those achieved by usual care stroke rehabilitation, safely delivered by either a physical therapist or a rehabilitation assistant.

A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study.

Science.gov (United States)

Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Hain, Bernhard; Mack, Isabelle; Schellberg, Dieter; Müller-Stich, Beat Peter; Weiner, Rudolf; Meile, Tobias; Rudofsky, Gottfried; Königsrainer, Alfred; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

2015-01-01

For severely obese patients, bariatric surgery has been recommended as an effective therapy. The Bariataric Surgery and Education (BaSE) study aimed to assess the efficacy of a videoconferencing-based psychoeducational group intervention in patients after bariatric surgery. The BaSE study is a randomized, controlled multicenter clinical trial involving 117 patients undergoing bariatric surgery (mean preoperative body mass index [BMI] 49.9 kg/m(2), SD 6.4). Patients were enrolled between May 2009 and November 2012 and were randomly assigned to receive either conventional postsurgical visits or, in addition, a videoconferencing-based 1-year group program. Primary outcome measures were weight in kilograms, health-related quality of life (HRQOL), and general self-efficacy (GSE). Secondary outcome measures were depression symptoms and eating behavior. 94% of the patients completed the study. Mean weight loss for all patients was 45.9 kg (SD 16.4) 1 year after surgery (mean excess weight loss [EWL] 63%). Intention-to-treat analyses revealed no differences in weight loss, EWL, HRQOL, or self-efficacy between study groups at 1 year after surgery. However, patients with clinically significant depression symptoms (CSD) at baseline assigned to the intervention group (n = 29) had a significantly better HRQOL (P = .03), lower depression scores (P = .02), and a trend for a better EWL (.06) 1 year after surgery compared with the control group (n = 20). We could not prove the efficacy of the group program for the whole study sample. However, results indicate that the intervention is effective for the important subgroup of patients with CSD. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial

Science.gov (United States)

2014-01-01

Background Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Methods Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. Results We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Conclusions Recruitment and retention of participants to a definitive trial with a

Group based prenatal care in a low-and high risk population in the Netherlands: a study protocol for a stepped wedge cluster randomized controlled trial.

Science.gov (United States)

van Zwicht, Birgit S; Crone, Matty R; van Lith, Jan M M; Rijnders, Marlies E B

2016-11-15

CenteringPregnancy (CP) is a multifaceted group based care-model integrated in routine prenatal care, combining health assessment, education, and support. CP has shown some positive results on perinatal outcomes. However, the effects are less obvious when limited to the results of randomized controlled trials: as there are few trials and there is a variation in reported outcomes. Furthermore, former research was mostly conducted in the United States of America and in specific (often high risk) populations. Our study aims to evaluate the effects of CP in the Netherlands in a general population of pregnant women (low and high risk). Furthermore we aim to explore the mechanisms leading to the eventual effects by measuring potential mediating factors. We will perform a stepped wedge cluster randomized controlled trial, in a Western region in the Netherlands. Inclusion criteria are care, women in the intervention period (starting at the randomized time-point) will be offered the choice between individual care or CP. Primary outcomes are maternal and neonatal morbidity, retrieved from a national routine database. Secondary outcomes are health behavior, psychosocial outcomes, satisfaction, health care utilization and process outcomes, collected through self-administered questionnaires, group-evaluations and individual interviews. We will conduct intention-to-treat analyses. Also a per protocol analysis will be performed comparing the three subgroups: control group, CP-participants and non-CP-participants, using multilevel techniques to account for clustering effects. This study contributes to the evidence regarding the effect of CP and gives a first indication of the effect and implementation of CP in both low and high-risk pregnancies in a high-income Western society other than the USA. Also, measuring factors that are hypothesized to mediate the effect of CP will enable to explain the mechanisms that lead to effects on maternal and neonatal outcomes. Dutch Trial

Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management

DEFF Research Database (Denmark)

Gottrup, F; Apelqvist, J; Price, P

2010-01-01

was to produce recommendations on clinical data collection in wound care. This document, produced by the group and disseminated by JWC, identifies criteria for producing rigorous outcomes in both randomised controlled trials and clinical studies, and describes how to ensure studies are consistent...

Outcomes of Children With and Without Hepatic Encephalopathy From the Pediatric Acute Liver Failure Study Group.

Science.gov (United States)

Ng, Vicky L; Li, Ruosha; Loomes, Kathleen M; Leonis, Mike A; Rudnick, David A; Belle, Steven H; Squires, Robert H

2016-09-01

Hepatic encephalopathy (HE) is challenging to identify in children with acute liver failure and was not a requirement for enrollment into the Pediatric Acute Liver Failure Study Group (PALFSG). The outcomes of PALFSG participants presenting with and without HE are presented. PALFSG participants were classified based on daily assessment of HE during the first 7 days following study enrollment: group 1-never developed HE; group 2-no HE at enrollment with subsequent HE development; and group 3-HE at study enrollment. Clinical and biochemical parameters and outcomes of death, spontaneous recovery, or liver transplantation were compared between groups. Data from 769 PALFSG (54% boys; median age 4.2 years; range 0-17.9 years) participants were analyzed, with 277 in group 1 (36%), 83 in group 2 (11%), and 409 in group 3 (53%). Mortality occurred in 11% of all participants and was highest among group 3 participants who demonstrated persistent grade III-IV HE (55%) or showed progression of HE (26%). Eleven (4%) group 1 participants died within 21 days of enrollment. Spontaneous recovery was highest in group 1 (79%) and lowest in group 2 (25%; P liver failure prognostication schema are needed.

Effect of laser-assisted zona thinning, during assisted reproduction, on pregnancy outcome in women with endometriosis: randomized controlled trial.

Science.gov (United States)

Nada, Adel Mohamed; El-Noury, Amr; Al-Inany, Hesham; Bibars, Mamdouh; Taha, Tamer; Salama, Sameh; Hassan, Fatma; Zein, Eman

2018-02-01

To compare the ICSI-ET outcomes in patients with endometriosis with or without laser-assisted zona pellucida thinning. Randomized controlled trial. The study was conducted in the Obstetrics & Gynecology Department, Cairo University hospital, and two private IVF centers in Cairo & Beni-Suif from July 2015 to January 2017 upon infertile and known endometriosis patients who planned to do ICSI-ET. Before randomization, all patients received the same ovarian stimulation preparation, oocyte retrieval procedures, and the same intracytoplasmic sperm injection procedures. After randomization, laser-assisted hatching was performed only for embryos of 158 patients, while the other group (n = 150) no laser-assisted hatching was made. The verification of pregnancy was achieved by the serum hCG concentration 14 days after the embryo transfer, and the clinical pregnancy was confirmed 2 weeks later by the presence of gestational sac with pulsating fetal pole on vaginal ultrasonography. The main outcome measures were the clinical pregnancy rate and the clinical implantation rate. Both groups were comparable with regard their baseline characteristics, baseline hormonal profile, the ovarian stimulation characteristics, and the ovulation characteristics. The mean number of embryos developed per patient and the mean transferred number of embryos per patient were comparable between groups (p value > 0.05). The implantation rate was significantly higher (p value 0.002) in the study group than the control group with an odds ratio of 1.86 (CI 95% 1.24-2.80) and NNT 13.81 (CI 95% 8.35-39.94). The clinical pregnancy rate, was significantly (p value 0.022) higher in the study group than in the control group with an odds ratio of 1.79 (CI 95% 1.05-3.06) and NNT 9.57 (CI 95% 5.03-98.99). That laser-assisted hatching by thinning of the zona pellucida may be a suitable method to improve the ICSI-ET outcomes, in term of the implantation and the pregnancy rates, in cases of endometriosis. Pan

A controller for controlling a group of lighting devices and a method thereof

NARCIS (Netherlands)

2017-01-01

A controller (100) for controlling a group (110) of lighting devices (112, 114) is disclosed. The group (110) comprises a first lighting device (112) and a second lighting device (114). The controller (100) comprises a communication unit (102) for communicating with the first and second lighting

Late outcome of a controlled trial of enalapril treatment in progressive chronic renal failure. Hard end-points and influence of proteinuria

DEFF Research Database (Denmark)

Kamper, A L; Strandgaard, S; Leyssac, P P

1995-01-01

An earlier controlled trial showed that over an average of 26 months, enalapril slowed the progression of chronic renal failure. Following completion of the trial, the patients continued to receive antihypertensive treatment according to ordinary clinical criteria. All but four patients...... end-stage renal failure (ESRF) (P renal outcome groups. In all patients, baseline Calb and CIgG were negatively correlated with the rate of change in GFR during the controlled trial (r = -0.37, P .... In the original enalapril group, 12 of the 35 patients (34%) were alive without renal replacement therapy versus five of the 35 patients (14%) in the control group. This difference of 20% in favour of having been in the enalapril group in the original trial was significant (P = 0.05; 95% confidence limits 0...

Group antenatal intervention to reduce perinatal stress and depressive symptoms related to intergenerational conflicts: a randomized controlled trial.

Science.gov (United States)

Leung, Sharron S K; Lam, T H

2012-11-01

Intergenerational conflicts are a major source of stress, which might lead to depression in new mothers. The conflict is heightened when grandparents are involved in childcare. To examine the effectiveness of an interpersonal psychotherapy oriented group intervention to reduce stress and depressive symptoms in new mothers and enhance happiness and self-efficacy in managing intergenerational conflict in childcare. This study is one of the intervention projects of FAMILY: A Jockey Club Initiative for a Harmonious Society, funded by The Hong Kong Jockey Club Charities Trust. Multisite randomized controlled trial with two arms: an intervention group attended an additional 4-week program and a control group who received usual care only. Six Maternal and Child Health Centres in Hong Kong From September 2009 to January 2010, 156 pregnant women who would have grandparents involved in childcare were recruited at their 14-32 weeks' gestation. Participants were randomized to groups using computer generated random sequences by blinded recruitment staff. Primary outcomes were stress and depressive symptoms immediately after the intervention and 6-8 weeks after delivery. Secondary outcomes were happiness and self-efficacy in managing conflict. After screening 2870 pregnant women, 156 eligible participants were randomized. Intention-to-treat analysis showed that the intervention group (n=78) had significantly lower perceived stress (p=0.017; Cohen d=0.38) and greater happiness (p=0.004; Cohen d=0.41) than the control group (n=78) immediately after the intervention. However, the effects were not sustained at postnatal follow-up. Subgroup analysis showed that participants with depressive symptoms (EPDS>12) at baseline reported significantly lower stress, greater happiness (p=0.035 and 0.037, respectively; both Cohen d=0.61), greater self-efficacy in managing conflict (p=0.012; Cohen d=0.76) than the control group after the intervention. Also, after delivery, they had significantly

Synthesis of Control Algorithm for a Leaderheaded UAVs Group

Directory of Open Access Journals (Sweden)

I. O. Samodov

2015-01-01

Full Text Available Currently, a defense sphere uses unmanned aerial vehicles (UAVs. UAVs have several advantages over manned aircrafts such as small size, reduced combat losses of personnel, etc. In addition, in threat environment, it is necessary to arrange both bringing together distant from each other UAVs in a group and their undetected in radar fields compact flying in terms of the joint flight security.However, the task to control a UAVs group is much more difficult than to control a single UAV, since it is necessary not only to control the aircraft, but also take into account the relative position of objects in the group.To solve this problem two ways are possible: using a network exchange between members of the group on the "everyone with everyone" principle and organizing the leader-headed flight.The aim of the article is to develop and study a possible option of the UAVs group control with arranging a leader-headed flight to provide the undetected in radar fields compact flying in terms of the joint flight security.The article develops a universal algorithm to control leader-headed group, based on a new modification of the statistical theory of optimal control. It studies effectiveness of the algorithm. While solving this task, a flight of seven UAVs was simulated in the horizontal plane in a rectangular coordinate system. Control time, linear errors of desired alignment of UAV, and control errors with respect to angular coordinates are used as measures of merit.The study results of the algorithm to control a leader-headed group of UAVs confirmed that it is possible to fulfill tasks of flying free-of-collision group of UAVs with essentially reduced computational costs.

The effect of a health promotion intervention for construction workers on work-related outcomes: results from a randomized controlled trial.

Science.gov (United States)

Viester, Laura; Verhagen, Evert A L M; Bongers, Paulien M; van der Beek, Allard J

2015-08-01

The objective of the present study is to investigate the effects of a worksite health promotion intervention on musculoskeletal symptoms, physical functioning, work ability, work-related vitality, work performance, and sickness absence. In a randomized controlled design, 314 construction workers were randomized into an intervention group (n = 162) receiving personal coaching, tailored information, and materials, and a control group (n = 152) receiving usual care. Sickness absence was recorded continuously in company records, and questionnaires were completed before, directly after the 6-month intervention period, and 12 months after baseline measurements. Linear and logistic regression analyses were performed to determine intervention effects. No significant changes at 6 or 12 months of follow-up were observed in musculoskeletal symptoms, physical functioning, work ability, work-related vitality, work performance, and sickness absence as a result of the intervention. This study shows that the intervention was not statistically significantly effective on secondary outcomes. Although the intervention improved physical activity, dietary, and weight-related outcomes, it was not successful in decreasing musculoskeletal symptoms and improving other work-related measures. Presumably, more multifaceted interventions are required to establish significant change in these outcomes.

A method to assess obstetric outcomes using the 10-Group Classification System: a quantitative descriptive study.

LENUS (Irish Health Repository)

Rossen, Janne

2017-01-01

Internationally, the 10-Group Classification System (TGCS) has been used to report caesarean section rates, but analysis of other outcomes is also recommended. We now aim to present the TGCS as a method to assess outcomes of labour and delivery using routine collection of perinatal information.

An interactive health communication application for supporting parents managing childhood long-term conditions: outcomes of a randomized controlled feasibility trial.

Science.gov (United States)

Swallow, Veronica M; Knafl, Kathleen; Santacroce, Sheila; Campbell, Malcolm; Hall, Andrew G; Smith, Trish; Carolan, Ian

2014-12-03

Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents' management ability-the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers' involvement between groups. We recruited 55 parents of 39 children (42% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73%) and control group parents (22/29, 76%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks

A Systematic Review of Group Social Skills Interventions, and Meta-analysis of Outcomes, for Children with High Functioning ASD.

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Wolstencroft, J; Robinson, L; Srinivasan, R; Kerry, E; Mandy, W; Skuse, D

2018-07-01

Group social skills interventions (GSSIs) are a commonly offered treatment for children with high functioning ASD. We critically evaluated GSSI randomised controlled trials for those aged 6-25 years. Our meta-analysis of outcomes emphasised internal validity, thus was restricted to trials that used the parent-report social responsiveness scale (SRS) or the social skills rating system (SSRS). Large positive effect sizes were found for the SRS total score, plus the social communication and restricted interests and repetitive behaviours subscales. The SSRS social skills subscale improved with moderate effect size. Moderator analysis of the SRS showed that GSSIs that include parent-groups, and are of greater duration or intensity, obtained larger effect sizes. We recommend future trials distinguish gains in children's social knowledge from social performance.

E-mail support as an adjunct to cognitive-behavioral group therapy for social anxiety disorder: Impact on dropout and outcome

OpenAIRE

Delsignore, Aba; Rufer, Michael; Emmerich, Juliane; Weidt, Steffi; Brühl, Annette Beatrix; Moergeli, Hanspeter

2016-01-01

The present study evaluates the impact of semi-individualized e-mail support as an adjunct to cognitive behavioral group therapy (CBGT) for social anxiety disorder (SAD) on dropout and outcome. The effectiveness of additional semi-individualized e-mail support was evaluated for the whole sample and for a subsample of patients at risk of dropping out of therapy. A total of 91 patients with SAD were allocated either to the intervention condition (CBGT with e-mail support), or to the control con...

Expressive writing intervention and self-reported physical health out-comes – Results from a nationwide randomized controlled trial with breast cancer patients

Science.gov (United States)

Jensen-Johansen, Mikael B.; Christensen, Søren; Valdimarsdottir, Heiddis; Zakowski, Sandra; Bovbjerg, Dana H.; Jensen, Anders B.; Zachariae, Robert

2018-01-01

The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related to emotion regulation as possible moderators of the effect. Women who had recently completed treatment for primary breast cancer (n = 507) were randomly assigned to three 20 min. home-based writing exercises, one week apart, focusing on emotional disclosure (EWI) of a distressing experience (their cancer or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about their own cancer, but not women writing about other topics, showed a larger decrease than controls. The results from this large randomized trial are concordant with previous findings showing that EWI is unlikely to be a generally applicable intervention to improve health-related outcomes in cancer patients and cancer survivors. However, written disclosure might have a beneficial impact for individuals who write about their own cancer, as well as for those low in alexithymia. PMID:29474441

Reducing Postpartum Weight Retention and Improving Breastfeeding Outcomes in Overweight Women: A Pilot Randomised Controlled Trial

Directory of Open Access Journals (Sweden)

Julia Martin

2015-02-01

Full Text Available Overweight and obesity is prevalent among women of reproductive age (42% BMI > 25 kg/m2 and parity is associated with risk of weight gain. Weight gain greater than that recommended by the Institute of Medicine (IOM is also associated with lower rates of breastfeeding initiation and duration in women. The aim of this pilot randomised controlled trial is to examine the feasibility of recruiting and maintaining a cohort of pregnant women with the view of reducing postpartum weight retention and improving breastfeeding outcomes. Women (BMI of 25–35 kg/m2 (n = 36 were recruited from the John Hunter Hospital antenatal clinic in New South Wales, Australia. Participants were stratified by BMI and randomised to one of three groups with follow-up to six months postpartum. Women received a dietary intervention with or without breastfeeding support from a lactation consultant, or were assigned to a wait-list control group where the dietary intervention was issued at three months postpartum. Feasibility and acceptability was assessed by participation rates and questionnaire. Analysis of variance and covariance was conducted to determine any differences between groups. Sixty-nine per cent of the participants were still enrolled at six months postpartum. This pilot demonstrated some difficulties in recruiting women from antenatal clinics and retaining them in the trial. Although underpowered; the results on weight; biomarkers and breastfeeding outcomes indicated improved metabolic health.

Comment on "Compromised birth outcomes and infant mortality among racial and ethnic groups"

NARCIS (Netherlands)

Van der Veen, WJ

Frisbie, Forbes, and Pullum (1996) show that it is meaningful to account for low birth weight, preterm delivery, and intrauterine growth-retardation when analyzing differences in compromised birth outcomes and infant mortality among racial and ethnic groups. I compare their findings for the 1987

Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial.

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Wells, Adrian; McNicol, Kirsten; Reeves, David; Salmon, Peter; Davies, Linda; Heagerty, Anthony; Doherty, Patrick; McPhillips, Rebecca; Anderson, Rebecca; Faija, Cintia; Capobianco, Lora; Morley, Helen; Gaffney, Hannah; Shields, Gemma; Fisher, Peter

2018-04-03

Anxiety and depression are prevalent among cardiac rehabilitation patients but pharmacological and psychological treatments have limited effectiveness in this group. Furthermore, psychological interventions have not been systematically integrated into cardiac rehabilitation services despite being a strategic priority for the UK National Health Service. A promising new treatment, metacognitive therapy, may be well-suited to the needs of cardiac rehabilitation patients and has the potential to improve outcomes. It is based on the metacognitive model, which proposes that a thinking style dominated by rumination, worry and threat monitoring maintains emotional distress. Metacognitive therapy is highly effective at reducing this thinking style and alleviating anxiety and depression in mental health settings. This trial aims to evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy for cardiac rehabilitation patients with elevated anxiety and/or depressive symptoms. The PATHWAY Group-MCT trial is a multicentre, two-arm, single-blind, randomised controlled trial comparing the clinical- and cost-effectiveness of group-based metacognitive therapy plus usual cardiac rehabilitation to usual cardiac rehabilitation alone. Cardiac rehabilitation patients (target sample n = 332) with elevated anxiety and/or depressive symptoms will be recruited across five UK National Health Service Trusts. Participants randomised to the intervention arm will receive six weekly sessions of group-based metacognitive therapy delivered by either cardiac rehabilitation professionals or research nurses. The intervention and control groups will both be offered the usual cardiac rehabilitation programme within their Trust. The primary outcome is severity of anxiety and depressive symptoms at 4-month follow-up measured by the Hospital Anxiety and Depression Scale total score. Secondary outcomes are severity of anxiety/depression at 12-month follow-up, health

The impact of web-based HOT (Healthy Outcomes for Teens) Project on risk for type 2 diabetes: a randomized controlled trial.

Science.gov (United States)

Muzaffar, Henna; Castelli, Darla M; Scherer, Jane; Chapman-Novakofski, Karen

2014-12-01

The HOT (Healthy Outcome for Teens) Project is an innovative online educational intervention for middle school children for prevention of diabetes and obesity by balancing food intake with physical activity. The objective was to improve knowledge, outcome expectations, self-efficacy, and self-reported food intake and skills and to compare a passive online learning (POL) control group with an active online learning (AOL) treatment group by implementing a social cognitive theory (SCT)-grounded online intervention. In total, 214 participants were recruited from three middle schools. Full data were secured for 181 students. Six valid, reliable questionnaires were administered online, pre/post, to both the AOL and POL groups to assess knowledge gain, self-reported intake, and meal planning skills, as well as change in SCT constructs. Subjects in the AOL group improved significantly for all five categories of planning a meal questionnaire (P=0.001) and also for outcome expectations for exercise (P=0.001). At postintervention, no significant differences were found for composite scores of exercise self-efficacy, weight efficacy lifestyle, and rapid eating assessment plan questionnaires between AOL versus POL (by Mann-Whitney test). We conclude that teens participating in the AOL version of the HOT Project intervention acquired skills for planning a meal and improved outcome expectations for exercise.

The efficacy of a group Cognitive Behavioural Therapy for war-affected young migrants living in Australia: A cluster randomised controlled trial

Directory of Open Access Journals (Sweden)

Chew Sia Ooi

2016-10-01

Full Text Available BackgroundPreventative and treatment programmes for people at risk of developing psychological problems after exposure to war trauma have mushroomed in the last decade. However, there is still much contention about evidence-based and culturally sensitive interventions for children. The aim of this study was to examine the efficacy of the Teaching Recovery Techniques in improving the emotional and behavioural outcomes of war-affected children resettled in Australia. Methods and findings A cluster randomised controlled trial with pretest, posttest, and 3-month follow-up design was employed. A total of 82 participants (aged 10 to 17 years were randomised by school into the 8-week intervention (n = 45 or the waiting list (WL control condition (n = 37. Study outcomes included symptoms of posttraumatic stress disorder, depression, internalising and externalising problems, as well as psychosocial functioning. A medium intervention effect was found for depression symptoms. Participants in the intervention condition experienced a greater symptom reduction than participants in the WL control condition, F(1,155 = 5.20, p = .024, partial ƞ2 = 0.07. This improvement was maintained at the 3-month follow-up, F(2,122 = 7.24, p = .001, partial ƞ2 = 0.20. ConclusionsThese findings suggest the potential benefit of the school and group-based intervention on depression symptoms but not on other outcomes, when compared to a waiting list control group.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12611000948998

Modelling variable dropout in randomised controlled trials with longitudinal outcomes: application to the MAGNETIC study.

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Kolamunnage-Dona, Ruwanthi; Powell, Colin; Williamson, Paula Ruth

2016-04-28

Clinical trials with longitudinally measured outcomes are often plagued by missing data due to patients withdrawing or dropping out from the trial before completing the measurement schedule. The reasons for dropout are sometimes clearly known and recorded during the trial, but in many instances these reasons are unknown or unclear. Often such reasons for dropout are non-ignorable. However, the standard methods for analysing longitudinal outcome data assume that missingness is non-informative and ignore the reasons for dropout, which could result in a biased comparison between the treatment groups. In this article, as a post hoc analysis, we explore the impact of informative dropout due to competing reasons on the evaluation of treatment effect in the MAGNETIC trial, the largest randomised placebo-controlled study to date comparing the addition of nebulised magnesium sulphate to standard treatment in acute severe asthma in children. We jointly model longitudinal outcome and informative dropout process to incorporate the information regarding the reasons for dropout by treatment group. The effect of nebulised magnesium sulphate compared with standard treatment is evaluated more accurately using a joint longitudinal-competing risk model by taking account of such complexities. The corresponding estimates indicate that the rate of dropout due to good prognosis is about twice as high in the magnesium group compared with standard treatment. We emphasise the importance of identifying reasons for dropout and undertaking an appropriate statistical analysis accounting for such dropout. The joint modelling approach accounting for competing reasons for dropout is proposed as a general approach for evaluating the sensitivity of conclusions to assumptions regarding missing data in clinical trials with longitudinal outcomes. EudraCT number 2007-006227-12 . Registration date 18 Mar 2008.

Outcomes and lessons from a pilot RCT of a community-based HIV prevention multi-session group intervention for gay men.

