The Influence of Maternal Obesity on Pregnancy Complications and Neonatal Outcomes in Diabetic and Nondiabetic Women

PubMed Central

Timur, Burcu Budak; Timur, Hakan; Tokmak, Aytekin; Isik, Hatice; Eyi, Elif Gul Yapar

2018-01-01

Introduction This study aimed to investigate the influence of obesity on pregnancy complications and neonatal outcomes in diabetic and nondiabetic women. Materials and Methods This retrospective case control study was conducted on 1193 pregnant women and their neonates at a tertiary level maternity hospital between March 2007 and 2011. The pregnant women were classified into 2 groups according to the presence of diabetes mellitus. Six hundred and seven patients with gestational diabetes or pregestational diabetes formed the diabetic group (study group) and 586 patients were in the nondiabetic group (control group). Demographic characteristics, body mass index, gestational weight gain, obstetric history, smoking status, type of delivery, gestational ages, pregnancy complications, neonatal outcomes were recorded for each patient. Multivariable logistic regression analysis was performed to evaluate the effect of obesity and diabetes on the pregnancy complications and neonatal outcomes. Results The mean age and pre-pregnancy body mass indices of women with diabetes mellitus were significantly higher than the control groupʼs (p < 0.001). Gestational weight gain and number of smokers were similar among the groups. Multiparity and obesity were more prevalent in the diabetic group compared to controls (both p < 0.001). Although gestational age at birth was earlier in the diabetic group, birth weights were higher in this group than in the control group (both p < 0.001). Cesarean delivery rates, the incidence of macrosomia, and neonatal intensive care unit admission rates were significantly higher in the diabetes group both with normal and increased body mass index (all p < 0.001). However, adverse pregnancy outcomes were comparable between the groups (p = 0.279). Multivariable logistic regression analysis showed that obesity is a significant risk factor for pregnancy complications (OR = 1.772 [95% CI, 1.283 – 2.449], p = 0.001) but not for adverse neonatal outcomes (OR = 1.068 [95% CI, 0.683 – 1.669], p = 0.773). Conclusion While obesity increases risk of developing a pregnancy complication, diabetes worsens neonatal outcomes. PMID:29720745

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

PubMed

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.

Intrapartum amnioinfusion in meconium-stained liquor: a case-control study.

PubMed

Bansal, Neeta; Gupta, Vineeta; Nanda, Anuja; Chaudhary, Priyanka; Tandon, Archna; Behl, Neelima

2013-06-01

The aim of this study was to investigate perinatal outcome and the rate of cesarean section (CS) following intrapartum amnioinfusion in women with meconium-stained amniotic fluid (MSAF). A total of 100 women at term in labor with meconium were randomized to infuse transcervical intrapartum amnioinfusion with saline (50) and routine obstetrical care (50). Perinatal outcome and obstetric outcome were recorded and analyzed in both groups by means of Chi-square test. The CS rate due to fetal distress was 40.0 % in the control group and 20.0 % in the study group. The difference was statistically significant (P < 0.01). Respiratory distress of the neonate was significantly less common in the study group than in the control group (4.0 % vs. 12 %; P = 0.0349). Amnioinfusion in cases of meconium-stained liquor significantly improved neonatal outcome and CS rate without increasing any maternal and fetal complications.

ModerateDrinking.com and Moderation Management: Outcomes of a randomized clinical trial with non-dependent problem drinkers1

PubMed Central

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

Effects of Tailored and ACT-Influenced Internet-Based CBT for Eating Disorders and the Relation Between Knowledge Acquisition and Outcome: A Randomized Controlled Trial.

PubMed

Strandskov, Sandra Weineland; Ghaderi, Ata; Andersson, Hedvig; Parmskog, Nicole; Hjort, Emelie; Wärn, Anna Svanberg; Jannert, Maria; Andersson, Gerhard

2017-09-01

This is the first trial to investigate the outcome of tailored and ACT-influenced, cognitive behavioral Internet treatment for eating disorder psychopathology, and the relation between knowledge acquisition and outcome. This study utilized a randomized controlled design, with computer-based allocation to treatment or waiting list control group. Participants were recruited via advertisements in social media and newspapers in Sweden. Participants fulfilling the criteria for bulimia nervosa (BN), or Eating Disorder Not Otherwise Specified (EDNOS), with a BMI above 17.5, were enrolled in the study (N = 92). The treatment group received an Internet-based, ACT-influenced CBT intervention, developed by the authors, for eating disorders. The treatment lasted 8 weeks, and was adapted to the participant's individual needs. A clinician provided support. The main outcome measures were eating disorder symptoms and body shape dissatisfaction. Intent-to-treat analysis showed that the treatment group (n = 46) improved significantly on eating disorder symptoms and body dissatisfaction, compared with the waiting list control group (n = 46), with small to moderate effect sizes (between group effects, d = 0.35-0.64). More than a third of the participants in the treatment group (36.6%), compared to 7.1% in the waiting list control condition, made clinically significant improvements. Results showed a significant increase in knowledge in the treatment group compared to the waiting list control group (between group effect, d = 1.12), but we found no significant correlations between knowledge acquisition and outcome (r= -0.27 to -r = 0.23). The results provide preliminary support for Internet-based, tailored, and ACT-influenced treatment, based on CBT for participants with eating disorder psychopathology. Copyright © 2017. Published by Elsevier Ltd.

Does the addition of specific acupuncture to standard swallowing training improve outcomes in patients with dysphagia after stroke? a randomized controlled trial

PubMed Central

Xia, Wenguang; Zheng, Chanjuan; Zhu, Suiqiang; Tang, Zhouping

2015-01-01

Objective: To assess the effect of adding acupuncture to standard swallowing training for patients with dysphagia after stroke. Design: Single-blind randomized controlled trial. Setting: Inpatient and outpatient clinics. Subjects: A total of 124 patients with dysphagia after stroke were randomly divided into two groups: acupuncture and control. Interventions: The acupuncture group received standard swallowing training and acupuncture treatment. In comparison, the control group only received standard swallowing training. Participants in both groups received six days of therapy per week for a four-week period. Main measures: The primary outcome measures included the Standardized Swallowing Assessment and the Dysphagia Outcome Severity Scale. The secondary outcome measures included the Modified Barthel Index and Swallowing-Related Quality of Life, which were assessed before and after the four-week therapy period. Results: A total of 120 dysphagic subjects completed the study (60 in acupuncture group and 60 in control group). Significant differences existed in the Standardized Swallowing Assessment, Dysphagia Outcome Severity Scale, Modified Barthel Index, and Swallowing-Related Quality of Life scores of each group after the treatment (P < 0.01). After the four-week treatment, the Standardized Swallowing Assessment (mean difference − 2.9; 95% confidence interval (CI) – 5.0 to − 0.81; P < 0.01), Dysphagia Outcome Severity Scale (mean difference 2.3; 95% CI 0.7 to 1.2; P < 0.01), Modified Barthel Index (mean difference 17.2; 95% CI 2.6 to 9.3; P < 0.05) and Swallowing-Related Quality of Life scores (mean difference 31.4; 95% CI 3.2 to 11.4; P < 0.01) showed more significant improvement in the acupuncture group than the control group. Conclusions: Acupuncture combined with the standard swallowing training may be beneficial for dysphagic patients after stroke. PMID:25819076

[Withdrawal of a specialised diabetes education program in primary care: long term impact on the metabolic control outcomes].

PubMed

Jurado Campos, Jerónimo; Caula Ros, Jacint A; Hernández Anguera, Josep M; Juvinyà Canal, Dolors; Pou Torelló, José M

2009-12-01

To evaluate the possible relationships between a health policy decision, in relation to the diabetes education strategies and the metabolic control outcomes. Longitudinal prospective cohort study. A random cohort sample of 276 type II diabetes mellitus subjects. All primary care centres in three regions of Catalonia. Patients were classified as specialised (n=59) or non-specialised (n=217) groups, as regards whether having received previous diabetes education before the start of the study. HbA1c values were evaluated in all subjects at baseline and after 5 years after receiving only conventional education. Baseline evaluation showed a better metabolic control in the specialised group (P=0.009). The final evaluation showed no significant differences in outcomes between the two groups (P=0.679). When baseline and outcomes values were compared, significant differences were observed in all subjects (P=0.001), the specialised group showed significantly poorer metabolic control (P<0.001), but in the group with previous conventional education no significant differences were observed (P=0.058). Our results suggest that the withdrawal of higher levels of diabetes education may play a major role in poor metabolic control, and that conventional diabetes education does not improve outcomes. Health policy in Primary Care should consider improving the level of diabetes education.

Simulation-based camera navigation training in laparoscopy-a randomized trial.

PubMed

Nilsson, Cecilia; Sorensen, Jette Led; Konge, Lars; Westen, Mikkel; Stadeager, Morten; Ottesen, Bent; Bjerrum, Flemming

2017-05-01

Inexperienced operating assistants are often tasked with the important role of handling camera navigation during laparoscopic surgery. Incorrect handling can lead to poor visualization, increased operating time, and frustration for the operating surgeon-all of which can compromise patient safety. The objectives of this trial were to examine how to train laparoscopic camera navigation and to explore the transfer of skills to the operating room. A randomized, single-center superiority trial with three groups: The first group practiced simulation-based camera navigation tasks (camera group), the second group practiced performing a simulation-based cholecystectomy (procedure group), and the third group received no training (control group). Participants were surgical novices without prior laparoscopic experience. The primary outcome was assessment of camera navigation skills during a laparoscopic cholecystectomy. The secondary outcome was technical skills after training, using a previously developed model for testing camera navigational skills. The exploratory outcome measured participants' motivation toward the task as an operating assistant. Thirty-six participants were randomized. No significant difference was found in the primary outcome between the three groups (p = 0.279). The secondary outcome showed no significant difference between the interventions groups, total time 167 s (95% CI, 118-217) and 194 s (95% CI, 152-236) for the camera group and the procedure group, respectively (p = 0.369). Both interventions groups were significantly faster than the control group, 307 s (95% CI, 202-412), p = 0.018 and p = 0.045, respectively. On the exploratory outcome, the control group for two dimensions, interest/enjoyment (p = 0.030) and perceived choice (p = 0.033), had a higher score. Simulation-based training improves the technical skills required for camera navigation, regardless of practicing camera navigation or the procedure itself. Transfer to the clinical setting could, however, not be demonstrated. The control group demonstrated higher interest/enjoyment and perceived choice than the camera group.

Effects of management in gestational diabetes mellitus with normal prepregnancy body mass index on pregnancy outcomes and placental ultrastructures: a prospective cohort study.

PubMed

Han, Yun; Zheng, Yan-Li; Wu, Ai-Min; Liu, Hong-Bin; Su, Jian-Bin; Lu, Xiao-Yan; Han, Yu-Wen; Ji, Jin-Long; Ji, Ju-Hua; Shi, Yue

2016-12-01

A great quantity of gestational diabetes mellitus with normal prepregnancy body mass index have emerged with the new criteria of gestational diabetes mellitus in China based on the International Diabetes in Pregnancy Consensus group criteria, and understanding placental changes and how they affect outcomes are necessary in order to develop effective management approach. The aim of this study was to prospectively explore the effect of active management starting from the late second trimester in gestational diabetes mellitus women with normal prepregnancy body mass index on pregnancy outcomes and placental ultrastructures, and to provide scientific evidences for optimizing the management of gestational diabetes mellitus in China. Gestational diabetes mellitus women with normal prepregnancy body mass index in the same period of this prospective cohort study were divided into intervention group (n = 51) and control group (n = 55). The intervention group was managed rigorously, while the control group received conventional prenatal cares. The glucose profile, gestational weight gain and pregnancy outcomes were followed up and placental ultrastructures were observed and recorded by transmission electron microscopy. The blood glucose level and gestational weight gain in intervention group were significantly better controlled than those in control group (P < 0.01). The incidences of fetal distress, cesarean section and large for gestational age were significantly lower in intervention group than in control group (P < 0.05). There was a significant reduction in the incidence of abnormal placental ultrastructure in the intervention group (P < 0.01). After adjustment for confounding factors, the undesirable glycemic control and conventional management were related to abnormal placental ultrastructure (P < 0.05). Meanwhile, the undesirable glycemic control, abnormal placental ultrastructure and conventional management made sense in the incidence of fetal distress (P < 0.05), and the target glycemic control, recommend weight gain and active management were associated with reductions in the prevalence of cesarean delivery and large for gestational age (P < 0.05). The active management of gestational diabetes mellitus women with normal prepregnancy body mass index can improve pregnancy outcomes and placental ultrastructures, and the abnormal placental ultrastructure might be closely associated with the undesirable glycemic control and adverse pregnancy outcomes.

Importance of sustained and "tight" blood pressure control in patients with high cardiovascular risk.

PubMed

Meredith, Peter A; Lloyd, Suzanne M; Ford, Ian; Elliott, Henry L

2016-01-01

A retrospective further analysis of the ACTION database evaluated the relationship between cardiovascular outcomes and the "quality" of the control of blood pressure (BP). The study population (n = 6287) comprised those patients with four BP measurements during year 1 subdivided according to the proportion of visits in which BP was controlled in relation to two BP targets: < 140/90mmHg and < 130/80 mmHg. Differences between the BP control groups for the major prespecified ACTION outcomes were investigated with Cox proportional hazards models. For all the prespecified cardiovascular endpoints the incidence declined as the proportion of visits with BP control increased. The greatest differences in outcomes between the different BP control groups were observed for the risk of stroke but were still apparent for all the other endpoints. For example, the risks for the primary outcome [hazard ratio (HR) 0.78; 95% confidence interval (CI) 0.67 to 0.90] were significantly less in the group with >_75% of visits with BP control than in the group with < 25% of visits with BP control. There were no significant treatment-related differences. Retrospective analyses are not definitive but these results highlight the importance of the attainment of BP control targets and the consistency of BP control during long-term follow-up.

Use of a reduced-carbohydrate, modified-fat enteral formula for improving metabolic control and clinical outcomes in long-term care residents with type 2 diabetes: results of a pilot trial.

PubMed

Craig, L D; Nicholson, S; SilVerstone, F A; Kennedy, R D

1998-06-01

Physiologic responses of 30 enterally-fed long-term care residents with type 2 diabetes receiving total nutrition support via either a disease-specific (reduced-carbohydrate, modified-fat) formula or a standard high-carbohydrate formula for 3 mo were compared. Objectives of the study included evaluating metabolic response (glycemic control and lipids) and clinical outcomes. Thirty-four subjects requiring total enteral nutrition support by tube were enrolled in this prospectively randomized, double-blind, controlled, parallel group 3-mo pilot trial. Thirty were evaluable in that they completed 4 wk. Twenty-seven completed all 12 wk. The groups were well-matched for physiologic and demographic parameters at baseline. Fasting serum glucose and capillary (fingerstick) glucose values demonstrated better control in the disease-specific formula-fed group. Serum lipid profiles of this group were similar to or better than those of the standard formula-fed group. The amount of insulin administered to insulin-using subjects in the disease-specific formula-fed group was consistently less than before initiation of the formula, whereas the amount administered was consistently higher in the group fed the standard formula. Overall, subjects randomized to the disease-specific formula experienced better numerical biochemical control and better clinical outcomes when expressed on a numerical and percentage basis. These included surrogate markers of diabetes control such as serum glucose and glycohemoglobin, as well as clinical outcomes such as incidence of infections and pressure ulcers. These findings confirm that the disease-specific formula provides better glycemic control, poses no risk to lipoprotein metabolism, and provides for better clinical outcomes.

Offspring Outcomes in Studies of Antidepressant-Treated Pregnancies Depend on the Choice of Control Group.

PubMed

Andrade, Chittaranjan

2017-03-01

Antenatal depression complicates 14%-23% of pregnancies; if the depression is left untreated, there is an increased risk of a wide range of adverse maternal and offspring outcomes. However, antidepressant use, and, more specifically, selective serotonin reuptake inhibitor (SSRI) use, has also been associated with adverse pregnancy outcomes. Regrettably, SSRIs have received bad press in this context even though the evidence linking them with the adverse outcomes has not disentangled depression effects from drug effects. The most important reason why depression and drug effects cannot be separated is that the evidence is derived mostly from retrospective observational studies and not from randomized controlled trials, which are necessary but which cannot be performed during pregnancy for ethical and practical reasons. In these observational studies, the control groups are formed from healthy women, depressed women, and/or propensity score-matched women who did not receive antidepressant drugs during pregnancy. A limitation of such control groups is that they cannot control for confounding arising from poorly measured, unmeasured, or unknown variables that influence the pregnancy outcomes being assessed. This article discusses problems involved in such research and illustrates how, when confounding is diminished by using sibling controls discordant for antidepressant exposure during pregnancy, the risks of adverse outcomes associated with antidepressant exposure diminish. However, a discordant sibling control group is associated with its own limitations, and these are also discussed. © Copyright 2017 Physicians Postgraduate Press, Inc.

Different labour outcomes in primiparous women that have been subjected to childhood sexual abuse or rape in adulthood: a case–control study in a clinical cohort

PubMed Central

Nerum, H; Halvorsen, L; Straume, B; Sørlie, T; Øian, P

2013-01-01

Objective To compare the duration and outcome of the first labour in women who have been subjected to childhood sexual abuse (CSA) and women who have been raped in adulthood (RA). Design Case–control study in a clinical cohort. Setting University Hospital of North Norway. Sample In all, 373 primiparas: 185 subjected to CSA, 47 to RA and 141 controls without a history of abuse. Methods Data on birth outcomes were retrieved from the patient files. Information on sexual abuse was reported in consultation with specialised midwives in the mental health team. Birth outcomes were analysed by multinominal regression analysis. Main outcome measures Vaginal births, delivery by caesarean section, operative vaginal delivery and duration of labour. Results As compared with controls, the RA group showed a significantly higher risk for caesarean section (adjusted OR 9.9, 95% CI 3.4–29.4) and operative vaginal delivery (adjusted OR 12.2, 95% CI 4.4–33.7). There were no significant differences between the CSA and the control group. The RA group displayed significantly longer duration of labour in all phases as compared with the control and CSA groups. Conclusions There were major differences in the duration of labour and birth outcomes in the two abuse groups. Despite a higher proportion of obstetric risk factors at onset of labour in the CSA group, women subjected to CSA had shorter labours and less risk for caesarean section and operative vaginal deliveries than women subjected to RA. The best care for birthing women subjected to sexual abuse needs to be explored in further studies. PMID:23157417

Glyburide as treatment option for gestational diabetes mellitus.

PubMed

Tempe, Anjali; Mayanglambam, Ronita Devi

2013-06-01

The aim of this study was to assess the efficacy of glyburide in the treatment of gestational diabetes mellitus and to compare the maternal and fetal outcome between two groups treated either with insulin or glyburide. Women with gestational diabetes not responding to diet control were randomized into two groups: (i) the control group receiving insulin (n = 32); and (ii) the study group receiving glyburide (n = 32). Primary outcome was assessed in terms of achievement of glycemic control and secondary outcome was assessed by the incidence of maternal and fetal complications in the insulin and glyburide treated groups. The achievement of glycemic control between the insulin and the glyburide treated groups showed no significant difference (97.1%, 93.8%). The occurrence of maternal complications (P = 0.87) and fetal complications (P = 0.32) were comparable between the insulin and glyburide treated groups. Glyburide was found to be as efficacious as insulin in achieving euglycemia in the treatment of gestational diabetic women who require treatment beyond diet control. © 2013 The Authors. Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology.

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

PubMed

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.

Methods to decrease blood loss and transfusion requirements for liver transplantation.

PubMed

Gurusamy, Kurinchi Selvan; Pissanou, Theodora; Pikhart, Hynek; Vaughan, Jessica; Burroughs, Andrew K; Davidson, Brian R

2011-12-07

Excessive blood loss and increased blood transfusion requirements may have significant impact on the short-term and long-term outcomes after liver transplantation. To compare the potential benefits and harms of different methods of decreasing blood loss and blood transfusion requirements during liver transplantation. We searched The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and metaRegister of Controlled Trials until September 2011. We included all randomised clinical trials that were performed to compare various methods of decreasing blood loss and blood transfusion requirements during liver transplantation. Two authors independently identified the trials and extracted the data. We analysed the data with both the fixed-effect and the random-effects model using RevMan Analysis. For each outcome we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI) based on available data analysis. We also conducted network meta-analysis. We included 33 trials involving 1913 patients. The sample size in the trials varied from 8 to 209 participants. The interventions included pharmacological interventions (aprotinin, tranexamic acid, epsilon amino caproic acid, antithrombin 3, recombinant factor (rFvIIa), oestrogen, prostaglandin, epinephrine), blood substitutes (blood components rather than whole blood, hydroxy-ethyl starch, thromboelastography), and cardiovascular interventions (low central venous pressure). All the trials were of high risk of bias. Primary outcomes were reported in at least two trials for the following comparisons: aprotinin versus control, tranexamic acid versus control, recombinant factor VIIa (rFVIIa) versus control, and tranexamic acid versus aprotinin. There were no significant differences in the 60-day mortality (3 trials; 6/161 (3.7%) in the aprotinin group versus 8/119 (6.7%) in the control group; RR 0.52; 95% CI 0.18 to 1.45), primary graft non-function (2 trials; 0/128 (0.0%) in the aprotinin group versus 4/89 (4.5%) in the control group; RR 0.15; 95% CI 0.02 to 1.25), retransplantation (3 trials; 2/256 (0.8%) in the aprotinin group versus 12/178 (6.7%) in the control group; RR 0.21; 95% CI 0.02 to 1.79), or thromboembolic episodes (3 trials; 4/161 (2.5%) in the aprotinin group versus 5/119 (4.2%) in the control group; RR 0.59; 95% CI 0.19 to 1.84) between the aprotinin and control groups. There were no significant differences in the 60-day mortality (3 trials; 4/83 (4.8%) in the tranexamic acid group versus 5/56 (8.9%) in the control group; RR 0.55; 95% CI 0.17 to 1.76), retransplantation (2 trials; 3/41 (7.3%) in the tranexamic acid group versus 3/36 (8.3%) in the control group; RR 0.79; 95% CI 0.18 to 3.48), or thromboembolic episodes (5 trials; 5/103 (4.9%) in the tranexamic acid group versus 1/76 (1.3%) in the control group; RR 2.20; 95% CI 0.38 to 12.64) between the tranexamic acid and control groups. There were no significant differences in the 60-day mortality (3 trials; 8/195 (4.1%) in the recombinant factor VIIa (rFVIIa) group versus 2/91 (2.2%) in the control group; RR 1.51; 95% CI 0.33 to 6.95), thromboembolic episodes (2 trials; 24/185 (13.0%) in the rFVIIa group versus 8/81 (9.9%) in the control group; RR 1.38; 95% CI 0.65 to 2.91), or serious adverse events (2 trials; 90/185 (48.6%) in the rFVIIa group versus 30/81 (37.0%) in the control group; RR 1.30; 95% CI 0.94 to 1.78) between the rFVIIa and control groups. There were no significant differences in the 60-day mortality (2 trials; 6/91 (6.6%) in the tranexamic acid group versus 1/87 (1.1%) in the aprotinin group; RR 4.12; 95% CI 0.71 to 23.76) or thromboembolic episodes (2 trials; 4/91 (4.4%) in the tranexamic acid group versus 2/87 (2.3%) in the aprotinin group; RR 1.97; 95% CI 0.37 to 10.37) between the tranexamic acid and aprotinin groups. The remaining outcomes in the above comparisons and the remaining comparisons included only only trial under the primary outcome or the outcome was not reported at all in the trials. There were no significant differences in the mortality, primary graft non-function, graft failure, retransplantation, thromboembolic episodes, or serious adverse events in any of these comparisons. However, the confidence intervals were wide, and it is not possible to reach any conclusion on the safety of the interventions. None of the trials reported the quality of life in patients.Secondary outcomes were reported in at least two trials for the following comparisons - aprotinin versus control, tranexamic acid versus control, rFVIIa versus control, thromboelastography versus control, and tranexamic acid versus aprotinin. There was significantly lower allogeneic blood transfusion requirements in the aprotinin group than the control group (8 trials; 185 patients in aprotinin group and 190 patients in control group; SMD -0.61; 95% CI -0.82 to -0.40). There were no significant differences in the allogeneic blood transfusion requirements between the tranexamic acid and control groups (4 trials; 93 patients in tranexamic acid group and 66 patients in control group; SMD -0.27; 95% CI -0.59 to 0.06); rFVIIa and control groups (2 trials; 141 patients in rFVIIa group and 80 patients in control group; SMD -0.05; 95% CI -0.32 to 0.23); thromboelastography and control groups (2 trials; 31 patients in thromboelastography group and 31 patients in control group; SMD -0.73; 95% CI -1.69 to 0.24); or between the tranexamic acid and aprotinin groups (3 trials; 101 patients in tranexamic acid group and 97 patients in aprotinin group; SMD -0.09; 95% CI -0.36 to 0.19). The remaining outcomes in the above comparisons and the remaining comparisons included only only trial under the primary outcome or the outcome was not reported at all in the trials. There were no significant differences in the blood loss, transfusion requirements, hospital stay, or intensive care unit stay in most of the comparisons. Aprotinin, recombinant factor VIIa, and thromboelastography groups may potentially reduce blood loss and transfusion requirements. However, risks of systematic errors (bias) and risks of random errors (play of chance) hamper the confidence in this conclusion. We need further well-designed randomised trials with low risk of systematic error and low risk of random errors before these interventions can be supported or refuted.

Nurse care coordination and technology effects on health status of frail older adults via enhanced self-management of medication: randomized clinical trial to test efficacy.

PubMed

Marek, Karen Dorman; Stetzer, Frank; Ryan, Polly A; Bub, Linda Denison; Adams, Scott J; Schlidt, Andrea; Lancaster, Rachelle; O'Brien, Anne-Marie

2013-01-01

Self-management of complex medication regimens for chronic illness is challenging for many older adults. The purpose of this study was to evaluate health status outcomes of frail older adults receiving a home-based support program that emphasized self-management of medications using both care coordination and technology. This study used a randomized controlled trial with three arms and longitudinal outcome measurement. Older adults having difficulty in self-managing medications (n = 414) were recruited at discharge from three Medicare-certified home healthcare agencies in a Midwestern urban area. All participants received baseline pharmacy screens. The control group received no further intervention. A team of advanced practice nurses and registered nurses coordinated care for 12 months to two intervention groups who also received either an MD.2 medication-dispensing machine or a medplanner. Health status outcomes (the Geriatric Depression Scale, Mini Mental Status Examination, Physical Performance Test, and SF-36 Physical Component Summary and Mental Component Summary) were measured at baseline and at 3, 6, 9, and 12 months. After covariate and baseline health status adjustment, time × group interactions for the MD.2 and medplanner groups on health status outcomes were not significant. Time × group interactions were significant for the medplanner and control group comparisons. Participants with care coordination had significantly better health status outcomes over time than those in the control group, but addition of the MD.2 machine to nurse care coordination did not result in better health status outcomes.

Cytomegalovirus seroprevalence in pregnant women and association with adverse pregnancy/neonatal outcomes in Jiangsu Province, China.

PubMed

Zhang, Shu; Hu, Lingqing; Chen, Jie; Xu, Biyun; Zhou, Yi-Hua; Hu, Yali

2014-01-01

In this study, we aimed to determine the provincial population-based seroprevalence in pregnant women and to further explore the association of maternal CMV infection status and adverse pregnancy/neonatal/growth outcomes in Jiangsu, China. In this case-control study, the sera from 527 pregnant women with adverse pregnancy/neonatal outcomes and 496 mothers of healthy infants in Jiangsu Province, collected at gestation age of 15-20 weeks, were tested for anti-CMV IgG, IgM and IgG avidity. Adverse pregnancy/neonatal outcomes were identified based on pregnancy/neonatal outcomes. The overall seroprevalence of anti-CMV IgG was 98.7%, with 99.4% and 98.0% in the case and control groups, respectively (P = 0.039). The prevalence of anti-CMV IgG+/IgM+, was higher in the case group than that in the control group (3.8% vs. 1.6%, P = 0.033). Anti-CMV IgG avidity assay showed that none in the control group were primarily infected, but five (0.9%) in the case group underwent primary infection (P = 0.084); all five infants of these women presented severe adverse neonatal/growth outcomes. Exact logistic regression analysis showed that anti-CMV IgG+/IgM+ was associated with adverse pregnancy/neonatal/growth outcomes (aOR = 2.44, 95% CI 1.01-6.48, P = 0.047). Maternal low education level and prior abnormal pregnancies also were risk factors for adverse pregnancy/neonatal outcomes. In populations with very high prevalence of latent CMV infection, active maternal CMV infection during pregnancy might be a risk factor for adverse pregnancy/neonatal outcomes.

Cytomegalovirus Seroprevalence in Pregnant Women and Association with Adverse Pregnancy/Neonatal Outcomes in Jiangsu Province, China

PubMed Central

Chen, Jie; Xu, Biyun; Zhou, Yi-Hua; Hu, Yali

2014-01-01

Background In this study, we aimed to determine the provincial population-based seroprevalence in pregnant women and to further explore the association of maternal CMV infection status and adverse pregnancy/neonatal/growth outcomes in Jiangsu, China. Methods In this case-control study, the sera from 527 pregnant women with adverse pregnancy/neonatal outcomes and 496 mothers of healthy infants in Jiangsu Province, collected at gestation age of 15–20 weeks, were tested for anti-CMV IgG, IgM and IgG avidity. Adverse pregnancy/neonatal outcomes were identified based on pregnancy/neonatal outcomes. Results The overall seroprevalence of anti-CMV IgG was 98.7%, with 99.4% and 98.0% in the case and control groups, respectively (P = 0.039). The prevalence of anti-CMV IgG+/IgM+, was higher in the case group than that in the control group (3.8% vs. 1.6%, P = 0.033). Anti-CMV IgG avidity assay showed that none in the control group were primarily infected, but five (0.9%) in the case group underwent primary infection (P = 0.084); all five infants of these women presented severe adverse neonatal/growth outcomes. Exact logistic regression analysis showed that anti-CMV IgG+/IgM+ was associated with adverse pregnancy/neonatal/growth outcomes (aOR = 2.44, 95% CI 1.01–6.48, P = 0.047). Maternal low education level and prior abnormal pregnancies also were risk factors for adverse pregnancy/neonatal outcomes. Conclusions In populations with very high prevalence of latent CMV infection, active maternal CMV infection during pregnancy might be a risk factor for adverse pregnancy/neonatal outcomes. PMID:25211647

Perioperative Care and the Importance of Continuous Quality Improvement—A Controlled Intervention Study in Three Tanzanian Hospitals

PubMed Central

Mtatifikolo, Ferdinand; Ngoli, Baltazar; Neuner, Bruno; Wernecke, Klaus–Dieter; Spies, Claudia

2015-01-01

Introduction Surgical services are increasingly seen to reduce death and disability in Sub-Saharan Africa, where hospital-based mortality remains alarmingly high. This study explores two implementation approaches to improve the quality of perioperative care in a Tanzanian hospital. Effects were compared to a control group of two other hospitals in the region without intervention. Methods All hospitals conducted quality assessments with a Hospital Performance Assessment Tool. Changes in immediate outcome indicators after one and two years were compared to final outcome indicators such as Anaesthetic Complication Rate and Surgical Case Fatality Rate. Results Immediate outcome indicators for Preoperative Care in the intervention hospital improved (52.5% in 2009; 84.2% in 2011, p<0.001). Postoperative Inpatient Care initially improved to then decline again (63.3% in 2009; 70% in 2010; 58.6% in 2011). In the control group, preoperative care declined from 50.8% (2009) to 32.8% (2011, p <0.001), while postoperative care did not significantly change. Anaesthetic Complication Rate in the intervention hospital declined (1.89% before intervention; 0.96% after intervention, p = 0.006). Surgical Case Fatality Rate in the intervention hospital declined from 5.67% before intervention to 2.93% after intervention (p<0.0010). Surgical Case Fatality Rate in the control group was 4% before intervention and 3.8% after intervention (p = 0.411). Anaesthetic Complication Rate in the control group was not available. Discussion Immediate outcome indicators initially improved, while at the same time final outcome declined (Surgical Case Fatality, Anaesthetic Complication Rate). Compared to the control group, final outcome improved more in the intervention hospital, although the effect was not significant over the whole study period. Documentation of final outcome indicators seemed inconsistent. Immediate outcome indicators seem more helpful to steer the Continuous Quality Improvement program. Conclusion Specific interventions as part of Continuous Quality Improvement might lead to sustainable improvement of the quality of care, if embedded in a multi-faceted approach. PMID:26327392

Perioperative Care and the Importance of Continuous Quality Improvement--A Controlled Intervention Study in Three Tanzanian Hospitals.

PubMed

Bosse, Goetz; Abels, Wiltrud; Mtatifikolo, Ferdinand; Ngoli, Baltazar; Neuner, Bruno; Wernecke, Klaus-Dieter; Spies, Claudia

2015-01-01

Surgical services are increasingly seen to reduce death and disability in Sub-Saharan Africa, where hospital-based mortality remains alarmingly high. This study explores two implementation approaches to improve the quality of perioperative care in a Tanzanian hospital. Effects were compared to a control group of two other hospitals in the region without intervention. All hospitals conducted quality assessments with a Hospital Performance Assessment Tool. Changes in immediate outcome indicators after one and two years were compared to final outcome indicators such as Anaesthetic Complication Rate and Surgical Case Fatality Rate. Immediate outcome indicators for Preoperative Care in the intervention hospital improved (52.5% in 2009; 84.2% in 2011, p<0.001). Postoperative Inpatient Care initially improved to then decline again (63.3% in 2009; 70% in 2010; 58.6% in 2011). In the control group, preoperative care declined from 50.8% (2009) to 32.8% (2011, p <0.001), while postoperative care did not significantly change. Anaesthetic Complication Rate in the intervention hospital declined (1.89% before intervention; 0.96% after intervention, p = 0.006). Surgical Case Fatality Rate in the intervention hospital declined from 5.67% before intervention to 2.93% after intervention (p<0.0010). Surgical Case Fatality Rate in the control group was 4% before intervention and 3.8% after intervention (p = 0.411). Anaesthetic Complication Rate in the control group was not available. Immediate outcome indicators initially improved, while at the same time final outcome declined (Surgical Case Fatality, Anaesthetic Complication Rate). Compared to the control group, final outcome improved more in the intervention hospital, although the effect was not significant over the whole study period. Documentation of final outcome indicators seemed inconsistent. Immediate outcome indicators seem more helpful to steer the Continuous Quality Improvement program. Specific interventions as part of Continuous Quality Improvement might lead to sustainable improvement of the quality of care, if embedded in a multi-faceted approach.

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

PubMed

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.

Effectiveness of a Text Messaging-Based Intervention Targeting Alcohol Consumption Among University Students: Randomized Controlled Trial.

PubMed

Thomas, Kristin; Müssener, Ulrika; Linderoth, Catharina; Karlsson, Nadine; Bendtsen, Preben; Bendtsen, Marcus

2018-06-25

Excessive drinking among university students is a global challenge, leading to significant health risks. However, heavy drinking among students is widely accepted and socially normalized. Mobile phone interventions have attempted to reach students who engage in excessive drinking. A growing number of studies suggest that text message-based interventions could potentially reach many students and, if effective, such an intervention might help reduce heavy drinking in the student community. The objective of this study was to test the effectiveness of a behavior change theory-based 6-week text message intervention among university students. This study was a two-arm, randomized controlled trial with an intervention group receiving a 6-week text message intervention and a control group that was referred to treatment as usual at the local student health care center. Outcome measures were collected at baseline and at 3 months after the initial invitation to participate in the intervention. The primary outcome was total weekly alcohol consumption. Secondary outcomes were frequency of heavy episodic drinking, highest estimated blood alcohol concentration, and number of negative consequences attributable to excessive drinking. A total of 896 students were randomized to either the intervention or control group. The primary outcome analysis included 92.0% of the participants in the intervention group and 90.1% of the control group. At follow-up, total weekly alcohol consumption decreased in both groups, but no significant between-group difference was seen. Data on the secondary outcomes included 49.1% of the participants in the intervention group and 41.3% of the control group. No significant between-group difference was seen for any of the secondary outcomes. The present study was under-powered, which could partly explain the lack of significance. However, the intervention, although theory-based, needs to be re-assessed and refined to better support the target group. Apart from establishing which content forms an effective intervention, the optimal length of an alcohol intervention targeting students also needs to be addressed in future studies. International Standard Randomised Controlled Trial Number ISRCTN95054707; http://www.isrctn.com/ISRCTN95054707 (Archived by WebCite at http://www.webcitation.org/70Ax4vXhd). ©Kristin Thomas, Ulrika Müssener, Catharina Linderoth, Nadine Karlsson, Preben Bendtsen, Marcus Bendtsen. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 25.06.2018.

Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial

PubMed Central

Britten, Jane; Prescott, Gordon J; Tappin, David; Ludbrook, Anne; Godden, David J

2009-01-01

Objective To assess the clinical effectiveness and cost effectiveness of a policy to provide breastfeeding groups for pregnant and breastfeeding women. Design Cluster randomised controlled trial with prospective mixed method embedded case studies to evaluate implementation processes. Setting Primary care in Scotland. Participants Pregnant women, breastfeeding mothers, and babies registered with 14 of 66 eligible clusters of general practices (localities) in Scotland that routinely collect breastfeeding outcome data. Intervention Localities set up new breastfeeding groups to provide population coverage; control localities did not change group activity. Main outcome measures Primary outcome: any breast feeding at 6-8 weeks from routinely collected data for two pre-trial years and two trial years. Secondary outcomes: any breast feeding at birth, 5-7 days, and 8-9 months; maternal satisfaction. Results Between 1 February 2005 and 31 January 2007, 9747 birth records existed for intervention localities and 9111 for control localities. The number of breastfeeding groups increased from 10 to 27 in intervention localities, where 1310 women attended, and remained at 10 groups in control localities. No significant differences in breastfeeding outcomes were found. Any breast feeding at 6-8 weeks declined from 27% to 26% in intervention localities and increased from 29% to 30% in control localities (P=0.08, adjusted for pre-trial rate). Any breast feeding at 6-8 weeks increased from 38% to 39% in localities not participating in the trial. Women who attended breastfeeding groups were older (P<0.001) than women initiating breast feeding who did not attend and had higher income (P=0.02) than women in the control localities who attended postnatal groups. The locality cost was £13 400 (€14 410; $20 144) a year. Conclusion A policy for providing breastfeeding groups in relatively deprived areas of Scotland did not improve breastfeeding rates at 6-8 weeks. The costs of running groups would be similar to the costs of visiting women at home. Trial registration Current Controlled Trials ISRCTN44857041. PMID:19181729

Randomized Controlled Trial of Exercise for ADHD and Disruptive Behavior Disorders

PubMed Central

Bustamante, Eduardo E.; Davis, Catherine L.; Frazier, Stacy L.; Rusch, Dana; Fogg, Louis F.; Atkins, Marc S.; Marquez, David X.

2016-01-01

Purpose To test feasibility and impact of a 10-week after-school exercise program for children with ADHD and/or disruptive behavior disorders (DBD) living in an urban poor community. Methods Children were randomized to exercise (n=19) or a comparable but sedentary attention control program (n=16). Cognitive and behavioral outcomes were collected pre-post. Intent-to-treat mixed models tested group × time and group × time × attendance interactions. Effect sizes were calculated within and between groups. Results Feasibility was evidenced by 86% retention, 60% attendance, and average 75% maximum heart rate. Group × time results were null on the primary outcome, parent-reported executive function. Among secondary outcomes, between-group effect sizes favored exercise on hyperactive symptoms (d=0.47) and verbal working memory (d=0.26), and controls on visuospatial working memory (d=-0.21) and oppositional defiant symptoms (d=-0.37). In each group, within-group effect sizes were moderate-large on most outcomes (d=0.67 to 1.60). A group × time × attendance interaction emerged on visuospatial working memory (F[1,33]=7.42, p<.05), such that attendance to the control program was related to greater improvements (r=.72, p<.01) while attendance to the exercise program was not (r=.25, p=.34). Conclusions While between-group findings on the primary outcome, parent-reported executive function, were null, between-group effect sizes on hyperactivity and visuospatial working memory may reflect adaptations to the specific challenges presented by distinct formats. Both groups demonstrated substantial within-group improvements on clinically relevant outcomes. Findings underscore the importance of programmatic features such as routines, engaging activities, behavior management strategies, and adult attention; and highlight the potential for after-school programs to benefit children with ADHD and DBD living in urban poverty where health needs are high and services resources few. PMID:26829000

Randomized Controlled Trial of Exercise for ADHD and Disruptive Behavior Disorders.

PubMed

Bustamante, Eduardo Esteban; Davis, Catherine Lucy; Frazier, Stacy Lynn; Rusch, Dana; Fogg, Louis F; Atkins, Marc S; Marquez, David Xavier

2016-07-01

The objective of this study is to test the feasibility and impact of a 10-wk after-school exercise program for children with attention deficit hyperactivity disorder and/or disruptive behavior disorders living in an urban poor community. Children were randomized to an exercise program (n = 19) or a comparable but sedentary attention control program (n = 16). Cognitive and behavioral outcomes were collected pre-/posttest. Intent-to-treat mixed models tested group-time and group-time-attendance interactions. Effect sizes were calculated within and between groups. Feasibility was evidenced by 86% retention, 60% attendance, and average 75% maximum HR. Group-time results were null on the primary outcome, parent-reported executive function. Among secondary outcomes, between-group effect sizes favored exercise on hyperactive symptoms (d = 0.47) and verbal working memory (d = 0.26), and controls on visuospatial working memory (d = -0.21) and oppositional defiant symptoms (d = -0.37). In each group, within-group effect sizes were moderate to large on most outcomes (d = 0.67 to 1.60). A group-time-attendance interaction emerged on visuospatial working memory (F[1,33] = 7.42, P < 0.05), such that attendance to the control program was related to greater improvements (r = 0.72, P < 0.01), whereas attendance to the exercise program was not (r = 0.25, P = 0.34). Although between-group findings on the primary outcome, parent-reported executive function, were null, between-group effect sizes on hyperactivity and visuospatial working memory may reflect adaptations to the specific challenges presented by distinct formats. Both groups demonstrated substantial within-group improvements on clinically relevant outcomes. Findings underscore the importance of programmatic features, such as routines, engaging activities, behavior management strategies, and adult attention, and highlight the potential for after-school programs to benefit children with attention deficit hyperactivity disorder and disruptive behavior disorder living in urban poverty where health needs are high and services resources few.

Self-management education for rehabilitation inpatients suffering from inflammatory bowel disease: a cluster-randomized controlled trial.

PubMed

Reusch, A; Weiland, R; Gerlich, C; Dreger, K; Derra, C; Mainos, D; Tuschhoff, T; Berding, A; Witte, C; Kaltz, B; Faller, H

2016-12-01

Although inflammatory bowel disease (IBD) affects patients' psychological well-being, previous educational programs have failed to demonstrate effects on psychosocial outcomes and quality of life. Therefore, we developed a group-based psychoeducational program that combined provision of both medical information and psychological self-management skills, delivered in an interactive manner, and evaluated it in a large, cluster-randomized trial. We assigned 540 rehabilitation inpatients suffering from IBD (mean age 43 years, 66% female) to either the new intervention or a control group comprising the same overall intensity and the same medical information, but only general psychosocial information. The primary outcome was patient-reported IBD-related concerns. Secondary outcomes included disease knowledge, coping, self-management skills, fear of progression, anxiety, depression and quality of life. Assessments took place at baseline, end of rehabilitation and after 3 and 12 months.The psychoeducational self-management program did not prove superior to the control group regarding primary and secondary outcomes. However, positive changes over time occurred in both groups regarding most outcomes. The superior effectiveness of the newly developed psychoeducational program could not be demonstrated. Since the intervention and control groups may have been too similar, this trial may have been too conservative to produce between-group effects. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Role of probiotics in the prevention of the enteric colonization by Candida in preterm newborns: incidence of late-onset sepsis and neurological outcome.

PubMed

Romeo, M G; Romeo, D M; Trovato, L; Oliveri, S; Palermo, F; Cota, F; Betta, P

2011-01-01

To evaluate the efficacy of probiotics in the prevention of gastrointestinal colonization by Candida species, of late-onset sepsis and neurological outcome in preterm newborns. A prospective study was conducted in 249 preterms who were subdivided into three groups: one group (n=83) was supplemented with Lactobacillus (L.) reuteri, one group with L. rhamnosus (n=83) and the other with no supplementation (n=83). The fungal colonization in the gastrointestinal tract, the late onset of sepsis and clinical parameters were recorded. A neurological structured assessment was further performed at 1 year of age. Candida stool colonization was significantly higher (P<0.01) in the control group than in the groups treated with probiotics. The L. reuteri group presented a significantly higher reduction in gastrointestinal symptoms than did the L. rhamnosus and control groups. Infants treated with probiotics showed a statistically significant lower incidence of abnormal neurological outcome than did the control group. The use of both probiotics seems to be effective in the prevention of gastrointestinal colonization by Candida, in the protection from late-onset sepis and in reducing abnormal neurological outcomes in preterms.

Continuous intra-arterial nimodipine infusion in patients with severe refractory cerebral vasospasm after aneurysmal subarachnoid hemorrhage: a feasibility study and outcome results.

PubMed

Bele, Sylvia; Proescholdt, Martin A; Hochreiter, Andreas; Schuierer, Gerhard; Scheitzach, Judith; Wendl, Christina; Kieninger, Martin; Schneiker, Andre; Bründl, Elisabeth; Schödel, Petra; Schebesch, Karl-Michael; Brawanski, Alexander

2015-12-01

Severe cerebral vasospasm is a major cause of death and disability in patients with aneurysmal subarachnoid hemorrhage. No causative treatment is yet available and hypertensive hypervolemic therapy (HHT) is often insufficient to avoid delayed cerebral ischemia and neurological deficits. We compared patients receiving continuous intra-arterial infusion of the calcium-antagonist nimodipine with a historical group treated with HHT and oral nimodipine alone. Between 0.5 and 1.2 mg/h of nimodipine were continuously administered by intra-arterial infusion via microcatheters either into the internal carotid or vertebral artery or both, depending on the areas of vasospasm. The effect was controlled via multimodal neuromonitoring and transcranial Doppler sonography. Outcome was determined by means of the Glasgow Outcome Scale at discharge and 6 months after the hemorrhage and compared to a historical control group. Twenty-one patients received 28 intra-arterial nimodipine infusions. Six months after discharge, the occurrence of cerebral infarctions was significantly lower (42.6 %) in the nimodipine group than in the control group (75.0 %). This result was reflected by a significantly higher proportion (76.0 %) of patients with good outcome in the nimodipine-treated group, when compared to 10.0 % good outcome in the control group. Median GOS was 4 in the nimodipine group and 2 in the control group (p = 0.001). Continuous intra-arterial nimodipine infusion is an effective treatment for patients with severe cerebral vasospasm who fail to respond to HHT and oral nimodipine alone. Key to the effective administration of continuous intra-arterial nimodipine is multimodal neuromonitoring and the individual adaptation of dosage and time of infusion for each patient.

Influences of granulocyte growth factor in uterine perfusion on pregnancy outcome of patients with failure of embryo implantation for unknown reason.

PubMed

He, Jun; Liu, Juan; Zhou, Hua; Chen, Chao Jun

2016-11-01

To investigate the influence of granulocyte growth factor in uterine perfusion on the pregnancy outcome of patients with failure of embryo implantation for unknown reason. Then, 68 patients with failure of embryo implantation for unknown reason were enrolled in our hospital from November 2013 to February 2015, which were divided into observation group and control group by random (34 patients in each group). Patients in observation group received basic treatment for granulocyte growth factor in uterine perfusion on the next day, while patients in control group received basic treatment with placebo. Then, endometrial preparation, adverse reaction and pregnancy outcome of patients were compared between the two groups. Comparing the endometrial preparation and average endometrial thickness of patients in control group (9.87±2.12) with those in observation group [(9.87±2.12), there is no significant difference (P<0.05). After treatment, patients in both groups performed diabetes, hypertension and other pregnancy complications without difference of statistical significance (P<0.05). The embryo implantation rate and clinical pregnancy rate of patients in observation group were significantly higher than those in control group [(82.35%) and (44.12%) vs (52.94%) and (17.65%)]. Moreover, the live birth rate of patients in observation group performed significantly higher than that in control group [(41.18%) vs (14.71%)] with significant difference (P<0.05). By taking treatment of granulocyte growth factor, patients with failure of embryo implantation can effectively improve clinical pregnancy rate and embryo implantation rate without severe complication. Therefore, treatment of granlocyte growth factor can improve the pregnancy outcome of patients.

Assessing the value of disease management: impact of 2 disease management strategies in an underserved asthma population.

PubMed

Galbreath, Autumn Dawn; Smith, Brad; Wood, Pamela R; Inscore, Stephen; Forkner, Emma; Vazquez, Marilu; Fallot, Andre; Ellis, Robert; Peters, Jay I

2008-12-01

The goal of disease management (DM) is to improve health outcomes and reduce cost through decreasing health care utilization. Although some studies have shown that DM improves asthma outcomes, these interventions have not been examined in a large randomized controlled trial. To compare the effectiveness of 2 previously successful DM programs with that of traditional care. Nine hundred two individuals with asthma (429 adults; 473 children) were randomly assigned to telephonic DM, augmented DM (ADM; DM plus in-home visits by a respiratory therapist), or traditional care. Data were collected at enrollment and at 6 and 12 months. Primary outcomes were time to first asthma-related event, quality of life (QOL), and rates of asthma-related health care utilization. Secondary outcomes included rate of controller medication initiation, number of oral corticosteroid bursts, asthma symptom scores, and number of school days missed. There were no significant differences between groups in time to first asthma-related event or health care utilization. Adult participants in the ADM group had greater improvement in QOL (P = .04) and a decrease in asthma symptoms (P = .001) compared with other groups. Of children not receiving controller medications at enrollment (13%), those in the intervention groups were more likely to have controller medications initiated than the control group (P = .01). Otherwise, there were no differences in outcomes. Overall, participation in asthma DM did not result in significant differences in utilization or clinical outcomes. The only significant impact was a higher rate of controllermedication initiation in children and improvement in asthma symptoms and QOL in adults who received ADM.

Effect of programmed intermittent epidural boluses and continuous epidural infusion on labor analgesia and obstetric outcomes: a randomized controlled trial.

PubMed

Ferrer, Leopoldo E; Romero, David J; Vásquez, Oscar I; Matute, Ednna C; Van de Velde, Marc

2017-11-01

Continuous epidural infusion and programmed intermittent epidural boluses are analgesic techniques routinely used for pain relief in laboring women. We aimed to assess both techniques and compare them with respect to labor analgesia and obstetric outcomes. After Institutional Review Board approval, 132 laboring women aged between 18 and 45 years were randomized to epidural analgesia of 10 mL of a mixture of 0.1% bupivacaine plus 2 µg/mL of fentanyl either by programmed intermittent boluses or continuous infusion (66 per group). Primary outcome was quality of analgesia. Secondary outcomes were duration of labor, total drug dose used, maternal satisfaction, sensory level, motor block level, presence of unilateral motor block, hemodynamics, side effects, mode of delivery, and newborn outcome. Patients in the programmed intermittent epidural boluses group received statistically less drug dose than those with continuous epidural infusion (24.9 vs 34.4 mL bupivacaine; P = 0.01). There was no difference between groups regarding pain control, characteristics of block, hemodynamics, side effects, and Apgar scores. Our study evidenced a lower anesthetic consumption in the programmed intermittent boluses group with similar labor analgesic control, and obstetric and newborn outcomes in both groups.

Musical dual-task training in patients with mild-to-moderate dementia: a randomized controlled trial.

PubMed

Chen, Yu-Ling; Pei, Yu-Cheng

2018-01-01

Dual-task training may improve dual-task gait performance, balance, and cognition in older adults with and without cognitive impairment. Although music has been widely utilized in dementia management, there are no existing protocols for music-based dual-task training. This randomized controlled study developed a Musical Dual-Task Training (MDTT) protocol that patients with dementia can use to practice walking and making music simultaneously, to enhance attention control in patients during dual-tasking. Twenty-eight adults diagnosed with mild-to-moderate dementia were assigned to the MDTT (n=15) or control groups (n=13). The MDTT group received MDTT, while the control group participated in non-musical cognitive and walking activities. The effects of MDTT were evaluated through the primary outcome of attention control, and secondary outcomes of dual-task performance, balance, falls efficacy, and agitation. The MDTT group showed a significant improvement in attention control, while the control group did not ( P <0.001). A significant effect favored MDTT over control treatment for the secondary outcome of falls efficacy ( P =0.02) and agitation ( P <0.01). MDTT, a music therapy intervention that demands a high level of cognitive processing, enhances attention control, falls efficacy, and helps alleviate agitation in patients with mild-to-moderate dementia.

Musical dual-task training in patients with mild-to-moderate dementia: a randomized controlled trial

PubMed Central

Chen, Yu-Ling; Pei, Yu-Cheng

2018-01-01

Background/aims Dual-task training may improve dual-task gait performance, balance, and cognition in older adults with and without cognitive impairment. Although music has been widely utilized in dementia management, there are no existing protocols for music-based dual-task training. This randomized controlled study developed a Musical Dual-Task Training (MDTT) protocol that patients with dementia can use to practice walking and making music simultaneously, to enhance attention control in patients during dual-tasking. Methods Twenty-eight adults diagnosed with mild-to-moderate dementia were assigned to the MDTT (n=15) or control groups (n=13). The MDTT group received MDTT, while the control group participated in non-musical cognitive and walking activities. The effects of MDTT were evaluated through the primary outcome of attention control, and secondary outcomes of dual-task performance, balance, falls efficacy, and agitation. Results The MDTT group showed a significant improvement in attention control, while the control group did not (P<0.001). A significant effect favored MDTT over control treatment for the secondary outcome of falls efficacy (P=0.02) and agitation (P<0.01). Conclusion MDTT, a music therapy intervention that demands a high level of cognitive processing, enhances attention control, falls efficacy, and helps alleviate agitation in patients with mild-to-moderate dementia. PMID:29881275

Effects of anticoagulant therapy on pregnancy outcomes in patients with thrombophilia and previous poor obstetric history.

PubMed

Mutlu, Ilknur; Mutlu, Mehmet Firat; Biri, Aydan; Bulut, Berk; Erdem, Mehmet; Erdem, Ahmet

2015-04-01

This study investigates the effects of anticoagulant therapy on pregnancy outcomes in 204 patients with thrombophilia and previous poor obstetric outcomes. Patients with poor obstetric history (pre-eclampsia, intrauterine growth retardation, fetal death, placental abruption, recurrent pregnancy loss) and having hereditary thrombophilia were included in this study. Poor obstetric outcomes were observed more frequently in patients who had not taken anticogulant therapy compared with treated group. Live birth rate, gestational age at birth and Apgar scores were significantly higher in the treated group when compared with the untreated group. There were no significant differences in terms of birthweight, mode of delivery and admission rates to the neonatal intensive care unit (NICU). Low-molecular-weight heparin (LMWH) plus acetylsalicylic acid (ASA) had higher gestational age at birth, Apgar scores, live birth rate and a lower abortion rates when compared with controls; in contrast, no significant difference was observed in terms of birthweight, mode of delivery, obstetric complications and admission rates to NICU. There were no significant differences between control group and both LMWH only and ASA only groups in terms of gestational age at birth, Apgar scores, birthweight, mode of delivery, obstetric complications and admission rates to NICU. Only LMWH group had higher live birth rate as compared with control group. The use of only ASA did not seem to affect the perinatal complication rates and outcomes. In conclusion, anticoagulant therapy with both LMWH and ASA seems to provide better obstetric outcomes in pregnant women with thrombophilia and previous poor obstetric outcomes.

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

PubMed

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.

Pregnancy outcomes among women with beta-thalassemia trait.

PubMed

Charoenboon, Chitrakan; Jatavan, Phudit; Traisrisilp, Kuntharee; Tongsong, Theera

2016-04-01

To compare the obstetric outcomes between pregnant women affected by beta-thalassemia trait and normal controls. A retrospective cohort study was conducted on singleton pregnant women complicated by beta-thalassemia trait and normal controls, randomly selected with the controls-to-case ratio of 2:1. All were low-risk pregnancies without underlying medical diseases and fetal anomalies. The pregnancies undergoing invasive prenatal diagnosis were excluded. A total of 597 pregnant women with beta-thalassemia trait and 1194 controls were recruited. Baseline characteristics and maternal outcomes in the two groups were similar, except that hemoglobin levels were slightly lower in the study group. The prevalence of small for gestational age and preterm birth tended to be higher in the study group but not reached the significant levels but the rate of low birth weight was significantly higher in the study group (relative risk 1.25; 95 % CI 1.00-1.57). Additionally, abortion rate was also significantly higher in the study group (relative risk 3.25; 95 % CI 1.35-7.80). Beta-thalassemia trait could minimally, but significantly, increase risk of low birth weight but did not increase rates of maternal adverse outcomes.

A randomised controlled trial of a self-management education program for osteoarthritis of the knee delivered by health care professionals.

PubMed

Coleman, Sophie; Briffa, N Kathryn; Carroll, Graeme; Inderjeeth, Charles; Cook, Nicola; McQuade, Jean

2012-01-27

Our aim in the present study was to determine whether a disease-specific self-management program for primary care patients with osteoarthritis (OA) of the knee (the Osteoarthritis of the Knee Self-Management Program (OAK)) implemented by health care professionals would achieve and maintain clinically meaningful improvements in health-related outcomes compared with a control group. Medical practitioners referred 146 primary care patients with OA of the knee. Volunteers with coexistent inflammatory joint disease or serious comorbidities were excluded. Randomisation was to either a control group or the OAK group. The OAK group completed a 6-week self-management program. The control group had a 6-month waiting period before entering the OAK program. Assessments were taken at baseline, 8 weeks and 6 months. The primary outcomes were the results measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain and Function subscales on the Short Form 36 version 1 questionnaire (SF-36) Secondary outcomes were Visual Analogue Scale (VAS) pain, Timed Up & Go Test (TUG), knee range of motion and quadriceps and hamstring strength-isometric contraction. Responses to treatment (responders) and minimal clinically important improvements (MCIIs) were determined. In the OAK group, VAS pain improved from baseline to week 8 from mean (SEM) 5.21 (0.30) to 3.65 (0.29) (P ≤ 0.001). During this period, improvements in the OAK group compared with the control group and responses to treatment were demonstrated according to the following outcomes: WOMAC Pain, Physical Function and Total dimensions, as well as SF-36 Physical Function, Role Physical, Body Pain, Vitality and Social Functioning domains. In addition, from baseline to week 8, the proportion of MCIIs was greater among the OAK group than the control group for all outcomes. For the period between baseline and month 6, WOMAC Pain, Physical Function and Total dimensions significantly improved in the OAK group compared to the control group, as did the SF-36 Physical Function, Role Physical, Body Pain, Vitality and Social Functioning domains, as well as hamstring strength in both legs. During the same period, the TUG Test, range of motion extension and left-knee flexion improved compared with the control group, although these improvements had little clinical relevance. We recorded statistically significant improvements compared with a control group with regard to pain, quality of life and function for participants in the OAK program on the basis of WOMAC and SF-36 measures taken 8 weeks and 6 months from baseline.

Risk-adjusted clinical outcomes in patients enrolled in a bloodless program

PubMed Central

Frank, Steven M.; Wick, Elizabeth C.; Dezern, Amy E.; Ness, Paul M.; Wasey, Jack O.; Pippa, Andrew C.; Dackiw, Elizabeth; Resar, Linda M.S.

2014-01-01

BACKGROUND Although clinical outcomes have been reported for patients who do not accept allogeneic blood transfusion (ABT), many previous studies lack a control group, fail to use risk adjustment, and focus exclusively on cardiac surgery. STUDY DESIGN AND METHODS We report a risk-adjusted, propensity score–matched, retrospective case-control study of clinical outcomes for inpatients who did not accept ABT (bloodless, n = 294) and those who did accept ABT (control, n = 1157). Multidisciplinary specialized care was rendered to the bloodless patients to conserve blood and optimize clinical outcomes. Differences in hemoglobin (Hb), mortality, five morbid outcomes, and hospital charges and costs were compared. Subgroups of medical and surgical patients were analyzed, and independent predictors of outcome were determined by multivariate analysis. RESULTS Overall, mortality was lower in the bloodless group (0.7%) than in the control group (2.7%; p = 0.046), primarily attributed to the surgical subgroup. After risk adjustment, bloodless care was not an independent predictor of the composite adverse outcome (death or any morbid event; p = 0.91; odds ratio, 1.02; 95% confidence interval, 0.68–1.53). Discharge Hb concentrations were similar in the bloodless (10.8 ± 2.7 g/dL) and control (10.9 ± 2.3 g/dL) groups (p = 0.42). Total and direct hospital costs were 12% (p = 0.02) and 18% (p = 0.02) less, respectively, in the bloodless patients, a difference attributed to the surgical subgroup. CONCLUSIONS Using appropriate blood conservation measures for patients who do not accept ABT results in similar or better outcomes and is associated with equivalent or lower costs. This specialized care may be beneficial even for those patients who accept ABT. PMID:24942198

Effect of audience response system technology on learning outcomes in health students and professionals: an updated systematic review.

PubMed

Atlantis, Evan; Cheema, Birinder S

2015-03-01

: Audience response system (ARS) technology is a recent innovation that is increasingly being used by health educators to improve learning outcomes. Equivocal results from previous systematic review research provide weak support for the use of ARS for improving learning outcomes at both short and long terms. This review sought to update and critically review the body of controlled experimental evidence on the use of ARS technology on learning outcomes in health students and professionals. This review searched using all identified keywords both electronic databases (CINAHL, Embase, ERIC, Medline, Science Direct, Scopus, and Web of Science) and reference lists of retrieved articles to find relevant published studies for review, from 2010 to April 2014. A descriptive synthesis of important study characteristics and effect estimates for learning outcomes was done. Three controlled trials in 321 participants from the United States were included for review. ARS knowledge retention scores were lower than the control group in one study, higher than control group provided that immediate feedback was given about each question in one study, and equivalent between intervention and control groups in another study. There is an absence of good quality evidence on effectiveness of ARS technologies for improving learning outcomes in health students and professionals.

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

PubMed

Deschamps, Alain; Hall, Richard; Grocott, Hilary; Mazer, C David; Choi, Peter T; Turgeon, Alexis F; de Medicis, Etienne; Bussières, Jean S; Hudson, Christopher; Syed, Summer; Seal, Doug; Herd, Stuart; Lambert, Jean; Denault, André; Deschamps, Alain; Mutch, Alan; Turgeon, Alexis; Denault, Andre; Todd, Andrea; Jerath, Angela; Fayad, Ashraf; Finnegan, Barry; Kent, Blaine; Kennedy, Brent; Cuthbertson, Brian H; Kavanagh, Brian; Warriner, Brian; MacAdams, Charles; Lehmann, Christian; Fudorow, Christine; Hudson, Christopher; McCartney, Colin; McIsaac, Dan; Dubois, Daniel; Campbell, David; Mazer, David; Neilpovitz, David; Rosen, David; Cheng, Davy; Drapeau, Dennis; Dillane, Derek; Tran, Diem; Mckeen, Dolores; Wijeysundera, Duminda; Jacobsohn, Eric; Couture, Etienne; de Medicis, Etienne; Alam, Fahad; Abdallah, Faraj; Ralley, Fiona E; Chung, Frances; Lellouche, Francois; Dobson, Gary; Germain, Genevieve; Djaiani, George; Gilron, Ian; Hare, Gregory; Bryson, Gregory; Clarke, Hance; McDonald, Heather; Roman-Smith, Helen; Grocott, Hilary; Yang, Homer; Douketis, James; Paul, James; Beaubien, Jean; Bussières, Jean; Pridham, Jeremy; Armstrong, J N; Parlow, Joel; Murkin, John; Gamble, Jonathan; Duttchen, Kaylene; Karkouti, Keyvan; Turner, Kim; Baghirzada, Leyla; Szabo, Linda; Lalu, Manoj; Wasowicz, Marcin; Bautista, Michael; Jacka, Michael; Murphy, Michael; Schmidt, Michael; Verret, Michaël; Perrault, Michel-Antoine; Beaudet, Nicolas; Buckley, Norman; Choi, Peter; MacDougall, Peter; Jones, Philip; Drolet, Pierre; Beaulieu, Pierre; Taneja, Ravi; Martin, Rene; Hall, Richard; George, Ronald; Chun, Rosa; McMullen, Sarah; Beattie, Scott; Sampson, Sonia; Choi, Stephen; Kowalski, Stephen; McCluskey, Stuart; Syed, Summer; Boet, Sylvain; Ramsay, Tim; Saha, Tarit; Mutter, Thomas; Chowdhury, Tumul; Uppal, Vishal; Mckay, William

2016-04-01

Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

Essential considerations in developing attention control groups in behavioral research.

PubMed

Aycock, Dawn M; Hayat, Matthew J; Helvig, Ashley; Dunbar, Sandra B; Clark, Patricia C

2018-06-01

Attention control groups strengthen randomized controlled trials of behavioral interventions, but researchers need to give careful consideration to the attention control activities. A comparative effectiveness research framework provides an ideal opportunity for an attention control group as a supplement to standard care, so participants potentially receive benefit regardless of group assignment. The anticipated benefit of the control condition must be independent of the study outcome. Resources needed for attention control activities need to be carefully considered and ethical considerations carefully weighed. In this paper we address nine considerations for the design and implementation of attention control groups: (1) ensure attention control activities are not associated with the outcome; (2) avoid contamination of the intervention or control group; (3) design comparable control and intervention activities; (4) ensure researcher training to adequately administer both treatment arms; (5) design control activities to be interesting and acceptable to participants; (6) evaluate attention control activities; (7) consider additional resources needed to implement attention control activities; (8) quantifying the effects of attention control and intervention groups; and (9) ethical considerations with attention control groups. Examples from the literature and ongoing research are presented. Careful planning for the attention control group is as important as for the intervention group. Researchers can use the considerations presented here to assist in planning for the best attention control group for their study. © 2018 Wiley Periodicals, Inc.

Yoga and massage therapy reduce prenatal depression and prematurity.

PubMed

Field, Tiffany; Diego, Miguel; Hernandez-Reif, Maria; Medina, Lissette; Delgado, Jeannette; Hernandez, Andrea

2012-04-01

Eighty-four prenatally depressed women were randomly assigned to yoga, massage therapy or standard prenatal care control groups to determine the relative effects of yoga and massage therapy on prenatal depression and neonatal outcomes. Following 12 weeks of twice weekly yoga or massage therapy sessions (20 min each) both therapy groups versus the control group had a greater decrease on depression, anxiety and back and leg pain scales and a greater increase on a relationship scale. In addition, the yoga and massage therapy groups did not differ on neonatal outcomes including gestational age and birthweight, and those groups, in turn, had greater gestational age and birthweight than the control group. Copyright © 2011 Elsevier Ltd. All rights reserved.

How standard is standard care? Exploring control group outcomes in behaviour change interventions for young people with type 1 diabetes.

PubMed

Ayling, K; Brierley, S; Johnson, B; Heller, S; Eiser, C

2015-01-01

Poor descriptions of standard care may compromise interpretation of results in randomised controlled trials (RCTs) of health interventions. We investigated quality of standard care in RCTs of behaviour change interventions for young people with type 1 diabetes and consider implications for evaluating trial outcomes. We conducted systematic searches for articles published between 1999 and 2012. We extracted standard care descriptions and contacted trial authors to complete a checklist of standard care activities. The relationship between standard care quality and outcomes was examined via subgroup meta-analyses and meta-regression. Standard care descriptions, standard care quality, and relationships between standard care quality with medical and psychological outcomes. We identified 20 RCTs described across 26 articles. Published descriptions of standard care were limited to service-level features. Author responses indicated standard care provision extended beyond published accounts. Subgroup analyses suggested control groups receiving higher standard care quality showed larger improvements in both medical and psychological outcomes, although standard care quality did not predict outcomes significantly. The quality of care delivered to control group participants can influence outcomes of RCTs. Inadequate reporting exacerbates this issue by masking variations between trials. We argue for increased clarity in reporting standard care in future trials.

The Value of Audio Devices in the Endoscopy Room (VADER) study: a randomised controlled trial.

PubMed

Ardalan, Zaid Sm; Vasudevan, Abhinav; Hew, Simon; Schulberg, Julien; Lontos, Steve

2015-12-14

To evaluate the effect of Star Wars music (SWM) compared with endoscopist-selected popular music (PM) on quality outcomes in colonoscopy. A single-centre, prospective, randomised controlled trial conducted in an endoscopy suite within a quaternary-centre gastroenterology unit, Melbourne, Australia. The primary outcome measures were procedure time, polyp detection rate (PDR) and adenoma detection rate (ADR). The secondary outcome measure was adenomas per colonoscopy (APC). 103 colonoscopies were analysed: 58 in the SWM group and 45 in the PM group. Bowel preparation was assessed as good or excellent in 57% of the SWM group compared with 69% of the PM group (P < 0.01). The PDR was significantly higher in the SWM group than in the PM group (60% v 35%; P = 0.006). Similarly, the ADR was significantly higher in the SWM group than in the PM group (48% v 27%; P = 0.01). The APC in the SWM group was 84% compared with 35% in the PM group (P = 0.01). SWM compared with PM improves key quality outcomes in colonoscopy, despite poorer bowel preparation.

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

PubMed

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 activity and wrist skin temperature, and urinary melatonin metabolite. Chronotype and visual function will be assessed using the 'morningness-eveningness' questionnaire, the Munich chronotype questionnaire, and the National Eye Institute Visual Function Questionnaire. Although there are potential limitations due to the difference in duration from baseline survey to outcome measurements between two groups, any seasonal effect on the outcome measurement will be balanced as a result of continuous inclusion of participants through the year, and outcomes will be adjusted for day length at outcome measurements at analysis. UMIN000014559, UMIN Clinical Trials Registry, registered on 15 July 2014.

RANDOMIZED CONTROLLED TRIAL OF PARENT-INFANT PSYCHOTHERAPY FOR PARENTS WITH MENTAL HEALTH PROBLEMS AND YOUNG INFANTS.

PubMed

Fonagy, Peter; Sleed, Michelle; Baradon, Tessa

2016-01-01

There is a dearth of good-quality research investigating the outcomes of psychoanalytic parent-infant psychotherapy (PIP). This randomized controlled trial investigated the outcomes of PIP for parents with mental health problems who also were experiencing high levels of social adversity and their young infants (<12 months). Dyads were clinically referred and randomly allocated to PIP or a control condition of standard secondary and specialist primary care treatment (n = 38 in each group). Outcomes were assessed at baseline and at 6-month and 12-month follow-ups. The primary outcome was infant development. Secondary outcomes included parent-infant interaction, maternal psychopathology, maternal representations, maternal reflective functioning, and infant attachment. There were no differential effects over time between the groups on measures of infant development, parent-infant interaction, or maternal reflective functioning. Infant attachment classifications, measured only at the 12-month follow-up, did not differ between the groups. There were favorable outcomes over time for the PIP-treated dyads relative to the control group on several measures of maternal mental health, parenting stress, and parental representations of the baby and their relationship. The findings indicate potential benefits of parent-infant psychotherapy for improving mothers' psychological well-being and their representations of their baby and the parent-infant relationship. © 2016 Michigan Association for Infant Mental Health.

Evaluation of a nurse-led disease management programme for chronic kidney disease: a randomized controlled trial.

PubMed

Wong, Frances Kam Yuet; Chow, Susan Ka Yee; Chan, Tony Moon Fai

2010-03-01

Patients with end stage renal failure require dialysis and strict adherence to treatment plans to sustain life. However, non-adherence is a common and serious problem among patients with chronic kidney disease. There is a scarcity of studies in examining the effects of disease management programmes on patients with chronic kidney disease. This paper examines whether the study group receiving the disease management programme have better improvement than the control group, comparing outcomes at baseline (O1), at 7 weeks at the completion of the programme (O2) and at 13 weeks (O3). This is a randomized controlled trial. The outcome measures were non-adherence in diet, fluid, dialysis and medication, quality of life, satisfaction, symptom control, complication control and health service utilisation. There was no significant difference between the control and study group for the baseline measures, except for sleep. Significant differences (p<0.05) were found between the control and study group at O2 in the outcome measures of diet degree non-adherence, sleep, symptom, staff encouragement, overall health and satisfaction. Sustained effects at O3 were noted in the outcome measures of continuous ambulatory peritoneal dialysis (CAPD) non-adherence degree, sleep, symptom, and effect of kidney disease. Many studies exploring chronic disease management have neglected the group with end stage renal failure and this study fills this gap. This study has employed an innovative model of skill mix using specialist and general nurses and demonstrated patient improvement in diet non-adherence, CAPD non-adherence, aspects of quality of life and satisfaction with care. Redesigning chronic disease management programmes helps to optimize the use of different levels of skills and resources to bring about positive outcomes. Copyright 2009 Elsevier Ltd. All rights reserved.

The Effect of Interactive Web-Based Monitoring on Breastfeeding Exclusivity, Intensity, and Duration in Healthy, Term Infants After Hospital Discharge.

PubMed

Ahmed, Azza H; Roumani, Ali M; Szucs, Kinga; Zhang, Lingsong; King, Demetra

2016-01-01

To determine whether a Web-based interactive breastfeeding monitoring system increased breastfeeding duration, exclusivity, and intensity as primary outcomes and decreased symptoms of postpartum depression as a secondary outcome. Two-arm, randomized controlled trial. Three hospitals in the Midwestern United States. One hundred forty one (141) mother-newborn dyads were recruited before discharge. Postpartum women were randomly assigned to the control or intervention groups. Women in the control group (n = 57) followed the standard hospital protocol, whereas women in the intervention group (n = 49) were given access to an online interactive breastfeeding monitoring system and were prompted to record breastfeeding and infant output data for 30 days. A follow-up online survey was sent to both groups at 1, 2, and 3 months to assess breastfeeding outcomes and postpartum depression. For mothers and infants, there were no significant differences in demographics between groups. No significant differences in breastfeeding outcomes were found between groups at discharge (p = .707). A significant difference in breastfeeding outcomes was found between groups at 1, 2, and 3 months (p = .027, p < .001, and p = .002, respectively). Members of the intervention group had greater exclusive breastfeeding rates at 1, 2, and 3 months. By the end of the third month, 84% of the intervention group was breastfeeding compared with 66% of the control group. Postpartum depression symptom scores decreased for both groups at 1, 2, and 3 months (control group: 4.9 ± 3.9, 4.3 ± 4.9, and 3.2 ± 3.9, respectively; intervention group: 4.7 ± 4.5, 3.0 ± 3.4, and 2.8 ± 3.6, respectively). However, there was no significant difference between groups at 1, 2, and 3 months (p = .389, .170, and .920, respectively) for depression. The Web-based interactive breastfeeding monitoring system may be a promising intervention to improve breastfeeding duration, exclusivity, and intensity. Copyright © 2016 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

Reverse shoulder prosthesis in the treatment of locked anterior shoulders: a comparison with classic reverse shoulder indications.

PubMed

Kurowicki, Jennifer; Triplet, Jacob J; Momoh, Enesi; Moor, Molly A; Levy, Jonathan C

2016-12-01

Locked anterior shoulder (LAS) with static instability and anterior glenoid bone loss is challenging in the elderly population. Reverse shoulder arthroplasty (RSA) has been employed in treating these patients. No study has compared RSA for LAS with classically indicated RSA. A retrospective case-control study of patients treated with RSA for LAS with glenoid bone loss and static instability was performed using matched controls treated with primary RSA for classic indications. Twenty-four cases and 48 controls were evaluated. Average follow-up was 25.5 months, and median age was 76 years. Motion, outcome assessments, and postoperative radiographs were compared. Preoperatively, LAS had significantly less rotation and lower baseline outcome scores. Glenoid bone grafting was more common (P = .05) in the control group (26%) than in the LAS group (6.3%). Larger glenospheres were used more often (P = .001) in the LAS group (75%) than in the control group (29%). Both groups demonstrated significant improvements in pain, function, and outcome scores. Postoperatively, the control group had significantly better elevation and functional outcome scores. With the exception of flexion and Simple Shoulder Test score, effectiveness of treatment was similar between groups. Postoperative acromion stress fractures were seen in 21% of LAS patients and 9% of controls (P = .023) with a predominance of type 3 fractures in LAS. Two LAS patients remained dislocated. Patients with LAS treated with RSA can anticipate improvements in pain and function by use of larger glenospheres, often without the need for glenoid bone grafting. Worse postoperative motion and function and a higher incidence of acromion stress fracture may be expected. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Effect of LI4 and BL32 acupressure on labor pain and delivery outcome in the first stage of labor in primiparous women: A randomized controlled trial.

PubMed

Ozgoli, Giti; Sedigh Mobarakabadi, Sedigheh; Heshmat, Reza; Alavi Majd, Hamid; Sheikhan, Zohreh

2016-12-01

This study examines and compares the effect of LI4 and BL32 acupressure with each other and control group on labor pain and delivery outcomes. In this randomized controlled trial, 105 primiparous women in active phase of first-stage of labor were equally assigned to two experimental groups [acupressure on LI4 (n=35) or BL32 (n=35)] and a control group (n=35). The experimental groups received routine labor care and acupressure in LI4 or BL32 points in three cervical dilatations (4-5, 6-7, and 8-10cm). The control group only received routine labor care. Pain was assessed by numerical rating scale in three cervical dilatations, before and after intervention. Type of delivery (cesarean, vaginal or operative delivery) and neonatal Apgar score were considered as delivery outcomes, these data collected by a check list. Data were analyzed using Repeated Measurement, ANOVA, Chi-Square, Kruskal-Wallis, and Mann-Whitney tests. Pain reduction was significantly greater in LI4 and BL32 groups compared with control in all periods of study. Also, acupressure on BL32 point was superior to LI4 point in pain relief in the first and second but not third intervention. No statistically significant difference was observed in terms of delivery outcomes. Acupressure on BL32 and LI4 points are effective in reducing labor pain compared to control group with a slight superiority for BL32 points. Acupressure on these points could apply for relief pain in labor as an inexpensive and easy to administered method. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed Central

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

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

PubMed

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 < 0,001). 41.3 % of the refugee patients had no antenatal care. However, this ratio was only 7.7 % for the control group (p < 0.001). Preterm birth rates showed no difference between the groups, however, postterm birth rates were significantly higher in the control group. Low Birthweight (<2500 gr), oligohydramnios, stillbirth and fetal anomaly rates were not different between the two groups. In comparison to non-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.

Short structured general mental health in service training programme in Kenya improves patient health and social outcomes but not detection of mental health problems - a pragmatic cluster randomised controlled trial

PubMed Central

2013-01-01

Trial design A pragmatic cluster randomised controlled trial. Methods Participants: Clusters were primary health care clinics on the Ministry of Health list. Clients were eligible if they were aged 18 and over. Interventions: Two members of staff from each intervention clinic received the training programme. Clients in both intervention and control clinics subsequently received normal routine care from their health workers. Objective: To examine the impact of a mental health inservice training on routine detection of mental disorder in the clinics and on client outcomes. Outcomes: The primary outcome was the rate of accurate routine clinic detection of mental disorder and the secondary outcome was client recovery over a twelve week follow up period. Randomisation: clinics were randomised to intervention and control groups using a table of random numbers. Blinding: researchers and clients were blind to group assignment. Results Numbers randomised: 49 and 50 clinics were assigned to intervention and control groups respectively. 12 GHQ positive clients per clinic were identified for follow up. Numbers analysed: 468 and 478 clients were followed up for three months in intervention and control groups respectively. Outcome: At twelve weeks after training of the intervention group, the rate of accurate routine clinic detection of mental disorder was greater than 0 in 5% versus 0% of the intervention and control groups respectively, in both the intention to treat analysis (p = 0.50) and the per protocol analysis (p =0.50). Standardised effect sizes for client improvement were 0.34 (95% CI = (0.01,0.68)) for the General Health Questionnaire, 0.39 ((95% CI = (0.22, 0.61)) for the EQ and 0.49 (95% CI = (0.11,0.87)) for WHODAS (using ITT analysis); and 0.43 (95% CI = (0.09,0.76)) for the GHQ, 0.44 (95% CI = (0.22,0.65)) for the EQ and 0.58 (95% CI = (0.18,0.97)) for WHODAS (using per protocol analysis). Harms: None identified. Conclusion The training programme did not result in significantly improved recorded diagnostic rates of mental disorders in the routine clinic consultation register, but did have significant effects on patient outcomes in routine clinical practice. Trial registration International Standard Randomised Controlled Trial Number Register ISRCTN53515024. PMID:24188964

Feto-maternal outcomes and Glycemic control in Metformin versus insulin treated Gestational Diabetics

PubMed Central

Arshad, Rabia; Khanam, Samia; Shaikh, Fuad; Karim, Nasim

2017-01-01

Objective: To evaluate and compare feto-maternal outcomes and glycemic control in metformin versus insulin treated gestational diabetics. Methods: The study was conducted in 2010- 2012 as a part of M. Phil at Civil hospital, Lyari General Hospital and Mamji Hospital in Karachi. After written informed consent, 71 GDM diagnosed females with WHO criteria were enrolled. They were divided into two groups. Group-A, 32 females were given oral metformin 500 mg TDS while Group-B, 39 females were given insulin 0.8-0.9 mg/kg/day in two divided doses subcutaneously. Patients were followed till term. Feto-maternal outcomes were evaluated in 25 patients in each group who completed the study. Results: When groups were compared, newborns in Group-B were significantly more in weight (p=0.01). Significant numbers of babies were delivered after 38 weeks of pregnancy in Group-B (P=0.021). There were two intrauterine deaths and significantly higher HbA1C at term in Group-B. (P=0.03). FBS at term was non-significant (p=0.079) and there was more number of cesarean sections due to feto-maternal disproportion in Group-B (28% vs.2%). Results analyzed for glycemic control before and after the treatment revealed that FBS was statistically less in Group-A (p=0.00) whereas for Group-B the value of FBS and HbA1C was statistically high. (p=0.002 & 0.04 respectively). Conclusion: Metformin has produced better effects on feto-maternal outcomes and glycemic control in comparison to Insulin in GDM. PMID:29142561

Feto-maternal outcomes and Glycemic control in Metformin versus insulin treated Gestational Diabetics.

PubMed

Arshad, Rabia; Khanam, Samia; Shaikh, Fuad; Karim, Nasim

2017-01-01

To evaluate and compare feto-maternal outcomes and glycemic control in metformin versus insulin treated gestational diabetics. The study was conducted in 2010- 2012 as a part of M. Phil at Civil hospital, Lyari General Hospital and Mamji Hospital in Karachi. After written informed consent, 71 GDM diagnosed females with WHO criteria were enrolled. They were divided into two groups. Group-A, 32 females were given oral metformin 500 mg TDS while Group-B, 39 females were given insulin 0.8-0.9 mg/kg/day in two divided doses subcutaneously. Patients were followed till term. Feto-maternal outcomes were evaluated in 25 patients in each group who completed the study. When groups were compared, newborns in Group-B were significantly more in weight (p=0.01). Significant numbers of babies were delivered after 38 weeks of pregnancy in Group-B (P=0.021). There were two intrauterine deaths and significantly higher HbA 1 C at term in Group-B. (P=0.03). FBS at term was non-significant (p=0.079) and there was more number of cesarean sections due to feto-maternal disproportion in Group-B (28% vs.2%). Results analyzed for glycemic control before and after the treatment revealed that FBS was statistically less in Group-A (p=0.00) whereas for Group-B the value of FBS and HbA 1 C was statistically high. (p=0.002 & 0.04 respectively). Metformin has produced better effects on feto-maternal outcomes and glycemic control in comparison to Insulin in GDM.

Feedback to semi-professional counselors in treating child aggression.

PubMed

Shechtman, Zipora; Tutian, Rony

2017-05-01

To investigate the impact of outcome feedback provided to semi-professional counselors of children and adolescents at risk for aggressive behavior, following group treatment. Participants included 230 aggressive children and adolescents and 64 educators in a quasi-experimental design of 3 conditions: experimental group with feedback, experimental group without feedback, and control group (no treatment). The current study employed a feedback system based on self-report aggression scores measured after each session, provided to teachers, including an alert system and weekly follow-up group support. Outcomes were more favorable for the treatment children than the control group, but feedback had no impact on the results. Outcome feedback provided to group therapists does not have an effect on children and adolescents' reduction of aggression. Further research is needed to identify possible reasons for failure to show feedback effect.

Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT.

PubMed

Voigt-Radloff, Sebastian; Graff, Maud; Leonhart, Rainer; Hüll, Michael; Rikkert, Marcel Olde; Vernooij-Dassen, Myrra

2011-08-09

Background The positive effects of the Dutch Community Occupational Therapy in Dementia programme on patients' daily functioning were not found in a multicentre randomised controlled trial (RCT) in Germany. Objectives To evaluate possible effect modification on the primary outcome within the German RCT with regard to (1) participant characteristics, (2) treatment performance and (3) healthcare service utilisation; and (4) to compare the design and primary outcome between the German and the original Dutch study. Methods (1) The impact of participant baseline data on the primary outcome was analysed in exploratory ANCOVA and regression analyses. (2) Therapists completed questionnaires on context and performance problems. The main problems were identified by a qualitative content analysis and focus-group discussion. Associations of the primary outcome with scores of participant adherence and treatment performance were evaluated by regression analysis. (3) Utilisation rates of healthcare services were controlled for significant group differences. (4) Differences in the Dutch and German study design were identified, and the primary outcome was contrasted at the item level. Results (1) Participant characteristics could not explain more than 5% of outcome variance. (2) The treatment performance of some active intervention components was poor but not significantly associated with the primary outcome. (3) There were no significant group differences in the utilisation of healthcare resources. (4) In contrast to the Dutch waiting-control group, the active intervention in the German control group may have reduced group differences in the current RCT. The German patients demonstrated a higher independence at baseline and less improvement in instrumental activities of daily living. Conclusion The differences in outcome may be explained by a more active control treatment, partially poor experimental treatment and less room for improvement in the German sample. Future cross-national transfers should be prepared by pilot studies assessing the applicability of the intervention and patient needs specific to the target country. Trial registration International Clinical Trials Registry Platform, DRKS00000053.

