The effects of long- and short-term interdisciplinary treatment approaches in women with fibromyalgia: a randomized controlled trial.

PubMed

Saral, Ilknur; Sindel, Dilsad; Esmaeilzadeh, Sina; Sertel-Berk, Hanife Ozlem; Oral, Aydan

2016-10-01

We investigated the effects of long- and short-term interdisciplinary treatment approaches for reducing symptoms and improving health-related quality of life (HRQoL) and physical functions of patients with fibromyalgia and compared the effects of two different interdisciplinary treatment approaches. We conducted a prospective, randomized, controlled trial involving 66 women with fibromyalgia eligible for the study at a university hospital setting. The patients were randomized into three groups (allocation ratio 1:1:1) using a computer-generated random numbers: a long-term interdisciplinary treatment group (LG, n = 22) that participated in 10 sessions (3-h once-weekly session for 10 weeks) of cognitive behavioral therapy (CBT) together with exercise training and other fibromyalgia related educational programs (two full days); a short-term interdisciplinary treatment group (SG, n = 22) that received two full days of educational, exercise, and CBT programs; and a control group (CG, n = 22). The patients were evaluated at baseline and 6 months after treatment using the visual analog scale (pain, fatigue, and sleep), Fibromyalgia Impact Questionnaire, Beck Depression Inventory, Short Form-36, tender point numbers, and pressure algometry as primary outcomes. The statistical analysis was confined to the 'per-protocol' set. No blinding was performed. The number of patients analyzed was 21 in the LG, 19 in the SG, and 19 in the CG. The intensity of pain (p < 0.001), severity of fatigue (p = 0.048), number of tender points (p = 0.002), and pressure pain threshold (p = 0.012) decreased significantly in both the LG and SG groups compared with controls. Moreover, physical functions (p = 0.017) and physical components of the HRQoL (p = 0.036) improved significantly in the intervention groups compared with the controls. However, there was no significant difference between intervention groups and the control group at the end of study in terms of quality of sleep (p = 0.055), severity of depressive symptoms (p = 0.696), and mental components of the HRQoL (p = 0.229). Finally, with the exception of the severity of fatigue and physical components of the HRQoL, there was no obvious significant difference between the efficacies of the two treatment approaches when compared with controls; the long-term treatment was found more effective in reducing pain than the short-term. Both, long- and short-term interdisciplinary treatments were effective in reducing the severity of some symptoms and disease activity in patients with fibromyalgia. The short-term program well meets the needs of women with fibromyalgia particularly in relation to pain and health status as measured using FIQ; however, a long-term program may be beneficial in reducing fatigue and improving physical function to a higher extent.

Long-Term Outcomes of Cognitive-Behavioral Treatments for Posttraumatic Stress Disorder among Female Rape Survivors

ERIC Educational Resources Information Center

Resick, Patricia A.; Williams, Lauren F.; Suvak, Michael K.; Monson, Candice M.; Gradus, Jaimie L.

2012-01-01

Objective: We conducted a long-term follow-up (LTFU) assessment of participants from a randomized controlled trial comparing cognitive processing therapy (CPT) with prolonged exposure (PE) for posttraumatic stress disorder (PTSD). Competing hypotheses for positive outcomes (i.e., additional therapy, medication) were examined. Method:…

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: long-term follow-up of a randomized controlled trial.

PubMed

Hallén, Magnus; Bergenfelz, Anders; Westerdahl, Johan

2008-03-01

We have conducted a randomized controlled trial of totally extraperitoneal hernia repair (TEP) versus tension-free open repair (Lichtenstein repair); we have presented the results previously up to 1 year after the operation. The aim of this study was to compare patient outcome in both groups at a median follow-up of 7.3 years after operation. Of 168 patients included in a prospective, randomized controlled trial designed to compare TEP with an open tension-free technique, 154 patients (92%) answered a questionnaire and 147 patients (88%) were followed up at an outpatient clinic after a minimum of 6 years after operation. Overall, 89% of patients in the TEP group and 95% of patients in the open group reported complete long-term recovery (P = .23). Permanent impaired inguinal sensibility was more common in the open group (P = .004), whereas the proportion of patients with reported testicular pain was higher in the TEP group (P = .003). Three recurrences were found in the TEP group, and 4 recurrences were found in the open group (P = .99). Four patients in the TEP group underwent operations for complications related to the hernia repair (small bowel obstruction, umbilical hernia, testicular pain, and neuralgia). Overall, both groups showed good long-term results with low rates of recurrences. However, the TEP group was associated with a higher proportion of patients with long-term testicular pain, whereas impaired inguinal sensibility was more common in the open group.

Efficacy and Safety of Proton Pump Inhibitors in the Long-Term Aspirin Users: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Dahal, Khagendra; Sharma, Sharan P; Kaur, Jaspreet; Anderson, Billie J; Singh, Gurpinder

Long-term aspirin use in cardiovascular disease prevention may result in gastrointestinal bleeding. Although proton pump inhibitors (PPI) have been shown to reduce the risks of peptic ulcers and dyspeptic symptoms in long-term aspirin users in the randomized controlled trials, there are safety concerns about the long-term use of PPI. What is the safety and efficacy of PPI in patients using aspirin in long term for prevention of cardiovascular diseases and stroke? We searched MEDLINE, EMBASE, CENTRAL, CINAHL, ProQuest, and relevant references from inception through February 2015, and used random-effects model for meta-analysis. A total of 10 publications from 9 studies (n = 6382) were included in the meta-analysis. Compared with control, PPI reduced the risks of peptic ulcers [risk ratio (RR): 0.19; 95% confidence interval: 0.13-0.26; P < 0.00001], gastric ulcers [0.24 (0.16-0.35); P < 0.00001], duodenal ulcers [0.12 (0.05-0.29); P < 0.00001], bleeding ulcers [0.22 (0.10-0.51); P = 0.0004], and erosive esophagitis [0.14 (0.07-0.28); P < 0.00001]. PPI increased the resolution of epigastric pain [1.13 (1.03-1.25); P = 0.01], heartburn [1.24 (1.18-1.31); P < 0.00001], and regurgitation [1.26 (1.13-1.40); P < 0.0001], but did not increase the risks of all-cause mortality [1.72 (0.61-4.87); P = 0.31], cardiovascular mortality [1.80 (0.59-5.44); P = 0.30], nonfatal myocardial infarction/ischemia [0.56 (0.22-1.41); P = 0.22], ischemic stroke/transient ischemic attack [1.09 (0.34-3.53); P = 0.89] and other adverse events. The PPI seems to be effective in preventing peptic ulcers and erosive esophagitis and in resolution of dyspeptic symptoms without increasing adverse events, cardiac risks or mortality in long-term aspirin users.

Efficacy of lifestyle modification for long-term weight control.

PubMed

Wadden, Thomas A; Butryn, Meghan L; Byrne, Kirstin J

2004-12-01

A comprehensive program of lifestyle modification induces loss of approximately 10% of initial weight in 16 to 26 weeks, as revealed by a review of recent randomized controlled trials, including the Diabetes Prevention Program. Long-term weight control is facilitated by continued patient-therapist contact, whether provided in person or by telephone, mail, or e-mail. High levels of physical activity and the consumption of low-calorie, portion-controlled meals, including liquid meal replacements, can also help maintain weight loss. Additional studies are needed of the effects of macronutrient content (e.g., low-fat vs. low-carbohydrate diets) on long-term changes in weight and health. Research also is needed on effective methods of providing comprehensive weight loss control to the millions of Americans who need it.

A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control.

PubMed

Carter, Barry L; Clarke, William; Ardery, Gail; Weber, Cynthia A; James, Paul A; Vander Weg, Mark; Chrischilles, Elizabeth A; Vaughn, Thomas; Egan, Brent M

2010-07-01

Numerous studies have demonstrated the value of team-based care to improve blood pressure (BP) control, but there is limited information on whether these models would be adopted in diverse populations. The purpose of this study was to evaluate whether a collaborative model between physicians and pharmacists can improve BP control in multiple primary care medical offices with diverse geographic and patient characteristics and whether long-term BP control can be sustained. This study is a randomized prospective trial in 27 primary care offices first stratified by the percentage of underrepresented minorities and the level of clinical pharmacy services within the office. Each office is then randomized to either a 9- or 24-month intervention or a control group. Patients will be enrolled in this study until 2012. The results of this study should provide information on whether this model can be implemented in large numbers of diverse offices, if it is effective in diverse populations, and whether BP control can be sustained long term. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00935077.

Long-term moderate calorie restriction inhibits inflammation without impairing cell-mediated immunity: a randomized controlled trial in non obese humans

USDA-ARS?s Scientific Manuscript database

Calorie restriction (CR) inhibits inflammation and slows aging in many animal species, but in rodents housed in pathogen-free facilities, CR impairs immunity against certain pathogens. However, little is known about the effects of long-term moderate CR on immune function in humans. In this multi-cen...

Remediating Organizational Functioning in Children with ADHD: Immediate and Long-Term Effects from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Abikoff, Howard; Gallagher, Richard; Wells, Karen C.; Murray, Desiree W.; Huang, Lei; Lu, Feihan; Petkova, Eva

2013-01-01

Objective: The study compared the efficacy of 2 behavioral interventions to ameliorate organization, time management, and planning (OTMP) difficulties in 3rd- to 5th-grade children with attention-deficit/hyperactivity disorder (ADHD). Method: In a dual-site randomized controlled trial, 158 children were assigned to organizational skills training…

Maintaining Engagement in Long-term Interventions with Relational Agents

PubMed Central

Bickmore, Timothy; Schulman, Daniel; Yin, Langxuan

2011-01-01

We discuss issues in designing virtual humans for applications which require long-term voluntary use, and the problem of maintaining engagement with users over time. Concepts and theories related to engagement from a variety of disciplines are reviewed. We describe a platform for conducting studies into long-term interactions between humans and virtual agents, and present the results of two longitudinal randomized controlled experiments in which the effect of manipulations of agent behavior on user engagement was assessed. PMID:21318052

Effects of resistance and functional-skills training on habitual activity and constipation among older adults living in long-term care facilities: a randomized controlled trial.

PubMed

Chin A Paw, Marijke J M; van Poppel, Mireille N M; van Mechelen, Willem

2006-07-31

Large-scale RCTs comparing different types of exercise training in institutionalised older people are scarce, especially regarding effects on habitual physical activity and constipation. This study investigated the effects of different training protocols on habitual physical activity and constipation of older adults living in long-term care facilities. A randomized controlled trial with 157 participants, aged 64 to 94 years, who were randomly assigned to 1) resistance training; 2) all-round functional-skills training; 3) both; or 4) an 'educational' control condition. Habitual physical activity was assessed with a physical activity questionnaire and accelerometers. Constipation was assessed by a questionnaire. Measurements were performed at baseline and after six months of training. At baseline the median time spent sitting was 8.2 hr/d, the median time spent on activity of at least moderate intensity was 32 min/d. At baseline, about 22% of the subjects were diagnosed with constipation and 23% were taking laxatives. There were no between-group differences for changes in habitual physical activity or constipation over 6-months. Six months of moderate intensity exercise training neither enhances habitual physical activity nor affects complaints of constipation among older people living in long-term care facilities.

Long-term outcomes and recurrence patterns of standard versus extended pancreatectomy for pancreatic head cancer: a multicenter prospective randomized controlled study.

PubMed

Jang, Jin-Young; Kang, Jae Seung; Han, Youngmin; Heo, Jin Seok; Choi, Seong Ho; Choi, Dong Wook; Park, Sang Jae; Han, Sung-Sik; Yoon, Dong Sup; Park, Joon Seong; Yu, Hee Chul; Kang, Koo Jeong; Kim, Sang Geol; Lee, Hongeun; Kwon, Wooil; Yoon, Yoo-Seok; Han, Ho-Seong; Kim, Sun-Whe

2017-07-01

Our previous randomized controlled trial revealed no difference in 2-year overall survival (OS) between extended and standard resection for pancreatic adenocarcinoma. The present study evaluated the 5-year OS and recurrence patterns according to the extent of pancreatectomy. Between 2006 and 2009, 169 consecutive patients were prospectively enrolled and randomized to standard (n = 83) or extended resection (n = 86) groups to compare 5-year OS rate, long-term recurrence patterns and factors associated with long-term survival. The surgical R0 rate was similar between the standard and extended groups (85.5 vs. 90.7%, P = 0.300). Five-year OS (18.4 vs. 14.4%, P = 0.388), 5-year disease-free survival (14.8 vs. 14.0%, P = 0.531), and overall recurrence rates (74.7 vs. 69.9%, P = 0.497) were not significantly different between the two groups, although the incidence of peritoneal seeding was higher in the extended group (25 vs. 8.1%, P = 0.014). Extended pancreatectomy does not have better short-term and long-term survival outcomes, and shows similar R0 rates and overall recurrence rates compared with standard pancreatectomy. Extended pancreatectomy does not have to be performed routinely for all cases of resectable pancreatic adenocarcinoma, especially considering its associated increased morbidity shown in our previous study. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

PubMed

Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Zhang-Jin; Chan, Wai-Chi; Zhang, Shi-Ping; Ng, Roger Man-Kin; Chan, Connie Lai-Wah; Ho, Lai-Ming; Yu, Yee-Man; Lao, Li-Xing

2017-03-31

Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. ClinicalTrials.gov NCT02475538 .

[Hyaluronate sodium treatment for internal derangement of temporomandibular joint: a systematic review based on randomized controlled trials].

PubMed

Li, Chunjie; Zhang, Yifan; Jia, Yuanyuan; Lü, Jun; Li, Longjiang; Shi, Zong-Dao

2011-10-01

To assess the efficacy and safety of hyaluronate sodium (HS) for internal derangement of temporomandibular joint by means of systematic review on relevant randomized controlled trials. After identifing the study question of the efficacy and safety of HS for internal derangement of temporomandibular joint, Medline, Cochrane Controlled Trials Register, EMBASE, OPEN SIGLE and CBM were searched electronically till October 3rd 2010. Hand-searching covering 19 dental journals in Chinese were also performed. Risk of bias assessment, with Cochrane Collaboration's tool, and data extraction of included studies were conducted by two reviewers in duplicate. Meta analysis was done with Revman 5.0.23 and the quality of evidence was evaluated by GRADE. 10 randomized controlled trials met the eligibility criteria and were included. All these studies had unclear risk of bias. When compared with negative control, HS showed a significant advantage on maximal mouth opening in short and long-term (P < 0.05), and clinical overall assessment in short-term (P < 0.05), but its effect on pain control and long-term effect on clinical overall assessment had no extra benefit (P > 0.05). Additionally, when compared with glucocorticoids, the participants who received HS injection would get a better clinical overall assessment in short-term and less adverse drug reactions (P < 0.05), but presented a similar temporomandibular joint pain relief and maximal mouth opening (P > 0.05). To a certain extent, HS had good efficacy and better safety than controls when treating internal derangement of temporomandibular joint. However, as the quality of some included studies were limited, more randomized controlled trials are needed to reinforce the conclusion.

Long-term Effects of Two Levels of Caloric Restriction on Body Composition, and Diet Satisfaction in CALERIE, a One Year Randomized Controlled Trial

USDA-ARS?s Scientific Manuscript database

There is little information on whether the extent of dietary energy restriction in a weight loss program influences long-term weight change. We examined the effects of two levels of caloric restriction (CR) over 12 months on body weight and fat loss, total energy expenditure (TEE), resting metabolic...

Habit Reversal versus Object Manipulation Training for Treating Nail Biting: A Randomized Controlled Clinical Trial

PubMed Central

Ghanizadeh, Ahmad; Bazrafshan, Amir; Dehbozorgi, Gholamreza

2013-01-01

Objective This is a parallel, three group, randomized, controlled clinical trial, with outcomes evaluated up to three months after randomization for children and adolescents with chronic nail biting. The current study investigates the efficacy of habit reversal training (HRT) and compares its effect with object manipulation training (OMT) considering the limitations of the current literature. Method Ninety one children and adolescents with nail biting were randomly allocated to one of the three groups. The three groups were HRT (n = 30), OMT (n = 30), and wait-list or control group (n = 31). The mean length of nail was considered as the main outcome. Results The mean length of the nails after one month in HRT and OMT groups increased compared to the waiting list group (P < 0.001, P < 0.001, respectively). In long term, both OMT and HRT increased the mean length of nails (P < 0.01), but HRT was more effective than OMT (P < 0.021). The parent-reported frequency of nail biting did show similar results as to the mean length of nails assessment in long term. The number of children who completely stopped nail biting in HRT and OMT groups during three months was 8 and 7, respectively. This number was zero during one month for the wait-list group. Conclusion This trial showed that HRT is more effective than wait-list and OMT in increasing the mean length of nails of children and adolescents in long terms. PMID:24130603

Does Maintenance CBT Contribute to Long-Term Treatment Response of Panic Disorder with or without Agoraphobia? A Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

White, Kamila S.; Payne, Laura A.; Gorman, Jack M.; Shear, M. Katherine; Woods, Scott W.; Saksa, John R.; Barlow, David H.

2013-01-01

Objective: We examined the possibility that maintenance cognitive behavior therapy (M-CBT) may improve the likelihood of sustained improvement and reduced relapse in a multi-site randomized controlled clinical trial of patients who met criteria for panic disorder with or without agoraphobia. Method: Participants were all patients (N = 379) who…

Long-term outcomes of acute kidney injury.

PubMed

Coca, Steven G

2010-05-01

The goal of this review is to summarize the recent plethora of data that relate to long-term outcomes after acute kidney injury (AKI). Surviving patients with AKI are still at high risk for long-term adverse outcomes, even if serum creatinine returns to normal. After adjusting for potential confounders, many recent studies have demonstrated that AKI is independently associated with chronic kidney disease, end-stage renal disease, and premature death. Unfortunately, definitive evidence from randomized controlled trials demonstrating that prevention or treatment of AKI prevents long-term adverse outcomes is not yet available. AKI is clearly a prognostic marker for poor long-term outcomes, but more studies will be needed to determine whether AKI is truly causal and whether or not the risk is modifiable.

Prevention of fall-related injuries in long-term care: a randomized controlled trial of staff education.

PubMed

Ray, Wayne A; Taylor, Jo A; Brown, Anne K; Gideon, Patricia; Hall, Kathi; Arbogast, Patrick; Meredith, Sarah

2005-10-24

Fall-related injuries, a major public health problem in long-term care, may be reduced by interventions that improve safety practices. Previous studies have shown that safety practice interventions can reduce falls; however, in long-term care these have relied heavily on external funding and staff. The aim of this study was to test whether a training program in safety practices for staff could reduce fall-related injuries in long-term care facilities. A cluster randomization clinical trial with 112 qualifying facilities and 10,558 study residents 65 years or older and not bedridden. The intervention was an intensive 2-day safety training program with 12-month follow-up. The training program targeted living space and personal safety; wheelchairs, canes, and walkers; psychotropic medication use; and transferring and ambulation. The main outcome measure was serious fall-related injuries during the follow-up period. There was no difference in injury occurrence between the intervention and control facilities (adjusted rate ratio, 0.98; 95% confidence interval, 0.83-1.16). For residents with a prior fall in facilities with the best program compliance, there was a nonsignificant trend toward fewer injuries in the intervention group (adjusted rate ratio, 0.79; 95% confidence interval, 0.57-1.10). More intensive interventions are required to prevent fall-related injuries in long-term care facilities.

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

PubMed

Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

2012-05-01

Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

Preventive Intervention for Preschoolers at High Risk for Antisocial Behavior: Long-Term Effects on Child Physical Aggression and Parenting Practices

ERIC Educational Resources Information Center

Brotman, Laurie Miller; Gouley, Kathleen Kiely; Huang, Keng-Yen; Rosenfelt, Amanda; O'Neal, Colleen; Klein, Rachel G.; Shrout, Patrick

2008-01-01

This article presents long-term effects of a preventive intervention for young children at high risk for antisocial behavior. Ninety-two children (M age = 4 years) were randomly assigned to an 8-month family intervention or no-intervention control condition and assessed 4 times over a 24-month period. Intent-to-treat analyses revealed significant…

Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

ERIC Educational Resources Information Center

Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

2009-01-01

Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

Short- and long-term eating habit modification predict weight change in overweight, post-menopausal women: results from the WOMAN Study

PubMed Central

Gibbs, Bethany Barone; Kinzel, Laura S.; Gabriel, Kelley Pettee; Chang, Yue-fang; Kuller, Lewis H.

2012-01-01

Background Standard behavioral obesity treatment produces poor long-term results. Focusing on healthy eating behaviors, rather than caloric intake, may be an alternative strategy. Furthermore, important behaviors might differ for short- vs. long-term weight control. Objective To describe and compare associations between changes in eating behaviors and weight after 6 and 48 months Design Secondary analysis of data collected during a randomized weight loss intervention trial with 48-month follow-up Participants 465 overweight and obese postmenopausal women enrolled in the Women on the Move through Activity and Nutrition (WOMAN) Study Main outcome measures Changes in weight from baseline to 6 and 48 months. Statistical analyses performed Linear regression models examined the associations between 6- and 48-month changes in eating habits assessed by the Conner Diet Habit Survey and changes in weight. Analyses were conducted in the combined study population and stratified by randomization group. Results At 6 months in the combined population, weight loss was independently associated with decreased desserts (p<0.001), restaurant eating (p=0.042), sugar-sweetened beverages (p=0.009), and fried foods (p<0.001), and increased fish consumption (p=0.003). Results were similar in intervention participants; only reduced desserts and fried foods associated with weight loss in controls. At 48 months in the combined population, weight loss was again associated with decreased desserts (p=0.003) and sugar-sweetened beverages (p=0.011), but also decreased meats/cheeses (p=0.024) and increased fruits/vegetables (p<0.001). Decreased meats/cheeses predicted weight loss in intervention participants; desserts, sugar-sweetened beverages, and fruits/vegetables were independently associated in controls. Conclusions Changes in eating behaviors were associated with weight change, though important behaviors differed for short- and long-term weight change and by randomization group. Future studies should determine whether interventions targeting these behaviors could improve long-term obesity treatment outcomes. PMID:22939439

Effects of long-term self-massage at the musculotendinous junction on hamstring extensibility, stiffness, stretch tolerance, and structural indices: A randomized controlled trial.

PubMed

Akazawa, Naoki; Okawa, Naomi; Kishi, Masaki; Nakatani, Kiyoshi; Nishikawa, Katsuya; Tokumura, Daichi; Matsui, Yuji; Moriyama, Hideki

2016-09-01

The purpose of this study was to examine the effect of long-term self-massage at the musculotendinous junction on hamstring extensibility, stiffness, stretch tolerance, and structural indices. Single-blind, randomized, controlled trial. Laboratory. Thirty-seven healthy men. The right or left leg of each participant was randomly assigned to the massage group, and the other leg was assigned to the control group. The participants conducted self-massage at the musculotendinous junction for 3 min daily, five times per week, for 12 weeks. Hamstring extensibility, stiffness, stretch tolerance, and structural indices were measured by a blinded examiner prior to the massage intervention and after 6 and 12 weeks of intervention. The maximum hip flexion angle (HFA) and the maximum passive pressure after 6 and 12 weeks of intervention in the massage group were significantly higher than prior to intervention. The visual analog scale (for pain perception) at maximum HFA, the stiffness of the hamstring, and the structural indices did not differ in either group over the 12 week period. Our results suggest that long-term self-massage at the musculotendinous junction increases hamstring extensibility by improving stretch tolerance. However, this intervention does not change hamstring stiffness. University Hospital Medical Information Network registration number UMIN000011233. Copyright © 2016 Elsevier Ltd. All rights reserved.

Dor Vs Toupet Fundoplication After Laparoscopic Heller Myotomy: Long-Term Randomized Controlled Trial Evaluated by High-Resolution Manometry.

PubMed

Torres-Villalobos, Gonzalo; Coss-Adame, Enrique; Furuzawa-Carballeda, Janette; Romero-Hernández, Fernanda; Blancas-Breña, Blanca; Torres-Landa, Samuel; Palacios-Ramírez, Axel; Alejandro-Medrano, Edgar; Hernández-Ávila, Axel; Flores-Najera, Athenea; Ávila Escobedo, Lourdes Margarita; Ramírez Angulo, Cecilia; Rodríguez-Garcés, Angélica; Valdovinos, Miguel Ángel

2018-01-01

Laparoscopic Heller myotomy (LHM) with partial fundoplication is an effective treatment for achalasia. However, the type of fundoplication is still a subject of debate. The aim of the study is to identify which partial fundoplication leads to better control of acid exposure, manometric parameters, and symptoms scores. A randomized controlled trial was performed to compare Dor vs Toupet fundoplication after LHM. The preoperative diagnosis was made by high-resolution manometry (HRM), upper endoscopy, and barium esophagogram. Preoperative and postoperative symptoms were evaluated with Eckardt, GERD-HRQL, and EAT-10 questionnaires. Seventy-three patients were randomized, 38 underwent Dor and 35 Toupet. Baseline characteristics were similar between groups. Postoperative HRM showed that the integrated relaxation pressure (IRP) and basal lower esophageal sphincter (LES) pressure were similar at 6 and 24 months. The number of patients with abnormal acid exposure was significantly lower for Dor (6.9%) than that of Toupet (34.0%) at 6 months, but it was not different at 12 or 24 months. No differences were found in postoperative symptom scores at 1, 6, or 24 months. There were no differences in symptom scores or HRM between fundoplications in the long term. A higher percentage of abnormal 24-h pH test were found for the Toupet group, with no difference in the long term.

Impact of eLearning course on nurses' professional competence in seclusion and restraint practices: 9-month follow-up results of a randomized controlled study (ISRCTN32869544).

PubMed

Kontio, R; Hätönen, H; Joffe, G; Pitkänen, A; Lahti, M; Välimäki, M

2013-04-01

eLearning may facilitate continuing vocational education, but data on the long-term effects of an eLearning course are lacking. The aim of this study was to explore the long-term impact of an eLearning course entitled ePsychNurse.Net on psychiatric nurses' professional competence in practicing seclusion and restraint and on their job satisfaction and general self-efficacy at 9-month follow-up. In a randomized controlled study, 12 wards were randomly assigned to the ePsychNurse.Net (intervention) or training as usual (control). Baseline and 9-month follow-up data on nurses' knowledge of coercion-related legislation, physical restraint and seclusion, their attitudes towards physical restraint and seclusion, job satisfaction and general self-efficacy were analysed for 137 completers (those who participated in the 9-month follow-up assessment). No between-group differences were found on any variable, with the exception of a change in attitude to seclusion in favour of the control group. The findings of the long-term effects did not differ from the immediate outcomes (3-month follow-up) and the improved level of knowledge acquired and further consolidation of that knowledge did not take place in the 6-month period after the 3-month ePsychNurse.Net course. The ePsychNurse.Net should be further developed and its future modifications will require additional studies, probably with some new outcome measures. © 2012 Blackwell Publishing.

Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke.

PubMed

Bethoux, Francois; Rogers, Helen L; Nolan, Karen J; Abrams, Gary M; Annaswamy, Thiru; Brandstater, Murray; Browne, Barbara; Burnfield, Judith M; Feng, Wuwei; Freed, Mitchell J; Geis, Carolyn; Greenberg, Jason; Gudesblatt, Mark; Ikramuddin, Farha; Jayaraman, Arun; Kautz, Steven A; Lutsep, Helmi L; Madhavan, Sangeetha; Meilahn, Jill; Pease, William S; Rao, Noel; Seetharama, Subramani; Sethi, Pramod; Turk, Margaret A; Wallis, Roi Ann; Kufta, Conrad

2015-01-01

Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle foot orthoses (AFO) for treatment of foot drop poststroke, but few long-term, randomized controlled comparisons exist. Compare changes in gait quality and function between FES and AFOs in individuals with foot drop poststroke over a 12-month period. Follow-up analysis of an unblinded randomized controlled trial (ClinicalTrials.gov #NCT01087957) conducted at 30 rehabilitation centers comparing FES to AFOs over 6 months. Subjects continued to wear their randomized device for another 6 months to final 12-month assessments. Subjects used study devices for all home and community ambulation. Multiply imputed intention-to-treat analyses were utilized; primary endpoints were tested for noninferiority and secondary endpoints for superiority. Primary endpoints: 10 Meter Walk Test (10MWT) and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test (6MWT), GaitRite Functional Ambulation Profile, and Modified Emory Functional Ambulation Profile (mEFAP). A total of 495 subjects were randomized, and 384 completed the 12-month follow-up. FES proved noninferior to AFOs for all primary endpoints. Both FES and AFO groups showed statistically and clinically significant improvement for 10MWT compared with initial measurement. No statistically significant between-group differences were found for primary or secondary endpoints. The FES group demonstrated statistically significant improvements for 6MWT and mEFAP Stair-time subscore. At 12 months, both FES and AFOs continue to demonstrate equivalent gains in gait speed. Results suggest that long-term FES use may lead to additional improvements in walking endurance and functional ambulation; further research is needed to confirm these findings. © The Author(s) 2015.

Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial.

PubMed

Mao, Jun J; Li, Qing S; Soeller, Irene; Rockwell, Kenneth; Xie, Sharon X; Amsterdam, Jay D

2014-11-01

Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile ( Matricaria recutita ) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and long-term safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD). 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500-1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500-1,500 mg daily or placebo for an additional 26 weeks. The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy. Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD.

Validity, Significance, Strengths, Limitations, and Evidentiary Value of Real-World Clinical Data for Combination Therapy in Alzheimer's Disease: Comparison of Efficacy and Effectiveness Studies

PubMed Central

Atri, Alireza; Rountree, Susan D.; Lopez, Oscar L.; Doody, Rachelle S.

2012-01-01

Background Randomized controlled efficacy trials (RCTs), the scientific gold standard, are required for regulatory approval of Alzheimer's disease (AD) interventions, yet provide limited information regarding real-world therapeutic effectiveness. Objective: To compare the nature of evidence regarding the combination of approved AD treatments from RCTs versus long-term observational controlled studies (LTOCs). Methods Comparisons of strengths, limitations, and evidence level for monotherapy [cholinesterase inhibitor (ChEI) or memantine] and combination therapy (ChEI + memantine) in RCTs versus LTOCs. Results RCTs examined highly selected populations over months. LTOCs collected data across multiple AD stages in large populations over many years. RCTs and LTOCs show similar patterns favoring combination over monotherapy over placebo/no treatment. Long-term combination therapy compared to monotherapy reduced cognitive and functional decline and delayed time to nursing home admission. Persistent treatment was associated with slower decline. While LTOCs used control groups, adjusted for multiple covariates, had higher external validity, and favorable ethical, practical and cost considerations, their limitations included potential selection bias due to lack of placebo comparisons and randomization. Conclusions Naturalistic LTOCs provide complementary long-term level II evidence to complement level I evidence from short-term RCTs regarding therapeutic effectiveness in AD that may otherwise be unobtainable. A coordinated strategy/consortium to pool LTOC data from multiple centers to estimate long-term comparative effectiveness, risks/benefits, and costs of AD treatments is needed. PMID:22327239

Cluster-randomized, controlled trial of computer-based decision support for selecting long-term anti-thrombotic therapy after acute ischaemic stroke.

PubMed

Weir, C J; Lees, K R; MacWalter, R S; Muir, K W; Wallesch, C-W; McLelland, E V; Hendry, A

2003-02-01

Identifying the appropriate long-term anti-thrombotic therapy following acute ischaemic stroke is a challenging area in which computer-based decision support may provide assistance. To evaluate the influence on prescribing practice of a computer-based decision support system (CDSS) that provided patient-specific estimates of the expected ischaemic and haemorrhagic vascular event rates under each potential anti-thrombotic therapy. Cluster-randomized controlled trial. We recruited patients who presented for a first investigation of ischaemic stroke or TIA symptoms, excluding those with a poor prognosis or major contraindication to anticoagulation. After observation of routine prescribing practice (6 months) in each hospital, centres were randomized for 6 months to either control (routine practice observed) or intervention (practice observed while the CDSS provided patient-specific information). We compared, between control and intervention centres, the risk reduction (estimated by the CDSS) in ischaemic and haemorrhagic vascular events achieved by long-term anti-thrombotic therapy, and the proportions of subjects prescribed the optimal therapy identified by the CDSS. Sixteen hospitals recruited 1952 subjects. When the CDSS provided information, the mean relative risk reduction attained by prescribing increased by 2.7 percentage units (95%CI -0.3 to 5.7) and the odds ratio for the optimal therapy being prescribed was 1.32 (0.83 to 1.80). Some 55% (5/9) of clinicians believed the CDSS had influenced their prescribing. Cluster-randomized trials provide excellent frameworks for evaluating novel clinical management methods. Our CDSS was feasible to implement and acceptable to clinicians, but did not substantially influence prescribing practice for anti-thrombotic drugs after acute ischaemic stroke.

Is the Whipple procedure harmful for long-term outcome in treatment of chronic pancreatitis? 15-years follow-up comparing the outcome after pylorus-preserving pancreatoduodenectomy and Frey procedure in chronic pancreatitis.

PubMed

Bachmann, Kai; Tomkoetter, Lena; Kutup, Asad; Erbes, Johannes; Vashist, Yogesh; Mann, Oliver; Bockhorn, Maximilian; Izbicki, Jakob R

2013-11-01

The aim of this study was to report on 15-year long-term results of a randomized controlled trial comparing extended drainage procedure (Frey) and classical resectional procedure [pylorus-preserving pancreatoduodenectomy (PD)] in patients with chronic pancreatitis. Chronic pancreatitis is a common inflammatory disease with a prevalence of 10 to 30 cases per 100,000 inhabitants. It is characterized by the progressive conversion of pancreatic parenchyma to fibrous tissue. Different surgical procedures are used in treatment of persistent pain. Sixty-four patients suffering from chronic pancreatitis with inflammatory mass in the pancreatic head were randomly assigned in 2 treatment groups (PD, n = 32) and (Frey, n = 32). The perioperative course of the randomized controlled trial and the 7 years follow-up have been previously published. All participating patients were contacted with a standardized, validated questionnaire (EORTC QLQ C30) to evaluate the long-term survival, quality-of-life pain, and exocrine and endocrine function. In the 15-year long-term follow-up, the pain control was good and comparable between both groups, but the quality of life was better after Frey procedure in regard of the physical status [PD: 100 (0-100) vs PD: 60 (0-100) (P = 0.011)]. No significant differences in terms of the Pain Score were detected between both groups [PD: 7 (0-100) vs Frey 4 (0-100) P = 0.258]. Seven patients after Frey OP and 6 patients after PD were free of pain. Analyzing the postoperative overall survival, a higher long-term mortality was found after PD (53%) than that found after Frey procedure (30%) resulting in a longer mean survival (14.5 ± 0.8 vs 11.3 ± 0.8 years; P = 0.037). No correlation between endocrine or exocrine pancreatic function and pain was found, whereas continuous alcohol consumption was associated with poorer outcome regarding quality of life (P < 0.001) and pain score (P < 0.001). PD and Frey procedure provide good and permanent pain relief and improvement of the quality of life in long-term follow-up. In addition, a longer survival was found after the organ sparing resection. Together with better short-term results, the organ-sparing procedure seems to be favorable in treatment of chronic pancreatitis.

Effect of whey protein supplementation on long and short term appetite: A meta-analysis of randomized controlled trials.

PubMed

Mollahosseini, Mehdi; Shab-Bidar, Sakineh; Rahimi, Mohammad Hossein; Djafarian, Kurosh

2017-08-01

Specific components of dairy, such as whey proteins may have beneficial effects on body composition by suppressing appetite, although the findings of existing studies have been inconsistent. Therefore, a meta-analysis of randomized controlled trials was performed to investigate effect of whey protein supplementation on long and short term appetite. A systematic search was conducted to identify eligible publications. Means and SDs for hunger, fullness, satiety, desire to eat and prospective consumption of food, before and after intervention, were extracted and then composite appetite score (CAS) calculated. To pool data, either a fixed-effects model or a random-effects model and for assessing heterogeneity, Cochran's Q and I 2 tests were used. Eight publications met inclusion criteria that 5 records were on short term and 3 records on long term appetite. The meta-analysis showed a significant reduction in long term appetite by 4.13 mm in combined appetite score (CAS) (95% Confidence interval (CI): -6.57, -1.96; p = 0.001). No significant reduction in short term appetite was also seen (Mean difference (MD) = -0.39 95% CI = -2.07, 1.30; p = 0.653). Subgroup analyses by time showed that compared with carbohydrate, the reduction in appetite following consumption of whey consumption was not significant (MD = -0.39, 95% CI = -2.07, 1.3, p = 0.65, I 2  = 0.0%.)A significant reduction in prospective food consumption was seen (MD = -2.17, 95% CI = -3.86, -0.48). The results of our meta-analysis showed that whey protein may reduce the long and short term appetite, but our finding did not show any significant difference in appetite reduction between whey protein and carbohydrate in short duration. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer.

PubMed

Björneklett, Helena Granstam; Rosenblad, Andreas; Lindemalm, Christina; Ojutkangas, Marja-Leena; Letocha, Henry; Strang, Peter; Bergkvist, Leif

2013-04-01

Despite a fairly good prognosis, many breast-cancer patients suffer from symptoms such as anxiety, depression and fatigue, which may affect health-related quality of life and may persist for several years. The aim of the present study was to perform a long-term follow-up of a randomized study of support group intervention in women after primary breast cancer treatment. Three hundred and eighty two women with primary breast cancer were randomized to support group intervention or control group, 181 in each group. Women in the intervention group participated in 1 week of intervention followed by 4 days of follow-up 2 months later. This is a long-term follow-up undertaken, in average, 6.5 years after randomization. Patients answered the questionnaires the European Organisation for Research and Treatment of Cancer, quality of life questionnaire (EORTC QLQ-C30) and the breast cancer module questionnaire (BR 23), the hospital anxiety and depression scale (HAD) and the Norwegian version of the fatigue scale (FQ). After adjusting for treatment with chemotherapy, age, marriage, education and children at home, there was a significant improvement in physical, mental and total fatigue (FQ), cognitive function, body image and future perspective (EORTC QLQ C30 and BR23) in the intervention group compared with controls. The proportion of women affected by high anxiety and depression scores were not significantly different between the groups. Support intervention significantly improved cognitive function, body image, future perspective and fatigue, compared with to the findings in the control group. Copyright © 2012 Elsevier Inc. All rights reserved.

Predictors of short- and long-term adherence with a Mediterranean-type diet intervention: the PREDIMED randomized trial.

PubMed

Downer, Mary Kathryn; Gea, Alfredo; Stampfer, Meir; Sánchez-Tainta, Ana; Corella, Dolores; Salas-Salvadó, Jordi; Ros, Emilio; Estruch, Ramón; Fitó, Montserrat; Gómez-Gracia, Enrique; Arós, Fernando; Fiol, Miquel; De-la-Corte, Francisco Jose Garcia; Serra-Majem, Lluís; Pinto, Xavier; Basora, Josep; Sorlí, José V; Vinyoles, Ernest; Zazpe, Itziar; Martínez-González, Miguel-Ángel

2016-06-14

Dietary intervention success requires strong participant adherence, but very few studies have examined factors related to both short-term and long-term adherence. A better understanding of predictors of adherence is necessary to improve the design and execution of dietary intervention trials. This study was designed to identify participant characteristics at baseline and study features that predict short-term and long-term adherence with interventions promoting the Mediterranean-type diet (MedDiet) in the PREvención con DIeta MEDiterránea (PREDIMED) randomized trial. Analyses included men and women living in Spain aged 55-80 at high risk for cardiovascular disease. Participants were randomized to the MedDiet supplemented with either complementary extra-virgin olive oil (EVOO) or tree nuts. The control group and participants with insufficient information on adherence were excluded. PREDIMED began in 2003 and ended in 2010. Investigators assessed covariates at baseline and dietary information was updated yearly throughout follow-up. Adherence was measured with a validated 14-point Mediterranean-type diet adherence score. Logistic regression was used to examine associations between baseline characteristics and adherence at one and four years of follow-up. Participants were randomized to the MedDiet supplemented with EVOO (n = 2,543; 1,962 after exclusions) or tree nuts (n = 2,454; 2,236 after exclusions). A higher number of cardiovascular risk factors, larger waist circumference, lower physical activity levels, lower total energy intake, poorer baseline adherence to the 14-point adherence score, and allocation to MedDiet + EVOO each independently predicted poorer adherence. Participants from PREDIMED recruiting centers with a higher total workload (measured as total number of persons-years of follow-up) achieved better adherence. No adverse events or side effects were reported. To maximize dietary adherence in dietary interventions, additional efforts to promote adherence should be used for participants with lower baseline adherence to the intended diet and poorer health status. The design of multicenter nutrition trials should prioritize few large centers with more participants in each, rather than many small centers. This study was registered at controlled-trials.com (http://www.controlled-trials. com/ISRCTN35739639). International Standard Randomized Controlled Trial Number (ISRCTN): 35739639. Registration date: 5 October 2005. parallel randomized trial.

The effect of foot massage on long-term care staff working with older people with dementia: a pilot, parallel group, randomized controlled trial.

PubMed

Moyle, Wendy; Cooke, Marie; O'Dwyer, Siobhan T; Murfield, Jenny; Johnston, Amy; Sung, Billy

2013-02-18

Caring for a person with dementia can be physically and emotionally demanding, with many long-term care facility staff experiencing increased levels of stress and burnout. Massage has been shown to be one way in which nurses' stress can be reduced. However, no research has been conducted to explore its effectiveness for care staff working with older people with dementia in long-term care facilities. This was a pilot, parallel group, randomized controlled trial aimed at exploring feasibility for a larger randomized controlled trial. Nineteen staff, providing direct care to residents with dementia and regularly working ≥ two day-shifts a week, from one long-term care facility in Queensland (Australia), were randomized into either a foot massage intervention (n=9) or a silent resting control (n=10). Each respective session lasted for 10-min, and participants could receive up to three sessions a week, during their allocated shift, over four-weeks. At pre- and post-intervention, participants were assessed on self-report outcome measures that rated mood state and experiences of working with people with dementia. Immediately before and after each intervention/control session, participants had their blood pressure and anxiety measured. An Intention To Treat framework was applied to the analyses. Individual qualitative interviews were also undertaken to explore participants' perceptions of the intervention. The results indicate the feasibility of undertaking such a study in terms of: recruitment; the intervention; timing of intervention; and completion rates. A change in the intervention indicated the importance of a quiet, restful environment when undertaking a relaxation intervention. For the psychological measures, although there were trends indicating improvement in mood there was no significant difference between groups when comparing their pre- and post- scores. There were significant differences between groups for diastolic blood pressure (p= 0.04, partial η2=0.22) and anxiety (p= 0.02, partial η2=0.31), with the foot massage group experiencing greatest decreases immediately after the session. The qualitative interviews suggest the foot massage was well tolerated and although taking staff away from their work resulted in some participants feeling guilty about taking time out, a 10-min foot massage was feasible during a working shift. This pilot trial provides data to support the feasibility of the study in terms of recruitment and consent, the intervention and completion rates. Although the outcome data should be treated with caution, the pilot demonstrated the foot massage intervention showed trends in improved mood, reduced anxiety and lower blood pressure in long-term care staff working with older people with dementia. A larger study is needed to build on these promising, but preliminary, findings. ACTRN: ACTRN12612000659808.

Anesthetic depth and long-term survival: an update.

PubMed

Leslie, Kate; Short, Timothy G

2016-02-01

The purpose of this paper is to review the current evidence relating anesthetic depth to long-term survival after surgery. Using PubMed as the principal source, this review included published studies in all languages comparing mortality in patients with low- and high-processed electro-encephalo-graphic index values. All published studies used the bispectral index (BIS) monitor to measure anesthetic depth. The majority of the published observational studies were post hoc analyses of studies undertaken for other purposes. Most of these studies report a statistically significant association between deep general anesthesia (i.e., BIS values < 45) and death. Some studies also suggest an association between deep general anesthesia and myocardial infarction or postoperative cognitive decline. The combination of low BIS values and low delivered anesthetic concentrations (thus defining increased anesthetic sensitivity) may identify patients at particularly high risk. One of the three available randomized controlled trials reports worse outcomes in the BIS = 50 group compared with the BIS > 80 group, and two report no difference in mortality between the BIS = 35 and BIS = 50-55 groups. The available evidence on anesthetic depth and long-term survival is inconclusive. Randomized controlled trials with carefully controlled arterial blood pressure are required.

Long-Term Effectiveness of a Stress Management Intervention at Work: A 9-Year Follow-Up Study Based on a Randomized Wait-List Controlled Trial in Male Managers.

PubMed

Li, Jian; Riedel, Natalie; Barrech, Amira; Herr, Raphael M; Aust, Birgit; Mörtl, Kathrin; Siegrist, Johannes; Gündel, Harald; Angerer, Peter

2017-01-01

Short- and medium-term effectiveness (up to 3 years) of individual level stress management interventions (SMI) at work were demonstrated, yet long-term effectiveness remains unexplored. We therefore aimed to address this research gap. 94 male middle managers participated in a randomized wait-list controlled trial between 2006 and 2008 and in a post-trial-follow-up survey in 2015. During the first two years, all received an 18-hour psychotherapeutic SMI intervention which was based on the Effort-Reward Imbalance (ERI) model: tackling stressor on mismatch between effort and reward and promoting recovery on overcommitment. Work stress (i.e., ERI indicators) was the primary outcome, and the secondary outcome was depressive symptoms. The long-term effectiveness of the SMI was examined by mixed modeling, using an external control group ( n = 94). Effort and reward were substantially improved with significant intervention ⁎ time interaction effects ( p < 0.001) compared to the external control group; effects on overcommitment and depressive symptoms were also significant ( p < 0.05 and p < 0.01, resp.), though their trajectories in the intervention group were less sustainable. The effectiveness of this psychotherapeutic SMI at work based on the ERI model was observed over a 9-year period, particularly on the effort-reward ratio.

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

PubMed

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

2017-12-01

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

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Long-Term Exercise in Older Adults: 4-Year Outcomes of Music-Based Multitask Training

PubMed Central

Herrmann, François R.; Fielding, Roger A.; Reid, Kieran F.; Rizzoli, René; Trombetti, Andrea

2016-01-01

Prospective controlled evidence supporting the efficacy of long-term exercise to prevent physical decline and reduce falls in old age is lacking. The present study aimed to assess the effects of long-term music-based multitask exercise (i.e., Jaques-Dalcroze eurhythmics) on physical function and fall risk in older adults. A 3-year follow-up extension of a 1-year randomized controlled trial (NCT01107288) was conducted in Geneva (Switzerland), in which 134 community-dwellers aged ≥65 years at increased risk of falls received a 6-month music-based multitask exercise program. Four years following original trial enrolment, 52 subjects (baseline mean ± SD age, 75 ± 8 years) who (i) have maintained exercise program participation through the 4-year follow-up visit (“long-term intervention group”, n = 23) or (ii) have discontinued participation following original trial completion (“control group”, n = 29) were studied. They were reassessed in a blind fashion, using the same procedures as at baseline. At 4 years, linear mixed-effects models showed significant gait (gait speed, P = 0.006) and balance (one-legged stance time, P = 0.015) improvements in the long-term intervention group, compared with the control group. Also, long-term intervention subjects did better on Timed Up & Go, Five-Times-Sit-to-Stand and handgrip strength tests, than controls (P < 0.05, for all comparisons). Furthermore, the exercise program reduced the risk of falling (relative risk, 0.69; 95 % confidence interval, 0.5–0.9; P = 0.008). These findings suggest that long-term maintenance of a music-based multitask exercise program is a promising strategy to prevent age-related physical decline in older adults. They also highlight the efficacy of sustained long-term adherence to exercise for falls prevention. PMID:25148876

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.

Effectiveness of cognitive-behavioural therapy on glycaemic control and psychological outcomes in adults with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Uchendu, C; Blake, H

2017-03-01

Diabetes is a chronic progressive condition presenting physical, social and psychological challenges that increase the risk of comorbid mental health problems. Cognitive-behavioural therapy (CBT) is effective in treating a variety of psychological disorders, and may potentially improve glycaemic control and psychological outcomes in diabetes. This systematic review and meta-analysis aims to establish the effectiveness of CBT on glycaemic control and comorbid diabetes-related distress, depression, anxiety and quality of life in the short, medium and longer term among adults with diabetes. An electronic search was conducted in PubMed, Embase, MEDLINE, PsycINFO, CINAHL, Web of Knowledge, Cochrane Central Register of Controlled Trials and references in reviews. Twelve randomized controlled trials (RCTs) were identified that evaluated the effectiveness of CBT on at least one of: glycaemic control, diabetes-related distress, anxiety, depression or quality of life in adults with Type 1 or Type 2 diabetes. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias assessment and meta-analysis, respectively. CBT is effective in reducing short-term and medium-term glycaemic control, although no significant effect was found for long-term glycaemic control. CBT improved short- and medium-term anxiety and depression, and long-term depression. Mixed results were found for diabetes-related distress and quality of life. CBT is beneficial in improving depression for adults with diabetes. It may have benefits for improving glycaemic control and other aspects of psychological health, although the findings are inconclusive. © 2016 Diabetes UK.

A Meta-Analysis of Smoking Cessation Interventions With Individuals in Substance Abuse Treatment or Recovery

ERIC Educational Resources Information Center

Prochaska, Judith J.; Delucchi, Kevin; Hall, Sharon M.

2004-01-01

This meta-analysis examined outcomes of smoking cessation interventions evaluated in 19 randomized controlled trials with individuals in current addictions treatment or recovery. Smoking and substance use outcomes at posttreatment and long-term follow-up (? 6 months) were summarized with random effects models. Intervention effects for smoking…

Neurorehabilitation in Parkinson's Disease: A Critical Review of Cognitive Rehabilitation Effects on Cognition and Brain.

PubMed

Díez-Cirarda, María; Ibarretxe-Bilbao, Naroa; Peña, Javier; Ojeda, Natalia

2018-01-01

Parkinson's disease (PD) patients experience cognitive impairment which has been related to reduced quality of life and functional disability. These symptoms usually progress until dementia occurs. Some studies have been published assessing the efficacy of cognitive treatments on improving cognition, functional outcome, and producing changes in brain activity. A critical review was performed to present up-to-date neurorehabilitation effects of cognitive rehabilitation in PD, with special emphasis on the efficacy on cognition, quality of life aspects, brain changes, and the longitudinal maintenance of these changes. After exclusions, 13 studies were reviewed, including 6 randomized controlled trials for the efficacy on cognition, 2 randomized controlled trials regarding the brain changes after cognitive training, and 5 studies which evaluated the long-term effects of cognitive treatments. Cognitive rehabilitation programs have demonstrated to be effective on improving cognitive functions, but more research is needed focusing on the efficacy on improving behavioral aspects and producing brain changes in patients with PD. Moreover, there is a need of randomized controlled trials with long-term follow-up periods.

Effects of Fluoxetine on Neural Functional Prognosis after Ischemic Stroke: A Randomized Controlled Study in China.

PubMed

He, Yi-Tao; Tang, Bing-Shan; Cai, Zhi-Li; Zeng, Si-Ling; Jiang, Xin; Guo, Yi

2016-04-01

We investigated the effects of fluoxetine on the short-term and long-term neural functional prognoses after ischemic stroke. In this prospective randomized controlled single-blind clinical study in China, eligible patients afflicted with ischemic stroke were randomized into control and treatment groups. Patients in the treatment group received fluoxetine in addition to the basic therapies in the control group over a period of 90 days. The follow-up period was 180 days. We evaluated the effects of fluoxetine on the National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index (BI) score after ischemic stroke through single- and multiple-factor analysis. The mean NIHSS score on day 180 after treatment was significantly lower in the treatment group than in the control group (P = .009). The mean BI scores on days 90 and 180 were significantly higher in the treatment group (P = .026) than in the control group (P = .011). The improvements in the NIHSS and BI scores on days 90 and 180 compared with baseline in the treatment group were all significantly greater than that in the control group (P = .033, P = .013, P = .013, P = .019, respectively). Treatment with fluoxetine was an independent factor affecting the NIHSS and BI scores on day 180 after treatment. Treatment with fluoxetine for 90 days after ischemic stroke can improve the long-term neural functional outcomes. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Impact of long-term contraceptive promotion on incident pregnancy: a randomized controlled trial among HIV-positive couples in Lusaka, Zambia.

PubMed

Wall, Kristin M; Vwalika, Bellington; Haddad, Lisa; Khu, Naw H; Vwalika, Cheswa; Kilembe, William; Chomba, Elwyn; Stephenson, Rob; Kleinbaum, David; Nizam, Azhar; Brill, Ilene; Tichacek, Amanda; Allen, Susan

2013-05-01

To evaluate the impact of family planning promotion on incident pregnancy in a combined effort to address Prongs 1 and 2 of prevention of mother-to-child transmission of HIV. We conducted a factorial randomized controlled trial of 2 video-based interventions. "Methods" and "Motivational" messages promoted long-term contraceptive use among 1060 couples with HIV in Lusaka, Zambia. Among couples not using contraception before randomization (n = 782), the video interventions had no impact on incident pregnancy. Among baseline contraceptive users, viewing the "Methods video" which focused on the intrauterine device and contraceptive implant was associated with a significantly lower pregnancy incidence [hazard ratio (HR) = 0.38; 95% confidence interval (CI): 0.19 to 0.75] relative to those viewing control and/or motivational videos. The effect was strongest in concordant positive couples (HR = 0.22; 95% CI: 0.08 to 0.58) and couples with HIV-positive women (HR = 0.23; 95% CI: 0.09 to 0.55). The "Methods video" intervention was previously shown to increase uptake of long-acting contraception and to prompt a shift from daily oral contraceptives to quarterly injectables and long-acting methods such as the intrauterine device and implant. Follow-up confirms sustained intervention impact on pregnancy incidence among baseline contraceptive users, in particular couples with HIV-positive women. Further work is needed to identify effective interventions to promote long-acting contraception among couples who have not yet adopted modern methods.

Online and offline effects of cerebellar transcranial direct current stimulation on motor learning in healthy older adults: a randomized double-blind sham-controlled study.

PubMed

Samaei, Afshin; Ehsani, Fatemeh; Zoghi, Maryam; Hafez Yosephi, Mohaddese; Jaberzadeh, Shapour

2017-05-01

The aim of this randomized double blinded sham-controlled study was to determine the effect of cerebellar anodal transcranial direct current stimulation (a-tDCS) on online and offline motor learning in healthy older individuals. Thirty participants were randomly assigned in experimental (n = 15) or sham tDCS (n = 15) groups. Participants in experimental group received 2 mA cerebellar a-tDCS for 20 min. However, the tDCS was turned off after 30 seconds in sham group. Response time (RT) and error rate (ER) in serial RT test were assessed before, during 35 minutes and 48 h after the intervention. Reduction of RT and ER following the intervention session was considered as short-term (35 min post intervention) and long-term offline learning (48 h post intervention), respectively. Online RT and ER reduction were similar in both groups (P > 0.05). RT was significantly reduced 48 hours post intervention in cerebellar a-tDCS group (P = 0.03). Moreover, RT was significantly increased after 35 minutes and 48 hours in sham tDCS group (P = 0.03, P = 0.007), which indicates a lack of short-term and long-term offline learning in older adults. A-tDCS on cerebellar region produced more short-term and long-term offline improvement in RT (P = 0.014, P = 0.01) compared to sham tDCS. In addition, online, short-term and long-term (48 h) offline error reduced in cerebellar a-tDCS as compared to sham-control group, although this reduction was not significant (P > 0.05). A deficit suggests that a direct comparison to a younger group was made. The findings suggested that cerebellar a-tDCS might be useful for improvement of offline motor learning in older individuals. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

White Matter Microstructural Correlates of Superior Long-term Skill Gained Implicitly under Randomized Practice

PubMed Central

Song, Sunbin; Sharma, Nikhil; Buch, Ethan R.

2012-01-01

We value skills we have learned intentionally, but equally important are skills acquired incidentally without ability to describe how or what is learned, referred to as implicit. Randomized practice schedules are superior to grouped schedules for long-term skill gained intentionally, but its relevance for implicit learning is not known. In a parallel design, we studied healthy subjects who learned a motor sequence implicitly under randomized or grouped practice schedule and obtained diffusion-weighted images to identify white matter microstructural correlates of long-term skill. Randomized practice led to superior long-term skill compared with grouped practice. Whole-brain analyses relating interindividual variability in fractional anisotropy (FA) to long-term skill demonstrated that 1) skill in randomized learners correlated with FA within the corticostriatal tract connecting left sensorimotor cortex to posterior putamen, while 2) skill in grouped learners correlated with FA within the right forceps minor connecting homologous regions of the prefrontal cortex (PFC) and the corticostriatal tract connecting lateral PFC to anterior putamen. These results demonstrate first that randomized practice schedules improve long-term implicit skill more than grouped practice schedules and, second, that the superior skill acquired through randomized practice can be related to white matter microstructure in the sensorimotor corticostriatal network. PMID:21914632

Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results.

PubMed

Rebecchi, Fabrizio; Giaccone, Claudio; Farinella, Eleonora; Campaci, Roberto; Morino, Mario

2008-12-01

To compare in a prospective, randomized trial the long-term results of laparoscopic Heller myotomy plus Dor fundoplication versus laparoscopic Heller myotomy plus floppy-Nissen for achalasia. Anterior fundoplication is usually performed after Heller myotomy to control GER; however, the incidence of postoperative GER ranges between 10% and 30%. Total fundoplication may aid in reducing GER rates. From December 1993 to September 2002, 153 patients with achalasia underwent Heller laparoscopic myotomy plus antireflux fundoplication. Of these, 9 were excluded from the study. The remaining 144 patients were randomly assigned to 2 treatment groups: Heller laparoscopic myotomy plus anterior fundoplication (Dor procedure) or Heller laparoscopic myotomy plus total fundoplication (floppy-Nissen procedure). The primary end point was incidence of clinical and instrumental GER after a minimum of 60 months follow-up. The secondary end point was recurrence of dysphagia. Follow-up clinical assessments were performed at 1, 3, 12, and 60 months using a modified DeMeester Symptom Scoring System (MDSS). Esophageal manometry and 24-hour pH monitoring were performed at 3, 12, and 60 months postoperative. Of the 144 patients originally included in the study, 138 were available for long-term analysis: 71 (51%) underwent antireflux fundoplication plus a Dor procedure (H + D group) and 67 (49%) antireflux fundoplication plus a Nissen procedure (H + N group). No mortality was observed. The mean follow-up period was 125 months. No statistically significant differences in clinical (5.6% vs. 0%) or instrumental GER (2.8% vs. 0%) were found between the 2 groups; however, a statistically significant difference in dysphagia rates was noted (2.8% vs. 15%; P < 0.001). Although both techniques achieved long-term GER control, the recurrence rate of dysphagia was significantly higher among the patients who underwent Nissen fundoplication. This evidence supports the use of Dor fundoplication as the preferred method to re-establish GER control in patients undergoing laparoscopic Heller myotomy.

Short and long-term effects of sham-controlled prefrontal EEG-neurofeedback training in healthy subjects.

PubMed

Engelbregt, H J; Keeser, D; van Eijk, L; Suiker, E M; Eichhorn, D; Karch, S; Deijen, J B; Pogarell, O

2016-04-01

In this study we evaluated long-term effects of frontal beta EEG-neurofeedback training (E-NFT) on healthy subjects. We hypothesized that E-NFT can change frontal beta activity in the long-term and that changes in frontal beta EEG activity are accompanied by altered cognitive performance. 25 healthy subjects were included and randomly assigned to active or sham E-NFT. On average the subjects underwent 15 E-NFT training sessions with a training duration of 45 min. Resting-state EEG was recorded prior to E-NFT training (t1) and in a 3-year follow-up (t3). Compared to sham E-NFT, which was used for the control group, real E-NFT increased beta activity in a predictable way. This increase was maintained over a period of three years post training. However, E-NFT did not result in significantly improved cognitive performance. Based on our results, we conclude that EEG-NFT can selectively modify EEG beta activity both in short and long-term. This is a sham controlled EEG neurofeedback study demonstrating long-term effects in resting state EEG. Copyright © 2016 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Long-term Diet and Biomarker Changes after a Short-term Intervention among Hispanic Breast Cancer Survivors: The ¡Cocinar Para Su Salud! Randomized Controlled Trial.

PubMed

Greenlee, Heather; Ogden Gaffney, Ann; Aycinena, A Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M; Shi, Zaixing; Lim, Emerson; Tsai, Wei-Yann; Santella, Regina M; Blaner, William S; Clugston, Robin D; Cremers, Serge; Pollak, Susan; Sirosh, Iryna; Crew, Katherine D; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L

2016-11-01

Among Hispanic breast cancer survivors, we examined the long-term effects of a short-term culturally based dietary intervention on increasing fruits/vegetables (F/V), decreasing fat, and changing biomarkers associated with breast cancer recurrence risk. Spanish-speaking women (n = 70) with a history of stage 0-III breast cancer who completed treatment were randomized to ¡Cocinar Para Su Salud! (n = 34), a culturally based 9-session program (24 hours over 12 weeks, including nutrition education, cooking classes, and food-shopping field trips), or a control group (n = 36, written dietary recommendations for breast cancer survivors). Diet recalls, fasting blood, and anthropometric measures were collected at baseline, 6, and 12 months. We report changes between groups at 12 months in dietary intake and biomarkers using 2-sample Wilcoxon t tests and generalized estimating equation (GEE) models. At 12 months, the intervention group compared with the control group reported higher increases in mean daily F/V servings (total: +2.0 vs. -0.4; P < 0.01), and nonsignificant decreases in the percentage of calories from fat (-2.2% vs. -1.1%; P = 0.69) and weight (-2.6 kg vs. -1.5 kg; P = 0.56). Compared with controls, participants in the intervention group had higher increases in plasma lutein (+20.4% vs. -11.5%; P < 0.01), and borderline significant increases in global DNA methylation (+0.8% vs. -0.5%; P = 0.06). The short-term ¡Cocinar Para Su Salud! program was effective at increasing long-term F/V intake in Hispanic breast cancer survivors and changed biomarkers associated with breast cancer recurrence risk. It is possible for short-term behavioral interventions to have long-term effects on behaviors and biomarkers in minority cancer patient populations. Results can inform future study designs. Cancer Epidemiol Biomarkers Prev; 25(11); 1491-502. ©2016 AACR. ©2016 American Association for Cancer Research.