Science.gov (United States)

Harding, R; Bensley, J; Corrigan, N; Franks, L; Stratman, J; Waller, Z; Warner, J

2004-07-01

This paper presents the first outcome evaluation of multi-session groupwork for HIV prevention among gay men in the UK. This community-based RCT recruited 50 men, of whom 42% were HIV-positive or untested, and 32% reported status unknown or serodiscordant UAI in the previous 12 months. No knowledge, skills, attitudinal or behavioural differences were detected between intervention and control at baseline. At eight weeks, those attending the group reported significant gains over their control in making sexual choices, physical safety, HIV and STI transmission knowledge, and sexual negotiation skills. At 20 weeks, significant differences remained for HIV and STI transmission knowledge and comfort with sexual choices. Although no behavioural differences were detected, the aims of the National Prevention Strategy were met. This pilot RCT is appraised in the light of modest sample size and attrition, and recommendations for establishing behavioural outcomes are presented. This study has demonstrated that high-risk community samples can be recruited to multi-session interventions, and has provided feasibility data for future rigorous evaluation designs.

Developmental outcome of the use of etamsylate for prevention of periventricular haemorrhage in a randomised controlled trial.

Science.gov (United States)

Schulte, J; Osborne, J; Benson, J W T; Cooke, R; Drayton, M; Murphy, J; Rennie, J; Speidel, B

2005-01-01

To compare neurodevelopmental outcome of survivors of the multicentre trial of etamsylate (the iRNN for ethamsylate) for prevention of periventricular haemorrhage in very low birthweight infants. Double blind, single observer, prospective follow up of placebo controlled study. Six neonatal intensive care units in the United Kingdom. Neurodevelopmental outcome was assessed in health premises or children's homes. 268 of 276 survivors of the original study were seen between 3.5 and 4.2 years of age. All were inborn and weighed 1500 g or less at birth. Etamsylate 12.5 mg/kg or placebo six hourly from within one hour of delivery for four days. McCarthy scales of children's abilities, standardised neurological examination, full physical examination, functional assessment, seven letter Stycar vision test, and audiometry. There was no difference between the groups in neuromotor outcome (cerebral palsy) or in the general cognitive index (GCI) of the McCarthy scales (mean GCI was 93.3 for the etamsylate group (n = 133) and 89.7 for the placebo group (n = 131); p = 0.10). There were more children with GCI < 70 (9 v 19; p = 0.047) or group. Fewer children in the etamsylate group had squints (17 v 30; p = 0.042) or required surgery for patent ductus arteriosus (1 v 8; p = 0.036). Etamsylate was not associated with a reduction in cerebral palsy. Severe cognitive impairment was reduced, but more children died and the improvement may be because fewer survived with low GCI.

An Online Intervention for Co-Occurring Depression and Problematic Alcohol Use in Young People: Primary Outcomes From a Randomized Controlled Trial.

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Deady, Mark; Mills, Katherine L; Teesson, Maree; Kay-Lambkin, Frances

2016-03-23

Depression and problematic alcohol use represent two of the major causes of disease burden in young adults. These conditions frequently co-occur and this is associated with increased harm and poorer outcomes than either disorder in isolation. Integrated treatments have been shown to be effective; however, there remains a significant gap between those in need of treatment and those receiving it. The increased availability of eHealth programs presents a unique opportunity to treat these conditions. This study aimed to evaluate the feasibility and preliminary efficacy of an automated Web-based self-help intervention (DEAL Project) in treating co-occurring depressive symptoms and problematic alcohol use in young people. Young people (aged 18 to 25 years) with moderate depression symptoms and drinking at hazardous levels (recruited largely via social media) were randomly allocated to the DEAL Project (n=60) or a Web-based attention-control condition (HealthWatch; n=44). The trial consisted of a 4-week intervention phase with follow-up assessment at posttreatment and at 3 and 6 months postbaseline. The primary outcomes were change in depression severity according to the Patient Health Questionnaire-9 as well as quantity and frequency of alcohol use (TOT-AL). The DEAL Project was associated with statistically significant improvement in depression symptom severity (d=0.71) and reductions in alcohol use quantity (d=0.99) and frequency (d=0.76) in the short term compared to the control group. At 6-month follow-up, the improvements in the intervention group were maintained; however, the differences between the intervention and control groups were no longer statistically significant, such that between-group effects were in the small to moderate range at 6 months (depression symptoms: d=0.39; alcohol quantity: d=-0.09; alcohol frequency: d=0.24). Overall, the DEAL Project was associated with more rapid improvement in both depression symptoms and alcohol use outcomes in young

Mobile Health (mHealth) Versus Clinic-Based Group Intervention for People With Serious Mental Illness: A Randomized Controlled Trial.

Science.gov (United States)

Ben-Zeev, Dror; Brian, Rachel M; Jonathan, Geneva; Razzano, Lisa; Pashka, Nicole; Carpenter-Song, Elizabeth; Drake, Robert E; Scherer, Emily A

2018-05-25

mHealth approaches that use mobile phones to deliver interventions can help improve access to care for people with serious mental illness. The goal was to evaluate how mHealth performs against more traditional treatment. A three-month randomized controlled trial was conducted of a smartphone-delivered intervention (FOCUS) versus a clinic-based group intervention (Wellness Recovery Action Plan [WRAP]). Participants were 163 clients, mostly from racial minority groups and with long-term, serious mental illness (schizophrenia or schizoaffective disorder, 49%; bipolar disorder, 28%; and major depressive disorder, 23%). Outcomes were engagement throughout the intervention; satisfaction posttreatment (three months); and improvement in clinical symptoms, recovery, and quality of life (assessed at baseline, posttreatment, and six months). Participants assigned to FOCUS were more likely than those assigned to WRAP to commence treatment (90% versus 58%) and remain fully engaged in eight weeks of care (56% versus 40%). Satisfaction ratings were comparably high for both interventions. Participants in both groups improved significantly and did not differ in clinical outcomes, including general psychopathology and depression. Significant improvements in recovery were seen for the WRAP group posttreatment, and significant improvements in recovery and quality of life were seen for the FOCUS group at six months. Both interventions produced significant gains among clients with serious and persistent mental illnesses who were mostly from racial minority groups. The mHealth intervention showed superior patient engagement and produced patient satisfaction and clinical and recovery outcomes that were comparable to those from a widely used clinic-based group intervention for illness management.

Treatment outcomes and dental anxiety in 18-year-olds with MIH, comparisons with healthy controls - a longitudinal study.

Science.gov (United States)

Jälevik, Birgitta; Klingberg, Gunilla

2012-03-01

In a previous study, 9-year-old children with severe Molar Incisor Hypomineralization (MIH) had undergone dental treatment of their first molars nearly ten times as often as children in a control group. They also showed more management problems (BMP) and fear and anxiety (DFA). To assess the long-term outcomes of dental treatments, dental anxiety, and patients' satisfaction in adolescents with MIH. Sixty-seven patients, identical with those in the baseline study, were studied at age 18-years. The participants answered the Children's Fear Survey Schedule - Dental Subscale the Dental Visit Satisfaction Scale (DVSS). Data were compiled from the dental records concerning dental health, number of restorative treatments and BMP. Molar Incisor Hypomineralization group had a significantly higher DMFT, and had undergone treatment of their permanent first molars 4.2 times as often as the controls. BMP was still significantly more common in the MIH group. However, DFS was reduced in MIH group and increased in the control groups. The DVSS scores did not differ between the groups. Conclusions.  Patients with severe MIH had a poorer dental health and were still more treatment consuming at age 18-years. However, their dental fear was now at the same level as the controls. © 2011 The Authors. International Journal of Paediatric Dentistry © 2011 BSPD, IAPD and Blackwell Publishing Ltd.

Effects of aerobic exercise training on maternal and neonatal outcome: a randomized controlled trial on pregnant women in Iran

International Nuclear Information System (INIS)

Ghodsi, Z.; Asltoghiri, M.

2014-01-01

Objective: To assess the effect of aerobic exercise training on maternal and neonatal outcome. Methods: The case-control study was conducted between January and July, 2011. It was approved by the Research Ethics Committee of Toyserkan Azad University, and data was collected at prenatal clinics and delivery centres located in Hamedan, Iran. It comprised 80 pregnant women between 20-26 weeks of gestation randomly assigned to two equal and matching groups of cases and controls. The intervention group did exercise continuously on a bicycle ergometre for 15 minutes, three times a week; the intensity being 50-60% of maximal heart rate. The control group did not do any exercise training. All information was obtained from the clinics, delivery centres, and from the reports of delivery room midwives. Results: No statistically significant difference was found between the two groups in gestational weight gain, pregnancy length, mode of delivery, first and second stage of labour, perineal tear, and 1st and 5th min Apgar score. Mean neonatal weight was significantly less in the intervention group than the control group (p<0.001). Conclusion: Exercising on a bicycle ergometer during pregnancy seems to be safe for the mother and the neonate. (author)

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

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Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

2015-07-01

Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

The Impact of Group Design Projects in Engineering on Achievement Goal Orientations and Academic Outcomes

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Rambo-Hernandez, Karen E.; Atadero, Rebecca A.; Balgopal, Meena

2017-01-01

This study examined the impact of incorporating group design projects into a second-year engineering class on achievement goal orientations and two academic outcomes: concept inventory and final exam scores. In this study, two sections were taught using lecture format, but one section also completed three group design projects as part of their…

Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

Science.gov (United States)

Wang, Sophia; Hammes, Jessica; Khan, Sikandar; Gao, Sujuan; Harrawood, Amanda; Martinez, Stephanie; Moser, Lyndsi; Perkins, Anthony; Unverzagt, Frederick W; Clark, Daniel O; Boustani, Malaz; Khan, Babar

2018-03-27

Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms

A controller for controlling a group of lighting devices and a method thereof

OpenAIRE

2017-01-01

A controller (100) for controlling a group (110) of lighting devices (112, 114) is disclosed. The group (110) comprises a first lighting device (112) and a second lighting device (114). The controller (100) comprises a communication unit (102) for communicating with the first and second lighting devices (112, 114), and for receiving a first current light setting of the first lighting device (112) and a second current light setting of the second lighting device (114). The controller (100) furt...

Effectiveness of the 'Home-but not Alone' mobile health application educational programme on parental outcomes: a randomized controlled trial, study protocol.

Science.gov (United States)

Shorey, Shefaly; Ng, Yvonne Peng Mei; Danbjørg, Dorthe Boe; Dennis, Cindy-Lee; Morelius, Evalotte

2017-01-01

The aim of this study was to describe a study protocol that evaluates the effectiveness of the 'Home-but not Alone' educational programme delivered via a mobile health application in improving parenting outcomes. The development in mobile-based technology gives us the opportunity to develop an accessible educational programme that can be potentially beneficial to new parents. However, there is a scarcity of theory-based educational programmes that have incorporated technology such as a mobile health application in the early postpartum period. A randomized controlled trial with a two-group pre-test and post-test design. The data will be collected from 118 couples. Eligible parents will be randomly allocated to either a control group (receiving routine care) or an intervention group (routine care plus access to the 'Home-but not Alone' mobile health application. Outcome measures comprise of parenting self-efficacy, social support, parenting satisfaction and postnatal depression. Data will be collected at the baseline (on the day of discharge) and at four weeks postpartum. This will be an empirical study that evaluates a theory-based educational programme delivered via an innovative mobile health application on parental outcomes. Results from this study will enhance parenting self-efficacy, social support and parenting satisfaction, which may then reduce parental risks of postnatal depression. © 2016 John Wiley & Sons Ltd.

Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

Directory of Open Access Journals (Sweden)

Andrzej Kotela

2015-01-01

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.

Who benefits? Outcome following a coping skills group intervention for traumatically brain injured individuals.

Science.gov (United States)

Anson, Katie; Ponsford, Jennie

2006-01-01

To investigate the variables associated with positive psychological outcome following a group intervention for 33 individuals with traumatic brain injury. Evaluation study which used multiple regression analysis to examine the variables associated with change in psychological adjustment following a 10-session cognitive behaviour therapy-based group. The predictor variables were age at injury, time since injury, injury severity, self-awareness, pre-morbid intellectual function, memory function, executive function and level of depression and anxiety prior to intervention. The predictor variables contributed a significant proportion of the variance in percentage change in depression. The major finding was that better outcomes following intervention were associated with greater self-awareness of injury-related deficits. The present study identified a number of variables that were associated with improvement in depression following psychological intervention and may assist future treatment resources to be directed most effectively.

Antenatal psychosomatic programming to reduce postpartum depression risk and improve childbirth outcomes: a randomized controlled trial in Spain and France.

Science.gov (United States)

Ortiz Collado, Maria Assumpta; Saez, Marc; Favrod, Jérôme; Hatem, Marie

2014-01-15

Postpartum depression (PPD) and poor childbirth outcomes are associated with poverty; these variables should be addressed by an adapted approach. The aim of this research was to evaluate the impact of an antenatal programme based on a novel psychosomatic approach to pregnancy and delivery, regarding the risk of PPD and childbirth outcomes in disadvantaged women. A multi-centre, randomized, controlled trial comparing a novel to standard antenatal programme. Primary outcome was depressive symptoms (using EPDS) and secondary outcome was preterm childbirth (fewer 37 weeks). The sample comprised 184 couples in which the women were identified to be at PPD risk by validated interview. The study was conducted in three public hospitals with comparable standards of perinatal care. Women were randomly distributed in to an experimental group (EG) or a control group (CG), and evaluated twice: during pregnancy (T1) and four weeks post-partum (T2). At T2, the variables were compared using the chi square test. Data analysis was based on intention to treat. The novel programme used the Tourné psychosomatic approach focusing on body awareness sensations, construction of an individualized childbirth model, and attachment. The 10 group antenatal sessions each lasted two hours, with one telephone conversation between sessions. In the control group, the participants choose the standard model of antenatal education, i.e., 8 to 10 two-hour sessions focused on childbirth by obstetrical prophylaxis. A difference of 11.2% was noted in postpartum percentages of PPD risk (EPDS ≥ 12): 34.3% (24) in EG and 45.5% (27) in CG (p = 0.26). The number of depressive symptoms among EG women decreased at T2 (intragroup p = 0.01). Premature childbirth was four times less in EG women: three (4.4%) compared to 13 (22.4%) among CG women (p = 0.003). Birth weight was higher in EG women (p = 0.01). The decrease of depressive symptoms in women was not conclusive. However, because birth weight was higher and

Supratentorial Ependymoma: Disease Control, Complications, and Functional Outcomes After Irradiation

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Landau, Efrat; Boop, Frederick A.; Conklin, Heather M.; Wu, Shengjie; Xiong, Xiaoping; Merchant, Thomas E.

2013-01-01

Purpose: Ependymoma is less commonly found in the supratentorial brain and has known clinical and molecular features that are unique. Our single-institution series provides valuable information about disease control for supratentorial ependymoma and the complications of supratentorial irradiation in children. Methods and Materials: A total of 50 children with newly diagnosed supratentorial ependymoma were treated with adjuvant radiation therapy (RT); conformal methods were used in 36 after 1996. The median age at RT was 6.5 years (range, 1-18.9 years). The entire group was characterized according to sex (girls 27), race (white 43), extent of resection (gross-total 46), and tumor grade (anaplastic 28). The conformal RT group was prospectively evaluated for neurologic, endocrine, and cognitive effects. Results: With a median follow-up time of 9.1 years from the start of RT for survivors (range, 0.2-23.2 years), the 10-year progression-free and overall survival were 73% + 7% and 76% + 6%, respectively. None of the evaluated factors was prognostic for disease control. Local and distant failures were evenly divided among the 16 patients who experienced progression. Eleven patients died of disease, and 1 of central nervous system necrosis. Seizure disorders were present in 17 patients, and 4 were considered to be clinically disabled. Clinically significant cognitive effects were limited to children with difficult-to-control seizures. The average values for intelligence quotient and academic achievement (reading, spelling, and math) were within the range of normal through 10 years of follow-up. Central hypothyroidism was the most commonly treated endocrinopathy. Conclusion: RT may be administered with acceptable risks for complications in children with supratentorial ependymoma. These results suggest that outcomes for these children are improving and that complications may be limited by use of focal irradiation methods

Supratentorial Ependymoma: Disease Control, Complications, and Functional Outcomes After Irradiation

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Landau, Efrat [Department of Radiation Oncology, Sheba Medical Center, Ramat Gan (Israel); Boop, Frederick A. [Department of Neurosurgery, St Jude Children' s Research Hospital, Memphis, Tennessee (United States); Conklin, Heather M. [Department of Psychology, St Jude Children' s Research Hospital, Memphis, Tennessee (United States); Wu, Shengjie; Xiong, Xiaoping [Department of Biostatistics, St Jude Children' s Research Hospital, Memphis, Tennessee (United States); Merchant, Thomas E., E-mail: thomas.merchant@stjude.org [Division of Radiation Oncology, St Jude Children' s Research Hospital, Memphis, Tennessee (United States)

2013-03-15

Purpose: Ependymoma is less commonly found in the supratentorial brain and has known clinical and molecular features that are unique. Our single-institution series provides valuable information about disease control for supratentorial ependymoma and the complications of supratentorial irradiation in children. Methods and Materials: A total of 50 children with newly diagnosed supratentorial ependymoma were treated with adjuvant radiation therapy (RT); conformal methods were used in 36 after 1996. The median age at RT was 6.5 years (range, 1-18.9 years). The entire group was characterized according to sex (girls 27), race (white 43), extent of resection (gross-total 46), and tumor grade (anaplastic 28). The conformal RT group was prospectively evaluated for neurologic, endocrine, and cognitive effects. Results: With a median follow-up time of 9.1 years from the start of RT for survivors (range, 0.2-23.2 years), the 10-year progression-free and overall survival were 73% + 7% and 76% + 6%, respectively. None of the evaluated factors was prognostic for disease control. Local and distant failures were evenly divided among the 16 patients who experienced progression. Eleven patients died of disease, and 1 of central nervous system necrosis. Seizure disorders were present in 17 patients, and 4 were considered to be clinically disabled. Clinically significant cognitive effects were limited to children with difficult-to-control seizures. The average values for intelligence quotient and academic achievement (reading, spelling, and math) were within the range of normal through 10 years of follow-up. Central hypothyroidism was the most commonly treated endocrinopathy. Conclusion: RT may be administered with acceptable risks for complications in children with supratentorial ependymoma. These results suggest that outcomes for these children are improving and that complications may be limited by use of focal irradiation methods.

Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial.

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Kon, Elizaveta; Engebretsen, Lars; Verdonk, Peter; Nehrer, Stefan; Filardo, Giuseppe

2018-01-01

Osteoarthritis (OA) is a debilitating disease resulting in substantial pain and functional limitations. A novel blood derivative has been developed to concentrate both growth factors and antagonists of inflammatory cytokines, with promising preliminary findings in terms of safety profile and clinical improvement. To investigate if one intra-articular injection of autologous protein solution (APS) can reduce pain and improve function in patients affected by knee OA in a multicenter, randomized, double-blind, saline-controlled study. Randomized controlled trial; Level of evidence, 2. Forty-six patients with unilateral knee OA (Kellgren-Lawrence 2 or 3) were randomized into the APS group (n = 31), which received a single ultrasound-guided injection of APS, and the saline (control) group (n = 15), which received a single saline injection. Patient-reported outcomes and adverse events were collected at 2 weeks and at 1, 3, 6, and 12 months through visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), Short Form-36 (SF-36), Clinical Global Impression of Severity/Change (CGI-S/C), Patient Global Impression of Severity/Change (PGI-S/C), and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. Imaging evaluation was also performed with radiograph and magnetic resonance imaging (MRI) before and after treatment (12 months and 3 and 12 months, respectively). The safety profile was positive, with no significant differences in frequency and severity of adverse events between groups. The improvement from baseline to 2 weeks and to 1, 3, and 6 months was similar between treatments. At 12 months, improvement in WOMAC pain score was 65% in the APS group and 41% in the saline group ( P = .02). There were no significant differences in VAS pain improvement between groups. At 12 months, APS group showed improved SF-36 Bodily Pain

Elevated Fasting Blood Glucose Is Predictive of Poor Outcome in Non-Diabetic Stroke Patients: A Sub-Group Analysis of SMART.

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Ming Yao

Full Text Available Although increasing evidence suggests that hyperglycemia following acute stroke adversely affects clinical outcome, whether the association between glycaemia and functional outcome varies between stroke patients with\\without pre-diagnosed diabetes remains controversial. We aimed to investigate the relationship between the fasting blood glucose (FBG and the 6-month functional outcome in a subgroup of SMART cohort and further to assess whether this association varied based on the status of pre-diagnosed diabetes.Data of 2862 patients with acute ischemic stroke (629 with pre-diagnosed diabetics enrolled from SMART cohort were analyzed. Functional outcome at 6-month post-stroke was measured by modified Rankin Scale (mRS and categorized as favorable (mRS:0-2 or poor (mRS:3-5. Binary logistic regression model, adjusting for age, gender, educational level, history of hypertension and stroke, baseline NIHSS and treatment group, was used in the whole cohort to evaluate the association between admission FBG and functional outcome. Stratified logistic regression analyses were further performed based on the presence/absence of pre-diabetes history.In the whole cohort, multivariable logistical regression showed that poor functional outcome was associated with elevated FBG (OR1.21 (95%CI 1.07-1.37, p = 0.002, older age (OR1.64 (95% CI1.38-1.94, p<0.001, higher NIHSS (OR2.90 (95%CI 2.52-3.33, p<0.001 and hypertension (OR1.42 (95%CI 1.13-1.98, p = 0.04. Stratified logistical regression analysis showed that the association between FBG and functional outcome remained significant only in patients without pre-diagnosed diabetes (OR1.26 (95%CI 1.03-1.55, p = 0.023, but not in those with premorbid diagnosis of diabetes (p = 0.885.The present results demonstrate a significant association between elevated FBG after stroke and poor functional outcome in patients without pre-diagnosed diabetes, but not in diabetics. This finding confirms the importance of glycemic

Life Design Counseling Group Intervention with Portuguese Adolescents: A Process and Outcome Study

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Cardoso, Paulo; Janeiro, Isabel Nunes; Duarte, Maria Eduarda

2018-01-01

This article examines the process and outcome of a life design counseling group intervention with students in Grades 9 and 12. First, we applied a quasi-experimental methodology to analyze the intervention's effectiveness in promoting career certainty, career decision-making, self-efficacy, and career adaptability in a sample of 236 students.…

Habit reversal training and educational group treatments for children with tourette syndrome: A preliminary randomised controlled trial.

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Yates, Rachel; Edwards, Katie; King, John; Luzon, Olga; Evangeli, Michael; Stark, Daniel; McFarlane, Fiona; Heyman, Isobel; İnce, Başak; Kodric, Jana; Murphy, Tara

2016-05-01

Quality of life of children with Tourette Syndrome (TS) is impacted greatly by its symptoms and their social consequences. Habit Reversal Training (HRT) is effective but has not, until now, been empirically evaluated in groups. This randomised controlled trial evaluated feasibility and preliminary efficacy of eight HRT group sessions compared to eight Education group sessions. Thirty-three children aged 9-13 years with TS or Chronic Tic Disorder took part. Outcomes evaluated were tic severity and quality of life (QoL). Tic severity improvements were found in both groups. Motor tic severity (Yale Global Tic Severity Scale) showed greatest improvements in the HRT group. Both groups showed a strong tendency toward improvements in patient reported QoL. In conclusion, group-based treatments for TS are feasible and exposure to other children with tics did not increase tic expression. HRT led to greater reductions in tic severity than Education. Implications, such as cost-effectiveness of treatment delivery, are discussed. Copyright © 2016. Published by Elsevier Ltd.

Effect of cognitive behavioral group therapy for recovery of self-esteem on community-living individuals with mental illness: Non-randomized controlled trial.

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Kunikata, Hiroko; Yoshinaga, Naoki; Nakajima, Kazuo

2016-10-01

The aim of this study was to examine over a 12-month post-intervention period whether the participation of community-living individuals with mental illness in cognitive behavioral group therapy for recovery of self-esteem (CBGTRS) resulted in improved outcomes. This was a non-randomized controlled trial. The participants were persons with mental illness who resided in communities in the Chugoku region of Japan. In total, 41 were assigned to an experimental group (CBGTRS intervention, 12 group sessions), and 21 to a control group. Outcome indices (self-esteem, moods, cognition, subjective well-being, psychiatric symptoms) were measured for the experimental group prior to intervention (T0), immediately post-intervention (T1), and at 3 (T2) and 12 (T3) months post-intervention. The control group was measured at the same intervals. For the experimental group, self-esteem scores at T1, T2, and T3 were significantly higher than at T0. Moods and cognition scores remained significantly low until T2. Scores for Inadequate Mental Mastery in the subjective well-being index had not decreased by T3. Confidence in Coping remained significantly high until T2. Psychiatric symptoms scores at T0, T1, T2, and T3 were significantly lower than at T0. The means and standard errors for self-esteem and Inadequate Mental Mastery increased until T3, and those for Tension-Anxiety, Depression-Dejection, and Confusion decreased until T2. From within-group trends and between-group differences in self-esteem, we conclude that CBGTRS may have a relatively long-term effect on self-esteem recovery. T2 is the turning point for moods and cognition; thus, follow-up is needed 3 months following the initial program. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

The effect of adding a background infusion to patient-controlled epidural labor analgesia on labor, maternal, and neonatal outcomes: a systematic review and meta-analysis.