Long-term effects of a 12-week exercise training program on clinical outcomes in idiopathic pulmonary fibrosis.

PubMed

Vainshelboim, Baruch; Oliveira, Jose; Fox, Benjamin Daniel; Soreck, Yafit; Fruchter, Oren; Kramer, Mordechai Reuven

2015-06-01

Idiopathic pulmonary fibrosis (IPF) is a chronic, devastating, lung disease, with few therapeutic options. Data are limited with respect to the long-term effect of exercise training (ET) in IPF. This study sought to evaluate the long-term effects of a 12-week ET program on clinical outcomes in IPF patients. Thirty-four IPF patients were randomly allocated to ET or control groups. ET group participated in a 12-week supervised exercise program, while the control group continued with regular medical treatment alone. Exercise capacity, 30 s-chair-stand test for leg strength, dyspnea, and Saint George's Respiratory Questionnaire (SGRQ) for quality of life (QOL) were assessed at baseline and re-evaluated at 11 months from baseline. In addition, at 30-month time point from baseline, the impact of the 12-week intervention was analyzed with respect to survival and cardio-respiratory-related hospitalizations. Thirty-two patients completed the 12-week intervention and 28 patients (14 in each group) were re-evaluated. At 11-month follow-up, no significant differences between the groups and time effect were demonstrated for most outcomes. ET group showed preserved values at the baseline level while the control group showed a trend of deterioration. Only the 30 s-chair-stand test (mean difference 3 stands, p = 0.01) and SGRQ (mean difference -6 units, p = 0.037) were significantly different between the groups. At 30 months, the survival analysis showed three deaths, eight hospitalizations occurred in the control group versus one death, one lung transplantation and seven hospitalizations in the ET group, with no significant differences between groups. At 11-month follow-up, the 12-week ET program showed clinical outcomes were preserved at baseline levels with some maintenance of improvements in leg strength and QOL in the ET group. The control group showed a trend of deterioration in the outcomes. At 30 months, the 12-week ET program did not show benefits in prognosis although the study was underpowered to detect such differences. We suggest including ET as a long-term continued treatment and as a core component of pulmonary rehabilitation programs for IPF patients.

Telehealth to improve asthma control in pregnancy: A randomized controlled trial.

PubMed

Zairina, Elida; Abramson, Michael J; McDonald, Christine F; Li, Jonathan; Dharmasiri, Thanuja; Stewart, Kay; Walker, Susan P; Paul, Eldho; George, Johnson

2016-07-01

Poorly controlled asthma during pregnancy is hazardous for both mother and foetus. Better asthma control may be achieved if patients are involved in regular self-monitoring of symptoms and self-management according to a written asthma action plan. Telehealth applications to optimize asthma management and outcomes in pregnant women have not yet been evaluated. This study evaluated the efficacy of a telehealth programme supported by a handheld respiratory device in improving asthma control during pregnancy. Pregnant women with asthma (n = 72) from two antenatal clinics in Melbourne, Australia, were randomized to one of two groups: (i) intervention-involving a telehealth programme (management of asthma with supportive telehealth of respiratory function in pregnancy (MASTERY(©) )) supported by a handheld respiratory device and an Android smart phone application (Breathe-easy(©) ) and written asthma action plan or (ii) control-usual care. The primary outcome was change in asthma control at 3 and 6 months (prenatal). Secondary outcomes included changes in quality of life and lung function, and perinatal/neonatal outcomes. At baseline, participants' mean (± standard deviation) age was 31.4 ± 4.5 years and gestational age 16.7 ± 3.1 weeks. At 6 months, the MASTERY group had better asthma control (P = 0.02) and asthma-related quality of life (P = 0.002) compared with usual care. There were no significant differences between groups in lung function, unscheduled health-care visits, days off work/study, oral corticosteroid use, or perinatal outcomes. Differences between groups were not significant at 3 months. Telehealth interventions supporting self-management are feasible and could potentially improve asthma control and asthma-related quality of life during pregnancy. © 2016 Asian Pacific Society of Respirology.

Hypothermia for Neuroprotection in Convulsive Status Epilepticus.

PubMed

Legriel, Stephane; Lemiale, Virginie; Schenck, Maleka; Chelly, Jonathan; Laurent, Virginie; Daviaud, Fabrice; Srairi, Mohamed; Hamdi, Aicha; Geri, Guillaume; Rossignol, Thomas; Hilly-Ginoux, Julia; Boisramé-Helms, Julie; Louart, Benjamin; Malissin, Isabelle; Mongardon, Nicolas; Planquette, Benjamin; Thirion, Marina; Merceron, Sybille; Canet, Emmanuel; Pico, Fernando; Tran-Dinh, Yves-Roger; Bedos, Jean-Pierre; Azoulay, Elie; Resche-Rigon, Matthieu; Cariou, Alain

2016-12-22

Convulsive status epilepticus often results in permanent neurologic impairment. We evaluated the effect of induced hypothermia on neurologic outcomes in patients with convulsive status epilepticus. In a multicenter trial, we randomly assigned 270 critically ill patients with convulsive status epilepticus who were receiving mechanical ventilation to hypothermia (32 to 34°C for 24 hours) in addition to standard care or to standard care alone; 268 patients were included in the analysis. The primary outcome was a good functional outcome at 90 days, defined as a Glasgow Outcome Scale (GOS) score of 5 (range, 1 to 5, with 1 representing death and 5 representing no or minimal neurologic deficit). The main secondary outcomes were mortality at 90 days, progression to electroencephalographically (EEG) confirmed status epilepticus, refractory status epilepticus on day 1, "super-refractory" status epilepticus (resistant to general anesthesia), and functional sequelae on day 90. A GOS score of 5 occurred in 67 of 138 patients (49%) in the hypothermia group and in 56 of 130 (43%) in the control group (adjusted common odds ratio, 1.22; 95% confidence interval [CI], 0.75 to 1.99; P=0.43). The rate of progression to EEG-confirmed status epilepticus on the first day was lower in the hypothermia group than in the control group (11% vs. 22%; odds ratio, 0.40; 95% CI, 0.20 to 0.79; P=0.009), but there were no significant differences between groups in the other secondary outcomes. Adverse events were more frequent in the hypothermia group than in the control group. In this trial, induced hypothermia added to standard care was not associated with significantly better 90-day outcomes than standard care alone in patients with convulsive status epilepticus. (Funded by the French Ministry of Health; HYBERNATUS ClinicalTrials.gov number, NCT01359332 .).

Evaluation of a standardized patient education program for inpatient asthma rehabilitation: Impact on patient-reported health outcomes up to one year.

PubMed

Bäuerle, Kathrin; Feicke, Janine; Scherer, Wolfgang; Spörhase, Ulrike; Bitzer, Eva-Maria

2017-05-01

To modify and evaluate a patient education program for adult asthma patients in consideration of quality criteria for teaching. This was a prospective single-center controlled trial in an inpatient rehabilitation center. The control group (n=215) received the usual lecture-based education program, and the intervention group (n=209) the modified patient education program. Data were assessed at admission, discharge, 6 and 12 months post discharge. The primary outcome was asthma control, the secondary outcomes were asthma knowledge, quality of life, and program acceptance. Analysis of change was performed by ANCOVA for each follow-up, adjusting for baseline values. Statistically significant increases in all health outcomes and in asthma control were maintained in both groups at 12 months: CG: +1.9 (95%-CI 1.3-2.6) IG: +1.6 (95%-CI 0.8-2.3). We observed no significant differences between the programs for asthma control and quality of life. Regarding practical asthma knowledge, after 12 months, a group*time interaction emerged with a small effect size (P=0.06, η2=0.01). The modified program was not superior to traditional patient education concerning asthma control. It permanently increased self-management knowledge. Structured and behavioral patient education fosters patient's disease management ability. Possible ways of improving asthma control need to be explored. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of Tai Chi on Physical and Psychological Health of College Students: Results of a Randomized Controlled Trial

PubMed Central

Li, Moyi; Ling, Kun; Lin, Hui; Chen, Lidian; Tao, Jing; Li, Junzhe; Zheng, Xin; Chen, Bai; Fang, Qianying

2015-01-01

Objective To investigate the effectiveness and safety of Tai Chi Chuan (TCC) on physical and psychological health of college students. Methods Two hundred six college students were recruited and randomly allocated to a control group or a TCC exercise group in an equal ratio. Participants in the control group were instructed to maintain their original activity level and those in the TCC exercise group received 12 weeks of TCC exercise training based on their original activity level. Physical and psychological outcomes were evaluated at baseline, 13 weeks and 25 weeks. Intention-to-treat analysis was performed for the above outcomes. Results Compared with the control group, the TCC exercise group showed significant improvements at the end of the 12-week intervention period for flexibility (length of Sit and Reach (cm): TCC group 14.09±7.40 versus control 12.88±6.57, P = 0.039 adjusted for its baseline measures using a general linear model) and balance ability (open eyes perimeter: TCC group 235.6(191~314) versus control 261(216~300); closed eyes perimeter: TCC group 370.5 (284~454) versus control 367 (293~483); P = 0.0414, 0.008, respectively, adjusted for corresponding baseline measures using a general linear model). No significant changes in other physical and mental outcomes were found between the two groups. No adverse events were reported during the study period. Conclusion TCC exercise was beneficial in college students for improving flexibility and balance capability to some extent, compared with usual exercise. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-13003328 PMID:26147842

Do antipsychotic drugs increase seizure frequency in epilepsy patients?

PubMed

Okazaki, Mitsutoshi; Adachi, Naoto; Akanuma, Nozomi; Hara, Koichiro; Ito, Masumi; Kato, Masaaki; Onuma, Teiichi

2014-11-01

To investigate whether addition of antipsychotic drugs (APD) would increase seizure frequency in epilepsy patients who were already treated with anti-epileptic drugs (AED), we compared a one-year seizure control outcome in 150 epilepsy patients with APD treatment for psychiatric conditions and 309 epilepsy patients without APD treatment matched for ages at epilepsy onset and the baseline evaluation and types of epilepsy. The seizure frequency was recorded at the baseline (immediately before the start of APD) and after the 1st, 3rd, 6th and 12th months. The seizure outcome at each of the four follow-up points was compared with the baseline. The seizure outcome was compared between the two groups as a whole and according to the types of epilepsy (idiopathic generalized and partial epilepsies). In the APD group, the seizure outcome was also analyzed according to the types of APD (first and second generation APD and combination of first and second generation APD) and the types of psychiatric conditions (psychosis and non-psychosis). The seizure outcome was significantly better in the APD group than control group at all the four follow-up points. According to the epilepsy types, the improvement in the seizure outcome was only observed in the patients with partial epilepsy. Of the APD group, there was no significant difference in the seizure outcome according to the types of APD or the psychiatric conditions. In epilepsy patients who are already treated with AED, APD treatment seems safe in seizure control outcome for treatment of psychiatric conditions. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

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

PubMed

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.

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

PubMed Central

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 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). MAIN OUTCOME MEASURE: Clinical pregnancy rate (CPR). RESULTS: 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 < 0.001). CONCLUSIONS: 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. PMID:26538858

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma.

PubMed

Kaminski, Rafal; Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome.

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma

PubMed Central

Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K.; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

Objective The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. Methods This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. Results After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. Conclusions The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome. PMID:29713647

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

The Effect of Auriculotherapy on the Stress and the Outcomes of Assistant Reproductive Technologies in Infertile Women.

PubMed

Saffari, Mozhgan; Khashavi, Zahra; Valiani, Mahboubeh

2018-01-01

Infertility means failure to achieve pregnancy after one year of regular unprotected sexual intercourse. Infertile women may experience severe stress and depression. Numerous studies have indicated that auriculotherapy could reduce stress. Thus, the aim of the present study was to determine the effect of auriculotherapy on the stress and the outcome assisted reproductive technology in infertile women. The present study was a clinical trial that was conducted on 56 infertile women aged 20-45, who were assigned into two groups of intervention and control, from November 2014 to November 2015. The control group only received the routine treatments, while the intervention group, in addition to their routine treatment, received auriculotherapy for 8-10 sessions during menstrual cycle. Both groups completed Newton's Fertility Problem Inventory in three stages. The datasets collected for the study were analyzed using independent t -test, repeated-measures analysis of variance, and Chi-square test. The mean score of stress in the intervention group decreased significantly, compared to the control group prior to the embryo transfer and pregnancy test stages. Although insignificant, the rate of pregnancy in the intervention group was higher than the control group. There was a significant increase in the rate of clinical pregnancy in the intervention group, compared to the control. The results indicated that auriculotherapy might be effective in reducing stress and improving the outcome of assisted reproductive treatment.

Learning to Obtain Reward, but Not Avoid Punishment, Is Affected by Presence of PTSD Symptoms in Male Veterans: Empirical Data and Computational Model

PubMed Central

Myers, Catherine E.; Moustafa, Ahmed A.; Sheynin, Jony; VanMeenen, Kirsten M.; Gilbertson, Mark W.; Orr, Scott P.; Beck, Kevin D.; Pang, Kevin C. H.; Servatius, Richard J.

2013-01-01

Post-traumatic stress disorder (PTSD) symptoms include behavioral avoidance which is acquired and tends to increase with time. This avoidance may represent a general learning bias; indeed, individuals with PTSD are often faster than controls on acquiring conditioned responses based on physiologically-aversive feedback. However, it is not clear whether this learning bias extends to cognitive feedback, or to learning from both reward and punishment. Here, male veterans with self-reported current, severe PTSD symptoms (PTSS group) or with few or no PTSD symptoms (control group) completed a probabilistic classification task that included both reward-based and punishment-based trials, where feedback could take the form of reward, punishment, or an ambiguous “no-feedback” outcome that could signal either successful avoidance of punishment or failure to obtain reward. The PTSS group outperformed the control group in total points obtained; the PTSS group specifically performed better than the control group on reward-based trials, with no difference on punishment-based trials. To better understand possible mechanisms underlying observed performance, we used a reinforcement learning model of the task, and applied maximum likelihood estimation techniques to derive estimated parameters describing individual participants’ behavior. Estimations of the reinforcement value of the no-feedback outcome were significantly greater in the control group than the PTSS group, suggesting that the control group was more likely to value this outcome as positively reinforcing (i.e., signaling successful avoidance of punishment). This is consistent with the control group’s generally poorer performance on reward trials, where reward feedback was to be obtained in preference to the no-feedback outcome. Differences in the interpretation of ambiguous feedback may contribute to the facilitated reinforcement learning often observed in PTSD patients, and may in turn provide new insight into how pathological behaviors are acquired and maintained in PTSD. PMID:24015254

Clinical Outcome And Arginine Serum of Acute Ischemic Stroke Patients Supplemented by Snakehead Fish Extract

NASA Astrophysics Data System (ADS)

Pudjonarko, Dwi; Retnaningsih; Abidin, Zainal

2018-02-01

Background: Levels of arginine associated with clinical outcome in acute ischemic stroke (AIS). Arginine is a protein needed to synthesis nitric oxide (NO), a potential vasodilator and antioxidant. Snakehead fish is a source of protein which has antioxidant activity. Snakehead fish contains mineral, vitamin, and amino acids. One of the amino acids that were found quite high in snakehead fish extract is arginine. The aim of this study was done to determine the effect of snakehead fish extracts (SFE) on serum arginin levels and clinical outcome of AIS patients. Methods: It was double-blind randomized pretest-posttest control group design, with. AIS patients were divided into two groups i.e. snakehead fish extracts (SFE) and control. SFE group were administered 15 grams SFE for 7 days . Arginine serum levels and clinical outcome (measured by National Institute of Health Stroke Scale = NIHSS) were measured before and after treatment, other related factors were also analyzed in Logistic regression. Results: A total of 42 subjects who were performed random allocation as SFE or control group. There was no differences in subject characteristics between the two groups. There was a differences Δ arginine serum levels between SFE and control (33.6±19.95 μmol/L 0.3±2.51 μmol/L p<0.001). Change in NIHSS score in SFE improved significantly compared to the control group (4.14 ± 2.03; 2.52 ± 1.81;p=0.009 ). Logistic regression analysis showed only female gender factor that affected on improvement of NIHSS (OR=7; p=0,01). Conclusion: There is Clinical outcome improvement and enhancement of arginine serum levels in AIS patient with snakehead fish extract supplementation.

Home-based step training using videogame technology in people with Parkinson's disease: a single-blinded randomised controlled trial.

PubMed

Song, Jooeun; Paul, Serene S; Caetano, Maria Joana D; Smith, Stuart; Dibble, Leland E; Love, Rachelle; Schoene, Daniel; Menant, Jasmine C; Sherrington, Cathie; Lord, Stephen R; Canning, Colleen G; Allen, Natalie E

2018-03-01

To determine whether 12-week home-based exergame step training can improve stepping performance, gait and complementary physical and neuropsychological measures associated with falls in Parkinson's disease. A single-blinded randomised controlled trial. Community (experimental intervention), university laboratory (outcome measures). Sixty community-dwelling people with Parkinson's disease. Home-based step training using videogame technology. The primary outcomes were the choice stepping reaction time test and Functional Gait Assessment. Secondary outcomes included physical and neuropsychological measures associated with falls in Parkinson's disease, number of falls over six months and self-reported mobility and balance. Post intervention, there were no differences between the intervention ( n = 28) and control ( n = 25) groups in the primary or secondary outcomes except for the Timed Up and Go test, where there was a significant difference in favour of the control group ( P = 0.02). Intervention participants reported mobility improvement, whereas control participants reported mobility deterioration-between-group difference on an 11-point scale = 0.9 (95% confidence interval: -1.8 to -0.1, P = 0.03). Interaction effects between intervention and disease severity on physical function measures were observed ( P = 0.01 to P = 0.08) with seemingly positive effects for the low-severity group and potentially negative effects for the high-severity group. Overall, home-based exergame step training was not effective in improving the outcomes assessed. However, the improved physical function in the lower disease severity intervention participants as well as the self-reported improved mobility in the intervention group suggest home-based exergame step training may have benefits for some people with Parkinson's disease.

Outcomes after implementing the enhanced recovery after surgery protocol for patients undergoing tuberculous empyema operations.

PubMed

Xia, Zhaohua; Qiao, Kun; Wang, Haijiang; Ning, Xinzhong; He, Jianxing

2017-07-01

Enhanced recovery after surgery (ERAS) protocols provide recommendations for care in various surgical fields. However, there is scarce information on the application of these protocols in tuberculous empyema surgery. The purpose of this research is to evaluate the outcomes of ERAS recommendations for patients who received tuberculous empyema surgery. A retrospective analysis was performed on patients who underwent tuberculous empyema surgery in our hospital from March 2011 to March 2016. The patients were divided into an ERAS group and a conventional control group. The main outcome measure was the postoperative median length of stay (including readmissions). Principles related to ERAS were documented, and the postoperative median hospital stay was analyzed statistically between the two groups. A total of 92 patients underwent 93 consecutive tuberculous empyema surgical treatments. The postoperative fasting time, chest tube duration, and length of stay were shorter in the ERAS group compared with the control group. The volume of chest tube drainage in the ERAS group was significantly smaller than that of the control group. No statistical differences were observed in the postoperative complications and reasons for readmission between the two groups. Application of ERAS recommendations in patients receiving tuberculous empyema operations decreased the length of stay and chest tube drainage compared to the control group.

The effects of a computer skill training programme adopting social comparison and self-efficacy enhancement strategies on self-concept and skill outcome in trainees with physical disabilities.

PubMed

Tam, S F

2000-10-15

The aim of this controlled, quasi-experimental study was to evaluate the effects of both self-efficacy enhancement and social comparison training strategy on computer skills learning and self-concept outcome of trainees with physical disabilities. The self-efficacy enhancement group comprised 16 trainees, the tutorial training group comprised 15 trainees, and there were 25 subjects in the control group. Both the self-efficacy enhancement group and the tutorial training group received a 15 week computer skills training course, including generic Chinese computer operation, Chinese word processing and Chinese desktop publishing skills. The self-efficacy enhancement group received training with tutorial instructions that incorporated self-efficacy enhancement strategies and experienced self-enhancing social comparisons. The tutorial training group received behavioural learning-based tutorials only, and the control group did not receive any training. The following measurements were employed to evaluate the outcomes: the Self-Concept Questionnaire for the Physically Disabled Hong Kong Chinese (SCQPD), the computer self-efficacy rating scale and the computer performance rating scale. The self-efficacy enhancement group showed significantly better computer skills learning outcome, total self-concept, and social self-concept than the tutorial training group. The self-efficacy enhancement group did not show significant changes in their computer self-efficacy: however, the tutorial training group showed a significant lowering of their computer self-efficacy. The training strategy that incorporated self-efficacy enhancement and positive social comparison experiences maintained the computer self-efficacy of trainees with physical disabilities. This strategy was more effective in improving the learning outcome (p = 0.01) and self-concept (p = 0.05) of the trainees than the conventional tutorial-based training strategy.

The association of funding source on effect size in randomized controlled trials: 2013-2015 - a cross-sectional survey and meta-analysis.

PubMed

Falk Delgado, Alberto; Falk Delgado, Anna

2017-03-14

Trials financed by for-profit organizations have been associated with favorable outcomes of new treatments, although the effect size of funding source impact on outcome is unknown. The aim of this study was to estimate the effect size for a favorable outcome in randomized controlled trials (RCTs), stratified by funding source, that have been published in general medical journals. Parallel-group RCTs published in The Lancet, New England Journal of Medicine, and JAMA between 2013 and 2015 were identified. RCTs with binary primary endpoints were included. The primary outcome was the OR of patients' having a favorable outcome in the intervention group compared with the control group. The OR of a favorable outcome in each trial was calculated by the number of positive events that occurred in the intervention and control groups. A meta-analytic technique with random effects model was used to calculate summary OR. Data were stratified by funding source as for-profit, mixed, and nonprofit. Prespecified sensitivity, subgroup, and metaregression analyses were performed. Five hundred nine trials were included. The OR for a favorable outcome in for-profit-funded RCTs was 1.92 (95% CI 1.72-2.14), which was higher than mixed source-funded RCTs (OR 1.34, 95% CI 1.25-1.43) and nonprofit-funded RCTs (OR 1.32, 95% CI 1.26-1.39). The OR for a favorable outcome was higher for both clinical and surrogate endpoints in for-profit-funded trials than in RCTs with other funding sources. Excluding drug trials lowered the OR for a favorable outcome in for-profit-funded RCTs. The OR for a favorable surrogate outcome in drug trials was higher in for-profit-funded trials than in nonprofit-funded trials. For-profit-funded RCTs have a higher OR for a favorable outcome than nonprofit- and mixed source-funded RCTs. This difference is associated mainly with the use of surrogate endpoints in for-profit-financed drug trials.

Retrospective study of the effect of remifentanil use during labor on fetal heart rate patterns.

PubMed

Boterenbrood, Danne; Wassen, Martine M; Visser, Gerard H A; Nijhuis, Jan G

2018-01-01

To investigate possible associations between remifentanil and the appearance of sinusoidal heart rate patterns in fetuses, and neonatal outcomes. The present retrospective cohort study included data from patients at over 37 weeks of singleton or multiple pregnancies attending Zuyderland Medical Center, Sittard, the Netherlands, in labor between June 1, and August 31, 2015. Patient data were stratified by whether remifentanil was administered during delivery (remifentanil group) or not (control group), and fetal heart rate tracings were reviewed to identify sinusoidal heart rate patterns. The neonatal outcomes compared were 5-minute Apgar scores and umbilical artery pH. There were 119 patients included in the study; 60 in the remifentanil group and 59 in the control group. Tracings from 20 (33%) patients in the remifentanil group exhibited a sinusoidal heart rate pattern after remifentanil administration, compared with 5 (8%) patients in the control group (P=0.001). The median time before the onset of sinusoidal patterns after remifentanil administration was 12 minutes. No adverse neonatal outcomes were recorded in either group. Remifentanil use during labor was associated with the occurrence of sinusoidal heart rate patterns in the fetus; this was not associated with adverse neonatal outcomes. © 2017 International Federation of Gynecology and Obstetrics.

Control groups in recent septic shock trials: a systematic review.

PubMed

Pettilä, Ville; Hjortrup, Peter Buhl; Jakob, Stephan M; Wilkman, Erika; Perner, Anders; Takala, Jukka

2016-12-01

The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. We searched for original articles presenting randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58 % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2-17) were reported. Only 2 (8 %) trials provided adequate data to confirm that their control group treatment represented usual care. Recent trials in septic shock provide inadequate data on the control group treatment and hemodynamic values. We propose a standardized trial dataset to be created and validated, comprising characteristics of patient population, interventions administered, hemodynamic values achieved, surrogate organ dysfunction, and mortality outcomes, to allow better analysis and interpretation of future trial results.

Randomized controlled trial of a comprehensive stroke education program for patients and caregivers.

PubMed

Rodgers, H; Atkinson, C; Bond, S; Suddes, M; Dobson, R; Curless, R

1999-12-01

We report the findings of a randomized controlled trial to determine the effectiveness of a multidisciplinary Stroke Education Program (SEP) for patients and their informal carers. Two hundred four patients admitted with acute stroke and their 176 informal carers were randomized to receive an invitation to the SEP or to receive conventional stroke unit care. The SEP consisted of one 1-hour small group educational session for inpatients followed by six 1-hour sessions after discharge. The primary outcome measure was patient- and carer-perceived health status (SF-36) at 6 months after stroke. Knowledge of stroke, satisfaction with services, emotional outcome, disability, and handicap and were secondary outcome measures. Only 51 of 108 (47%) surviving patients randomized to the SEP completed the program, as did 20 of 93 (22%) informal carers of surviving patients. Perceived health status (Short Form 36 [SF-36] health survey) scores were similar for SEP patients and controls. Informal carers in the control group scored better on the social functioning component of the SF-36 than the SEP group (P=0.04). Patients and informal carers in the SEP group scored higher on the stroke knowledge scale than controls (patients, P=0.02; carers, P=0. 01). Patients in the SEP group were more satisfied with the information that they had received about stroke (P=0.004). There were no differences in emotional or functional outcomes between groups. Although the SEP improved patient and informal carer knowledge about stroke and patient satisfaction with some components of stroke services, this was not associated with an improvement in their perceived health status. Indeed, the social functioning of informal carers randomized to the SEP was less than in the control group.

A Randomized Controlled Trial of the Impact of Schema-Based Instruction on Mathematical Outcomes for Third-Grade Students with Mathematics Difficulties

ERIC Educational Resources Information Center

Jitendra, Asha K.; Dupuis, Danielle N.; Rodriguez, Michael C.; Zaslofsky, Anne F.; Slater, Susan; Cozine-Corroy, Kelly; Church, Chris

2013-01-01

This study compared the effects of delivering a supplemental, small-group tutoring intervention on the mathematics outcomes of third-grade students at risk for mathematics difficulties (MD) who were randomly assigned to either a schema-based instruction (SBI) or control group. SBI emphasized the underlying mathematical structure of additive…

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

PubMed

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

2010-11-12

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

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

PubMed Central

2010-01-01

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

No efficacy for silicone gel sheeting in prevention of abnormal scar formation in children with cancer: a randomized controlled trial.

PubMed

Braam, Katja I; Kooijmans, Esmee C M; van Dulmen-den Broeder, Eline; Veening, Margreet A; Schouten-van Meeteren, Antoinette Y N; Verhaegen, Pauline D H M; Kaspers, Gertjan J L; Niessen, Frank B; Heij, Hugo A

2015-04-01

Placement of a totally implantable venous access device in children with cancer often leads to hypertrophic scars after its removal. This study investigates whether the use of silicone gel sheets has a beneficial effect on scar outcome in children with cancer. In a three-arm randomized controlled trial, the effects of use of silicone gel sheets for 2 and 6 months were assessed and compared with no intervention in children with cancer after removal of the totally implantable venous access device. Silicone gel sheets were first administered 14 days after surgery. The 1-year follow-up included measurements at seven time points. Next to scar size assessment, the modified Vancouver Scar Scale was used to assess scar outcome. Thirty-six children participated. For hypertrophy, no significant differences were found between the two intervention groups and the control group. However, at 1-year follow-up, the 2-month application group showed significantly smaller scars compared with the group receiving silicone gel sheet treatment for 6 months (p = 0.04), but not when compared with the control group (p = 0.22). Longitudinal multilevel analyses could not confirm these findings and showed no significant intervention effects on both outcomes. This study provides no strong evidence to support the use of silicone gel sheets after totally implantable venous access device removal in children with cancer. There seems to be a small benefit for scar width with application for 2 months. However, for hypertrophy, the scar outcome shows no significant difference between the control group and the 2-month and 6-month treatment groups.

Social, educational and vocational outcomes in patients with childhood-onset and young-adult-onset growth hormone deficiency.

PubMed

Mitra, M Tanya; Jönsson, Peter; Åkerblad, Ann-Charlotte; Clayton, Peter; Kołtowska-Häggström, Maria; Korbonits, Márta; Toogood, Andy; Gleeson, Helena

2017-04-01

Hypopituitarism diagnosed in childhood, adolescence and young adulthood has the potential to affect growth and somatic development. Less is known about the impact of such a diagnosis on other aspects of development. An analysis of the KIMS database (Pfizer International Metabolic Database) was performed to explore social, educational and vocational outcomes of adult patients diagnosed in childhood, adolescence and young adulthood compared with adult-onset controls. A total of 2952 adult patients diagnosed with hypothalamic pituitary conditions before the age of 25 were divided into two groups: childhood-onset [<16 years (CO)] (n = 1782) and young-adult-onset [16 to <25 years (YAO)] (n = 1170). A total of 1617 adult patients diagnosed with a nonfunctioning pituitary adenoma at the age of 25 or older formed the adult-onset control group (AO). KIMS Patient Life Situation Form which provided information on social, educational and vocational outcomes. Compared with the AO control group, CO and YAO patients were between 4·5 and 8·0 times more likely to live with their parents in adulthood; CO and YAO patients were also less likely to live in partnership and to have children. The impact on educational and vocational outcomes was less marked than on social outcomes with no significant differences compared with the AO control group. Educational and vocational outcomes showed the lowest level in male and female CO and YAO patients who had been previously diagnosed with a brain tumour. Social outcomes were more affected than educational and vocational outcomes. Although CO patients are more adversely affected, YAO patients were also failing to achieve social milestones. This has consequences for the delivery of endocrine care in both paediatric and adult services. © 2016 John Wiley & Sons Ltd.

Effectiveness of the palliative care ‘Availability, Current issues and Anticipation’ (ACA) communication training programme for general practitioners on patient outcomes: A controlled trial

PubMed Central

Blankenstein, Annette H; Schweitzer, Bart PM; Knol, Dirk L; van der Horst, Henriëtte E; Aaronson, Neil K; Deliens, Luc

2014-01-01

Background: Although communicating effectively with patients receiving palliative care can be difficult, it may contribute to maintaining or enhancing patients’ quality of life. Little is known about the effect of training general practitioners in palliative care–specific communication. We hypothesized that palliative care patients of general practitioners exposed to the ‘Availability, Current issues and Anticipation’ communication training programme would report better outcomes than patients of control general practitioners. Aim: To evaluate the effectiveness of the Availability, Current issues and Anticipation training programme for general practitioners on patient-reported outcomes. Design: In a controlled trial, general practitioners followed the Availability, Current issues and Anticipation programme or were part of the control group. Patients receiving palliative care of participating general practitioners completed the Palliative Care Outcome Scale, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative, the Rest & Peace Scale, the Patient Satisfaction Questionnaire–III and the Availability, Current issues and Anticipation Scale, at baseline and 12 months follow-up. We analysed differences between groups using linear mixed models. Trial registration: ISRCTN56722368. Setting/participants: General practitioners who attended a 2-year Palliative Care Training Course in the Netherlands. Results: Questionnaire data were available for 145 patients (89 in intervention and 56 in control group). We found no significant differences over time between the intervention and control groups in any of the five outcome measures. Ceiling effects were observed for the Rest & Peace Scale, Patient Satisfaction Questionnaire–III and Availability, Current issues and Anticipation Scale. Conclusion: General practitioner participation in the Availability, Current issues and Anticipation training programme did not have a measurable effect on any of the outcomes investigated. Patients reported high levels of satisfaction with general practitioner care, regardless of group assignment. Future research might focus on general practitioners without special interest in palliative care. PMID:24951633

Meat supplementation improves growth, cognitive, and behavioral outcomes in Kenyan children.

PubMed

Neumann, Charlotte G; Murphy, Suzanne P; Gewa, Connie; Grillenberger, Monika; Bwibo, Nimrod O

2007-04-01

A randomized, controlled school feeding study was conducted in rural Embu District, Kenya to test for a causal link between animal-source food intake and changes in micronutrient nutrition and growth, cognitive, and behavioral outcomes. Twelve primary schools were randomly assigned to 1 of 4 groups. Children in Standard I classes received the local plant-based dish githeri as a midmorning school snack supplemented with meat, milk, or fat added to equalize energy content in all feedings. The Control children received no feedings but participated in data collection. Main outcome measures assessed at baseline and longitudinally were 24-h food intake recall, anthropometry, cognitive function, physical activity, and behaviors during school free play. For cognitive function, the Meat group showed the steepest rate of increase on Raven's Progressive Matrices scores and in zone-wide school end-term total and arithmetic test scores. The Plain githeri and Meat groups performed better over time than the Milk and Control groups (P < 0.02-0.03) on arithmetic tests. The Meat group showed the greatest increase in percentage time in high levels of physical activity and in initiative and leadership behaviors compared with all other groups. For growth, in the Milk group only younger and stunted children showed a greater rate of gain in height. The Meat group showed near doubling of upper midarm muscle area, and the Milk group a smaller degree of increase. This is the first randomized, controlled feeding study to examine the effect of meat- vs. milk- vs. plant-based snacks on functional outcomes in children.

Effects of exercise training on pulmonary mechanics and functional status in patients with prolonged mechanical ventilation.

PubMed

Chen, Yen-Huey; Lin, Hui-Ling; Hsiao, Hsiu-Feng; Chou, Lan-Ti; Kao, Kuo-Chin; Huang, Chung-Chi; Tsai, Ying-Huang

2012-05-01

The functional status and outcomes in patients with prolonged mechanical ventilation (PMV) are often limited by poor endurance and pulmonary mechanics, which result from the primary diseases or prolonged time bedridden. We evaluate the impact of exercise training on pulmonary mechanics, physical functional status, and hospitalization outcomes in PMV patients. Twenty-seven subjects with PMV in our respiratory care center (RCC) were divided randomly into an exercise training group (n = 12) and a control group (n = 15). The exercise program comprised 10 sessions of exercise training. The measurement of pulmonary mechanics and physical functional status (Functional Independence Measurement and Barthel index) were performed pre-study and post-study. The hospitalization outcomes included: days of mechanical ventilation, hospitalization days, and weaning and mortality rates during RCC stay. The training group had significant improvement in tidal volume (143.6 mL vs 192.5 mL, P = .02) and rapid shallow breathing index after training (162.2 vs 110.6, P = .009). No significant change was found in the control group except respiratory rate. Both groups had significant improvement in functional status during the study. However, the training group had greater changes in FIM score than the control group (44.6 vs 34.2, P = .024). The training group also had shorter RCC stay and higher weaning and survival rates than the control group, although no statistical difference was found. Subjects with PMV in our RCC demonstrated significant improvement in pulmonary mechanics and functional status after exercise training. The application of exercise training may be helpful for PMV patients to improve hospitalization outcomes.

Social Stories in mainstream schools for children with autism spectrum disorder: a feasibility randomised controlled trial.

PubMed

Marshall, David; Wright, Barry; Allgar, Victoria; Adamson, Joy; Williams, Christine; Ainsworth, Hannah; Cook, Liz; Varley, Danielle; Hackney, Lisa; Dempster, Paul; Ali, Shehzad; Trepel, Dominic; Collingridge Moore, Danielle; Littlewood, Elizabeth; McMillan, Dean

2016-08-11

To assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial. A single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control. 37 primary schools in York, UK. 50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27). Acceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial. An assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups. Results suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools. ISRCTN96286707; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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

PubMed

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 <37 weeks of gestation, and low birth weight (LBW) was recorded when the infant weighed<2,500 g. There were 53 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 are affected by periodontitis. Additional multicentered, randomized, controlled clinical trials are required to confirm this link between periodontitis and PLBW.

Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches

PubMed Central

Browning, Colette; Chapman, Anna; Yang, Hui; Liu, Shuo; Zhang, Tuohong; Enticott, Joanne C; Thomas, Shane A

2016-01-01

Objective To assess the effectiveness of a coach-led motivational interviewing (MI) intervention in improving glycaemic control, as well as clinical, psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus (T2DM) compared with usual care. Design Pragmatic cluster randomised controlled trial (RCT). Setting Community Health Stations (CHSs) in Fengtai district, Beijing, China. Participants Of the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation. Intervention Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS. Control participants received usual care only. Medical fees were waived for both groups. Outcome measures Outcomes were assessed at baseline, 6 and 12 months. Primary outcome measure was glycated haemoglobin (HbA1c). Secondary outcomes included a suite of anthropometric, blood pressure (BP), fasting blood, psychosocial and self-care measures. Results At 12 months, no differential treatment effect was found for HbA1c (adjusted difference 0.02, 95% CI −0.40 to 0.44, p=0.929), with both treatment and control groups showing significant improvements. However, two secondary outcomes: psychological distress (adjusted difference −2.38, 95% CI −4.64 to −0.12, p=0.039) and systolic BP (adjusted difference −3.57, 95% CI −6.08 to −1.05, p=0.005) were robust outcomes consistent with significant differential treatment effects, as supported in sensitivity analyses. Interestingly, in addition to HbA1c, both groups displayed significant improvements in triglycerides, LDL cholesterol and HDL cholesterol. Conclusions In line with the current Chinese primary healthcare reform, this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China, specifically addressing T2DM. Although a differential treatment effect was not observed for HbA1c, numerous outcomes (including HbA1c) improved in both groups, supporting the establishment of regular, free clinical health checks for people with T2DM in China. Trial registration number ISRCTN01010526; Pre-results. PMID:26944692

Kinesio Taping® is not better than placebo in reducing pain and disability in patients with chronic non-specific low back pain: a randomized controlled trial

PubMed Central

Luz, Maurício A.; Sousa, Manoel V.; Neves, Luciana A. F. S.; Cezar, Aline A. C.; Costa, Leonardo O. P.

2015-01-01

Background: Kinesio Taping ® has been widely used in clinical practice. However, it is unknown whether this type of tape is more effective than placebo taping in patients with chronic lower back pain. Objective: To compare the effectiveness of Kinesio Taping ® in patients with chronic non-specific low back pain against a placebo tape and a control group. Method: This is a 3-arm, randomized controlled trial with a blinded assessor. Sixty patients with chronic non-specific low back pain were randomized into one of the three groups: Kinesio Taping ® group (n=20), Micropore® (placebo) group (n=20) and control group (n=20). Patients allocated to both the Kinesio Taping ® group and the placebo group used the different types of tape for a period of 48 hours. The control group did not receive any intervention. The outcomes measured were pain intensity (measured by an 11-point numerical rating scale) and disability (measured by the 24-item Roland Morris Disability Questionnaire). A blinded assessor measured the outcomes at baseline, 48 hours and 7 days after randomization. Results: After 48 hours, there was a statistically significant difference between the Kinesio Taping ® group versus the control group (mean between-group difference = -3.1 points, 95% CI=-5.2 to -1.1, p=0.003), but no difference when compared to the placebo group (mean between-group difference= 1.9 points, 95% CI=-0.2 to 3.9, p=0.08). For the other outcomes no differences were observed. Conclusions: The Kinesio Taping ® is not better than placebo (Micropore®) in patients with chronic low back pain. PMID:26647750

Lack of Prognostic Impact of Adjuvant Radiation on Oncologic Outcomes in Elderly Women with Breast Cancer.

PubMed

Omidvari, Shapour; Talei, Abdolrasoul; Tahmasebi, Sedigheh; Moaddabshoar, Leila; Dayani, Maliheh; Mosalaei, Ahmad; Ahmadloo, Niloofar; Ansari, Mansour; Mohammadianpanah, Mohammad

2015-01-01

Radiotherapy plays an important role as adjuvant treatment in locally advanced breast cancer and in those patients who have undergone breast-conserving surgery. This study aimed to investigate the prognostic impact of adjuvant radiation on oncologic outcomes in elderly women with breast cancer. In this retrospective study, we reviewed and analyzed the characteristics, treatment outcome and survival of elderly women (aged ≥ 60 years) with breast cancer who were treated and followed-up between 1993 and 2014. The median follow up for the surviving patients was 38 (range 3-207) months. One hundred and seventy-eight patients with a median age of 74 (range 60-95) years were enrolled in the study. Of the total, 60 patients received postoperative adjuvant radiation (radiation group) and the remaining 118 did not (control group). Patients in the radiation group were significantly younger than those in the control group (P value=0.004). In addition, patients in radiation group had higher node stage (P value<0.001) and disease stage (P=0.003) and tended to have higher tumor grade (P=0.031) and received more frequent (P value <0.001) adjuvant and neoadjuvant chemotherapy compared to those in the control group. There was no statistically significant difference between two groups regarding the local control, disease-free survival and overall survival rates. In this study, we did not find a prognostic impact for adjuvant radiation on oncologic outcomes in elderly women with breast cancer.

Visual outcomes after balanced salt solution infiltration during lenticule separation in small-incision lenticule extraction for myopic astigmatism.

PubMed

Liu, Ting; Zhu, Xiaomin; Chen, Kaijian; Bai, Ji

2017-07-01

To evaluate the refractive outcomes of balanced salt solution infiltration during small-incision lenticule extraction (SMILE).This randomized prospective study enrolled 52 patients (104 eyes) with myopic astigmatism. Patients underwent SMILE to correct the myopic astigmatism in Daping Hospital of the Third Military Medical University between January and July 2013. One eye of each patient received traditional SMILE (control group) and the other received a modified SMILE procedure (liquid infiltration group). The corrected distance visual acuity (CDVA), postoperative uncorrected distance visual acuity (UDVA), refraction, wavefront aberration, intraocular pressure (IOP), modulation transfer function (MTF) cut-off frequency, and objective scattering index (OSI) were evaluated.UDVA in the liquid infiltration group was significantly higher than that in the control group at 1 day postoperatively, but not at 1 month after surgery. Moreover, OSI and MTF cut-off frequency in the liquid infiltration group were higher than those in the control group at early follow-up. However, no significant intergroup difference was observed in the OSI and MTF cut-off frequency at 3 months after surgery. In addition, the predictability was better in the liquid infiltration group than in the control group. The changes of horizontal coma in the liquid infiltration group were lesser than those in the control group. However, no intergroup difference was observed in the reduction of IOP at 1 month after surgery.The modified SMILE procedure results in better visual outcomes than did the traditional SMILE procedure when used for treating myopic astigmatism.

Yoga Practice for Reducing the Male Obesity and Weight Related Psychological Difficulties-A Randomized Controlled Trial

PubMed Central

Subramanya, Pailoor; Nidhi, Ram

2016-01-01

Introduction Obesity is a health disorder and increasing all over the world. It is also a cause for many non-communicable diseases. Yoga practice reduces the stress level which may improve the eating habits and help in weight reduction. Aim To assess the final outcome of the effects after 3 months of the 14 weeks yoga training on obesity of adult male in an urban setting. Materials and Methods This was a randomized controlled trial with parallel groups (Yoga and Control groups) on male obese. Total 80 subjects with Body Mass Index (BMI) between 25 to 35 kg/cm2 were enrolled and randomized into two equal groups in which 72 subjects (yoga n = 37 and control n=35) completed the trial. Yoga group mean age ± SD was 40.03±8.74 and Control group mean age±SD was 42.20±12.06. A 14 weeks special IAYT (Integrated Approach of Yoga Therapy) yoga training was given to the Yoga group and no specific activity was given to Control group. The interim results of this study at 14 weeks were covered in another article which is under process. After the 14 weeks of yoga training the Yoga group was asked to continue the yoga practice for the next 3 months and the Control group was not given any physical activity. The final outcome is covered in this paper. The assessments were anthropometric parameters of body weight (Wt), BMI (Body Mass Index), MAC (Mid-upper Arm Circumferences of left and right arm), WC (Waist Circumference), HC (Hip Circumference), WHR (Waist Hip Ratio), SKF (Skin Fold Thickness) of biceps, triceps, sub scapular, suprailiac and cumulative skin fold thickness value), Percentage body fat based on SKF and Psychological questionnaires of PSS (Perceived Stress Scale) and AAQW (Acceptance and Action Questionnaire for Weight related difficulty). Assessments were taken after 3 months of yoga training, for both Yoga and Control groups. Within group, between group and correlation analyses were carried out using SPSS 21. Results Improvement in anthropometric and psychological parameters such as Wt, Percentage body fat, PSS were observed in the final outcome. Also, some of the improvements such as AAQW score were lost in the final outcome, compared to interim results. Conclusion The yoga practice is effective for obesity control for adult male in an urban setting. PMID:28050422

Postoperative Radiotherapy for Maxillary Sinus Cancer: Long-Term Outcomes and Toxicities of Treatment

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

Bristol, Ian J.; Ahamad, Anesa; Garden, Adam S.

2007-07-01

Purpose: To determine the effects of three changes in radiotherapy technique on the outcomes for patients irradiated postoperatively for maxillary sinus cancer. Methods and Materials: The data of 146 patients treated between 1969 and 2002 were reviewed. The patients were separated into two groups according to the date of treatment. Group 1 included 90 patients treated before 1991 and Group 2 included 56 patients treated after 1991, when the three changes were implemented. The outcomes were compared between the two groups. Results: No differences were found in the 5-year overall survival, recurrence-free survival, local control, nodal control, or distant metastasismore » rates between the two groups (51% vs. 62%, 51% vs. 57%, 76% vs. 70%, 82% vs. 83%, and 28% vs. 17% for Groups 1 and 2, respectively). The three changes were to increase the portals to cover the base of the skull in patients with perineural invasion, reducing their risk of local recurrence; the addition of elective neck irradiation in patients with squamous or undifferentiated histologic features, improving the nodal control, distant metastasis, and recurrence-free survival rates (64% vs. 93%, 20% vs. 3%, and 45% vs. 67%, respectively; p < 0.05 for all comparisons); and improving the dose distributions within the target volume, reducing the late Grade 3-4 complication rates (34% in Group 1 vs. 8% in Group 2, p = 0.014). Multivariate analysis revealed advancing age, the need for enucleation, and positive margins as independent predictors of worse overall survival. The need for enucleation also predicted for worse local control. Conclusion: The three changes in radiotherapy technique improved the outcomes for select patients as predicted. Despite these changes, little demonstrable overall improvement occurred in local control or survival for these patients and additional work must be done.« less

Effects of extended childbirth education by midwives on the childbirth fear of first-time mothers: an RCT.

PubMed

Haapio, Sari; Kaunonen, Marja; Arffman, Martti; Åstedt-Kurki, Päivi

2017-06-01

This study evaluates how extended childbirth education intervention affects first-time mothers' fear of childbirth and its manifestation during pregnancy. A randomised controlled trial was conducted. A total of 659 first-time mothers were recruited before week 14 of gestation during the first ultrasound screening at the hospital's maternity outpatient clinic. The mothers were randomly assigned into an intervention group (n = 338) or a control group (n = 321). The control group received all available regular childbirth education. In addition, the intervention group received an enhanced 2-hour childbirth education at the maternity hospital. The objects of childbirth fears (childbirth-related fear, fear for the mother's and the child's well-being, fear related to Caesarean section) were the primary outcomes. The manifestations of childbirth fears (everyday life, stress symptoms and the wish to have a Caesarean section) were the secondary outcomes. These outcomes were measured over 34 weeks of gestation using two parts of the instrument 'Feelings of Fear and Security Associated with Pregnancy and Childbirth'. Logistic and ordinal linear regression models were used to model the effect of the intervention on the outcomes. The mothers in the intervention group had less childbirth-related fear than those in the control group [odds ratio (OR) 0.58, 95% confidence level (CL) 0.38-0.88]. Also, fear influenced the mothers in the intervention group less in everyday life than it did the mothers in the control group [OR 0.64, 95% CL 0.44-0.94]. The effectiveness of the intervention can be considered moderate: one of three objects and one of three manifestations of fears were reduced. The intervention proved most efficient in alleviating relatively limited objects of fears. © 2016 Nordic College of Caring Science.

Preliminary Clinical Evaluation of Acupuncture Therapy in Patients With Postpartum Sciatica.

PubMed

He, Bing-Shu; Li, Yang; Gui, Tong

2018-03-01

This study evaluated clinical outcomes following acupuncture treatment of postpartum sciatica. One hundred eleven women with postpartum sciatica were enrolled in an acupuncture group (n = 86) or a control group (n = 25), according to their preference. Participants in the acupuncture group attended acupuncture therapy sessions 3 times a week for 4 weeks, while participants in the control group were assigned to bed rest. Outcome measures included the Roland Disability Questionnaire for sciatica, a visual analog scale for leg pain, and patient-reported perceived recovery. In addition, participants were surveyed after treatment to assess the acceptability of acupuncture therapy. The outcome scores for disability and leg pain were significantly lower in the acupuncture group compared with the control group (P < .05). All 86 women in the treatment group stated that acupuncture improved their well-being after treatment. At one month after treatment, 98% of participants in the treatment group reported recovery compared with 24% of the control group participants (P < .001). After treatment, 95% of lactating women in the acupuncture group believed that acupuncture had no significant interference with breast milk production. No adverse effects of acupuncture were reported. All participants in the acupuncture group stated they would choose acupuncture in case of relapse. However, the recurrence rate of sciatica in the acupuncture group (32%) was comparable to that of the control group (35%) at the one-year follow-up interview. Compared with bed rest, acupuncture might be an effective and acceptable strategy to relieve symptoms of postpartum sciatica. © 2018 by the American College of Nurse-Midwives.

Treatment Outcome and Maintenance in Systematic Desensitization: Professional versus Paraprofessional Effectiveness.

ERIC Educational Resources Information Center

Shelton, John L.; Madrazo-Peterson, Rita

1978-01-01

Anxious students were randomly assigned to a wait-list control group; to three groups aided by experienced behavior therapists; or to three groups led by paraprofessionals. Results show paraprofessionals can achieve outcome and maintenance effects equivalent to more rigorously trained professionals. Paraprofessionals can conduct desensitization in…

Health outcomes can be improved by implementing an occupational physiotherapy provider programme.

PubMed

Pizzari, Tania; Davidson, Megan

2013-03-01

To evaluate the return to work and health outcomes of a physiotherapy network provider programme. A prospective case-control study was conducted with 21 clients of network occupational physiotherapy (OP) providers and 21 matched clients of non-network providers. Health outcomes and return to work were recorded 3 and 6 months following the commencement of physiotherapy. Health outcomes included the Short Form (SF)-12, return to usual activities and the global perceived effect of treatment. Within-group changes and between-group differences were analysed. Within-group changes showed the OP group improved significantly in physical functioning (p = 0.006), and the control group deteriorated in mental health status (p = 0.016) as measured by the SF-12. Mean change over time between groups from the 3-month to 6-month follow-ups showed a significant difference favouring the OP group for return to usual activities (p = 0.027) and the physical component of the SF-12 (p = 0.009). All job-attached participants returned to work following their accident, so there was no difference between the groups. The OP clients demonstrated a greater change in physical functioning health outcomes over time. This study provides preliminary support for the implementation of the OP scheme. Copyright © 2012 John Wiley & Sons, Ltd.

Microwave Ablation of Porcine Kidneys in vivo: Effect of two Different Ablation Modes ('Temperature Control' and 'Power Control') on Procedural Outcome

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

Sommer, C. M., E-mail: christof.sommer@med.uni-heidelberg.de; Arnegger, F.; Koch, V.

2012-06-15

Purpose: This study was designed to analyze the effect of two different ablation modes ('temperature control' and 'power control') of a microwave system on procedural outcome in porcine kidneys in vivo. Methods: A commercially available microwave system (Avecure Microwave Generator; MedWaves, San Diego, CA) was used. The system offers the possibility to ablate with two different ablation modes: temperature control and power control. Thirty-two microwave ablations were performed in 16 kidneys of 8 pigs. In each animal, one kidney was ablated twice by applying temperature control (ablation duration set point at 60 s, ablation temperature set point at 96 Degree-Signmore » C, automatic power set point; group I). The other kidney was ablated twice by applying power control (ablation duration set point at 60 s, ablation temperature set point at 96 Degree-Sign C, ablation power set point at 24 W; group II). Procedural outcome was analyzed: (1) technical success (e.g., system failures, duration of the ablation cycle), and (2) ablation geometry (e.g., long axis diameter, short axis diameter, and circularity). Results: System failures occurred in 0% in group I and 13% in group II. Duration of the ablation cycle was 60 {+-} 0 s in group I and 102 {+-} 21 s in group II. Long axis diameter was 20.3 {+-} 4.6 mm in group I and 19.8 {+-} 3.5 mm in group II (not significant (NS)). Short axis diameter was 10.3 {+-} 2 mm in group I and 10.5 {+-} 2.4 mm in group II (NS). Circularity was 0.5 {+-} 0.1 in group I and 0.5 {+-} 0.1 in group II (NS). Conclusions: Microwave ablations performed with temperature control showed fewer system failures and were finished faster. Both ablation modes demonstrated no significant differences with respect to ablation geometry.« less

Acupuncture for migraine prophylaxis: a randomized controlled trial

PubMed Central

Li, Ying; Zheng, Hui; Witt, Claudia M.; Roll, Stephanie; Yu, Shu-guang; Yan, Jie; Sun, Guo-jie; Zhao, Ling; Huang, Wen-jing; Chang, Xiao-rong; Zhang, Hong-xing; Wang, De-jun; Lan, Lei; Zou, Ran; Liang, Fan-rong

2012-01-01

Background: Acupuncture is commonly used to treat migraine. We assessed the efficacy of acupuncture at migraine-specific acupuncture points compared with other acupuncture points and sham acupuncture. Methods: We performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5–8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life. Results: Compared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5–8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13–16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference –1.06 [95% confidence interval (CI) –1.77 to –0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference –1.22 [95% CI –1.92 to –0.52], p < 0.001; Yangming-specific acupuncture v. control: difference –0.91 [95% CI –1.61 to –0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups. Interpretation: Acupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture. Trial Registration: Clinicaltrials.gov NCT00599586 PMID:22231691

Assessment of treatment outcome in patients with craniomandibular dysfunction.

PubMed

de Leeuw, J R; Steenks, M H; Ros, W J; Lobbezoo-Scholte, A M; Bosman, F; Winnubst, J A

1994-11-01

Psychosocial, socio-demographic and symptom characteristics have been shown to be associated with treatment outcome in patients with craniomandibular dysfunction (CMD). This study was performed to assess to what extent symptoms and correlates of CMD change as a consequence of conservative treatment for CMD. Treatment outcome in a group of CMD patients treated with a stabilization splint (experimental group) was compared with that of a group of patients with CMD who were not treated for CMD (control group). Patients in the experimental group had fewer symptoms of CMD at the end of treatment. However, several symptoms and correlates of CMD also improved in the control group (severity of pain, joint noises, ear symptoms). It was therefore questioned whether all improvements in symptoms and correlates of CMD in the experimental group could be attributed to the treatment received. Results suggest that the main improvement that might be ascribed to therapy was a decrease in 'jaw symptoms'. There was a noticeable decrease in depression and an increased use of 'planned actions and rational thinking' as a coping style in the experimental group whereas these variables did not change in the control group. Implications and suggestions for further research are discussed.

Fight for Your Right to Fruit: Psychosocial Outcomes of a Manga Comic Promoting Fruit Consumption in Middle-School Youth.

PubMed

Leung, May May; Green, Melanie C; Tate, Deborah F; Cai, Jianwen; Wyka, Katarzyna; Ammerman, Alice S

2017-05-01

The purpose of this study was to determine whether exposure to a manga comic (Japanese comic art) with messages promoting fruit consumption influenced psychosocial variables associated with increased fruit intake in middle-school youth. A three-group, randomized, single-session study was conducted in two public middle schools in central North Carolina. Participants were randomly assigned to one of three groups: (a) comic (manga comic promoting fruit consumption, (b) newsletter (newsletter about fruit), or (c) attention-control (newsletter about ancient Greece). Participants included N = 263 youth, with a mean age of 13.18 years (SD = 1.12). Outcome expectations, self-efficacy, and knowledge related to fruit intake were measured at baseline and immediately after reading. Secondary outcomes included transportation (degree to which participants are immersed in their media) and enjoyment, measured at posttest. Data were analyzed using regression analyses. Comic group participants tended to have greater change in outcome expectations related to fruit intake compared to the attention-control group and greater transportation and enjoyment than the newsletter and attention-control groups. Study results are promising and suggest that manga comics may be a useful format to promote positive health beliefs in youth.

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

PubMed

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 < .001). There was no significant difference for all patient-reported outcome (PRO) scores at final follow-up between both groups. When we compared the change in PRO scores (Δ) from preoperatively to 2 years postoperatively, there was no significant difference between both groups. The overall survivorship rate was 98.1% for the younger control group and 82.7% for the older study group. Survivors aged 50 years or older show similar improvement to patients aged 30 years or younger in PRO and patient satisfaction scores. The 2-year survivorship rate was 98.1% for the younger control group and 82.7% for the older study group. Therefore we believe that hip 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 should be counseled on the possibility of later conversion to total hip arthroplasty. Future work may include development of a decision-making tool to assess for prognosis to better delineate the indications for hip arthroscopy in the older population. Level III, therapeutic case-control study. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

A Translational Worksite Diabetes Prevention Trial Improves Psychosocial Status, Dietary Intake, and Step Counts among Employees with Prediabetes: A Randomized Controlled Trial.

PubMed

Miller, Carla K; Weinhold, Kellie; Marrero, David G; Nagaraja, Haikady N; Focht, Brian C

Few worksite trials have examined the impact of diabetes prevention interventions on psychological and behavioral outcomes. Thus, the impact of a worksite lifestyle intervention on psychosocial outcomes, food group intake, and step counts for physical activity (PA) was evaluated. A randomized pretest/posttest control group design with 3-month follow-up was employed from October 2012 to May 2014 at a U.S. university worksite among employees with prediabetes. The experimental group (n=35) received a 16-week group-based intervention while the control group received usual care (n=33). Repeated measures analysis of variance compared the change in outcomes between groups across time. A significant difference occurred between groups post-intervention for self-efficacy associated with eating and PA; goal commitment and difficulty; satisfaction with weight loss and physical fitness; peer social support for healthful eating; generation of alternatives for problem solving; and intake of fruits, meat, fish, poultry, nuts, and seeds (all ps < .05). The experimental group significantly increased step counts post-intervention (p = .0279) and were significantly more likely to report completing their work at study end (p = .0231). The worksite trial facilitated improvement in modifiable psychosocial outcomes, dietary patterns, and step counts; the long-term impact on diabetes prevention warrants further investigation. ClinicalTrials.gov identifier: NCT01682954.

Influence of psychologic features on rehabilitation outcomes in patients with subacute stroke trained with robotic-aided walking therapy.

PubMed

Bragoni, Maura; Broccoli, Marco; Iosa, Marco; Morone, Giovanni; De Angelis, Domenico; Venturiero, Vincenzo; Coiro, Paola; Pratesi, Luca; Mezzetti, Giulia; Fusco, Augusto; Paolucci, Stefano

2013-10-01

The aim of this study was to investigate whether the rehabilitation outcomes with robotic-aided gait therapy may be affected by patients' and caregivers' psychologic features after subacute stroke. This is a controlled, longitudinal, observational pilot study conducted on 42 patients divided in robotic-assisted gait training plus conventional physical therapy group, robotic-assisted gait training dropout group, and conventional physical therapy group. The outcome measures were walking ability (Functional Ambulation Category) and independency in activities of daily living (Barthel Index) measured before and after intervention. Psychologic features were measured before intervention using the Hospital Anxiety and Depression Scale, the Eysenck Personality Questionnaire, and recovery locus of control in the patients and the State-Trait Anxiety Inventory and the Beck Depression Inventory in the caregivers. Patient anxiety was significantly higher in those who refused/abandoned robotic therapy (P = 0.002). In the subjects allocated to the robotic group, the recovery of walking ability was significantly affected by the perceived recovery locus of control (P = 0.039, odds ratio = 14); and the recovery of independency in activities of daily living, by anxiety (P = 0.018, odds ratio = 0.042). Conversely, psychologic factors did not significantly affect the outcomes of conventional rehabilitation. Psychologic features, particularly recovery locus of control and anxiety, affected the rehabilitative outcomes of the patients involved in robotic treatment more than those in conventional rehabilitation.

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

PubMed

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 < 0.05). The main indications for a cesarean section in the study group were arrest of the active phase of labor, fetal distress and intrapartum fever; the percentages of each indication were significantly different from those of the control group (P < 0.001). The rates of postpartum hemorrhage in the study group and control group were 7.74% (130/1678) and 8.1% (121/1493), respectively (P = 0.710). The incidence rates of severe perineal lacerations were 0.48% (8/1678) for the study group and 0.2% (3/1493) for the control group (P = 0.187). The rates of forceps use were 4.29% (72/1678) in the study group and 2.41% (36/1493) in the control group (P = 0.004). The incidence rate of fetal distress in the study group was 6.24% (169/2709) and 4.67% (105/2246) (P = 0.006) in the control group. No significant difference was observed in the incidence of neonatal asphyxia and pediatric interventions between the two groups (0.74% (20/2709) vs. 8.12% (220/2709) and 17 (0.76%) vs. 161 (7.17%), respectively). The average length of hospital stay was 4.74 ± 1.15 and 2.13 ± 1.23 days (P < 0.01). The incidence of medical disputes was significantly different between the two groups: 1.44% (30/2079) in the study group and 0.53% (12/2246) in the control group (P < 0.01). The hospitalization expenses were 5401.29 ± 296.33 yuan in the study group and 5253.53 ± 3655.79 yuan in the control group (P = 0.06). The implementation of the new 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.

Long-term effects of three multicomponent exercise interventions on physical performance and fall-related psychological outcomes in community-dwelling older adults: a randomized controlled trial.

PubMed

Freiberger, Ellen; Häberle, Lothar; Spirduso, Waneen W; Zijlstra, G A Rixt

2012-03-01

To determine the long-term effects of three strength and balance exercise interventions on physical performance, fall-related psychological outcomes, and falls in older people. A single-blinded, four-group, randomized controlled trial. Community, Germany. Community-dwelling adults aged 70 to 90 who had fallen in the past 6 months or reported fear of falling. After baseline assessment, 280 participants were randomly assigned to the control group (CG; no intervention; n = 80) or one of three strength and balance exercise interventions (the strength and balance group (SBG; strength and balance only; n = 63), the fitness group (FG; strength and balance plus endurance training; n = 64), or the multifaceted group (MG; strength and balance plus fall risk education; n = 73). The interventions consisted of 32 one-hour group sessions in 16 weeks. Data on physical performance, fall-related psychological outcomes, and falls were collected for 24 months. Mixed-effects regression analyses showed improved short- and long-term (12 and 24 months, respectively) physical performance for the SBG and FG, particularly regarding mobility, balance, and walking speed (P < .05). The improvements in physical performance outcomes were most prominent in the FG. Fall-related psychological outcomes, number of falls, and injurious falls were not significantly different from in the control group. Training focusing on strength, balance, and endurance can enhance physical performance for up to 24 months in community-dwelling older adults. These findings did not translate to improved fall-related psychological outcomes or reduced incidence of falls. This demonstrates the need for a different approach (e.g., regarding intervention dose and components) to gain intervention benefits in the multiple domains that contribute to independence and well-being in older adults. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

Can Physical Education and Physical Activity Outcomes Be Developed Simultaneously Using a Game-Centered Approach?

ERIC Educational Resources Information Center

Miller, Andrew; Christensen, Erin; Eather, Narelle; Gray, Shirley; Sproule, John; Keay, Jeanne; Lubans, David

2016-01-01

The primary objective of this study was to evaluate the efficacy of a pilot intervention using a game-centered approach for improvement of physical activity (PA) and physical education (PE) outcomes simultaneously, and if this had an impact on enjoyment of PE. A group-randomized controlled trial with a 7-week wait-list control group was conducted…

Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial.

PubMed

Finkelstein, Eric A; Haaland, Benjamin A; Bilger, Marcel; Sahasranaman, Aarti; Sloan, Robert A; Nang, Ei Ei Khaing; Evenson, Kelly R

2016-12-01

Despite the increasing popularity of activity trackers, little evidence exists that they can improve health outcomes. We aimed to investigate whether use of activity trackers, alone or in combination with cash incentives or charitable donations, lead to increases in physical activity and improvements in health outcomes. In this randomised controlled trial, employees from 13 organisations in Singapore were randomly assigned (1:1:1:1) with a computer generated assignment schedule to control (no tracker or incentives), Fitbit Zip activity tracker, tracker plus charity incentives, or tracker plus cash incentives. Participants had to be English speaking, full-time employees, aged 21-65 years, able to walk at least ten steps continuously, and non-pregnant. Incentives were tied to weekly steps, and the primary outcome, moderate-to-vigorous physical activity (MVPA) bout min per week, was measured via a sealed accelerometer and assessed on an intention-to-treat basis at 6 months (end of intervention) and 12 months (after a 6 month post-intervention follow-up period). Other outcome measures included steps, participants meeting 70 000 steps per week target, and health-related outcomes including weight, blood pressure, and quality-of-life measures. This trial is registered at ClinicalTrials.gov, number NCT01855776. Between June 13, 2013, and Aug 15, 2014, 800 participants were recruited and randomly assigned to the control (n=201), Fitbit (n=203), charity (n=199), and cash (n=197) groups. At 6 months, compared with control, the cash group logged an additional 29 MVPA bout min per week (95% CI 10-47; p=0·0024) and the charity group an additional 21 MVPA bout min per week (2-39; p=0·0310); the difference between Fitbit only and control was not significant (16 MVPA bout min per week [-2 to 35; p=0·0854]). Increases in MVPA bout min per week in the cash and charity groups were not significantly greater than that of the Fitbit group. At 12 months, the Fitbit group logged an additional 37 MVPA bout min per week (19-56; p=0·0001) and the charity group an additional 32 MVPA bout min per week (12-51; p=0·0013) compared with control; the difference between cash and control was not significant (15 MVPA bout min per week [-5 to 34; p=0·1363]). A decrease in physical activity of -23 MVPA bout min per week (95% CI -42 to -4; p=0·0184) was seen when comparing the cash group with the Fitbit group. There were no improvements in any health outcomes (weight, blood pressure, etc) at either assessment. The cash incentive was most effective at increasing MVPA bout min per week at 6 months, but this effect was not sustained 6 months after the incentives were discontinued. At 12 months, the activity tracker with or without charity incentives were effective at stemming the reduction in MVPA bout min per week seen in the control group, but we identified no evidence of improvements in health outcomes, either with or without incentives, calling into question the value of these devices for health promotion. Although other incentive strategies might generate greater increases in step activity and improvements in health outcomes, incentives would probably need to be in place long term to avoid any potential decrease in physical activity resulting from discontinuation. Ministry of Health, Singapore. Copyright © 2016 Elsevier Ltd. All rights reserved.

Do nonsteroidal anti-inflammatory drugs affect the outcome of arthroscopic Bankart repair?

PubMed Central

Blomquist, J; Solheim, E; Liavaag, S; Baste, V; Havelin, L I

2014-01-01

To achieve pain control after arthroscopic shoulder surgery, nonsteroidal anti-inflammatory drugs (NSAIDs) are a complement to other analgesics. However, experimental studies have raised concerns that these drugs may have a detrimental effect on soft tissue-to-bone healing and, thus, have a negative effect on the outcome. We wanted to investigate if there are any differences in the clinical outcome after the arthroscopic Bankart procedure for patients who received NSAIDs prescription compared with those who did not. 477 patients with a primary arthroscopic Bankart procedure were identified in the Norwegian shoulder instability register and included in the study. 32.5% received prescription of NSAIDs post-operatively. 370 (78%) of the patients answered a follow-up questionnaire containing the Western Ontario Shoulder Instability index (WOSI). Mean follow-up was 21 months. WOSI at follow-up were 75% in the NSAID group and 74% in the control group. 12% of the patients in the NSAID group and 14% in the control group reported recurrence of instability. The reoperation rate was 5% in both groups. There were no statistically significant differences between the groups. Prescription of short-term post-operative NSAID treatment in the post-operative period did not influence on the functional outcome after arthroscopic Bankart procedures. PMID:24750379

Effectiveness of physical therapy for patients with neck pain: an individualized approach using a clinical decision-making algorithm.

PubMed

Wang, Wendy T J; Olson, Sharon L; Campbell, Anne H; Hanten, William P; Gleeson, Peggy B

2003-03-01

The purpose of this study was to determine the effectiveness of an individualized physical therapy intervention in treating neck pain based on a clinical reasoning algorithm. Treatment effectiveness was examined by assessing changes in impairment, physical performance, and disability in response to intervention. One treatment group of 30 patients with neck pain completed physical therapy treatment. The control group of convenience was formed by a cohort group of 27 subjects who also had neck pain but did not receive treatment for various reasons. There were no significant differences between groups in demographic data and the initial test scores of the outcome measures. A quasi-experimental, nonequivalent, pretest-posttest control group design was used. A physical therapist rendered an eclectic intervention to the treatment group based on a clinical decision-making algorithm. Treatment outcome measures included the following five dependent variables: cervical range of motion, numeric pain rating, timed weighted overhead endurance, the supine capital flexion endurance test, and the Patient Specific Functional Scale. Both the treatment and control groups completed the initial and follow-up examinations, with an average duration of 4 wk between tests. Five mixed analyses of variance with follow-up tests showed a significant difference for all outcome measures in the treatment group compared with the control group. After an average 4 wk of physical therapy intervention, patients in the treatment group demonstrated statistically significant increases of cervical range of motion, decrease of pain, increases of physical performance measures, and decreases in the level of disability. The control group showed no differences in all five outcome variables between the initial and follow-up test scores. This study delineated algorithm-based clinical reasoning strategies for evaluating and treating patients with cervical pain. The algorithm can help clinicians classify patients with cervical pain into clinical patterns and provides pattern-specific guidelines for physical therapy interventions. An organized and specific physical therapy program was effective in improving the status of patients with neck pain.

The impact of generalized joint laxity (GJL) on the posterior neck pain, cervical disc herniation, and cervical disc degeneration in the cervical spine.

PubMed

Lee, Sun-Mi; Oh, Su Chan; Yeom, Jin S; Shin, Ji-Hoon; Park, Sam-Guk; Shin, Duk-Seop; Ahn, Myun-Whan; Lee, Gun Woo

2016-12-01

Generalized joint laxity (GJL) can have a negative impact on lumbar spine pathology, including low back pain, disc degeneration, and disc herniation, but the relationship between GJL and cervical spine conditions remains unknown. To investigate the relationship between GJL and cervical spine conditions, including the prevalence of posterior neck pain (PNP), cervical disc herniation (CDH), and cervical disc degeneration (CDD), in a young, active population. Retrospective 1:2 matched cohort (case-control) study from prospectively collected data PATIENT SAMPLE: Of a total of 1853 individuals reviewed, 73 individuals with GJL (study group, gruop A) and 146 without GJL (control group, Group B) were included in the study according to a 1:2 case-control matched design for age, sex, and body mass index. The primary outcome measure was the prevalence and intensity of PNP at enrollment based on a visual analogue scale score for pain. The secondary outcome measures were (1) clinical outcomes as measured with the neck disability index (NDI) and 12-item short form health survey (SF-12) at enrollment, and (2) radiological outcomes of CDH and CDD at enrollment. We compared baseline data between groups. Descriptive statistical analyses were performed to compare the 2 groups in terms of the outcome measures. The prevalence and intensity of PNP were significantly greater in group A (patients with GJL) than in group B (patients without GJL) (prevalence: p=.02; intensity: p=.001). Clinical outcomes as measured with NDI and SF-12 did not differ significantly between groups. For radiologic outcomes, the prevalence of CDD was significantly greater in group A than in group B (p=.04), whereas the prevalence of CDH did not differ significantly between groups (p=.91). The current study revealed that GJL was closely related to the prevalence and intensity of PNP, suggesting that GJL may be a causative factor for PNP. In addition, GJL may contribute to the occurrence of CDD, but not CDH. Spine surgeons should screen for GJL in patientswith PNP and inform patients of its potential negative impact on disc degeneration of the cervical spine. Copyright © 2016 Elsevier Inc. All rights reserved.

Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial.

PubMed

González-Ortega, Itxaso; Echeburúa, Enrique; García-Alocén, Adriana; Vega, Patricia; González-Pinto, Ana

2016-07-29

The high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventions in these populations. However, to date, there have been few clinical treatment trials (of pharmacological or psychological interventions) that have specifically focused on addressing comorbid cannabis use among these patients. The aim of this paper is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of a specific cognitive behavioral therapy program for cannabis cessation in patients with FEP compared to standard treatment (psychoeducation). This is a single-blind randomized study with 1 year of follow-up. Patients are to be randomly assigned to one of two treatments: (1) specific cognitive behavioral therapy for cannabis cessation composed of 1-hour sessions once a week for 16 weeks, in addition to pharmacological treatment scheduled by the psychiatrist, or (2) a control group (psychoeducation + pharmacological treatment) following the same format as the experimental group. Participants in both groups will be evaluated at baseline (pre-treatment), at 16 weeks (post-treatment), and at 3 and 6 months and 1 year of follow-up. The primary outcome will be that patients in the experimental group will have greater cannabis cessation than patients in the control group at post-treatment. The secondary outcome will be that the experimental group will have better clinical and functional outcomes than the control group. This study provides the description of a clinical trial design based on specific cognitive behavioral therapy for cannabis cessation in FEP patients, aiming to improve clinical and functional outcome, as well as tackling the addictive disorder. NCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014.

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

PubMed Central

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

2015-01-01

Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

Long-lasting effects of a new memory self-efficacy training for stroke patients: a randomized controlled trial.

PubMed

Aben, Laurien; Heijenbrok-Kal, Majanka H; Ponds, Rudolf W H M; Busschbach, Jan J V; Ribbers, Gerard M

2014-01-01

This study aims to determine the long-term effects of a new Memory Self-efficacy (MSE) training program for stroke patients on MSE, depression, and quality of life. In a randomized controlled trial, patients were allocated to a MSE training or a peer support group. Outcome measures were MSE, depression, and quality of life, measured with the Metamemory-In-Adulthood questionnaire, Center for Epidemiological Studies-Depression Scale (CES-D), and the Who-Qol Bref questionnaire, respectively. We used linear mixed models to compare the outcomes of both groups immediately after training, after 6 months, and after 12 months, adjusted for baseline. In total, 153 former inpatients from 2 rehabilitation centers were randomized-77 to the experimental and 76 to the control group. MSE increased significantly more in the experimental group and remained significantly higher than in the control group after 6 and 12 months (B = 0.42; P = .010). Psychological quality of life also increased more in the experimental group but not significantly (B = 0.09; P = .077). However, in the younger subgroup of patients (<65 years old), psychological quality of life significantly improved in the experimental group compared to the control group and remained significantly higher over time (B = 0.14; P = .030). Other outcome measures were not significantly different between both groups. An MSE training program improved MSE and psychological quality of life in stroke patients aged <65 years. These effects persisted during 12 months of follow-up.

Methodology Series Module 2: Case-control Studies.

PubMed

Setia, Maninder Singh

2016-01-01

Case-Control study design is a type of observational study. In this design, participants are selected for the study based on their outcome status. Thus, some participants have the outcome of interest (referred to as cases), whereas others do not have the outcome of interest (referred to as controls). The investigator then assesses the exposure in both these groups. The investigator should define the cases as specifically as possible. Sometimes, definition of a disease may be based on multiple criteria; thus, all these points should be explicitly stated in case definition. An important aspect of selecting a control is that they should be from the same 'study base' as that of the cases. We can select controls from a variety of groups. Some of them are: General population; relatives or friends; and hospital patients. Matching is often used in case-control control studies to ensure that the cases and controls are similar in certain characteristics, and it is a useful technique to increase the efficiency of the study. Case-Control studies can usually be conducted relatively faster and are inexpensive - particularly when compared with cohort studies (prospective). It is useful to study rare outcomes and outcomes with long latent periods. This design is not very useful to study rare exposures. Furthermore, they may also be prone to certain biases - selection bias and recall bias.

Matched cohort study of topical tranexamic acid in cementless primary total hip replacement.

PubMed

Sanz-Reig, Javier; Mas Martinez, Jesus; Verdu Román, Carmen; Morales Santias, Manuel; Martínez Gimenez, Enrique; Bustamante Suarez de Puga, David

2018-03-29

Tranexamic acid has been shown to be effective in reducing blood loss after total hip replacement. The purpose of this study was to prospectively assess the effectiveness of topical TXA use to reduce blood loss after primary total hip replacement and to compare these outcomes with those of a matched control group from a similar cohort that did not have received tranexamic acid. This is a prospective matched control study to assess the effect of a 2 g topical tranexamic acid in 50 mL physiological saline solution in total hip replacement. Primary outcomes were hemoglobin and hematocrit drop, and total blood loss. Secondary outcomes were transfusion rates, length of hospital stay, deep vein thrombosis, and pulmonary embolism events. We could match 100 patients to a control group. There were no statistical significantly differences between the two groups. The hemoglobin and hematocrit postoperative values were significantly higher in topical tranexamic acid group than in control group (P < 0.001). The mean total blood loss was 769 in topical tranexamic acid group and 1163 in control group with significant differences (P = 0.001), which meant 34% reduction in total blood loss. Length of stay was lower in topical tranexamic acid group. The risk of deep vein thrombosis and pulmonary events did not increase. A single dose of 2 g tranexamic acid in 50 mL physiological saline solution topical administration was effective and safe in reducing bleeding in patients undergoing unilateral primary non-cemented total hip replacement compared to a matched control group.

77 FR 40590 - Notice of Submission for OMB Review; Institute of Education Sciences; Pell Grant Experiments Study

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

...) a treatment group, which will have expanded access to Pell grants; or (2) a control group, which will not have access. Within both experiments, the treatment group will be very similar to the control... employment and earnings outcomes between treatment and control group members can then be attributed to Pell...

Periapical healing outcome following single visit endodontic treatment in patients with type 2 diabetes mellitus

PubMed Central

Nayak, Moksha; Babshet, Medha

2016-01-01

Background The prevalence of apical periodontitis in diabetes mellitus patients is high. The altered immunity in diabetes affects the healing process of periapical tissue. Single visit endodontic treatment has shown to increase the periapical healing rate with better patient compliance. Hence the present study aims at evaluating the clinical and radiographic healing outcome of single visit endodontic treatment, in type 2 diabetes mellitus patients with periapical disease. Material and Methods Eighty patients with periapical disease were divided into 2 groups of 40 each: Group I, Control subjects and Group II, Type 2 diabetics. Glycosylated hemoglobin levels were assessed preoperatively and at follow up intervals in diabetics. Pre-operative assessment of periapical status was done using CPDR (Clinical periapical diagnosis of root), QLDR (Qualitative radiographic diagnosis of tooth) and QTDR (Quantitative radiographic diagnosis of tooth) criteria. Postoperative healing was evaluated following single-visit endodontic treatment by Strindberg criteria. Results Group 2 subjects had chronic and exacerbating lesions with significantly larger lesions (p=0.029). 100 % clinical healing outcome in diabetic group was seen in two months. Group 2 showed 85% success in one year on radiographic evaluation. Poor controlled diabetics showed failure compared to fair and good controlled. Conclusions Type 2 diabetics had chronic and larger sized lesions when compared to control subjects. The periapical lesions in patients with poor diabetic control showed failure. The clinical and radiographic healing outcome of single visit endodontic therapy was delayed in diabetic patients. Key words:Apical periodontitis, diabetes mellitus type 2, endodontics, periapical lesion, strindberg criteria. PMID:27957260

Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

PubMed

Al-Tamimi, Yahia Z; Bhargava, Deepti; Feltbower, Richard G; Hall, Gregory; Goddard, Anthony J P; Quinn, Audrey C; Ross, Stuart A

2012-03-01

A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome. Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit. Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively). Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage. URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

Transversus abdominis plane block reduces morphine consumption in the early postoperative period following microsurgical abdominal tissue breast reconstruction: a double-blind, placebo-controlled, randomized trial.

PubMed

Zhong, Toni; Ojha, M; Bagher, Shaghayegh; Butler, Kate; Srinivas, Coimbatore; McCluskey, Stuart A; Clarke, Hance; O'Neill, Anne C; Novak, Christine B; Hofer, Stefan O P

2014-11-01

The analgesic efficacy of the transversus abdominis plane peripheral nerve block following abdominal tissue breast reconstruction has not been studied in a randomized controlled trial. The authors conducted a double-blind, placebo-controlled, 1:1 allocation, two-arm parallel group, superiority design, randomized controlled trial in patients undergoing microsurgical abdominally based breast reconstruction. Intraoperatively, epidural catheters were inserted under direct vision through the triangle of Petit on both sides of the abdomen into the transversus abdominis plane just before rectus fascial closure. Patients received either bupivacaine (study group) or saline (placebo group) through the catheters for 2 postoperative days. All patients received hydromorphone by means of a patient-controlled analgesic pump. The primary outcome was the difference in the parenteral opioid consumption on each postoperative day between the groups. The secondary outcome measures included the following: total in-hospital opioid; antinausea medication; pain, nausea, and sedation scores; Quality of Recovery Score; time to ambulation; and hospital stay duration. Between September of 2011 and June of 2013, 93 patients were enrolled: 49 received bupivacaine and 44 received saline. There were 11 postoperative complications (13 percent); none were related to the catheter. Primary outcomes were completed by 85 of 93 patients (91.3 percent); the mean parenteral morphine consumption was significantly reduced on postoperative day 1 in the bupivacaine group (20.7±20.1 mg) compared with 30.0±19.1 mg in the control group (p=0.02). There were no significant differences in secondary outcomes. Following abdominally based breast reconstruction, transversus abdominis plane peripheral nerve block is safe and significantly reduces morphine consumption in the early postoperative period. Therapeutic, II.

Long-Term Outcomes of Medication Intervention Using the Screening Tool of Older Persons Potentially Inappropriate Prescriptions Screening Tool to Alert Doctors to Right Treatment Criteria.

PubMed

Frankenthal, Dvora; Israeli, Avi; Caraco, Yoseph; Lerman, Yaffa; Kalendaryev, Edward; Zandman-Goddard, Gisele; Lerman, Yehuda

2017-02-01

To compare 24-month outcomes of participants of a prospective randomized controlled trial (RCT) assigned to undergo a medication intervention of orally communicated recommendations based on Screening Tool of Older Persons potentially inappropriate Prescriptions (STOPP) and Screening Tool to Alert Doctors to Right Treatment (START) (intervention group) with outcomes of those assigned to undergo written medication review (control group). Retrospective cohort study. Chronic care geriatric facility. Of 359 participants from a prospective RCT conducted between April 2012 and September 2013, 306 were evaluable for another 12-month follow-up. Outcomes at 24-month follow-up included quality of prescribing (assessed according to STOPP/START), hospitalizations, falls, costs of medications, and all-cause mortality. Outcomes were compared with those reported at the beginning (baseline) and end (12-month follow-up) of the RCT. There was a significant rise in potentially inappropriate prescriptions (PIPs) (P = .01) and potentially prescriptions omissions (PPOs) (P < .001) in the intervention group between 12 and 24 months, although the prevalence of PIPs was significantly lower in the intervention group (33.3%) than the control group (48.4%) at 24-month follow-up (P = .02). Costs of medications were significantly lower in the intervention group than the control group (P < .001) at 24-month follow-up. The average number of falls in both groups dropped significantly between baseline and study closure (P = .04 and P = .008, respectively). There was no significant difference in hospitalizations and mortality between the two groups at 24-month follow-up. The effect of an orally communicated medication intervention with the STOPP/START criteria on falls was maintained over time. Direct communication between pharmacists and prescribing physicians is more efficient than written medication review and is recommended every 6 months in geriatric facilities. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Efficacy of Cognitive-Functional (Cog-Fun) Occupational Therapy Intervention Among Children With ADHD: An RCT.

PubMed

Hahn-Markowitz, Jeri; Berger, Itai; Manor, Iris; Maeir, Adina

2016-09-16

To examine the efficacy of a Cognitive-Functional (Cog-Fun) intervention for children with ADHD. Random allocation of 107 children to study or control groups preceded 10 parent-child weekly Cog-Fun sessions emphasizing executive strategy training in games and daily activities. Controls received treatment after crossover. Study participants were followed up 3 months post-treatment. Outcomes included parent/teacher ratings of executive functions, ADHD symptoms, and parent ratings of quality of life. Eight children withdrew prior to treatment. All children in both groups who began treatment completed it. Mixed effects ANOVA revealed significant Time × Group interaction effects on all parent-reported outcomes. Treatment effects were moderate to large, replicated after crossover in the control group and not moderated by medication. Parent-reported treatment gains in the study group were maintained at follow-up. No significant Time × Group interaction effects were found on teacher outcomes. Cog-Fun occupational therapy (OT) intervention shows positive context-specific effects on parent, but not teacher, ratings. © The Author(s) 2016.

Dynamic multi-segmental postural control in patients with chronic non-specific low back pain compared to pain-free controls: A cross-sectional study.