Long-term diet and biomarker changes after a short-term intervention among Hispanic breast cancer survivors: The ¡Cocinar Para Su Salud! randomized controlled trial

PubMed Central

Greenlee, Heather; Gaffney, Ann Ogden; Aycinena, A. Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M.; Shi, Zaixing; Lim, Emerson; Tsai, Wei-Yann; Santella, Regina M.; Blaner, William S.; Clugston, Robin D.; Cremers, Serge; Pollak, Susan; Sirosh, Iryna; Crew, Katherine D.; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L.

2017-01-01

Background Among Hispanic breast cancer (BC) survivors, we examined the long-term effects of a short-term culturally-based dietary intervention on increasing fruits/vegetables (F/V), decreasing fat and changing biomarkers associated with BC recurrence risk. Methods Spanish-speaking women (n=70) with a history of stage 0-III BC who completed treatment were randomized to ¡Cocinar Para Su Salud! (n=34), a culturally-based 9-session program (24 hours over 12 weeks, including nutrition education, cooking classes, and food-shopping field trips), or a control group (n=36, written dietary recommendations for BC survivors). Diet recalls, fasting blood, and anthropometric measures were collected at baseline, 6, and 12 months. We report changes between groups at 12 months in dietary intake and biomarkers using 2-sample Wilcoxon t-tests and Generalized Estimating Equation (GEE) models. Results At 12 months, the intervention group compared to the control group reported higher increases in mean daily F/V servings (total: +2.0 vs. −0.4; P=0.006), and non-significant decreases in percent calories from fat (−2.2% vs. −1.1%; P=0.69) and weight (−2.6 kg vs. −1.5 kg; P=0.56). Compared to controls, participants in the intervention group had higher increases in plasma lutein (+20.4% vs. −11.5%; P=0.002), and borderline significant increases in global DNA methylation (+0.8% vs. −0.5%; P=0.06). Conclusions The short-term ¡Cocinar Para Su Salud! program was effective at increasing long-term F/V intake in Hispanic BC survivors and changed biomarkers associated with BC recurrence risk. Impact It is possible for short-term behavioral interventions to have long-term effects on behaviors and biomarkers in minority cancer patient populations. Results can inform future study designs. PMID:27461049

Design of a completely model free adaptive control in the presence of parametric, non-parametric uncertainties and random control signal delay.

PubMed

Tutsoy, Onder; Barkana, Duygun Erol; Tugal, Harun

2018-05-01

In this paper, an adaptive controller is developed for discrete time linear systems that takes into account parametric uncertainty, internal-external non-parametric random uncertainties, and time varying control signal delay. Additionally, the proposed adaptive control is designed in such a way that it is utterly model free. Even though these properties are studied separately in the literature, they are not taken into account all together in adaptive control literature. The Q-function is used to estimate long-term performance of the proposed adaptive controller. Control policy is generated based on the long-term predicted value, and this policy searches an optimal stabilizing control signal for uncertain and unstable systems. The derived control law does not require an initial stabilizing control assumption as in the ones in the recent literature. Learning error, control signal convergence, minimized Q-function, and instantaneous reward are analyzed to demonstrate the stability and effectiveness of the proposed adaptive controller in a simulation environment. Finally, key insights on parameters convergence of the learning and control signals are provided. Copyright © 2018 ISA. Published by Elsevier Ltd. All rights reserved.

Evaluating the Sustained Health Impact of Household Chlorination of Drinking Water in Rural Haiti

PubMed Central

Harshfield, Eric; Lantagne, Daniele; Turbes, Anna; Null, Clair

2012-01-01

The Jolivert Safe Water for Families program has sold sodium hypochlorite solution (chlorine) and conducted household visits in rural Haiti since 2002. To assess the impact of the program on diarrheal disease, in 2010 we conducted a survey and water quality testing in 201 program participants and 425 control households selected at random. Fifty-six percent of participants (versus 10% of controls) had free chlorine residuals between 0.2 and 2.0 mg/L, indicating correct water treatment. Using intention-to-treat analysis, we found that significantly fewer children < 5 in participant households had an episode of diarrhea in the previous 48 hours (32% versus 52%; P < 0.001) with 59% reduced odds (odds ratio = 0.41, 95% confidence interval = 0.21–0.79). Treatment-on-treated estimates of the odds of diarrhea indicated larger program effects for participants who met more stringent verifications of participation. Diarrheal disease reduction in this long-term program was comparable with that seen in short-term randomized, controlled interventions, suggesting that household chlorination can be an effective long-term water treatment strategy. PMID:22987657

Evaluating the sustained health impact of household chlorination of drinking water in rural Haiti.

PubMed

Harshfield, Eric; Lantagne, Daniele; Turbes, Anna; Null, Clair

2012-11-01

The Jolivert Safe Water for Families program has sold sodium hypochlorite solution (chlorine) and conducted household visits in rural Haiti since 2002. To assess the impact of the program on diarrheal disease, in 2010 we conducted a survey and water quality testing in 201 program participants and 425 control households selected at random. Fifty-six percent of participants (versus 10% of controls) had free chlorine residuals between 0.2 and 2.0 mg/L, indicating correct water treatment. Using intention-to-treat analysis, we found that significantly fewer children < 5 in participant households had an episode of diarrhea in the previous 48 hours (32% versus 52%; P < 0.001) with 59% reduced odds (odds ratio = 0.41, 95% confidence interval = 0.21-0.79). Treatment-on-treated estimates of the odds of diarrhea indicated larger program effects for participants who met more stringent verifications of participation. Diarrheal disease reduction in this long-term program was comparable with that seen in short-term randomized, controlled interventions, suggesting that household chlorination can be an effective long-term water treatment strategy.

Preventing Youth Violence and Dropout: A Randomized Field Experiment. NBER Working Paper No. 19014

ERIC Educational Resources Information Center

Heller, Sara; Pollack, Harold A.; Ander, Roseanna; Ludwig, Jens

2013-01-01

Improving the long-term life outcomes of disadvantaged youth remains a top policy priority in the United States, although identifying successful interventions for adolescents--particularly males--has proven challenging. This paper reports results from a large randomized controlled trial of an intervention for disadvantaged male youth grades 7-10…

Unilateral versus bilateral neck exploration for primary hyperparathyroidism: five-year follow-up of a randomized controlled trial.

PubMed

Westerdahl, Johan; Bergenfelz, Anders

2007-12-01

To compare long-term patient outcome in a prospective randomized controlled trial between unilateral and bilateral neck exploration for primary hyperparathyroidism (pHPT). Minimal invasive and/or focused parathyroidectomy has challenged the traditional bilateral neck exploration for pHPT. Between 1997 and 2001, we conducted the first unselected randomized controlled trial of unilateral versus bilateral neck exploration for pHPT. The results showed that unilateral exploration is a surgical strategy with distinct advantages in the early postoperative period. However, concerns have been raised that limited parathyroid exploration could increase the risk for recurrent pHPT during long-term follow-up. Ninety-one patients with the diagnosis of pHPT were randomized to unilateral or bilateral neck exploration. Preoperative scintigraphy and intraoperative parathyroid hormone measurement guided the unilateral exploration. Gross morphology and frozen section determined the extent of parathyroid tissue resection in the bilateral group. Follow-up was performed after 6 weeks, 1 year, and 5 years postoperatively. Seventy-one patients were available for 5-year follow-up. There were no differences in serum ionized calcium and parathyroid hormone, respectively, between patients in the unilateral and bilateral group. Overall 6 patients have been found to have persistent (n = 3) or recurrent (n = 3) pHPT; 4 patients in the unilateral group (3 of these 4 patients were bilaterally explored) and 2 patients in the bilateral group. Three of 6 failures were unexpectedly found to have multiple endocrine neoplasia mutations. One patient with solitary adenoma in the bilateral group still required vitamin D substitution 5 years after surgery. Unilateral neck exploration with intraoperative parathyroid hormone assessment provides the same long-term results as bilateral neck exploration, and is thus a valid strategy for the surgical treatment of pHPT.

The short- and long-term outcomes of percutaneous intervention with drug-eluting stent vs bare-metal stent in saphenous vein graft disease: An updated meta-analysis of all randomized clinical trials.

PubMed

Kheiri, Babikir; Osman, Mohammed; Abdalla, Ahmed; Ahmed, Sahar; Bachuwa, Ghassan; Hassan, Mustafa

2018-05-11

The use of drug-eluting stents (DES) vs bare-metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta-analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short- and long-term clinical outcomes of the following: all-cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target-vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short-term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35-0.91, P = 0.02; OR: 0.43, 95% CI: 0.19-0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22-0.95, P = 0.04, respectively). However, there were no different outcomes for all-cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long-term follow-up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all-cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short-term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long-term follow-up. © 2018 Wiley Periodicals, Inc.

THE LONG-TERM EFFICACY OF ACUTE-PHASE PSYCHOTHERAPY FOR DEPRESSION: A META-ANALYSIS OF RANDOMIZED TRIALS.

PubMed

Karyotaki, Eirini; Smit, Yolba; de Beurs, Derek P; Henningsen, Kirsten Holdt; Robays, Jo; Huibers, Marcus J H; Weitz, Erica; Cuijpers, Pim

2016-05-01

Understanding the effectiveness of treatment for depression in both the short term and long term is essential for clinical decision making. The present meta-analysis examined treatment effects on depression and quality of life in acute-phase psychotherapeutic interventions compared to no treatment control groups for adult depression at 6 months or longer postrandomization. A systematic literature search resulted in 44 randomized controlled trials with 6,096 participants. Acute-phase psychotherapy was compared to control groups at 6-month or longer postrandomization. Odds ratios of a positive outcome were calculated. Psychotherapy outperformed control groups at 6 months or longer postrandomization (OR = 1.92, 95% CI: 1.60-2.31, P < .001). Heterogeneity was moderate (I²: 65, 95% CI: 53-74, P < .001). However, effects significantly decreased with longer follow-up periods. Additionally, a small positive effect of psychotherapy was observed for quality of life, while similar effects were obtained in separate analyses of each type of psychotherapy, with the exception of nondirective supportive therapy. Studies that provided booster sessions had better treatment results compared with studies that did not provide any further sessions. Finally, we found that trials on psychotherapy aimed at major depressive disorder (MDD) had better outcomes than those that were aimed at elevated depressive symptoms. There is substantial evidence that acute-phase psychotherapy results in a better treatment effects on depression and quality of life in the long term for adult patients with depression. © 2016 Wiley Periodicals, Inc.

Systematic review and meta-analysis of serious infections with tofacitinib and biologic disease-modifying antirheumatic drug treatment in rheumatoid arthritis clinical trials.

PubMed

Strand, Vibeke; Ahadieh, Sima; French, Jonathan; Geier, Jamie; Krishnaswami, Sriram; Menon, Sujatha; Checchio, Tina; Tensfeldt, Thomas G; Hoffman, Elaine; Riese, Richard; Boy, Mary; Gómez-Reino, Juan J

2015-12-15

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib modulates the signaling of cytokines that are integral to lymphocyte activation, proliferation, and function. Thus, tofacitinib therapy may result in suppression of multiple elements of the immune response. Serious infections have been reported in tofacitinib RA trials. However, limited head-to-head comparator data were available within the tofacitinib RA development program to directly compare rates of serious infections with tofacitinib relative to biologic agents, and specifically adalimumab (employed as an active control agent in two randomized controlled trials of tofacitinib). A systematic literature search of data from interventional randomized controlled trials and long-term extension studies with biologics in RA was carried out. Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) consensus was followed for reporting results of the review and meta-analysis. Incidence rates (unique patients with events/100 patient-years) for each therapy were estimated based on data from randomized controlled trials and long-term extension studies using a random-effects model. Relative and absolute risk comparisons versus placebo used Mantel-Haenszel methods. The search produced 657 hits. In total, 66 randomized controlled trials and 22 long-term extension studies met the selection criteria. Estimated incidence rates (95% confidence intervals [CIs]) for abatacept, rituximab, tocilizumab, and tumor necrosis factor inhibitors were 3.04 (2.49, 3.72), 3.72 (2.99, 4.62), 5.45 (4.26, 6.96), and 4.90 (4.41, 5.44), respectively. Incidence rates (95% CIs) for tofacitinib 5 and 10 mg twice daily (BID) in phase 3 trials were 3.02 (2.25, 4.05) and 3.00 (2.24, 4.02), respectively. Corresponding incidence rates in long-term extension studies were 2.50 (2.05, 3.04) and 3.19 (2.74, 3.72). The risk ratios (95% CIs) versus placebo for tofacitinib 5 and 10 mg BID were 2.21 (0.60, 8.14) and 2.02 (0.56, 7.28), respectively. Risk differences (95% CIs) versus placebo for tofacitinib 5 and 10 mg BID were 0.38% (-0.24%, 0.99%) and 0.40% (-0.22%, 1.02%), respectively. In interventional studies, the risk of serious infections with tofacitinib is comparable to published rates for biologic disease-modifying antirheumatic drugs in patients with moderate to severely active RA.

Short- and long-term eating habit modification predicts weight change in overweight, postmenopausal women: results from the WOMAN study.

PubMed

Barone Gibbs, Bethany; Kinzel, Laura S; Pettee Gabriel, Kelley; Chang, Yue-Fang; Kuller, Lewis H

2012-09-01

Standard behavioral obesity treatment produces poor long-term results. Focusing on healthy eating behaviors rather than energy intake may be an alternative strategy. In addition, important behaviors might differ for short- vs long-term weight control. Our aim was to describe and compare associations between changes in eating behaviors and weight after 6 and 48 months. We performed secondary analysis of data collected during a randomized weight-loss intervention trial with 48-month follow-up. We studied 481 overweight and obese postmenopausal women enrolled in the Women on the Move through Activity and Nutrition (WOMAN) Study. We measured changes in weight from baseline to 6 and 48 months. Linear regression models were used to examine the associations between 6- and 48-month changes in eating habits assessed by the Conner Diet Habit Survey and changes in weight. Analyses were conducted in the combined study population and stratified by randomization group. At 6 months in the combined population, weight loss was independently associated with decreased desserts (P<0.001), restaurant eating (P=0.042), sugar-sweetened beverages (P=0.009), and fried foods (P<0.001), and increased fish consumption (P=0.003). Results were similar in intervention participants; only reduced desserts and fried foods associated with weight loss in controls. At 48 months in the combined population, weight loss was again associated with decreased desserts (P=0.003) and sugar-sweetened beverages (P=0.011), but also decreased meats/cheeses (P=0.024) and increased fruits/vegetables (P<0.001). Decreased meats/cheeses predicted weight loss in intervention participants; desserts, sugar-sweetened beverages, and fruits/vegetables were independently associated in controls. Changes in eating behaviors were associated with weight change, although important behaviors differed for short- and long-term weight change and by randomization group. Future studies should determine whether interventions targeting these behaviors could improve long-term obesity treatment outcomes. Copyright © 2012 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Cost effectiveness of interpersonal community psychiatric treatment for people with long-term severe non-psychotic mental disorders: protocol of a multi-centre randomized controlled trial.

PubMed

van Veen, Mark; Koekkoek, Bauke; Mulder, Niels; Postulart, Debby; Adang, Eddy; Teerenstra, Steven; Schoonhoven, Lisette; van Achterberg, Theo

2015-05-02

This study aims for health gain and cost reduction in the care for people with long-term non-psychotic psychiatric disorders. Present care for this population has a limited evidence base, is often open ended, little effective, and expensive. Recent epidemiological data shows that 43.5% of the Dutch are affected by mental illness during their life. About 80% of all patients receiving mental health services (MHS) have one or more non-psychotic disorders. Particularly for this group, long-term treatment and care is poorly developed. Care As Usual (CAU) currently is a form of low-structured treatment/care. Interpersonal Community Psychiatric Treatment (ICPT) is a structured treatment for people with long-term, non-psychotic disorders, developed together with patients, professionals, and experts. ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study. Multi-centre cluster-randomized clinical trial: 36 professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12 months, and a follow-up of 6 months. 180 Patients between 18-65 years of age will be included, who have been diagnosed with a non-psychotic psychiatric disorder (depressive, anxiety, personality or substance abuse disorder), have long-term (>2 years) or high care use (>1 outpatient contact per week or >2 crisis contacts per year or >1 inpatient admission per year), and who receive treatment in a specialized mental health care setting. The primary outcome variable is quality of life; secondary outcomes are costs, recovery, general mental health, therapeutic alliance, professional-perceived difficulty of patient, care needs and social contacts. No RCT, nor cost-effectiveness study, has been conducted on ICPT so far. The empirical base for current CAU is weak, if not absent. This study will fill this void, and generate data needed to improve daily mental health care. Netherlands Trial Register (NTR): 3988 . Registered 13th of May 2013.

Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up

PubMed Central

Fea, Antonio Maria; Consolandi, Giulia; Zola, Marta; Pignata, Giulia; Cannizzo, Paola; Lavia, Carlo; Rolle, Teresa; Grignolo, Federico Maria

2015-01-01

Purpose. To report the long-term follow-up results in patients with cataract and primary open-angle glaucoma (POAG) randomly assigned to cataract surgery combined with micro-bypass stent implantation or phacoemulsification alone. Methods. 36 subjects with cataract and POAG were randomized in a 1 : 2 ratio to either iStent implantation and cataract surgery (combined group) or cataract surgery alone (control group). 24 subjects agreed to be evaluated again 48 months after surgery. Patients returned one month later for unmedicated washout assessment. Results. At the long-term follow-up visit we reported a mean IOP of 15,9 ± 2,3 mmHg in the iStent group and 17 ± 2,5 mmHg in the control group (p = NS). After washout, a 14,2% between group difference in favour of the combined group was statistically significant (p = 0,02) for mean IOP reduction. A significant reduction in the mean number of medications was observed in both groups compared to baseline values (p = 0,005 in the combined group and p = 0,01 in the control group). Conclusion. Patients in the combined group maintained low IOP levels after long-term follow-up. Cataract surgery alone showed a loss of efficacy in controlling IOP over time. Both treatments reduced the number of ocular hypotensive medications prescribed. This trial is registered with: NCT00847158. PMID:26587282

An update on the role of opioids in the management of chronic pain of nonmalignant origin.

PubMed

Højsted, Jette; Sjøgren, Per

2007-10-01

To summarize and reflect over primarily recent epidemiological and randomized controlled trials in opioid-treated chronic nonmalignant pain patients, focusing on effects, side effects, risks and long-term consequences of the treatment. In the western world opioids are increasingly being used for long-term treatment of chronic nonmalignant pain. While the long-term benefits of opioids regarding pain relief, functional capacity and health-related quality of life still remain to be proven, studies are emerging that describe serious long-term consequences such as addiction, opioid-induced hyperalgesia, cognitive disorders, and suppression of the immune and reproductive systems. Much more research is needed concerning long-time effects and consequences of opioid therapy in chronic nonmalignant pain patients; however, some clear warning signals have been sent out within recent years.

Optimizing polypharmacy among elderly hospital patients with chronic diseases--study protocol of the cluster randomized controlled POLITE-RCT trial.

PubMed

Löffler, Christin; Drewelow, Eva; Paschka, Susanne D; Frankenstein, Martina; Eger, Julia; Jatsch, Lisa; Reisinger, Emil C; Hallauer, Johannes F; Drewelow, Bernd; Heidorn, Karen; Schröder, Helmut; Wollny, Anja; Kundt, Günther; Schmidt, Christian; Altiner, Attila

2014-10-06

Treatment of patients with multimorbidity is challenging. A rational reduction of long-term drugs can lead to decreased mortality, less acute hospital treatment, and a reduction of costs. Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence. The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients. The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based, patient-centered medication review prior to the patient's discharge from hospital. The POLITE-RCT trial is a cluster randomized controlled trial. Two major secondary health care providers of Mecklenburg-Western Pomerania, Germany, take part in the study. Clusters are wards of both medical centers. All wards where patients with chronic diseases and multimorbidity are regularly treated will be included. Patients aged 65+ years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively. Cluster-randomization takes place after a six-month baseline data collection period. Patients of the control group receive care as usual. The independent two main primary outcomes are (1) health-related quality of life (EQ-5D) and (2) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group. The secondary outcomes are appropriateness of prescribed medication (PRISCUS list, Beers Criteria, MAI), patient satisfaction (TSQM), patient empowerment (PEF-FB-9), patient autonomy (IADL), falls, re-hospitalization, and death. The points of measurement are at admission to (T0) and discharge from hospital (T1) as well as 6 and 12 months after discharge from the hospital (T2 and T3). In 42 wards, 1,626 patients will be recruited. In case of positive evaluation, the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy. Current Controlled Trials ISRCTN42003273.

Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Rockwell, Kenneth; Xie, Sharon X; Amsterdam, Jay D.

2017-01-01

Background Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile (Matricaria recutita) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and long-term safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD). Methods/Design 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500–1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500–1,500 mg daily or placebo for an additional 26 weeks. The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy. Discussion Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD. PMID:29057164

Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: a randomized controlled trial.

PubMed

DeFulio, Anthony; Donlin, Wendy D; Wong, Conrad J; Silverman, Kenneth

2009-09-01

Due to the chronic nature of cocaine dependence, long-term maintenance treatments may be required to sustain abstinence. Abstinence reinforcement is among the most effective means of initiating cocaine abstinence. Practical and effective means of maintaining abstinence reinforcement programs over time are needed. To determine whether employment-based abstinence reinforcement can be an effective long-term maintenance intervention for cocaine dependence. Participants (n = 128) were enrolled in a 6-month job skills training and abstinence initiation program. Participants who initiated abstinence, attended regularly and developed needed job skills during the first 6 months were hired as operators in a data entry business and assigned randomly to an employment-only (control, n = 24) or abstinence-contingent employment (n = 27) group. A non-profit data entry business. Participants Unemployed welfare recipients who used cocaine persistently while enrolled in methadone treatment in Baltimore. Abstinence-contingent employment participants received 1 year of employment-based contingency management, in which access to employment was contingent upon provision of drug-free urine samples under routine and then random drug testing. If a participant provided drug-positive urine or failed to provide a mandatory sample, then that participant received a temporary reduction in pay and could not work until urinalysis confirmed recent abstinence. Cocaine-negative urine samples at monthly assessments across 1 year of employment. During the 1 year of employment, abstinence-contingent employment participants provided significantly more cocaine-negative urine samples than employment-only participants [79.3% and 50.7%, respectively; P = 0.004, odds ratio (OR) = 3.73, 95% confidence interval (CI) = 1.60-8.69]. Conclusions Employment-based abstinence reinforcement that includes random drug testing is effective as a long-term maintenance intervention, and is among the most promising treatments for drug dependence. Work-places could serve as therapeutic agents in the treatment of drug dependence by arranging long-term employment-based contingency management programs.

Long-term effect of acupuncture for treatment of tinnitus: a randomized, patient- and assessor-blind, sham-acupuncture-controlled, pilot trial.

PubMed

Jeon, Sun Woo; Kim, Kyu Seok; Nam, Hae Jeong

2012-07-01

The aim of this study was to investigate the long-term effect of acupuncture for treatment of tinnitus. This study is a randomized, patient- and assessor-blind, sham-acupuncture-controlled, pilot trial. Participants were adults (18-60 years old) with chronic (≥6 months), unilateral tinnitus, and without moderate or severe hearing loss. Thirty-three (33) participants were randomized to one of two treatment groups: real acupuncture and sham-acupuncture (nonmeridian; no specific response, de qi). Participants received 10 sessions of acupuncture treatment (twice a week for 5 weeks), and usual patient care education. The subjective outcome was the score of Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS) from baseline to 3 months after. Pure Tone Average (PTA) and Speech Discrimination (SD) from baseline to 3 months after were assessed as objective outcomes. A significant interaction between time and group in VAS (p=0.017) was evident, but not in THI, PTA, and SD scores. THI showed significant improvement at the end of treatment and 3 months after, compared to baseline, in real acupuncture (p=0.004). In SD, a significant long-term effect of real acupuncture was observed until 3 months after (p=0.011). However, the effect of real acupuncture in PTA was not maintained until 3 months after the end of treatment. No significant difference in the sham-acupuncture treatment group was evident. No statistical difference in any outcome was observed between real and sham acupuncture. Only in the mean percent change of VAS, real acupuncture showed statistical significance, compared with sham-acupuncture from baseline to 3 months after (p=0.019). Through evaluation of subjective (THI and VAS) and objective outcomes (PTA and SD), this study demonstrates the long-term effect of real acupuncture.

Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study.

PubMed

Roberts, D; Vause, S; Martin, W; Green, P; Walkinshaw, S; Bricker, L; Beardsmore, C; Shaw, N; McKay, A; Skotny, G; Williamson, P; Alfirevic, Z

2014-05-01

To assess short- and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. This was a prospective non-blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups. Intention-to-treat analysis was used. The study was conducted in four UK hospital-based fetal medicine units (Liverpool Women's NHS Trust, St Mary's Hospital Manchester, Birmingham Women's NHS Foundation Trust and Wirral University Hospitals Trust). The participants were women with confirmed preterm prelabor rupture of membranes at 16 + 0 to 24 + 0 weeks' gestation. Women with multiple pregnancy, fetal abnormality or obstetric indication for immediate delivery were excluded. Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was < 2 cm or expectant management until 37 weeks' gestation. Short-term maternal, pregnancy and neonatal and long-term outcomes for the child were studied. Long-term respiratory morbidity was assessed using validated respiratory questionnaires at 6, 12 and 18 months of age and infant lung function test at around 12 months of age. Neurodevelopment was assessed using the Bayley Scales of Infant Development, second edition (BSID-II) at corrected age of 2 years. Fifty-eight women were randomized to the study. Two babies were excluded from the analysis because of termination of pregnancy for lethal anomaly, leaving 56 participants (28 assigned to serial amnioinfusion and 28 to expectant management) recruited between 2002 and 2009. There was no significant difference in perinatal mortality (19/28 vs 19/28; relative risk (RR) 1.0 (95% CI, 0.70-1.43)) and maternal or neonatal morbidity. The overall chance of surviving without long-term respiratory or neurodevelopmental disability was 4/56 (7.1%); 4/28 (14.3%) in the amnioinfusion group and 0/28 in the expectant group (RR 9.0 (95% CI, 0.51-159.70)). This pilot study found no major differences in maternal, perinatal or pregnancy outcomes. The study was not designed to show a difference between the groups and the number of survivors was too small to draw any conclusions about long-term outcomes. It does, however, signal that a larger definitive study to evaluate amnioinfusion for improvement in healthy survival is needed. The pilot suggests that, with appropriate funding, such a study is feasible. Copyright © 2013 ISUOG. Published by John Wiley & Sons Ltd.

Long-term efficacy of pressure immobilization bandages in a porcine model of coral snake envenomation.

PubMed

Smyrnioudis, Mary E; O'Rourke, Dorcas P; Rosenbaum, Matthew D; Brewer, Kori L; Meggs, William J

2014-09-01

Pressure immobilization bandages delay mortality for 8 hours after coral snake envenomation, but long-term efficacy has not been established. The objective of this study is to determine the long-term efficacy of pressure immobilization bandages after coral snake envenomation in the absence of antivenom therapy. A randomized, observational pilot study was conducted. Ten pigs (17.3-25.6 kg) were sedated, intubated for 5 hours, and injected subcutaneously with 10 mg of lyophilized Micrurus fulvius venom resuspended in water. Pigs were randomly assigned to a control group (no treatment) or a treatment group (compression bandage and splint) approximately 1 minute after envenomation. Bandage pressure was not controlled. Pigs were monitored daily for 21 days for signs of respiratory depression, decreased oxygen saturations, and paralysis. In case of respiratory depression, pigs were humanely euthanized and time to death recorded. Statistical analysis was performed with Fisher exact test, Mann-Whitney U test, and Kaplan-Meier survival curve as appropriate. Median survival time of control animals was 307 minutes compared with 1172 minutes in treated animals (P = .10). Sixty percent of pigs in the treatment group survived to 24 hours vs 0% of control pigs (P = .08). Two of the treatment pigs survived to the end point of 21 days but showed necrosis of the distal lower extremity. Long-term survival after coral snake envenomation is possible in the absence of antivenom with the use of pressure immobilization bandages. The applied pressure of the bandage is critical to allowing survival without necrosis. Future studies should be designed to accurately monitor the pressures applied. Copyright © 2014 Elsevier Inc. All rights reserved.

Aniracetam tested in chronic psychosyndrome after long-term exposure to organic solvents. A randomized, double-blind, placebo-controlled cross-over study with neuropsychological tests.

PubMed

Somnier, F E; Ostergaard, M S; Boysen, G; Bruhn, P; Mikkelsen, B O

1990-01-01

In order to examine if the nootropic drug, aniracetam, was capable of improving cognitive performance, 44 subjects suffering from chronic psychosyndrome after long-term exposure to organic solvents were included in a randomized, double-blind, placebo-controlled, cross-over study. The treatment periods were 3 months with aniracetam 1 g daily and 3 months with placebo. Neuropsychological tests as well as a physical and neurological examination were performed at entry into the study and after each treatment period, together with an evaluation of the subjects' overall condition. Neither the doctors' nor the subjects' own assessment of the overall condition indicated that the trial medication had had any effect. No significant changes in neuropsychological symptoms were observed. A statistically significant difference in favour of antiracetam was found in only 1 of the 19 neuropsychological test measures, namely a test for constructional ability. However, in another test on visuo-spatial function, a statistically significant result was found in favour of placebo. Thus, aniracetam was found to be ineffective in the treatment of subjects suffering from chronic psychosyndrome after long-term exposure to organic solvents.

Effects of introducing a specialized nurse in the care of community-dwelling women suffering from urinary incontinence: a randomized controlled trial.

PubMed

Du Moulin, M F M T; Hamers, J P H; Paulus, A; Berendsen, C L; Halfens, R

2007-01-01

Urinary incontinence (UI) often remains inadequately treated. In the literature, there are indications that continence nurses' diagnoses and treatment advices are beneficial in terms of clinical outcomes. However, the precise short-term and long-term effects are unclear. This study investigates the short-term and long-term effects of the introduction of a continence nurse in the care of community-dwelling women suffering from UI. In a cluster randomized study, 38 women were referred to the continence nurse who, guided by a protocol, assessed and advised the patients about therapy, lifestyle, or medication. If progress was disappointing, therapy was revised. Results were compared to a group of 13 women who received "usual care" by the general practitioner. Data on frequency and volume of incontinence, quality of life, and patient satisfaction were collected at baseline and after 3, 6, and 12 months. After 6 months, women in the intervention group reported a greater reduction in "moderate" incontinent episodes when compared to women in the control group. No treatment effect was found after 12 months. Although there was a stronger improvement in scores as regards to quality of life in the intervention group, with the exception of the dimension "physical," no treatment effect was found. The introduction of a continence nurse demonstrates short-term benefit to community-dwelling women suffering from UI. However, the long-term effects should be further explored with larger study populations. ISRCTN15553880.

Long-term symptom control of gastro-oesophageal reflux disease 12 years after laparoscopic Nissen or 180° anterior partial fundoplication in a randomized clinical trial.

PubMed

Roks, D J; Broeders, J A; Baigrie, R J

2017-06-01

Laparoscopic 180° anterior fundoplication has been shown to achieve similar reflux control to Nissen fundoplication, with fewer side-effects, up to 5 years. However, there is a paucity of long-term follow-up data on this technique and antireflux surgery in general. This study reports 12-year outcomes of a double-blind RCT comparing laparoscopic Nissen versus 180° laparoscopic anterior fundoplication for gastro-oesophageal reflux disease (GORD). Patients with proven GORD were randomized to laparoscopic Nissen or 180° anterior fundoplication. The 12-year outcome measures included reflux control, dysphagia, gas-related symptoms and patient satisfaction. Measures included scores on a visual analogue scale, a validated Dakkak score for dysphagia and Visick scores. Of the initial 163 patients randomized (Nissen 84, anterior 79), 90 (55·2 per cent) completed 12-year follow-up (Nissen 52, anterior 38). There were no differences in heartburn, dysphagia, gas-related symptoms, patient satisfaction or surgical reintervention rate. Use of acid-suppressing drugs was less common after Nissen than after 180° anterior fundoplication: four of 52 (8 per cent) and 11 of 38 (29 per cent) respectively (P = 0·008). The proportion of patients with absent or only mild symptoms was slightly higher after Nissen fundoplication: 45 of 50 (90 per cent) versus 28 of 38 (74 per cent) (P = 0·044). The two surgical procedures provided similar control of heartburn and post-fundoplication symptoms, with similar patient satisfaction and reoperation rates on long-term follow-up. © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study.

PubMed

Essebag, Vidal; Verma, Atul; Healey, Jeff S; Krahn, Andrew D; Kalfon, Eli; Coutu, Benoit; Ayala-Paredes, Felix; Tang, Anthony S; Sapp, John; Sturmer, Marcio; Keren, Arieh; Wells, George A; Birnie, David H

2016-03-22

The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma. The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection. The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection. The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk. CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

RCT of working memory training in ADHD: long-term near-transfer effects.

PubMed

Hovik, Kjell Tore; Saunes, Brit-Kari; Aarlien, Anne Kristine; Egeland, Jens

2013-01-01

The aim of the study is to evaluate the long-term near-transfer effects of computerized working memory (WM) training on standard WM tasks in children with Attention-Deficit/Hyperactivity Disorder (ADHD). Sixty-seven children aged 10-12 years in Vestfold/Telemark counties (Norway) diagnosed with F90.0 Hyperkinetic disorder (ICD-10) were randomly assigned to training or control group. The training group participated in a 25-day training program at school, while the control group received treatment-as-usual. Participants were tested one week before intervention, immediately after and eight months later. Based on a component analysis, six measures of WM were grouped into composites representing Visual, Auditory and Manipulation WM. The training group had significant long-term differential gains compared to the control group on all outcome measures. Performance gains for the training group were significantly higher in the visual domain than in the auditory domain. The differential gain in Manipulation WM persisted after controlling for an increase in simple storage capacity. Systematic training resulted in a long-term positive gain in performance on similar tasks, indicating the viability of training interventions for children with ADHD. The results provide evidence for both domain-general and domain-specific models. Far-transfer effects were not investigated in this article. Controlled-Trials.com ISRCTN19133620.

[Long-term effect of policosanol on the functional recovery of non-cardioembolic ischemic stroke patients: a one year study].

PubMed

Sanchez, J; Illnait, J; Mas, R; Mendoza, S; Fernandez, L; Mesa, M; Vega, H; Fernandez, J; Reyes, P; Ruiz, D

2017-02-16

Stroke is a leading cause of mortality and disability. Policosanol has been effective in brain ischemia models. The aim of this study is to investigate whether policosanol, added to aspirin therapy within 30 days of stroke onset, is better than placebo + aspirine for the long-term recovery of non-cardioembolic ischemic stroke subjects. Randomized, double-blind, placebo-controlled study. Eighty patients (mean age: 69 years) within 30 days of onset, with a modified Rankin Scale score (mRS) 2 to 4, were included. They were randomized in two groups (policosanol + aspirine or placebo + aspirine) for 12 months. Policosanol + aspirine decreased significantly mean mRS from the first interim check-up (1.5 months). The treatment even improved after long-term therapy. More policosanol + aspirin (87.5%) than placebo + aspirine (0%) patients achieved mRSs <= 1. Policosanol + aspirine increased significantly Barthel Index, lowered LDL-cholesterol and increased HDL-cholesterol versus placebo + aspirin. Long-term (12 months) administration of policosanol + aspirin given after suffering non-cardioembolic ischemic stroke was shown to be better than placebo + aspirin in improving functional outcomes when used among patients with non-cardioembolic ischemic stroke of moderate severity.

Long-term effects of melatonin on quality of life and sleep in haemodialysis patients (Melody study): a randomized controlled trial.

PubMed

Russcher, Marije; Koch, Birgit C P; Nagtegaal, J Elsbeth; van Ittersum, Frans J; Pasker-de Jong, Pieternel C M; Hagen, E Chris; van Dorp, Wim Th; Gabreëls, Bas; Wildbergh, Thierry X; van der Westerlaken, Monique M L; Gaillard, Carlo A J M; Ter Wee, Piet M

2013-11-01

The disturbed circadian rhythm in haemodialysis patients results in perturbed sleep. Short term melatonin supplementation has alleviated these sleep problems. Our aim was to investigate the effects of long-term melatonin supplementation on quality of life and sleep. In this randomized double-blind placebo-controlled trial haemodialysis patients suffering from subjective sleep problems received melatonin 3 mg day(-1) vs. placebo during 12 months. The primary endpoint quality of life parameter 'vitality' was measured with Medical Outcomes Study Short Form-36. Secondary outcomes were improvement of three sleep parameters measured by actigraphy and nighttime salivary melatonin concentrations. Sixty-seven patients were randomized. Forty-two patients completed the trial. With melatonin, no beneficial effect on vitality was seen. Other quality of life parameters showed both advantageous and disadvantageous effects of melatonin. Considering sleep, at 3 months sleep efficiency and actual sleep time had improved with melatonin compared with placebo on haemodialysis days (difference 7.6%, 95% CI 0.77, 14.4 and 49 min, 95% CI 2.1, 95.9, respectively). At 12 months none of the sleep parameters differed significantly from placebo. Melatonin salivary concentrations at 6 months had significantly increased in the melatonin group compared with the placebo group. The high drop-out rate limits the strength of our conclusions. However, although a previous study reported beneficial short term effects of melatonin on sleep in haemodialysis patients, in this long-term study the positive effects disappeared during follow up (6-12 months). Also the quality of life parameter, vitality, did not improve. Efforts should be made to elucidate the mechanism responsible for the loss of effect with chronic use. © 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.

Promoting ball skills in preschool-age girls.

PubMed

Veldman, Sanne L C; Palmer, Kara K; Okely, Anthony D; Robinson, Leah E

2017-01-01

Evidence supports that girls are less proficient than boys at performing ball skills. This study examined the immediate and long-term effects of a ball skill intervention on preschool-age girls' ball skill performance. Randomized controlled trial. Girls (M age =47.24±7.38 months) were randomly assigned to a high autonomy, mastery-based 9-week motor skill intervention (the Children's Health Activity Motor Program; CHAMP, 540min; n=38) or a control group (free-play; n=16). Ball skill proficiency was assessed at pretest, posttest, and retention test (after 9 weeks) using the object control subscale of the Test of Gross Motor Development - 2nd Edition. Treatment efficacy was examined using linear mixed models. Two models were fit: one for short-term changes (pretest to posttest) and one for long-term changes (pretest to retention). Linear mixed models revealed a significantly time*treatment interaction for both models. Post hoc analysis confirmed that girls in CHAMP experienced significant gains in ball skills from pretest to posttest (p<.001) and pretest to retention (p<.001). Moreover, girls in CHAMP were no different from the control group at pretest (p>.05) but had significantly higher ball skills scores at both posttest (p<.001) and retention (p<.001). This study demonstrates the positive effects of a ball skill intervention (i.e., CHAMP) on improving girls' ball skills both short- and long-term. Findings suggest that early childhood interventions that focus on the development of ball skills in young girls might be an avenue to improve girls' ball skill performance. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial.

PubMed

Keijmel, Stephan P; Delsing, Corine E; Bleijenberg, Gijs; van der Meer, Jos W M; Donders, Rogier T; Leclercq, Monique; Kampschreur, Linda M; van den Berg, Michel; Sprong, Tom; Nabuurs-Franssen, Marrigje H; Knoop, Hans; Bleeker-Rovers, Chantal P

2017-04-15

Approximately 20% of patients with acute Q fever will develop chronic fatigue, referred to as Q fever fatigue syndrome (QFS). The objective of this randomized controlled clinical trial was to assess the efficacy of either long-term treatment with doxycycline or cognitive-behavioral therapy (CBT) in reducing fatigue severity in patients with QFS. Adult patients were included who met the QFS criteria according to the Dutch guideline: a new onset of severe fatigue lasting ≥6 months with significant disabilities, related to an acute Q fever infection, without other somatic or psychiatric comorbidity explaining the fatigue. Using block randomization, patients were randomized between oral study medication and CBT (2:1) for 24 weeks. Second, a double-blind randomization between doxycycline (200 mg/day, once daily) and placebo was performed in the medication group. Primary outcome was fatigue severity at end of treatment (EOT; week 26), assessed with the Checklist Individual Strength subscale Fatigue Severity. Of 155 patients randomized, 154 were included in the intention-to-treat analysis (doxycycline, 52; placebo, 52; CBT, 50). At EOT, fatigue severity was similar between doxycycline (40.8 [95% confidence interval {CI}, 37.3-44.3]) and placebo (37.8 [95% CI, 34.3-41.2]; difference, doxycycline vs placebo, -3.0 [97.5% CI, -8.7 to 2.6]; P = .45). Fatigue severity was significantly lower after CBT (31.6 [95% CI, 28.0-35.1]) than after placebo (difference, CBT vs placebo, 6.2 [97.5% CI, .5-11.9]; P = .03). CBT is effective in reducing fatigue severity in QFS patients. Long-term treatment with doxycycline does not reduce fatigue severity in QFS patients compared to placebo. NCT01318356. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com

Effects of Large Financial Incentives for Long-Term Smoking Cessation: A Randomized Trial.

PubMed

Etter, Jean-François; Schmid, Felicia

2016-08-23

It is not known whether large financial incentives enhance long-term smoking cessation rates outside clinical or workplace settings. The goal of this study was to test whether large financial incentives improved long-term smoking cessation rates in low-income smokers, in a general population setting, without face-to-face or telephone counseling. This was a 2-arm, parallel group, individually randomized controlled trial, with follow-up after 3, 6, and 18 months. Participants were 805 low-income smokers enrolled between 2011 and 2013 from the general population in Geneva, Switzerland. We randomly assigned participants to receive either booklets plus access to a smoking cessation website (control group, n = 404), or the same intervention plus financial incentives (intervention group, n = 401). Incremental financial rewards, to a maximum of U.S. $1,650, were offered for biochemically verified abstinence at 1, 2, and 3 weeks, and 1, 3, and 6 months. No in-person counseling, telephone counseling, or medications were provided. The primary outcome was continuous abstinence between 6 months (end of incentives) and 18 months (12 months after the incentives ended), verified by expired carbon monoxide and salivary cotinine. We also assessed biochemically verified 7-day abstinence at 3, 6, and 18 months. Rates of continuous abstinence between months 6 and 18 were 9.5% in the incentive group and 3.7% in the control group (p = 0.001). Rates of 7-day abstinence were higher in the incentive group than in the control group at 3 (54.9% vs. 11.9%; p < 0.001), 6 (44.6% vs. 11.1%; p < 0.001), and 18 months (18.2% vs. 11.4%; p = 0.006). In low-income smokers who did not receive face-to-face or telephone smoking cessation counseling, large financial incentives increased long-term rates of smoking cessation. (Financial incentives for smoking cessation in low-income smokers; ISRCTN04019434). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Lack of long-term benefits of a 6-month heart failure disease management program.

PubMed

Nguyen, Viviane; Ducharme, Anique; White, Michel; Racine, Normand; O'Meara, Eileen; Zhang, Bin; Rouleau, Jean L; Brophy, James

2007-05-01

Heart failure (HF) represents a major burden on the health care system, causing repeated hospitalizations and numerous emergency department (ED) visits. In a 6-month randomized study of a multidisciplinary HF clinic, we have previously shown decreased hospital readmissions and improved quality of life. Despite these encouraging results, it is unknown if these beneficial effects are sustained. To assess long-term recurrent ED visits, readmissions, and mortality among HF patients who were discharged after a 6-month intensive HF management program (HFMP). Of the 230 subjects (New York Heart Association Class II-IV) who were initially randomized to standard follow-up care or to a HFMP for 6 months, 190 were studied retrospectively for long-term evaluation. Long-term data was obtained from the Quebec administrative health databases. We compared the intervention and control groups for the number of recurrent ED visits, hospital readmissions, and all-cause deaths. After a mean follow-up of 2.8 +/- 1.7 years, there was no difference in the composite end point of all-cause death, hospital admissions, and ED visits between those patients initially in the HFMP group and the controls. After multivariable adjustment, there was no difference in the composite primary endpoint (HR 1.01, 95% CI: 0.75-1.37) or in the secondary end point of all-cause death alone (HR 1.09, 95%CI:0.69-1.72) between those initially assigned to the HF clinic and those receiving usual care. For severely ill patients, the clinical and resource benefits of a 6-month HFMP are not sustained upon program cessation. Further research into the benefits of long-term HFMP is required.

A systematic review of non-pharmacological interventions to improve nighttime sleep among residents of long-term care settings.

PubMed

Capezuti, Elizabeth; Sagha Zadeh, Rana; Pain, Kevin; Basara, Aleksa; Jiang, Nancy Ziyan; Krieger, Ana C

2018-06-18

Disturbances in sleep and circadian rhythms are common among residents of long-term care facilities. In this systematic review, we aim to identify and evaluate the literature documenting the outcomes associated with non-pharmacological interventions to improve nighttime sleep among long-term care residents. The Preferred Reporting Items for Systematic Reviews guided searches of five databases (MEDLINE, Embase, CINAHL, Scopus, and Cochrane Library) for articles reporting results of experimental or quasi-experimental studies conducted in long-term care settings (nursing homes, assisted-living facilities, or group homes) in which nighttime sleep was subjectively or objectively measured as a primary outcome. We categorized each intervention by its intended use and how it was administered. Of the 54 included studies evaluating the effects of 25 different non-pharmacological interventions, more than half employed a randomized controlled trial design (n = 30); the others used a pre-post design with (n = 11) or without (n = 13) a comparison group. The majority of randomized controlled trials were at low risk for most types of bias, and most other studies met the standard quality criteria. The interventions were categorized as environmental interventions (n = 14), complementary health practices (n = 12), social/physical stimulation (n = 11), clinical care practices (n = 3), or mind-body practices (n = 3). Although there was no clear pattern of positive findings, three interventions had the most promising results: increased daytime light exposure, nighttime use of melatonin, and acupressure. Non-pharmacological interventions have the potential to improve sleep for residents of long-term care facilities. Further research is needed to better standardize such interventions and provide clear implementation guidelines using cost-effective practices.

Effectiveness of Cranberry Capsules to Prevent Urinary Tract Infections in Vulnerable Older Persons: A Double-Blind Randomized Placebo-Controlled Trial in Long-Term Care Facilities

PubMed Central

Caljouw, Monique A A; van den Hout, Wilbert B; Putter, Hein; Achterberg, Wilco P; Cools, Herman J M; Gussekloo, Jacobijn

2014-01-01

Objectives To determine whether cranberry capsules prevent urinary tract infection (UTI) in long-term care facility (LTCF) residents. Design Double-blind randomized placebo-controlled multicenter trial. Setting Long-term care facilities (LTCFs). Participants LTCF residents (N = 928; 703 women, median age 84). Measurements Cranberry and placebo capsules were taken twice daily for 12 months. Participants were stratified according to UTI risk (risk factors included long-term catheterization, diabetes mellitus, ≥1 UTI in preceding year). Main outcomes were incidence of UTI according to a clinical definition and a strict definition. Results In participants with high UTI risk at baseline (n = 516), the incidence of clinically defined UTI was lower with cranberry capsules than with placebo (62.8 vs 84.8 per 100 person-years at risk, P = .04); the treatment effect was 0.74 (95% confidence interval (CI) = 0.57–0.97). For the strict definition, the treatment effect was 1.02 (95% CI = 0.68–1.55). No difference in UTI incidence between cranberry and placebo was found in participants with low UTI risk (n = 412). Conclusion In LTCF residents with high UTI risk at baseline, taking cranberry capsules twice daily reduces the incidence of clinically defined UTI, although it does not reduce the incidence of strictly defined UTI. No difference in incidence of UTI was found in residents with low UTI risk. PMID:25180378

Meta-analysis of long-term outcomes of drug-eluting stent implantations for chronic total coronary occlusions.

PubMed

Ma, Jian; Yang, Weiwei; Singh, Manpreet; Peng, Tianqing; Fang, Ningyuan; Wei, Meng

2011-01-01

In the treatment of chronic total occlusions (CTOs), some uncertainty exists regarding the effect of drug-eluting stents (DESs) compared with the effects of bare mental stents (BMSs). We reviewed outcomes of DES vs. BMS implantation for CTO lesions, to evaluate the risk-benefit ratio of DES implantation. Relevant studies of long-term clinical outcomes or angiographic outcomes of both BMS and DES implantation were examined. The primary endpoint comprised major adverse cardiovascular events (MACEs), including all-cause deaths, myocardial infarctions (MIs), and target lesion revascularizations (TLRs). A fixed-effect model and random-effect model were used to analyze the pooling results. Ten studies were included according to the selection criteria. Eight were nonrandomized controlled trials, and two consisted of a randomized controlled comparison between DES and BMS implantation. No significant difference was evident for in-hospital MACE rates between the two groups (odds ratio [OR], 1.07; 95% confidence interval [CI], .53 to 2.13), but the long-term MACE rates in the DES group were significantly lower than in the BMS group (OR, .22; 95% CI, .13 to .38; P < .00001). The rates of stent restenosis and reocclusions were also significantly lower in the DES group (OR, .14; 95% CI, .09 to .20; and OR, .23; 95% CI, .12 to .41, respectively). Implantation of the DES improves long-term angiographic and clinical outcomes compared with BMS in the treatment of CTO lesions. Copyright © 2011 Elsevier Inc. All rights reserved.

The effectiveness of regular leisure-time physical activities on long-term glycemic control in people with type 2 diabetes: A systematic review and meta-analysis.

PubMed

Pai, Lee-Wen; Li, Tsai-Chung; Hwu, Yueh-Juen; Chang, Shu-Chuan; Chen, Li-Li; Chang, Pi-Ying

2016-03-01

The objective of this study was to systematically review the effectiveness of different types of regular leisure-time physical activities and pooled the effect sizes of those activities on long-term glycemic control in people with type 2 diabetes compared with routine care. This review included randomized controlled trials from 1960 to May 2014. A total of 10 Chinese and English databases were searched, following selection and critical appraisal, 18 randomized controlled trials with 915 participants were included. The standardized mean difference was reported as the summary statistic for the overall effect size in a random effects model. The results indicated yoga was the most effective in lowering glycated haemoglobin A1c (HbA1c) levels. Meta-analysis also revealed that the decrease in HbA1c levels of the subjects who took part in regular leisure-time physical activities was 0.60% more than that of control group participants. A higher frequency of regular leisure-time physical activities was found to be more effective in reducing HbA1c levels. The results of this review provide evidence of the benefits associated with regular leisure-time physical activities compared with routine care for lowering HbA1c levels in people with type 2 diabetes. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Meta-analysis of Prolene Hernia System mesh versus Lichtenstein mesh in open inguinal hernia repair.

PubMed

Sanjay, Pandanaboyana; Watt, David G; Ogston, Simon A; Alijani, Afshin; Windsor, John A

2012-10-01

This study was designed to systematically analyse all published randomized clinical trials comparing the Prolene Hernia System (PHS) mesh and Lichtenstein mesh for open inguinal hernia repair. A literature search was performed using the Cochrane Colorectal Cancer Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials in the Cochrane Library, MEDLINE, Embase and Science Citation Index Expanded. Randomized trials comparing the Lichtenstein Mesh repair (LMR) with the Prolene Hernia System were included. Statistical analysis was performed using Review Manager Version 5.1 software. The primary outcome measures were hernia recurrence and chronic pain after operation. Secondary outcome measures included surgical time, peri-operative complications, time to return to work, early and long-term postoperative complications. Six randomized clinical trials were identified as suitable, containing 1313 patients. There was no statistical difference between the two types of repair in operation time, time to return to work, incidence of chronic groin pain, hernia recurrence or long-term complications. The PHS group had a higher rate of peri-operative complications, compared to Lichtenstein mesh repair (risk ratio (RR) 0.71, 95% confidence interval 0.55-0.93, P=0.01). The use of PHS mesh was associated with an increased risk of peri-operative complications compared to LMR. Both mesh repair techniques have comparable short- and long-term outcomes. Copyright © 2012 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: long-term symptomatic follow-up of a prospective randomized controlled trial.

PubMed

Kummerow Broman, Kristy; Phillips, Sharon E; Faqih, Adil; Kaiser, Joan; Pierce, Richard A; Poulose, Benjamin K; Richards, William O; Sharp, Kenneth W; Holzman, Michael D

2018-04-01

Our prior randomized controlled trial of Heller myotomy alone versus Heller plus Dor fundoplication for achalasia from 2000 to 2004 demonstrated comparable postoperative resolution of dysphagia but less gastroesophageal reflux after Heller plus Dor. Patient-reported outcomes are needed to determine whether the findings are sustained long-term. We actively engaged participants from the prior randomized cohort, making up to six contact attempts per person using telephone, mail, and electronic messaging. We collected patient-reported measures of dysphagia and gastroesophageal reflux using the Dysphagia Score and the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) instrument. Patient-reported re-interventions for dysphagia were verified by obtaining longitudinal medical records. Among living participants, 27/41 (66%) were contacted and all completed the follow-up study at a mean of 11.8 years postoperatively. Median Dysphagia Scores and GERD-HRQL scores were slightly worse for Heller than Heller plus Dor but were not statistically different (6 vs 3, p = 0.08 for dysphagia, 15 vs 13, p = 0.25 for reflux). Five patients in the Heller group and 6 in Heller plus Dor underwent re-intervention for dysphagia with most occurring more than five years postoperatively. One patient in each group underwent redo Heller myotomy and subsequent esophagectomy. Nearly all patients (96%) would undergo operation again. Long-term patient-reported outcomes after Heller alone and Heller plus Dor for achalasia are comparable, providing support for either procedure.

A Therapeutic Workplace for the Long-Term Treatment of Drug Addiction and Unemployment: Eight-Year Outcomes of a Social Business Intervention

PubMed Central

Aklin, Will M.; Wong, Conrad J.; Hampton, Jacqueline; Svikis, Dace S.; Stitzer, Maxine L.; Bigelow, George E.; Silverman, Kenneth

2014-01-01

This study evaluated the long-term effects of a Therapeutic Workplace social business on drug abstinence and employment. Pregnant and postpartum women (N=40) enrolled in methadone treatment were randomly assigned to a Therapeutic Workplace or Usual Care Control group. Therapeutic Workplace participants could work weekdays in training and then as employees of a social business, but were required to provide drug-free urine samples to work and maintain maximum pay. Three-year outcomes were reported previously. This paper reports 4- to 8- year outcomes. During year 4 when the business was open, Therapeutic Workplace participants provided significantly more cocaine- and opiate-negative urine samples than controls; reported more days employed, higher employment income, and less money spent on drugs. During the 3 years after the business closed, Therapeutic Workplace participants only reported higher income than controls. A Therapeutic Workplace social business can maintain long-term abstinence and employment, but additional intervention may be required to sustain effects. PMID:25124257

The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

PubMed

Huang, Jia; Lin, Zhengkun; Wang, Qin; Liu, Feiwen; Liu, Jiao; Fang, Yunhua; Chen, Shanjia; Zhou, Xiaoxuan; Hong, Wenjun; Wu, Jinsong; Madrigal-Mora, Natalia; Zheng, Guohua; Yang, Shanli; Tao, Jing; Chen, Lidian

2015-06-16

Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI. A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period). This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages. This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.

Prophylaxis of Venous Thromboembolism in Geriatric Settings: A Cluster-Randomized Multicomponent Interventional Trial.

PubMed

Rwabihama, Jean Paul; Audureau, Etienne; Laurent, Marie; Rakotoarisoa, Lalaina; Jegou, Marc; Saddedine, Sofiane; Krypciak, Sébastien; Herbaud, Stéphane; Benzengli, Hind; Segaux, Lauriane; Guery, Esther; Ambime, Gabin; Rabus, Marie-Thérèse; Perilliat, Jean-Guy; David, Jean-Philippe; Paillaud, Elena

2018-06-01

To evaluate the efficacy of an intervention on the practice of venous thromboembolism prevention. A multicenter, prospective, controlled, cluster-randomized, multifaceted intervention trial consisting of educational lectures, posters, and pocket cards reminding physicians of the guidelines for thromboprophylaxis use. Twelve geriatric departments with 1861 beds total, of which 202, 803, and 856 in acute care, post-acute care, and long-term care wards, respectively. Patients hospitalized between January 1 and May 31, 2015, in participating departments. The primary endpoint was the overall adequacy of thromboprophylaxis prescription at the patient level, defined as a composite endpoint consisting of indication, regimen, and duration of treatment. Geriatric departments were divided into an intervention group (6 departments) and control group (6 departments). The preintervention period was 1 month to provide baseline practice levels, the intervention period 2 months, and the postintervention period 1 month in acute care and post-acute care wards or 2 months in long-term care wards. Multivariable regression was used to analyze factors associated with the composite outcome. We included 2962 patients (1426 preintervention and 1536 postintervention), with median age 85 [79;90] years. For the overall 18.9% rate of inadequate thromboprophylaxis, 11.1% was attributable to underuse and 7.9% overuse. Intervention effects were more apparent in post-acute and long-term care wards although not significantly [odds ratio 1.44 (95% confidence interval 0.78;2.66), P = .241; and 1.44 (0.68, 3.06), P = .345]. Adequacy rates significantly improved in the postintervention period for the intervention group overall (from 78.9% to 83.4%; P = .027) and in post-acute care (from 75.4% to 86.3%; P = .004) and long-term care (from 87.0% to 91.7%; P = .050) wards, with no significant trend observed in the control group. This study failed to demonstrate improvement in prophylaxis adequacy with our intervention. However, the intervention seemed to improve practices in post-acute and long-term care but not acute care wards. Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

PKA-CREB-BDNF signaling pathway mediates propofol-induced long-term learning and memory impairment in hippocampus of rats.

PubMed

Zhong, Yu; Chen, Jing; Li, Li; Qin, Yi; Wei, Yi; Pan, Shining; Jiang, Yage; Chen, Jialin; Xie, Yubo

2018-04-20

Studies have found that propofol can induce widespread neuroapoptosis in developing brains, which leads to cause long-term learning and memory abnormalities. However, the specific cellular and molecular mechanisms underlying propofol-induced neuroapoptosis remain elusive. The aim of the present study was to explore the role of PKA-CREB-BDNF signaling pathway in propofol-induced long-term learning and memory impairment during brain development. Seven-day-old rats were randomly assigned to control, intralipid and three treatment groups (n = 5). Rats in control group received no treatment. Intralipid (10%, 10 mL/kg) for vehicle control and different dosage of propofol for three treatment groups (50, 100 and 200 mg/kg) were administered intraperitoneally. FJB staining, immunohistochemistry analysis for neuronal nuclei antigen and transmission electron microscopy were used to detect neuronal apoptosis and structure changes. MWM test examines the long-term spatial learning and memory impairment. The expression of PKA, pCREB and BDNF was quantified using western blots. Propofol induced significant increase of FJB-positive cells and decrease of PKA, pCREB and BDNF protein levels in the immature brain of P7 rats. Using the MWM test, propofol-treated rats demonstrated long-term spatial learning and memory impairment. Moreover, hippocampal NeuN-positive cell loss, long-lasting ultrastructural abnormalities of the neurons and synapses, and long-term down-regulation of PKA, pCREB and BDNF protein expression in adult hippocampus were also found. Our results indicated that neonatal propofol exposure can significantly result in long-term learning and memory impairment in adulthood. The possible mechanism involved in the propofol-induced neuroapoptosis was related to down-regulation of PKA-CREB-BDNF signaling pathway. Copyright © 2018. Published by Elsevier B.V.

Effects of edaravone on muscle atrophy and locomotor function in patients with ischemic stroke: a randomized controlled pilot study.

PubMed

Naritomi, Hiroaki; Moriwaki, Hiroshi; Metoki, Norifumi; Nishimura, Hiroyuki; Higashi, Yasuto; Yamamoto, Yasumasa; Yuasa, Hiroyuki; Oe, Hiroshi; Tanaka, Kortaro; Saito, Kozue; Terayama, Yasuo; Oda, Tadafumi; Tanahashi, Norio; Kondo, Hisao

2010-01-01

Stroke patients with severe leg paralysis are often bedridden in the acute and subacute phase, which increases the risk of disuse muscle atrophy in the chronic phase. The evidence to date indicates that oxidative stress plays an important role in the mechanism of disuse muscle atrophy. Therefore, the aim of this study was to determine if long-term radical scavenger treatment with edaravone following an acute stroke prevents the progression of disuse muscle atrophy and improves leg locomotor function in the chronic phase. This randomized controlled pilot study was conducted at 19 acute stroke and rehabilitation centers across Japan. Forty-seven ischemic stroke patients with at least leg motor weakness admitted within 24 hours of onset were randomly assigned to receive continuous intravenous infusions of edaravone 30 mg twice daily for 3 days (short-term group) or 10-14 days (long-term group). The primary endpoints of the study included the degree of leg disuse muscle atrophy, as measured by the percentage change from baseline in femoral muscle circumference 15 cm above the knee, and the improvement in leg locomotor function, as assessed by the maximum walking speed over 10 m, 3 months after the onset of stroke. Three-month follow-up was completed by a total of 41 patients (21 in the short-term group and 20 in the long-term group). On admission, there was no significant difference in the severity of stroke or the grade of leg paresis between the two treatment groups. The grade of disuse muscle atrophy and incidence of gait impairment 3 weeks after stroke onset were also similar between the short- and long-term groups. However, disuse muscle atrophy of the paretic and non-paretic legs was significantly less severe in the long-term versus the short-term treatment group (3.6 ± 5.9% and 1.5 ± 6.0% vs 8.3 ± 5.2% and 5.7 ± 6.4%; p < 0.01 and p < 0.05) 3 months after stroke onset. Additionally, the maximum walking speed over a distance of 10 m was significantly greater in the long-term group (98 ± 67 vs 54 ± 55 cm/sec; p < 0.05). Edaravone treatment for up to 14 days suppresses the progression of disuse muscle atrophy and improves leg locomotor function to a greater extent than shorter-term treatment in acute stroke patients. This suggests that the management of stroke may be improved with long-term edaravone therapy by providing myoprotective effects that ameliorate functional outcome in the chronic phase.