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Heesen, Michael; Böhmer, Johannes; Klöhr, Sven; Hofmann, Thomas; Rossaint, Rolf; Straube, Sebastian

2015-07-01

Patient-controlled epidural analgesia (PCEA) has gained popularity, but it is still unclear whether adding a background infusion confers any benefit. A systematic literature search in PubMed, Embase, CINAHL, LILACS, CENTRAL, Clinicaltrials.gov, and ISI WOS was performed to identify randomized controlled double-blind trials that compare PCEA-only with PCEA combined with a continuous infusion (PCEA + CI) in parturients. The data were subjected to meta-analyses using the random-effects model. Our primary outcome was the incidence of instrumental vaginal delivery. Secondary outcomes were incidences of spontaneous vaginal and cesarean deliveries, duration of labor, analgesic outcomes, maternal outcomes (visual analog scale scores for pain, maternal satisfaction, nausea, pruritus, hypotension), and neonatal outcomes (Apgar score, umbilical artery pH). We identified 7 trials with a low risk of bias, reporting on 891 parturients, for inclusion in our systematic review. The risk of instrumental vaginal delivery was increased in the PCEA + CI group, risk ratio (RR) 1.66 (95% confidence interval 1.08-2.56, P = 0.02; I = 0%); the RR for cesarean delivery was 0.83 (95% confidence interval 0.61-1.13, I = 0%). The second stage of labor was prolonged (weighted mean difference 12.3 minutes, 95% confidence interval 5.1-19.5 minutes, P = 0.0008; I = 0%) in the PCEA + CI group. Fewer patients in the PCEA + CI group required physician-administered boluses (RR 0.35 [95% confidence interval 0.25-0.47, P neonatal outcomes (Apgar scores analgesia. Further high-quality studies involving a sufficient number of patients are required.

The evaluation of perinatal outcomes in pregnancies complicated with thrombophilias

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Yusuf Taner Kafadar

2014-06-01

Full Text Available Aim: In our study we included pregnant patients diagnosed with thrombophilia and evaluated their follow up by thromboprophylaxy for perinatal outcomes. (pregnancy loss, preclampsia,small for gestational age, preterm labour, venous thrombosis. In addition to our study group we aimed to evaluate a control group with negative thrombophilia screen results and hypothesized similar perinatal outcomes in comparison with the study group. Materials-Methods: Pregnant subjects that applied to Çukurova University Hospital, between June 2010 - February 2012 were recruited in the study. Patients with a positive thrombophilia screen for primary and secondary recurrent pregnancy loss were initiated a thromboprophylaxia protocol in the first trimester and their demographic backgrounds and past obstetric histories were also recorded. In addition to this, the type of thrombophilia and number of thrombophilia defects were also noted and the route of birth and perinatal outcomes were evaluated prospectively. The control group included patients who had a history of recurrent unexplained miscarriages, with a negative thrombophilia screen. Differences between both groups were statistically significant at a p value <0.05. Results: 60 patients diagnosed thrombophilia were included in the study group, while 50 patients with unexplained recurrent miscarriage composed the control group. When the perinatal outcomes were compared; pregnancy loss, development of preeclampsia/eclampsia (p=0.257, small for gestational age birth rate (p=0.619, preterm birth rate (p=0.232 and the incidence of venous thrombosis (p=0.246 did not differ significantly. The cesarean section rate in the study group was 55% and 18% in the study group (p=0.000 and it was statistically significant between both groups. Discussion: Our study discovered similar findings and perinatal outcomes in patients with and without thrombophilia. The only significant difference between both groups was the difference in

Impulsivity-focused group intervention to reduce binge eating episodes in patients with binge eating disorder: study protocol of the randomised controlled IMPULS trial.

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Schag, Kathrin; Leehr, Elisabeth J; Martus, Peter; Bethge, Wolfgang; Becker, Sandra; Zipfel, Stephan; Giel, Katrin E

2015-12-18

The core symptom of binge eating disorder (BED) is recurrent binge eating that is accompanied by a sense of loss of control. BED is frequently associated with obesity, one of the main public health challenges today. Experimental studies deliver evidence that general trait impulsivity and disorder-specific food-related impulsivity constitute risk factors for BED. Cognitive-behavioural treatment (CBT) is deemed to be the most effective intervention concerning BED. We developed a group intervention based on CBT and especially focusing on impulsivity. We hypothesise that such an impulsivity-focused group intervention is able to increase control over impulsive eating behaviour, that is, reduce binge eating episodes, further eating pathology and impulsivity. Body weight might also be influenced in the long term. The present randomised controlled trial investigates the feasibility, acceptance and efficacy of this impulsivity-focused group intervention in patients with BED. We compare 39 patients with BED in the experimental group to 39 patients with BED in the control group at three appointments: before and after the group intervention and in a 3-month follow-up. Patients with BED in the experimental group receive 8 weekly sessions of the impulsivity-focused group intervention with 5-6 patients per group. Patients with BED in the control group receive no group intervention. The primary outcome is the binge eating frequency over the past 4 weeks. Secondary outcomes comprise further eating pathology, general impulsivity and food-related impulsivity assessed by eye tracking methodology, and body weight. Additionally, we assess binge eating and other impulsive behaviour weekly in process analyses during the time period of the group intervention. This study has been approved by the ethics committee of the medical faculty of Eberhard Karls University Tübingen and the University Hospital Tübingen. Data are monitored by the Centre of Clinical Studies, University Hospital T�

Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

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Soyeon Cheon

2018-01-01

Full Text Available Abstract Background While full disclosure of information on placebo control in participant information leaflets (PILs in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Methods Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. Results In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38. In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03, probably due to enhanced expectations. Conclusions How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we

Propensity scores as a basis for equating groups: basic principles and application in clinical treatment outcome research.

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West, Stephen G; Cham, Heining; Thoemmes, Felix; Renneberg, Babette; Schulze, Julian; Weiler, Matthias

2014-10-01

A propensity score is the probability that a participant is assigned to the treatment group based on a set of baseline covariates. Propensity scores provide an excellent basis for equating treatment groups on a large set of covariates when randomization is not possible. This article provides a nontechnical introduction to propensity scores for clinical researchers. If all important covariates are measured, then methods that equate on propensity scores can achieve balance on a large set of covariates that mimics that achieved by a randomized experiment. We present an illustration of the steps in the construction and checking of propensity scores in a study of the effectiveness of a health coach versus treatment as usual on the well-being of seriously ill individuals. We then consider alternative methods of equating groups on propensity scores and estimating treatment effects including matching, stratification, weighting, and analysis of covariance. We illustrate a sensitivity analysis that can probe for the potential effects of omitted covariates on the estimate of the causal effect. Finally, we briefly consider several practical and theoretical issues in the use of propensity scores in applied settings. Propensity score methods have advantages over alternative approaches to equating groups particularly when the treatment and control groups do not fully overlap, and there are nonlinear relationships between covariates and the outcome. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Group cognitive behavioural therapy and weight regain after diet in type 2 diabetes: results from the randomised controlled POWER trial.

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Berk, Kirsten A; Buijks, Hanneke I M; Verhoeven, Adrie J M; Mulder, Monique T; Özcan, Behiye; van 't Spijker, Adriaan; Timman, Reinier; Busschbach, Jan J; Sijbrands, Eric J

2018-04-01

Weight-loss programmes for adults with type 2 diabetes are less effective in the long term owing to regain of weight. Our aim was to determine the 2 year effectiveness of a cognitive behavioural group therapy (group-CBT) programme in weight maintenance after diet-induced weight loss in overweight and obese adults with type 2 diabetes, using a randomised, parallel, non-blinded, pragmatic study design. We included 158 obese adults (median BMI 36.3 [IQR 32.5-40.0] kg/m 2 ) with type 2 diabetes from the outpatient diabetes clinic of Erasmus MC, the Netherlands, who achieved ≥5% weight loss on an 8 week very low calorie diet. Participants were randomised (stratified by weight loss) to usual care or usual care plus group-CBT (17 group sessions). The primary outcomes were the between-group differences after 2 years in: (1) body weight; and (2) weight regain. Secondary outcomes were HbA 1c levels, insulin dose, plasma lipid levels, depression, anxiety, self-esteem, quality of life, fatigue, physical activity, eating disorders and related cognitions. Data were analysed using linear mixed modelling. During the initial 8 week dieting phase, the control group (n = 75) lost a mean of 10.0 (95% CI 9.1, 10.9) kg and the intervention group (n = 83) lost 9.2 (95% CI 8.4, 10.0) kg (p = 0.206 for the between-group difference). During 2 years of follow-up, mean weight regain was 4.7 (95% CI 3.0, 6.3) kg for the control group and 4.0 (95% CI 2.3, 5.6) kg for the intervention group, with a between-group difference of -0.7 (95% CI -3.1, 1.6) kg (p = 0.6). The mean difference in body weight at 2 years was -1.2 (95% CI -7.7, 5.3) kg (p = 0.7). None of the secondary outcomes differed between the two groups. Despite increased treatment contact, a group-CBT programme for long-term weight maintenance after an initial ≥5% weight loss from dieting in obese individuals with type 2 diabetes was not superior to usual care alone. Trialregister.nl NTR2264 FUNDING: The

Complications and Outcome of Pregnancy in Extremes of Reproductive Age Groups: Experience at Tertiary Care Center

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Manju Lata Verma

2016-09-01

Full Text Available Background Pregnant women of extremes of reproductive age group at both ends ( 35 years age comprise high risk groups. Pregnant women up to 35 years get many complications like diabetes, spontaneous abortion, hypertensive disorders, autosomal trisomies, increased newborn and maternal morbidity and mortality and cesarean sections. Pregnancies of 35 year age group and to compare both the groups. Methods This retrospective study was done at department of obstetrics and gynaecology, Chatrapati Shahuji Maharaj Medical University, Lucknow, from January 2010 to December 2010. Data were collected from institutional logbook and various complications and outcome were studied. Statistical analyses were carried out by using the statistical package for SPSS-15. Results Present study showed that the definite increased risk of preeclampsia, eclampsia, obstetric cholestasis, twin gestation, anemia, preterm labor, premature rupture of membranes, intrauterine fetal growth restriction, and intrauterine fetal death in adolescent pregnancies and increased risk of eclampsia, diabetes, and cesarean sections in advanced age pregnancies. Conclusions Both adolescent and advanced age groups are high risk pregnancy groups so for best reproductive outcome, pregnancies at these ages should be very carefully supervised with both good maternal and fetal surveillance to achieve best maternal and fetal results.

Cognitive Dysfunction, Locus of Control and Treatment Outcome among Chronic Alcoholics.

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Abbott, Max W.

While alcoholism is no longer regarded as a unitary disorder, conventional measures of congition and personality have yet to be shown capable of consistently predicting clinical outcomes. To investigate cognitive dysfunction and locus of control as predictors of post treatment outcome in a large sample of alcoholics, 106 alcoholics (74 men, 32…

Maternal and perinatal outcomes in pregnancies with multiple sclerosis: a case-control study.

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Yalcin, Serenat Eris; Yalcin, Yakup; Yavuz, And; Akkurt, Mehmet Ozgur; Sezik, Mekin

2017-05-24

To assess whether maternal multiple sclerosis (MS) is associated with adverse pregnancy outcomes by determining the clinical course of disease during pregnancy and postpartum throughout a 10-year-period in a single tertiary center. We conducted a case-control study that included pregnancies with a definitive diagnosis of MS (n=43), matched with 100 healthy pregnant women with similar characteristics. Maternal and perinatal data were retrieved from hospital files. Groups were compared with the Mann-Whitney and χ2 tests. Logistic regression models were constructed to determine independent effects. Maternal demographic and baseline laboratory data were similar across the groups. Rates of preterm delivery, fetal growth restriction, preeclampsia, gestational diabetes, stillbirth, cesarean delivery, congenital malformation, and 5-min Apgar score were comparable (P>0.05 for all). General anesthesia during cesarean delivery (96% vs. 39%, P=0.002), urinary tract infection (UTI) (12% vs. 3%, P=0.04), low 1-min Apgar score (21% vs. 9%, P=0.04), and nonbreastfeeding (33% vs. 2%, P=0.001) were more frequent in women with MS. The low 1-min Apgar score and breastfeeding rates were independent of general anesthesia and UTI in regression models. MS during pregnancy was not associated with adverse maternal and perinatal outcomes except UTI, low 1-min Apgar scores, and decreased breastfeeding rates.

78 FR 68779 - Controlled Group Regulation Examples; Hearing Cancellation

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2013-11-15

... DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-114122-12] RIN 1545-BK96 Controlled Group Regulation Examples; Hearing Cancellation AGENCY: Internal Revenue Service (IRS), Treasury... controlled group rules related to regulated investment companies. DATES: The public hearing originally...

Sex differences in in-group cooperation vary dynamically with competitive conditions and outcomes.

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Bailey, Drew H; Winegard, Benjamin; Oxford, Jon; Geary, David C

2012-03-18

Men's but not women's investment in a public goods game varied dynamically with the presence or absence of a perceived out-group. Three hundred fifty-four (167 male) young adults participated in multiple iterations of a public goods game under intergroup and individual competition conditions. Participants received feedback about whether their investments in the group were sufficient to earn a bonus to be shared among all in-group members. Results for the first trial confirm previous research in which men's but not women's investments were higher when there was a competing out-group. We extended these findings by showing that men's investment in the in-group varied dynamically by condition depending on the outcome of the previous trial: In the group condition, men, but not women, decreased spending following a win (i.e., earning an in-group bonus). In the individual condition, men, but not women, increased spending following a win. We hypothesize that these patterns reflect a male bias to calibrate their level of in-group investment such that they sacrifice only what is necessary for their group to successfully compete against a rival group.

Sex Differences in In-Group Cooperation Vary Dynamically with Competitive Conditions and Outcomes

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Drew H. Bailey

2012-01-01

Full Text Available Men's but not women's investment in a public goods game varied dynamically with the presence or absence of a perceived out-group. Three hundred fifty-four (167 male young adults participated in multiple iterations of a public goods game under intergroup and individual competition conditions. Participants received feedback about whether their investments in the group were sufficient to earn a bonus to be shared among all in-group members. Results for the first trial confirm previous research in which men's but not women's investments were higher when there was a competing out-group. We extended these findings by showing that men's investment in the in-group varied dynamically by condition depending on the outcome of the previous trial: In the group condition, men, but not women, decreased spending following a win (i.e., earning an in-group bonus. In the individual condition, men, but not women, increased spending following a win. We hypothesize that these patterns reflect a male bias to calibrate their level of in-group investment such that they sacrifice only what is necessary for their group to successfully compete against a rival group.

Comparison between group and personal rehabilitation for dementia in a geriatric health service facility: single-blinded randomized controlled study.

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Tanaka, Shigeya; Honda, Shin; Nakano, Hajime; Sato, Yuko; Araya, Kazufumi; Yamaguchi, Haruyasu

2017-05-01

The aim of this study was to compare the effects of rehabilitation involving group and personal sessions on demented participants. This single-blinded randomized controlled trial included 60 elderly participants with dementia in a geriatric health service facility, or R oken. Staff members, who did not participate in the intervention, examined cognitive function, mood, communication ability, severity of dementia, objective quality of life, vitality, and daily behaviour. After a baseline assessment, participants were randomly divided into three groups: (i) group intervention; (ii) personal intervention; and (iii) control. The 1-h group intervention (3-5 subjects) and 20-min personal intervention (one staff member per participant) were performed twice a week for 12 weeks (24 total sessions). The cognitive rehabilitation programme consisted of reminiscence, reality orientation, and physical exercise, and it was based on five principles of brain-activating rehabilitation; (i) pleasant atmosphere; (ii) communication; (iii) social roles; (iv) praising; and (v) errorless support. Data were analyzed after the second assessment. Outcome measures were analyzed in 43 participants-14 in the control group, 13 in group intervention, and 16 in personal intervention. Repeated measure ancova showed a significant interaction for cognitive function score (Mini-Mental State Examination) between group intervention and controls ( F  = 5.535, P = 0.029). In the post-hoc analysis, group intervention showed significant improvement (P = 0.016). Global severity of dementia tended to improve (P = 0.094) in group intervention compared to control (Mann-Whitney U -test). There were no significant interactions or improvements for other measurements. Group rehabilitation for dementia is more effective for improving cognitive function and global severity of dementia than personal rehabilitation in Roken. © 2016 Japanese Psychogeriatric Society.

Controlling Chronic Diseases Through Evidence-Based Decision Making: A Group-Randomized Trial.

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Brownson, Ross C; Allen, Peg; Jacob, Rebekah R; deRuyter, Anna; Lakshman, Meenakshi; Reis, Rodrigo S; Yan, Yan

2017-11-30

Although practitioners in state health departments are ideally positioned to implement evidence-based interventions, few studies have examined how to build their capacity to do so. The objective of this study was to explore how to increase the use of evidence-based decision-making processes at both the individual and organization levels. We conducted a 2-arm, group-randomized trial with baseline data collection and follow-up at 18 to 24 months. Twelve state health departments were paired and randomly assigned to intervention or control condition. In the 6 intervention states, a multiday training on evidence-based decision making was conducted from March 2014 through March 2015 along with a set of supplemental capacity-building activities. Individual-level outcomes were evidence-based decision making skills of public health practitioners; organization-level outcomes were access to research evidence and participatory decision making. Mixed analysis of covariance models was used to evaluate the intervention effect by accounting for the cluster randomized trial design. Analysis was performed from March through May 2017. Participation 18 to 24 months after initial training was 73.5%. In mixed models adjusted for participant and state characteristics, the intervention group improved significantly in the overall skill gap (P = .01) and in 6 skill areas. Among the 4 organizational variables, only access to evidence and skilled staff showed an intervention effect (P = .04). Tailored and active strategies are needed to build capacity at the individual and organization levels for evidence-based decision making. Our study suggests several dissemination interventions for consideration by leaders seeking to improve public health practice.

The Role of Clinical and Instrumented Outcome Measures in Balance Control of Individuals with Multiple Sclerosis

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Neeta Kanekar

2013-01-01

Full Text Available Purpose. The aim of the study was to investigate differences in balance control between individuals with multiple sclerosis (MS and healthy control subjects using clinical scales and instrumented measures of balance and determine relationships between balance measures, fatigue, and disability levels in individuals with MS with and without a history of falls. Method. Twelve individuals with MS and twelve healthy controls were evaluated using the Berg Balance and Activities-specific Balance Confidence Scales, Modified Clinical Test of Sensory Interaction on Balance, and Limits of Stability Tests as well as Fatigue Severity Scale and Barthel Index. Results. Mildly affected individuals with MS had significant balance performance deficits and poor balance confidence levels (P<0.05. MS group had higher sway velocities and diminished stability limits (P<0.05, significant sensory impairments, high fatigue and disability levels (P<0.05. Sway velocity was a significant predictor of balance performance and the ability to move towards stability limits for the MS group. For the MS-fallers group, those with lower disability levels had faster movement velocities and better balance performance. Conclusion. Implementation of both clinical and instrumented tests of balance is important for the planning and evaluation of treatment outcomes in balance rehabilitation of people with MS.

Cognitive cooperation groups mediated by computers and internet present significant improvement of cognitive status in older adults with memory complaints: a controlled prospective study

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Rodrigo de Rosso Krug

Full Text Available ABSTRACT Objective To estimate the effect of participating in cognitive cooperation groups, mediated by computers and the internet, on the Mini-Mental State Examination (MMSE percent variation of outpatients with memory complaints attending two memory clinics. Methods A prospective controlled intervention study carried out from 2006 to 2013 with 293 elders. The intervention group (n = 160 attended a cognitive cooperation group (20 sessions of 1.5 hours each. The control group (n = 133 received routine medical care. Outcome was the percent variation in the MMSE. Control variables included gender, age, marital status, schooling, hypertension, diabetes, dyslipidaemia, hypothyroidism, depression, vascular diseases, polymedication, use of benzodiazepines, exposure to tobacco, sedentary lifestyle, obesity and functional capacity. The final model was obtained by multivariate linear regression. Results The intervention group obtained an independent positive variation of 24.39% (CI 95% = 14.86/33.91 in the MMSE compared to the control group. Conclusion The results suggested that cognitive cooperation groups, mediated by computers and the internet, are associated with cognitive status improvement of older adults in memory clinics.

Coordination of baseload power plant group control with static reactive power compensator control

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Zbigniew Szczerba

2012-06-01

Full Text Available Reactive power sources in power system nodes: generators and static reactive power compensators, are controlled by control systems. Generators – by generator node group controllers, compensators – by voltage controllers. The paper presents issues of these control systems’ coordination and proposals for its implementation.

Internet versus face-to-face group cognitive-behavioral therapy for fibromyalgia: A randomized control trial.

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Vallejo, Miguel A; Ortega, José; Rivera, Javier; Comeche, María I; Vallejo-Slocker, Laura

2015-09-01

The aim of this study was to explore the effectiveness of Internet-delivered cognitive-behavioral therapy (iCBT) in treating fibromyalgia (FM) compared with an identical protocol using conventional group face-to-face CBT. Sixty participants were assigned to either (a) the waiting list group, (b) the CBT group, or (c) the iCBT group. The groups were assessed at baseline, after 10 weeks of treatment, and at 3-, 6-, and 12-month follow-ups. The primary outcome measured was the impact of FM on daily functioning, as measured by the Fibromyalgia Impact Questionnaire (FIQ). The secondary outcomes were psychological distress, depression, and cognitive variables, including self-efficacy, catastrophizing, and coping strategies. In post-treatment, only the CBT group showed improvement in the primary outcome. The CBT and iCBT groups both demonstrated improvement in psychological distress, depression, catastrophizing, and utilizing relaxation as a coping strategy. The iCBT group showed an improvement in self-efficacy that was not obtained in the CBT group. CBT and iCBT were dissimilar in efficacy at follow-up. The iCBT group members improved their post-treatment scores at their 6- and 12-month follow-ups. At the 12-month follow-up, the iCBT group showed improvement over their primary outcome and catastrophizing post-treatment scores. A similar effect of CBT was expected, but the positive results observed at the post-treatment assessment were not maintained at follow-up. The results suggest that some factors, such as self-efficacy or catastrophizing, could be enhanced by iCBT. Specific characteristics of iCBT may potentiate the social support needed to improve treatment adherence. Copyright © 2015 Elsevier Ltd. All rights reserved.

A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes.

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Tanner, Jeremy A; Black, Betty S; Johnston, Deirdre; Hess, Edward; Leoutsakos, Jeannie-Marie; Gitlin, Laura N; Rabins, Peter V; Lyketsos, Constantine G; Samus, Quincy M

2015-04-01

To assess whether MIND at Home, a community-based, multicomponent, care coordination intervention, reduces unmet caregiving needs and burden in informal caregivers of persons with memory disorders. An 18-month randomized controlled trial of 289 community-living care recipient (CR)-caregiver (informal caregivers, i.e., unpaid individuals who regularly assisted the CR) dyads from 28 postal code areas of Baltimore, Maryland was conducted. All dyads and the CR's primary care physician received the written needs assessment results and intervention recommendations. Intervention dyads then received an 18-month care coordination intervention delivered by nonclinical community workers to address unmet care needs through individualized care planning, referral and linkage to dementia services, provision of caregiver dementia education and skill-building strategies, and care progress monitoring by an interdisciplinary team. Primary outcome was total percent of unmet caregiver needs at 18 months. Secondary outcomes included objective and subjective caregiver burden measures, quality of life (QOL), and depression. Total percent of unmet caregiver needs declined in both groups from baseline to 18 months, with no statistically significant between-group difference. No significant group differences occurred in most caregiver burden measures, depression, or QOL. There was a potentially clinically relevant reduction in self-reported number of hours caregivers spent with the CR for MIND participants compared with control subjects. No statistically significant impacts on caregiver outcomes were found after multiple comparison adjustments. However, MIND at Home appeared to have had a modest and clinically meaningful impact on informal caregiver time spent with CRs. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

The effectiveness of "Exercise on Prescription" in stimulating physical activity among women in ethnic minority groups in the Netherlands: protocol for a randomized controlled trial.