PubMed

McCaskey, Michael A; Wirth, Brigitte; Schuster-Amft, Corina; de Bruin, Eling D

2018-01-01

Reduced postural control is thought to contribute to the development and persistence of chronic non-specific low back pain (CNLBP). It is therefore frequently assessed in affected patients and commonly reported as the average amount of postural sway while standing upright under a variety of sensory conditions. These averaged linear outcomes, such as mean centre of pressure (CP) displacement or mean CP surface areas, may not reflect the true postural status. Adding nonlinear outcomes and multi-segmental kinematic analysis has been reported to better reflect the complexity of postural control and may detect subtler postural differences. In this cross-sectional study, a combination of linear and nonlinear postural parameters were assessed in patients with CNLBP (n = 24, 24-75 years, 9 females) and compared to symptom-free controls (CG, n = 34, 22-67 years, 11 females). Primary outcome was postural control measured by variance of joint configurations (uncontrolled manifold index, UI), confidence ellipse surface areas (CEA) and approximate entropy (ApEn) of CP dispersion during the response phase of a perturbed postural control task on a swaying platform. Secondary outcomes were segment excursions and clinical outcome correlates for pain and function. Non-parametric tests for group comparison with P-adjustment for multiple comparisons were conducted. Principal component analysis was applied to identify patterns of segmental contribution in both groups. CNLBP and CG performed similarly with respect to the primary outcomes. Comparison of joint kinematics revealed significant differences of hip (P < .001) and neck (P < .025) angular excursion, representing medium to large group effects (r's = .36 - .51). Significant (P's < .05), but moderate correlations of ApEn (r = -.42) and UI (r = -.46) with the health-related outcomes were observed. These findings lend further support to the notion that averaged linear outcomes do not suffice to describe subtle postural differences in CNLBP patients with low to moderate pain status.

Mobile-based intervention intended to stop obesity in preschool-aged children: the MINISTOP randomized controlled trial.

PubMed

Nyström, Christine Delisle; Sandin, Sven; Henriksson, Pontus; Henriksson, Hanna; Trolle-Lagerros, Ylva; Larsson, Christel; Maddison, Ralph; Ortega, Francisco B; Pomeroy, Jeremy; Ruiz, Jonatan R; Silfvernagel, Kristin; Timpka, Toomas; Löf, Marie

2017-06-01

Background: Traditional obesity prevention programs are time- and cost-intensive. Mobile phone technology has been successful in changing behaviors and managing weight; however, to our knowledge, its potential in young children has yet to be examined. Objective: We assessed the effectiveness of a mobile health (mHealth) obesity prevention program on body fat, dietary habits, and physical activity in healthy Swedish children aged 4.5 y. Design: From 2014 to 2015, 315 children were randomly assigned to an intervention or control group. Parents in the intervention group received a 6-mo mHealth program. The primary outcome was fat mass index (FMI), whereas the secondary outcomes were intakes of fruits, vegetables, candy, and sweetened beverages and time spent sedentary and in moderate-to-vigorous physical activity. Composite scores for the primary and secondary outcomes were computed. Results: No statistically significant intervention effect was observed for FMI between the intervention and control group (mean ± SD: -0.23 ± 0.56 compared with -0.20 ± 0.49 kg/m 2 ). However, the intervention group increased their mean composite score from baseline to follow-up, whereas the control group did not (+0.36 ± 1.47 compared with -0.06 ± 1.33 units; P = 0.021). This improvement was more pronounced among the children with an FMI above the median (4.11 kg/m 2 ) ( P = 0.019). The odds of increasing the composite score for the 6 dietary and physical activity behaviors were 99% higher for the intervention group than the control group ( P = 0.008). Conclusions: This mHealth obesity prevention study in preschool-aged children found no difference between the intervention and control group for FMI. However, the intervention group showed a considerably higher postintervention composite score (a secondary outcome) than the control group, especially in children with a higher FMI. Further studies targeting specific obesity classes within preschool-aged children are warranted. This trial was registered at clinicaltrials.gov as NCT02021786. © 2017 American Society for Nutrition.

Impact of early postoperative enteral nutrition on clinical outcomes in patients with gastric cancer.

PubMed

Li, B; Liu, H Y; Guo, S H; Sun, P; Gong, F M; Jia, B Q

2015-06-29

The impact of early enteral nutrition (EEN) on clinical outcomes of gastric cancer patients was investigated. Three hundred pa-tients undergoing gastric cancer surgery from July 2010 to May 2014 were randomly divided into experimental and control groups (n = 150/group). Experimental group patients received enteral nutrition in water during the early postoperative period. Control group patients received conventional perioperative treatment. Patients' clinical outcomes, post-operative immune function, and nutritional statuses were compared, which revealed that the postoperative fever duration (80.2 ± 6.0 vs 88.1 ± 8.1 h, P < 0.05), anal exhaust time (78.8 ± 9.3 vs 85.3 ± 8.4 h, P < 0.05), and length of hospitalization (7.73 ± 2.13 vs 9.77 ± 1.76 days, P < 0.01) differed significantly. Treatment costs in thousands of dol-lars were 31.24 ± 3.21 for the experimental group and 35.61 ± 2.32 for the control group; this difference was statistically significant (P < 0.01). The incidence of postoperative complications did not significantly differ between the experimental and control groups [14.0% (21/150) vs 17.3% (26/150), P > 0.05]. At postoperative days 3 and 7, the CD3(+), CD4(+), natural killer cell, albumin, and prealbumin levels and CD4(+)/CD8(+) ra-tio were significantly higher in the experimental group than the control group (all P < 0.05). CD8(+) cell counts were significantly lower in the experimental group than the control group (P < 0.05). Postsurgical oral EEN can improve nutritional status and immune function and promote early recovery of intestinal function in patients with gastric cancer.

Substance use outcomes 5½ years past baseline for partnership-based, family-school preventive interventions

PubMed Central

Spoth, Richard L.; Randall, G. Kevin; Trudeau, Linda; Shin, Chungyeol; Redmond, Cleve

2008-01-01

This article reports adolescent substance use outcomes of universal family and school preventive interventions 5½ years past baseline. Participants were 1677 7th grade students from schools (N = 36) randomly assigned to the school-based Life Skills Training plus the Strengthening Families Program: For Parents and Youth 10–14 (LST + SFP 10–14), LST-alone, or a control condition. Self-reports were collected at baseline, 6 months later following the interventions, then yearly through the 12th grade. Measures included initiation—alcohol, cigarette, marijuana, and drunkenness, along with a Substance Initiation Index (SII)—and measures of more serious use—frequency of alcohol, cigarette, and marijuana use, drunkenness frequency, monthly poly-substance use, and advanced poly-substance use. Analyses ruled out differential attrition. For all substance initiation outcomes, one or both intervention groups showed significant, positive point-in-time differences at 12th grade and/or significant growth trajectory outcomes when compared with the control group. Although no main effects for the more serious substance use outcomes were observed, a higher-risk subsample demonstrated significant, positive 12th grade point-in-time and/or growth trajectory outcomes for one or both intervention groups on all measures. The observed pattern of results likely reflects a combination of predispositions of the higher-risk subsample, the timing of the interventions, and baseline differences between experimental conditions favoring the control group. PMID:18434045

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

PubMed Central

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

Effect of Dexmedetomidine on Mortality and Ventilator-Free Days in Patients Requiring Mechanical Ventilation With Sepsis

PubMed Central

Kawazoe, Yu; Miyamoto, Kyohei; Morimoto, Takeshi; Yamamoto, Tomonori; Fuke, Akihiro; Hashimoto, Atsunori; Koami, Hiroyuki; Beppu, Satoru; Katayama, Yoichi; Itoh, Makoto; Ohta, Yoshinori

2017-01-01

Importance Dexmedetomidine provides sedation for patients undergoing ventilation; however, its effects on mortality and ventilator-free days have not been well studied among patients with sepsis. Objectives To examine whether a sedation strategy with dexmedetomidine can improve clinical outcomes in patients with sepsis undergoing ventilation. Design, Setting, and Participants Open-label, multicenter randomized clinical trial conducted at 8 intensive care units in Japan from February 2013 until January 2016 among 201 consecutive adult patients with sepsis requiring mechanical ventilation for at least 24 hours. Interventions Patients were randomized to receive either sedation with dexmedetomidine (n = 100) or sedation without dexmedetomidine (control group; n = 101). Other agents used in both groups were fentanyl, propofol, and midazolam. Main Outcomes and Measures The co–primary outcomes were mortality and ventilator-free days (over a 28-day duration). Sequential Organ Failure Assessment score (days 1, 2, 4, 6, 8), sedation control, occurrence of delirium and coma, intensive care unit stay duration, renal function, inflammation, and nutrition state were assessed as secondary outcomes. Results Of the 203 screened patients, 201 were randomized. The mean age was 69 years (SD, 14 years); 63% were male. Mortality at 28 days was not significantly different in the dexmedetomidine group vs the control group (19 patients [22.8%] vs 28 patients [30.8%]; hazard ratio, 0.69; 95% CI, 0.38-1.22; P = .20). Ventilator-free days over 28 days were not significantly different between groups (dexmedetomidine group: median, 20 [interquartile range, 5-24] days; control group: median, 18 [interquartile range, 0.5-23] days; P = .20). The dexmedetomidine group had a significantly higher rate of well-controlled sedation during mechanical ventilation (range, 17%-58% vs 20%-39%; P = .01); other outcomes were not significantly different between groups. Adverse events occurred in 8 (8%) and 3 (3%) patients in the dexmedetomidine and control groups, respectively. Conclusions and Relevance Among patients requiring mechanical ventilation, the use of dexmedetomidine compared with no dexmedetomidine did not result in statistically significant improvement in mortality or ventilator-free days. However, the study may have been underpowered for mortality, and additional research may be needed to evaluate this further. Trial Registration clinicaltrials.gov Identifier: NCT01760967 PMID:28322414

Cognitive Training and Transcranial Direct Current Stimulation for Mild Cognitive Impairment in Parkinson's Disease: A Randomized Controlled Trial

PubMed Central

Gasson, Natalie; Johnson, Andrew R.; Booth, Leon; Loftus, Andrea M.

2018-01-01

This study examined whether standard cognitive training, tailored cognitive training, transcranial direct current stimulation (tDCS), standard cognitive training + tDCS, or tailored cognitive training + tDCS improved cognitive function and functional outcomes in participants with PD and mild cognitive impairment (PD-MCI). Forty-two participants with PD-MCI were randomized to one of six groups: (1) standard cognitive training, (2) tailored cognitive training, (3) tDCS, (4) standard cognitive training + tDCS, (5) tailored cognitive training + tDCS, or (6) a control group. Interventions lasted 4 weeks, with cognitive and functional outcomes measured at baseline, post-intervention, and follow-up. The trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR: 12614001039673). While controlling for moderator variables, Generalized Linear Mixed Models (GLMMs) showed that when compared to the control group, the intervention groups demonstrated variable statistically significant improvements across executive function, attention/working memory, memory, language, activities of daily living (ADL), and quality of life (QOL; Hedge's g range = 0.01 to 1.75). More outcomes improved for the groups that received standard or tailored cognitive training combined with tDCS. Participants with PD-MCI receiving cognitive training (standard or tailored) or tDCS demonstrated significant improvements on cognitive and functional outcomes, and combining these interventions provided greater therapeutic effects. PMID:29780572

Effect of peer education on stroke prevention: the prevent recurrence of all inner-city strokes through education randomized controlled trial.

PubMed

Kronish, Ian M; Goldfinger, Judith Z; Negron, Rennie; Fei, Kezhen; Tuhrim, Stanley; Arniella, Guedy; Horowitz, Carol R

2014-11-01

Efforts to reduce disparities in recurrent stroke among Black and Latino stroke survivors have met with limited success. We aimed to determine the effect of peer education on secondary stroke prevention among predominantly minority stroke survivors. Between 2009 and 2012, we enrolled 600 stroke or transient ischemic attack survivors from diverse, low-income communities in New York City into a 2-arm randomized clinical trial that compared a 6 week (1 session/week), peer-led, community-based, stroke prevention self-management group workshop (N=301) to a wait-list control group (N=299). The primary outcome was the proportion with a composite of controlled blood pressure (<140/90 mm Hg), low-density lipoprotein cholesterol <100 mg/dL, and use of antithrombotic medications at 6 months. Secondary outcomes included control of the individual stroke risk factors. All analyses were by intent-to-treat. There was no difference in the proportion of intervention and control group participants achieving the composite outcome (34% versus 34%; P=0.98). The proportion with controlled blood pressure at 6 months was greater in the intervention group than in the control group (76% versus 67%; P=0.02). This corresponded to a greater change in systolic blood pressure in the intervention versus control group (-3.63 SD, 19.81 mm Hg versus +0.34 SD, 23.76 mm Hg; P=0.04). There were no group differences in the control of cholesterol or use of antithrombotics. A low-cost peer education self-management workshop modestly improved blood pressure, but not low-density lipoprotein cholesterol or antithrombotic use, among stroke and transient ischemic attack survivors from vulnerable, predominantly minority urban communities. http://www.clinicaltrials.gov/show/NCT0102727. Unique identifier: NCT01027273. © 2014 American Heart Association, Inc.

Exercise and manual physiotherapy arthritis research trial (EMPART) for osteoarthritis of the hip: a multicenter randomized controlled trial.

PubMed

French, Helen P; Cusack, Tara; Brennan, Aisling; Caffrey, Aoife; Conroy, Ronán; Cuddy, Vanessa; FitzGerald, Oliver M; Fitzpatrick, Martina; Gilsenan, Clare; Kane, David; O'Connell, Paul G; White, Breon; McCarthy, Geraldine M

2013-02-01

To determine the effectiveness of exercise therapy (ET) compared with ET with adjunctive manual therapy (MT) for people with hip osteoarthritis (OA); and to identify if immediate commencement of treatment (ET or ET+MT) was more beneficial than a 9-week waiting period for either intervention. Assessor-blind randomized controlled trial with a 9-week and 18-week follow-up. Four academic teaching hospitals in Dublin, Ireland. Patients (N=131) with hip OA recruited from general practitioners, rheumatologists, orthopedic surgeons, and other hospital consultants were randomized to 1 of 3 groups: ET (n=45), ET+MT (n=43), and waitlist controls (n=43). Participants in both the ET and ET+MT groups received up to 8 treatments over 8 weeks. Control group participants were rerandomized into either ET or ET+MT groups after 9 week follow-up. Their data were pooled with original treatment group data: ET (n=66) and ET+MT (n=65). The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function (PF) subscale. Secondary outcomes included physical performance, pain severity, hip range of motion (ROM), anxiety/depression, quality of life, medication usage, patient-perceived change, and patient satisfaction. There was no significant difference in WOMAC PF between the ET (n=66) and ET+MT (n=65) groups at 9 weeks (mean difference, .09; 95% confidence interval [CI] -2.93 to 3.11) or 18 weeks (mean difference, .42; 95% CI, -4.41 to 5.25), or between other outcomes, except patient satisfaction with outcomes, which was higher in the ET+MT group (P=.02). Improvements in WOMAC, hip ROM, and patient-perceived change occurred in both treatment groups compared with the control group. Self-reported function, hip ROM, and patient-perceived improvement occurred after an 8-week program of ET for patients with OA of the hip. MT as an adjunct to exercise provided no further benefit, except for higher patient satisfaction with outcome. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Effect of immune-enhancing diets on the outcomes of patients after major burns

PubMed Central

Mahmoud, W.H..; Mostafa, W.; Abdel-Khalek, A.H.; Shalaby, H.

2014-01-01

Summary The use of immune-enhancing diets (IEDs) has been shown to be beneficial in some categories of critically ill patients. This study aimed to evaluate the effect of early enteral feeding supplemented with glutamine and omega-3 fatty acids, as immune-enhancing diets, on the outcomes of patients after major burns. Forty thermally injured adult patients with 30-50% total body surface area (TBSA) burns, including deep areas ranging from 5-20%, were randomized into a prospective, double-blind, controlled clinical trial. They were placed into two equal groups: group A (IED group), in which patients received early enteral feeding supplemented with glutamine and omega-3 fatty acids as immune-enhancing diets; and group B (control group), in which patients received early enteral feeding not supplemented with immune-enhancing diets. Laboratory assessment of serum albumin, serum C-reactive protein, total lymphocytic count and serum immunoglobulins (IgA, IgG and IgM) was performed at admission, and on days 4, 7 and 14. Finally, outcomes were assessed by monitoring the survival rate, the length of hospital stay and the incidence of infection. There were no significant differences between the IED and control group regarding age (28.7±5.32 versus 29.85±5.94), sex, weight, %TBSA (37.75±4.4 versus 38.3±4.84) and %burn depth (11.7±2.36 versus 10.7±2.036). The incidence of infection (2 versus 8) and the length of hospital stay (16.3±0.92 days versus 17.95±2.96 days) were decreased significantly in the IED group versus the control group. There was no significant difference between the survival rates in both groups as there was only one death in the control group. Thanks to IEDs, patient outcome was improved and infectious morbidity and length of hospital stay were reduced, but there was no effect on the survival rates following major burns. PMID:26336366

A randomised, controlled trial of circumpatellar electrocautery in total knee replacement without patellar resurfacing.

PubMed

van Jonbergen, H P W; Scholtes, V A B; van Kampen, A; Poolman, R W

2011-08-01

The efficacy of circumpatellar electrocautery in reducing the incidence of post-operative anterior knee pain is unknown. We conducted a single-centre, outcome-assessor and patient-blinded, parallel-group, randomised, controlled trial to compare circumpatellar electrocautery with no electrocautery in total knee replacement in the absence of patellar resurfacing. Patients requiring knee replacement for primary osteoarthritis were randomly assigned circumpatellar electrocautery (intervention group) or no electrocautery (control group). The primary outcome measure was the incidence of anterior knee pain. A secondary measure was the standardised clinical and patient-reported outcomes determined by the American Knee Society scores and the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. A total of 131 knees received circumpatellar electrocautery and 131 had no electrocautery. The overall incidence of anterior knee pain at follow-up at one year was 26% (20% to 31%), with 19% (12% to 26%) in the intervention group and 32% (24% to 40%) in the control group (p = 0.02). The relative risk reduction from electrocautery was 40% (9% to 61%) and the number needed to treat was 7.7 (4.3 to 41.4). The intervention group had a better mean total WOMAC score at follow-up at one year compared with the control group (16.3 (0 to 77.7) versus 21.6 (0 to 76.7), p = 0.04). The mean post-operative American Knee Society knee scores and function scores were similar in the intervention and control groups (knee score: 92.4 (55 to 100) versus 90.4 (51 to 100), respectively (p = 0.14); function score: 86.5 (15 to 100) versus 84.5 (30 to 100), respectively (p = 0.49)). Our study suggests that in the absence of patellar resurfacing electrocautery around the margin of the patella improves the outcome of total knee replacement.

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD

PubMed Central

Moy, Marilyn L.; Collins, Riley J.; Martinez, Carlos H.; Kadri, Reema; Roman, Pia; Holleman, Robert G.; Kim, Hyungjin Myra; Nguyen, Huong Q.; Cohen, Miriam D.; Goodrich, David E.; Giardino, Nicholas D.

2015-01-01

BACKGROUND: Low levels of physical activity (PA) are associated with poor outcomes in people with COPD. Interventions to increase PA could improve outcomes. METHODS: We tested the efficacy of a novel Internet-mediated, pedometer-based exercise intervention. Veterans with COPD (N = 239) were randomized in a 2:1 ratio to the (1) intervention group (Omron HJ-720 ITC pedometer and Internet-mediated program) or (2) wait-list control group (pedometer). The primary outcome was health-related quality of life (HRQL), assessed by the St. George’s Respiratory Questionnaire (SGRQ), at 4 months. We examined the SGRQ total score (SGRQ-TS) and three domain scores: Symptoms, Activities, and Impact. The secondary outcome was daily step counts. Linear regression models assessed the effect of intervention on outcomes. RESULTS: Participants had a mean age of 67 ± 9 years, and 94% were men. There was no significant between-group difference in mean 4-month SGRQ-TS (2.3 units, P = .14). Nevertheless, a significantly greater proportion of intervention participants than control subjects had at least a 4-unit improvement in SGRQ-TS, the minimum clinically important difference (53% vs 39%, respectively, P = .05). For domain scores, the intervention group had a lower (reflecting better HRQL) mean than the control group by 4.6 units for Symptoms (P = .046) and by 3.3 units for Impact (P = .049). There was no significant difference in Activities score between the two groups. Compared with the control subjects, intervention participants walked 779 more steps per day at 4 months (P = .005). CONCLUSIONS: An Internet-mediated, pedometer-based walking program can improve domains of HRQL and daily step counts at 4 months in people with COPD. TRIAL REGISTRY: Clinical Trials.gov; No.: NCT01102777; URL: www.clinicaltrials.gov PMID:25811395

Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

PubMed

Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

2014-02-01

Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

Air versus ground transport of the major trauma patient: a natural experiment.

PubMed

McVey, Jennifer; Petrie, David A; Tallon, John M

2010-01-01

1) To compare the outcomes of adult trauma patients transported to a level I trauma center by helicopter vs. ground ambulance. 2) To determine whether using a unique "natural experiment" design to obtain the ground comparison group will reduce potential confounders. Outcomes in adult trauma patients transported to a tertiary care trauma center by air were compared with outcomes in a group of patients who were accepted by the online medical control physician for air transport, but whose air missions were aborted for aviation reasons (weather, maintenance, out on a mission); these patients were subsequently transported by ground ambulance instead. Outcomes were also analyzed for a third ground control group composed of all other adult trauma patients transported by ground during this time period. Data were collected by retrospective database review of trauma patients transferred between July 1, 1997, and June 30, 2003. Outcomes were measured by Trauma Injury Severity Score (TRISS) analysis. Z and W scores were calculated. Three hundred ninety-seven missions were flown by LifeFlight during the study period vs. 57 in the clinical accept-aviation abort ground transport group. The mean ages, gender distributions, mechanisms of injury, and Injury Severity Scores (ISSs) were similar in the two groups. Per 100 patients transported, 5.61 more lives were saved in the air group vs. the clinical accept-aviation abort ground transport group (Z = 3.37). As per TRISS analysis, this is relative to the expected mortality seen with a similar group in the Major Trauma Outcomes Study (MTOS). The Z score for the clinical accept-aviation abort ground transport group was 0.4. The 1,195 patients in the third all-other ground control group had a higher mean age, lower mean ISS, and worse outcomes according to TRISS analysis (W = -2.02). This unique natural experiment led to better matched air vs. ground cohorts for comparison. As per TRISS analysis, air transport of the adult major trauma patient is associated with significantly improved survival as compared with ground transport.

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

PubMed

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 (<3 months poststroke), who were enrolled in a stroke rehabilitation program. Patients participated in 2 separate intervention weeks. Each intervention week included 5 daily sessions of 45-minute word-finding therapy combined with either anodal 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.

Prospectively assessed clinical outcomes in concussive blast vs nonblast traumatic brain injury among evacuated US military personnel.

PubMed

Mac Donald, Christine L; Johnson, Ann M; Wierzechowski, Linda; Kassner, Elizabeth; Stewart, Theresa; Nelson, Elliot C; Werner, Nicole J; Zonies, David; Oh, John; Fang, Raymond; Brody, David L

2014-08-01

Blast injury has been identified as the signature injury in the conflicts in Iraq and Afghanistan. However it remains to be determined whether fundamental differences may exist between blast-related traumatic brain injury (TBI) and TBI due to other mechanisms. To determine similarities and differences between clinical outcomes in US military personnel with blast-related vs. non-blast-related concussive TBI and to identify the specific domains of impairment that best correlate with overall disability. Prospective cohort study involving active duty US Military personnel evacuated from Iraq or Afghanistan to Landstuhl Regional Medical Center, in Landstuhl, Germany. Four groups of participants were enrolled from 2010 to 2013: (1) blast plus impact complex TBI (n=53), (2) non-blast related TBI with injury due to other mechanisms (n=29), (3) blast-exposed controls evacuated for other medical reasons (n=27) (4) non-blast-exposed controls evacuated for other medical reasons (n=69). All patients with TBI met Department of Defense criteria for concussive (mild) TBI. The study participants were evaluated 6-12 months after injury at Washington University in St Louis. In total, 255 subjects were enrolled in the study, and 183 participated in follow-up evaluations, 5 of whom were disqualified. In-person clinical examinations included evaluation for overall disability, a standardized neurological exam, headache questionnaires, neuropsychological test battery, combat exposure and alcohol use surveys, and structured interview evaluations for post-traumatic stress disorder (PTSD) and depression. Global outcomes, headache severity, neuropsychological performance, and surprisingly even PTSD severity and depression were indistinguishable between the two TBI groups, independent of mechanism of injury. Both TBI groups had higher rates of moderate to severe overall disability than the respective control groups: 41/53 (77%) of blast plus impact TBI and 23/29 (79%) of nonblast TBI vs. 16/27 (59%) of blast-exposed controls and 28/69 (41%) of non-blast-exposed controls. In addition, blast-exposed controls had worse headaches and more severe PTSD than non-blast-exposed controls. Self-reported combat exposure intensity was higher in the blast plus impact TBI group than in nonblast TBI group and was higher in blast-exposed controls than in non-blast-exposed controls. However, combat exposure intensity did not correlate with PTSD severity in the TBI groups, but a modest positive correlation was observed in the controls. Overall outcomes were most strongly correlated with depression, headache severity, and number of abnormalities on neuropsychological testing. However a substantial fraction of the variance in overall outcome was not explained by any of the assessed measures. One potential interpretation of these results is that TBI itself, independent of injury mechanism and combat exposure intensity, is a primary driver of adverse outcomes. Many other important factors may be as yet unmeasured, and adverse outcomes following war-time injuries are difficult to fully explain. clinicaltrials.gov Identifier: NCT01313130.

Comparing type 1 and type 2 diabetes in pregnancy- similar conditions or is a separate approach required?

PubMed

Owens, Lisa A; Sedar, Jon; Carmody, Louise; Dunne, Fidelma

2015-03-27

Pregnancy in women with type 1 (T1DM) or type 2 diabetes (T2DM) is associated with increased risk. These conditions are managed similarly during pregnancy, and compared directly in analyses, however they affect women of different age, body mass index and ethnicity. We assess if differences exist in pregnancy outcomes between T1DM and T2DM by comparing them directly and with matched controls. We also analyze the effect of glycemic control on pregnancy outcomes and analyze predictive variables for poor outcome. We include 323 women with diabetes and 660 glucose-tolerant controls. T2DM women had higher BMI, age and parity with a shorter duration of diabetes and better glycemic control. Preeclampsia occurred more in women with T1DM only. Rates of elective cesarean section were similar between groups but greater than in controls, emergency cesarean section was increased in women with type 1 diabetes. Maternal morbidity in T1DM was double that of matched controls but T2DM was similar to controls. Babies of mothers with diabetes were more likely to be delivered prematurely. Neonatal hypoglycemia occurred more in T1DM than T2DM and contributed to a higher rate of admission to neonatal intensive care for both groups. Adverse neonatal outcomes including stillbirths and congenital abnormalities were seen in both groups but were more common in T1DM pregnancies. HbA1C values at which these poor outcomes occurred differed between T1 and T2DM. Pregnancy outcomes in T1DM and T2DM are different and occur at different levels of glycemia. This should be considered when planning and managing pregnancy and when counseling women.

Nifedipine versus atosiban for threatened preterm birth (APOSTEL III): a multicentre, randomised controlled trial.

PubMed

van Vliet, Elvira O G; Nijman, Tobias A J; Schuit, Ewoud; Heida, Karst Y; Opmeer, Brent C; Kok, Marjolein; Gyselaers, Wilfried; Porath, Martina M; Woiski, Mallory; Bax, Caroline J; Bloemenkamp, Kitty W M; Scheepers, Hubertina C J; Jacquemyn, Yves; Beek, Erik van; Duvekot, Johannes J; Franssen, Maureen T M; Papatsonis, Dimitri N; Kok, Joke H; van der Post, Joris A M; Franx, Arie; Mol, Ben W; Oudijk, Martijn A

2016-05-21

In women with threatened preterm birth, delay of delivery by 48 h allows antenatal corticosteroids to improve neonatal outcomes. For this reason, tocolytics are often administered for 48 h; however, there is no consensus about which drug results in the best maternal and neonatal outcomes. In the APOSTEL III trial we aimed to compare the effectiveness and safety of the calcium-channel blocker nifedipine and the oxytocin inhibitor atosiban in women with threatened preterm birth. We did this multicentre, randomised controlled trial in ten tertiary and nine teaching hospitals in the Netherlands and Belgium. Women with threatened preterm birth (gestational age 25-34 weeks) were randomly assigned (1:1) to either oral nifedipine or intravenous atosiban for 48 h. An independent data manager used a web-based computerised programme to randomly assign women in permuted block sizes of four, with groups stratified by centre. Clinicians, outcome assessors, and women were not masked to treatment group. The primary outcome was a composite of adverse perinatal outcomes, which included perinatal mortality, bronchopulmonary dysplasia, sepsis, intraventricular haemorrhage, periventricular leukomalacia, and necrotising enterocolitis. Analysis was done in all women and babies with follow-up data. The study is registered at the Dutch Clinical Trial Registry, number NTR2947. Between July 6, 2011, and July 7, 2014, we randomly assigned 254 women to nifedipine and 256 to atosiban. Primary outcome data were available for 248 women and 297 babies in the nifedipine group and 255 women and 294 babies in the atosiban group. The primary outcome occurred in 42 babies (14%) in the nifedipine group and in 45 (15%) in the atosiban group (relative risk [RR] 0·91, 95% CI 0·61-1·37). 16 (5%) babies died in the nifedipine group and seven (2%) died in the atosiban group (RR 2·20, 95% CI 0·91-5·33); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups. In women with threatened preterm birth, 48 h of tocolysis with nifedipine or atosiban results in similar perinatal outcomes. Future clinical research should focus on large placebo-controlled trials, powered for perinatal outcomes. ZonMw (the Netherlands Organisation for Health Research and Development). Copyright © 2016 Elsevier Ltd. All rights reserved.

The impact of endometriosis on the outcome of Assisted Reproductive Technology.

PubMed

González-Comadran, Mireia; Schwarze, Juan Enrique; Zegers-Hochschild, Fernando; Souza, Maria do Carmo B; Carreras, Ramon; Checa, Miguel Ángel

2017-01-24

Endometriosis has been described to impair fertility through various mechanisms. However, studies evaluating the reproductive outcomes of women undergoing assisted reproductive technologies show controversial results. The aim of this study is to assess whether the reproductive outcome is impaired among women with endometriosis-associated infertility undergoing IVF. A retrospective cohort study was performed, including women undergoing IVF reported by the Red Latinoamericana de Reproduccion Asistida (Redlara) registry, between January 2010 and December 2012. The study group included women with endometriosis-associated infertility, and the control group women with tubal factor, endocrine disorders or unexplained infertility. Women above 40 years, severe male factor and premature ovarian failure were excluded. The reproductive outcomes of between both groups were compared. The primary outcome was live birth. Secondary outcomes included clinical pregnancy, miscarriage, number of oocytes retrieved and number of fertilized oocytes. Outcomes were assessed after the first fresh IVF cycle, and were adjusted for age and number of embryos transferred. A total of 22.416 women were included (3.583 with endometriosis and 18.833 in the control group). Mean age of patients in the endometriosis group and control group was 34.86 (3.47) and 34.61 (3.91) respectively, p = 0.000. The mean number of oocytes retrieved were 8.89 (6.23) and 9.86 (7.02) respectively, p = 0.000. No significant differences were observed between groups in terms of live birth (odds ratio (OR) 1.032, p = 0.556), clinical pregnancy (OR 1.044, p = 0.428) and miscarriage rates (OR 1.049, p = 0.623). Women with endometriosis had significantly lower number of oocytes retrieved (incidence risk ratio (IRR) 0.917, 95% CI 0.895-0.940), however, the number of fertilized oocytes did not differ among the two groups when adjusting for the number of oocytes retrieved (IRR 1.003, p = 0.794). An age-stratified analysis was performed, and no differences were observed in the reproductive outcomes between groups for women aged under 35 and 35 to 40. Reproductive outcomes among women undergoing IVF and diagnosed with endometriosis-associated infertility do not differ significantly from women without the disease. Although women with endometriosis generate fewer oocytes, fertilization rate is not impaired and the likelihood of achieving a live birth is also not affected.

Infarction of Uterine Fibroids After Embolization: Relationship Between Postprocedural Enhanced MRI Findings and Long-Term Clinical Outcomes

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

Katsumori, Tetsuya, E-mail: katsumo@eurus.dti.ne.jp; Kasahara, Toshiyuki; Kin, Yoko

2008-01-15

Purpose. To retrospectively evaluate the relationship between the degree of infarction of uterine fibroids on enhanced MRI after embolization and long-term clinical outcomes. Methods. During 92 months, 290 consecutive patients with symptomatic uterine fibroids were treated with embolization; 221 who underwent enhanced MRI before embolization and 1 week after embolization were included in this study. The infarction rates of all fibroid tissue were assessed using enhanced MRI after embolization. Patients were divided into three groups according to the infarction rates: group A (100% infarction, n 142), group B (90-99% infarction, n = 74), group C (<90% infarction, n = 5).more » The cumulative rates of clinical outcomes were compared among groups using the Kaplan-Meier limited method. Results. Group A had a significantly higher rate of symptom control than groups B and C. The cumulative rates of symptom control at 5 years were 93%, 71%, and 60% in groups A, B, and C, respectively. Group A had a significantly lower rate of gynecologic intervention after embolization than groups B and C. The cumulative rates of additional gynecologic intervention at 5 years were 3%, 15%, and 20% in groups A, B, and C, respectively. Conclusions. The degree of infarction of uterine fibroids after embolization on enhanced MRI was related to long-term clinical outcomes. Complete infarction of all fibroid tissue can induce a higher rate of symptom control, with a lower rate of additional gynecologic intervention in the long term compared with incomplete infarction of fibroid tissue.« less

Effects of postexercise ice-water and room-temperature water immersion on the sensory organization of balance control and lower limb proprioception in amateur rugby players: A randomized controlled trial.

PubMed

Chow, Gary C C; Yam, Timothy T T; Chung, Joanne W Y; Fong, Shirley S M

2017-02-01

This single-blinded, three-armed randomized controlled trial aimed to compare the effects of postexercise ice-water immersion (IWI), room-temperature water immersion (RWI), and no water immersion on the balance performance and knee joint proprioception of amateur rugby players. Fifty-three eligible amateur rugby players (mean age ± standard deviation: 21.6 ± 2.9 years) were randomly assigned to the IWI group (5.3 °C), RWI group (25.0 °C), or the no immersion control group. The participants in each group underwent the same fatigue protocol followed by their allocated recovery intervention, which lasted for 1 minute. Measurements were taken before and after the fatigue-recovery intervention. The primary outcomes were the sensory organization test (SOT) composite equilibrium score (ES) and the condition-specific ES, which were measured using a computerized dynamic posturography machine. The secondary outcome was the knee joint repositioning error. Two-way repeated measures analysis of variance was used to test the effect of water immersion on each outcome variable. There were no significant within- and between-group differences in the SOT composite ESs or the condition-specific ESs. However, there was a group-by-time interaction effect on the knee joint repositioning error. It seems that participants in the RWI group had lower errors over time, but those in the IWI and control groups had increased errors over time. The RWI group had significantly lower error score than the IWI group at postintervention. One minute of postexercise IWI or RWI did not impair rugby players' sensory organization of balance control. RWI had a less detrimental effect on knee joint proprioception to IWI at postintervention.

Can research assessments themselves cause bias in behaviour change trials? A systematic review of evidence from solomon 4-group studies.

PubMed

McCambridge, Jim; Butor-Bhavsar, Kaanan; Witton, John; Elbourne, Diana

2011-01-01

The possible effects of research assessments on participant behaviour have attracted research interest, especially in studies with behavioural interventions and/or outcomes. Assessments may introduce bias in randomised controlled trials by altering receptivity to intervention in experimental groups and differentially impacting on the behaviour of control groups. In a Solomon 4-group design, participants are randomly allocated to one of four arms: (1) assessed experimental group; (2) unassessed experimental group (3) assessed control group; or (4) unassessed control group. This design provides a test of the internal validity of effect sizes obtained in conventional two-group trials by controlling for the effects of baseline assessment, and assessing interactions between the intervention and baseline assessment. The aim of this systematic review is to evaluate evidence from Solomon 4-group studies with behavioural outcomes that baseline research assessments themselves can introduce bias into trials. Electronic databases were searched, supplemented by citation searching. Studies were eligible if they reported appropriately analysed results in peer-reviewed journals and used Solomon 4-group designs in non-laboratory settings with behavioural outcome measures and sample sizes of 20 per group or greater. Ten studies from a range of applied areas were included. There was inconsistent evidence of main effects of assessment, sparse evidence of interactions with behavioural interventions, and a lack of convincing data in relation to the research question for this review. There were too few high quality completed studies to infer conclusively that biases stemming from baseline research assessments do or do not exist. There is, therefore a need for new rigorous Solomon 4-group studies that are purposively designed to evaluate the potential for research assessments to cause bias in behaviour change trials.

Effects on employees of controlling working hours and working schedules.

PubMed

Kubo, T; Takahashi, M; Togo, F; Liu, X; Shimazu, A; Tanaka, K; Takaya, M

2013-03-01

High levels of control over working time and low variability in working hours have been associated with improved health-related outcomes. The potential mechanisms for this association remain unclear. To examine how work-time control and variability of working times are associated with fatigue recovery, sleep quality, work-life balance, and 'near misses' at work. Manufacturing sector employees completed a questionnaire that assessed work-time control, work-time variability, fatigue recovery, sleep quality, work-life balance and the frequency of near misses in the past 6 months. Mixed model analysis of covariance and multiple logistic regression analysis tested the main effects of work-time control and variability and their interaction, while adjusting for age, sex, work schedules, and overtime work in the past month. Subscales of work-time control were also investigated (control over daily working hours and over days off). One thousand three hundred and seventy-two completed questionnaires were returned, a response rate of 69%. A significantly higher quality of sleep and better work-life balance were found in the 'high control with low variability' reference group than in the other groups. Significantly better recovery of fatigue was also observed in the group having control over days off with low variability. While near misses were more frequent in the group with high control over daily working hours coupled with high variability compared with the reference group this was not significant. High work-time control and low variability were associated with favourable outcomes of health and work-life balance. This combined effect was not observed for the safety outcome addressed here.

Comparison of epidemiology and outcomes of arthroscopic rotator cuff repair for anterosuperior and posterosuperior rotator cuff tears.

PubMed

Teratani, Takeshi

2017-12-01

The purpose of this study was to investigate the prevalence, epidemiology, and outcomes of anterosuperior (A group) rotator cuff tears (RCTs) and posterosuperior (P group) RCTs treated by arthroscopic rotator cuff repair (ARCR). A total of 67 A group patients and 14 P group patients were included in the study. The prevalence of the A group (82.3%) was significantly higher than that of the P group (17.7%). The outcomes in both groups were good, even though the A group had a higher rate of injury to the LHB than the P group. Level III, case-control Study, treatment study.

Ultrasound-Guided Intratendinous Injections With Platelet-Rich Plasma or Autologous Whole Blood for Treatment of Proximal Hamstring Tendinopathy: A Double-Blind Randomized Controlled Trial.

PubMed

Davenport, Kathleen L; Campos, Jose Santiago; Nguyen, Joseph; Saboeiro, Gregory; Adler, Ronald S; Moley, Peter J

2015-08-01

To compare the effects of ultrasound-guided platelet-rich plasma (PRP) and whole blood (WB) injections in patients with chronic hamstring tendinopathy. In a prospective double-blind randomized controlled trial, PRP or WB was injected under ultrasound guidance into the proximal hamstring tendon in a cohort of patients with clinically suspected hamstring tendinosis. Questionnaires were administered before injection and 2, 6, and 12 weeks and 6 months after injection. Pain and function outcomes were measured via the Modified Harris Hip Score (MHHS), Hip Outcome Scores for activities of daily living (ADL) and sport-specific function, and International Hip Outcome Tool 33 (IHOT-33). Diagnostic ultrasound was used to compare preinjection and 6-month postinjection tendon appearances. The WB group showed greater improvements in pain and function over the PRP group before 12 weeks, whereas the PRP group showed improved outcomes over WB at 6 months. None of these between-group outcome measures, except 6-week IHOT-33, showed statistical significance. Comparing preinjection and 6-month scores, the PRP group showed significant improvements in ADL (P = .018) and IHOT-33 (P = .28) scores, whereas the WB group showed no significant improvements from baseline. The WB group showed significantly decreased pain with 15-minute sitting (P= .008) at 6 months. Ultrasound imaging showed no significant differences between PRP and WB group tendon appearances. Both PRP and WB groups showed improvements in all outcome measures at 6 months. The PRP group showed significant improvements in 6-month ADL and IHOT-33 scores. The WB group reached significance in 15-minute sitting pain. No significant between-group differences were observed at any time point. © 2015 by the American Institute of Ultrasound in Medicine.

Maternal Voice and Short-Term Outcomes in Preterm Infants

PubMed Central

Krueger, Charlene; Parker, Leslie; Chiu, Sheau-Huey; Theriaque, Douglas

2013-01-01

This study explored effects of exposure to maternal voice on short-term outcomes in very low birth weight preterm infants cared for within an neonatal intensive care unit (NICU) without an ongoing program of developmental care. Using a comparative design, 53 infants born during their 27th to 28th postmenstrual week were sampled by convenience. Experimental groups were exposed to maternal voice during two developmental time periods. Group 1 listened to a recording of their mothers reciting a rhyme from 28 to 34 postmenstrual weeks. Group 2 waited 4 weeks and heard the recording from 32 to 34 weeks. The control group received routine care. The primary analysis of combined experimental groups compared to the control group revealed that the experimental infants experienced significantly fewer episodes of feeding intolerance and achieved full enteral feeds quicker compared to the control group. Further, in an analysis evaluating all three groups separately, it was noted that Group 1 experienced significantly fewer episodes of feeding intolerance compared to the control group. Study findings warrant further investigation of exposure to maternal voice and the developmental timing at which exposure is begun. PMID:20112262

Illness Beliefs, Treatment Beliefs and Information Needs as Starting Points for Patient Information: The Evaluation of an Intervention for Patients with Depression.

PubMed

Glattacker, Manuela; Heyduck, Katja; Meffert, Cornelia; Jakob, Teresa

2018-02-16

Patients with depression are often dissatisfied with disease- and therapy-related information. The objective of this study was to evaluate an intervention that applied the Common Sense Model to the provision of information during inpatient rehabilitation for patients with depression. The intervention was evaluated in a sequential control group design. Analyses of covariance were used to assess differences between the control and intervention groups. Changes with respect to illness and treatment beliefs (personal control, treatment control, coherence and concerns about medicines), satisfaction with information about medicines, illness and rehabilitation, and depressive burden were selected as primary outcome measures. We observed significant between-group differences indicating the intervention group's superiority in terms of satisfaction with information regarding medicines. However, the two groups' changes during rehabilitation did not differ in terms of the other outcomes. The intervention resulted in patients judging that their medication information needs had been more thoroughly fulfilled than those patients who received care-as-usual information. However, the intervention did not prove to be effective when the other outcome variables are considered. Taken together and bearing in mind the limitations of our study-particularly the non-randomised design-our results should be replicated in a randomised controlled trial.

Relationship of Depression, Sociopathy, and Locus of Control to Treatment Outcome in Alcoholics

ERIC Educational Resources Information Center

Caster, David U.; Parsons, Oscar A.

1977-01-01

Depression, sociopathy, and Levenson's tridimensional locus of control orientation were studied in four groups of veteran male alcoholics, who varied as to degree of benefit from therapeutic programs, and a group of controls. Higher depression scores were found in those groups that appeared to benefit less from treatment. (Author)

Group-based multimodal exercises integrated with cognitive-behavioural therapy improve disability, pain and quality of life of subjects with chronic neck pain: a randomized controlled trial with one-year follow-up.

PubMed

Monticone, Marco; Ambrosini, Emilia; Rocca, Barbara; Cazzaniga, Daniele; Liquori, Valentina; Pedrocchi, Alessandra; Vernon, Howard

2017-06-01

To evaluate the effect of a group-based multidisciplinary rehabilitation programme on disability, pain and quality of life in subjects with chronic neck pain. Randomized controlled trial. Specialized rehabilitation centre. A total of 170 patients (mean age of 53 years (13); 121 females). The multidisciplinary group underwent a multidisciplinary rehabilitation programme combining multimodal exercises with psychologist-lead cognitive-behavioural therapy sessions. The general exercise group underwent general physiotherapy. Both groups followed group-based programmes once a week for ten weeks. Additionally, the multidisciplinary group met with the psychologist once a week for a 60-minute session. The Neck Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, a pain numerical rating scale and the Short-Form Health Survey. The participants were evaluated before, after training and after 12 months. A linear mixed model for repeated measures was used for each outcome measure. Significant effects ( p-value <0.001) were found over time and between groups for all outcome measures. After training, significant improvements were found for both groups for all outcome measures except kinesiophobia and catastrophizing, which did not change in the control group; however, the improvements were significantly greater for the multidisciplinary group. At 12-month follow-up a clinically meaningful between-group difference of 12.4 Neck Disability Index points was found for disability. A group-based multidisciplinary rehabilitation programme including cognitive-behavioural therapy was superior to group-based general physiotherapy in improving disability, pain and quality of life of subjects with chronic neck pain. The effects lasted for at least one year.

A long-term outcome study of selective mutism in childhood.

PubMed

Steinhausen, Hans-Christoph; Wachter, Miriam; Laimböck, Karin; Metzke, Christa Winkler

2006-07-01

Controlled study of the long-term outcome of selective mutism (SM) in childhood. A sample of 33 young adults with SM in childhood and two age- and gender-matched comparison groups were studied. The latter comprised 26 young adults with anxiety disorders in childhood (ANX) and 30 young adults with no psychiatric disorders during childhood. The three groups were compared with regard to psychiatric disorder in young adulthood by use of the Composite International Diagnostic Interview (CIDI). In addition, the effect of various predictors on outcome of SM was studied. The symptoms of SM improved considerably in the entire SM sample. However, both SM and ANX had significantly higher rates for phobic disorder and any psychiatric disorder than controls at outcome. Taciturnity in the family and, by trend, immigrant status and a severity indicator of SM had an impact on psychopathology and symptomatic outcome in young adulthood. This first controlled long-term outcome study of SM provides evidence of symptomatic improvement of SM in young adulthood. However, a high rate of phobic disorder at outcome points to the fact that SM may be regarded as an anxiety disorder variant.

Can small group education and peer review improve care for patients with asthma/chronic obstructive pulmonary disease?

PubMed Central

Smeele, I. J.; Grol, R. P.; van Schayck, C. P.; van den Bosch, W. J.; van den Hoogen, H. J.; Muris, J. W.

1999-01-01

OBJECTIVE: To study the effectiveness of an intensive small group education and peer review programme aimed at implementing national guidelines on asthma/chronic obstructive pulmonary disease (COPD) on care provision by general practitioners (GPs) and on patient outcomes. DESIGN: A randomised experimental study with pre-measurement and post- measurement (after one year) in an experimental group and a control group in Dutch general practice. SUBJECTS AND INTERVENTION: Two groups of GPs were formed and randomised. The education and peer review group (17 GPs with 210 patients) had an intervention consisting of an interactive group education and peer review programme (four sessions each lasting two hours). The control group consisted of 17 GPs with 223 patients (no intervention). MAIN OUTCOME MEASURES: Knowledge, skills, opinion about asthma and COPD care, presence of equipment in practice; actual performance about peakflow measurement, non-pharmacological and pharmacological treatment; asthma symptoms (Dutch Medical Research Council), smoking habits, exacerbation ratio, and disease specific quality of life (QOL-RIQ). Data were collected by a written questionnaire for GPs, by self recording of consultations by GPs, and by a written self administered questionnaire for adult patients with asthma/COPD. RESULTS: Data from 34 GP questionnaires, 433 patient questionnaires, and recordings from 934 consultations/visits and 350 repeat prescriptions were available. Compared with the control group there were only significant changes for self estimated skills (+16%, 95% confidence interval 4% to 26%) and presence of peakflow meters in practice (+18%, p < 0.05). No significant changes were found for provided care and patient outcomes compared with the control group. In the subgroup of more severe patients, the group of older patients, and in the group of patients not using anti-inflammatory medication at baseline, no significant changes compared with the control group were seen in patient outcomes. CONCLUSION: Except for two aspects, intensive small group education and peer review in asthma and COPD care do not seem to be effective in changing relevant aspects of the provided care by GPs in accordance with guidelines, nor in changing patients' health status. PMID:10557684

Surgical outcomes after application of a liquid adhesive ocular bandage to clear corneal incisions during cataract surgery.

PubMed

Uy, Harvey S; Kenyon, Kenneth R

2013-11-01

To compare the anatomic and refractive outcomes in eyes having phacoemulsification with 1 of 3 clear corneal incision (CCI) closure methods. Ambulatory surgical center, Makati, Philippines. Prospective randomized clinical trial. Patients having phacoemulsification cataract surgery had wound closure using no additional treatment (control), a single 10-0 nylon suture, or a liquid adhesive ocular bandage (Ocuseal). The main outcome measures were wound-edge closure rates, surgically induced astigmatism (SIA), foreign-body sensation, and intraocular pressure (IOP) 1, 3, 5, 7, and 14 days postoperatively. The study evaluated 90 eyes. There was a significant improvement in wound-edge closure rates in the suture group and the ocular bandage group compared with the control group (P<.001). A significant increase in SIA occurred in the sutured group but not in the control or ocular bandage groups (P<.001). The ocular bandage group had significantly less foreign-body sensation than the control and suture groups (P<.001). There were no significant differences in IOP between the groups (P=.515). The liquid adhesive ocular bandage resulted in improved wound-edge closure, reduced SIA, and diminished foreign-body sensation. Suturing was associated with improved wound-edge closure but increased SIA and foreign-body sensation. Unsutured incisions led to delayed wound-edge closure and increased foreign-body sensation. Copyright © 2013 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Ongoing pregnancies in patients with unexplained recurrent pregnancy loss: adverse obstetric outcomes.

PubMed

Cozzolino, Mauro; Rizzello, Francesca; Riviello, Chiara; Romanelli, Chiara; Coccia Elisabetta, Maria

2018-05-25

To investigate the incidence of adverse pregnancy outcomes in couples with an unexplained Recurrent Pregnancy Loss (RPL) history, a retrospective cohort study was conducted between 2014 and 2015. The study group (A) included couples with an unexplained RPL, and the control group (B) was composed of couples who attended the Low-Risk Antenatal Unit during the same period. On the other hand, 53 couples were included in the study group (A) and on the other hand, 65 in the control group (B). Women with previous unexplained recurrent pregnancies loss had a significantly increased risk of gestational diabetes with 12 cases (22.6%) in the study group and 3 cases (4.6%) in the control (OR: 6.048; 95% CI: 1.607-22.762; p = 0.007). A slight increase in the risk of preterm delivery and hepatic cholestasis was observed in the study group (6 cases, 11.3%, in study group and 1 case, 1.5% in the controls (OR: 8.170; 95% CI: 0.951-70.158; p = 0.0555). Women with a history of RPL delivered more frequently by caesarean section (OR: 3.252; 95% CI: 1.460-7.241; p = 0.0039). Women with a history of RPL were at an increased risk for adverse pregnancy outcomes, mainly gestational diabetes. Therefore, a closer surveillance during the antenatal period is recommended in this group of patients.

Effects of Cash and Counseling on Personal Care and Well-Being

PubMed Central

Carlson, Barbara Lepidus; Foster, Leslie; Dale, Stacy B; Brown, Randall

2007-01-01

Objective To examine how a new model of consumer-directed care changes the way that consumers with disabilities meet their personal care needs and, in turn, affects their well-being. Study Setting Eligible Medicaid beneficiaries in Arkansas, Florida, and New Jersey volunteered to participate in the demonstration and were randomly assigned to receive an allowance and direct their own Medicaid supportive services as Cash and Counseling consumers (the treatment group) or to rely on Medicaid services as usual (the control group). The demonstration included elderly and nonelderly adults in all three states and children in Florida. Data Sources Telephone interviews administered 9 months after random assignment. Methods Outcomes for the treatment and control group were compared, using regression analysis to control for consumers' baseline characteristics. Principal Findings Treatment group members were more likely to receive paid care, had greater satisfaction with their care, and had fewer unmet needs than control group members in nearly every state and age group. However, among the elderly in Florida, Cash and Counseling had little effect on these outcomes because so few treatment group members actually received the allowance. Within each state and age group, consumers were not more susceptible to adverse health outcomes or injuries under Cash and Counseling. Conclusions Cash and Counseling substantially improves the lives of Medicaid beneficiaries of all ages if consumers actually receive the allowance that the program offers. PMID:17244293

Low-Carbohydrate Diet for the Treatment of Gestational Diabetes Mellitus

PubMed Central

Moreno-Castilla, Cristina; Hernandez, Marta; Bergua, Merce; Alvarez, Maria C.; Arce, Maria A.; Rodriguez, Karen; Martinez-Alonso, Montserrat; Iglesias, Montserrat; Mateu, Magdalena; Santos, Maria D.; Pacheco, Linda R.; Blasco, Yolanda; Martin, Eva; Balsells, Nuria; Aranda, Nuria; Mauricio, Didac

2013-01-01

OBJECTIVE Medical nutrition therapy based on the control of the amount and distribution of carbohydrates (CHO) is the initial treatment for gestational diabetes mellitus (GDM), but there is a need for randomized controlled trials comparing different dietary strategies. The purpose of this study was to test the hypothesis that a low-CHO diet for the treatment of GDM would lead to a lower rate of insulin treatment with similar pregnancy outcomes compared with a control diet. RESEARCH DESIGN AND METHODS A total of 152 women with GDM were included in this open, randomized controlled trial and assigned to follow either a diet with low-CHO content (40% of the total diet energy content as CHO) or a control diet (55% of the total diet energy content as CHO). CHO intake was assessed by 3-day food records. The main pregnancy outcomes were also assessed. RESULTS The rate of women requiring insulin was not significantly different between the treatment groups (low CHO 54.7% vs. control 54.7%; P = 1). Daily food records confirmed a difference in the amount of CHO consumed between the groups (P = 0.0001). No differences were found in the obstetric and perinatal outcomes between the treatment groups. CONCLUSIONS Treatment of women with GDM using a low-CHO diet did not reduce the number of women needing insulin and produced similar pregnancy outcomes. In GDM, CHO amount (40 vs. 55% of calories) did not influence insulin need or pregnancy outcomes. PMID:23564917

Obstetric outcomes in women with polycystic ovary syndrome and isolated polycystic ovaries undergoing in vitro fertilization: a retrospective cohort analysis.

PubMed

Wan, Hei Lok Tiffany; Hui, Pui Wah; Li, Hang Wun Raymond; Ng, Ernest Hung Yu

2015-03-01

This retrospective cohort study evaluated the obstetric outcomes in women with polycystic ovary syndrome (PCOS) and isolated polycystic ovaries (PCO) undergoing in vitro fertilization (IVF) treatment. We studied 104 women with PCOS, 184 with PCO and 576 age-matched controls undergoing the first IVF treatment cycle between 2002 and 2009. Obstetric outcomes and complications including gestational diabetes (GDM), gestational hypertension (GHT), gestational proteinuric hypertension (PET), intrauterine growth restriction (IUGR), gestation at delivery, baby's Apgar scores and admission to the neonatal intensive care unit (NICU) were reviewed. Among the 864 patients undergoing IVF treatment, there were 253 live births in total (25 live births in the PCOS group, 54 in the PCO group and 174 in the control group). The prevalence of obstetric complications (GDM, GHT, PET and IUGR) and the obstetric outcomes (gestation at delivery, birth weight, Apgar scores and NICU admissions) were comparable among the three groups. Adjustments for age and multiple pregnancies were made using multiple logistic regression and we found no statistically significant difference among the three groups. Patients with PCO ± PCOS do not have more adverse obstetric outcomes when compared with non-PCO patients undergoing IVF treatment.

Critical reappraisal of embryo quality as a predictive parameter for pregnancy outcome: a pilot study.

PubMed

Campo, R; Binda, M M; Van Kerkhoven, G; Frederickx, V; Serneels, A; Roziers, P; Lopes, A S; Gordts, S; Puttemans, P; Gordts, S

2010-01-01

Pilot study to analyse the efficacy and embryo morphology using a new human embryo culture medium (GM501) versus the conventional used medium (ISM1). Over a four-month period, all patients at the Leuven Institute of Fertility and Embryology (LIFE) were -randomly allocated to have their embryos cultured in either the standard sequential culture medium ISM1 (control) or in a new universal medium (GM501) (study group). Primary outcome parameters were clinical pregnancy and live birth rate. The secondary outcome parameter was the correlation of embryo fragmentation rate with pregnancy outcome. We did not observe any differences between the ISM1 control group and GM501 study group with regard to fertilization, pregnancy, implantation rates, ongoing pregnancy, and babies born. The number of embryos with a minimal fragmentation rate (less than 30%) was significantly higher in the GM501 study group. Although a significant higher embryo fragmentation rate was seen in In vitro culture of embryos in GM501, pregnancy outcome results were comparable to those of embryos cultured in ISM1. According to our results the value of embryo morphological criteria as a parameter for pregnancy outcome should be examined and discussed again.

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.

PubMed

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 < .001); lower mean blood glucose (105.1 ± 8.6 mg/dL vs 112.6 ± 7.4 mg/dL, P < .001); lower rates of off-target measurements both fasting (4.7 ± 0.4% vs 8.4 ± 0.6%, P < .001) and 1-hour postprandial (7.7 ± 0.8% vs 14.3 ± 0.8%, P < .001); and a lower rate of pregnancies requiring insulin treatment (13.3% vs 30.0%, P = .044). The rates of macrosomia, neonatal hypoglycemia, shoulder dystocia, and other delivery and neonatal complications did not differ between the groups. Patients in the smartphone group reported excellent satisfaction from the use of the application and from their overall prenatal care. Introduction of a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and the multidisciplinary diabetes-in-pregnancy clinic team improved patient compliance and glycemic control, and lowered the rate of insulin treatment. Copyright © 2018 Elsevier Inc. All rights reserved.

Immediate outcomes of eptifibatide therapy during intracoronary stent implantation.

PubMed

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.

Training balance with opto-kinetic stimuli in the home: a randomized controlled feasibility study in people with pure cerebellar disease.

PubMed

Bunn, Lisa M; Marsden, Jonathan F; Giunti, Paola; Day, Brian L

2015-02-01

To investigate the feasibility of a randomized controlled trial of a home-based balance intervention for people with cerebellar ataxia. A randomized controlled trial design. Intervention and assessment took place in the home environment. A total of 12 people with spinocerebellar ataxia type 6 were randomized into a therapy or control group. Both groups received identical assessments at baseline, four and eight weeks. Therapy group participants undertook balance exercises in front of optokinetic stimuli during weeks 4-8, while control group participants received no intervention. Test-retest reliability was analysed from outcome measures collected twice at baseline and four weeks later. Feasibility issues were evaluated using daily diaries and end trial exit interviews. The home-based training intervention with opto-kinetic stimuli was feasible for people with pure ataxia, with one drop-out. Test-retest reliability is strong (intraclass correlation coefficient >0.7) for selected outcome measures evaluating balance at impairment and activity levels. Some measures reveal trends towards improvement for those in the therapy group. Sample size estimations indicate that Bal-SARA scores could detect a clinically significant change of 0.8 points in this functional balance score if 80 people per group were analysed in future trials. Home-based targeted training of functional balance for people with pure cerebellar ataxia is feasible and the outcome measures employed are reliable. © The Author(s) 2014.

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial.

PubMed

Peters-Klimm, Frank; Campbell, Stephen; Müller-Tasch, Thomas; Schellberg, Dieter; Gelbrich, Goetz; Herzog, Wolfgang; Szecsenyi, Joachim

2009-08-13

Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes. This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2-13; p = 0.02). The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care. ISRCTN08601529.

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial

PubMed Central

Peters-Klimm, Frank; Campbell, Stephen; Müller-Tasch, Thomas; Schellberg, Dieter; Gelbrich, Goetz; Herzog, Wolfgang; Szecsenyi, Joachim

2009-01-01

Background Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes. Methods This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. Results There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2–13; p = 0.02). Conclusion The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care. Trial registration ISRCTN08601529. PMID:19678944

Impact of Computerized Decision Support on Blood Pressure Management and Control: A Randomized Controlled Trial

PubMed Central

Sequist, Thomas D.; Ayanian, John Z.; Shaykevich, Shimon; Fairchild, David G.; Orav, E. John; Bates, David W.

2008-01-01

BACKGROUND We conducted a cluster randomized controlled trial to examine the effectiveness of computerized decision support (CDS) designed to improve hypertension care and outcomes in a racially diverse sample of primary care patients. METHODS We randomized 2,027 adult patients receiving hypertension care in 14 primary care practices to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group. We assessed prescribing of guideline-recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients’ race/ethnicity using interaction terms. MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42% at baseline and 46% at the outcome visit with no significant differences between groups. After adjustment for patients’ demographic and clinical characteristics, number of prior visits, and levels of baseline blood pressure control, there were no differences between intervention groups in the odds of outcome blood pressure control. The use of CDS to providers significantly improved Joint National Committee (JNC) guideline adherent medication prescribing compared to usual care (7% versus 5%, P < 0.001); the effects of the intervention remained after multivariable adjustment (odds ratio [OR] 1.39 [CI, 1.13–1.72]) and the effects of the intervention did not differ by patients’ race and ethnicity. CONCLUSIONS CDS improved appropriate medication prescribing with no improvement in disparities in care and overall blood pressure control. Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed. PMID:18373141

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

PubMed

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.

Text to Move: A Randomized Controlled Trial of a Text-Messaging Program to Improve Physical Activity Behaviors in Patients With Type 2 Diabetes Mellitus.

PubMed

Agboola, Stephen; Jethwani, Kamal; Lopez, Lenny; Searl, Meghan; O'Keefe, Sandra; Kvedar, Joseph

2016-11-18

Text messages are increasingly being used because of the low cost and the ubiquitous nature of mobile phones to engage patients in self-care behaviors. Self-care is particularly important in achieving treatment outcomes in type 2 diabetes mellitus (T2DM). This study examined the effect of personalized text messages on physical activity, as measured by a pedometer, and clinical outcomes in a diverse population of patients with T2DM. Text to Move (TTM) incorporates physical activity monitoring and coaching to provide automated and personalized text messages to help patients with T2DM achieve their physical activity goals. A total of 126 English- or Spanish-speaking patients with glycated hemoglobin A 1c (HbA 1c ) >7 were enrolled in-person to participate in the study for 6 months and were randomized into either the intervention arm that received the full complement of the intervention or a control arm that received only pedometers. The primary outcome was change in physical activity. We also assessed the effect of the intervention on HbA 1c , weight, and participant engagement. All participants (intervention: n=64; control: n=62) were included in the analyses. The intervention group had significantly higher monthly step counts in the third (risk ratio [RR] 4.89, 95% CI 1.20 to 19.92, P=.03) and fourth (RR 6.88, 95% CI 1.21 to 39.00, P=.03) months of the study compared to the control group. However, over the 6-month follow-up period, monthly step counts did not differ statistically by group (intervention group: 9092 steps; control group: 3722 steps; RR 2.44, 95% CI 0.68 to 8.74, P=.17). HbA 1c decreased by 0.07% (95% CI -0.47 to 0.34, P=.75) in the TTM group compared to the control group. Within groups, HbA 1c decreased significantly from baseline in the TTM group by -0.43% (95% CI -0.75 to -0.12, P=.01), but nonsignificantly in the control group by -0.21% (95% CI -0.49 to 0.06, P=.13). Similar changes were observed for other secondary outcomes. Personalized text messaging can be used to improve outcomes in patients with T2DM by employing optimal patient engagement measures. ©Stephen Agboola, Kamal Jethwani, Lenny Lopez, Meghan Searl, Sandra O’Keefe, Joseph Kvedar. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 18.11.2016.

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

PubMed

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 discounting) with respect to specific outcomes (e.g., monetary and sexual) to understand decision making in problematic behavior.

Delay and Probability Discounting of Sexual and Monetary Outcomes in Individuals with Cocaine Use Disorders and Matched Controls

PubMed Central

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 discounting) with respect to specific outcomes (e.g., monetary and sexual) to understand decision making in problematic behavior. PMID:26017273

Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.

PubMed

Zhang, Zhe; Zhang, Fan; Wang, Yang; Du, Yi; Zhang, Huiyong; Kong, Dezhao; Liu, Yue; Yang, Guanlin

2014-10-30

Stable angina pectoris is experienced as trans-sternal or retro-sternal pressure or pain that may radiate to the left arm, neck or back. Although available evidence relating to its effectiveness and mechanism are weak, traditional Chinese medicine is used as an alternative therapy for stable angina pectoris. We report a protocol of a randomized controlled trial using traditional Chinese medicine to investigate the effectiveness, mechanism and safety for patients with stable angina pectoris. This is a north-east Chinese, multi-center, multi-blinded, placebo-controlled and superiority randomized trail. A total of 240 patients with stable angina pectoris will be randomly assigned to three groups: two treatment groups and a control group. The treatment groups will receive Chinese herbal medicine consisting of Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo granule and Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu granule, respectively, and conventional medicine. The control group will receive placebo medicine in addition to conventional medicine. All 3 groups will undergo a 12-week treatment and 2-week follow-up. Four visits in sum will be scheduled for each subject: 1 visit each in week 0, week 4, week 12 and week 14. The primary outcomes include: the frequency of angina pectoris attack; the dosage of nitroglycerin; body limited dimension of Seattle Angina Questionnaire. The secondary outcomes include: except for the body limited dimension of SAQ, traditional Chinese medicine pattern questionnaire and so on. Therapeutic mechanism outcomes, safety outcomes and endpoint outcomes will be also assessed. The primary aim of this trial is to develop a standard protocol to utilize high-quality EBM evidence for assessing the effectiveness and safety of SAP via TCM pattern differentiation as well as exploring the efficacy mechanism and regulation with the molecular biology and systems biology. ChiCTR-TRC-13003608, registered 18 June 2013.

Do Ligamentum Teres Tears Portend Inferior Outcomes in Patients With Borderline Dysplasia Undergoing Hip Arthroscopic Surgery? A Match-Controlled Study With a Minimum 2-Year Follow-up.

PubMed

Chaharbakhshi, Edwin O; Perets, Itay; Ashberg, Lyall; Mu, Brian; Lenkeit, Christopher; Domb, Benjamin G

2017-09-01

Arthroscopic surgery in borderline dysplastic hips remains controversial, but the role of the ligamentum teres (LT) has not been studied in this setting. Borderline dysplastic patients with LT tears have worse short-term outcomes than those without LT tears. Cohort study; Level of evidence, 3. Data were prospectively collected on patients who underwent arthroscopic surgery between February 2008 and April 2014. The inclusion criteria were borderline dysplasia (lateral center-edge angle [LCEA], 18°-25°) and labral tears; arthroscopic treatments including labral preservation and capsular plication; and preoperative patient-reported outcome scores including the modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score-Sport-Specific Subscale, and visual analog scale for pain. Patients were excluded for preoperative Tönnis osteoarthritis grade >0, workers' compensation claims, previous ipsilateral hip surgery and conditions, or frank dysplasia (LCEA <18°). Patients with LT tears were pair-matched to patients without tears for sex, age at surgery ±10 years, body mass index (<30 kg/m 2 vs ≥30 kg/m 2 ), labral treatment type, and microfracture. Of 68 eligible patients, 63 (93%) had a minimum 2-year follow-up, and 30 (48%) had LT tears. Twenty patients in each group were pair-matched. The mean follow-up time was 54.3 months (range, 24.2-83.8 months) for the LT tear group and 38.6 months (range, 24.6-70.6 months) for the control group ( P = .002). Ninety percent were female. There were no significant differences regarding demographics or intra-operative procedures. The LT tear group trended toward lower postoperative mHHS ( P = .09) and NAHS ( P = .09) values. Mean satisfaction was 8.1 for the LT tear group and 7.9 for the control group. Preoperative and follow-up scores were not significantly different between the groups. The LT tear group had 5 revisions, with 1 revision in the control group. Three patients (15%) in the LT tear group underwent total hip arthroplasty (THA); no patients in the control group required THA. In borderline dysplastic patients undergoing hip arthroscopic surgery with labral treatment and capsular plication, LT tears may indicate advanced instability and portend slightly inferior outcomes when compared with a match-controlled group. Borderline dysplastic patients with LT tears may have increased propensities toward revision arthroscopic surgery and conversion to THA. LT tears in these patients may warrant consideration for additional procedures including periacetabular osteotomy and LT reconstruction.

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

PubMed Central

Yang, Han Seok; Yeom, Jin S.; Ahn, Myun-Whan

2017-01-01

Background 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. Methods 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. Results 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. Conclusions 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 postoperative months. PMID:28861199

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

PubMed

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 postoperative months.

Personalised telehealth intervention for chronic disease management: A pilot randomised controlled trial.

PubMed

Bohingamu Mudiyanselage, Shalika; Stevens, Jo; Watts, Jennifer J; Toscano, Julian; Kotowicz, Mark A; Steinfort, Christopher L; Bell, Jennifer; Byrnes, Janette; Bruce, Stephanie; Carter, Sarah; Hunter, Claire; Barrand, Chris; Hayles, Robyn

2018-01-01

Introduction The aim of this study was to assess the impact of home-based telehealth monitoring on health outcomes, quality of life and costs over 12 months for patients with diabetes and/or chronic obstructive pulmonary disease (COPD) who were identified as being at high risk of readmission to hospital. Methods This pilot study was a randomised controlled trial combined with an economic analysis to examine the outcomes of standard care versus home-based telehealth for people with diabetes and/or COPD who were at risk of hospital readmission within one year. The primary outcomes were (i) hospital admission and length of stay (LOS); and (ii) health-related quality of life (HRQOL); and the secondary outcomes were (i) health-related clinical outcomes; (ii) anxiety and depression scores; and (iii) health literacy. The costs of the intervention and hospitalisations were included. Results A total of 86 and 85 participants were randomised to the intervention and control groups respectively. The difference between groups in hospital LOS was -3.89 (95% confidence interval (CI): -9.40, 1.62) days, and for HRQOL, 0.09 (95% CI: 0.05, 0.14) in favour of the telehealth monitoring group. There was a saving of AUD$6553 (95% CI: -12145, -961) in the cost of hospitalisation over 12 months, which offset the increased cost of tele-monitoring. The intervention group showed an improvement in anxiety, depression and health literacy at 12 months, and in the diabetes group, a reduction in microalbuminuria. Discussion The telehealth monitoring intervention improved patient's health outcomes and quality of life at no additional cost.

Inpatient palliative care for patients with acute heart failure: outcomes from a randomized trial.

PubMed

Sidebottom, Abbey C; Jorgenson, Ann; Richards, Hallie; Kirven, Justin; Sillah, Arthur

2015-02-01

Heart failure (HF) is associated with a high symptom burden and reduced quality of life (QOL). Models integrating palliative care (PC) into HF care have been proposed, but limited research is available on the outcomes of such models. Our aim was to assess if inpatient PC for HF patients is associated with improvements in symptom burden, depressive symptoms, QOL, or differential use of services. Patients hospitalized with acute HF were randomized to receive a PC consult with follow-up as determined by provider or standard care. Two hundred thirty-two patients (116 intervention/116 control) from a large tertiary-care urban hospital were recruited over a 10-month period. Primary outcomes were symptom burden, depressive symptoms, and QOL measured at baseline, 1, and 3 months. Secondary outcomes included advance care planning (ACP), inpatient 30-day readmission, hospice use, and death. Improvements were greater at both 1 and 3 months in the intervention group for primary outcome summary measures after adjusting for age, gender, and marital status differences between study groups. QOL scores increased by 12.92 points in the intervention and 8 points in the control group at 1 month (difference+4.92, p<0.001). Improvement in symptom burden was 8.39 in the intervention group and 4.7 in the control group at 1 month (+3.69, p<0.001). ACP was the only secondary outcome associated with the intervention (hazard ratio [HR] 2.87, p=0.033). An inpatient PC model for patients with acute HF is associated with short-term improvement in symptom burden, QOL, and depressive symptoms.

Cervical Spinal Cord Dimensions and Clinical Outcomes in Adults with Klippel-Feil Syndrome: A Comparison with Matched Controls

PubMed Central

Cho, Woojin; Lee, Dong-Ho; Auerbach, Joshua D.; Sehn, Jennifer K.; Nabb, Colin E.; Riew, K. Daniel

2014-01-01

Study Design Retrospective case–control study. Objectives To confirm the fact that spinal cord dimensions are smaller in adults with Klippel-Feil syndrome (KFS) than in pediatric patients with KFS and to compare the clinical characteristics and outcomes of neurologic complications in patients with KFS with matched controls. Methods We performed an independent 1:2 case–control retrospective radiographic and chart review of a consecutive series of adults with KFS who underwent surgical intervention. The control group consisted of consecutive non-KFS surgical patients. Patients were matched in 1:2 case–control manner. Their charts were reviewed and the clinical characteristics were compared. Axial T2-weighted magnetic resonance imaging (MRI) was used to measure the anteroposterior and mediolateral axial spinal cord and spinal canal at the operative levels and measurements were compared. Results A total of 22 patients with KFS and 44 controls were identified. The KFS group had a tendency of more myeloradiculopathy, and the control group had a tendency toward more radiculopathy. Both tendencies, however, were not significantly different. MRIs of 10 patients from the KFS group and 22 controls were available. There was no difference in the area of both spinal cord and canal at the operative levels. Conclusion Contrary to the finding in previous reports on pediatric patients, there were no differences between KFS and well-matched control groups in terms of age of onset, presentation, revision rate, complication rate, surgical outcome, and cross-sectional spinal cord and canal dimensions at the operative level. PMID:25396101

Effects of behavioral stress reduction Transcendental Meditation intervention in Persons with HIV

PubMed Central

Chhatre, Sumedha; Metzger, David S.; Frank, Ian; Boyer, Jean; Thompson, Edward; Nidich, Sanford; Montaner, Luis J.; Jayadevappa, Ravishankar

2013-01-01

Stress is implicated in the pathogenesis and progression of HIV. The Transcendental Meditation is a behavioral stress reduction program that incorporates mind-body approach, and has demonstrated effectiveness in improving outcomes via stress reduction. We evaluated the feasibility of implementing Transcendental Meditation and its effects on outcomes in persons with HIV. In this community based single blinded Phase-I, randomized controlled trial, outcomes (psychological and physiological stress, immune activation, generic and HIV-specific health related quality of life, depression and quality of well-being) were assessed at baseline and at six months, and were compared using parametric and non-parametric tests. Twenty two persons with HIV were equally randomized to Transcendental Meditation intervention or healthy eating (HE) education control group. Retention was 100% in Transcendental Meditation group and 91% in healthy eating control group. The Transcendental Meditation group exhibited significant improvement in vitality. Significant between group differences were observed for generic and HIV-specific health related quality of life.. Small sample size may possibly limit the ability to observe significant differences in some outcomes. Transcendental Meditation stress reduction intervention in community dwelling adults with HIV is viable and can enhance health related quality of life. Further research with large sample and longer follow-up is needed to validate our results. PMID:23394825

Serum uric acid levels and multiple health outcomes: umbrella review of evidence from observational studies, randomised controlled trials, and Mendelian randomisation studies.

PubMed

Li, Xue; Meng, Xiangrui; Timofeeva, Maria; Tzoulaki, Ioanna; Tsilidis, Konstantinos K; Ioannidis, John PA; Campbell, Harry; Theodoratou, Evropi

2017-06-07

Objective  To map the diverse health outcomes associated with serum uric acid (SUA) levels. Design  Umbrella review. Data sources  Medline, Embase, Cochrane Database of Systematic Reviews, and screening of citations and references. Eligibility criteria  Systematic reviews and meta-analyses of observational studies that examined associations between SUA level and health outcomes, meta-analyses of randomised controlled trials that investigated health outcomes related to SUA lowering treatment, and Mendelian randomisation studies that explored the causal associations of SUA level with health outcomes. Results  57 articles reporting 15 systematic reviews and144 meta-analyses of observational studies (76 unique outcomes), 8 articles reporting 31 meta-analyses of randomised controlled trials (20 unique outcomes), and 36 articles reporting 107 Mendelian randomisation studies (56 unique outcomes) met the eligibility criteria. Across all three study types, 136 unique health outcomes were reported. 16 unique outcomes in meta-analyses of observational studies had P<10 -6 , 8 unique outcomes in meta-analyses of randomised controlled trials had P<0.001, and 4 unique outcomes in Mendelian randomisation studies had P<0.01. Large between study heterogeneity was common (80% and 45% in meta-analyses of observational studies and of randomised controlled trials, respectively). 42 (55%) meta-analyses of observational studies and 7 (35%) meta-analyses of randomised controlled trials showed evidence of small study effects or excess significance bias. No associations from meta-analyses of observational studies were classified as convincing; five associations were classified as highly suggestive (increased risk of heart failure, hypertension, impaired fasting glucose or diabetes, chronic kidney disease, coronary heart disease mortality with high SUA levels). Only one outcome from randomised controlled trials (decreased risk of nephrolithiasis recurrence with SUA lowering treatment) had P<0.001, a 95% prediction interval excluding the null, and no large heterogeneity or bias. Only one outcome from Mendelian randomisation studies (increased risk of gout with high SUA levels) presented convincing evidence. Hypertension and chronic kidney disease showed concordant evidence in meta-analyses of observational studies, and in some (but not all) meta-analyses of randomised controlled trials with respective intermediate or surrogate outcomes, but they were not statistically significant in Mendelian randomisation studies. Conclusion  Despite a few hundred systematic reviews, meta-analyses, and Mendelian randomisation studies exploring 136 unique health outcomes, convincing evidence of a clear role of SUA level only exists for gout and nephrolithiasis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The Effects of Ketorolac Injected via Patient Controlled Analgesia Postoperatively on Spinal Fusion

PubMed Central

Park, Si-Young; Moon, Seong-Hwan; Park, Moon-Soo; Oh, Kyung-Soo

2005-01-01

Lumbar spinal fusions have been performed for spinal stability, pain relief and improved function in spinal stenosis, scoliosis, spinal fractures, infectious conditions and other lumbar spinal problems. The success of lumbar spinal fusion depends on multifactors, such as types of bone graft materials, levels and numbers of fusion, spinal instrumentation, electrical stimulation, smoking and some drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs). From January 2000 to December 2001, 88 consecutive patients, who were diagnosed with spinal stenosis or spondylolisthesis, were retrospectively enrolled in this study. One surgeon performed all 88 posterolateral spinal fusions with instrumentation and autoiliac bone graft. The patients were divided into two groups. The first group (n=30) was infused with ketorolac and fentanyl intravenously via patient controlled analgesia (PCA) postoperatively and the second group (n=58) was infused only with fentanyl. The spinal fusion rates and clinical outcomes of the two groups were compared. The incidence of incomplete union or nonunion was much higher in the ketorolac group, and the relative risk was approximately 6 times higher than control group (odds ratio: 5.64). The clinical outcomes, which were checked at least 1 year after surgery, showed strong correlations with the spinal fusion status. The control group (93.1%) showed significantly better clinical results than the ketorolac group (77.6%). Smoking had no effect on the spinal fusion outcome in this study. Even though the use of ketorolac after spinal fusion can reduce the need for morphine, thereby decreasing morphine related complications, ketorolac used via PCA at the immediate postoperative state inhibits spinal fusion resulting in a poorer clinical outcome. Therefore, NSAIDs such as ketorolac, should be avoided after posterolateral spinal fusion. PMID:15861498

Snoezelen Room and Childbirth Outcome: A Randomized Clinical Trial.

PubMed

Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh

2015-05-01

One of the strategies for a good outcome and pain free childbearing is to design the delivery room. The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants' intervention vs. 66% of control participants had perinea laceration (P = 0.041). According to the findings of the present study, distracting senses in snoezelen room decreases mother's pain intensity, the length of labor, and incidence of episiotomy.

Snoezelen Room and Childbirth Outcome: A Randomized Clinical Trial

PubMed Central

Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh

2015-01-01

Background: One of the strategies for a good outcome and pain free childbearing is to design the delivery room. Objectives: The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. Patients and Methods: This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. Results: The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants’ intervention vs. 66% of control participants had perinea laceration (P = 0.041). Conclusions: According to the findings of the present study, distracting senses in snoezelen room decreases mother’s pain intensity, the length of labor, and incidence of episiotomy. PMID:26082849

Effects of five-minute internet-based cognitive behavioral therapy and simplified emotion-focused mindfulness on depressive symptoms: a randomized controlled trial.

PubMed

Noguchi, Remi; Sekizawa, Yoichi; So, Mirai; Yamaguchi, Sosei; Shimizu, Eiji

2017-03-04

Notwithstanding a high expectation for internet-based cognitive behavioral therapy (iCBT) for reducing depressive symptoms, many of iCBT programs have limitations such as temporary effects and high drop-out rates, possibly due to their complexity. We examined the effects of a free, simplified, 5-minute iCBT program by comparing it with a simplified emotion-focused mindfulness (sEFM) exercise and with a waiting list control group. A total of 974 participants, who were recruited using the website of a market research company, were randomly assigned to the iCBT group, the sEFM group, and the control group. Those in the intervention arms performed each exercise for 5 weeks. The primary outcome measure was the Center for Epidemiological Studies Depression scale (CES-D) at postintervention. Secondary outcome measures were the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 scale (GAD-7). Intention-to-treat analyses were conducted. During postintervention assessment, there were no significant differences between the intervention arms and the control group in the CES-D, although the difference between the iCBT arm and control group was close to significance (p = 0.05) in favor of iCBT. There was a significant difference in the PHQ-9 in favor of the sEFM group compared with the control group. There were no significant differences in outcome measures between the three groups at the 6-week follow-up. Although both iCBT and sEFM have the potential to temporarily reduce depressive symptoms, substantial improvements are required to enhance and maintain their effects. This trial is registered with the UMIN Clinical Trial Registry (UMIN-CTR) (ID: UMIN000015097 ) on 1 October 2014.

The "physician on call patient engagement trial" (POPET): measuring the impact of a mobile patient engagement application on health outcomes and quality of life in allergic rhinitis and asthma patients.

PubMed

Cingi, Cemal; Yorgancioglu, Arzu; Cingi, Can Cemal; Oguzulgen, Kıvılcım; Muluk, Nuray Bayar; Ulusoy, Seçkin; Orhon, Nezih; Yumru, Cengiz; Gokdag, Dursun; Karakaya, Gul; Çelebi, Şaban; Çobanoglu, H Bengü; Unlu, Halis; Aksoy, Mehmet Akif

2015-06-01

In this prospective, multicenter, randomized, controlled, double-blind study, we investigated the impact of a mobile patient engagement application on health outcomes and quality of life in allergic rhinitis (AR) and asthma patients. In total, 327 patients with diagnoses of persistent AR or mild-to-severe persistent asthma were randomized into 2 intervention groups and 2 control groups upon their admission at outpatient clinics. The intervention groups (POPET-AR and POPET-Asthma) received a mobile phone application ("physician on call patient engagement trial" [POPET]), enabling them to communicate with their physician, and record their health status and medication compliance. The AR groups completed the Rhinitis Quality of Life Questionnaire (RQLQ) at initiation and at the first month of the study. The asthma groups completed the Asthma Control Test (ACT) at initiation and at the third month of the study. The POPET-AR group showed better clinical improvement than the control group in terms of the overall RQLQ score as well in measures of general problems, activity, symptoms other than nose/eye, and emotion domains (p < 0.05). In the POPET-Asthma group, more patients (49%) achieved a well-controlled asthma score (ACT > 19) compared with the control group (27%); this was statistically significant (p < 0.05). Use of a mobile engagement platform, such as POPET, can have a significant impact on health outcomes and quality of life in both AR and asthma, potentially decreasing the number of hospital admissions, repeat doctor visits, and losses in productivity. Improvements were seen in domains related to activity, productivity, perception of disease, and emotion. © 2015 ARS-AAOA, LLC.

Evaluation of active living every day in adults with arthritis.

PubMed

Callahan, Leigh F; Cleveland, Rebecca J; Shreffler, Jack; Hootman, Jennifer M; Mielenz, Thelma J; Schoster, Britta; Brady, Teresa; Schwartz, Todd

2014-02-01

Adults with arthritis can benefit from participation in physical activity and may be assisted by organized programs. The purpose of this study was to evaluate the effectiveness of a 20-week behavioral lifestyle intervention, Active Living Every Day (ALED), for improvements in primary outcomes (physical activity levels, aerobic endurance, function, symptoms). A 20-week randomized controlled community trial was conducted in 354 adults. Outcomes were assessed at baseline and 20 weeks in the intervention and wait-list control groups. The intervention group was also assessed at 6 and 12 months. Mean outcomes were determined by multilevel regression models in the intervention and control groups at follow-up points. At 20 weeks, the intervention group significantly increased participation in physical activity, and improved aerobic endurance, and select measures of function while pain, fatigue and stiffness remained status quo. In the intervention group, significant improvements in physical activity at 20 weeks were maintained at 6 and 12 months, and stiffness decreased. ALED appears to improve participation in physical activity, aerobic endurance, and function without exacerbating disease symptoms in adults with arthritis.

A randomized clinical trial on the effects of remote intercessory prayer in the adverse outcomes of pregnancies.