Improved survival with ursodeoxycholic acid prophylaxis in allogeneic stem cell transplantation: long-term follow-up of a randomized study.

PubMed

Ruutu, Tapani; Juvonen, Eeva; Remberger, Mats; Remes, Kari; Volin, Liisa; Mattsson, Jonas; Nihtinen, Anne; Hägglund, Hans; Ringdén, Olle

2014-01-01

We report the long-term results of a prospective randomized study on the use of ursodeoxycholic acid (UDCA) for prevention of hepatic complications after allogeneic stem cell transplantation. Two hundred forty-two patients, 232 with malignant disease, were randomized to receive (n = 123) or not to receive (n = 119) UDCA from the beginning of the conditioning until 90 days post-transplantation. The results were reported after 1-year follow-up. UDCA administration reduced significantly the proportion of patients developing high serum bilirubin levels as well as the incidence of severe acute graft-versus-host disease (GVHD), liver GVHD, and intestinal GVHD. In the UDCA prophylaxis group, nonrelapse mortality (NRM) was lower and overall survival better than in the control group. After a 10-year follow-up, the difference in the survival and NRM in favor of the UDCA-treated group, seen at 1 year, was maintained (survival 48% versus 38%, P = .037; NRM 28% versus 41%, P = .01). A landmark analysis in patients surviving at 1 year post-transplantation showed no significant differences between the study groups in the long-term follow-up in chronic GVHD, relapse rate, NRM, disease-free survival, or overall survival. These long-term results continue to support the useful role of UDCA in the prevention of transplant-related complications in allogeneic transplantation. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Promoting Healthy Weight with "Stability Skills First": A Randomized Trial

ERIC Educational Resources Information Center

Kiernan, Michaela; Brown, Susan D.; Schoffman, Danielle E.; Lee, Katherine; King, Abby C.; Taylor, C. Barr; Schleicher, Nina C.; Perri, Michael G.

2013-01-01

Objective: Although behavioral weight-loss interventions produce short-term weight loss, long-term maintenance remains elusive. This randomized trial examined whether learning a novel set of "stability skills" before losing weight improved long-term weight management. Stability skills were designed to optimize individuals' current…

Long-Term Outcome of Cognitive Behavior Therapy for Body Dysmorphic Disorder: A Naturalistic Case Series of 1 to 4 Years After a Controlled Trial.

PubMed

Veale, David; Miles, Sarah; Anson, Martin

2015-11-01

There is some evidence for the efficacy of cognitive behavior therapy (CBT) for body dysmorphic disorder (BDD) after 1 to 6months but none in the long term. The aim of this study was to follow up the participants in a randomized controlled trial of CBT versus anxiety management to determine whether or not the treatment gains were maintained over time. Thirty of the original 39 participants who had CBT were followed up over 1 to 4years and assessed using a number of clinician and self-report measures, which included the primary outcome measure of the Yale-Brown Obsessive Compulsive Scale modified for BDD. Outcome scores generally maintained over time from end of treatment to long-term follow-up. There was a slight deterioration from n=20 (51.3%) to n=18 (46.2%) who met improvement criteria at long-term follow-up. Eleven (28.2%) were in full remission and 22 (56.4%) were in partial remission. The gains made were generally maintained at long-term follow-up. However, there were a significant number of participants who maintained chronic symptoms after treatment and may need a longer-term or more complex intervention and active medication management. Copyright © 2015. Published by Elsevier Ltd.

Relapse Prevention in Pediatric Patients with ADHD Treated with Atomoxetine: A Randomized, Double-Blind, Placebo-Controlled Study

ERIC Educational Resources Information Center

Michelson, David; Buitelaar, Jan K.; Danckaerts, Marina; Gillberg, Christopher; Spencer, Thomas J.; Zuddas, Alessandro; Faries, Douglas E.; Zhang, Shuyu; Biederman, Joseph

2004-01-01

Objective: Attention-deficit/hyperactivity disorder (ADHD) is typically treated over extended periods; however, few placebo-controlled, long-term studies of efficacy have been reported. Method: In a global multicenter study, children and adolescents who responded to an initial 12-week, open-label period of treatment with atomoxetine, a…

Long-Term Impact of Fit and Strong! On Older Adults with Osteoarthritis

ERIC Educational Resources Information Center

Hughes, Susan L.; Seymour, Rachel B.; Campbell, Richard T.; Huber, Gail; Pollak, Naomi; Sharma, Leena; Desai, Pankaja

2006-01-01

Purpose: We present final outcomes from the multiple-component Fit and Strong! intervention for older adults with lower extremity osteoarthritis. Design and Methods: A randomized controlled trial compared the effects of this exercise and behavior-change program followed by home-based reinforcement (n = 115) with a wait list control (n = 100) at 2,…

Motivational Interviewing to Treat Overweight Children: 24-Month Follow-Up of a Randomized Controlled Trial.

PubMed

Broccoli, Serena; Davoli, Anna Maria; Bonvicini, Laura; Fabbri, Alessandra; Ferrari, Elena; Montagna, Gino; Panza, Costantino; Pinotti, Mirco; Storani, Simone; Tamelli, Marco; Candela, Silvia; Bellocchio, Eletta; Giorgi Rossi, Paolo

2016-01-01

Pediatrician-led motivational interviewing can be an effective way of controlling BMI in overweight children in the short term. Its long-term efficacy is unknown. The primary aim was to determine whether the short-term (12-month) impact of family pediatrician-led motivational interviews on the BMI of overweight children could be sustained in the long term (24 months), in the absence of any other intervention. Children were recruited in 2011 by family pediatricians working in the province of Reggio Emilia, Italy, and randomly allocated to receive either 5 interviews delivered over a 12-month period or usual care. Eligible participants were all 4- to 7-year-old overweight children resident in the province of Reggio Emilia who had been receiving care from the pediatrician for ≥ 12 months. The primary outcome of this study was individual variation in BMI between the baseline visit and the 24-month follow-up, assessed by pediatricians not blinded to treatment group allocation. Of 419 eligible families, 372 (89%) participated; 187 children were randomized to receive intervention and 185 to usual care. Ninety-five percent of the children attended the 12-month follow-up, and 91% attended the 24-month follow-up. After the 12-month intervention period, BMI in the intervention group increased less than in the control group (0.46 and 0.78, respectively; difference -0.32; P = .005). At the 24-month follow-up, the difference had disappeared (1.52 and 1.56, respectively; difference -0.04; P = .986). The intervention lost its effectiveness within 1 year of cessation. Sustainable boosters are required for weight control and obesity prevention. Copyright © 2016 by the American Academy of Pediatrics.

Whole Grain Intake and Glycaemic Control in Healthy Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

Marventano, Stefano; Vetrani, Claudia; Vitale, Marilena; Godos, Justyna; Riccardi, Gabriele; Grosso, Giuseppe

2017-07-19

There is growing evidence from both observational and intervention studies that Whole Grain (WG) cereals exert beneficial effects on human health, especially on the metabolic profile. The aim of this study was to perform a meta-analysis of randomised controlled trials (RCT) to assess the acute and medium/long-term effect of WG foods on glycaemic control and insulin sensitivity in healthy individuals. A search for all the published RCT on the effect of WG food intake on glycaemic and insulin response was performed up to December 2016. Effect size consisted of mean difference (MD) and 95% CI between the outcomes of intervention and the control groups using the generic inverse-variance random effects model. The meta-analysis of the 14 studies testing the acute effects of WG foods showed significant reductions of the post-prandial values of the glucose iAUC (0-120 min) by -29.71 mmol min/L (95% CI: -43.57, -15.85 mmol min/L), the insulin iAUC (0-120 min) by -2.01 nmol min/L (95% CI: -2.88, -1.14 nmol min/L), and the maximal glucose and insulin response. In 16 medium- and long-term RCTs, effects of WG foods on fasting glucose and insulin and homeostatic model assessment-insulin resistance values were not significant. The consumption of WG foods is able to improve acutely the postprandial glucose and insulin homeostasis compared to similar refined foods in healthy subjects. Further research is needed to better understand the long-term effects and the biological mechanisms.

Long-term effectiveness of mailed nicotine replacement therapy: study protocol of a randomized controlled trial 5-year follow-up.

PubMed

Kushnir, Vladyslav; Selby, Peter; Zawertailo, Laurie; Tyndale, Rachel F; Leatherdale, Scott T; Cunningham, John A

2017-07-18

Our group recently completed a randomized controlled trial, evaluating the efficacy of providing 5 weeks of free nicotine replacement therapy (NRT; in the form of the nicotine patch) by expedited postal mail without behavioral assistance to regular adult smokers interested in receiving it. The findings revealed that mailed provision of nicotine patches resulted in more than a doubling of quit rates at a six-month follow-up compared to a no intervention control group. While this trial provided evidence for the effectiveness of mailed nicotine patches in promoting cessation, the findings speak only to the short term effectiveness of this approach. As relapse to smoking is known to occur beyond the 6 month period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term. The present study aims to perform a 5-year follow-up survey of participants in the original trial to evaluate the long-term effectiveness of mailed NRT. Trained interviewers will contact participants in the randomized controlled trial 5 years post-enrollment. A total of 924 participants will be eligible to be contacted. Interviewers will first assess participants' smoking status and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: 30-day point prevalence abstinence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the 8-week follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. It is hypothesized that participants who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to participants who did not receive nicotine patches at baseline. If the study finds that the mailed distribution of free NRT is effective at promoting long-term cessation, it would provide further evidence to move forward with policies designed to make NRT treatment readily and freely available to smokers who request it. ClinicalTrials.gov : NCT01429129 , Registered 2 September 2011; NCT03097445 , Registered 25 March 2017.

Long-term efficacy and safety of carotid artery stenting versus endarterectomy: A meta-analysis of randomized controlled trials

PubMed Central

Xu, Biao; Wang, Lian

2017-01-01

Background Many recent trials have investigated the long-term efficacy and safety of endarterectomy versus stenting in treating patients with carotid artery stenosis. We aimed to determine the long-term comparative efficacy and safety of both procedures by pooling this evidence in a meta-analysis. Methods We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials for studies published until May 6, 2016. Randomized controlled trials, which reported outcomes of interest with a median follow-up of at least 4-year, were included. Results Eight trials involving 7005 patients and 41824 patient-years of follow-up were included. In terms of the periprocedural outcomes, stenting was associated with a lower risk of myocardial infarction (OR: 0.51; 95% CI: 0.33 to 0.80; P = 0.003) but a higher risk of death or stroke (the composite endpoint, OR: 1.76; 95% CI: 1.38 to 2.25; P < 0.0001), a result that was primarily driven by minor stroke (OR: 2.19; 95% CI: 1.59 to 3.01; P < 0.0001), less so by periprocedural death (OR: 1.68; 95% CI: 0.82 to 3.44; P = 0.16) and major stroke (OR: 1.41; 95% CI: 0.95 to 2.09; P = 0.09). In terms of the long-term outcomes, stenting was associated with a higher risk of stroke (OR 1.45; 95% CI: 1.22 to 1.73; P < 0.0001) and the composite outcome of death or stroke (OR 1.25; 95% CI: 1.05 to 1.48; P = 0.01). No difference was found in long-term all-cause mortality between stenting and endarterectomy (OR: 1.09; 95% CI: 0.95 to 1.26; P = 0.21) and restenosis (OR: 1.48 (95% CI: 0.93 to 2.35; P = 0.10). No evidence of significant heterogeneity was found in any of the analyses. Conclusions Carotid endarterectomy was found to be superior to stenting for short- and long-term outcomes, although endarterectomy was associated with a higher risk of periprocedural myocardial infarction. Carotid endarterectomy should be offered as the first choice for carotid stenosis at present, however, more evidence is needed because rapid progress in concurrent devices and medical treatments is being made. PMID:28708869

Ovarian Suppression With Triptorelin During Adjuvant Breast Cancer Chemotherapy and Long-term Ovarian Function, Pregnancies, and Disease-Free Survival: A Randomized Clinical Trial.

PubMed

Lambertini, Matteo; Boni, Luca; Michelotti, Andrea; Gamucci, Teresa; Scotto, Tiziana; Gori, Stefania; Giordano, Monica; Garrone, Ornella; Levaggi, Alessia; Poggio, Francesca; Giraudi, Sara; Bighin, Claudia; Vecchio, Carlo; Sertoli, Mario Roberto; Pronzato, Paolo; Del Mastro, Lucia

Whether the administration of luteinizing hormone-releasing hormone analogues (LHRHa) during chemotherapy is a reliable strategy to preserve ovarian function is controversial owing to both the lack of data on long-term ovarian function and pregnancies and the safety concerns about the potential negative interactions between endocrine therapy and chemotherapy. To evaluate long-term results of LHRHa-induced ovarian suppression during breast cancer chemotherapy. Parallel, randomized, open-label, phase 3 superiority trial conducted at 16 Italian sites. Between October 2003 and January 2008, 281 premenopausal women with stage I to III hormone receptor-positive or hormone receptor-negative breast cancer were enrolled. Last annual follow-up was June 3, 2014. Patients were randomized to receive adjuvant or neoadjuvant chemotherapy alone (control group) or chemotherapy plus triptorelin (LHRHa group). The primary planned end point was incidence of chemotherapy-induced early menopause. Post hoc end points were long-term ovarian function (evaluated by yearly assessment of menstrual activity and defined as resumed by the occurrence of at least 1 menstrual cycle), pregnancies, and disease-free survival (DFS). A total of 281 women (median age, 39 [range, 24-45] years) were randomized. Median follow-up was 7.3 years (interquartile range, 6.3-8.2 years). The 5-year cumulative incidence estimate of menstrual resumption was 72.6% (95% CI, 65.7%-80.3%) among the 148 patients in the LHRHa group and 64.0% (95% CI, 56.2%-72.8%) among the 133 patients in the control group (hazard ratio [HR], 1.28 [95% CI, 0.98-1.68]; P = .07; age-adjusted HR, 1.48 [95% CI, 1.12-1.95]; P = .006). Eight pregnancies (5-year cumulative incidence estimate of pregnancy, 2.1% [95% CI, 0.7%-6.3%]) occurred in the LHRHa group and 3 (5-year cumulative incidence estimate of pregnancy, 1.6% [95% CI, 0.4%-6.2%]) in the control group (HR, 2.56 [95% CI, 0.68-9.60]; P = .14; age-adjusted HR, 2.40 [95% CI, 0.62-9.22]; P = .20). Five-year DFS was 80.5% (95% CI, 73.1%-86.1%) in the LHRHa group and 83.7% (95% CI, 76.1%-89.1%) in the control group (LHRHa vs control: HR, 1.17 [95% CI, 0.72-1.92]; P = .52). Among premenopausal women with either hormone receptor-positive or hormone receptor-negative breast cancer, concurrent administration of triptorelin and chemotherapy, compared with chemotherapy alone, was associated with higher long-term probability of ovarian function recovery, without a statistically significant difference in pregnancy rate. There was no statistically significant difference in DFS for women assigned to triptorelin and those assigned to chemotherapy alone, although study power was limited. clinicaltrials.gov Identifier:NCT00311636.

Improving oral hygiene in the long-term care of the elderly--a RCT.

PubMed

Zenthöfer, Andreas; Dieke, Reinhard; Dieke, Anke; Wege, Karl-Christian; Rammelsberg, Peter; Hassel, Alexander J

2013-06-01

Oral hygiene and health of the institutionalized elderly are frequently described as inadequate. This randomized and single-blinded (outcome evaluation) study compared three types of intervention for improving oral hygiene with a control. The purpose was to investigate whether there were any significant differences between the intervention and control groups. One hundred and six participants living in long-term care homes in South-West Germany were recruited and randomly divided into four groups-three therapy groups and one control group. For all three therapy groups, teeth and dentures were cleaned professionally and individual instruction was given. One of these groups was also re-instructed and remotivated by a dentist (n = 27). One also received help from, and was remotivation by, staff educated in dental hygiene (n = 26). The third therapy group was not remotivated after professional cleaning of teeth and dentures (n = 26). For the control group, there was no intervention (n = 23). The main target clinical data were mean plaque (plaque-control record, O'Leary), gingival bleeding (Ainamo/Bay), and denture hygiene indices. For assessment of the difference between being in an intervention group and in a control group, mixed-model analysis for repeated measurements was performed for each main target variable. In addition, target clinical data were evaluated in long-term follow-up after 3 years. Compared with controls, denture hygiene, plaque, and gingival bleeding indices were significantly lower in the intervention groups over a twelve-week period (mixed model for repeated measurements; P < 0.023). Estimates of effects between control and each treatment group were comparable among the three therapy groups; however, even though two of the groups received further help and instruction. Long-term follow-up showed that all indices were significantly worse than at the last study recall (P < 0.001). Professional cleaning of teeth and dentures, with individual instruction, can be recommended to improve oral hygiene. However, the effect decreases over time and renewal of the intervention is necessary. © 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Randomized Controlled Trial to Determine the Efficacy of Long-Term Growth Hormone Treatment in Severely Burned Children

PubMed Central

Branski, Ludwik K.; Herndon, David N.; Barrow, Robert E.; Kulp, Gabriela A.; Klein, Gordon L.; Suman, Oscar E.; Przkora, Rene; Meyer, Walter; Huang, Ted; Lee, Jong O.; Chinkes, David L.; Mlcak, Ronald P.; Jeschke, Marc G.

2014-01-01

Background Recovery from a massive burn is characterized by catabolic and hypermetabolic responses that persist up to 2 years and impair rehabilitation and reintegration. The objective of this study was to determine the effects of long-term treatment with recombinant human growth hormone (rhGH) on growth, hypermetabolism, body composition, bone metabolism, cardiac work, and scarring in a large prospective randomized single-center controlled clinical trial in pediatric patients with massive burns. Patients and Methods A total of 205 pediatric patients with massive burns over 40% total body surface area were prospectively enrolled between 1998 and 2007 (clinicaltrials.gov ID NCT00675714). Patients were randomized to receive either placebo (n = 94) or long-term rhGH at 0.05, 0.1, or 0.2 mg/kg/d (n = 101). Changes in weight, body composition, bone metabolism, cardiac output, resting energy expenditure, hormones, and scar development were measured at patient discharge and at 6, 9, 12, 18, and 24 months postburn. Statistical analysis used Tukey t test or ANOVA followed by Bonferroni correction. Significance was accepted at P < 0.05. Results RhGH administration markedly improved growth and lean body mass, whereas hypermetabolism was significantly attenuated. Serum growth hormone, insulin-like growth factor-I, and IGFBP-3 was significantly increased, whereas percent body fat content significantly decreased when compared with placebo, P < 0.05. A subset analysis revealed most lean body mass gain in the 0.2 mg/kg group, P < 0.05. Bone mineral content showed an unexpected decrease in the 0.2 mg/kg group, along with a decrease in PTH and increase in osteocalcin levels, P < 0.05. Resting energy expenditure improved with rhGH administration, most markedly in the 0.1 mg/kg/d rhGH group, P < 0.05. Cardiac output was decreased at 12 and 18 months postburn in the rhGH group. Long-term administration of 0.1 and 0.2 mg/kg/d rhGH significantly improved scarring at 12 months postburn, P < 0.05. Conclusion This large prospective clinical trial showed that long-term treatment with rhGH effectively enhances recovery of severely burned pediatric patients. PMID:19734776

Lifestyle interventions and independence for elders study: Recruitment and baseline characteristics

USDA-ARS?s Scientific Manuscript database

Recruitment of older adults into long-term clinical trials involving behavioral interventions is a significant challenge. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled multisite trial, designed to compare the effects of a moderate...

Long-term followup of a phase I/II randomized, placebo-controlled trial of palifermin to prevent graft-versus-host disease (GVHD) after related donor allogeneic hematopoietic cell transplantation (HCT)

PubMed Central

Levine, John E.; Blazar, Bruce R.; DeFor, Todd; Ferrara, James L.M.; Weisdorf, Daniel J.

2008-01-01

We previously conducted a randomized, double-blind, placebo-controlled study conducted from 2000–2003 of palifermin, a recombinant human keratinocyte growth factor, dosed from 240 mcg/kg to 720 mcg/kg, in 100 allogeneic hematopoietic stem cell transplantation (HCT) recipients. Treatment with palifermin showed beneficial effects on mucositis, but no significant effect on engraftment, acute GVHD, or early survival. In addition to the effect of palifermin on mucosa, other pleotrophic effects, including more rapid immune reconstitution, have been seen in experimental transplant models. Therefore, we investigated whether with longer follow-up we could detect additional differences between the palifermin treated and placebo cohorts. We found no differences in CMV or invasive fungal infections, chronic GVHD, or long-term survival between cohorts. We conclude that the benefits of palifermin appear to primarily be limited to ameliorating mucotoxicity when given to allogeneic HCT recipients. PMID:18721764

A Randomized Controlled Trial of Group Coping-Oriented Therapy vs Supportive Therapy in Schizophrenia: Results of a 2-Year Follow-up.

PubMed

Schaub, Annette; Mueser, Kim T; von Werder, Thomas; Engel, Rolf; Möller, Hans-Jürgen; Falkai, Peter

2016-07-01

Over the past 30 years, illness management programs and cognitive-behavioral therapy for psychosis have gained prominence in the treatment of schizophrenia. However, little is known about the long-term benefits of these types of programs when delivered during inpatient treatment following a symptom exacerbation. To evaluate this question, we conducted a randomized controlled trial comparing the long-term effects of a group-based coping-oriented program (COP) that combined the elements of illness management with cognitive behavioral-therapy for psychosis, with an equally intensive supportive therapy (SUP) program. 196 inpatients with DSM-IV schizophrenia were randomized to COP or SUP, each lasting 12 sessions provided over 6-8 weeks. Outcome measures were collected in the hospital at baseline and post-assessment, and following discharge into the community 1 and 2 years later. We compared the groups on rehospitalizations, symptoms, psychosocial functioning, and knowledge about psychosis. Intent-to-treat analyses indicated that patients in COP learned significantly more information about psychosis, and had greater reductions in overall symptoms and depression/anxiety over the treatment and follow-up period than patients in SUP. Patients in both groups improved significantly in other symptoms and psychosocial functioning. There were no differences between the groups in hospitalization rates, which were low. People with schizophrenia can benefit from short-term COPs delivered during the inpatient phase, with improvements sustaining for 2 years following discharge from the hospital. More research is needed to evaluate the long-term impact of coping-oriented and similar programs provided during inpatient treatment. © The Author 2016. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation.

PubMed

Camenzind, Edoardo; Wijns, William; Mauri, Laura; Boersma, Eric; Parikh, Keyur; Kurowski, Volkhard; Gao, Runlin; Bode, Christoph; Greenwood, John P; Gershlick, Anthony; O'Neill, William; Serruys, Patrick W; Jorissen, Brenda; Steg, P Gabriel

2009-12-01

Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operator's discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturer's instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes.

Educational network comparative analysis of small groups: Short- and long-term communications

NASA Astrophysics Data System (ADS)

Berg, D. B.; Zvereva, O. M.; Nazarova, Yu. Yu.; Chepurov, E. G.; Kokovin, A. V.; Ranyuk, S. V.

2017-11-01

The present study is devoted to the discussion of small group communication network structures. These communications were observed in student groups, where actors were united with a regular educational activity. The comparative analysis was carried out for networks of short-term (1 hour) and long-term (4 weeks) communications, it was based on seven structural parameters, and consisted of two stages. At the first stage, differences between the network graphs were examined, and the random corresponding Bernoulli graphs were built. At the second stage, revealed differences were compared. Calculations were performed using UCINET software framework. It was found out that networks of long-term and short-term communications are quite different: the structure of a short-term communication network is close to a random one, whereas the most of long-term communication network parameters differ from the corresponding random ones by more than 30%. This difference can be explained by strong "noisiness" of a short-term communication network, and the lack of social in it.

C-A4-01: Computerized Clinical Decision Support During Drug Ordering for Long-term Care Residents With Renal Insufficiency

PubMed Central

Field, Terry S; Rochon, Paula; Lee, Monica; Gavendo, Linda; Baril, Joann L; Gurwitz, Jerry H

2010-01-01

Objective: To determine whether a computerized clinical decision support system (CDSS) providing patient specific recommendations in real- time improves the quality of prescribing for long-term care residents with renal insufficiency. Design: A randomized trial within the long-stay units of a large long-term care facility. Randomization was within blocks by unit type. Alerts related to medication prescribing for residents with renal insufficiency were displayed to prescribers in the intervention units and hidden but tracked in control units. Measurement: The proportions of final drug orders that were appropriate were compared between intervention and control units within alert categories: recommended medication doses; recommended administration frequencies; recommendations to avoid the drug; 4) warnings of missing information. Results: The rates of alerts were nearly equal in the intervention and control units: 2.5 per 1000 resident days in the intervention units and 2.4 in the control units. The proportions of dose alerts for which the final drug orders were appropriate were similar between the intervention and control units (relative risk 0.95, 95% confidence interval 0.83, 1.1). For the remaining alert categories significantly higher proportions of final drug orders were appropriate in the intervention units: relative risk 2.4 for maximum frequency (1.4, 4.4); 2.6 for drugs that should be avoided (1.4, 5.0); and 1.8 for alerts to acquire missing information (1.1, 3.4). Overall, final drug orders were appropriate significantly more often than a relative risk 1.2 (1.0, 1.4). By tracking personnel time and expenditures, we estimated the cost of developing the CDSS as $48,668.57. Drug costs saved during the 12 months of the trial are estimated at $2,137. Conclusion: Clinical decision support for physicians prescribing medications for long-term care residents with renal insufficiency can improve the quality of prescribing decisions. However, patient well-being and quality of care rather than the business case related to cost savings are likely to be the key drivers for adoption of this HIT application.

Does maintenance CBT contribute to long-term treatment response of panic disorder with or without agoraphobia? A randomized controlled clinical trial.

PubMed

White, Kamila S; Payne, Laura A; Gorman, Jack M; Shear, M Katherine; Woods, Scott W; Saksa, John R; Barlow, David H

2013-02-01

We examined the possibility that maintenance cognitive behavior therapy (M-CBT) may improve the likelihood of sustained improvement and reduced relapse in a multi-site randomized controlled clinical trial of patients who met criteria for panic disorder with or without agoraphobia. Participants were all patients (N = 379) who first began an open trial of acute-phase CBT. Patients completing and responding to acute-phase treatment were randomized to receive either 9 monthly sessions of M-CBT (n = 79) or assessment only (n = 78) and were then followed for an additional 12 months without treatment. M-CBT produced significantly lower relapse rates (5.2%) and reduced work and social impairment compared to the assessment only condition (18.4%) at a 21-month follow-up. Multivariate Cox proportional hazards models showed that residual symptoms of agoraphobia at the end of acute-phase treatment were independently predictive of time to relapse during 21-month follow-up (hazards ratio = 1.15, p < .01). M-CBT aimed at reinforcing acute treatment gains to prevent relapse and offset disorder recurrence may improve long-term outcome for panic disorder with and without agoraphobia.

Does Maintenance CBT Contribute to Long-Term Treatment Response of Panic Disorder With or Without Agoraphobia? A Randomized Controlled Clinical Trial

PubMed Central

White, Kamila S.; Payne, Laura A.; Gorman, Jack M.; Shear, M. Katherine; Woods, Scott W.; Saksa, John R.; Barlow, David H.

2012-01-01

Objective To examine the possibility that maintenance cognitive behavior therapy (M–CBT) may improve the likelihood of sustained improvement and reduced relapse in a multi-site randomized controlled clinical trial of patients who met criteria for panic disorder with or without agoraphobia. Method Participants were all patients (N = 379) who first began an open trial of acute-phase CBT. Patients completing and responding to acute-phase treatment were randomized to receive either nine monthly sessions of M-CBT (n = 79) or assessment only (n = 78) and were then followed for an additional 12 months without treatment. Results M–CBT produced significantly lower relapse rates (5.2%) and reduced work and social impairment compared to the assessment only condition (18.4%) at a 21-month follow-up (MFU). Multivariate Cox proportional hazards models showed that residual symptoms of agoraphobia at the end of acute-phase treatment were independently predictive of time to relapse during 21-MFU (HR = 1.15, p < .01). Conclusions M–CBT aimed at reinforcing acute treatment gains to prevent relapse and offset disorder recurrence may improve long-term outcome in PD/A. PMID:23127290

Do catheter washouts extend patency time in long-term indwelling urethral catheters? A randomized controlled trial of acidic washout solution, normal saline washout, or standard care.

PubMed

Moore, Katherine N; Hunter, Kathleen F; McGinnis, Rosemary; Bacsu, Chasta; Fader, Mandy; Gray, Mikel; Getliffe, Kathy; Chobanuk, Janice; Puttagunta, Lakshmi; Voaklander, Donald C

2009-01-01

Blockage of long-term indwelling catheters with mineral deposit is an ongoing management issue, but evidence on optimal management is lacking. Our purpose was to examine whether catheter washouts prevent or reduce catheter blockage. A multisite randomized controlled trial. Adults with long-term indwelling catheters that required changing every 3 weeks or less, living in the community, and requiring supportive or continuing care were recruited. Participants were randomly assigned to 1 of 3 groups: control (usual care, no washout), saline washout, or commercially available acidic washout solution (Contisol Maelor Pharmaceuticals Ltd, Wrexham, UK). At baseline visit, the catheter was changed and participants were followed weekly for 8 weeks, with checks for catheter patency and urine pH. Participants randomized to saline or commercial solution had a weekly washout with the appropriate solution. Endpoints were 8 weeks (completion data), 3 or more catheter changes in the 8-week period, or symptomatic urinary tract infection (UTI) requiring antibiotics. The study hypothesis was that catheter life would be extended by 25% in the commercial solution group. It was not possible to blind participants or research nurses to washout versus no intervention, but participants in the saline and washout solution groups were blinded to solution type. One hundred twelve potential participants were screened; 73 were enrolled, randomized, and included in the final analysis. Of these, 53 completed the full 8 weeks of data collection; 16 terminated early because of 3 catheter changes or self-reported 'UTI'. Other reasons for termination were hematuria, latex sensitivity, deceased/severe illness, or personal choice. Analysis of variance was used to analyze mean differences on demographic variables and mean number of weeks in study. Kaplan-Meier survival curve analysis showed no statistical difference between the groups in time to first catheter change. At this time, the evidence is insufficient to state whether catheter washout with saline or Contisol is more effective than usual care with no washout in preventing blocking. No increased risk of UTI was associated with washout regimes.

Long-Term Effects of a Parent-Based Language Intervention on Language Outcomes and Working Memory for Late-Talking Toddlers

ERIC Educational Resources Information Center

Buschmann, Anke; Multhauf, Bettina; Hasselhorn, Marcus; Pietz, Joachim

2015-01-01

A randomized control intervention study was conducted to evaluate the effects of the highly structured Heidelberg Parent-Based Language Intervention (HPLI). The outcomes of 43 children (n = 23 intervention, n = 20 control) who had been identified as late talkers during routine developmental check-ups carried out in pediatric practices at the age…

Efficacy of a Tailored Tobacco Control Program on Long-Term Use in a Population of U.S. Military Troops

ERIC Educational Resources Information Center

Klesges, Robert C.; DeBon, Margaret; Vander Weg, Mark W.; Haddock, C. Keith; Lando, Harry A.; Relyea, George E.; Peterson, Alan L.; Talcott, G. Wayne

2006-01-01

The authors evaluated the effect of a brief tailored smoking control intervention delivered during basic military training on tobacco use in a population of military personnel (N = 33,215). Participants were randomized to either a tobacco use intervention (smoking cessation, smokeless tobacco use cessation, or prevention depending on tobacco…

Effects of a prevention program for divorced families on youth cortisol reactivity 15 years later

PubMed Central

Luecken, Linda J.; Hagan, Melissa J.; Mahrer, Nicole E.; Wolchik, Sharlene A.; Sandler, Irwin N.; Tein, Jenn-Yun

2015-01-01

Objective We examined whether an empirically-based, randomized controlled trial of a preventive intervention for divorced mothers and children had a long-term impact on offspring cortisol regulation. Design Divorced mothers and children (age 9-12) were randomly assigned to a literature control condition or the 11-week New Beginnings Program (NBP), a family-focused group preventive intervention for mothers and children in newly divorced families. Main Outcome Measures Fifteen years after the trial, offspring salivary cortisol (n=161) was measured before and after a social stress task. Results Multilevel mixed models were used to predict cortisol from internalizing symptoms, externalizing symptoms, group assignment and potential moderators of intervention effects. Across the sample, higher externalizing symptoms were associated with lower cortisol reactivity. There was a significant group by age interaction such that older offspring in the control group had higher reactivity relative to the intervention group, and younger offspring in the control group exhibited a decline across the task relative to younger offspring in the intervention group. Conclusions Preventive interventions for youth from divorced families may have a long-term impact on cortisol reactivity to stress. Results highlight the importance of examining moderators of program effects. PMID:25367835

Long-term effects of transference interpretation in dynamic psychotherapy of personality disorders.

PubMed

Høglend, P; Dahl, H-S; Hersoug, A G; Lorentzen, S; Perry, J C

2011-10-01

Only a few treatment studies of personality disorders (PD) patients are on longer-term psychotherapy, general outcome measures are used, and follow-up periods are usually short. More studies of long-term therapies, using outcome measures of core psychopathology, are needed. This study is a dismantling randomized controlled clinical trial, specifically designed to study long-term effects of transference interpretation. Forty-six patients with mainly cluster C personality disorders were randomly assigned to 1 year of dynamic psychotherapy with or without transference interpretations. The outcome measures were remission from PD, improvement in interpersonal functioning, and use of mental health resources in the 3-year period after treatment termination. After therapy with transference interpretation PD-patients improved significantly more in core psychopathology and interpersonal functioning, the drop-out rate was reduced to zero, and use of health services was reduced to 50%, compared to therapy without this ingredient. Three years after treatment termination, 73% no longer met diagnostic criteria for any PD in the transference group, compared to 44% in the comparison group. PD-patients with co-morbid disorders improved in both treatment arms in this study. However, transference interpretation improved outcome substantially more. Long-term psychotherapy that includes transference interpretation is an effective treatment for cluster C personality disorders and milder cluster B personality disorders. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

A New Approach for the Treatment of Lateral Periodontal Cysts with an 810-nm Diode Laser.

PubMed

Isola, Gaetano; Matarese, Giovanni; Lo Giudice, Giuseppe; Briguglio, Francesco; Alibrandi, Angela; Crupi, Andrea; Cordasco, Giancarlo; Ramaglia, Luca

The aim of this study was to test whether the combination of diode laser therapy and surgical treatment for a lateral periodontal cyst (LPC) would result in greater clinical improvement compared with surgery alone. A total of 18 patients with LPCs were assessed for eligibility for this study. At baseline, each patient was randomly allocated to one of two regimens: diode laser plus surgery (test group) or traditional surgical treatment alone (control group). Healing parameters were assessed at 7 to 21 days to monitor short-term complications, and periodontal parameters were assessed at 3, 6, and 12 months to evaluate long-term healing. The test group demonstrated highly significant differences in both the short-term and long-term parameters compared with the control group. This study showed that diode laser treatment results in a shorter wound-healing period and could be considered valuable for the surgical treatment of LPCs.

Hypogonadism associated with long-term opioid therapy: A systematic review.

PubMed

Birthi, Pravardhan; Nagar, Vittal R; Nickerson, Robert; Sloan, Paul A

2015-01-01

Sexual dysfunction and Opioid-Induced Sexual Hormone Deficiency (OPISHD) have been associated with patients on long-term opioid pain therapy. There have been few comprehensive reviews to establish a relation between hypogonadism with chronic opioid pain management. The OPISHD is often not treated and literature guiding this topic is scarce. To investigate hypogonadism associated with long-term opioid therapy based on qualitative data analysis of the available literature. Systematic review. The review included relevant literature identified through searches of PubMed, Cochrane, Clinical Trials, US National Guideline Clearinghouse, and EMBASE, for the years 1960 to September 2013. The quality assessment and clinical relevance criteria used were the Cochrane Musculoskeletal Review Group Criteria for randomized control trials and the Newcastle-Ottawa Scale Criteria for observational studies. The level of evidence was classified as good, fair, and poor, based on the quality of evidence. The primary outcome measures were clinical symptoms and laboratory markers of hypogonadism. Secondary outcome measure was management of OPISHD. Thirty-one studies were identified, of which 14 studies met inclusion criteria. There were no randomized control trials and eight of 14 studies were of moderate quality. The remaining studies were of poor quality. Four studies report most patients on long-term oral opioid therapy have associated hypogonadism and three studies of patients receiving intrathecal opioid therapy suggest that hypogonadism is common. There is lack of high-quality studies to associate chronic opioid pain management with hypogonadism. At present, there is fair evidence to associate hypogonadism with chronic opioid pain management, and only limited evidence for treatment of OPISHD.

Coronary artery bypass surgery compared with percutaneous coronary interventions in patients with insulin-treated type 2 diabetes mellitus: a systematic review and meta-analysis of 6 randomized controlled trials.

PubMed

Bundhun, Pravesh Kumar; Wu, Zi Jia; Chen, Meng-Hua

2016-01-06

Data regarding the long-term clinical outcomes in patients with insulin-treated type 2 diabetes mellitus (ITDM) revascularized by either coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) are still controversial. We sought to compare the long-term (≥1 year) adverse clinical outcomes in patients with ITDM who underwent revascularization by either CABG or PCI. Randomized Controlled Trials (RCTs) comparing the long-term clinical outcomes in patients with ITDM and non-ITDM revascularized by either CABG or PCI were searched from electronic databases. Data for patients with ITDM were carefully retrieved. Odd Ratio (OR) with 95 % confidence interval (CI) was used to express the pooled effect on discontinuous variables and the pooled analyses were performed with RevMan 5.3. Six RCTs involving 10 studies, with a total of 1297 patients with ITDM were analyzed (639 patients from the CABG group and 658 patients from the PCI group). CABG was associated with a significantly lower mortality rate compared to PCI with OR: 0.59, 95 % CI 0.42-0.85; P = 0.004. Major adverse cardiovascular and cerebrovascular events as well as repeated revascularization were also significantly lower in the CABG group with OR: 0.51, 95 % CI 0.27-0.99; P = 0.03 and OR 0.34, 95 % CI 0.24-0.49; P < 0.00001 respectively. However, compared to PCI, the rate of stroke was higher in the CABG group with OR: 1.41, 95 % CI 0.64-3.09; P = 0.40, but this result was not statistically significant. CABG was associated with significantly lower long-term adverse clinical outcomes compared to PCI in patients with ITDM. However, due to an insignificantly higher rate of stroke in the CABG group, further researches with a larger number of randomized patients are required to completely solve this issue.

Prospective, randomized, controlled trial using best-selling smoking-cessation book.

PubMed

Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David

2017-07-01

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

Effects of Transcranial Direct Current Stimulation With Sensory Modulation on Stroke Motor Rehabilitation: A Randomized Controlled Trial.

PubMed

Koh, Chia-Lin; Lin, Jau-Hong; Jeng, Jiann-Shing; Huang, Sheau-Ling; Hsieh, Ching-Lin

2017-12-01

To test whether a multistrategy intervention enhanced recovery immediately and longitudinally in patients with severe to moderate upper extremity (UE) paresis. Double-blind, randomized controlled trial with placebo control. Outpatient department of a local medical center. People (N=25) with chronic stroke were randomly assigned to 1 of 2 groups: a transcranial direct current stimulation with sensory modulation (tDCS-SM) group (n=14; mean age ± SD, 55.3±11.4y) or a control group (n=11; mean age ± SD, 56.9±13.5y). Eight-week intervention. The tDCS-SM group received bilateral tDCS, bilateral cutaneous anesthesia, and high repetitions of passive movements on the paretic hand. The control group received the same passive movements but with sham tDCS and sham anesthesia. During the experiment, all participants continued their regular rehabilitation. Voluntary UE movement, spasticity, UE function, and basic activities of daily living. Outcomes were assessed at baseline, at postintervention, and at 3- and 6-month follow-ups. No significant differences were found between groups. However, there was a trend that the voluntary UE movement improved more in the tDCS-SM group than in the control group, with a moderate immediate effect (partial η 2 [η p 2 ]=.14, P=.07) and moderate long-term effects (3-mo follow-up: η p 2 =.17, P=.05; 6-mo follow-up: η p 2 =.12, P=.10). Compared with the control group, the tDCS-SM group had a trend of a small immediate effect (η p 2 =.02-.04) on reducing spasticity, but no long-term effect. A trend of small immediate and long-term effects in favor of tDCS-SM was found on UE function and daily function recovery (η p 2 =.02-.09). Accompanied with traditional rehabilitation, tDCS-SM had a nonsignificant trend of having immediate and longitudinal effects on voluntary UE movement recovery in patients with severe to moderate UE paresis after stroke, but its effects on spasticity reduction and functional recovery may be limited. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Autonomic nervous system function in chronic exogenous subclinical thyrotoxicosis and the effect of restoring euthyroidism.

PubMed

Eustatia-Rutten, Carmen F A; Corssmit, Eleonora P M; Heemstra, Karen A; Smit, Johannes W A; Schoemaker, Rik C; Romijn, Johannes A; Burggraaf, Jacobus

2008-07-01

Knowledge on the relationship between the autonomic nervous system and subclinical hyperthyroidism is mainly based upon cross-sectional studies in heterogeneous patient populations, and the effect of restoration to euthyroidism in subclinical hyperthyroidism has not been studied. We investigated the long-term effects of exogenous subclinical hyperthyroidism on the autonomic nervous system and the potential effects of restoration of euthyroidism. This was a prospective single-blinded, placebo-controlled, randomized trial. The study was performed at a university hospital. A total of 25 patients who were on more than 10-yr TSH suppressive therapy after thyroidectomy was examined. Patients were studied at baseline and subsequently randomized to a 6-month thyroid hormone substitution regimen to obtain either euthyroidism or maintenance of the subclinical hyperthyroid state. Urinary excretion of catecholamines and heart rate variability were measured. Baseline data of the subclinical hyperthyroidism patients were compared with data obtained in patients with hyperthyroidism and controls. Urinary excretion of norepinephrine and vanillylmandelic acid was higher in the subclinical hyperthyroidism patients compared with controls and lower compared with patients with overt hyperthyroidism. Heart rate variability was lower in patients with hyperthyroidism, intermediate in subclinical hyperthyroidism patients, and highest in the healthy controls. No differences were observed after restoration of euthyroidism. Long-term exogenous subclinical hyperthyroidism has effects on the autonomic nervous system measured by heart rate variability and urinary catecholamine excretion. No differences were observed after restoration to euthyroidism. This may indicate the occurrence of irreversible changes or adaptation during long-term exposure to excess thyroid hormone that is not remedied by 6-month euthyroidism.

Establishing Long-Term Efficacy in Chronic Disease: Use of Recursive Partitioning and Propensity Score Adjustment to Estimate Outcome in MS

PubMed Central

Goodin, Douglas S.; Jones, Jason; Li, David; Traboulsee, Anthony; Reder, Anthony T.; Beckmann, Karola; Konieczny, Andreas; Knappertz, Volker

2011-01-01

Context Establishing the long-term benefit of therapy in chronic diseases has been challenging. Long-term studies require non-randomized designs and, thus, are often confounded by biases. For example, although disease-modifying therapy in MS has a convincing benefit on several short-term outcome-measures in randomized trials, its impact on long-term function remains uncertain. Objective Data from the 16-year Long-Term Follow-up study of interferon-beta-1b is used to assess the relationship between drug-exposure and long-term disability in MS patients. Design/Setting To mitigate the bias of outcome-dependent exposure variation in non-randomized long-term studies, drug-exposure was measured as the medication-possession-ratio, adjusted up or down according to multiple different weighting-schemes based on MS severity and MS duration at treatment initiation. A recursive-partitioning algorithm assessed whether exposure (using any weighing scheme) affected long-term outcome. The optimal cut-point that was used to define “high” or “low” exposure-groups was chosen by the algorithm. Subsequent to verification of an exposure-impact that included all predictor variables, the two groups were compared using a weighted propensity-stratified analysis in order to mitigate any treatment-selection bias that may have been present. Finally, multiple sensitivity-analyses were undertaken using different definitions of long-term outcome and different assumptions about the data. Main Outcome Measure Long-Term Disability. Results In these analyses, the same weighting-scheme was consistently selected by the recursive-partitioning algorithm. This scheme reduced (down-weighted) the effectiveness of drug exposure as either disease duration or disability at treatment-onset increased. Applying this scheme and using propensity-stratification to further mitigate bias, high-exposure had a consistently better clinical outcome compared to low-exposure (Cox proportional hazard ratio = 0.30–0.42; p<0.0001). Conclusions Early initiation and sustained use of interferon-beta-1b has a beneficial impact on long-term outcome in MS. Our analysis strategy provides a methodological framework for bias-mitigation in the analysis of non-randomized clinical data. Trial Registration Clinicaltrials.gov NCT00206635 PMID:22140424

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.

Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT.

PubMed

Amirdelfan, Kasra; Yu, Cong; Doust, Matthew W; Gliner, Bradford E; Morgan, Donna M; Kapural, Leonardo; Vallejo, Ricardo; Sitzman, B Todd; Yearwood, Thomas L; Bundschu, Richard; Yang, Thomas; Benyamin, Ramsin; Burgher, Abram H; Brooks, Elizabeth S; Powell, Ashley A; Subbaroyan, Jeyakumar

2018-06-01

Chronic axial low-back pain is a debilitating disorder that impacts all aspects of an afflicted individual's life. Effective, durable treatments have historically been elusive. Interventional therapies, such as spinal cord stimulation (SCS), have shown limited efficacy at best. Recently, a novel treatment, 10 kHz SCS, has demonstrated superior pain relief compared with traditional SCS in a randomized controlled trial (RCT). In this manuscript, we report on the long-term improvements in quality of life (QoL) outcomes for subjects enrolled in this study. A prospective, multicenter, randomized controlled trial (SENZA-RCT) was conducted. Patients with both chronic back and leg pain were enrolled and randomized (1:1) into 10 kHz SCS or traditional SCS treatment groups. A total of 171 subjects received a permanent SCS device implant. QoL and functionality measures were collected up to 12 months. The device remote control utilization, which is an indication of patient interaction with the device for adjustments, was collected at 24-month post-implantation. At 12 months, a higher proportion of 10 kHz SCS subjects had marked improvement of their disability (Oswestry Disability Index) to a "moderate" or "minimal" impact on their daily function versus the control group. The subjects also reported better improvement in the Global Assessment of Functioning, Clinician Global Impression of Change, Pittsburgh Sleep Quality Index, and short-form McGill Pain Questionnaire, compared to traditional SCS subjects. The 10 kHz SCS subjects also reported far higher rates of both driving and sleeping with their device turned on, as well as reduced reliance on their programmers to adjust therapy settings. In addition to superior pain relief, 10 kHz SCS provides long-term improvements in quality of life and functionality for subjects with chronic low-back and leg pain. ClinicalTrials.gov (NCT01609972).

Comparison of the Ahmed glaucoma valve with the Baerveldt glaucoma implant: a meta-analysis.

PubMed

Wang, Yi-Wen; Wang, Ping-Bao; Zeng, Chao; Xia, Xiao-Bo

2015-10-13

This study aims to compare the efficacy and safety of the Ahmed glaucoma valve (AGV) with the Baerveldt glaucoma implant (BGI) in glaucoma patients. Databases were searched to identify studies that met pre-stated inclusion criteria, involving randomized controlled clinical trials (RCTs) and non-randomized controlled clinical trials. Treatment effect was analyzed using a random-effect model. Ten controlled clinical trials (1048 eyes) were analyzed, involving two RCTs and eight retrospective comparative studies. Short-term results (6-18 months) and long-term results (>18 months) were analyzed separately. There was no significant difference in the success rate for short-term follow-up between the AGV and BGI groups (5 studies, 714 eyes, odds ratio [OR]: 0.97; 95 % confidence interval [CI]: 0.56, 1.66; P = 0.90). For long-term pooled results (7 studies, 835 eyes), the success rate of AGVs was lower than that of BGIs (OR: 0.73; 95 % CI: 0.54, 0.99, P = 0.04), However, subgroup and sensitivity analyses did not show a significant difference in the success rate between the two groups (P ≥0.05). The AGV group had a higher mean intraocular pressure than the BGI group in short-term (6 studies, 685 eyes, weighted mean difference [WMD]: 2.12 mmHg; 95 % CI: 0.72-3.52; P <0.05) and long-term pooled results (7 studies, 659 eyes, WMD: 1.85 mmHg; 95 % CI: 0.43, 3.28; P = 0.01). The BGI group required fewer glaucoma medications after implantation than the AGV group in two follow-up periods (all P <0.05). The AGV was found to be associated with a significantly lower frequency of total complications (8 studies, 971 eyes, OR: 0.67; 95 % CI: 0.50-0.90; P = 0.007) and severe complications (8 studies, 971 eyes, OR: 0.57; 95 % CI: 0.36-0.91; P = 0.02) than the BGI. The study showed no significant difference in success rate between the two groups. The BGI was more effective for control of intraocular pressure and required fewer medications than the AGV, but the AGV had lower incidence of total and severe complications than the BGI.

The Effects of Intra-Aortic Balloon Pumps on Mortality in Patients Undergoing High-Risk Coronary Revascularization: A Meta-Analysis of Randomized Controlled Trials of Coronary Artery Bypass Grafting and Stenting Era

PubMed Central

Wan, You-Dong; Sun, Tong-Wen; Kan, Quan-Cheng; Guan, Fang-Xia; Liu, Zi-Qi; Zhang, Shu-Guang

2016-01-01

Background Intra-aortic balloon pumps (IABP) have generally been used for patients undergoing high-risk mechanical coronary revascularization. However, there is still insufficient evidence to determine whether they can improve outcomes in reperfusion therapy patients, mainly by percutaneous coronary intervention (PCI) with stenting or coronary artery bypass graft (CABG). This study was designed to determine the difference between high-risk mechanical coronary revascularization with and without IABPs on mortality, by performing a meta-analysis on randomized controlled trials of the current era. Methods Pubmed and Embase databases were searched from inception to May 2015. Unpublished data were obtained from the investigators. Randomized clinical trials of IABP and non-IABP in high-risk coronary revascularization procedures (PCI or CABG) were included. In the case of PCI procedures, stents should be used in more than 80% of patients. Numbers of events at the short-term and long-term follow-up were extracted. Results A total of 12 randomized trials enrolling 2155 patients were included. IABPs did not significantly decrease short-term mortality (relative risk (RR) 0.66; 95% CI, 0.42–1.01), or long-term mortality (RR 0.79; 95% CI, 0.47–1.35), with low heterogeneity across the studies. The findings remained stable in patients with acute myocardial infarction with or without cardiogenic shock. But in high-risk CABG patients, IABP was associated with reduced mortality (71 events in 846 patients; RR 0.40; 95%CI 0.25–0.67). Conclusion In patients undergoing high-risk coronary revascularization, IABP did not significantly decrease mortality. But high-risk CABG patients may be benefit from IABP. Rigorous criteria should be applied to the use of IABPs. PMID:26784578

A multicenter randomized controlled evaluation of automated home monitoring and telephonic disease management in patients recently hospitalized for congestive heart failure: the SPAN-CHF II trial.

PubMed

Weintraub, Andrew; Gregory, Douglas; Patel, Ayan R; Levine, Daniel; Venesy, David; Perry, Kathleen; Delano, Christine; Konstam, Marvin A

2010-04-01

We performed a prospective, randomized investigation assessing the incremental effect of automated health monitoring (AHM) technology over and above that of a previously described nurse directed heart failure (HF) disease management program. The AHM system measured and transmitted body weight, blood pressure, and heart rate data as well as subjective patient self-assessments via a standard telephone line to a central server. A total of 188 consented and eligible patients were randomized between intervention and control groups in 1:1 ratio. Subjects randomized to the control arm received the Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) heart failure disease management program. Subjects randomized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system. The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days. The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 (95%CI [0.25-0.99], P = .05). Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment. Long-term benefits in this model remain to be studied. (c) 2010 Elsevier Inc. All rights reserved.

Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial.

PubMed

Pomerantz, Hyemin; Hogan, Daniel; Eilers, David; Swetter, Susan M; Chen, Suephy C; Jacob, Sharon E; Warshaw, Erin M; Stricklin, George; Dellavalle, Robert P; Sidhu-Malik, Navjeet; Konnikov, Nellie; Werth, Victoria P; Keri, Jonette; Lew, Robert; Weinstock, Martin A

2015-09-01

Topical fluorouracil was demonstrated to be effective in reducing the number of actinic keratoses (AKs) for up to 6 months, but no randomized trials studied its long-term efficacy. To evaluate the long-term efficacy of a single course of fluorouracil cream, 5%, for AK treatment. The Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) trial was a randomized, double-blinded, placebo-controlled trial with patients from dermatology clinics at 12 VA medical centers recruited from 2009 to 2011 and followed up until 2013. Our study population comprised 932 veterans with 2 or more keratinocyte carcinomas in the 5 years prior to enrollment. The mean follow-up duration was 2.6 years in both treatment and control groups. Participants applied either topical fluorouracil cream, 5% (n = 468), or vehicle control cream (n = 464) to the face and ears twice daily for up to 4 weeks. This study reports on AK counts and treatments, which were secondary outcomes of the VAKCC trial. Actinic keratoses on the face and ears were counted by study dermatologists at enrollment and at study visits every 6 months. The number of spot treatments for AKs on the face and ears at semiannual study visits and in between study visits was recorded. The number of AKs on the face and ears per participant was not different between the fluorouracil and control groups at randomization (11.1 vs 10.6, P > .10). After randomization, the fluorouracil group had fewer AKs compared with the control group at 6 months (3.0 vs 8.1, P < .001) and for the overall study duration (P < .001). The fluorouracil group also had higher complete AK clearance rates (38% vs 17% at 6 months) and fewer spot treatments at 6-month intervals, at study visits, and in between study visits during the trial (P < .01 for all). The fluorouracil group took longer to require the first spot AK treatment (6.2 months) compared with the control group (6.0 months) (hazard ratio, 0.69; 95% CI, 0.60-0.79). The number of hypertrophic AKs was not different between the 2 groups overall (P = .60), although there were fewer hypertrophic AKs in the fluorouracil group at 6 months (0.23 vs 0.41) (P = .05). Our results indicate that a single course of fluorouracil cream, 5%, effectively reduces AK counts and the need for spot treatments for longer than 2 years. clinicaltrials.gov Identifier:NCT00847912.

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency

PubMed Central

Kapadia, Naaz; Masani, Kei; Catharine Craven, B.; Giangregorio, Lora M.; Hitzig, Sander L.; Richards, Kieva; Popovic, Milos R.

2014-01-01

Background Multi-channel surface functional electrical stimulation (FES) for walking has been used to improve voluntary walking and balance in individuals with spinal cord injury (SCI). Objective To investigate short- and long-term benefits of 16 weeks of thrice-weekly FES-assisted walking program, while ambulating on a body weight support treadmill and harness system, versus a non-FES exercise program, on improvements in gait and balance in individuals with chronic incomplete traumatic SCI, in a randomized controlled trial design. Methods Individuals with traumatic and chronic (≥18 months) motor incomplete SCI (level C2 to T12, American Spinal Cord Injury Association Impairment Scale C or D) were recruited from an outpatient SCI rehabilitation hospital, and randomized to FES-assisted walking therapy (intervention group) or aerobic and resistance training program (control group). Outcomes were assessed at baseline, and after 4, 6, and 12 months. Gait, balance, spasticity, and functional measures were collected. Results Spinal cord independence measure (SCIM) mobility sub-score improved over time in the intervention group compared with the control group (baseline/12 months: 17.27/21.33 vs. 19.09/17.36, respectively). On all other outcome measures the intervention and control groups had similar improvements. Irrespective of group allocation walking speed, endurance, and balance during ambulation all improved upon completion of therapy, and majority of participants retained these gains at long-term follow-ups. Conclusions Task-oriented training improves walking ability in individuals with incomplete SCI, even in the chronic stage. Further randomized controlled trials, involving a large number of participants are needed, to verify if FES-assisted treadmill training is superior to aerobic and strength training. PMID:25229735

Short-Term-Effectiveness of a Relationship Education Program for Distressed Military Couples, in the Context of Foreign Assignments for the German Armed Forces. Preliminary Findings From a Randomized Controlled Study.

PubMed

Kröger, Christoph; Kliem, Sören; Zimmermann, Peter; Kowalski, Jens

2018-04-01

This study examines the short-term effectiveness of a relationship education program designed for military couples. Distressed couples were randomly placed in either a wait-list control group or an intervention group. We conducted training sessions before a 3-month foreign assignment, and refresher courses approximately 6-week post-assignment. We analyzed the dyadic data of 32 couples, using hierarchical linear modeling in a two-level model. Reduction in unresolved conflicts was found in the intervention group, with large pre-post effects for both partners. Relationship satisfaction scores were improved, with moderate-to-large effects only for soldiers, rather than their partners. Post-follow-up effect sizes suggested further improvement in the intervention group. Future research should examine the long-term effectiveness of this treatment. © 2017 American Association for Marriage and Family Therapy.

A therapeutic workplace for the long-term treatment of drug addiction and unemployment: eight-year outcomes of a social business intervention.

PubMed

Aklin, Will M; Wong, Conrad J; Hampton, Jacqueline; Svikis, Dace S; Stitzer, Maxine L; Bigelow, George E; Silverman, Kenneth

2014-01-01

This study evaluated the long-term effects of a therapeutic workplace social business on drug abstinence and employment. Pregnant and postpartum women (N = 40) enrolled in methadone treatment were randomly assigned to a therapeutic workplace or usual care control group. Therapeutic workplace participants could work weekdays in training and then as employees of a social business, but were required to provide drug-free urine samples to work and maintain maximum pay. Three-year outcomes were reported previously. This paper reports 4- to 8-year outcomes. During year 4 when the business was open, therapeutic workplace participants provided significantly more cocaine- and opiate-negative urine samples than controls; reported more days employed, higher employment income, and less money spent on drugs. During the 3 years after the business closed, therapeutic workplace participants only reported higher income than controls. A therapeutic workplace social business can maintain long-term abstinence and employment, but additional intervention may be required to sustain effects. Copyright © 2014 Elsevier Inc. All rights reserved.

Efficacy and safety of stenting for elderly patients with severe and symptomatic carotid artery stenosis: a critical meta-analysis of randomized controlled trials.

PubMed

Ouyang, Yi-An; Jiang, Yugang; Yu, Mengqiang; Zhang, Yunze; Huang, Hao

2015-01-01

To investigate both short-term and long-term therapeutic efficacy and safety of carotid artery stenting (CAS) and carotid artery endarterectomy (CEA) for elderly patients with severe and symptomatic carotid artery stenosis. PubMed, EMBASE, Cochrane Library, Clinical Trials Register Centers, and Google Scholar were comprehensively searched. After identifying relevant randomized controlled trials, methodological quality was assessed by using Cochrane tools of bias assessment. Meta-analysis was performed by RevMan software, and subgroup analyses according to different follow-up periods were also conducted. Sixteen articles of nine randomized controlled trials containing 6,984 patients were included. Compared with CEA, CAS was associated with high risks of stroke during periprocedural 30 days (risk ratio [RR]=1.47, 95% confidence interval [CI]: 1.15-1.88), 48 months (RR=1.37, 95% CI: 1.11-1.70), and >48 months (RR=1.76, 95% CI: 1.34-2.31). There was no significant difference in the aspects of death, disabling stroke, or death at any time between the groups. For other periprocedural complications, CAS decreased the risk of myocardial infarction (RR=0.44, 95% CI: 0.26-0.75), cranial nerve palsy (RR=0.09, 95% CI: 0.04-0.22) and hematoma (RR=0.31, 95% CI: 0.14-0.68) compared with CEA, while it increased the risk of bradycardia or hypotension (RR=8.45, 95% CI 2.91-24.58). Compared with CEA, CAS reduced hematoma, periprocedural myocardial infarction, and cranial nerve palsy, while it was associated with higher risks of both short-term and long-term nondisabling stroke. And they seemed to be equivalent in other outcome measures. As regards to its minimal invasion, it should be applied only in specific patients.