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Hosper, Karen; Deutekom, Marije; Stronks, Karien

2008-12-10

Lack of physical activity is an important risk factor for overweight, diabetes, cardiovascular disease and other chronic conditions. In the Netherlands, ethnic minority groups are generally less physically active and rate their own health poorer compared to ethnic Dutch. This applies in particular to women. For this reason women from ethnic minority groups are an important target group for interventions to promote physical activity.In the Netherlands, an exercise referral program ("Exercise on Prescription") seems successful in reaching women from ethnic minority groups, in particular because of referral by the general practitioner and because the program fits well with the needs of these women. However, the effect of the intervention on the level of physical activity and related health outcomes has not been formally evaluated within this population. This paper describes the study design for the evaluation of the effect of "Exercise on Prescription" on level of physical activity and related health outcomes. The randomized controlled trial will include 360 inactive women from ethnic minority groups, with the majority having a non-Western background, aged between 18 and 65 years old, with regular visits to their general practitioner. Participants will be recruited at healthcare centres within a deprived neighbourhood in the city of The Hague, the Netherlands. An intervention group of 180 women will participate in an exercise program with weekly exercise sessions during 20 weeks. The control group (n = 180) will be offered care as usual. Measurements will take place at baseline, and after 6 and 12 months. Main outcome measure is minutes of self reported physical activity per week. Secondary outcomes are the mediating motivational factors regarding physical activity, subjective and objective health outcomes (including wellbeing, perceived health, fitness and body size) and use of (primary) health care. Attendance and attrition during the program will be determined

76 FR 31543 - Controlled Groups; Deferral of Losses; Hearing

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2011-06-01

... DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-118761-09] RIN 1545-BI92 Controlled Groups; Deferral of Losses; Hearing AGENCY: Internal Revenue Service (IRS), Treasury. ACTION... deferred losses on the sale or exchange of property between members of a controlled group. DATES: The...

76 FR 30052 - Controlled Groups; Deferral of Losses; Correction

Science.gov (United States)

2011-05-24

... DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-118761-09] RIN 1545-BI92 Controlled Groups; Deferral of Losses; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION... deferred losses on the sale or exchange of property between members of a controlled group. FOR FURTHER...

Effects of Assist-As-Needed Upper Extremity Robotic Therapy after Incomplete Spinal Cord Injury: A Parallel-Group Controlled Trial

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John Michael Frullo

2017-06-01

Full Text Available BackgroundRobotic rehabilitation of the upper limb following neurological injury has been supported through several large clinical studies for individuals with chronic stroke. The application of robotic rehabilitation to the treatment of other neurological injuries is less developed, despite indications that strategies successful for restoration of motor capability following stroke may benefit individuals with incomplete spinal cord injury (SCI as well. Although recent studies suggest that robot-aided rehabilitation might be beneficial after incomplete SCI, it is still unclear what type of robot-aided intervention contributes to motor recovery.MethodsWe developed a novel assist-as-needed (AAN robotic controller to adjust challenge and robotic assistance continuously during rehabilitation therapy delivered via an upper extremity exoskeleton, the MAHI Exo-II, to train independent elbow and wrist joint movements. We further enrolled seventeen patients with incomplete spinal cord injury (AIS C and D levels in a parallel-group balanced controlled trial to test the efficacy of the AAN controller, compared to a subject-triggered (ST controller that does not adjust assistance or challenge levels continuously during therapy. The conducted study is a stage two, development-of-concept pilot study.ResultsWe validated the AAN controller in its capability of modulating assistance and challenge during therapy via analysis of longitudinal robotic metrics. For the selected primary outcome measure, the pre–post difference in ARAT score, no statistically significant change was measured in either group of subjects. Ancillary analysis of secondary outcome measures obtained via robotic testing indicates gradual improvement in movement quality during the therapy program in both groups, with the AAN controller affording greater increases in movement quality over the ST controller.ConclusionThe present study demonstrates feasibility of subject-adaptive robotic therapy

Intensive Versus Distributed Aphasia Therapy: A Nonrandomized, Parallel-Group, Dosage-Controlled Study.

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Dignam, Jade; Copland, David; McKinnon, Eril; Burfein, Penni; O'Brien, Kate; Farrell, Anna; Rodriguez, Amy D

2015-08-01

Most studies comparing different levels of aphasia treatment intensity have not controlled the dosage of therapy provided. Consequently, the true effect of treatment intensity in aphasia rehabilitation remains unknown. Aphasia Language Impairment and Functioning Therapy is an intensive, comprehensive aphasia program. We investigated the efficacy of a dosage-controlled trial of Aphasia Language Impairment and Functioning Therapy, when delivered in an intensive versus distributed therapy schedule, on communication outcomes in participants with chronic aphasia. Thirty-four adults with chronic, poststroke aphasia were recruited to participate in an intensive (n=16; 16 hours per week; 3 weeks) versus distributed (n=18; 6 hours per week; 8 weeks) therapy program. Treatment included 48 hours of impairment, functional, computer, and group-based aphasia therapy. Distributed therapy resulted in significantly greater improvements on the Boston Naming Test when compared with intensive therapy immediately post therapy (P=0.04) and at 1-month follow-up (P=0.002). We found comparable gains on measures of participants' communicative effectiveness, communication confidence, and communication-related quality of life for the intensive and distributed treatment conditions at post-therapy and 1-month follow-up. Aphasia Language Impairment and Functioning Therapy resulted in superior clinical outcomes on measures of language impairment when delivered in a distributed versus intensive schedule. The therapy progam had a positive effect on participants' functional communication and communication-related quality of life, regardless of treatment intensity. These findings contribute to our understanding of the effect of treatment intensity in aphasia rehabilitation and have important clinical implications for service delivery models. © 2015 American Heart Association, Inc.

Healthy ageing at work- Efficacy of group interventions on the mental health of nurses aged 45 and older: Results of a randomised, controlled trial.

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Imad Maatouk

Full Text Available This multicentre, randomised controlled trial (RCT aimed to evaluate the efficacy of a small-group intervention promoting successful ageing at work in older nurses (aged ≥45.A sample of 115 nurses aged ≥45 from 4 trial sites in Germany were randomly assigned to either the intervention group (IG, that received a small-group intervention of seven weekly sessions of 120 min with a booster session after six weeks or to a wait-list control condition (WLC. Outcomes were measured via validated self-report questionnaires at baseline (T1 and at post-treatment (T2. Primary outcomes were mental health-related well-being and mental health-related quality of life (QOL. The secondary outcomes included mental health-related and work-related measures.The intention to treat (ITT analysis showed significant positive effects of the intervention on mental health. A significant small effect (d = 0.3 in favour of the IG was found for psychological health-related quality of life. Positive small effects (d = 0.24 to d = 0.31 were also found for work related mental strain.Our small-group intervention based on a theory of successful ageing for nurses aged ≥45 was found to be effective with regard to improvements of psychological health related quality of life and other mental health-related outcomes. Thus, our study shows that the ageing workforce can be reached through specifically designed preventive interventions. The components of our intervention could be easily adapted to the belongings of other professions. Our results suggest that these components should be evaluated in various settings outside the healthcare sector.

Sami-speaking municipalities and a control group's access to somatic specialist health care (SHC): a retrospective study on general practitioners’ referrals

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Norum, Jan; Nieder, Carsten

2012-01-01

Objectives The Sami people constitute the indigenous people in northern Norway. The objective of this study was to clarify whether they have a similar supply of somatic specialist health care (SHC) as others. Methods The referrals from general practitioners (GPs) in the primary health care (PHC) in the administration area of the Sami language law (8 municipalities) were matched with a control group of 11 municipalities. Population data was accessed from Statistics Norway and the time period 2007–2010 was analysed. The main outcome was the number of referrals per 1,000 inhabitants according to age group, gender and place of living. Results 504,292 referrals in northern Norway were indentified and the Sami and control group constituted 23,093 and 22,541 referrals, respectively. The major findings were a similar referral ratio (RR) (1.14 and 1.17) (p =0.624) and women more commonly referred (female/male ratio 1.45 and 1.41) in both groups. GPs in both groups were loyal to their local hospital trust. Conclusion Inhabitants in Sami-speaking municipalities in northern Norway have a similar supply of SHC services as controls. Inter-municipal variation was significant in both groups. PMID:22456052

Sami-speaking municipalities and a control group's access to somatic specialist health care (SHC): a retrospective study on general practitioners' referrals.

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Norum, Jan; Nieder, Carsten

2012-03-19

The Sami people constitute the indigenous people in northern Norway. The objective of this study was to clarify whether they have a similar supply of somatic specialist health care (SHC) as others. The referrals from general practitioners (GPs) in the primary health care (PHC) in the administration area of the Sami language law (8 municipalities) were matched with a control group of 11 municipalities. Population data was accessed from Statistics Norway and the time period 2007-2010 was analysed. The main outcome was the number of referrals per 1,000 inhabitants according to age group, gender and place of living. 504,292 referrals in northern Norway were indentified and the Sami and control group constituted 23,093 and 22,541 referrals, respectively. The major findings were a similar referral ratio (RR) (1.14 and 1.17) (p = 0.624) and women more commonly referred (female/male ratio 1.45 and 1.41) in both groups. GPs in both groups were loyal to their local hospital trust. Inhabitants in Sami-speaking municipalities in northern Norway have a similar supply of SHC services as controls. Inter-municipal variation was significant in both groups.

Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers.

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Muzik, Maria; Rosenblum, Katherine L; Alfafara, Emily A; Schuster, Melisa M; Miller, Nicole M; Waddell, Rachel M; Stanton Kohler, Emily

2015-06-01

Maternal psychopathology and traumatic life experiences may adversely impact family functioning, the quality of the parent-child relationship and the attachment bond, placing the child's early social-emotional development at risk. Attachment-based parenting interventions may be particularly useful in decreasing negative outcomes for children exposed to risk contexts, yet high risk families frequently do not engage in programs to address mental health and/or parenting needs. This study evaluated the effects of Mom Power (MP), a 13-session parenting and self-care skills group program for high-risk mothers and their young children (age parenting competence, and engagement in treatment. Mothers were referred from community health providers for a phase 1 trial to assess feasibility, acceptability, and pilot outcomes. At baseline, many reported several identified risk factors, including trauma exposure, psychopathology, poverty, and single parenthood. Ninety-nine mother-child pairs were initially recruited into the MP program with 68 women completing and providing pre- and post-self-report measures assessing demographics and trauma history (pre-assessment only), maternal mental health (depression and post-traumatic stress disorder (PTSD)), parenting, and intervention satisfaction. Results indicate that MP participation was associated with reduction in depression, PTSD, and caregiving helplessness. A dose response relationship was evident in that, despite baseline equivalence, women who attended ≥70 % of the 10 groups (completers; N = 68) improved on parenting and mental health outcomes, in contrast to non-completers (N = 12). Effects were most pronounced for women with a mental health diagnosis at baseline. The intervention was perceived as helpful and user-friendly. Results indicate that MP is feasible, acceptable, and holds promise for improving maternal mental health and parenting competence among high-risk dyads. Further research is warranted to evaluate

Periodontal disease as a risk factor for adverse pregnancy outcomes: a systematic review and meta-analysis of case-control studies.

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Corbella, Stefano; Taschieri, Silvio; Francetti, Luca; De Siena, Francesca; Del Fabbro, Massimo

2012-07-01

Periodontal disease is a highly prevalent group of illnesses of microbial etiology, whose consequence is a severe breakdown of tooth-supporting structures. A link between periodontal infection and several systemic conditions, among which adverse pregnancy outcomes, has been suggested in the recent years. The aim of this review based on case-control studies was to evaluate if periodontal disease could be considered as a risk factor for preterm birth, low birth-weight and preterm low birth-weight. An electronic search (via Pubmed) was performed for case-control studies investigating the relationship between periodontal disease and adverse pregnancy outcomes. From the initially retrieved 417 articles, 17 case-control studies, accounting for a total of 10,148 patients, were included in the review and in the meta-analysis. The estimated odds ratio was 1.78 (CI 95%: 1.58, 2.01) for preterm birth, 1.82 (CI 95%: 1.51, 1.20) for low birth-weight and 3.00 (CI 95%: 1.93, 4.68) for preterm low birth-weight. Despite the results of the analysis of pooled data suggested a link between periodontal diseases and adverse pregnancy outcomes, the presence of important confounders, whose effect could not be addressed, prevents a validation of the meta-analysis outcomes. Further more accurate investigations based on individual data analysis could give a better insight into the topic of the present review.

Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial.

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van der Roer, Nicole; van Tulder, Maurits; Barendse, Johanna; Knol, Dirk; van Mechelen, Willem; de Vet, Henrica

2008-09-01

Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study. In the intensive group training protocol exercise therapy, back school and operant-conditioning behavioural principles are combined. Patients were treated during 10 individual sessions along 20 group sessions. Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain. Main outcome measures were functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain assessed at baseline and after 6, 13, 26 and 52 weeks. Both an intention-to-treat analysis and a per-protocol analysis were performed. Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception. After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group, but this difference was absent after 52 weeks. We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain.

Multicomponent cognitive-behavioral group therapy with hypnosis for the treatment of fibromyalgia: long-term outcome.

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Castel, Antoni; Cascón, Rosalia; Padrol, Anna; Sala, José; Rull, Maria

2012-03-01

This study compared the efficacy of 2 psychological treatments for fibromyalgia with each other and with standard care. Ninety-three patients with fibromyalgia (FM) were randomly assigned to 1 of the 3 experimental conditions: 1) multicomponent cognitive-behavioral therapy (CBT); 2) multicomponent CBT with hypnosis; and 3) pharmacological treatment (standard care control group). The outcome measures of pain intensity, catastrophizing, psychological distress, functionality, and sleep disturbances were assessed before treatment, immediately after treatment, and at 3- and 6-month follow-up visits. CBT and CBT with hypnosis participants received the standard pharmacological management plus 14 weekly, 120-minute-long sessions of psychological treatment. All but 1 session followed a group format; the remaining session was individual. The analyses indicated that: 1) patients with FM who received multicomponent CBT alone or multicomponent CBT with hypnosis showed greater improvements than patients who received only standard care; and 2) adding hypnosis enhanced the effectiveness of multicomponent CBT. This study presents new evidence about the efficacy of multicomponent CBT for FM and about the additional effects of hypnosis as a complement to CBT. The relevance and implications of the obtained results are discussed. This article highlights the beneficial effects of adding hypnosis in a multicomponent cognitive-behavioral group treatment of fibromyalgia patients. Also, this research showed that by adding hypnosis the length of treatment did not increase. Copyright © 2012 American Pain Society. Published by Elsevier Inc. All rights reserved.

Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

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Nuria eRuffini

2015-08-01

Full Text Available Context: Heart Rate Variability (HRV indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT on ANS activity through changes of High Frequency, a heart rate variability index indicating the parasympathetic activity, in healthy subjects, compared with sham therapy and control group.Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults, both smokers and non-smokers and not on medications. At enrollment subjects were randomized in 3 groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920.Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 minutes.Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency rate (p<0.001, and decrease of sympathetic activity, as revealed by Low Frequency rate (p<0.01; results also showed a reduction of Low Frequency/High Frequency ratio (p<0.001 and Detrended fluctuation scaling exponent (p<0.05. Conclusions: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

Group Counseling with College Underachievers: Comparisons with a Control Group and Relationship to Empathy, Warmth and Genuineness.

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Dickenson, Walter A.; Traux, Charles B.

Some of the controversy concerning the efficacy of psychotherapy or counseling has been resolved by recent evidence that studies reporting no effects had indiscriminately lumped together the high and low therapeutic conditions which are associated with successful and unsuccessful outcomes. The present study extends these findings to a group of…

Group cognitive behavioral therapy for patients with generalized social anxiety disorder in Japan: outcomes at 1-year follow up and outcome predictors

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Kawaguchi A

2013-02-01

Full Text Available Akiko Kawaguchi,1 Norio Watanabe,1 Yumi Nakano,2 Sei Ogawa,1 Masako Suzuki,1 Masaki Kondo,1 Toshi A Furukawa,3 Tatsuo Akechi11Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 2Sugiyama Jogakuen University School of Human Sciences, Nisshin, Japan; 3Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, JapanBackground: Social anxiety disorder (SAD is one of the most common psychiatric disorders worldwide. Cognitive behavioral therapy (CBT is an effective treatment option for patients with SAD. In the present study, we examined the efficacy of group CBT for patients with generalized SAD in Japan at 1-year follow-up and investigated predictors with regard to outcomes.Methods: This study was conducted as a single-arm, naturalistic, follow-up study in a routine Japanese clinical setting. A total of 113 outpatients with generalized SAD participated in group CBT from July 2003 to August 2010 and were assessed at follow-ups for up to 1 year. Primary outcome was the total score on the Social Phobia Scale/Social Interaction Anxiety Scale (SPS/SIAS at 1 year. Possible baseline predictors were investigated using mixed-model analyses.Results: Among the 113 patients, 70 completed the assessment at the 1-year follow-up. The SPS/SIAS scores showed significant improvement throughout the follow-ups for up to 1 year. The effect sizes of SPS/SIAS at the 1-year follow-up were 0.68 (95% confidence interval 0.41–0.95/0.76 (0.49–1.03 in the intention-to-treat group and 0.77 (0.42–1.10/0.84 (0.49–1.18 in completers. Older age at baseline, late onset, and lower severity of SAD were significantly associated with good outcomes as a result of mixed-model analyses.Conclusions: CBT for patients with generalized SAD in Japan is effective for up to 1 year after treatment. The effect sizes were as large as those in

The Discover artificial disc replacement versus fusion in cervical radiculopathy--a randomized controlled outcome trial with 2-year follow-up.

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Skeppholm, Martin; Lindgren, Lars; Henriques, Thomas; Vavruch, Ludek; Löfgren, Håkan; Olerud, Claes

2015-06-01

Several previous studies comparing artificial disc replacement (ADR) and fusion have been conducted with cautiously positive results in favor of ADR. This study is not, in contrast to most previous studies, an investigational device exemption study required by the Food and Drug Administration for approval to market the product in the United States. This study was partially funded with unrestricted institutional research grants by the company marketing the artificial disc used in this study. To compare outcomes between the concepts of an artificial disc to treatment with anterior cervical decompression and fusion (ACDF) and to register complications associated to the two treatments during a follow-up time of 2 years. This is a randomized controlled multicenter trial, including three spine centers in Sweden. The study included patients seeking care for cervical radiculopathy who fulfilled inclusion criteria. In total, 153 patients were included. Self-assessment with Neck Disability Index (NDI) as a primary outcome variable and EQ-5D and visual analog scale as secondary outcome variables. Patients were randomly allocated to either treatment with the Depuy Discover artificial disc or fusion with iliac crest bone graft and plating. Randomization was blinded to both patient and caregivers until time for implantation. Adverse events, complications, and revision surgery were registered as well as loss of follow-up. Data were available in 137 (91%) of the included and initially treated patients. Both groups improved significantly after surgery. NDI changed from 63.1 to 39.8 in an intention-to-treat analysis. No statistically significant difference between the ADR and the ACDF groups could be demonstrated with NDI values of 39.1 and 40.1, respectively. Nor in secondary outcome measures (EQ-5D and visual analog scale) could any statistically significant differences be demonstrated between the groups. Nine patients in the ADR group and three in the fusion group underwent

Sedimentological and Stratigraphic Controls on Natural Fracture Distribution in Wajid Group, SW Saudi Arabia

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Benaafi, Mohammed; Hariri, Mustafa; Abdullatif, Osman; Makkawi, Mohammed; Korvin, Gabor

2016-04-01

The Cambro-Permian Wajid Group, SW Saudi Arabia, is the main groundwater aquifer in Wadi Al-Dawasir and Najran areas. In addition, it has a reservoir potentiality for oil and natural gas in Rub' Al-Khali Basin. Wajid Group divided into four formations, ascending Dibsiyah, Sanamah, Khussyayan and Juwayl. They are mainly sandstone and exposed in an area extend from Wadi Al-Dawasir southward to Najran city and deposited within fluvial, shallow marine and glacial environments. This study aims to investigate the sedimentological and stratigraphic controls on the distribution of natural fractures within Wajid Group outcrops. A scanline sampling method was used to study the natural fracture network within Wajid Group outcrops, where the natural fractures were measured and characterized in 12 locations. Four regional natural fracture sets were observed with mean strikes of 050o, 075o, 345o, and 320o. Seven lithofacies characterized the Wajid Group at these locations and include fine-grained sandstone, coarse to pebbly sandstone, cross-bedded sandstone, massive sandstone, bioturbated sandstone, conglomerate sandstone, and conglomerate lithofacies. We found that the fine-grained and small scale cross-bedded sandstones lithofacies are characterized by high fracture intensity. In contrast, the coarse-grained sandstone and conglomerate lithofacies have low fracture intensity. Therefore, the relative fracture intensity and spacing of natural fractures within Wajid Group in the subsurface can be predicted by using the lithofacies and their depositional environments. In terms of stratigraphy, we found that the bed thickness and the stratigraphic architecture are the main controls on fractures intensity. The outcomes of this study can help to understand and predict the natural fracture distribution within the subsurface fractured sandstone hosting groundwater and hydrocarbon in Wajid and Rub' Al-Khali Basins. Hence, the finding of this study might help to explore and develop the

Surgical Outcome of Intermittent Exotropia With Improvement in Control Grade Subsequent to Part-time Preoperative Occlusion Therapy.

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Bang, Seung Pil; Lee, Dong Cheol; Lee, Se Youp

2018-01-01

To evaluate the effect of improvement in the control grade of intermittent exotropia using part-time occlusion therapy on the final postoperative outcome. Control of intermittent exotropia was graded as good, fair, or poor in 89 consecutive patients with intermittent exotropia during their first visit. The patients were reevaluated after part-time preoperative occlusion therapy and divided into two groups (improvement and no improvement) according to whether they showed improvement in control grade. The surgical success rate was compared retrospectively between the two groups. The mean angle of deviation on the first visit was 27.61 ± 5.40 prism diopters (PD) at distance and 29.82 ± 5.28 PD at near. There were significant improvements in the angles of deviation for distance (26.17 ± 5.09 PD) and near (27.26 ± 5.56 PD) after part-time occlusion (both P Part-time occlusion therapy improves the control grade of intermittent exotropia, leading to a better likelihood of successful surgery and a reduction of the angles of deviation for distance and near. [J Pediatr Ophthalmol Strabismus. 2018;55(1):59-64.]. Copyright 2017, SLACK Incorporated.

A Phase II Trial of Brachytherapy Alone After Lumpectomy for Select Breast Cancer: Tumor Control and Survival Outcomes of RTOG 95-17

International Nuclear Information System (INIS)

Arthur, Douglas W.; Winter, Kathryn; Kuske, Robert R.; Bolton, John; Rabinovitch, Rachel; White, Julia; Hanson, William F.; Wilenzick, Raymond M.; McCormick, Beryl

2008-01-01

Purpose: Radiation Therapy Oncology Group 95-17 is a prospective Phase II cooperative group trial of accelerated partial breast irradiation (APBI) alone using multicatheter brachytherapy after lumpectomy in select early-stage breast cancers. Tumor control and survival outcomes are reported. Methods and Materials: Eligibility criteria included Stage I/II breast carcinoma confirmed to be <3 cm, unifocal, invasive nonlobular histology with zero to three positive axillary nodes without extracapsular extension. APBI treatment was delivered with either low-dose-rate (LDR) (45 Gy in 3.5-5 days) or high-dose-rate (HDR) brachytherapy (34 Gy in 10 twice-daily fractions over 5 days). End points evaluated included in-breast control, regional control, mastectomy-free rate, mastectomy-free survival, disease-free survival, and overall survival. The study was designed to analyze the HDR and LDR groups separately and without comparison. Results: Between 1997 and 2000, 100 patients were accrued and 99 were eligible; 66 treated with HDR brachytherapy and 33 treated with LDR brachytherapy. Eighty-seven patients had T1 lesions and 12 had T2 lesions. Seventy-nine were pathologically N0 and 20 were N1. Median follow-up in the HDR group is 6.14 years with the 5-year estimates of in-breast, regional, and contralateral failure rates of 3%, 5%, and 2%, respectively. The LDR group experienced similar results with a median follow-up of 6.22 years. The 5-year estimates of in-breast, regional, and contralateral failure rates of 6%, 0%, and 6%, respectively. Conclusion: Patients treated with multicatheter partial breast brachytherapy in this trial experienced excellent in-breast control rates and overall outcome that compare with reports from APBI studies with similar extended follow-up

Effect of Taichi Softball on Function-Related Outcomes in Older Adults: A Randomized Control Trial

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Lin Lou

2017-01-01

Full Text Available The purpose of this present study was to examine the effect of Taichi softball (TCSB on physical function in Chinese older adults. Eighty Chinese older adults were randomly assigned into either an experimental group experiencing four 90-minute TCSB sessions weekly for seven consecutive weeks or a control group. At baseline and 7 weeks later, all participants were asked to perform physical functional tests for both lower and upper limbs. Multiple separate Analyses of Variance (ANOVA with repeated measures were applied to evaluate the effects of TCSB on function-related outcomes between baseline and postintervention in the two groups. The findings indicate that a short-term and intensive TCSB training program does not only improve low limb-related physical function such as dynamic balance and leg strength, but also strengthen upper limb-related physical function (e.g., arm and forearm strength, shoulder mobility, fine motor control, handgrip strength, and fine motor function. Health professionals could take into account TCSB exercise as an alternative method to help maintain or alleviate the inevitable age-related physical function degeneration in healthy older adults. In addition, researchers could investigate the effect of TCSB exercise on physical function in special populations such as patients with different chronic diseases or neurological disorder (e.g., Parkinson’s disease.