PubMed

da Rosa, Maria Inês; Silva, Fabio Rosa; Silva, Bruno Rosa; Costa, Luciana Carvalho; Bergamo, Angela Mendes; Silva, Napoleão Chiaramonte; Medeiros, Lidia Rosi de Freitas; Battisti, Iara Denise Endruweit; Azevedo, Rafael

2013-08-01

The scope of this article was to investigate whether intercessory prayer (IP) influences the adverse outcomes of pregnancies. A double-blind, randomized clinical trial was conducted with 564 pregnant women attending a prenatal public health care service. The women were randomly assigned to an IP group or to a control group (n = 289 per group). They were simultaneously and randomly assigned to practice prayer off-site or not. The following parameters were evaluated: Apgar scores, type of delivery and birth weight. The mean age of the women was 25.1 years of age (± 7.4), and the average gestational age was 23.4 weeks (± 8.1). The average number of years of schooling for the women was 8.1 years (± 3.1). The women in the IP and control groups presented a similar number of adverse medical events with non-significant p. No significant differences were detected in the frequency of adverse outcomes in pregnant women who practiced IP and those in the control group.

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

PubMed

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.

Is pregnancy over 45 with very high parity related with adverse maternal and fetal outcomes?

PubMed

Kale, A; Kuyumcuoğlu, U; Güzel, A

2009-01-01

To examine whether very high parity and age over 45 years are related with adverse maternal and fetal outcomes. This study was carried out at the Department of Obstetrics and Gynecology from January 1, 2007 to December 31, 2007. Sixty-one pregnant women were enrolled in this prospective study. Mothers were classified in two groups: the study group (n = 23) included women with very high parity over 45 years of age (age > 45 and > or = 10 previous live births), and a control group (n = 38) included women with high parity between 40-45 years of age (between 40-45 years and 5-9 previous live births). Hypertensive disorders complicating pregnancy, preterm labor, breech presentation, cesarean section ratio, mean APGAR scores, birthweight, fetal sex, fetal macrosomia, and early neonatal death were compared within groups. Six (26%) patients in the study group and 12 (31.5%) patients in the control group had hypertensive disorders of pregnancies (p > 0.05). Twelve (52.1%) patients in the study group and 22 (57.8%) patients in the control group had preterm labor (p > 0.05). One (4%) patient in the study group and two (5.2%) patients in the control group had breech presentation during delivery (p > 00.5). Twelve (52.1%) patients in the study group and 21 (55.2%) patients in the control group had cesarean operations (p > 0.05). Mean APGAR scores (at 1 min and 5 min), mean birthweight, fetal sex ratio, fetal macrosomia ratio, and early neonatal death ratio due to prematurity were not statistically significant in the study group as compared with the control group. It is generally assumed that women with advanced age have an increased risk for complications during pregnancy. However, prospective population-based studies do not exist and available publications give conflicting views. Based on our results, we hypothesized that cases aged 45 or over with very high parity are not always related with adverse maternal and fetal outcomes.

A randomized controlled trial undertaken to test a nurse-led weight management and exercise intervention designed for people with serious mental illness who take second generation antipsychotics.

PubMed

Usher, Kim; Park, Tanya; Foster, Kim; Buettner, Petra

2013-07-01

To test the effect of a nurse-led intervention on weight gain in people with serious mental illness prescribed and taking second generation antipsychotic medication. Weight gain and obesity has reached epidemic proportions in the general population with the prevalence of Metabolic Syndrome reaching 20-25% of the global population. People with serious mental illness are at even higher risk, particularly those taking second generation antipsychotic medication. An experimental randomized controlled trial was undertaken. The control group received a 12-week healthy lifestyle booklet. In addition to the booklet, the intervention group received weekly nutrition and exercise education, exercise sessions, and nurse support. Participants (n = 101) were assessed at baseline and 12 weeks. Data were collected between March 2008-December 2010. Seven outcome measures were used: body measurements included girth (cm), weight (kg), height (cm), and body mass index (kg/m(2) ); questionnaires included the medication compliance questionnaire, the Drug Attitude Inventory, the Liverpool University Neuroleptic Side Effect Rating Scale, and the Medical Outcomes Study Short Form 36. Differences in primary outcome measures between baseline and 12 weeks follow-up were compared between intervention and control groups using standard bi-variate statistical tests. The study was conducted between 2008-2010. The analysis of outcome measures for the control group (n = 50) and intervention group (n = 51) was not statistically significant. There was a mean weight change of -0·74 kg at 12 weeks for the intervention group (n = 51), while the control group (n = 50) had a mean weight change of -0·17 kg at 12 weeks. The results were not statistically significant. © 2012 Blackwell Publishing Ltd.

Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.

PubMed

Wise, Robert A; Bartlett, Susan J; Brown, Ellen D; Castro, Mario; Cohen, Rubin; Holbrook, Janet T; Irvin, Charles G; Rand, Cynthia S; Sockrider, Marianna M; Sugar, Elizabeth A

2009-09-01

Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

Effectiveness of an intervention to improve diabetes self-management on clinical outcomes in patients with low educational level.

PubMed

Olry de Labry Lima, Antonio; Bermúdez Tamayo, Clara; Pastor Moreno, Guadalupe; Bolívar Muñoz, Julia; Ruiz Pérez, Isabel; Johri, Mira; Quesada Jiménez, Fermín; Cruz Vela, Pilar; de Los Ríos Álvarez, Ana M; Prados Quel, Miguel Ángel; Moratalla López, Enrique; Domínguez Martín, Susana; Lopez de Hierro, José Andrés; Ricci Cabello, Ignacio

To determine whether an intervention based on patient-practitioner communication is more effective than usual care in improving diabetes self-management in patients with type 2 diabetes with low educational level. 12-month, pragmatic cluster randomised controlled trial. Nine physicians and 184 patients registered at two practices in a deprived area of Granada (Andalusia, Spain) participated in the study. Adult patients with type 2 diabetes, low educational level and glycated haemoglobin (HbA1c) > 7% (53.01 mmol/mol) were eligible. The physicians in the intervention group received training on communication skills and the use of a tool for monitoring glycaemic control and providing feedback to patients. The control group continued standard care. The primary outcome was difference in HbA1c after 12 months. Dyslipidaemia, blood pressure, body mass index and waist circumference were also assessed as secondary outcomes. Two-level (patient and provider) regression analyses controlling for sex, social support and comorbidity were conducted. The HbA1c levels at 12 months decreased in both groups. Multilevel analysis showed a greater improvement in the intervention group (between-group HbA1c difference= 0.16; p=0.049). No statistically significant differences between groups were observed for dyslipidaemia, blood pressure, body mass index and waist circumference. In this pragmatic study, a simple and inexpensive intervention delivered in primary care showed a modest benefit in glycaemic control compared with usual care, although no effect was observed in the secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients. Copyright © 2016 SESPAS. All rights reserved.

Do nonsteroidal anti-inflammatory drugs affect the outcome of arthroscopic Bankart repair?

PubMed

Blomquist, J; Solheim, E; Liavaag, S; Baste, V; Havelin, L I

2014-12-01

To achieve pain control after arthroscopic shoulder surgery, nonsteroidal anti-inflammatory drugs (NSAIDs) are a complement to other analgesics. However, experimental studies have raised concerns that these drugs may have a detrimental effect on soft tissue-to-bone healing and, thus, have a negative effect on the outcome. We wanted to investigate if there are any differences in the clinical outcome after the arthroscopic Bankart procedure for patients who received NSAIDs prescription compared with those who did not. 477 patients with a primary arthroscopic Bankart procedure were identified in the Norwegian shoulder instability register and included in the study. 32.5% received prescription of NSAIDs post-operatively. 370 (78%) of the patients answered a follow-up questionnaire containing the Western Ontario Shoulder Instability index (WOSI). Mean follow-up was 21 months. WOSI at follow-up were 75% in the NSAID group and 74% in the control group. 12% of the patients in the NSAID group and 14% in the control group reported recurrence of instability. The reoperation rate was 5% in both groups. There were no statistically significant differences between the groups. Prescription of short-term post-operative NSAID treatment in the post-operative period did not influence on the functional outcome after arthroscopic Bankart procedures. © 2014 The Authors. Scandinavian Journal of Medicine & Science in Sports published by John Wiley & Sons Ltd.

Diabetes risk reduction in overweight first degree relatives of type 2 diabetes patients: effects of a low-intensive lifestyle education program (DiAlert) A randomized controlled trial.

PubMed

Heideman, Wieke H; de Wit, Maartje; Middelkoop, Barend J C; Nierkens, Vera; Stronks, Karien; Verhoeff, Arnoud P; Snoek, Frank J

2015-04-01

To test the efficacy of a low-intensive lifestyle education program (DiAlert) for overweight first degree relatives of type 2 diabetes patients aimed at reducing diabetes risk. Overweight first degree relatives of type 2 diabetes patients were randomly assigned to the DiAlert intervention (N=45) or control group who received leaflets (N=51). DiAlert consists of two group sessions and newsletters. Assessments were scheduled at baseline, three and nine months, with weight loss as primary outcome. Secondary outcomes included anthropometric, metabolic, behavioral and psychological measures. Comparisons were made over time and between groups. Both groups showed modest weight loss with no difference between randomization groups. However, after DiAlert significantly more participants lost 5% of their weight compared to controls (P=0.03). Significant improvement of waist circumference sustained after 9 months in the intervention group (intervention: -4.33cm, P<0.01/control: -1.25cm, P=0.08). Systolic blood pressure improved within the intervention group (intervention: -8.77mmHg, P<0.01/control: -1.03mmHg, P=0.60). No effect was observed for biomedical and psychosocial outcomes. Our low-intensive structured lifestyle education program helps overweight relatives to improve waist circumference and supports relevant weight loss. The family approach provides opportunities to reach and engage relatives at risk in diabetes prevention education. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Treatment of Focal Articular Cartilage Defects in the Knee

PubMed Central

Magnussen, Robert A.; Dunn, Warren R.; Carey, James L.

2008-01-01

We asked whether autologous chondrocyte implantation or osteochondral autograft transfer yields better clinical outcomes compared with one another or with traditional abrasive techniques for treatment of isolated articular cartilage defects and whether lesion size influences this clinical outcome. We performed a literature search and identified five randomized, controlled trials and one prospective comparative trial evaluating these treatment techniques in 421 patients. The operative procedures included autologous chondrocyte implantation, osteochondral autograft transfer, matrix-induced autologous chondrocyte implantation, and microfracture. Minimum followup was 1 year (mean, 1.7 years; range, 1–3 years). All studies documented greater than 95% followup for clinical outcome measures. No technique consistently had superior results compared with the others. Outcomes for microfracture tended to be worse in larger lesions. All studies reported improvement in clinical outcome measures in all treatment groups when compared with preoperative assessment; however, no control (nonoperative) groups were used in any of the studies. A large prospective trial investigating these techniques with the addition of a control group would be the best way to definitively address the clinical questions. Level of Evidence: Level II, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18196358

Methodology Series Module 2: Case-control Studies

PubMed Central

Setia, Maninder Singh

2016-01-01

Case-Control study design is a type of observational study. In this design, participants are selected for the study based on their outcome status. Thus, some participants have the outcome of interest (referred to as cases), whereas others do not have the outcome of interest (referred to as controls). The investigator then assesses the exposure in both these groups. The investigator should define the cases as specifically as possible. Sometimes, definition of a disease may be based on multiple criteria; thus, all these points should be explicitly stated in case definition. An important aspect of selecting a control is that they should be from the same ‘study base’ as that of the cases. We can select controls from a variety of groups. Some of them are: General population; relatives or friends; and hospital patients. Matching is often used in case-control control studies to ensure that the cases and controls are similar in certain characteristics, and it is a useful technique to increase the efficiency of the study. Case-Control studies can usually be conducted relatively faster and are inexpensive – particularly when compared with cohort studies (prospective). It is useful to study rare outcomes and outcomes with long latent periods. This design is not very useful to study rare exposures. Furthermore, they may also be prone to certain biases – selection bias and recall bias. PMID:27057012

Evaluation of alternative school feeding models on nutrition, education, agriculture and other social outcomes in Ghana: rationale, randomised design and baseline data.

PubMed

Gelli, Aulo; Masset, Edoardo; Folson, Gloria; Kusi, Anthoni; Arhinful, Daniel K; Asante, Felix; Ayi, Irene; Bosompem, Kwabena M; Watkins, Kristie; Abdul-Rahman, Lutuf; Agble, Rosanna; Ananse-Baden, Getrude; Mumuni, Daniel; Aurino, Elisabetta; Fernandes, Meena; Drake, Lesley

2016-01-20

'Home-grown' school feeding programmes are complex interventions with the potential to link the increased demand for school feeding goods and services to community-based stakeholders, including smallholder farmers and women's groups. There is limited rigorous evidence, however, that this is the case in practice. This evaluation will examine explicitly, and from a holistic perspective, the simultaneous impact of a national school meals programme on micronutrient status, alongside outcomes in nutrition, education and agriculture domains. The 3-year study involves a cluster-randomised control trial designed around the scale-up of the national school feeding programme, including 116 primary schools in 58 districts in Ghana. The randomly assigned interventions are: 1) a school feeding programme group, including schools and communities where the standard government programme is implemented; 2) 'home-grown' school feeding, including schools and communities where the standard programme is implemented alongside an innovative pilot project aimed at enhancing nutrition and agriculture; and 3) a control group, including schools and households from communities where the intervention will be delayed by at least 3 years, preferably without informing schools and households. Primary outcomes include child health and nutritional status, school participation and learning, and smallholder farmer income. Intermediate outcomes along the agriculture and nutrition pathways will also be measured. The evaluation will follow a mixed-method approach, including child-, household-, school- and community-level surveys as well as focus group discussions with project stakeholders. The baseline survey was completed in August 2013 and the endline survey is planned for November 2015. The tests of balance show significant differences in the means of a number of outcome and control variables across the intervention groups. Important differences across groups include marketed surplus, livestock income, per capita food consumption and intake, school attendance, and anthropometric status in the 2-5 and 5-15 years age groups. In addition, approximately 19 % of children in the target age group received some form of free school meals at baseline. Designing and implementing the evaluation of complex interventions is in itself a complex undertaking, involving a multi-disciplinary research team working in close collaboration with programme- and policy-level stakeholders. Managing the complexity from an analytical and operational perspective is an important challenge. The analysis of the baseline data indicates that the random allocation process did not achieve statistically comparable treatment groups. Differences in outcomes and control variables across groups will be controlled for when estimating treatment effects. ISRCTN66918874 (registered on 5 March 2015).

A retrospective cost-analysis of additional homeopathic treatment in Germany: Long-term economic outcomes

PubMed Central

Ostermann, Julia K.; Witt, Claudia M.; Reinhold, Thomas

2017-01-01

Objectives This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months. Methods Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache. Results Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022–12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036–10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118–6,460]; control: EUR 5,498 [5,326–5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770–1,818]; control: EUR 1,438 [1,414–1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients. Conclusion The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group. PMID:28915242

Decreased Sperm Motility Retarded ICSI Fertilization Rate in Severe Oligozoospermia but Good-Quality Embryo Transfer Had Achieved the Prospective Clinical Outcomes.

PubMed

Zheng, Jufeng; Lu, Yongning; Qu, Xianqin; Wang, Peng; Zhao, Luiwen; Gao, Minzhi; Shi, Huijuan; Jin, Xingliang

Spermatozoa motility is the critical parameter to affect the treatment outcomes during assisted reproductive technologies (ART), but its reproductive capability remains a little informed in condition of severe male factor infertility. This retrospective cohort study aimed to evaluate the effects of reduced sperm motility on the embryological and clinical outcomes in intra-cytoplasmic sperm injection (ICSI) treatment of severe oligozoospermia. 966 cycles (812 couples) of severe oligozoospermia diagnosed by spermatozoa count ≤ 5 × 106/mL and motile spermatozoa ≤ 2 × 106/mL were divided into four groups in according to the number of motile spermatozoa in one ejaculate on the day of oocyte retrieval (Group B-E). The control (Group A) was 188 cycles of moderate oligozoospermia with spermatozoa count > 5 × 106/mL and motile spermatozoa > 2 × 106/mL. All female partners were younger than 35 years of age. Logistic regression analyzed embryological outcomes (the rates of fertilization, cleavage and good-quality embryo) and clinical outcomes (the rates of pregnancy, implantation, early miscarriage and live birth). Quality of embryo transfer (ET) was divided into three classes as continuous factor to test the effects of embryo quality on clinical outcomes. The reduction in the number of motile sperm in four groups of severe oligozoospermia gave rise to comparable inability of the fertilization (p < 0.001) and a decreased rate of good-quality embryo at Day 3 (p < 0.001) by compared to the control. The cleavage rate of the derived zygotes was similar to the control. ET classes significantly affected the clinical outcomes (p < 0.001). Class I ET gave rise to similar rates of clinical outcomes between five groups, but Class II and Class III ET retarded the rates of pregnancy, implantation and live birth and this particularly occurred in Group C, D and E. The rate of early miscarriage was not comparably different between groups. Overall rates in all groups were 41.26% clinical pregnancy, 25.74% implantation and 36.32% live birth, which gave live birth to 252 girls and 252 boys. The reduction of motile spermatozoa in severe oligozoospermia decreased the rates of fertilization and good-quality embryo. Obtaining and transfer of good-quality embryos was the good prognostic to achieve prospective clinical outcomes regardless of the severity of oligozoospermia.

An intervention to increase patients' trust in their physicians. Stanford Trust Study Physician Group.

PubMed

Thom, D H; Bloch, D A; Segal, E S

1999-02-01

To investigate the effect of a one-day workshop in which physicians were taught trust-building behaviors on their patients' levels of trust and on outcomes of care. In 1994, the study recruited 20 community-based family physicians and enrolled 412 consecutive adult patients from those physicians' practices. Ten of the physicians (the intervention group) were randomly assigned to receive a one-day training course in building and maintaining patients' trust. Outcomes were patients' trust in their physicians, patients' and physicians' satisfaction with the office visit, continuity in the patient-physician relationship, patients' adherence to their treatment plans, and the numbers of diagnostic tests and referrals. Physicians and patients in the intervention and control groups were similar in demographic and other data. There was no significant difference in any outcome. Although their overall ratings were not statistically significantly different, the patients of physicians in the intervention group reported more positive physician behaviors than did the patients of physicians in the control group. The trust-building workshop had no measurable effect on patients' trust or on outcomes hypothesized to be related to trust.

Effects of glargine insulin on glycemic control in patients with diabetes mellitus type II undergoing off-pump coronary artery bypass graft.

PubMed

Gandhi, Hemang; Sarvaia, Alpesh; Malhotra, Amber; Acharya, Himanshu; Shah, Komal; Rajavat, Jeevraj

2018-01-01

The prevalence of diabetes mellitus in patients requiring coronary artery bypass grafting (CABG) is noticeably high (20%-30%). These patients have inferior perioperative outcome, reduced long-term survival, and high risk of recurrent episodes of angina. To improve perioperative outcome surgical unit defined satisfactory glycemic control is desired during this period. Hence, the aim of our study is to compare the efficacy of glargine insulin combination with continuous human insulin infusion for perioperative glycemic control in patients with diabetes undergoing CABG. Fifty Patients, who were posted for off-pump CABG with diabetes mellitus type II, were randomized in two group, Group I normal saline + human insulin infusion during the perioperative period, Group II (glargine group): Glargine + human insulin infusion during perioperative period. During surgery and in the postoperative period, random blood sugar and human insulin requirement are significantly higher in control group than glargine group. Other infection, step-up antibiotics, intensive care unit (ICU) stay, and hospital stay were significantly higher in control groups in postoperative period. Our study results suggest that glargine effectively manages blood glucose level with significantly greater control over postoperative morbidity.

A Randomized Controlled Trial of Storytelling as a Communication Tool

PubMed Central

Hartling, Lisa; Scott, Shannon D.; Johnson, David W.; Bishop, Ted; Klassen, Terry P.

2013-01-01

Introduction Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup. Methods Parents were randomized to receive story booklets (n=208) or standard information sheets (n=205) during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms), and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution. Results There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78). The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001): 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement “I would go for the same choice if I had to do it over again”. The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04). No other outcomes were different between study groups. Conclusions Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes. Trial Registration Current Controlled Trials, ISRCTN39642997 (http://www.controlled-trials.com/ISRCTN39642997) PMID:24204974

A randomized controlled trial of storytelling as a communication tool.

PubMed

Hartling, Lisa; Scott, Shannon D; Johnson, David W; Bishop, Ted; Klassen, Terry P

2013-01-01

Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup. Parents were randomized to receive story booklets (n=208) or standard information sheets (n=205) during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms), and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution. There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78). The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001): 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement "I would go for the same choice if I had to do it over again". The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04). No other outcomes were different between study groups. Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes. Current Controlled Trials, ISRCTN39642997 (http://www.controlled-trials.com/ISRCTN39642997).

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

PubMed

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

PubMed Central

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

Worse self-reported outcomes but no limitations in performance-based measures in patients with long-standing hip and groin pain compared with healthy controls.

PubMed

Wörner, Tobias; Sigurðsson, Haraldur B; Pålsson, Anders; Kostogiannis, Ioannis; Ageberg, Eva

2017-01-01

This study aimed to evaluate patient-reported outcomes as well as lower extremity and trunk muscle function in patients with long-standing hip and groin pain, in comparison with matched, healthy controls. It was hypothesized that patients with long-standing hip and groin pain would report more deficiency on the Copenhagen Hip and Groin Outcome Score (HAGOS) and have worse outcomes on performance-based measures than healthy controls. Nineteen patients with long-standing hip and groin pain and 19 healthy, activity level-, age-, gender-, and weight-matched controls were assessed with the HAGOS for self-reported outcomes, and a parallel squat (w/kg), single-leg triple jump (cm), single-leg rise (n), barbell roll-out (% of height), and plank test (s) for performance-based measures. Independent sample t test was performed to assess between-group differences. The paired t test was used to analyse between-limb differences in unilateral performance tasks. The patients had worse scores than the controls in all HAGOS subscales (p ≤ 0.001), while no statistically significant differences were observed for any performance measure between groups or between symptomatic and non-symptomatic limbs. Despite significant self-reported functional limitations on the HAGOS, there were no significant differences between groups in performance-based strength or power measures. The results of this study highlight the need to identify performance-based measures, sensitive to functional deficiencies in patients with long-standing hip and groin pain in order to complement the clinical picture obtained by patient-reported outcomes such as the HAGOS. III.

Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

2014-01-01

Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

PubMed

Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

2011-03-01

To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of follow-up. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

The effect of deep shoulder infections on patient outcomes after arthroscopic rotator cuff repair: a retrospective comparative study.

PubMed

Atesok, Kivanc; MacDonald, Peter; Leiter, Jeff; McRae, Sheila; Singh, Mandip; Stranges, Greg; Old, Jason

2017-01-01

The purpose of this study was to evaluate the effects of deep shoulder infections after RCR on patient outcomes. A retrospective chart review was conducted involving all patients with deep shoulder infections after arthroscopic RCR (study group). Another group of patients who were matched with the study group by age, gender and rotator cuff tear size, and did not develop deep shoulder infections after arthroscopic RCR were randomly identified (control group). The two groups were compared in terms of time to start physiotherapy, shoulder function, and delay in return to work. There were 10 patients in each group. The mean time to start physiotherapy after surgery was 145.3 (SD=158.8) days for the study group and 40.0 (SD=13.7) days for the control group (p=.051). The average forward elevation of the operated shoulder was 133 (SD=33.4) degrees for the study group, and 172 (SD=12.0) degrees for the control group (p=0.003). The average time to return to work at preoperative level was 5.6 months for the study group and 3 months for the control group. Deep shoulder infections after RCR significantly impedes time to start physiotherapy, shoulder function, and patients' ability to return to work. III b [retrospective comparative (case-control) study].

Efficacy of strength and aerobic exercise on patient-reported outcomes and structural changes in patients with knee osteoarthritis: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Despite an extensive literature on treatment interventions for patients with knee osteoarthritis, studies comparing the efficacy of different exercise interventions and living the life as usual on quality of life, cartilage quality and cost-effectiveness are lacking. The aim of the present study is to compare the efficacy of two different exercise programs compared to a control group in individuals with established radiographic and symptomatic knee osteoarthritis on self-reported knee-related quality of life, knee pain, physical function, and cartilage quality. Methods/Design A three-armed randomized controlled trial involving two exercise interventions and a control group of individuals doing as they usually do is described. The patients will have mild to moderate radiographic osteoarthritis according to the Kellgren and Lawrence classification (grade 2–3), and fulfill the American College of Rheumatology clinical criteria, be aged between 45 and 65 years, and have no other serious physical or mental illnesses. The patients will be randomly allocated to a strength exercise group; a cycling group, or a control group. The primary outcome is the Knee injury and Osteoarthritis Outcome Score knee-related quality of life subscale. Secondary outcomes include all five Knee Injury and Osteoarthritis Outcome Score subscales, morphological evaluation of cartilage including focal thickness, subchondral bone marrow edema, proteoglycan content and collagen degradation (measured using magnetic resonance imaging clinical sequences, T2 mapping and T1ρ), specific serum biomarkers, isokinetic muscle strength, maximal oxygen uptake, quality of life (EuroQol 5D), and self-efficacy (Arthritis Self-Efficacy Scale). A sample size calculation on the primary outcome showed that 207 individuals, 69 in each group, is needed to detect a clinically relevant difference of 10 points with 80% power and a significance level of 5%. Assessments will be conducted at baseline, 14 weeks, 1 year and 2 years post-randomization. The interventions will be a 14 weeks exercise program. Discussion Although exercise therapy has been found to be effective in knee osteoarthritis, the knowledge of the underlying mechanisms for why exercise works is lacking. This study will contribute with knowledge on the efficacy of strength exercise versus cycling on patient-reported outcomes, cartilage quality and cost-effectiveness. Trial registration Clinicaltrial.gov Identifier: NCT01682980. PMID:24028201

Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in Healthy Term Infants

PubMed Central

Billeaud, Claude; Puccio, Giuseppe; Saliba, Elie; Guillois, Bernard; Vaysse, Carole; Pecquet, Sophie; Steenhout, Philippe

2014-01-01

OBJECTIVE This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions. METHODS Healthy, full-term infants (n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: −3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated. RESULTS Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]). CONCLUSION Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group. PMID:25452707

Feasibility and effects of a physical exercise programme in adults with myotonic dystrophy type 1: a randomized controlled pilot study.

PubMed

Kierkegaard, Marie; Harms-Ringdahl, Karin; Edström, Lars; Widén Holmqvist, Lotta; Tollbäck, Anna

2011-07-01

To investigate the feasibility and effects of a physical exercise programme on functioning and health-related quality of life in adults with myotonic dystrophy type 1. A randomized controlled trial. Thirty-five adults with myotonic dystrophy type 1. After stratification for level of functioning, study participants were assigned by lot to either a training group or a control group. Training-group participants attended a 60-minute comprehensive group-training programme, Friskis&Svettis® Open Doors, twice a week for 14 weeks. The six-minute walk test was the primary outcome measure and the timed-stands test, the timed up-and-go test, the Epworth sleepiness scale and the Short Form-36 health survey were secondary outcome measures. Intention-to-treat analyses revealed no significant differences in any outcome measures, except for an increased between-group difference after intervention in the Short Form-36 mental health subscale and a decrease in the vitality subscale for the control group. The programme was well tolerated and many training-group participants perceived subjective changes for the better. No negative effects were reported. The Friskis&Svettis® Open Doors programme was feasible for adults with myotonic dystrophy type 1 who had been screened for cardiac involvement, had distal or mild-to-moderate proximal muscle impairment, and no severe cognitive impairments. No beneficial or detrimental effects were evident.

Promoting employee health by integrating health protection, health promotion, and continuous improvement: a longitudinal quasi-experimental intervention study.

PubMed

von Thiele Schwarz, Ulrica; Augustsson, Hanna; Hasson, Henna; Stenfors-Hayes, Terese

2015-02-01

To test the effects of integrating health protection and health promotion with a continuous improvement system (Kaizen) on proximal employee outcomes (health promotion, integration, and Kaizen) and distal outcomes (workability, productivity, self-rated health and self-rated sickness absence). Twelve units in a county hospital in Sweden were randomized to control or intervention groups using a quasiexperimental study design. All staff (approximately 500) provided self-ratings in questionnaires at baseline, and a 12- and 24-month follow-up (response rate, 79% to 87.5%). There was a significant increase in the proximal outcomes over time in the intervention group compared with the control group, and a trend toward improvement in the distal outcomes workability and productivity. Integration seems to promote staff engagement in health protection and promotion, as well as to improve their understanding of the link between work and health.

Neurocognition and functional outcome in early-onset schizophrenia and attention-deficit/hyperactivity disorder: a 13-year follow-up.

PubMed

Oie, Merete; Sundet, Kjetil; Ueland, Torill

2011-01-01

The relation between neurocognitive impairments and functional outcome has been documented in both early onset schizophrenia (EOS) and attention-deficit/hyperactivity disorder (ADHD), but less is known about the long-term relation between these factors. The present study investigates how neurocognition at baseline is related to measures of functional outcome at 13-year follow-up in subjects with EOS and ADHD. Subjects with EOS (n = 15), ADHD (n = 19), and healthy controls (n = 30) were followed up 13 years after initial assessment. All subjects were between 12 and 18 years of age at baseline and between 24 and 30 at follow-up. They were retested at T2 with the same comprehensive neurocognitive test battery as used at T1, and reassessed with various symptom and behavior ratings and functional outcome measures. Both groups were characterized by reduced functional outcome at follow-up, although of different magnitude and type, compared with healthy controls. In the EOS group, neurocognitive baseline measures were associated with social functioning at follow-up (η2 between .26 and .41), while for the ADHD group, no significant predictions were found. Adolescents with EOS and ADHD are characterized by poor functional outcome compared with healthy controls when reassessed as young adults. Executive function, memory and attention were related to social and community functioning in EOS. For ADHD no significant predictions were found although functional outcome was poor. For both groups treatment should focus on training of social skills and activities of daily living to enhance the long-term functional outcome. For EOS cognitive remediation should also be considered. (c) 2010 APA, all rights reserved.

Learning and generalization from reward and punishment in opioid addiction

PubMed Central

Myers, Catherine E.; Rego, Janice; Haber, Paul; Morley, Kirsten; Beck, Kevin D.; Hogarth, Lee; Moustafa, Ahmed A.

2016-01-01

This study adapts a widely-used acquired equivalence paradigm to investigate how opioid-addicted individuals learn from positive and negative feedback, and how they generalize this learning. The opioid-addicted group consisted of 33 participants with a history of heroin dependency currently in a methadone maintenance program; the control group consisted of 32 healthy participants without a history of drug addiction. All participants performed a novel variant of the acquired equivalence task, where they learned to map some stimuli to correct outcomes in order to obtain reward, and to map other stimuli to correct outcomes in order to avoid punishment; some stimuli were implicitly “equivalent” in the sense of being paired with the same outcome. On the initial training phase, both groups performed similarly on learning to obtain reward, but as memory load grew, the control group outperformed the addicted group on learning to avoid punishment. On a subsequent testing phase, the addicted and control groups performed similarly on retention trials involving previously-trained stimulus-outcome pairs, as well as on generalization trials to assess acquired equivalence. Since prior work with acquired equivalence tasks has associated stimulus-outcome learning with the nigrostriatal dopamine system, and generalization with the hippocampal region, the current results are consistent with basal ganglia dysfunction in the opioid-addicted patients. Further, a selective deficit in learning from punishment could contribute to processes by which addicted individuals continue to pursue drug use even at the cost of negative consequences such as loss of income and the opportunity to engage in other life activities. PMID:27641323

Learning and generalization from reward and punishment in opioid addiction.

PubMed

Myers, Catherine E; Rego, Janice; Haber, Paul; Morley, Kirsten; Beck, Kevin D; Hogarth, Lee; Moustafa, Ahmed A

2017-01-15

This study adapts a widely-used acquired equivalence paradigm to investigate how opioid-addicted individuals learn from positive and negative feedback, and how they generalize this learning. The opioid-addicted group consisted of 33 participants with a history of heroin dependency currently in a methadone maintenance program; the control group consisted of 32 healthy participants without a history of drug addiction. All participants performed a novel variant of the acquired equivalence task, where they learned to map some stimuli to correct outcomes in order to obtain reward, and to map other stimuli to correct outcomes in order to avoid punishment; some stimuli were implicitly "equivalent" in the sense of being paired with the same outcome. On the initial training phase, both groups performed similarly on learning to obtain reward, but as memory load grew, the control group outperformed the addicted group on learning to avoid punishment. On a subsequent testing phase, the addicted and control groups performed similarly on retention trials involving previously-trained stimulus-outcome pairs, as well as on generalization trials to assess acquired equivalence. Since prior work with acquired equivalence tasks has associated stimulus-outcome learning with the nigrostriatal dopamine system, and generalization with the hippocampal region, the current results are consistent with basal ganglia dysfunction in the opioid-addicted patients. Further, a selective deficit in learning from punishment could contribute to processes by which addicted individuals continue to pursue drug use even at the cost of negative consequences such as loss of income and the opportunity to engage in other life activities. Published by Elsevier B.V.

Enhancing the parent-child relationship: a Hong Kong community-based randomized controlled trial.

PubMed

Fabrizio, Cecilia S; Stewart, Sunita M; Ip, Alison K Y; Lam, Tai Hing

2014-02-01

Adolescence is a critical risk period for negative academic and behavioral outcomes, but a strong parent-child relationship can be a powerful protective factor. Our previous pilot of an academic-community agency collaborative randomized controlled trial (RCT) demonstrated initial evidence of benefit for a parenting intervention with preadolescents in Hong Kong. The present RCT assessed the effect of brief training in positive discipline parenting skills on parental satisfaction with the parent-child relationship. A community sample of 461 Hong Kong Chinese parents of children aged 10-13 years were randomized to (a) the Harmony@Home intervention, (b) an attention control, or (c) a third active intervention that shared the control group. Participants were followed for 12 months and multiple methods of assessment were used. Compared with the control group, the Harmony@Home group reported an increase in the primary outcome of satisfaction with the parent-child relationship at 3 months' postintervention. Although results are mixed, this study demonstrates how a culturally adaptive community intervention can improve the parental behaviors that serve as protective factors against negative academic and behavioral outcomes for Chinese adolescents.

Work-focused cognitive behavioral intervention for psychological complaints in patients on sick leave due to work-related stress: Results from a randomized controlled trial.

PubMed

Dalgaard, Vita Ligaya; Andersen, Lars Peter Sønderbo; Andersen, Johan Hviid; Willert, Morten Vejs; Carstensen, Ole; Glasscock, David John

2017-08-22

Work-related stress is a global problem with negative implications for individuals and society. The purpose of the current study was to evaluate a stress management intervention for patients on sick leave due to work-related stress complaints using a three-armed randomized controlled design. Participants were patients referred from three municipalities to the regional Department of Occupational Medicine. Inclusion criteria were: 1) sick leave due to work-related stress complaints, 2) a diagnosis of adjustment disorder or reactions to severe stress (ICD 10 code: F43,2 - F 43,9 not PTSD) or mild depressive episode (F 32.0). Through a double randomization procedure patients (n = 163) were randomized to either an intervention group (n = 58), a 'control group A' receiving a clinical examination (n = 56), or 'control group B' (n = 49) receiving no offers at the department. The intervention comprised six sessions of individual cognitive behavioral therapy and the offer of a small workplace intervention. Questionnaire data were analyzed with multivariate repeated measurements analysis. Primary outcomes assessed were perceived stress and general mental health. Secondary outcomes were sleep quality and cognitive failures. Follow-up was at four and 10 months after baseline. Complaints were significantly reduced in all groups over time. No group effects were observed between the intervention group and control group A that was clinically assessed. Significant group effects were found for perceived stress and memory when comparing the intervention group to group B, but most likely not due to an intervention effect. Psychological complaints improved substantially over time in all groups, but there was no significant treatment effect on any outcomes when the intervention group was compared to control group A that received a clinical assessment. ISRCTN ISRCTN91404229. Registered 03 August 2012 (retrospectively registered).

Use of a goal setting intervention to increase adherence to low back pain rehabilitation: a randomized controlled trial.

PubMed

Coppack, Russell J; Kristensen, Jakob; Karageorghis, Costas I

2012-11-01

To examine the effects of a goal setting intervention on self-efficacy, treatment efficacy, adherence and treatment outcome in patients undergoing low back pain rehabilitation. A mixed-model 2 (time) × 3 (group) randomized controlled trial. A residential rehabilitation centre for military personnel. UK military personnel volunteers (N = 48); mean age was 32.9 (SD 7.9) with a diagnosis of non-specific low back pain. Subjects were randomly assigned to either a goal setting experimental group (Exp, n = 16), therapist-led exercise therapy group (C1, n = 16) or non-therapist-led exercise therapy group (C2, n = 16). Treatment duration for all groups was three weeks. Self-efficacy, treatment efficacy and treatment outcome were recorded before and after the treatment period. Adherence was rated during regularly scheduled treatment sessions using the Sports Injury Rehabilitation Adherence Scale (SIRAS). The Biering-Sørensen test was used as the primary measure of treatment outcome. ANCOVA results showed that adherence scores were significantly higher in the experimental group (13.70 ± 1.58) compared with C2 (11.74 ± 1.35), (P < 0.025). There was no significant difference for adherence between the experimental group and C1 (P = 0.13). Self-efficacy was significantly higher in the experimental group compared to both C1 and C2 (P < 0.05), whereas no significant difference was found for treatment efficacy. Treatment outcome did not differ significantly between the experimental and two control groups. The findings provide partial support for the use of goal setting to enhance adherence in clinical rehabilitation.

Awake craniotomy may further improve neurological outcome of intraoperative MRI-guided brain tumor surgery.

PubMed

Tuominen, Juho; Yrjänä, Sanna; Ukkonen, Anssi; Koivukangas, John

2013-10-01

Results of awake craniotomy are compared to results of resections done under general anesthesia in patients operated with IMRI control. We hypothesized that stimulation of the cortex and white matter during awake surgery supplements IMRI control allowing for safer resection of eloquent brain area tumors. The study group consisted of 20 consecutive patients undergoing awake craniotomy with IMRI control. Resection outcome of these patients was compared to a control group of 20 patients operated in the same IMRI suite but under general anesthesia without cortical stimulation. The control group was composed of those patients whose age, sex, tumor location, recurrence and histology best matched to patients in study group. Cortical stimulation identified functional cortex in eight patients (40 %). Postoperatively the neurological condition in 16 patients (80 %) in the study group was unchanged or improved compared with 13 patients (65 %) in the control group. In both groups, three patients (15 %) had transient impairment symptoms. There was one patient (5 %) with permanent neurological impairment in the study group compared to four patients (20 %) in the control group. These differences between groups were not statistically significant. There was no surgical mortality in either group and the overall infection rate was 5 %. Mean operation time was 4 h 45 min in the study group and 3 h 15 min in the control group. The study consisted of a limited patient series, but it implies that awake craniotomy with bipolar cortical stimulation may help to reduce the risk of postoperative impairment following resection of tumors located in or near speech and motor areas also under IMRI control.

Effect of Health Education Based on Integrative Therapy of Chinese and Western Medicine for Adult Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Study.

PubMed

Shi, Mai; Liu, Zhao-Lan; Zhu, Yan-Bo; Xu, Mei-Yan; Duan, Xue-Ying; Shi, Hui-Mei; Jiang, Bo; Zhang, Xiao-Mei; Yu, Xiao-Han

2018-02-01

To investigate the effects of health education based on integrative therapy of Chinese and Western medicine for type 2 diabetes mellitus (T2DM) from the aspects of knowledge, attitude and practice (KAP), health-related quality of life (HRQoL), body mass index (BMI) and glucose control. Patients were individually randomized into intervention group (receiving integrative education, n=120) and control group (receiving usual education, n=120). The primary outcome was the changes in glycosylated hemoglobin A1c (HbA1c) levels after 3, 6, 9 and 12 months from baseline. Hierarchical linear models (HLMs) were used to assess within-group changes in outcomes over time and between-group differences in patterns of change. Secondary outcomes were KAP scores, HRQoL scores and BMI after 6 and 12 months, paired-sample t test was used to assess within-group changes in outcomes in 6 and 12 months, independent-sample t test was used to assess between-group differences in patterns of change. HbA1c decreased statistically from baseline to 3 months, from 3 to 6 months, from 6 to 9 months and from 9 to 12 months in the intervention group (all P<0.01); and decreased significantly from baseline to 3 months, and from 3 to 6 months in the control group P<0.01). There was a significant between-group difference from baseline to 3 months (P=0.044), from 6 to 9 months (P<0.01) and from 9 to 12 months (P<0.01). Significant improvements in the intervention group along with significant between-group differences were found in KAP and HRQoL scores respectively (all P<0.05). The number in the intervention group of normal weight increased from 56 at baseline to 81 (6 months), 94 (12 months), the number in the control group were 63 (baseline), 69 (6 months), 70 (12 months), the χ 2 of hierarchical analysis of BMI were 6.93 (P=0.075), 10.31 (P=0.016), 15.53 (P<0.01), respectively. Health education based on integrative therapy of Chinese and Western medicine is beneficial to the control of T2DM and should be recommended for T2DM.

Opportunistic salpingectomy in women undergoing hysterectomy: Results from the HYSTUB randomised controlled trial.

PubMed

Van Lieshout, L A M; Pijlman, B; Vos, M C; de Groot, M J M; Houterman, S; Coppus, S F P J; Harmsen, M G; Vandenput, I; Piek, J M J

2018-01-01

To evaluate whether opportunistic salpingectomy in premenopausal women undergoing hysterectomy for benign indications is both hormonally and surgically safe, compared with hysterectomy without salpingectomy. In this multicentre randomised controlled trial, women were randomised to undergo either hysterectomy with opportunistic bilateral salpingectomy (intervention group) or standard hysterectomy with preservation of the Fallopian tubes (control group). The primary outcome was the difference in serum anti-Müllerian hormone concentration (ΔAMH), measured pre-surgery and 6 months post-surgery. Secondary outcomes were surgical outcomes and duration of hospital stay. The sample size was powered at 50 participants per group (n=100) to compare ΔAMH after hysterectomy with salpingectomy to ΔAMH after standard hysterectomy. Between March 2013 and December 2016, 104 women, aged 30-55 years, were randomly allocated to hysterectomy with opportunistic bilateral salpingectomy (n=52) or standard hysterectomy (n=52). The baseline characteristics did not differ between the two groups. The median ΔAMH was -0.14pmol/L (IQR -1.47-0.95) in the intervention group and 0.00pmol/L (IQR -1.05-0.80) in the control group (p=0.49). The addition of salpingectomy did not impair surgical results and it did not affect duration of hospital stay. Addition of opportunistic bilateral salpingectomy during hysterectomy did not result in a larger effect on ovarian reserve when compared with hysterectomy alone, neither did it affect surgical outcomes. Therefore, opportunistic salpingectomy seems to be a safe procedure in premenopausal women undergoing hysterectomy for benign gynaecological conditions. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of oral contraceptives and metformin on the outcome of in vitro maturation in infertile women with polycystic ovary syndrome.

PubMed

Zhao, Jun-Zhao; Lin, Jin-Ju; Yang, Hai-Yan; Zhang, Wei; Huang, Xue-Feng; Huang, Yin-Ping

2010-02-01

Abstract Objective: To evaluate the effects of oral contraceptives and metformin on the outcome of in vitro maturation (IVM) in infertile women with polycystic ovary syndrome (PCOS). This is a retrospective study of 108 women with PCOS, subject to 152 cycles of IVM treatment. The study was held at the Reproductive Medicine Center of the First Affiliated Hospital of Wenzhou Medical College, People's Republic of China. Before entering IVM treatment, 54 patients who received oral contraceptive pill (marvelon, 0.15 mg desogestrel, and 0.03 mg ethinylestradiol), one tablet every day, and metformin 500 mg twice or three times per day were defined as the pretreated group, and another 64 patients who were not administered any drugs as the control group. The main outcome measures were the rates of oocyte maturation, fertilization, cleavage, miscarriage, clinical pregnancy, and live birth. There were no significant differences between the two groups in the rates of oocyte maturation, fertilization, cleavage, and clinical pregnancy (p > 0.05). A significantly lower miscarriage rate was obtained in the pretreated group than in the control group (16.13% vs 4.0%, p < 0.01). The live birth rate per embryo transfer seemed to be higher in the pretreated group than in the control group (37.70% vs 30.38%, p = 0.363), but was not statistically significant. Pretreatment with oral contraceptives and metformin improved the outcome of IVM related to the miscarriage rate and possibly also live birth rate.

A self-management intervention for African Americans with comorbid diabetes and hypertension: a pilot randomized controlled trial.

PubMed

Lynch, Elizabeth B; Liebman, Rebecca; Ventrelle, Jennifer; Avery, Elizabeth F; Richardson, DeJuran

2014-05-29

The objective of this pilot 6-month randomized controlled trial was to determine the effectiveness of an intensive, community-based, group intervention that focused on diet, physical activity, and peer support for reducing weight among urban-dwelling African Americans with comorbid type 2 diabetes and hypertension. Sixty-one participants were randomized into an intervention or control group. The 6-month intervention consisted of 18 group sessions led by a dietitian in a community setting and weekly telephone calls from a peer supporter. The intervention featured culturally tailored nutrition education, behavioral skills training, and social support focused on changes to diet and physical activity. The control group consisted of two 3-hour group sessions of diabetes self-management education taught by a community health worker. Outcome measures were assessed at baseline and 6 months. The primary outcome was achievement of a 5% weight reduction at 6 months. A secondary outcome was achievement of a 0.5 percentage-point reduction in hemoglobin A1c (HbA1c). Groups did not differ in achievement of the weight-loss goal. Intervention participants lost a mean of 2.8 kg (P = .01); control participants did not lose a significant amount of weight. A greater proportion of intervention (50.0%) than control (21.4%) participants reduced HbA1c by 0.5 percentage points or more at 6 months (P = .03). The intervention was more effective than usual care (short-term diabetes education) at improving glycemic control, but not weight, in low-income African Americans with comorbid diabetes and hypertension. A community-based 6-month group class with culturally tailored education, behavioral skills training, and peer support can lead to a clinically significant reduction in HbA1c.

Effectiveness of an exercise programme on physical function in patients discharged from hospital following critical illness: a randomised controlled trial (the REVIVE trial).

PubMed

McDowell, Kathryn; O'Neill, Brenda; Blackwood, Bronagh; Clarke, Chris; Gardner, Evie; Johnston, Paul; Kelly, Michaeline; McCaffrey, John; Mullan, Brian; Murphy, Sally; Trinder, T John; Lavery, Gavin; McAuley, Daniel F; Bradley, Judy M

2017-07-01

To investigate the effectiveness of a 6-week exercise programme in patients discharged home following critical illness compared with standard care. Multicentre prospective phase II randomised controlled trial, with blinded outcome assessment after hospital discharge, following the 6-week intervention and at 6 months. 60 patients (30 per group) aged ≥18 years, mechanically ventilated >96 hours, and not in other rehabilitation, that is, cardiac or pulmonary rehabilitation programmes. Participants in the intervention group completed an individually tailored (personalised) exercise programme. Primary outcome measure was SF-36 physical functioning following the intervention. Secondary outcomes included a range of performance-based and patient-reported measures. Improvements in the primary outcome did not differ significantly between groups (mean difference (95% CI) 3.0 (-2.2 to 8.2), p=0.26). The intervention group showed significant improvement compared with the control group (mean difference (95% CI)) in SF-36 role physical (6.6 (0.73 to 12.5), p=0.03); incremental shuttle walk test (83.1 m (8.3 to 157.9), p=0.03); functional limitations profile (-4.8 (-8.7 to -0.9), p=0.02); self-efficacy to exercise (2.2 (0.8 to 3.7), p=0.01) and readiness to exercise (1.3 (0.8 to 1.9), p<0.001). These improvements were not sustained at 6 months except readiness to exercise. Improvements in all other secondary outcome measures were not significant. There was no statistically significant difference in the primary outcome measure of self-reported physical function following this 6-week exercise programme. Secondary outcome results will help inform future studies. NCT01463579. (results), https://clinicaltrials.gov/. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Support and Assessment for Fall Emergency Referrals (SAFER) 2: a cluster randomised trial and systematic review of clinical effectiveness and cost-effectiveness of new protocols for emergency ambulance paramedics to assess older people following a fall with referral to community-based care when appropriate.

PubMed

Snooks, Helen A; Anthony, Rebecca; Chatters, Robin; Dale, Jeremy; Fothergill, Rachael; Gaze, Sarah; Halter, Mary; Humphreys, Ioan; Koniotou, Marina; Logan, Phillipa; Lyons, Ronan; Mason, Suzanne; Nicholl, Jon; Peconi, Julie; Phillips, Ceri; Phillips, Judith; Porter, Alison; Siriwardena, A Niroshan; Smith, Graham; Toghill, Alun; Wani, Mushtaq; Watkins, Alan; Whitfield, Richard; Wilson, Lynsey; Russell, Ian T

2017-03-01

Emergency calls are frequently made to ambulance services for older people who have fallen, but ambulance crews often leave patients at the scene without any ongoing care. We evaluated a new clinical protocol which allowed paramedics to assess older people who had fallen and, if appropriate, refer them to community-based falls services. To compare outcomes, processes and costs of care between intervention and control groups; and to understand factors which facilitate or hinder use. Cluster randomised controlled trial. Participating paramedics at three ambulance services in England and Wales were based at stations randomised to intervention or control arms. Participants were aged 65 years and over, attended by a study paramedic for a fall-related emergency service call, and resident in the trial catchment areas. Intervention paramedics received a clinical protocol with referral pathway, training and support to change practice. Control paramedics continued practice as normal. The primary outcome comprised subsequent emergency health-care contacts (emergency admissions, emergency department attendances, emergency service calls) or death at 1 month and 6 months. Secondary outcomes included pathway of care, ambulance service operational indicators, self-reported outcomes and costs of care. Those assessing outcomes remained blinded to group allocation. Across sites, 3073 eligible patients attended by 105 paramedics from 14 ambulance stations were randomly allocated to the intervention group, and 2841 eligible patients attended by 110 paramedics from 11 stations were randomly allocated to the control group. After excluding dissenting and unmatched patients, 2391 intervention group patients and 2264 control group patients were included in primary outcome analyses. We did not find an effect on our overall primary outcome at 1 month or 6 months. However, further emergency service calls were reduced at both 1 month and 6 months; a smaller proportion of patients had made further emergency service calls at 1 month (18.5% vs. 21.8%) and the rate per patient-day at risk at 6 months was lower in the intervention group (0.013 vs. 0.017). Rate of conveyance to emergency department at index incident was similar between groups. Eight per cent of trial eligible patients in the intervention arm were referred to falls services by attending paramedics, compared with 1% in the control arm. The proportion of patients left at scene without further care was lower in the intervention group than in the control group (22.6% vs. 30.3%). We found no differences in duration of episode of care or job cycle. No adverse events were reported. Mean cost of the intervention was £17.30 per patient. There were no significant differences in mean resource utilisation, utilities at 1 month or 6 months or quality-adjusted life-years. In total, 58 patients, 25 paramedics and 31 stakeholders participated in focus groups or interviews. Patients were very satisfied with assessments carried out by paramedics. Paramedics reported that the intervention had increased their confidence to leave patients at home, but barriers to referral included patients' social situations and autonomy. Findings indicate that this new pathway may be introduced by ambulance services at modest cost, without risk of harm and with some reductions in further emergency calls. However, we did not find evidence of improved health outcomes or reductions in overall NHS emergency workload. Further research is necessary to understand issues in implementation, the costs and benefits of e-trials and the performance of the modified Falls Efficacy Scale. Current Controlled Trials ISRCTN60481756 and PROSPERO CRD42013006418. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 13. See the NIHR Journals Library website for further project information.

Eight Weeks of Strength and Power Training Improves Club Head Speed in Collegiate Golfers.

PubMed

Oranchuk, Dustin J; Mannerberg, Jason M; Robinson, Tracey L; Nelson, Megan C

2018-02-14

Club head speed (CHS) is a major determinant of drive distance, a key component of golf performance. The purpose of this study was to determine the indirect effects of an eight-week strength and power program on CHS. Twelve (6 male, 6 female) NCAA Division II golfers (20.3±1.5 years) randomly assigned to an intervention or control group, underwent either a periodized strength and power program consisting of high-load barbell movements or a bodyweight and rotational movement focused resistance training program. Outcomes were CHS, countermovement jump (CMJ) height, and 1RM back squat (BS), power clean (PC), and deadlift (DL). Dependent t-tests were utilized to assess differences in outcome variables pre-to-post for each group, independent t-tests were utilized to assess differences between groups, and Pearson correlations were utilized to assess associations between CHS and outcome variables. On average, the intervention group experienced improvements in all outcome variables except peak CHS (p=0.60); the control group displayed no changes in any outcome variable except a decrease in average CHS (p=0.028). Compared to the control group, the intervention group experienced greater improvements in average CHS, BS, PC, and average and peak CMJ height (p<0.05). Additionally, CHS had large associations with PC (r=0.70, p=0.012), BS (r=0.64, p=0.025), DL (r=0.54, p=0.068) and CMJ (r=0.73, p=0.007). These results suggest improving muscular strength and power by increasing PC, BS, and CMJ is associated with increased CHS in collegiate golfers. Integrating a high-load, barbell-focused strength and power program may be beneficial for improving CHS and indirectly, golf performance.

Hydrotherapy improves pain and function in older women with knee osteoarthritis: a randomized controlled trial.

PubMed

Dias, João Marcos; Cisneros, Lígia; Dias, Rosângela; Fritsch, Carolina; Gomes, Wellington; Pereira, Leani; Santos, Mary Luci; Ferreira, Paulo Henrique

Currently, there is poor evidence of the effect of hydrotherapy alone on patients with hip or knee osteoarthritis. The study aimed to assess the impact of hydrotherapy on pain, function, and muscle function in older women with knee osteoarthritis. A randomized controlled trial was conducted to evaluate the efficacy of hydrotherapy in women with knee osteoarthritis. Seventy-three women aged 65 and older were randomized to hydrotherapy (n=36) or a control group (n=37). The hydrotherapy group received the intervention program in a heated pool (twice per week for six weeks) and an educational protocol while the control group received an educational protocol only. Primary outcomes (before and post-treatment) were pain intensity (0-100) and function (0-100), assessed with the WOMAC questionnaire. Secondary outcomes (before and post-treatment) were knee extensor and knee flexor muscle performance (strength, power, and endurance), assessed by an isokinetic dynamometer. The magnitude of change between the groups for the outcomes was calculated using linear regression models adjusted by baseline outcome values. The hydrotherapy group had better outcomes for pain (adjusted mean difference=11 points, 95% CI: 3-18) and function (adjusted mean difference=12 points, 95% CI: 5-18). Patients receiving hydrotherapy had better performance for knee flexor and extensor strength, knee flexor power, and knee extensor endurance. Older women with knee osteoarthritis are likely to have benefits from a course of hydrotherapy exercises. Registry of clinical trials (Trial number RBR-8F57KR) - http://www.ensaiosclinicos.gov.br/rg/RBR-8f57kr/. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Recovery of function following hip resurfacing arthroplasty: a randomized controlled trial comparing an accelerated versus standard physiotherapy rehabilitation programme.

PubMed

Barker, Karen L; Newman, Meredith A; Hughes, Tamsin; Sackley, Cath; Pandit, Hemant; Kiran, Amit; Murray, David W

2013-09-01

To identify if a tailored rehabilitation programme is more effective than standard practice at improving function in patients undergoing metal-on-metal hip resurfacing arthroplasty. Randomized controlled trial. Specialist orthopaedic hospital. 80 men with a median age of 56 years. Tailored post-operative physiotherapy programme compared with standard physiotherapy. Primary outcome - Oxford Hip Score (OHS), Secondary outcomes: Hip disability and Osteoarthritis Outcome Score (HOOS), EuroQol (EQ-5D-3L) and UCLA activity score. Hip range of motion, hip muscle strength and patient selected goals were also assessed. At one year the mean (SD) Oxford Hip Score of the intervention group was higher, 45.1 (5.3), than the control group, 39.6 (8.8). This was supported by a linear regression model, which detected a 5.8 unit change in Oxford Hip Score (p < 0.001), effect size 0.76. There was a statistically significant increase in Hip disability and Osteoarthritis Outcome Score of 12.4% (p < 0.0005), effect size 0.76; UCLA activity score differed by 0.66 points (p < 0.019), effect size 0.43; EQ 5D showed an improvement of 0.85 (p < 0.0005), effect size 0.76. A total of 80% (32 of 40) of the intervention group fully met their self-selected goal compared with 55% (22 of 40) of the control group. Hip range of motion increased significantly; hip flexion by a mean difference 17.9 degrees (p < 0.0005), hip extension by 5.7 degrees (p < 0.004) and abduction by 4 degrees (p < 0.05). Muscle strength improved more in the intervention group but was not statistically significant. A tailored physiotherapy programme improved self-reported functional outcomes and hip range of motion in patients undergoing hip resurfacing.

Common and distinct neural features of social and non-social reward processing in autism and social anxiety disorder.

PubMed

Richey, John A; Rittenberg, Alison; Hughes, Lauren; Damiano, Cara R; Sabatino, Antoinette; Miller, Stephanie; Hanna, Eleanor; Bodfish, James W; Dichter, Gabriel S

2014-03-01

Autism spectrum disorders (ASDs) and social anxiety disorder (SAD) are both characterized by social dysfunction, but no study to date has compared neural responses to social rewards in ASDs and SAD. Neural responses during social and non-social reward anticipation and outcomes were examined in individuals with ASD (n = 16), SAD (n = 15) and a control group (n = 19) via functional magnetic resonance imaging. Analyses modeling all three groups revealed increased nucleus accumbens (NAc) activation in SAD relative to ASD during monetary reward anticipation, whereas both the SAD and ASD group demonstrated decreased bilateral NAc activation relative to the control group during social reward anticipation. During reward outcomes, the SAD group did not differ significantly from the other two groups in ventromedial prefrontal cortex activation to either reward type. Analyses comparing only the ASD and SAD groups revealed greater bilateral amygdala activation to social rewards in SAD relative to ASD during both anticipation and outcome phases, and the magnitude of left amygdala hyperactivation in the SAD group during social reward anticipation was significantly correlated with the severity of trait anxiety symptoms. Results suggest reward network dysfunction to both monetary and social rewards in SAD and ASD during reward anticipation and outcomes, but that NAc hypoactivation during monetary reward anticipation differentiates ASD from SAD.

Moderating effect of gender on the prospective relation of physical activity with psychosocial outcomes and asthma control in adolescents: a longitudinal study.

PubMed

Tiggelman, Dana; van de Ven, Monique O M; van Schayck, Onno C P; Engels, Rutger C M E

2014-12-01

Adolescents with asthma experience more psychosocial and physiological problems compared to their healthy peers. Physical activity (PA) might decrease these problems. This study was the first observational longitudinal study to examine whether habitual PA could predict changes in psychosocial outcomes (i.e., symptoms of anxiety and depression, quality of life [QOL] and stress) and asthma control over time in adolescents with asthma and whether gender moderated these relationships. Adolescents with asthma (N = 253; aged 10-14 years at baseline) were visited at home in the spring/summer of 2012 and 2013. They completed questionnaires assessing their habitual PA, symptoms of anxiety and depression, QOL, perceived stress and asthma control. Path analyses using Mplus were conducted to examine longitudinal relationships among habitual PA, psychosocial outcomes and asthma control (controlled for body mass index, age and gender). Using multi-group analyses, we examined whether gender moderated these relationships. Path analyses in the total group showed that habitual PA did not predict changes in psychosocial outcomes or asthma control over time. Multi-group analyses showed that gender moderated the relation of habitual PA with anxiety and depression. Habitual PA only significantly predicted a decrease in anxiety and depression over time for girls but not for boys. Increasing habitual PA in girls with asthma might decrease their symptoms of anxiety and depression.

Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial.

PubMed

Waldén, Markus; Atroshi, Isam; Magnusson, Henrik; Wagner, Philippe; Hägglund, Martin

2012-05-03

To evaluate the effectiveness of neuromuscular training in reducing the rate of acute knee injury in adolescent female football players. Stratified cluster randomised controlled trial with clubs as the unit of randomisation. 230 Swedish football clubs (121 in the intervention group, 109 in the control group) were followed for one season (2009, seven months). 4564 players aged 12-17 years (2479 in the intervention group, 2085 in the control group) completed the study. 15 minute neuromuscular warm-up programme (targeting core stability, balance, and proper knee alignment) to be carried out twice a week throughout the season. The primary outcome was rate of anterior cruciate ligament injury; secondary outcomes were rates of severe knee injury (>4 weeks' absence) and any acute knee injury. Seven players (0.28%) in the intervention group, and 14 (0.67%) in the control group had an anterior cruciate ligament injury. By Cox regression analysis according to intention to treat, a 64% reduction in the rate of anterior cruciate ligament injury was seen in the intervention group (rate ratio 0.36, 95% confidence interval 0.15 to 0.85). The absolute rate difference was -0.07 (95% confidence interval -0.13 to 0.001) per 1000 playing hours in favour of the intervention group. No significant rate reductions were seen for secondary outcomes. A neuromuscular warm-up programme significantly reduced the rate of anterior cruciate ligament injury in adolescent female football players. However, the absolute rate difference did not reach statistical significance, possibly owing to the small number of events. Clinical trials NCT00894595.

Randomized web-based physical activity intervention in adolescent survivors of childhood cancer.

PubMed

Howell, Carrie R; Krull, Kevin R; Partin, Robyn E; Kadan-Lottick, Nina S; Robison, Leslie L; Hudson, Melissa M; Ness, Kirsten K

2018-05-03

Healthy lifestyle choices, including participation in regular physical activity, may improve health outcomes in survivors of childhood cancer. We aimed to evaluate the efficacy of a web-delivered physical activity intervention among adolescent survivors to increase moderate to vigorous physical activity (MVPA) and improve fitness and neurocognitive and health-related quality of life (HRQoL) over 24 weeks. This randomized controlled trial was conducted among survivors (aged ≥11 to <15 years) treated at a single institution. Participants were randomized to either a physical activity intervention delivered over the internet or a control group. The intervention group received educational materials, an activity monitor, and access to an interactive website designed to motivate increased physical activity via rewards; the control group received an activity monitor and educational materials. Physical activity, fitness, and neurocognitive and HRQoL outcomes were assessed at baseline and at 24 weeks. Mean changes were compared between groups using paired t-tests. Of the 97 survivors enrolled, 78 completed the study; the mean age was 12.7 (standard deviation 1.1), 80% were White, and 55.1% were female. Fifty-three survivors were assigned to the intervention and 25 to the control group. While survivors in the intervention group increased, and those in the control group decreased (4.7 ± 119.9 vs. -24.3 ± 89.7 min) weekly MVPA, this difference was not significant (P = 0.30). However, hand grip strength, number of sit-ups and pushups, neurocognitive function, and HRQoL outcomes improved in the intervention, but not in the control group. An interactive, rewards-based intervention designed to increase MVPA is feasible in adolescent survivors of childhood cancer. © 2018 Wiley Periodicals, Inc.

Randomized controlled trial of a good practice approach to treatment of childhood obesity in Malaysia: Malaysian Childhood Obesity Treatment Trial (MASCOT).

PubMed

Wafa, Sharifah W; Talib, Ruzita A; Hamzaid, Nur H; McColl, John H; Rajikan, Roslee; Ng, Lai O; Ramli, Ayiesah H; Reilly, John J

2011-06-01

Few randomized controlled trials (RCTs) of interventions for the treatment of childhood obesity have taken place outside the Western world. To test whether a good practice intervention for the treatment of childhood obesity would have a greater impact on weight status and other outcomes than a control condition in Kuala Lumpur, Malaysia. Assessor-blinded RCT of a treatment intervention in 107 obese 7- to 11-year olds. The intervention was relatively low intensity (8 hours contact over 26 weeks, group based), aiming to change child sedentary behavior, physical activity, and diet using behavior change counselling. Outcomes were measured at baseline and six months after the start of the intervention. Primary outcome was BMI z-score, other outcomes were weight change, health-related quality of life (Peds QL), objectively measured physical activity and sedentary behavior (Actigraph accelerometry over 5 days). The intervention had no significant effect on BMI z score relative to control. Weight gain was reduced significantly in the intervention group compared to the control group (+1.5 kg vs. +3.5 kg, respectively, t-test p < 0.01). Changes in health-related quality of life and objectively measured physical activity and sedentary behavior favored the intervention group. Treatment was associated with reduced rate of weight gain, and improvements in physical activity and quality of life. More substantial benefits may require longer term and more intensive interventions which aim for more substantive lifestyle changes.

Effects of Periodontal Therapy on Rate of Preterm Delivery A Randomized Controlled Trial

PubMed Central

Offenbacher, Steven; Beck, James D.; Jared, Heather L.; Mauriello, Sally M.; Mendoza, Luisto C.; Couper, David J.; Stewart, Dawn D.; Murtha, Amy P.; Cochran, David L.; Dudley, Donald J.; Reddy, Michael S.; Geurs, Nicolaas C.; Hauth, John C.

2010-01-01

OBJECTIVE To test the effects of maternal periodontal disease treatment on the incidence of preterm birth (delivery before 37 weeks of gestation). METHODS The Maternal Oral Therapy to Reduce Obstetric Risk Study was a randomized, treatment-masked, controlled clinical trial of pregnant women with periodontal disease who were receiving standard obstetric care. Participants were assigned to either a periodontal treatment arm, consisting of scaling and root planing early in the second trimester, or a delayed treatment arm that provided periodontal care after delivery. Pregnancy and maternal periodontal status were followed to delivery and neonatal outcomes until discharge. The primary outcome (gestational age less than 37 weeks) and the secondary outcome (gestational age less than 35 weeks) were analyzed using a χ2 test of equality of two proportions. RESULTS The study randomized 1,806 patients at three performance sites and completed 1,760 evaluable patients. At baseline, there were no differences comparing the treatment and control arms for any of the periodontal or obstetric measures. The rate of preterm delivery for the treatment group was 13.1% and 11.5% for the control group (P=.316). There were no significant differences when comparing women in the treatment group with those in the control group with regard to the adverse event rate or the major obstetric and neonatal outcomes. CONCLUSION Periodontal therapy did not reduce the incidence of preterm delivery. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, www.clinicaltrials.gov, NCT00097656. LEVEL OF EVIDENCE I PMID:19701034

Effects of postexercise ice-water and room-temperature water immersion on the sensory organization of balance control and lower limb proprioception in amateur rugby players

PubMed Central

Chow, Gary C.C.; Yam, Timothy T.T.; Chung, Joanne W.Y.; Fong, Shirley S.M.

2017-01-01

Abstract Background: This single-blinded, three-armed randomized controlled trial aimed to compare the effects of postexercise ice-water immersion (IWI), room-temperature water immersion (RWI), and no water immersion on the balance performance and knee joint proprioception of amateur rugby players. Methods: Fifty-three eligible amateur rugby players (mean age ± standard deviation: 21.6 ± 2.9 years) were randomly assigned to the IWI group (5.3 °C), RWI group (25.0 °C), or the no immersion control group. The participants in each group underwent the same fatigue protocol followed by their allocated recovery intervention, which lasted for 1 minute. Measurements were taken before and after the fatigue-recovery intervention. The primary outcomes were the sensory organization test (SOT) composite equilibrium score (ES) and the condition-specific ES, which were measured using a computerized dynamic posturography machine. The secondary outcome was the knee joint repositioning error. Two-way repeated measures analysis of variance was used to test the effect of water immersion on each outcome variable. Results: There were no significant within- and between-group differences in the SOT composite ESs or the condition-specific ESs. However, there was a group-by-time interaction effect on the knee joint repositioning error. It seems that participants in the RWI group had lower errors over time, but those in the IWI and control groups had increased errors over time. The RWI group had significantly lower error score than the IWI group at postintervention. Conclusion: One minute of postexercise IWI or RWI did not impair rugby players’ sensory organization of balance control. RWI had a less detrimental effect on knee joint proprioception to IWI at postintervention. PMID:28207546

Effects of friendship closeness in an adolescent group HIV prevention intervention.

PubMed

Morrison, Diane M; Casey, Erin A; Beadnell, Blair A; Hoppe, Marilyn J; Gillmore, Mary Rogers; Wilsdon, Anthony; Higa, Darrel; Carlisle, Shauna; Wells, Elizabeth A

2007-12-01

Although many interventions for youth rely, explicitly or implicitly, on group effects, sparse theoretical or empirical attention has been paid to the rationale for choosing a small-group design. The present study assesses the role of friendship closeness among youth in prevention intervention groups in shaping their HIV risk-related attitudes, intentions, perceived self-efficacy and perceived norms. Data from an experimental test of a group HIV prevention intervention are used to assess the relationship of friendship on cognitive outcomes at posttest and 6-month follow-up, in a multilevel regression design. Friendship among group members was assessed at baseline and post-intervention, for youth in the experimental intervention and in a control, career exploration, condition. Level of friendship within the group was positively related to attendance and enjoyment of the intervention in the control group only. Most cognitive outcomes were unaffected by individual or group levels of friendship closeness, but those effects observed were opposite to those desired. Friendly groups were no more likely to converge in their cognitions over time than were less-friendly groups. The need for more research on the effects of friendship on intervention outcomes, and for multilevel analyses of group effects, are discussed.

A Randomized, Controlled Trial of Mindfulness-Based Stress Reduction in HIV Infection.

PubMed

Hecht, Frederick M; Moskowitz, Judith T; Moran, Patricia; Epel, Elissa S; Bacchetti, Peter; Acree, Michael; Kemeny, Margaret E; Mendes, Wendy B; Duncan, Larissa G; Weng, Helen; Levy, Jay A; Deeks, Steven G; Folkman, Susan

2018-05-26

Evidence links depression and stress to more rapid progression of HIV-1 disease. We conducted a randomized controlled trial to test whether an intervention aimed at improving stress management and emotion regulation, mindfulness-based stress reduction (MBSR), would improve immunological (i.e. CD4+ t-cell counts) and psychological outcomes in persons with HIV-1 infection. We randomly assigned participants with HIV-1 infection and CD4 T-cell counts > 350 cells/μl who were not on antiretroviral therapy in a 1:1 ratio to either an MBSR group (n=89) or an HIV disease self-management skills group (n=88). The study was conducted at the University of California at San Francisco. We assessed immunologic (CD4, c-reactive protein, IL-6, and d-dimer) and psychological measures (Beck Depression Inventory for depression, modified Differential Emotions Scale for positive and negative affect, Perceived stress-scale, and mindfulness) at 3, 6 and 12 months after initiation of the intervention; we used multiple imputation to address missing values. We observed statistically significant improvements from baseline to 3-months within the MBSR group in depression, positive and negative affect, perceived stress, and mindfulness; between group differences in change were significantly greater in the MBSR group only for positive affect (per item difference on DES-positive 0.25, 95% CI 0.049, 0.44, p = .015). By 12 months the between group difference in positive affect was not statistically significant, although both groups had trends toward improvements compared to baseline in several psychological outcomes that were maintained at 12-months; these improvements were only statistically significant for depression and negative affect in the MBSR group and perceived stress for the control group. The groups did not differ significantly on rates of antiretroviral therapy initiation (MBSR = 39%, control = 29%, p = .22). After 12 months, the mean decrease in CD4+ T-cell count was 49.6 cells/μl in participants in the MBSR arm, compared to 54.2 cells/μl in the control group, a difference of 4.6 cells favoring the MBSR group (95% CI, -44.6, 53.7, p=.85). The between group differences in other immunologic-related outcomes (c-reactive protein, IL-6, HIV-1 viral load, and d-dimer) were not statistically significant at any time point. MBSR improved positive affect more than an active control arm in the 3 months following the start of the intervention. However, this difference was not maintained over the 12-month follow-up and there were no significant differences in immunologic outcomes between intervention groups. These results emphasize the need for further carefully designed research if we are to translate evidence linking psychological states to immunological outcomes into evidence-based clinical practices. Copyright © 2018. Published by Elsevier Inc.

Inflammatory bowel disease: risk factors for adverse pregnancy outcome and the impact of maternal weight gain.

PubMed

Oron, Galia; Yogev, Yariv; Shcolnick, Smadar; Shkolnik, Smadar; Hod, Moshe; Fraser, Gerald; Wiznitzer, Arnon; Melamed, Nir

2012-11-01

To identify risk factors for adverse pregnancy outcome in women with inflammatory bowel disease (IBD) and to assess the effect of maternal pre-pregnancy weight and weight gain during pregnancy on pregnancy outcome. A retrospective, matched control study of all gravid women with IBD treated in a single tertiary center. Data were compared with healthy controls matched to by age, parity and pre-pregnancy BMI in a 3:1 ratio. Overall, 300 women were enrolled, 75 women in the study group (28 with ulcerative colitis and 47 with Crohn's disease) and 225 in the control group. The rates of preterm delivery and small for gestational age were higher in the study group (13.3 vs. 5.3% p = 0.02 and 6.7 vs. 0.9%, p = 0.004). The rate of cesarean section (36 vs. 19.1%; p = 0.002), NICU admission (10.7 vs. 4.0%, p = 0.03) and low 5-Min Apgar (4.0 vs. 0.4%, p = 0.02) were increased in the study group. Disease activity within 3 months of conception [OR 8.4 (1.3-16.3)] and maternal weight gain of less than 12 kg. [OR 3.6 (1.1-12.2)] were associated with adverse pregnancy outcome. Active disease at conception and inappropriate weight gain during pregnancy are associated with increased adverse pregnancy outcome in patients with IBD.

Can we alter pregnancy outcome by adjusting progesterone treatment at mid-luteal phase: a randomized controlled trial.

PubMed

Aslih, Nardin; Ellenbogen, Adrian; Shavit, Tal; Michaeli, Medeia; Yakobi, Devora; Shalom-Paz, Einat

2017-08-01

Our study aimed to determine whether mid-luteal serum P concentrations can serve as a predictive factor for in vitro fertilization (IVF) outcomes and whether increasing P dosage for patients with low levels at mid-luteal phase may improve pregnancy rates. It was a prospective, randomized controlled study. A total of 146 patients undergoing IVF treatment were prospectively enrolled and received routine luteal phase support (LPS) regimen of Endometrin® (progesterone) 200 mg/day. Serum P levels were measured 7 days after embryo transfer (ET). Considering a cutoff level of 15 ng/ml on this day, patients with higher levels continued the same dosage until pregnancy test (control group). Patients with lower levels were randomly allocated to continue Endometrin® 200 mg/day (Group A) or to increase Endometrin® dosage to 300 mg/day (Group B). The Main Outcome Measures were pregnancy rates. Both biochemical and clinical pregnancy and live birth rates were comparable between all groups regardless of P level on day 7 of luteal phase and regardless of dose adjustment. ROC analysis determined that mid-luteal P levels of 17 ng/ml can be a better predictor of cycle outcome. In conclusion raising the P dose at mid-luteal phase to 300 mg daily did not improve cycle outcomes.

Rotator cuff healing after needling of a calcific deposit using platelet-rich plasma augmentation: a randomized, prospective clinical trial.

PubMed

Verhaegen, Filip; Brys, Peter; Debeer, Philippe

2016-02-01

Arthroscopic needling of a rotator cuff calcification is a highly reliable operation in terms of pain relief and return of function. However, during the needling process, a cuff defect is created. Little is known about the evolution of this defect. We conducted a prospective, randomized controlled clinical trial to investigate the evolution of the aforementioned defect and the role of platelet-rich plasma (PRP) augmentation in this healing process. Patients were randomized to either group 1 (PRP, n = 20) or group 2 (no PRP [control group], n = 20). Patients in group 1 received a perioperative PRP infiltration at the rotator cuff defect, whereas the control group did not. Patients were assessed clinically preoperatively and postoperatively at 6 weeks, 3 and 6 months, and 1 year. The Constant score, Simple Shoulder Test, and QuickDASH (short version of Disabilities of the Arm, Shoulder and Hand questionnaire) were used as outcome measures. The evolution of the cuff defect was evaluated on sonography at 3 and 6 months and with magnetic resonance imaging after 1 year. All patients improved significantly after surgery (P < .05). There was no difference in clinical outcome or rotator cuff healing between groups. We observed a high rate of persistent rotator cuff defects after 1 year in both groups. The presence of residual cuff defects did not influence the clinical outcome. Arthroscopic needling is an operation with a predictive, good clinical outcome. We found a high rate of persistent rotator cuff defects after 1 year. This study could not identify any beneficial effect of the addition of PRP on rotator cuff healing. Level II; Randomized Controlled Trial; Treatment Study. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial.

PubMed

Fioravanti, Antonella; Manica, Patrizia; Bortolotti, Roberto; Cevenini, Gabriele; Tenti, Sara; Paolazzi, Giuseppe

2018-05-05

The aim of this study was to assess the efficacy and tolerability of balneotherapy (BT) in patients with primary fibromyalgia syndrome (FS). In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 100 FS patients were randomized to receive a cycle of BT with highly mineralized sulfate water (BT group) or with tap water (control group). Clinical assessments were performed at screening visit, at basal time, and after treatment (2 weeks, 3 and 6 months). The primary outcome measures were the change of global pain on the Visual Analogue Scale (VAS) and Fibromyalgia Impact Questionnaire total score (FIQ-Total) from baseline to 15 days. Secondary outcomes included Widespread Pain Index, Symptom Severity Scale Score, Short Form Health Survey, State-Trait Anxiety Inventory (STAI), and Center for Epidemiologic Studies Depression Scale. We performed an intent-to-treat analysis. The Kolmogorov-Smirnov test was applied to verify the normality distribution of all quantitative variables and the Student's t test to compare sample data. In the BT group, we observed a significant improvement of VAS and FIQ-Total at the end of the treatment that persisted until 6 months, while no significant differences were found in the control group. The differences between groups were significant for primary parameters at each time point. Similar results were obtained for the other secondary outcomes except for the STAI outcome. Adverse events were reported by 10 patients in the BT group and by 22 patients in the control group. Our results support the short- and long-term therapeutic efficacy of BT in FS. NCT02548065.

Effect of loss control service on reported injury incidence.

PubMed

Nave, Michael E; Veltri, Anthony

2004-01-01

A retrospective analysis evaluated the effectiveness of an insurance carrier's flexible loss control service strategy in reducing workers' compensation policyholders' reported injury and illness claims. To assess the effects of a loss control service strategy on workers' compensation claim frequency rates, on medical-only claim rates, on severity-claim rates, and on claim cost among a group of California employers. Eighty-two small- and medium-sized companies with workers' compensation policies expiring in 1999 were randomly selected from a population of policyholders assigned to loss control consultants for two or more years. Claim performance data were obtained for each company's first expired in-force policy year and its 1999 expired policy year. The retrospective design was combined with a control component based on a randomly selected comparison group of 45 companies whose first policy year with the insurer expired in 1999 and who received safety services from the loss control staff. The flexible loss control consultation service strategy was associated with lower average claim rates and costs. Companies assigned to a loss control consultant for two or more years (the "outcome group") had an average claim rate of 1.24 per $10,000 premium, compared with a rate of 1.62 in the "initial group" and a rate of 1.60 in the "comparison group." The average severity-claim rate of the outcome group was 0.32, compared with the initial-year and comparison-group means of 0.48 and 0.46, respectively. The average medical-only claim rate was 0.92, compared with the initial- and comparison-group means of 1.14 and 1.14. The outcome group's average loss ratio was over 10% lower than that of the initial and comparison groups. Statistical analysis indicated that differences among the groups' claim rates and severity-claim rates were [F=(2,206) 4.938, P=0.008] and [F=(2,206) 8.208, P<0.001], respectively. A loss control service strategy that provides service flexibility and develops partnership between employer and consultant can help reduce the frequency and severity of workers' compensation claims. Barriers to consultation service flexibility, both internal and external, should be identified and removed to enhance service efficacy.

The effectiveness of Pilates for partial anterior cruciate ligament injury.

PubMed

Çelik, Derya; Turkel, Nilgun

2017-08-01

This study explored the effects of Pilates on the muscle strength, function, and instability of patients with partial anterior cruciate ligament (ACL) injuries in situations in which a non-surgical treatment option is preferred. Fifty participants 20-45 years of age who were diagnosed with isolated ACL injuries were included in the study. The participants were randomly assigned to either the Pilates exercise group (n = 24) or the control group (n = 26). The subjects in the Pilates exercise group performed basic mat exercises that focused on the muscle strength and flexibility of the lower limbs and core muscles during each class session, which met three times per week for 12 weeks. The control group did not receive any treatment or home exercise programme. All patients were evaluated using the Lysholm Knee Scale, the Cincinnati Knee Rating System, and isokinetic quadriceps and hamstring strength. Patient satisfaction regarding improvement in knee stability was assessed using the Global Rating of Change scale. The Pilates group experienced significant improvement over the control group as measured by the difference in quadriceps strength at 12 weeks (p = 0.03). Both groups showed some clinical change over time, but the Pilates group improved for all outcome measurements at the 12-week follow-up, and the control group only improved for functional outcomes. Patient satisfaction with the level of knee stability based on the Global Rating of Change scale was higher in the Pilates group than in the control group. Although both groups exhibited improvements in knee strength and functional outcomes, the results suggest that Pilates is a superior management approach over a control treatment for increasing quadriceps strength in participants with partial ACL injury. Pilates may provide clinicians a novel option when choosing a treatment for a partial ACL injury. Further study is needed to determine whether certain subgroups of individuals might achieve an added benefit with this approach. II.

Fertility and pregnancy outcome in women with systemic sclerosis.

PubMed

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. However, a well-timed pregnancy with careful obstetric monitoring will maximize the likelihood of a successful outcome.

Nifedipine as a uterine relaxant for external cephalic version: a randomized controlled trial.

PubMed

Kok, Marjolein; Bais, Joke M; van Lith, Jan M; Papatsonis, Dimitri M; Kleiverda, Gunilla; Hanny, Dahrs; Doornbos, Johannes P; Mol, Ben W; van der Post, Joris A

2008-08-01

To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. In this randomized, double-blind, placebo-controlled trial, women with a singleton fetus in breech presentation and a gestational age of 36 weeks or more were eligible for enrollment. Participating women received two doses of either nifedipine 10 mg or placebo, 30 and 15 minutes before the external cephalic version attempt. The primary outcome was a cephalic-presenting fetus immediately after the procedure. Secondary outcome measures were cephalic presentation at delivery, mode of delivery, and adverse events. A sample size of 292 was calculated to provide 80% power to detect a 17% improvement of the external cephalic version success rate, assuming a placebo group rate of 40% and alpha of .05. Outcome data for 310 of 320 randomly assigned participants revealed no significant difference in external cephalic version success rates between treatment (42%) and control group (37%) (relative risk 1.1, 95%; 95% confidence interval 0.85-1.5). The cesarean delivery rate was 51% in the treatment group and 46% in the control group (relative risk 1.1, 95% confidence interval 0.88-1.4). Nifedipine did not significantly improve the success of external cephalic version. Future use of nifedipine to improve the outcome of external cephalic version should be limited to large clinical trials.

A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis.

PubMed

Forster, Anne; Dickerson, Josie; Young, John; Patel, Anita; Kalra, Lalit; Nixon, Jane; Smithard, David; Knapp, Martin; Holloway, Ivana; Anwar, Shamaila; Farrin, Amanda

2013-12-21

Most patients who have had a stroke are dependent on informal caregivers for activities of daily living. The TRACS trial investigated a training programme for caregivers (the London Stroke Carers Training Course, LSCTC) on physical and psychological outcomes, including cost-effectiveness, for patients and caregivers after a disabling stroke. We undertook a pragmatic, multicentre, cluster randomised controlled trial with a parallel cost-effectiveness analysis. Stroke units were eligible if four of five criteria used to define a stroke unit were met, a substantial number of patients on the unit had a diagnosis of stroke, staff were able to deliver the LSCTC, and most patients were discharged to a permanent place of residence. Stroke units were randomly assigned to either LSCTC or usual care (control group), stratified by geographical region and quality of care, and using blocks of size 2. Patients with a diagnosis of stroke, likely to return home with residual disability and with a caregiver providing support were eligible. The primary outcome for patients was self-reported extended activities of daily living at 6 months, measured with the Nottingham Extended Activities of Daily Living (NEADL) scale. The primary outcome for caregivers was self-reported burden at 6 months, measured with the caregivers burden scale (CBS). We combined patient and caregiver costs with primary outcomes and quality-adjusted life-years (QALYs) to assess cost-effectiveness. This trial is registered with controlled-trials.com, number ISRCTN 49208824. We assessed 49 stroke units for eligibility, of which 36 were randomly assigned to either the intervention group or the control group. Between Feb 27, 2008, and Feb 9, 2010, 928 patient and caregiver dyads were registered, of which 450 were in the intervention group, and 478 in the control group. Patients' self-reported extended activities of daily living did not differ between groups at 6 months (adjusted mean NEADL score 27·4 in the intervention group versus 27·6 in the control group, difference -0·2 points [95% CI -3·0 to 2·5], p value=0·866, ICC=0·027). The caregiver burden scale did not differ between groups either (adjusted mean CBS 45·5 in the intervention group versus 45·0 in the control group, difference 0·5 points [95% CI -1·7 to 2·7], p value=0·660, ICC=0·013). Patient and caregiver costs were similar in both groups (length of the initial stroke admission and associated costs were £13,127 for the intervention group and £12,471 for the control group; adjusted mean difference £1243 [95% CI -1533 to 4019]; p value=0·380). Probabilities of cost-effectiveness based on QALYs were low. In a large scale, robust evaluation, results from this study have shown no differences between the LSCTC and usual care on any of the assessed outcomes. The immediate period after stroke might not be the ideal time to deliver structured caregiver training. Medical Research Council. Copyright © 2013 Elsevier Ltd. All rights reserved.

Long-term outcomes after adolescent in-patient treatment due to alcohol intoxication: A control group study.