Whole Grain Intake and Glycaemic Control in Healthy Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Marventano, Stefano; Vetrani, Claudia; Vitale, Marilena; Riccardi, Gabriele; Grosso, Giuseppe

2017-01-01

Backgrounds: There is growing evidence from both observational and intervention studies that Whole Grain (WG) cereals exert beneficial effects on human health, especially on the metabolic profile. The aim of this study was to perform a meta-analysis of randomised controlled trials (RCT) to assess the acute and medium/long-term effect of WG foods on glycaemic control and insulin sensitivity in healthy individuals. Methods: A search for all the published RCT on the effect of WG food intake on glycaemic and insulin response was performed up to December 2016. Effect size consisted of mean difference (MD) and 95% CI between the outcomes of intervention and the control groups using the generic inverse-variance random effects model. Results: The meta-analysis of the 14 studies testing the acute effects of WG foods showed significant reductions of the post-prandial values of the glucose iAUC (0–120 min) by −29.71 mmol min/L (95% CI: −43.57, −15.85 mmol min/L), the insulin iAUC (0–120 min) by −2.01 nmol min/L (95% CI: −2.88, −1.14 nmol min/L), and the maximal glucose and insulin response. In 16 medium- and long-term RCTs, effects of WG foods on fasting glucose and insulin and homeostatic model assessment-insulin resistance values were not significant. Conclusions: The consumption of WG foods is able to improve acutely the postprandial glucose and insulin homeostasis compared to similar refined foods in healthy subjects. Further research is needed to better understand the long-term effects and the biological mechanisms. PMID:28753929

FIVE-YEAR OUTCOMES AFTER LONG-TERM OXANDROLONE ADMINISTRATION IN SEVERELY BURNED CHILDREN: A RANDOMIZED CLINICAL TRIAL.

PubMed

Reeves, Patrick T; Herndon, David N; Tanksley, Jessica D; Jennings, Kristofer; Klein, Gordon L; Mlcak, Ronald P; Clayton, Robert P; Crites, Nancy N; Hays, Joshua P; Andersen, Clark; Lee, Jong O; Meyer, Walter; Suman, Oscar E; Finnerty, Celeste C

2016-04-01

Administration of oxandrolone, a nonaromatizable testosterone analog, to children for 12 months following severe burn injury has been shown to improve height, increase bone mineral content (BMC), reduce cardiac work, and augment muscle strength. Surprisingly, the increase in BMC persists well beyond the period of oxandrolone administration. This study was undertaken to determine if administration of oxandrolone for 2 years yields greater effects on long-term BMC and bone mineral density (BMD). Patients between 0 and 18 years of age with ≥30% of total body surface area burned were consented to an IRB-approved protocol and randomized to receive either placebo (n = 84) or 0.1 mg/kg oxandrolone orally twice daily for 24 months (n = 35). Patients were followed prospectively from the time of admission until 5 years postburn in a single-center, intent-to-treat setting. Height, weight, BMC, and BMD were recorded annually through 5 years postinjury. The long-term administration of oxandrolone for 16 ± 1 months postburn (range, 12.1-25.2 months) significantly increased whole-body (WB) BMC (p < 0.02) and lumbar spine (LS) BMC (p < 0.05); these effects were significantly pronounced for a longer time in patients who were in growth spurt years (7-18 years). When adjusted for height, sex, and age, LS BMD was found to significantly increase with long-term oxandrolone administration (p < 0.0009). Fewer patients receiving oxandrolone exhibited LS BMD z scores below -2.0 as compared with controls, indicating a significantly reduced risk for future fracture with oxandrolone administration. Long-term oxandrolone patients had significantly greater height velocity than controls throughout the first 2-year postburn (p < 0.05). No adverse side effects were attributed to the long-term administration of oxandrolone. A comparison of the current patients receiving long-term oxandrolone to previously described patients receiving 12 months of oxandrolone revealed that long-term oxandrolone administration imparted significantly greater increases in WB-BMC, WB-BMD, and LS-BMD (p < 0.05). In conclusion, the administration of oxandrolone for up to 24 months to severely burned pediatric patients significantly improves WB BMC, LS BMC, LS BMD, and height velocity. The administration of long-term oxandrolone was more efficacious than administration for 12 months. Additionally, fewer patients in the oxandrolone cohort met the diagnostic criteria for pediatric osteoporosis, pointing to a reduced risk for future bone fracture. This study demonstrates that administering oxandrolone for up to 2 years following severe burn injury results in greater improvements in BMC, BMD, and height velocity.

Investigating the (cost-) effectiveness of attention bias modification (ABM) for outpatients with major depressive disorder (MDD): a randomized controlled trial protocol.

PubMed

Ferrari, Gina R A; Becker, Eni S; Smit, Filip; Rinck, Mike; Spijker, Jan

2016-11-03

Despite the range of available, evidence-based treatment options for Major Depressive Disorder (MDD), the rather low response and remission rates suggest that treatment is not optimal, yet. Computerized attention bias modification (ABM) trainings may have the potential to be provided as cost-effective intervention as adjunct to usual care (UC), by speeding up recovery and bringing more patients into remission. Research suggests, that a selective attention for negative information contributes to development and maintenance of depression and that reducing this negative bias might be of therapeutic value. Previous ABM studies in depression, however, have been limited by small sample sizes, lack of long-term follow-up measures or focus on sub-clinical samples. This study aims at evaluating the long-term (cost-) effectiveness of internet-based ABM, as add-on treatment to UC in adult outpatients with MDD, in a specialized mental health care setting. This study presents a double-blind randomized controlled trial in two parallel groups with follow-ups at 1, 6, and 12 months, combined with an economic evaluation. One hundred twenty six patients, diagnosed with MDD, who are registered for specialized outpatient services at a mental health care organization in the Netherlands, are randomized into either a positive training (towards positive and away from negative stimuli) or a sham training, as control condition (continuous attentional bias assessment). Patients complete eight training sessions (seven at home) during a period of two weeks (four weekly sessions). Primary outcome measures are change in attentional bias (pre- to post-test), mood response to stress (at post-test) and long-term effects on depressive symptoms (up to 1-year follow-up). Secondary outcome measures include rumination, resilience, positive and negative affect, and transfer to other cognitive measures (i.e., attentional bias for verbal stimuli, cognitive control, positive mental imagery), as well as quality of life and costs. This is the first study investigating the long-term effects of ABM in adult outpatients with MDD, alongside an economic evaluation. Next to exploring the mechanism underlying ABM effects, this study provides first insight into the effects of combining ABM and UC and the potential implementation of ABM in clinical practice. Trialregister.nl, NTR5285 . Registered 20 July 2015.

Effect of physical activity on frailty and associated negative outcomes: the LIFE randomized trial

USDA-ARS?s Scientific Manuscript database

Background: Limited evidence suggests that physical activity may prevent frailty and associated negative outcomes in older adults. Definitive data from large, long-term, randomized trials are lacking. Objective: To determine whether a long-term structured moderate-intensity physical activity (PA) p...

A Derivation of the Dick Effect from Control-Loop Models for Periodically Interrogated Passive Frequency Standards

NASA Technical Reports Server (NTRS)

Greenhall, Charles A.

1996-01-01

The phase of a frequency standard that uses periodic interrogation and control of a local oscillator (LO) is degraded by a long-term random-walk component induced by downconversion of LO noise into the loop passband. The Dick formula for the noise level of this degradation can be derived from explicit solotions of two LO control-loop models. A summary of the derivations is given here.

Clobetasol propionate shampoo 0.05% is efficacious and safe for long-term control of moderate scalp psoriasis.

PubMed

Poulin, Yves; Papp, Kim; Bissonnette, Robert; Barber, Kirk; Kerrouche, Nabil; Villemagne, Hervé

2010-05-01

We evaluated in this study the efficacy and safety of an alternate regimen using clobetasol propionate 0.05% shampoo (CP shampoo) for long-term control of scalp psoriasis. Patients with moderate scalp psoriasis (Global Severity Score [GSS] of 3 on a 0-5 scale) first received CP shampoo once daily for 4 weeks. Patients with a GSS 2) occurred, patients received the 4-week daily CP shampoo treatment. Patients who had a GSS

Progressive Resistance and Balance Training for Falls Prevention in Long-Term Residential Aged Care: A Cluster Randomized Trial of the Sunbeam Program.

PubMed

Hewitt, Jennifer; Goodall, Stephen; Clemson, Lindy; Henwood, Timothy; Refshauge, Kathryn

2018-04-01

Falls prevention is an international priority, and residents of long-term aged care fall approximately 3 times more often than community dwellers. There is a relative scarcity of published trials in this setting. Our objective was to undertake a randomized controlled trial to test the effect of published best practice exercise in long-term residential aged care. The trial was designed to determine if combined high level balance and moderate intensity progressive resistance training (the Sunbeam Program) is effective in reducing the rate of falls in residents of aged care facilities. A cluster randomized controlled trial of 16 residential aged care facilities and 221 participants was conducted. The broad inclusion criterion was permanent residents of aged care. Exclusions were diagnosed terminal illness, no medical clearance, permanent bed- or wheelchair-bound status, advanced Parkinson's disease, or insufficient cognition to participate in group exercise. Assessments were taken at baseline, after intervention, and at 12 months. Randomization was performed by computer-generated sequence to receive either the Sunbeam program or usual care. A cluster refers to an aged care facility. The program consisted of individually prescribed progressive resistance training plus balance exercise performed in a group setting for 50 hours over a 25-week period, followed by a maintenance period for 6 months. The primary outcome measure was the rate of falls (number of falls and days followed up). Secondary outcomes included physical performance (Short Physical Performance Battery), quality of life (36-item Short-Form Health Survey), functional mobility (University of Alabama Life Space Assessment), fear of falling (Falls Efficacy Scale International), and cognition (Addenbrooke's Cognitive Evaluation-revised). The rate of falls was reduced by 55% in the exercise group (incidence rate ratio = 0.45, 95% confidence interval 0.17-0.74); an improvement was also seen in physical performance (P = .02). There were no serious adverse events. The Sunbeam Program significantly reduced the rate of falls and improved physical performance in residents of aged care. This finding is important as prior work in this setting has returned inconsistent outcomes, resulting in best practice guidelines being cautious about recommending exercise in this setting. This work provides an opportunity to improve clinical practice and health outcomes for long-term care residents. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study.

PubMed

Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

2015-01-01

The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.

PubMed

Gareb, B; van Bakelen, N B; Buijs, G J; Jansma, J; de Visscher, J G A M; Hoppenreijs, Th J M; Bergsma, J E; van Minnen, B; Stegenga, B; Bos, R R M

2017-01-01

Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation. The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery. The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS). After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups. In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures. http://controlled-trials.com ISRCTN44212338.

Effect of renal sympathetic denervation on the progression of paroxysmal atrial fibrillation in canines with long-term intermittent atrial pacing.

PubMed

Wang, Xule; Huang, Congxin; Zhao, Qingyan; Huang, He; Tang, Yanhong; Dai, Zixuan; Wang, Xiaozhan; Guo, Zongwen; Xiao, Jinping

2015-04-01

The aim of the present study was to explore the effect of renal sympathetic denervation (RSD) on the progression of paroxysmal atrial fibrillation (AF) in canines with long-term intermittent atrial pacing. Nineteen beagles were randomly divided into sham-operated group (six dogs), control group (six dogs), and RSD group (seven dogs). Sham-operated group were implanted with pacemakers without pacing; control group were implanted with pacemakers with long-term intermittent atrial pacing; and RSD group underwent catheter-based RSD bilaterally and were simultaneously implanted with pacemakers. Atrial pacing was maintained for 8 h a day and a total of 12 weeks in the control group and RSD group. Echocardiography showed that the left atrial structure and function were significantly improved in the RSD group compared with the control group (P < 0.05). Compared with the control group, the RSD group had fewer incidences of AF and a shorter duration of AF (P < 0.05) after long-term intermittent atrial pacing. In addition to increased atrial effective refractory period (AERP) and AF cycle length, AERP dispersion and P-wave duration and dispersion were significantly decreased in the RSD group compared with the control group (P < 0.05). Atrial morphological evaluation suggested that fibrosis and ultrastructural changes induced by long-term intermittent atrial pacing were markedly suppressed in the RSD dogs compared with controls (P < 0.05). Immunohistochemistry results showed that connexin 43 distribution in RSD mid-myocardial was significantly fewer heterogeneous than that in control mid-myocardial (P < 0.05). Renal denervation inhibits the progression of paroxysmal AF, which might be related to the suppression of atrial electrophysiology and structural heterogeneity. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Pain physiology education improves health status and endogenous pain inhibition in fibromyalgia: a double-blind randomized controlled trial.

PubMed

Van Oosterwijck, Jessica; Meeus, Mira; Paul, Lorna; De Schryver, Mieke; Pascal, Aurelie; Lambrecht, Luc; Nijs, Jo

2013-10-01

There is evidence that education on pain physiology can have positive effects on pain, disability, and catastrophization in patients with chronic musculoskeletal pain disorders. A double-blind randomized controlled trial (RCT) was performed to examine whether intensive pain physiology education is also effective in fibromyalgia (FM) patients, and whether it is able to influence the impaired endogenous pain inhibition of these patients. Thirty FM patients were randomly allocated to either the experimental (receiving pain physiology education) or the control group (receiving pacing self-management education). The primary outcome was the efficacy of the pain inhibitory mechanisms, which was evaluated by spatially accumulating thermal nociceptive stimuli. Secondary outcome measures included pressure pain threshold measurements and questionnaires assessing pain cognitions, behavior, and health status. Assessments were performed at baseline, 2 weeks, and 3 months follow-up. Repeated measures ANOVAS were used to reveal possible therapy effects and effect sizes were calculated. After the intervention the experimental group had improved knowledge of pain neurophysiology (P<0.001). Patients from this group worried less about their pain in the short term (P=0.004). Long-term improvements in physical functioning (P=0.046), vitality (P=0.047), mental health (P<0.001), and general health perceptions (P<0.001) were observed. In addition, the intervention group reported lower pain scores and showed improved endogenous pain inhibition (P=0.041) compared with the control group. These results suggest that FM patients are able to understand and remember the complex material about pain physiology. Pain physiology education seems to be a useful component in the treatment of FM patients as it improves health status and endogenous pain inhibition in the long term.

Survival in Malnourished Older Patients Receiving Post-Discharge Nutritional Support; Long-Term Results of a Randomized Controlled Trial.

PubMed

Neelemaat, F; van Keeken, S; Langius, J A E; de van der Schueren, M A E; Thijs, A; Bosmans, J E

2017-01-01

Previous analyses have shown that a post-discharge individualized nutritional intervention had positive effects on body weight, lean body mass, functional limitations and fall incidents in malnourished older patients. However, the impact of this intervention on survival has not yet been studied. The objective of this randomized controlled study was to examine the effect of a post-discharge individualized nutritional intervention on survival in malnourished older patients. Malnourished older patients, aged ≥ 60 years, were randomized during hospitalization to a three-months post-discharge nutritional intervention group (protein and energy enriched diet, oral nutritional supplements, vitamin D3/calcium supplement and telephone counseling by a dietitian) or to a usual care regimen (control group). Survival data were collected 4 years after enrollment. Survival analyses were performed using intention-to-treat analysis by Log-rank tests and Cox regression adjusted for confounders. The study population consisted of 94 men (45%) and 116 women with a mean age of 74.5 (SD 9.5) years. There were no statistically significant differences in baseline characteristics. Survival data was available in 208 out of 210 patients. After 1 and 4 years of follow-up, survival rates were respectively 66% and 29% in the intervention group (n=104) and 73% and 30% in the control group (n=104). There were no statistically significant differences in survival between the two groups 1 year (HR= 0.933, 95% CI=0.675-1.289) and 4 years after enrollment (HR=0.928, 95% CI=0.671-1.283). The current study failed to show an effect of a three-months post-discharge multi-component nutritional intervention in malnourished older patients on long-term survival, despite the positive effects on short-term outcome such as functional limitations and falls.

Effect of combination therapy with repaglinide and metformin hydrochloride on glycemic control in Japanese patients with type 2 diabetes mellitus.

PubMed

Kawamori, Ryuzo; Kaku, Kohei; Hanafusa, Toshiaki; Oikawa, Tatsuya; Kageyama, Shigeru; Hotta, Nigishi

2014-02-12

We investigated the efficacy and safety of repaglinide as an add-on therapy for Japanese patients with type 2 diabetes mellitus receiving metformin monotherapy (at a dose of 1,500 mg/day, mainly) in addition to diet and exercise. In the 16-week multicenter, placebo-controlled, randomized, double-blind, parallel-group trial (the phase III study), patients with type 2 diabetes mellitus with metformin monotherapy were randomly assigned to the repaglinide or placebo group. Thereafter, a 36-week, multicenter, uncontrolled, dose-titration method study was extended to a total duration of 52 weeks (the long-term study). The primary end-point of each study was a change in glycated hemoglobin (HbA1c) from baseline. After 16 weeks, mean reductions in HbA1c were significantly greater for the repaglinide group than for the placebo group (-0.98 ± 0.72% vs 0.13 ± 0.63%, P < 0.001). In the long-term study, the mean change in HbA1c was -0.76 ± 0.83%. The rate of adverse events was 60.6 and 50.0% in the repaglinide and placebo groups, respectively, in the phase III study, and 78.3% in the long-term study. Hypoglycemia was reported in 11.7, 0 and 13.3% of patients in the repaglinide group, placebo group and long-term study, respectively. Combination therapy with repaglinide and metformin resulted in an approximately 1% reduction in HbA1c at week 16 and in a significant long-term improvement in HbA1c at the end of the study. No safety problems were noted during the concomitant use of repaglinide and metformin. These studies were registered with JapicCTI (nos. JapicCTI-101202 and JapicCTI-101203).

The Aged Residential Care Healthcare Utilization Study (ARCHUS): a multidisciplinary, cluster randomized controlled trial designed to reduce acute avoidable hospitalizations from long-term care facilities.

PubMed

Connolly, Martin J; Boyd, Michal; Broad, Joanna B; Kerse, Ngaire; Lumley, Thomas; Whitehead, Noeline; Foster, Susan

2015-01-01

To assess effect of a complex, multidisciplinary intervention aimed at reducing avoidable acute hospitalization of residents of residential aged care (RAC) facilities. Cluster randomized controlled trial. RAC facilities with higher than expected hospitalizations in Auckland, New Zealand, were recruited and randomized to intervention or control. A total of 1998 residents of 18 intervention facilities and 18 control facilities. A facility-based complex intervention of 9 months' duration. The intervention comprised gerontology nurse specialist (GNS)-led staff education, facility bench-marking, GNS resident review, and multidisciplinary (geriatrician, primary-care physician, pharmacist, GNS, and facility nurse) discussion of residents selected using standard criteria. Primary end point was avoidable hospitalizations. Secondary end points were all acute admissions, mortality, and acute bed-days. Follow-up was for a total of 14 months. The intervention did not affect main study end points: number of acute avoidable hospital admissions (RR 1.07; 95% CI 0.85-1.36; P = .59) or mortality (RR 1.11; 95% CI 0.76-1.61; P = .62). This multidisciplinary intervention, packaging selected case review, and staff education had no overall impact on acute hospital admissions or mortality. This may have considerable implications for resourcing in the acute and RAC sectors in the face of population aging. Australian and New Zealand Clinical Trials Registry (ACTRN12611000187943). Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial.

PubMed

Yang, Xuyang; Wu, Qingbin; Jin, Chengwu; He, Wanbin; Wang, Meng; Yang, Tinghan; Wei, Mingtian; Deng, Xiangbing; Meng, Wenjian; Wang, Ziqiang

2017-07-26

Although conventional laparoscopic and hand-assisted laparoscopic surgery for colorectal cancer is widely used today, there remain many technical challenges especially for right colon cancer in obese patients. Herein, we develop a novel hand-assisted laparoscopic surgery (HALS) with complete mesocolic excision (CME), D3 lymphadenectomy, and a total "no-touch" isolation technique (HALS-CME) in right hemicolectomy to overcome these issues. According to previous clinic practice, this novel procedure is not only feasible and safe but has several technical merits. However, the feasibility, short-term minimally invasive virtues, long-term oncological superiority, and potential total "no-touch" isolation technique benefits of HALS-CME should be confirmed by a prospective randomized controlled trial. This is a single-center, open-label, noninferiority, randomized controlled trial. Eligible participants will be randomly assigned to the HALS-CME group or to the laparoscopic surgery with CME, D3 lymphadenectomy, and total "no-touch" isolation technique (LAP-CME) group, or to conventional laparoscopic surgery with CME and D3 lymphadenectomy (cLAP) group at a 1:1:1 ratio using a centralized randomization list. Primary endpoints include safety, efficacy, and being oncologically clear, and 3-year disease-free, progression-free, and overall survival. Second endpoints include operative outcomes (operation time, blood loss, and incision length), pathologic evaluation (grading the plane of surgery, length of proximal and distal resection margins, distance between the tumor and the central arterial high tie, distance between the nearest bowel wall and the same high tie, area of mesentery resected, width of the chain of lymph-adipose tissue, length of the central lymph-adipose chain, number of harvested lymph nodes), and postoperative outcomes (pain intensity, postoperative inflammatory and immune responses, postoperative recovery). This trial will provide valuable clinical evidence for the feasibility, safety, and potential total "no-touch" isolation technique benefits of HALS-CME for right hemicolectomy. The hypothesis is that HALS-CME is feasible for the radical D3 resection of right colon cancer and offers short-term safety and long-term oncological superiority compared with conventional laparoscopic surgery. ClinicalTrials.gov, NCT02625272 . Registered on 8 December 2015.

Long-term indoor air conditioner filtration and cardiovascular health: A randomized crossover intervention study.

PubMed

Chuang, Hsiao-Chi; Ho, Kin-Fai; Lin, Lian-Yu; Chang, Ta-Yuan; Hong, Gui-Bing; Ma, Chi-Ming; Liu, I-Jung; Chuang, Kai-Jen

2017-09-01

The association of short-term air pollution filtration with cardiovascular health has been documented. However, the effect of long-term indoor air conditioner filtration on the association between air pollution and cardiovascular health is still unclear. We recruited 200 homemakers from Taipei and randomly assigned 100 of them to air filtration or control intervention; six home visits were conducted per year from 2013 to 2014. The participants under air filtration intervention during 2013 were reassigned to control intervention in 2014. The air pollution measurements consisted of particulate matter less than or equal to 2.5μm in diameter (PM 2.5 ) and total volatile organic compounds (VOCs); blood pressure was monitored for each participant during each visit. The following morning, blood samples were collected after air pollution monitoring. The blood samples were used to analyze biological markers, including high sensitivity-C-reactive protein (hs-CRP), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and fibrinogen. Household information, including cleaning, cooking, and air conditioning, was collected by a questionnaire. Mixed-effects models were used to investigate the associations among air pollution measurements, blood pressure and biological markers. The results showed that increased levels of PM 2.5 and total VOCs were associated with increased hs-CRP, 8-OHdG and blood pressure. The health variables were higher among participants in the control intervention phase than among those in the air filtration intervention phase. We concluded that air pollution exposure was associated with systemic inflammation, oxidative stress and elevated blood pressure. The long-term filtration of air pollution with an air conditioner filter was associated with cardiovascular health of adults. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effects of long-term androgen replacement therapy on the physical and mental statuses of aging males with late-onset hypogonadism: a multicenter, randomized controlled trial in Japan (EARTH Study)

PubMed Central

Konaka, Hiroyuki; Sugimoto, Kazuhiro; Orikasa, Hideki; Iwamoto, Teruaki; Takamura, Toshinari; Takeda, Yoshiyu; Shigehara, Kazuyoshi; Iijima, Masashi; Koh, Eitetsu; Namiki, Mikio

2016-01-01

Androgen replacement therapy (ART) efficacy on late-onset hypogonadism (LOH) has been widely investigated in Western countries; however, it remains controversial whether ART can improve health and prolong active lifestyles. We prospectively assessed long-term ART effects on the physical and mental statuses of aging men with LOH in Japan. The primary endpoint was health-related quality of life assessed by questionnaires. Secondary endpoints included glycemic control, lipid parameters, blood pressure, waist circumference, body composition, muscular strength, International Prostate Symptom Scores (IPSS), International Index of Erectile Function-5 (IIEF-5) scores, and serum prostate-specific antigen levels. Of the 1637 eligible volunteers, 334 patients > 40 years with LOH were randomly assigned to either the ART (n = 169) or control groups (n = 165). Fifty-two weeks after the initial treatment, ART significantly affected the role physical subdomain of the short form-36 health survey (SF-36) scale (P = 0.0318). ART was also associated with significant decreases in waist circumstance (P = 0.002) and serum triglyceride (TG) (P = 0.013) and with significant increases in whole-body and leg muscle mass volumes (P = 0.071 and 0.0108, respectively), serum hemoglobin (P < 0.001), IPSS voiding subscore (P = 0.0418), and the second question on IIEF-5 (P = 0.0049). There was no significant difference between the groups in terms of severe adverse events. In conclusion, in patients with LOH, long-term ART exerted beneficial effects on Role Physical subdomain of the SF-36 scale, serum TG, waist circumstance, muscle mass volume, voiding subscore of IPSS, and the second question of IIEF-5. We hope our study will contribute to the future development of this area. PMID:25761833

Time on androgen deprivation therapy and adaptations to exercise: secondary analysis from a 12-month randomized controlled trial in men with prostate cancer.

PubMed

Taaffe, Dennis R; Buffart, Laurien M; Newton, Robert U; Spry, Nigel; Denham, James; Joseph, David; Lamb, David; Chambers, Suzanne K; Galvão, Daniel A

2018-02-01

To explore if duration of previous exposure to androgen deprivation therapy (ADT) in men with prostate cancer (PCa) undertaking a year-long exercise programme moderates the exercise response with regard to body composition and muscle performance, and also to explore the moderator effects of baseline testosterone, time since ADT, and baseline value of the outcome. In a multicentre randomized controlled trial, 100 men who had previously undergone either 6 months (short-term) or 18 months (long-term) of ADT in combination with radiotherapy, as part of the TROG 03.04 RADAR trial, were randomized to 6 months supervised exercise, followed by a 6-month home-based maintenance programme, or to printed physical activity educational material for 12 months across 13 university-affiliated exercise clinics in Australia and New Zealand. The participants were long-term survivors of PCa with a mean age of 71.7 ± 6.4 years, and were assessed for lower extremity performance (repeated chair rise), with a subset of men (n = 57) undergoing additional measures for upper and lower body muscle strength and body composition (lean mass, fat mass, appendicular skeletal muscle [ASM]) by dual X-ray absorptiometry. Data were analysed using generalized estimating equations. Time on ADT significantly moderated the exercise effects on chair rise (β interaction = -1.3 s, 95% confidence interval [CI] -2.6 to 0.0), whole-body lean mass (β interaction = 1194 g, 95% CI 234 to 2153) and ASM mass (β interaction = 562 g, 95% CI 49 to 1075), and approached significance for fat mass (β interaction = -1107 g, 95% CI -2346 to 132), with greater benefits for men previously on long-term ADT. At 6 months, the intervention effects on chair rise time -1.5 s (95% CI -2.5 to -0.5), whole-body lean mass 824 g (95% CI 8 to 1640), ASM mass 709 g (95% CI 260 to 1158), and fat mass -1377 g (95% CI -2156 to -598) were significant for men previously on long-term ADT, but not for men on short-term ADT. At 12 months, the intervention effects for men on long-term ADT remained significant for the chair rise, with improved performance (-2.0 s, 95% CI -3.0 to -1.0) and increased ASM (537 g, 95% CI 153 to 921). Time on ADT did not moderate the exercise effects on muscle strength, nor did time since ADT cessation moderate any intervention effects. Similarly, testosterone and baseline values of the outcome had negligible moderator effects. Men with PCa previously treated long-term with ADT respond more favourably to exercise in terms of lower body muscle performance and body composition (lean and fat mass, and ASM) than those with short-term ADT exposure. As a result, men who were formerly on long-term androgen suppression regimens should be especially prescribed exercise medicine interventions to alleviate residual treatment-related adverse effects. © 2017 The Authors. BJU International.

Effectiveness of a program to facilitate recovery for people with long-term mental illness in Japan.

PubMed

Chiba, Rie; Miyamoto, Yuki; Kawakami, Norito; Harada, Naoko

2014-09-01

Recovery is defined as the process of developing new meaning and purpose in life as one grows beyond the catastrophic effects of mental illness. This study aimed to develop a program to facilitate recovery and examine its effectiveness in a randomized controlled trial. The program was developed with three components that enhance benefit finding, personal meaning, and a sense of happiness. Sixty-three participants with long-term mental illness were randomly allocated to the intervention group (n = 32) or the control group (n = 31). The intervention group attended eight 2-h group sessions, with one held every week. Recovery was assessed at baseline, post-intervention, and at a three-month follow-up. In the per-protocol analysis, after excluding those who dropped out, the intervention group showed significant improvement in recovery compared with the control group (P < 0.05). In the intention-to-treat analysis, a repeated measures analysis of variance did not show any significant intervention effect (time × group) (P > 0.05). The program had the potential to facilitate recovery. © 2013 Wiley Publishing Asia Pty Ltd.

Long-term outcomes of internet-based self-management support in adults with asthma: randomized controlled trial.

PubMed

van Gaalen, Johanna L; Beerthuizen, Thijs; van der Meer, Victor; van Reisen, Patricia; Redelijkheid, Geertje W; Snoeck-Stroband, Jiska B; Sont, Jacob K

2013-09-12

Long-term asthma management falls short of the goals set by international guidelines. The Internet is proposed as an attractive medium to support guided self-management in asthma. Recently, in a multicenter, pragmatic randomized controlled parallel trial with a follow-up period of 1 year, patients were allocated Internet-based self-management (IBSM) support (Internet group [IG]) or usual care (UC) alone. IBSM support was automatically terminated after 12 months of follow-up. In this study, IBSM support has been demonstrated to improve asthma-related quality of life, asthma control, lung function, and the number of symptom-free days as compared to UC. IBSM support was based on known key components for effective self-management and included weekly asthma control monitoring and treatment advice, online and group education, and communication (both online and offline) with a respiratory nurse. The objective of the study was to assess the long-term effects of providing patients 1 year of IBSM support as compared to UC alone. Two hundred adults with physician-diagnosed asthma (3 or more months of inhaled corticosteroids prescribed in the past year) from 37 general practices and 1 academic outpatient department who previously participated were invited by letter for additional follow-up at 1.5 years after finishing the study. The Asthma Control Questionnaire (ACQ) and the Asthma Quality of Life Questionnaire (AQLQ) were completed by 107 participants (60 UC participants and 47 IG participants). A minimal clinical important difference in both questionnaires is 0.5 on a 7-point scale. At 30 months after baseline, a sustained and significant difference in terms of asthma-related quality of life of 0.29 (95% CI 0.01-0.57) and asthma control of -0.33 (95% CI -0.61 to -0.05) was found in favor of the IBSM group. No such differences were found for inhaled corticosteroid dosage or for lung function, measured as forced expiratory volume in 1 second. Improvements in asthma-related quality of life and asthma control were sustained in patients who received IBSM support for 1 year, even up to 1.5 years after terminating support. Future research should be focused on implementation of IBSM on a wider scale within routine asthma care. International Standard Randomized Controlled Trial Number (ISRCTN): 79864465; http://www.controlled-trials.com/ISRCTN79864465 (Archived by WebCite at http://www.webcitation.org/6J4VHhPk4).

Hysteroscopic Endometrial Resection Versus Laparoscopic Supracervical Hysterectomy for Abnormal Uterine Bleeding: Long-term Follow-up of a Randomized Trial.

PubMed

Zupi, Errico; Centini, Gabriele; Lazzeri, Lucia; Finco, Andrea; Exacoustos, Caterina; Afors, Karolina; Zullo, Fulvio; Petraglia, Felice

2015-01-01

To compare long-term efficacy of laparoscopic supracervical hysterectomy (LSH) and hysteroscopic endometrial ablation (HEA) in treating persistent abnormal uterine bleeding. Canadian Task Force II-2. University hospital. One hundred fifty-three women treated for abnormal uterine bleeding by LSH or HEA. Long-term follow-up assessment of reintervention rate and quality of life (QoL) using the Quality Metric's Health Survey Short Form 12. This study is the long-term follow-up of a randomized control trial conducted in 2003 comparing LSH and HEA in terms of reoperation rate and QoL. Starting from November 2010 all patients included in the first trial were invited to participate in this study and clinically evaluated through vaginal examination and transvaginal ultrasound. After a mean follow-up of 14.4 years, 29% of patients (20/71) treated with HEA underwent further surgery, whereas no patients after LSH had symptom recurrence. The reintervention rate was significantly higher in the HEA group (p < .0001), with a relative risk of 1.39 (95% confidence interval, 1.20-1.61). The assessment of QoL demonstrated a higher score, in both physical and mental components, in the LSH group (p < .0001). The lower reintervention rate and the better physical and mental health scores make LSH a more suitable procedure to treat recurrent abnormal uterine bleeding when compared with HEA. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

Phosphatidylcholine supplementation in pregnant women consuming moderate-choline diets does not enhance infant cognitive function: a randomized, double-blind, placebo-controlled trial123

PubMed Central

Goldman, Barbara Davis; Fischer, Leslie M; da Costa, Kerry-Ann; Reznick, J Steven; Zeisel, Steven H

2012-01-01

Background: Choline is essential for fetal brain development, and it is not known whether a typical American diet contains enough choline to ensure optimal brain development. Objective: The study was undertaken to determine whether supplementing pregnant women with phosphatidylcholine (the main dietary source of choline) improves the cognitive abilities of their offspring. Design: In a double-blind, randomized controlled trial, 140 pregnant women were randomly assigned to receive supplemental phosphatidylcholine (750 mg) or a placebo (corn oil) from 18 wk gestation through 90 d postpartum. Their infants (n = 99) were tested for short-term visuospatial memory, long-term episodic memory, language development, and global development at 10 and 12 mo of age. Results: The women studied ate diets that delivered ∼360 mg choline/d in foods (∼80% of the recommended intake for pregnant women, 65% of the recommended intake for lactating women). The phosphatidylcholine supplements were well tolerated. Groups did not differ significantly in global development, language development, short-term visuospatial memory, or long-term episodic memory. Conclusions: Phosphatidylcholine supplementation of pregnant women eating diets containing moderate amounts of choline did not enhance their infants’ brain function. It is possible that a longer follow-up period would reveal late-emerging effects. Moreover, future studies should determine whether supplementing mothers eating diets much lower in choline content, such as those consumed in several low-income countries, would enhance infant brain development. This trial was registered at clinicaltrials.gov as NCT00678925. PMID:23134891

Long-term Use of Opioids for Complex Chronic Pain

PubMed Central

Von Korff, Michael R.

2014-01-01

Increased opioid prescribing for back pain and other chronic musculoskeletal pain conditions has been accompanied by dramatic increases in prescription opioid addiction and fatal overdose. Opioid-related risks appear to increase with dose. While short-term randomized trials of opioids for chronic pain have found modest analgesic benefits (a one-third reduction in pain intensity on average), the long-term safety and effectiveness of opioids for chronic musculoskeletal pain is unknown. Given the lack of large, long-term randomized trials, recent epidemiologic data suggests the need for caution when considering long-term use of opioids to manage chronic musculoskeletal pain, particularly at higher dosage levels. Principles for achieving more selective and cautious use of opioids for chronic musculoskeletal pain are proposed. PMID:24315147

Seated T'ai Chi in Older Taiwanese People Using Wheelchairs: A Randomized Controlled Trial Investigating Mood States and Self-Efficacy.

PubMed

Hsu, Chen-Yuan; Moyle, Wendy; Cooke, Marie; Jones, Cindy

2016-12-01

There is growing interest in t'ai chi, but little research has addressed whether t'ai chi is effective in older people using wheelchairs for mobilization. The aim of this study was to compare the effects of seated t'ai chi exercise and usual standard activities on mood states and self-efficacy in older people living in a long-term care facility and using wheelchairs for mobilization. Randomized controlled trial (trial registration no. ACTRN12613000029796). One long-term-care facility in Taiwan. Sixty participants were randomly assigned by a computer-generated random sequence to a t'ai chi group (n = 30) or a usual exercise and entertainment activities group (n = 30). Seated t'ai chi exercise for 40 minutes three times a week for 26 weeks was provided. Mood states (Profile of Mood States Short Form [POMS-SF]) and self-efficacy (Self-Efficacy for Exercise [SEE]). At week 26, participants in the t'ai chi group reported significantly lower mood states on the fatigue-inertia dimension of the POMS-SF (mean score ± standard deviation, 3.56 ± 3.71) than did the control group (mean score, 7.16 ± 6.36) (F [1, 58] = 7.15; p < 0.05). The t'ai chi group recorded significantly higher SEE levels (mean, 35.66 ± 36.83) than did those in the control group (mean, 15.30 ± 26.43) (F [1, 58] = 6.05; p < 0.05). The findings highlight the importance of t'ai chi for a reduction in the fatigue-inertia mood state and an increase in self-efficacy for older people using wheelchairs.

Long-term effects of a 12 weeks high-intensity functional exercise program on physical function and mental health in nursing home residents with dementia: a single blinded randomized controlled trial.

PubMed

Telenius, Elisabeth Wiken; Engedal, Knut; Bergland, Astrid

2015-12-03

Research indicates that exercise can have a positive effect on both physical and mental health in nursing home patients with dementia, however the lasting effect is rarely studied. In a previously published article we investigated the immediate effect of a 12 weeks functional exercise program on physical function and mental health in nursing home residents with dementia. In this paper we studied the long-term effect of this exercise program. We explored the differences between the exercise and control group from baseline to 6 months follow-up and during the detraining period from month 3 to 6. A single blind, randomized controlled trial was conducted and a total of 170 nursing home residents with dementia were included. The participants were randomly allocated to an intervention (n = 87) or a control group (n = 83). The intervention consisted of intensive strengthening and balance exercises in small groups twice a week for 12 weeks. The control condition was leisure activities. Thirty participants were lost between baseline and six-month follow-up. Linear mixed model analyses for repeated measurements were used to investigate the effect of exercise after detraining period. The exercise group improved their scores on Berg Balance Scale from baseline to 6 months follow-up by 2.7 points in average. The control group deteriorated in the same period and the difference between groups was statistically significant (p = 0.031). The exercise group also scored better on NPI agitation sub-score after 6 months (p = 0.045). The results demonstrate long-time positive effects of a high intensity functional exercise program on balance and indicate a positive effect on agitation, after an intervention period of 12 weeks followed by a detraining period of 12 weeks. Identifier at ClinicalTrials.gov: NCT02262104.

Mindfulness Enhances Episodic Memory Performance: Evidence from a Multimethod Investigation

PubMed Central

Goodman, Robert J.; Ryan, Richard M.; Anālayo, Bhikkhu

2016-01-01

Training in mindfulness, classically described as a receptive attentiveness to present events and experiences, has been shown to improve attention and working memory. Both are key to long-term memory formation, and the present three-study series used multiple methods to examine whether mindfulness would enhance episodic memory, a key form of long-term memory. In Study 1 (N = 143), a self-reported state of mindful attention predicted better recognition performance in the Remember-Know (R-K) paradigm. In Study 2 (N = 93), very brief training in a focused attention form of mindfulness also produced better recognition memory performance on the R-K task relative to a randomized, well-matched active control condition. Study 3 (N = 57) extended these findings by showing that relative to randomized active and inactive control conditions the effect of very brief mindfulness training generalized to free-recall memory performance. This study also found evidence for mediation of the mindfulness training—episodic memory relation by intrinsic motivation. These findings indicate that mindful attention can beneficially impact motivation and episodic memory, with potential implications for educational and occupational performance. PMID:27115491

Mindfulness Enhances Episodic Memory Performance: Evidence from a Multimethod Investigation.

PubMed

Brown, Kirk Warren; Goodman, Robert J; Ryan, Richard M; Anālayo, Bhikkhu

2016-01-01

Training in mindfulness, classically described as a receptive attentiveness to present events and experiences, has been shown to improve attention and working memory. Both are key to long-term memory formation, and the present three-study series used multiple methods to examine whether mindfulness would enhance episodic memory, a key form of long-term memory. In Study 1 (N = 143), a self-reported state of mindful attention predicted better recognition performance in the Remember-Know (R-K) paradigm. In Study 2 (N = 93), very brief training in a focused attention form of mindfulness also produced better recognition memory performance on the R-K task relative to a randomized, well-matched active control condition. Study 3 (N = 57) extended these findings by showing that relative to randomized active and inactive control conditions the effect of very brief mindfulness training generalized to free-recall memory performance. This study also found evidence for mediation of the mindfulness training-episodic memory relation by intrinsic motivation. These findings indicate that mindful attention can beneficially impact motivation and episodic memory, with potential implications for educational and occupational performance.

Longitudinal follow-up comparison of educational interventions: multimedia textbook, traditional lecture, and printed textbook.

PubMed

D'Alessandro, D M; Kreiter, C D; Erkonen, W E; Winter, R J; Knapp, H R

1997-11-01

The goal of this prospective, interinstitutional study was to compare the long-term instructional effectiveness of a pediatric multimedia textbook (MMTB) to that of a standard lecture and a printed textbook. A randomized cohort of 89 3rd-year medical students from two institutions were initially evaluated from June 1992 to June 1993 and reevaluated in May 1994. Students were randomly assigned to one of four instructional groups: computer-aided instruction by means of MMTBs (n = 21), traditional lecture (n = 23), printed textbook (n = 19), and a control group (n = 26). After instruction, all groups were tested by means of a multiple choice test at the end of their pediatric clerkship; they were given this same test 11-22 months later. The long-term instructional effectiveness of the MMTB, printed textbook, and lecture were the same as that in the control group, as determined by analysis of variance of mean test scores. The educational advantage of MMTBs observed immediately after instruction was not detected 1 year later. Because attrition reduced statistical power, further research is necessary to determine how educational fading affects these instructional formats.

Effects of a 12-Week Exercise Training Program on Physical Function in Institutionalized Frail Elderly

PubMed Central

Ferreira, Cristiane Batisti; Teixeira, Pâmela dos Santos; Alves dos Santos, Geiane; Dantas Maya, Athila Teles; Americano do Brasil, Paula; Souza, Vinícius Carolino; Córdova, Cláudio; Lima, Ricardo Moreno; Nóbrega, Otávio de Toledo

2018-01-01

With the increase in life expectancy, the Brazilian elderly population has risen considerably. However, longevity is usually accompanied by problems such as the loss of functional capacity, cognitive decline, frailty syndrome, and deterioration in anthropometric parameters, particularly among those living in long-term care facilities. This randomized controlled trial aimed to verify the effects of exercise training on biochemical, inflammatory, and anthropometric indices and functional performance in institutionalized frail elderly. The sample consisted of 37 elderly people of both genders, aged 76.1 ± 7.7 years, who were randomly allocated into 2 groups: 13 individuals in the exercise group (EG) and 24 in the control group (CG). Anthropometrics, clinical history, functional tests, and biochemical evaluation were measured before and after the completion of a physical exercise program, which lasted for 12 weeks. The 12-week exercise program for frail elderly residents in a long-term care facility was efficient in improving muscle strength, speed, agility, and biochemical variables, with reversal of the frailty condition in a considerable number. However, no effects in anthropometric and inflammatory parameters were noted. PMID:29593907

Current outcomes of off-pump versus on-pump coronary artery bypass grafting: evidence from randomized controlled trials

PubMed Central

Benedetto, Umberto; Pecchinenda, Gustavo Guida; Chivasso, Pierpaolo; Bruno, Vito Domenico; Rapetto, Filippo; Bryan, Alan; Angelini, Gianni Davide

2016-01-01

Coronary artery bypass grafting remains the standard treatment for patients with extensive coronary artery disease. Coronary surgery without use of cardiopulmonary bypass avoids the deleterious systemic inflammatory effects of the extracorporeal circuit. However there is an ongoing debate surrounding the clinical outcomes after on-pump versus off-pump coronary artery bypass (ONCAB versus OPCAB) surgery. The current review is based on evidence from randomized controlled trials (RCTs) and meta-analyses of randomized studies. It focuses on operative mortality, mid- and long-term survival, graft patency, completeness of revascularisation, neurologic and neurophysiologic outcomes, perioperative complications and outcomes in the high risk groups. Early and late survival rates for both OPCAB and ONCAB grafting are similar. Some studies suggest early poorer vein graft patency with off-pump when compared with on-pump, comparable midterm arterial conduit patency with no difference in long term venous and arterial graft patency. A recent, pooled analysis of randomised trials shows a reduction in stroke rates with use off-pump techniques. Furthermore, OPCAB grafting seems to reduce postoperative renal dysfunction, bleeding, transfusion requirement and respiratory complications while perioperative myocardial infarction rates are similar to ONCAB grafting. The high risk patient groups seem to benefit from off-pump coronary surgery. PMID:27942394

Foot massage and physiological stress in people with dementia: a randomized controlled trial.

PubMed

Moyle, Wendy; Cooke, Marie Louise; Beattie, Elizabeth; Shum, David H K; O'Dwyer, Siobhan T; Barrett, Sue; Sung, Billy

2014-04-01

The anxiety associated with unfamiliar surroundings, the disorientation and mental confusion, and the social isolation that accompanies dementia can often create increased stress for people living in long-term care settings. Such a response is thought to affect the autonomic nervous system and result in emotional and physical symptoms of distress that may be manifested as agitation. There is the potential for such distress to influence the physiological response and in particular Blood Pressure and Heart Rate. A relaxation intervention such as massage may influence the physiological stress response. This randomized controlled trial aimed to compare the effect of foot massage (FM) versus a control activity (quiet presence, QP) on physiological stress response (i.e., blood pressure [BP] and heart rate [HR]) in people living with moderate-to-severe dementia in long-term-care settings. Fifty-three residents were randomized to intervention (10-minute FM) or control group (QP). While the FM group experienced a greater reduction in HR than the control group, these reductions were not significantly different between groups (p=0.83; see Table 1 ), or across time (p=0.46). Both groups experienced a reduction in systolic BP and diastolic BP, while the mean reduction in systolic BP was greater for those in the FM group. While the findings do not provide strong support for FM, the finding that both conditions allowed the person with dementia to rest in the presence of another human being is of importance in the care of people with dementia. The close presence of another person may in fact promote relaxation and therefore improve BP and HR measures.

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention.

PubMed

Brendryen, Håvar; Kraft, Pål

2008-03-01

To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention. Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway. Subjects (n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older. The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT). Abstinence was defined as 'not even a puff of smoke, for the last 7 days', and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation. Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12-3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group. As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change.

Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older.

PubMed

Gardin, Claude; Chevret, Sylvie; Pautas, Cécile; Turlure, Pascal; Raffoux, Emmanuel; Thomas, Xavier; Quesnel, Bruno; de Revel, Thierry; de Botton, Stéphane; Gachard, Nathalie; Renneville, Aline; Boissel, Nicolas; Preudhomme, Claude; Terré, Christine; Fenaux, Pierre; Bordessoule, Dominique; Celli-Lebras, Karine; Castaigne, Sylvie; Dombret, Hervé

2013-01-20

Although standard chemotherapy remains associated with a poor outcome in older patients with acute myeloid leukemia (AML), it is unclear which patients can survive long enough to be considered as cured. This study aimed to identify factors influencing the long-term outcome in these patients. The study included 727 older patients with AML (median age, 67 years) treated in two idarubicin (IDA) versus daunorubicin (DNR) Acute Leukemia French Association trials. Prognostic analysis was based on standard univariate and multivariate models and also included a cure fraction model to focus on long-term outcome. Age, WBC count, secondary AML, Eastern Cooperative Oncology Group (ECOG) performance status (PS), and adverse-risk and favorable-risk AML subsets (European LeukemiaNet classification) all influenced complete remission (CR) rate and overall survival (OS). IDA random assignment was associated with higher CR rate, but not with longer OS (P = .13). The overall cure rate was 13.3%. Older age and ECOG-PS more than 1 negatively influenced cure rate, which was higher in patients with favorable-risk AML (39.1% v 8.0% in adverse-risk AML; P < .001) and those treated with IDA (16.6% v 9.8% with DNR; P = .018). The long-term impact of IDA was still observed in patients younger than age 65 years, although all of the younger patients in the DNR control arm received high DNR doses (cure rate, 27.4% for IDA v 15.9% for DNR; P = .049). In multivariate analysis, IDA random assignment remained associated with a higher cure rate (P = .04), together with younger age and favorable-risk AML, despite not influencing OS (P = .11). In older patients with AML, younger age, favorable-risk AML, and IDA treatment predict a better long-term outcome.

Differential effects of primary motor cortex and cerebellar transcranial direct current stimulation on motor learning in healthy individuals: A randomized double-blind sham-controlled study.

PubMed

Ehsani, F; Bakhtiary, A H; Jaberzadeh, S; Talimkhani, A; Hajihasani, A

2016-11-01

The purpose of study was to compare the effect of primary motor cortex (M1) and cerebellar anodal transcranial direct current stimulation (a-tDCS) on online and offline motor learning in healthy individuals. Fifty-nine healthy volunteers were randomly divided into three groups (n=20 in two experimental groups and n=19 in sham-control group). One experimental group received M1a-tDCSand another received cerebellar a-tDCS. The main outcome measure were response time (RT) and number of errors during serial response time test (SRTT) which were assessed prior, 35min and 48h after the interventions. Reduction of response time (RT) and error numbers at last block of the test compared to the first block was considered online learning. Comparison of assessments during retention tests was considered as short-term and long-term offline learning. Online RT reduction was not different among groups (P>0.05), while online error reduction was significantly greater in cerebellar a-tDCS than sham-control group (P<0.017). Moreover, a-tDCS on both M1 and cerebellar regions produced more long-term offline learning as compared to sham tDCS (P<0.01), while short-term offline RT reduction was significantly greater in M1a-tDCS than sham-control group (P<0.05). The findings indicated that although cerebellar a-tDCS enhances online learning and M1a-tDCS has more effect on short-term offline learning, both M 1 and cerebellar a-tDCS can be used as a boosting technique for improvement of offline motor learning in healthy individuals. Crown Copyright © 2016. Published by Elsevier Ireland Ltd. All rights reserved.

The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis.

PubMed

Aksamit, Timothy; Bandel, Tiemo-Joerg; Criollo, Margarita; De Soyza, Anthony; Elborn, J Stuart; Operschall, Elisabeth; Polverino, Eva; Roth, Katrin; Winthrop, Kevin L; Wilson, Robert

2017-07-01

The primary goals of long-term disease management in non-cystic fibrosis bronchiectasis (NCFB) are to reduce the number of exacerbations, and improve quality of life. However, currently no therapies are licensed for this. Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) has potential to be the first long-term intermittent therapy approved to reduce exacerbations in NCFB patients. The RESPIRE programme consists of two international phase III prospective, parallel-group, randomized, double-blinded, multicentre, placebo-controlled trials of the same design. Adult patients with idiopathic or post-infectious NCFB, a history of ≥2 exacerbations in the previous 12months, and positive sputum culture for one of seven pre-specified pathogens, undergo stratified randomization 2:1 to receive twice-daily Ciprofloxacin DPI 32.5mg or placebo using a pocket-sized inhaler in one of two regimens: 28days on/off treatment or 14days on/off treatment. The treatment period is 48weeks plus an 8-week follow-up after the last dose. The primary efficacy endpoints are time to first exacerbation after treatment initiation and frequency of exacerbations using a stringent definition of exacerbation. Secondary endpoints, including frequency of events using different exacerbation definitions, microbiology, quality of life and lung function will also be evaluated. The RESPIRE trials will determine the efficacy and safety of Ciprofloxacin DPI. The strict entry criteria and stratified randomization, the inclusion of two treatment regimens and a stringent definition of exacerbation should clarify the patient population best positioned to benefit from long-term inhaled antibiotic therapy. Additionally RESPIRE will increase understanding of NCFB treatment and could lead to an important new therapy for sufferers. The RESPIRE trials are registered in ClinicalTrials.gov, ID number NCT01764841 (RESPIRE 1; date of registration January 8, 2013) and NCT02106832 (RESPIRE 2; date of registration April 4, 2014). Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Preventing adolescent drug use: long-term results of a junior high program.

PubMed Central

Ellickson, P L; Bell, R M; McGuigan, K

1993-01-01

OBJECTIVES. Although several studies have reported short-term gains for drug-use prevention programs targeted at young adolescents, few have assessed the long-term effects of such programs. Such information is essential for judging how long prevention benefits last. This paper reports results over a 6-year period for a multisite randomized trial that achieved reductions in drug use during the junior high school years. METHODS. The 11-lesson curriculum, which was tested in 30 schools in eight highly diverse West Coast communities, focused on helping 7th and 8th grade students develop the motivation and skills to resist drugs. Schools were randomly assigned to treatment and control conditions. About 4000 students were assessed in grade 7 and six times thereafter through grade 12. Program effects were adjusted for pretest covariates and school effects. RESULTS. Once the lessons stopped, the program's effects on drug use stopped. Effects on cognitive risk factors persisted for a longer time (many through grade 10), but were not sufficient to produce corresponding reductions in use. CONCLUSIONS. It is unlikely that early prevention gains can be maintained without additional prevention efforts during high school. Future research is needed to develop and test such efforts. PMID:8498624

Clobetasol propionate shampoo 0.05% is efficacious and safe for long-term control of scalp psoriasis.

PubMed

Poulin, Yves; Papp, Kim; Bissonnette, Robert; Guenther, Lyn; Tan, Jerry; Lynde, Charles; Kerrouche, Nabil; Villemagne, Hervé

2010-01-01

Clobetasol propionate (CP) shampoo 0.05% is an efficacious and safe treatment for scalp psoriasis. The aim of this double-blind, randomized, placebo-controlled study was to determine if CP shampoo is suitable for long-term disease control. Participants with moderate to severe scalp psoriasis (global severity score [GSS] of 3 or 4 on a scale of 0 [clear] to 5 [very severe]) first received once daily CP shampoo treatment for up to 4 weeks. Responders were subsequently randomized to receive the CP shampoo or vehicle twice weekly maintenance regimen for up to 6 months. When relapse occurred (defined as GSS > 2), participants resumed once daily CP shampoo treatment; when symptoms diminished (GSS < or = 2), they readopted the twice weekly maintenance regimen. At all visits significantly more participants treated with CP shampoo did not relapse compared with participants treated with vehicle (P < .001). Only approximately one-third of participants treated with vehicle remained relapse free at 1 month, while this rate was observed approximately 3.5 months later (4.5 months after baseline of maintenance phase) in the CP shampoo group. After 6 months 31.1% (33/106) of participants in the CP shampoo group were still relapse free versus 8.1% (9/111) of participants in the vehicle group. There was no greater incidence of skin atrophy, telangiectasia, or hypothalamic-pituitary-adrenal (HPA) axis suppression in the CP shampoo group compared with the vehicle group. Clobetasol propionate shampoo is efficacious and safe for acute management and long-term maintenance of moderate to severe scalp psoriasis.

Preventing growth in amphetamine use: long-term effects of the Midwestern Prevention Project (MPP) from early adolescence to early adulthood.

PubMed

Riggs, Nathaniel R; Chou, Chih-Ping; Pentz, Mary Ann

2009-10-01

The aim of the current study was to examine the long-term effect of an early adolescent substance abuse prevention program on trajectories and initiation of amphetamine use into early adulthood. Eight middle schools were assigned randomly to a program or control condition. The randomized controlled trial followed participants through 15 waves of data, from ages 11-28 years. This longitudinal study design includes four separate periods of development from early adolescence to early adulthood. The intervention took place in middle schools. A total of 1002 adolescents from one large mid-western US city were the participants in the study. The intervention was a multi-component community-based program delivered in early adolescence with a primary emphasis on tobacco, alcohol and marijuana use. At each wave of data collection participants completed a self-report survey that included questions about life-time amphetamine use. Compared to a control group, participants in the Midwestern Prevention Project (MPP) intervention condition had reduced growth (slope) in amphetamine use in emerging adulthood, a lower amphetamine use intercept at the commencement of the early adulthood and delayed amphetamine use initiation. The pattern of results suggests that the program worked first to prevent amphetamine use, and then to maintain the preventive effect into adulthood. Study findings suggest that early adolescent substance use prevention programs that focus initially on the 'gateway' drugs have utility for long-term prevention of amphetamine use. © 2009 The Authors. Journal compilation © 2009 Society for the Study of Addiction.

Genetic and phenotypic correlations of quantitative traits in two long-term randomly mated soybean populations

USDA-ARS?s Scientific Manuscript database

The genetic effects of long term random mating and natural selection aided by genetic male sterility (gms) were evaluated in two soybean [Glycine max (L.) Merr.] populations designated: RSII and RSIII. These populations were evaluated in the field at three locations each with two replications. Genot...

Long-term Results of the UCSF-LBNL Randomized Trial: Charged Particle With Helium Ion Versus Iodine-125 Plaque Therapy for Choroidal and Ciliary Body Melanoma

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

Mishra, Kavita K., E-mail: Kavita.mishra@ucsf.edu; Quivey, Jeanne M.; Daftari, Inder K.

Purpose: Relevant clinical data are needed given the increasing national interest in charged particle radiation therapy (CPT) programs. Here we report long-term outcomes from the only randomized, stratified trial comparing CPT with iodine-125 plaque therapy for choroidal and ciliary body melanoma. Methods and Materials: From 1985 to 1991, 184 patients met eligibility criteria and were randomized to receive particle (86 patients) or plaque therapy (98 patients). Patients were stratified by tumor diameter, thickness, distance to disc/fovea, anterior extension, and visual acuity. Tumors close to the optic disc were included. Local tumor control, as well as eye preservation, metastases due tomore » melanoma, and survival were evaluated. Results: Median follow-up times for particle and plaque arm patients were 14.6 years and 12.3 years, respectively (P=.22), and for those alive at last follow-up, 18.5 and 16.5 years, respectively (P=.81). Local control (LC) for particle versus plaque treatment was 100% versus 84% at 5 years, and 98% versus 79% at 12 years, respectively (log rank: P=.0006). If patients with tumors close to the disc (<2 mm) were excluded, CPT still resulted in significantly improved LC: 100% versus 90% at 5 years and 98% versus 86% at 12 years, respectively (log rank: P=.048). Enucleation rate was lower after CPT: 11% versus 22% at 5 years and 17% versus 37% at 12 years, respectively (log rank: P=.01). Using Cox regression model, likelihood ratio test, treatment was the most important predictor of LC (P=.0002) and eye preservation (P=.01). CPT was a significant predictor of prolonged disease-free survival (log rank: P=.001). Conclusions: Particle therapy resulted in significantly improved local control, eye preservation, and disease-free survival as confirmed by long-term outcomes from the only randomized study available to date comparing radiation modalities in choroidal and ciliary body melanoma.« less

Competency-Based Training and Worker Turnover in Community Supports for People With IDD: Results From a Group Randomized Controlled Study.

PubMed

Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

2015-06-01

Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training intervention for DSPs on site-level turnover rates over a one year period. Results suggested that, compared with the control group, sites receiving the training intervention experienced a significant decrease in annual turnover, when multiple factors were controlled. Implications, including the importance of considering quality training as a long term organizational investment and intervention to reduce turnover, are discussed.

Titanium-nitride-oxide-coated coronary stents: insights from the available evidence.

PubMed

Karjalainen, Pasi P; Nammas, Wail

2017-06-01

Coating of stent surface with a biocompatible material is suggested to improve stent safety profile. A proprietary process was developed to coat titanium-nitride-oxide on the stent surface, based on plasma technology that uses the nano-synthesis of gas and metal. Preclinical in vitro and in vivo investigation confirmed blood compatibility of titanium (nitride-) oxide films. Titanium-nitride-oxide-coated stents demonstrated a better angiographic outcome, compared with bare-metal stents at mid-term follow-up; however, they failed to achieve non-inferiority for angiographic outcome versus second-generation drug-eluting stents. Observational studies showed adequate clinical outcome at mid-term follow-up. Non-randomized studies showed an outcome of titanium-nitride-oxide-coated stents comparable to - or better than - first-generation drug-eluting stents at long-term follow-up. Two randomized controlled trials demonstrated comparable efficacy outcome, and a better safety outcome of titanium-nitride-oxide-coated stents versus drug-eluting stents at long-term follow-up. Evaluation by optical coherence tomography at mid-term follow-up revealed better neointimal strut coverage associated with titanium-nitride-oxide-coated stents versus drug-eluting stents; yet, neointimal hyperplasia thickness was greater. Key messages Stents coated with titanium-nitride-oxide demonstrated biocompatibility in preclinical studies: they inhibit platelet and fibrin deposition, and reduce neointimal growth. In observational and non-randomized studies, titanium-nitride-oxide-coated stents were associated with adequate safety and efficacy outcome. In randomized trials of patients with acute coronary syndrome, titanium-nitride-oxide-coated stents were associated with a better safety outcome, compared with drug-eluting stents; efficacy outcome was comparable.

Randomized Control Trial of Peer-Delivered, Modified Directly Observed Therapy for HAART in Mozambique

PubMed Central

Pearson, Cynthia R.; Micek, Mark A.; Simoni, Jane M.; Hoff, Peter D.; Matediana, Eduardo; Martin, Diane P.; Gloyd, Stephen S.

2014-01-01

Objective To assess the efficacy of a peer-delivered intervention to promote short-term (6-month) and long-term (12-month) adherence to HAART in a Mozambican clinic population. Design A 2-arm randomized controlled trial was conducted between October 2004 and June 2006. Participants Of 350 men and women (≥18 years) initiating HAART, 53.7% were female, and 97% were on 1 fixed-dose combination pill twice a day. Intervention Participants were randomly assigned to receive 6 weeks (Monday through Friday; 30 daily visits) of peer-delivered, modified directly observed therapy (mDOT) or standard care. Peers provided education about treatment and adherence and sought to identify and mitigate adherence barriers. Outcome Participants' self-reported medication adherence was assessed 6 months and 12 months after starting HAART. Adherence was defined as the proportion of prescribed doses taken over the previous 7 days. Statistical analyses were performed using intention-to-treat (missing = failure). Results Intervention participants, compared to those in standard care, showed significantly higher mean medication adherence at 6 months (92.7% vs. 84.9%, difference 7.8, 95% confidence interval [CI]: 0.0.02, 13.0) and 12 months (94.4% vs. 87.7%, difference 6.8, 95% CI: 0.9, 12.9). There were no between-arm differences in chart-abstracted CD4 counts. Conclusions A peer-delivered mDOT program may be an effective strategy to promote long-term adherence among persons initiating HAART in resource-poor settings. PMID:17693890

A reinforcement-based therapeutic workplace for the treatment of drug abuse: three-year abstinence outcomes.