Dysphagia management: an analysis of patient outcomes using VitalStim therapy compared to traditional swallow therapy.

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Kiger, Mary; Brown, Catherine S; Watkins, Lynn

2006-10-01

This study compares the outcomes using VitalStim therapy to outcomes using traditional swallowing therapy for deglutition disorders. Twenty-two patients had an initial and a followup videofluoroscopic swallowing study or fiberoptic endoscopic evaluation of swallowing and were divided into an experimental group that received VitalStim treatments and a control group that received traditional swallowing therapy. Outcomes were analyzed for changes in oral and pharyngeal phase dysphagia severity, dietary consistency restrictions, and progression from nonoral to oral intake. Results of chi(2) analysis showed no statistically significant difference in outcomes between the experimental and control groups.

Fertility and pregnancy outcome in women with systemic sclerosis.

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Steen, V D; Medsger, T A

1999-04-01

To determine fertility and pregnancy outcome in women with systemic sclerosis (SSc; scleroderma) who had disease onset before age 45 years. All living women with scleroderma who had first been evaluated at the University of Pittsburgh Scleroderma Clinic after January 1, 1972 were sent a detailed self-administered questionnaire in 1986 specifically concerning pregnancy outcomes and infertility. This group was compared with 2 race- and age-matched control groups, one comprising women with rheumatoid arthritis (RA) and one comprising healthy neighborhood women identified by random-digit dialing. We determined the number, history, treatment, and outcome of women who either had never been pregnant or had attempted to become pregnant unsuccessfully for more than 1 year. We also obtained data regarding pregnancy outcomes, including the frequency of miscarriage, premature births, small full-term infants, perinatal deaths, and births of live healthy infants. The study group comprised 214 women with SSc, 167 with RA, and 105 neighborhood controls. There were no significant differences in the overall rates of miscarriage, premature births, small full-term births, or neonatal deaths between the 3 groups. Women with SSc were more likely than those without SSc to have adverse outcomes of pregnancy after the onset of their rheumatic disease, particularly premature births (also seen in RA women after disease onset) and small full-term infants. Although a significantly greater number of women with SSc had never been pregnant, there were no significant differences in the frequency of never having been pregnant or of infertility in the 3 groups after adjustment for contributing factors. This study indicates that women with SSc have acceptable pregnancy outcomes compared with those of women with other rheumatic disease and healthy neighborhood controls. Infertility was not a frequent problem. We believe that there are no excessive pregnancy risks to women with SSc or their infants

Expect With Me: development and evaluation design for an innovative model of group prenatal care to improve perinatal outcomes.

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Cunningham, Shayna D; Lewis, Jessica B; Thomas, Jordan L; Grilo, Stephanie A; Ickovics, Jeannette R

2017-05-18

Despite biomedical advances and intervention efforts, rates of preterm birth and other adverse outcomes in the United States have remained relatively intransigent. Evidence suggests that group prenatal care can reduce these risks, with implications for maternal and child health as well as substantial cost savings. However, widespread dissemination presents challenges, in part because training and health systems have not been designed to deliver care in a group setting. This manuscript describes the design and evaluation of Expect With Me, an innovative model of group prenatal care with a strong integrated information technology (IT) platform designed to be scalable nationally. Expect With Me follows clinical guidelines from the American Congress of Obstetricians and Gynecologists. Expect With Me incorporates the best evidence-based features of existing models of group care with a novel integrated IT platform designed to improve patient engagement and support, enhance health behaviors and decision making, connect providers and patients, and improve health service delivery. A multisite prospective longitudinal cohort study is being conducted to examine the impact of Expect With Me on perinatal and postpartum outcomes, and to identify and address barriers to national scalability. Process and outcome evaluation will include quantitative and qualitative data collection at patient, provider, and organizational levels. Mixed-method data collection includes patient surveys, medical record reviews, patient focus groups; provider surveys, session evaluations, provider focus groups and in-depth interviews; an online tracking system; and clinical site visits. A two-to-one matched cohort of women receiving individual care from each site will provide a comparison group (n = 1,000 Expect With Me patients; n = 2,000 individual care patients) for outcome and cost analyses. By bundling prevention and care services into a high-touch, high-tech group prenatal care model

Group therapy use and its impact on the outcomes of inpatient rehabilitation following traumatic brain injury: Data from TBI-PBE project

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Hammond, Flora M.; Barrett, Ryan; Dijkers, Marcel P.; Zanca, Jeanne M.; Horn, Susan D.; Smout, Randall J.; Guerrier, Tami; Hauser, Elizabeth; Dunning, Megan R.

2015-01-01

Objective To describe the amount and content of group therapies provided during inpatient rehabilitation for traumatic brain injury (TBI), and assess the relationships of group therapy with patient, injury, and treatment factors as well as outcomes. Design Prospective observational cohort. Setting Inpatient rehabilitation. Participants 2,130 consecutive admissions for initial TBI rehabilitation at 10 inpatient rehabilitation facilities (9 in US and 1 Canada) from October 2008 to September 2011. Interventions n/a Main Outcome Measure(s) proportion of sessions that were group therapy (two or more patients were treated simultaneously by one or more clinicians); proportion of patients receiving group therapy; type of activity performed and amount of time spent in group therapy, by discipline; rehabilitation length of stay (RLOS); discharge location; FIM Cognitive and Motor scores at discharge. Results 79% of patients received at least 1 session of group therapy, with group therapy accounting for 13.7% of all therapy sessions and 15.8% of therapy hours. On average, patients spent 2.9 hours per week in group therapy. The greatest proportion of treatment time in group format was in Therapeutic Recreation (25.6%), followed by Speech Therapy (16.2%), Occupational Therapy (10.4%), Psychology (8.1%), and Physical Therapy (7.9%). Group therapy time and type of treatment activities varied among admission FIM cognitive subgroups and treatment sites. Several factors appear to be predictive of receiving group therapy, with treatment site being a major influence. However, group therapy as a whole offered little explanation of differences in the outcomes studied. Conclusion(s) Group therapy is commonly used in TBI rehabilitation, to varying degrees among disciplines, sites, and cognitive impairment subgroups. Various therapeutic activities take place in group therapy, indicating its perceived value in addressing many domains of functioning. Variation in outcomes is not explained

Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial

International Nuclear Information System (INIS)

Schofield, Penelope; Gough, Karla; Lotfi-Jam, Kerryann; Bergin, Rebecca; Ugalde, Anna; Dudgeon, Paul; Crellin, Wallace; Schubach, Kathryn; Foroudi, Farshard; Tai, Keen Hun; Duchesne, Gillian; Sanson-Fisher, Rob; Aranda, Sanchia

2016-01-01

Radiotherapy for localised prostate cancer has many known and distressing side effects. The efficacy of group interventions for reducing psychological morbidity is lacking. This study investigated the relative benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns and prostate cancer-specific quality of life in men receiving curative intent radiotherapy for prostate cancer. This phase III, two-arm cluster randomised controlled trial included 331 men (consent rate: 72 %; attrition: 5 %) randomised to the intervention (n = 166) or usual care (n = 165). The intervention comprised four group and one individual consultation all delivered by specialist uro-oncology nurses. Primary outcomes were anxious and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale. Unmet needs were assessed with the Supportive Care Needs Survey-SF34 Revised, treatment-related concerns with the Cancer Treatment Scale and quality of life with the Expanded Prostate Cancer Index −26. Assessments occurred before, at the end of and 6 months post-radiotherapy. Primary outcome analysis was by intention-to-treat and performed by fitting a linear mixed model to each outcome separately using all observed data. Mixed models analysis indicated that group consultations had a significant beneficial effect on one of two primary endpoints, depressive symptoms (p = 0.009), and one of twelve secondary endpoints, procedural concerns related to cancer treatment (p = 0.049). Group consultations did not have a significant beneficial effect on generalised anxiety, unmet needs and prostate cancer-specific quality of life. Compared with individual consultations offered as part of usual care, the intervention provides a means of delivering patient education and is associated with modest reductions in depressive symptoms and procedural concerns. Future work should seek to confirm the clinical feasibility and cost-effectiveness of group

Impact of continuous quality improvement initiatives on clinical outcomes in peritoneal dialysis.

Science.gov (United States)

Yu, Yusheng; Zhou, Yan; Wang, Han; Zhou, Tingting; Li, Qing; Li, Taoyu; Wu, Yan; Liu, Zhihong

2014-06-01

We evaluated the role of a quality improvement initiative in improving clinical outcomes in peritoneal dialysis (PD). In a retrospective analysis of 6 years of data from a hospital registry, the period between 1 July 2005 and 30 June 2008 (control group) provided baseline data from before implementation of systemic outcomes monitoring, and the period between 1 July 2008 and 30 June 2011 [continuous quality improvement (CQI) group] represented the time when a CQI program was in place. Peritonitis incidence, patient and technique survival, cardiovascular status, causes of death, and drop-out were compared between the groups. In the 370 patients of the CQI group and the 249 patients of the control group, the predominant underlying kidney diseases were chronic glomerulonephritis and diabetic nephropathy. After implementation of the CQI initiative, the peritonitis rate declined to 1 episode in 77.25 patient-months from 1 episode in 22.86 patient-months. Ultrasound parameters of cardiac structure were generally unchanged in the CQI group, but significant increases in cardiothoracic ratio and interventricular septal thickness were observed in the control group (both p improve technique survival rates: 95.6%, 92.6%, and 92.6% in the CQI group compared with 89.6%, 79.2%, and 76.8% in the control group (p improve the quality of therapy and its outcomes. Copyright © 2014 International Society for Peritoneal Dialysis.

Does circumpatellar electrocautery improve the outcome after total knee replacement?: a prospective, randomised, blinded controlled trial.

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Baliga, S; McNair, C J; Barnett, K J; MacLeod, J; Humphry, R W; Finlayson, D

2012-09-01

The incidence of anterior knee pain following total knee replacement (TKR) is reported to be as high as 49%. The source of the pain is poorly understood but the soft tissues around the patella have been implicated. In theory circumferential electrocautery denervates the patella thereby reducing efferent pain signals. However, there is mixed evidence that this practice translates into improved outcomes. We aimed to investigate the clinical effect of intra-operative circumpatellar electrocautery in patients undergoing TKR using the LCS mobile bearing or Kinemax fixed bearing TKR. A total of 200 patients were randomised to receive either circumpatellar electrocautery (diathermy) or not (control). Patients were assessed by visual analogue scale (VAS) for anterior knee pain and Oxford knee score (OKS) pre-operatively and three months, six months and one year post-operatively. Patients and assessors were blinded. There were 91 patients in the diathermy group and 94 in the control. The mean VAS improvement at one year was 3.9 in both groups (control; -10 to 6, diathermy; -9 to 8, p electrocautery on either VAS anterior knee pain or OKS for patients undergoing LCS and Kinemax TKR.

Physical activity and nutrition behavioural outcomes of a home-based intervention program for seniors: a randomized controlled trial

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Burke Linda

2013-01-01

Full Text Available Abstract Background This intervention aimed to ascertain whether a low-cost, accessible, physical activity and nutrition program could improve physical activity and nutrition behaviours of insufficiently active 60–70 year olds residing in Perth, Australia. Methods A 6-month home-based randomised controlled trial was conducted on 478 older adults (intervention, n = 248; control, n = 230 of low to medium socioeconomic status. Both intervention and control groups completed postal questionnaires at baseline and post-program, but only the intervention participants received project materials. A modified fat and fibre questionnaire measured nutritional behaviours, whereas physical activity was measured using the International Physical Activity Questionnaire. Generalised estimating equation models were used to assess the repeated outcomes over both time points. Results The final sample consisted of 176 intervention participants and 199 controls (response rate 78.5% with complete data. After controlling for demographic and other confounding factors, the intervention group demonstrated increased participation in strength exercise (p Conclusions A minimal contact, low-cost and home-based physical activity program can positively influence seniors’ physical activity and nutrition behaviours. Trial registration anzctr.org.au Identifier: ACTRN12609000735257

The effect of a pedometer-based community walking intervention "Walking for Wellbeing in the West" on physical activity levels and health outcomes: a 12-week randomized controlled trial

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Nimmo Myra

2008-09-01

Full Text Available Abstract Background Recent systematic reviews have suggested that pedometers may be effective motivational tools to promote walking. However, studies tend to be of a relatively short duration, with small clinical based samples. Further research is required to demonstrate their effectiveness in adequately powered, community based studies. Objective Using a randomized controlled trial design, this study assessed the impact of a 12-week graduated pedometer-based walking intervention on daily step-counts, self-reported physical activity and health outcomes in a Scottish community sample not meeting current physical activity recommendations. Method Sixty-three women and 16 men (49.2 years ± 8.8 were randomly assigned to either an intervention (physical activity consultation and 12-week pedometer-based walking program or control (no action group. Measures for step-counts, 7-day physical activity recall, affect, quality of life (n = 79, body mass, BMI, % body fat, waist and hip circumference (n = 76, systolic/diastolic blood pressure, total cholesterol and HDL cholesterol (n = 66 were taken at baseline and week 12. Analyses were performed on an intention to treat basis using 2-way mixed factorial analyses of variance for parametric data and Mann Whitney and Wilcoxon tests for non-parametric data. Results Significant increases were found in the intervention group for step-counts (p p = .02 and positive affect (p = .027. Significant decreases were found in this group for time spent in weekday (p = .003, weekend (p = .001 and total sitting (p = .001 with no corresponding changes in the control group. No significant changes in any other health outcomes were found in either group. In comparison with the control group at week 12, the intervention group reported a significantly greater number of minutes spent in leisure time (p = .008, occupational (p = .045 and total walking (p = .03, and significantly fewer minutes in time spent in weekend (p = .003 and

Comparison of folic acid levels in schizophrenic patients and control groups

Science.gov (United States)

Arthy, C. C.; Amin, M. M.; Effendy, E.

2018-03-01

Folic acid deficiency is a risk factor for schizophrenia through epidemiology, biochemistry and gene-related studies. Compared with healthy people, schizophrenic patients may have high homocysteine plasma values and homocysteine or low levels of folic acid, which seems to correlate with extrapyramidal motor symptoms caused by neuroleptic therapy and with symptoms of schizophrenia. In this present study, we focus on the difference of folic acid level between schizophrenic patient and control group. The study sample consisted of schizophrenic patients and 14 people in the control group and performed blood sampling to obtain the results of folic acid levels. The folic acid level in both groups was within normal range, but the schizophrenic patient group had lower mean folic acid values of 5.00 ng/ml (sb 1.66), compared with the control group with mean folic acid values of 10.75 ng/ml (sb 4.33). there was the group of the control group had a higher value of folic acid than the schizophrenic group.

Group Milieu in systemic and psychodynamic group therapy

DEFF Research Database (Denmark)

Lau, Marianne Engelbrecht; Kristensen, Ellids

Objectives: A recent meta-analysis also concluded that psychotherapeutic approaches are beneficial for adult with a history of CSA and maintained for at least six months follow-up. The results suggest that different characteristics of therapy moderate the therapeutic outcome. We found in a random......Objectives: A recent meta-analysis also concluded that psychotherapeutic approaches are beneficial for adult with a history of CSA and maintained for at least six months follow-up. The results suggest that different characteristics of therapy moderate the therapeutic outcome. We found...... in a randomized study of systemic versus psychodynamic group therapy, that the short-term outcome for patients who received systemic group psychotherapy was significantly better than the outcome for patients who received psychodynamic group psychotherapy. The current study assessed the group milieu in both groups....... Methods: This randomized prospective study included 106 women: 52 assigned to psychodynamic group psychotherapy and 54 assigned to systemic group psychotherapy. The Group Environment Scale (GES) was filled in the mid phase of therapy and analysed in three dimensions and 10 subscales. Results: The systemic...

Clinical outcome of increased flexion gap after total knee arthroplasty. Can controlled gap imbalance improve knee flexion?

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Ismailidis, P; Kuster, M S; Jost, B; Giesinger, K; Behrend, H

2017-06-01

Increased range of motion (ROM) while maintaining joint stability is the goal of modern total knee arthroplasty (TKA). A biomechanical study has shown that small increases in flexion gap result in decreased tibiofemoral force beyond 90° flexion. The purpose of this paper was to investigate clinical implications of controlled increased flexion gap. Four hundred and four TKAs were allocated into one of two groups and analysed retrospectively. In the first group (n = 352), flexion gap exceeded extension gap by 2.5 mm, while in the second group (n = 52) flexion gap was equal to the extension gap. The procedures were performed from 2008 to 2012. The patients were reviewed 12 months postoperatively. Objective clinical results were assessed for ROM, mediolateral and sagittal stability. Patient-reported outcome measures were the WOMAC score and the Forgotten Joint Score (FJS-12). After categorizing postoperative flexion into three groups (poor < 90°, satisfactory 91°-119°, good ≥ 120°) significantly more patients in group 1 achieved satisfactory or good ROM (p = 0.006). Group 1 also showed a significantly higher mean FJS-12 (group 1: 73, group 2: 61, p = 0.02). The mean WOMAC score was 11 in the first and 14 in the second group (n.s.). Increase in flexion gap did not influence knee stability. The clinical relevance of this study is that a controlled flexion gap increase of 2.5 mm may have a positive effect on postoperative flexion and patient satisfaction after TKA. Neither knee stability in the coronal and sagittal planes nor complications were influenced by a controlled increase in flexion gap. III.

Transcranial Direct Current Stimulation Does Not Improve Language Outcome in Subacute Poststroke Aphasia.

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Spielmann, Kerstin; van de Sandt-Koenderman, W Mieke E; Heijenbrok-Kal, Majanka H; Ribbers, Gerard M

2018-04-01

The aim of the present study is to investigate the effect of transcranial direct current stimulation on word-finding treatment outcome in subacute poststroke aphasia. In this multi-center, double-blind, randomized controlled trial with 6-month follow-up, we included 58 patients with subacute aphasia (transcranial direct current stimulation (1 mA, 20 minutes; experimental group) or sham transcranial direct current stimulation (control group) over the left inferior frontal gyrus. The primary outcome measure was the Boston Naming Test. Secondary outcome measures included naming performance for trained/untrained picture items and verbal communication. Both the experimental (n=26) and the control group (n=32) improved on the Boston Naming Test over the intervention period and 6-month follow-up; however, there were no significant differences between groups. Also for the secondary outcome measures, no significant differences were found. The results of the present study do not support an effect of transcranial direct current stimulation as an adjuvant treatment in subacute poststroke aphasia. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp. Unique identifier: NTR4364. © 2018 American Heart Association, Inc.

Perinatal Outcomes in Advanced Age Pregnancies

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Ertuğrul Yılmaz

2016-06-01

Full Text Available Objective: The aim of this study is to evaluate the impact of advanced maternal age on pregnancy outcomes Methods: A retrospective analysis of 951 birth registry records of Zeynep Kamil Hospital, were analyzed between Janu­ary 2003 and December 2007. Study group was made up of women ≥40 years old and control group was made up of women younger than 40 years. Results: Mean maternal age was 41.48 years in the study group and 26.41 years in the control group. Mean gesta­tional age at the time of delivery is 37.73 weeks in study group and 38.10 weeks in the control group. There was no statistical difference in terms of preterm delivery, multiple pregnancy, fetal anomaly, IUGR, superimpose preeclampsia oligohidramnios, presentation anomaly and placenta previa rates between the study and control groups. Incidence of preeclampsia (p=0.041, Chronic hypertension (p=0.001, GDM (p= 0.003,is found to be higher in study group. Cesar­ean birth rate is higher (p<0.05 and hospitalization time is longer in study group (p=0.001. 1st minute and 5th minute APGAR scores of the study group (6.99±2, 8.27±2 was lower than the 1st minute and 5th Minutes APGAR scores of the control group (7.38±1.6, 8.58±1.7. Neonatal intensive care unit administration rate is seen also higher in study group (p<0.01. Conclusion: Advanced maternal age was related to increased pregnancy complications and poor perinatal outcome. Preeclampsia, GDM, chronic hypertension is seen more common in advanced age pregnancies. Neonatal intensive care administration is higher and APGAR scores are lower; cesarean delivery was performed more common, and hospitaliza­tion time was longer in advanced age pregnancies. J Clin Exp Invest 2016; 7 (2: 157-162

Carbapenem Breakpoints for Acinetobacter baumannii Group: Supporting Clinical Outcome Data from Patients with Bacteremia.

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Lee, Yi-Tzu; Chiang, Mei-Chun; Kuo, Shu-Chen; Wang, Yung-Chih; Lee, I-Hsin; Chen, Te-Li; Yang, Ya-Sung

2016-01-01

The carbapenem breakpoints set by different organizations for Acinetobacter are discordant, but supporting clinical data are lacking. This study aimed to provide the first clinical outcome data to support the carbapenem breakpoints for Acinetobacter baumannii (Ab) group in patients with bacteremia. This study included 117 adults who received carbapenems for treatment of Ab group bacteremia in Taipei Veterans General Hospital over an 8-year period. We analyzed 30-day mortality rates among patient groups acquiring isolates with different carbapenem minimal inhibitory concentrations (MICs). The carbapenem MIC breakpoint derived from classification and regression tree (CART) analysis to delineate the risk of 30-day mortality was between MICs of ≤ 4 mg/L and ≥ 8 mg/L. Mortality rate was higher in patients acquiring isolates with carbapenem MIC ≥ 8 mg/L than ≤ 4 mg/L, by bivariate (54.9% [28/51] vs 25.8% [17/66]; P = 0.003) and survival analysis (P = 0.001 by log-rank test). Multivariate analysis using logistic regression and Cox regression models including severity of illness indices demonstrated that treating patients with Ab group bacteremia caused by isolates with a carbapenem MIC ≥ 8 mg/L with carbapenem was an independent predictor of 30-day mortality (odds ratio, 5.125; 95% confidence interval [CI], 1.946-13.498; P = 0.001, and hazard ratio, 2.630; 95% CI, 1.431-4.834; P = 0.002, respectively). The clinical outcome data confirmed that isolates with MIC ≤ 4 mg/L were susceptible to carbapenem, and those with MIC ≥ 8 mg/L were resistant in patients with Ab group bacteremia.

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus.

Science.gov (United States)

Petrak, Frank; Herpertz, Stephan; Albus, Christian; Hermanns, Norbert; Hiemke, Christoph; Hiller, Wolfgang; Kronfeld, Kai; Kruse, Johannes; Kulzer, Bernd; Ruckes, Christian; Müller, Matthias J

2013-08-06

Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50-200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT

Sami-speaking municipalities and a control group's access to somatic specialist health care (SHC: a retrospective study on general practitioners’ referrals

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Jan Norum

2012-03-01

Full Text Available Objectives: The Sami people constitute the indigenous people in northern Norway. The objective of this study was to clarify whether they have a similar supply of somatic specialist health care (SHC as others. Methods: The referrals from general practitioners (GPs in the primary health care (PHC in the administration area of the Sami language law (8 municipalities were matched with a control group of 11 municipalities. Population data was accessed from Statistics Norway and the time period 2007–2010 was analysed. The main outcome was the number of referrals per 1,000 inhabitants according to age group, gender and place of living. Results: 504,292 referrals in northern Norway were indentified and the Sami and control group constituted 23,093 and 22,541 referrals, respectively. The major findings were a similar referral ratio (RR (1.14 and 1.17 (p = 0.624 and women more commonly referred (female/male ratio 1.45 and 1.41 in both groups. GPs in both groups were loyal to their local hospital trust. Conclusion: Inhabitants in Sami-speaking municipalities in northern Norway have a similar supply of SHC services as controls. Inter-municipal variation was significant in both groups.

Patient-reported outcomes and aesthetic evaluation of root coverage procedures: a 12-month follow-up of a randomized controlled clinical trial.