PubMed

Groß, Cornelius; Reis, Olaf; Kraus, Ludwig; Piontek, Daniela; Zimmermann, Ulrich S

2016-05-01

The long-term psychosocial development of adolescents admitted to in-patient treatment with alcohol intoxication (AIA) is largely unknown. We invited all 1603 AIAs and 641 age- and sex-matched controls, who had been hospitalized in one of five pediatric departments between 2000 and 2007, to participate in a telephone interview. 277 cases of AIA and 116 controls (mean age 24.2 years (SD 2.2); 46% female) could be studied 5-13 years (mean 8.3, SD 2.3) after the event. The control group consisted of subjects who were admitted due to conditions other than alcohol intoxication. Blood alcohol concentration on admission was systematically measured in the AIA but, owing to the retrospective study design, not in the control group. Subtle alcohol intoxication could therefore not be entirely ruled out in the control group. Long-term outcome measures included current DSM-5 alcohol use disorders (AUD), drinking patterns, illicit substance use, regular smoking, general life satisfaction, use of mental health treatment, and delinquency. AIA had a significantly elevated risk to engage in problematic habitual alcohol use, to exhibit delinquent behaviors, and to use illicit substances in young adulthood compared to the control group. Severe AUD also occurred considerably more often in the AIA than the control group. In the majority of AIAs, further development until their mid-twenties appears to be unremarkable. However, their risk to develop severe AUD and other problematic outcomes is significantly increased. This finding calls for a diagnostic instrument distinguishing between high- and low-risk AIAs already in the emergency room. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of facilitated introduction of a standard operating procedure into routine processes in the operating theatre: a controlled interrupted time series.

PubMed

Morgan, Lauren; New, Steve; Robertson, Eleanor; Collins, Gary; Rivero-Arias, Oliver; Catchpole, Ken; Pickering, Sharon P; Hadi, Mohammed; Griffin, Damian; McCulloch, Peter

2015-02-01

Standard operating procedures (SOPs) should improve safety in the operating theatre, but controlled studies evaluating the effect of staff-led implementation are needed. In a controlled interrupted time series, we evaluated three team process measures (compliance with WHO surgical safety checklist, non-technical skills and technical performance) and three clinical outcome measures (length of hospital stay, complications and readmissions) before and after a 3-month staff-led development of SOPs. Process measures were evaluated by direct observation, using Oxford Non-Technical Skills II for non-technical skills and the 'glitch count' for technical performance. All staff in two orthopaedic operating theatres were trained in the principles of SOPs and then assisted to develop standardised procedures. Staff in a control operating theatre underwent the same observations but received no training. The change in difference between active and control groups was compared before and after the intervention using repeated measures analysis of variance. We observed 50 operations before and 55 after the intervention and analysed clinical data on 1022 and 861 operations, respectively. The staff chose to structure their efforts around revising the 'whiteboard' which documented and prompted tasks, rather than directly addressing specific task problems. Although staff preferred and sustained the new system, we found no significant differences in process or outcome measures before/after intervention in the active versus the control group. There was a secular trend towards worse outcomes in the postintervention period, seen in both active and control theatres. SOPs when developed and introduced by frontline staff do not necessarily improve operative processes or outcomes. The inherent tension in improvement work between giving staff ownership of improvement and maintaining control of direction needs to be managed, to ensure staff are engaged but invest energy in appropriate change. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Heart failure and the discrepancy between trials of intensive blood pressure management: an analysis of individual patient data.

PubMed

Aggarwal, Rahul; Mirzan, Haares; Chiu, Nicholas; Steinkamp, Jackson

2018-02-26

ACCORD and SPRINT are the best randomized controlled trial data evaluating the effects of blood pressure targets below 140 mmHg. These trials had contradictory results regarding the benefits of intensive antihypertensive therapy. We investigate if this discordance was driven by SPRINT's inclusion of Heart Failure in its primary outcome, as this is a parameter not included in ACCORD's original primary outcome. This analysis helps to resolve a significant area of contention. Individual patient data from 4733 participants in ACCORD were analyzed from time of randomization. All participants were diabetic and at increased cardiovascular risk. Participants were assigned to their original intervention, a standard blood pressure target of less than 140 mmHg or an intensive target of less than 120 mmHg. Primary composite outcome was defined as in SPRINT: a composite of first occurrence of myocardial infarction, stroke, heart failure, death from cardiovascular causes, and other acute coronary syndromes. Primary outcome was not significantly different between standard and intensive groups [HR: 0.89; 95% CI: (0.76-1.03); p = 0.108]. The primary composite outcome occurred in 370 participants in the standard group (15.6%) and 324 participants in the intensive group (13.7%), with an event rate of 3.38% per year for the standard group and 3.01% per year for the intensive group. Differing results between ACCORD and SPRINT are not attributable to ACCORD's exclusion of Heart Failure from its original primary outcome measurement. No significant differences in primary outcome were observed between intensive and standard blood pressure groups in the ACCORD patients under the SPRINT primary outcome definition. Caution should be taken in extrapolating the intensive blood pressure control benefits of SPRINT to the diabetic population.

Influence of continuous positive airway pressure on outcomes of rehabilitation in stroke patients with obstructive sleep apnea.

PubMed

Ryan, Clodagh M; Bayley, Mark; Green, Robin; Murray, Brian J; Bradley, T Douglas

2011-04-01

In stroke patients, obstructive sleep apnea (OSA) is associated with poorer functional outcomes than in those without OSA. We hypothesized that treatment of OSA by continuous positive airway pressure (CPAP) in stroke patients would enhance motor, functional, and neurocognitive recovery. This was a randomized, open label, parallel group trial with blind assessment of outcomes performed in stroke patients with OSA in a stroke rehabilitation unit. Patients were assigned to standard rehabilitation alone (control group) or to CPAP (CPAP group). The primary outcomes were the Canadian Neurological scale, the 6-minute walk test distance, sustained attention response test, and the digit or spatial span-backward. Secondary outcomes included Epworth Sleepiness scale, Stanford Sleepiness scale, Functional Independence measure, Chedoke McMaster Stroke assessment, neurocognitive function, and Beck depression inventory. Tests were performed at baseline and 1 month later. Patients assigned to CPAP (n=22) experienced no adverse events. Regarding primary outcomes, compared to the control group (n=22), the CPAP group experienced improvement in stroke-related impairment (Canadian Neurological scale score, P<0.001) but not in 6-minute walk test distance, sustained attention response test, or digit or spatial span-backward. Regarding secondary outcomes, the CPAP group experienced improvements in the Epworth Sleepiness scale (P<0.001), motor component of the Functional Independence measure (P=0.05), Chedoke-McMaster Stroke assessment of upper and lower limb motor recovery test of the leg (P=0.001), and the affective component of depression (P=0.006), but not neurocognitive function. Treatment of OSA by CPAP in stroke patients undergoing rehabilitation improved functional and motor, but not neurocognitive outcomes. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00221065.

Efficacy of adding a physiotherapy rehabilitation programme to arthroscopic management of femoroacetabular impingement syndrome: a randomised controlled trial (FAIR)

PubMed Central

Bennell, Kim L; Spiers, Libby; Takla, Amir; O’Donnell, John; Kasza, Jessica; Hunter, David J; Hinman, Rana S

2017-01-01

Objectives Although several rehabilitation programmes following hip arthroscopy for femoracetabular impingement (FAI) syndrome have been described, there are no clinical trials evaluating whether formal physiotherapy-prescribed rehabilitation improves recovery compared with self-directed rehabilitation. The objective of this study was to evaluate the efficacy of adding a physiotherapist-prescribed rehabilitation programme to arthroscopic surgery for FAI syndrome. Design Randomised controlled trial. Methods People aged ≥16 years with FAI syndrome scheduled for hip arthroscopy were recruited and randomly allocated to physiotherapy (PT) or control. The PT group received seven PT sessions (one preoperative and six postoperative) incorporating education, manual therapy and a progressive rehabilitation programme of home, aquatic and gym exercises while the control group did not undertake PT rehabilitation. Measurements were taken at baseline (2 weeks presurgery) and 14 and 24 weeks postsurgery. The primary outcomes were the International Hip Outcome Tool (iHOT-33) and the sport subscale of the Hip Outcome Score (HOS) at week 14. Results Due to slower than expected recruitment and funding constraints, recruitment was ceased after 23 months. Thirty participants (14 PT and 16 control) were randomised and 28 (14 PT and 14 control; 93%) and 22 (11 PT and 11 control; 73%) completed week 14 and 24 measurements, respectively. For the 14-week primary outcomes, the PT group showed significantly greater improvements on the iHOT-33 (mean difference 14.2 units; 95% CI 1.2 to 27.2) and sport subscale of the HOS (13.8 units; 95% CI 0.3 to 27.3). There were no significant between-group differences at week 24. Conclusions An individual PT treatment and rehabilitation programme may augment improvements in patient-reported outcomes following arthroscopy for FAI syndrome. However, given the small sample size, larger trials are needed to validate the findings. Trial registration number Trial registered with the Australian New Zealand Clinical Trials Registry :ACTRN12613000282785, Results. PMID:28645960

Does Pure Platelet-Rich Plasma Affect Postoperative Clinical Outcomes After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial.

PubMed

Flury, Matthias; Rickenbacher, Dominik; Schwyzer, Hans-Kaspar; Jung, Christian; Schneider, Marco M; Stahnke, Katharina; Goldhahn, Jörg; Audigé, Laurent

2016-08-01

The exact role of platelet-rich plasma (PRP) in rotator cuff tendon reconstruction remains unclear. This study investigated whether an intraoperative pure PRP injection, compared with a local anesthetic injection, improves patient-reported outcomes at 3 and 6 months after arthroscopic rotator cuff repair. The hypothesis was that pure PRP improves patient-reported outcomes (Oxford Shoulder Score [OSS]) at 3 and 6 months after surgery and has the same pain-reducing effect compared with a postoperative subacromial local anesthetic (ropivacaine) injection. Randomized controlled trial; Level of evidence, 1. Between January 2011 and November 2012, a total of 120 patients who underwent arthroscopic double-row repair of a supraspinatus tendon rupture were randomized to receive either pure PRP by an injection at the footprint (PRP group; n = 60) or ropivacaine injected in the subacromial region (control group; n = 60). Seventy-eight percent of patients had other concomitant tears. All patients, surgeons, and follow-up investigators were blinded. Clinical parameters and various outcome scores (Constant-Murley shoulder score; OSS; patient American Shoulder and Elbow Surgeons score; quick Disabilities of the Arm, Shoulder and Hand score; EuroQol 5 dimensions) were documented preoperatively and at 3, 6, and 24 months postoperatively. The repair integrity was assessed by magnetic resonance imaging or ultrasound at 24 months. Furthermore, a pain diary was completed within the first 10 postoperative days, and adverse events were recorded. Group outcome differences were analyzed using t tests, Fisher exact tests, and mixed models. The final follow-up rate was 91%. An associated tear of the subscapularis tendon was diagnosed in 23% of PRP-treated patients and 36% of control patients. Three months after surgery, the mean (±SD) OSS was 32.9 ± 8.6 in PRP-treated patients and 30.7 ± 10.0 in control patients (P = .221). No significant differences were noted for other outcome parameters as well as at 6 and 24 months postoperatively. Smoking was a significant effect modifier. Pain for both groups decreased from postoperative day 1 to 10 without any significant group difference (P = .864). Six (12.2%) and 11 (20.8%) patients were diagnosed with a recurrent supraspinatus tendon defect in the PRP and control groups, respectively (P = .295). Twenty-two (40.7%) and 18 (30.5%) PRP-treated and control patients, respectively, experienced a local adverse event within 24 months (P = .325). Patients treated with pure PRP showed no significantly improved function at 3, 6, and 24 months after arthroscopic repair compared with control patients receiving ropivacaine; however, a similar pain reduction was documented in both groups. The negative influence of smoking on the effect of pure PRP requires further investigation. NCT01266226 (ClinicalTrials.gov). © 2016 The Author(s).

Clinical and Aesthetic Outcome with Post-Extractive Implants with or without Soft Tissue Augmentation: A 2-Year Randomized Clinical Trial.

PubMed

Migliorati, Marco; Amorfini, Leonardo; Signori, Alessio; Biavati, Armando Silvestrini; Benedicenti, Stefano

2015-10-01

The aesthetic outcome of an implant-supported restoration is first of all dependent on the soft tissue volume. Because the labial bone plate resorbs in every direction after tooth extraction, even when an implant is placed immediately, most patients end up with compromised aesthetics. In this parallel-designed, randomized clinical trial, participants were randomly assigned to the test group (immediate load post-extractive implant treated with subepithelial connective tissue graft placed using the tunnel technique in the labial area) and control group (immediate load post-extractive implant treated without raising a flap) with an allocation ratio of 1:1. Both groups received deproteinized bovine bone mineral. Patients were observed at baseline, crown insertion, 1-year follow-up, and 2-year follow-up. Clinical, radiological and aesthetic parameters were recorded to assess primary treatment outcomes. A random permuted block system was blindly generated ensuring uniformity of the patient allocation during the trial by randomly distributing three participants to the test and three participants to the control group every six treated patients. At the 2-year examination, all 47 implants were successfully integrated, demonstrating stability and healthy peri-implant soft tissues as documented by standard clinical parameters. The results showed a soft tissue remodeling of -10% in thickness and -18% in highness in the non-grafted group, whereas in the grafted group there was a gain of 35% in thickness and a slight reduction of -11% in highness. Test group reported an increase of aesthetic result (mean pink aesthetic score [PES] 8) compared with control group (mean PES 6.65). This prospective study demonstrates the effectiveness of placing a soft tissue graft at the time of immediate implant placement in the aesthetic zone. At the 2-year follow-up, test group revealed a better aesthetic outcomes and stable facial soft tissues compared with control group. © 2013 Wiley Periodicals, Inc.

Impact of Platelet-Rich Plasma on Arthroscopic Repair of Small- to Medium-Sized Rotator Cuff Tears: A Randomized Controlled Trial.

PubMed

Holtby, Richard; Christakis, Monique; Maman, Eran; MacDermid, Joy C; Dwyer, Tim; Athwal, George S; Faber, Kenneth; Theodoropoulos, John; Woodhouse, Linda J; Razmjou, Helen

2016-09-01

Increased interest in using platelet-rich plasma (PRP) as an augment to rotator cuff repair warrants further investigation, particularly in smaller rotator cuff tears. To examine the effectiveness of PRP application in improving perioperative pain and function and promoting healing at 6 months after arthroscopic repair of small- or medium-sized rotator cuff tears. Randomized controlled trial; Level of evidence, 1. This was a double-blinded randomized controlled trial of patients undergoing arthroscopic repair of partial- or full-thickness rotator cuff tears of up to 3 cm who were observed for 6 months. Patients were randomized to either repair and PRP application (study group) or repair only (control group) groups. The patient-oriented outcome measures utilized were the visual analog scale (VAS), the Short Western Ontario Rotator Cuff Index (ShortWORC), the American Shoulder and Elbow Surgeons (ASES) form, and the Constant-Murley Score (CMS). Range of motion (ROM) and inflammatory and coagulation markers were measured before and after surgery. Magnetic resonance imaging was used at 6 months to assess retear and fatty infiltration rate. Eighty-two patients (41 males) with a mean age of 59 ± 8 years were enrolled; 41 patients were included in each group. Both the PRP and control groups showed a significant improvement in their pain level based on the VAS within the first 30 days (P < .0001), with the PRP group reporting less pain than the control group (P = .012), which was clinically significantly different from days 8 through 11. The PRP group reported taking less painkillers (P = .026) than the control group within the first 30 days. All outcome measure scores and ROM improved significantly after surgery (P < .0001), with no between-group differences. No differences were observed between groups in inflammatory or coagulation marker test results (P > .05), retear (14% vs 18% full retear; P = .44), or fatty infiltration rate (P = .08). The PRP biological augmentation for repair of small- to medium-sized rotator cuff tears has a short-term effect on perioperative pain without any significant impact on patient-oriented outcome measures or structural integrity of the repair compared with control group.

Inpatient rehabilitation improves functional capacity, peripheral muscle strength and quality of life in patients with community-acquired pneumonia: a randomised trial.

PubMed

José, Anderson; Dal Corso, Simone

2016-04-01

Among people who are hospitalised for community-acquired pneumonia, does an inpatient exercise-based rehabilitation program improve functional outcomes, symptoms, quality of life and length of hospital stay more than a respiratory physiotherapy regimen? Randomised trial with concealed allocation, intention-to-treat analysis and blinding of some outcomes. Forty-nine adults hospitalised for community-acquired pneumonia. The experimental group (n=32) underwent a physical training program that included warm-up, stretching, peripheral muscle strength training and walking at a controlled speed for 15 minutes. The control group (n=17) underwent a respiratory physiotherapy regimen that included percussion, vibrocompression, respiratory exercises and free walking. The intervention regimens lasted 8 days. The primary outcome was the Glittre Activities of Daily Living test, which assesses the time taken to complete a series of functional tasks (eg, rising from a chair, walking, stairs, lifting and bending). Secondary outcomes were distance walked in the incremental shuttle walk test, peripheral muscle strength, quality of life, dyspnoea, lung function, C-reactive protein and length of hospital stay. Measures were taken 1 day before and 1 day after the intervention period. There was greater improvement in the experimental group than in the control group on the Glittre Activities of Daily Living test (mean between-group difference 39 seconds, 95% CI 20 to 59) and the incremental shuttle walk test (mean between-group difference 130 m, 95% CI 77 to 182). There were also significantly greater improvements in quality of life, dyspnoea and peripheral muscle strength in the experimental group than in the control group. There were no between-group differences in lung function, C-reactive protein or length of hospital stay. The improvement in functional outcomes after an inpatient rehabilitation program was greater than the improvement after standard respiratory physiotherapy. The exercise training program led to greater benefits in functional capacity, peripheral muscle strength, dyspnoea and quality of life. ClinicalTrials.gov, NCT02103400. Copyright © 2016 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Pain and efficacy rating of a microprocessor-controlled metered injection system for local anaesthesia in minor hand surgery.

PubMed

Nimigan, André S; Gan, Bing Siang

2011-01-01

Purpose. Little attention has been given to syringe design and local anaesthetic administration methods. A microprocessor-controlled anaesthetic delivery device has become available that may minimize discomfort during injection. The purpose of this study was to document the pain experience associated with the use of this system and to compare it with use of a conventional syringe. Methods. A prospective, randomized clinical trial was designed. 40 patients undergoing carpal tunnel release were block randomized according to sex into a two groups: a traditional syringe group and a microprocessor-controlled device group. The primary outcome measure was surgical pain and local anaesthetic administration pain. Secondary outcomes included volume of anaesthetic used and injection time. Results. Analysis showed that equivalent anaesthesia was achieved in the microprocessor-controlled group despite using a significantly lower volume of local anaesthetic (P = .0002). This same group, however, has significantly longer injection times (P < .0001). Pain during the injection process or during surgery was not different between the two groups. Conclusions. This RCT comparing traditional and microprocessor controlled methods of administering local anaesthetic showed similar levels of discomfort in both groups. While the microprocessor-controlled group used less volume, the total time for the administration was significantly greater.

Intra- versus retroplacental hematomas: a retrospective case-control study on pregnancy outcomes.

PubMed

Ott, Johannes; Pecnik, Philipp; Promberger, Regina; Pils, Sophie; Binder, Julia; Chalubinski, Kinga M

2017-10-26

Intrauterine hematomas are a common pregnancy complication. The literature lacks studies about outcomes based on hematoma localization. Thus, we aimed to compare pregnancies complicated by an intraplacental hematoma to cases with a retroplacental hematoma and to a control group. In a retrospective case-control study, 32 women with an intraplacental hematoma, 199 women with a retroplacental hematoma, and a control group consisting of 113 age-matched women with no signs of placental abnormalities were included. Main outcome measures were pregnancy complications. Second-trimester miscarriage was most common in the intraplacental hematoma group (9.4%), followed by women with a retroplacental hematoma (4.2%), and controls (0%; p = 0.007). The intraplacental hematoma group revealed the highest rates for placental insufficiency, intrauterine growth retardation, premature preterm rupture of membranes, preterm labor, preterm delivery <37 weeks, and early preterm delivery <34 weeks (p < 0.05), followed by the retroplacental hematoma group. When tested in multivariate models, intraplacental hematomas were independent predictors for placental insufficiency (ß = 4.19, p < 0.001) and intrauterine growth restriction (ß = 1.44, p = 0.035). Intrauterine fetal deaths occurred only in women with a retroplacental hematoma (p = 0.042). Intra- and retroplacental hematomas have different risk profiles for the affected pregnancy and act as independent risk factors.

Hemostatic Agents in Periapical Surgery: A Randomized Study of Gauze Impregnated in Epinephrine versus Aluminum Chloride.

PubMed

Menéndez-Nieto, Isabel; Cervera-Ballester, Juan; Maestre-Ferrín, Laura; Blaya-Tárraga, Juan Antonio; Peñarrocha-Oltra, David; Peñarrocha-Diago, Miguel

2016-11-01

Adequate bleeding control is essential for the success of periapical surgery. The aim of this study was to evaluate the effects of 2 hemostatic agents on the outcome of periapical surgery and their relationship with patient and teeth parameters. A prospective study was designed with 2 randomized parallel groups, depending on the hemostatic agent used: gauze impregnated in epinephrine (epinephrine group) and aluminum chloride (aluminum chloride group). The analysis of the hemorrhage control was judged before and after the application of the hemostatic agents by the surgeon, and 2 examiners independently recorded it as adequate (complete hemorrhage control) or inadequate (incomplete hemorrhage control). Ninety-nine patients with a periradicular lesion were enrolled in this study and divided into 2 groups: gauze impregnated in epinephrine in 48 patients (epinephrine group) or aluminum chloride in 51 (aluminum chloride group). In epinephrine group adequate hemostasis was achieved in 25 cases, and in aluminum chloride group it was achieved in 37 cases (P < .05). The outcome was better in the aluminum chloride group than in the gauze impregnated in epinephrine group. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Impact of pediatric obstructive sleep apnea on the development of Class II hyperdivergent patients receiving orthodontic treatment: A pilot study.

PubMed

Zhao, Tingting; Ngan, Peter; Hua, Fang; Zheng, Jie; Zhou, Shunquan; Zhang, Man; Xiong, Hui; He, Hong

2018-05-22

To conduct a pilot study to determine if the presence of obstructive sleep apnea (OSA) influences the orthodontic treatment outcome of Class II hyperdivergent patients receiving comprehensive orthodontic treatment. Patients between the ages of 12 and 14 who received orthodontic treatment at the Hospital of Stomatology, Wuhan University, China, were included in this study. Patients were divided into two groups: the OSA group and the control group, based on the outcome of pretreatment polysomnography findings and lateral cephalometric radiograph examination. Patients in the control group were matched with the OSA group for age, sex, ethnicity, weight, and height. Cephalometric measurements were used to record the skeletal and dental changes from before to after treatment. Data were analyzed using the t-test. Twenty three OSA patients and 23 control patients were included. After comprehensive orthodontic treatment, the mandibular plane angle (SN-GoMe), articular angle (SArGo), sum of Jarabak angles (SUM) and the lower gonial angle (NGoMe) were found to increase significantly in the OSA group but remained unchanged or decreased slightly in the control group ( P < .05). In the non-OSA group, the growth pattern became more horizontal. In contrast, in the OSA group the growth pattern became more vertical. Otherwise, similar treatment results were obtained for both groups in terms of sagittal change and occlusion. The presence of OSA in pediatric patients has a deleterious effect on the development of hyperdivergent malocclusions. Early diagnosis and management of pediatric OSA can affect the orthodontic treatment outcome of these patients.

Therapeutic effect of acupuncture combining standard swallowing training for post-stroke dysphagia: A prospective cohort study.

PubMed

Mao, Li-Ya; Li, Li-Li; Mao, Zhong-Nan; Han, Yan-Ping; Zhang, Xiao-Ling; Yao, Jun-Xiao; Li, Ming

2016-07-01

To assess the therapeutic effect of acupuncture combining standard swallowing training for patients with dysphagia after stroke. A total of 105 consecutively admitted patients with post-stroke dysphagia in the Affiliated Hospital of Gansu University of Chinese Medicine were included: 50 patients from the Department of Neurology and Rehabilitation received standard swallowing training and acupuncture treatment (acupuncture group); 55 patients from the Department of Neurology received standard swallowing training only (control group). Participants in both groups received 5-day therapy per week for a 4-week period. The primary outcome measures included the scores of Videofluoroscopic Swallow Study (VFSS) and the Standardized Swallowing Assessment (SSA); the secondary outcome measure was the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS), all of which were assessed before and after the 4-week treatment. A total of 98 subjects completed the study (45 in the acupuncture group and 53 in the control group). Significant differences were seen in VFSS, SSA and RBHOMS scores in each group after 4-week treatment as compared with before treatment (P<0.01). Comparison between the groups after 4-week treatment showed that the VFSS P=0.007) and SSA scores (P=0.000) were more significantly improved in the acupuncture group than the control group. However, there was no statistical difference (P=0.710) between the acupuncture and the control groups in RBHOMS scores. Acupuncture combined with the standard swallowing training was an effective therapy for post-stroke dysphagia, and acupuncture therapy is worth further investigation in the treatment of post-stroke dysphagia.

Platelet-rich plasma to treat experimentally-induced skin wounds in animals: A systematic review and meta-analysis.

PubMed

Tambella, Adolfo Maria; Attili, Anna Rita; Dupré, Gilles; Cantalamessa, Andrea; Martin, Stefano; Cuteri, Vincenzo; Marcazzan, Sabrina; Del Fabbro, Massimo

2018-01-01

The objective of the study was to review current literature to determine whether the topical application of platelet-rich plasma (PRP) promotes healing in experimentally-induced full-thickness skin wounds in animals. The hypothesis was that the adjunct of PRP has a positive effect on wound healing. An electronic search was carried out on the following databases: Web of Science, Cochrane Library, PubMed, Research Gate, Cochrane Wounds Group, Veterinary Information Network. No publication date nor language restrictions were applied. Randomised and not randomised controlled clinical trials comparing PRP with placebo or with other treatments were included. The reduction of open wound area in PRP-treated (test) wounds compared to control wounds was the primary outcome. Secondary outcomes were healing time and number of healed cases in test group compared to control. The following effect sizes were calculated: the Hedges' g for continuous variables; the odds ratio for binary data. Eighteen controlled clinical trials were included in the qualitative and quantitative synthesis, with a total of 661 wounds. All studies were published in the period 2007-2016. Eight studies were carried out on rodent/lagomorph mammals and 10 on non-rodent/lagomorph mammals. In all included studies, control wounds underwent placebo or were left untreated. The PRP group showed a better healing performance than the control group in each outcome. The effect size was statistically significant considering the primary outcome and the overall aggregation of the three outcomes. The effect size, although in favour of the treatment with PRP, was not significant considering the healing time and the number of healings. The overall heterogeneity was mild or moderate. Five studies reported a high risk of selection bias. The publication bias was always mild or absent. The results support the hypothesis of the positive effects of the PRP when compared to control groups in the treatment of experimentally-induced full-thickness skin wounds in animals. PRP can therefore be considered an effective adjunctive therapy in stimulating second intention healing of acute wounds in healthy animals.

Platelet-rich plasma to treat experimentally-induced skin wounds in animals: A systematic review and meta-analysis

PubMed Central

Attili, Anna Rita; Dupré, Gilles; Cantalamessa, Andrea; Martin, Stefano; Cuteri, Vincenzo; Marcazzan, Sabrina; Del Fabbro, Massimo

2018-01-01

The objective of the study was to review current literature to determine whether the topical application of platelet-rich plasma (PRP) promotes healing in experimentally-induced full-thickness skin wounds in animals. The hypothesis was that the adjunct of PRP has a positive effect on wound healing. An electronic search was carried out on the following databases: Web of Science, Cochrane Library, PubMed, Research Gate, Cochrane Wounds Group, Veterinary Information Network. No publication date nor language restrictions were applied. Randomised and not randomised controlled clinical trials comparing PRP with placebo or with other treatments were included. The reduction of open wound area in PRP-treated (test) wounds compared to control wounds was the primary outcome. Secondary outcomes were healing time and number of healed cases in test group compared to control. The following effect sizes were calculated: the Hedges’ g for continuous variables; the odds ratio for binary data. Eighteen controlled clinical trials were included in the qualitative and quantitative synthesis, with a total of 661 wounds. All studies were published in the period 2007–2016. Eight studies were carried out on rodent/lagomorph mammals and 10 on non-rodent/lagomorph mammals. In all included studies, control wounds underwent placebo or were left untreated. The PRP group showed a better healing performance than the control group in each outcome. The effect size was statistically significant considering the primary outcome and the overall aggregation of the three outcomes. The effect size, although in favour of the treatment with PRP, was not significant considering the healing time and the number of healings. The overall heterogeneity was mild or moderate. Five studies reported a high risk of selection bias. The publication bias was always mild or absent. The results support the hypothesis of the positive effects of the PRP when compared to control groups in the treatment of experimentally-induced full-thickness skin wounds in animals. PRP can therefore be considered an effective adjunctive therapy in stimulating second intention healing of acute wounds in healthy animals. PMID:29324848

76 FR 55658 - Applications for New Awards; Supporting Effective Educator Development Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-08

... defined in this notice), or other strategies. Definitions: Carefully matched comparison group design means... in the project (control group). The effect of the project is the average difference in outcomes between the treatment and control groups. High-need students means students at risk of educational failure...

Randomised trial of amnioinfusion during labour with meconium stained amniotic fluid.

PubMed

Rathor, Asmita Muthal; Singh, Ruchira; Ramji, S; Tripathi, Reva

2002-01-01

To assess the effect of amnioinfusion during labour with meconium stained amniotic fluid on caesarean section rate and perinatal outcome. Prospective randomised controlled study. A tertiary care teaching hospital in India. Women in labour at term with meconium stained amniotic fluid. Two hundred women in labour with > or = 37 weeks gestation, single cephalic presentation with moderate or thick meconium were randomised to control and amnioinfusion groups at a 1:1 ratio. Amnioinfusion was performed using 500 mL of normal saline over a period of 30 minutes in a study group. The control group received routine care. Both groups had intermittent auscultation of fetal heart rate during labour. The primary outcome measure was caesarean section rate. Secondary outcome measures were meconium aspiration syndrome, 1 minute and 5 minute apgar < 7, hypoxic ischaemic encephalopathy, neonatal intensive care unit admission, meconium at the level of vocal cords. The caesarean section rate in the amnioinfusion group was less than the control group (RR 0.47; 95% CI 0.24-0.93). Amnioinfusion was associated with a significant decrease in the incidence of meconium at the vocal cords (P = 0.001); improvement in 1 minute apgar scores (P < 0.05), respiratory distress (P = 0.002) and fewer admissions to nursery compared with the controls. This sample size was inadequate to study the impact on meconium aspiration syndrome. Amnioinfusion in an under resourced labour ward decreases caesarean section rates and fetal morbidity.

Prevention of symptomatic vasospasm by continuous cisternal irrigation with mock-CSF containing ascorbic acid and Mg(2+).

PubMed

Satoh, Akira; Sugiyama, Tatsuya; Ooigawa, Hidetoshi; Nakajima, Hiroyuki; Ogura, Takeshi; Neki, Hiroaki; Morikawa, Eiharu

2010-01-01

Symptomatic vasospasm (SVS) is still a major cause of poor outcome in cases undergoing early surgical intervention for ruptured intracranial aneurysm. Among the numbers of therapeutic trials to prevent and ameliorate neurological deterioration due to SVS, removal or quenching of oxy-hemoglobin (OxyHb) from subarachnoid colts and administration of Mg(2+) (Mg) have especially been expected to be effective. In this report the authors investigated the effect of continuous cisternal irrigation (CCI) with mock CSF containing ascorbic acid (ASA) and Mg, performed after early surgery for ruptured aneurysm. Sixty-three cases which had received CCI were retrospectively compared with 40 control cases as to the incidence of SVS and outcome. Incidence of SVS was significantly less frequent (P < 0.05) in the CCI group (11%) than in the control group (25%). Severe and definitive SVS requiring additional specific treatment occurred only in 3.2% of the CCI group, while 22.5% in the control (P < 0.01). Overall outcome at discharge was significantly better in the CCI group than in the control (P < 0.01). Postoperative CCI with ASA and Mg was definitively effective in preventing SVS and in lessening severity of SVS if it occurs.

Effects of weight management program on postural stability and neuromuscular function among obese children: study protocol for a randomized controlled trial.

PubMed

Sun, Fenghua; Wang, Li-Juan; Wang, Lin

2015-04-10

Childhood obesity is one of the most critical public health problems in the world. It is associated with low neuromuscular function and postural deformities. Whether weight loss can improve postural stability and neuromuscular control, benefit daily activities, or prevent injury is unknown. Therefore, this study attempts to investigate the effect of a 6 month weight management program on postural stability and neuromuscular control among obese children. We will conduct a prospective, single-blind, randomized controlled trial with 120 prepubescent obese children. Participants will be randomly assigned to a weight management group or a control group. The weight management group will participate in a dietary and exercise program. The control group will receive health education. After the intervention, participants will be followed for 6 months with no active intervention. The primary and secondary outcomes will be assessed at the baseline, and after 6 months and 12 months. Primary outcome measures will include body weight, body height, body mass index, waist circumference, hip circumference, and body fat percentage. Secondary outcome measures will include three-dimensional functional biomechanics in different tasks, proprioception tests of the knee and ankle, neuromuscular response of the leg muscles, and muscle strength tests of the knee and ankle. Furthermore, adverse events will be recorded and analyzed. An intention-to-treat analysis will be performed if any participants withdraw from the trial. The important features of this trial include the randomization procedures and large sample size. This study attempts to estimate the effect of weight loss intervention on outcomes, including daily life function, postural stability, and neuromuscular control in prepubescent obese children. Therefore, our results can be useful for obese children, medical staff, and healthcare decision makers. Chinese Clinical Trial Registry ChiCTR-IOB-15005874.

Three-unit posterior zirconia-ceramic fixed dental prostheses (FDPs) veneered with layered and milled (CAD-on) veneering ceramics: 1-year follow-up of a randomized controlled clinical trial.

PubMed

Grohmann, Philipp; Bindl, Andreas; Hämmerle, Christoph; Mehl, Albert; Sailer, Irena

2015-01-01

The aim of this multicenter randomized controlled clinical trial was to test posterior zirconia-ceramic fixed dental prostheses (FDPs) veneered with a computer-aided design/computer- assisted manufacture (CAD/CAM) lithium disilicate veneering ceramic (CAD-on) and manually layered zirconia veneering ceramic with respect to survival of the FDPs, and technical and biologic outcomes. Sixty patients in need of one posterior three-unit FDP were included. The zirconia frameworks were produced with a CAD/CAM system (Cerec inLab 3D/Cerec inEOS inLab). Thirty FDPs were veneered with a CAD/CAM lithium disilicate veneering ceramic (Cad-on) (test) and 30 were veneered with a layered zirconia veneering ceramic (control). For the clinical evaluation at baseline, 6, and 12 months, the United States Public Health Service (USPHS) criteria were used. The biologic outcome was judged by comparing the plaque control record (PCR), bleeding on probing (BOP), and probing pocket depth (PPD). Data were statistically analyzed. Fifty-six patients were examined at a mean follow-up of 13.9 months. At the 1-year follow-up the survival rate was 100% in the test and in the control group. No significant differences of the technical outcomes occurred. Major chipping occurred in the control group (n = 3) and predominantly minor chipping in the test group (minor n = 2, major n = 1). No biologic problems or differences were found. Both types of zirconia-ceramic FDPs exhibited very good clinical outcomes without differences between groups. Chipping occurred in both types of FDPs at small amounts, yet the extension of the chippings differed. The test FDPs predominantly exhibited minor chipping, the control FDPs major chipping.

Critical reappraisal of embryo quality as a predictive parameter for pregnancy outcome: a pilot study

PubMed Central

Campo, R.; Binda, M.M.; Van Kerkhoven, G.; Frederickx, V.; Serneels, A.; Roziers, P.; Lopes, A.S.; Gordts, S.; Puttemans, P.; Gordts, S.

2010-01-01

Aim of the study: Pilot study to analyse the efficacy and embryo morphology using a new human embryo culture medium (GM501) versus the conventional used medium (ISM1). Methods: Over a four-month period, all patients at the Leuven Institute of Fertility and Embryology (LIFE) were randomly allocated to have their embryos cultured in either the standard sequential culture medium ISM1 (control) or in a new universal medium (GM501) (study group). Primary outcome parameters were clinical pregnancy and live birth rate. The secondary outcome parameter was the correlation of embryo fragmentation rate with pregnancy outcome. Results: We did not observe any differences between the ISM1 control group and GM501 study group with regard to fertilization, pregnancy, implantation rates, ongoing pregnancy, and babies born. The number of embryos with a minimal fragmentation rate (less than 30%) was significantly higher in the GM501 study group. Conclusion: Although a significant higher embryo fragmentation rate was seen in In vitro culture of embryos in GM501, pregnancy outcome results were comparable to those of embryos cultured in ISM1. According to our results the value of embryo morphological criteria as a parameter for pregnancy outcome should be examined and discussed again. PMID:25009716

Virtual Reality for Upper Limb Rehabilitation in Subacute and Chronic Stroke: A Randomized Controlled Trial.

PubMed

Kiper, Pawel; Szczudlik, Andrzej; Agostini, Michela; Opara, Jozef; Nowobilski, Roman; Ventura, Laura; Tonin, Paolo; Turolla, Andrea

2018-05-01

To evaluate the effectiveness of reinforced feedback in virtual environment (RFVE) treatment combined with conventional rehabilitation (CR) in comparison with CR alone, and to study whether changes are related to stroke etiology (ie, ischemic, hemorrhagic). Randomized controlled trial. Hospital facility for intensive rehabilitation. Patients (N=136) within 1 year from onset of a single stroke (ischemic: n=78, hemorrhagic: n=58). The experimental treatment was based on the combination of RFVE with CR, whereas control treatment was based on the same amount of CR. Both treatments lasted 2 hours daily, 5d/wk, for 4 weeks. Fugl-Meyer upper extremity scale (F-M UE) (primary outcome), FIM, National Institutes of Health Stroke Scale (NIHSS), and Edmonton Symptom Assessment Scale (ESAS) (secondary outcomes). Kinematic parameters of requested movements included duration (time), mean linear velocity (speed), and number of submovements (peak) (secondary outcomes). Patients were randomized in 2 groups (RFVE with CR: n=68, CR: n=68) and stratified by stroke etiology (ischemic or hemorrhagic). Both groups improved after treatment, but the experimental group had better results than the control group (Mann-Whitney U test) for F-M UE (P<.001), FIM (P<.001), NIHSS (P≤.014), ESAS (P≤.022), time (P<.001), speed (P<.001), and peak (P<.001). Stroke etiology did not have significant effects on patient outcomes. The RFVE therapy combined with CR treatment promotes better outcomes for upper limb than the same amount of CR, regardless of stroke etiology. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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

PubMed

Gottrup, F; Apelqvist, J; Price, P

2010-06-01

While there is a consensus that clinical practice should be evidence based, this can be difficult to achieve due to confusion about the value of the various approaches to wound management. To address this, the European Wound Management Association (EWMA) set up a Patient Outcome Group whose remit 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 and reproducible.

Effects of unconditional cash transfers on the outcome of treatment for severe acute malnutrition (SAM): a cluster-randomised trial in the Democratic Republic of the Congo.

PubMed

Grellety, Emmanuel; Babakazo, Pélagie; Bangana, Amina; Mwamba, Gustave; Lezama, Ines; Zagre, Noël Marie; Ategbo, Eric-Alain

2017-04-26

Cash transfer programs (CTPs) aim to strengthen financial security for vulnerable households. This potentially enables improvements in diet, hygiene, health service access and investment in food production or income generation. The effect of CTPs on the outcome of children already severely malnourished is not well delineated. The objective of this study was to test whether CTPs will improve the outcome of children treated for severe acute malnutrition (SAM) in the Democratic Republic of the Congo over 6 months. We conducted a cluster-randomised controlled trial in children with uncomplicated SAM who received treatment according to the national protocol and counselling with or without a cash supplement of US$40 monthly for 6 months. Analyses were by intention to treat. The hazard ratio of reaching full recovery from SAM was 35% higher in the intervention group than the control group (adjusted hazard ratio, 1.35, 95% confidence interval (CI) = 1.10 to 1.69, P = 0.007). The adjusted hazard ratios in the intervention group for relapse to moderate acute malnutrition (MAM) and SAM were 0.21 (95% CI = 0.11 to 0.41, P = 0.001) and 0.30 (95% CI = 0.16 to 0.58, P = 0.001) respectively. Non-response and defaulting were lower when the households received cash. All the nutritional outcomes in the intervention group were significantly better than those in the control group. After 6 months, 80% of cash-intervened children had re-gained their mid-upper arm circumference measurements and weight-for-height/length Z-scores and showed evidence of catch-up. Less than 40% of the control group had a fully successful outcome, with many deteriorating after discharge. There was a significant increase in diet diversity and food consumption scores for both groups from baseline; the increase was significantly greater in the intervention group than the control group. CTPs can increase recovery from SAM and decrease default, non-response and relapse rates during and following treatment. Household developmental support is critical in food insecure areas to maximise the efficiency of SAM treatment programs. ClinicalTrials.gov, NCT02460848 . Registered on 27 May 2015.

Fetal growth and perinatal outcome of pregnancies continuing after threatened abortion.

PubMed

Das, A G; Gopalan, S; Dhaliwal, L K

1996-05-01

The present study was conducted with the aim to find out the effect of threatened abortion in the current pregnancy on the subsequent perinatal outcome and follow the growth pattern of the fetuses of such complicated pregnancies. The study group consisted of 55 women with threatened abortion and 55 women with normal pregnancies formed the control group. Most of the patients presented at 6-12 weeks' gestation. The fetal growth was monitored by both clinical as well as ultrasound (USG) parameters. The mean growth rates were almost identical throughout gestation. The mean values of each parameter of the study group were found lying with 95% confidence limit values of their control group. The apparent increased incidence of low lying placenta in early pregnancy probably contributed to threatened abortion. There was no significant difference in preterm delivery, low birth-weight and overall perinatal outcome.

Anaemia management protocols in the care of haemodialysis patients: examining patient outcomes.

PubMed

Saunders, Sushila; MacLeod, Martha L P; Salyers, Vince; MacMillan, Peter D; Ogborn, Malcolm R

2013-08-01

To determine whether the use of a nurse-driven protocol in the haemodialysis setting is as safe and effective as traditional physician-driven approaches to anaemia management. The role of haemodialysis nurses in renal anaemia management has evolved through the implementation of nurse-driven protocols, addressing the trend of exceeding haemoglobin targets and rising costs of erythropoietin-stimulating agents. Retrospective, non-equivalent case control group design. The sample was from three haemodialysis units in a control group (n = 64) and three haemodialysis units in a protocol group (n = 43). The protocol group used a nurse-driven renal anaemia management protocol, while the control group used a traditional physician-driven approach to renal anaemia management. All retrospective data were obtained from a provincial renal database. Data were analysed using chi-square tests and t-tests. Patient outcomes examined were haemoglobin levels, transferrin saturation levels, erythropoietin-stimulating agents use and intravenous iron use. Cost comparisons were determined using average use of erythropoietin-stimulating agents and intravenous iron. Control and protocol groups reached haemoglobin target levels. In the protocol group, 75% reached transferrin saturation target levels in comparison with 25% of the control group. Use and costs for iron was higher in the control group, while use and costs for erythropoietin was higher in the protocol group. The higher usage of erythropoietin-stimulating agents was potentially related to comorbid conditions amongst the protocol group. A nurse-driven protocol approach to renal anaemia management was as effective as the physician-driven approach in reaching haemoglobin and transferrin saturation levels. Further examination of the use and dosing of erythropoietin-stimulating agents and intravenous iron, their impact on haemoglobin levels related to patient comorbidities and subsequent cost effectiveness of protocols is required. Using a nurse-driven protocol in practice supports the independent nursing role while contributing to safe patient outcomes. © 2013 Blackwell Publishing Ltd.

Evaluating the short-term and long-term effects of an internet-based aural rehabilitation programme for hearing aid users in general clinical practice: a randomised controlled trial

PubMed Central

Malmberg, Milijana; Lunner, Thomas; Kähäri, Kim; Andersson, Gerhard

2017-01-01

Objective Guided internet-based intervention beyond hearing aid (HA) fitting has been shown to be efficacious in randomised controlled trials (RCTs). However, internet interventions have rarely been applied clinically as a part of regular aural rehabilitation (AR). Our aim was to evaluate the effectiveness of internet-based AR for HA users from a clinical population. Outcome measures The Hearing Handicap Inventory for the Elderly (HHIE) was used as the primary outcome measure, and the Communication Strategies Scale (CSS) and the Hospital Anxiety and Depression Scale were used as secondary outcome measures. All questionnaires were administered before and directly after the intervention and at 6 months postintervention. Methods We used a parallel group design (RCT). The data were collected in 2013–2014 at three different clinics. Seventy-four HA users were randomly assigned to receive either full internet-based AR (intervention group, n=37) or one element of the internet-based AR (control group, n=37). Results Data were analysed following the intention-to-treat principle. Each group showed improved HHIE scores over time and did not differ significantly from each other. The intervention group showed significantly greater improvement compared with the control group for the CSS total and the non-verbal subscale scores. The intervention group and control group were also subdivided into two age groups: 20–59 years and 60–80 years. Significantly better improvement on the CSS total and non-verbal subscale scores was found in the older group compared with the younger participants. Conclusions This study indicates that participants in an internet-based intervention applied in general clinical practice showed improved self-reported communication skills compared with a control group. Receiving a full intervention was not more effective in improving self-reported hearing problems than receiving just one element of the internet-based intervention. Trial registration number This trial is registered at ClinicalTrals.gov, NCT01837550; results. PMID:28592571

The effects of self-efficacy enhancing program on foot self-care behaviour of older adults with diabetes: A randomised controlled trial in elderly care facility, Peninsular Malaysia.

PubMed

Ahmad Sharoni, Siti Khuzaimah; Abdul Rahman, Hejar; Minhat, Halimatus Sakdiah; Shariff-Ghazali, Sazlina; Azman Ong, Mohd Hanafi

2018-01-01

Self-care behaviour is essential in preventing diabetes foot problems. This study aimed to evaluate the effectiveness of health education programs based on the self-efficacy theory on foot self-care behaviour for older adults with diabetes. A randomised controlled trial was conducted for 12 weeks among older adults with diabetes in elderly care facility in Peninsular Malaysia. Six elderly care facility were randomly allocated by an independent person into two groups (intervention and control). The intervention group (three elderly care facility) received a health education program on foot self-care behaviour while the control group (three elderly care facility) received standard care. Participants were assessed at baseline, and at week-4 and week-12 follow-ups. The primary outcome was foot-self-care behaviour. Foot care self-efficacy (efficacy expectation), foot care outcome expectation, knowledge of foot care and quality of life were the secondary outcomes. Data were analysed with Mixed Design Analysis of Variance using the Statistical Package for the Social Sciences version 22.0. 184 respondents were recruited but only 76 met the selection criteria and were included in the analysis. Foot self-care behaviour, foot care self-efficacy (efficacy expectation), foot care outcome expectation and knowledge of foot care improved in the intervention group compared to the control group (p < 0.05). However, some of these improvements did not significantly differ compared to the control group for QoL physical symptoms and QoL psychosocial functioning (p > 0.05). The self-efficacy enhancing program improved foot self-care behaviour with respect to the delivered program. It is expected that in the future, the self-efficacy theory can be incorporated into diabetes education to enhance foot self-care behaviour for elderly with diabetes living in other institutional care facilities. Australian New Zealand Clinical Trial Registry ACTRN12616000210471.

The effects of self-efficacy enhancing program on foot self-care behaviour of older adults with diabetes: A randomised controlled trial in elderly care facility, Peninsular Malaysia

PubMed Central

Abdul Rahman, Hejar; Minhat, Halimatus Sakdiah; Shariff-Ghazali, Sazlina; Azman Ong, Mohd Hanafi

2018-01-01

Background Self-care behaviour is essential in preventing diabetes foot problems. This study aimed to evaluate the effectiveness of health education programs based on the self-efficacy theory on foot self-care behaviour for older adults with diabetes. Methods A randomised controlled trial was conducted for 12 weeks among older adults with diabetes in elderly care facility in Peninsular Malaysia. Six elderly care facility were randomly allocated by an independent person into two groups (intervention and control). The intervention group (three elderly care facility) received a health education program on foot self-care behaviour while the control group (three elderly care facility) received standard care. Participants were assessed at baseline, and at week-4 and week-12 follow-ups. The primary outcome was foot-self-care behaviour. Foot care self-efficacy (efficacy expectation), foot care outcome expectation, knowledge of foot care and quality of life were the secondary outcomes. Data were analysed with Mixed Design Analysis of Variance using the Statistical Package for the Social Sciences version 22.0. Results 184 respondents were recruited but only 76 met the selection criteria and were included in the analysis. Foot self-care behaviour, foot care self-efficacy (efficacy expectation), foot care outcome expectation and knowledge of foot care improved in the intervention group compared to the control group (p < 0.05). However, some of these improvements did not significantly differ compared to the control group for QoL physical symptoms and QoL psychosocial functioning (p > 0.05). Conclusion The self-efficacy enhancing program improved foot self-care behaviour with respect to the delivered program. It is expected that in the future, the self-efficacy theory can be incorporated into diabetes education to enhance foot self-care behaviour for elderly with diabetes living in other institutional care facilities. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12616000210471 PMID:29534070

The Impact of Simulated Nature on Patient Outcomes: A Study of Photographic Sky Compositions.

PubMed

Pati, Debajyoti; Freier, Patricia; O'Boyle, Michael; Amor, Cherif; Valipoor, Shabboo

2016-01-01

To examine whether incorporation of simulated nature, in the form of ceiling mounted photographic sky compositions, influences patient outcomes. Previous studies have shown that most forms of nature exposure have a positive influence on patients. However, earlier studies have mostly focused on wall-hung nature representations. The emergence of simulated nature products has raised the question regarding the effects of the new product on patient outcomes. A between-subject experimental design was adopted, where outcomes from five inpatient rooms with sky composition ceiling fixture were compared to corresponding outcomes in five identical rooms without the intervention. Data were collected from a total of 181 subjects on 11 outcomes. Independent sample tests were performed to identify differences in mean outcomes. Significant positive outcomes were observed in environmental satisfaction and diastolic blood pressure (BP). Environmental satisfaction in the experimental group was 12.4% higher than the control group. Direction of association for diastolic BP, nausea/indigestion medication, acute stress, anxiety, pain, and environmental satisfaction were consistent with a priori hypothesis. A post hoc exploratory assessment involving patients who did not self-request additional pain and sleep medication demonstrated confirmatory directions for all outcomes except Systolic BP, and statistically significant outcomes for Acute Stress and Anxiety-Acute Stress and Anxiety levels of the experimental group subjects was 53.4% and 34.79% lower, respectively, than that of the control group subjects. Salutogenic benefits of photographic sky compositions render them better than traditional ceiling tiles and offer an alternative to other nature interventions. © The Author(s) 2015.

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.

PubMed

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

2009-01-01

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 each delivery mode offered to children individually or in groups. To investigate the relative effectiveness of indirect and direct intervention therapy modes delivered individually or in groups for children with primary language impairment. A multi-centre randomized controlled trial investigated 161 children with primary language impairment aged 6-11 years randomized to a usual-therapy control group or to direct individual, indirect individual, direct group or indirect group therapy modes. Intervention was delivered three times a week for 30-40-min sessions in mainstream schools over 15 weeks. Language performance was assessed at baseline, post-therapy and at 12 months. Cost analysis was based on salary and travel costs for intervention modes and usual therapy. Compared with controls, children receiving project therapy made short-term improvements in expressive (p = 0.031), but not receptive, language immediately following intervention. Children with specific expressive language delay were more likely to show improvement than those with mixed receptive-expressive difficulties. The four project therapy modes did not differ on primary language outcomes (all p-values>0.392) and there were no further improvements evident at follow-up. Indirect group therapy was the least costly mode, with direct individual therapy the most costly. Intervention in this age group can be effective for expressive language and can be delivered equally effectively though speech and language therapy assistants and to children in groups.

Effects of a culturally adapted lifestyle intervention on cardio-metabolic outcomes: a randomized controlled trial in Iraqi immigrants to Sweden at high risk for Type 2 diabetes.

PubMed

Siddiqui, Faiza; Kurbasic, Azra; Lindblad, Ulf; Nilsson, Peter M; Bennet, Louise

2017-01-01

Middle-Eastern immigrants constitute a growing proportion of the Swedish population and are at high risk for Type 2 diabetes. This calls for a more proactive preventive approach for dealing with diabetes risk in this target group. The aim was to test the effect of a culturally adapted lifestyle intervention programme on changes in lifestyle habits and cardio-metabolic outcomes comparing an intervention group with a control group receiving usual care. Citizens of Malmö, Sweden born in Iraq and at high risk for Type 2 diabetes (n=636) were invited. Participation rate was 15.1%. In all, 96 participants were randomized to the intervention group (n=50) or to the control group (n=46). The intervention group was offered seven group sessions addressing healthy diet and physical activity including one cooking class. Changes in body weight, physical activity levels and cardio-metabolic outcomes were evaluated using linear mixed-effects models. The mean follow-up time was 3.9 and 3.5months in the intervention and control groups, respectively. The drop-out rate from baseline to the last visit was 30.0% in the intervention group (n=15) and 30.4% in the control group (n=14). The mean insulin sensitivity index increased significantly at follow-up in the intervention group compared to the control group (10.9% per month, p=0.005). The intervention group also reached a significant reduction in body weight (0.4% per month, p=0.004), body mass index (0.4% per month, p=0.004) and LDL-cholesterol (2.1% per month, p=0.036) compared to the control group. In total, 14.3% in the intervention group reached the goal to lose ≥5% of body weight versus none in the control group. This culturally adapted lifestyle intervention programme shows a beneficial effect on insulin action, body weight reduction, as well as LDL-cholesterol reduction, in Middle-Eastern immigrants. The programme adapted to resources in primary health care provides tools for improved primary prevention and reduced cardio-metabolic risk in this high-risk group for Type 2 diabetes. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Enhancing Peripheral Nerve Regeneration with a Novel Drug Delivering Nerve Conduit

DTIC Science & Technology

2017-12-01

control group ) or a conduit that released GDNF. The main outcome measures were muscle atrophy, electrophysiology, motor endplate reinnervation...prepared NGF+GDNF ( Control groups ). 8 Gastrocnemius Atrophy The gastrocnemius muscle weight of the GDNF treated group was ~ 60% of the non...experimental side at 10 weeks. GDNF conduit group (49.4±1.4 %) had statistically less muscle atrophy than the control group (65.1±5.1 %) (pɘ.05) at 10

A randomized controlled trial of water-based exercise for cardiovascular fitness in individuals with chronic stroke

PubMed Central

Chu, Kelly S; Eng, Janice J; Dawson, Andrew S; Harris, Jocelyn E.; Ozkaplan, Atila; Gylfadóttir, Sif

2011-01-01

Objective To evaluate the effect of an 8-week water-based exercise program (experimental group) over an upper extremity function program (control group) to increase cardiovascular fitness within a community setting for individuals with stroke. Design Single-blind randomized controlled trial Setting Public community centre Participants 12 community-dwelling individuals who have had a stroke with mild to moderate motor deficits; volunteer sample Intervention Experimental and control groups participated in group exercise programs undertaken in one hour sessions, three times per week for 8 weeks. The experimental group undertook chest deep water exercises at targeted heart rates. The control group performed arm and hand exercises while sitting. Main Outcome Measures The primary outcome measure was cardiovascular fitness (VO2max). Secondary measures were maximal workload, muscle strength, gait speed, and the Berg Balance Score. Results The experimental group attained significant improvements over the control group in cardiovascular fitness, maximal workload, gait speed, and paretic lower extremity muscle strength. The relatively short program (8 weeks) of water-based exercise resulted in a large improvement (22%) in cardiovascular fitness in a small group of individuals with stroke with relatively high function. Conclusions A water-based exercise program can be undertaken in the community as a group program and may be an effective means to promote fitness in individuals with stroke. PMID:15179638

The effects of implementing a point-of-care electronic template to prompt routine anxiety and depression screening in patients consulting for osteoarthritis (the Primary Care Osteoarthritis Trial): A cluster randomised trial in primary care.

PubMed

Mallen, Christian D; Nicholl, Barbara I; Lewis, Martyn; Bartlam, Bernadette; Green, Daniel; Jowett, Sue; Kigozi, Jesse; Belcher, John; Clarkson, Kris; Lingard, Zoe; Pope, Christopher; Chew-Graham, Carolyn A; Croft, Peter; Hay, Elaine M; Peat, George

2017-04-01

This study aimed to evaluate whether prompting general practitioners (GPs) to routinely assess and manage anxiety and depression in patients consulting with osteoarthritis (OA) improves pain outcomes. We conducted a cluster randomised controlled trial involving 45 English general practices. In intervention practices, patients aged ≥45 y consulting with OA received point-of-care anxiety and depression screening by the GP, prompted by an automated electronic template comprising five questions (a two-item Patient Health Questionnaire-2 for depression, a two-item Generalized Anxiety Disorder-2 questionnaire for anxiety, and a question about current pain intensity [0-10 numerical rating scale]). The template signposted GPs to follow National Institute for Health and Care Excellence clinical guidelines for anxiety, depression, and OA and was supported by a brief training package. The template in control practices prompted GPs to ask the pain intensity question only. The primary outcome was patient-reported current pain intensity post-consultation and at 3-, 6-, and 12-mo follow-up. Secondary outcomes included pain-related disability, anxiety, depression, and general health. During the trial period, 7,279 patients aged ≥45 y consulted with a relevant OA-related code, and 4,240 patients were deemed potentially eligible by participating GPs. Templates were completed for 2,042 patients (1,339 [31.6%] in the control arm and 703 [23.1%] in the intervention arm). Of these 2,042 patients, 1,412 returned questionnaires (501 [71.3%] from 20 intervention practices, 911 [68.0%] from 24 control practices). Follow-up rates were similar in both arms, totalling 1,093 (77.4%) at 3 mo, 1,064 (75.4%) at 6 mo, and 1,017 (72.0%) at 12 mo. For the primary endpoint, multilevel modelling yielded significantly higher average pain intensity across follow-up to 12 mo in the intervention group than the control group (adjusted mean difference 0.31; 95% CI 0.04, 0.59). Secondary outcomes were consistent with the primary outcome measure in reflecting better outcomes as a whole for the control group than the intervention group. Anxiety and depression scores did not reduce following the intervention. The main limitations of this study are two potential sources of bias: an imbalance in cluster size (mean practice size 7,397 [intervention] versus 5,850 [control]) and a difference in the proportion of patients for whom the GP deactivated the template (33.6% [intervention] versus 27.8% [control]). In this study, we observed no beneficial effect on pain outcomes of prompting GPs to routinely screen for and manage comorbid anxiety and depression in patients presenting with symptoms due to OA, with those in the intervention group reporting statistically significantly higher average pain scores over the four follow-up time points than those in the control group. ISRCTN registry ISRCTN40721988.

A prospective randomised controlled trial of nutritional supplementation in malnourished elderly in the community: clinical and health economic outcomes.

PubMed

Edington, J; Barnes, R; Bryan, F; Dupree, E; Frost, G; Hickson, M; Lancaster, J; Mongia, S; Smith, J; Torrance, A; West, R; Pang, F; Coles, S J

2004-04-01

Malnutrition is common in sick elderly people on admission to hospital and in the community. We conducted a randomised controlled trial to determine if nutritional supplementation after discharge from hospital improved nutritional status and functional outcomes, or reduced health-care costs. Elderly malnourished subjects were randomised to 8 weeks of supplementation or no supplementation post discharge, and followed up for 24 weeks. Weight, body mass index, anthropometrics, handgrip strength, quality of life and requirements for health-care professionals' services and social services were measured throughout the study. Nutritional status improved significantly from baseline to week 24 in the intervention group (P<0.05), but not in the control group. There was no significant difference in nutritional status between groups at week 24. Handgrip strength improved significantly in the intervention group during supplementation, and was significantly different from that of the control group at week 8, but decreased thereafter. There was no significant difference in quality of life or health economic outcomes between groups at week 24. In already malnourished elderly subjects, it may be too late to expect to improve function or quality of life or to reduce health-care costs simply by providing nutritional supplements after hospitalisation. Prevention is key. All elderly patients should be nutritionally assessed as part of their routine care, and appropriate intervention initiated early.

Benefits and problems of health-care robots in aged care settings: A comparison trial.

PubMed

Broadbent, Elizabeth; Kerse, Ngaire; Peri, Kathryn; Robinson, Hayley; Jayawardena, Chandimal; Kuo, Tony; Datta, Chandan; Stafford, Rebecca; Butler, Haley; Jawalkar, Pratyusha; Amor, Maddy; Robins, Ben; MacDonald, Bruce

2016-03-01

This study investigated whether multiple health-care robots could have any benefits or cause any problems in an aged care facility. Fifty-three residents and 53 staff participated in a non-randomised controlled trial over 12 weeks. Six robots provided entertainment, communication and health-monitoring functions in staff rooms and activity lounges. These settings were compared to control settings without robots. There were no significant differences between groups in resident or staff outcomes, except a significant increase in job satisfaction in the control group only. The intervention group perceived the robots had more agency and experience than the control group did. Perceived agency of the robots decreased over time in both groups. Overall, we received very mixed responses with positive, neutral and negative comments. The robots had no major benefits or problems. Future research could give robots stronger operational roles, use more specific outcome measures, and perform cost-benefit analyses. © 2015 AJA Inc.

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

PubMed Central

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

Clinical outcome in neonates with twin anemia-polycythemia sequence.

PubMed

Lopriore, Enrico; Slaghekke, Femke; Oepkes, Dick; Middeldorp, Johanna M; Vandenbussche, Frank P; Walther, Frans J

2010-07-01

The purpose of this study was to evaluate neonatal outcome of monochorionic twin pregnancies complicated by twin anemia-polycythemia sequence (TAPS). A cohort of consecutive monochorionic twins with TAPS with double survivors was included in the study. Each twin pair with TAPS was compared with 2 monochorionic twin pairs who were unaffected by TAPS or twin-to-twin transfusion syndrome and who were matched for gestational age at birth. Neonatal death, severe morbidity, and cerebral injury were studied. We included 19 twin pairs in the TAPS group and 38 control twin pairs. The incidence of neonatal death and severe neonatal morbidity was similar in the TAPS group and control group (3% [1/38] vs 1% [1/76] and 24% [9/38] vs 28% [21/76], respectively). Severe cerebral injury was detected in 1 infant (5%) in the TAPS group and 1 infant (2%) in the control group. Neonatal mortality and morbidity rates in a select population of TAPS neonates are similar to control neonatal rates. Copyright (c) 2010 Mosby, Inc. All rights reserved.

Rigid versus semi-rigid orthotic use following TMC arthroplasty: a randomized controlled trial.

PubMed

Prosser, Rosemary; Hancock, Mark J; Nicholson, Leslie; Merry, Cathy; Thorley, Felicity; Wheen, Douglass

2014-01-01

The trapeziometacarpal (TMC) joint of the human thumb is the second most common joint in the hand affected by osteoarthritis. TMC arthroplasty is a common procedure used to alleviate symptoms. No randomized controlled trials have been published on the efficacy of different post-operative orthotic regimes. Fifty six participants who underwent TMC arthroplasty were allocated to either rigid orthotic or semi-rigid orthotic groups. Both groups started an identical exercise program at two weeks following surgery. Outcome measures were assessed by an assessor blinded to group allocation. The primary outcome was the Patient Rated Wrist and Hand Evaluation (PRWHE) and secondary outcomes included the Michigan Hand Questionnaire (MHQ), thumb palmar abduction, first metacarpophalangeal extension and three point pinch grip. Measures were taken pre-operatively, at six weeks, three months and one year post-operatively. Between-group differences were analyzed with linear regression. Both groups performed equally well. There was no significant between-group difference for PRWHE scores (0.47, CI -11.5 to 12.4), including subscales for pain and function, or for any of the secondary outcomes at one year follow-up. We found no difference in outcomes between using a rigid or semi-rigid orthosis after TMC arthroplasty. Patient comfort, cost and availability may determine choice between orthoses in clinical practice. 1b RCT. Copyright © 2014 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Motion versus fixed distraction of the joint in the treatment of ankle osteoarthritis: a prospective randomized controlled trial.

PubMed

Saltzman, Charles L; Hillis, Stephen L; Stolley, Mary P; Anderson, Donald D; Amendola, Annunziato

2012-06-06

Initial reports have shown the efficacy of fixed distraction for the treatment of ankle osteoarthritis. We hypothesized that allowing ankle motion during distraction would result in significant improvements in outcomes compared with distraction without ankle motion. We conducted a prospective randomized controlled trial comparing the outcomes for patients with advanced ankle osteoarthritis who were managed with anterior osteophyte removal and either (1) fixed ankle distraction or (2) ankle distraction permitting joint motion. Thirty-six patients were randomized to treatment with either fixed distraction or distraction with motion. The patients were followed for twenty-four months after frame removal. The Ankle Osteoarthritis Scale (AOS) was the main outcome variable. Two years after frame removal, subjects in both groups showed significant improvement compared with the status before treatment (p < 0.02 for both groups). The motion-distraction group had significantly better AOS scores than the fixed-distraction group at twenty-six, fifty-two, and 104 weeks after frame removal (p < 0.01 at each time point). At 104 weeks, the motion-distraction group had an overall mean improvement of 56.6% in the AOS score, whereas the fixed-distraction group had a mean improvement of 22.9% (p < 0.01). Distraction improved the patient-reported outcomes of treatment of ankle osteoarthritis. Adding ankle motion to distraction showed an early and sustained beneficial effect on outcome.

Use of eCompliance, an innovative biometric system for monitoring of tuberculosis treatment in rural Uganda.

PubMed

Snidal, Sarah Jane; Barnard, Genevieve; Atuhairwe, Emmanuel; Ben Amor, Yanis

2015-06-01

Directly observed therapy short-course (DOTS) requires direct observation of tuberculosis (TB) patients and manual recording of doses taken. Programmatically, manual tracking is both time-consuming and prone to human error. Our project in western Uganda assessed the impact on TB treatment outcomes of a comprehensive patient support program including eCompliance, a biometric medical record device, with the aim of increasing TB patient retention. Through an observational study of 142 patients, DOTS outcomes of patients in the intervention group were compared with two control groups. Descriptive statistical comparisons, case-cohort analysis, and difference in change over time were used to assess the impact. Intervention patients had a higher cure rate than all other patients (55.6% versus 28.3% [P < 0.01]) and the odds of having a "cured" outcome were 3.17 higher (P < 0.05). The intervention group had a statistically significantly lower odds of having a negative outcome (0% versus.17% [P < 0.01]) than patients from the control groups. Additionally, the intervention group had a lost to follow-up rate lower than all other groups (0% versus 7%) that was trending on significant. In resource-limited settings, implementing comprehensive DOTS including eCompliance may reduce the occurrence of negative DOTS outcomes for patients. © The American Society of Tropical Medicine and Hygiene.

Evaluation of a randomized controlled trial on the effect on return to work with coaching combined with light therapy and pulsed electromagnetic field therapy for workers with work-related chronic stress.

PubMed

Nieuwenhuijsen, Karen; Schoutens, Antonius M C; Frings-Dresen, Monique H W; Sluiter, Judith K

2017-10-02

Chronic work-related stress is quite prevalent in the working population and is in some cases accompanied by long-term sick leave. These stress complaints highly impact employees and are costly due to lost productivity and medical expenses. A new treatment platform with light therapy plus Pulsed Electro Magnetic Fields (PEMF) in combination with coaching was used to assess whether more positive effects on return to work, stress, work-related fatigue, and quality of life could be induced compared to coaching alone. A placebo-controlled trial was executed after inclusion of 96 workers, aged 18-65 with work-related chronic stress complaints and who were on sick leave (either part-time or full-time). Participants were divided into three arms at random. Group 1 (n = 28) received the treatment and coaching (Intervention group), group 2 (n = 28) received the treatment with the device turned off and coaching (Placebo group) and group 3 (n = 28) received coaching only (Control group). The data were collected at baseline, and after 6, 12 and 24 weeks. The primary outcome was % return to work, and secondary outcomes were work-related fatigue (emotional exhaustion and need for recovery after work), stress (distress and hair cortisol), and quality of life (SF-36 dimensions: vitality, emotional role limitation, and social functioning). Eighty-four workers completed all measurements, 28 in each group. All groups improved significantly over time in the level of return to work, as well as on all secondary outcomes. No statistical differences between the three groups were found either on the primary outcome or on any of the secondary outcomes. Light therapy with Pulsed Electro Magnetic Fields PEMF therapy has no additional effect on return to work, stress, fatigue, and quality of live compared to coaching alone. NTR4794 , registration date: 18-sep-2014.

Participation and diffusion effects of a peer-intervention for HIV prevention among adults in rural Malawi.

PubMed

Crittenden, Kathleen S; Kaponda, Chrissie P N; Jere, Diana L; McCreary, Linda L; Norr, Kathleen F

2015-05-01

This paper examines whether a peer group intervention that reduced self-reported risky behaviors for rural adults in Malawi also had impacts on non-participants in the same communities. We randomly assigned two districts to the intervention and control conditions, and conducted surveys at baseline and 18 months post-intervention using unmatched independent random samples of intervention and control communities in 2003-2006. The six-session peer group intervention was offered to same-gender groups by trained volunteers. In this analysis, we divided the post-intervention sample into three exposure groups: 243 participants and 170 non-participants from the intervention district (total n = 415) and 413 control individuals. Controlling for demographics and participation, there were significant favorable diffusion effects on five partially overlapping behavioral outcomes: partner communication, ever used condoms, unprotected sex, recent HIV test, and a community HIV prevention index. Non-participants in the intervention district had more favorable outcomes on these behaviors than survey respondents in the control district. One behavioral outcome, community HIV prevention, showed both participation and diffusion effects. Participating in the intervention had a significant effect on six psychosocial outcomes: HIV knowledge (two measures), hope, condom attitudes, and self-efficacy for community HIV prevention and for safer sex; there were no diffusion effects. This pattern of results suggests that the behavioral changes promoted in the intervention spread to others in the same community, most likely through direct contact between participants and non-participants. These findings support the idea that diffusion of HIV-related behavior changes can occur for peer group interventions in communities, adding to the body of research supporting diffusion of innovations theory as a robust approach to accelerating change. If diffusion occurs, peer group intervention may be more cost-effective than previously realized. Wider implementation of peer group interventions can help meet the global goal of reducing new HIV infections. Copyright © 2015 Elsevier Ltd. All rights reserved.

Participation and Diffusion Effects of a Peer-Intervention for HIV Prevention among Adults in Rural Malawi

PubMed Central

Crittenden, Kathleen S.; Kaponda, Chrissie P. N.; Jere, Diana L.; McCreary, Linda L.; Norr, Kathleen F.

2015-01-01

This paper examines whether a peer group intervention that reduced self-reported risky behaviors for rural adults in Malawi also had impacts on non-participants in the same communities. We randomly assigned two districts to the intervention and control conditions, and conducted surveys at baseline and 18 months post-intervention using unmatched independent random samples of intervention and control communities in 2003-2006. The six-session peer group intervention was offered to same-gender groups by trained volunteers. In this analysis, we divided the post-intervention sample into three exposure groups: 243 participants and 170 non-participants from the intervention district (total n=415) and 413 control individuals. Controlling for demographics and participation, there were significant favorable diffusion effects on five partially overlapping behavioral outcomes: partner communication, ever used condoms, unprotected sex, recent HIV test, and a community HIV prevention index. Non-participants in the intervention district had more favorable outcomes on these behaviors than survey respondents in the control district. One behavioral outcome, community HIV prevention, showed both participation and diffusion effects. Participating in the intervention had a significant effect on six psychosocial outcomes: HIV knowledge (two measures), hope, condom attitudes, and self-efficacy for community HIV prevention and for safer sex; there were no diffusion effects. This pattern of results suggests that the behavioral changes promoted in the intervention spread to others in the same community, most likely through direct contact between participants and non-participants. These findings support the idea that diffusion of HIV-related behavior changes can occur for peer group interventions in communities, adding to the body of research supporting diffusion of innovations theory as a robust approach to accelerating change. If diffusion occurs, peer group intervention may be more cost-effective than previously realized. Wider implementation of peer group interventions can help meet the global goal of reducing new HIV infections. PMID:25864150

The benefits of a simplified method for CPR training of medical professionals: a randomized controlled study.

PubMed

Allan, Katherine S; Wong, Natalie; Aves, Theresa; Dorian, Paul

2013-08-01

We developed and tested a training method for basic life support incorporating defibrillator feedback during simulated cardiac arrest (CA) to determine the impact on the quality and retention of CPR skills. 298 subjects were randomized into 3 groups. All groups received a 2h training session followed by a simulated CA test scenario, immediately after training and at 3 months. Controls used a non-feedback defibrillator during training and testing. Group 1 was trained and tested with an audiovisual feedback defibrillator. During training, Group 1 reviewed quantitative CPR data from the defibrillator. Group 2 was trained as per Group 1, but was tested using the non-feedback defibrillator. The primary outcome was difference in compression depth between groups at initial testing. Secondary outcomes included differences in rate, depth at retesting, compression fraction, and self-assessment. Groups 1 and 2 had significantly deeper compressions than the controls (35.3 ± 7.6 mm, 43.7 ± 5.8 mm, 42.2 ± 6.6 mm for controls, Groups 1 and 2, P=0.001 for Group 1 vs. controls; P=0.001 for Group 2 vs. controls). At three months, CPR depth was maintained in all groups but remained significantly higher in Group 1 (39.1 ± 9.9 mm, 47.0 ± 7.4 mm, 42.2 ± 8.4 mm for controls, Groups 1 and 2, P=0.001 for Group 1 vs. control). No significant differences were noted between groups in compression rate or fraction. A simplified 2h training method using audiovisual feedback combined with quantitative review of CPR performance improved CPR quality and retention of these skills. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

PubMed Central

Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN; Block, J; Borok, N; Burton, T; Chamlin, SL; Deckert, S; DeKlotz, CC; Graff, LB; Hanifin, JM; Hebert, AA; Humphreys, R; Katoh, N; Kisa, RM; Margolis, DJ; Merhand, S; Minnillo, R; Mizutani, H; Nankervis, H; Ohya, Y; Rodgers, P; Schram, ME; Stalder, JF; Svensson, A; Takaoka, R; Teper, A; Tom, WL; von Kobyletzki, L; Weisshaar, E; Zelt, S; Williams, HC

2014-01-01

Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure. What's already known about this topic? Many different scales have been used to measure eczema, making it difficult to compare trials in meta-analyses and hampering improvements in clinical practice. HOME core outcome measures must pass the OMERACT (Outcome Measures in Rheumatology) filter of truth (validity), discrimination (sensitivity to change and responsiveness) and feasibility (ease of use, costs, time to perform and interpret). It has been previously agreed as part of the consensus process that four domains should be measured by the core outcomes: clinical signs, patient-reported symptoms, long-term control and health-related quality of life. What does this study add? Progress was made towards developing a core outcome set for measuring eczema in clinical trials. The group established the essential items to be included in the outcome measure for the clinical signs of eczema and was able to recommend a scale for the core set. The remaining three domains of patient-reported symptoms, long-term control and health-related quality of life require further work and meetings to determine the core outcome measures. PMID:24980543

Community-based walking exercise for peripheral artery disease: An exploratory pilot study

PubMed Central

Mays, Ryan J; Hiatt, William R; Casserly, Ivan P; Rogers, R Kevin; Main, Deborah S; Kohrt, Wendy M; Ho, P Michael; Regensteiner, Judith G

2016-01-01

Supervised walking exercise is an effective treatment to improve walking ability of patients with peripheral artery disease (PAD), but few exercise programs in community settings have been effective. The aim of this study was to determine the efficacy of a community-based walking exercise program with training, monitoring, and coaching (TMC) components to improve exercise performance and patient-reported outcomes in PAD patients. This was a randomized, controlled trial including PAD patients who previously received peripheral endovascular therapy or presented with stable claudication. Patients randomized (n=25) to the intervention group received a comprehensive community-based walking exercise program with elements of TMC over 14 weeks. Patients in the control group did not receive treatment beyond standard advice to walk. The primary outcome in the intent-to-treat (ITT) analyses was peak walking time (PWT) on a graded treadmill. Secondary outcomes included claudication onset time (COT) and patient-reported outcomes assessed via the Walking Impairment Questionnaire (WIQ). Intervention group patients (n=10) did not significantly improve PWT when compared with the control group patients (n=10) (mean±standard error: +2.1±0.7 vs. 0.0±0.7 min, p=0.052). Changes in COT and WIQ scores were greater for intervention patients compared with control patients (COT: +1.6±0.8 vs. −0.6±0.7 min, p=0.045; WIQ: +18.3±4.2 vs. −4.6±4.2%, p=0.001). This pilot using a walking program with TMC and an ITT analyses did not improve the primary outcome in PAD patients. Other walking performance and patient self-reported outcomes were improved following exercise in community settings. Further study is needed to determine whether this intervention improves outcomes in a trial employing a larger sample size. PMID:25755148

Effects of online group exercises for older adults on physical, psychological and social wellbeing: a randomized pilot trial.

PubMed

Baez, Marcos; Khaghani Far, Iman; Ibarra, Francisco; Ferron, Michela; Didino, Daniele; Casati, Fabio

2017-01-01

Intervention programs to promote physical activity in older adults, either in group or home settings, have shown equivalent health outcomes but different results when considering adherence. Group-based interventions seem to achieve higher participation in the long-term. However, there are many factors that can make of group exercises a challenging setting for older adults. A major one, due to the heterogeneity of this particular population, is the difference in the level of skills. In this paper we report on the physical, psychological and social wellbeing outcomes of a technology-based intervention that enable online group exercises in older adults with different levels of skills. A total of 37 older adults between 65 and 87 years old followed a personalized exercise program based on the OTAGO program for fall prevention, for a period of eight weeks. Participants could join online group exercises using a tablet-based application. Participants were assigned either to the Control group, representing the traditional individual home-based training program, or the Social group, representing the online group exercising. Pre- and post- measurements were taken to analyze the physical, psychological and social wellbeing outcomes. After the eight-weeks training program there were improvements in both the Social and Control groups in terms of physical outcomes, given the high level of adherence of both groups. Considering the baseline measures, however, the results suggest that while in the Control group fitter individuals tended to adhere more to the training, this was not the case for the Social group, where the initial level had no effect on adherence. For psychological outcomes there were improvements on both groups, regardless of the application used. There was no significant difference between groups in social wellbeing outcomes, both groups seeing a decrease in loneliness despite the presence of social features in the Social group. However, online social interactions have shown to be correlated to the decrease in loneliness in the Social group. The results indicate that technology-supported online group-exercising which conceals individual differences in physical skills is effective in motivating and enabling individuals who are less fit to train as much as fitter individuals. This not only indicates the feasibility of training together despite differences in physical skills but also suggests that online exercise might reduce the effect of skills on adherence in a social context. However, results from this pilot are limited to a small sample size and therefore are not conclusive. Longer term interventions with more participants are instead recommended to assess impacts on wellbeing and behavior change.

Pregnancy Outcome of Multiparous Women Aged over 40 Years

PubMed Central

Ates, Seda; Batmaz, Gonca; Sevket, Osman; Molla, Taner; Dane, Cem; Dane, Banu

2013-01-01

Objective. The aim of this study was to evaluate the effect of maternal age on prenatal and obstetric outcome in multiparaous women. Materials and Methods. A retrospective case control study was conducted, including women aged 40 years and over (study group, n = 97) who delivered at 20 week's gestation or beyond and women aged 20–29 years (control group, n = 97). Results. The mean age of women in the study group was 41.2 ± 1.7 years versus 25.4 ± 2.3 years in the control group. Advanced maternal age was associated with a significantly higher rate of hypertension, diabetes mellitus, fetal complication, and 5-minute Apgar scores <7 (P < 0.05). Caeserean section rate, incidence of placental abruption, preterm delivery, and neonatal intensive care unit admission were more common in the older group, but the differences were not statistically significant. Conclusions. Advanced maternal age is related to maternal and neonatal complications. PMID:25954770

Resource Allocation and Resident Outcomes In Nursing Homes: Comparisons between the Best and Worst1

PubMed Central

Anderson, Ruth A.; Hsieh, Pi-Ching; Su, Hui-Fang

2005-01-01

The purpose of this study was to identify patterns of resource allocation that related to resident outcomes in nursing homes. Data on structure, staffing levels, salaries, cost, casemix, and resident outcomes were obtained from state-level, administrative databases on 494 nursing homes. We identified two sets of comparison groups and showed that the group of homes with the greatest percentage of improvement in resident outcomes had higher levels of RN staffing and higher costs. However, comparison groups based on best/worst average outcomes did not differ in resource allocation patterns. Additional analysis demonstrated that when controlling for RN staffing, resident outcomes in high and low cost homes did not differ. The results suggest that, although RN staffing is more expensive, it is key to improving resident outcomes. PMID:9679807

Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial.

PubMed

Firouzi, Somayyeh; Majid, Hazreen Abdul; Ismail, Amin; Kamaruddin, Nor Azmi; Barakatun-Nisak, Mohd-Yusof

2017-06-01

Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation-also refers to multi-strain probiotics-on glycemic control and other diabetes-related outcomes in people with type 2 diabetes. A randomized, double-blind, parallel-group, controlled clinical trial. Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia. A total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks. Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract. Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate. With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p < 0.05, small effect size of 0.050), while these changes were not significant in ITT analysis. Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis. These changes were significant between groups at both analyses (p < 0.05, medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis). Secondary outcomes did not change significantly. Probiotics successfully passed through the gastrointestinal tract. Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes.

A Randomised Controlled Trial of Two Early Intervention Programs for Young Children with Autism: Centre-Based with Parent Program and Home-Based

ERIC Educational Resources Information Center

Roberts, Jacqueline; Williams, Katrina; Carter, Mark; Evans, David; Parmenter, Trevor; Silove, Natalie; Clark, Trevor; Warren, Anthony

2011-01-01

This study compares outcomes of early intervention programs for young children with autism; an individualised home-based program (HB), a small group centre-based program for children combined with a parent training and support group (CB) and a non-treatment comparison group (WL). Outcome measures of interest include social and communication skill…

Group art therapy as an adjunctive treatment for people with schizophrenia: multicentre pragmatic randomised trial

PubMed Central

Killaspy, Helen; Barnes, Thomas R E; Barrett, Barbara; Byford, Sarah; Clayton, Katie; Dinsmore, John; Floyd, Siobhan; Hoadley, Angela; Johnson, Tony; Kalaitzaki, Eleftheria; King, Michael; Leurent, Baptiste; Maratos, Anna; O’Neill, Francis A; Osborn, David P; Patterson, Sue; Soteriou, Tony; Tyrer, Peter; Waller, Diane

2012-01-01

Objectives To evaluate the clinical effectiveness of group art therapy for people with schizophrenia and to test whether any benefits exceed those of an active control treatment. Design Three arm, rater blinded, pragmatic, randomised controlled trial. Setting Secondary care services across 15 sites in the United Kingdom. Participants 417 people aged 18 or over, who had a diagnosis of schizophrenia and provided written informed consent to take part in the study. Interventions Participants, stratified by site, were randomised to 12 months of weekly group art therapy plus standard care, 12 months of weekly activity groups plus standard care, or standard care alone. Art therapy and activity groups had up to eight members and lasted for 90 minutes. In art therapy, members were given access to a range of art materials and encouraged to use these to express themselves freely. Members of activity groups were offered various activities that did not involve use of art or craft materials and were encouraged to collectively select those they wanted to pursue. Main outcome measures The primary outcomes were global functioning, measured using the global assessment of functioning scale, and mental health symptoms, measured using the positive and negative syndrome scale, 24 months after randomisation. Main secondary outcomes were levels of group attendance, social functioning, and satisfaction with care at 12 and 24 months. Results 417 participants were assigned to either art therapy (n=140), activity groups (n=140), or standard care alone (n=137). Primary outcomes between the three study arms did not differ. The adjusted mean difference between art therapy and standard care at 24 months on the global assessment of functioning scale was −0.9 (95% confidence interval −3.8 to 2.1), and on the positive and negative syndrome scale was 0.7 (−3.1 to 4.6). Secondary outcomes did not differ between those referred to art therapy or those referred to standard care at 12 or 24 months. Conclusions Referring people with established schizophrenia to group art therapy as delivered in this trial did not improve global functioning, mental health, or other health related outcomes. Trial registration Current Controlled Trials ISRCTN46150447. PMID:22374932

Randomized controlled trial of foot reflexology for patients with symptomatic idiopathic detrusor overactivity.

PubMed

Mak, Ho-Leung Jimmy; Cheon, Willy Cecilia; Wong, To; Liu, Yu Sun John; Tong, Wai Mei Anny

2007-06-01

The aim of this study was to examine whether foot reflexology has beneficial effects on patients with idiopathic detrusor overactivity. One hundred and nine women with symptomatic idiopathic detrusor overactivity were randomized into either foot reflexology treatment group or nonspecific foot massage control group. The primary outcome measure was the change in the diurnal micturition frequency. There was significant change in the number of daytime frequency in the reflexology group when compared with the massage group (-1.90 vs -0.55, p = 0.029). There was also a decrease in the 24-h micturition frequency in both groups, but the change was not statistically significant (-2.80 vs -1.04 p = 0.055). In the reflexology group, more patients believed to have received "true" reflexology (88.9 vs 67.4%, p = 0.012). This reflects the difficulty of blinding in trials of reflexology. Larger scale studies with a better-designed control group and an improved blinding are required to examine if reflexology is effective in improving patients' overall outcome.

Effects of metabolic syndrome on the functional outcomes of corticosteroid injection for De Quervain tenosynovitis.