PubMed

Silverman, Kenneth; Svikis, Dace; Wong, Conrad J; Hampton, Jacqueline; Stitzer, Maxine L; Bigelow, George E

2002-08-01

Long-term Therapeutic Workplace effects were evaluated in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers. Participants were paid to work or to train in the Therapeutic Workplace but had to provide drug-free urine samples to gain daily access. Participants (N = 40) were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants could work for 3 years. Relative to controls, Therapeutic Workplace participants increased cocaine (28% vs. 54% negative; p = .04) and opiate (37% vs. 60% negative; p = .05) abstinence on the basis of monthly urine samples collected until 3 years after intake. The Therapeutic Workplace can be an effective long-term treatment of cocaine and heroin addiction in poor and chronically unemployed young mothers.

Preventive intervention for preschoolers at high risk for antisocial behavior: long-term effects on child physical aggression and parenting practices.

PubMed

Brotman, Laurie Miller; Gouley, Kathleen Kiely; Huang, Keng-Yen; Rosenfelt, Amanda; O'Neal, Colleen; Klein, Rachel G; Shrout, Patrick

2008-04-01

This article presents long-term effects of a preventive intervention for young children at high risk for antisocial behavior. Ninety-two children (M age = 4 years) were randomly assigned to an 8-month family intervention or no-intervention control condition and assessed 4 times over a 24-month period. Intent-to-treat analyses revealed significant intervention effects on observed child physical aggression, and significant intervention effects found at the end of the program were maintained at follow-up for responsive parenting, harsh parenting and stimulation for learning. Parent ratings of child aggression did not show significant effects of intervention.

Mindful movement program for older breast cancer survivors: a pilot study.

PubMed

Crane-Okada, Rebecca; Kiger, Holly; Sugerman, Fred; Uman, Gwen C; Shapiro, Shauna L; Wyman-McGinty, Wendy; Anderson, Nancy L R

2012-01-01

Older breast cancer survivors (BCSs) are at risk for late and long-term treatment effects on quality of life (QOL), including lower physical functioning and fear of recurrence. Two promising approaches to address this include dance/movement therapy and mindfulness. The purpose of this 2-group randomized controlled pilot feasibility study was to test short-term effects of a 12-week Mindful Movement Program (MMP) intervention combining mindfulness with self-directed movement on QOL and mindfulness in female BCSs 50 years or older and at 12 months or more following treatment. Consented participants were randomized to an experimental group (EG) (12 weekly MMP sessions) or a control group (no sessions). All completed questionnaires 3 times. The EG participants kept home practice diaries. Analysis was conducted after intervention for immediate effects on outcome variables and 6 weeks later for maintenance of effects. Participants (n = 49) ranged in age from 50 to 90 years (average, 65.6 years) and were at 9.8 years since diagnosis (range, 1-32 years), and the majority were white, unpartnered, and retired. After intervention, EG participants showed improved QOL via decreased fear of recurrence and increased mindfulness attitude. At 6 weeks, initial effects were retained. The MMP appears to benefit older BCSs by reducing fear of recurrence and improving mindfulness attitude. Although these findings are promising, a larger study is needed to determine more specifically what short- and long-term effects are possible. The combination of self-directed movement and mindfulness, as tested here, may be a valuable tool for promoting health and well-being in older long-term survivors of breast cancer.

Long-term effects of the Focus on Families project on substance use disorders among children of parents in methadone treatment.

PubMed

Haggerty, Kevin P; Skinner, Martie; Fleming, Charles B; Gainey, Randy R; Catalano, Richard F

2008-12-01

This study examines the efficacy of the Focus on Families project (currently called Families Facing the Future), a preventive intervention to reduce substance use disorders among children in families with a parent in methadone treatment. One hundred and thirty families were assigned randomly to a methadone clinic treatment-as-usual control condition or treatment-as-usual plus the Focus on Families intervention between 1991 and 1993. Setting Participants were recruited from two methadone clinics in the Pacific Northwest. This study examines the development of substance use disorders among the 177 children (56.84% male) involved in the program using data from a long-term follow-up in 2005, when these participants ranged in age from 15 to 29 years. The intervention was delivered through group parent-training workshops at the methadone clinics and through individualized home-based services. The intervention taught parenting skills and skills for avoiding relapse to drug abuse. At long-term follow-up, substance use disorders were measured by the Composite International Diagnostic Interview (CIDI). Survival analyses were used to assess intervention versus control differences in the hazard of developing substance use disorders. Overall, intervention and control participants did not differ significantly in risk of developing substance use disorders. However, there was evidence of a significant difference in intervention effect by gender. There was a significant reduction in the risk of developing a substance use disorder for intervention group males compared to control group males (hazard ratio = 0.53, P = 0.03), while intervention versus control differences among females were non-significant and favored the control condition. Results from this study suggest that helping parents in recovery focus on both reducing their drug use and improving their parenting skills may have long-term effects on reducing substance use disorders among their male children. However, the overall long-term benefits of this program are not supported by the results for female children.

Effectiveness of psychological interventions to improve quality of life in people with long-term conditions: rapid systematic review of randomised controlled trials.

PubMed

Anderson, Niall; Ozakinci, Gozde

2018-03-27

Long-term conditions may negatively impact multiple aspects of quality of life including physical functioning and mental wellbeing. The rapid systematic review aimed to examine the effectiveness of psychological interventions to improve quality of life in people with long-term conditions to inform future healthcare provision and research. EBSCOhost and OVID were used to search four databases (PsychInfo, PBSC, Medline and Embase). Relevant papers were systematically extracted by one researcher using the predefined inclusion/exclusion criteria based on titles, abstracts, and full texts. Randomized controlled trial psychological interventions conducted between 2006 and February 2016 to directly target and assess people with long-term conditions in order to improve quality of life were included. Interventions without long-term condition populations, psychological intervention and/or patient-assessed quality of life were excluded. From 2223 citations identified, 6 satisfied the inclusion/exclusion criteria. All 6 studies significantly improved at least one quality of life outcome immediately post-intervention. Significant quality of life improvements were maintained at 12-months follow-up in one out of two studies for each of the short- (0-3 months), medium- (3-12 months), and long-term (≥ 12 months) study duration categories. All 6 psychological intervention studies significantly improved at least one quality of life outcome immediately post-intervention, with three out of six studies maintaining effects up to 12-months post-intervention. Future studies should seek to assess the efficacy of tailored psychological interventions using different formats, durations and facilitators to supplement healthcare provision and practice.

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

PubMed

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

2015-07-01

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

Effects of information framing on the intentions of family physicians to prescribe long-term hormone replacement therapy.

PubMed

Nikolajevic-Sarunac, J; Henry, D A; O'Connell, D L; Robertson, J

1999-10-01

To determine whether the way in which information on benefits and harms of long-term hormone replacement therapy (HRT) is presented influences family physicians' intentions to prescribe this treatment. Family physicians were randomized to receive information on treatment outcomes expressed in relative terms, or as the number needing to be treated (NNT) with HRT to prevent or cause an event. A control group received no information. Primary care. Family physicians practicing in the Hunter Valley, New South Wales, Australia. Estimates of the impact of long-term HRT on risk of coronary events, hip fractures, and breast cancer were summarized as relative (proportional) decreases or increases in risk, or as NNT. Intention to prescribe HRT for seven hypothetical patients was measured on Likert scales. Of 389 family physicians working in the Hunter Valley, 243 completed the baseline survey and 215 participated in the randomized trial. Baseline intention to prescribe varied across patients-it was highest in the presence of risk factors for hip fracture, but coexisting risk factors for breast cancer had a strong negative influence. Overall, a larger proportion of subjects receiving information expressed as NNT had reduced intentions, and a smaller proportion had increased intentions to prescribe HRT than those receiving the information expressed in relative terms, or the control group. However, the differences were small and only reached statistical significance for three hypothetical patients. Framing effects were minimal when the hypothetical patient had coexisting risk factors for breast cancer. Information framing had some effect on family physicians' intentions to prescribe HRT, but the effects were smaller than those previously reported, and they were modified by the presence of serious potential adverse treatment effects.

Effects of Information Framing on the Intentions of Family Physicians to Prescribe Long-Term Hormone Replacement Therapy

PubMed Central

Nikolajevic-Sarunac, Jasminka; Henry, David A; Henry, David A; O'Connell, Dianne L; Robertson, Jane; Robertson, Jane

1999-01-01

OBJECTIVE To determine whether the way in which information on benefits and harms of long-term hormone replacement therapy (HRT) is presented influences family physicians' intentions to prescribe this treatment. DESIGN Family physicians were randomized to receive information on treatment outcomes expressed in relative terms, or as the number needing to be treated (NNT) with HRT to prevent or cause an event. A control group received no information. SETTING Primary care. PARTICIPANTS Family physicians practicing in the Hunter Valley, New South Wales, Australia. INTERVENTION Estimates of the impact of long-term HRT on risk of coronary events, hip fractures, and breast cancer were summarized as relative (proportional) decreases or increases in risk, or as NNT. MEASUREMENTS AND MAIN RESULTS Intention to prescribe HRT for seven hypothetical patients was measured on Likert scales. Of 389 family physicians working in the Hunter Valley, 243 completed the baseline survey and 215 participated in the randomized trial. Baseline intention to prescribe varied across patients—it was highest in the presence of risk factors for hip fracture, but coexisting risk factors for breast cancer had a strong negative influence. Overall, a larger proportion of subjects receiving information expressed as NNT had reduced intentions, and a smaller proportion had increased intentions to prescribe HRT than those receiving the information expressed in relative terms, or the control group. However, the differences were small and only reached statistical significance for three hypothetical patients. Framing effects were minimal when the hypothetical patient had coexisting risk factors for breast cancer. CONCLUSIONS Information framing had some effect on family physicians' intentions to prescribe HRT, but the effects were smaller than those previously reported, and they were modified by the presence of serious potential adverse treatment effects. PMID:10571703

Effect of short-term administration of cinnamon on blood pressure in patients with prediabetes and type 2 diabetes.

PubMed

Akilen, Rajadurai; Pimlott, Zeller; Tsiami, Amalia; Robinson, Nicola

2013-10-01

The aim of this study was to systematically review and evaluate the effect of short-term administration of cinnamon on blood pressure regulation in patients with prediabetes and type 2 diabetes by performing a meta-analysis of randomized, placebo-controlled clinical trials. Medical literature for randomized controlled trials (RCTs) of the effect of cinnamon on blood pressure was systematically searched; three original articles published between January 2000 and September 2012 were identified from the MEDLINE database and a hand search of the reference lists of the articles obtained through MEDLINE. The search terms included cinnamon or blood pressure or systolic blood pressure (SBP) or diastolic blood pressure (DBP) or diabetes. A random effects model was used to calculate weighted mean difference and 95% confidence intervals (CI). The pooled estimate of the effect of cinnamon intake on SBP and DBP demonstrated that the use of cinnamon significantly decreased SBP and DBP by 5.39 mm Hg (95% CI, -6.89 to -3.89) and 2.6 mm Hg (95% CI, -4.53 to -0.66) respectively. Consumption of cinnamon (short term) is associated with a notable reduction in SBP and DBP. Although cinnamon shows hopeful effects on BP-lowering potential, it would be premature to recommend cinnamon for BP control because of the limited number of studies available. Thus, undoubtedly a long-term, adequately powered RCT involving a larger number of patients is needed to appraise the clinical potential of cinnamon on BP control among patients with type 2 diabetes mellitus. Copyright © 2013 Elsevier Inc. All rights reserved.

75 FR 55764 - Dynamic Random Access Memory Semiconductors From the Republic of Korea: Preliminary Results of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-14

... lending rates published by the IMF for each year. For countervailable short-term and long-term foreign... administrative reviews. For long-term, won-denominated loans originating in 1986 through 1995, we used the... International Monetary Fund's (``IMF's'') International Financial Statistics Yearbook. For long-term won...

Probabilistic Modeling of Settlement Risk at Land Disposal Facilities - 12304

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

Foye, Kevin C.; Soong, Te-Yang

2012-07-01

The long-term reliability of land disposal facility final cover systems - and therefore the overall waste containment - depends on the distortions imposed on these systems by differential settlement/subsidence. The evaluation of differential settlement is challenging because of the heterogeneity of the waste mass (caused by inconsistent compaction, void space distribution, debris-soil mix ratio, waste material stiffness, time-dependent primary compression of the fine-grained soil matrix, long-term creep settlement of the soil matrix and the debris, etc.) at most land disposal facilities. Deterministic approaches to long-term final cover settlement prediction are not able to capture the spatial variability in the wastemore » mass and sub-grade properties which control differential settlement. An alternative, probabilistic solution is to use random fields to model the waste and sub-grade properties. The modeling effort informs the design, construction, operation, and maintenance of land disposal facilities. A probabilistic method to establish design criteria for waste placement and compaction is introduced using the model. Random fields are ideally suited to problems of differential settlement modeling of highly heterogeneous foundations, such as waste. Random fields model the seemingly random spatial distribution of a design parameter, such as compressibility. When used for design, the use of these models prompts the need for probabilistic design criteria. It also allows for a statistical approach to waste placement acceptance criteria. An example design evaluation was performed, illustrating the use of the probabilistic differential settlement simulation methodology to assemble a design guidance chart. The purpose of this design evaluation is to enable the designer to select optimal initial combinations of design slopes and quality control acceptance criteria that yield an acceptable proportion of post-settlement slopes meeting some design minimum. For this specific example, relative density, which can be determined through field measurements, was selected as the field quality control parameter for waste placement. This technique can be extended to include a rigorous performance-based methodology using other parameters (void space criteria, debris-soil mix ratio, pre-loading, etc.). As shown in this example, each parameter range, or sets of parameter ranges can be selected such that they can result in an acceptable, long-term differential settlement according to the probabilistic model. The methodology can also be used to re-evaluate the long-term differential settlement behavior at closed land disposal facilities to identify, if any, problematic facilities so that remedial action (e.g., reinforcement of upper and intermediate waste layers) can be implemented. Considering the inherent spatial variability in waste and earth materials and the need for engineers to apply sound quantitative practices to engineering analysis, it is important to apply the available probabilistic techniques to problems of differential settlement. One such method to implement probability-based differential settlement analyses for the design of landfill final covers has been presented. The design evaluation technique presented is one tool to bridge the gap from deterministic practice to probabilistic practice. (authors)« less

Work and family: associations with long-term sick-listing in Swedish women - a case-control study.

PubMed

Sandmark, Hélène

2007-10-11

The number of Swedish women who are long-term sick-listed is high, and twice as high as for men. Also the periods of sickness absence have on average been longer for women than for men. The objective of this study was to investigate the associations between factors in work- and family life and long-term sick-listing in Swedish women. This case-control study included 283 women on long-term sick-listing > or =90 days, and 250 female referents, randomly chosen, living in five counties in Sweden. Bivariate and multivariate logistic regression analyses with odds ratios were calculated to estimate the associations between long-term sick-listing and factors related to occupational work and family life. Long-term sick-listing in women is associated with self-reported lack of competence for work tasks (OR 2.42 1.23-11.21 log reg), workplace dissatisfaction (OR 1.89 1.14-6.62 log reg), physical workload above capacity (1.78 1.50-5.94), too high mental strain in work tasks (1.61 1.08-5.01 log reg), number of employers during work life (OR 1.39 1.35-4.03 log reg), earlier part-time work (OR 1.39 1.18-4.03 log reg), and lack of influence on working hours (OR 1.35 1.47-3.86 log reg). A younger age at first child, number of children, and main responsibility for own children was also found to be associated with long-term sick-listing. Almost all of the sick-listed women (93%) wanted to return to working life, and 54% reported they could work immediately if adjustments at work or part-time work were possible. Factors in work and in family life could be important to consider to prevent women from being long-term sick-listed and promote their opportunities to remain in working life. Measures ought to be taken to improve their mobility in work life and control over decisions and actions regarding theirs lives.

Translational models of infection prevention and control: lessons from studying high risk aging populations.

PubMed

Mody, Lona

2018-06-13

The present review describes our research experiences and efforts in advancing the field of infection prevention and control in nursing facilities including postacute and long-term care settings. There are over two million infections in postacute and long-term care settings each year in the United States and $4 billion in associated costs. To define a target group most amenable to infection prevention and control interventions, we sought to quantify the relation between indwelling device use and microbial colonization in nursing facility patients. Using various methodologies including survey methods, observational epidemiology, randomized controlled studies, and collaboratives, we showed that indwelling device type is related to the site of multidrug-resistant organism (MDRO) colonization; multianatomic site colonization with MDROs is common; community-associated methicillin-resistant Staphylococcus aureus (MRSA) appeared in the nursing facility setting almost immediately following its emergence in acute care; (4) MDRO prevalence and catheter-associated infection rates can be reduced through a multimodal targeted infection prevention intervention; and (5) using a collaborative approach, such an intervention can be successfully scaled up. Our work advances the infection prevention field through translational research utilizing various methodologies, including quantitative and qualitative surveys, patient-oriented randomized controlled trials, and clinical microbiologic and molecular methods. The resulting interventions employ patient-oriented methods to reduce infections and antimicrobial resistance, and with partnerships from major national entities, can be implemented nationally.

Determinants of high and low attendance to diet and exercise interventions among overweight and obese older adults. Results from the arthritis, diet, and activity promotion trial.

PubMed

van Gool, Coen H; Penninx, Brenda W J H; Kempen, Gertrudis I J M; Miller, Gary D; van Eijk, Jacques Th M; Pahor, Marco; Messier, Stephen P

2006-06-01

Determinants of adherence to lifestyle regimens are ill understood. Attendance to intervention sessions is crucial for patients to acquire knowledge and skills regarding the core elements of an intervention. Therefore, we explored demographic, health-related, and social determinants of high and low attendance to diet and exercise sessions among overweight and obese patients with knee osteoarthritis (> or = 60 years; N = 206). The Arthritis, Diet, and Activity Promotion Trial was an 18-month randomized controlled trial on the effectiveness of dietary weight loss and exercise interventions. We conducted chi-square and t-tests, and logistic regression analyses on categories of short- and long-term attendance to intervention sessions. Over the 18-month duration of the study, 60.7% (+/- 28.5) of diet sessions, and 53.2% (+/- 29.0) of exercise sessions were attended. Not being married, low social participation, and single intervention randomization predicted high attendance to diet sessions during months 1-4. Exercising at home, and single intervention randomization predicted high attendance to exercise sessions during months 5-18. High attendance to sessions early in the intervention was a significant determinant of high session attendance thereafter. Offering people a choice where to exercise, and stimulating early intervention session attendance can be effective in improving long-term attendance to both interventions. Several determinants we found may be amenable to change to enhance intervention adherence of future randomized controlled trials involving dietary weight loss and/or physical exercise.

The effect of massage therapy and/or exercise therapy on subacute or long-lasting neck pain--the Stockholm neck trial (STONE): study protocol for a randomized controlled trial.

PubMed

Skillgate, Eva; Bill, Anne-Sylvie; Côté, Pierre; Viklund, Peter; Peterson, Anna; Holm, Lena W

2015-09-16

Neck pain is a major health problem in populations worldwide and an economic burden in modern societies due to its high prevalence and costs in terms of health care expenditures and lost productivity. Massage and exercise therapy are widely used management options for neck pain. However, there is a lack of scientific evidence regarding their effectiveness for subacute and long-lasting neck pain. This study protocol describes a randomized controlled trial aiming to determine the effect of massage and/or exercise therapy on subacute and long-lasting neck pain over the course of 1 year. A randomized controlled trial in which at least 600 study participants with subacute or long-lasting nonspecific neck pain will be recruited and randomly allocated to one of four treatment arms: massage therapy (A), exercise therapy (B), exercise therapy plus massage therapy (C) and advice to stay active (D). The study has an E-health approach, and study participants are being recruited through advertising with a mix of traditional and online marketing channels. Web-based self-report questionnaires measure the main outcomes at 7, 12, 26 and 52 weeks after inclusion. The primary outcomes are a clinically important improvement in pain intensity and pain-related disability at follow-up, measured with a modified version of the Chronic Pain Questionnaire (CPQ). The secondary outcomes are global improvement, health-related quality of life (EQ-5D), sick leave, drug consumption and healthcare utilization. Adverse events are measured by questionnaires at return visits to the clinic, and automated text messages (SMSes) survey neck pain intensity and pain-related disability every week over one year. The results of this study will provide clinicians and stakeholders much needed knowledge to plan medical care for subacute and long-lasting neck pain disorders. Current Controlled Trials ISRCTN01453590. Date of registration: 3 July 2014.

Using spaced retrieval and Montessori-based activities in improving eating ability for residents with dementia.

PubMed

Lin, Li-Chan; Huang, Ya-Ju; Su, Su-Gen; Watson, Roger; Tsai, Belina W-J; Wu, Shiao-Chi

2010-10-01

To construct a training protocol for spaced retrieval (SR) and to investigate the effectiveness of SR and Montessori-based activities in decreasing eating difficulty in older residents with dementia. A single evaluator, blind, and randomized control trial was used. Eighty-five residents with dementia were chosen from three special care units for residents with dementia in long-term care facilities in Taiwan. To avoid any confounding of subjects, the three institutions were randomized into three groups: spaced retrieval, Montessori-based activities, and a control group. The invention consisted of three 30-40 min sessions per week, for 8 weeks. After receiving the intervention, the Edinburgh Feeding Evaluation in Dementia (EdFED) scores and assisted feeding scores for the SR and Montessori-based activity groups were significantly lower than that of the control group. However, the frequencies of physical assistance and verbal assistance for the Montessori-based activity group after intervention were significantly higher than that of the control group, which suggests that residents who received Montessori-based activity need more physical and verbal assistance during mealtimes. In terms of the effects of nutritional status after intervention, Mini-Nutritional Assessment (MNA) in the SR group was significantly higher than that of the control group. This study confirms the efficacy of SR and Montessori-based activities for eating difficulty and eating ability. A longitudinal study to follow the long-term effects of SR and Montessori-based activities on eating ability and nutritional status is recommended. Copyright © 2010 John Wiley & Sons, Ltd.

Long-Term Effects of Strategic Reading Instruction in the Intermediate Elementary Grades

ERIC Educational Resources Information Center

Droop, Mienke; van Elsäcker, Willy; Voeten, Marinus J. M.; Verhoeven, Ludo

2016-01-01

The purpose of the present study was to examine the effects of a program that offered sustained strategic reading instruction on reading abilities of third and fourth graders. The study was conducted among 1,469 children from 40 schools in the Netherlands. Schools were randomly assigned to either the experimental or control group. Multilevel…

Long-Term Effects of Leisure Education on Leisure Needs and Stress in Older Adults

ERIC Educational Resources Information Center

Kao, I-Chan; Chang, Liang-Chih

2017-01-01

We examined whether a 12-week leisure education program could promote leisure autonomy and leisure competence and reduce stress in older adults. Forty subjects were randomly assigned to either an experimental group or a control group. Before the experiment, pretest data were collected using leisure autonomy, leisure competence, and stress scales.…

Soy isoflavone (IF) supplementation appears safe after a two-year randomized controlled trial (RCT)

USDA-ARS?s Scientific Manuscript database

Although RCTs quantifying a benefit for menopausal soy IF supplementation abound, few studies have considered the safety of long-term soy IF intake, particularly when exposure levels are in the form of a tablet, as opposed to food. To evaluate the effect of soy IF on bone loss, 403 early postmenopau...

75 FR 19976 - Agency Information Collection Request; 30-Day Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-16

...) hours Initial Telephone Screen...... Experimental 240 1 20/60 80 Group. In-person interview 240 1 80/60... Telephone Screen...... Active Control 240 1 20/60 80 Group. Quarterly phone calls......... 240 4 10/60 160... private long-term care insurance who are age 75 and over using a multi- tiered random experimental...

Long-Term Effects of Physically Active Academic Lessons on Physical Fitness and Executive Functions in Primary School Children

ERIC Educational Resources Information Center

de Greeff, J. W.; Hartman, E.; Mullender-Wijnsma, M. J.; Bosker, R. J.; Doolaard, S.; Visscher, C.

2016-01-01

Integrating physical activity into the curriculum has potential health and cognitive benefits in primary school children. The aim of this study was to investigate the effects of physically active academic lessons on cardiovascular fitness, muscular fitness and executive functions. In the current randomized controlled trial, 499 second and third…

Time course of upper limb function and return-to-work post-radiotherapy in young adults with breast cancer: a pilot randomized control trial on effects of targeted exercise program.

PubMed

Ibrahim, Marize; Muanza, Thierry; Smirnow, Nadia; Sateren, Warren; Fournier, Beatrice; Kavan, Petr; Palumbo, Michael; Dalfen, Richard; Dalzell, Mary-Ann

2017-12-01

Breast cancer (BC) diagnosis in young adults (YA) is rising, and both disease and treatments are aggressive in this population. Evidence supports the use of physical activity in reducing shoulder dysfunction, which is common among BC survivors. A pilot randomized clinical trial was performed to determine the effectiveness of a 12-week post-radiation exercise program in minimizing upper extremity dysfunction in YA with BC. Participants were randomized to either an exercise arm or a control arm receiving standard care. Data was collected over six time points using: the Disability of Arm, Shoulder, and Hand (DASH); the Metabolic Equivalent of Task-hours per week (MET-hours/week), and a post hoc questionnaire on return to work. In total, 59 young women participated in the study (n = 29 exercise; n = 30 control). No statistically significant differences were found in overall DASH results between groups; however, those who underwent total mastectomy had residual upper limb dysfunction (p < 0.05). Both groups returned to pre-diagnosis activity levels by 18 months. Final evaluation showed that 86% of the women returned to work, and 89% resumed prior work activities with a decrease of 8.5 h/week. Although the short-term targeted exercise program had no effect on long-term upper limb function post-radiation, timing and program specificity may require consideration of tissue healing post-radiation and surgery type. The majority of participants returned to work, however not returning to pre-diagnosis work hours. Exercise interventions alone may not reverse the long-term sequelae of breast cancer treatment and allow young adult patients to return to work.

Short- and long-term effects of mud-bath treatment on hand osteoarthritis: a randomized clinical trial

NASA Astrophysics Data System (ADS)

Fioravanti, Antonella; Tenti, Sara; Giannitti, Chiara; Fortunati, Nicola Angelo; Galeazzi, Mauro

2014-01-01

The aim of this study was to evaluate both the short-term and the long-term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA). This was a prospective randomized, single blind controlled trial. Sixty outpatients with primary bilateral hand OA were included in the study and randomized to one of two groups. One group ( n = 30) was treated with 12 daily local mud packs and generalized thermal baths with a sulfate-calcium-magnesium-fluorides mineral water added to usual treatment. The control group ( n = 30) continued regular outpatient care routine (exercise, NSAIDs and/or analgesics). Each patient was examined at baseline, after 2 weeks, and after 3, 6, 9 and 12 months. Primary outcome measures were global spontaneous hand pain on a visual analogue scale (VAS) and the functional index for hand osteoarthritis (FIHOA) score; secondary outcomes were health assessment questionnaire (HAQ), duration of morning stiffness, medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption. Our results demonstrated that the efficacy of spa therapy was significant in all the assessed parameters, both at the end of therapy and after 3 months; the values of FIHOA, HAQ and drugs consumption continued to be significantly better after 6 months in comparison with baseline. There were no significant modifications of the parameters throughout the follow-up in the control group. Differences between the two groups were significant for all parameters at the 15th day and at 3 months follow-up; regarding FIHOA, HAQ, and symptomatic drugs consumption, the difference between the two groups persisted and was significant at 6month follow-up. Tolerability of spa therapy seemed to be good. In conclusion, our results confirm that the beneficial effects of spa therapy in patients with hand OA last over time.

Growth hormone for intestinal adaptation in patients with short bowel syndrome: systematic review and meta-analysis of randomized controlled trials.

PubMed

Guo, Ming-Xiao; Li, You-Sheng; Fan, Lei; Li, Jie-Shou

2011-06-01

The purpose of this systematic review was to assess the efficacy of growth hormone (GH) treatment in patients with short bowel syndrome (SBS). Electronic searches were performed to identify all publications describing randomized controlled trials (RCTs) on the use of GH with or without glutamine for the treatment of patients with SBS. The outcomes of interest were body weight, lean body mass, and intestinal absorption function. Four trials involving 70 patients were included in the review. A meta-analysis of these trials suggested that GH had a positive effect in terms of increased weight (mean difference [MD] = 1.66; 95% CI, 0.69-2.63, P < 0.001), lean body mass (MD = 1.93; 95% CI, 0.97-2.90; P < 0.001), energy absorption (MD = 4.42; 95% CI, 0.26-8.58; P = 0.04), nitrogen absorption (MD = 4.85; 95% CI, 0.20-9.49; P = 0.04), and fat absorption (MD = 5.02; 95% CI, 0.21-9.82; P = 0.04) for patients with SBS. Adverse effects occurred during active treatment in all trials. Only 1 trial included a 12-week follow-up study. The results suggest a possible short-term benefit in terms of body weight, lean body mass, and absorptive capacities; however, no conclusion of long-term efficacy of GH could be obtained. Large-scale, long-term follow-up RCTs are needed to confirm the efficacy and tolerability of GH in the future.

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial

PubMed Central

van Bakelen, N. B.; Buijs, G. J.; Jansma, J.; de Visscher, J. G. A. M.; Hoppenreijs, Th. J. M.; Bergsma, J. E.; van Minnen, B.; Stegenga, B.; Bos, R. R. M.

2017-01-01

Background Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation. Aim The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery. Materials and methods The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS). Results After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05–3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups. Conclusion In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures. Trial registration http://controlled-trials.com ISRCTN44212338. PMID:28493922

Effects of Exercise on Cognition: The Finnish Alzheimer Disease Exercise Trial: A Randomized, Controlled Trial.

PubMed

Öhman, Hannareeta; Savikko, Niina; Strandberg, Timo E; Kautiainen, Hannu; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo; Pitkälä, Kaisu H

2016-04-01

To examine whether a regular, long-term exercise program performed by individuals with Alzheimer's disease (AD) at home or as group-based exercise at an adult daycare center has beneficial effects on cognition; to examine secondary outcomes of a trial that has been published earlier. Randomized, controlled trial. Community. Community-dwelling dyads (N = 210) of individuals with AD and their spousal caregivers randomized into three groups. Two types of intervention comprising customized home-based exercise (HE) and group-based exercise (GE), each twice a week for 1 year, were compared with a control group (CG) receiving usual community care. Cognitive function was measured using the Clock Drawing Test (CDT), Verbal Fluency (VF), Clinical Dementia Rating (CDR), and Mini-Mental State Examination (MMSE) at baseline and 3, 6, and 12 months of follow-up. Executive function, measured using CDT, improved in the HE group, and changes in the score were significantly better than those of the CG at 12 months (adjusted for age, sex, and CDR, P = .03). All groups deteriorated in VF and MMSE score during the intervention, and no significant differences between the groups were detected at 12-month follow-up when analyses were adjusted for age, sex, and CDR. Regular, long-term, customized HE improved the executive function of community-dwelling older people with memory disorders, but the effects were mild and were not observed in other domains of cognition. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Optimizing the delivery of contraceptives in low- and middle-income countries through task shifting: a systematic review of effectiveness and safety.

PubMed

Polus, Stephanie; Lewin, Simon; Glenton, Claire; Lerberg, Priya M; Rehfuess, Eva; Gülmezoglu, A Metin

2015-04-01

To assess the effectiveness and safety of task shifting for the delivery of injectable contraceptives, contraceptive implants, intrauterine devices (IUDs), tubal ligation and vasectomy in low- and middle-income countries. Multiple electronic databases were searched up to 25 May 2012 for studies which had assessed the delivery of contraceptives by health workers with lower levels of training, compared to delivery by health workers usually assigned this role, or compared to no organized provision of contraceptives. We included randomized controlled trials, non-randomized controlled trials, controlled before-after studies, and interrupted time series. Data were extracted using a standard form and the certainty of the evidence found was assessed using GRADE. We identified six randomized controlled trials published between 1977 and 1995 that assessed the safety and effectiveness of task shifting for the delivery of long-term contraceptives. Two studies assessed IUD insertion by nurses compared to doctors, two assessed IUD insertion by auxiliary nurse-midwives compared to doctors, one assessed tubal ligation by midwives compared to doctors, and one assessed the delivery of vasectomy by medical students compared to doctors. In general, little or no difference was found in contraceptive outcomes between cadres. Study design limitations and the low number of eligible studies, however, allow only limited conclusions to be drawn. The findings indicate that task shifting for the delivery of long-term contraceptives may be a safe and effective approach to increasing access to contraception. Further research is needed because the certainty of the evidence identified is variable.

Soy proteins and isoflavones affect bone mineral density in older women: a randomized controlled trial.

PubMed

Kenny, Anne M; Mangano, Kelsey M; Abourizk, Robin H; Bruno, Richard S; Anamani, Denise E; Kleppinger, Alison; Walsh, Stephen J; Prestwood, Karen M; Kerstetter, Jane E

2009-07-01

Soy foods contain several components (isoflavones and amino acids) that potentially affect bone. Few long-term, large clinical trials of soy as a means of improving bone mineral density (BMD) in late postmenopausal women have been conducted. Our goal was to evaluate the long-term effect of dietary soy protein and/or soy isoflavone consumption on skeletal health in late postmenopausal women. We conducted a randomized, double-blind, placebo-controlled clinical trial in 131 healthy ambulatory women aged >60 y. Ninety-seven women completed the trial. After a 1-mo baseline period, subjects were randomly assigned into 1 of 4 intervention groups: soy protein (18 g) + isoflavone tablets (105 mg isoflavone aglycone equivalents), soy protein + placebo tablets, control protein + isoflavone tablets, and control protein + placebo tablets. Consumption of protein powder and isoflavone pills did not differ between groups, and compliance with the study powder and pills was 80-90%. No significant differences in BMD were observed between groups from baseline to 1 y after the intervention or in BMD change between equol and non-equol producers. However, there were significant negative correlations between total dietary protein (per kg) and markers of bone turnover (P < 0.05). Because soy protein and isoflavones (either alone or together) did not affect BMD, they should not be considered as effective interventions for preserving skeletal health in older women. The negative correlation between dietary protein and bone turnover suggests that increasing protein intakes may suppress skeletal turnover. This trial was registered at ClinicalTrials.gov as NCT00668447.

Cupping for chronic nonspecific neck pain: a 2-year follow-up.

PubMed

Lauche, Romy; Cramer, Holger; Langhorst, Jost; Dobos, Gustav

2013-01-01

Several trials have shown that cupping might be an effective treatment for chronic nonspecific neck pain, but little is known about the long-term effectiveness. This study aimed to investigate long-term effects of a short series of cupping; therefore additional follow-up measurements were conducted 2 years after completion of 3 studies. Participants from 3 randomized waitlist controlled trials on cupping for chronic nonspecific neck pain were followed 2 years after treatment. Outcome measures included neck pain intensity (100 mm Visual Analog Scale; VAS), functional disability (Neck Disability Index, NDI), and health-related quality of life (Short Form 36 Health Survey Questionnaire; SF-36). 133 of 150 patients had received cupping treatment and were contacted; 82 of them (61.7%) returned the follow-up questionnaires. No effect was found for neck pain intensity, but for physical function (∆ NDI: -3.15; 95% CI: -5.89; -0.41; p = 0.025) and quality of life (∆ physical component summary: 2.97; 95% CI: 0.97; 4.97; p = 0.004; ∆ bodily pain: 14.53; 95 % CI: 9.67; 19.39; p < 0.001). Mean duration of cupping effect was 8.9 ± 8.7 months with 16 patients reporting that neck pain had not yet reached the level before cupping. The majority of the patients did not continue cupping therapy, mostly due to lack of providers, costs or loss of interest. A series of cupping treatments did not influence neck pain intensity on the longer term, however significant increases were found for physical function and quality of life in patients with chronic nonspecific neck pain. Due to the considerable drop-out rate conclusions are limited. There is evidence suggesting that cupping treatment might have sustainable effects in some patients. Further randomized controlled trials with long-term follow-up are urgently needed for conclusive judgment of long-term effectiveness. © 2013 S. Karger GmbH, Freiburg.

Bridging the gap: support groups do not enhance long-term outcome in chronic back pain.

PubMed

Linton, S J; Hellsing, A L; Larsson, I

1997-09-01

Because back pain patients often relapse within months of treatment, the effects of two types of support groups as a complement to usual medical treatment was investigated on long-term outcome. Regular treatment was compared with an "educational" support group and a professional support group before and 1 year after intervention in a randomized controlled trial. A total of 76 women and 27 men, average age of 50 years and with an accumulated sick leave for musculoskeletal pain of 2-24 weeks during the past year, were randomly assigned to the three groups. Sick leave records were obtained from the National Insurance Authority. A battery of standardized instruments was employed, which featured the Sickness Impact Profile, the Coping Strategies Questionnaire, the Multidimensional Pain Inventory, the Pain and Impairment Relationship Scale, the Pain and Discomfort Scale, the Pain Beliefs and Perceptions Inventory, and the Outcome Evaluation Questionnaire. The Educational Support Group demonstrated greater attendance than did the Professional Support Group. However, long-term outcome was not significantly different between any of the groups for sick leave, coping, function, or experienced pain. Both support groups, relative to the Regular Treatment Group, made greater improvements on the Sickness Impact Profile. This study provides little evidence that support groups, as a complement to regular treatment, enhance long-term outcome for subacute musculoskeletal pain problems. Specific treatment techniques, matched to the patient's needs, stringently taught, and delivered in a more compact form, may be necessary for enhancing outcome.

Long-term safety and real-world effectiveness of fingolimod in relapsing multiple sclerosis

PubMed Central

Druart, Charlotte; El Sankari, Souraya; van Pesch, Vincent

2018-01-01

With a growing number of disease-modifying therapies becoming available for relapsing multiple sclerosis, there is an important need to gather real-world evidence data regarding long-term treatment effectiveness and safety in unselected patient populations. Although not providing as high a level of evidence as randomized controlled trials, and prone to bias, real-world studies from observational studies or registries nevertheless provide crucial information on real-world outcomes of a given therapy. In addition, evaluation of treatment satisfaction and impact on quality of life are increasingly regarded as complementary outcome measures. Fingolimod was the first oral disease-modifying therapy approved for relapsing multiple sclerosis. This review aims to summarize current knowledge on the long-term effectiveness and safety outcomes of multiple sclerosis patients on fingolimod. Impact on treatment satisfaction and quality of life will be discussed according to available data. PMID:29317850

Design of the Quality of Life in Motion (QLIM) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical exercise and psychosocial training program to improve physical fitness in children with cancer.

PubMed

Braam, Katja I; van Dijk, Elisabeth M; Veening, Margreet A; Bierings, Marc B; Merks, Johannes H M; Grootenhuis, Martha A; Chinapaw, Mai J M; Sinnema, Gerben; Takken, Tim; Huisman, Jaap; Kaspers, Gertjan J L; van Dulmen-den Broeder, Eline

2010-11-11

Childhood cancer and its treatment have considerable impact on a child's physical and mental wellbeing. Especially long-term administration of chemotherapy and/or radiotherapy impairs physical fitness both during and after therapy, when children often present with muscle weakness and/or low cardiorespiratory fitness. Physical exercise can improve these two elements of physical fitness, but the positive effects of physical exercise might be further increased when a child's wellbeing is simultaneously enhanced by psychosocial training. Feeling better may increase the willingness and motivation to engage in sports activities. Therefore, this multi-centre study evaluates the short and long-term changes in physical fitness of a child with a childhood malignancy, using a combined physical exercise and psychosocial intervention program, implemented during or shortly after treatment. Also examined is whether positive effects on physical fitness reduce inactivity-related adverse health problems, improve quality of life, and are cost-effective. This multi-centre randomized controlled trial compares a combined physical and psychosocial intervention program for children with cancer, with care as usual (controls). Children with cancer (aged 8-18 years) treated with chemotherapy and/or radiotherapy, and who are no longer than 1 year post-treatment, are eligible for participation. A total of 100 children are being recruited from the paediatric oncology/haematology departments of three Dutch university medical centres. Patients are stratified according to pubertal stage (girls: age ≤10 or >10 years; boys: ≤11 or >11 years), type of malignancy (haematological or solid tumour), and moment of inclusion into the study (during or after treatment), and are randomly assigned to the intervention or control group. Childhood cancer patients undergoing long-term cancer therapy may benefit from a combined physical exercise and psychosocial intervention program since it may maintain or enhance their physical fitness and increase their quality of life. However, the feasibility, patient need, and effectiveness of such a program should be established before the program can be implemented as part of standard care. NTR1531 (The Netherlands National Trial Register).

Does perioperative nutrition and oral carbohydrate load sustainably preserve muscle mass after bariatric surgery? A randomized control trial.

PubMed

Azagury, D E; Ris, F; Pichard, C; Volonté, F; Karsegard, L; Huber, O

2015-01-01

Perioperative nutrition and preoperative oral carbohydrate loading (CHL) have a beneficial impact on the outcomes of gastrointestinal oncological surgery. However no data exists on their effect on morbidly obese patients. Our aim was to establish the short-term and long-term impact of these modalities, notably on metabolically active lean body mass (LBM) - an important factor in maintaining long-term weight loss. Patients undergoing laparoscopic Roux-en-Y gastric bypass were randomized to standard management or intervention: CHL drinks consumed 12 and 2 hours presurgery, and immediate postoperative peripheral parenteral nutrition. The primary outcome measured was LBM, measured by Bioelectrical Impedance Analysis (BIA), one and 12 months postsurgery. Secondary outcomes included excess weight loss (EBWL), 30-day complication rate, and length of stay. Of the 203 randomized patients, 198 were included in the analysis. All 101 patients in the control group completed the one-year follow up and 76 completed the BIA. In the intervention group, 93 of 97 patients completed the one-year follow-up and 71 completed the BIA. At one and 12 months follow-up, body composition, LBM, or EBWL were comparable. There was no difference in operative outcomes, complications rates, or length of stay. There was no adverse effect in the intervention group. In a highly homogeneous group of morbidly obese patients with one-year follow-up, CHL and short-term parenteral nutrition did not lead to significant or sustained LBM preservation or modification in EBWL. There was no significant decrease in complications or length of stay. Our study confirms the safety of these interventions, even in previously unstudied Type 2 diabetic patients. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Physical activity after commitment lotteries: examining long-term results in a cluster randomized trial.

PubMed

van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Berkhout, Stef; Polder, Johan J; Prast, Henriëtte M

2018-02-26

To overcome self-control difficulties, people can commit to their health goals by voluntarily accepting deadlines with consequences. In a commitment lottery, the winners are drawn from all participants, but can only claim their prize if they also attained their gym-attendance goals. In a 52-week, three-arm trial across six company gyms, we tested if commitment lotteries with behavioral economic underpinnings would promote physical activity among overweight adults. In previous work, we presented an effective 26-week intervention. In the present paper we analyzed maintenance of goal attainment at 52-week follow-up and the development of weight over time. We compared weight and goal attainment (gym attendance ≥ 2 per week) between three arms that-in the intervention period- consisted of (I) weekly short-term lotteries for 13 weeks; (II) the same short-term lotteries in combination with an additional long-term lottery after 26 weeks; and (III) a control arm without lottery-deadlines. After a successful 26-week intervention, goal attainment declined between weeks 27 and 52 in the long-term lottery arm, but remained higher than in the control group. Goal attainment did not differ between the short-term lottery arm and control arm. Weight declined slightly in all arms in the first 13 weeks of the trial and remained stable from there on. Commitment lotteries can support regular gym attendance up to 52 weeks, but more research is needed to achieve higher levels of maintenance and weight loss.

Problems identified by dual sensory impaired older adults in long-term care when using a self-management program: A qualitative study

PubMed Central

Zuidema, Sytse; Vernooij-Dassen, Myrra; Dees, Marianne; Hermsen, Pieter; Kempen, Gertrudis; Graff, Maud

2017-01-01

Objective To gain insights into the problems of dual sensory impaired older adults in long-term care. Insights into these problems are essential for developing adequate policies which address the needs of the increasing population of dual sensory impaired older adults in long-term care. Methods A qualitative study was conducted in parallel with a cluster randomized controlled trial. Dual sensory impaired older adults in the intervention group (n = 47, age range 82–98) were invited by a familiar nurse to identify the problems they wanted to address. Data were taken from the semi-structured intervention diaries in which nurses noted the older adults’ verbal responses during a five-month intervention period in 17 long-term care homes across the Netherlands. The data were analyzed using descriptive statistics and qualitative content analysis based on the Grounded Theory. Findings The 47 dual sensory impaired older adults identified a total of 122 problems. Qualitative content analysis showed that the older adults encountered participation problems and problems controlling what happens in their personal environment. Three categories of participation problems emerged: (1) existential concerns of not belonging or not being able to connect with other people, (2) lack of access to communication, information and mobility, and (3) the desire to be actively involved in care delivery. Two categories of control-in-personal-space problems emerged: (1) lack of control of their own physical belongings, and (2) lack of control regarding the behavior of nurses providing daily care in their personal environment. Conclusions The invasive problems identified indicate that dual sensory impaired older adults experience great existential pressures on their lives. Long-term care providers need to develop and implement policies that identify and address these problems, and be aware of adverse consequences of usual care, in order to improve dual sensory impaired residents’ autonomy and quality of life. PMID:28323846

Problems identified by dual sensory impaired older adults in long-term care when using a self-management program: A qualitative study.

PubMed

Roets-Merken, Lieve; Zuidema, Sytse; Vernooij-Dassen, Myrra; Dees, Marianne; Hermsen, Pieter; Kempen, Gertrudis; Graff, Maud

2017-01-01

To gain insights into the problems of dual sensory impaired older adults in long-term care. Insights into these problems are essential for developing adequate policies which address the needs of the increasing population of dual sensory impaired older adults in long-term care. A qualitative study was conducted in parallel with a cluster randomized controlled trial. Dual sensory impaired older adults in the intervention group (n = 47, age range 82-98) were invited by a familiar nurse to identify the problems they wanted to address. Data were taken from the semi-structured intervention diaries in which nurses noted the older adults' verbal responses during a five-month intervention period in 17 long-term care homes across the Netherlands. The data were analyzed using descriptive statistics and qualitative content analysis based on the Grounded Theory. The 47 dual sensory impaired older adults identified a total of 122 problems. Qualitative content analysis showed that the older adults encountered participation problems and problems controlling what happens in their personal environment. Three categories of participation problems emerged: (1) existential concerns of not belonging or not being able to connect with other people, (2) lack of access to communication, information and mobility, and (3) the desire to be actively involved in care delivery. Two categories of control-in-personal-space problems emerged: (1) lack of control of their own physical belongings, and (2) lack of control regarding the behavior of nurses providing daily care in their personal environment. The invasive problems identified indicate that dual sensory impaired older adults experience great existential pressures on their lives. Long-term care providers need to develop and implement policies that identify and address these problems, and be aware of adverse consequences of usual care, in order to improve dual sensory impaired residents' autonomy and quality of life.

Acute and long-term management of food allergy: systematic review.

PubMed

de Silva, D; Geromi, M; Panesar, S S; Muraro, A; Werfel, T; Hoffmann-Sommergruber, K; Roberts, G; Cardona, V; Dubois, A E J; Halken, S; Host, A; Poulsen, L K; Van Ree, R; Vlieg-Boerstra, B J; Agache, I; Sheikh, A

2014-02-01

Allergic reactions to food can have serious consequences. This systematic review summarizes evidence about the immediate management of reactions and longer-term approaches to minimize adverse impacts. Seven bibliographic databases were searched from their inception to September 30, 2012, for systematic reviews, randomized controlled trials, quasi-randomized controlled trials, controlled clinical trials, controlled before-and-after and interrupted time series studies. Experts were consulted for additional studies. There was no language or geographic restrictions. Two reviewers critically appraised the studies using the appropriate tools. Data were not suitable for meta-analysis due to heterogeneity so were narratively synthesized. Eighty-four studies were included, but two-thirds were at high risk of potential bias. There was little evidence about acute management for non-life-threatening reactions. H1-antihistamines may be of benefit, but this evidence was in part derived from studies on those with cross-reactive birch pollen allergy. Regarding long-term management, avoiding the allergenic food or substituting an alternative was commonly recommended, but apart from for infants with cow's milk allergy, there was little high-quality research on this management approach. To reduce symptoms in children with cow's milk allergy, there was evidence to recommend alternatives such as extensively hydrolyzed formula. Supplements such as probiotics have not proved helpful, but allergen-specific immunotherapy may be disease modifying and therefore warrants further exploration. Food allergy can be debilitating and affects a significant number of people. However, the evidence base about acute and longer-term management is weak and needs to be strengthened as a matter of priority. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder.

PubMed

Banaschewski, Tobias; Johnson, Mats; Lecendreux, Michel; Zuddas, Alessandro; Adeyi, Ben; Hodgkins, Paul; Squires, Liza A; Coghill, David R

2014-12-01

The stimulant prodrug lisdexamfetamine dimesylate (LDX) is an effective and generally well tolerated treatment for the symptoms of attention-deficit/hyperactivity disorder (ADHD). Positive impacts of LDX on health-related quality of life and functional impairment have previously been demonstrated in a 7-week, randomized, double-blind, placebo-controlled, phase III study in children and adolescents in Europe. Maintenance of these broad benefits, as well as symptomatic control, is a key goal of long-term management of ADHD. Secondary objectives of this multinational study in children and adolescents with ADHD were to assess the long-term maintenance of effectiveness of LDX in improving health-related quality of life and reducing functional impairment, as gauged using the Child Health and Illness Profile-Child Edition: Parent Report Form (CHIP-CE: PRF) and the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P), respectively. Patients aged 6-17 years with diagnosed ADHD and a baseline ADHD Rating Scale IV total score of at least 28 were enrolled from the previous European study and from US sites. Patients who completed an open-label LDX treatment period of at least 26 weeks were randomized (1:1) to continue on their optimized dose of LDX or to switch to placebo for a 6-week, double-blind, withdrawal period. Parents completed CHIP-CE: PRF and WFIRS-P questionnaires at weeks 0, 8 and 26 of the open-label period and at weeks 0 and 6 of the randomized-withdrawal period, or at early termination. The endpoint of each period was defined as the last visit with valid data. Effect sizes were the difference (LDX minus placebo) in least-squares (LS)-mean change from baseline to endpoint divided by root-mean-square error. P values were nominal and not adjusted for multiple comparisons. The open-label and randomized full analysis sets comprised 262 and 153 (LDX n = 76; placebo n = 77) patients, respectively. Mean pretreatment CHIP-CE: PRF T-scores were more than one standard deviation below the normative mean in four of the five domains, and there was significant improvement across all domains from baseline to endpoint of the open-label period. In the randomized-withdrawal period, LS-mean CHIP-CE: PRF T-scores deteriorated in all domains in the placebo group, but not in the LDX group. Compared with placebo, the effect of LDX was significant in the Risk Avoidance (effect size 0.829; p < 0.001), Achievement (0.696; p < 0.001) and Satisfaction (0.636; p < 0.001) domains. Mean pretreatment WFIRS-P scores were lowest in the Family domain and the Learning and School domain. WFIRS-P total score and scores in all domains improved significantly from baseline to endpoint of the open-label period. In the randomized-withdrawal period, LS-mean scores deteriorated in the placebo group but not in the LDX group. Compared with placebo, the effect of LDX was significant in the Family, Learning and School, and Risky Activities domains and in total (effect size 0.908; p < 0.001). Using parent-rated instruments, long-term maintenance of the beneficial effect of LDX in multiple domains of health-related quality of life and functional impairment was demonstrated by comparison of treatment continuation and withdrawal under randomized, double-blind, placebo-controlled conditions.

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia.

PubMed

Chow, Philip I; Ingersoll, Karen S; Thorndike, Frances P; Lord, Holly R; Gonder-Frederick, Linda; Morin, Charles M; Ritterband, Lee M

2018-07-01

The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral therapy intervention for insomnia (CBT-I) (Sleep Healthy Using the Internet [SHUTi]). Three hundred and three participants (M age  = 43.3 years; SD = 11.6) were randomly assigned to SHUTi or an online patient education condition and assessed at baseline, postintervention (nine weeks after baseline), and six and 12 months after the intervention period. Cognitive variables were self-reported internal and chance sleep locus of control, dysfunctional beliefs and attitudes about sleep (DBAS), sleep specific self-efficacy, and insomnia knowledge. Primary outcomes were self-reported online ratings of insomnia severity (Insomnia Severity Index), and sleep onset latency and wake after sleep onset from online sleep diaries, collected 12 months after the intervention period. Those who received SHUTi had, at postassessment, higher levels of insomnia knowledge (95% confidence interval [CI] = 0.10-0.16) and internal sleep locus of control (95% CI = 0.04-0.55) as well as lower DBAS (95% CI = 1.52-2.39) and sleep locus of control attributed to chance (95% CI = 0.15-0.71). Insomnia knowledge, chance sleep locus of control, and DBAS mediated the relationship between condition and at least one 12-month postassessment sleep outcome. Within the SHUTi condition, changes in each cognitive variable (with the exception of internal sleep locus of control) predicted improvement in at least one sleep outcome one year later. Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep outcomes. Published by Elsevier B.V.

Efficacy, tolerability, and safety of hypnosis in adult irritable bowel syndrome: systematic review and meta-analysis.

PubMed

Schaefert, Rainer; Klose, Petra; Moser, Gabriele; Häuser, Winfried

2014-06-01

To assess the efficacy, tolerability, and safety of hypnosis in adult irritable bowel syndrome by a meta-analysis of randomized controlled trials. Studies were identified by a literature search of the databases Allied and Complementary Medicine Database, Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, PubMed, PsycINFO, and Scopus (from inception to June 30, 2013). Primary outcomes were adequate symptom relief, global gastrointestinal score, and safety. Summary relative risks (RRs) with number needed to treat (NNT) and standardized mean differences (SMDs) with 95% confidence intervals (95% CIs) were calculated using random-effects models. Eight randomized controlled trials with a total of 464 patients and a median of 8.5 (7-12) hypnosis sessions over a median of 12 (5-12) weeks were included into the analysis. At the end of therapy, hypnosis was superior to control conditions in producing adequate symptom relief (RR, 1.69 [95% CI = 1.14-2.51]; NNT, 5 [3-10]) and in reducing global gastrointestinal score (SMD, 0.32 [95% CI = -0.56 to -0.08]). At long-term follow-up, hypnosis was superior to controls in adequate symptom relief (RR, 2.17 [95% CI = 1.22-3.87]; NNT, 3 [2-10]), but not in reducing global gastrointestinal score (SMD, -0.57 [-1.40 to 0.26]). One (0.4%) of 238 patients in the hypnosis group dropped out due to an adverse event (panic attack). This meta-analysis demonstrated that hypnosis was safe and provided long-term adequate symptom relief in 54% of patients with irritable bowel syndrome refractory to conventional therapy.

Foot Massage and Physiological Stress in People with Dementia: A Randomized Controlled Trial

PubMed Central

Cooke, Marie Louise; Beattie, Elizabeth; Shum, David H.K.; O'Dwyer, Siobhan T.; Barrett, Sue; Sung, Billy

2014-01-01

Abstract Background: The anxiety associated with unfamiliar surroundings, the disorientation and mental confusion, and the social isolation that accompanies dementia can often create increased stress for people living in long-term care settings. Such a response is thought to affect the autonomic nervous system and result in emotional and physical symptoms of distress that may be manifested as agitation. There is the potential for such distress to influence the physiological response and in particular Blood Pressure and Heart Rate. A relaxation intervention such as massage may influence the physiological stress response. Methods: This randomized controlled trial aimed to compare the effect of foot massage (FM) versus a control activity (quiet presence, QP) on physiological stress response (i.e., blood pressure [BP] and heart rate [HR]) in people living with moderate-to-severe dementia in long-term-care settings. Results: Fifty-three residents were randomized to intervention (10-minute FM) or control group (QP). While the FM group experienced a greater reduction in HR than the control group, these reductions were not significantly different between groups (p=0.83; see Table 1), or across time (p=0.46). Both groups experienced a reduction in systolic BP and diastolic BP, while the mean reduction in systolic BP was greater for those in the FM group. Conclusions: While the findings do not provide strong support for FM, the finding that both conditions allowed the person with dementia to rest in the presence of another human being is of importance in the care of people with dementia. The close presence of another person may in fact promote relaxation and therefore improve BP and HR measures. PMID:24047244

Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials.

PubMed

Gerson, Lauren; Stouch, Bruce; Lobonţiu, Adrian

2018-01-01

The TIF procedure has emerged as an endoscopic treatment for patients with refractory gastro-esophageal reflux disease (GERD). Previous systematic reviews of the TIF procedure conflated findings from studies with modalities that do not reflect the current 2.0 procedure technique or refined data-backed patient selection criteria. A meta-analysis was conducted using data only from randomized studies that assessed the TIF 2.0 procedure compared to a control. The purpose of the meta-analysis was to determine the efficacy and long-term outcomes associated with performance of the TIF 2.0 procedure in patients with chronic long-term refractory GERD on optimized PPI therapy, including esophageal pH, PPI utilization and quality of life. Methods: Three prospective research questions were predicated on the outcomes of the TIF procedure compared to patients who received PPI therapy or sham, concomitant treatment for GERD, and the patient-reported quality of life. Event rates were calculated using the random effect model. Since the time of follow-up post-TIF procedure was variable, analysis was performed to incorporate the time of follow-up for each individual patient at the 3-year time point. Results: Results from this meta-analysis, including data from 233 patients, demonstrated that TIF subjects at 3 years had improved esophageal pH, a decrease in PPI utilization, and improved quality of life. Conclusions: In a meta-analysis of randomized, controlled trials (RCTs), the TIF procedure data for patients with GERD refractory to PPI's produces significant changes, compared with sham or PPI therapy, in esophageal pH, decreased PPI utilization, and improved quality of life. Celsius.

Self-concept and quality of object relations as predictors of outcome in short- and long-term psychotherapy.

PubMed

Lindfors, Olavi; Knekt, Paul; Heinonen, Erkki; Virtala, Esa

2014-01-01

Quality of object relations and self-concept reflect clinically relevant aspects of personality functioning, but their prediction as suitability factors for psychotherapies of different lengths has not been compared. This study compared their prediction on psychiatric symptoms and work ability in short- and long-term psychotherapy. Altogether 326 patients, 20-46 years of age, with mood and/or anxiety disorder, were randomized to short-term (solution-focused or short-term psychodynamic) psychotherapy and long-term psychodynamic psychotherapy. The Quality of Object Relations Scale (QORS) and the Structural Analysis of Social Behavior (SASB) self-concept questionnaire were measured at baseline, and their prediction on outcome during the 3-year follow-up was assessed by the Symptom Check List Global Severity Index and the Anxiety Scale, the Beck Depression Inventory and by the Work Ability Index, Social Adjustment Scale work subscale and the Perceived Psychological Functioning scale. Negative self-concept strongly and self-controlling characteristics modestly predicted better 3-year outcomes in long-term therapy, after faster early gains in short-term therapy. Patients with a more positive or self-emancipating self-concept, or more mature object relations, experienced more extensive benefits after long-term psychotherapy. The importance of length vs. long-term therapy technique on the differences found is not known. Patients with mild to moderate personality pathology, indicated by poor self-concept, seem to benefit more from long-term than short-term psychotherapy, in reducing risk of depression. Long-term therapy may also be indicated for patients with relatively good psychological functioning. More research is needed on the relative importance of these characteristics in comparison with other patient-related factors. © 2013 Published by Elsevier B.V.

[Cannabinoids in pain medicine].

PubMed

Karst, M

2018-06-07

The endocannabinoid system (ECS) controls a large number of vital functions. Suboptimal tone of the ECS in certain regions of the nervous system may be associated with disorders that are also associated with pain. Pain and inflammation processes can be modulated by the exogenous supply of cannabinoids. Low-to-moderate pain-relieving effects and in individual cases large pain-relieving effects were observed in randomized, controlled studies of various types of chronic pain. People with chronic neuropathic pain and stress symptoms seem to particularly benefit. The therapeutic range of cannabinoids is small; often small doses are sufficient for clinically significant effects. The "Cannabis-als-Medizin-Gesetz" (cannabis as medicine law) allows the prescription of cannabis preparations under certain conditions. Available data indicate good long-term efficacy and tolerability. However, there is little systematic long-term experience from clinical studies.

The influence of a formula supplemented with dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in healthy full-term infants: a double-blind randomized controlled trial

PubMed Central

2012-01-01

Background Human milk is the optimal nutrition for infants. When breastfeeding is not possible, supplementation of infant formula with long chain polyunsaturated fatty acids appears to promote neurodevelopmental outcome and visual function. Plant oils, that are the only source of fat in most of infant formulas, do not contain specific fatty acids that are present in human and cow milk and do not encounter milk fat triglyceride structure. Experimental data suggest that a mix of dairy lipids and plant oils can potentiate endogenous synthesis of n-3 long chain polyunsaturated fatty acids. This trial aims to determine the effect of an infant formula supplemented with a mixture of dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in full-term infants (primary outcome). Erythrocyte membrane long chain polyunsaturated fatty acids and fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level, the gastrointestinal tolerance, the changes throughout the study in blood fatty acids content, in growth and body composition are evaluated as secondary outcomes. Methods/Design In a double-blind controlled randomized trial, 75 healthy full-term infants are randomly allocated to receive for four months a formula supplemented with a mixture of dairy lipids and plant oils or a formula containing only plant oils or a formula containing plant oils supplemented with arachidonic acid and docosahexaenoic acid. Twenty-five breast-fed infants constitute the reference group. Erythrocyte membrane omega-3 fatty acid profile, long chain polyunsaturated fatty acids and the other fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level are measured after four months of intervention. Gastrointestinal tolerance, the changes in blood fatty acids content, in growth and body composition, assessed by means of an air displacement plethysmography system, are also evaluated throughout the study. Discussion The achievement of an appropriate long chain polyunsaturated fatty acids status represents an important goal in neonatal nutrition. Gaining further insight in the effects of the supplementation of a formula with dairy lipids and plant oils in healthy full-term infants could help to produce a formula whose fat content, composition and structure is more similar to human milk. Trial registration ClinicalTrials.gov Identifier NCT01611649 PMID:23072617

The influence of a formula supplemented with dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in healthy full-term infants: a double-blind randomized controlled trial.