Science.gov (United States)

Stefanini, Martina; Jepsen, Karin; de Sanctis, Massimo; Baldini, Nicola; Greven, Björn; Heinz, Bernd; Wennström, Jan; Cassel, Björn; Vignoletti, Fabio; Sanz, Mariano; Jepsen, Søren; Zucchelli, Giovanni

2016-12-01

To assess patient-reported outcome measures (PROMs), aesthetics and stability of root coverage procedures from a previous 6-month RCT after 1 year. Forty-five patients (90 recessions) had received a coronally advanced flap (CAF = control) only or a xenogeneic collagen matrix in addition (CAF + CMX = test). Visual analogue scales (VAS) and questionnaires were used for PROMs and the root coverage aesthetic score (RES) for professional aesthetic evaluations. VAS scores (patient satisfaction) amounted to 8.58 ± 1.86 (test) versus 8.38 ± 2.46 (control). Six patients preferred CAF + CMX concerning surgical procedure and aesthetics, six preferred CAF and 29 were equally satisfied. RES was 7.85 ± 2.42 for the test group versus 7.34 ± 2.90 for the controls. Root coverage (RC) was 76.28% for test and 75.05% for control defects. The mean increase in keratinized tissue width was higher in test (from 1.97 to 3.02 mm) than in controls (from 2.00 to 2.64 mm) (p = 0.0413). Likewise, test sites showed more gain in gingival thickness (0.52 mm) than control sites (0.27 mm) (p = 0.0023). Compared to 6 months, clinical outcomes were stable. Results for PROMs, RES and RC did not significantly differ between treatment groups. Thickness and width of keratinized tissue were enhanced following CAF + CMX compared to CAF alone. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Communicating program outcomes to encourage policymaker support for evidence-based state tobacco control.

Science.gov (United States)

Schmidt, Allison M; Ranney, Leah M; Goldstein, Adam O

2014-12-04

Tobacco use, the leading cause of preventable death in the U.S., can be reduced through state-level tobacco prevention and cessation programs. In the absence of research about how to communicate the need for these programs to policymakers, this qualitative study aimed to understand the motivations and priorities of policymakers in North Carolina, a state that enacted a strong tobacco control program from 2003-2011, but drastically reduced funding in recent years. Six former legislators (three Democrats, three Republicans) and three lobbyists for health organizations were interviewed about their attitudes towards tobacco use, support of state-funded programs, and reactions to two policy briefs. Five themes emerged: (1) high awareness of tobacco-related health concerns but limited awareness of program impacts and funding, (2) the primacy of economic concerns in making policy decisions, (3) ideological differences in views of the state's role in tobacco control, (4) the impact of lobbyist and constituent in-person appeals, and (5) the utility of concise, contextualized data. These findings suggest that building relationships with policymakers to communicate ongoing program outcomes, emphasizing economic data, and developing a constituent advocacy group would be valuable to encourage continued support of state tobacco control programs.

Controllability of linear vector fields on Lie groups

International Nuclear Information System (INIS)

Ayala, V.; Tirao, J.

1994-11-01

In this paper, we shall deal with a linear control system Σ defined on a Lie group G with Lie algebra g. The dynamic of Σ is determined by the drift vector field which is an element in the normalizer of g in the Lie algebra of all smooth vector field on G and by the control vectors which are elements in g considered as left-invariant vector fields. We characterize the normalizer of g identifying vector fields on G with C ∞ -functions defined on G into g. For this class of control systems we study algebraic conditions for the controllability problem. Indeed, we prove that if the drift vector field has a singularity then the Lie algebra rank condition is necessary for the controllability property, but in general this condition does not determine this property. On the other hand, we show that the rank (ad-rank) condition is sufficient for the controllability of Σ. In particular, we extend the fundamental Kalman's theorem when G is an Abelian connected Lie group. Our work is related with a paper of L. Markus and we also improve his results. (author). 7 refs

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

Directory of Open Access Journals (Sweden)

Hadi Yousefi

2015-11-01

Full Text Available OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA. METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS, patient general health (GH on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%, tobacco usage (25% vs. 19.8%, mean age (42.6±13.2 years vs. 46.6±10.9 years, and disease duration (15.3±6.7 months vs. 14.5±6.6 months. The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities.

Preoperative nonsteroidal anti-inflammatory drug or steroid and outcomes after trabeculectomy: a randomized controlled trial.

Science.gov (United States)

Breusegem, Christophe; Spielberg, Leigh; Van Ginderdeuren, Rita; Vandewalle, Evelien; Renier, Charlotte; Van de Veire, Sara; Fieuws, Steffen; Zeyen, Thierry; Stalmans, Ingeborg

2010-07-01

To investigate the benefit of preoperative treatment with either topical nonsteroidal anti-inflammatory drug (NSAID) or steroid in terms of clinical outcomes following trabeculectomy. Prospective, randomized placebo-controlled trial. Sixty-one patients. Between July 2005 and October 2007, 61 consecutive medically uncontrolled glaucoma patients scheduled for first-time trabeculectomy were randomized to 1 of 3 study topical medication groups: nonsteroidal anti-inflammatory drugs (ketorolac), steroids (fluorometholone), or placebo (artificial tears). Patients instilled 1 drop 4 times daily for 1 month before the procedure and were examined on days 1 and 2, at weeks 1, 2, and 4, and at months 3, 6, 12, 18, and 24 after trabeculectomy. Incidence of postoperative surgical or medical interventions (needling, laser suture lysis, needling revision, and intraocular pressure [IOP]-lowering medication). Fifty-four patients (54 eyes) were entered for analysis. The mean number of preoperative medications was 2.3+/-0.9. The mean baseline IOP was 21.0+/-6.0 mmHg. The mean postoperative target IOP was 16.5+/-1.8 mmHg. The mean follow-up was 23.6+/-4.0 months. The percentage of patients requiring needling within the first year was 41% in the placebo group, 6% in the NSAID, and 5% in the steroid group (P = 0.006). The percentage of patients requiring IOP-lowering medication to reach the target IOP at 1 year was 24% in the placebo group, 18% in the NSAID group, and 0% in the steroid group (P = 0.054 overall; P = 0.038 for steroids vs. others). The log-rank test showed a significant (P = 0.019) difference in medication-free survival curves between the different groups. More specifically, patients in the steroid group needed significantly less medication over the total follow-up (P = 0.007). Topical ketorolac or fluorometholone for 1 month before surgery was associated with improved trabeculectomy outcomes in terms of likelihood of postoperative needling. In the steroid group, there was

Correlation of Endometrial Glycodelin Expression and Pregnancy Outcome in Cases with Polycystic Ovary Syndrome Treated with Clomiphene Citrate Plus Metformin: A Controlled Study

Directory of Open Access Journals (Sweden)

Selda Uysal

2015-01-01

Full Text Available Objective. The purpose of this study was to evaluate the relationship between clomiphene citrate (CC plus metformin treatment and endometrial glycodelin expression and to then correlate this relationship with pregnancy outcomes. Material and Methods. A total of 30 patients diagnosed with polycystic ovary syndrome (PCOS according to the Rotterdam criteria constituted our study group. All had been admitted to the gynecology outpatient clinic between June 1, 2011, and January 1, 2012, for infertility treatment. Our control group consisted of 20 patients admitted for routine Pap smear control. They had no history of infertility and were not using contraceptives and they were actively attempting pregnancy. Midluteal progesterone measurement and pipelle endometrial biopsies were performed with both groups. For PCOS patients, metformin treatment was initiated right after the biopsy and CC was added in the second menstrual cycle. Pipelle endometrial biopsies were repeated. Histological dating and immunohistochemistry for glycodelin were performed by a single pathologist who was blinded to the patients’ clinical data. Result(s. The posttreatment ovulation rate in the study group was 93.3%. No pregnancies were achieved in either group when glycodelin expression was not present, even in the presence of ovulation. When glycodelin expression was high in PCOS group, the pregnancy rate was 60% and all pregnancies ended in live births. In weak expression group, however, three out of four pregnancies ended as early pregnancy losses. Conclusion(s. Endometrial glycodelin expression is an important predictor of pregnancy outcomes in both PCOS and fertile groups.

Feedback versus no feedback in improving patient outcome in group psychotherapy for eating disorders (F-EAT)

DEFF Research Database (Denmark)

Davidsen, Annika Helgadóttir; Poulsen, Stig Bernt; Waaddegaard, Mette

2014-01-01

or control group at a ratio of 1:1. The experimental group will receive standard treatment (systemic and narrative group psychotherapy) with feedback intervention, whereas the control group will receive standard treatment only. The participants are diagnosed with bulimia nervosa binge eating disorder...

The impact of socioeconomic position on severe maternal morbidity outcomes among women in Australia: a national case-control study.

Science.gov (United States)

Lindquist, A; Noor, N; Sullivan, E; Knight, M

2015-11-01

Studies in other developed countries have suggested that socioeconomic position may be a risk factor for poorer pregnancy outcomes. This analysis aimed to explore the independent impact of socioeconomic position on selected severe maternal morbidities among women in Australia. A case-control study using data on severe maternal morbidities associated with direct maternal death collected through the Australasian Maternity Outcomes Surveillance System. Australia. 623 cases, 820 controls. Logistic regression analysis to investigate differences in outcomes among different socioeconomic groups, classified by Socio-Economic Indexes for Areas (SEIFA) quintile. Severe maternal morbidity (amniotic fluid embolism, placenta accreta, peripartum hysterectomy, eclampsia or pulmonary embolism). SEIFA quintile was statistically significantly associated with maternal morbidity, with cases being twice as likely as controls to reside in the most disadvantaged areas (adjusted OR 2.00, 95%CI 1.29-3.10). Maternal age [adjusted odds ratio (aOR) 2.20 for women aged 35 or over compared with women aged 25-29, 95%CI 1.64-3.15] and previous pregnancy complications (aOR 1.30, 95%CI 1.21-1.87) were significantly associated with morbidity. A parity of 1 or 2 was protective (aOR 0.58, 95%CI 0.43-0.79), whereas previous caesarean delivery was associated with maternal morbidity (aOR 2.20 for women with one caesarean delivery, 95%CI 1.44-2.85, compared with women with no caesareans). The risk of severe maternal morbidity among women in Australia is significantly increased by social disadvantage. This study suggests that future efforts in improving maternity care provision and maternal outcomes in Australia should include socioeconomic position as an independent risk factor for adverse outcome. © 2014 Royal College of Obstetricians and Gynaecologists.

Direct versus Indirect and Individual versus Group Modes of Language Therapy for Children with Primary Language Impairment: Principal Outcomes from a Randomized Controlled Trial and Economic Evaluation

Science.gov (United States)

Boyle, James M.; McCartney, Elspeth; O'Hare, Anne; Forbes, John

2009-01-01

Background: Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and…

Effect of rehabilitation worker input on visual function outcomes in individuals with low vision: study protocol for a randomised controlled trial.

Science.gov (United States)

Acton, Jennifer H; Molik, Bablin; Binns, Alison; Court, Helen; Margrain, Tom H

2016-02-24

Visual Rehabilitation Officers help people with a visual impairment maintain their independence. This intervention adopts a flexible, goal-centred approach, which may include training in mobility, use of optical and non-optical aids, and performance of activities of daily living. Although Visual Rehabilitation Officers are an integral part of the low vision service in the United Kingdom, evidence that they are effective is lacking. The purpose of this exploratory trial is to estimate the impact of a Visual Rehabilitation Officer on self-reported visual function, psychosocial and quality-of-life outcomes in individuals with low vision. In this exploratory, assessor-masked, parallel group, randomised controlled trial, participants will be allocated either to receive home visits from a Visual Rehabilitation Officer (n = 30) or to a waiting list control group (n = 30) in a 1:1 ratio. Adult volunteers with a visual impairment, who have been identified as needing rehabilitation officer input by a social worker, will take part. Those with an urgent need for a Visual Rehabilitation Officer or who have a cognitive impairment will be excluded. The primary outcome measure will be self-reported visual function (48-item Veterans Affairs Low Vision Visual Functioning Questionnaire). Secondary outcome measures will include psychological and quality-of-life metrics: the Patient Health Questionnaire (PHQ-9), the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), the Adjustment to Age-related Visual Loss Scale (AVL-12), the Standardised Health-related Quality of Life Questionnaire (EQ-5D) and the UCLA Loneliness Scale. The interviewer collecting the outcomes will be masked to the group allocations. The analysis will be undertaken on a complete case and intention-to-treat basis. Analysis of covariance (ANCOVA) will be applied to follow-up questionnaire scores, with the baseline score as a covariate. This trial is expected to provide robust effect size estimates of the intervention

Social outcomes of young adults with childhood-onset epilepsy: A case-sibling-control study.

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Baca, Christine B; Barry, Frances; Vickrey, Barbara G; Caplan, Rochelle; Berg, Anne T

2017-05-01

We aimed to compare long-term social outcomes in young adults with childhood-onset epilepsy (cases) with neurologically normal sibling controls. Long-term social outcomes were assessed at the 15-year follow-up of the Connecticut Study of Epilepsy, a community-based prospective cohort study of children with newly diagnosed epilepsy. Young adults with childhood-onset epilepsy with complicated (abnormal neurologic exam findings, abnormal brain imaging with lesion referable to epilepsy, intellectual disability (ID; IQ < 60) or informative history of neurologic insults to which the occurrence of epilepsy might be attributed), and uncomplicated epilepsy presentations were compared to healthy sibling controls. Age, gender, and matched-pair adjusted generalized linear models stratified by complicated epilepsy and 5-year seizure-free status estimated adjusted odds ratios (aORs) and 95% confidence intervals [CIs] for each outcome. The 15-year follow-up included 361 individuals with epilepsy (59% of initial cases; N = 291 uncomplicated and N = 70 complicated epilepsy; mean age 22 years [standard deviation, SD 3.5]; mean epilepsy onset 6.2 years [SD 3.9]) and 173 controls. Social outcomes for cases with uncomplicated epilepsy with ≥5 years terminal remission were comparable to controls; cases with uncomplicated epilepsy <5 years seizure-free were more likely to be less productive (school/employment < 20 h/week) (aOR 3.63, 95% CI 1.83-7.20) and not to have a driver's license (aOR 6.25, 95% CI 2.85-13.72). Complicated cases with epilepsy <5 years seizure-free had worse outcomes across multiple domains; including not graduating high school (aOR 24.97, 95% CI 7.49-83.30), being un- or underemployed (<20 h/week) (aOR 11.06, 95% CI 4.44-27.57), being less productively engaged (aOR 15.71, 95% CI 6.88-35.88), and not living independently (aOR 10.24, 95% CI 3.98-26.36). Complicated cases without ID (N = 36) had worse outcomes with respect to productive engagement (aOR 6.02; 95% CI 2

[Relationship between factors of labour pain and delivery outcomes].

Science.gov (United States)

Ye, Hui-jun; Jiang, Yan-jiao; Ruan, Zhi-fang

2011-10-01

To evaluate factors associated with labor pain and delivery outcomes. From Jul. to Dec. 2009, 111 normal singleton cephalic presentation pregnancies (including 5 elderly parturient) who delivered at the Department of Obstetrics and Gynecology, Second Affiliated Hospital, Zhejiang Chinese Medical University were enrolled in this study to evaluate the relationship between factors of labor pain and delivery outcomes. The labor pain of latent phase and active phase were scored by the visual analogue scale (VAS). Factors associated with pain included the age of parturient, the number of gravidity and parity, occupation, education profile, dwell location, etc. The questionnaire was designed by ourselves. Childbirth awareness, psychological preparation of delivery, emotional controllability, couple relationship, the relationship of parturient and mother-in-law, the relationship of parturient and parents, family economic status, use of sedative during the labor process and delivery outcomes were collected and analyzed. (1) Factors associated with pain: in the latent phase, the rate of moderate labour pain of 1/5 in women with more than 35 years old was statistically lower than 76.4% (81/106) in suitable age group (P emotion control expressed significantly severe labour pain (59.0%, 36/61) than 35.6% (16/45) in well-prepared group. The rate of severe labour pain in good control of emotion group of 44.8% (43/96) was a statistically lower than 9/10 in poor control group. There was a statistically lower severe labour pain in women given by sedatives (29.2%, 7/24) than 54.9% (45/82) in women without sedatives treatment (P emotion control, young age and uniparous have severe labour pain. Sedative use could alleviate pain in active phase. Women with mild labour pain have good delivery outcomes.

A Web-Based, Social Networking Beginners’ Running Intervention for Adults Aged 18 to 50 Years Delivered via a Facebook Group: Randomized Controlled Trial

Science.gov (United States)

Boshoff, Kobie; Maher, Carol

2018-01-01

Background Online social networks continue to grow in popularity, with 1.7 billion users worldwide accessing Facebook each month. The use of social networking sites such as Facebook for the delivery of health behavior programs is relatively new. Objective The primary aim of this study was to determine the effectiveness of a Web-based beginners’ running program for adults aged 18 to 50 years, delivered via a Facebook group, in increasing physical activity (PA) and cardiorespiratory fitness. Methods A total of 89 adults with a mean age of 35.2 years (SD 10.9) were recruited online and via print media. Participants were randomly allocated to receive the UniSA Run Free program, an 8-week Web-based beginners’ running intervention, delivered via a closed Facebook group (n=41) that included daily interactive posts (information with links, motivational quotes, opinion polls, or questions) and details of the running sessions; or to the control group who received a hard copy of the running program (n=48). Assessments were completed online at baseline, 2 months, and 5 months. The primary outcome measures were self-reported weekly moderate to vigorous physical activity (MVPA) and objectively measured cardiorespiratory fitness. Secondary outcomes were social support, exercise attitudes, and self-efficacy. Analyses were undertaken using random effects mixed modeling. Compliance with the running program and engagement with the Facebook group were analyzed descriptively. Results Both groups significantly increased MVPA across the study period (P=.004); however, this was significantly higher in the Facebook group (P=.04). The Facebook group increased their MVPA from baseline by 140 min/week versus 91 min for the control at 2 months. MVPA remained elevated for the Facebook group (from baseline) by 129 min/week versus a 50 min/week decrease for the control at 5 months. Both groups had significant increases in social support scores at 2 months (P=.02); however, there were no group

Resilience following spinal cord injury: A prospective controlled study investigating the influence of the provision of group cognitive behavior therapy during inpatient rehabilitation.

Science.gov (United States)

Guest, Rebecca; Craig, Ashley; Nicholson Perry, Kathryn; Tran, Yvonne; Ephraums, Catherine; Hales, Alison; Dezarnaulds, Annalisa; Crino, Rocco; Middleton, James

2015-11-01

To examine change in resilience in people with spinal cord injury (SCI) when group cognitive behavior therapy (GCBT) was added to routine psychosocial rehabilitation (RPR). A prospective repeated-measures cohort design was used to determine the efficacy of the addition of GCBT (n = 50). The control group consisted of individuals receiving RPR, which included access to individual CBT (ICBT) when required (n = 38). Groups were assessed on 3 occasions: soon after admission, within 2 weeks of discharge, and 6-months postdischarge. Measures included sociodemographic, injury, and psychosocial factors. The outcome variable was resilience, considered an important outcome measure for recovery. To adjust for baseline differences in self-efficacy, depressive mood and anxiety between the 2 groups, these factors were entered into a repeated measures multivariate analysis of covariance (MANCOVA) as covariates. Latent class analysis was used to determine the best-fitting model of resilience trajectories for both groups. The MANCOVA indicated that the addition of GCBT to psychosocial rehabilitation did not result in improved resilience compared with the ICBT group. Trajectory data indicated over 60% were demonstrating acceptable resilience irrespective of group. Changes in resilience mean scores suggest the addition of GCBT adds little to resilience outcomes. Latent class modeling indicated both groups experienced similar trajectories of improvement and deterioration. Results highlight the importance of conducting multivariate modeling analysis that isolates subgroups of related cases over time to understand complex trajectories. Further research is needed to clarify individual differences in CBT intervention preference as well as other factors which impact on resilience. (c) 2015 APA, all rights reserved).

A cluster randomized controlled platform trial comparing group MEmory specificity training (MEST) to group psychoeducation and supportive counselling (PSC) in the treatment of recurrent depression.

Science.gov (United States)

Werner-Seidler, Aliza; Hitchcock, Caitlin; Bevan, Anna; McKinnon, Anna; Gillard, Julia; Dahm, Theresa; Chadwick, Isobel; Panesar, Inderpal; Breakwell, Lauren; Mueller, Viola; Rodrigues, Evangeline; Rees, Catrin; Gormley, Siobhan; Schweizer, Susanne; Watson, Peter; Raes, Filip; Jobson, Laura; Dalgleish, Tim

2018-06-01

Impaired ability to recall specific autobiographical memories is characteristic of depression, which when reversed, may have therapeutic benefits. This cluster-randomized controlled pilot trial investigated efficacy and aspects of acceptability, and feasibility of MEmory Specificity Training (MEST) relative to Psychoeducation and Supportive Counselling (PSC) for Major Depressive Disorder (N = 62). A key aim of this study was to determine a range of effect size estimates to inform a later phase trial. Assessments were completed at baseline, post-treatment and 3-month follow-up. The cognitive process outcome was memory specificity. The primary clinical outcome was symptoms on the Beck Depression Inventory-II at 3-month follow-up. The MEST group demonstrated greater improvement in memory specificity relative to PSC at post-intervention (d = 0.88) and follow-up (d = 0.74), relative to PSC. Both groups experienced a reduction in depressive symptoms at 3-month follow-up (d = 0.67). However, there was no support for a greater improvement in depressive symptoms at 3 months following MEST relative to PSC (d = -0.04). Although MEST generated changes on memory specificity and improved depressive symptoms, results provide no indication that MEST is superior to PSC in the resolution of self-reported depressive symptoms. Implications for later-phase definitive trials of MEST are discussed. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Gender discrepancies in the outcomes of schedule control on overtime hours and income in Germany

OpenAIRE

Lott, Yvonne; Chung, Heejung

2016-01-01

Schedule control can have both positive – e.g., increased income – but also negative outcomes – e.g., increased overtime. Here our core interest is whether there are gender discrepancies in these outcomes. Given the different ways in which schedule control can be used, and perceived to be used by men and women, their outcomes are also expected to be different. This is examined using the German Socio-Economic Panel Study (2003-2011), and panel regression models. The results show that schedule ...

The impact of a new standard labor protocol on maternal and neonatal outcomes.

Science.gov (United States)

Wang, Dingran; Ye, Shenglong; Tao, Liyuan; Wang, Yongqing

2017-12-01

To analyze the clinical outcomes following the implementation of a new standard labor procedure. This was a retrospective analysis that included a study group consisting of patients managed based on a new standard labor protocol and a control group comprising patients managed under an old standard labor protocol. The following maternal and perinatal outcomes were compared in the two groups: the indications for a cesarean section and the incidence of cesarean section, postpartum hemorrhage, fetal distress, neonatal asphyxia and pediatric intervention. We also compared the average number of days spent in the hospital, the incidence of medical disputes and hospitalization expenses. The cesarean section rates for the study and control groups were 19.29% (401/2079) and 33.53% (753/2246), respectively (P labor, fetal distress and intrapartum fever; the percentages of each indication were significantly different from those of the control group (P labor protocol reduced the cesarean section rate without negatively impacting maternal and neonatal outcomes. In practice, bed turnover and the hospital utilization rate should be better controlled, patient-doctor communication should be strengthened and the quality of obstetrical service should be improved.

The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults.

Science.gov (United States)

Ogedegbe, Gbenga; Fernandez, Senaida; Fournier, Leanne; Silver, Stephanie A; Kong, Jian; Gallagher, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A

2013-05-01

The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination. Copyright © 2013. Published by Elsevier Inc.

Control group design: enhancing rigor in research of mind-body therapies for depression.

Science.gov (United States)

Kinser, Patricia Anne; Robins, Jo Lynne

2013-01-01

Although a growing body of research suggests that mind-body therapies may be appropriate to integrate into the treatment of depression, studies consistently lack methodological sophistication particularly in the area of control groups. In order to better understand the relationship between control group selection and methodological rigor, we provide a brief review of the literature on control group design in yoga and tai chi studies for depression, and we discuss challenges we have faced in the design of control groups for our recent clinical trials of these mind-body complementary therapies for women with depression. To address the multiple challenges of research about mind-body therapies, we suggest that researchers should consider 4 key questions: whether the study design matches the research question; whether the control group addresses performance, expectation, and detection bias; whether the control group is ethical, feasible, and attractive; and whether the control group is designed to adequately control for nonspecific intervention effects. Based on these questions, we provide specific recommendations about control group design with the goal of minimizing bias and maximizing validity in future research.

Group prenatal care.