PubMed

Roh, Y H; Noh, J H; Gong, H S; Baek, G H

2017-06-01

Metabolic syndrome is a constellation of medical conditions that arise from insulin resistance and abnormal adipose deposition and function. In patients with metabolic syndrome and De Quervain tenosynovitis this might affect the outcome of treatment by local corticosteroid injection. A total of 64 consecutive patients with De Quervain tenosynovitis and metabolic syndrome treated with corticosteroid injection were age- and sex-matched with 64 control patients without metabolic syndrome. The response to treatment, including visual analogue scale score for pain, objective findings consistent with De Quervain tenosynovitis (tenderness at first dorsal compartment, Finkelstein test result), and Disability of the Arm, Shoulder, and Hand score were assessed at 6, 12, and 24 weeks follow-up. Treatment failure was defined as persistence of symptoms or surgical intervention. Prior to treatment, patients with metabolic syndrome had mean initial pain visual analogue scale and Disability of the Arm, Shoulder, and Hand scores similar to those in the control group. The proportion of treatment failure in the metabolic syndrome group (43%) was significantly higher than that in the control group (20%) at 6 months follow-up. The pain visual analogue scale scores in the metabolic syndrome group were higher than the scores in the control group at the 12- and 24-week follow-ups. The Disability of the Arm, Shoulder, and Hand scores of the metabolic syndrome group were higher (more severe symptoms) than those of the control group at the 12- and 24-week follow-ups. Although considerable improvements in symptom severity and hand function will likely occur in patients with metabolic syndrome, corticosteroid injection for De Quervain tenosynovitis is not as effective in these patients compared with age- and sex-matched controls in terms of functional outcomes and treatment failure. III.

Stroke Self-Management Support Improves Survivors' Self-Efficacy and Outcome Expectation of Self-Management Behaviors.

PubMed

Lo, Suzanne H S; Chang, Anne M; Chau, Janita P C

2018-03-01

Evidence shows self-management programs are associated with improved recovery outcomes. This article reports on the effectiveness of a new nurse-led self-efficacy-based stroke self-management program. A randomized controlled trial of participants recruited from 3 acute stroke units was conducted. The intervention group received the 4-week stroke self-management program. The control group received usual care. All participants were assessed at baseline and 8 weeks after randomization. Data were analyzed using generalized estimating equations. Outcomes included self-efficacy, outcome expectation, and satisfaction with performance of self-management behaviors. One hundred twenty-eight participants were randomized with mean age, 67.46 years (SD, 11.95); 59% men; and mean duration poststroke, 45 days (SD, 26.16). At 8 weeks of follow-up in the intention-to-treat population, the intervention group improved significantly in self-efficacy (95% confidence interval, 2.55-12.45; P <0.01), outcome expectation (95% confidence interval, 5.47-14.01; P <0.01), and satisfaction with performance of self-management behaviors (95% confidence interval, 3.38-13.87; P <0.01) compared with the control. Similar results were obtained at 8 weeks of follow-up in the per-protocol population. The stroke self-management program improved survivors' self-efficacy, outcome expectation, and satisfaction with performance of self-management behaviors. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02112955. © 2018 American Heart Association, Inc.

Minimizing variance in pediatric gastrostomy: does standardized perioperative feeding plan decrease cost and improve outcomes?

PubMed

Sunstrom, Rachel; Hamilton, Nicholas; Fialkowski, Elizabeth; Lofberg, Katrine; McKee, Julie; Sims, Thomas; Krishnaswami, Sanjay; Azarow, Kenneth

2016-05-01

A protocol for laparoscopic gastrostomy placement was implemented which specified perioperative antibiotics, feeding regimens, and discharge criteria. Our hypothesis was that hospital cost could be decreased, whereas at the same time improving or maintaining patient outcomes. Data were collected on consecutive patients beginning 6 months after implementation of our protocol. We recorded surgeon compliance, patient outcomes (as defined by 30-day NSQIP complication rates), and cost of initial hospitalization, which was then compare to a 6-month historical control period. Our control group n = 26 and protocol group n = 39. Length of stay was shorter in the protocol group (P ≤ .05 by nonparametric analysis). The complication rate was similar in both groups (23% control vs 15% protocol, P = .43). Initial hospital costs were not different. Surgeon compliance to protocol was 82%. A standard protocol is achievable for gastrostomy tube management. After implementation of our protocol, we were able to show a significant decrease in length of stay, whereas maintaining quality. Copyright © 2016 Elsevier Inc. All rights reserved.

Should Young Children with Traumatic Brain Injury Be Compared with Community or Orthopedic Control Participants?

PubMed

Beauchamp, Miriam H; Landry-Roy, Catherine; Gravel, Jocelyn; Beaudoin, Cindy; Bernier, Annie

2017-09-01

Pediatric traumatic brain injury (TBI) research depends on comparisons of profiles and outcomes between brain-injured individuals and groups consisting either of injured controls (e.g., orthopedic injuries, OI) or uninjured, typically developing children recruited from the community (community controls, CC). Children with OI are thought to provide optimal comparisons for individuals with TBI because they share injury-related experiences and pre-morbid characteristics; however, a study by Mathias and colleagues (2013) 1 in adults has called into question the added value of injury control groups in TBI research. The comparability of these control groups has not been established in young children. Seventy-two children with OI and 84 CC aged between 18 and 60 months were compared on a range of demographic variables, developmental and medical history, pre-injury behavioral and adaptive profiles, as well as on measures of adaptive functioning, behavior, family functioning, post-concussive symptoms, and cognition (intellectual functioning, verbal abilities, executive functioning, social cognition) 6 months after the OI. There were no statistically significant differences between the OI and CC groups on any of the variables tested, whether they related to pre-injury or post-injury characteristics. The findings are applicable to studies seeking to identify appropriate control groups in the context of preschool TBI research, and suggest no clear advantage in recruiting OI controls based on the variables studied and the methodology used. However, further work is necessary to verify additional factors and outcomes relevant to pediatric TBI research, as well as to compare outcomes between these two groups at more acute stages (i.e., prior to 6 months post-injury).

The London Exercise And Pregnant smokers (LEAP) trial: a randomised controlled trial of physical activity for smoking cessation in pregnancy with an economic evaluation.

PubMed

Ussher, Michael; Lewis, Sarah; Aveyard, Paul; Manyonda, Isaac; West, Robert; Lewis, Beth; Marcus, Bess; Riaz, Muhammad; Taylor, Adrian H; Barton, Pelham; Daley, Amanda; Essex, Holly; Esliger, Dale; Coleman, Tim

2015-10-01

Smoking during pregnancy is the main preventable cause of poor birth outcomes. Improved methods are needed to help women to stop smoking during pregnancy. Pregnancy provides a compelling rationale for physical activity (PA) interventions as cessation medication is contraindicated or ineffective, and an effective PA intervention could be highly cost-effective. To examine the effectiveness and cost-effectiveness of a PA intervention plus standard behavioural support for smoking cessation relative to behavioural support alone for achieving smoking cessation at the end of pregnancy. Multicentre, two-group, pragmatic randomised controlled trial and economic evaluation with follow-up at the end of pregnancy and 6 months postnatally. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1 : 1 ratio. 13 hospitals offering antenatal care in the UK. Women between 10 and 24 weeks' gestation smoking five or more cigarettes a day before pregnancy and one or more during pregnancy. Participants were randomised to behavioural support for smoking cessation (control) or behavioural support plus a PA intervention consisting of supervised treadmill exercise plus PA consultations. Neither participants nor researchers were blinded to treatment allocation. The primary outcome was self-reported, continuous smoking abstinence between a quit date and end of pregnancy, validated by expired carbon monoxide and/or salivary cotinine. Secondary outcomes were maternal weight, depression, birth outcomes, withdrawal symptoms and urges to smoke. The economic evaluation investigated the costs of the PA intervention compared with the control intervention. In total, 789 women were randomised (n = 394 PA, n = 395 control). Four were excluded post randomisation (two had been enrolled twice in sequential pregnancies and two were ineligible and randomised erroneously). The intention-to-treat analysis comprised 785 participants (n = 392 PA, n = 393 control). There was no significant difference in the rate of abstinence at the end of pregnancy between the PA group (7.7%) and the control group (6.4%) [odds ratio for PA group abstinence 1.21, 95% confidence interval (CI) 0.70 to 2.10]. For the PA group compared with the control group, there was a 33% (95% CI 14% to 56%), 28% (95% CI 7% to 52%) and 36% (95% CI 12% to 65%) significantly greater increase in self-reported minutes of moderate- and vigorous-intensity PA from baseline to 1 week, 4 weeks and 6 weeks respectively. Accelerometer data showed that there was no significant difference in PA levels between the groups. There were no significant differences between the groups for change in maternal weight, depression, withdrawal symptoms or urges to smoke. Adverse events and birth outcomes were similar between the groups except for there being significantly more caesarean births in the control group than in the PA group (28.7% vs. 21.3%; p < 0.023). The PA intervention was less costly than the control intervention by £35 per participant. This was mainly attributable to increased health-care usage in the control group. However, there was considerable statistical uncertainty around this estimate. During pregnancy, offering an intervention combining supervised exercise and PA counselling does not add to the effectiveness of behavioural support for smoking cessation. Only 10% of participants had PA levels accessed by accelerometer and it is, therefore, unclear whether or not the lack of an effect on the primary outcome is the result of insufficient increases in PA. Research is needed to identify the smoking populations most suitable for PA interventions and methods for increasing PA adherence. Current Controlled Trials ISRCTN48600346. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 84. See the NIHR Journals Library website for further project information.

The Perioperative Educational Program for Improving Upper Arm Dysfunction in Patients with Breast Cancer at 1-Year Follow-Up: A Prospective, Controlled Trial.

PubMed

Sato, Fumiko; Arinaga, Yoko; Sato, Naoko; Ishida, Takanori; Ohuchi, Noriaki

2016-03-01

The many women with breast cancer who underwent axillary lymph node dissection (ALND) suffer from the upper arm dysfunction. In this study, we investigated the effectiveness of a perioperative educational program for improving upper arm dysfunction in breast cancer patients following ALND. This study was a sub-analysis of a previous controlled trial with an educational program. The subjects of this analysis included 64 patients following ALND who completed measurements at 12 months. The perioperative educational program consisted of monitoring of arm dysfunction, exercises, massage, and lifestyle adjustments. The intervention group (37 patients) received this perioperative educational program over 12 months, while 27 patients in the control group received written information about shoulder exercise from on-site staff only before surgery. Primary outcomes were shoulder range of motion (ROM), arm girth, and grip strength. Secondary outcomes were evaluated with the Subjective Perception of Post-Operative Functional Impairment of the Arm (SPOFIA) scores, the Disabilities of the Arm, Shoulder and Hand (DASH) scores, and the Medical Outcome Study 36-Item Short-Form Health Survey v2 (SF-36v2). The SF-36v2 measures health-related quality of life (QOL). Primary and secondary outcomes were compared between groups at 1 week (after drainage tube removal) and 12 months after surgery, using the Mann-Whitney U test. The horizontal extension was significantly improved only in the intervention group. Moreover, the SPOFIA score was significantly improved in the intervention group, and other scores of the secondary outcomes were similar between the two groups. The perioperative educational program may improve postoperative upper arm dysfunction and symptoms.

Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial.

PubMed

Avis, Nancy E; Coeytaux, Remy R; Isom, Scott; Prevette, Kristen; Morgan, Timothy

2016-06-01

The aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. A total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. The VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (P < 0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (P < 0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained after treatment. Statistically significant clinical improvement was observed after three acupuncture treatments, and maximal clinical effects occurred after a median of eight treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. We found that a course of acupuncture treatments was associated with significant reduction in VMS, and several quality-of-life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment.

Increasing physical activity in stroke survivors using STARFISH, an interactive mobile phone application: a pilot study.

PubMed

Paul, Lorna; Wyke, Sally; Brewster, Stephen; Sattar, Naveed; Gill, Jason M R; Alexander, Gillian; Rafferty, Danny; McFadyen, Angus K; Ramsay, Andrew; Dybus, Aleksandra

2016-06-01

Following stroke, people are generally less active and more sedentary which can worsen outcomes. Mobile phone applications (apps) can support change in health behaviors. We developed STARFISH, a mobile phone app-based intervention, which incorporates evidence-based behavior change techniques (feedback, self-monitoring and social support), in which users' physical activity is visualized by fish swimming. To evaluate the potential effectiveness of STARFISH in stroke survivors. Twenty-three people with stroke (12 women; age: 56.0 ± 10.0 years, time since stroke: 4.2 ± 4.0 years) from support groups in Glasgow completed the study. Participants were sequentially allocated in a 2:1 ratio to intervention (n = 15) or control (n = 8) groups. The intervention group followed the STARFISH program for six weeks; the control group received usual care. Outcome measures included physical activity, sedentary time, heart rate, blood pressure, body mass index, Fatigue Severity Scale, Instrumental Activity of Daily Living Scale, Ten-Meter Walk Test, Stroke Specific Quality of Life Scale, and Psychological General Well-Being Index. The average daily step count increased by 39.3% (4158 to 5791 steps/day) in the intervention group and reduced by 20.2% (3694 to 2947 steps/day) in the control group (p = 0.005 for group-time interaction). Similar patterns of data and group-time interaction were seen for walking time (p = 0.002) and fatigue (p = 0.003). There were no significant group-time interactions for other outcome measures. Use of STARFISH has the potential to improve physical activity and health outcomes in people after stroke and longer term intervention trials are warranted.

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

PubMed

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 < 0.001). 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.

Do Tibial Plateau Fractures Worsen Outcomes of Knee Ligament Injuries? A Matched Cohort Analysis

PubMed Central

Cinque, Mark E.; Godin, Jonathan A.; Moatshe, Gilbert; Chahla, Jorge; Kruckeberg, Bradley M.; Pogorzelski, Jonas; LaPrade, Robert F.

2017-01-01

Background: Tibial plateau fractures account for a small portion of all fractures; however, these fractures can pose a surgical challenge when occurring concomitantly with ligament injuries. Purpose/Hypothesis: The purpose of this study was to compare 2-year outcomes of soft tissue reconstruction with or without a concomitant tibial plateau fracture and open reduction internal fixation. We hypothesized that patients with a concomitant tibial plateau fracture at the time of soft tissue surgery would have inferior outcomes compared with patients without an associated tibial plateau fracture. Study Design: Cohort study; Level of evidence, 3. Methods: Forty patients were included in this study: 8 in the fracture group and 32 in the matched control group. Inclusion criteria for the fracture group included patients who were at least 18 years old at the time of surgery and sustained a tibial plateau fracture and a concomitant injury of the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, or fibular collateral ligament in isolation or any combination of cruciate or collateral ligaments and who subsequently underwent isolated or combined ligament reconstruction. Patients were excluded if they underwent prior ipsilateral knee surgery, sustained additional bony injuries, or sustained an isolated extra-articular ligament injury at the time of injury. Each patient with a fracture was matched with 4 patients from a control group who had no evidence of a tibial plateau fracture but underwent the same soft tissue reconstruction procedure. Results: Patients in the fracture group improved significantly from preoperatively to postoperatively with respect to Short Form–12 (P < .05) and Western Ontario and McMaster Universities Osteoarthritis Index total scores (P < .05). The Lysholm (P = .075) and Tegner scores (P = .086) also improved, although this was not statistically significant. Patients in the control group improved significantly from preoperatively to postoperatively across all measured scores. A comparison of the postoperative results between the 2 groups showed no statistically significant difference. Conclusion: The presence of a tibial plateau fracture in conjunction with a ligamentous knee injury did not have a negative effect on postoperative patient-reported outcomes. Patient-reported outcome scores after surgery in both the fracture and control groups improved beyond the minimally clinically important difference, indicating that the presence of a fracture did not detract from the outcomes observed in patients without fractures undergoing concomitant ligament reconstruction. PMID:28840154

Does application of moderately concentrated platelet-rich plasma improve clinical and structural outcome after arthroscopic repair of medium-sized to large rotator cuff tear? A randomized controlled trial.

PubMed

Pandey, Vivek; Bandi, Atul; Madi, Sandesh; Agarwal, Lipisha; Acharya, Kiran K V; Maddukuri, Satish; Sambhaji, Charudutt; Willems, W Jaap

2016-08-01

Platelet-rich plasma (PRP) has the potential to improve tendon-bone healing. The evidence is still controversial as to whether PRP application after repair of medium-sized to large cuff tears leads to superior structural and clinical outcome, especially after single-row repair. In a randomized study, 102 patients (PRP group, 52 patients; control group, 50 patients) with medium-sized and large degenerative posterosuperior tears were included for arthroscopic repair with a minimum follow-up of 2 years. Patients were evaluated with clinical scores (visual analog scale score, Constant-Murley score, University of California-Los Angeles score, and American Shoulder and Elbow Surgeons score) and ultrasound to assess retear and vascularity pattern of the cuff. Visual analog scale scores were significantly lower in the PRP group than in controls at 1 month, 3 months, and 6 months but not later. Constant-Murley scores were significantly better in the PRP group compared with controls at 12 and 24 months, whereas University of California-Los Angeles scores were significantly higher in the PRP group at 6 and 12 months (P < .05). The American Shoulder and Elbow Surgeons score in both groups was comparable at all the times. At 24 months, retear in the PRP group (n = 2; 3.8%) was significantly lower than in the control group (n = 10; 20%; P = .01). The retear difference was significant only for large tears (PRP:control group, 1:6; P = .03). Doppler ultrasound examination showed significant vascularity in the PRP group repair site at 3 months postoperatively (P < .05) and in peribursal tissue until 12 months. Application of moderately concentrated PRP improves clinical and structural outcome in large cuff tears. PRP also enhances vascularity around the repair site in the early phase. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

How effective is the comprehensive approach to rehabilitation (CARe) methodology? A cluster randomized controlled trial.

PubMed

Bitter, Neis; Roeg, Diana; van Assen, Marcel; van Nieuwenhuizen, Chijs; van Weeghel, Jaap

2017-12-11

The CARe methodology aims to improve the quality of life of people with severe mental illness by supporting them in realizing their goals, handling their vulnerability and improving the quality of their social environment. This study aims to investigate the effectiveness of the CARe methodology for people with severe mental illness on their quality of life, personal recovery, participation, hope, empowerment, self-efficacy beliefs and unmet needs. A cluster Randomized Controlled Trial (RCT) was conducted in 14 teams of three organizations for sheltered and supported housing in the Netherlands. Teams in the intervention group received training in the CARe methodology. Teams in the control group continued working according to care as usual. Questionnaires were filled out at baseline, after 10 months and after 20 months. A total of 263 clients participated in the study. Quality of life increased in both groups, however, no differences between the intervention and control group were found. Recovery and social functioning did not change over time. Regarding the secondary outcomes, the number of unmet needs decreased in both groups. All intervention teams received the complete training program. The model fidelity at T1 was 53.4% for the intervention group and 33.4% for the control group. At T2 this was 50.6% for the intervention group and 37.2% for the control group. All clients improved in quality of life. However we did not find significant differences between the clients of the both conditions on any outcome measure. Possible explanations of these results are: the difficulty to implement rehabilitation-supporting practice, the content of the methodology and the difficulty to improve the lives of a group of people with longstanding and severe impairments in a relatively short period. More research is needed on how to improve effects of rehabilitation trainings in practice and on outcome level. ISRCTN77355880 , retrospectively registered (05/07/2013).

Pregnancy in infertile PCOD patients. Complications and outcome.

PubMed

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 < .05); however, the proportion of lean versus obese subjects in the two groups was similar. The incidence of an abnormal glucose challenge test, gestational diabetes mellitus and pregnancy-induced hypertension was significantly increased in pregnant women with PCOD (P < .05). When lean PCOD subjects were compared with lean control subjects, the difference in the incidence of the above complications was still significant (P < .05). The incidence of pregnancy complications was similar when obese 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 Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease.

PubMed

Pohl, Petra; Dizdar, Nil; Hallert, Eva

2013-01-01

To assess the feasibility of the novel intervention, Ronnie Gardiner Rhythm and Music (RGRM™) Method compared to a control group for patients with Parkinson's disease (PD). Eighteen patients, mean age 68, participating in a disability study within a neurological rehabilitation centre, were randomly allocated to intervention group (n = 12) or control group (n = 6). Feasibility was assessed by comparing effects of the intervention on clinical outcome measures (primary outcome: mobility as assessed by two-dimensional motion analysis, secondary outcomes: mobility, cognition, quality of life, adherence, adverse events and eligibility). Univariable analyses showed no significant differences between groups following intervention. However, analyses suggested that patients in the intervention group improved more on mobility (p = 0.006), cognition and quality of life than patients in the control group. There were no adverse events and a high level of adherence to therapy was observed. In this disability study, the use of the RGRM™ Method showed promising results in the intervention group and the adherence level was high. Our results suggest that most assessments chosen are eligible to use in a larger randomized controlled study for patients with PD. The RGRM™ Method appeared to be a useful and safe method that showed promising results in both motor and cognitive functions as well as quality of life in patients with moderate PD. The RGRM™ Method can be used by physiotherapists, occupational, speech and music therapists in neurological rehabilitation. Most measurements were feasible except for Timed-Up-and-Go.

The effect of placenta previa on fetal growth and pregnancy outcome, in correlation with placental pathology.

PubMed

Weiner, E; Miremberg, H; Grinstein, E; Mizrachi, Y; Schreiber, L; Bar, J; Kovo, M

2016-12-01

To compare the clinical characteristics and placental histopathology between pregnancies complicated by placenta previa and controls. Between 2009 and 2015, cesarean deliveries (CDs) of 119 pregnancies with placenta previa were identified from which maternal outcomes, neonatal outcomes and placental pathology were reviewed. Results were compared with CDs matched for maternal age and pregnancy complications (control group, n=119). Placental lesions were classified into maternal and fetal vascular supply lesions and inflammatory response. Composite neonatal outcome was defined as one or more of early neonatal complications. Small-for-gestational age (SGA) was defined as birth weight ⩽10th percentile. Placentas from the previa group had higher rates of weights <10th percentile (P<0.001) and of maternal and fetal vascular supply lesions (P<0.001, for both). Higher rate of SGA (P=0.003) and worse composite neonatal outcome (P<0.001) were also observed in the previa group as compared with controls. After controlling for potential confounding bias using multivariable logistic regression models, placenta previa remained statistically significantly associated with placental maternal (adjusted odds ratio (aOR) 2.48, 95% confidence interval (CI) 1.2-4.9, P=0.009) and fetal (aOR 7.05, 95% CI 2.4-20.2, P<0.001) vascular supply lesions, SGA (aOR 10, 95% CI 2.3-44.2, P=0.002) and adverse neonatal outcome (aOR 6.87, 95% CI 2.9-11.8, P<0.001). More placental vascular supply lesions, higher rate of SGA and worse neonatal outcome characterized pregnancies with placenta previa in the current study. These findings may suggest that abnormal placentation is accompanied by suboptimal implantation that interferes with fetal growth.

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

PubMed

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.

A Semantic Differential Evaluation of Attitudinal Outcomes of Introductory Physical Science.

ERIC Educational Resources Information Center

Hecht, Alfred Roland

This study was designed to assess the attitudinal outcomes of Introductory Physical Science (IPS) curriculum materials used in schools. Random samples of 240 students receiving IPS instruction and 240 non-science students were assigned to separate Solomon four-group designs with non-equivalent control groups. Random samples of 60 traditional…

Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial.

PubMed

Claessen, Femke M A P; Mellema, Jos J; Stoop, Nicky; Lubberts, Bart; Ring, David; Poolman, Rudolf W

2016-01-01

Patient-reported outcome measures (PROMs) are influenced by psychosocial factors, but it is unknown whether we can influence PROM scores by modifying the mindset of the patient. We assessed whether priming affects scores on PROMs. In all, 168 patients with musculoskeletal illness participated in this double-blinded, randomized, controlled, parallel study between July 2014 and October 2014 in a level I trauma center. Inclusion criteria were patients aged 18 years or older with English fluency and literacy and the ability to provide informed consent. Priming was performed by means of the Pain Catastrophizing Scale (PCS). The patients were randomized (1:1:1) into 3 groups: intervention group I was negatively primed with the original PCS; intervention group II was positively primed with a positively phrased PCS group; and control group III was not primed. Assessments were performed using PROMs on the domain of physical function, depression, and pain. Bivariate and multivariable regression analyses were conducted. The intervention and control groups were well balanced in demographic and condition-specific characteristics. The positive PCS was independently associated with higher PROM scores in the physical function domain (Patient-Reported Outcome Measurement Information System Upper Extremity Function: coefficient = 4.7, partial R(2) = 0.042; CI: 1.2-8.2; p < 0.010). Patients primed with a positively phrased version of the PCS reported less functional disability as compared with patients who were either negatively primed or not primed at all. This suggests that by influencing the mindset, PROMs can be influenced, resulting in better outcome if positively primed. Level 1 therapeutic study. NCT02209259. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

The efficacy of motivational counselling and SMS reminders on daily sitting time in patients with rheumatoid arthritis: a randomised controlled trial.

PubMed

Thomsen, Tanja; Aadahl, Mette; Beyer, Nina; Hetland, Merete Lund; Løppenthin, Katrine; Midtgaard, Julie; Christensen, Robin; Østergaard, Mikkel; Jennum, Poul Jørgen; Esbensen, Bente Appel

2017-09-01

The aim of this report is to investigate the efficacy of an individually tailored, theory-based behavioural intervention for reducing daily sitting time, pain and fatigue, as well as improving health-related quality of life, general self-efficacy, physical function and cardiometabolic biomarkers in patients with rheumatoid arthritis (RA). In this randomised controlled trial 150 patients with RA were randomised to an intervention or a no-intervention control group. The intervention group received three individual motivational counselling sessions and short message service or text messages aimed at reduction of sedentary behaviour during the 16-week intervention period. Primary outcome was change in daily sitting time measured objectively by ActivPAL. Secondary outcomes included change in pain, fatigue, physical function, general self-efficacy, quality of life, blood pressure, blood lipids, haemoglobin A1c, body weight, body mass index, waist circumference and waist-hip ratio. 75 patients were allocated to each group. Mean reduction in daily sitting time was -1.61 hours/day in the intervention versus 0.59 hours/day increase in the control group between-group difference -2.20 (95% CI -2.72 to -1.69; p<0.0001) hours/day in favour of the intervention group. Most of the secondary outcomes were also in favour of the intervention. An individually tailored, behavioural intervention reduced daily sitting time in patients with RA and improved patient-reported outcomes and cholesterol levels. NCT01969604; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Corticotomy-assisted retraction: an outcome assessment.

PubMed

Sakthi, S Vijayashri; Vikraman, B; Shobana, V R; Iyer, S Kavitha; Krishnaswamy, N R

2014-01-01

To assess the efficiency and treatment outcome of patients treated with corticotomy-assisted en-masse orthodontic retraction as compared with the en-masse retraction without corticotomy. Forty adult patients with bimaxillary protrusion requiring correction of bidental proclination constituted the sample. The study group consisted of 22 patients (male 11, female 11) willing to undergo surgery to reduce the duration of their orthodontic treatment and 18 patients (male 9, female 9) desirous of undergoing conventional orthodontic treatment without surgical intervention constituted the control group. Comparison of rate of retraction and anchor loss between the study and the control group was assessed. Average rate of space closure of 1.8 mm/month in the maxilla and 1.57 mm/month in the mandible was observed in the study group compared to 1.02 mm/month in the maxilla and 0.87 mm/month in the mandible in the control group. The rate of retraction accelerated during the first 2 months of retraction. Molar anchor loss of approximately 0.6 mm occurred in the study group, and 1.8 mm occurred in the control group during the 4 months. The rate of retraction with study group was twice as faster when compared to the control group, accelerating during the first 2 months of retraction. There was better anchorage control with the undecorticated molar segment during the retraction period but was found to increase as time advanced.

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

PubMed

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

2015-08-01

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

Quality of Life and Bariatric Surgery: Cross-Sectional Study and Analysis of Factors Influencing Outcome.

PubMed

Janik, Michał Robert; Rogula, Tomasz; Bielecka, Ilona; Kwiatkowski, Andrzej; Paśnik, Krzysztof

2016-12-01

The aims of our study were to compare quality of life (QOL) in obese patients after bariatric surgery with that in controls seeking surgery and to investigate which factors are associated with QOL in the Moorehead-Ardelt Quality of Life Questionnaire II (MA II). This was a cross-sectional study. The operated group consisted of patients after laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass. The MA II was administered by e-mail to 305 patients 12-18 months after surgery. The control groups consisted of 101 obese patients. We compared the QOL scores and considered good and very good outcomes to be satisfactory. Multiple logistic regression and correlation analysis was performed to identify factors associated with QOL. In the operated group, the total MA II score was 1.70 ± 0.76, which was higher than 0.59 ± 1.17 in the control group. The score adjusted for the type of surgery was comparable. The prevalence of satisfactory QOL outcomes was similar in both post-operative subgroups and was still higher than in the control group. We identified four factors associated with higher QOL in obese patients. Weight loss was not correlated with total score in MAII. This study demonstrates that patients after bariatric surgery have a higher score in MA II, which reflects better QOL. The scoring adjusted by type of operation is comparable. QOL among obese patients is dependent on age, gender, history of bariatric surgery, and partnered status. Body mass reduction was not associated with outcome in MAII.

Emergent Start Peritoneal Dialysis for End-Stage Renal Disease: Outcomes and Advantages.

PubMed

Nayak, K Shivanand; Subhramanyam, Sreepada V; Pavankumar, Navva; Antony, Sinoj; Sarfaraz Khan, M A

2018-01-01

Initiating renal replacement therapy in late referred patients with central venous catheter (CVC) hemodialysis (HD) causes serious complications. In urgent start peritoneal dialysis, initiating peritoneal dialysis (PD) within 14 days of catheter insertion still needs HD with CVC. We initiated Emergent start PD (ESPD) with Automated PD (APD) at our center within 48 h from the time of presentation. A prospective, case-controlled, intention-to-treat study with 56 patients was conducted between March 2016 and August 2017. Group A (24 patients) underwent conventional PD 14 days after catheter insertion. Group B (32 patients), underwent ESPD with APD. Exit site leak (ESL), catheter blockage, and peritonitis at 90 days were primary outcomes. Technique survival was secondary outcome. Baseline characteristics were similar with 3 episodes of ESLs (9.4%) in the study group and none in the control group (p = 0.123). Catheter blockage (16.7%-Group A, 25%-Group B) and peritonitis (none vs. 9.4% in study group) were similar in terms of statistical details just as technique survival (95%-Group A, 88.2%-Group B at 90 days). ESPD with APD in the unplanned patient is an appropriate approach. © 2018 S. Karger AG, Basel.

Impact of treatment protocol on outcome of localized Ewing's sarcoma.

PubMed

Nasaka, Srividya; Gundeti, Sadashivudu; Ganta, Ranga Raman; Arigela, Ravi Sankar; Linga, Vijay Gandhi; Maddali, Lakshmi Srinivas

2016-01-01

The outcome of localized Ewing's sarcoma has improved with multi-disciplinary approach. Survivals of Ewing's sarcoma from the Asian countries differed between centers. We retrospectively analyzed the records of newly diagnosed localized Ewing's sarcoma patients from 2002 to 2012. The patients were analyzed in three groups; Group 1(2002-2004) who received non-ifosfomide based regimens, Group 2(2005-2008) who received VDC/IE for 12 cycles, and Group 3(2009-2012), who received VDC/IE for 17 cycles. The groups were compared for their baseline characteristics, treatment protocol and outcome. Seventy three patients were included in the study. The median age of presentation was 15 years, with slight male predominance. Axial primary was seen in 62%. The median RFS of the three groups was 26.4, 31.4 and 36.8 months respectively ( P = 0.0018). The median OS was 27.9, 35 and 43 months respectively ( P = 0.0007). At a median follow-up of 35 months, the 3 year RFS and OS for the three treatment groups were 17%, 31%, 60% and 35%, 45% and 70% respectively. Larger tumor size, axial primary, high LDH were associated with poorer survival. Radiotherapy was associated with inferior local control and survival. We found that the survival of our ESFT patients improved over time with intensified multiagent chemotherapy and with lesser time to local therapy. But the results were still inferior to those reported in literature. We had majority of patients presenting in axial site and radiotherapy as the predominant mode of local control. The outcome may further improve with surgery as local control procedure.

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

PubMed

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.

The effect of an information and communication technology (ICT) on older adults' quality of life: study protocol for a randomized control trial.

PubMed

Gustafson, David H; McTavish, Fiona; Gustafson, David H; Mahoney, Jane E; Johnson, Roberta A; Lee, John D; Quanbeck, Andrew; Atwood, Amy K; Isham, Andrew; Veeramani, Raj; Clemson, Lindy; Shah, Dhavan

2015-04-25

This study investigates the use of an information and communication technology (Elder Tree) designed for older adults and their informal caregivers to improve older adult quality of life and address challenges older adults face in maintaining their independence (for example, loneliness and isolation, falling, managing medications, driving and transportation). This study, an unblinded randomized controlled trial, will evaluate the effectiveness and cost of Elder Tree. Older adults who are at risk for losing their independence - along with their informal caregivers, if they name them - are randomized to two groups. The intervention group has access to their usual sources of information and communication as well as to Elder Tree for 18 months while the control group uses only their usual sources of information and communication. The primary outcome of the study is older adult quality of life. Secondary outcomes are cost per Quality-Adjusted Life Year and the impact of the technology on independence, loneliness, falls, medication management, driving and transportation, and caregiver appraisal and mastery. We will also examine the mediating effect of self-determination theory. We will evaluate the effectiveness of Elder Tree by comparing intervention- and control-group participants at baseline and months 6, 12, and 18. We will use mixed-effect models to evaluate the primary and secondary outcomes, where pretest score functions as a covariate, treatment condition is a between-subjects factor, and the multivariate outcome reflects scores for a given assessment at the three time points. Separate analyses will be conducted for each outcome. Cost per Quality-Adjusted Life Year will be compared between the intervention and control groups. Additional analyses will examine the mediating effect of self-determination theory on each outcome. Elder Tree is a multifaceted intervention, making it a challenge to assess which services or combinations of services account for outcomes in which subsets of older adults. If Elder Tree can improve quality of life and reduce healthcare costs among older adults, it could suggest a promising way to ease the burden that advancing age can place on older adults, their families, and the healthcare system. ClinicalTrials.gov NCT02128789 . Registered on 26 March 2014.

Effects of team-based learning on problem-solving, knowledge and clinical performance of Korean nursing students.

PubMed

Kim, Hae-Ran; Song, Yeoungsuk; Lindquist, Ruth; Kang, Hee-Young

2016-03-01

Team-based learning (TBL) has been used as a learner-centered teaching strategy in efforts to improve students' problem-solving, knowledge and practice performance. Although TBL has been used in nursing education in Korea for a decade, few studies have studied its effects on Korean nursing students' learning outcomes. To examine the effects of TBL on problem-solving ability and learning outcomes (knowledge and clinical performance) of Korean nursing students. Randomized controlled trial. 63 third-year undergraduate nursing students attending a single university were randomly assigned to the TBL group (n=32), or a control group (n=31). The TBL and control groups attended 2h of class weekly for 3weeks. Three scenarios with pulmonary disease content were employed in both groups. However, the control group received lectures and traditional case study teaching/learning strategies instead of TBL. A questionnaire of problem-solving ability was administered at baseline, prior to students' exposure to the teaching strategies. Students' problem-solving ability, knowledge of pulmonary nursing care, and clinical performance were assessed following completion of the three-week pulmonary unit. After the three-week educational interventions, the scores on problem-solving ability in the TBL group were significantly improved relative to that of the control group (t=10.89, p<.001). In addition, there were significant differences in knowledge, and in clinical performance with standardized patients between the two groups (t=2.48, p=.016, t=12.22, p<.001). This study demonstrated that TBL is an effective teaching strategy to enhance problem-solving ability, knowledge and clinical performance. More research on other specific learning outcomes of TBL for nursing students is recommended. Copyright © 2015 Elsevier Ltd. All rights reserved.

An intensive social cognitive program (can do treatment) in people with relapsing remitting multiple sclerosis and low disability: a randomized controlled trial protocol.

PubMed

Jongen, Peter Joseph; Heerings, Marco; Ruimschotel, Rob; Hussaarts, Astrid; Evers, Silvia; Duyverman, Lotte; Valkenburg-Vissers, Joyce; Cornelissen, Job; Bos, Michel; van Droffelaar, Maarten; Lemmens, Wim A; Donders, Rogier; van der Zande, Anneke; Visser, Leo H

2016-05-28

In people with multiple sclerosis (MS) disabilities and limitations may negatively affect self-efficacy. Lowered self-efficacy has been associated with decreases in health-related quality of life, physical activity and cognitive performance. In an explorative observational study we found that a 3-day intensive social cognitive program (Can Do Treatment [CDT]) with the participation of support partners was followed by substantial increases in self-efficacy control and health-related quality of life 6 months after treatment in those people with MS who had relapsing remitting disease and low disability. CDT is a sociologically oriented approach, its goal is to uncover and promote existing capabilities, and the notion "stressor" is the central concept. CDT's components are plenary group sessions, small group sessions, consultations, a theatre evening, and start of the day with a joint activity. The small group sessions form the actual training. Depending on their individual goals the participants join the training groups 'Body', 'Feeling' or 'Life', to work out their aims and to reduce their stressors. The multidisciplinary team includes a psychiatrist, psychiatric nurse, neurologist, specialized MS nurse, physiotherapist, dance therapist, and a person with MS. To evaluate the (cost)effectiveness of CDT in persons with relapsing remitting MS and low disability we perform a single-centre, randomized controlled trial in 140 patients, with or without support partners. The primary outcome is self-efficacy control. The secondary outcomes are self-efficacy function, health-related quality of life, autonomy and participation, anxiety, depression, cost effectiveness and cost utility. The tertiary outcome is care-related strain to support partners. Outcomes are assessed at baseline and at 1, 3 and 6 months after CDT. This randomized controlled trial will adequately evaluate the clinical and cost effectiveness of a 3-day intensive social cognitive program in people with relapsing remitting MS and low disability, with self-efficacy control as primary outcome. Application number: 22444.

Goal-directed therapy improves the outcome of high-risk cardiac patients undergoing off-pump coronary artery bypass.

PubMed

Kapoor, Poonam Malhotra; Magoon, Rohan; Rawat, Rajinder Singh; Mehta, Yatin; Taneja, Sameer; Ravi, R; Hote, Milind P

2017-01-01

There has been a constant emphasis on developing management strategies to improve the outcome of high-risk cardiac patients undergoing surgical revascularization. The performance of coronary artery bypass surgery on an off-pump coronary artery bypass (OPCAB) avoids the risks associated with extra-corporeal circulation. The preliminary results of goal-directed therapy (GDT) for hemodynamic management of high-risk cardiac surgical patients are encouraging. The present study was conducted to study the outcome benefits with the combined use of GDT with OPCAB as compared to the conventional hemodynamic management. Patients with the European System for Cardiac Operative Risk Evaluation ≥3 scheduled for OPCAB were randomly divided into two groups; the control and GDT groups. The GDT group included the monitoring and optimization of advanced parameters, including cardiac index (CI), systemic vascular resistance index, oxygen delivery index, stroke volume variation; continuous central venous oxygen saturation (ScVO 2 ), global end-diastolic volume, and extravascular lung water (EVLW), using FloTrac™ , PreSep™ , and EV-1000 ® monitoring panels, in addition to the conventional hemodynamic management in the control group. The hemodynamic parameters were continuously monitored for 48 h in Intensive Care Unit (ICU) and corrected according to GDT protocol. A total of 163 patients consented for the study. Seventy-five patients were assigned to the GDT group and 88 patients were in the control group. In view of 9 exclusions from the GDT group and 12 exclusions from control group, 66 patients in the GDT group and 76 patients in control group completed the study. The length of stay in hospital (LOS-H) (7.42 ± 1.48 vs. 5.61 ± 1.11 days, P < 0.001) and ICU stay (4.2 ± 0.82 vs. 2.53 ± 0.56 days, P < 0.001) were significantly lower in the GDT group as compared to control group. The duration of inotropes (3.24 ± 0.73 vs. 2.89 ± 0.68 h, P = 0.005) was also significantly lower in the GDT group. The two groups did not differ in duration of ventilated hours, mortality, and other complications. The parameters such as ScVO 2 , CI, and EVLW had a strong negative and positive correlation with the LOS-H with r values of - 0.331, -0.319, and 0.798, respectively. The study elucidates the role of a goal-directed hemodynamic optimization for improved outcome in high-risk cardiac patients undergoing OPCAB.

Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

PubMed Central

Jerosch-Herold, C.; Houghton, J.; Miller, L.; Shepstone, L.

2016-01-01

Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning (n = 52) or control (n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II PMID:27402282

Impact of oral probiotics on neurodevelopmental outcomes in preterm infants.

PubMed

Akar, Melek; Eras, Zeynep; Oncel, Mehmet Yekta; Arayici, Sema; Guzoglu, Nilufer; Canpolat, Fuat Emre; Uras, Nurdan; Oguz, Serife Suna

2017-02-01

The aim of the study was to evaluate the neurodevelopment outcomes of very low birth weight (VLBW) preterm infants supplemented with oral probiotics for the prevention of necrotizing enterocolitis (NEC). A prospective follow-up study was performed in a cohort of VLBW preterm infants enrolled in a single center randomized controlled clinical trial to evaluate the efficacy of oral probiotics for the prevention of NEC. Cognitive and neuromotor developments were assessed by using the Bayley scales of infant development II. Sensory and neurological performance was evaluated by standard techniques. The primary outcome was neurodevelopmental impairment at 18-24 months' corrected age. A total of 400 infants completed the trial protocol. Of the 370 infants eligible for follow-up, 249 infants (124 in the probiotics group and 125 in the control group) were evaluated. There was no significant difference in any of the neurodevelopmental and sensory outcomes between the two groups. Oral probiotic given to VLBW infants to reduce the incidense and severity of NEC started with the first feed did not affect neuromotor, neurosensory and cognitive outcomes at 18-24 months' corrected age.

Visual working memory in deaf children with diverse communication modes: improvement by differential outcomes.

PubMed

López-Crespo, Ginesa; Daza, María Teresa; Méndez-López, Magdalena

2012-01-01

Although visual functions have been proposed to be enhanced in deaf individuals, empirical studies have not yet established clear evidence on this issue. The present study aimed to determine whether deaf children with diverse communication modes had superior visual memory and whether their performance was improved by the use of differential outcomes. Severely or profoundly deaf children who employed spoken Spanish, Spanish Sign Language (SSL), and both spoken Spanish and SSL modes of communication were tested in a delayed matching-to-sample task for visual working memory assessment. Hearing controls were used to compare performance. Participants were tested in two conditions, differential outcome and non-differential outcome conditions. Deaf groups with either oral or SSL modes of communication completed the task with less accuracy than bilingual and control hearing children. In addition, the performances of all groups improved through the use of differential outcomes. Copyright © 2011 Elsevier Ltd. All rights reserved.

Efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II trial): study protocol for a randomized controlled trial.

PubMed

Tamura, Tomoyoshi; Hayashida, Kei; Sano, Motoaki; Onuki, Shuko; Suzuki, Masaru

2017-10-23

Hydrogen gas inhalation (HI) improved survival and neurological outcomes in an animal model of post-cardiac arrest syndrome (PCAS). The feasibility and safety of HI for patients with PCAS was confirmed in a pilot study. The objective of this study is to evaluate the efficacy of HI for patients with PCAS. The efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II) trial is an investigator-initiated, randomized, double-blind, placebo-controlled trial designed to enroll 360 adult comatose (Glasgow Coma Scale score < 8) patients who will be resuscitated following an out-of-hospital cardiac arrest of a presumed cardiac cause. The patients will be randomized (1:1) to either the HI or control group. Patients in the HI group will inhale 2% hydrogen with 24% to 50% oxygen, and those in the control group will inhale 24% to 50% oxygen for 18 h after admission via mechanical ventilation. Multidisciplinary post-arrest care, including targeted temperature management (TTM) between 33 °C and 36 °C, will be provided in accordance with the latest guidelines. The primary outcome of interest is the 90-day neurological outcome, as evaluated using the Cerebral Performance Categories scale (CPC). The secondary outcomes of interest are the 90-day survival rate and other neurological outcomes. This study will provide 80% power to detect a 15% change in the proportion of patients with good neurological outcomes (CPCs of 1 and 2), from 50% to 65%, with an overall significance level of 0.05. The first multicenter randomized trial is underway to confirm the efficacy of HI on neurological outcomes in comatose out-of-hospital cardiac arrest survivors. Our study has the potential to address HI as an appealing and innovative therapeutic strategy for PCAS in combination with TTM. University Hospital Medical Information Network (UMIN), 000019820 . Registered on 17 November 2015.

78 FR 11858 - Applications for New Awards; Arts in Education Model Development and Dissemination Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-20

... the treatment for project participants and, where feasible, for a comparison group of non... in the project (control group). The effect of the project is the average difference in outcomes between the treatment and control groups. Integrating means (i) encouraging the use of high-quality arts...

Evaluating the Effectiveness Roles of Variables in the Novice Programmers Learning

ERIC Educational Resources Information Center

Shi, Nianfeng; Cui, Wen; Zhang, Ping; Sun, Ximing

2018-01-01

This research applies the roles of variables to the novice programmers in the C language programming. The results are evaluated using the Structure of Observed Learning Outcomes (SOLO) taxonomy. The participants were divided into an experimental group and a control group. The students from the control group learned programming in the traditional…

[Value of anti-Müllerian hormone in predicting pregnant outcomes of polycystic ovary syndrome patients undergone assisted reproductive technology].

PubMed

Li, Y; Tan, J Q; Mai, Z Y; Yang, D Z

2018-01-25

Objective: Explore the value of anti-Müllerian hormone (AMH) in predicting pregnant outcomes of polycystic ovary syndrome (PCOS) patients undergone assisted reproductive technology. Methods: The study totally recruited 1 697 patients who underwent the first in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle in Sun Yat-sen Memorial Hospital from the January 2014 to December 2015. The patients were divided into two groups based on the age<35 ( n= 758) and ≥35 years old ( n= 939) , compare the basic data and pregnant outcomes of controlled ovarian hyerstimulation. Spearman correlation method was conducted to analyze the relations between AMH and clinical outcomes. The logistic regression method and partial correlation analysis were used to judge the main factors which determine pregnancy outcomes by controlled the confounding factors. The receiver operating characteristic curve (ROC) was used to evaluate the predictive sensitivity and specificity of AMH. Results: In the group of PCOS patient younger than 35 years, AMH were correlated with the number of antral follicles ( r= 0.388) and retrieved oocytes ( r= 0.235) . When the effect of total dosage and starting dosage of gonadotropin were controlled, AMH was still significantly associated with the number of retrieved oocytes ( P< 0.05) . AMH had no predictive value for the clinical pregnancy of PCOS patient younger than 35 years (area under ROC curve=0.481, P= 0.768) . In the group of PCOS patient≥35 years old, AMH were correlated with the number of antral follicles ( r= 0.450) , retrieved oocytes ( r= 0.399) , available embryo ( r= 0.336) and high quality embryo ( r= 0.235) . When the effect of total dosage and starting dosage of gonadotropin were controlled, the correlations were still significant between those indexes (all P< 0.05) . AMH had no predictive value for the clinical pregnancy of PCOS patient ≥35 years old (area under ROC curve=0.535, P= 0.560) . However, the clinical pregnancy rate of the group of PCOS patient ≥35 years old was slightly higher than the control group ( P= 0.062) . Conclusions: AMH has no predictive value for the pregnancy outcome of PCOS patient. The pregnancy rate of PCOS patient ≥35 years old is slightly higher than the younger group, because the PCOS patient may have better ovarian reserve.

Clinical outcomes of Joint Crisis Plans to reduce compulsory treatment for people with psychosis: a randomised controlled trial.

PubMed

Thornicroft, Graham; Farrelly, Simone; Szmukler, George; Birchwood, Max; Waheed, Waquas; Flach, Clare; Barrett, Barbara; Byford, Sarah; Henderson, Claire; Sutherby, Kim; Lester, Helen; Rose, Diana; Dunn, Graham; Leese, Morven; Marshall, Max

2013-05-11

The CRIMSON (CRisis plan IMpact: Subjective and Objective coercion and eNgagement) study is an individual level, randomised controlled trial that compared the effectiveness of Joint Crisis Plans (JCPs) with treatment as usual for people with severe mental illness. The JCP is a negotiated statement by a patient of treatment preferences for any future psychiatric emergency, when he or she might be unable to express clear views. We assessed whether the additional use of JCPs improved patient outcomes compared with treatment as usual. Patients were eligible if they had at least one psychiatric admission in the previous 2 years and were on the Enhanced Care Programme Approach register. The study was done with 64 generic and specialist community mental health teams in four English mental health care provider organisations (trusts). Hypotheses tested were that, compared with the control group, the intervention group would experience: fewer compulsory admissions (primary outcome); fewer psychiatric admissions; shorter psychiatric stays; lower perceived coercion; improved therapeutic relationships; and improved engagement. We stratified participants by centre. The research team but not participants nor clinical staff were masked to allocation. This study is registered with ClinicalTrials.gov, number ISRCTN11501328. 569 participants were randomly assigned (285 to the intervention group and 284 to the control group). No significant treatment effect was seen for the primary outcome (56 [20%] sectioned in the control group and 49 [18%] in the JCP group; odds ratio 0·90 [95% CI 0·58-1·39, p=0·63]) or any secondary outcomes, with the exception of an improved secondary outcome of therapeutic relationships (17·3 [7·6] vs 16·0 [7·1]; adjusted difference -1·28 [95% CI -2·56 to -0·01, p=0·049]). Qualitative data supported this finding. Our findings are inconsistent with two earlier JCP studies, and show that the JCP is not significantly more effective than treatment as usual. There is evidence to suggest the JCPs were not fully implemented in all study sites, and were combined with routine clinical review meetings which did not actively incorporate patients' preferences. The study therefore raises important questions about implementing new interventions in routine clinical practice. Medical Research Council UK and the National Institute for Health Research. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

PubMed Central

Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

2012-01-01

Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

Music as an auxiliary analgesic during first trimester surgical abortion: a randomized controlled trial.

PubMed

Guerrero, Jacqueline M; Castaño, Paula M; Schmidt, Elizabeth O; Rosario, Linette; Westhoff, Carolyn L

2012-08-01

Music has served as an auxiliary analgesic in perioperative settings. This study evaluates the impact of intraoperative music added to routine pain control measures during first trimester surgical abortion. We analyzed data from 101 women randomized to undergo abortion with routine pain control measures only (ibuprofen and paracervical block) or with the addition of intraoperative music via headphones. The primary outcome was the change in preoperative and postoperative pain scores on a 100-mm visual analog scale. Secondary outcomes included change in anxiety and vital signs, and satisfaction. Baseline characteristics were similar between groups. The magnitude of increase in pain scores was greater in the intervention than in the control group (+51.0 mm versus +39.3 mm, p=.045). Overall pain control was rated as good or very good by 70% of the intervention and 75% of the control group (p=.65). Intraoperative music added to routine pain control measures increases pain reported during abortion. Copyright © 2012 Elsevier Inc. All rights reserved.

Effects of an internet-based cognitive behavioral therapy intervention on improving work engagement and other work-related outcomes: an analysis of secondary outcomes of a randomized controlled trial.

PubMed

Imamura, Kotaro; Kawakami, Norito; Furukawa, Toshi A; Matsuyama, Yutaka; Shimazu, Akihito; Umanodan, Rino; Kawakami, Sonoko; Kasai, Kiyoto

2015-05-01

This study reported a randomized controlled trial of the effectiveness of an Internet-based cognitive behavioral therapy (iCBT) program on work engagement and secondary work-related outcomes. Participants who fulfilled the inclusion criteria were randomly allocated to an intervention or a control group (N = 381 for each). A 6-week, 6-lesson iCBT program using a Manga (Japanese comic) story was provided only to the intervention group. Work engagement was assessed at baseline and at 3- and 6-month follow-ups for both groups. The iCBT program showed a significant intervention effect on work engagement (P = 0.04) with small effect sizes (Cohen's d = 0.16 at 6-month follow-up). The study showed computerized cognitive behavior therapy delivered via the Internet to be effective (with a small effect size) in increasing work engagement in the general working population. UMIN Clinical Trials Registry (UMIN-CTR) UMIN000006210.

Prenatal emotion management improves obstetric outcomes: a randomized control study

PubMed Central

Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

2015-01-01

Introduction: Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. Methods: All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. Results: The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P < 0.01), and a lower EPDS score 42 days postpartum (P < 0.05). The rate of cesarean section in the EM group was lower than the UC group (P < 0.01), and the cesarean section rate without a medical indication was lower (P < 0.01). The duration of the second stage of labor in the EM group was shorter than the UC group (P < 0.01). Conclusions: Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China. PMID:26309641

Interventions to enhance adherence to dietary advice for preventing and managing chronic diseases in adults

PubMed Central

Desroches, Sophie; Lapointe, Annie; Ratté, Stéphane; Gravel, Karine; Légaré, France; Turcotte, Stéphane

2016-01-01

Background It has been recognized that poor adherence can be a serious risk to the health and wellbeing of patients, and greater adherence to dietary advice is a critical component in preventing and managing chronic diseases. Objectives To assess the effects of interventions for enhancing adherence to dietary advice for preventing and managing chronic diseases in adults. Search methods We searched the following electronic databases up to 29 September 2010: The Cochrane Library (issue 9 2010), PubMed, EMBASE (Embase.com), CINAHL (Ebsco) and PsycINFO (PsycNET) with no language restrictions. We also reviewed: a) recent years of relevant conferences, symposium and colloquium proceedings and abstracts; b) web-based registries of clinical trials; and c) the bibliographies of included studies. Selection criteria We included randomized controlled trials that evaluated interventions enhancing adherence to dietary advice for preventing and managing chronic diseases in adults. Studies were eligible if the primary outcome was the client’s adherence to dietary advice. We defined ‘client’ as an adult participating in a chronic disease prevention or chronic disease management study involving dietary advice. Data collection and analysis Two review authors independently assessed the eligibility of the studies. They also assessed the risk of bias and extracted data using a modified version of the Cochrane Consumers and Communication Review Group data extraction template. Any discrepancies in judgement were resolved by discussion and consensus, or with a third review author. Because the studies differed widely with respect to interventions, measures of diet adherence, dietary advice, nature of the chronic diseases and duration of interventions and follow-up, we conducted a qualitative analysis. We classified included studies according to the function of the intervention and present results in a narrative table using vote counting for each category of intervention. Main results We included 38 studies involving 9445 participants. Among studies that measured diet adherence outcomes between an intervention group and a control/usual care group, 32 out of 123 diet adherence outcomes favoured the intervention group, 4 favoured the control group whereas 62 had no significant difference between groups (assessment was impossible for 25 diet adherence outcomes since data and/or statistical analyses needed for comparison between groups were not provided). Interventions shown to improve at least one diet adherence outcome are: telephone follow-up, video, contract, feedback, nutritional tools and more complex interventions including multiple interventions. However, these interventions also shown no difference in some diet adherence outcomes compared to a control/usual care group making inconclusive results about the most effective intervention to enhance dietary advice. The majority of studies reporting a diet adherence outcome favouring the intervention group compared to the control/usual care group in the short-term also reported no significant effect at later time points. Studies investigating interventions such as a group session, individual session, reminders, restriction and behaviour change techniques reported no diet adherence outcome showing a statistically significant difference favouring the intervention group. Finally, studies were generally of short duration and low quality, and adherence measures varied widely. Authors’ conclusions There is a need for further, long-term, good-quality studies using more standardized and validated measures of adherence to identify the interventions that should be used in practice to enhance adherence to dietary advice in the context of a variety of chronic diseases. PMID:23450587

Spontaneous Pushing in Lateral Position versus Valsalva Maneuver During Second Stage of Labor on Maternal and Fetal Outcomes: A Randomized Clinical Trial

PubMed Central

Vaziri, Farideh; Arzhe, Amene; Asadi, Nasrin; Pourahmad, Saeedeh; Moshfeghy, Zeinab

2016-01-01

Background There are concerns about the harmful effects of the Valsalva maneuver during the second stage of labor. Objectives Comparing the effects of spontaneous pushing in the lateral position with the Valsalva maneuver during the second stage of labor on maternal and fetal outcomes. Methods Inclusion criteria in this randomized clinical trial conducted in Iran were as follows: nulliparous mothers, live fetus with vertex presentation, gestational age of 37 - 40 weeks, spontaneous labor, and no complications. The intervention group pushed spontaneously while they were in the lateral position, whereas the control group pushed using Valsalva method while in the supine position at the onset of the second stage of labor. Maternal outcomes such as pain and fatigue severity and fetal outcomes such as pH and pO2 of the umbilical cord blood were measured. Results Data pertaining to 69 patients, divided into the intervention group (35 subjects) and control group (34 subjects), were analyzed statistically. The mean pain (7.80 ± 1.21 versus 9.05 ± 1.11) and fatigue scores (46.59 ± 21 versus 123.36 ± 43.20) of the two groups showed a statistically significant difference (P < 0.001). Moreover, the mean duration of the second stage in the intervention group was significantly higher than that in the control group (76.32 ± 8.26 minutes versus 64.56 ± 15.24 minutes, P = 0.001). The umbilical cord blood pO2 levels of both groups showed a statistically significant difference (28.29 ± 11.76 versus 18.83 ± 9.86, P < 0.001), whereas their pH levels were not significantly different (P = 0.10). Conclusions Spontaneous pushing in the lateral position reduced fatigue and pain severity of the mothers. Also, it did not worsen fetal outcomes. Thus, it can be used as an alternative method for the Valsalva maneuver. PMID:28180019

Spontaneous Pushing in Lateral Position versus Valsalva Maneuver During Second Stage of Labor on Maternal and Fetal Outcomes: A Randomized Clinical Trial.

PubMed

Vaziri, Farideh; Arzhe, Amene; Asadi, Nasrin; Pourahmad, Saeedeh; Moshfeghy, Zeinab

2016-10-01

There are concerns about the harmful effects of the Valsalva maneuver during the second stage of labor. Comparing the effects of spontaneous pushing in the lateral position with the Valsalva maneuver during the second stage of labor on maternal and fetal outcomes. Inclusion criteria in this randomized clinical trial conducted in Iran were as follows: nulliparous mothers, live fetus with vertex presentation, gestational age of 37 - 40 weeks, spontaneous labor, and no complications. The intervention group pushed spontaneously while they were in the lateral position, whereas the control group pushed using Valsalva method while in the supine position at the onset of the second stage of labor. Maternal outcomes such as pain and fatigue severity and fetal outcomes such as pH and pO2 of the umbilical cord blood were measured. Data pertaining to 69 patients, divided into the intervention group (35 subjects) and control group (34 subjects), were analyzed statistically. The mean pain (7.80 ± 1.21 versus 9.05 ± 1.11) and fatigue scores (46.59 ± 21 versus 123.36 ± 43.20) of the two groups showed a statistically significant difference (P < 0.001). Moreover, the mean duration of the second stage in the intervention group was significantly higher than that in the control group (76.32 ± 8.26 minutes versus 64.56 ± 15.24 minutes, P = 0.001). The umbilical cord blood pO 2 levels of both groups showed a statistically significant difference (28.29 ± 11.76 versus 18.83 ± 9.86, P < 0.001), whereas their pH levels were not significantly different (P = 0.10). Spontaneous pushing in the lateral position reduced fatigue and pain severity of the mothers. Also, it did not worsen fetal outcomes. Thus, it can be used as an alternative method for the Valsalva maneuver.

Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial).

PubMed

Sanghvi, Kishore Pratap; Kabra, Nandkishor S; Padhi, Phalguni; Singh, Umesh; Dash, Swarup Kumar; Avasthi, Bhupendra S

2017-09-01

To evaluate the role of prophylactic propranolol in the prevention of retinopathy of prematurity (ROP) in infants ≤32 weeks of gestational age and their visual outcome at 1 year of corrected gestational age. Randomised double blind placebo controlled trial, parallel group nrolment with allocation ratio of 1:1. Two level III neonatal intensive care units. 109 preterm neonates of ≤32 weeks of gestation with postnatal age ≤8 days old. Study group: Infants with gestational age between 26 and 32 weeks were started on propranolol prophylaxis (0.5 mg/kg/dose every 12 hours) on seventh completed day of life, till a corrected gestational age of 37 weeks or complete vascularisation of retina whichever was later. Control group infants received a placebo. Primary : ROP of all grades; Secondary : evaluation of complications due to propranolol, ROP needing treatment with laser and/or antivascular endothelial growth factor (anti-VEGF) and visual outcome at 12 months corrected age. Prophylactic propranolol in the prescribed dose of 1 mg/kg/day showed a decreasing trend in the incidence of ROP (56.8% vs 68.6%; p=0.39), need for laser therapy (21.56% vs 31.37%; p=0.37), treatment with anti-VEGF (3.92% vs 15.68%; p=0.09) or visual outcomes at 1 year in the study and control groups, respectively, though these reductions were not statistically significant. Decreasing trends favouring propranolol in all other ROP-related outcomes were also noted in the study group. Prophylactic propranolol in the prescribed dose of 1 mg/kg/day showed a decreasing trend in all outcomes of ROP though statistically not significant. CTRI/2013/11/004131. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial.

PubMed

Griffin, Damian; Parsons, Nick; Shaw, Ewart; Kulikov, Yuri; Hutchinson, Charles; Thorogood, Margaret; Lamb, Sarah E

2014-07-24

To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures. Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial). 22 tertiary referral hospitals, United Kingdom. 151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment. The primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat. 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference -7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8). Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541. © Griffin et al 2014.

Routine obstetric ultrasound examinations in South Africa: cost and effect on perinatal outcome--a prospective randomised controlled trial.

PubMed

Geerts, L T; Brand, E J; Theron, G B

1996-06-01

To compare routine midtrimester with selective obstetric ultrasonography concerning the Health Service cost and the effect on perinatal outcome. A randomised controlled trial. Urban area served by Tygerberg Hospital, a tertiary referral centre in South Africa. Pregnant patients without risk factors for congenital anomalies referred for ultrasonography between 18 and 24 weeks of gestation. Between 18 and 24 weeks, a level one ultrasound examination was performed on study patients only. Except for the routine scan, both groups received the same antenatal care and could be referred later for additional scans as judged by their clinicians. Overall adverse perinatal outcome and use of antenatal and neonatal services. The groups did not differ significantly in their use of antenatal and neonatal services except for a greater number of ultrasound scans in the study group. More suspected postdate pregnancies occurred in control patients, as well as more amniocenteses for confirmation of lung maturity. More babies of low birthweight were born in the study group. The incidence of overall or major adverse perinatal outcome was comparable. Routine ultrasonography was accompanied by a considerable increase in costs. Selective use of obstetric ultrasonography did not increase the use of antenatal and neonatal services. Not routinely performing ultrasonography has led to considerable Health Service savings without increasing the risk for adverse perinatal outcome. It saved 75% of selected patients a referral to an ultrasound unit. Specific problems related to inaccurate gestational age determination need to be addressed.

The postoperative clinical outcomes and safety of early enteral nutrition in operated gastric cancer patients.

PubMed

Li, Bing; Liu, Hong-Yi; Guo, Shao-Hua; Sun, Peng; Gong, Fang-Ming; Jia, Bao-Qing

2015-01-01

This study investigated the impact of early enteral nutrition (EEN) on the clinical outcomes of gastric cancer patients after radical gastrectomy. Four hundred gastric cancer patients undergoing radical gastrectomy of any extend with D2 nodal dissection were randomly divided into an experimental and a control group with 200 cases in each group. Patients in the control group received postoperative parenteral nutrition (PN), while patients in the experimental group received postoperative EEN. After treatment, the clinical outcomes, postoperative immune function, and nutritional status of the two groups were evaluated. The postoperative fever time, intestinal function recovery time, anal exhaust time, and the length of hospital stay for patients in the experimental group were significantly shorter than those of the control group. We did not find significant differences in anastomotic leak, postoperative ileus and regurgitation between the two groups. The activities of multiple immune cell types, including CD3⁺, CD4⁺, CD4⁺/CD8⁺, and natural killer (NK) cells, were significantly lower in both groups on postoperative day 1 when compared with the preoperative levels (p<0.05). The level of CD8⁺ was not significantly different between the two groups (p>0.05). After treatment, levels of CD3⁺, CD4⁺, CD4⁺/CD8⁺, and NK cells in the experimental group patients were 35.6 ± 4.2, 42.2 ± 3.0, 1.7 ± 0.3, and 27.3 ± 5.3%, respectively, on postoperative day 7, which were similar to the preoperative levels. The immune cell levels from the control group patients remained significantly lower when compared with preoperative values; in addition, these values were also significantly lower when compared with the EEN patients (p<0.05) CONCLUSION: For gastric cancer patients undergoing radical gastrectomy, the clinical outcome, immune function and nutritional status after EEN were significantly improved. These data suggest the widespread use of EEN in clinical practice.

Physiotherapy program through home visits for community-dwelling elderly Japanese women with mild knee pain.

PubMed

Konishi, Isamu; Tanabe, Naohito; Seki, Nao; Suzuki, Hiroshi; Okamura, Taro; Shinoda, Kunihiko; Hoshino, Emiko

2009-10-01

Knee pain is extremely common among the elderly, particularly women. Hence, there is an urgent need for applicable community-based intervention models for halting the progression of knee pain and related disabilities in elderly women. We aimed to assess the efficacy of home-visit physiotherapy as a new intervention model. This non-randomized 5-month-long controlled trial enrolled elderly community-dwelling women (aged 60-83 years) with mild knee pain. The intervention consisted of two home visits by a physiotherapist, with instructions on routinely performing muscle-strengthening exercises at home and implementing simple environmental modifications when necessary. Outcome measures were assessed at baseline and 5 months later. The primary outcomes were measured as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a newly devised seiza-style sitting score. People in Japan, especially elderly women, are accustomed to seiza-style sitting that involves kneeling on one's lower legs while resting the buttocks on the heels. The secondary outcomes included quadriceps isometric strength, knee alignment in the frontal and sagittal planes, and passive knee extension range. Forty-two subjects (20 in the intervention group and 22 in the control group) completed the study. At baseline, characteristics and the primary outcomes did not significantly differ between the 2 groups. At 5 months, the primary outcomes improved significantly in the intervention group. Estimated differences in the change from baseline for each outcome between the 2 groups were computed, adjusting for outcome variables imbalanced at baseline. Even after the adjustment, the home-visit physiotherapy regimen provides favorable improvement in the seiza-style sitting score.

The women's heart health programme: a pilot trial of sex-specific cardiovascular management.

PubMed

Low, Ting Ting; Chan, Siew Pang; Wai, Shin Hnin; Ang, Zhou; Kyu, Kyu; Lee, Kim Yee; Ching, Anne; Comer, Sarah; Tan, Naomi Qiu Pin; Thong, Elizabeth Grace Hui En; Nang, Tracy; Dutta, Mohan; Lam, Carolyn S P

2018-04-16

There is increasing knowledge of sex-specific differences in cardiovascular disease and recognition of sex disparities in management. In our study, we investigated whether a cardiovascular programme tailored to the specific needs of women could lead to improved outcomes. We randomised 100 female patients to receive cardiology follow-up with the conventional sex-neutral cardiac programme (control), or the sex-tailored Women's Heart Health Programme (intervention). The intervention group was managed by an all-women multidisciplinary team and received culture-centred health intervention workshops, designed through in-depth interviews with the participants. The primary outcome was cardiovascular risk factor improvement at 1 year. Secondary outcomes include cardiovascular event rates, quality of life scores, and self-reported improvement in knowledge, attitudes, intentions and practices. Generalised structural equation model analysis was used to determine if the intervention group had better outcomes at alpha level 0.1. The mean age was 67.3 ± 12.7 years, with an ethnic distribution of 70% Chinese, 18% Malays, and 12% Indians. The majority of these patients had no formal or primary level of education (63%), and were mostly unemployed (78%). Patients in intervention group had better control of diabetes mellitus (lower HbA1c of 0.63% [CI 0.21-1.04], p = 0.015) and lower body-mass-index (0.74 kg/m 2 [CI 0.02-1.46], p = 0.092) at 1 year, but there was no significant difference in blood pressure or lipid control. Overall, there was a trend towards better risk factor control, 31.6% of intervention group versus 26.5% of control group achieved improvement in at least 1 CV risk factor control to target range. There was no significant difference in incidence of cardiovascular events, quality of life, or domains in knowledge, attitudes, intention and practices. This pilot study is the first of its kind evaluating a new model of care for women with heart disease. The potential to improve outcomes needs to be studied in a larger trial with longer follow up. This trial was prospectively registered clinicaltrials.gov on 6 May 2013. Trial Number: 2013/00088. Identifier: NCT02017470.

Effects of Statins on Renal Outcome in Chronic Kidney Disease Patients: A Systematic Review and Meta-Analysis

PubMed Central

Sanguankeo, Anawin; Upala, Sikarin; Cheungpasitporn, Wisit; Ungprasert, Patompong; Knight, Eric L.

2015-01-01

Background HMG CoA reductase inhibitors (statins) are known to prevent cardiovascular disease and improve lipid profiles. However, the effects of statins on renal outcomes, including decline in estimated glomerular filtration rate (eGFR) and proteinuria in patients with chronic kidney disease (CKD), are controversial. This meta-analysis evaluated the impact of statins on renal outcomes in patients with CKD. Materials and Methods We comprehensively searched the databases of MEDLINE, EMBASE, and Cochrane Databases. The inclusion criteria were published RCT and cohort studies comparing statin therapy to placebo or active controls in patients with CKD (eGFR <60 ml/min/1.73 m2) not requiring dialysis. The primary outcome was the differences in the change of eGFR. We also examined change of protein concentration in urine as a secondary outcome. A meta-analysis comparing statin and its control groups and a subgroup analysis examining intensity of statin were performed. Results From 142 full-text articles, 10 studies were included in the meta-analysis. Overall, there was a significant difference in rate of eGFR change per year favoring statin group (mean difference (MD) = 0.10 ml/min/1.73 m2, 95% CI: 0.09 to 0.12). In our subgroup analysis, those who received high-intensity statins had a significant difference in eGFR with a MD of 3.35 (95% CI: 0.91 to 5.79) ml/min/1.73 m2 compared to control. No significant change in eGFR was found with moderate- and low-intensity statin therapy. Compared with the control group, the statin group did not have a difference in reduction of proteinuria with MD in change of proteinuria of 0.19 gm/day (95% CI: -0.02 to 0.40). Conclusion Overall, there was a difference in change of eGFR between the statin and control group. High-intensity statins were found to improve a decline in eGFR in population with CKD not requiring dialysis compared with control, but moderate- and low-intensity statins were not. Statins were not found to decrease proteinuria in patients with CKD. PMID:26151753

The relationship between brain volume and walking outcomes in older adults with and without diabetic peripheral neuropathy.

PubMed

Manor, Brad; Newton, Elizabeth; Abduljalil, Amir; Novak, Vera

2012-09-01

Diabetic peripheral neuropathy (DPN) alters walking. Yet, the compensatory role of central locomotor circuits remains unclear. We hypothesized that walking outcomes would be more closely related to regional gray matter volumes in older adults with DPN as compared with nonneuropathic diabetic patients and nondiabetic control subjects. Clinically important outcomes of walking (i.e., speed, stride duration variability, and double support time) were measured in 29 patients with DPN (type 2 diabetes with foot-sole somatosensory impairment), 68 diabetic (DM) patients (type 2 diabetes with intact foot-sole sensation), and 89 control subjects. Global and regional gray matter volumes were calculated from 3 Tesla magnetic resonance imaging. DPN subjects walked more slowly (P = 0.005) with greater stride duration variability (P < 0.001) and longer double support (P < 0.001) as compared with DM and control subjects. Diabetes was associated with less cerebellar gray matter volume (P < 0.001), but global gray matter volume was similar between groups. DPN subjects with lower gray matter volume globally (P < 0.004) and regionally (i.e., cerebellum, right-hemisphere dorsolateral prefrontal cortex, basal ganglia, P < 0.005) walked more slowly with greater stride duration variability and/or longer double support. Each relationship was stronger in DPN than DM subjects. In control subjects, brain volumes did not relate to walking patterns. Strong relationships between brain volumes and walking outcomes were observed in the DPN group and to a lesser extent the DM group, but not in control subjects. Individuals with DPN may be more dependent upon supraspinal elements of the motor control system to regulate several walking outcomes linked to poor health in elderly adults.

The Relationship Between Brain Volume and Walking Outcomes in Older Adults With and Without Diabetic Peripheral Neuropathy

PubMed Central

Manor, Brad; Newton, Elizabeth; Abduljalil, Amir; Novak, Vera

2012-01-01

OBJECTIVE Diabetic peripheral neuropathy (DPN) alters walking. Yet, the compensatory role of central locomotor circuits remains unclear. We hypothesized that walking outcomes would be more closely related to regional gray matter volumes in older adults with DPN as compared with nonneuropathic diabetic patients and nondiabetic control subjects. RESEARCH DESIGN AND METHODS Clinically important outcomes of walking (i.e., speed, stride duration variability, and double support time) were measured in 29 patients with DPN (type 2 diabetes with foot-sole somatosensory impairment), 68 diabetic (DM) patients (type 2 diabetes with intact foot-sole sensation), and 89 control subjects. Global and regional gray matter volumes were calculated from 3 Tesla magnetic resonance imaging. RESULTS DPN subjects walked more slowly (P = 0.005) with greater stride duration variability (P < 0.001) and longer double support (P < 0.001) as compared with DM and control subjects. Diabetes was associated with less cerebellar gray matter volume (P < 0.001), but global gray matter volume was similar between groups. DPN subjects with lower gray matter volume globally (P < 0.004) and regionally (i.e., cerebellum, right-hemisphere dorsolateral prefrontal cortex, basal ganglia, P < 0.005) walked more slowly with greater stride duration variability and/or longer double support. Each relationship was stronger in DPN than DM subjects. In control subjects, brain volumes did not relate to walking patterns. CONCLUSIONS Strong relationships between brain volumes and walking outcomes were observed in the DPN group and to a lesser extent the DM group, but not in control subjects. Individuals with DPN may be more dependent upon supraspinal elements of the motor control system to regulate several walking outcomes linked to poor health in elderly adults. PMID:22665216

Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial

PubMed Central

Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

2016-01-01

To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton’s Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation. PMID:27174221

Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial.

PubMed

Groeneweg, Ruud; van Assen, Luite; Kropman, Hans; Leopold, Huco; Mulder, Jan; Smits-Engelsman, Bouwien C M; Ostelo, Raymond W J G; Oostendorp, Rob A B; van Tulder, Maurits W

2017-01-01

Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. ClinicalTrials.gov Identifier: NCT00713843.

Factors influencing polymerase chain reaction outcomes in patients with clinically suspected ocular tuberculosis.

PubMed

Balne, Praveen Kumar; Modi, Rohit Ramesh; Choudhury, Nuzhat; Mohan, Neha; Barik, Manas Ranjan; Padhi, Tapas Ranjan; Sharma, Savitri; Panigrahi, Satya Ranjan; Basu, Soumyava

2014-03-25

Polymerase chain reaction (PCR) assay can be a useful method for definitive diagnosis in paucibacillary infections such as ocular tuberculosis (TB). In this study, we have evaluated factors affecting PCR outcomes in patients with clinically suspected ocular TB. Patients with clinically suspected ocular TB were investigated by PCR of aqueous or vitreous samples. Three control groups were also tested: group 1 included culture-proven non-tuberculous endophthalmitis, group 2 culture-negative non-tuberculous endophthalmitis, and group 3 patients undergoing surgery for uncomplicated cataract. PCR targeted one or more of following targets: IS6110, MPB64, and protein b genes of Mycobacterium tuberculosis complex. Multiple regression analysis (5% level of significance) was done to evaluate the associations between positive PCR outcome and laterality of disease, tuberculin skin test (TST)/interferon-gamma release assay (IGRA), chest radiography, and type of sample (aqueous or vitreous). The main outcome measures were positive PCR by one or more gene targets, and factors influencing positive PCR outcomes. All 114 samples were tested for MPB64, 110 for protein b, and 88 for IS6110. MPB64 was positive in 70.2% (n = 80) of tested samples, protein b in 40.0% (n = 44), and IS6110 in only 9.1% (n = 8). DNA sequencing of amplicons from four randomly chosen PCR reactions showed homology for M. tuberculosis complex. Of the 80 PCR-positive patients, 71 completed a full course of antitubercular therapy, of which 65 patients (91.5%) had complete resolution of inflammation at final follow-up. Among controls, 12.5% (3 out of 24) in group 1 and 18.7% (6 out of 32) in group 2 also tested positive by PCR. No PCR-positive outcome was observed in control group 3 (n = 25). Multiple regression analysis revealed significant association of positive PCR outcome with bilateral presentation, but not with a positive TST/IGRA, chest radiography, or type of sample (aqueous/vitreous) used. Careful selection of gene targets can yield high PCR positivity in clinically suspected ocular TB. Bilateral disease presentation but not any evidence of latent systemic TB influences PCR outcomes. False-positive results may be seen in ocular inflammation unrelated to ocular TB.

Application of the statistical process control method for prospective patient safety monitoring during the learning phase: robotic kidney transplantation with regional hypothermia (IDEAL phase 2a-b).

PubMed

Sood, Akshay; Ghani, Khurshid R; Ahlawat, Rajesh; Modi, Pranjal; Abaza, Ronney; Jeong, Wooju; Sammon, Jesse D; Diaz, Mireya; Kher, Vijay; Menon, Mani; Bhandari, Mahendra

2014-08-01

Traditional evaluation of the learning curve (LC) of an operation has been retrospective. Furthermore, LC analysis does not permit patient safety monitoring. To prospectively monitor patient safety during the learning phase of robotic kidney transplantation (RKT) and determine when it could be considered learned using the techniques of statistical process control (SPC). From January through May 2013, 41 patients with end-stage renal disease underwent RKT with regional hypothermia at one of two tertiary referral centers adopting RKT. Transplant recipients were classified into three groups based on the robotic training and kidney transplant experience of the surgeons: group 1, robot trained with limited kidney transplant experience (n=7); group 2, robot trained and kidney transplant experienced (n=20); and group 3, kidney transplant experienced with limited robot training (n=14). We employed prospective monitoring using SPC techniques, including cumulative summation (CUSUM) and Shewhart control charts, to perform LC analysis and patient safety monitoring, respectively. Outcomes assessed included post-transplant graft function and measures of surgical process (anastomotic and ischemic times). CUSUM and Shewhart control charts are time trend analytic techniques that allow comparative assessment of outcomes following a new intervention (RKT) relative to those achieved with established techniques (open kidney transplant; target value) in a prospective fashion. CUSUM analysis revealed an initial learning phase for group 3, whereas groups 1 and 2 had no to minimal learning time. The learning phase for group 3 varied depending on the parameter assessed. Shewhart control charts demonstrated no compromise in functional outcomes for groups 1 and 2. Graft function was compromised in one patient in group 3 (p<0.05) secondary to reasons unrelated to RKT. In multivariable analysis, robot training was significantly associated with improved task-completion times (p<0.01). Graft function was not adversely affected by either the lack of robotic training (p=0.22) or kidney transplant experience (p=0.72). The LC and patient safety of a new surgical technique can be assessed prospectively using CUSUM and Shewhart control chart analytic techniques. These methods allow determination of the duration of mentorship and identification of adverse events in a timely manner. A new operation can be considered learned when outcomes achieved with the new intervention are at par with outcomes following established techniques. Statistical process control techniques allowed for robust, objective, and prospective monitoring of robotic kidney transplantation and can similarly be applied to other new interventions during the introduction and adoption phase. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Effectiveness of job rotation for preventing work-related musculoskeletal diseases: a cluster randomised controlled trial.

PubMed

Comper, Maria Luiza Caires; Dennerlein, Jack Tigh; Evangelista, Gabriela Dos Santos; Rodrigues da Silva, Patricia; Padula, Rosimeire Simprini

2017-08-01

Job rotation is an organisational strategy widely used on assembly lines in manufacturing industries to mitigate workers' exposure so as to prevent musculoskeletal disorders. This study aimed to evaluate the effectiveness of job rotation for reducing working hours lost due to sick leave resulting from musculoskeletal diseases. The design consisted of a 1-year cluster randomised controlled trial with a blinded assessor. Production sectors of the textile industry were randomised to intervention and control groups. Both groups received ergonomic training. The intervention group performed a job rotation programme. The primary outcome measure was number of working hours lost due to sick leave as a result of musculoskeletal disease (ICD-10). The secondary outcome measures were musculoskeletal symptoms (Yes/No), risk factors for musculoskeletal diseases (0-10), psychosocial factors and fatigue (0-100), general health (0-100), and productivity (0-10). All secondary outcomes were measured at baseline and 12-month follow-up. At the 12-month follow-up, both groups showed an increase in the number of working hours lost due to sick leave for musculoskeletal disease. There was no significant difference between the job rotation intervention group (mean deviation -5.6 hours, 95% CI -25.0 to 13.8) at the 12-month follow-up and the control group. There were no significant differences between groups for the secondary outcomes (p>0.05). The job rotation programme was not effective in reducing the number of working hours lost due to sick leave, decreasing the prevalence of musculoskeletal symptoms, or improving perception of musculoskeletal pain and workplace risk factors, psychosocial risk factors and productivity. NCT01979731. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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

PubMed

Bourgault, Patricia; Lacasse, Anaïs; Marchand, Serge; Courtemanche-Harel, Roxanne; Charest, Jacques; Gaumond, Isabelle; Barcellos de Souza, Juliana; Choinière, Manon

2015-01-01

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 Register ISRCTN14526380.

A randomized trial of a motivational interviewing intervention to increase lifestyle physical activity and improve self-reported function in adults with arthritis.

PubMed

Gilbert, Abigail L; Lee, Jungwha; Ehrlich-Jones, Linda; Semanik, Pamela A; Song, Jing; Pellegrini, Christine A; Pinto Pt, Daniel; Dunlop, Dorothy D; Chang, Rowland W

2018-04-01

Arthritis is a leading cause of chronic pain and functional limitations. Exercise is beneficial for improving strength and function and decreasing pain. We evaluated the effect of a motivational interviewing-based lifestyle physical activity intervention on self-reported physical function in adults with knee osteoarthritis (KOA) or rheumatoid arthritis (RA). Participants were randomized to intervention or control. Control participants received a brief physician recommendation to increase physical activity to meet national guidelines. Intervention participants received the same brief baseline physician recommendation in addition to motivational interviewing sessions at baseline, 3, 6, and 12 months. These sessions focused on facilitating individualized lifestyle physical activity goal setting. The primary outcome was change in self-reported physical function. Secondary outcomes were self-reported pain and accelerometer-measured physical activity. Self-reported KOA outcomes were evaluated by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for KOA (WOMAC scores range from 0 to 68 for function and 0 to 20 for pain) and the Health Assessment Questionnaire (HAQ) for RA. Outcomes were measured at baseline, 3, 6, 12, and 24 months. Multiple regression accounting for repeated measures was used to evaluate the overall intervention effect on outcomes controlling for baseline values. Participants included 155 adults with KOA (76 intervention and 79 control) and 185 adults with RA (93 intervention and 92 control). Among KOA participants, WOMAC physical function improvement was greater in the intervention group compared to the control group [difference = 2.21 (95% CI: 0.01, 4.41)]. WOMAC pain improvement was greater in the intervention group compared to the control group [difference = 0.70 (95% CI: -0.004, 1.41)]. There were no significant changes in physical activity. Among RA participants, no significant intervention effects were found. Participants with KOA receiving the lifestyle intervention experienced modest improvement in self-reported function and a trend toward improved pain compared to controls. There was no intervention effect for RA participants. Further refinement of this intervention is needed for more robust improvement in function, pain, and physical activity. Copyright © 2018 Elsevier Inc. All rights reserved.

Effects of lifestyle intervention using patient-centered cognitive behavioral therapy among patients with cardio-metabolic syndrome: a randomized, controlled trial.

PubMed

Zhang, Ying; Mei, Songli; Yang, Rui; Chen, Ling; Gao, Hang; Li, Li

2016-11-18

Cardio-metabolic syndrome (CMS) is a highly prevalent condition. There is an urgent need to identify effective and integrated multi-disciplinary approaches that can reduce risk factors for CMS. Sixty-two patients with a history of CMS were randomized 1:1 into two groups: a standard information -only group (control), or a self-regulated lifestyle waist circumference (patient-centered cognitive behavioral therapy) intervention group. A pretest and posttest, controlled, experimental design was used. Outcomes were measured at the baseline (week 0) and at the end of intervention (week 12). Comparisons were drawn between groups and over time. The mean (standard deviation) age of the subjects was 48.6 (5.8) years ranging from 32 to 63, and 56.9% of the participants were female. Both groups showed no significant differences in Demographic variables and the metabolic syndrome indicators at baseline. While the control group only showed modest improvement after 12 weeks, compared to baseline, the intervention group demonstrated significant improvement from baseline. This study controlled for patients' demographics and baseline characteristics when assessing the effects of intervention. After adjusting for age, education and baseline level, the experimental group and the control group were statistically significant different in the following post-treatment outcomes: WC (F = 35.96, P < 0.001), TG (F = 18.93, P < 0.001), RSBP (F = 33.89, P < 0.001) and SF-36(F = 157.93, P < 0.001). The results showed patients' age and education were not strong predictors of patients' outcome (including WC, TG, RSBP and SF-36). Lifestyle intervention on patient-centered cognitive behavioral therapy can improve the physical and mental health conditions among individuals reporting a history of cardio-metabolic syndrome, and possibly provided preliminary benefits for the treatment of CMS. Chinese Clinical Trial Register #, ChiCTR15006148 .