PubMed

Giannì, Maria Lorella; Roggero, Paola; Baudry, Charlotte; Ligneul, Amandine; Morniroli, Daniela; Garbarino, Francesca; le Ruyet, Pascale; Mosca, Fabio

2012-10-17

Human milk is the optimal nutrition for infants. When breastfeeding is not possible, supplementation of infant formula with long chain polyunsaturated fatty acids appears to promote neurodevelopmental outcome and visual function. Plant oils, that are the only source of fat in most of infant formulas, do not contain specific fatty acids that are present in human and cow milk and do not encounter milk fat triglyceride structure. Experimental data suggest that a mix of dairy lipids and plant oils can potentiate endogenous synthesis of n-3 long chain polyunsaturated fatty acids. This trial aims to determine the effect of an infant formula supplemented with a mixture of dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in full-term infants (primary outcome). Erythrocyte membrane long chain polyunsaturated fatty acids and fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level, the gastrointestinal tolerance, the changes throughout the study in blood fatty acids content, in growth and body composition are evaluated as secondary outcomes. In a double-blind controlled randomized trial, 75 healthy full-term infants are randomly allocated to receive for four months a formula supplemented with a mixture of dairy lipids and plant oils or a formula containing only plant oils or a formula containing plant oils supplemented with arachidonic acid and docosahexaenoic acid. Twenty-five breast-fed infants constitute the reference group. Erythrocyte membrane omega-3 fatty acid profile, long chain polyunsaturated fatty acids and the other fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level are measured after four months of intervention. Gastrointestinal tolerance, the changes in blood fatty acids content, in growth and body composition, assessed by means of an air displacement plethysmography system, are also evaluated throughout the study. The achievement of an appropriate long chain polyunsaturated fatty acids status represents an important goal in neonatal nutrition. Gaining further insight in the effects of the supplementation of a formula with dairy lipids and plant oils in healthy full-term infants could help to produce a formula whose fat content, composition and structure is more similar to human milk. ClinicalTrials.gov Identifier NCT01611649.

Long-term effects of high-intensity interval training in heart transplant recipients: A 5-year follow-up study of a randomized controlled trial.

PubMed

Yardley, Marianne; Gullestad, Lars; Bendz, Bjørn; Bjørkelund, Elisabeth; Rolid, Katrine; Arora, Satish; Nytrøen, Kari

2017-01-01

Previous studies have demonstrated that high-intensity interval training (HIT) is superior to moderate-continuous exercise in general and in cardiovascular diseases. Recently, we also found HIT safe and efficient after heart transplantation (HTx). This study reports the 5-year long-term effects. Forty-one HTx patients who had completed the previous 12-month randomized controlled trial, comparing HIT intervention with usual care, were eligible. In particular, we measured VO 2peak , muscular capacity, intravascular ultrasound, and questionnaires measuring physical and mental health. The baseline mean±SD values were as follows: age; 49.1±16.5 years, men; 68%, time since HTx: 4.1±2.2 years. Within the HIT group, initial VO 2peak increased significantly from 27.7±5.7 to 31.2±5.3 mL/kg/min. However, during the next 4 years, VO 2peak decreased to 26.0±6.2 mL/kg/min. The control group showed slightly decreasing VO 2peak values during the entire 5-year period. The HIT group reported significantly less anxiety symptoms, but there were no long-term differences in VO 2peak , muscular capacity, or cardiac allograft vasculopathy between the groups. The similar VO 2peak values correspond to our findings of similar everyday activity. Our findings suggest that intermittent periods of HIT may be necessary to maintain the initial benefits gained from the intervention. However, HIT probably reduces the burden of anxiety, which is a frequent health issue following HTx. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Amino Acid-based Formula in Cow's Milk Allergy: Long-term Effects on Body Growth and Protein Metabolism.

PubMed

Canani, Roberto Berni; Nocerino, Rita; Frediani, Tullio; Lucarelli, Sandra; Di Scala, Carmen; Varin, Elena; Leone, Ludovica; Muraro, Antonella; Agostoni, Carlo

2017-04-01

The long-term effects of amino acid-based formula (AAF) in the treatment of cow's milk allergy (CMA) are largely unexplored. The present study comparatively evaluates body growth and protein metabolism in CMA children treated with AAF or with extensively hydrolyzed whey formula (eHWF), and healthy controls. A 12-month multicenter randomized control trial was conducted in outpatients with CMA (age 5-12 m) randomized in 2 groups, treated with AAF (group 1) and eHWF (group 2), and compared with healthy controls (group 3) fed with follow-on (if age <12 months) or growing-up formula (if age >12 months). At enrolment (T0), after 3 (T3), 6 (T6), and 12 months (T12) a clinical evaluation was performed. At T0 and T3, in subjects with CMA serum levels of albumin, urea, total protein, retinol-binding protein, and insulin-like growth factor 1 were measured. Twenty-one subjects in group 1 (61.9% boys, age 6.5 ± 1.5 months), 19 in group 2 (57.9% boys, age 7 ± 1.7 months) and 25 subjects in group 3 (48% boys, age 5.5 ± 0.5 months) completed the study. At T0, the weight z score was similar in group 1 (-0.74) and 2 (-0.76), with differences compared to group 3 (-0.17, P < 0.05). At T12, the weight z score value was similar between the 3 groups without significant differences. There were no significant changes in protein metabolism in children in groups 1 and 2. Long-term treatment with AAF is safe and allows adequate body growth in children with CMA.

The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients.

PubMed

Ederer, F; Gaasterland, D E; Sullivan, E K

1994-08-01

Medical therapy has been the standard initial treatment for open-angle glaucoma. When some visual field has been lost and maximum tolerated and effective medical therapy does not succeed in controlling the disease, the patient is considered to have advanced glaucoma, and the first of a potential sequence of surgical treatments is usually indicated. Little is known about the long-term course and prognosis of advanced glaucoma or about the long-term effectiveness of sequential surgical treatments in controlling the disease and preventing vision loss and blindness. The Advanced Glaucoma Intervention Study was designed to study, in advanced glaucoma, the long-term clinical course and prognosis, and, in a randomized trial, the comparative outcomes of two sequences of surgical treatments. Toward these goals, 789 eyes in 591 patients were enrolled at 11 clinical centers between 1988 and 1992. Follow-up will continue until 1996. Eyes were randomly assigned to one of two sequences of surgical treatments. One sequence begins with argon laser trabeculoplasty (ALT), is followed by trabeculectomy, an incisional surgical filtering procedure, should ALT fail to control the disease, and by a second trabeculectomy should the first trabeculectomy fail. The other sequence begins with trabeculectomy, is followed by ALT should the trabeculectomy fail, and by a second trabeculectomy should ALT fail. The main outcome of interest is visual function (visual field and visual acuity). Other important outcomes are intraocular pressure, complications of surgery, time to treatment failure, and extent of need for additional medical therapy. We present in this paper the rationale, objectives, design and methods of the study, and the baseline characteristics of study patients and eyes.

Long-Term Control Medications for Lung Diseases

MedlinePlus

... Asthma Medications Long-Term Control Medications Long-Term Control Medications Make an Appointment Ask a Question Refer Patient Long-term control medications are taken daily to control and prevent ...

[Long-term efficacy of submandibular gland transfer for prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma].

PubMed

Zhang, Xiangmin; Yu, Lijiang; Wu, Wei; Wu, Xiuhong; Xiao, Fufu; Zeng, Guoxing; Lan, Xiaolin

2013-02-01

To evaluate the long-term efficacy of submandibular gland transfer for prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma. Sixty-five cases of nasopharyngeal carcinoma patients were randomly divided into study group of 32 patients and control group of 33 patents. The submandibular gland was transferred to submental region on 32 cases with nasopharyngeal carcinoma before receiving conventional radiotherapy and a block was used to cover the submental region. Before radiotherapy, two groups of submandibular gland function was detected by imaging of the submandibular gland. At 60 months after radiotherapy, submandibular gland function was detected by 99mTc radionuclide scanning, the questionnaire about the degree of xerostomia was investigated respectively. Five-year survival rate was counted. After following up for 60 months, submandibular gland uptake and secretion function in the study group was significantly higher than that in the control group, there was significant difference between the two groups (P < 0.01) respectively. The incidence of moderate or severe xerostomia in the study group was significantly lower than that in the control group (15.4% vs 76.9%, P < 0.01). Five-year survival rate of the study group and control group was 81.3% and 78.8% respectively, there was no significant difference between the two groups (P > 0.05). The long-term efficacy of submandibular gland transfer for prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma was well. It could improve the quality of life in nasopharyngeal carcinoma patients after radiotherapy, and did not affect the long-term efficacy of nasopharyngeal carcinoma.

Recreational music-making: a cost-effective group interdisciplinary strategy for reducing burnout and improving mood states in long-term care workers.

PubMed

Bittman, Barry; Bruhn, Karl T; Stevens, Christine; Westengard, James; Umbach, Paul O

2003-01-01

This controlled, prospective, randomized study examined the clinical and potential economic impact of a 6-session Recreational Music-making (RMM) protocol on burnout and mood dimensions, as well as on Total Mood Disturbance (TMD) in an interdisciplinary group of long-term care workers. A total of 112 employees participated in a 6-session RMM protocol focusing on building support, communication, and interdisciplinary respect utilizing group drumming and keyboard accompaniment. Changes in burnout and mood dimensions were assessed with the Maslach Burnout Inventory and the Profile of Mood States respectively. Cost savings were projected by an independent consulting firm, which developed an economic impact model. Statistically-significant reductions of multiple burnout and mood dimensions, as well as TMD scores, were noted. Economic-impact analysis projected cost savings of $89,100 for a single typical 100-bed facility, with total annual potential savings to the long-term care industry of $1.46 billion. A cost-effective, 6-session RMM protocol reduces burnout and mood dimensions, as well as TMD, in long-term care workers.

Long-Term Improvements in Knowledge and Psychosocial Factors of a Teen Pregnancy Prevention Intervention Implemented in Group Homes.

PubMed

Green, Jennifer; Oman, Roy F; Lu, Minggen; Clements-Nolle, Kristen D

2017-06-01

Youth in out-of-home care have higher rates of sexual risk behaviors and pregnancy than youth nationally. This study aimed to determine if Power Through Choices (PTC), a teen pregnancy prevention program developed for youth in out-of-home care, significantly improves knowledge and psychosocial outcomes regarding HIV and sexually transmitted infections (STIs), sexual activity and contraception methods, long term. A cluster randomized controlled trial was conducted with 1,036 ethnically diverse youths (aged 13-18 years) recruited from 44 residential group homes in three states. Intervention participants received the 10-session PTC intervention; control participants received usual care. Participants were administered self-report surveys at baseline, after intervention, 6 and 12 months after the intervention. Survey items assessed knowledge, attitudes, self-efficacy, and behavioral intentions regarding HIV and STIs, sexual activity and contraception methods. Random intercept logistic regression analyses were used to assess differences between the intervention and control groups. Compared with youth in the control group, youth in the PTC intervention demonstrated significant improvements in knowledge about anatomy and fertility (adjusted odds ratio [AOR] = 1.07, 95% confidence interval [CI] = 1.03-1.11), HIV and STIs (AOR = 1.03, 95% CI = 1.002-1.07), and methods of protection (AOR = 1.06, 95% CI = 1.03-1.09), as well as self-efficacy regarding self-efficacy to communicate with a partner (AOR = 1.14, 95% CI = 1.04-1.26), plan for protected sex and avoid unprotected sex (AOR = 1.16, 95% CI = 1.04-1.28), and where to get methods of birth control (AOR = 1.13, 95% CI = 1.01-1.26) 12 months after the intervention. Findings suggest that the PTC intervention can have positive long-term knowledge and psychosocial effects regarding contraception methods on youth in out-of-home care. Copyright © 2017 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Long-term effectiveness of bee venom acupuncture and physiotherapy in the treatment of adhesive capsulitis: a one-year follow-up analysis of a previous randomized controlled trial.

PubMed

Park, Yeon Cheol; Koh, Pil Seong; Seo, Byung Kwan; Lee, Jung Woo; Cho, Nam Su; Park, Hyung Soon; Park, Dong Suk; Baek, Yong Hyeon

2014-12-01

An earlier randomized controlled trial (RCT) study showed that bee venom acupuncture (BVA) in combination with physiotherapy can be more effective in functional improvement and pain reduction in patients with adhesive capsulitis (AC). The objective of the current study was to examine the long-term effect of BVA in combination with physiotherapy on AC of the shoulder. Retrospective 1-year follow-up analysis of a previous RCT using a telephone interview method. Outpatient joint center at the Gang Dong Kyung Hee University Hospital of Seoul, Republic of Korea. A total of 192 patients had been enrolled in the previous study, and 124 of these were excluded from the current study. Sixty-eight patients who had been treated with combined BVA and physiotherapy for AC of the shoulder for 2 months were interviewed at approximately 1 year after treatment by telephone. Sixty of 68 patients were included in the follow-up analysis. Twenty received BV 1 treatment (1:10,000 concentration BVA plus physiotherapy), 22 received BV 2 treatment (1:30,000 concentration BVA plus physiotherapy), and 18 received control treatment (normal saline injection plus physiotherapy). The primary outcome measure was Shoulder Pain And Disability Index (SPADI) score. Secondary outcome measure was score on verbal rating scale for pain and patient satisfaction. Baseline characteristics of the groups did not significantly differ. SPADI scores at 1 year significantly differed between the BV 1 group and the control group (p=0.043). No significant differences were found in pain verbal rating scores after 1 year. Treatment satisfaction with therapy was also assessed, and the BV 1 and BV 2 groups showed significantly greater satisfaction compared with the control group. BVA combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.

[Donepezil in patients with Alzheimer's disease--a critical appraisal of the AD2000 study].

PubMed

Kaiser, Thomas; Florack, Christiane; Franz, Heinrich; Sawicki, Peter T

2005-03-15

The AD2000 study was a randomized placebo-controlled trial, the effects of donepezil, a cholinesterase inhibitor, in patients with Alzheimer's disease. It was the first long-term RCT not sponsored by the pharmaceutical industry. The study did not show any significant effect on patient-relevant outcomes. However, donepezil had a significant effect on cognitive scores. More patients taking donepezil stopped treatment due to adverse events, even when taking only 5 mg once daily. There are major concerns regarding the conduction of the AD2000 study as well as the presentation of the results. Much less patients than previously planned have been recruited, resulting in a low statistical power to detect a significant difference between both treatments. In addition, no true intention-to-treat analysis based on the first randomization is presented. The validity of the AD2000 trial has to be questioned. However, there is still insufficient evidence to support the claim that cholinesterase inhibitors have beneficial effects on patient-relevant outcomes in patients with Alzheimer's disease. The change of cognitive performance as measured by different scales does not necessarily correspond to substantial changes in patient-relevant outcomes. In conclusion, the widespread use of cholinesterase inhibitors in patients with Alzheimer's disease is not supported by current evidence. Long-term-randomized controlled trials focusing on patient-relevant outcomes instead of cognitive scores are urgently needed.

Cost-effectiveness of a long-term Internet-delivered worksite health promotion programme on physical activity and nutrition: a cluster randomized controlled trial

PubMed Central

Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

2012-01-01

This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a standard programme consisting of a physical health check with face-to-face advice and personal feedback on a website. The intervention consisted of several additional website functionalities: action-oriented feedback, self-monitoring, possibility to ask questions and monthly e-mail messages. Primary outcomes were meeting the guidelines for PA and fruit and vegetable intake. Secondary outcomes were self-perceived health, obesity, elevated blood pressure, elevated cholesterol level and maximum oxygen uptake. Direct and indirect costs were calculated from a societal perspective, and a process evaluation was performed. Of the 924 participants, 72% participated in the first and 60% in the second follow-up. No statistically significant differences were found on primary and secondary outcomes, nor on costs. Average direct costs per participant over the 2-year period were €376, and average indirect costs were €9476. In conclusion, no additional benefits were found in effects or cost savings. Therefore, the programme in its current form cannot be recommended for implementation. PMID:22350194

Short-Term and Long-Term Effects of an Exercise-Based Patient Education Programme in People with Multiple Sclerosis: A Pilot Study

PubMed Central

Haas, Christian T.

2017-01-01

Background. Although people with Multiple Sclerosis (pwMS) benefit from physical exercise, they still show reduced physical activity and exercise behaviour. This study aimed to investigate short- and long-term effects of an exercise-based patient education programme (ePEP) that focuses on empowering pwMS to a sustainable and self-regulated exercise training management. Methods. Fourteen pwMS were randomly assigned to immediate experimental group (EG-I: n = 8) and waitlist-control group (EG-W: n = 6) and attended biweekly in a six-week ePEP. All participants were measured for walking ability, quality of life, fatigue, and self-efficacy towards physical exercise before and after the ePEP, after 12 weeks, and one year after baseline. Short-term effects were analysed in a randomised control trial and long-term effects of all ePEP participants (EG-I + EG-W = EG-all) in a quasi-experimental design. Results. Only functional gait significantly improved in EG-I compared to EG-W (p = 0.008, r = −0.67). Moderate to large effects were found in EG-all for walking ability. Not significant, however, relevant changes were detected for quality of life and fatigue. Self-efficacy showed no changes. Conclusion. The ePEP seems to be a feasible option to empower pwMS to a self-regulated and sustainable exercise training management shown in long-term walking improvements. PMID:28900546

Family Economic Empowerment and Mental Health Among AIDS-Affected Children Living in AIDS-Impacted Communities: Evidence from a Randomized Evaluation in Southwestern Uganda

PubMed Central

Han, Chang-Keun; Ssewamala, Fred M.; Wang, Julia Shu-Huah

2012-01-01

OBJECTIVE We examine whether an innovative family economic empowerment intervention addresses mental health functioning of AIDS-affected children in communities heavily impacted by HIV/AIDS in Uganda. METHODS A cluster randomized controlled trial (RCT) consisting of two study arms: a treatment condition (n=179) and a control condition (n=118) was used to examine the impact of the family economic empowerment intervention on children’s levels of hopelessness and depression. The intervention comprised of matched children savings accounts, financial management workshops, and mentorship. Data were collected at baseline and 12 months post-intervention. RESULTS Using multivariate analysis with several socio-economic controls, we find that children in the treatment condition (receiving the intervention) report significant improvement in their mental health functioning. Specifically, the intervention reduces hopelessness and depression levels. On the other hand, children in the control condition (not receiving the intervention) report no changes on both measures. CONCLUSIONS The findings indicate that children with poor mental health functioning living in communities affected by HIV/AIDS may benefit from innovative family economic empowerment interventions. As measures of mental health functioning, both hopelessness and depression have long-term negative psychosocial and developmental impacts on children. These findings have implications for public health programs intended for long-term care and support of children living in resource poor, AIDS-impacted communities. PMID:23410851

The effect of physical rehabilitation on activities of daily living in older residents of long-term care facilities: systematic review with meta-analysis.

PubMed

Crocker, Tom; Young, John; Forster, Anne; Brown, Lesley; Ozer, Seline; Greenwood, Darren C

2013-11-01

the worldwide population is ageing. One expected consequence of this is an increase in morbidity and an associated increased demand for long-term care. Physical rehabilitation is beneficial in older people, but relatively little is known about effects in residents of long-term care facilities. to examine the effects of physical rehabilitation on activities of daily living (ADL) in elderly residents of long-term care facilities. systematic review with meta-analysis of randomised controlled trials. We included studies that compared the effect of a physical rehabilitation intervention on independence in ADL with either no intervention or an alternative intervention in older people (over 60 years) living in long-term care facilities. We searched 19 databases including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, AMED, Web of Knowledge and Google Scholar. Two researchers independently screened papers and extracted data. Outcomes of included studies were combined in a standardised mean difference random-effects meta-analysis. thirteen of 14 studies identified were included in the meta-analysis. Independence in ADL was improved by 0.24 standard units (95% CI: 0.11-0.38; P = 0.0005). This is equivalent to 1.3 points on the Barthel Index (0-20 scale). No significant differences in effect were found based on participant or intervention characteristics. Larger sample size and low attrition were associated with smaller estimates of effect. All studies were assessed to be at risk of bias. physical rehabilitation may improve independence for elderly long-term care facility residents, but mean effects are small. It is unclear which interventions are most appropriate.

Review: long-term impact of bariatric surgery on body weight, comorbidities, and nutritional status.

PubMed

Shah, Meena; Simha, Vinaya; Garg, Abhimanyu

2006-11-01

The number of patients who undergo Roux-en-Y gastric bypass (RYGB) and gastric banding (GB) surgeries has increased dramatically over the past decade, yet the long-term impact of these surgeries on body weight, comorbidities, and nutritional status remains unclear, as do the mechanisms of weight regain. The articles were found via PubMed searches. To review the impact of bariatric surgery on weight maintenance and comorbidities, only articles with a postoperative follow-up of 3 yr or longer were included. The articles on nutritional status had a follow-up of 12 months or longer. RYGB and GB surgeries lead to substantial weight loss in individuals with morbid obesity. However, significant weight regain occurs over the long term, and according to the only well-designed prospective controlled study, the improvement in comorbidities associated with weight loss mitigates in the long term on weight regain. There is some evidence from a retrospective study that RYGB surgery is associated with a modest decrease in long-term mortality. These results remain to be substantiated by well-designed, long-term, randomized and prospective controlled studies. The mechanisms that lead to weight regain need to be further examined and may include increase in energy intake due to enlargement of stoma and adaptive changes in the levels of gut and adipocyte hormones such as ghrelin and leptin, which regulate energy intake; decrease in physical activity; changes in energy expenditure; and other factors. In addition to weight regain, RYGB surgery is associated with frequent incidence of iron, vitamin B12, folate, calcium, and vitamin D deficiency, which requires regular supplementation and monitoring.

Mental Illness Training for Licensed Staff in Long-Term Care

PubMed Central

Irvine, A. Blair; Billow, Molly B.; Eberhage, Mark G.; Seeley, John R.; McMahon, Edward; Bourgeois, Michelle

2013-01-01

Licensed care staff working in long-term care facilities may be poorly prepared to work with residents with mental illness. This research reports on the program evaluation of Caring Skills: Working with Mental Illness, a training program delivered on the Internet. It was tested with a randomized treatment-control design, with an eight-week follow-up. The training provided video-based behavioral skills and knowledge training. Measures included video situations testing and assessment of psycho-social constructs including empathy and stigmatization. ANCOVA analysis at 4-weeks posttest showed significant positive effects with medium-large effect sizes, which were largely maintained at the 8-week follow-up. The training was well-received by the users. PMID:22364430

Peri-apatite coating decreases uncemented tibial component migration: long-term RSA results of a randomized controlled trial and limitations of short-term results.

PubMed

Van Hamersveld, Koen T; Marang-Van De Mheen, Perla J; Nelissen, Rob G H H; Toksvig-Larsen, Sören

2018-05-09

Background and purpose - Biological fixation of uncemented knee prostheses can be improved by applying hydroxyapatite coating around the porous surface via a solution deposition technique called Peri-Apatite (PA). The 2-year results of a randomized controlled trial, evaluating the effect of PA, revealed several components with continuous migration in the second postoperative year, particularly in the uncoated group. To evaluate whether absence of early stabilization is diagnostic of loosening, we now present long-term follow-up results. Patients and methods - 60 patients were randomized to PA-coated or uncoated (porous only) total knee arthroplasty of which 58 were evaluated with radiostereometric analysis (RSA) performed at baseline, at 3 months postoperatively and at 1, 2, 5, 7, and 10 years. A linear mixed-effects model was used to analyze the repeated measurements. Results - PA-coated components had a statistically significantly lower mean migration at 10 years of 0.94 mm (95% CI 0.72-1.2) compared with the uncoated group showing a mean migration of 1.72 mm (95% CI 1.4-2.1). Continuous migration in the second postoperative year was seen in 7 uncoated components and in 1 PA-coated component. All of these implants stabilized after 2 years except for 2 uncoated components. Interpretation - Peri-apatite enhances stabilization of uncemented components. The number of components that stabilized after 2 years emphasizes the importance of longer follow-up to determine full stabilization and risk of loosening in uncemented components with biphasic migration profiles.

Long-Term Effects of Weight Loss and Exercise on Biomarkers Associated with Angiogenesis.

PubMed

Duggan, Catherine; Tapsoba, Jean de Dieu; Wang, Ching-Yun; Schubert, Karen E Foster; McTiernan, Anne

2017-12-01

Background: We tested the effect of weight loss on circulating levels of the angiogenic factors VEGF and pigment epithelium-derived factor (PEDF) in postmenopausal overweight/obese women, 18 months after completing a year-long 4-arm randomized controlled trial of behavioral weight loss and/or exercise versus control (i.e., 30 months postrandomization). Methods: The 439 overweight/obese, postmenopausal women, ages 50 to 75 years, were randomized to: diet (goal: 10% weight loss, N = 118), exercise (225 min/wk moderate-to-vigorous activity, N = 117), diet + exercise ( N = 117), or control ( N = 87). At 12 months, 399 women gave a blood sample; 156 returned at 30 months. Biomarkers were measured by immunoassay. Changes were compared using generalized estimating equations, adjusting for baseline BMI, age, and race/ethnicity. Results: Participants randomized to diet, exercise, and diet + exercise arms had greater reductions in VEGF at 30 months (-14.1% P = 0.02; -19.7% P = 0.003; -14.5% P = 0.002, respectively) versus controls (-4.5%). There were no statistically significant changes in PEDF in any intervention arm. Participants maintaining ≥10% of baseline weight loss at 30 months had greater reductions in VEGF versus those who gained weight/had no weight change (-22.3% vs. -10.2% respectively, P = 0.002). Participants maintaining any weight loss had significantly lower levels of PEDF at 30 months versus those who gained weight/no weight change. Conclusions: Sustained weight loss via diet and/or exercise results in reductions in angiogenic factors, and can be maintained up to 30-month follow-up. Limitations include relatively small numbers, and possible bias toward more successful weight loss among women who returned at 30 months. Impact: Maintaining weight loss can achieve long-term reductions in biomarkers of angiogenesis that can persist up to 18 months after completion of a weight loss intervention. Cancer Epidemiol Biomarkers Prev; 26(12); 1788-94. ©2017 AACR . ©2017 American Association for Cancer Research.

Effects of long-term exercise training on autonomic control in myocardial infarction patients.

PubMed

Martinez, Daniel G; Nicolau, José C; Lage, Rony L; Toschi-Dias, Edgar; de Matos, Luciana D N J; Alves, Maria Janieire N N; Trombetta, Ivani C; Dias da Silva, Valdo J; Middlekauff, Holly R; Negrão, Carlos E; Rondon, Maria U P B

2011-12-01

Autonomic dysfunction, including baroreceptor attenuation and sympathetic activation, has been reported in patients with myocardial infarction (MI) and has been associated with increased mortality. We tested the hypotheses that exercise training (ET) in post-MI patients would normalize arterial baroreflex sensitivity (BRS) and muscle sympathetic nerve activity (MSNA), and long-term ET would maintain the benefits in BRS and MSNA. Twenty-eight patients after 1 month of uncomplicated MI were randomly assigned to 2 groups, ET (MI-ET) and untrained. A normal control group was also studied. ET consisted of three 60-minute exercise sessions per week for 6 months. We evaluated MSNA (microneurography), blood pressure (automatic oscillometric method), heart rate (ECG), and spectral analysis of RR interval, systolic arterial pressure (SAP), and MSNA. Baroreflex gain of SAP-RR interval and SAP-MSNA were calculated using the α-index. At 3 to 5 days and 1 month after MI, MSNA and low-frequency SAP were significantly higher and BRS significantly lower in MI patients when compared with the normal control group. ET significantly decreased MSNA (bursts per 100 heartbeats) and the low-frequency component of SAP and significantly increased the low-frequency component of MSNA and BRS of the RR interval and MSNA. These changes were so marked that the differences between patients with MI and the normal control group were no longer observed after ET. MSNA and BRS in the MI-untrained group did not change from baseline over the same time period. ET normalizes BRS, low-frequency SAP, and MSNA in patients with MI. These improvements in autonomic control are maintained by long-term ET. These findings highlight the clinical importance of this nonpharmacological therapy based on ET in the long-term treatment of patients with MI.

A Randomized Controlled Trial of a Long-Term Professional Mentoring Program for Children at Risk: Outcomes Across the First 5 Years.

PubMed

Eddy, J Mark; Martinez, Charles R; Grossman, Jean Baldwin; Cearley, Jennifer J; Herrera, Danita; Wheeler, Alice C; Rempel, Jeff S; Foney, Dana; Gau, Jeff M; Burraston, Bert O; Harachi, Tracy W; Haggerty, Kevin P; Seeley, John R

2017-11-01

Child outcomes due to a paid professional mentoring program, Friends of the Children (FOTC), were investigated across the first 5 years of an ongoing multi-site randomized controlled trial. Participants were 278 children attending kindergarten or first grade who were identified as "at risk" for adjustment problems during adolescence. The program was delivered through established nonprofit community-based organizations. Mentors were hired to work full time and were provided training, supervision, and support to work individually with small numbers of children. Recruitment took place across a 3-year period. Random assignment to the intervention condition or a services as usual control condition was conducted at the level of the individual, blocking on school and child sex. After the initial assessment, follow-up assessments were conducted every 6 months. Differences in growth curves across the elementary school years were examined in intent-to-treat analyses. Significant effects favoring FOTC were found in terms of caregiver ratings of positive school behavior and less trouble in school, with a trend for higher child behavioral and emotional strengths. Effect sizes were in the range typical in recent trials of youth mentoring.

Follow-Up of the Cues and Care Trial: Mother and Infant Outcomes at 6 Months

ERIC Educational Resources Information Center

Feeley, Nancy; Zelkowitz, Phyllis; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

2012-01-01

The long-term effects of the Cues intervention to reduce anxiety and enhance the interactive behavior of mothers of very low birth weight (VLBW) infants were investigated. A randomized trial comparing the Cues intervention to an attention control condition was conducted. A total of 122 mothers of newborns weighing less than 1,500 g were…

Long-Term Effects of CBT on Social Impairment in Adolescents with ASD

ERIC Educational Resources Information Center

Maddox, Brenna B.; Miyazaki, Yasuo; White, Susan W.

2017-01-01

Anxiety interventions involving social skills training and CBT for youth with ASD have shown promise, but few studies have examined the effects on social functioning or the maintenance of treatment gains. This study evaluated change in social skills during a randomized controlled trial of CBT and during the 1-year follow-up for 25 adolescents with…

Transoral incisionless fundoplication: current status.

PubMed

Sami Trad, Karim

2016-07-01

Transoral incisionless fundoplication (TIF) performed with the EsophyX device (Redmond, Washington, USA) is a totally endoscopic procedure with the objectives to mechanically repair a defective gastroesophageal valve and to reduce small hiatal hernias. The recent publication of randomized controlled trials and long-term follow-up data offers the opportunity to reevaluate this treatment modality and its role in the management of patients with chronic gastroesophageal reflux disease (GERD). Randomized controlled trials have confirmed the ability of TIF to eliminate troublesome GERD symptoms, heal esophagitis, and improve distal esophageal acid exposure in appropriately selected patient populations. These studies establish TIF's superiority to conventional medical therapy, especially in clinical scenarios where proton-pump inhibitors fail to provide complete symptom relief across the spectrum of classic and atypical GERD manifestations, including regurgitation and laryngopharyngeal reflux. Long-term data indicate sustained positive outcomes and durability up to 6 years after procedure. These results were achieved with a low rate of serious adverse events and usually without introducing troublesome dysphagia, gas bloat, or flatulence. Based on the most recent data, TIF appears to be a valuable treatment alternative for the management of appropriately selected patients with moderate to severe chronic GERD symptoms.

Provision of mouth-care in long-term care facilities: an educational trial.

PubMed

MacEntee, M I; Wyatt, C C L; Beattie, B L; Paterson, B; Levy-Milne, R; McCandless, L; Kazanjian, A

2007-02-01

This randomized clinical trial aimed to assess the effectiveness of a pyramid-based education for improving the oral health of elders in long-term care (LTC) facilities. Fourteen facilities matched for size were assigned randomly to an active or control group. At baseline in each facility, care-aides in the active group participated with a full-time nurse educator in a seminar about oral health care, and had unlimited access to the educator for oral health-related advice throughout the 3-month trial. Care-aides in the control group participated in a similar seminar with a dental hygienist but they received no additional advice. The residents in the facilities at baseline and after 3 months were examined clinically to measure their oral hygiene, gingival health, masticatory potential, Body Mass Index and Malnutrition Indicator Score, and asked to report on chewing difficulties. Clinical measures after 3 months were not significantly different from baseline in either group, indicating that education neither influenced the oral health nor the dental hygiene of the residents. A pyramid-based educational scheme with nurses and care-aides did not improve the oral health of frail elders in this urban sample of LTC facilities.

EARLY CHILDHOOD INVESTMENTS SUBSTANTIALLY BOOST ADULT HEALTH

PubMed Central

Campbell, Frances; Conti, Gabriella; Heckman, James J.; Moon, Seong Hyeok; Pinto, Rodrigo; Pungello, Elizabeth; Pan, Yi

2014-01-01

High-quality early childhood programs have been shown to have substantial benefits in reducing crime, raising earnings, and promoting education. Much less is known about their benefits for adult health. We report the long-term health impacts of one of the oldest and most heavily cited early childhood interventions with long-term follow-up evaluated by the method of randomization: the Carolina Abecedarian Project (ABC). Using recently collected biomedical data, we find that disadvantaged children randomly assigned to treatment have significantly lower prevalence of risk factors for cardiovascular and metabolic diseases in their mid-30s. The evidence is especially strong for males. The mean systolic blood pressure among the control males is 143, while only 126 among the treated. One in four males in the control group is affected by metabolic syndrome, while none in the treatment group is. To reach these conclusions, we address several statistical challenges. We use exact permutation tests to account for small sample sizes and conduct a parallel bootstrap confidence interval analysis to confirm the permutation analysis. We adjust inference to account for the multiple hypotheses tested and for nonrandom attrition. Our evidence shows the potential of early life interventions for preventing disease and promoting health. PMID:24675955

A Pilot Randomized Controlled Trial on the Effects of a Progressive Exercise Program on the Range of Motion and Upper Extremity Grip Strength in Young Adults With Breast Cancer.

PubMed

Ibrahim, Marize; Muanza, Thierry; Smirnow, Nadia; Sateren, Warren; Fournier, Beatrice; Kavan, Petr; Palumbo, Michael; Dalfen, Richard; Dalzell, Mary-Ann

2018-02-01

The diagnosis of breast cancer in young women (aged 18-45 years) has been increasing. Women are commonly left coping with treatment-related disabilities of the upper limb that can persist for > 2 years postoperatively. A total of 59 young breast cancer patients (29 in the intervention group and 30 in the control group) participated in a pilot prospective randomized controlled trial to determine whether a 12-week postradiation exercise program would improve long-term arm mobility, pain, and handgrip strength. During an 18-month period, range of motion, handgrip strength, and pain with shoulder movements were evaluated at 6 points. Although the differences were not statistically significant, external rotation and horizontal abduction of the shoulder improved in the intervention group immediately after the exercise intervention (3 months) and showed a trend toward less pain on movement. However, at 18 months after radiation the control and intervention groups both retained a residual loss of range and persistent pain with movement. Radiation to the axilla and/or chest wall yielded long-term (18 months) limitations in flexion and horizontal abduction compared with hypofractionation, which resulted in greater flexion and external rotation at 18 months. The median grip strength of the study participants corresponded to the 10th percentile of healthy aged-matched white women. The exercise intervention timed shortly after radiation improved short-term shoulder mobility and pain; however, these gains were not sustained at 18 months after radiation. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of selenium on short-term control of hyperthyroidism due to Graves' disease treated with methimazole: results of a randomized clinical trial.

PubMed

Leo, M; Bartalena, L; Rotondo Dottore, G; Piantanida, E; Premoli, P; Ionni, I; Di Cera, M; Masiello, E; Sassi, L; Tanda, M L; Latrofa, F; Vitti, P; Marcocci, C; Marinò, M

2017-03-01

In spite of previous conflicting results, an adjuvant role of selenium in the treatment of Graves' disease (GD) hyperthyroidism has been proposed. To address this issue, a randomized clinical trial was carried out aimed at investigating whether selenium is beneficial on the short-term control of GD hyperthyroidism treated with methimazole (MMI). Thirty newly diagnosed hyperthyroid GD patients were randomly assigned to treatment with: (i) MMI or (ii) MMI plus selenium. Primary outcomes were: control of hyperthyroidism and clinical and biochemical manifestations of hyperthyroidism [heart rate, cholesterol, sex hormone-binding globulin (SHBG), hyperthyroidism symptoms] at 90 days. Baseline features of the two groups did not differ. Serum selenium at baseline was similar in the two groups and within the recommended range to define selenium sufficiency. Selenium increased with treatment in the MMI-selenium group and became significantly higher than in the MMI group. Serum malondialdehyde, a marker of oxidative stress, was similar in the two groups and decreased significantly with treatment, with no difference between groups. Administration of MMI was followed by a reduction of FT 3 and FT 4 , with no difference between groups. Heart rate, SHBG and symptoms of hyperthyroidism decreased, whereas total cholesterol increased in both groups with no difference between groups. Our study, carried out in a selenium-sufficient cohort of GD patients, failed to show an adjuvant role of selenium in the short-term control of hyperthyroidism. However, selenium might be beneficial in patients from selenium-deficient areas, as well as in the long-term outcome of antithyroid treatment.

Effect of Frequent or Extended Hemodialysis on Cardiovascular Parameters: A Meta-analysis

PubMed Central

Susantitaphong, Paweena; Koulouridis, Ioannis; Balk, Ethan M.; Madias, Nicolaos E.; Jaber, Bertrand L.

2012-01-01

Background Increased left ventricular (LV) mass is a risk factor for cardiovascular mortality in patients with chronic kidney failure. More frequent or extended hemodialysis (HD) has been hypothesized to have a beneficial effect on LV mass. Study Design Meta-analysis. Setting & Population MEDLINE literature search (inception-April 2011), Cochrane Central Register of Controlled Trials and ClinicalTrials.gov using the search terms “short daily HD”, “daily HD”, “quotidian HD”, “frequent HD”, “intensive HD”, “nocturnal HD”, and “home HD”. Selection Criteria for Studies Single-arm cohort studies (with pre- and post-study evaluations) and randomized controlled trials examining the effect of frequent or extended HD on cardiac morphology and function, and blood pressure parameters. Studies of hemofiltration, hemodiafiltration and peritoneal dialysis were excluded. Intervention Frequent (2–8 hours,> thrice weekly) or extended (>4 hours, thrice weekly) HD as compared with conventional (≤ 4 hours, thrice weekly) HD. Outcomes Absolute changes in cardiac morphology and function, including LV mass index (LVMI) (primary), and blood pressure parameters (secondary). Results We identified 38 single-arm studies, 5 crossover trials and 3 randomized controlled trials. By meta-analysis of 23 study arms, frequent or extended HD significantly reduced LVMI from baseline (−31.2 g/m2, 95% CI, −39.8 to −22.5; P<0.001).The 3 randomized trials found a less pronounced net reduction in LVMI (−7.0 g/m2; 95% CI, −10.2 to −3.7; P<0.001). LV ejection fraction improved by 6.7% (95% CI, 1.6 to 11.9; P=0.01). Other cardiac morphological parameters displayed similar improvements. There were also significant decreases in systolic, diastolic, and mean blood pressure, and mean number of anti-hypertensive medications. Limitations Paucity of randomized controlled trials. Conclusions Conversion from conventional to frequent or extended HD is associated with an improvement in cardiac morphology and function, including LVMI and LV ejection fraction, respectively, and in several blood pressure parameters, which collectively might confer long-term cardiovascular benefit. Trials with long-term clinical outcomes are needed. PMID:22370022

Health effects of cow's milk consumption in infants up to 3 years of age: a systematic review and meta-analysis.

PubMed

Griebler, Ursula; Bruckmüller, Melanie U; Kien, Christina; Dieminger, Birgit; Meidlinger, Bettina; Seper, Katrin; Hitthaller, Ariane; Emprechtinger, Robert; Wolf, Alexandra; Gartlehner, Gerald

2016-02-01

To summarize the best available evidence regarding the short- and long-term health effects of cow's milk intake in healthy, full-term infants up to 3 years of age. We conducted a systematic review and meta-analysis. We searched MEDLINE (via PubMed), EMBASE and the Cochrane Library between 1960 and July 2013 and manually reviewed reference lists of pertinent articles. Two researchers independently reviewed abstracts and full-text articles and extracted relevant data. We included (randomized/non-randomized) controlled trials and observational studies. We included data from twenty-three studies (one randomized controlled trial, four non-randomized controlled trials, eight case-control studies and ten cohort studies) for the evidence synthesis. Pooled results of four studies revealed a higher risk of Fe-deficiency anaemia for infants consuming cow's milk compared with those consuming follow-on formula (relative risk=3·76; 95 % CI 2·73, 5·19). For type 1 diabetes mellitus, six out of seven case-control studies did not show a difference in the risk of developing this disease based on the age of introduction of cow's milk. We did not find negative associations for other health effects. Cow's milk consumption in infancy is associated with an increased risk of developing Fe-deficiency anaemia. Limiting cow's milk consumption may be important to ensure an adequate Fe intake for infants and toddlers. High-quality patient information for caregivers is needed on how infants' Fe requirements can be met.

Psychotherapy for bulimia nervosa on symptoms of depression: A meta-analysis of randomized controlled trials.

PubMed

Linardon, Jake; Wade, Tracey; de la Piedad Garcia, Xochitl; Brennan, Leah

2017-10-01

Depressive symptoms are an important risk factor and consequence of binge eating and purging behavior in bulimia nervosa (BN). Although psychotherapy is effective in reducing symptoms of BN in the short- and long-term, it is unclear whether psychotherapy for BN is also effective in reducing depressive symptoms. This meta-analysis examined the efficacy of psychotherapy for BN on depressive symptoms in the short- and long-term. Randomized controlled trials (RCTs) on BN that assessed depressive symptoms as an outcome were identified. Twenty-six RCTs were included. Psychotherapy was more efficacious at reducing symptoms of depression at post-treatment (g = 0.47) than wait-lists. This effect was strongest when studies delivered therapist-led, rather than guided self-help, treatment. No significant differences were observed between psychotherapy and antidepressants. There was no significant post-treatment difference between CBT and other active psychological comparisons at reducing symptoms of depression. However, when only therapist-led CBT was analyzed, therapist-led CBT was significantly more efficacious (g = 0.25) than active comparisons at reducing depressive symptoms. The magnitude of the improvement in depressive symptoms was predicted by the magnitude of the improvement in BN symptoms. These findings suggest that psychotherapy is effective for reducing depressive symptoms in BN in the short-term. Whether these effects are sustained in the long-term is yet to be determined, as too few studies conducted follow-up assessments. Moreover, findings demonstrate that, in addition to being the front-running treatment for BN symptoms, CBT might also be the most effective psychotherapy for improving the symptoms of depression that commonly co-occur in BN. © 2017 Wiley Periodicals, Inc.

Mid- and Long-Term Efficacy of Non-Invasive Ventilation in Obesity Hypoventilation Syndrome: The Pickwick's Study.

PubMed

López-Jiménez, María José; Masa, Juan F; Corral, Jaime; Terán, Joaquín; Ordaz, Estrella; Troncoso, Maria F; González-Mangado, Nicolás; González, Mónica; Lopez-Martínez, Soledad; De Lucas, Pilar; Marín, José M; Martí, Sergi; Díaz-Cambriles, Trinidad; Díaz-de-Atauri, Josefa; Chiner, Eusebi; Aizpuru, Felipe; Egea, Carlos; Romero, Auxiliadora; Benítez, José M; Sánchez-Gómez, Jesús; Golpe, Rafael; Santiago-Recuerda, Ana; Gómez, Silvia; Barbe, Ferrán; Bengoa, Mónica

2016-03-01

The Pickwick project was a prospective, randomized and controlled study, which addressed the issue of obesity hypoventilation syndrome (OHS), a growing problem in developed countries. OHS patients were divided according to apnea-hypopnea index (AHI) ≥30 and <30 determined by polysomnography. The group with AHI≥30 was randomized to intervention with lifestyle changes, noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP); the group with AHI<30 received NIV or lifestyle changes. The aim of the study was to evaluate the efficacy of NIV treatment, CPAP and lifestyle changes (control) in the medium and long-term management of patients with OHS. The primary variables were PaCO2 and days of hospitalization, and operating variables were the percentage of dropouts for medical reasons and mortality. Secondary medium-term objectives were: (i)to evaluate clinical-functional effectiveness on quality of life, echocardiographic and polysomnographic variables; (ii)to investigate the importance of apneic events and leptin in the pathogenesis of daytime alveolar hypoventilation and change according to the different treatments; (ii)to investigate whether metabolic, biochemical and vascular endothelial dysfunction disorders depend on the presence of apneas and hypopneasm and (iv)changes in inflammatory markers and endothelial damage according to treatment. Secondary long-term objectives were to evaluate: (i)clinical and functional effectiveness and quality of life with NIV and CPAP; (ii)changes in leptin, inflammatory markers and endothelial damage according to treatment; (iii)changes in pulmonary hypertension and other echocardiographic variables, as well as blood pressure and incidence of cardiovascular events, and (iv)dropout rate and mortality. Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.

The implementation of a community-based aerobic walking program for mild to moderate knee osteoarthritis (OA): a knowledge translation (KT) randomized controlled trial (RCT): Part I: The Uptake of the Ottawa Panel clinical practice guidelines (CPGs)

PubMed Central

2012-01-01

Background The implementation of evidence based clinical practice guidelines on self-management interventions to patients with chronic diseases is a complex process. A multifaceted strategy may offer an effective knowledge translation (KT) intervention to promote knowledge uptake and improve adherence in an effective walking program based on the Ottawa Panel Evidence Based Clinical Practice Guidelines among individuals with moderate osteoarthritis (OA). Methods A single-blind, randomized control trial was conducted. Patients with mild to moderate (OA) of the knee (n=222) were randomized to one of three KT 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 for OA; 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 Short-term program adherence was greater in WB compared to C (p<0.012) after 3 months. No statistical significance (p> 0.05) was observed for long-term adherence (6 to 12 months), and total adherence between the three groups. The three knowledge translation strategies demonstrated equivalent long-term results for the implementation of a walking program for older individuals with moderate OA. Lower dropout rates as well as higher retention rates were observed for WB at 12 and 18 months. Conclusion The additional knowledge translation behavioural component facilitated the implementation of clinical practice guidelines on walking over a short-term period. More studies are needed to improve the long-term walking adherence or longer guidelines uptake on walking among participants with OA. Particular attention should be taken into account related to patient’s characteristic and preference. OA can be managed through the implementation of a walking program based on clinical practice guidelines in existing community-based walking clubs as well as at home with the minimal support of an exercise therapist or a trained volunteer. Trial Registration Current Controlled Trials IRSCTNO9193542 PMID:23061875

Angiotensin-converting enzyme inhibitors in patients with coronary artery disease and absence of heart failure or left ventricular systolic dysfunction: an overview of long-term randomized controlled trials.

PubMed

Danchin, Nicolas; Cucherat, Michel; Thuillez, Christian; Durand, Eric; Kadri, Zena; Steg, Philippe G

2006-04-10

Results of randomized trials of angiotensin-converting enzyme inhibitors in patients with coronary artery disease (CAD) and preserved left ventricular function are conflicting. We undertook this study to determine whether long-term prescription of angiotensin-converting enzyme inhibitors decreases major cardiovascular events and mortality in patients who have CAD and no evidence of left ventricular systolic dysfunction. We searched MEDLINE, EMBASE, and IPA databases, the Cochrane Controlled Trials Register (1990-2004), and reports from scientific meetings (2003-2004), and we reviewed secondary sources. Search terms included angiotensin-converting enzyme inhibitors, coronary artery disease, randomi(s)zed controlled trials, clinical trials, and myocardial infarction. Eligible studies included randomized controlled trials in patients who had CAD and no heart failure or left ventricular dysfunction, with follow-up omicronf 2 years or longer. Of 1146 publications screened, 7 met our selection criteria and included a total of 33 960 patients followed up for a mean of 4.4 years. Five trials included only patients with documented CAD. One trial included patients with documented CAD (80%) or patients who had diabetes mellitus and 1 or more additional risk factors, and another trial included patients who had CAD, a history of transient ischemic attack, or intermittent claudication. Treatment with angiotensin-converting enzyme inhibitors decreased overall mortality (odds ratio, 0.86; 95% confidence interval, 0.79-0.93), cardiovascular mortality (odds ratio, 0.81; 95% confidence interval, 0.73-0.90), myocardial infarction (odds ratio, 0.82; 95% confidence interval, 0.75-0.89), and stroke (odds ratio, 0.77; 95% confidence interval, 0.66-0.88). Other end points, including resuscitation after cardiac arrest, myocardial revascularization, and hospitalization because of heart failure, were also reduced. Angiotensin-converting enzyme inhibitors reduce total mortality and major cardiovascular end points in patients who have CAD and no left ventricular systolic dysfunction or heart failure.

A randomized, controlled clinical trial of standard, group and brief cognitive-behavioral therapy for panic disorder with agoraphobia: a two-year follow-up.

PubMed

Marchand, André; Roberge, Pasquale; Primiano, Sandra; Germain, Vanessa

2009-12-01

A randomized controlled clinical trial with a wait-list control group was conducted to examine the effectiveness of three modalities (brief, group, and standard) of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants meeting DSM-IV criteria were randomly assigned to each treatment condition: a 14-session standard CBT (n=33), a 14-session group CBT (n=35) and a 7-session brief CBT (n=32). Participants received a self-study manual and were assigned weekly readings and exercises. The results indicate that regardless of the treatment condition, CBT for moderate to severe PDA is beneficial in medium and long term. To this effect, all three-treatment conditions significantly reduced the intensity of symptoms, increased participants' quality of life, offered high effect sizes, superior maintenance of gains over time, and lower rates of relapse, compared to the wait-list control.

Strategies to retain participants in a long-term HIV prevention randomized controlled trial: Lessons from the MINTS-II study

PubMed Central

Horvath, Keith J.; Nygaard, Kate; Danilenko, Gene P.; Goknur, Sinan; Oakes, J. Michael; Rosser, B.R. Simon

2012-01-01

Achieving satisfactory retention in online HIV prevention trials typically have proved difficult, particularly over extended timeframes. The overall aim of this study was to assess factors associated with retention in the Men’s INTernet Study II (MINTS-II), a randomized controlled trial of a sexual risk reduction intervention for men who have sex with men. Participants were recruited via e-mails and banner advertisements in December, 2007 to participate in the MINTS-II Sexpulse intervention and followed over a 12-month period. Retention across the treatment and control arms was 85.2% at 12 months. Factors associated with higher retention included: randomization to the control arm, previous participation in a study by the research team, e-mail and telephone reminders to complete a survey once it was available to take, and fewer e-mail contacts between surveys. The results provide evidence that achieving satisfactory retention is possible in online HIV prevention trials, and suggest best practices for maximizing retention. PMID:21538084

The effect of positive and negative message framing on short term continuous positive airway pressure compliance in patients with obstructive sleep apnea

PubMed Central

Czaban, Marcin; Berry, Marc P.; Nirmalan, Prajeshan; Brown, Richard; Birdseye, Adam; Woroszyl, Asia; Chapman, Julia; Kent, Brian D.; Hart, Nicholas; Rossi, Gian Paolo; Steier, Joerg

2018-01-01

Background Continuous positive airway pressure (CPAP), the best available treatment for obstructive sleep apnea (OSA), requires long-term compliance to be effective. Behavioral interventions may be used to improve adherence to CPAP. We aimed to investigate whether positive or negative message framing impacts on CPAP compliance in patients with OSA, when compared to standard care. Methods Consenting patients with confirmed OSA were randomly allocated to receive along with their CPAP either positively or negatively framed messages (Pos; Neg), or standard care (Con). Standardized motivational messages were read out to patients during an initial teaching session and through weekly telephone calls. Patients’ compliance data were reviewed 2 and 6 weeks following CPAP initiation. Results We randomized 112 patients to groups that were matched for age, BMI, and OSA severity. The positively framed group (Pos) showed greater CPAP usage after 2 weeks (total use 53.7±31.4 hours) as compared to the negatively framed and the control group (35.6±27.4 and 40.8±33.5 hours, P<0.05); however, no differences were seen at 6 weeks. There were more dropouts in the control group than in either framed groups (Pos n=5; Neg n=8; Con n=11; P<0.05). Conclusions Positively framed messages can improve CPAP adherence in patients with OSA in the short-term; however, strategies for implementing its long-term use need to be developed. PMID:29445540

The effect of positive and negative message framing on short term continuous positive airway pressure compliance in patients with obstructive sleep apnea.

PubMed

Pengo, Martino F; Czaban, Marcin; Berry, Marc P; Nirmalan, Prajeshan; Brown, Richard; Birdseye, Adam; Woroszyl, Asia; Chapman, Julia; Kent, Brian D; Hart, Nicholas; Rossi, Gian Paolo; Steier, Joerg

2018-01-01

Continuous positive airway pressure (CPAP), the best available treatment for obstructive sleep apnea (OSA), requires long-term compliance to be effective. Behavioral interventions may be used to improve adherence to CPAP. We aimed to investigate whether positive or negative message framing impacts on CPAP compliance in patients with OSA, when compared to standard care. Consenting patients with confirmed OSA were randomly allocated to receive along with their CPAP either positively or negatively framed messages (Pos; Neg), or standard care (Con). Standardized motivational messages were read out to patients during an initial teaching session and through weekly telephone calls. Patients' compliance data were reviewed 2 and 6 weeks following CPAP initiation. We randomized 112 patients to groups that were matched for age, BMI, and OSA severity. The positively framed group (Pos) showed greater CPAP usage after 2 weeks (total use 53.7±31.4 hours) as compared to the negatively framed and the control group (35.6±27.4 and 40.8±33.5 hours, P<0.05); however, no differences were seen at 6 weeks. There were more dropouts in the control group than in either framed groups (Pos n=5; Neg n=8; Con n=11; P<0.05). Positively framed messages can improve CPAP adherence in patients with OSA in the short-term; however, strategies for implementing its long-term use need to be developed.

Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial.

PubMed

Morey, Miriam C; Snyder, Denise C; Sloane, Richard; Cohen, Harvey Jay; Peterson, Bercedis; Hartman, Terryl J; Miller, Paige; Mitchell, Diane C; Demark-Wahnefried, Wendy

2009-05-13

Five-year survival rates for early stage colorectal, breast, and prostate cancer currently exceed 90% and are increasing. Cancer survivors are at greater risk for second malignancies, other comorbidities, and accelerated functional decline. Lifestyle interventions may provide benefit, but it is unknown whether long-term cancer survivors can modify their lifestyle behaviors sufficiently to improve functional status. To determine whether a telephone counseling and mailed print material-based diet and exercise intervention is effective in reorienting functional decline in older, overweight cancer survivors. Randomized controlled trial of 641 overweight (body mass index > or = 25 and < 40), long-term (> or = 5 years) survivors (aged 65-91 years) of colorectal, breast, and prostate cancer, who were randomly assigned to an intervention group (n = 319) or delayed intervention (control) group (n = 322) in Canada, the United Kingdom, and 21 US states. Individuals were recruited for the Reach out to Enhance Wellness (RENEW) trial from July 1, 2005, through May 17, 2007. A 12-month, home-based tailored program of telephone counseling and mailed materials promoting exercise, improved diet quality, and modest weight loss. The control group was wait-listed for 12 months. Change in self-reported physical function on the Short-Form 36 physical function subscale (score range, 0-100; a high score indicates better functioning) from baseline to 12 months was the primary end point. Secondary outcomes included changes in function on the basic and advanced lower extremity function subscales of the Late Life Function and Disability Index (score range, 0-100), physical activity, body mass index, and overall health-related quality of life. The mean baseline Short-Form 36 physical function score was 75.7. At the 12-month follow-up, the mean function scores declined less rapidly in the intervention group (-2.15; 95% confidence interval [CI], -0.36 to -3.93) compared with the control group (-4.84; 95% CI, -3.04 to -6.63) (P = .03). The mean baseline basic lower extremity function score was 78.2. The mean changes in basic lower extremity function were 0.34 (95% CI, -0.84 to 1.52) in the intervention group compared with -1.89 (95% CI, -0.70 to -3.09) in the control group (P = .005). Physical activity, dietary behaviors, and overall quality of life increased significantly in the intervention group compared with the control group, and weight loss also was greater (2.06 kg [95% CI, 1.69 to 2.43 kg] vs 0.92 kg [95% CI, 0.51 to 1.33 kg], respectively; P < .001). Among older, long-term survivors of colorectal, breast, and prostate cancer, a diet and exercise intervention reduced the rate of self-reported functional decline compared with no intervention. clinicaltrials.gov Identifier: NCT00303875.

Long-Term Pioglitazone Treatment for Patients With Nonalcoholic Steatohepatitis and Prediabetes or Type 2 Diabetes Mellitus: A Randomized Trial.

PubMed

Cusi, Kenneth; Orsak, Beverly; Bril, Fernando; Lomonaco, Romina; Hecht, Joan; Ortiz-Lopez, Carolina; Tio, Fermin; Hardies, Jean; Darland, Celia; Musi, Nicolas; Webb, Amy; Portillo-Sanchez, Paola

2016-09-06

The metabolic defects of nonalcoholic steatohepatitis (NASH) and prediabetes or type 2 diabetes mellitus (T2DM) seem to be specifically targeted by pioglitazone. However, information about its long-term use in this population is limited. To determine the efficacy and safety of long-term pioglitazone treatment in patients with NASH and prediabetes or T2DM. Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT00994682). University hospital. Patients (n = 101) with prediabetes or T2DM and biopsy-proven NASH were recruited from the general population and outpatient clinics. All patients were prescribed a hypocaloric diet (500-kcal/d deficit from weight-maintaining caloric intake) and then randomly assigned to pioglitazone, 45 mg/d, or placebo for 18 months, followed by an 18-month open-label phase with pioglitazone treatment. The primary outcome was a reduction of at least 2 points in the nonalcoholic fatty liver disease activity score in 2 histologic categories without worsening of fibrosis. Secondary outcomes included other histologic outcomes, hepatic triglyceride content measured by magnetic resonance and proton spectroscopy, and metabolic parameters. Among patients randomly assigned to pioglitazone, 58% achieved the primary outcome (treatment difference, 41 percentage points [95% CI, 23 to 59 percentage points]) and 51% had resolution of NASH (treatment difference, 32 percentage points [CI, 13 to 51 percentage points]) (P < 0.001 for each). Pioglitazone treatment also was associated with improvement in individual histologic scores, including the fibrosis score (treatment difference, -0.5 [CI, -0.9 to 0.0]; P = 0.039); reduced hepatic triglyceride content from 19% to 7% (treatment difference, -7 percentage points [CI, -10 to -4 percentage points]; P < 0.001); and improved adipose tissue, hepatic, and muscle insulin sensitivity (P < 0.001 vs. placebo for all). All 18-month metabolic and histologic improvements persisted over 36 months of therapy. The overall rate of adverse events did not differ between groups, although weight gain was greater with pioglitazone (2.5 kg vs. placebo). Single-center study. Long-term pioglitazone treatment is safe and effective in patients with prediabetes or T2DM and NASH. Burroughs Wellcome Fund and American Diabetes Association.

Long-term strength and damage accumulation in laminates

NASA Astrophysics Data System (ADS)

Dzenis, Yuris A.; Joshi, Shiv P.

1993-04-01

A modified version of the probabilistic model developed by authors for damage evolution analysis of laminates subjected to random loading is utilized to predict long-term strength of laminates. The model assumes that each ply in a laminate consists of a large number of mesovolumes. Probabilistic variation functions for mesovolumes stiffnesses as well as strengths are used in the analysis. Stochastic strains are calculated using the lamination theory and random function theory. Deterioration of ply stiffnesses is calculated on the basis of the probabilities of mesovolumes failures using the theory of excursions of random process beyond the limits. Long-term strength and damage accumulation in a Kevlar/epoxy laminate under tension and complex in-plane loading are investigated. Effects of the mean level and stochastic deviation of loading on damage evolution and time-to-failure of laminate are discussed. Long-term cumulative damage at the time of the final failure at low loading levels is more than at high loading levels. The effect of the deviation in loading is more pronounced at lower mean loading levels.

Factors Affecting Long-Term Abstinence from Substances Use

ERIC Educational Resources Information Center

Elsheikh, Salah Elgaily

2008-01-01

Objective: The purpose of this study is to explore the attitudes of abstainers from drug use that relate to the factors leading to long-term abstinence. Materials and Methods: Cross-sectional study was carried out in Al-Amal Hospital to examine, which attitudes of abstainers related to long-term abstinence. A random survey was conducted on 62…

Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial

PubMed Central

Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie

2017-01-01

Background Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. Objective This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. Methods We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. Results We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly measured peak oxygen consumption. Secondary clinical outcomes include health-related quality of life and anthropometric measures. All outcome measures are administered at baseline, after exercise program (month 3), and 6 months after program (month 9). Conclusions This pilot RCT will inform full-scale RCT planning. We will assess pilot procedures and interventions and collect preliminary effect estimates. Trial Registration ClinicalTrials.gov NCT02620735; https://clinicaltrials.gov/ct2/show/NCT02620735 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02620735) PMID:28838886

Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial.