Science.gov (United States)

Mazzoni, Sara E; Carter, Ebony B

2017-06-01

Patients participating in group prenatal care gather together with women of similar gestational ages and 2 providers who cofacilitate an educational session after a brief medical assessment. The model was first described in the 1990s by a midwife for low-risk patients and is now practiced by midwives and physicians for both low-risk patients and some high-risk patients, such as those with diabetes. The majority of literature on group prenatal care uses CenteringPregnancy, the most popular model. The first randomized controlled trial of CenteringPregnancy showed that it reduced the risk of preterm birth in low-risk women. However, recent meta-analyses have shown similar rates of preterm birth, low birthweight, and neonatal intensive care unit admission between women participating in group prenatal care and individual prenatal care. There may be subgroups, such as African Americans, who benefit from this type of prenatal care with significantly lower rates of preterm birth. Group prenatal care seems to result in increased patient satisfaction and knowledge and use of postpartum family planning as well as improved weight gain parameters. The literature is inconclusive regarding breast-feeding, stress, depression, and positive health behaviors, although it is theorized that group prenatal care positively affects these outcomes. It is unclear whether group prenatal care results in cost savings, although it may in large-volume practices if each group consists of approximately 8-10 women. Group prenatal care requires a significant paradigm shift. It can be difficult to implement and sustain. More randomized trials are needed to ascertain the true benefits of the model, best practices for implementation, and subgroups who may benefit most from this innovative way to provide prenatal care. In short, group prenatal care is an innovative and promising model with comparable pregnancy outcomes to individual prenatal care in the general population and improved outcomes in some

Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study.

Science.gov (United States)

Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

2017-10-04

Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical industry or not, published in 2011. A structured search of PubMed identified RCTs examining the efficacy of pharmaceutical interventions. Number of outcome measures, number of animals enrolled per trial, whether a primary outcome was identified, and the presence of a sample size calculation were extracted from the RCTs. The source of funding was identified for each trial and groups compared on the above parameters. Literature searches returned 972 papers; 86 papers comprising 126 individual trials were analysed. The median number of outcomes per trial was 5.0; there were no significant differences across funding groups (p = 0.133). The median number of animals enrolled per trial was 30.0; this was similar across funding groups (p = 0.302). A primary outcome was identified in 40.5% of trials and was significantly more likely to be stated in trials funded by a pharmaceutical company. A very low percentage of trials reported a sample size calculation (14.3%). Failure to report primary outcomes, justify sample sizes and the reporting of multiple outcome measures was a common feature in all of the clinical trials examined in this study. It is possible some of these factors may be affected by the source of funding of the studies, but the influence of funding needs to be explored with a larger number of trials. Some veterinary RCTs provide a weak evidence base and targeted strategies are required to improve the quality of veterinary RCTs to ensure there is reliable evidence on which to base clinical decisions.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

Science.gov (United States)

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

Periodontal treatment outcomes during pregnancy and postpartum.

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Moreira, Carlos Heitor Cunha; Weidlich, Patrícia; Fiorini, Tiago; da Rocha, José Mariano; Musskopf, Marta Liliana; Susin, Cristiano; Oppermann, Rui Vicente; Rösing, Cassiano Kuchenbecker

2015-09-01

This study was conducted to compare periodontal therapy outcomes during pregnancy and after delivery. One hundred nine pregnant women up to the 20th gestational week (GW) were randomized into two groups: the test group (comprehensive periodontal therapy during pregnancy) and the control group (comprehensive periodontal therapy after delivery). Periodontal examinations comprised plaque index (PI), gingival index (GI), periodontal probing depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), and gingival crevicular fluid (GCF) volume. After baseline examination, women in the test group received periodontal treatment up to the 24th GW. The final examination was performed at the 26th to the 28th GW. Women in the control group were treated 30 days after delivery and reexamined 30 days after treatment. Periodontal therapy significantly reduced periodontal inflammation in both groups. The mean percentage of sites with BOP was reduced from 49.14 % (±22.49) to 11.10 % (±7.84) and from 45.71 % (±17.86) to 8.07 % (±5.21) in the test and control groups, respectively (p = 0.95). No statistically significant differences were observed between groups concerning PI, GI, PPD, CAL, and GCF. The reduction in mean percentage of sites with BOP stratified for initial PPD ≥4 mm was higher in the control group (p pregnancy do not interfere in treatment outcomes in women with widespread gingival inflammation and limited periodontal destruction. The role of these hormonal changes in pregnant women with different disease patterns remains uncertain. Periodontal health can be reestablished irrespective of the hormonal challenge that takes place during pregnancy.

A Cluster Randomized-Controlled Trial of a Classroom-Based Drama Workshop Program to Improve Mental Health Outcomes among Immigrant and Refugee Youth in Special Classes

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Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D.; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily

2014-01-01

Objectives The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Methods Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom. Results The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents. Conclusion The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences

Testing the Efficacy of a Kindergarten Mathematics Intervention by Small Group Size

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Ben Clarke

2017-04-01

Full Text Available This study used a randomized controlled trial design to investigate the ROOTS curriculum, a 50-lesson kindergarten mathematics intervention. Ten ROOTS-eligible students per classroom (n = 60 were randomly assigned to one of three conditions: a ROOTS five-student group, a ROOTS two-student group, and a no-treatment control group. Two primary research questions were investigated as part of this study: What was the overall impact of the treatment (the ROOTS intervention as compared with the control (business as usual? Was there a differential impact on student outcomes between the two treatment conditions (two- vs. five-student group? Initial analyses for the first research question indicated a significant impact on three outcomes and positive but nonsignificant impacts on three additional measures. Results for the second research question, comparing the two- and five-student groups, indicated negligible and nonsignificant differences. Implications for practice are discussed.

The outcomes of a 12-week Internet intervention aimed at improving fitness and health-related quality of life in overweight adolescents: the Young & Active controlled trial.

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Kirsti Riiser

Full Text Available Overweight and obesity among adolescents may have consequences, with potentially lasting effects on health and health-related quality of life (HRQoL. Excess weight is also associated with decreases in physical activity and cardiorespiratory fitness. The aim of the current study was to investigate the short-term effects of a 12-week Internet intervention in a primary care setting intended to increase cardiorespiratory fitness and HRQoL among overweight and obese adolescents.In this controlled trial, participants (13-15 years were non-randomly allocated to an intervention- or a control group. The intervention group received 12-weeks access to an online program providing tailored physical activity counseling based on principles from Self-determination Theory and Motivational Interviewing. The control group received standard follow-up by the school nurses. The primary outcome measure of cardiorespiratory fitness was determined using a shuttle run test. The secondary outcomes: HRQoL, leisure time exercise, body image and self-determined motivation for physical activity and exercise, were assessed by self-report measures. Age- and gender-adjusted body mass index (BMI was calculated based on measurements of height and weight. To compare pre-to post intervention differences within groups, a paired samples t-test was used while crude differences between groups were analyzed with an independent samples t-test.Of the 120 participants, 108 completed the study, 75 in the intervention group and 33 in the control group. Exposure to the intervention had a small effect on cardiorespiratory fitness (0.14; 95% CI [0.01;0.28]; P = 0.04, and a moderate effect on HRQoL (5.22; 95% CI [0.90; 9.53]; P = 0.02. Moreover, the control group increased significantly in BMI, yielding a moderate preventive effect on BMI (-0.39; 95% CI [-0.74;-0.03]; P = 0.03 for the intervention group.The results suggest that the Internet intervention with tailored physical activity counseling

Clinical outcomes of an early intervention program for preschool children with Autism Spectrum Disorder in a community group setting.

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Eapen, Valsamma; Crnčec, Rudi; Walter, Amelia

2013-01-07

Available evidence indicates that early intervention programs, such as the Early Start Denver Model (ESDM), can positively affect key outcomes for children with Autism Spectrum Disorder (ASD). However, programs involving resource intensive one-to-one clinical intervention are not readily available or deliverable in the community, resulting in many children with ASD missing out on evidence-based intervention during their early and most critical preschool years. This study evaluated the effectiveness of the ESDM for preschool-aged children with ASD using a predominantly group-based intervention in a community child care setting. Participants were 26 children (21 male) with ASD with a mean age of 49.6 months. The ESDM, a comprehensive early intervention program that integrates applied behaviour analysis with developmental and relationship-based approaches, was delivered by trained therapists during the child's attendance at a child care centre for preschool-aged children with ASD. Children received 15-20 hours of group-based, and one hour of one-to-one, ESDM intervention per week. The average intervention period was ten months. Outcome measures were administered pre- and post-intervention, and comprised a developmental assessment - the Mullen Scales of Early Learning (MSEL); and two parent-report questionnaires - the Social Communication Questionnaire (SCQ) and Vineland Adaptive Behaviours Scales-Second Edition (VABS-II). Statistically significant post-intervention improvements were found in children's performance on the visual reception, receptive language and expressive language domains of the MSEL in addition to their overall intellectual functioning, as assessed by standardised developmental quotients. Parents reported significant increases in their child's receptive communication and motor skills on the VABS-II, and a significant decrease in autism-specific features on the SCQ. These effects were of around medium size, and appeared to be in excess of what may

Cognitive impairment in schizophrenia across age groups: a case-control study.

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Mosiołek, Anna; Gierus, Jacek; Koweszko, Tytus; Szulc, Agata

2016-02-24

The potential dynamics of cognitive impairment in schizophrenia is discussed in the literature of the field. Recent publications suggest modest changes in level of cognitive impairment after first psychotic episode. Present article attempts to explore cognitive differences between patients and controls across age groups and differences between age groups in clinical group. One hundred and twenty-eight hospitalized patients with schizophrenia (64 women and 64 men) and 68 individuals from the control group (32 women and 32 men) aged 18-55 years were examined. The patients were divided into age groups (18-25, 26-35, 36-45, 46-55). Both groups were examined using Wisconsin Card Sorting Test, Rey Auditory Verbal Learning Test, Rey Osterrieth Complex Figure Test, Trail Making Test (A and B), Stroop Test, verbal fluency test and Wechsler digit span. Patients with schizophrenia obtained significantly lower scores versus the control group in regard to all the measured cognitive functions (Mann-Whitney U; p age groups, however, statistically important impairment in executive functions (WCST) were present only in "older" groups. Patients with schizophrenia obtained less favourable results than the control group in all age groups. Deficits regarding executive functions do not seem to be at a significant level among the youngest group, whereas they are more noticeable in the group of 46-55-year-olds. Executive functions are significantly lowered in the group aged 36-45 in comparison to the "younger" groups. The level of cognitive functions shows a mild exacerbation in connection with age, whereas cognitive rigidity proved to be related to the number of years spent without hospital treatment.

Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes.

NARCIS (Netherlands)

Patel, A.; MacMahon, S; Chalmers, J.; Neal, B.; Billot, L.; Woodward, M.; Marre, M.; Cooper, M.; Glasziou, P.; Grobbee, D.E.; Hamet, P.; Harrap, S.; Heller, S.; Liu, L.; Mancia, G.; Mogensen, C.E.; Pan, C.; Poulter, N.; Rodgers, A.; Williams, B.; Bompoint, S.; Galan, B.E. de; Joshi, R.; Travert, F.

2008-01-01

BACKGROUND: In patients with type 2 diabetes, the effects of intensive glucose control on vascular outcomes remain uncertain. METHODS: We randomly assigned 11,140 patients with type 2 diabetes to undergo either standard glucose control or intensive glucose control, defined as the use of gliclazide

Adolescent and parent motivation for change affects psychotherapy outcomes among youth with poorly controlled diabetes.

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Ellis, Deborah A; Berio, Heidi; Carcone, April Idalski; Naar-King, Sylvie

2012-01-01

Investigate effect of baseline motivation for change on treatment fidelity, therapeutic alliance, treatment dose, and treatment outcome in a randomized controlled trial of family therapy for youth with poorly controlled diabetes. Seventy-four adolescents and caregivers completed measures of motivation for change. Measures of fidelity, alliance, dose, and youth health status were collected. Structural equation modeling was used to test the direct and indirect effects of motivation on treatment outcomes. Parent motivation was significantly related to alliance and fidelity. Only alliance was significantly related to posttreatment metabolic control. In adolescent models, only motivation was significantly related to alliance. In both models, motivation had a significant indirect effect on metabolic control through alliance. Findings demonstrate the importance of parent and youth initial motivational status and treatment alliance to treatment outcome among youth with poorly controlled diabetes. Additional research on treatment techniques that promote motivation for change is needed.

[Effects of blood glucose control on glucose variability and clinical outcomes in patients with severe acute pancreatitis in intensive care unit].

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Wu, Jing; Sun, Qiuhong; Yang, Hua

2015-05-19

To explore the effects of blood glucose control on glucose variability and clinical outcomes in patients with severe acute pancreatitis in intensive care unit (ICU). A total of 72 ICU patients with severe acute pancreatitis were recruited and divided randomly into observation and control groups (n = 36 each). Both groups were treated conventionally. And the observation group achieved stable blood glucose at 6.1-8.3 mmol/L with intensive glucose control. The length of ICU and hospital stays, ICU mortality rate, transit operative rate, concurrent infection rate, admission blood glucose, glycosylated hemoglobin, mean insulin dose, mean blood glucose, blood glucose value standard deviation (GLUSD), glycemic liability index (GLUGLI) and mean amplitude of glycemic excursion (GLUMAGE) of two groups were compared. At the same time, the relationship between blood glucose variability, ICU mortality rate and its predictive value were analyzed by correlation analysis and receiver operating characteristic curve (ROC). The lengths of ICU and hospital stays of observation group were all significantly less than those of the control group [(11.7 ± 9.9) vs (15.9 ± 8.02) days, (21.8 ± 10.8) vs (28.2 ± 12.7) days, P blood glucose value and GLUSD of observation group were significantly lower than those of control group [(7.4 ± 1.1) vs (9.6 ± 1.2), (1.8 ± 1.0) vs (2.5 ± 1.3) mmol/L]. The differences were statistically significant (P curve analysis showed that, AUC of GLUGLI was 0.748 and 95% CI 0.551-0.965 (P glucose control in patients with severe acute pancreatitis helps reduce the blood sugar fluctuations, lower the risks of infectious complications and promote the patient rehabilitation. And GLUGLI is positively correlated with ICU mortality rate. It has good predictive values.

Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial

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Golant Mitch

2011-08-01

Full Text Available Abstract Background The Internet can increase access to psychosocial care for breast cancer survivors through online support groups. This study will test a novel prosocial online group that emphasizes both opportunities for getting and giving help. Based on the helper therapy principle, it is hypothesized that the addition of structured helping opportunities and coaching on how to help others online will increase the psychological benefits of a standard online group. Methods/Design A two-armed randomized controlled trial with pretest and posttest. Non-metastatic breast cancer survivors with elevated psychological distress will be randomized to either a standard facilitated online group or to a prosocial facilitated online group, which combines online exchanges of support with structured helping opportunities (blogging, breast cancer outreach and coaching on how best to give support to others. Validated and reliable measures will be administered to women approximately one month before and after the interventions. Self-esteem, positive affect, and sense of belonging will be tested as potential mediators of the primary outcomes of depressive/anxious symptoms and sense of purpose in life. Discussion This study will test an innovative approach to maximizing the psychological benefits of cancer online support groups. The theory-based prosocial online support group intervention model is sustainable, because it can be implemented by private non-profit or other organizations, such as cancer centers, which mostly offer face-to-face support groups with limited patient reach. Trial Registration ClinicalTrials.gov: NCT01396174

Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial.

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Lepore, Stephen J; Buzaglo, Joanne S; Lieberman, Morton A; Golant, Mitch; Davey, Adam

2011-08-25

The Internet can increase access to psychosocial care for breast cancer survivors through online support groups. This study will test a novel prosocial online group that emphasizes both opportunities for getting and giving help. Based on the helper therapy principle, it is hypothesized that the addition of structured helping opportunities and coaching on how to help others online will increase the psychological benefits of a standard online group. A two-armed randomized controlled trial with pretest and posttest. Non-metastatic breast cancer survivors with elevated psychological distress will be randomized to either a standard facilitated online group or to a prosocial facilitated online group, which combines online exchanges of support with structured helping opportunities (blogging, breast cancer outreach) and coaching on how best to give support to others. Validated and reliable measures will be administered to women approximately one month before and after the interventions. Self-esteem, positive affect, and sense of belonging will be tested as potential mediators of the primary outcomes of depressive/anxious symptoms and sense of purpose in life. This study will test an innovative approach to maximizing the psychological benefits of cancer online support groups. The theory-based prosocial online support group intervention model is sustainable, because it can be implemented by private non-profit or other organizations, such as cancer centers, which mostly offer face-to-face support groups with limited patient reach. ClinicalTrials.gov: NCT01396174.

Examining the relationships between span of control and manager job and unit performance outcomes.

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Wong, Carol A; Elliott-Miller, Pat; Laschinger, Heather; Cuddihy, Michael; Meyer, Raquel M; Keatings, Margaret; Burnett, Camille; Szudy, Natalie

2015-03-01

Our aim was to examine the combination of frontline manager (FLM) personal characteristics and span of control (SOC) on their job and unit performance outcomes. Healthcare downsizing and reform have contributed to larger spans for FLMs in Canadian hospitals and increased concerns about manager workload. Despite a heightened awareness of SOC issues among decision makers, there is limited empirical evidence related to the effects of SOC on outcomes. A non-experimental predictive survey design was used to examine FLM SOC in 14 Canadian academic hospitals. Managers (n = 121) completed an online survey of work characteristics and The Ottawa Hospital (TOH) SOC tool. Unit turnover data were collected from organisational databases. The combination of SOC and core self-evaluation significantly predicted role overload, work control and job satisfaction, but only SOC predicted unit adverse outcomes and neither significantly predicted unit turnover. The findings contribute to an understanding of connections between the combination of SOC and core self-evaluation and manager job and unit performance outcomes. Organisational strategies to create manageable FLM SOC are essential to ensure exemplary job and unit outcomes. Core self-evaluation is a personality characteristic that may enhance manager performance in the face of high spans of control. © 2013 John Wiley & Sons Ltd.

Impact of obesity on pregnancy outcome in different ethnic groups: calculating population attributable fractions.

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Eugene Oteng-Ntim

Full Text Available OBJECTIVES: To quantify the proportion of adverse pregnancy outcome attributable to maternal obesity. DESIGN: Cross sectional analysis of routine obstetric dataset. SETTING: Guy's and St Thomas's NHS Foundation Trust (GSTFT. POPULATION: 23,668 women who had singleton deliveries at GSTFT between 2004 and 2008. METHODS: Logistic regression was used to estimate the association between BMI and outcome in different ethnic groups. Adjusted odds ratios, and the proportions of obese women, were used to calculate population attributable risk fractions (PAFs. MAIN OUTCOME MEASURES: (I MATERNAL OUTCOMES: diabetes, type of delivery, post-partum haemorrhage, and preterm delivery. (ii Perinatal outcomes: macrosomia, low birth weight, admission to neonatal intensive care/special care baby unit, and perinatal death. RESULTS: The prevalence of maternal obesity was 14%. Increasing BMI was independently associated with increasing risk of adverse obstetric and neonatal outcome. At the individual level, the effect of obesity on diabetes was highest in Asian women compared to white women (p for interaction = 0.03. Calculation of population attributable risk fractions demonstrated that one third of diabetes cases and one in six Caesarean sections could be avoided in this population if all obese women were of normal BMI. At the population level, the contribution of obesity to diabetes was highest for Black women (42%, and lowest for oriental women (8%. Seven percent of neonatal macrosomia in all the population, and 13% in Black mothers, were attributable to obesity. CONCLUSIONS: Preventing obesity prior to pregnancy will substantially reduce the burden of obstetric and neonatal morbidity in this population. This reduction will be higher in Black women.

Student Teaching Abroad Inter-Group Outcomes: A Comparative, Country-Specific Analysis

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Binbin Jiang

2010-11-01

Full Text Available As student diversity becomes the norm in U.S. schools, future teachers must be comprehensively prepared to work with the increasingly diverse student population through application of informed instruction that enhances general and individual student learning and outcomes. Teacher Education programs increasingly promote student teaching in international settings as a substantive step to develop teachers who embody these new competencies and instructional practices. The proposed paper presentation offers a framework and analysis highlighting similarities and differences between two groups of student teachers in Belize (2005 and 2008. Findings are comparative and relate to the type and degree of (1 cultural-, professional-, and character-development influences on student teachers, and (2 emergent common intergroup patterns.

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial.

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Bardutzky, Jürgen; Witsch, Jens; Jüttler, Eric; Schwab, Stefan; Vajkoczy, Peter; Wolf, Stefan

2011-09-14

Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines.In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage.

Effects of low-frequency repetitive transcranial magnetic stimulation on upper extremity motor recovery and functional outcomes in chronic stroke patients: A randomized controlled trial.

Science.gov (United States)

Aşkın, Ayhan; Tosun, Aliye; Demirdal, Ümit Seçil

2017-06-01

Repetitive transcranial magnetic stimulation (rTMS) was suggested as a preconditioning method that would increase brain plasticity and that it would be optimal to combine rTMS with intensive rehabilitation. To assess the efficacy of inhibitory rTMS on upper extremity motor recovery and functional outcomes in chronic ischemic stroke patients. In this randomized controlled trial, experimental group received low-frequency (LF) rTMS to the primary motor cortex of the unaffected side + physical therapy (PT), and control group received PT. No statistically significant difference was found in baseline demographical and clinical characteristics of the subjects including stroke severity or severity of paralysis prior to intervention. There were statistically significant improvements in all clinical outcome measures except for the Brunnstrom Recovery Stages. Fugl-Meyer Assessment, Box and Block test, motor and total scores of Functional Independence Measurement (FIM), and Functional Ambulation Scale (FAS) scores were significantly increased in both groups, however, these changes were significantly greater in the rTMS group except for FAS score. FIM cognitive scores and standardized mini-mental test scores were significantly increased and distal and hand Modified Ashworth Scale scores were significantly decreased only in the rTMS group (p functional, and cognitive deficits in chronic stroke. Further studies with a larger number of patients with longer follow-up periods are needed to establish its effectiveness in stroke rehabilitation.

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

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Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Tong, Seng Fah; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H

2016-11-14

The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c diabetes mellitus patients were recruited at baseline (intervention: 471 vs. 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. -4.1%, P diabetes in the Malaysian public primary care setting. Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

Pregnancy in infertile PCOD patients. Complications and outcome.

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Urman, B; Sarac, E; Dogan, L; Gurgan, T

1997-08-01

To evaluate the complications and outcome of pregnancy in women with polycystic ovary disease (PCOD). The course and outcome of 47 singleton pregnancies in women with well-documented PCOD were compared with those in 100 healthy controls. Women with PCOD had a significantly higher body mass index as compared to the control group (P PCOD (P PCOD subjects were compared with lean control subjects, the difference in the incidence of the above complications was still significant (P PCOD subjects were compared with obese controls. Women with PCOD were at increased risk of gestational diabetes and pregnancy-induced hypertension, and this risk appeared to be independent of body mass index.

The influence of cold pack on labour pain relief and birth outcomes: a randomised controlled trial.

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Shirvani, Marjan Ahmad; Ganji, Zhila

2014-09-01

(1) To evaluate the influence of local cold on severity of labour pain and (2) to identify the effect of local cold on maternal and neonatal outcomes. Fear of labour pain results in an increase in pain and duration of labour, maternal discontent and demand for caesarean section. Regarding maternal and foetal complications of analgesic medications, the attention to application of nonpharmacological methods including cold therapy is increased. Randomised controlled trial. Sixty-four pregnant women, at initiation of active phase of labour, were allocated randomly to cold therapy and control groups (n = 64). Null parity, term pregnancy, presence of single foetus, cephalic presentation and completing informed consent were considered as inclusion criteria. Administration of analgesic and anaesthesia, foetal distress, skin lesions in regions of cold therapy and high-risk pregnancy provided exclusion criteria. Cold pack was applied over abdomen and back, for 10 minutes every 30 minutes during first phase of labour. Additionally, cold pack was placed over perineum, for 5 minutes every 15 minutes during second phase. Pain severity was assessed based on the visual analogue scale. The two groups were not significantly different considering demographic data, gestational age, foetal weight, rupture of membranes and primary severity of pain. Degree of pain was lower in cold therapy group during all parts of active phase and second stage. Duration of all phases was shorter in cold therapy group in all phases. Foetal heart rate, perineal laceration, type of birth, application of oxytocin and APGAR score were not significantly different between two groups. Labour pain is probably reduced based on gate theory using cold. Pain control by cold maybe improves labour progression without affecting mother and foetus adversely. Local cold therapy could be included in labour pain management. © 2013 John Wiley & Sons Ltd.

Functional outcome of microsurgical clipping compared to endovascular coiling.