Additional standing balance circuit classes during inpatient rehabilitation improved balance outcomes: an assessor-blinded randomised controlled trial.

PubMed

Treacy, Daniel; Schurr, Karl; Lloyd, Bradley; Sherrington, Catherine

2015-07-01

to evaluate the impact on balance (postural control) of six 1-h circuit classes that targeted balance in addition to usual therapy for rehabilitation inpatients. a randomised controlled trial with 2-week and 3-month follow-up. one hundred and sixty-two general rehabilitation inpatients, Bankstown-Lidcombe Hospital, Australia. intervention group participants received six 1-h circuit classes over a 2-week period in addition to usual therapy. Control group participants received usual therapy. standing balance performance (primary outcome) was better in the intervention group than in the control group at 2 weeks (between-group difference after adjusting for baseline values 3.3 s; 95% confidence interval (CI) 0.84 to 5.7, P = 0.009), but the between-group difference was not statistically significant at 3 months (3.4 s; 95% CI -0.56 to 7.38, P = 0.092). Intervention group outcomes were significantly better than the control groups for mobility performance (Short Physical Performance Battery) at 2 weeks (1.19, 95% CI 0.52 to 1.87, P <0.01) and 3 months (1.00, 95% CI 0.00 to 2.00, P < 0.049) and self-reported functioning (AM-PAC) at 2 weeks (5.39, 95% CI 1.20 to 9.57, P = 0.012). The intervention group had a 4.1-day shorter rehabilitation unit stay (95% CI -8.3 to 0.16, P = 0.059) and a lower risk of readmission in the 3 months after randomisation (incidence rate ratio 0.70, 95% CI 0.42 to 1.18, P = 0.184), but these differences were not statistically significant. two weeks of standing balance circuit classes in addition to usual therapy improved balance in general rehabilitation inpatients at 2 weeks. © The Author 2015. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Comparison of perioperative outcomes between endoscope-assisted technique and handheld acoustic Doppler for perforator identification in fasciocutaneous flaps.

PubMed

Huang, Jen-Wu; Huang, Chih-Sheng; Shih, Yu-Chung; Perng, Cherng-Kang; Lin, Yi-Ying; Wu, Szu-Hsien

2018-06-01

The endoscopic technique has been utilized to harvest muscle flaps and detect perforators of fasciocutaneous flaps. This study aimed to compare the perioperative outcomes between the endoscope-assisted technique and handheld acoustic Doppler for perforator identification in fasciocutaneous flaps.This retrospective case-control study included patients who underwent fasciocutaneous flap reconstruction for traumatic soft tissue defects. In the case group, perforator identification was assisted by the endoscope-assisted technique. In the control group, age- and sex-matched patients received handheld acoustic Doppler to detect perforators. Perioperative outcomes, flap characteristics, and postoperative complications were compared.There were 12 patients in the case group and 12 in the control group. Compared with the control group, the case group had a significantly shorter length of donor-site wounds (9 cm vs 12 cm, P = .023) and a significantly smaller proportion of patients receiving skin grafting at the donor sites (0% vs 41.7%, P = .037). The case group had a longer operative time, but the difference was not statistically significant (180 minutes vs 150 minutes, P = .367). The amount of blood loss, the time length of postoperative drainage, and complications did not significantly differ between the 2 groups.The endoscope-assisted technique for perforator identification of fasciocutaneous flaps provided less donor-site morbidity and a significantly shorter length of donor-site wounds than the conventional handheld acoustic Doppler, which suggests that this technique could be a valuable alternative when a precise design is indicated.

Outcomes 18 years after implementation of a nonoperative caries preventive program--the Nexö-method--on children in Moscow, Russia.

PubMed

Kuzmina, Irina; Ekstrand, Kim R

2015-08-01

To report the long-term effect (18 years) of the Nexö-method, initially implemented in groups of children in Moscow in 1994. Three groups of children were included in the initial study in 1994. This study is a follow-up study of two of the three initial groups: a group of 6-year-olds (test group6 ; control group6 ) and a group of 11-year-olds (test group11 , control group11) , n = 50 individuals in each of the four subgroups. In 2012, >80% of the participants in the two groups (now aged 24 and 28 years old) were re-examined by the original examiner, who was blinded to which group the patients had belonged in the initial study. After re-examination, the participants were interviewed by a person not otherwise attached to the study. Finally, caries data were collected from 100 24-year-olds and 100 28-year-olds who attended the dental school (50%) and private clinic (50%) in Moscow (External control groups24,28 ). The outcome variables of the study were plaque and gingival status, and DMFT/S. In 2012, the control groups24,28 displayed significantly higher plaque scores than the test groups24,28 (P-values < 0.05). No differences were seen regarding gingivitis scores (P-values > 0.41). Mean DMFT/S in 2012 was test group24 = 6.98/10.51, control group24 = 8.84/13.14 (P = 0.02/0.06). External control group24 = 8.89/15.86 (test24 versus external control group24 , P = 0.01/0.007; control24 versus external control group24 , P = 0.94/0.16). Test group28 = 6.74/10.83, control group28 = 8.70/14.48 (P = 0.02/0.008). External control group28 = 9.03/18.06 (test28 versus external control28 , P = 0.03/0.001; control28 versus external control28 , P = 0.68/0.07). The interview indicated that the participants in the test groups were more aware of factors that are considered important for control of caries than participants in the control groups. The data from this group of Moscow citizens suggest a long-term positive effect of the Nexö-method implemented during childhood. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Virtual reality to augment robot-assisted gait training in non-ambulatory patients with a subacute stroke: a pilot randomized controlled trial.

PubMed

Bergmann, Jeannine; Krewer, Carmen; Bauer, Petra; Koenig, Alexander; Riener, Robert; Müller, Friedemann

2018-06-01

Active performance is crucial for motor learning, and, together with motivation, is believed to be associated with a better rehabilitation outcome. Virtual reality (VR) is an innovative approach to engage and motivate patients during training. There is promising evidence for its efficiency in retraining upper limb function. However, there is insufficient proof for its effectiveness in gait training. To evaluate the acceptability of robot-assisted gait training (RAGT) with and without VR and the feasibility of potential outcome measures to guide the planning of a larger randomized controlled trial (RCT). Single-blind randomized controlled pilot trial with two parallel arms. Rehabilitation hospital. Twenty subacute stroke patients (64±9 years) with a Functional Ambulation Classification (FAC) ≤2. Twelve sessions (over 4 weeks) of either VR-augmented RAGT (intervention group) or standard RAGT (control group). Acceptability of the interventions (drop-out rate, questionnaire), patients' motivation (Intrinsic Motivation Inventory [IMI], individual mean walking time), and feasibility of potential outcome measures (completion rate and response to interventions) were determined. We found high acceptability of repetitive VR-augmented RAGT. The drop-out rate was 1/11 in the intervention and 4/14 in the control group. Patients of the intervention group spent significantly more time walking in the robot than the control group (per session and total walking time; P<0.03). In both groups, motivation measured with the IMI was high over the entire intervention period. The felt pressure and tension significantly decreased in the intervention group (P<0.01) and was significantly lower than in the control group at the last therapy session (r=-0.66, P=0.005). The FAC is suggested as a potential primary outcome measure for a definitive RCT, as it could be assessed in all patients and showed significant response to interventions (P<0.01). We estimated a sample size of 44 for a future RCT. VR-augmented RAGT resulted in high acceptability and motivation, and in a reduced drop-out rate and an extended training time compared to standard RAGT. This pilot trial provides guidance for a prospective RCT on the effectiveness of VR-augmented RAGT. VR might be a promising approach to enrich and improve gait rehabilitation after stroke.

Deep inferior epigastric artery perforator flap donor-site closure with cannula-assisted, limited undermining, and progressive high-tension sutures versus standard abdominoplasty: complications, sensitivity, and cosmetic outcomes.

PubMed

Visconti, Giuseppe; Tomaselli, Federica; Monda, Anna; Barone-Adesi, Liliana; Salgarello, Marzia

2015-01-01

In deep inferior epigastric artery perforator (DIEP) flap breast reconstruction, abdominal donor-site cosmetic and sensibility outcomes and the closure technique have drawn little attention in the literature, with many surgeons still following the principles of standard abdominoplasty. In this article, the authors report their experience with the cannula-assisted, limited undermining, and progressive high-tension suture ("CALP") technique of DIEP donor-site closure compared with standard abdominoplasty. Between December of 2008 and January of 2013, 137 consecutive women underwent DIEP flap breast reconstruction. Of these, 82 patients (between December of 2008 and November of 2011) underwent DIEP flap donor-site closure by means of standard abdominoplasty (control group) and 55 patients (from December of 2011 to January of 2013) by means of cannula-assisted, limited undermining, and progressive high-tension suture (study group). The abdominal drainage daily output, donor-site complications, abdominal skin sensitivity at 1-year follow-up, cosmetic outcomes, and patient satisfaction were recorded and analyzed statistically. Daily drainage output was significantly lower in the study group. Donor-site complications were significantly higher in the control group (37.8 percent versus 9 percent). Seroma and wound healing problems were experienced in the control group. Abdominal skin sensibility was better preserved in the study group. Overall, abdominal wall aesthetic outcomes were similar in both groups, except for scar quality (better in the study group). According to the authors' experience, cannula-assisted, limited undermining, and progressive high-tension suture should be always preferred to standard abdominoplasty for DIEP donor-site closure to reduce the complication rate to improve abdominal skin sensitivity and scar quality. Therapeutic, II.

Impact of Target Distance, Target Size, and Visual Acuity on the Video Head Impulse Test.

PubMed

Judge, Paul D; Rodriguez, Amanda I; Barin, Kamran; Janky, Kristen L

2018-05-01

The video head impulse test (vHIT) assesses the vestibulo-ocular reflex. Few have evaluated whether environmental factors or visual acuity influence the vHIT. The purpose of this study was to evaluate the influence of target distance, target size, and visual acuity on vHIT outcomes. Thirty-eight normal controls and 8 subjects with vestibular loss (VL) participated. vHIT was completed at 3 distances and with 3 target sizes. Normal controls were subdivided on the basis of visual acuity. Corrective saccade frequency, corrective saccade amplitude, and gain were tabulated. In the normal control group, there were no significant effects of target size or visual acuity for any vHIT outcome parameters; however, gain increased as target distance decreased. The VL group demonstrated higher corrective saccade frequency and amplitude and lower gain as compared with controls. In conclusion, decreasing target distance increases gain for normal controls but not subjects with VL. Preliminarily, visual acuity does not affect vHIT outcomes.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

PubMed

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. NCT02093520.

A controlled study of the role of cryopreserved amniotic membrane transplant during strabismus reoperations.

PubMed

Kassem, Rehab Rashad; Kamal, Ahmed Mostafa; El-Mofty, Randa Mohamed Abdel-Moneim; Elhilali, Hala Mostafa

2017-04-01

To evaluate the effects of using cryopreserved human amniotic membrane (AM) transplant during strabismus reoperations. A total of 30 patients with persistent strabismus were included in this prospective study. Patients were divided into two groups of 15 patients each. The AM group underwent strabismus reoperation with wrapping of the muscles with cryopreserved amniotic membrane. Controls underwent strabismus reoperation without an AM wrap. Final follow-up visit was scheduled between 3 and 12 months postoperatively. Surgical success was defined as 0 Δ -10 Δ of horizontal tropia and 0 Δ -4 Δ of vertical tropia, with no limitation of ductions exceeding -1. A cosmetically acceptable outcome was defined as a tropia of 0 Δ -15 Δ . Three patients were excluded in the AM group due to incomplete follow-up. A successful outcome was achieved in 7 patients in each group (58% and 47% in groups AM and C, resp.; P = 0.63). A cosmetically acceptable outcome was achieved in 10 patients in the AM group (83.3%) and 12 (80%) in the control group (P = 0.48). The mean ocular deviation angles improved to 8.7 Δ ± 12 Δ in the AM group and 12.3 Δ ± 17.4 Δ in the control group (P = 0.63). Ductions improved in 66.7% and 36.4% of the muscles with limited motility in groups AM and C, respectively (P = 0.019). Wrapping the extraocular muscles with cryopreserved AM during strabismus reoperations was of limited clinical benefit. We attributed this to the small segment of AM used and to the presence of other causes of failure rather than adhesions. Copyright © 2017 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

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

PubMed

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 the effect of pre-pregnancy periodontal treatment is confirmed, this intervention could be recommended for application in low- or middle-income countries to improve both oral health and maternal and child health. This trial is registered with Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-12001913.

The Effect Of Different Corrective Feedback Methods on the Outcome and Self Confidence of Young Athletes

PubMed Central

Tzetzis, George; Votsis, Evandros; Kourtessis, Thomas

2008-01-01

This experiment investigated the effects of three corrective feedback methods, using different combinations of correction, or error cues and positive feedback for learning two badminton skills with different difficulty (forehand clear - low difficulty, backhand clear - high difficulty). Outcome and self-confidence scores were used as dependent variables. The 48 participants were randomly assigned into four groups. Group A received correction cues and positive feedback. Group B received cues on errors of execution. Group C received positive feedback, correction cues and error cues. Group D was the control group. A pre, post and a retention test was conducted. A three way analysis of variance ANOVA (4 groups X 2 task difficulty X 3 measures) with repeated measures on the last factor revealed significant interactions for each depended variable. All the corrective feedback methods groups, increased their outcome scores over time for the easy skill, but only groups A and C for the difficult skill. Groups A and B had significantly better outcome scores than group C and the control group for the easy skill on the retention test. However, for the difficult skill, group C was better than groups A, B and D. The self confidence scores of groups A and C improved over time for the easy skill but not for group B and D. Again, for the difficult skill, only group C improved over time. Finally a regression analysis depicted that the improvement in performance predicted a proportion of the improvement in self confidence for both the easy and the difficult skill. It was concluded that when young athletes are taught skills of different difficulty, different type of instruction, might be more appropriate in order to improve outcome and self confidence. A more integrated approach on teaching will assist coaches or physical education teachers to be more efficient and effective. Key pointsThe type of the skill is a critical factor in determining the effectiveness of the feedback types.Different instructional methods of corrective feedback could have beneficial effects in the outcome and self-confidence of young athletesInstructions focusing on the correct cues or errors increase performance of easy skills.Positive feedback or correction cues increase self-confidence of easy skills but only the combination of error and correction cues increase self confidence and outcome scores of difficult skills. PMID:24149905

Managing the space between visits: a randomized trial of disease management for diabetes in a community health center.

PubMed

Anderson, Daren R; Christison-Lagay, Joan; Villagra, Victor; Liu, Haibei; Dziura, James

2010-10-01

Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority populations. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients. We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center. Randomized controlled trial. All patients had type 2 diabetes, and the majority was Hispanic or African American. Most were urban-dwelling with low socioeconomic status, and nearly all had Medicaid or were uninsured. Clinical measures included glycemic control, blood pressure, lipid levels, and body mass index. Validated surveys were used to measure dietary habits and physical activity. A total of 146 patients were randomized to the intervention and 149 to the control group. Depressive symptoms were highly prevalent in both groups. Using an intention to treat analysis, there were no significant differences in the primary outcome (HbA1c) between the intervention and control groups at 12 months. There were also no significant differences for secondary clinical or behavioral outcome measures including BMI, systolic or diastolic blood pressure, LDL cholesterol, smoking, or intake of fruits and vegetables, or physical activity. A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone.

The effect of a clinical medical librarian on in-patient care outcomes.

PubMed

Esparza, Julia M; Shi, Runhua; McLarty, Jerry; Comegys, Marianne; Banks, Daniel E

2013-07-01

The research sought to determine the effect of a clinical medical librarian (CML) on outcomes of in-patients on the internal medicine service. A prospective study was performed with two internal medicine in-patient teams. Team 1 included a CML who accompanied the team on daily rounds. The CML answered questions posed at the point of care immediately or in emails post-rounds. Patients on Team 2, which did not include a CML, as well as patients who did not require consultation by the CML on Team 1, served as the control population. Numerous clinical and library metrics were gathered on each question. Patients on Team 1 who required an answer to a clinical question were more ill and had a longer length of stay, higher costs, and higher readmission rates compared to those in the control group. Using a matched pair analysis, we showed no difference in clinical outcomes between the intervention group and the control group. This study is the largest attempt to prospectively measure changes in patient outcomes when physicians were accompanied by a CML on rounds. This approach may serve as a model for further studies to define when and how CMLs are most effective.

Cost-effectiveness of a health-social partnership transitional program for post-discharge medical patients.

PubMed

Wong, Frances Kam Yuet; Chau, June; So, Ching; Tam, Stanley Ku Fu; McGhee, Sarah

2012-12-24

Readmissions are costly and have implications for quality of care. Studies have been reported to support effects of transitional care programs in reducing hospital readmissions and enhancing clinical outcomes. However, there is a paucity of studies executing full economic evaluation to assess the cost-effectiveness of these transitional care programs. This study is therefore launched to fill this knowledge gap. Cost-effectiveness analysis was conducted alongside a randomized controlled trial that examined the effects of a Health-Social Transitional Care Management Program (HSTCMP) for medical patients discharged from an acute regional hospital in Hong Kong. The cost and health outcomes were compared between the patients receiving the HSTCMP and usual care. The total costs comprised the pre-program, program, and healthcare utilization costs. Quality of life was measured with SF-36 and transformed to utility values between 0 and 1. The readmission rates within 28 (control 10.2%, study 4.0%) and 84 days (control 19.4%, study 8.1%) were significantly higher in the control group. Utility values showed no difference between the control and study groups at baseline (p = 0.308). Utility values for the study group were significantly higher than in the control group at 28 (p < 0.001) and 84 days (p = 0.002). The study group also had a significantly higher QALYs gain (p < 0.001) over time at 28 and 84 days when compared with the control group. The intervention had an 89% chance of being cost-effective at the threshold of £20000/QALY. Previous studies on transitional care focused mainly on clinical outcomes and not too many included cost as an outcome measure. Studies examining the cost-effectiveness of the post-discharge support services are scanty. This study is the first to examine the cost-effectiveness of a transitional care program that used nurse-led services participated by volunteers. Results have shown that a health-social partnership transitional care program is cost-effective in reducing healthcare costs and attaining QALY gains. Economic evaluation helps to inform funders and guide decisions for the effective use of competing healthcare resources.

Recommending Oral Probiotics to Reduce Winter Antibiotic Prescriptions in People With Asthma: A Pragmatic Randomized Controlled Trial.

PubMed

Smith, Timothy D H; Watt, Hilary; Gunn, Laura; Car, Josip; Boyle, Robert J

2016-09-01

Evidence from studies mainly in children has shown that orally administered probiotics may prevent respiratory tract infections and associated antibiotic use. We evaluated whether advice to take daily probiotics can reduce antibiotic prescribing for winter respiratory tract infections in people with asthma. We conducted a randomized controlled, parallel-group pragmatic study for participants aged 5 years and older with asthma in a UK primary care setting. The intervention was a postal leaflet with advice to take daily probiotics from October 2013 to March 2014, compared with a standard winter advice leaflet. Primary outcome was the proportion of participants prescribed antibiotics for respiratory tract infections. There were 1,302 participants randomly assigned to a control group (n = 650) or intervention group (n = 652). There was no significant difference in the primary outcome measure, with 27.7% receiving antibiotics in the intervention group and 26.9% receiving antibiotics in the control group (odds ratio = 1.04; 95% CI, 0.82-1.34). Uptake of probiotics was low, but outcomes were similar in those who accessed probiotics (adjusted odds ratio = 1.08; 95% CI, 0.69-1.69, compared with controls). We also found no evidence of an effect on respiratory tract infections or asthma exacerbations. In this pragmatic community-based trial in people with asthma, we found no evidence that advising use of winter probiotics reduces antibiotic prescribing. © 2016 Annals of Family Medicine, Inc.

Outcome of urinary tract infections caused by extended spectrum β-lactamase-producing Enterobacteriaceae in children.

PubMed

Tratselas, Athanasios; Iosifidis, Elias; Ioannidou, Maria; Saoulidis, Stamatis; Kollios, Konstantinos; Antachopoulos, Charalampos; Sofianou, Danai; Roilides, Emmanuel J

2011-08-01

The outcome of patients with urinary tract infections caused by extended spectrum β-lactamases (ESBL)-producing bacteria (cases) was compared with that of matched controls with urinary tract infections caused by non-extended spectrum β-lactamases-producing isolates. Significantly, more case patients received inappropriate empiric therapy than controls. Nevertheless, clinical and microbiologic outcomes as well as formation of renal scars did not differ between the 2 groups.

The efficacy of imagery rescripting (IR) for social phobia: a randomized controlled trial.

PubMed

Lee, Seung Won; Kwon, Jung-Hye

2013-12-01

There is a need for brief effective treatment of social phobia and Imagery Rescripting (IR) is a potential candidate. The purpose of this study was to examine the efficacy of IR preceded by cognitive restructuring as a stand-alone brief treatment using a randomized controlled design. Twenty-three individuals with social phobia were randomly assigned to an IR group or to a control group. Participants in the IR group were provided with one session of imagery interviewing and two sessions of cognitive restructuring and Imagery Rescripting. Those in the control group had one session of clinical interviewing and two sessions of supportive therapy. Outcome measures including the Korean version of the social avoidance and distress scale (K-SADS) were administered before and after treatment, and at three-month follow-up. The short version of the Questionnaire upon Mental Imagery and the Traumatic Experience Scale were also administered before treatment. Participants in the IR group improved significantly on K-SADS and other outcome measures, compared to the control group. The beneficial effects of IR were maintained at three-month follow-up. It was also found that mental imagery ability and the severity of the traumatic experience did not moderate the outcome of IR. Further studies are needed to replicate the findings of our study using a large sample. The efficacy of IR as a stand-alone brief treatment was demonstrated for social phobia. The findings indicate that IR could be utilized as a cost-effective intervention for social phobia. Copyright © 2013 Elsevier Ltd. All rights reserved.

Virtual reality for upper extremity rehabilitation in early stroke: a pilot randomized controlled trial.

PubMed

Yin, Chan Wai; Sien, Ng Yee; Ying, Low Ai; Chung, Stephanie Fook-Chong Man; Tan May Leng, Dawn

2014-11-01

To investigate the effect of virtual reality (VR) rehabilitation on upper extremity motor performance of patients with early stroke. Pilot randomized controlled trial. Rehabilitation wards. Twenty three adults with stroke (mean age (SD) = 58.35 (13.45) years and mean time since stroke (SD) = 16.30 (7.44) days). Participants were randomly assigned to VR group (n=11) or control group (n=12). VR group received nine 30 minutes upper extremity VR therapy in standing (five weekdays in two weeks) plus conventional therapy, which included physical and occupational therapy. Control group received only conventional therapy, which was comparable to total training time received by VR group (mean training hours (SD):VR = 17.07 (2.86); control = 15.50 (2.79)). The main outcome measure was the Fugl-Meyer Assessment (FMA). Secondary outcomes included Action Research Arm Test, Motor Activity Log and Functional Independence Measure. Results were taken at baseline, post intervention and 1-month post intervention. Participants' feedback and adverse effects were recorded. All participants improved in FMA scores (mean change (SD) = 11.65 (8.56), P<.001). These effects were sustained at one month after intervention (mean (SD) change from baseline = 18.67 (13.26), P<.001). All other outcome measures showed similar patterns. There were no significant differences in improvement between both groups. Majority of the participants found VR training useful and enjoyable, with no serious adverse effects reported. Although additional VR training was not superior to conventional therapy alone, this study demonstrates the feasibility of VR training in early stroke. © The Author(s) 2014.

The Application of an Evidence-Based Clinical Nursing Path for Improving the Preoperative and Postoperative Quality of Care of Pediatric Retroperitoneal Neuroblastoma Patients: A Randomized Controlled Trial at a Tertiary Medical Institution.

PubMed

Liu, Yang; Mo, Lin; Tang, Yan; Wang, Qiuhong; Huang, Xiaoyan

A clinical nursing path (CNP) that encourages patients and their families to become actively involved in healthcare decision-making processes may improve outcomes of pediatric retroperitoneal neuroblastoma (NB) patients. The aim of this study was to evaluate the utility and value of an evidence-based CNP provided to pediatric retroperitoneal NB patients undergoing resection surgery. One hundred twenty NB cases were assigned to a control group or a CNP group. The control group was provided with standard nursing care. The CNP group was provided with nursing care in accordance with an evidence-based CNP. The utility and value of the CNP were compared with standard nursing care. Outcome measures included rates of postoperative complications, lengths of hospital stay, and cost of hospitalization, as well as preoperative and postoperative quality of care and patient satisfaction with care. The rates of postoperative complications, length of preoperative hospitalization, total length of hospital stay, and costs of hospitalization were significantly lower for patients receiving the CNP compared with the control group. Preoperative and postoperative quality of care and patient satisfaction with care were significantly higher in patients receiving the CNP compared with the control group. Adoption of a CNP for preoperative and postoperative care of pediatric retroperitoneal NB patients undergoing resection surgery improves clinical outcomes and patient satisfaction with care. A CNP can increase families' participation in a patient's recovery process, enhance nurses' understanding of the services they are providing, and improve the quality of healthcare received by patients.

Evaluation of a long-term home care program.

PubMed

Hughes, S L; Cordray, D S; Spiker, V A

1984-05-01

This article reports the outcomes of a 9-month evaluation of the Five Hospital Homebound Elderly Program ( FHHEP ), a model long-term, comprehensive, coordinated home care program in Chicago. Outcomes assessed include the mortality, comprehensive functional status, and rates of hospitalization and of institutionalization of the elderly (mean age, 80.4 years), chronically impaired population served by the FHHEP . The evaluation utilized a quasi-experimental, preposttest design with a nonequivalent control group consisting of similarly elderly and impaired subjects who received OAA Title III-c home-delivered meals. Consecutively accepted experimental (n = 122) and control group clients (n = 123) were interviewed using the Duke/ OARS Multi-dimensional Functional Assessment Questionnaire at the time of acceptance to service and 9 months later. Service utilization data were also obtained for both groups to correlate client outcomes and characteristics with level and type of services used. Data collection took place over a 31-month period. Posttest functional status measures were obtained for 83% of experimental and 81% of control subjects. Multivariate analysis was used to control measured pretest differences. Major findings include a significant reduction in the nursing home admissions (16 vs. 28) and nursing home days (including sheltered care) of experimental group clients. The reported analyses also show an increase in experimental clients' sense of physical health well-being and a decrease in their number of previously unmet needs for community services. Somewhat paradoxically, the experimental sample also demonstrated a decrease in physical activities of daily living ( PADL ) functioning. The mortality and hospitalization rate were equal for both groups. Despite savings in nursing home days of care, average per-capita costs for experimental group clients were 19% higher than for controls. However, this additional cost was accompanied by an increase in quality of life. Longer-range cost and outcomes are being assessed through a 4-year follow-up study currently in progress.

Effectiveness of Senior Dance on risk factors for falls in older adults (DanSE): a study protocol for a randomised controlled trial

PubMed Central

Franco, Marcia R; Sherrington, Catherine; Tiedemann, Anne; Pereira, Leani S; Perracini, Monica R; Faria, Claudia R S; Pinto, Rafael Z; Pastre, Carlos M

2016-01-01

Introduction Strong evidence shows that exercise is effective to improve fall risk factors among older people. However, older people's participation and adherence to exercise programmes is suboptimal. Type of exercise and apathy are reported to be barriers to exercise participation, suggesting that new effective interventions are needed. The primary aim of this randomised controlled trial is to investigate the effect of Senior Dance plus brief education for falls prevention on balance among people aged 60 years or over, compared with a control group receiving only brief education. Methods and analysis This single-blind randomised controlled trial will involve 82 community-dwelling older people aged 60 years or over who are cognitively intact. Participants allocated to the intervention group will attend a single educational class on strategies to prevent falls, and will participate in a 12-week, twice-weekly group-based programme of Senior Dance. The Senior Dance consists of different choreographies, which include rhythmic and simple movements with rhythmic folk songs. Participants allocated to the control group will attend the same educational class that intervention group participants will receive, and will be instructed not to take part in any regular exercise programme. The primary outcome will be single-leg stance with eyes closed. Secondary outcomes include: Short Physical Performance Battery, Falls Efficacy Scale, Trail Making Test and the Montreal Cognitive Assessment. Continuous outcomes will be reported using mean (SD) or median (IQR), depending on the distribution of the data. The linear regression approach to analysis of covariance will be used to compare the mean effect between groups. All patients will be included in the analyses following an intention-to-treat approach. Ethics and dissemination Ethics approval has been granted by the Human Ethics Committee of the São Paulo State University (CAAE 48665215.9.0000.5402). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at conferences. Trial registration number NCT02603523, Pre-results. PMID:28039296

Immediate effect of subliminal priming with positive reward stimuli on standing balance in healthy individuals: A randomized controlled trial.

PubMed

Aoyama, Yasuhiro; Uchida, Hiroyuki; Sugi, Yasuyuki; Kawakami, Akinobu; Fujii, Miki; Kiso, Kanae; Kono, Ryota; Takebayashi, Takashi; Hirao, Kazuki

2017-07-01

Information received subconsciously can influence exercise performance; however, it remains unclear whether subliminal or supraliminal reward is more effective in improving standing balance ability when priming stimuli are subconsciously delivered. The present study aimed to compare the effects of subliminal priming-plus-subliminal reward stimuli (experimental) with subliminal priming-plus-supraliminal reward stimuli (control) on standing balance ability. This was a single-blind (outcome assessor), parallel-group, randomized controlled trial involving healthy young adults recruited from a university in Japan. Assessments were conducted at baseline and immediately after intervention. The primary outcome was the functional reach test (FRT) measurement. The secondary outcome was one-leg standing time (OLST) with eyes closed. Of the 52 participants screened, 25 were randomly assigned to experimental and control groups each. Both interventions were effective for improving the FRT between the baseline and intervention; however, smaller improvements were observed in the experimental group. We found a large between-groups effect size immediately after the intervention for the FRT (d = -0.92). In contrast, there were no differences in improvements in OLST between the 2 groups (d = -0.06); furthermore, neither intervention was found to be effective for this parameter. We concluded that subliminal priming with conscious reward stimuli results in improvements in immediate-term forward reach ability, which is superior to that achieved by subliminal priming with subconscious reward stimuli.

A randomized controlled trial reporting functional outcomes of cognitive-behavioural therapy in medication-treated adults with ADHD and comorbid psychopathology.

PubMed

Young, Susan; Emilsson, Brynjar; Sigurdsson, Jon Fridrik; Khondoker, Mizanur; Philipp-Wiegmann, Florence; Baldursson, Gisli; Olafsdottir, Halldora; Gudjonsson, Gisli

2017-04-01

Studies assessing psychological treatment of attention deficit hyperactivity disorder (ADHD) in adults are increasingly reported. However, functional outcomes are often neglected in favour of symptom outcomes. We investigated functional outcomes in 95 adults with ADHD who were already treated with medication and randomized to receive treatment as usual (TAU/MED) or psychological treatment (CBT/MED) using a cognitive-behavioural programme, R&R2ADHD, which employs both group and individual modalities. RATE-S functional outcomes associated with ADHD symptoms, social functioning, emotional control and antisocial behaviour were given at baseline, end of treatment and three-month follow-up. The Total composite score of these scales is associated with life satisfaction. In addition, independent evaluator ratings of clinicians who were blind to treatment arm were obtained on the Clinical Global Impression scale at each time point. CBT/MED showed overall (combined outcome at end of treatment and 3-month follow-up) significantly greater functional improvement on all scales. Post-group treatment effects were maintained at follow-up with the exception of emotional control and the Total composite scales, which continued to improve. The largest treatment effect was for the RATE-S Total composite scale, associated with life satisfaction. CGI significantly correlated with all outcomes except for social functioning scale at follow-up. The study provides further evidence for the effectiveness of R&R2ADHD and demonstrates the importance of measuring functional outcomes. The key mechanism associated with improved functional outcomes is likely to be behavioural control.

Randomized Controlled Trial of BASICS for Heavy Drinking Mandated and Volunteer Undergraduates: 12-Month Outcomes

PubMed Central

Terlecki, Meredith A.; Buckner, Julia D.; Larimer, Mary E.; Copeland, Amy L.

2014-01-01

This is the first randomized trial testing whether heavy drinking undergraduates mandated to the Brief Alcohol Screening and Intervention for College Students (BASICS) program following a campus alcohol violation would benefit as much as heavy drinking volunteers up to one year post-intervention using control groups with high-risk drinkers to model disciplinary-related and naturalistic changes in drinking. Participants (61% male; 51% mandated; 84% Caucasian; Mage = 20.14 years) were screened for heavy drinking and randomized to BASICS (n = 115) or assessment-only control (n = 110). Outcome measures (drinking, alcohol problems) were collected at baseline, 4 weeks, 3, 6, and 12 months post-intervention. At 4 weeks post-intervention, intent-to-treat multilevel longitudinal models showed that regardless of referral group (mandated or volunteer) BASICS significantly decreased weekly drinking, typical drinks, and peak drinks relative to controls (ds = .41-.92). BASICS had a large effect on decreases in alcohol problems (d = .87). At 12 months post-intervention, BASICS participants (regardless of referral group) reported significantly fewer alcohol problems (d = .56) compared to controls. Significant long-term intervention gains for peak and typical drinks were sustained in both referral groups relative to controls (ds = .42; .11). Referral group had no significant main effect and did not interact with intervention condition to predict outcomes. Given that BASICS was associated with less drinking and fewer alcohol problems (even among heavier drinking mandated students up to one year post-intervention), provision of BASICS-style programs within disciplinary settings may help reduce heavy and problematic drinking among at-risk students. PMID:25844834

The effect of inflatable obstetric belts in nulliparous pregnant women receiving patient-controlled epidural analgesia during the second stage of labor.

PubMed

Kim, Jong-Woon; Kim, Yoon Ha; Cho, Hye Yon; Shin, Hee-Young; Shin, Jong Chul; Choi, Sea Kyung; Lee, Keun-Young; Song, Ji-Eun; Lee, Pil-Ryang

2013-11-01

The aim of this study was to evaluate the effect of inflatable obstetric belts on uterine fundal pressure in the management of the second stage of labor. Between July 2009 and December 2010, 188 nulliparous women with a singleton pregnancy at term were enrolled and only one dropped. The participants were randomized to receive either standard care (control group, n = 91) or uterine fundal pressure by the Labor Assister (Baidy M-520/Curexo, Inc., Seoul, Korea; active group, n = 97) during the second stage of labor in addition to standard care. The Labor Assister is an inflatable obstetric belt that is synchronized to apply constant fundal pressure during a uterine contraction. The primary endpoint was duration of the second stage of labor in women who delivered vaginally (control, n = 80 versus active, n = 93). It was not analyzed in women who delivered by cesarean section (n = 14) and delivered precipitously (n = 1). The secondary outcomes are perinatal outcomes and perineal laceration. Participants received patient-controlled epidural analgesia. The 93 women in the active group spent less time in the second stage of labor when compared to the 80 women in the control group (46.51 ± 28.01 min versus 75.02 ± 37.48 min, p < 0.001). There was no significant difference in perinatal outcomes and perineal laceration between the two groups. The uterine fundal pressure exerted by the inflatable obstetric belt reduces the duration of the second stage of labor without complications in nulliparous women who receive patient-controlled epidural analgesia.

Effect of dextran-70 on outcome in severe sepsis; a propensity-score matching study.

PubMed

Bentzer, Peter; Broman, Marcus; Kander, Thomas

2017-07-06

Albumin may be beneficial in patients with septic shock but availability is limited and cost is high. The objective of the present study was to investigate if the use of dextran-70 in addition to albumin and crystalloids influences organ failure or mortality in patients with severe sepsis or septic shock. Patients with severe sepsis or septic shock (n = 778) admitted to a university hospital intensive care unit (ICU) between 2007 and 2015 that received dextran-70 during resuscitation were propensity score matched to controls at a 1 to 1 ratio. Outcomes were highest acute kidney injury network (AKIN) score the first 10 days in the ICU, use of renal replacement therapy, days alive and free of organ support the first 28 days after admission to ICU, mortality and events of severe bleeding. Outcomes were assessed using paired hypothesis testing. Propensity score matching resulted in two groups of patients with 245 patients in each group. The dextran group received a median volume of 1483 ml (interquartile range, 1000-2000 ml) of dextran-70 during the ICU stay. Highest AKIN score did not differ between the control- and dextran groups (1 (0-3) versus 2 (0-3), p = 0.06). Incidence of renal replacement therapy in the control- and dextran groups was similar (19% versus 22%, p = 0.42, absolute risk reduction -2.9% [95% CI: -9.9 to 4.2]). Days alive and free of renal replacement, vasopressors and mechanical ventilation did not differ between the control- and dextran groups. The 180-day mortality was 50.2% in the control group and 41.6% in the dextran group (p = 0.046, absolute risk reduction 8.6% [-0.2 to 17.4]). Fraction of patients experiencing a severe bleeding in the first 10 days in the ICU did not differ between the control and dextran groups (14% versus 18%, p = 0.21). There is a paucity of high quality data regarding effects of dextran solutions on outcome in sepsis. In the present study, propensity score matching was used in attempt to reduce bias. No evidence to support a detrimental effect of dextran-70 on mortality or on organ failures in patients with severe sepsis or septic shock could be detected.

Comparison of Fetomaternal Outcome between 47 Deliveries Following Successful External Cephalic Version for Breech Presentation and 7456 Deliveries Following Spontaneous Cephalic Presentation.

PubMed

de Gregorio, Nikolaus; Friedl, Thomas; Schramm, Amelie; Reister, Frank; Janni, Wolfgang; Ebner, Florian

2017-08-25

Achieving a cephalic position after a successful external cephalic version (ECV) is desired to result in delivery and fetal outcomes that are similar to those of deliveries following spontaneous cephalic presentation. We performed a retrospective cohort study including patients with successful ECV following fetal breech position (ECV cohort, n = 47) or with a singleton spontaneous cephalic pregnancy at ≥37 weeks of gestational age (control group, n = 7,456) attempting a vaginal delivery between 2010 and 2013 at the University Hospital Ulm. The mode of delivery and fetal outcome parameters were compared between these 2 groups using nonparametric statistics. ECV cohort and control group did not differ with respect to maternal age, parity, gestational age at birth, and fetal gender. There were no significant differences between the 2 groups with regard to all parameters indicating fetal outcome. However, the rate of cesarean sections was higher after successful ECV compared to spontaneous cephalic presentation (27.7 vs. 12.8%, OR 2.615). While vaginal delivery is less likely to happen after a successful ECV compared to spontaneous cephalic singleton pregnancies, fetal outcome parameters showed no difference between the 2 groups. Physicians should be counseling and encouraging women to attempt ECV, as it is a safe and effective procedure. © 2017 S. Karger AG, Basel.

A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy.

PubMed

Tupper-Carey, Darell Alexander; Fathil, Shahridan Mohd; Tan, Yin Kiat Glenn; Kan, Yuk Man; Cheong, Chern Yuen; Siddiqui, Fahad Javaid; Assam, Pryseley Nkouibert

2017-08-01

We conducted a single-centre, prospective randomised clinical trial to investigate the analgesic efficacy of transversus abdominis plane (TAP) block in adult patients undergoing laparoscopic appendicectomy. Patients undergoing urgent laparoscopic appendicectomy under general anaesthesia alone (control group) and general anaesthesia supplemented by TAP block (TAP intervention group) were compared. All patients received a multimodal analgesia regime, which included postoperative morphine via a patient-controlled analgesia device. The primary endpoints were morphine consumption at 12 hours and 24 hours postoperatively. Secondary endpoints included pain scores, incidence of nausea and vomiting, and time to hospital discharge. A total of 58 patients were recruited, with 29 patients in each group. Mean postoperative morphine consumption at 12 hours (control group: 11.45 ± 7.64 mg, TAP intervention group: 9.79 ± 8.09 mg; p = 0.4264) and 24 hours (control group: 13.38 ± 8.72 mg, TAP intervention group: 11.31 ± 8.66 mg; p = 0.3686) for the control and TAP intervention groups were not statistically different. Secondary outcomes were also not different between the two groups. Length of stay in the post-anaesthesia care unit was significantly shorter for the TAP intervention group, with a trend toward faster hospital discharge being observed. TAP block, a regional anaesthetic procedure performed immediately prior to skin incision for laparoscopic appendicectomy, did not significantly improve postoperative analgesia outcomes. Copyright: © Singapore Medical Association

Efficacy of an Electromechanical Gait Trainer Poststroke in Singapore: A Randomized Controlled Trial.

PubMed

Chua, Joyce; Culpan, Jane; Menon, Edward

2016-05-01

To evaluate the longer-term effects of electromechanical gait trainers (GTs) combined with conventional physiotherapy on health status, function, and ambulation in people with subacute stroke in comparison with conventional physiotherapy given alone. Randomized controlled trial with intention-to-treat analysis. Community hospital in Singapore. Nonambulant individuals (N=106) recruited approximately 1 month poststroke. Both groups received 45 minutes of physiotherapy 6 times per week for 8 weeks as follows: the GT group received 20 minutes of GT training and 5 minutes of stance/gait training in contrast with 25 minutes of stance/gait training for the control group. Both groups completed 10 minutes of standing and 10 minutes of cycling. The primary outcome was the Functional Ambulation Category (FAC). Secondary outcomes were the Barthel Index (BI), gait speed and endurance, and Stroke Impact Scale (SIS). Measures were taken at baseline and 4, 8, 12, 24, and 48 weeks. Generalized linear model analysis showed significant improvement over time (independent of group) for the FAC, BI, and SIS physical and participation subscales. However, no significant group × time or group differences were observed for any of the outcome variables after generalized linear model analysis. The use of GTs combined with conventional physiotherapy can be as effective as conventional physiotherapy applied alone for people with subacute stroke. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Intensive versus conventional glucose control in critically ill patients with traumatic brain injury: long-term follow-up of a subgroup of patients from the NICE-SUGAR study.

PubMed

Finfer, Simon; Chittock, Dean; Li, Yang; Foster, Denise; Dhingra, Vinay; Bellomo, Rinaldo; Cook, Deborah; Dodek, Peter; Hebert, Paul; Henderson, William; Heyland, Daren; Higgins, Alisa; McArthur, Colin; Mitchell, Imogen; Myburgh, John; Robinson, Bruce; Ronco, Juan

2015-06-01

To compare the effect of intensive versus conventional blood glucose control in patients with traumatic brain injury. In a large international randomized trial patients were randomly assigned to a target blood glucose (BG) range of either 4.5-6.0 mmol/L (intensive control) or <10 mmol/L (conventional control). Patients with traumatic brain injury (TBI) were identified at randomization and data were collected to examine the extended Glasgow outcome score (includes mortality) at 24 months. Of the 6104 randomized patients, 391 satisfied diagnostic criteria for TBI; 203 (51.9%) were assigned to intensive and 188 (48.1%) to conventional control; the primary outcome was available for 166 (81.8%) and 149 (79.3%) patients, respectively. The two groups had similar baseline characteristics. At 2 years 98 (58.7%) patients in the intensive group and 79 (53.0%) in the conventional group had a favorable neurological outcome (odds ratio [OR] 1.26, 95% CI 0.81-1.97; P = 0.3); 35 patients (20.9%) in the intensive group and 34 (22.8%) in the conventional group had died (OR 0.90, 95% CI 0.53-1.53; P = 0.7); moderate hypoglycemia (BG 2.3-3.9 mmol/L; 41-70 mg/dL) occurred in 160/202 (79.2%) and 17/188 (9.0%), respectively (OR 38.3, 95% CI 21.0-70.1; P < 0.0001); severe hypoglycemia (BG ≤ 2.2 mmol/L; ≤40 mg/dL) in 10 (4.9%) and 0 (0.0%), respectively (OR 20.5 95% CI 1.2-351.6, P = 0.003). Although patients with traumatic brain injury randomly assigned to intensive compared to conventional glucose control experienced moderate and severe hypoglycemia more frequently, we found no significant difference in clinically important outcomes.

Effect of a group-based rehabilitation programme on glycaemic control and cardiovascular risk factors in type 2 diabetes patients: the Copenhagen Type 2 Diabetes Rehabilitation Project.

PubMed

Vadstrup, Eva Soelberg; Frølich, Anne; Perrild, Hans; Borg, Eva; Røder, Michael

2011-08-01

To compare the effectiveness of a group-based rehabilitation programme with an individual counselling programme at improving glycaemic control and cardiovascular risk factors among patients with type 2 diabetes. We randomised 143 adult type 2 diabetes patients to either a 6-month multidisciplinary group-based rehabilitation programme or a 6-month individual counselling programme. Outcome measures included glycated haemoglobin (HbA(1c)), blood pressure, lipid profile, weight, and waist circumference. Mean HbA(1c) decreased 0.3%-point (95% confidence interval [CI] = -0.5, -0.1) in the rehabilitation group and 0.6%-point (95% CI = -0.8, -0.4) among individual counselling participants (p<0.05). Within both groups, equal reductions occurred in body weight, waist circumference, systolic blood pressure and diastolic blood pressure, but no significant between-group differences between occurred for any of the cardiovascular outcomes. The group-based rehabilitation programme consumed twice as many personnel resources. The group-based rehabilitation programme resulted in changes in glycaemic control and cardiovascular risk factor reduction that were equivalent or inferior to those of an individual counselling programme. The group-based rehabilitation programme, tested in the current design, did not offer additionally improved outcomes and consumed more personnel resources than the individual counselling programme; its broad implementation is not supported by this study. Trial registration Clinicaltrials.gov NCT00284609. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Diagnostic value of non stress test in latent phase of labor and maternal and fetal outcomes.

PubMed

Raouf, Shiva; Sheikhan, Fatemeh; Hassanpour, Shirin; Bani, Soheila; Torabi, Rogayye; Shamsalizadeh, Neda

2014-10-28

The Non Stress Test (NST) is the one of the significant diagnostic fetal well being testes. The purpose of this study is to access diagnostic value of NST during latent phase of labor by considering maternal and neonatal outcomes. This case study control study was performed on 450 healthy pregnant women with gestational age between 38-42 weeks in AL-Zahra teaching hospital in Tabriz, Iran. All participants underwent NST after being admitted to labor during their latent phase of delivery. Participants were divided into groups including the study group which included 150 participants with non-reactive NST results whereas 300 subjects with reactive NST results assigned in the control group. Subjects in both groups were hospitalized for pregnancy termination because of the delivery time. In order to find out the importance of routine performance of NST during delivery, the relationship between NST results and maternal and fetal outcomes was evaluated. Several criteria including type of delivery, meconium defecation, descent arrest, bradicardia, Apgar score, and still birth were compared between two types. Finding of this study showed that descent arrest occurred in 2.7% of the subjects in the study group, whereas it occurred in 4.7% of the participants in the control group (p=0.44). Bradicardia found in 28% of the participants in study group and 3.3% of the control group (p<0.001). The low Apgar Score was found in 2.7% of case group however; no the low apgar score detected in the control group. Meconium defecation observed in 11.3% of the subjects in the study group and 9.7% of the participants in control group (p=0.62). The amount of stillbirth were found in control group. There was a significant difference between the results of both groups in terms of bradicardia, descent arrest, and the low Apgar score and cesarean section. Results of this study revealed that participants in study group with nonreactive NST results had more fetal complications than those with reactive NST results. NST was found to be a value diagnostic test for diagnosis of fetal distress during delivery in the latent phase. This findings of this study suggest that NST should be performed routinely as a valuable diagnostic test during the latent phase of delivery.

Children, parents and pets exercising together (CPET): exploratory randomised controlled trial.

PubMed

Morrison, Ryan; Reilly, John J; Penpraze, Victoria; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; McNicol, Lindsay; Calvert, Michael; Yam, Philippa S

2013-11-27

Levels of physical activity (PA) in UK children are much lower than recommended and novel approaches to its promotion are needed. The Children, Parents and Pets Exercising Together (CPET) study is the first exploratory randomised controlled trial (RCT) to develop and evaluate an intervention aimed at dog-based PA promotion in families. CPET aimed to assess the feasibility, acceptability and potential efficacy of a theory-driven, family-based, dog walking intervention for 9-11 year olds. Twenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group. Families in the intervention group were motivated and supported to increase the frequency, intensity and duration of dog walking using a number of behaviour change techniques. Parents in the intervention group were asked to complete a short study exit questionnaire. In addition, focus groups with parents and children in the intervention group, and with key stakeholders were undertaken. The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute (cpm). Intervention and control groups were compared using analysis of covariance. Analysis was performed on an intention to treat basis. Twenty five families were retained at follow up (89%) and 97% of all outcome data were collected at baseline and follow up. Thirteen of 14 (93%) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable. There was a mean difference in child total volume of PA of 27 cpm (95% CI -70, 123) and -3 cpm (95% CI -60, 54) for intervention and control group children, respectively. This was not statistically significant. Approximately 21% of dog walking time for parents and 39% of dog walking time for children was moderate-vigorous PA. The acceptability of the CPET intervention and outcome measures was high. Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable, but did not result in a significant increase in child PA in this exploratory trial. ISRCTN85939423.

Children, parents and pets exercising together (CPET): exploratory randomised controlled trial

PubMed Central

2013-01-01

Background Levels of physical activity (PA) in UK children are much lower than recommended and novel approaches to its promotion are needed. The Children, Parents and Pets Exercising Together (CPET) study is the first exploratory randomised controlled trial (RCT) to develop and evaluate an intervention aimed at dog-based PA promotion in families. CPET aimed to assess the feasibility, acceptability and potential efficacy of a theory-driven, family-based, dog walking intervention for 9–11 year olds. Methods Twenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group. Families in the intervention group were motivated and supported to increase the frequency, intensity and duration of dog walking using a number of behaviour change techniques. Parents in the intervention group were asked to complete a short study exit questionnaire. In addition, focus groups with parents and children in the intervention group, and with key stakeholders were undertaken. The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute (cpm). Intervention and control groups were compared using analysis of covariance. Analysis was performed on an intention to treat basis. Results Twenty five families were retained at follow up (89%) and 97% of all outcome data were collected at baseline and follow up. Thirteen of 14 (93%) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable. There was a mean difference in child total volume of PA of 27 cpm (95% CI -70, 123) and -3 cpm (95% CI -60, 54) for intervention and control group children, respectively. This was not statistically significant. Approximately 21% of dog walking time for parents and 39% of dog walking time for children was moderate-vigorous PA. Conclusions The acceptability of the CPET intervention and outcome measures was high. Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable, but did not result in a significant increase in child PA in this exploratory trial. Trial registration ISRCTN85939423 PMID:24279294

Supporting stress management for women undergoing the early stages of fertility treatment: a cluster-randomized controlled trial.

PubMed

Mori, Akiko

2009-06-01

The purpose of this study was to determine the effects of a support program for the stress management of women undergoing fertility treatment to reduce stress related to infertility and treatment. We randomly assigned seven institutions into an experimental group (four institutions, n = 96) and a control group (three institutions, n = 44) using cluster randomization. The women in the experimental group were asked to continue stress management homework for 3 months. A nurse provided feedback on the homework every month. Those in the control group were given only the booklet. The primary outcomes were the risk ratios of "depression" and "anxiety" according to the Hospital Anxiety and Depression Scale. The secondary outcomes were "health status" from the Medical Outcomes Study Short-Form 36-item Health Survey (SF-36) v2 and "satisfaction" from the Visual Analogue Scale. We excluded 15 women who became pregnant and performed an intention-to-treat analysis of 125 women. There were no differences in the incidence of depression and anxiety between the experimental and control groups. There were significant interaction effects between the program and time in the scores of the two subscales of SF-36 and the summary. There was no difference in satisfaction. The use of ovulation-enhancing agents showed that the scores of "role functioning physical" and "physical component summary" in the non-use subgroup were higher at 2 and 3 months in the experimental group, compared to the control group. Positive effects of the support program were observed on two subscales of the SF-36 in the subgroup that did not use ovulation-enhancing agents.

Diet and anthropometry at 2 years of age following an oral health promotion programme for Australian Aboriginal children and their carers: a randomised controlled trial.

PubMed

Smithers, Lisa G; Lynch, John; Hedges, Joanne; Jamieson, Lisa M

2017-12-01

There are marked disparities between indigenous and non-indigenous children's diets and oral health. Both diet and oral health are linked to longer-term health problems. We aimed to investigate whether a culturally appropriate multi-faceted oral health promotion intervention reduced Aboriginal children's intake of sugars from discretionary foods at 2 years of age. We conducted a single-blind, parallel-arm randomised controlled trial involving women who were pregnant or had given birth to an Aboriginal child in the previous 6 weeks. The treatment group received anticipatory guidance, Motivational Interviewing, health and dental care for mothers during pregnancy and children at 6, 12 and 18 months. The control group received usual care. The key dietary outcome was the percent energy intake from sugars in discretionary foods (%EI), collected from up to three 24-h dietary recalls by trained research officers who were blind to intervention group. Secondary outcomes included intake of macronutrients, food groups, anthropometric z scores (weight, height, BMI and mid-upper arm circumference) and blood pressure. We enrolled 224 children to the treatment group and 230 to the control group. Intention-to-treat analyses showed that the %EI of sugars in discretionary foods was 1·6 % lower in the treatment group compared with control (95 % CI -3·4, 0·2). This culturally appropriate intervention at four time-points from pregnancy to 18 months resulted in small changes to 2-year-old Aboriginal children's diets, which was insufficient to warrant broader implementation of the intervention. Further consultation with Aboriginal communities is necessary for understanding how to improve the diet and diet-related health outcomes of young Aboriginal children.

Communicating uncertainties about prescription drugs to the public: a national randomized trial.

PubMed

Schwartz, Lisa M; Woloshin, Steven

2011-09-12

Many new drugs are aggressively promoted. The public may not realize that even with US Food and Drug Administration (FDA) approval, important uncertainties about the benefits and harms of these drugs remain. We assessed the US public's understanding of the meaning of FDA drug approval and tested how brief explanations communicating drug uncertainties affect consumer choices. We conducted an Internet-based randomized controlled trial using a national sample of US adults from a research panel of approximately 30,000 households. A total of 2944 participants were randomized to receive 1 of 3 explanations about a pair of cholesterol drugs (1 approved based only on a surrogate outcome [lower cholesterol] and 1 based on a patient outcome [reduced myocardial infarctions]). Participants were randomized a second time to receive 1 of 3 explanations about a pair of heartburn drugs (1 newly approved and 1 approved 8 years earlier). Controls received no explanation; the nondirective group received explanations (for the cholesterol drugs, surrogates do not always translate into patient outcomes; for the heartburn drugs, it takes time to establish the safety of new drugs); the directive group received explanations plus advice to "Ask for a drug shown to reduce heart attacks or ask for one with a longer track record." The primary outcomes were choice: the cholesterol drug reducing myocardial infarctions, and the older heartburn drug. Thirty-nine percent mistakenly believed that the FDA approves only "extremely effective" drugs; 25% mistakenly believed that the FDA approves only drugs without serious side effects. Explanations affected choices: 71% of those in the directive group, 71% in the nondirective group, and 59% of controls chose the cholesterol drug that reduced myocardial infarctions (absolute difference, 12% [95% confidence interval, 7%-18%] for each explanation vs control). For the heartburn drugs, 53% of the directive group, 53% of the nondirective group, and 34% of controls chose the older drug (absolute difference, 19% [95% confidence interval, 13%-24%] for each explanation vs control). A substantial proportion of the public mistakenly believes that the FDA approves only extremely effective drugs and drugs lacking serious side effects. Brief explanations highlighting uncertainties about the benefit of drugs approved based on surrogate outcomes and the safety of new prescription drugs improved choices. Nondirective explanations worked as well as directive ones. clinicaltrials.gov Identifiers: NCT00950157, NCT00950131.

Behavioural intervention to increase physical activity in adults with coronary heart disease in Jordan.

PubMed

Alsaleh, Eman; Windle, Richard; Blake, Holly

2016-07-26

Patients with coronary heart disease often do not follow prescribed physical activity recommendations. The aim of this study was to assess the efficacy of a behavioural intervention to increase physical activity in patients with coronary heart disease not attending structured cardiac rehabilitation programmes. Parallel randomised controlled trial comparing 6-month multi-component behavioural change intervention (n = 71) with usual care (n = 85) was conducted in two hospitals in Jordan, Middle East. Intervention included one face-to-face individualised consultation, 6 telephone support calls (for goal-setting, feedback and self-monitoring) and 18 reminder text messages. Patients were randomly allocated to the two groups by opening opaque sealed sequence envelopes. The patients and the researcher who provided the intervention and assessed the outcomes were not blinded. Outcomes were assessed at baseline and 6 months. Primary outcome was physical activity level, secondary outcomes were blood pressure, body mass index, exercise self-efficacy for exercise and health-related quality of life. Intervention and control groups were comparable at baseline. Moderate physical activity significantly increased in the intervention group compared with control group (mean change (SD) of frequency: 0.23 (0.87) days/week versus -.06 (0.40); duration: 15.53 (90.15) minutes/week versus -3.67 (22.60) minutes/week; intensity: 31.05 (105.98) Metabolic equivalents (METs) versus 14.68 (90.40) METs). Effect size was 0.03 for moderate PA frequency, 0.02 for moderate PA duration and 0.01 for moderate PA intensity. Walking significantly increased in the intervention group compared with control group (mean change (SD) of frequency: 3.15 (2.75) days/week versus 0.37 (1.83) days/week; duration: 150.90 (124.47) minutes/week versus 24.05 (195.93) minutes/week; intensity: 495.12 (413.74) METs versus14.62 (265.06) METs). Effect size was 0.36 for walking frequency, 0.05 for walking duration, 0.32 for walking intensity and 0.29 for total PA intensity. Intervention participants had significantly lower blood pressure, lower body mass index, greater exercise self-efficacy and better health-related quality of life at 6 months compared with controls. Multi-component behavioural intervention increases physical activity, and improves body composition, physiological and psychological outcomes in CHD patients not attending structured rehabilitation programmes. Current Controlled Trials retrospectively registered in 21-03-2012. ISRCTN48570595 .

Mild traumatic brain injuries in early adolescent rugby players: Long-term neurocognitive and academic outcomes.

PubMed

Alexander, D G; Shuttleworth-Edwards, A B; Kidd, M; Malcolm, C M

2015-01-01

Information is scant concerning enduring brain injury effects of participation in the contact sport of Rugby Union (hereafter rugby) on early adolescents. The objective was prospectively to investigate differences between young adolescent male rugby players and non-contact sports controls on neurocognitive test performance over 3 years and academic achievement over 6 years. A sample of boys from the same school and grade was divided into three groups: rugby with seasonal concussions (n = 45), rugby no seasonal concussions (n = 21) and non-contact sports controls (n = 30). Baseline neurocognitive testing was conducted pre-season in Grade 7 and post-season in Grades 8 and 9. Year-end academic grades were documented for Grades 6-9 and 12 (pre-high school to year of school leaving). A mixed model repeated measures ANOVA was conducted to investigate comparative neurocognitive and academic outcomes between the three sub-groups. Compared with controls, both rugby groups were significantly lower on the WISC-III Coding Immediate Recall sub-test. There was a significant interaction effect on the academic measure, with improved scores over time for controls, that was not in evidence for either rugby group. Tentatively, the outcome suggests cognitive vulnerability in association with school level participation in rugby.

The effect of midwifery continuing care on childbirth outcomes

PubMed Central

Sehhatie, Fahimeh; Najjarzadeh, Maryam; Zamanzadeh, Vahid; Seyyedrasooli, Alehe

2014-01-01

Background: Continuation of delivery care by a midwife, and establishing a relationship between the midwife and the delivering woman, is so important for women, and preserving such relationship increases woman's calmness and self-confidence. The current research aims at studying the effect of midwifery continuing care during delivery on delivery outcomes. Materials and Methods: This study was a quasi-experimental research conducted on childbearing women referring to Tabriz 29 Bahman Hospital. One hundred women were randomly assigned to either experimental (n = 50) or control (n = 50) group. In the experimental group, the women were cared exclusively with a midwife from the active phase continuously, while in the control group, women were cared with several midwifes conventionally. The birth outcomes were recorded in both valid and reliable groups (checklists). Data were analyzed using SPSS version 13.0. Results: Type of delivery was the same in both the groups (P = 0.051). In the experimental group, grade of the perineal lacerations was lower (P = 0.001); also, in this group, less oxytocin was used in the labor stage (P = 0.001). Conclusions: The results showed that providing one-to-one delivery care and continuous attendance of the midwife on the bedside of delivering woman had positive effect on improvement of birth outcomes. So, providing the choice of one-to-one care for women in delivery rooms must be considered where it is logistically possible. PMID:24949059

Efficacy of a new device to optimize positive pressure ventilation via face mask in edentulous patients: a randomized trial.

PubMed

Niño, Maria C; Pauwels, Andres; Raffan, Fernando; Arango, Enrique; Romero, David J; Benitez, Daniel

2017-04-01

Mask ventilation is routinely performed during anesthesia. Under some circumstances, it might be difficult to perform, such as in edentulous patients, due to inadequate mask seal. We developed a new device called NIPARA and studied its use For ventilation optimization in edentulous patients. This randomized controlled trial included edentulous adults who had no other predictors of difficult airway, scheduled to undergo general anesthesia. Patients were assigned either to the NIPARA device group or to the control group (oral airway only). The primary outcomes were peak inspiratory pressure and tidal volume values of the first 14 breaths. The secondary outcome was the incidence of complications. Data from 37 patients were collected during a one-year period (twenty in the NIPARA device group and 17 in the control group). The difference in mean PIP was not statistically significant. The tidal volume was 1.5 times greater in the NIPARA group than in the control group. One patient from the intervention group had minimal oral trauma. In the administration of face mask ventilation, NIPARA is an effective device that significantly improves the tidal volume administered in edentulous patients.

The efficacy of problem solving therapy to reduce post stroke emotional distress in younger (18-65) stroke survivors.

PubMed

Chalmers, Charlotte; Leathem, Janet; Bennett, Simon; McNaughton, Harry; Mahawish, Karim

2017-11-26

To investigate the efficacy of problem solving therapy for reducing the emotional distress experienced by younger stroke survivors. A non-randomized waitlist controlled design was used to compare outcome measures for the treatment group and a waitlist control group at baseline and post-waitlist/post-therapy. After the waitlist group received problem solving therapy an analysis was completed on the pooled outcome measures at baseline, post-treatment, and three-month follow-up. Changes on outcome measures between baseline and post-treatment (n = 13) were not significantly different between the two groups, treatment (n = 13), and the waitlist control group (n = 16) (between-subject design). The pooled data (n = 28) indicated that receiving problem solving therapy significantly reduced participants levels of depression and anxiety and increased quality of life levels from baseline to follow up (within-subject design), however, methodological limitations, such as the lack of a control group reduce the validity of this finding. The between-subject results suggest that there was no significant difference between those that received problem solving therapy and a waitlist control group between baseline and post-waitlist/post-therapy. The within-subject design suggests that problem solving therapy may be beneficial for younger stroke survivors when they are given some time to learn and implement the skills into their day to day life. However, additional research with a control group is required to investigate this further. This study provides limited evidence for the provision of support groups for younger stroke survivors post stroke, however, it remains unclear about what type of support this should be. Implications for Rehabilitation Problem solving therapy is no more effective for reducing post stroke distress than a wait-list control group. Problem solving therapy may be perceived as helpful and enjoyable by younger stroke survivors. Younger stroke survivors may use the skills learnt from problem solving therapy to solve problems in their day to day lives. Younger stroke survivors may benefit from age appropriate psychological support; however, future research is needed to determine what type of support this should be.

Effects of edaravone on early outcomes in acute ischemic stroke patients treated with recombinant tissue plasminogen activator.

PubMed

Wada, Tomoki; Yasunaga, Hideo; Inokuchi, Ryota; Horiguchi, Hiromasa; Fushimi, Kiyohide; Matsubara, Takehiro; Nakajima, Susumu; Yahagi, Naoki

2014-10-15

We investigated whether edaravone could improve early outcomes in acute ischemic stroke patients treated with recombinant tissue plasminogen activator (rtPA). We conducted a retrospective cohort study using the Japanese Diagnosis Procedure Combination database. We identified patients admitted with a primary diagnosis of ischemic stroke from 1 July 2010 to 31 March 2012 and treated with rtPA on the same day of stroke onset or the following day. Thereafter, we selected those who received edaravone on the same day of rtPA administration (edaravone group), and those who received rtPA without edaravone (control group). The primary outcomes were modified Rankin Scale (mRS) scores at discharge. One-to-one propensity-score matching was performed between the edaravone and control groups. An ordinal logistic regression analysis for mRS scores at discharge was performed with adjustment for possible variables as well as clustering of patients within hospitals using a generalized estimating equation. We identified 6336 eligible patients for inclusion in the edaravone group (n=5979; 94%) and the control group (n=357; 6%) as the total population. In 356 pairs of the propensity-matched population, the ordinal logistic regression analysis showed that edaravone was significantly associated with lower mRS scores of patients at discharge (adjusted odds ratio: 0.74; 95% confidence interval: 0.57-0.96). Edaravone may improve early outcomes in acute ischemic stroke patients treated with rtPA. Copyright © 2014 Elsevier B.V. All rights reserved.

Combining social cognitive treatment, cognitive remediation, and functional skills training in schizophrenia: a randomized controlled trial

PubMed Central

Peña, Javier; Ibarretxe-Bilbao, Naroa; Sánchez, Pedro; Iriarte, Maria B; Elizagarate, Edorta; Garay, Maria A; Gutiérrez, Miguel; Iribarren, Aránzazu; Ojeda, Natalia

2016-01-01

This study examined the efficacy of an integrative cognitive remediation program (REHACOP) in improving cognition and functional outcome in patients with schizophrenia. The program combines cognitive remediation, social cognitive intervention, and functional skills training. Few studies have attempted this approach. One hundred and eleven patients diagnosed with schizophrenia were randomly assigned to either the cognitive remediation group (REHACOP) or an active control group (occupational activities) for 4 months (three sessions per week, 90 min). Primary outcomes were change on general neurocognitive performance and social cognition, including theory of mind (ToM), emotion perception (EP), attributional style, and social perception (SP). Secondary outcomes included changes on clinical symptoms (Positive and Negative Syndrome Scale) and functional outcome (UCSD Performance-Based Skills Assessment and the Global Assessment of Functioning). The trial was registered with clinicaltrials.gov (NCT02796417). No baseline group differences were found. Significant differences were found in the mean change between the REHACOP group and control group in neurocognition (ηp2=0.138), SP (ηp2=0.082), ToM (ηp2=0.148), EP (ηp2=0.071), negative symptoms (ηp2=0.082), emotional distress (ηp2=0.136), Global Assessment of Functioning (ηp2=0.081), and UCSD Performance-Based Skills Assessment (ηp2=0.154). The combination of cognitive remediation, social cognitive intervention, and functional skills training demonstrated statistically significant and clinically meaningful changes in neurocognition, social cognition, negative, and functional disability. PMID:27868083

Effect of early amniotomy on the outcome of spontaneous labour: a randomized controlled trial of pregnant women in Enugu, South-east Nigeria.

PubMed

Onah, Livinus N; Dim, Cyril C; Nwagha, Uchenna I; Ozumba, Benjamin C

2015-12-01

Early amniotomy is common in obstetric practice but, its effectiveness has not been proven. To determine the effects of early amniotomy on the duration of labour, and other maternal / neonatal outcomes of uncomplicated pregnancies in Enugu, South-east Nigeria. A randomized controlled study of 214 consenting term pregnant women at the University of Nigeria Teaching Hospital Enugu, Nigeria. Intervention group received amniotomy early in active labour while the control group had their membranes conserved. Mean duration of labour for the amniotomy group (279.4 ± 53.7 minutes) was significantly lower than that of control group (354.4 ± 67.5 minutes), (t = -8.988, p <0.001). Three (3.8%) women in amniotomy group needed oxytocin augmentation as against 21 (19.6%) women in the control group RR = 0.14, (CI 95%: 0.04 - 0.46), NNT = 16. The two groups did not vary with respect to cesarean section rate, newborn Apgar scores, and need for new born special care unit admission. Early amniotomy when compared to fetal membrane conservation reduced the duration of labour and need for oxytocin augmentation among term singleton pregnant women in Enugu, Nigeria. Its routine use in well selected cases may reduce prolonged labour and its complications.

Intratympanic dexamethasone versus high dosage of betahistine in the treatment of intractable unilateral Meniere disease.

PubMed

Albu, Silviu; Chirtes, Felician; Trombitas, Veronica; Nagy, Alina; Marceanu, Luigi; Babighian, Gregorio; Trabalzini, Franco

2015-01-01

The objective of our randomized, double-blind study was to compare the effectiveness of intratympanic (IT) dexamethasone versus high-dosage of betahistine in the treatment of patients with intractable unilateral Meniere disease (MD). Sixty six patients with definite unilateral MD were randomly divided in two groups: Group A received a combination of IT dexamethasone (DX) and identical-appearing placebo pills while Group B received a combination of high-dosage betahistine and IT saline. Intratympanic injections were repeated for three times with an interlude of 3days. High-dosage of betahistine entailed 144mg/day. Mean outcome measures consisted of vertigo control, pure tone average (PTA), speech discrimination score, Functional Level Score, Dizziness Handicap Inventory and Tinnitus Handicap Inventory. Fifty nine patients completed the study and were available at 12months for analysis. In Group A complete vertigo control (class A) was attained in 14 patients (46.6%) and substantial control (class B) in 7 patients (20%). In Group B, 12 patients (41%) achieved complete vertigo control (class A), 5 patients (17%) substantial control (class B). There is no statistical difference in vertigo control between the two treatment groups. In Group A hearing was unchanged in 14 patients and improved in 4 patients, while in Group B hearing was unchanged in 16 patients and improved in 2 patients. Our preliminary results demonstrate that high-dosage of betahistine achieved similar outcomes as IT dexamethasone in the control of vertigo and hearing preservation. Copyright © 2015 Elsevier Inc. All rights reserved.

The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial.

PubMed

Sönnichsen, Andreas C; Winkler, Henrike; Flamm, Maria; Panisch, Sigrid; Kowatsch, Peter; Klima, Gert; Fürthauer, Bernhard; Weitgasser, Raimund

2010-11-05

Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. 92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye- (71.0% vs. 51.2%, p < 0.0001), foot examinations (73.8% vs. 45.1%, p < 0.0001), and regular HbA1c checks (44.1% vs. 36.0%, p < 0.01) in the intervention group. The Austrian DMP implemented by statutory health insurance improves process quality and enhances weight reduction, but does not significantly improve metabolic control for patients with type 2 diabetes mellitus. Whether the small benefit seen in secondary outcome measures leads to better patient outcomes, remains unclear. Current Controlled trials Ltd., ISRCTN27414162.

Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial.

PubMed

Mackillop, Lucy; Hirst, Jane Elizabeth; Bartlett, Katy Jane; Birks, Jacqueline Susan; Clifton, Lei; Farmer, Andrew J; Gibson, Oliver; Kenworthy, Yvonne; Levy, Jonathan Cummings; Loerup, Lise; Rivero-Arias, Oliver; Ming, Wai-Kit; Velardo, Carmelo; Tarassenko, Lionel

2018-03-20

Treatment of hyperglycemia in women with gestational diabetes mellitus (GDM) is associated with improved maternal and neonatal outcomes and requires intensive clinical input. This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits. We conducted a randomized controlled trial to determine whether the use of a mobile phone-based real-time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance. Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone-based blood glucose management solution (GDm-health, the intervention) or routine clinic care. The primary outcome was change in mean blood glucose in each group from recruitment to delivery, calculated with adjustments made for number of blood glucose measurements, proportion of preprandial and postprandial readings, baseline characteristics, and length of time in the study. A total of 203 women were randomized. Blood glucose data were available for 98 intervention and 85 control women. There was no significant difference in rate of change of blood glucose (-0.16 mmol/L in the intervention and -0.14 mmol/L in the control group per 28 days, P=.78). Women using the intervention had higher satisfaction with care (P=.049). Preterm birth was less common in the intervention group (5/101, 5.0% vs 13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01). There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group (27/101, 26.7% vs 47/102, 46.1%, P=.005). Other glycemic, maternal, and neonatal outcomes were similar in both groups. The median time from recruitment to delivery was similar (intervention: 54 days; control: 49 days; P=.23). However, there were significantly more blood glucose readings in the intervention group (mean 3.80 [SD 1.80] and mean 2.63 [SD 1.71] readings per day in the intervention and control groups, respectively; P<.001). There was no significant difference in direct health care costs between the two groups, with a mean cost difference of the intervention group compared to control of -£1044 (95% CI -£2186 to £99). There were no unexpected adverse outcomes. Remote blood glucocse monitoring in women with GDM is safe. We demonstrated superior data capture using GDm-health. Although glycemic control and maternal and neonatal outcomes were similar, women preferred this model of care. Further studies are required to explore whether digital health solutions can promote desired self-management lifestyle behaviors and dietetic adherence, and influence maternal and neonatal outcomes. Digital blood glucose monitoring may provide a scalable, practical method to address the growing burden of GDM around the world. ClinicalTrials.gov NCT01916694; https://clinicaltrials.gov/ct2/show/NCT01916694 (Archived by WebCite at http://www.webcitation.org/6y3lh2BOQ). ©Lucy Mackillop, Jane Elizabeth Hirst, Katy Jane Bartlett, Jacqueline Susan Birks, Lei Clifton, Andrew J Farmer, Oliver Gibson, Yvonne Kenworthy, Jonathan Cummings Levy, Lise Loerup, Oliver Rivero-Arias, Wai-Kit Ming, Carmelo Velardo, Lionel Tarassenko. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.03.2018.

Implementation and evaluation of a pharmacist-led hypertension management service in primary care: outcomes and methodological challenges.

PubMed

Bajorek, Beata; Lemay, Kate S; Magin, Parker; Roberts, Christopher; Krass, Ines; Armour, Carol L

2016-01-01

Suboptimal utilisation of pharmacotherapy, non-adherence to prescribed treatment, and a lack of monitoring all contribute to poor blood (BP) pressure control in patients with hypertension. The objective of this study was to evaluate the implementation of a pharmacist-led hypertension management service in terms of processes, outcomes, and methodological challenges. A prospective, controlled study was undertaken within the Australian primary care setting. Community pharmacists were recruited to one of three study groups: Group A (Control - usual care), Group B (Intervention), or Group C (Short Intervention). Pharmacists in Groups B and C delivered a service comprising screening and monitoring of BP, as well as addressing poor BP control through therapeutic adjustment and adherence strategies. Pharmacists in Group C delivered the shortened version of the service. Significant changes to key outcome measures were observed in Group C: reduction in systolic and diastolic BPs at the 3-month visit (P<0.01 and P<0.01, respectively), improvement in medication adherence scores (P=0.01), and a slight improvement in quality of life (EQ-5D-3L Index) scores (P=0.91). There were no significant changes in Group B (the full intervention), and no differences in comparison to Group A (usual care). Pharmacists fed-back that patient recruitment was a key barrier to service implementation, highlighting the methodological implications of screening. A collaborative, pharmacist-led hypertension management service can help monitor BP, improve medication adherence, and optimise therapy in a step-wise approach. However, blood pressure screening can effect behaviour change in patients, presenting methodological challenges in the evaluation of services in this context.

Implementation and evaluation of a pharmacist-led hypertension management service in primary care: outcomes and methodological challenges

PubMed Central

2016-01-01

Background: Suboptimal utilisation of pharmacotherapy, non-adherence to prescribed treatment, and a lack of monitoring all contribute to poor blood (BP) pressure control in patients with hypertension. Objective: The objective of this study was to evaluate the implementation of a pharmacist-led hypertension management service in terms of processes, outcomes, and methodological challenges. Method: A prospective, controlled study was undertaken within the Australian primary care setting. Community pharmacists were recruited to one of three study groups: Group A (Control – usual care), Group B (Intervention), or Group C (Short Intervention). Pharmacists in Groups B and C delivered a service comprising screening and monitoring of BP, as well as addressing poor BP control through therapeutic adjustment and adherence strategies. Pharmacists in Group C delivered the shortened version of the service. Results: Significant changes to key outcome measures were observed in Group C: reduction in systolic and diastolic BPs at the 3-month visit (P<0.01 and P<0.01, respectively), improvement in medication adherence scores (P=0.01), and a slight improvement in quality of life (EQ-5D-3L Index) scores (P=0.91). There were no significant changes in Group B (the full intervention), and no differences in comparison to Group A (usual care). Pharmacists fed-back that patient recruitment was a key barrier to service implementation, highlighting the methodological implications of screening. Conclusion: A collaborative, pharmacist-led hypertension management service can help monitor BP, improve medication adherence, and optimise therapy in a step-wise approach. However, blood pressure screening can effect behaviour change in patients, presenting methodological challenges in the evaluation of services in this context. PMID:27382427

Moxibustion for the treatment of pressure ulcers: study protocol for a pilot, multicentre, randomised controlled trial.

PubMed

Zhang, Qin-hong; Yue, Jin-huan; Li, Chao-ran; Sun, Zhong-ren

2014-12-30

Pressure ulcers are common in the elderly and immobile. Currently, there are few proven effective treatments for pressure ulcers. This trial aims to evaluate the feasibility, efficacy and safety of moxibustion for pressure ulcers. This is a multicentre, two-armed, parallel-design randomised controlled trial (RCT). 30 eligible patients with pressure ulcers will be randomised in a ratio of 1:1 to the treatment group and control group. The participants in the treatment group will undergo indirect moxibustion for 30 min before application of a dressing, one session daily, five sessions weekly for 4 weeks. The patients in the control group will only receive a dressing, applied in the same way as in the treatment group. Both groups will be followed up for 3 months. The primary outcome measures will be wound surface area (WSA) and proportion of ulcers healed within trial period (PUHTP). The secondary outcomes will be the Pressure Ulcer Scale for Healing (PUSH Tool), visual analogue scale (VAS) and adverse events. All outcomes will be evaluated at the beginning of the study, at the end of the second week, at 4 weeks after randomisation and at 1 and 3 months after treatment cessation. This trial has undergone ethical scrutiny and been approved by the ethics review boards of First Affiliated Hospital of Heilongjiang University of Chinese Medicine and Second Affiliated Hospital of Heilongjiang University of Chinese Medicine (Permission number: HZYEYLP2014). The results of this study will provide clinical evidence for the feasibility, efficacy and safety of moxibustion for pressure ulcers. ChiCTR-TRC-13003959. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial.

PubMed

Fritel, Xavier; de Tayrac, Renaud; Bader, Georges; Savary, Denis; Gueye, Ameth; Deffieux, Xavier; Fernandez, Hervé; Richet, Claude; Guilhot, Joëlle; Fauconnier, Arnaud

2015-08-01

To compare, in an unselected population of nulliparous pregnant women, the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence (UI). In a randomized controlled trial in two parallel groups, 282 women were recruited from five university teaching hospitals in France and randomized during the second trimester of pregnancy. The physiotherapy group received prenatal individually supervised exercises. Both groups received written instructions about how to perform exercises at home. Women were blindly assessed at baseline, end of pregnancy, and 2 and 12 months postpartum. The primary outcome measured was UI severity, assessed with an International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score (range 0-21; 1-5 is slight UI) at 12 months postpartum; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered questionnaires. To give a 1-point difference in UI severity score, we needed 91 women in each group (standard deviation 2.4, α=0.05, β=0.20, and bilateral analysis). Between February 2008 and June 2010, 140 women were randomized in the physiotherapy group and 142 in the control group. No difference was observed between the two groups in UI severity, prevalence, or pelvic floor troubles at baseline, end of pregnancy, and at 2 and 12 months postpartum. At 12 months postpartum, the primary outcome was available for 190 women (67.4%); mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group (P=.38). Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI. ClinicalTrials.gov; www.clinicaltrials.gov, NCT00551551. I.

The Effects of Highly Challenging Balance Training in Elderly With Parkinson's Disease: A Randomized Controlled Trial.

PubMed

Conradsson, David; Löfgren, Niklas; Nero, Håkan; Hagströmer, Maria; Ståhle, Agneta; Lökk, Johan; Franzén, Erika

2015-10-01

Highly challenging exercises have been suggested to induce neuroplasticity in individuals with Parkinson's disease (PD); however, its effect on clinical outcomes remains largely unknown. To evaluate the short-term effects of the HiBalance program, a highly challenging balance-training regimen that incorporates both dual-tasking and PD-specific balance components, compared with usual care in elderly with mild to moderate PD. Participants with PD (n = 100) were randomized, either to the 10-week HiBalance program (n = 51) or to the control group (n = 49). Participants were evaluated before and after the intervention. The main outcomes were balance performance (Mini-BESTest), gait velocity (during normal and dual-task gait), and concerns about falling (Falls Efficacy Scale-International). Performance of a cognitive task while walking, physical activity level (average steps per day), and activities of daily living were secondary outcomes. A total of 91 participants completed the study. After the intervention, the between group comparison showed significantly improved balance and gait performance in the training group. Moreover, although no significant between group difference was observed regarding gait performance during dual-tasking; the participants in the training group improved their performance of the cognitive task while walking, as compared with the control group. Regarding physical activity levels and activities of daily living, in comparison to the control group, favorable results were found for the training group. No group differences were found for concerns about falling. The HiBalance program significantly benefited balance and gait abilities when compared with usual care and showed promising transfer effects to everyday living. Long-term follow-up assessments will further explore these effects. © The Author(s) 2015.

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.

PubMed

Baker, Graham; Gray, Stuart R; Wright, Annemarie; Fitzsimons, Claire; Nimmo, Myra; Lowry, Ruth; Mutrie, Nanette

2008-09-05

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. 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. 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. Significant increases were found in the intervention group for step-counts (p < .001), time spent in leisure walking (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 total sitting (p = .022). A pedometer-based walking program, incorporating a physical activity consultation, is effective in promoting walking and improving positive affect over 12 weeks in community based individuals. The discussion examines possible explanations for the lack of significant changes in health outcomes. Continued follow-up of this study will examine adherence to the intervention and possible resulting effects on health outcomes.

Effectiveness of peer-led dissonance-based eating disorder prevention groups: results from two randomized pilot trials.

PubMed

Stice, Eric; Rohde, Paul; Durant, Shelley; Shaw, Heather; Wade, Emily

2013-05-01

The present preliminary trials tested whether undergraduate peer leaders can effectively deliver a dissonance-based eating disorder prevention program, which could facilitate broad dissemination of this efficacious intervention. In Study 1, female undergraduates (N=171) were randomized to peer-led groups, clinician-led groups, or an educational brochure control condition. In Study 2, which improved a design limitation of Study 1 by using completely parallel outcome measures across conditions, female undergraduates (N=148) were randomized to either immediate peer-led groups or a waitlist control condition. In Study 1, participants in peer- and clinician-led groups showed significantly greater pre-post reductions in risk factors and eating disorder symptoms than controls (M d=.64 and .98 respectively), though clinician- versus peer-led groups had higher attendance and competence ratings, and produced stronger effects at posttest (M d=.32) and at 1-year follow-up (M d=.26). In Study 2, participants in peer-led groups showed greater pre-post reductions in all outcomes than waitlist controls (M d=.75). Results provide novel evidence that dissonance-based eating disorder prevention groups led by undergraduate peers are feasible and produce greater reductions in eating disorder risk factors and symptoms than minimal-intervention control conditions, but indicate that effects are smaller for peer- versus clinician-led groups. Copyright © 2013 Elsevier Ltd. All rights reserved.

Experience of diffusion tensor imaging and 1H spectroscopy for outcome prediction in severe traumatic brain injury: Preliminary results.

PubMed

Tollard, Eléonore; Galanaud, Damien; Perlbarg, Vincent; Sanchez-Pena, Paola; Le Fur, Yann; Abdennour, Lamine; Cozzone, Patrick; Lehericy, Stéphane; Chiras, Jacques; Puybasset, Louis

2009-04-01

The objective of the study is to test whether multimodal magnetic resonance imaging can provide a reliable outcome prediction of the clinical status, focusing on consciousness at 1 year after severe traumatic brain injury (TBI). Single center prospective cohort with consecutive inclusions. Critical Care Neurosurgical Unit of a university hospital. Forty-three TBI patients not responding to simple orders after sedation cessation and 15 healthy controls. A multimodal magnetic resonance imaging combining morphologic sequences, diffusion tensor imaging (DTI), and H proton magnetic resonance spectroscopy (MRS) was performed 24 +/- 11 days after severe TBI. The ability of DTI and MRS to predict 1-year outcome was assessed by linear discriminant analysis (LDA). Robustness of the classification was tested using a bootstrap procedure. Fractional anisotropy (FA) was computed as the mean of values at discrete brain sites in the infratentorial and supratentorial regions. The N-acetyl aspartate/creatine (NAA/Cr) ratio was measured in the thalamus, lenticular nucleus, insular cortex, occipital periventricular white matter, and pons. After 1 year, 19 (44%) patients had unfavorable outcomes (death, persistent vegetative state, or minimally conscious state) and 24 (56%) favorable outcomes (normal consciousness with or without functional impairments). Analysis of variance was performed to compare FA and NAA/Cr in the two outcome groups and controls. FA and MRS findings showed highly significant differences between the outcome groups, with significant variables by LDA being supratentorial FA, NAA/Cr (pons), NAA/Cr (thalamus), NAA/Cr (insula), and infratentorial FA. LDA of combined FA and MRS data clearly separated the unfavorable outcome, favorable outcome, and control groups, with no overlap. Unfavorable outcome was predicted with up to 86% sensitivity and 97% specificity; these values were better than those obtained with DTI or MRS alone. FA and NAA/Cr hold potential as quantitative outcome-prediction tools at the subacute phase of TBI.

Effects of a lifestyle education program on glycemic control among patients with diabetes at Kigali University Hospital, Rwanda: A randomized controlled trial.