PubMed

Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie; Jones, Jennifer Michelle

2017-08-24

Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly measured peak oxygen consumption. Secondary clinical outcomes include health-related quality of life and anthropometric measures. All outcome measures are administered at baseline, after exercise program (month 3), and 6 months after program (month 9). This pilot RCT will inform full-scale RCT planning. We will assess pilot procedures and interventions and collect preliminary effect estimates. ClinicalTrials.gov NCT02620735; https://clinicaltrials.gov/ct2/show/NCT02620735 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02620735). ©Paul Ritvo, Maya Obadia, Daniel Santa Mina, Shabbir Alibhai, Catherine Sabiston, Paul Oh, Kristin Campbell, David McCready, Leslie Auger, Jennifer Michelle Jones. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.08.2017.

Long-term mobile phone use and brain tumor risk.

PubMed

Lönn, Stefan; Ahlbom, Anders; Hall, Per; Feychting, Maria

2005-03-15

Handheld mobile phones were introduced in Sweden during the late 1980s. The purpose of this population-based, case-control study was to test the hypothesis that long-term mobile phone use increases the risk of brain tumors. The authors identified all cases aged 20-69 years who were diagnosed with glioma or meningioma during 2000-2002 in certain parts of Sweden. Randomly selected controls were stratified on age, gender, and residential area. Detailed information about mobile phone use was collected from 371 (74%) glioma and 273 (85%) meningioma cases and 674 (71%) controls. For regular mobile phone use, the odds ratio was 0.8 (95% confidence interval: 0.6, 1.0) for glioma and 0.7 (95% confidence interval: 0.5, 0.9) for meningioma. Similar results were found for more than 10 years' duration of mobile phone use. No risk increase was found for ipsilateral phone use for tumors located in the temporal and parietal lobes. Furthermore, the odds ratio did not increase, regardless of tumor histology, type of phone, and amount of use. This study includes a large number of long-term mobile phone users, and the authors conclude that the data do not support the hypothesis that mobile phone use is related to an increased risk of glioma or meningioma.

Cost-Effectiveness of Cranberry Capsules to Prevent Urinary Tract Infection in Long-Term Care Facilities: Economic Evaluation with a Randomized Controlled Trial

PubMed Central

van den Hout, Wilbert B; Caljouw, Monique A A; Putter, Hein; Cools, Herman J M; Gussekloo, Jacobijn

2014-01-01

Objectives To investigate whether the preventive use of cranberry capsules in long-term care facility (LTCF) residents is cost-effective depending on urinary tract infection (UTI) risk. Design Economic evaluation with a randomized controlled trial. Setting Long-term care facilities. Participants LTCF residents (N = 928, 703 female, median age 84), stratified according to UTI risk. Measurements UTI incidence (clinically or strictly defined), survival, quality of life, quality-adjusted life years (QALYs), and costs. Results In the weeks after a clinical UTI, participants showed a significant but moderate deterioration in quality of life, survival, care dependency, and costs. In high-UTI-risk participants, cranberry costs were estimated at €439 per year (1.00 euro = 1.37 U.S. dollar), which is €3,800 per prevented clinically defined UTI (95% confidence interval = €1,300–infinity). Using the strict UTI definition, the use of cranberry increased costs without preventing UTIs. Taking cranberry capsules had a 22% probability of being cost-effective compared with placebo (at a willingness to pay of €40,000 per QALY). In low-UTI-risk participants, use of cranberry capsules was only 3% likely to be cost-effective. Conclusion In high-UTI-risk residents, taking cranberry capsules may be effective in preventing UTIs but is not likely to be cost-effective in the investigated dosage, frequency, and setting. In low-UTI-risk LTCF residents, taking cranberry capsules twice daily is neither effective nor cost-effective. PMID:25180379

The long-term effect of a zinc acetate and chlorhexidine diacetate containing mouth rinse on intra-oral halitosis-A randomized clinical trial.

PubMed

Erovic Ademovski, Seida; Mårtensson, Carina; Persson, Gösta Rutger; Renvert, Stefan

2017-10-01

To evaluate the long-term effects of a zinc acetate and chlorhexidine diacetate mouth rinse (Zn/CHX) on intra-oral halitosis. Forty-six adults with intra-oral halitosis were randomized into a 6-month, double-blind, placebo-controlled clinical study. The presence of intra-oral halitosis was evaluated at baseline, 3 and 6 months after treatment by assessment of organoleptic score (OLS) and by total volatile sulphur compounds (T-VSC), hydrogen sulphide (H 2 S) and methyl mercaptan (MM) concentrations in exhaled air. A Zn/CHX mouth rinse provided significantly better control of intra-oral halitosis than a placebo mouth rinse. At 3 and 6 months, individuals rinsing with the Zn/CHX rinse presented with reductions of the OLS, T-VSC (p < .01, respectively), H 2 S (p < .001), and MM (p < .01) in subjects' exhaled air. At 6 months, 68.2% of individuals using the Zn/CHX rinse experienced a 1 or 2 category improvement in OLS compared with 19.1% of placebo-treated subjects. 91% of subjects in the Zn/CHX group were categorized as being effectively treated for intra-oral halitosis (i.e. H 2 S < 112 ppb), compared to 43% in the placebo group. Zn/CHX mouth rinse provides effective long-term efficacy against intra-oral halitosis, assessed both objectively and subjectively. With regular rinsing, the effect was sustained for 6 months. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effectiveness of balneotherapy and spa therapy for the treatment of chronic low back pain: a review on latest evidence.

PubMed

Karagülle, Mine; Karagülle, Müfit Zeki

2015-02-01

In most European countries, balneotherapy and spa therapy are widely prescribed by physicians and preferred by European citizens for the treatment of musculoskeletal problems including chronic low back pain (LBP). We aimed to review and evaluate the recent evidence on the effectiveness of balneotherapy and spa therapy for patients with LBP. We comprehensively searched data bases for randomized controlled trials (RCTs) published in English between July 2005 and December 2013. We identified all trials testing balneotherapy or spa therapy for LBP that reported that the sequence of allocation was randomized. We finally included total of eight RCTs: two on balneotherapy and six on spa therapy. All reviewed trials reported that balneotherapy was superior in long term to tap water therapy in relieving pain and improving function and that spa therapy combining balneotherapy with mud pack therapy and/or exercise therapy, physiotherapy, and/or education was effective in the management of low back pain and superior or equally effective to the control treatments in short and long terms. We used Jadad scale to grade the methodological quality. Only three out of total eight had a score of above 3 indicating the good quality. The data from the RCTs indicates that overall evidence on effectiveness of balneotherapy and spa therapy in LBP is encouraging and reflects the consistency of previous evidence. However, the overall quality of trials is generally low. Better quality RCTs (well designed, conducted, and reported) are needed testing short- and long-term effects for relieving chronic back pain and proving broader beneficial effects.

Physiotherapy and physical functioning post-stroke: exercise habits and functioning 4 years later? Long-term follow-up after a 1-year long-term intervention period: a randomized controlled trial.

PubMed

Langhammer, Birgitta; Lindmark, Birgitta; Stanghelle, Johan K

2014-01-01

Physical activity is mandatory if patients are to remain healthy and independent after stroke. Maintenance of motor function, tone, grip strength, balance, mobility, gait, independence in personal and instrumental activities of daily living, health-related quality-of-life and an active lifestyle 4 years post-stroke. A prospective randomized controlled trial. Four years post-stroke, 37 of the 75 participating persons were eligible for follow-up; 19 (54.3%) from the intensive exercise group and 18 (45%) from the regular exercise group. Both groups were performing equally well with no significant differences in total scores on the BI (p = 0.3), MAS (p = 0.4), BBS (p = 0.1), TUG (p = 0.08), 6MWT (p = 0.1), bilateral grip strength (affected hand, p = 0.8; non-affected hand, p = 0.9) nor in the items of NHP (p > 0.005). Independence in performing the IADL was 40%, while 60% had help from relatives or community-based services. This longitudinal study shows that persons with stroke in two groups with different exercise regimes during the first year after stroke did not differ in long-term outcomes. Both groups maintained function and had a relatively active life style 4 years after the acute incident. The results underline the importance of follow-up testing and encouragement to exercise, to motivate and sustain physical activity patterns, to maintain physical function, not only in the acute but also in the chronic phase of stroke.

Effects of dietary fibre on subjective appetite, energy intake and body weight: a systematic review of randomized controlled trials.

PubMed

Wanders, A J; van den Borne, J J G C; de Graaf, C; Hulshof, T; Jonathan, M C; Kristensen, M; Mars, M; Schols, H A; Feskens, E J M

2011-09-01

Dietary fibres are believed to reduce subjective appetite, energy intake and body weight. However, different types of dietary fibre may affect these outcomes differently. The aim of this review was to systematically investigate the available literature on the relationship between dietary fibre types, appetite, acute and long-term energy intake, and body weight. Fibres were grouped according to chemical structure and physicochemical properties (viscosity, solubility and fermentability). Effect rates were calculated as the proportion of all fibre-control comparisons that reduced appetite (n = 58 comparisons), acute energy intake (n = 26), long-term energy intake (n = 38) or body weight (n = 66). For appetite, acute energy intake, long-term energy intake and body weight, there were clear differences in effect rates depending on chemical structure. Interestingly, fibres characterized as being more viscous (e.g. pectins, β-glucans and guar gum) reduced appetite more often than those less viscous fibres (59% vs. 14%), which also applied to acute energy intake (69% vs. 30%). Overall, effects on energy intake and body weight were relatively small, and distinct dose-response relationships were not observed. Short- and long-term effects of dietary fibres appear to differ and multiple mechanisms relating to their different physicochemical properties seem to interplay. This warrants further exploration. © 2011 The Authors. obesity reviews © 2011 International Association for the Study of Obesity.

Effect of eating vegetables before carbohydrates on glucose excursions in patients with type 2 diabetes

PubMed Central

Imai, Saeko; Fukui, Michiaki; Kajiyama, Shizuo

2014-01-01

The aim of this review was to evaluate whether eating vegetables before carbohydrates could reduce the postprandial glucose, insulin, and improve long-term glycemic control in Japanese patients with type 2 diabetes. We studied the effect of eating vegetables before carbohydrates on postprandial plasma glucose, insulin, and glycemic control for 2.5 y in patients with type 2 diabetes. The postprandial glucose and insulin levels decreased significantly when the patients ate vegetables before carbohydrates compared to the reverse regimen, and the improvement of glycemic control was observed for 2.5 y. We also compared the postprandial glucose and glucose fluctuations assessed by continuous glucose monitoring system for 72-h in patients with type 2 diabetes and subjects with normal glucose tolerance when subjects ate vegetables before carbohydrates and carbohydrates before vegetables in a randomized crossover design. The glycemic excursions and incremental glucose peak were significantly lower when the subjects ate vegetables before carbohydrates compared to the reverse regimen. This evidence supports the effectiveness of eating vegetables before carbohydrates on glucose excursions in the short-term and glycemic control in the long-term in patients with type 2 diabetes. PMID:24426184

Effect of eating vegetables before carbohydrates on glucose excursions in patients with type 2 diabetes.

PubMed

Imai, Saeko; Fukui, Michiaki; Kajiyama, Shizuo

2014-01-01

The aim of this review was to evaluate whether eating vegetables before carbohydrates could reduce the postprandial glucose, insulin, and improve long-term glycemic control in Japanese patients with type 2 diabetes. We studied the effect of eating vegetables before carbohydrates on postprandial plasma glucose, insulin, and glycemic control for 2.5 y in patients with type 2 diabetes. The postprandial glucose and insulin levels decreased significantly when the patients ate vegetables before carbohydrates compared to the reverse regimen, and the improvement of glycemic control was observed for 2.5 y. We also compared the postprandial glucose and glucose fluctuations assessed by continuous glucose monitoring system for 72-h in patients with type 2 diabetes and subjects with normal glucose tolerance when subjects ate vegetables before carbohydrates and carbohydrates before vegetables in a randomized crossover design. The glycemic excursions and incremental glucose peak were significantly lower when the subjects ate vegetables before carbohydrates compared to the reverse regimen. This evidence supports the effectiveness of eating vegetables before carbohydrates on glucose excursions in the short-term and glycemic control in the long-term in patients with type 2 diabetes.

Long-term safety, efficacy, and tolerability of imidafenacin in the treatment of overactive bladder: a review of the Japanese literature

PubMed Central

Masumori, Naoya

2013-01-01

Imidafenacin is an antimuscarinic agent with high affinity for the M3 and M1 muscarinic receptor subtypes and low affinity for the M2 subtype, and is used to treat overactive bladder. Several animal studies have demonstrated that imidafenacin has organ selectivity for the bladder over the salivary glands, colon, heart, and brain. In Phase I studies in humans, the approximately 2.9-hour elimination half-life of imidafenacin was shorter than that of other antimuscarinics such as tolterodine and solifenacin. Imidafenacin was approved for clinical use in overactive bladder in Japan in 2007 after a randomized, double-blind, placebo-controlled Phase II study and a propiverine-controlled Phase III study conducted in Japanese patients demonstrated that imidafenacin 0.1 mg twice daily was clinically effective for treating overactive bladder and was not inferior to propiverine for reduction of episodes of incontinence, with a better safety profile than propiverine. Several short-term clinical studies have demonstrated that imidafenacin also improves sleep disorders, nocturia, and nocturia-related quality of life. In addition, it is speculated that addon therapy with imidafenacin is beneficial for men with benign prostatic hyperplasia whose overactive bladder symptoms are not controlled by alpha-1 adrenoceptor antagonists. No cognitive impairment or influence of imidafenacin on the QTc interval has been observed. Although there have been very few relevant long-term clinical studies, the available information suggests the long-term efficacy, safety, and tolerability of imidafenacin, with less frequent severe adverse events, such as dry mouth and constipation. In addition, imidafenacin can be used safely for a long time even for cognitively vulnerable elderly patients with symptoms of overactive bladder. Thus, it is highly likely that imidafenacin is safe, efficacious, and tolerable to control symptoms of overactive bladder even over the long term. However, it remains unknown if the practical effectiveness of imidafenacin is applicable to ethnic groups other than Japanese. PMID:23390360

Global estimation of long-term persistence in annual river runoff

NASA Astrophysics Data System (ADS)

Markonis, Y.; Moustakis, Y.; Nasika, C.; Sychova, P.; Dimitriadis, P.; Hanel, M.; Máca, P.; Papalexiou, S. M.

2018-03-01

Long-term persistence (LTP) of annual river runoff is a topic of ongoing hydrological research, due to its implications to water resources management. Here, we estimate its strength, measured by the Hurst coefficient H, in 696 annual, globally distributed, streamflow records with at least 80 years of data. We use three estimation methods (maximum likelihood estimator, Whittle estimator and least squares variance) resulting in similar mean values of H close to 0.65. Subsequently, we explore potential factors influencing H by two linear (Spearman's rank correlation, multiple linear regression) and two non-linear (self-organizing maps, random forests) techniques. Catchment area is found to be crucial for medium to larger watersheds, while climatic controls, such as aridity index, have higher impact to smaller ones. Our findings indicate that long-term persistence is weaker than found in other studies, suggesting that enhanced LTP is encountered in large-catchment rivers, were the effect of spatial aggregation is more intense. However, we also show that the estimated values of H can be reproduced by a short-term persistence stochastic model such as an auto-regressive AR(1) process. A direct consequence is that some of the most common methods for the estimation of H coefficient, might not be suitable for discriminating short- and long-term persistence even in long observational records.

Effects of Intranasal Oxytocin on Long-Term Memory in Healthy Humans: A Systematic Review.

PubMed

Brambilla, Michela; Manenti, Rosa; de Girolamo, Giovanni; Adenzato, Mauro; Bocchio-Chiavetto, Luisella; Cotelli, Maria

2016-12-01

Preclinical Research The neuropeptide oxytocin (Oxt) is implicated in complex emotional and social behaviors and appears to play an important role in learning and memory. Animal studies have shown that the effects of exogenous Oxt on memory vary according to the timing of administration, context, gender, and dose and may improve the memory of social, but not nonsocial stimuli. Oxt is intimately involved in a broad array of neuropsychiatric functions and may therefore be a pharmacological target for several psychiatric disorders. This review summarizes the potential effects of Oxt on long-term memory processes in healthy humans based on a PubMed search over the period 1980-2016. The effects of intranasal Oxt on human memory are controversial and the studies included in this review have applied a variety of learning paradigms, in turn producing variable outcomes. Specifically, data on the long-term memory of nonemotional stimuli found no effect or even worsening in memory, while studies using emotional stimuli showed an improvement of long-term memory performance. In conclusion, this review identified a link between long-term memory performance and exogenous intranasal Oxt in humans, although these results still warrant further confirmation in large, multicenter randomized controlled trials. Drug Dev Res 77 : 479-488, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Identifying Feasible Physical Activity Programs for Long-Term Care Homes in the Ontario Context

PubMed Central

Shakeel, Saad; Newhouse, Ian; Malik, Ali; Heckman, George

2015-01-01

Background Structured exercise programs for frail institutionalized seniors have shown improvement in physical, functional, and psychological health of this population. However, the ‘feasibility’ of implementation of such programs in real settings is seldom discussed. The purpose of this systematic review was to gauge feasibility of exercise and falls prevention programs from the perspective of long-term care homes in Ontario, given the recent changes in funding for publically funded physiotherapy services. Method Six electronic databases were searched by two independent researchers for randomized controlled trials that targeted long-term care residents and included exercise as an independent component of the intervention. Results A total of 39 studies were included in this review. A majority of these interventions were led by physiotherapist(s), carried out three times per week for 30–45 minutes per session. However, a few group-based interventions that were led by long-term care staff, volunteers, or trained non-exercise specialists were identified that also required minimal equipment. Conclusion This systematic review has identified ‘feasible’ physical activity and falls prevention programs that required minimal investment in staff and equipment, and demonstrated positive outcomes. Implementation of such programs represents cost-effective means of providing long-term care residents with meaningful gains in physical, psychological, and social health. PMID:26180563

Effects of long-term estrogen replacement therapy on bone turnover in periarticular tibial osteophytes in surgically postmenopausal cynomolgus monkeys

PubMed Central

Olson, Erik J.; Lindgren, Bruce R.; Carlson, Cathy S.

2008-01-01

The aims of the present study were to assess the effects of long-term estrogen replacement therapy (ERT) on size and indices of bone turnover in periarticular osteophytes in ovariectomized cynomolgus monkeys and to compare dynamic indices of bone turnover in osteophyte bone with those of subchondral bone (SCB) and epiphyseal/metaphyseal cancellous (EMC) bone. One hundred sixty-five adult female cynomolgus macaques were bilaterally ovariectomized and randomly divided into three age- and weight-matched treatment groups for a 36-month treatment period. Group 1 (OVX control) received no treatment, Group 2 (SPE) received soy phytoestrogens, and Group 3 (ERT) received conjugated equine estrogens in the diet; all monkeys were labeled with calcein before necropsy. A midcoronal, plastic-embedded section of the right proximal tibia from 20 randomly selected animals per treatment group was examined histologically. Forty-nine of the sections (OVX control, n=16; SPE, n=16; ERT, n=17) contained lateral abaxial osteophytes, and static and dynamic histomorphometry measurements were taken from osteophyte bone, SCB from the lateral tibial plateau, and EMC bone. Data were analyzed using the ANOVA and Kruskal-Wallis test, correlation and regression methods, and the Friedman and Wilcoxon signed rank test. There was no significant effect of long-term ERT on osteophyte area or on any static or dynamic histomorphometry parameters. The bone volume, trabecular number, and trabecular thickness in osteophyte bone were considerably higher than in EMC bone; whereas, trabecular separation was considerably lower in osteophyte bone. In all three treatment groups, BS/BV was significantly lower in osteophyte bone vs. EMC bone and significantly higher in osteophyte bone vs. lateral SCB. We conclude that osteophyte area and static and dynamic histomorphometry parameters within periarticular tibial osteophytes in ovariectomized cynomolgus monkeys are not significantly influenced by long-term ERT, but that site differences in static and dynamic bone histomorphometry parameters exist, particularly between EMC and osteophyte bone. PMID:18291743

Effects of long-term estrogen replacement therapy on bone turnover in periarticular tibial osteophytes in surgically postmenopausal cynomolgus monkeys.

PubMed

Olson, Erik J; Lindgren, Bruce R; Carlson, Cathy S

2008-05-01

The aims of the present study were to assess the effects of long-term estrogen replacement therapy (ERT) on size and indices of bone turnover in periarticular osteophytes in ovariectomized cynomolgus monkeys and to compare dynamic indices of bone turnover in osteophyte bone with those of subchondral bone (SCB) and epiphyseal/metaphyseal cancellous (EMC) bone. One hundred sixty-five adult female cynomolgus macaques were bilaterally ovariectomized and randomly divided into three age- and weight-matched treatment groups for a 36-month treatment period. Group 1 (OVX control) received no treatment, Group 2 (SPE) received soy phytoestrogens, and Group 3 (ERT) received conjugated equine estrogens in the diet; all monkeys were labeled with calcein before necropsy. A midcoronal, plastic-embedded section of the right proximal tibia from 20 randomly selected animals per treatment group was examined histologically. Forty-nine of the sections (OVX control, n=16; SPE, n=16; ERT, n=17) contained lateral abaxial osteophytes, and static and dynamic histomorphometry measurements were taken from osteophyte bone, SCB from the lateral tibial plateau, and EMC bone. Data were analyzed using the ANOVA and Kruskal-Wallis test, correlation and regression methods, and the Friedman and Wilcoxon signed rank test. There was no significant effect of long-term ERT on osteophyte area or on any static or dynamic histomorphometry parameters. The bone volume, trabecular number, and trabecular thickness in osteophyte bone were considerably higher than in EMC bone; whereas, trabecular separation was considerably lower in osteophyte bone. In all three treatment groups, BS/BV was significantly lower in osteophyte bone vs. EMC bone and significantly higher in osteophyte bone vs. lateral SCB. We conclude that osteophyte area and static and dynamic histomorphometry parameters within periarticular tibial osteophytes in ovariectomized cynomolgus monkeys are not significantly influenced by long-term ERT, but that site differences in static and dynamic bone histomorphometry parameters exist, particularly between EMC and osteophyte bone.

A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Long-term (12-month) follow-up at one site.

PubMed

Hugos, Cinda L; Cameron, Michelle H; Chen, Zunqiu; Chen, Yiyi; Bourdette, Dennis

2018-05-01

A four-site RCT of Fatigue: Take Control (FTC), a multicomponent group program, found no significant differences from a control program, MS: Take Control (MSTC), in fatigue on the Modified Fatigue Impact Scale (MFIS) through 6 months. Assess FTC for a delayed effect on fatigue. Of 78 subjects at one site, 74 randomized to FTC or MSTC completed the MFIS at 12 months. Compared to baseline, FTC produced greater improvements in MFIS scores than MSTC (FTC -8.9 (confidence interval (CI): 32.2, 45), MSTC -2.5 (CI 39.6, 47.7), p = 0.03) at 12 months. The delayed effect of FTC on fatigue suggests the need for longer follow-up when assessing interventions for fatigue.

Effectiveness of multifaceted hand hygiene interventions in long-term care facilities in Hong Kong: a cluster-randomized controlled trial.

PubMed

Ho, Mei-lin; Seto, Wing-hong; Wong, Lai-chin; Wong, Tin-yau

2012-08-01

To determine the effectiveness of World Health Organization (WHO) multimodal strategy in promoting hand hygiene (HH) among healthcare workers (HCWs) in long-term care facilities (LTCFs). Cluster-randomized controlled trial. Eighteen homes for the elderly in Hong Kong were randomly allocated to 2 intervention arms and a control arm. Direct observation of HH practice was conducted by trained nurses. Either handrubbing with alcohol-based handrub (ABHR) or handwashing with liquid soap and water was counted as a compliant action. Disease notification data during 2007-2010 were used to calculate incidence rate ratio (IRR). Managers and HCWs of the participating homes. The WHO multimodal strategy was employed. All intervention homes were supplied with ABHR (WHO formulation I), ABHR racks, pull reels, HH posters and reminders, a health talk, video clips, training materials, and performance feedback. The only difference was that intervention arms 1 and 2 were provided with slightly powdered and powderless gloves, respectively. A total of 11,669 HH opportunities were observed. HH compliance increased from 27.0% to 60.6% and from 22.2% to 48.6% in intervention arms 1 and 2, respectively. Both intervention arms showed increased HH compliance after intervention compared to controls, at 21.6% compliance (both [Formula: see text]). Provision of slightly powdered versus powderless gloves did not have any significant impact on ABHR usage. Respiratory outbreaks (IRR, 0.12; 95% confidence interval [CI], 0.01-0.93; [Formula: see text]) and methicillin-resistant Staphylococcus aureus infections requiring hospital admission (IRR, 0.61; 95% CI, 0.38-0.97; [Formula: see text]) were reduced after intervention. A promotion program applying the WHO multimodal strategy was effective in improving HH among HCWs in LTCFs.

The effectiveness of a construction worksite prevention program on work ability, health, and sick leave: results from a cluster randomized controlled trial.

PubMed

Oude Hengel, Karen M; Blatter, Brigitte M; van der Molen, Henk F; Bongers, Paulien M; van der Beek, Allard J

2013-09-01

This study aimed to investigate the effectiveness of a prevention program on work ability, health, and sick leave targeted at construction worksites. A total of 15 departments (N = 297 workers) from 6 construction companies participated in this cluster randomized controlled trial and were randomly allocated to the intervention (8 departments; N = 171 workers) or control (7 departments; N = 122 workers) group. The intervention consisted of two individual training sessions with a physical therapist aimed at lowering the physical workload, a rest-break tool to improve the balance between work and recovery, and two empowerment training sessions to increase the worker's influence at the worksite. Data on work ability, physical and mental health status, and musculoskeletal symptoms were collected at baseline, and at 3, 6, and 12 months follow-up. Sick leave data were obtained from the companies. Overall, no differences in work ability [β 0.02, 95% confidence interval (95% CI) -0.34-0.37] or physical and mental health status (β -0.04, 95% CI -1.43-1.35, and β 0.80 95% CI -0.51-2.11, respectively) were found between the intervention and control group. The intervention showed an overall decline in musculoskeletal symptoms (ranging from OR 0.68, 95% CI 0.34-1.33, to OR 0.86, 95% CI 0.47-1.57) and long-term sick leave (OR 0.44, 95% CI 0.13-1.26) among construction workers. Both reductions were not statistically significant. The prevention program seemed to result in a beneficial but not statistically significant decline in the prevalence of musculoskeletal symptoms and long-term sick leave among construction workers, but showed no effects with regard to work ability, physical health, and mental health.

A randomized controlled trial of cognitive-behavioral stress management in breast cancer: survival and recurrence at 11-year follow-up.

PubMed

Stagl, Jamie M; Lechner, Suzanne C; Carver, Charles S; Bouchard, Laura C; Gudenkauf, Lisa M; Jutagir, Devika R; Diaz, Alain; Yu, Qilu; Blomberg, Bonnie B; Ironson, Gail; Glück, Stefan; Antoni, Michael H

2015-11-01

Non-metastatic breast cancer patients often experience psychological distress which may influence disease progression and survival. Cognitive-behavioral stress management (CBSM) improves psychological adaptation and lowers distress during breast cancer treatment and long-term follow-ups. We examined whether breast cancer patients randomized to CBSM had improved survival and recurrence 8-15 years post-enrollment. From 1998 to 2005, women (N = 240) 2-10 weeks post-surgery for non-metastatic Stage 0-IIIb breast cancer were randomized to a 10-week, group-based CBSM intervention (n = 120) or a 1-day psychoeducational seminar control (n = 120). In 2013, 8-15 years post-study enrollment (11-year median), recurrence and survival data were collected. Cox Proportional Hazards Models and Weibull Accelerated Failure Time tests were used to assess group differences in all-cause mortality, breast cancer-specific mortality, and disease-free interval, controlling for biomedical confounders. Relative to the control, the CBSM group was found to have a reduced risk of all-cause mortality (HR = 0.21; 95 % CI [0.05, 0.93]; p = .040). Restricting analyses to women with invasive disease revealed significant effects of CBSM on breast cancer-related mortality (p = .006) and disease-free interval (p = .011). CBSM intervention delivered post-surgery may provide long-term clinical benefit for non-metastatic breast cancer patients in addition to previously established psychological benefits. Results should be interpreted with caution; however, the findings contribute to the limited evidence regarding physical benefits of psychosocial intervention post-surgery for non-metastatic breast cancer. Additional research is necessary to confirm these results and investigate potential explanatory mechanisms, including physiological pathways, health behaviors, and treatment adherence changes.

Divergent short- and long-term effects of acute stress in object recognition memory are mediated by endogenous opioid system activation.

PubMed

Nava-Mesa, Mauricio O; Lamprea, Marisol R; Múnera, Alejandro

2013-11-01

Acute stress induces short-term object recognition memory impairment and elicits endogenous opioid system activation. The aim of this study was thus to evaluate whether opiate system activation mediates the acute stress-induced object recognition memory changes. Adult male Wistar rats were trained in an object recognition task designed to test both short- and long-term memory. Subjects were randomly assigned to receive an intraperitoneal injection of saline, 1 mg/kg naltrexone or 3 mg/kg naltrexone, four and a half hours before the sample trial. Five minutes after the injection, half the subjects were submitted to movement restraint during four hours while the other half remained in their home cages. Non-stressed subjects receiving saline (control) performed adequately during the short-term memory test, while stressed subjects receiving saline displayed impaired performance. Naltrexone prevented such deleterious effect, in spite of the fact that it had no intrinsic effect on short-term object recognition memory. Stressed subjects receiving saline and non-stressed subjects receiving naltrexone performed adequately during the long-term memory test; however, control subjects as well as stressed subjects receiving a high dose of naltrexone performed poorly. Control subjects' dissociated performance during both memory tests suggests that the short-term memory test induced a retroactive interference effect mediated through light opioid system activation; such effect was prevented either by low dose naltrexone administration or by strongly activating the opioid system through acute stress. Both short-term memory retrieval impairment and long-term memory improvement observed in stressed subjects may have been mediated through strong opioid system activation, since they were prevented by high dose naltrexone administration. Therefore, the activation of the opioid system plays a dual modulating role in object recognition memory. Copyright © 2013 Elsevier Inc. All rights reserved.

Adding methylphenidate to prism-adaptation improves outcome in neglect patients. A randomized clinical trial.

PubMed

Luauté, Jacques; Villeneuve, Laurent; Roux, Adeline; Nash, Stuart; Bar, Jean-Yves; Chabanat, Eric; Cotton, François; Ciancia, Sophie; Sancho, Pierre-Olivier; Hovantruc, Patrick; Quelard, François; Sarraf, Thierry; Cojan, Yann; Hadj-Bouziane, Fadila; Farné, Alessandro; Janoly-Dumenil, Audrey; Boisson, Dominique; Jacquin-Courtois, Sophie; Rode, Gilles; Rossetti, Yves

2018-04-04

Spatial neglect is one of the main predictors of poor functional recovery after stroke. Many therapeutic interventions have been developed to alleviate this condition, but to date the evidence of their effectiveness is still scarce. The purpose of this study was to test whether combining prism adaptation (PA) and methylphenidate (MP) could enhance the recovery of neglect patients at a functional level. RITAPRISM is a multicentre, randomized, double-blind, placebo-controlled study comparing PA plus placebo (control) versus PA plus MP. 24 patients were prospectively enrolled (10 in the placebo group and 14 in the MP group). The main result is a long-term functional improvement (on the functional independence measure (FIM) and on Bergego's scale) induced by MP combined with PA. No serious adverse event occurred. The long-term benefit on activities of daily living (ADL) obtained in this randomized controlled trial set this intervention apart from previous attempts and supports with a high level of evidence the value of combining PA and MP in order to improve the autonomy of neglect patients. Further studies will be needed to clarify the mechanism of this improvement. Although not specifically assessed at this stage, a part of the improvement in ADL might be related to the collateral effect of MP on mood, executive functions or fatigue, and/or the combined effect of PA and MP on motor intentional bias of neglect patients. This study provides Class I evidence that adding MP to PA improves the functional outcome of neglect patients. EUCTR2008-000325-20-FR. Copyright © 2018 Elsevier Ltd. All rights reserved.

Does cognitive behavioral therapy strengthen the effect of bariatric surgery for obesity? Design and methods of a randomized and controlled study.

PubMed

Paul, Linda; van Rongen, Sofie; van Hoeken, Daphne; Deen, Mathijs; Klaassen, René; Biter, L Ulas; Hoek, Hans W; van der Heiden, Colin

2015-05-01

(Extreme) obesity is a chronic harmful condition with high risk of medical comorbidities and negative social and emotional consequences. Bariatric surgery is an effective intervention for obesity, but approximately 20 to 30% of the patients experience adverse outcomes after surgery and there is a need for augmentation of current treatment strategies. This study examines the added value of pre-operative cognitive behavioral therapy (CBT) focused on modification of thoughts and behaviors in terms of eating behavior and physical exercise as well as preparation for surgery and postoperative life style. We hypothesize that pre-operative CBT will result in better weight loss maintenance, reduction of maladaptive eating behavior and better adherence to postoperative lifestyle on the long term as compared to bariatric surgery alone. One hundred and twenty eight patients that are on a waiting list for bariatric surgery are randomly assigned to the control or treatment condition. Patients in the treatment condition receive 10 sessions of CBT before surgery aimed at modifying dysfunctional eating habits and behaviors and developing more rational weight and body-related beliefs in order to enable long term maintenance of a healthier lifestyle after surgery. Weight loss, eating behavior, eating disorders, depression, quality of life and psychological distress are assessed before and after treatment, as well as 1, 3, and 5 year following surgery. Copyright © 2015 Elsevier Inc. All rights reserved.

Factors important in the purchase of partnership long-term care insurance.

PubMed

McCall, N; Mangle, S; Bauer, E; Knickman, J

1998-06-01

To understand the factors important in the purchase of long-term care insurance through the Robert Wood Johnson Foundation Partnership for Long-Term Care. Information on the Partnership programs, telephone surveys, data on Partnership purchasers, and random sample frames. Logistic regression analysis is used to examine characteristics associated with the purchase of a Partnership insurance policy. Independent variables are health status, demographic and financial characteristics, knowledge, and attitudes. A telephone survey of Partnership purchasers and a random sample of the population in each Partnership state were conducted. Survey questions included health status, opinions about long-term care and long-term care insurance, financial planning, demographic characteristics, and income and assets. Important in the purchase of a Partnership policy were variables associated with education and knowledge about long-term care. Other important factors include attitudes and health status. Partnership purchase is associated with higher income and asset levels up to a point, with the effect plateauing and decreasing at the highest income and asset levels. Improved education and knowledge are important in increasing long-term care insurance purchase. Attitudes about having a caregiver, and about the government's role in paying for long-term care as well as the potential purchaser's willingness to consider nursing home care affect policy purchase. Also associated with Partnership policy purchase are better health and middle income and asset levels.

Fiber facts: benefits and recommendations for individuals with type 2 diabetes.

PubMed

Vuksan, Vladimir; Rogovik, Alexander L; Jovanovski, Elena; Jenkins, Alexandra L

2009-10-01

In randomized controlled trials, viscous soluble fibers have demonstrated acute and long-term metabolic improvements in type 2 diabetes, such as reductions in hemoglobin A1c, fasting and post-prandial glycemia, insulinemia, and cardiovascular risk factors. In addition, they may be helpful in weight control through promoting feelings of fullness. Increasing consumption of foods containing fiber or use of fiber supplements could play an important role in managing diabetes with positive outcomes on vascular complications and reduced cardio-vascular disease risk.

Randomized controlled trial comparing prolene hernia system and lichtenstein method for inguinal hernia repair.

PubMed

Sanjay, Pandanaboyana; Harris, Dean; Jones, Philippa; Woodward, Alan

2006-07-01

There are no data regarding the long-term outcomes of prolene hernia system (PHS) mesh in the published reports. The aim of the study was to compare the short-term and long-term outcomes of the PHS mesh with the Lichtenstein mesh technique. Sixty-four patients with inguinal hernia were randomized to undergo either a PHS or a Lichtenstein repair under local anaesthesia as a day case. Early outcome measures were duration of surgery, pain scores, analgesic requirements, time to return to work, driving and full activity. Long-term outcome measures were chronic groin pain and recurrence. Mean duration of surgery in the PHS group was 36 min (SD +/- 11) versus 34 min in the Lichtenstein group (SD +/- 8; P = 0.3). There was no significant difference in analgesic requirements (P = 0.65). Overall mean pain score was 3.5/10 versus 2.5/10 (P = 0.1). Mean time to return to work was 42 versus 30 days (P = 0.3), returning to driving was 20 versus 14 days (P = 0.2) and full activity was 21 versus 22 days (P = 0.8). Chronic groin pain developed in four patients in the PHS group (12.9%) and in five patients in the Lichtenstein group (15.1%; P > 0.05). One patient developed recurrent herniation in the PHS group. The median follow up was 4.2 years (range, 4-4.6 years). Patient satisfaction was very high with both the techniques. There is no significant difference in the early and long-term outcomes between PHS and Lichtenstein hernia repairs. The PHS technique involving preperitoneal dissection is well tolerated and easy to carry out under local anaesthesia.

Genetic Drift, Not Life History or RNAi, Determine Long-Term Evolution of Transposable Elements

PubMed Central

Szitenberg, Amir; Cha, Soyeon; Opperman, Charles H.; Bird, David M.; Blaxter, Mark L.; Lunt, David H.

2016-01-01

Abstract Transposable elements (TEs) are a major source of genome variation across the branches of life. Although TEs may play an adaptive role in their host’s genome, they are more often deleterious, and purifying selection is an important factor controlling their genomic loads. In contrast, life history, mating system, GC content, and RNAi pathways have been suggested to account for the disparity of TE loads in different species. Previous studies of fungal, plant, and animal genomes have reported conflicting results regarding the direction in which these genomic features drive TE evolution. Many of these studies have had limited power, however, because they studied taxonomically narrow systems, comparing only a limited number of phylogenetically independent contrasts, and did not address long-term effects on TE evolution. Here, we test the long-term determinants of TE evolution by comparing 42 nematode genomes spanning over 500 million years of diversification. This analysis includes numerous transitions between life history states, and RNAi pathways, and evaluates if these forces are sufficiently persistent to affect the long-term evolution of TE loads in eukaryotic genomes. Although we demonstrate statistical power to detect selection, we find no evidence that variation in these factors influence genomic TE loads across extended periods of time. In contrast, the effects of genetic drift appear to persist and control TE variation among species. We suggest that variation in the tested factors are largely inconsequential to the large differences in TE content observed between genomes, and only by these large-scale comparisons can we distinguish long-term and persistent effects from transient or random changes. PMID:27566762

Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study.

PubMed

Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching

2014-02-01

The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.

Effects Of Reinforcement History On Response Rate And Response Pattern In Periodic Reinforcement

PubMed Central

López, Florente; Menez, Marina

2005-01-01

Several researchers have suggested that conditioning history may have long-term effects on fixed-interval performances of rats. To test this idea and to identify possible factors involved in temporal control development, groups of rats initially were exposed to different reinforcement schedules: continuous, fixed-time, and random-interval. Afterwards, half of the rats in each group were studied on a fixed-interval 30-s schedule of reinforcement and the other half on a fixed-interval 90-s schedule of reinforcement. No evidence of long-term effects attributable to conditioning history on either response output or response patterning was found; history effects were transitory. Different tendencies in trajectory across sessions were observed for measures of early and late responding within the interreinforcer interval, suggesting that temporal control is the result of two separate processes: one involved in response output and the other in time allocation of responding and not responding. PMID:16047607

Effects of Long-Term Acupuncture Treatment on Resting-State Brain Activity in Migraine Patients: A Randomized Controlled Trial on Active Acupoints and Inactive Acupoints

PubMed Central

Zhao, Ling; Liu, Jixin; Zhang, Fuwen; Dong, Xilin; Peng, Yulin; Qin, Wei; Wu, Fumei; Li, Ying; Yuan, Kai; von Deneen, Karen M.; Gong, Qiyong; Tang, Zili; Liang, Fanrong

2014-01-01

Background Acupuncture has been commonly used for preventing migraine attacks and relieving pain during a migraine, although there is limited knowledge on the physiological mechanism behind this method. The objectives of this study were to compare the differences in brain activities evoked by active acupoints and inactive acupoints and to investigate the possible correlation between clinical variables and brain responses. Methods and Results A randomized controlled trial and resting-state functional magnetic resonance imaging (fMRI) were conducted. A total of eighty migraineurs without aura were enrolled to receive either active acupoint acupuncture or inactive acupoint acupuncture treatment for 8 weeks, and twenty patients in each group were randomly selected for the fMRI scan at the end of baseline and at the end of treatment. The neuroimaging data indicated that long-term active acupoint therapy elicited a more extensive and remarkable cerebral response compared with acupuncture at inactive acupoints. Most of the regions were involved in the pain matrix, lateral pain system, medial pain system, default mode network, and cognitive components of pain processing. Correlation analysis showed that the decrease in the visual analogue scale (VAS) was significantly related to the increased average Regional homogeneity (ReHo) values in the anterior cingulate cortex in the two groups. Moreover, the decrease in the VAS was associated with increased average ReHo values in the insula which could be detected in the active acupoint group. Conclusions Long-term active acupoint therapy and inactive acupoint therapy have different brain activities. We postulate that acupuncture at the active acupoint might have the potential effect of regulating some disease-affected key regions and the pain circuitry for migraine, and promote establishing psychophysical pain homeostasis. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-13003635 PMID:24915066

Long-term outcome of a multicentre randomized clinical trial of stapled haemorrhoidopexy versus Milligan-Morgan haemorrhoidectomy.

PubMed

Ganio, E; Altomare, D F; Milito, G; Gabrielli, F; Canuti, S

2007-08-01

Stapled haemorrhoidopexy is less painful than Milligan-Morgan haemorrhoidectomy, allowing an earlier return to working activities, but its long-term efficacy is not fully established. This study reports the long-term follow-up of a randomized clinical trial comparing the two techniques in 100 patients affected by third- and fourth-degree haemorrhoids. All patients were contacted and invited to attend the clinic to assess long-term functional outcome. The degree of continence and satisfaction were assessed by questionnaire. Anal manometry and anoscopy were performed. Eighty patients were available after a median follow-up of 87 months. No statistically significant differences were found between the two groups in terms of incontinence, stenosis, pain, bleeding, residual skin tags or recurrent prolapse. A tendency towards a higher recurrence rate was reported in patients with fourth-degree haemorrhoids, irrespective of the technique used. No significant changes in anal manometric values were found after surgery in either group. Both techniques are effective in the long term. Copyright (c) 2007 British Journal of Surgery Society Ltd.

Comparison of intra-articular hyaluronic acid and methylprednisolone for pain management in knee osteoarthritis: A meta-analysis of randomized controlled trials.

PubMed

Ran, Jian; Yang, Xiaohui; Ren, Zheng; Wang, Jian; Dong, Hui

2018-05-01

We performed a meta-analysis of randomized controlled trials (RCTs) to compare the efficacy and safety of intra-articular methylprednisolone and hyaluronic acid (HA) in term of pain reduction and improvements of knee function in patients with knee osteoarthritis (OA). The PubMed, EMBASE, ScienceDirect, and Cochrane Library databases were systematically searched for literature up to January 2018. RCTs involving HA and methylprednisolone in knee OA were included. Two independent reviewers performed independent data abstraction. The I 2 statistic was used to assess heterogeneity. A fixed or random effects model was adopted for meta-analysis. All meta-analyses were performed by using STATA 14.0. Five RCTs with 1004 patients were included in the meta-analysis. The present meta-analysis indicated that there were no significant differences in terms of WOMAC pain, physical function and stiffness at 4 week, 12 weeks and 26 weeks between HA and methylprednisolone groups. No increased risk of adverse events were identified in both groups. Both HA and methylprednisolone injections were effective therapies for patients with knee OA. Methylprednisolone showed comparable efficacy in reducing pain and improving functional recovery to HA. And no significant difference was found in long-term of follow-up in terms of adverse effects. Copyright © 2018 IJS Publishing Group Ltd. All rights reserved.

The Use of Self-Directed Relapse Prevention Booklets to Assist in Maintaining Abstinence after a 6-Week Group Smoking Cessation Treatment Program: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Veldheer, Susan; Hrabovsky, Shari; Yingst, Jessica; Sciamanna, Chris; Berg, Arthur; Foulds, Jonathan

2018-01-01

Background: Identifying effective relapse prevention interventions is a vital step to help smokers maintain abstinence for the long term. Aims: The purpose of this study is to determine if providing recently quit smokers with self-directed relapse prevention booklets is effective at maintaining abstinence after intensive group smoking cessation…

The Effect of Karate Techniques Training on Communication Deficit of Children with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Bahrami, Fatimah; Movahedi, Ahmadreza; Marandi, Sayed Mohammad; Sorensen, Carl

2016-01-01

This investigation examined the long term effect of Karate techniques training on communication of children with autism spectrum disorders (ASD). Thirty school aged children with ASD were randomly assigned to an exercise (n = 15) or a control group (n = 15). Participants in the exercise group were engaged in 14 weeks of Karate techniques training.…

Feeding fat from distillers dried grains with solubles to dairy heifers: III. Effects on long-term reproductive and lactation performance

USDA-ARS?s Scientific Manuscript database

During the prepubertal growth phase, 33 Holstein heifers (133 ± 18 d old) were used in a 24-week randomized complete block design. Treatments included: 1) a control diet (CON) containing ground corn (15.9% of DM) and soybean products (17.9%); 2) a low-fat diet (LFDG) formulated with 21.9% fat-extrac...

Engaging Parents of Children with and without Asthma in Smoking-Specific Parenting: Results from a 3-Year Randomized Controlled Trial Evaluation

ERIC Educational Resources Information Center

Ringlever, Linda; Hiemstra, Marieke; Engels, Rutger C. M. E.; van Schayck, Onno C. P.; Otten, Roy

2016-01-01

The present study evaluated long-term effects of a home-based smoking prevention program targeting smoking-specific parenting in families with children with and without asthma. A total of 1398 non-smoking children ("mean age" 10.1) participated, of which 197 (14.1%) were diagnosed with asthma. Families were blinded to group assignment.…

Enhanced Vaccine Control of Epidemics in Adaptive Networks

DTIC Science & Technology

2010-04-29

than random vaccination 32. When vaccine is very limited, outbreaks can be minimized by fragmenting the network via a graph partitioning strategy...Although an outbreak could transiently decrease network connectivity in a real social network, long term reductions in average connectivity are...37, cholera and typhoid fever 35, as well as pertussis 38. Although not all of the above diseases currently possess a vaccine, research is ongo

Does behaviour modification affect post-stroke risk factor control? Three-year follow-up of a randomized controlled trial.

PubMed

McManus, Julie Ann; Craig, Alison; McAlpine, Christine; Langhorne, Peter; Ellis, Graham

2009-02-01

Little is known about the long-term effectiveness after stroke of interventions for behaviour modification and ensuring concordance with therapies. We describe a follow-up study of a previous randomized controlled trial of a brief period of behaviour modification. The aim of this study was to determine outcomes three years after the initial intervention. Survivors of the original cohort were contacted and asked to attend for follow-up interview, within a geriatric day hospital. This study was carried out in the Geriatric Day Hospital at Stobhill Hospital, Balornock Road, Glasgow. Details of risk factor control, including blood pressure, cholesterol levels and diabetic control, were assessed. Questionnaires used in the initial study were repeated including the Geriatric Depression Scale score, Euroqol Perceived Health Status and Stroke Services Satisfaction Questionnaire. Primary outcome was collective risk factor control. Clinical outcomes including recurrent cerebrovascular events, medication persistence and perceived health status were also recorded. Mean length of follow-up was 3.6 years (SD 0.43). Of the 205 patients enrolled in the initial study, 102 patients attended for repeat interview(49 intervention/53 control). There were no significant differences in the percentage of controlled risk factors between groups (intervention 51.7% versus control 55.9%, P = 0.53). Similarities were observed in the number of recurrent clinical events and medication persistence between groups. No overall difference was observed in perceived health status, satisfaction with care or depression scores. Brief intervention with respect to behaviour modification and risk factor control does not appear to have any long-term benefit. These results must be cautiously interpreted in light of the small study number and further research is required.

Low-dose hydrocortisone replacement improves wellbeing and pain tolerance in chronic pain patients with opioid-induced hypocortisolemic responses. A pilot randomized, placebo-controlled trial.

PubMed

Nenke, Marni A; Haylock, Clare L; Rankin, Wayne; Inder, Warrick J; Gagliardi, Lucia; Eldridge, Crystal; Rolan, Paul; Torpy, David J

2015-06-01

Long-term opioid therapy has been associated with low cortisol levels due to central suppression of the hypothalamic-pituitary-adrenal axis. The implications of hypocortisolism on wellbeing have not been established. Our aim was to determine whether intervention with physiologic glucocorticoid replacement therapy improves wellbeing and analgesic responses in patients with chronic non-cancer pain on long-term opioid therapy with mild cortisol deficiency. We performed a pilot randomized, double-blind, placebo-controlled crossover study of oral hydrocortisone replacement therapy in 17 patients recruited from a Pain Clinic at a single tertiary center in Adelaide, Australia. Patients were receiving long-term opioid therapy (≥ 20 mg morphine equivalents per day for ≥ 4 weeks) for chronic non-cancer pain with mild hypocortisolism, as defined by a plasma cortisol response ≤ 350 nmol/L at 60 min following a cold pressor test. The crossover intervention included 28-day treatment with either 10mg/m(2)/day of oral hydrocortisone in three divided doses or placebo. Improvement in wellbeing was assessed using Version 2 of the Short Form-36 (SF-36v2), Brief Pain Inventory-Short Form, and Addison's disease quality of life questionnaires; improvement in analgesic response was assessed using cold pressor threshold and tolerance times. Following treatment with hydrocortisone, the bodily pain (P=0.042) and vitality (P=0.013) subscales of the SF-36v2 were significantly better than scores following treatment with placebo. There was also an improvement in pain interference on general activity (P=0.035), mood (P=0.03) and work (P=0.04) following hydrocortisone compared with placebo. This is the first randomized, double-blind placebo-controlled trial of glucocorticoid replacement in opioid users with chronic non-cancer pain and mild hypocortisolism. Our data suggest that physiologic hydrocortisone replacement produces improvements in vitality and pain experiences in this cohort compared with placebo. Therapeutic Goods Administration Clinical Trials Notification Scheme (Drugs), Trial Number 2012/0476. Copyright © 2015 Elsevier Ltd. All rights reserved.

Reminiscence Therapy Improves Cognitive Functions and Reduces Depressive Symptoms in Elderly People With Dementia: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Huang, Hui-Chuan; Chen, Yu-Ting; Chen, Pin-Yuan; Huey-Lan Hu, Sophia; Liu, Fang; Kuo, Ying-Ling; Chiu, Hsiao-Yean

2015-12-01

Cognitive function impairments and depressive symptoms are common in elderly people with dementia. Previous meta-analyses of outdated and small-scale studies have reported inconsistent results regarding the effects of reminiscence therapy on cognitive functions and depressive symptoms; therefore, we conducted a meta-analysis by including more recent randomized controlled trials (RCTs) with large sample sizes to investigate the immediate and long-term (6-10 months) effects of reminiscence therapy on cognitive functions and depressive symptoms in elderly people with dementia. Electronic databases, including PubMed, Medline, CINAHL, PsycINFO, the Cochrane Central Register of Controlled Trials, ProQuest, Google Scholar, and Chinese databases were searched to select eligible articles. Primary outcome measures included the scores of cognitive functions and depressive symptoms. In total, 12 RCT studies investigating the effects of reminiscence therapy on cognitive functions and depressive symptoms in elderly people with dementia were included. Two reviewers independently extracted data. All analyses were performed using a random-effects model. Reminiscence therapy had a small-size effect on cognitive functions (g = 0.18, 95% confidence interval [CI] 0.05-0.30) and a moderate-size effect on depressive symptoms (g = -0.49, 95% CI -0.70 to -0.28) in elderly people with dementia. Long-term effects of reminiscence therapy on cognitive functions and depressive symptoms were not confirmed. Moderator analysis revealed that institutionalized elderly people with dementia exhibited greater improvement in depressive symptoms than community-dwelling people with dementia did (g = -0.59 vs. -0.16, P = .003). This meta-analysis confirms that reminiscence therapy is effective in improving cognitive functions and depressive symptoms in elderly people with dementia. Our findings suggest that regular reminiscence therapy should be considered for inclusion as routine care for the improvement of cognitive functions and depressive symptoms in elderly people with dementia, particularly in institutionalized residents with dementia. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Does packaging with a calendar feature improve adherence to self-administered medication for long-term use? A systematic review.

PubMed

Zedler, Barbara K; Kakad, Priyanka; Colilla, Susan; Murrelle, Lenn; Shah, Nirav R

2011-01-01

The therapeutic benefit of self-administered medications for long-term use is limited by an average 50% nonadherence rate. Patient forgetfulness is a common factor in unintentional nonadherence. Unit-of-use packaging that incorporates a simple day-and-date feature (calendar packaging) is designed to improve adherence by prompting patients to maintain the prescribed dosing schedule. To review systematically, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, randomized controlled trial evidence of the adherence benefits and harms of calendar blister packaging (CBP) and calendar pill organizers (CPO) for self-administered, long-term medication use. Data sources included the MEDLINE and Web of Science and Cochrane Library databases from their inception to September 2010 and communication with researchers in the field. Key search terms included blister-calendar pack, blister pack, drug packaging, medication adherence, medication compliance, medication compliance devices, medication containers, medication organizers, multicompartment compliance aid, persistence, pill-box organizers, prescription refill, randomized controlled trials, and refill compliance. Selected studies had an English-language title; a randomized controlled design; medication packaged in CBP or CPO; a requirement of solid, oral medication self-administered daily for longer than 1 month in community-dwelling adults; and at least 1 quantitative outcome measure of adherence. Two reviewers extracted data independently on study design, sample size, type of intervention and control, and outcomes. Ten trials with a total of 1045 subjects met the inclusion criteria, and 9 also examined clinical outcomes (seizures, blood pressure, psychiatric symptoms) or health care resource utilization. Substantial heterogeneity among trials precluded meta-analysis. In 3 studies, calendar packaging was part of a multicomponent adherence intervention. Six of 10 trials reported higher adherence, but it was associated with clinically significant improvement in only 1 study: 50% decreased seizure frequency with a CPO-based, multicomponent intervention. No study reported sufficient information to examine conclusively potential harms related to calendar packaging. All trials had significant methodological limitations, such as inadequate randomization or blinding, or reported insufficient information regarding enrolled subjects and attrition, which resulted in a moderate-to-high risk of bias and, in 2 studies, unevaluable outcome data. Trials were generally short and sample sizes small, with heterogeneous adherence outcome measures. Calendar packaging, especially in combination with education and reminder strategies, may improve medication adherence. Methodological limitations preclude definitive conclusions about the effect size of adherence and clinical benefits or harms associated with CBP and CPO. High-quality trials of adequate size and duration are needed to assess the clinical effectiveness of such interventions. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

Short- and long-term clinical outcomes of use of beta-interferon or glatiramer acetate for people with clinically isolated syndrome: a systematic review of randomised controlled trials and network meta-analysis.

PubMed

Armoiry, X; Kan, A; Melendez-Torres, G J; Court, R; Sutcliffe, P; Auguste, P; Madan, J; Counsell, C; Clarke, A

2018-05-01

Beta-interferon (IFN-β) and glatiramer acetate (GA) have been evaluated in people with clinically isolated syndrome (CIS) with the aim to delay a second clinical attack and a diagnosis of clinically definite multiple sclerosis (CDMS). We systematically reviewed trials evaluating the short- and long-term clinical effectiveness of these drugs in CIS. We searched multiple electronic databases. We selected randomised controlled studies (RCTs) conducted in CIS patients and where the interventions were IFN-β and GA. Main outcomes were time to CDMS, and discontinuation due to adverse events (AE). We compared interventions using random-effect network meta-analyses (NMA). We also reported outcomes from long-term open-label extension (OLE) studies. We identified five primary studies. Four had open-label extensions following double-blind periods comparing outcomes between early vs delayed DMT. Short-term clinical results (double-blind period) showed that all drugs delayed CDMS compared to placebo. Indirect comparisons did not suggest superiority of any one active drug over another. We could not undertake a NMA for discontinuation due to AE. Long-term clinical results (OLE studies) showed that the risk of developing CDMS was consistently reduced across studies after early DMT treatment compared to delayed DMT (HR = 0.64, 95% CI 0.55, 0.74). No data supported the benefit of DMTs in reducing the time to, and magnitude of, disability progression. Meta-analyses confirmed that IFN-β and GA delay time to CDMS compared to placebo. In the absence of evidence that early DMTs can reduce disability progression, future research is needed to better identify patients most likely to benefit from long-term DMTs.

Mechanical, histological, and functional properties remain inferior in conservatively treated Achilles tendons in rodents: Long term evaluation.

PubMed

Freedman, Benjamin R; Fryhofer, George W; Salka, Nabeel S; Raja, Harina A; Hillin, Cody D; Nuss, Courtney A; Farber, Daniel C; Soslowsky, Louis J

2017-05-03

Conservative treatment (non-operative) of Achilles tendon ruptures is suggested to produce equivalent capacity for return to function; however, long term results and the role of return to activity (RTA) for this treatment paradigm remain unclear. Therefore, the objective of this study was to evaluate the long term response of conservatively treated Achilles tendons in rodents with varied RTA. Sprague Dawley rats (n=32) received unilateral blunt transection of the Achilles tendon followed by randomization into groups that returned to activity after 1-week (RTA1) or 3-weeks (RTA3) of limb casting in plantarflexion, before being euthanized at 16-weeks post-injury. Uninjured age-matched control animals were used as a control group (n=10). Limb function, passive joint mechanics, tendon properties (mechanical, histological), and muscle properties (histological, immunohistochemical) were evaluated. Results showed that although hindlimb ground reaction forces and range of motion returned to baseline levels by 16-weeks post-injury regardless of RTA, ankle joint stiffness remained altered. RTA1 and RTA3 groups both exhibited no differences in fatigue properties; however, the secant modulus, hysteresis, and laxity were inferior compared to uninjured age-matched control tendons. Despite these changes, tendons 16-weeks post-injury achieved secant stiffness levels of uninjured tendons. RTA1 and RTA3 groups had no differences in histological properties, but had higher cell numbers compared to control tendons. No changes in gastrocnemius fiber size or type in the superficial or deep regions were detected, except for type 2x fiber fraction. Together, this work highlights RTA-dependent deficits in limb function and tissue-level properties in long-term Achilles tendon and muscle healing. Copyright © 2017 Elsevier Ltd. All rights reserved.

Mechanical, histological, and functional properties remain inferior in conservatively treated Achilles tendons in rodents: Long term evaluation

PubMed Central

Freedman, Benjamin R; Fryhofer, George W; Salka, Nabeel S; Raja, Harina A; Hillin, Cody D; Nuss, Courtney A; Farber, Daniel C; Soslowsky, Louis J

2017-01-01

Conservative treatment (non-operative) of Achilles tendon ruptures is suggested to produce equivalent capacity for return to function; however, long term results and the role of return to activity (RTA) for this treatment paradigm remain unclear. Therefore, the objective of this study was to evaluate the long term response of conservatively treated Achilles tendons in rodents with varied RTA. Sprague Dawley rats (n=32) received unilateral blunt transection of the Achilles tendon followed by randomization into groups that returned to activity after 1-week (RTA1) or 3-weeks (RTA3) of limb casting in plantarflexion, before being sacrificed at 16-weeks post-injury. Uninjured age-matched control animals were used as a control group (N=10). Limb function, passive joint mechanics, tendon properties (mechanical, histological), and muscle properties (histological, immunohistochemical) were evaluated. Results showed that although hindlimb ground reaction forces and range of motion returned to baseline levels by 16-weeks regardless of RTA, ankle stiffness remained altered. RTA1 and RTA3 groups both exhibited no differences in fatigue properties; however, the secant modulus, hysteresis, and laxity were inferior compared to uninjured age-matched control tendons. Despite these changes, tendons 16-weeks post-injury achieved secant stiffness levels of uninjured tendons. RTA1 and RTA3 groups had no differences in histological properties, but had higher cell numbers compared to control tendons. No changes in gastrocnemius fiber size or type in the superficial or deep regions were detected, except for type 2× fiber fraction. Together, this work highlights RTA-dependent deficits in limb function and tissue-level properties in long-term Achilles tendon and muscle healing. PMID:28366437

Internet-delivered cognitive-behavioural therapy v. conventional guided self-help for bulimia nervosa: long-term evaluation of a randomised controlled trial.