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Premananda, R M; Ramesh, N; Hillol, K P

2012-12-01

Endovascular coiling has been used increasingly as an alternative to neurosurgical clipping for treating subarachnoid hemorrhage secondary to aneurysm rupture. In a retrospective cohort review on the treatment methods of aneurysm rupture in Hospital Kuala Lumpur over the period of five years (2005-2009) a total of 268 patients were treated. These patients were broadly categorized into two groups based on their treatment mode for ruptured aneurysms. Statistical analysis was determined using Chi- Square tests to study these associations. In our study, 67.5% of patients presented with Good World Federation of Neurosurgical Societies (WFNS) grade (WFNS1-2) while 32.5% patients presented with Poor WFNS prior to intervention. In our outcome, it was noted that 60.4% had good functional outcome (mRS grade 0-2) as compared to 39.6% patients who had poor mRS(modified rankin scale) outcome (mRS 3-6). In the good WFNS group, 76% of patients in clipping group had a good mRS outcome while, 86.5% patients in coiling group had good mRS outcome (p=0.114). In poor WFNS presentation, it was noted that in 77.3% patients in clipping group, had poor mRS outcome. Similarly with poor WFNS presentation, 83.3% of patient in coiling group had poor outcome. (p=1.00). Hence when we control the WFNS group, there was no significant association between treatment group (clipping and coiling) and mRS outcome at 6 months. The outcome of patient is determined by initial clinical presentation (WFNS grade) and influenced by requirement of Extraventricular drain (EVD) in presence of hydrocephalus, CSF infection and pneumonia. Therefore the decision regarding treatment option needs to be individualized based on the presentation of the patient.

Age-dependent effect of apolipoprotein E4 on functional outcome after controlled cortical impact in mice.

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Mannix, Rebekah C; Zhang, Jimmy; Park, Juyeon; Zhang, Xuan; Bilal, Kiran; Walker, Kendall; Tanzi, Rudolph E; Tesco, Giuseppina; Whalen, Michael J

2011-01-01

The apolipoprotein E4 (APOE4) gene leads to increased brain amyloid beta (Aβ) and poor outcome in adults with traumatic brain injury (TBI); however, its role in childhood TBI is controversial. We hypothesized that the transgenic expression of human APOE4 worsens the outcome after controlled cortical impact (CCI) in adult but not immature mice. Adult and immature APOE4 mice had worse motor outcome after CCI (P<0.001 versus wild type (WT)), but the Morris water maze performance was worse only in adult APOE4 mice (P=0.028 at 2 weeks, P=0.019 at 6 months versus WT), because immature APOE4 mice had performance similar to WT for up to 1 year after injury. Brain lesion size was similar in adult APOE4 mice but was decreased (P=0.029 versus WT) in injured immature APOE4 mice. Microgliosis was similar in all groups. Soluble brain Aβ(40) was increased at 48 hours after CCI in adult and immature APOE4 mice and in adult WT (P<0.05), and was dynamically regulated during the chronic period by APOE4 in adults but not immature mice. The data suggest age-dependent effects of APOE4 on cognitive outcome after TBI, and that therapies targeting APOE4 may be more effective in adults versus children with TBI.

Effect of periodontal therapy on pregnancy outcome in women affected by periodontitis.

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Tarannum, Fouzia; Faizuddin, Mohamed

2007-11-01

There is convincing evidence to suggest that infections affecting the mother during pregnancy may produce alterations in the normal cytokine- and hormone-regulated gestation, which could result in preterm labor, premature rupture of membranes, and preterm birth (PTB). Studies in the late 1990s associated periodontitis with preterm low birth weight (PLBW) deliveries, and this may have similar pathogenic mechanisms as other maternal infections. This study determined the effect of non-surgical periodontal therapy on pregnancy outcome. A total of 200 pregnant women with periodontitis were randomly assigned to treatment and control groups. Detailed data about previous and current pregnancies were obtained. All women received a full-mouth periodontal examination, including oral hygiene index-simplified, bleeding index, and clinical attachment level. The women in the treatment group received non-surgical periodontal therapy during the gestational period, and those in the control group received periodontal treatment after delivery. Periodontal therapy included plaque control instructions and scaling and root planing performed under local anesthesia. The outcome measures assessed were gestational age and birth weight of the infant. PTB was recorded when delivery occurred at PTBs in the treatment group and 68 PTBs in the control group. Twenty-six LBW infants were recorded in the treatment group, and 48 LBW infants were noted in the control group. The mean gestational ages were 33.8+/-2.8 weeks and 32.7+/-2.8 weeks in the treatment and control groups, respectively. The difference was statistically significant at P<0.006. The mean birth weight was 2,565.3+/-331.2 g in the treatment group and 2,459.6+/-380.7 g in the control group, with the difference being statistically significant at P<0.044. A multiple regression model showed a significant effect of periodontal treatment on birth outcomes. Non-surgical periodontal therapy can reduce the risk for preterm births in mothers who

The outcome of infected total knee arthroplasty: culture-positive versus culture-negative.

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Kim, Young-Hoo; Park, Jang-Won; Kim, Jun-Shik; Kim, Dong-Jin

2015-10-01

We studied the outcome in culture-positive and culture-negative infected total knee arthroplasty (TKA). We retrospectively reviewed 140 patients with culture-positive and 102 patients with culture-negative infected TKAs. We determined the infection control rate and clinical outcome after repeated debridement, and repeated 2-stage TKA in the culture-positive and culture-negative groups. The mean follow-up was 9.3 years (range 5-14 years) in the culture-positive group and 10.6 years (5-22) in the culture-negative group. The overall infection control rate was 56 % in both groups after the first treatment. The overall infection control rate was 90 % in the culture-positive group and 95 % in the culture-negative group. A functional knee was obtained in 90 % in the culture-positive group and 95 % in the culture-negative group. The data suggest that treatment according to the types of infection in both culture-positive and culture-negative groups after TKA controlled infection and maintained functional TKA with a firm level of fixation for most patients. Repeated debridement and repeated two-stage exchange TKA further improved infection control rates after the initial treatment and increased the likelihood of maintaining a functional TKA.

Efficacy of individualized social competence training for children with oppositional defiant disorders/conduct disorders: a randomized controlled trial with an active control group.

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Goertz-Dorten, Anja; Benesch, Christina; Berk-Pawlitzek, Emel; Faber, Martin; Hautmann, Christopher; Hellmich, Martin; Lindenschmidt, Timo; Schuh, Lioba; Stadermann, Rahel; Doepfner, Manfred

2018-03-28

Patient-focused cognitive-behavioral therapy in children with aggressive behavior, which uses group-based social skills training, has resulted in significant reductions in behavioral problems, with effect sizes in the small-to-medium range. However, effects of individually delivered treatments and effects on aggressive behavior and comorbid conditions rated from different perspectives, child functional impairment, child quality of life, parent-child relationship, and parental psychopathology have rarely been assessed. In a randomized controlled trial, 91 boys aged 6-12 years with a diagnosis of oppositional defiant disorder/conduct disorder and peer-related aggression were randomized to receive individually delivered social competence training (Treatment Program for Children with Aggressive Behavior, THAV) or to an active control involving group play that included techniques to activate resources and the opportunity to train prosocial interactions in groups (PLAY). Outcome measures were rated by parents, teachers, or clinicians. Mostly moderate treatment effects for THAV compared to PLAY were found in parent ratings and/or clinician ratings on aggressive behavior, comorbid symptoms, psychosocial impairment, quality of life, parental stress, and negative expressed emotions. In teacher ratings, significant effects were found for ADHD symptoms and prosocial behavior only. THAV is a specifically effective intervention for boys aged 6-12 years with oppositional defiant disorder/conduct disorder and peer-related aggressive behavior as rated by parents and clinicians.

Immediate outcomes of eptifibatide therapy during intracoronary stent implantation.

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Shariati, Hooman; Sanei, Hamid; Pourmoghadas, Ali; Salehizadeh, Leila; Amirpour, Afshin

2016-01-01

The objective of the present study was to assess the major immediate outcomes of eptifibatide therapy during intracoronary stent implantation. In an interventional study, patients undergoing percutaneous coronary intervention (PCI) were randomized into either the eptifibatide ( n = 100) or the control ( n = 107) group. In each group, demographic and clinical characteristics such as cardiac death, stent thrombosis (ST), myocardial infarction (MI), rates of target lesion and vessel revascularization, cerebral vascular accident (CVA), and emergency coronary artery bypass grafting (CABG) were recorded. The overall rates of major adverse events such as mortality, Stent thrombosis (ST), Myocardial Infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), CVA, and emergency CABG within 24 h after stent implantation were low and comparable between the two groups; P > 0.05 considered significant for all comparisons. There were no statistical differences between the clinical outcomes of groups administered with single-dose intracoronary eptifibatide and control groups among patients undergoing PCI during stent implantation.

Testing links between childhood positive peer relations and externalizing outcomes through a randomized controlled intervention study.

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Witvliet, Miranda; van Lier, Pol A C; Cuijpers, Pim; Koot, Hans M

2009-10-01

In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal classroom-based preventive intervention, or a control condition. Children's acceptance by peers, their number of mutual friends, and their proximity to others were assessed annually through peer ratings. Externalizing behavior was annually rated by teachers. Reductions in children's externalizing behavior and improvements in positive peer relations were found among GBG children, as compared with control-group children. Reductions in externalizing behavior appeared to be partly mediated by the improvements in peer acceptance. This mediating role of peer acceptance was found for boys only. The results suggest that positive peer relations are not just markers, but they are environmental mediators of boys' externalizing behavior development. Implications for research and prevention are discussed. (c) 2009 APA, all rights reserved.

Cytoreductive surgery and HIPEC offers similar outcomes in patients with rectal peritoneal metastases compared to colon cancer patients: a matched case control study.

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Simkens, Geert A; van Oudheusden, Thijs R; Braam, Hidde J; Wiezer, Marinus J; Nienhuijs, Simon W; Rutten, Harm J; van Ramshorst, Bert; de Hingh, Ignace H

2016-04-01

The effect of cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with rectal peritoneal metastases (PM) is unclear. This case-control study aims to assess the results of cytoreduction and HIPEC in patients with rectal PM compared to colon PM patients. Colorectal PM patients treated with complete macroscopic cytoreduction and HIPEC were included. Two colon cancer patients were case-matched for each rectal cancer patient, based on prognostic factors (T stage, N stage, histology type, and extent of PM). Short- and long-term outcomes were compared between both groups. From 317 patients treated with complete macroscopic cytoreduction and HIPEC, 29 patients (9.1%) had rectal PM. Fifty-eight colon cases were selected as control patients. Baseline characteristics were similar between groups. Major morbidity was 27.6% and 34.5% in the rectal and colon group, respectively (P = 0.516). Median disease-free survival was 13.5 months in the rectal group and 13.6 months in the colon group (P = 0.621). Two- and five-year overall survival rates were 54%/32% in rectal cancer patients, and 61%/24% in colon cancer patients (P = 0.987). Cytoreduction and HIPEC in selected patients with rectal PM is feasible and provides similar outcomes as in colon cancer patients. Rectal PM should not be regarded a contra-indication for cytoreduction and HIPEC in selected patients. J. Surg. Oncol. 2016;113:548-553. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

The ACTIVATE study: results from a group-randomized controlled trial comparing a traditional worksite health promotion program with an activated consumer program.

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Terry, Paul E; Fowles, Jinnet Briggs; Xi, Min; Harvey, Lisa

2011-01-01

PURPOSE. This study compares a traditional worksite-based health promotion program with an activated consumer program and a control program DESIGN. Group randomized controlled trial with 18-month intervention. SETTING. Two large Midwestern companies. SUBJECTS. Three hundred and twenty employees (51% response). INTERVENTION. The traditional health promotion intervention offered population-level campaigns on physical activity, nutrition, and stress management. The activated consumer intervention included population-level campaigns for evaluating health information, choosing a health benefits plan, and understanding the risks of not taking medications as prescribed. The personal development intervention (control group) offered information on hobbies. The interventions also offered individual-level coaching for high risk individuals in both active intervention groups. MEASURES. Health risk status, general health status, consumer activation, productivity, and the ability to evaluate health information. ANALYSIS. Multivariate analyses controlled for baseline differences among the study groups. RESULTS. At the population level, compared with baseline performance, the traditional health promotion intervention improved health risk status, consumer activation, and the ability to recognize reliable health websites. Compared with baseline performance, the activated consumer intervention improved consumer activation, productivity, and the ability to recognize reliable health websites. At the population level, however, only the activated consumer intervention improved any outcome more than the control group did; that outcome was consumer activation. At the individual level for high risk individuals, both traditional health coaching and activated consumer coaching positively affected health risk status and consumer activation. In addition, both coaching interventions improved participant ability to recognize a reliable health website. Consumer activation coaching also

Children with and without Learning Disabilities: A Comparison of Processes and Outcomes Following Group Counseling

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Leichtentritt, Judith; Shechtman, Zipora

2010-01-01

This study compared outcomes and processes in counseling groups of an expressive-supportive modality for children with learning disabilities (LD) and without them (NLD). Participants were 266 students (ages 10-18), all referred for emotional, social, and behavioral difficulties; of these, 123 were identified with LD and 143 were not. There were 40…

Educational Outcomes of Small-Group Discussion Versus Traditional Lecture Format in Dental Students' Learning and Skills Acquisition.

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Arias, Ana; Scott, Raymond; Peters, Ove A; McClain, Elizabeth; Gluskin, Alan H

2016-04-01

The aim of this prospective quantitative study was to compare the effect of different instructional formats on dental students' skills and knowledge acquisition for access cavity preparation. All first-year dental students were invited to participate in this study conducted during the four consecutive two-week endodontic rotation courses at the University of the Pacific Arthur A. Dugoni School of Dentistry in spring semester 2015. Four alphabetically distributed intact groups of students were randomly allocated to two groups (n=70 each) that participated in either small-group discussion or a traditional lecture on access preparation. The first outcome measure was skill acquisition, measured by the quality of access cavities prepared in extracted teeth at the conclusion of the session. Two blinded raters scored direct observations on a continuous scale. Knowledge, the second outcome measure, was scored with a multiple-choice and open-ended question test at the end of each two-week session. Data were obtained for 134 of the 140 students, for a 96% response rate. The results showed that students in the small-group discussion groups scored significantly higher than those in the lecture groups when skill performance was tested (p=8.9 × 10(-7)). However, no significant differences were found in the acquisition of knowledge between the two groups on the written test. Active student participation was significantly related to improved manual skill acquisition, but the format of the session does not seem to have had a direct influence on acquired knowledge.

Randomized controlled trial of group cognitive behavioral therapy compared to a discussion group for co-morbid anxiety and depression in older adults.

Science.gov (United States)

Wuthrich, V M; Rapee, R M; Kangas, M; Perini, S

2016-03-01

Co-morbid anxiety and depression in older adults is associated with worse physical and mental health outcomes and poorer response to psychological and pharmacological treatments in older adults. However, there is a paucity of research focused on testing the efficacy of the co-morbid treatment of anxiety and depression in older adults using psychological interventions. Accordingly, the primary objective of the current study was to test the effects of a group cognitive behavior therapy (CBT) program in treating co-morbid anxiety and depression in a sample of older age adults. A total of 133 community-dwelling participants aged ⩾60 years (mean age = 67.35, s.d. = 5.44, male = 59) with both an anxiety disorder and unipolar mood disorder, as assessed on the Anxiety Disorder Interview Schedule (ADIS), were randomly allocated to an 11-week CBT group or discussion group. Participants with Mini-Mental State Examination scores <26 were excluded. Participants were assessed pre-treatment, post-treatment and at 6 months follow-up on the ADIS, a brief measure of well-being, Geriatric Anxiety Inventory and Geriatric Depression Scale. Both conditions resulted in significant improvements over time on all diagnostic, symptom and wellbeing measures. Significant group × time interaction effects emerged at post-treatment only for diagnostic severity of the primary disorder, mean severity of all anxiety disorders, mood disorders, and all disorders, and recovery rates on primary disorder. Group CBT produced faster and sustained improvements in anxiety and depression on diagnostic severity and recovery rates compared to an active control in older adults.

ModerateDrinking.com and Moderation Management: Outcomes of a randomized clinical trial with non-dependent problem drinkers1

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Hester, Reid K.; Delaney, Harold D.; Campbell, William

2011-01-01

Objective To evaluate the effectiveness of a web-based protocol, Moderate Drinking (MD) (www.moderatedrinking.com) combined with use of the online resources of Moderation Management (MM) (www.moderation.org) as opposed to the use of the online resources of MM alone. Method We randomly assigned 80 problem drinkers to either the experimental or control group with follow-ups at 3, 6, and 12 months. Results Seventy-five participants (94%) had outcome data at one or more follow-up points and 59 (73%) were assessed at all three follow-ups. Comparing baseline measures to the average outcomes at follow-ups indicated a significant overall reduction in both groups in alcohol-related problems and consumption variables. Compared to the control group, the experimental group had better outcomes on percent days abstinent (PDA). There was an interaction between intensity of drinking at baseline and treatment in determining outcomes assessing drinking. Less heavy drinkers in the experimental group had better outcomes on log Mean BAC per drinking day compared to the control group. Heavier drinkers did not differentially benefit from the MD program on this measure. Mixed model analyses in general corroborated these outcomes. Conclusion The outcome data provide partial evidence for the effectiveness of the MD web application combined with MM, compared to the effectiveness of the resources available online at MM by themselves. PMID:21319896

Assessing the efficacy of imagery-enhanced cognitive behavioral group therapy for social anxiety disorder: Study protocol for a randomized controlled trial.

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McEvoy, Peter M; Moulds, Michelle L; Grisham, Jessica R; Holmes, Emily A; Moscovitch, David A; Hendrie, Delia; Saulsman, Lisa M; Lipp, Ottmar V; Kane, Robert T; Rapee, Ronald M; Hyett, Matthew P; Erceg-Hurn, David M

2017-09-01

Cognitive behavior group therapy (CBGT) is effective for social anxiety disorder (SAD), but a substantial proportion of patients do not typically achieve normative functioning. Cognitive behavioral models of SAD emphasize negative self-imagery as an important maintaining factor, and evidence suggests that imagery is a powerful cognitive mode for facilitating affective change. This study will compare two group CBGT interventions, one that predominantly uses verbally-based strategies (VB-CBGT) and another that predominantly uses imagery-enhanced strategies (IE-CBGT), in terms of (a) efficacy, (b) mechanisms of change, and (c) cost-effectiveness. This study is a parallel groups (two-arm) single-blind randomized controlled trial. A minimum of 96 patients with SAD will be recruited within a public outpatient community mental health clinic in Perth, Australia. The primary outcomes will be self-reported symptom severity, caseness (SAD present: yes/no) based on a structured diagnostic interview, and clinician-rated severity and life impact. Secondary outcomes and mechanism measures include blind observer-rated use of safety behaviors, physiological activity (heart rate variability and skin conductance level) during a standardized speech task, negative self-beliefs, imagery suppression, fear of negative and positive evaluation, repetitive negative thinking, anxiety, depression, self-consciousness, use of safety behaviors, and the EQ-5D-5L and TiC-P for the health economic analysis. Homework completion, group cohesion, and working alliance will also be monitored. The outcomes of this trial will inform clinicians as to whether integrating imagery-based strategies in cognitive behavior therapy for SAD is likely to improve outcomes. Common and distinct mechanisms of change might be identified, along with relative cost-effectiveness of each intervention. Copyright © 2017 Elsevier Inc. All rights reserved.

Locus of control, self-efficacy, and the mediating effect of outcome control: predicting course-level and global outcomes in an academic context.

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Au, Evelyn W M

2015-01-01

The current study utilizes Skinner's framework to examine the unique contributions of internal locus of control, self-efficacy, and perceived outcome control over course performance on students' academic experiences. Undergraduate students (N = 225) took part in a longitudinal study and completed two surveys (Time 1: just before their mid-term exams; Time 2: just before their final exam in the same semester). Both locus of control and self-efficacy at Time 1 predicted course-level perceived control over course performance at Time 2. Student-level perceived control over course performance at Time 2 mediated the relationship between self-efficacy at Time 1 and course-level perseverance, course-specific stress, and course enjoyment at Time 2. For global perceived stress and life satisfaction measured at Time 2, both locus of control and self-efficacy at Time 1 had only a direct effect on global perceived stress at Time 2, but only self-efficacy at Time 1 predicted life satisfaction at Time 2. Both locus of control and self-efficacy uniquely contribute to students' academic experiences. Student-level perceived control plays an important mediating role between locus of control and self-efficacy at Time 1, and course-level perseverance, course-specific stress, and course enjoyment at Time 2.

Impact of cardiovascular risk factors on the outcome of renal transplantation

Directory of Open Access Journals (Sweden)

Moghimi Mehrdad

2010-01-01

Full Text Available Cardiovascular diseases are common in renal transplant recipients and renal insuf-ficiency has been shown to be a risk factor for cardiovascular disease. Some studies have reported that cardiovascular risk factors may contribute to the outcome of renal transplantation. This study was performed to determine the impact of cardiovascular risk factors on the outcome of renal transplantation in Iranian subjects. This is a retrospective, observational study including patients of 20-85 years of age who had undergone renal transplantation. Parameters documented and analyzed included demographics, cardiovascular risk factors, past medical history, date of last transplan-tation, the outcome of transplant, last measured serum creatinine, cause of graft failure, rejection, and death. A total of 192 patients were analyzed including 152 in the case group (with identifiable cardiovascular risk factors and 40 controls (transplant recipients without identifiable risk factors. The mean serum creatinine in the case and control groups were 1.33 ± 0.13 and 1.29 ± 0.36 mg/dL respectively (P= 0.493. Response to transplantation was categorized based on a report from the World Health Organization. Complete response to grafting occurred in the control group more than the case group (P= 0.009, while frequency of partial response to grafting was higher in the case group (0.008. A history of chronic obstructive pulmonary diseases (COPD could significantly predict the outcome of grafting (P= 0.008 as could the occurrence of renal failure (P= 0.022. Results were consistently reproduced using multivariate cumulative log it model. Our study indicates that the measured cardiovascular risk factors do not significantly influence the outcome of renal transplantation.

Explaining the impact of a women's group led community mobilisation intervention on maternal and newborn health outcomes: the Ekjut trial process evaluation

Directory of Open Access Journals (Sweden)

Sinha Rajesh

2010-10-01

Full Text Available Abstract Background Few large and rigorous evaluations of participatory interventions systematically describe their context and implementation, or attempt to explain the mechanisms behind their impact. This study reports process evaluation data from the Ekjut cluster-randomised controlled trial of a participatory learning and action cycle with women's groups to improve maternal and newborn health outcomes in Jharkhand and Orissa, eastern India (2005-2008. The study demonstrated a 45% reduction in neonatal mortality in the last two years of the intervention, largely driven by improvements in safe practices for home deliveries. Methods A participatory learning and action cycle with 244 women's groups was implemented in 18 intervention clusters covering an estimated population of 114 141. We describe the context, content, and implementation of this intervention, identify potential mechanisms behind its impact, and report challenges experienced in the field. Methods included a review of intervention documents, qualitative structured discussions with group members and non-group members, meeting observations, as well as descriptive statistical analysis of data on meeting attendance, activities, and characteristics of group attendees. Results Six broad, interrelated factors influenced the intervention's impact: (1 acceptability; (2 a participatory approach to the development of knowledge, skills and 'critical consciousness'; (3 community involvement beyond the groups; (4 a focus on marginalized communities; (5 the active recruitment of newly pregnant women into groups; (6 high population coverage. We hypothesize that these factors were responsible for the increase in safe delivery and care practices that led to the reduction in neonatal mortality demonstrated in the Ekjut trial. Conclusions Participatory interventions with community groups can influence maternal and child health outcomes if key intervention characteristics are preserved and tailored to

Use and Outcomes of Noninvasive Ventilation for Acute Respiratory Failure in Different Age Groups.

Science.gov (United States)

Ozsancak Ugurlu, Aylin; Sidhom, Samy S; Khodabandeh, Ali; Ieong, Michael; Mohr, Chester; Lin, Denis Y; Buchwald, Irwin; Bahhady, Imad; Wengryn, John; Maheshwari, Vinay; Hill, Nicholas S

2016-01-01

The prevalence of chronic disease and do-not-intubate status increases with age. Thus, we aimed to determine characteristics and outcomes associated with noninvasive ventilation (NIV) use for acute respiratory failure (ARF) in different age groups. A database comprising prospective data collected on site on all adult patients with ARF requiring ventilatory support from 8 acute care hospitals in Massachusetts was used. From a total of 1,225 ventilator starts, overall NIV utilization, success, and in-hospital mortality rates were 22, 54, and 18% in younger (18-44 y); 34, 65, and 13% in middle-aged (45-64 y); 49, 68, and 17% in elderly (65-79 y); and 47, 76, and 24% in aged (≥ 80 y) groups, respectively (P age (25, 57, 57, and 74% and 7, 12, 18, and 31%, respectively, in the 4 age groups [P age groups (P = .27 and P = .98, respectively). NIV use and a do-not-intubate status are more frequent in subjects with ARF ≥ 65 y than in those age groups. (ClinicalTrials.gov registration NCT00458926.). Copyright © 2016 by Daedalus Enterprises.

Influence of control group therapy on the benefit from dose-dense chemotherapy in early breast cancer: a systemic review and meta-analysis.