PubMed

Amendezo, Etienne; Walker Timothy, David; Karamuka, Vincent; Robinson, Brian; Kavabushi, Patrick; Ntirenganya, Cyprien; Uwiragiye, Joseph; Mukantagwabira, Donatille; Bisimwa, Jeanne; Uwintwali Marie, Henriette; Umulisa, Henriette; Niyomwungeri, Scholastique; Ndayambaje, Bernard; Dusabejambo, Vincent; Bavuma, Charlotte

2017-04-01

Evidence to show whether lifestyle intervention programs are beneficial for patients with diabetes in resource-limited countries is lacking. The present study assessed the additional efficacy of a structured lifestyle education program, as compared to the current standard of diabetic care in Rwanda. 251 consecutive adult patients attending a tertiary diabetic care practice were randomly assigned to either an intervention group (standard of care plus monthly lifestyle group education sessions of 45min duration) or to a control group. The primary outcome was between-groups difference in glycated hemoglobin (HbA1c) observed after 12-months follow up. Outcome measures in the intervention and control groups were compared using the ANCOVA test with a two-sided significance of 5%. Of the 251 subjects recruited, 223 were included in the analysis; of whom 115 were assigned to the intervention group, and 108 to the control group. After 12-months, the median HbA1c levels reduced by 1.70 (95% CI: -2.09 to -1.31; p<0.001) in the intervention group; and by 0.52 (95% CI: -0.95 to -0.10; p=0.01) in the control group. The difference in HbA1c reduction between the intervention and control groups was statistically significant (p<0.001) after adjustment for subjects' age, sex, education level, BMI, diabetes duration and diabetic medications. This study demonstrated that a structured lifestyle group education program for people with diabetes is an attractive option in a resource-limited setting, as it showed significant benefits in improved glycemic control over a 12-month period. ClinicalTrials.gov: NCT02032108. Copyright © 2017 Elsevier B.V. All rights reserved.

Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste

PubMed Central

Martins, Nelson; Morris, Peter

2009-01-01

Objective To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis. Design Parallel group randomised controlled trial. Setting Three primary care clinics in Dili, Timor-Leste. Participants 270 adults aged ≥18 with previously untreated newly diagnosed pulmonary tuberculosis. Main outcome measures Completion of treatment (including cure). Secondary outcomes included adherence to treatment, weight gain, and clearance of sputum smears. Outcomes were assessed remotely, blinded to allocation status. Interventions Participants started standard tuberculosis treatment and were randomly assigned to intervention (nutritious, culturally appropriate daily meal (weeks 1-8) and food package (weeks 9-32) (n=137) or control (nutritional advice, n=133) groups. Randomisation sequence was computer generated with allocation concealment by sequentially numbered, opaque, sealed envelopes. Results Most patients with tuberculosis were poor, malnourished men living close to the clinics; 265/270 (98%) contributed to the analysis. The intervention had no significant beneficial or harmful impact on the outcome of treatment (76% v 78% completion, P=0.7) or adherence (93% for both groups, P=0.7) but did lead to improved weight gain at the end of treatment (10.1% v 7.5% improvement, P=0.04). Itch was more common in the intervention group (21% v 9%, P<0.01). In a subgroup analysis of patients with positive results on sputum smears, there were clinically important improvements in one month sputum clearance (85% v 67%, P=0.13) and completion of treatment (78% v 68%, P=0.3). Conclusion Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste. Further studies in different settings and measuring different outcomes are required. Trial registration Clinical Trials NCT0019256. PMID:19858174

Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial

PubMed Central

Pak, Linda Ma; Haroutounian, Simon; Hawkins, William G; Worley, Lori; Kurtz, Monika; Frey, Karen; Karanikolas, Menelaos; Swarm, Robert A; Bottros, Michael M

2018-01-01

Introduction Epidural analgesia provides an important synergistic method of pain control. In addition to reducing perioperative opioid consumption, the deliverance of analgesia into the epidural space, effectively creating a sympathetic blockade, has a multitude of additional potential benefits, from decreasing the incidence of postoperative delirium to reducing the development of persistent postsurgical pain (PPSP). Prior studies have also identified a correlation between the use of epidural analgesia and improved oncological outcomes and survival. The aim of this study is to evaluate the effect of epidural analgesia in pancreatic operations on immediate postoperative outcomes, the development of PPSP and oncological outcomes in a prospective, single-blind, randomised controlled trial. Methods The Epidurals in Pancreatic Resection Outcomes (E-PRO) study is a prospective, single-centre, randomised controlled trial. 150 patients undergoing either pancreaticoduodenectomy or distal pancreatectomy will be randomised to receive an epidural bupivacaine infusion following anaesthetic induction followed by continued epidural bupivacaine infusion postoperatively in addition to the institutional standardised pain regimen of hydromorphone patient-controlled analgesia (PCA), acetaminophen and ketorolac (intervention group) or no epidural infusion and only the standardised postoperative pain regimen (control group). The primary outcome was the postoperative opioid consumption, measured in morphine or morphine-equivalents. Secondary outcomes include patient-reported postoperative pain numerical rating scores, trend and relative ratios of serum inflammatory markers (interleukin (IL)-1β, IL-6, tumour necrosis factor-α, IL-10), occurrence of postoperative delirium, development of PPSP as determined by quantitative sensory testing, and disease-free and overall survival. Ethics and dissemination The E-PRO trial has been approved by the institutional review board. Recruitment began in May 2016 and will continue until the end of May 2018. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration number NCT02681796. PMID:29374667

Intraperitoneal ketorolac for post-cholecystectomy pain: a double-blind randomized-controlled trial.

PubMed

Murdoch, John; Ramsey, Gillian; Day, Andrew G; McMullen, Michael; Orr, Elizabeth; Phelan, Rachel; Jalink, Diederick

2016-06-01

Ketorolac is a parenterally active nonsteroidal anti-inflammatory drug with localized anti-inflammatory properties. We examine the postoperative analgesic efficacy of locally administered intraperitoneal (IP) ketorolac compared with intravenous (IV) ketorolac during laparoscopic cholecystectomy. With institutional ethics approval, 120 patients undergoing elective laparoscopic cholecystectomy were randomized to receive intraoperative 1) IP ketorolac 30 mg + intravenous saline (IP group), 2) intraperitoneal saline + IV ketorolac 30 mg (IV group), or 3) intraperitoneal saline + intravenous saline (Control group) under standardized anesthesia. The primary and secondary outcomes were postoperative fentanyl requirements in the postanesthesia care unit and the time to first analgesic request, respectively. Other outcomes examined included abdominal pain (at rest and with coughing), shoulder pain, nausea, vomiting, and any other postoperative complications. On average, patients receiving IP ketorolac required less (mean difference, 29 μg; 95% confidence interval [CI], 2 to 56; P = 0.04) fentanyl than patients in the Control group but a similar (mean difference, 16 μg; 95% CI, 12 to 43; P = 0.27) amount compared to patients in the IV group. There was an increase in the median (interquartile range [IQR]) time to first request in the IP group (43[30-52] min) compared with the Control group (35 [27-49]min; P = 0.04) but no difference between the IP group compared with the IV group (47 [40-75] min; P = 0.22). Shoulder pain and resting pain were reduced with IP and IV ketorolac compared with Control, but there was no difference between the IP and IV groups. No differences were observed in any other outcomes, side effects, or complications attributable to opioids or ketorolac at any time points. This study did not demonstrate any advantage for the off-label topical intraperitoneal administration of ketorolac in this surgical population. Intraperitoneal and IV ketorolac showed comparable analgesic efficacy following laparoscopic cholecystectomy.

Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.

PubMed

Von Korff, Michael; Vitiello, Michael V; McCurry, Susan M; Balderson, Benjamin H; Moore, Amy L; Baker, Laura D; Yarbro, Patricia; Saunders, Kathleen; Keefe, Francis J; Rybarczyk, Bruce D

2012-07-01

Six weekly sessions of group cognitive-behavioral therapy for insomnia and osteoarthritis pain (CBT-PI), and for osteoarthritis pain alone (CBT-P) were compared to an education only control (EOC). Basic education about pain and sleep was comparable, so EOC controlled for information and group participation. Active interventions differed from EOC in training pain coping skills (CBT-P and CBT-PI) and sleep enhancement techniques (CBT-PI). Persons with osteoarthritis age 60 or older were screened for osteoarthritis pain and insomnia severity via mailed survey. Primary outcomes were pain severity (pain intensity and interference ratings from the Graded Chronic Pain Scale) and insomnia severity (Insomnia Severity Index). Secondary outcomes were arthritis pain (AIMS-2 symptom scale) and sleep efficiency assessed by wrist actigraphy. Ancillary outcomes included: cognitive function, depression, and health care use. A clustered randomized design provided adequate power to identify moderate effects on primary outcomes (effect size>0.35). Modified intent to treat analyses, including all participants who attended the first session, assessed effects across CBT-PI, CBT-P, and EOC groups. Treatment effects were assessed post-intervention (2 months) and at 9 months, with durability of intervention effects evaluated at 18 months. The trial was executed in 6 primary clinics, randomizing 367 participants, with 93.2% of randomized patients attending at least 4 group sessions. Response rates for post-intervention and 9 month assessments were 96.7% and 92.9% respectively. This hybrid efficacy-effectiveness trial design evaluates whether interventions yield specific benefits for clinical and behavioral outcomes relative to an education only control when implemented in a primary care setting. Copyright © 2012 Elsevier Inc. All rights reserved.

Medical and Obstetric Complications Among Pregnant Women With Liver Cirrhosis.

PubMed

Palatnik, Anna; Rinella, Mary E

2017-06-01

To evaluate clinical characteristics and obstetric outcomes in pregnant women with liver cirrhosis. This was a retrospective matched cohort study of women with liver cirrhosis between January 2005 and January 2016 in a university hospital. Women in a case group were matched to women in a control group according to year of delivery, age, body mass index, and parity in a 1:4 ratio. Bivariable and multivariable analyses were performed to compare the prevalence of the primary composite outcome, which included any one of the following: fetal or neonatal demise, placental abruption, preeclampsia, preterm delivery at less than 37 weeks of gestation, and small-for-gestational age neonate between women in the case group and those in the control group. During the study period, the number of deliveries was approximately 110,000. Of these, 33 women with liver cirrhosis were identified, yielding an estimated frequency of cirrhosis of 1 per 3,333 pregnancies [95% confidence interval (CI) 3,313-3,353]. Thirty-one of these 33 women met all inclusion criteria. The most common etiology of cirrhosis was alcoholic liver disease. The rate of the primary outcome was 61% in women with cirrhosis and 12% in women in the control group. There were no cases of maternal death, and the livebirth rate was 97%. Women with cirrhosis were more likely to be non-Hispanic black, have chronic hypertension, and use alcohol. Multivariable logistic regression demonstrated that cirrhosis in pregnancy was associated with the composite outcome (adjusted odds ratio 9.4, 95% CI 3.4-26.2). Despite lower rates of maternal and fetal mortality compared with earlier studies, pregnancy in women with liver cirrhosis is still associated with a high risk of adverse obstetric outcomes.

Hypothermia for Traumatic Brain Injury in Children-A Phase II Randomized Controlled Trial.

PubMed

Beca, John; McSharry, Brent; Erickson, Simon; Yung, Michael; Schibler, Andreas; Slater, Anthony; Wilkins, Barry; Singhal, Ash; Williams, Gary; Sherring, Claire; Butt, Warwick

2015-07-01

To perform a pilot study to assess the feasibility of performing a phase III trial of therapeutic hypothermia started early and continued for at least 72 hours in children with severe traumatic brain injury. Multicenter prospective randomized controlled phase II trial. All eight of the PICUs in Australia and New Zealand and one in Canada. Children 1-15 years old with severe traumatic brain injury and who could be randomized within 6 hours of injury. The control group had strict normothermia to a temperature of 36-37°C for 72 hours. The intervention group had therapeutic hypothermia to a temperature of 32-33°C for 72 hours followed by slow rewarming at a rate compatible with maintaining intracranial pressure and cerebral perfusion pressure. Of 764 children admitted to PICU with traumatic brain injury, 92 (12%) were eligible and 55 (7.2%) were recruited. There were five major protocol violations (9%): three related to recruitment and consent processes and two to incorrect temperature management. Rewarming took a median of 21.5 hours (16-35 hr) and was performed without compromise in the cerebral perfusion pressure. There was no increase in any complications, including infections, bleeding, and arrhythmias. There was no difference in outcomes 12 months after injury; in the therapeutic hypothermia group, four (17%) had a bad outcome (pediatric cerebral performance category, 4-6) and three (13%) died, whereas in the normothermia group, three (12%) had a bad outcome and one (4%) died. Early therapeutic hypothermia in children with severe traumatic brain injury does not improve outcome and should not be used outside a clinical trial. Recruitment rates were lower and outcomes were better than expected. Conventional randomized controlled trials in children with severe traumatic brain injury are unlikely to be feasible. A large international trials group and alternative approaches to trial design will be required to further inform practice.

Necrotizing enterocolitis as a prognostic factor for the neurodevelopmental outcome of preterm infants - match control study after 2years.

PubMed

Allendorf, Antje; Dewitz, Ruth; Weber, Joy; Bakthiar, Shahrzad; Schloesser, Rolf; Rolle, Udo

2018-01-31

Necrotizing enterocolitis (NEC) in very low birth weight infants is a risk factor for developmental delay. To our knowledge, there are no studies published investigating the neurodevelopmental outcome of patients with NEC comparing surgically treated and conservatively treated patients versus match paired controls. The aim of this retrospective case control study was to measure the neurodevelopmental outcome of patients with NEC who were treated surgically or conservatively METHODS: All patients were identified, who have been diagnosed with NEC (ICD-10 code, P77) born between 2006 and 2013. Patients with NEC received antibiotic therapy, nasogastric decompression and fasting. Surgical treatment was indicated for patients with Bell stages IIIb. We excluded patients suffering from other relevant diseases with a possible impact on their neurodevelopmental outcome (e.g., intraventricular hemorrhage, associated malformations, asphyxia, focal intestinal perforation, short bowel syndrome). Patients were tested at the corrected gestational age of 24months according to the Bayley Scales of Infant Development II. Each participant was compared to a child of the same sex, gestational age at birth (+/-two days), birth weight (+/-10%), and age at neurodevelopmental testing (IRB approval, No. 14/2014). The outcome measures were the psychomotor index (PDI) and the mental developmental index (MDI). We included 13 conservatively and 24 surgically treated patients. The patients in group A (without surgery) achieved a mean PDI of 106, and those in group B (with surgery) a mean PDI of 90. These values were significantly higher in the conservative group A. The mean MDIs were 99 in the patient group A and 85 in patient group B. This difference was also significant. We found significantly lower MDIs and PDIs in children with surgical treatment of NEC. Further systematic prospective research on the prevention of NEC and systematic follow-ups at later stages in the patients' development are necessary in order to implement early intervention. case control study. III. Copyright © 2018. Published by Elsevier Inc.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia--a multi-centre randomised controlled trial.

PubMed

Priebe, Stefan; Savill, Mark; Reininghaus, Ulrich; Wykes, Til; Bentall, Richard; Lauber, Christoph; McCrone, Paul; Röhricht, Frank; Eldridge, Sandra

2013-01-14

Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Current Controlled Trials ISRCTN84216587.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia – a multi-centre randomised controlled trial

PubMed Central

2013-01-01

Background Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. Methods/Design In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. Discussion The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Trial registration Current Controlled Trials ISRCTN84216587 PMID:23317474

Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial.

PubMed

Barfod, Kristoffer Weisskirchner; Hansen, Maria Swennergren; Holmich, Per; Troelsen, Anders; Kristensen, Morten Tange

2016-11-29

Early controlled ankle motion is widely used in the non-operative treatment of acute Achilles tendon rupture, though its safety and efficacy have never been investigated in a randomized setup. The objectives of this study are to investigate if early controlled motion of the ankle affects functional and patient-reported outcomes. The study is performed as a blinded, randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged from 18 to 70 years are eligible for inclusion. The intervention group performs early controlled motion of the ankle in weeks 3-8 after rupture. The control group is immobilized. In total, 130 patients will be included from one big orthopedic center over a period of 2½ years. The primary outcome is the patient-reported Achilles tendon Total Rupture Score evaluated at 12 months post-injury. Secondary outcome measures are the heel-rise work test, Achilles tendon elongation, and the rate of re-rupture. The primary analysis will be conducted as intention-to-treat analyses. This trial is the first to investigate the safety and efficacy of early controlled motion in the treatment of acute Achilles tendon rupture in a randomized setup. The study uses the patient-reported outcome measure, the Achilles tendon Total Rupture Score, as the primary endpoint, as it is believed to be the best surrogate measure for the tendon's actual capability to function in everyday life. ClinicalTrials.gov: NCT02015364 . Registered on 13 December 2013.

Using Technology to Expand and Enhance Applied Behavior Analysis Programs for Children with Autism in Military Families

DTIC Science & Technology

2016-07-01

the parents assigned to the control group during the pretest and posttest are depicted on the left (white bar), and the mean performance of the...technology-enhanced test group and parents in the waitlist-control group . Efficacy Outcomes a. We now have pretest and posttest data for the...other two parents in the control group , there was a minor, unsatisfactory improvement from the pretest (9% and 18%, respectively) to posttest (43

A Human-Centered Command and Control (C2) Assessment of an Experimental Campaign Planning Tool

DTIC Science & Technology

2014-04-01

and control (team without the CPT) groups . The two groups were designed to have an equal number of members; however, one member of the experimental...the researchers to analyze the planning process and outcomes. 3.3 Design and Procedure An experimental versus control group design was implemented...the post -PFnet (figure 16b). Within the PFnets, a concept can be focused on in order to identify how the individual or group is defining or

Improving magnetic resonance imaging (MRI) examinations: Development and evaluation of an intervention to reduce movement in scanners and facilitate scan completion.

PubMed

Powell, Rachael; Ahmad, Mahadir; Gilbert, Fiona J; Brian, David; Johnston, Marie

2015-09-01

The movement of patients in magnetic resonance imaging (MRI) scanners results in motion artefacts which impair image quality. Non-completion of scans leads to delay in diagnosis and increased costs. This study aimed to develop and evaluate an intervention to enable patients to stay still in MRI scanners (reducing motion artefacts) and to enhance scan completion. Successful scan outcome was deemed to be completing the scan with no motion artefacts. Previous research indicated self-efficacy to predict successful scan outcome, and interviews with patients identified a need for procedural and sensory information to facilitate successful scan behaviour. A DVD intervention was developed which targeted self-efficacy and included procedural and sensory information. It was successfully piloted with 10 patients and then evaluated in a randomized controlled trial compared with the standard hospital information leaflet (intervention group N = 41; control group N = 42). The clinic radiographer, who was blind to group allocation, rated MRI scans for motion artefact and recorded whether the participant completed the scan; participants completed MRI self-efficacy and anxiety measures. Only one participant reported not finding the DVD useful. Thirty-five participants in the intervention group and 23 in the control group completed scans and had no motion artefacts, χ(2) (1, 83) = 7.84, p < .001 (relative risk of an unsatisfactory outcome in the control group/intervention group = 3.09). The intervention effect was mediated by self-efficacy. The DVD intervention was efficacious and warrants further research to examine generalizability. © 2015 The British Psychological Society.

Effects of online group exercises for older adults on physical, psychological and social wellbeing: a randomized pilot trial

PubMed Central

Khaghani Far, Iman; Ibarra, Francisco; Ferron, Michela; Didino, Daniele; Casati, Fabio

2017-01-01

Background Intervention programs to promote physical activity in older adults, either in group or home settings, have shown equivalent health outcomes but different results when considering adherence. Group-based interventions seem to achieve higher participation in the long-term. However, there are many factors that can make of group exercises a challenging setting for older adults. A major one, due to the heterogeneity of this particular population, is the difference in the level of skills. In this paper we report on the physical, psychological and social wellbeing outcomes of a technology-based intervention that enable online group exercises in older adults with different levels of skills. Methods A total of 37 older adults between 65 and 87 years old followed a personalized exercise program based on the OTAGO program for fall prevention, for a period of eight weeks. Participants could join online group exercises using a tablet-based application. Participants were assigned either to the Control group, representing the traditional individual home-based training program, or the Social group, representing the online group exercising. Pre- and post- measurements were taken to analyze the physical, psychological and social wellbeing outcomes. Results After the eight-weeks training program there were improvements in both the Social and Control groups in terms of physical outcomes, given the high level of adherence of both groups. Considering the baseline measures, however, the results suggest that while in the Control group fitter individuals tended to adhere more to the training, this was not the case for the Social group, where the initial level had no effect on adherence. For psychological outcomes there were improvements on both groups, regardless of the application used. There was no significant difference between groups in social wellbeing outcomes, both groups seeing a decrease in loneliness despite the presence of social features in the Social group. However, online social interactions have shown to be correlated to the decrease in loneliness in the Social group. Conclusion The results indicate that technology-supported online group-exercising which conceals individual differences in physical skills is effective in motivating and enabling individuals who are less fit to train as much as fitter individuals. This not only indicates the feasibility of training together despite differences in physical skills but also suggests that online exercise might reduce the effect of skills on adherence in a social context. However, results from this pilot are limited to a small sample size and therefore are not conclusive. Longer term interventions with more participants are instead recommended to assess impacts on wellbeing and behavior change. PMID:28392983

Randomized controlled trial of video self-modeling following speech restructuring treatment for stuttering.

PubMed

Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

2010-08-01

In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech restructuring treatment. Post treatment, participants were randomly assigned to 2 trial arms: standard maintenance and standard maintenance plus VSM. Participants in the latter arm viewed stutter-free videos of themselves each day for 1 month. The addition of VSM did not improve speech outcomes, as measured by percent syllables stuttered, at either 1 or 6 months postrandomization. However, at the latter assessment, self-rating of worst stuttering severity by the VSM group was 10% better than that of the control group, and satisfaction with speech fluency was 20% better. Quality of life was also better for the VSM group, which was mildly to moderately impaired compared with moderate impairment in the control group. VSM intervention after treatment was associated with improvements in self-reported outcomes. The clinical implications of this finding are discussed.

Long-term efficacy of cognitive-behavioral therapy by general practitioners for fatigue: a 4-year follow-up study.

PubMed

Leone, Stephanie S; Huibers, Marcus J H; Kant, Ijmert; van Amelsvoort, Ludovic G P M; van Schayck, Constant P; Bleijenberg, Gijs; Knottnerus, J André

2006-11-01

In an earlier study, we found that cognitive-behavioral therapy (CBT) delivered by general practitioners (GPs) for fatigue among employees on sick leave was not effective after 12 months. In this study we aim to assess the long-term efficacy of CBT by GPs for fatigue. It was hypothesized that the intervention could prevent deterioration as well as relapse of fatigue complaints and relapse into absenteeism in the long term. Patients who participated in the original randomized controlled trial were followed up 4 years later. Fatigue and absenteeism were the main outcomes. Fatigue and absenteeism were high in the intervention and control groups at the 4-year follow-up. There was no significant difference between the intervention group and the control group on fatigue and absenteeism. The intervention group however tended toward less-favorable outcomes as compared with the control group. Like that of chronic fatigue syndrome, the prognosis of less-advanced fatigue is rather poor. CBT delivered by GPs is not effective in the long term.

Effect of preoperative injection of carbon nanoparticle suspension on the outcomes of selected patients with mid-low rectal cancer.

PubMed

Zhang, Xing-Mao; Liang, Jian-Wei; Wang, Zheng; Kou, Jian-tao; Zhou, Zhi-Xiang

2016-04-04

Carbon nanoparticles show significant lymphatic tropism and can be used to identify lymph nodes surrounding mid-low rectal tumors. In this study, we analyzed the effect of trans anal injection of a carbon nanoparticle suspension on the outcomes of patients with mid-low rectal cancer who underwent laparoscopic resection. We collected the data of 87 patients with mid-low rectal cancer who underwent laparoscopic resection between November 2014 and March 2015 at Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. For 35 patients in the experimental group, the carbon nanoparticle suspension was injected transanally into the submucosa of the rectum around the tumor 30 min before the operation; 52 patients in the control group underwent the operation directly without the injection of carbon nanoparticle suspension. We then compared the operation outcomes between the two groups. In the experimental group, the rate of incomplete mesorectal excision was lower than that in the control group, but no significant difference was found (2.9% vs. 7.7%, P = 0.342). The distance between the tumor and the circumferential resection margin was 5.8 ± 1.4 mm in the experimental group and 4.8 ± 1.1 mm in the control group (P = 0.001). The mean number of lymph nodes removed was 28.2 ± 9.4 in the experimental group and 22.7 ± 7.3 in the control group (P = 0.003); the mean number of lymph nodes smaller than 5 mm in diameter was 10.1 ± 7.5 and 4.5 ± 3.7, respectively (P < 0.001). Three patients in the experimental group received lateral lymph node resection. Among the three patients, we retrieved three nodes (one stained node) from the first patient, three nodes (two stained nodes) from the second patient, and two nodes (no stained nodes) from the third patient. Injecting a carbon nanoparticle suspension improved the outcomes of patients who underwent laparoscopic resection for mid-low rectal cancer; it also improved the accuracy of pathologic staging. Moreover, for selected patients, this technique narrowed the scope of lateral lymph node dissection.

Early self-managed focal sensorimotor rehabilitative training enhances functional mobility and sensorimotor function in patients following total knee replacement: a controlled clinical trial.

PubMed

Moutzouri, Maria; Gleeson, Nigel; Coutts, Fiona; Tsepis, Elias; John, Gliatis

2018-02-01

To assess the effects of early self-managed focal sensorimotor training compared to functional exercise training after total knee replacement on functional mobility and sensorimotor function. A single-blind controlled clinical trial. University Hospital of Rion, Greece. A total of 52 participants following total knee replacement. The primary outcome was the Timed Up and Go Test and the secondary outcomes were balance, joint position error, the Knee Outcome Survey Activities of Daily Living Scale, and pain. Patients were assessed on three separate occasions (presurgery, 8 weeks post surgery, and 14 weeks post surgery). Participants were randomized to either focal sensorimotor exercise training (experimental group) or functional exercise training (control group). Both groups received a 12-week home-based programme prescribed for 3-5 sessions/week (35-45 minutes). Consistently greater improvements ( F 2,98  = 4.3 to 24.8; P < 0.05) in group mean scores favour the experimental group compared to the control group: Timed Up and Go (7.8 ± 2.9 seconds vs. 4.6 ± 2.6 seconds); balance (2.1 ± 0.9° vs. 0.7 ± 1.2°); joint position error (13.8 ± 7.3° vs. 6.2 ± 9.1°); Knee Outcome Survey Activities of Daily Living Scale (44.2 ± 11.3 vs. 26.1 ± 11.4); and pain (5.9 ± 1.3 cm vs. 4.6 ± 1.1 cm). Patterns of improvement for the experimental group over time were represented by a relative effect size range of 1.3-6.5. Overall, the magnitude of improvements in functional mobility and sensorimotor function endorses using focal sensorimotor training as an effective mode of rehabilitation following knee replacement.

Effects of a home care mobile app on the outcomes of discharged patients with a stoma: a randomized controlled trial.

PubMed

Wang, Qing-Qing; Zhao, Jing; Huo, Xiao-Rong; Wu, Ling; Yang, Li-Fang; Li, Ju-Yun; Wang, Jie

2018-05-18

The aim of this study is to explore the effects of a home care mobile app on the outcomes of stoma patients who discharged from hospital. Patients with a newly formed stoma experience many difficulties after surgery. Mobile application (app) has the potential to help patients self-manage their diseases and adjust to the changes in their lives and is a convenient way to ensure the continuity of care. However, there is a lack of studies about the effects of a mobile app on the transitional care for improving discharged stoma-related health outcomes. A randomized controlled trial. 203 patients with a permanent stoma in tertiary hospitals in China were randomly assigned into two groups. Patients in the control group (n=103) received routine discharge care. Patients in the intervention group (n=100) received home care via a mobile app besides routine care. The psychosocial adjustment level, self-efficacy scale and stoma complications incidence were measured in the follow-up period and compared between the two groups. Data was collected at four time points: before intervention (baseline), at 1, 3 and 6 months after discharge. The psychosocial adjustment level and stoma self-efficacy score of the intervention group were significantly higher than those of the control group respectively at 1, 3 and 6-month follow-up (all P<0.05). The incidence of stoma complications in the intervention group were tending to reduce at 1, 3 and 6 months after discharge. The findings indicated that follow-up care at home via a mobile app can effectively improve the psychosocial adjustment level, self-efficacy scale and other related outcomes of stoma patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Extracorporeal membrane oxygenation in children with heart disease and down syndrome: a multicenter analysis.

PubMed

Gupta, Punkaj; Gossett, Jeffrey M; Rycus, Peter T; Prodhan, Parthak

2014-12-01

The data on the outcomes of children with heart disease and Down syndrome receiving extracorporeal membrane oxygenation (ECMO) for cardiac or respiratory failure are limited. This study aimed to evaluate morbidity and mortality associated with ECMO in children with Down syndrome and heart disease. Children younger than 18 years undergoing heart surgery and ECMO reported in the Extracorporeal Life Support Organization (ELSO) registry (1998-2011) were included in the study. The registry was queried for the following five heart defects: common atrioventricular (AV) canal, tetralogy of Fallot, truncus arteriosus, transposition of great vessels, and interrupted aortic arch. Data collection included patient characteristics, ECMO characteristics, and outcomes. The outcomes evaluated included mortality, ECMO duration, and length of hospital stay for patients with Down syndrome and those with no Down syndrome. The study enrolled 2,815 patients qualified for inclusion. Of these patients, 121 had Down syndrome, whereas 2,694 had no genetic syndrome and were included in the control group. The median age of the patients was 45 days (interquartile range [IQR] 9-192 days), and the median weight was 3.8 kg (IQR 3.0-6.1 kg). The most common cardiac defects in Down syndrome group were common AV canal (63 %) and tetralogy of Fallot (40 %). The Down syndrome group included older patients with greater body weight than the control group. The mortality rate was lower in the Down syndrome group than in the control group (44 vs. 56 %; p = 0.01). The duration of ECMO and length of hospital stay were similar in the two groups. The findings showed that ECMO can be used for children with heart disease and Down syndrome with good results. The outcomes were comparable between the children with Down syndrome and the children without Down syndrome.

An eye movement pre-training fosters the comprehension of processes and functions in technical systems.

PubMed

Skuballa, Irene T; Fortunski, Caroline; Renkl, Alexander

2015-01-01

The main research goal of the present study was to investigate in how far pre-training eye movements can facilitate knowledge acquisition in multimedia (pre-training principle). We combined considerations from research on eye movement modeling and pre-training to design and test a non-verbal eye movement-based pre-training. Participants in the experimental condition watched an animated circle moving in close spatial resemblance to a static visualization of a solar plant accompanied by a narration in a subsequently presented learning environment. This training was expected to foster top-down processes as reflected in gaze behavior during the learning process and enhance knowledge acquisition. We compared two groups (N = 45): participants in the experimental condition received pre-training in a first step and processed the learning material in a second step, whereas the control group underwent the second step without any pre-training. The pre-training group outperformed the control group in their learning outcomes, particularly in knowledge about processes and functions of the solar plant. However, the superior learning outcomes in the pre-training group could not be explained by eye-movement patterns. Furthermore, the pre-training moderated the relationship between experienced stress and learning outcomes. In the control group, high stress levels hindered learning, which was not found for the pre-training group. On a delayed posttest participants were requested to draw a picture of the learning content. Despite a non-significant effect of training on the quality of drawings, the pre-training showed associations between learning outcomes at the first testing time and process-related aspects in the quality of their drawings. Overall, non-verbal pre-training is a successful instructional intervention to promote learning processes in novices although these processes did not directly reflect in learners' eye movement behavior during learning.

Does vitamin C and vitamin E supplementation prolong the latency period before delivery following the preterm premature rupture of membranes? A randomized controlled study.

PubMed

Gungorduk, Kemal; Asicioglu, Osman; Gungorduk, Ozgu Celikkol; Yildirim, Gokhan; Besimoğlu, Berhan; Ark, Cemal

2014-03-01

To determine whether maternal vitamin C and vitamin E supplementation after the premature rupture of membranes is associated with an increase in the latency period before delivery. In the present prospective open randomized trial, 229 pregnant women with preterm premature rupture of membranes (PPROM) at ≥ 24.0 and < 34.0 weeks' gestation were randomly assigned to receive either 1,000 mg of vitamin C and 400 IU of vitamin E (n = 126) or a placebo (n = 123). The primary outcome was the latency period until delivery. Analysis was performed on an intention-to-treat basis. No significant differences in demographic or clinical characteristics were observed between the groups. Latency period until delivery was significantly higher in the group that received vitamins compared with the control group (11.2 ± 6.3 days versus 6.2 ± 4.0 days; p < 0.001). Gestational age at delivery was also significantly higher in the vitamin group compared with the control group (31.9 ± 2.6 weeks versus 31.0 ± 2.6 weeks; p = 0.01). No significant differences in adverse maternal outcome (i.e., chorioamnionitis or endometritis) or neonatal outcome (i.e., neonatal sepsis, neonatal death, necrotizing enterocolitis, or grade 3 to 4 intraventricular hemorrhage) were noted between groups. The findings of the present study suggest that the use of vitamins C and E in women with PPROM is associated with a longer latency period before delivery. Moreover, adverse neonatal and maternal outcomes, which are often associated with prolonged latency periods, were similar between the groups. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

PubMed

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.

Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458].

PubMed

Nagle, C; Gunn, J; Bell, R; Lewis, S; Meiser, B; Metcalfe, S; Ukoumunne, O C; Halliday, J

2008-02-01

To evaluate the effectiveness of a decision aid for prenatal testing of fetal abnormalities compared with a pamphlet in supporting women's decision making. A cluster randomised controlled trial. Primary health care. Women in early pregnancy consulting a GP. GPs were randomised to provide women with either a decision aid or a pamphlet. The decision aid was a 24-page booklet designed using the Ottowa Decision Framework. The pamphlet was an existing resource available in the trial setting. Validated scales were used to measure the primary outcomes, informed choice and decisional conflict, and the secondary outcomes, anxiety, depression, attitudes to the pregnancy/fetus and acceptability of the resource. Outcomes were measured at 14 weeks of gestation from questionnaires that women completed and returned by post. Women in the intervention group were more likely to make an informed decision 76% (126/165) than those in the control group 65% (107/165) (adjusted OR 2.08; 95% CI 1.14-3.81). A greater proportion of women in the intervention group 88% (147/167) had a 'good' level of knowledge than those in the control group 72% (123/171) (adjusted OR 3.43; 95% CI 1.79-6.58). Mean (SD) decisional conflict scores were low in both groups, decision aid 1.71 (0.49), pamphlet 1.65 (0.55) (adjusted mean difference 0.10; 95% CI -0.02 to 0.22). There was no strong evidence of differences between the trial arms in the measures of psychological or acceptability outcomes. A tailored prenatal testing decision aid plays an important role in improving women's knowledge of first and second trimester screening tests and assisting them to make decisions about screening and diagnostic tests that are consistent with their values.

The recovery status from delayed graft function can predict long-term outcome after deceased donor kidney transplantation.

PubMed

Lee, Juhan; Song, Seung Hwan; Lee, Jee Youn; Kim, Deok Gie; Lee, Jae Geun; Kim, Beom Seok; Kim, Myoung Soo; Huh, Kyu Ha

2017-10-20

The effect of delayed graft function (DGF) recovery on long-term graft outcome is unclear. The aim of this study was to examine the association of DGF recovery status with long-term outcome. We analyzed 385 recipients who underwent single kidney transplantation from brain-dead donors between 2004 and 2015. Patients were grouped according to renal function at 1 month post-transplantation: control (without DGF); recovered DGF (glomerular filtration rate [GFR] ≥ 30 mL/min/1.73 m 2 ); and incompletely recovered DGF group (GFR < 30 mL/min/1.73 m 2 ). DGF occurred in 104 of 385 (27%) recipients. Of the DGF patients, 70 recovered from DGF and 34 incompletely recovered from DGF. Death-censored graft survival rates for control, recovered DGF, and incompletely recovered DGF groups were 95.3%, 94.7%, and 80.7%, respectively, at 5 years post-transplantation (P = 0.003). Incompletely recovered DGF was an independent risk factor for death-censored graft loss (HR = 3.410, 95%CI, 1.114-10.437). DGF was associated with increased risk for patient death regardless of DGF recovery status. Mean GFRs at 5 years were 65.5 ± 20.8, 62.2 ± 27.0, and 45.8 ± 15.4 mL/min/1.73 m 2 for control, recovered, and incompletely recovered DGF groups, respectively (P < 0.001). Control group and recovered DGF patients had similar renal outcomes. However, DGF was associated with increased risk for patient death regardless of DGF recovery status.

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

PubMed

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 rehabilitation may be warranted.

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

PubMed

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 study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV).

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

PubMed Central

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 serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Conclusions Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV). PMID:26883052

Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial

PubMed Central

Erhart-Hledik, Jennifer C; Perez, Daniel A; Hunter, Simon

2018-01-01

Background Chronic knee pain, most commonly caused by knee osteoarthritis, is a prevalent condition which in most cases can be effectively treated through conservative, non-surgical care involving exercise therapy, education, psychosocial support, and weight loss. However, most people living with chronic knee pain do not receive adequate care, leading to unnecessary use of opiates and surgical procedures. Objective Assess the efficacy of a remotely delivered digital care program for chronic knee pain. Methods We enrolled 162 participants into a randomized controlled trial between January and March 2017. Participants were recruited from participating employers using questionnaires for self-assessment of their knee pain, and randomized into treatment (n=101) and control (n=61) groups. Participants in the treatment group were enrolled in the Hinge Health digital care program for chronic knee pain. This is a remotely delivered, home-based 12-week intervention that includes sensor-guided exercise therapy, education, cognitive behavioral therapy, weight loss, and psychosocial support through a personal coach and team-based interactions. The control group received three education pieces regarding self-care for chronic knee pain. Both groups had access to treatment-as-usual. The primary outcome was the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale and KOOS Physical Function Shortform (KOOS-PS). Secondary outcomes were visual analog scales (VAS) for pain and stiffness respectively, surgery intent, and self-reported understanding of the condition and treatment options. Outcome measures were analyzed by intention to treat (excluding 7 control participants who received the digital care program due to administrative error) and per protocol. Results In an intent-to-treat analysis the digital care program group had a significantly greater reduction in KOOS Pain compared to the control group at the end of the program (greater reduction of 7.7, 95% CI 3.0 to 12.3, P=.002), as well as a significantly greater improvement in physical function (7.2, 95% CI 3.0 to 11.5, P=.001). This was also reflected in the secondary outcomes VAS pain (12.3, 95% CI 5.4 to 19.1, P<.001) and VAS stiffness (13.4, 95% CI 5.6 to 21.1, P=.001). Participants’ self-reported likelihood (from 0% to 100%) of having surgery also reduced more strongly in the digital care program group compared to the control group over the next 1 year (–9.4 percentage points, pp, 95% CI –16.6 to –2.2, P=.01), 2 years (–11.3 pp, 95% CI –20.1 to –2.5, P=.01), and 5 years (–14.6 pp, 95% CI –23.6 to –5.5, P=.002). Interest in surgery (from 0 to 10) also reduced more so in the digital care program compared to control group (–1.0, 95% CI –1.7 to –0.2, P=.01). Participants’ understanding of the condition and treatment options (on a scale from 0 to 4) increased more substantially for participants in the digital care program than those in the control group (0.9, 95% CI 0.6 to 1.3, P<.001). In an analysis on participants that completed the intervention (per protocol analysis) all primary and secondary outcomes remained significant at greater effect magnitudes compared to intention to treat, with those completing the program showing a 61% (95% CI 48 to 74) reduction in VAS pain compared to 21% (95% CI 5 to 38) in the control group (P<.001). Accounting for the cost of administering the program, we estimate net cost savings on surgery alone of US $4340 over 1 year and $7900 over 5 years for those participants completing the digital care program compared to those in the control group receiving treatment-as-usual. In an exploratory subgroup analysis including only participants exhibiting clinical symptoms of osteoarthritis the program proved equally effective. Conclusions This trial provides strong evidence that a comprehensive 12-week digital care program for chronic knee pain, including osteoarthritis, yields significantly improved outcomes for pain, physical function, stiffness, surgery risk, and understanding of the condition, compared to a control group. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 13307390; http://www.isrctn.com/ISRCTN13307390 (Archived by WebCite at http://www.webcitation.org/6ycwjGL73) PMID:29695370

Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial.

PubMed

Mecklenburg, Gabriel; Smittenaar, Peter; Erhart-Hledik, Jennifer C; Perez, Daniel A; Hunter, Simon

2018-04-25

Chronic knee pain, most commonly caused by knee osteoarthritis, is a prevalent condition which in most cases can be effectively treated through conservative, non-surgical care involving exercise therapy, education, psychosocial support, and weight loss. However, most people living with chronic knee pain do not receive adequate care, leading to unnecessary use of opiates and surgical procedures. Assess the efficacy of a remotely delivered digital care program for chronic knee pain. We enrolled 162 participants into a randomized controlled trial between January and March 2017. Participants were recruited from participating employers using questionnaires for self-assessment of their knee pain, and randomized into treatment (n=101) and control (n=61) groups. Participants in the treatment group were enrolled in the Hinge Health digital care program for chronic knee pain. This is a remotely delivered, home-based 12-week intervention that includes sensor-guided exercise therapy, education, cognitive behavioral therapy, weight loss, and psychosocial support through a personal coach and team-based interactions. The control group received three education pieces regarding self-care for chronic knee pain. Both groups had access to treatment-as-usual. The primary outcome was the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale and KOOS Physical Function Shortform (KOOS-PS). Secondary outcomes were visual analog scales (VAS) for pain and stiffness respectively, surgery intent, and self-reported understanding of the condition and treatment options. Outcome measures were analyzed by intention to treat (excluding 7 control participants who received the digital care program due to administrative error) and per protocol. In an intent-to-treat analysis the digital care program group had a significantly greater reduction in KOOS Pain compared to the control group at the end of the program (greater reduction of 7.7, 95% CI 3.0 to 12.3, P=.002), as well as a significantly greater improvement in physical function (7.2, 95% CI 3.0 to 11.5, P=.001). This was also reflected in the secondary outcomes VAS pain (12.3, 95% CI 5.4 to 19.1, P<.001) and VAS stiffness (13.4, 95% CI 5.6 to 21.1, P=.001). Participants' self-reported likelihood (from 0% to 100%) of having surgery also reduced more strongly in the digital care program group compared to the control group over the next 1 year (-9.4 percentage points, pp, 95% CI -16.6 to -2.2, P=.01), 2 years (-11.3 pp, 95% CI -20.1 to -2.5, P=.01), and 5 years (-14.6 pp, 95% CI -23.6 to -5.5, P=.002). Interest in surgery (from 0 to 10) also reduced more so in the digital care program compared to control group (-1.0, 95% CI -1.7 to -0.2, P=.01). Participants' understanding of the condition and treatment options (on a scale from 0 to 4) increased more substantially for participants in the digital care program than those in the control group (0.9, 95% CI 0.6 to 1.3, P<.001). In an analysis on participants that completed the intervention (per protocol analysis) all primary and secondary outcomes remained significant at greater effect magnitudes compared to intention to treat, with those completing the program showing a 61% (95% CI 48 to 74) reduction in VAS pain compared to 21% (95% CI 5 to 38) in the control group (P<.001). Accounting for the cost of administering the program, we estimate net cost savings on surgery alone of US $4340 over 1 year and $7900 over 5 years for those participants completing the digital care program compared to those in the control group receiving treatment-as-usual. In an exploratory subgroup analysis including only participants exhibiting clinical symptoms of osteoarthritis the program proved equally effective. This trial provides strong evidence that a comprehensive 12-week digital care program for chronic knee pain, including osteoarthritis, yields significantly improved outcomes for pain, physical function, stiffness, surgery risk, and understanding of the condition, compared to a control group. International Standard Randomized Controlled Trial Number (ISRCTN) 13307390; http://www.isrctn.com/ISRCTN13307390 (Archived by WebCite at http://www.webcitation.org/6ycwjGL73). ©Gabriel Mecklenburg, Peter Smittenaar, Jennifer C Erhart-Hledik, Daniel A Perez, Simon Hunter. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 25.04.2018.

Extending surgeon response times in tier 2 traumas does not adversely affect patient outcomes.

PubMed

Zimmerman, Steven Anthony; Reed, Christopher S; Reed, Alexander N; Jones, Ronald J; Chard, Annette; Reed, Donald N

2018-06-01

The presence of a trauma surgeon during patient resuscitations is required at most American College of Surgeons-verified trauma centers despite little evidence showing improved patient outcomes in the less-than-critically injured (Tier 2) trauma patients. This study was designed to identify the impact of extending required surgeon response times on outcomes in tier 2 trauma patients. An American College of Surgeons-verified level 2 trauma center extended the maximum allowed surgeon response time for tier 2 activations from 60 min to 120 min on November 1, 2011. Surgeon response time and patient outcomes of the retrospective control group (January 1, 2008-October 31, 2011) were then compared with the prospective test group (November 1, 2011-December 31, 2014). Primary outcomes included mortality and hospital length of stay (HLOS). Secondary outcomes were emergency department length of stay, and time from ED arrival to CT scan. A subset analysis of all patients evaluated by a surgeon within 60 min of arrival versus those evaluated by a surgeon after 60 min was also performed. The control and test groups were composed of 757 and 792 patients, and their mean injury severity score was 9.0 and 6.0, respectively. Emergency department length of stay showed a statistically significant increase of 12 min, whereas HLOS was unchanged throughout the study. Mortality was not significantly different between the groups. Subset analysis revealed a median surgeon arrival time of 15 min in the <60-min group and 85 min in the >60-min group, whereas the injury severity score, HLOS, and mortality were not significantly different between these subsets. No correlation existed between these outcomes and surgeon arrival time. Doubling required surgeon response time in tier 2 trauma patients does not produce negative outcomes in this patient group. Mandatory surgeon response times in similar patient groups can be re-evaluated to allow for greater flexibility of a limited surgeon workforce while still providing safe care. Copyright © 2018 Elsevier Inc. All rights reserved.

It is the outcome that counts! Damage to the ventromedial prefrontal cortex disrupts the integration of outcome and belief information for moral judgment.

PubMed

Ciaramelli, Elisa; Braghittoni, Davide; di Pellegrino, Giuseppe

2012-11-01

Moral judgment involves considering not only the outcome of an action but also the intention with which it was pursued. Previous functional magnetic resonance imaging (fMRI) research has shown that integrating outcome and belief information for moral judgment relies on a brain network including temporo-parietal, precuneus, and medial prefrontal regions. Here, we investigated whether the ventromedial prefrontal cortex (vmPFC) plays a crucial role in this process. Patients with lesions in vmPFC (vmPFC patients), and brain-damaged and healthy controls considered scenarios in which the protagonist caused intentional harm (negative-outcome, negative-belief), accidental harm (negative-outcome, neutral-belief), attempted harm (neutral-outcome, negative-belief), or no harm (neutral-outcome, neutral-belief), and rated the moral permissibility of the protagonists' behavior. All groups responded similarly to scenarios involving intentional harm and no harm. vmPFC patients, however, judged attempted harm as more permissible, and accidental harm as less permissible, than the control groups. For vmPFC patients, outcome information, rather than belief information, shaped moral judgment. The results indicate that vmPFC is necessary for integrating outcome and belief information during moral reasoning. During moral judgment vmPFC may mediate intentions' understanding, and overriding of prepotent responses to salient outcomes.

The effectiveness of various computer-based interventions for patients with chronic pain or functional somatic syndromes: A systematic review and meta-analysis.

PubMed

Vugts, Miel A P; Joosen, Margot C W; van der Geer, Jessica E; Zedlitz, Aglaia M E E; Vrijhoef, Hubertus J M

2018-01-01

Computer-based interventions target improvement of physical and emotional functioning in patients with chronic pain and functional somatic syndromes. However, it is unclear to what extent which interventions work and for whom. This systematic review and meta-analysis (registered at PROSPERO, 2016: CRD42016050839) assesses efficacy relative to passive and active control conditions, and explores patient and intervention factors. Controlled studies were identified from MEDLINE, EMBASE, PsychInfo, Web of Science, and Cochrane Library. Pooled standardized mean differences by comparison type, and somatic symptom, health-related quality of life, functional interference, catastrophizing, and depression outcomes were calculated at post-treatment and at 6 or more months follow-up. Risk of bias was assessed. Sub-group analyses were performed by patient and intervention characteristics when heterogeneous outcomes were observed. Maximally, 30 out of 46 eligible studies and 3,387 participants were included per meta-analysis. Mostly, internet-based cognitive behavioral therapies were identified. Significantly higher patient reported outcomes were found in comparisons with passive control groups (standardized mean differences ranged between -.41 and -.18), but not in comparisons with active control groups (SMD = -.26 - -.14). For some outcomes, significant heterogeneity related to patient and intervention characteristics. To conclude, there is a minority of good quality evidence for small positive average effects of computer-based (cognitive) behavior change interventions, similar to traditional modes. These effects may be sustainable. Indications were found as of which interventions work better or more consistently across outcomes for which patients. Future process analyses are recommended in the aim of better understanding individual chances of clinically relevant outcomes.

Proximalisation of the tibial tubercle gives a good outcome in patients undergoing revision total knee arthroplasty who have pseudo patella baja.

PubMed

Vandeputte, F-J; Vandenneucker, H

2017-07-01

The aim of this study was to compare the outcome of revision total knee arthroplasty (TKA) with and without proximalisation of the tibial tubercle in patients with a failed primary TKA who have pseudo patella baja. All revision TKAs, performed between January 2008 and November 2013 at a tertiary referral University Orthopaedic Department were retrospectively reviewed. Pseudo patella baja was defined using the modified Insall-Salvati and the Blackburne-Peel ratios. A proximalisation of the tibial tubercle was performed in 13 patients with pseudo patella baja who were matched with a control group of 13 patients for gender, age, height, weight, body mass index, length of surgery and Blackburne-Peel ratio. Outcome was assessed two years post-operatively using the Knee Society Score (KSS). The increase in KSS was significantly higher in the osteotomy group compared with the control group. The outcome was statistically better in patients in whom proximalisation of > 1 cm had been achieved compared with those in whom the proximalisation was < 1 cm. In this retrospective case-control study, a proximal transfer of the tibial tubercle at revision TKA in patients with pseudo patella baja gives good outcomes without major complications. Cite this article: Bone Joint J 2017;99-B:912-16. ©2017 The British Editorial Society of Bone & Joint Surgery.

Outcome of delivery following first-pregnancy abortion.

PubMed

Tangtrakul, S; Thongjerm, M; Suthutvoravuth, S; Phromboon, S; Chaturachinda, K

1988-03-01

To determine whether or not a previous abortion has a deleterious effect on the outcome of a subsequent pregnancy, 6443 delivery records at Ramathibodi hospital between January and December 1982 were reviewed. The 2 study groups consisted of 143 women who had previously had an induced abortion and 315 women who had previously had a spontaneous abortion. Control groups were women having a 2nd child after a normal 1st pregnancy. The 1st study group had fewer women under 19 and over 35 and a lower educational level. Group 2 had more women with a pregnancy interval of less than 2 years. There was no difference between the study groups and the controls in premature rupture of fetal membranes, placenta previa, cesarean sections, manual removal of placenta, retained secundine, postpartum hemorrhage, low birth weight, Apgar score less than 6, congenital abnormalities, or perinatal mortality. The only difference between both study groups and the controls was that there was a higher percentage of assisted deliveries in both study groups. This finding is probably the result of the fact that these were 1st births and is totally unrelated to previous abortion.

Methylprednisolone for prevention of ovarian hyperstimulation syndrome in patients with polycystic ovarian syndrome undergoing in-vitro fertilisation: a randomised controlled trial.

PubMed

Mohammadi Yeganeh, Ladan; Moini, Ashraf; Shiva, Marzieh; Mirghavam, Naimeh; Bagheri Lankarani, Narges

2018-02-01

This study aimed to evaluate the effect of methylprednisolone on prevention of ovarian hyperstimulation syndrome (OHSS) in polycystic ovarian syndrome (PCOS) patients undergoing in-vitro fertilisation (IVF). This randomised controlled trial was carried out between November 2009 and December 2013. A total of 219 eligible patients were randomly allocated for treatment (n = 108) or control groups (n = 111). The treatment group received oral methylprednisolone starting from the first day of stimulation. These patients also received an intravenous dose of methylprednisolone on the days of egg collection and embryo transfer. The control group received no glucocorticoid treatment to prevent OHSS. Nineteen percent of patients (18/93) who received methylprednisolone developed OHSS compared with 16.5% (15/91) in the control group and no significant difference was found (p = .61). There were no significant differences between treatment and control groups in the rates of implantation (10% versus 11%, p = .77) and clinical pregnancy (23.2% versus 17.7%, p = .46). Methylprednisolone did not reduce the incidence and severity of OHSS in PCOS patients undergoing IVF and no improvement in clinical outcomes was observed. Impact statement No significant differences were found in OHSS incidence and clinical outcomes between women who received methylprednisolone and control group. There seems to be no benefit for the routine use of glucocorticoids in IVF/ICSI treatments.

A nonrandomized controlled clinical pilot trial on 8 wk of intermittent fasting (24 h/wk).

PubMed

Kessler, Christian S; Stange, Rainer; Schlenkermann, Maike; Jeitler, Michael; Michalsen, Andreas; Selle, Antonia; Raucci, Franca; Steckhan, Nico

2018-02-01

The aim of the study was to evaluate whether intermittent fasting (IF) is an effective preventive measure, and whether it is feasible for healthy volunteers under every day conditions. A nonrandomized controlled clinical trial on IF was performed with healthy volunteers over a period of 8 wk, and a subsequent 4-mo follow-up. Outcomes were assessed at baseline, after 8 wk, and after 6 mo. Volunteers who were not interested in fasting served as a control group. Participants in the fasting group were asked to continue their regular nutritional habits on the nonfasting days, whereas the control group maintained their habitual nutrition throughout the whole period. Outcomes included changes of metabolic parameters (insulin, glucose, insulin resistance, insulin-like growth factor-1, brain-derived neurotropic factor, lipids, liver enzymes, hemoglobin A1c) and coagulation markers; bioelectrical impedance analysis; body mass index; abdominal girth; blood pressure; general quality of life (five-item World Health Organization Well-Being Index [WHO-5] questionnaire), as well as mood and anxiety (Hospital Anxiety and Depression Scale [HADS], Profile of Mood States, Flourishing-Scale, visual analog scale, Likert scales). The intervention consisted of a fasting day, which was repeated every week for 8 wk, with abstinence from solid food between 00:00 and 23:59 at minimum and a maximum caloric intake of 300 kcal on each fasting day. A per-protocol analysis was performed. P < 0.05 was considered significant. Thirty-six volunteers were included; 22 allocated themselves to the fasting group, and 14 to the control group. Thirty-three data sets were included in the final analysis. Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo, no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6 mo, all in favor of the fasting group. However, none of the between-group differences were clinically relevant. We did not find any clinically relevant differences between groups in this controlled clinical pilot trial of 8 wk of IF in healthy volunteers. Further clinical research in this field is warranted to further analyze mechanisms and effects of IF. Copyright © 2017 Elsevier Inc. All rights reserved.

The implementation of a community-based aerobic walking program for mild to moderate knee osteoarthritis: A knowledge translation randomized controlled trial: Part II: Clinical outcomes

PubMed Central

2012-01-01

Background Osteoarthritis (OA) is the most common joint disorder in the world, as it is appears to be prevalent among 80% of individuals over the age of 75. Although physical activities such as walking have been scientifically proven to improve physical function and arthritic symptoms, individuals with OA tend to adopt a sedentary lifestyle. There is therefore a need to improve knowledge translation in order to influence individuals to adopt effective self-management interventions, such as an adapted walking program. Methods A single-blind, randomized control trial was conducted. Subjects (n = 222) were randomized to one of three knowledge translation groups: 1) Walking and Behavioural intervention (WB) (18 males, 57 females) which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking; 2) Walking intervention (W) (24 males, 57 females) wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet; 3) Self-directed control (C) (32 males, 52 females) wherein participants only received the educational pamphlet. One-way analyses of variance were used to test for differences in quality of life, adherence, confidence, and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period. Results The clinical and quality of life outcomes improved among participants in each of the three comparative groups. However, there were few statistically significant differences observed for quality of life and clinical outcomes at long-term measurements at 12-months end of intervention and at 6- months post intervention (18-month follow-up). Outcome results varied among the three groups. Conclusion The three groups were equivalent when determining the effectiveness of knowledge uptake and improvements in quality of life and other clinical outcomes. OA can be managed through the implementation of a proven effective walking program in existing community-based walking clubs. Trial registration Current Controlled Trials IRSCTNO9193542 PMID:23234575

The Effect of Latent Binary Variables on the Uncertainty of the Prediction of a Dichotomous Outcome Using Logistic Regression Based Propensity Score Matching.

PubMed

Szekér, Szabolcs; Vathy-Fogarassy, Ágnes

2018-01-01

Logistic regression based propensity score matching is a widely used method in case-control studies to select the individuals of the control group. This method creates a suitable control group if all factors affecting the output variable are known. However, if relevant latent variables exist as well, which are not taken into account during the calculations, the quality of the control group is uncertain. In this paper, we present a statistics-based research in which we try to determine the relationship between the accuracy of the logistic regression model and the uncertainty of the dependent variable of the control group defined by propensity score matching. Our analyses show that there is a linear correlation between the fit of the logistic regression model and the uncertainty of the output variable. In certain cases, a latent binary explanatory variable can result in a relative error of up to 70% in the prediction of the outcome variable. The observed phenomenon calls the attention of analysts to an important point, which must be taken into account when deducting conclusions.

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

PubMed Central

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 < 0.001). No other adaptations were noted. Post hoc analysis comparing participants who completed ≥70% of 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. Future investigations should incorporate strategies to promote adherence, involve more frequent and longer durations of yoga training, and enrol cohorts who suffer from higher levels of work-related stress. Trial registration ACTRN12611000536965 PMID:23574691

Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized controlled trial.

PubMed

Gaete, Jorge; Martinez, Vania; Fritsch, Rosemarie; Rojas, Graciela; Montgomery, Alan A; Araya, Ricardo

2016-08-04

Depression is a disabling condition affecting people of all ages, but generally starting during adolescence. Schools seem to be an excellent setting where preventive interventions may be delivered. This study aimed to test the effectiveness of an indicated school-based intervention to reduce depressive symptoms among at-risk adolescents from low-income families. A two-arm, parallel, randomized controlled trial was conducted in 11 secondary schools in vulnerable socioeconomic areas in Santiago, Chile. High-risk students in year 10 (2° Medio) were invited to a baseline assessment (n = 1048). Those who scored ≥10 (boys) and ≥15 (girls) in the BDI-II were invited to the trial (n = 376). A total of 342 students consented and were randomly allocated into an intervention or a control arm in a ratio of 2:1. The intervention consisted of 8 group sessions of 45 min each, based on cognitive-behavioural models and delivered by two trained psychologists in the schools. Primary (BDI-II) and secondary outcomes (measures of anxiety, automatic thoughts and problem-solving skills) were administered before and at 3 months post intervention. The primary outcome was the recovery rate, defined as the proportion of participants who scored in the BDI-II <10 (among boys) and <15 (among girls) at 3 months after completing the intervention. There were 229 participants in the intervention group and 113 in the control group. At 3-month follow-up 81.4 % in the intervention and 81.7 % in the control group provided outcome data. The recovery rate was 10 % higher in the intervention (50.3 %) than in the control (40.2 %) group; with an adjusted OR = 1.62 (95 % CI: 0.95 to 2.77) (p = 0.08). No difference between groups was found in any of the secondary outcomes. Secondary analyses revealed an interaction between group and baseline BDI-II score. We found no clear evidence of the effectiveness of a brief, indicated school-based intervention based on cognitive-behavioural models on reducing depressive symptoms among Chilean adolescents from low-income families. More research is needed in order to find better solutions to prevent depression among adolescents. Current Controlled Trials ISRCTN33871591 . Retrospectively registered 29 June 2011.

Physical activity measurements affected participants' behavior in a randomized controlled trial.

PubMed

van Sluijs, Esther M F; van Poppel, Mireille N M; Twisk, Jos W R; van Mechelen, Willem

2006-04-01

Assessing levels and determinants of physical activity as outcome measurements might have an independent effect on participant's physical activity behavior. The objective is to study this effect in a randomized controlled trial (RCT) promoting regular physical activity in Dutch general practice. Using a Solomon four-group design, participants were randomized twice. After randomization to a control or intervention-condition at general practice level (N = 29), participants were randomized to a group participating in measurements at baseline, 2 and 6 months (3M-group, N = 361), or a group only participating in measurements at 6 months (1M-group, N = 356). Outcome measures assessed at 6 months included: level of physical activity (self-reported and objectively measured with accelerometry), meeting ACSM/CDC guideline for regular physical activity, stage of change, and determinants of physical activity. Follow-up data on 635 participants (89%) was collected. Statistically significant measurement effects were found for meeting the ACSM/CDC guideline (self-reported), self-efficacy for resisting relapse, knowledge, and on awareness. Other outcome measures showed positive trends, except stages of change. Measurements of physical activity affect participant's physical activity behavior, possibly triggered by a raised awareness about their own physical activity level. Implications for future research are discussed, as well as methodologic limitations of the study design.

Cognitive Outcomes for Extremely Preterm/Extremely Low Birth Weight Children in Kindergarten

PubMed Central

Orchinik, Leah J.; Taylor, H. Gerry; Espy, Kimberly Andrews; Minich, Nori; Klein, Nancy; Sheffield, Tiffany; Hack, Maureen

2012-01-01

Our objectives were to examine cognitive outcomes for extremely preterm/extremely low birth weight (EPT/ELBW, gestational age <28 weeks and/or birth weight <1000 g) children in kindergarten and the associations of these outcomes with neonatal factors, early childhood neurodevelopmental impairment, and socioeconomic status (SES). The sample comprised a hospital-based 2001-2003 birth cohort of 148 EPT/ELBW children (mean birth weight 818 g; mean gestational age 26 weeks) and a comparison group of 111 term-born normal birth weight (NBW) classmate controls. Controlling for background factors, the EPT/ELBW group had pervasive deficits relative to the NBW group on a comprehensive test battery, with rates of cognitive deficits that were 3 to 6 times higher in the EPT/ELBW group. Deficits on a measure of response inhibition were found in 48% versus 10%, OR (95% CI) = 7.32 (3.32, 16.16), p <.001. Deficits on measures of executive function and motor and perceptual-motor abilities were found even when controlling for acquired verbal knowledge. Neonatal risk factors, early neurodevelopmental impairment, and lower SES were associated with higher rates of deficits within the EPT/ELBW group. The findings document both global and selective cognitive deficits in EPT/ELBW children at school entry and justify efforts at early identification and intervention. PMID:21923973

The effect of a behaviour change intervention on the diets and physical activity levels of women attending Sure Start Children’s Centres: results from a complex public health intervention

PubMed Central

Baird, Janis; Jarman, Megan; Lawrence, Wendy; Black, Christina; Davies, Jenny; Tinati, Tannaze; Begum, Rufia; Mortimore, Andrew; Robinson, Sian; Margetts, Barrie; Cooper, Cyrus; Barker, Mary; Inskip, Hazel

2014-01-01

Objectives The UK government's response to the obesity epidemic calls for action in communities to improve people's health behaviour. This study evaluated the effects of a community intervention on dietary quality and levels of physical activity of women from disadvantaged backgrounds. Design Non-randomised controlled evaluation of a complex public health intervention. Participants 527 women attending Sure Start Children's Centres (SSCC) in Southampton (intervention) and 495 women attending SSCCs in Gosport and Havant (control). Intervention Training SSCC staff in behaviour change skills that would empower women to change their health behaviours. Outcomes Main outcomes dietary quality and physical activity. Intermediate outcomes self-efficacy and sense of control. Results 1-year post-training, intervention staff used skills to support behaviour change significantly more than control staff. There were statistically significant reductions of 0.1 SD in the dietary quality of all women between baseline and follow-up and reductions in self-efficacy and sense of control. The decline in self-efficacy and control was significantly smaller in women in the intervention group than in women in the control group (adjusted differences in self-efficacy and control, respectively, 0.26 (95% CI 0.001 to 0.50) and 0.35 (0.05 to 0.65)). A lower decline in control was associated with higher levels of exposure in women in the intervention group. There was a statistically significant improvement in physical activity in the intervention group, with 22.9% of women reporting the highest level of physical activity compared with 12.4% at baseline, and a smaller improvement in the control group. The difference in change in physical activity level between the groups was not statistically significant (adjusted difference 1.02 (0.74 to 1.41)). Conclusions While the intervention did not improve women's diets and physical activity levels, it had a protective effect on intermediate factors—control and self-efficacy—suggesting that a more prolonged exposure to the intervention might improve health behaviour. Further evaluation in a more controlled setting is justified. PMID:25031194

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

PubMed

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.

Zoledronic acid infusion for lumbar interbody fusion in osteoporosis.

PubMed

Tu, Chao-Wei; Huang, Kuo-Feng; Hsu, Hsien-Ta; Li, Hung-Yu; Yang, Stephen Shei-Dei; Chen, Yi-Chu

2014-11-01

Clinical outcomes of intravenous (IV) infusion of zoledronic acid (ZOL) for lumbar interbody fusion surgery (LIFS) remain unknown. We investigated the efficacy of IV ZOL on clinical outcome and bone fusion after LIFS. We retrospectively analyzed 64 patients with both degenerative lumbar spondylolisthesis and osteoporosis who underwent LIFS from January 2007 to April 2010. All patients were followed up for 2 y. Thirty-two were treated with an IV infusion of ZOL 3 d after surgery and a second injection 1 y later, and the other 32 patients did not receive ZOL. Preoperatively and every 3 mo postoperatively, oswestry disability index questionnaire and visual analog scale (VAS) scores for back and leg were compared. Preoperative and final postoperative follow-up to evaluate for subsequent compression fractures were also performed. Pedicle screw loosening, cage subsidence, and fusion rate were documented 2 y after surgery. At 2-y follow-up, a solid fusion was achieved in 75% of the ZOL group and only 56% of the control group. At final follow up, the incidence of final subsequent vertebral compression fractures (19% of the ZOL group and 51% of the control group, P = 0.006), pedicle screw loosening (18% of the ZOL group and 45% of the control group, P = 0.03), and cage subsidence >2 mm (28% of the ZOL group and only 54% of the control group, P = 0.04) were significantly lower in the ZOL group than in the control group. The ZOL group demonstrated improvement in VAS (for leg pain VAS, 2/10 for the ZOL group and 5/10 for the control group; for back pain VAS, 2/10 for the ZOL group and 6/10 for the control group) and oswestry disability index scores (7/25 for the ZOL group and 16/25 for the control group). ZOL treatment has beneficial effects on instrumented LIFS both radiographic and clinically. Thus, ZOL treatment can be recommended for osteoporosis patients undergoing LIFS. Copyright © 2014 Elsevier Inc. All rights reserved.

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

PubMed

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 Pilot Randomized Controlled Trial of a Guided Self-Help Intervention to Manage Chronic Orofacial Pain.

PubMed

Goldthorpe, Joanna; Lovell, Karina; Peters, Sarah; McGowan, Linda; Nemeth, Imola; Roberts, Christopher; Aggarwal, Vishal R

2017-01-01

To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain. A pilot randomized controlled trial was conducted to compare the intervention with usual treatment. A total of 37 patients with chronic orofacial pain were randomized into either the intervention group (n = 19) or the usual treatment (control) group (n = 18). Validated outcome measures were used to measure the potential effectiveness of the intervention over a number of domains: physical and mental functioning (Short Form 36 [SF-36]); anxiety and depression (Hospital Anxiety and Depression Scale [HADS]); pain intensity and interference with life (Brief Pain Inventory [BPI]); disability (Manchester Orofacial Pain Disability Scale [MOPDS]); and illness behavior (Revised Illness Perceptions Questionnaire [IPQr]). Bootstrap confidence intervals were computed for the treatment effect (ES) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance. At posttreatment and the 3-month follow-up, 11 participants in the intervention group and 7 in the control group failed to complete outcome measures. The intervention was acceptable and could be feasibly delivered face to face or over the telephone. Although the pilot trial was not powered to draw conclusions about the effectiveness, it showed significant (P < .05) effects of the intervention on physical and mental functioning and treatment control. The self-help intervention was acceptable to patients and allowed them to better understand and self-manage chronic orofacial pain. It showed potential effectiveness on outcome domains related to functioning and illness perception. Further research is needed to understand the cost effectiveness of the intervention for chronic orofacial pain.

Parity, pregnancy and neonatal outcomes in women treated for hyperprolactinaemia compared with a control group.

PubMed

Berinder, Katarina; Hulting, Anna-Lena; Granath, Fredrik; Hirschberg, Angelica Lindén; Akre, Olof

2007-09-01

Infertility is a common problem in women with hyperprolactinaemia. There are limited data on the fertility and pregnancy course among these women. The objective was to study parity, pregnancy and neonatal outcomes in women with hyperprolactinaemia as compared with a control group. Register study. Two hundred and seventy-one female patients treated for primary hyperprolactinaemia were identified in the hospital record archives between 1974 and 2002. For each patient four comparison subjects, matched by sex, birth year and county of residence were identified in the Register of Population. Data were retrieved from the Swedish medical birth register and were analysed using logistic regression and analysis of variance. Measurements Parity, maternal age at first delivery, weeks of gestation, induction of labour, caesarean delivery, multiple birth, Apgar score, birth weight, length, sex, congenital malformations, neonatal care. One hundred and sixty-two deliveries in the hyperprolactinaemia group and 1220 deliveries in the control group were analysed. with hyperprolactinaemia were significantly older at their first pregnancy than their controls: 29.0 (+/- 4.4) and 27.2 (+/- 4.8) years, respectively (P = 0.0002). Furthermore, parity was inversely associated with hyperprolactinaemia status (P for trend = 0.0009). The odds of having three or more children were threefold lower among the patients (OR 0.31 (95% CI 0.16, 0.60)). There were no differences between patients and controls with respect to pregnancy complications, delivery or neonatal outcome variables. We found no evidence of increased risk of pregnancy complications or adverse pregnancy outcomes in women with treated hyperprolactinaemia. However, the patients were older at their first pregnancy and had a reduced overall parity.

Therapeutic temperature modulation for fever after intracerebral hemorrhage.

PubMed

Lord, Aaron S; Karinja, Sarah; Lantigua, Hector; Carpenter, Amanda; Schmidt, J Michael; Claassen, Jan; Agarwal, Sachin; Connolly, E Sander; Mayer, Stephan A; Badjatia, Neeraj

2014-10-01

We sought to determine whether therapeutic temperature modulation (TTM) to treat fever after intracerebral hemorrhage (ICH) is associated with improved hospital complications and discharge outcomes. We performed a retrospective case-control study of patients admitted with spontaneous ICH having two consecutive fevers ≥38.3 °C despite acetaminophen administration. Cases were enrolled from a prospective database of patients receiving TTM from 2006 to 2010. All cases received TTM for fever control with goal temperature of 37 °C with a shiver-control protocol. Controls were matched in severity by ICH score and retrospectively obtained from 2001 to 2004, before routine use of TTM for ICH. Primary outcome was discharge-modified Rankin score. Forty patients were enrolled in each group. Median admission ICH Score, ICH volume, and GCS were similar. TTM was initiated with a median of 3 days after ICH onset and for a median duration of 7 days. Mean daily T max was significantly higher in the control group over the first 12 days (38.1 vs. 38.7 °C, p ≤ 0.001). The TTM group had more days of IV sedation (median 8 vs. 1, p < 0.001) and mechanical ventilation (18 vs. 9, p = 0.003), and more frequently underwent tracheostomy (55 vs. 23 %, p = 0.005). Mean NICU length of stay was longer for TTM patients (15 vs. 11 days, p = 0.007). There was no difference in discharge outcomes between the two groups (overall mortality 33 %, moderate or severe disability 67 %). Therapeutic normothermia is associated with increased duration of sedation, mechanical ventilation, and NICU stay, but is not clearly associated with improved discharge outcome.

Hypnosis for childbirth: a retrospective comparative analysis of outcomes in one obstetrician's practice.

PubMed

VandeVusse, Leona; Irland, Jacqueline; Healthcare, Wheaton Franciscan; Berner, Margaret A; Fuller, Shauna; Adams, Debra

2007-10-01

This exploratory, descriptive study, done retrospectively from perinatal medical records, compared childbirth outcomes in one obstetrician's caseload between 50 women who elected antepartal hypnosis preparation (usually a 5-class series) and 51 who did not. The groups were demographically similar. To achieve similar numbers to the hypnosis group, the control group was randomly selected from the women in the caseload who opted not to take hypnosis preparation, based on characteristics of parity and delivery mode. Prenatal hypnosis preparation resulted in significantly less use of sedatives, analgesia, and regional anesthesia during labor and in higher 1-minute neonatal Apgar scores. Other physiologic and outcome measures did not reveal statistical significance, although some trends were of clinical interest. Well-controlled studies are warranted for clinicians to offer hypnosis more frequently as a pain relief option for childbirth. Additional information provided includes pragmatic, clinical, and cost information about incorporating hypnosis into a physician's practice.

Internet-Delivered Exposure Therapy for Fibromyalgia: A Randomized Controlled Trial.

PubMed

Hedman-Lagerlöf, Maria; Hedman-Lagerlöf, Erik; Axelsson, Erland; Ljótsson, Brjánn; Engelbrektsson, Johanna; Hultkrantz, Sofia; Lundbäck, Karolina; Björkander, Daniel; Wicksell, Rikard K; Flink, Ida; Andersson, Erik

2018-06-01

Fibromyalgia (FM) is a common and disabling chronic pain disorder, for which existing pharmacological and psychological treatments have yet yielded insufficient effects. Previous literature has shown that exposure therapy may be an effective treatment for chronic pain. This study constitutes the first randomized controlled trial evaluating exposure therapy for FM. A total of 140 participants with diagnosed FM were randomized to a 10-week Internet-delivered exposure treatment (iExp; n=70) or a waitlist control condition (WLC; n=70). Primary outcome measure were FM symptoms and impact, and secondary outcome measures were fatigue, disability, quality of life, pain-related distress and avoidance behaviors, insomnia, depression, and anxiety. Data retention was high (100% data completion at posttreatment for primary outcome, 96% at 6-month follow-up and 94% at 12-month follow-up). Results showed that participants in the iExp group made large and superior improvements compared with WLC on FM symptoms and impact (B, -1.93; z, -10.14; P<0.001, between-group Cohen d=0.90), as well as all secondary outcomes (between-group Cohen d ranging from 0.44 to 1.38) with sustained results. We conclude that iExp seems to be an efficacious treatment for FM compared with no treatment, and the results also highlight the potential increase of accessibility by using the Internet format to deliver psychological treatments for these patients. Future trials with active control conditions are warranted.

Improving social functioning and reducing social isolation and loneliness among people with enduring mental illness: Report of a randomised controlled trial of supported socialisation.

PubMed

Sheridan, Ann J; Drennan, Jonathan; Coughlan, Barbara; O'Keeffe, Donal; Frazer, Kate; Kemple, Mary; Alexander, Denise; Howlin, Frances; Fahy, Anne; Kow, Veronica; O'Callaghan, Eadbhard

2015-05-01

This randomised controlled trial examined if for people with enduring mental illness, being supported to socialise leads to improved social functioning, increased self-esteem and extended social networks; a reduction in social isolation, social, emotional and family loneliness and a reduction in illness symptoms, namely depression. A prospective randomised controlled trial was undertaken from November 2007 to September 2011. Service users with a diagnosis of enduring mental illness (>18 years) were invited to participate. Participants were randomly allocated to intervention or control group conditions in a 1:1 ratio. Intervention group participants were matched with a volunteer partner, asked to engage in social/leisure activities for 2 hours weekly over a 9-month period, and received a €20 stipend monthly. Control group participants received a €20 monthly stipend and were asked to engage in a weekly social/leisure activity. Social functioning, the primary outcome, was measured using the Social Functioning Scale (SFS) at three time points (baseline, midpoint and endpoint). In all, 107 people completed this study. There were no significant differences between control and intervention groups at the commencement of the intervention on demographic characteristics or the main outcome measures of interest. Overall social functioning positively changed throughout the three time points from a mean of 99·7 (standard deviation (SD) = 15.1) at baseline, to a mean of 106.0 (SD = 27.0) at the endpoint for the control group, and from a mean of 100·4 (SD = 15.0) at Time 1 for the intervention group, to a mean of 104.1 (SD = 23.4) at the endpoint for the intervention group. The intervention showed no statistical differences between the control and intervention groups on primary or secondary outcome measures. The stipend and the stipend plus volunteer partner led to an increase in recreational social functioning; a decrease in levels of social loneliness, in depression and in the proportion living within a vulnerable social network. © The Author(s) 2014.

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

PubMed

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, <2500 g) and preterm birth (PTB, <37 gestational weeks) were adjusted for maternal age, parity, child gender and year of childbirth. The study group was identified from the Danish national database on children born after TPT. Control groups were obtained from the IVF register and the MBR. All information included in the study was retrieved from the national registers. Considering singletons and twins as one group, the sex ratio (♂/♀) was significantly lower for children born after TPT (0.89) compared with conventional IVF (1.11; P = 0.017) but did not differ significantly when compared with ICSI with ejaculated sperm (0.94) and NC (1.05). The mean birthweight (BW) for singletons did not differ significantly between groups when including only first-born children. The mean gestational age (GA) in the TPT singletons (279 ± 12 days) was significantly higher compared with IVF (276 ± 18 days; P = 0.02), but similar to ICSI with ejaculated sperm and NC singletons when including only first-born children (277 ± 16 days and 279 ± 14 days, respectively). Rate of stillbirths, perinatal and neonatal mortality in the group of TPT singletons did not differ significantly from any of the control groups. Comparable results were found for the TPT twin group, except for perinatal mortality, which was significantly lower in the TPT group compared with naturally conceived twins. The adjusted risk of LBW was significantly higher for TPT versus NC singletons [adjusted odds ratio (AOR) = 0.67 (0.48-0.93)]; however AOR for PTB was similar in the two groups. Regarding twins, similar adjusted risks were observed for PTB and LBW between the TPT and all three control groups. Significantly more Caesarean sections were performed after IVF (27.3% for singletons) and ICSI (25.1% for singletons) with ejaculated sperm compared with the TPT group (16.4% for singletons). The total rate of 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 malformations in singleton boys, and undescended testicles for singleton as well as twin boys were each significantly increased from NC to IVF to ICSI to TPT (P < 0.001). The rate of hypospadias showed the same pattern, but the TPT group did not differ significantly compared with the control groups. One of the limitations is that the TPT group could not be classified according to testicular or epididymal sperm, as these data were not available in the IVF register. Another limitation is that registry-based studies are encumbered with the risk of reporting or coding errors or missing data due to insufficient coding. However, the quality of data on congenital malformations in HDR has, in other studies, been validated and found acceptable for epidemiological research, and furthermore, recordings on study and control groups are performed similarly. Accumulating data show that TPT treatment is equally safe as conventional ICSI and IVF treatment and as NC with regard to neonatal outcome including congenital malformation. This study is supported by Laboratory of Reproductive Biology, Scientific Unit, Horsens Hospital. No competing interests declared.

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

PubMed

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 <1250 g birth weight (n = 168) were randomly assigned in a blinded fashion to receive parenteral nutrition providing 1-2 g/kg/d AA and advancing daily by 0.5 g/kg/d to a goal of 4 g/kg/d (standard AA) or 3-4 g/kg/d and advancing to 4 g/kg/d by day 1. The primary outcome was neurodevelopmental outcomes measured by the Bayley Scales of Infant and 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.

Effects of team-based learning on self-regulated online learning.

PubMed

Whittaker, Alice A

2015-04-10

Online learning requires higher levels of self-regulation in order to achieve optimal learning outcomes. As nursing education moves further into the blended and online learning venue, new teaching/learning strategies will be required to develop and enhance self-regulated learning skills in nursing students. The purpose of this study was to compare the effectiveness of team-based learning (TBL) with traditional instructor-led (IL) learning, on self-regulated online learning outcomes, in a blended undergraduate research and evidence-based practice course. The nonrandomized sample consisted of 98 students enrolled in the IL control group and 86 students enrolled in the TBL intervention group. The percentage of total possible online viewing time was used as the measure of self-regulated online learning activity. The TBL group demonstrated a significantly higher percentage (p < 0.001) of self-regulated learning activities than the IL control group. The TBL group scored significantly higher on the course examinations (p = 0.003). The findings indicate that TBL is an effective instructional strategy that can be used to achieve the essential outcomes of baccalaureate nursing education by increasing self-regulated learning capabilities in nursing students.

Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial.

PubMed

Epstein, Dana R; Sidani, Souraya; Bootzin, Richard R; Belyea, Michael J

2012-06-01

Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. A randomized, controlled study. Veterans Affairs medical center. 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1.

Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial

PubMed Central

Adam, Sophia Helen; Fleischmann, Rebecca Jessica; Baumeister, Harald; Auerbach, Randy; Bruffaerts, Ronny; Cuijpers, Pim; Kessler, Ronald C; Berking, Matthias; Lehr, Dirk; Ebert, David Daniel

2018-01-01

Background Mental health problems are highly prevalent among college students. Most students with poor mental health, however, do not receive professional help. Internet-based self-help formats may increase the utilization of treatment. Objective The aim of this randomized controlled trial was to evaluate the efficacy of an internet-based, app-supported stress management intervention for college students. Methods College students (n=150) with elevated levels of stress (Perceived Stress Scale 4-item version, PSS-4 ≥8) were randomly assigned to either an internet- and mobile-based stress intervention group with feedback on demand or a waitlist control group. Self-report data were assessed at baseline, posttreatment (7 weeks), and 3-month follow-up. The primary outcome was perceived stress posttreatment (PSS-4). Secondary outcomes included mental health outcomes, modifiable risk and protective factors, and college-related outcomes. Subgroup analyses were conducted in students with clinically relevant symptoms of depression (Center for Epidemiological Studies’ Depression Scale >17). Results A total of 106 participants (76.8%) indicated that they were first-time help-seekers, and 77.3% (intervention group: 58/75; waitlist control group: 58/75) showed clinically relevant depressive symptoms at baseline. Findings indicated significant effects of the intervention compared with the waitlist control group for stress (d=0.69; 95% CI 0.36-1.02), anxiety (d=0.76; 95% CI 0.43-1.09), depression (d=0.63; 95% CI 0.30-0.96), college-related productivity (d=0.33; 95% CI 0.01-0.65), academic work impairment (d=0.34; 95% CI 0.01-0.66), and other outcomes after 7 weeks (posttreatment). Response rates for stress symptoms were significantly higher for the intervention group (69%, 52/75) compared with the waitlist control group (35%, 26/75, P<.001; number needed to treat=2.89, 95% CI 2.01-5.08) at posttest (7 weeks). Effects were sustained at 3-month follow-up, and similar findings emerged in students with symptoms of depression. Conclusions Internet- and mobile-based interventions could be an effective and cost-effective approach to reduce consequences of college-related stress and might potentially attract students with clinically relevant depression who would not otherwise seek help. Trial Registration German Clinical Trial Register DRKS00010212; http://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010212 (Archived by WebCite at http://www.webcitation.org/6w55Ewhjd) PMID:29685870

Modified constraint-induced movement therapy or bimanual occupational therapy following injection of Botulinum toxin-A to improve bimanual performance in young children with hemiplegic cerebral palsy: a randomised controlled trial methods paper

PubMed Central

2010-01-01

Background Use of Botulinum toxin-A (BoNT-A) for treatment of upper limb spasticity in children with cerebral palsy has become routine clinical practice in many paediatric treatment centres worldwide. There is now high-level evidence that upper limb BoNT-A injection, in combination with occupational therapy, improves outcomes in children with cerebral palsy at both the body function/structure and activity level domains of the International Classification of Functioning, Disability and Health. Investigation is now required to establish what amount and specific type of occupational therapy will further enhance functional outcomes and prolong the beneficial effects of BoNT-A. Methods/Design A randomised, controlled, evaluator blinded, prospective parallel-group trial. Eligible participants were children aged 18 months to 6 years, diagnosed with spastic hemiplegic cerebral palsy and who were able to demonstrate selective motor control of the affected upper limb. Both groups received upper limb injections of BoNT-A. Children were randomised to either the modified constraint-induced movement therapy group (experimental) or bimanual occupational therapy group (control). Outcome assessments were undertaken at pre-injection and 1, 3 and 6 months following injection of BoNT-A. The primary outcome measure was the Assisting Hand Assessment. Secondary outcomes included: the Quality of Upper Extremity Skills Test; Pediatric Evaluation of Disability Inventory; Canadian Occupational Performance Measure; Goal Attainment Scaling; Pediatric Motor Activity Log; modified Ashworth Scale and; the modified Tardieu Scale. Discussion The aim of this paper is to describe the methodology of a randomised controlled trial comparing the effects of modified constraint-induced movement therapy (a uni-manual therapy) versus bimanual occupational therapy (a bimanual therapy) on improving bimanual upper limb performance of children with hemiplegic cerebral palsy following upper limb injection of BoNT-A. The paper outlines the background to the study, the study hypotheses, outcome measures and trial methodology. It also provides a comprehensive description of the interventions provided. Trial Registration ACTRN12605000002684 PMID:20602795

PBL-GIS in Secondary Geography Education: Does It Result in Higher-Order Learning Outcomes?

ERIC Educational Resources Information Center

Liu, Yan; Bui, Elisabeth N.; Chang, Chew-Hung; Lossman, Hans G.

2010-01-01

This article presents research on evaluating problem-based learning using GIS technology in a Singapore secondary school. A quasi-experimental research design was carried to test the PBL pedagogy (PBL-GIS) with an experimental group of students and compare their learning outcomes with a control group who were exposed to PBL but not GIS. The…