PubMed

Wagner, Gudrun; Penelo, Eva; Wanner, Christian; Gwinner, Paulina; Trofaier, Marie-Louise; Imgart, Hartmut; Waldherr, Karin; Wöber-Bingöl, Ciçek; Karwautz, Andreas F K

2013-02-01

Cognitive-behavioural therapy (CBT)-based guided self-help is recommended as a first step in the treatment of bulimia nervosa. To evaluate in a randomised controlled trial (Clinicaltrials.gov registration number: NCT00461071) the long-term effectiveness of internet-based guided self-help (INT-GSH) compared with conventional guided bibliotherapy (BIB-GSH) in females with bulimia nervosa. A total of 155 participants were randomly assigned to INT-GSH or BIB-GSH for 7 months. Outcomes were assessed at baseline, month 4, month 7 and month 18. The greatest improvement was reported after 4 months with a continued reduction in eating disorder symptomatology reported at month 7 and 18. After 18 months, 14.6% (n = 7/48) of the participants in the INT-GSH group and 25% (n = 7/28) in the BIB-GSH group were abstinent from binge eating and compensatory measures, 43.8% (n = 21/48) and 39.2% (n = 11/28) respectively were in remission. No differences regarding outcome between the two groups were found. Internet-based guided self-help for bulimia nervosa was not superior compared with bibliotherapy, the gold standard of self-help. Improvements remain stable in the long term.

Additional 4-week capecitabine during the resting periods after 6-week neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer: long-term oncologic outcomes.

PubMed

Park, Sang Woo; Kim, Jin Soo; Kim, Ji Yeon; Lee, Kyung Ha

2018-06-01

The aim of this study was to evaluate the long-term outcome of additional 4-week chemotherapy with capecitabine during the resting periods following a 6-week neoadjuvant chemoradiotherapy (NCRT) regimen, in patients with locally advanced rectal cancer. Radiotherapy was delivered to the whole pelvis at a total dose of 50.4 Gy for 6 weeks. Oral capecitabine was administered at a dose of 825 mg/m 2 twice daily for 10 weeks. Surgery was performed 2-4 weeks following the completion of chemotherapy. Between January 2010 and September 2011, 41 patients completed the scheduled neoadjuvant therapy and surgery. The pathologic complete response rate, 5-year overall survival, and 5-year disease-free survival rates were 22%, 85.4%, and 78.0%, respectively. The 5-year systemic recurrence and 5-year local recurrence rates were 22% and 0%, respectively. Additional 4-week chemotherapy with capecitabine, during the resting periods following a 6-week NCRT regimen, has favorable long-term oncologic outcomes. Further randomized controlled trials are however necessary to evaluate if substantial improvement in local control is achieved with this additional chemotherapy modality for locally advanced rectal cancer.

Histomorphometric examination of long-term changes in temporomandibular joints after mandibular lengthening by distraction osteogenesis in rabbits.

PubMed

Mihmanli, Ahmet; Dolanmaz, Doğan; Tüz, Hakan; Pampu, Alper; Dönmez, Hasan Hüseyin

2012-05-01

The purpose of this study was to evaluate long-term histomorphometric changes in temporomandibular joints (TMJs) of rabbits after mandibular distraction osteogenesis (DO). Twenty-six rabbits were used in this study. Two of them served as control subjects, and the remaining 24 underwent DO procedures in their left mandibular bodies. After a latency period of 5 days, 5 mm lengthening was performed at a rate of 1 mm/d. The rabbits in the experimental group were randomly divided into 4 subgroups and killed after 1, 2, 4, and 6 months. TMJs from both sides were harvested and prepared with hematoxylin and eosin stain for histomorphometric examination under an optical microscope. Compared with control subjects and nondistracted sides, fibrous articular, proliferative, and hypertrophic areas were significantly increased (P < .05) in the first 2 months in distracted sides. The changes were insignificant in the fourth and sixth postoperative months. Unilateral mandibular distraction of 5 mm was found to be well tolerated and no degenerative changes were observed histologically in the rabbit TMJs in the long-term period. Copyright © 2012 Elsevier Inc. All rights reserved.

Immediate effects on adult drinkers of exposure to alcohol harm reduction advertisements with and without drinking guideline messages: experimental study.

PubMed

Wakefield, Melanie A; Brennan, Emily; Dunstone, Kimberley; Durkin, Sarah J; Dixon, Helen G; Pettigrew, Simone; Slater, Michael D

2018-06-01

To compare the immediate effects on drinkers of television advertisements focusing upon short- versus long-term harms with and without low-risk drinking guidelines. Between-participants on-line experiment, with random assignment to view: (a) alcohol product advertisements (ALC control); (b) advertisements unrelated to alcohol (NON-ALC control); (c) advertisements featuring short-term harms (STH) of alcohol; (d) advertisements featuring STH plus a STH guideline (STH+G); (e) advertisements featuring long-term harms (LTH); or (f) advertisements featuring LTH plus a LTH guideline (LTH+G). Australia, 2016. A total of 3718 drinkers aged 18-64 years (48.5% male). Post-exposure likelihood that participants provided a correct estimate of drinking levels associated with short- and long-term harms; post-exposure intentions to avoid alcohol or reduce consumption. After exposure to STH+G or LTH+G advertisements, participants were more likely to estimate correctly rather than overestimate drinking levels associated with harm, compared with those exposed to STH (P < 0.001) and LTH advertisements without guidelines, respectively (P = 0.019) and ALC control (STH+G, P < 0.001; LTH+G, P < 0.001) and NON-ALC control conditions (STH+G, P < 0.001; LTH+G, P = 0.011). Drinkers exposed to STH conditions were more likely to intend to reduce next-week alcohol consumption than those exposed to ALC control (both P < 0.001) and NON-ALC control conditions (STH, P = 0.001; STH+G, P < 0.001); a similar pattern was observed for intentions to avoid alcohol. Drinkers exposed to LTH conditions were also more likely than drinkers exposed to ALC or NON-ALC controls to intend to avoid and reduce alcohol in the next week. Additionally, drinkers exposed to LTH+G were more likely to intend to reduce drinking than those exposed to LTH advertisements without guidelines (P = 0.022). Response patterns for low- and high-risk drinkers by condition were similar. Alcohol harm television advertisements increase intentions to reduce alcohol consumption among both low- and high-risk drinkers. The addition of low-risk drinking guidelines can enhance these effects for advertisements featuring long-term harms and improve estimates of both short- and long-term harmful drinking levels. © 2018 Society for the Study of Addiction.

A Randomized Controlled Trial Comparing Suture-Fixation Mucopexy and Doppler-Guided Hemorrhoidal Artery Ligation in Patients with Grade III Hemorrhoids

PubMed Central

Zhai, Min; Zhang, Yong-An; Wang, Zhen-Yi; Sun, Jian-Hua; Wen, Jie; Zhang, Qi; Li, Jin-De; Wu, Yi-Zheng; Zhou, Feng; Xu, Hui-Lei

2016-01-01

Background. We aimed to evaluate the effectiveness of a suture-fixation mucopexy procedure by comparing with Doppler-guided hemorrhoidal artery ligation (DGHAL) in the management of patients with grade III hemorrhoids. Methods. This was a randomized controlled trial. One hundred patients with grade III hemorrhoids were randomly assigned to receive suture-fixation mucopexy (n = 50) or DGHAL (n = 50). Outcome assessments were performed at 2 weeks, 12 months, and 24 months. Assessments included resolution of clinical symptoms, postoperative complications, duration of hospitalization, and total costs. Results. At 2 weeks, one (2%) patient in suture-fixation group and four (8%) patients in DGHAL group had persistent prolapsing hemorrhoids. Postoperative bleeding was observed in two patients (4%) in suture-fixation group and one patient in DGHAL group. There was no significant difference in short-term recurrence between groups. Postoperative complications and duration of hospitalization were comparable between the two groups. Rates of recurrence of prolapse or bleeding at 12 months did not differ between groups. However, recurrence of prolapse at 24 months was significantly more common in DGHAL group (19.0% versus 2.3%, p = 0.030). Conclusions. Compared with DGHAL, the suture-fixation mucopexy technique had comparable short-term outcomes and favorable long-term outcomes. PMID:27066071

Long-term integrated telerehabilitation of COPD Patients: a multicentre randomised controlled trial (iTrain).

PubMed

Zanaboni, Paolo; Dinesen, Birthe; Hjalmarsen, Audhild; Hoaas, Hanne; Holland, Anne E; Oliveira, Cristino Carneiro; Wootton, Richard

2016-08-22

Pulmonary rehabilitation (PR) is an effective intervention for the management of people with chronic obstructive pulmonary disease (COPD). However, available resources are often limited, and many patients bear with poor availability of programmes. Sustaining PR benefits and regular exercise over the long term is difficult without any exercise maintenance strategy. In contrast to traditional centre-based PR programmes, telerehabilitation may promote more effective integration of exercise routines into daily life over the longer term and broaden its applicability and availability. A few studies showed promising results for telerehabilitation, but mostly with short-term interventions. The aim of this study is to compare long-term telerehabilitation with unsupervised exercise training at home and with standard care. An international multicentre randomised controlled trial conducted across sites in three countries will recruit 120 patients with COPD. Participants will be randomly assigned to telerehabilitation, treadmill and control, and followed up for 2 years. The telerehabilitation intervention consists of individualised exercise training at home on a treadmill, telemonitoring by a physiotherapist via videoconferencing using a tablet computer, and self-management via a customised website. Patients in the treadmill arm are provided with a treadmill only to perform unsupervised exercise training at home. Patients in the control arm are offered standard care. The primary outcome is the combined number of hospitalisations and emergency department presentations. Secondary outcomes include changes in health status, quality of life, anxiety and depression, self-efficacy, subjective impression of change, physical performance, level of physical activity, and personal experiences in telerehabilitation. This trial will provide evidence on whether long-term telerehabilitation represents a cost-effective strategy for the follow-up of patients with COPD. The delivery of telerehabilitation services will also broaden the availability of PR and maintenance strategies, especially to those living in remote areas and with no access to centre-based exercise programmes. ClinicalTrials.gov: NCT02258646 .

Systemic hydrocortisone to prevent bronchopulmonary dysplasia in preterm infants (the SToP-BPD study); a multicenter randomized placebo controlled trial

PubMed Central

2011-01-01

Background Randomized controlled trials have shown that treatment of chronically ventilated preterm infants after the first week of life with dexamethasone reduces the incidence of the combined outcome death or bronchopulmonary dysplasia (BPD). However, there are concerns that dexamethasone may increase the risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. So far no randomized controlled trial has investigated its efficacy when administered after the first week of life to ventilated preterm infants. Methods/Design The SToP-BPD trial is a randomized double blind placebo controlled multicenter study including 400 very low birth weight infants (gestational age < 30 weeks and/or birth weight < 1250 grams), who are ventilator dependent at a postnatal age of 7 - 14 days. Hydrocortisone (cumulative dose 72.5 mg/kg) or placebo is administered during a 22 day tapering schedule. Primary outcome measure is the combined outcome mortality or BPD at 36 weeks postmenstrual age. Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalization, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age. Analysis will be on an intention to treat basis. Discussion This trial will determine the efficacy and safety of postnatal hydrocortisone administration at a moderately early postnatal onset compared to placebo for the reduction of the combined outcome mortality and BPD at 36 weeks postmenstrual age in ventilator dependent preterm infants. Trial registration number Netherlands Trial Register (NTR): NTR2768 PMID:22070744

Does extended proactive telephone support increase smoking cessation among low-income women using nicotine patches?

PubMed

Solomon, Laura J; Marcy, Theodore W; Howe, Kathleen D; Skelly, Joan M; Reinier, Kyndaron; Flynn, Brian S

2005-03-01

It is unclear whether proactive telephone support enhances smoking cessation beyond the provision of nicotine replacement therapy alone. We randomly assigned 330 low-income women smokers to receive either free nicotine patches (control condition) or free nicotine patches with up to 16 weeks of proactive telephone support (experimental condition). All participants were assessed by telephone at baseline and at 2 weeks, 3 months, and 6 months post-baseline to determine smoking status. Results revealed a significant effect for the telephone support at 3 months, with 43% of experimental versus 26% of control condition women reporting 30-day point prevalent abstinence (P = 0.002). The difference was no longer significant at 6 months. A metaanalysis conducted with five randomized studies revealed a slight but non-significant long-term benefit of proactive telephone support when added to the provision of free nicotine patches for smoking cessation. This is the second study to demonstrate a short-term effect for proactive telephone support added to free nicotine replacement therapy; however, neither the current study, nor the metaanalysis including the four other published trials, confirmed a longer-term benefit.

Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes.

PubMed

Rosenstock, J; Gross, J L; Aguilar-Salinas, C; Hissa, M; Berglind, N; Ravichandran, S; Fleming, D

2013-12-01

To evaluate the safety of saxagliptin ± metformin over 4 years in patients with Type 2 diabetes mellitus. Drug-naive (n = 401; study 11) or metformin-treated (n = 743; study 14) adults with HbA(1c) of 53-86 mmol/mol (7.0-10%) were enrolled in two randomized, placebo-controlled, double-blind trials of saxagliptin 2.5, 5 or 10 mg/day. Patients rescued during or completing 24 weeks of treatment could continue in a 42-month long-term blinded phase, for which the primary goal was assessment of safety and tolerability. Between-group efficacy was not evaluated in the long-term phase of study 11. Time to rescue or discontinuation because of inadequate glycaemic control, change from baseline in HbA(1c) and percentages of patients achieving HbA(1c) < 53 mmol/mol (< 7.0%) were assessed in study 14. No new safety findings were noted during the long-term phase. Most adverse events were mild or moderate, with slightly greater frequency of upper respiratory infections with saxagliptin. Hypoglycaemic event rates were similar with saxagliptin and placebo. In study 14, time to rescue or discontinuation because of inadequate glycaemic control was longer with saxagliptin plus metformin than for placebo plus metformin. From baseline to week 154, HbA(1c) decreased with saxagliptin but increased with placebo. Saxagliptin monotherapy or add-on to metformin is generally safe and well tolerated, with no increased risk of hypoglycaemia, for up to 4 years. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

On the simple random-walk models of ion-channel gate dynamics reflecting long-term memory.

PubMed

Wawrzkiewicz, Agata; Pawelek, Krzysztof; Borys, Przemyslaw; Dworakowska, Beata; Grzywna, Zbigniew J

2012-06-01

Several approaches to ion-channel gating modelling have been proposed. Although many models describe the dwell-time distributions correctly, they are incapable of predicting and explaining the long-term correlations between the lengths of adjacent openings and closings of a channel. In this paper we propose two simple random-walk models of the gating dynamics of voltage and Ca(2+)-activated potassium channels which qualitatively reproduce the dwell-time distributions, and describe the experimentally observed long-term memory quite well. Biological interpretation of both models is presented. In particular, the origin of the correlations is associated with fluctuations of channel mass density. The long-term memory effect, as measured by Hurst R/S analysis of experimental single-channel patch-clamp recordings, is close to the behaviour predicted by our models. The flexibility of the models enables their use as templates for other types of ion channel.

Oral supplementation with carbohydrate- and branched-chain amino acid-enriched nutrients improves postoperative quality of life in patients undergoing hepatic resection.

PubMed

Okabayashi, Takehiro; Iyoki, Miho; Sugimoto, Takeki; Kobayashi, Michiya; Hanazaki, Kazuhiro

2011-04-01

The long-term outcomes of branched-chain amino acid (BCAA) administration in patients undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of oral supplementation with BCAA-enriched nutrients on postoperative quality of life (QOL) in patients undergoing liver resection. A prospective randomized clinical trial was conducted in 96 patients undergoing hepatic resection. Patients were randomly assigned to receive BCAA supplementation (AEN group, n = 48) or a conventional diet (control group, n = 48). Postoperative QOL and short-term outcomes were regularly and continuously evaluated in all patients using a short-form 36 (SF-36) health questionnaire and by measuring various clinical parameters. This study demonstrated a significant improvement in QOL after hepatectomy for liver neoplasm in the AEN group based on the same patients' preoperative SF-36 scores (P < 0.05). Perioperative BCAA supplementation preserved liver function and general patient health in the short term for AEN group patients compared to those not receiving the nutritional supplement. BCAA supplementation improved postoperative QOL after hepatic resection over the long term by restoring and maintaining nutritional status and whole-body kinetics. This study was registered at http://www.clinicaltrials.gov (registration number: NCT00945568).

Low-Intensity Wheelchair Training in Inactive People with Long-Term Spinal Cord Injury: A Randomized Controlled Trial on Propulsion Technique.

PubMed

van der Scheer, Jan W; de Groot, Sonja; Vegter, Riemer J K; Hartog, Johanneke; Tepper, Marga; Slootman, Hans; Veeger, DirkJan H E J; van der Woude, Lucas H V

2015-11-01

The objective of this study was to investigate the effects of a low-intensity wheelchair training on propulsion technique in inactive people with long-term spinal cord injury. Participants in this multicenter nonblinded randomized controlled trial were inactive manual wheelchair users with spinal cord injury for at least 10 yrs (N = 29), allocated to exercise (n = 14) or no exercise. The 16-wk training consisted of wheelchair treadmill propulsion at 30%-40% heart rate reserve or equivalent in rate of perceived exertion, twice a week, 30 mins per session. Propulsion technique was assessed at baseline as well as after 8, 16, and 42 wks during two submaximal treadmill-exercise blocks using a measurement wheel attached to a participant's own wheelchair. Changes over time between the groups were analyzed using Mann-Whitney U tests on difference scores (P < 0.05/3). Data of 16 participants could be analyzed (exercise: n = 8). Significant differences between the exercise and control groups were only found in peak force after 8 wks (respective medians, -20 N vs. 1 N; P = 0.01; r(u) = 0.78). Significant training effects on propulsion technique were not found in this group. Perhaps, substantial effects require a higher intensity or frequency. Investigating whether more effective and feasible interventions exist might help reduce the population's risk of upper-body joint damage during daily wheelchair propulsion.

Long-term outcome of a randomized controlled universal prevention trial through a positive parenting program: is it worth the effort?

PubMed

Hahlweg, Kurt; Heinrichs, Nina; Kuschel, Annett; Bertram, Heike; Naumann, Sebastian

2010-05-16

Approximately 20% of children experience internalizing or externalizing DSM-IV-TR disorders. This prevalence rate cannot be reduced through treatment only. Effective preventive interventions are therefore urgently needed. The aim of the current investigation is to evaluate the two-year efficacy of the group Triple P parenting program administered universally for the prevention of child behavior problems. Based on their respective preschool, N = 280 families were randomly assigned either to the parent training or to the control group. The efficacy was analyzed using multi-source assessments, including questionnaires by mother and father, behavioral observation of mother-child interaction, and teacher evaluations. At the 2-year follow-up, both parents in the Triple P intervention reported significant reductions in dysfunctional parenting behavior, and mothers also an increase in positive parenting behavior. In addition, mothers reported significant reductions in internalizing and externalizing child behavior. Single-parent mothers in the Triple P intervention did not report significant changes in parenting or child problem behavior which is primarily due to inexplicable high positive effects in single parent mothers of the control group. Neither mother-child interactions nor teacher ratings yielded significant results. The results support the long-term efficacy of the Triple P - group program as a universal prevention intervention for changing parenting behavior in two-parent households, but not necessarily in single-parent mothers.

Mechanisms of behavioural maintenance: Long-term effects of theory-based interventions to promote safe water consumption.

PubMed

Inauen, Jennifer; Mosler, Hans-Joachim

2016-01-01

Theory-based interventions can enhance people's safe water consumption, but the sustainability of these interventions and the mechanisms of maintenance remain unclear. We investigated these questions based on an extended theory of planned behaviour. Seven hundred and ten (445 analysed) randomly selected households participated in two cluster-randomised controlled trials in Bangladesh. Study 1 promoted switching to neighbours' arsenic-safe wells, and Study 2 promoted switching to arsenic-safe deep wells. Both studies included two intervention phases. Structured interviews were conducted at baseline (T1), and at 1-month (T2), 2-month (T3) and 9-month (T4) follow-ups. In intervention phase 1 (between T1 and T2), commitment-based behaviour change techniques--reminders, implementation intentions and public commitment--were combined with information and compared to an information-only control group. In phase 2 (between T2 and T3), half of each phase 1 intervention group was randomly assigned to receive either commitment-based techniques once more or coping planning with reminders and information. Initial well-switching rates of up to 60% significantly declined by T4: 38.3% of T2 safe water users stopped consuming arsenic-safe water. The decline depended on the intervention. Perceived behavioural control, intentions, commitment strength and coping planning were associated with maintenance. In line with previous studies, the results indicate that commitment and reminders engender long-term behavioural change.

Predictors of short- and long-term avoidance in completers of inpatient group interventions for agoraphobia.

PubMed

Hoffart, Asle; Øktedalen, Tuva; Svanøe, Karol; Hedley, Liv M; Sexton, Harold

2015-08-01

Little is currently known about predictors of follow-up outcome of psychological treatment of agoraphobia. In this study, we wished to examine predictors of short- and long-term avoidance after inpatient group interventions for agoraphobia. Ninety-six (68%) of 141 agoraphobic patients (74% women) who had completed treatment in two open and one randomized controlled trial (RCT) were followed up 13 to 21 years after start of treatment. Major depression at pre-treatment predicted less short-term (up to one year after end of treatment) improvement in agoraphobic avoidance. Working and being married/cohabiting at pre-treatment predicted greater long-term (across one-year, two-year, and 13-21 years follow-up) improvement. In contrast, the duration of agoraphobia, amount of Axis I and II co-morbidity, being diagnosed with avoidant, dependent, and obsessive-compulsive personality disorder, and the use of antidepressants and benzodiazepines the month before intake to treatment, were unrelated to short-term as well as long-term outcome. As many as 31.9% of the included patients did not attend long-term follow-up and the power of the study was limited. The long time period between the two and 13-21 year follow-ups is a limitation, in which it is difficult to assess what actually happened. Although all the patients received some form of CBT, there was variability among the treatments. The only short-term predictor identified represented a clinical feature, whereas the long-term predictors represented features of the patients' life situation. The limited power of the study precludes the inference that non-significant predictors are unrelated to follow-up outcome. Copyright © 2015 Elsevier B.V. All rights reserved.

Impact of Short- and Long-term Tai Chi Mind-Body Exercise Training on Cognitive Function in Healthy Adults: Results From a Hybrid Observational Study and Randomized Trial.

PubMed

Walsh, Jacquelyn N; Manor, Brad; Hausdorff, Jeffrey; Novak, Vera; Lipsitz, Lewis; Gow, Brian; Macklin, Eric A; Peng, Chung-Kang; Wayne, Peter M

2015-07-01

Cognitive decline amongst older adults is a significant public health concern. There is growing interest in behavioral interventions, including exercise, for improving cognition. Studies to date suggest tai chi (TC) may be a safe and potentially effective exercise for preserving cognitive function with aging; however, its short-term and potential long-term impact on physically active, healthy adults is unclear. To compare differences in cognitive function among long-term TC expert practitioners and age-matched and gender-matched TC-naïve adults and to determine the effects of short-term TC training on measures of cognitive function in healthy, nonsedentary adults. A hybrid design including an observational comparison and a 2-arm randomized clinical trial (RCT). Healthy, nonsedentary, TC-naive adults (50 y-79 y) and age-matched and gender-matched long-term TC experts. A cross-sectional comparison of cognitive function in healthy TC-naïve (n=60) and TC expert (24.5 y ÷ 12 y experience; n=27) adults: TC-naïve adults then completed a 6-month, 2-arm, wait-list randomized clinical trial of TC training. Six measures of cognitive function were assessed for both cross-sectional and longitudinal comparisons. TC experts exhibited trends towards better scores on all cognitive measures, significantly so for category fluency (P=.01), as well as a composite z score summarizing all 6 cognitive assessments (P=.03). In contrast, random assignment to 6 months of TC training in TC-naïve adults did not significantly improve any measures of cognitive function. In healthy nonsedentary adults, long-term TC training may help preserve cognitive function; however, the effect of short-term TC training in healthy adults remains unclear. ClinicalTrials.gov NCT01340365.

Effects of additional oxazepam in long-term users of oxazepam.

PubMed

Voshaar, Richard C Oude; Verkes, Robbert-Jan; van Luijtelaar, Gilles L J M; Edelbroek, Peter M; Zitman, Frans G

2005-02-01

Although additional dosages of benzodiazepines in long-term users of benzodiazepines are common, it is unknown whether these additional dosages resort any effect. The effects of an additional 20-mg dosage oxazepam were assessed in a double-blind, balanced-order, crossover randomized study comparing 16 long-term users of oxazepam (patients) with 18 benzodiazepine-naive controls (controls). The effects of 10 and 30 mg oxazepam were assessed at pretest and 2.5 hours after drug administration on: (a) saccadic eye movements as proxy for the sedative effect, (b) acoustic startle response (ASR) as proxy for the anxiolytic effects, (c) memory, (d) reaction time tasks, and (e) subjective measurements. Dose-related effects were found in patients on the peak velocity of saccadic eye movement and on response probability, respectively peak amplitude of the ASR. Comparison with controls, however, suggests that in patients the sedative effects might be mixed up with suppression of sedative withdrawal symptoms, whereas patients were as sensitive as benzodiazepine-naive controls for the effects of an additional dosage on the ASR. Neither 10 nor 30 mg oxazepam challenge affected the reaction time tasks in patients, whereas controls show a dose-related impairment. The memory impairing effects, however, did not differ significantly between patients and controls. In contrast to controls, patients could not discriminate between a 10- and 30-mg dosage as assessed by visual analogue scales and the STAI-DY-1, which might indicate a placebo effect in the 10-mg challenge in patients. We conclude that additional dosages of oxazepam still exert pronounced effects after daily use for more than 10 years.

Effects of Sustained Abstinence Among Treated Substance-Abusing Homeless Persons on Housing and Employment

PubMed Central

Schumacher, Joseph E.; Wallace, Dennis; Vuchinich, Rudy; Mennemeyer, Stephen T.; Kertesz, Stefan G.

2010-01-01

Objectives. We examined whether cocaine-dependent homeless persons had stable housing and were employed 6, 12, and 18 months after they entered a randomized controlled trial comparing 2 treatments. Methods. One group (n = 103) received abstinence-contingent housing, vocational training, and work; another group (n = 103) received the same intervention plus cognitive behavioral day treatment. We examined baseline and early treatment variables for association with long-term housing and employment. Results. Although the enhanced-treatment group achieved better abstinence rates, the groups did not differ in long-term housing and employment stability. However, consecutive weeks of abstinence during treatment (and to a lesser extent, older age and male gender) predicted long-term housing and employment stability after adjustment for baseline differences in employment, housing, and treatment. Conclusions. Our data showed a relationship of abstinence with housing stability. Contrasting these results with the increasingly popular Housing First interventions reveals important gaps in our knowledge to be addressed in future research. PMID:19833998

WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial.

PubMed

Compare, Angelo; Kouloulias, Vassilis; Apostolos, Vontas; Peña, Wendy Moreno; Molinari, Enrico; Grossi, Enzo; Efstathios, Efstathopoulos; Carenini, Michele

2012-09-03

There is compelling evidence that psychological factors may have the same or even greater impact on the possibility of adverse events on cardiac diseases (CD) than other traditional clinical risk factors. Anxiety and depression are predictors of short- and long-term adverse outcomes, increased risk for higher rates of in-hospital complications, re-infarction, malignant arrhythmias, and mortality in CD patients. Despite researchers finding that cognitive behavior therapy (CBT) reduced depressive and anxiety symptoms, the fact that such results are maintained only in the short term and the lack of maintenance of the long-term affects the absence of changes in lifestyles, preventing the possibility of a wide generalization of results. Recently wellbeing therapy (WBT) has been proposed as a useful approach to improve healthy lifestyle behaviors and reduce psychological distress. The present randomized controlled study will test WBT, in comparison with CBT, as far as the reduction of symptoms of depression, anxiety and psychological distress, and the improvement of lifestyle behaviors and quality of life in cardiac patients are concerned. Moreover, innovations in communication technologies allow patients to be constantly followed in real life. Therefore WBT based on personalized mobile technology will allow the testing of its effectiveness in comparison with usual WBT. The present study is a large outpatient study on the treatment of co-morbid depression, anxiety, and psychological distress in cardiac patients. The most important issues of this study are its randomized design, the focus on promotion of health-related behaviors, and the use of innovative technologies supporting patients' wellbeing in real life and in a continuous way. First results are expected in 2012. ClinicalTrials.gov Identifier: NCT01543815.

Inferior vena cava filters in pulmonary embolism: A historic controversy.

PubMed

Jerjes-Sanchez, Carlos; Rodriguez, David; Navarrete, Aline; Parra-Cantu, Carolina; Joya-Harrison, Jorge; Vazquez, Eduardo; Ramirez-Rivera, Alicia

Rationale for non-routine use of inferior venous cava filters (IVCF) in pulmonary embolism (PE) patients. Thrombosis mechanisms involved with IVCF placement and removal, the blood-contacting medical device inducing clotting, and the inorganic polyphosphate in the contact activation pathway were analyzed. In addition, we analyzed clinical evidence from randomized trials, including patients with and without cancer. Furthermore, we estimated the absolute risk reduction (ARR), the relative risk reduction (RRR), and the number needed to treat (NNT) based on the results of each study using a frequency table. Finally, we analyzed the outcome of our PE patients that were submitted to thrombolysis with short and long term follow-up. IVCF induces thrombosis by several mechanisms including placement and removal, rapid protein adsorption, and simultaneous surface-induced activation via the contact activation pathway. Also, inorganic polyphosphate has an important role as a procoagulant, reversing the effect of anticoagulants. Randomized control trials included 904 cancer and non-cancer PE patients. In terms of ARR, RRR, and NNT, there is no evidence for routine use of IVCF. In 290 patients with proved PE, extensive thrombotic burden and right ventricular dysfunction under thrombolysis and oral anticoagulation, we observed a favorable outcome in a short- and long-term follow-up; additionally, IVCF was only used in 5% of these patients. Considering the complex mechanisms of thrombosis related with IVCF, the evidence from randomized control trials and ARR, RRR, and NNT obtained from venous thromboembolism patients with and without cancer, non-routine use of IVCF is recommended. Copyright © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

Preschool-based social communication treatment for children with autism: 12-month follow-up of a randomized trial.

PubMed

Kaale, Anett; Fagerland, Morten W; Martinsen, Egil W; Smith, Lars

2014-02-01

This study reports 12-month follow-up data from a randomized controlled trial of preschool-based social communication treatment for young children with autism. A total of 61 children (48 males) with autism, 29 to 60 months of age, had earlier been randomized either to 8 weeks of preschool-based social communication treatment in addition to standard preschool program (n = 34) or to standard preschool program only (n = 27). Significant short-term effects on targeted social communication skills have previously been published. Long-term gains in social communication, language and global social functioning and communication were assessed from video-taped preschool teacher-child and mother-child interactions, Early Social Communication Scales, Reynell Developmental Language Scale, and Social Communication Questionnaire. Compared with those in the control group, the treated children achieved significantly larger improvements in joint attention and joint engagement from baseline to 12-month follow-up. However, no effects were detected on language and global ratings of social functioning and communication. The treatment effect on child initiation of joint attention increased with increasing level of sociability at baseline, whereas nonverbal IQ and expressive language had no moderating effect. This study is the first to show that, similar to specialist-delivered treatment, preschool-based treatment may produce small but possibly clinically important long-term changes in social communication in young children with autism. The treatment did not affect language and global ratings of social functioning and communication. More studies are needed to better understand whether treatment effects may be improved by increasing the intensity and duration of the treatment. Clinical trial registration information--Joint Attention Intervention and Young Children With Autism; http://clinicaltrials.gov/; NCT00378157. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Twelve-year follow-up of a randomized controlled trial of comprehensive physiotherapy following disc herniation operation.

PubMed

Ebenbichler, Gerold R; Inschlag, Silke; Pflüger, Verena; Stemberger, Regina; Wiesinger, Günther; Novak, Klaus; Christoph, Krall; Resch, Karl L

2015-06-01

To evaluate the long-term effects of postoperative comprehensive physiotherapy starting one week after lumbar disc surgery. Twelve-year follow-up of a three-armed, randomized, controlled, single-blinded clinical trial. Department of Physical Medicine & Rehabilitation. Of 111 patients following first-time, uncomplicated lumbar disc surgery who participated in the original study and completed the treatment originally allocated, 74 ((67%; 29 (73%) physiotherapy, 22 (58%) sham therapy, 23 (68%) no therapy) completed a 12-year follow-up examination. In the original study, patients had been randomly assigned to comprehensive physiotherapy, sham intervention (neck massage), or no therapy. Low Back Pain Rating Scale; best score 0, worst score 130 points). At 12 years after surgery, the group participating in comprehensive physiotherapy had significantly better functional outcomes, as rated on the Low Back Pain Rating Score, than the untreated group (mean difference: -13.2 (95% CI: (-25.4; -1.0)). Equally, there was a clinically relevant, non-significant difference between the sham therapy and no therapy (mean difference: -12.5 (95%CI: -26.1; 1.1)). Consequently, the Low Back Pain Rating Score outcome did not differ between physiotherapy and sham therapy (mean difference: -0.7 (95%CI: -14.2; 12.8)). Participating in a comprehensive physiotherapy program following lumbar disc surgery may be associated with better long-term health benefits over no intervention, but may not be superior to sham therapy. © The Author(s) 2014.

Six Weeks of Massage Therapy Produces Changes in Balance, Neurological and Cardiovascular Measures in Older Persons

PubMed Central

Sefton, JoEllen M.; Yarar, Ceren; Berry, Jack W.

2012-01-01

Objectives: Falls in older adults represent a primary cause of decreased mobility and independence, increased morbidity, and accidental death. Research and clinical reports indicate that therapeutic massage (TM) may positively influence suggested causative factors. The second in a two-part study, this project assessed the effects of six weeks of TM treatment on balance, nervous system, and cardiovascular measures in older adults. Design: A randomized controlled trial assessed the effects of six weekly 60-minute sessions of TM on balance, cardiovascular, and nervous system measures. Thirty-five volunteers (19 male and 16 female; ages 62.9 ± 4.6) were randomly assigned to relaxation control or TM groups. A 2 × 4 [treatment condition X time (week 1 and 6)] mixed factorial experimental design was utilized for cardiovascular/balance variables assessed at pretreatment baseline, immediate post-treatment, and 20- and 60-minutes post-treatment; nervous system measures were assessed only at pretreatment and at 60-minute follow-up (2 × 2 mixed design). Long-term benefits were assessed by comparing the TM and control groups on pretreatment baseline measures at week six and a follow-up assessment at week seven (2 × 3 mixed design). Setting: Laboratory Intervention: Six weekly 60-minute, full-body TM. Outcome Measures: Postural control/cardiovascular measures were assessed weeks one, six, and seven; pretreatment and immediate, 20- and 60-minutes post-treatment. Motoneuron pool excitability was assessed pretreatment and 60 minutes post-treatment. Results: The TM group showed significant differences relative to controls in cardiovascular and displacement area/velocity after the week six session, with decreasing blood pressure and increasing stability over time from immediate post-TM to 60 minutes post-TM. The TM group revealed lower H-max/M-max ratios 60-minutes post-treatment. Long-term differences between the groups were detected at week seven in displacement area/velocity and systolic blood pressure. Conclusions: Results suggest six weeks of TM resulted in immediate and long-term improvements in postural stability and blood pressure, compared to a controlled condition. PMID:23087776

Laparoscopic vs open approach for transverse colon cancer. A systematic review and meta-analysis of short and long term outcomes.

PubMed

Athanasiou, Christos D; Robinson, Jonathan; Yiasemidou, Marina; Lockwood, Sonia; Markides, Georgios A

2017-05-01

Transverse colon malignancies have been excluded from all randomized controlled trials comparing laparoscopic against open colectomies, potentially due to the advanced laparoscopic skills required for dissecting around the middle colic vessels and the associated morbidity. Concerns have been expressed that the laparoscopic approach may compromise the oncological clearance in transverse colon cancer. This study aimed to comprehensively compare the laparoscopic (LPA) to the open (OPA) approach by performing a meta-analysis of long and short term outcomes. Medline, Embase, Cochrane library, Scopus and Web of Knowledge databases were interrogated. Selected studies were critically appraised and the short-term morbidity and long term oncological outcomes were meta-analyzed. Sensitivity analysis according to the quality of the study, type of procedure (laparoscopic vs laparoscopically assisted) and level of lymphadenectomy was performed. Statistical heterogeneity and publication bias were also investigated. Eleven case control trials (1415 patients) were included in the study. There was no difference between the LPA and the OPA in overall survival [Hazard Ratio (HR) = 0.83 (0.56, 1.22); P = 0.34], disease free survival (p = 0.20), local recurrence (p = 0.81) or distant metastases (p = 0.24). LPA was found to have longer operative time [Weighted mean difference (WMD) = 45.00 (29.48, 60.52); P < 0.00001] with earlier establishment of oral intake [WMD = -1.68 (-1.84, -1.53); P < 0.00001] and shorter hospital stay [WMD = -2.94 (-4.27, -1.62); P = 0.0001]. No difference was found in relation to anastomotic leakage (p = 0.39), intra-abdominal abscess (p = 0.25), lymph nodes harvested (p = 0.17). LPA seems to be safe with equivalent oncological outcomes to OPA and better short term outcomes in selected patient populations. High quality Randomized control trials are required to further investigate the role of laparoscopy in transverse colon cancer. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Regional analgesia for improvement of long-term functional outcome after elective large joint replacement.

PubMed

Atchabahian, Arthur; Schwartz, Gary; Hall, Charles B; Lajam, Claudette M; Andreae, Michael H

2015-08-13

Regional analgesia is more effective than conventional analgesia for controlling pain and may facilitate rehabilitation after large joint replacement in the short term. It remains unclear if regional anaesthesia improves functional outcomes after joint replacement beyond three months after surgery. To assess the effects of regional anaesthesia and analgesia on long-term functional outcomes 3, 6 and 12 months after elective major joint (knee, shoulder and hip) replacement surgery. We performed an electronic search of several databases (CENTRAL, MEDLINE, EMBASE, CINAHL), and handsearched reference lists and conference abstracts. We updated our search in June 2015. We included randomized controlled trials (RCTs) comparing regional analgesia versus conventional analgesia in patients undergoing total shoulder, hip or knee replacement. We included studies that reported a functional outcome with a follow-up of at least three months after surgery. We used standard methodological procedures expected by Cochrane. We contacted study authors for additional information. We included six studies with 350 participants followed for at least three months. All of these studies enrolled participants undergoing total knee replacement. Studies were at least partially blinded. Three studies had a high risk of performance bias and one a high risk of attrition bias, but the risk of bias was otherwise unclear or low.Only one study assessed joint function using a global score. Due to heterogeneity in outcome and reporting, we could only pool three out of six RCTs, with range of motion assessed at three months after surgery used as a surrogate for joint function. All studies had a high risk of detection bias. Using the random-effects model, there was no statistically significant difference between the experimental and control groups (mean difference 3.99 degrees, 95% confidence interval (CI) - 2.23 to 10.21; P value = 0.21, 3 studies, 140 participants, very low quality evidence).We did not perform further analyses because immediate adverse effects were not part of the explicit outcomes of any of these typically small studies, and long-term adverse events after regional anaesthesia are rare.None of the included studies elicited or reported long-term adverse effects like persistent nerve damage. More high-quality studies are needed to establish the effects of regional analgesia on function after major joint replacement, as well as on the risk of adverse events (falls).

Effects of a short-term parental education program on childhood atopic dermatitis: a randomized controlled trial.

PubMed

Futamura, Masaki; Masuko, Ikuyo; Hayashi, Keiichi; Ohya, Yukihiro; Ito, Komei

2013-01-01

Parental education is important in managing childhood atopic dermatitis (AD). We evaluated the long-term effects of a 2-day parental education program (PEP) on childhood AD. In an investigator-blinded, randomized controlled trial, 59 children age 6 months to 6 years with moderate to severe AD and their mothers were recruited in Japan. Participants were given a booklet about AD and received conventional treatment alone or in combination with a 2-day PEP comprising three lectures, three practical sessions, and a group discussion. The primary outcome was evaluation of eczema severity using SCORing Atopic Dermatitis (SCORAD) at 6 months. Secondary outcomes included changes in symptom scores, amount of corticosteroid used, parental quality of life as determined according to the Dermatitis Family Impact questionnaire, and change in parental anxiety regarding the use of corticosteroids in their children. Participants in the PEP group had a significantly lower SCORAD score than those in the control group at 6 months (mean difference 10.0, 95% confidence interval [CI] = 2.3-17.7, p = 0.01) and objective SCORAD score (mean difference 7.1, 95% CI = 0.8-13.5, p = 0.03). The sleeplessness symptom score (mean difference 1.6, 95% CI = 0.0-3.1, p = 0.048) and corticosteroid anxiety score (p = 0.02) in the PEP group were significantly better than in the control group at 6 months. There was no significant difference between groups in the amount of corticosteroid used or quality of life. The PEP had positive long-term effects on eczema severity and parental anxiety about corticosteroid usage. © 2013 Wiley Periodicals, Inc.

A systematic review on the relations between pasta consumption and cardio-metabolic risk factors.

PubMed

Huang, M; Li, J; Ha, M-A; Riccardi, G; Liu, S

2017-11-01

The traditional Italian dish pasta is a major food source of starch with low glycemic index (GI) and an important low-GI component of the Mediterranean diet. This systematic review aimed at assessing comprehensively and in-depth the potential benefit of pasta on cardio-metabolic disease risk factors. Following a standard protocol, we conducted a systematic literature search of PubMed, CINAHL, and Cochrane Central Register of Controlled Trials for prospective cohort studies and randomized controlled dietary intervention trials that examined pasta and pasta-related fiber and grain intake in relation to cardio-metabolic risk factors of interest. Studies comparing postprandial glucose response to pasta with that to bread or potato were quantitatively summarized using meta-analysis of standardized mean difference. Evidence from studies with pasta as part of low-GI dietary intervention and studies investigating different types of pasta were qualitatively summarized. Pasta meals have significantly lower postprandial glucose response than bread or potato meals, but evidence was lacking in terms of how the intake of pasta can influence cardio-metabolic disease risk. More long-term randomized controlled trials are needed where investigators directly contrast the cardio-metabolic effects of pasta and bread or potato. Long-term prospective cohort studies with required data available should also be analyzed regarding the effect of pasta intake on disease endpoints. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Proton Pump Inhibitors Decrease Phlebotomy Need in HFE Hemochromatosis: Double-Blind Randomized Placebo-Controlled Trial.

PubMed

Vanclooster, Annick; van Deursen, Cees; Jaspers, Reggy; Cassiman, David; Koek, Ger

2017-09-01

Phlebotomy constitutes the established treatment for HFE-related hemochromatosis. Retrospective studies have suggested proton pump inhibitors (PPIs) reduce the need for phlebotomy in this population. We conducted a randomized controlled trial to prove this. Thirty p.C282Y homozygous patients were randomly allocated to PPI (pantoprazole 40 mg/day) or placebo for 12 months. Phlebotomies were performed when serum ferritin was > 100 μg/L. Phlebotomy need turned out to be significantly lower in patients taking PPI (P = .0052). PPI treatment significantly reduces the need for phlebotomies in p.C282Y homozygous patients. In view of the known long-term safety profile of PPI, they can be a valuable addition to standard therapy. Clinicaltrials.gov: NCT01524757. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Is there a role for e-cigarettes in smoking cessation?

PubMed

Leduc, Charlotte; Quoix, Elisabeth

2016-04-01

The use of e-cigarettes has dramatically increased over the past few years and their role in smoking cessation remains controversial. Several clinical studies have evaluated their efficacy in smoking cessation but most of them are prospective cohort studies. Only two randomized, controlled trials have compared e-cigarettes versus placebo or patches. A meta-analysis of these two randomized, controlled trials has been performed. Nicotine-containing e-cigarettes appear to help smokers unable to stop smoking altogether to reduce their cigarette consumption when compared with placebo. However, these results are rated 'low' by GRADE standards. Many cohort studies have been conducted, with contradictory results. For some, e-cigarettes could increase the risk of nonsmokers developing nicotine dependence and of current smokers maintaining their dependence. The debate remains open and more randomized trials are needed with long-term data about the efficacy and safety of e-cigarettes. © The Author(s), 2015.

Baseline Predictors of Missed Visits in the Look AHEAD Study

PubMed Central

Fitzpatrick, Stephanie L.; Jeffery, Robert; Johnson, Karen C.; Roche, Cathy C.; Van Dorsten, Brent; Gee, Molly; Johnson, Ruby Ann; Charleston, Jeanne; Dotson, Kathy; Walkup, Michael P.; Hill-Briggs, Felicia; Brancati, Frederick L.

2013-01-01

Objective To identify baseline attributes associated with consecutively missed data collection visits during the first 48 months of Look AHEAD—a randomized, controlled trial in 5145 overweight/obese adults with type 2 diabetes designed to determine the long-term health benefits of weight loss achieved by lifestyle change. Design and Methods The analyzed sample consisted of 5016 participants who were alive at month 48 and enrolled at Look AHEAD sites. Demographic, baseline behavior, psychosocial factors, and treatment randomization were included as predictors of missed consecutive visits in proportional hazard models. Results In multivariate Cox proportional hazard models, baseline attributes of participants who missed consecutive visits (n=222) included: younger age ( Hazard Ratio [HR] 1.18 per 5 years younger; 95% Confidence Interval 1.05, 1.30), higher depression score (HR 1.04; 1.01, 1.06), non-married status (HR 1.37; 1.04, 1.82), never self-weighing prior to enrollment (HR 2.01; 1.25, 3.23), and randomization to minimal vs. intensive lifestyle intervention (HR 1.46; 1.11, 1.91). Conclusions Younger age, symptoms of depression, non-married status, never self-weighing, and randomization to minimal intervention were associated with a higher likelihood of missing consecutive data collection visits, even in a high-retention trial like Look AHEAD. Whether modifications to screening or retention efforts targeted to these attributes might enhance long-term retention in behavioral trials requires further investigation. PMID:23996977

Brain Training in Children and Adolescents: Is It Scientifically Valid?

PubMed

Rossignoli-Palomeque, Teresa; Perez-Hernandez, Elena; González-Marqués, Javier

2018-01-01

Background: Brain training products are becoming increasingly popular for children and adolescents. Despite the marketing aimed at their use in the general population, these products may provide more benefits for specific neurologically impaired populations. A review of Brain Training (BT) products analyzing their efficacy while considering the methodological limitations of supporting research is required for practical applications. Method: searches were made of the PubMed database (until March 2017) for studies including: (1) empirical data on the use of brain training for children or adolescents and any effects on near transfer (NT) and/or far transfer (FT) and/or neuroplasticity, (2) use of brain training for cognitive training purposes, (3) commercially available training applications, (4) computer-based programs for children developed since the 1990s, and (5) relevant printed and peer-reviewed material. Results: Database searches yielded a total of 16,402 references, of which 70 met the inclusion criteria for the review. We classified programs in terms of neuroplasticity, near and far transfer, and long-term effects and their applied methodology. Regarding efficacy, only 10 studies (14.2%) have been found that support neuroplasticity, and the majority of brain training platforms claimed to be based on such concepts without providing any supporting scientific data. Thirty-six studies (51.4%) have shown far transfer (7 of them are non-independent) and only 11 (15.7%) maintained far transfer at follow-up. Considering the methodology, 40 studies (68.2%) were not randomized and controlled; for those randomized, only 9 studies (12.9%) were double-blind, and only 13 studies (18.6%) included active controls in their trials. Conclusion: Overall, few independent studies have found far transfer and long-term effects. The majority of independent results found only near transfer. There is a lack of double-blind randomized trials which include an active control group as well as a passive control to properly control for contaminant variables. Based on our results, Brain Training Programs as commercially available products are not as effective as first expected or as they promise in their advertisements.

Brain Training in Children and Adolescents: Is It Scientifically Valid?

PubMed Central

Rossignoli-Palomeque, Teresa; Perez-Hernandez, Elena; González-Marqués, Javier

2018-01-01

Background: Brain training products are becoming increasingly popular for children and adolescents. Despite the marketing aimed at their use in the general population, these products may provide more benefits for specific neurologically impaired populations. A review of Brain Training (BT) products analyzing their efficacy while considering the methodological limitations of supporting research is required for practical applications. Method: searches were made of the PubMed database (until March 2017) for studies including: (1) empirical data on the use of brain training for children or adolescents and any effects on near transfer (NT) and/or far transfer (FT) and/or neuroplasticity, (2) use of brain training for cognitive training purposes, (3) commercially available training applications, (4) computer-based programs for children developed since the 1990s, and (5) relevant printed and peer-reviewed material. Results: Database searches yielded a total of 16,402 references, of which 70 met the inclusion criteria for the review. We classified programs in terms of neuroplasticity, near and far transfer, and long-term effects and their applied methodology. Regarding efficacy, only 10 studies (14.2%) have been found that support neuroplasticity, and the majority of brain training platforms claimed to be based on such concepts without providing any supporting scientific data. Thirty-six studies (51.4%) have shown far transfer (7 of them are non-independent) and only 11 (15.7%) maintained far transfer at follow-up. Considering the methodology, 40 studies (68.2%) were not randomized and controlled; for those randomized, only 9 studies (12.9%) were double-blind, and only 13 studies (18.6%) included active controls in their trials. Conclusion: Overall, few independent studies have found far transfer and long-term effects. The majority of independent results found only near transfer. There is a lack of double-blind randomized trials which include an active control group as well as a passive control to properly control for contaminant variables. Based on our results, Brain Training Programs as commercially available products are not as effective as first expected or as they promise in their advertisements. PMID:29780336

Recovery in remitted first-episode psychosis at 7 years of follow-up of an early dose reduction/discontinuation or maintenance treatment strategy: long-term follow-up of a 2-year randomized clinical trial.

PubMed

Wunderink, Lex; Nieboer, Roeline M; Wiersma, Durk; Sytema, Sjoerd; Nienhuis, Fokko J

2013-09-01

Short-term outcome studies of antipsychotic dose-reduction/discontinuation strategies in patients with remitted first-episode psychosis (FEP) showed higher relapse rates but no other disadvantages compared with maintenance treatment; however, long-term effects on recovery have not been studied before. To compare rates of recovery in patients with remitted FEP after 7 years of follow-up of a dose reduction/discontinuation (DR) vs maintenance treatment (MT) trial. Seven-year follow-up of a 2-year open randomized clinical trial comparing MT and DR. One hundred twenty-eight patients participating in the original trial were recruited from 257 patients with FEP referred from October 2001 to December 2002 to 7 mental health care services in a 3.2 million-population catchment area. Of these, 111 patients refused to participate and 18 patients did not experience remission. PARTICIPANTS After 7 years, 103 patients (80.5%) of 128 patients who were included in the original trial were located and consented to follow-up assessment. After 6 months of remission, patients were randomly assigned to DR strategy or MT for 18 months. After the trial, treatment was at the discretion of the clinician. Primary outcome was rate of recovery, defined as meeting the criteria of symptomatic and functional remission. Determinants of recovery were examined using logistic regression analysis; the treatment strategy (MT or DR) was controlled for baseline parameters. The DR patients experienced twice the recovery rate of the MT patients (40.4% vs 17.6%). Logistic regression showed an odds ratio of 3.49 (P = .01). Better DR recovery rates were related to higher functional remission rates in the DR group but were not related to symptomatic remission rates. Dose reduction/discontinuation of antipsychotics during the early stages of remitted FEP shows superior long-term recovery rates compared with the rates achieved with MT. To our knowledge, this is the first study showing long-term gains of an early-course DR strategy in patients with remitted FEP. Additional studies are necessary before these results are incorporated into general practice. isrctn.org Identifier: ISRCTN16228411.

Not merely a question of self-control: The longitudinal effects of overeating behaviors, diet quality and physical activity on dieters' perceived diet success.

PubMed

Keller, Carmen; Hartmann, Christina

2016-12-01

This longitudinal study was conducted between 2010 (T1) and 2014 (T2) on a random sample from the general Swiss population (N = 2781, 46% male). Results showed that dieters (restrained eaters) who reported lack of success in T2 were overweight in T1, had higher levels of emotional and external eating, overeating, and ambivalence toward eating palatable food in T1, and a significantly increased body mass index (BMI) in the period between T1 and T2. Dieters who reported success in T2 had maintained a normal BMI between T1 and T2, had a higher diet quality in T1 and had maintained regular physical activity for at least one year before T2. The logistic regression revealed that high levels of dispositional self-control provided the most important predictor of being a successful dieter. When controlling for dispositional self-control, high levels of emotional eating, overeating, and ambivalence in T1, together with increases in these levels between T1 and T2, were associated with a decreased likelihood of being a successful dieter in T2. High levels of diet quality in T1 and the maintenance of regular physical activity were associated with an increased likelihood of being a successful dieter in T2. Results suggest that diet success and failure is a long-term phenomenon, partly but not fully explained by dispositional self-control. Independent of self-control persistent patterns of overeating due to emotional eating and ambivalent feelings toward eating palatable food, also explain long-term diet failure. A high diet quality and maintenance of regular physical activity accounted for dieters' long-term success. This is the first study that examined the long-term psychological and behavioral characteristics of successful and unsuccessful restrained eaters. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effect of a participatory organizational-level occupational health intervention on short-term sickness absence: a cluster randomized controlled trial.

PubMed

Framke, Elisabeth; Sørensen, Ole Henning; Pedersen, Jacob; Rugulies, Reiner

2016-05-01

The aim of this study was to examine whether employees in pre-schools that implemented a participatory organizational-level intervention focusing on the core task at work had a lower incidence of short-term sickness absence compared to employees in the control group. The cluster randomized controlled trial (RCT) comprised 78 pre-schools that were allocated to the intervention (44 pre-schools with 1760 employees) or control (34 pre-schools with 1279 employees) group. The intervention lasted 25 months and followed a stepwise and structured approach, consisting of seminars, workshops, and workplace-directed intervention activities focusing on the core task at work. Using Poisson regression, we tested differences in incidence rates in short-term sickness absence between the intervention and control groups during a 29-months follow-up. Estimated short-term sickness absence days per person-year during follow-up were 8.68 and 9.17 in the intervention and control groups, respectively. The rate ratio (RR) for comparing incident sickness absence in the intervention to control groups during follow-up was 0.93 [95% confidence interval (95% CI) 0.86-1.00] in the crude analysis and 0.89 (95% CI 0.83-0.96) when adjusting for age, sex, job group, type and size of workplace, and workplace average level of previous short-term sickness absence. A supplementary analysis showed that the intervention also was associated with a reduced risk of long-term sickness absence with a crude RR of 0.83 (95% CI 0.69-0.99) and an adjusted RR of 0.84 (95% CI 0.69-1.01). Pre-school employees participating in an organizational-level occupational health intervention focusing on the core task at work had a lower incidence of short-term sickness absence during a 29-month follow-up compared with control group employees.

Efficacy of venlafaxine extended-release capsules in nondepressed outpatients with generalized anxiety disorder: A 6-month randomized controlled trial.

PubMed

Gelenberg, A J; Lydiard, R B; Rudolph, R L; Aguiar, L; Haskins, J T; Salinas, E

2000-06-21

Generalized anxiety disorder (GAD) is a chronic disorder that is associated with debilitating psychic and somatic symptoms. Venlafaxine extended-release (XR) capsules have been shown to be effective in short-term treatment of patients with GAD without major depressive disorder (MDD), but long-term data are needed to establish whether this agent confers persistent benefits. To compare the 6-month efficacy and safety of a flexible dosage of venlafaxine XR in outpatients with GAD without associated MDD. Six-month, randomized, double-blind, placebo-controlled, parallel-group trial conducted May 1996 to October 1997. Fourteen outpatient clinics and private psychiatric practices in the United States. A total of 251 outpatients aged 18 years or older who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for GAD, had sufficient symptoms to require treatment, and did not have coexisting MDD. Participants were randomly assigned to receive either placebo (n=127) or venlafaxine XR (75, 150, or 225 mg/d, as required to control symptoms; n=124) for 28 weeks. Changes from baseline in the Hamilton Rating Scale for Anxiety (HAM-A) total score, the HAM-A psychic anxiety factor score, and the Clinical Global Impressions (CGI) scale Severity of Illness and Global Improvement scores, compared by intervention group. During weeks 6 through 28, response rates in the venlafaxine XR group were 69% or higher compared with rates of 42% to 46% in the placebo group (P<.001). By an evaluable-patient analysis, venlafaxine XR compared with placebo significantly improved anxiety scores from week 1 or 2 through week 28 on all primary efficacy measures, including the HAM-A total (P<.001), the HAM-A psychic anxiety factor (P<.001), and the CGI scale scores (P<.001). Adjusted mean changes from baseline to week 28 using last-observation-carried-forward methods were for HAM-A, venlafaxine XR -13.4, placebo -8.7 (P<.001); for HAM-A psychic anxiety score, venlafaxine XR -7.4, placebo -4.2 (P<.001); and for CGI-Improvement, venlafaxine XR 2.2, placebo 3.0 (P<.001). The most common treatment-emergent adverse event was nausea, followed by somnolence and dry mouth. This study is the first placebo-controlled demonstration of the long-term efficacy of any drug class in treating outpatients with DSM-IV-diagnosed GAD. Venlafaxine XR is an effective, rapidly acting, safe, once-daily agent for both the short- and long-term treatment of anxiety and may provide an important alternative to currently available anxiolytics. JAMA. 2000.

Baduanjin Exercise for Stroke Rehabilitation: A Systematic Review with Meta-Analysis of Randomized Controlled Trials

PubMed Central

Wang, Chaoyi; Chen, Xiaoan; Wang, Huiru

2018-01-01

Objective: The purpose of this review was to objectively evaluate the effects of Baduanjin exercise on rehabilitative outcomes in stroke patients. Methods: Both Chinese and English electronic databases were searched for potentially relevant trials. Two review authors independently screened eligible trials against the inclusion criteria, extracted data, and assessed the methodological quality by using the revised PEDro scale. Meta-analysis was only performed for balance function. Results: In total, there were eight randomized controlled trials selected in this systematic review. The aggregated result of four trials has shown a significant benefit in favor of Baduanjin on balance function (Hedges’ g = 2.39, 95% CI 2.14 to 2.65, p < 0.001, I2 = 61.54). Additionally, Baduanjin exercise effectively improved sensorimotor function of lower extremities and ability of daily activities as well as reduced depressive level, leading to improved quality of life. Conclusion: Baduanjin exercise as an adjunctive and safe method may be conducive to help stroke patients achieve the best possible short-term outcome and should be integrated with mainstream rehabilitation programs. More rigorous randomized controlled trials with long-term intervention periods among a large sample size of stroke patients are needed to draw a firm conclusion regarding the rehabilitative effects for this population. PMID:29584623

Long-term effects of the Diabetes Prevention Program interventions on cardiovascular risk factors: a report from the DPP Outcomes Study.

PubMed

Orchard, T J; Temprosa, M; Barrett-Connor, E; Fowler, S E; Goldberg, R B; Mather, K J; Marcovina, S M; Montez, M; Ratner, R E; Saudek, C D; Sherif, H; Watson, K E

2013-01-01

Whether long-term cardiovascular risk is reduced by the Diabetes Prevention Program interventions is unknown. The aim of this study was to determine the long-term differences in cardiovascular disease risk factors and the use of lipid and blood pressure medications by the original Diabetes Prevention Program intervention group. This long-term follow-up (median 10 years, interquartile range 9.0-10.5) of the three-arm Diabetes Prevention Program randomized controlled clinical trial (metformin, intensive lifestyle and placebo), performed on 2766 (88%) of the Diabetes Prevention Program participants (who originally had impaired glucose tolerance), comprised a mean of 3.2 years of randomized treatment, approximately 1-year transition (during which all participants were offered intensive lifestyle intervention) and 5 years follow-up (Diabetes Prevention Program Outcomes Study). During the study, participants were followed in their original groups with their clinical care being provided by practitioners outside the research setting. The study determined lipoprotein profiles and blood pressure and medication use annually. After 10 years' follow-up from Diabetes Prevention Program baseline, major reductions were seen for systolic (-2 to -3) and diastolic (-6 to -6.5 mmHg) blood pressure, and for LDL cholesterol (-0.51 to -0.6 mmol/l) and triglycerides (-0.23 to -0.25 mmol/l) in all groups, with no between-group differences. HDL cholesterol also rose significantly (0.14 to 0.15 mmol/l) in all groups. Lipid (P = 0.01) and blood pressure (P = 0.09) medication use, however, were lower for the lifestyle group during the Diabetes Prevention Program Outcomes Study. Overall, intensive lifestyle intervention achieved, with less medication, a comparable long-term effect on cardiovascular disease risk factors, to that seen in the metformin and placebo groups. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

Long-term outcomes of ultrasonic scalpel treatment in giant cell tumor of long bones

PubMed Central

SUN, SHENG; ZHANG, QIANG; ZHAO, CHANG-SONG; CAI, JUAN

2014-01-01

Giant cell tumors (GCTs) are generally benign, locally aggressive lesions with the potential to metastasize and a tendency of local recurrence. The present study aimed to investigate the advantages and long-term outcomes of application of ultrasonic scalpel in the treatment of GCT of long bones. This study retrospectively analyzed 32 cases of GCT of long bones, including 24 males and eight females. The age range was from 8 to 34 years old (mean age, 23.5 years old). The 32 cases were randomly divided into an observation group (n=10) and a control group (n=22). Patients in the observation group received curettage by ultrasonic scalpel combined with local methotrexate gelfoam adjuvant treatment, and then the cavity was filled with allograft and/or homograft bone. Patients in the control group eceived curettage by local methotrexate gelfoam adjuvant treatment and bone grafting. No local recurrence or pulmonary metastases were observed among patients in the observation group, however, six patients in the control group exhibited recurrence following surgery, although none of the patients demonstrated distant metastasis (P<0.05). Additionally, all 10 patients showed good bone knitting and rehabilitation without deformity and functional issues. The segmental bone graft was perfectly incorporated without obvious immune rejection, collapse and fracture. Curettage by ultrasonic scalpel with local methotrexate gelfoam adjuvant treatment and filling the site by allograft and/or homograft bone showed satisfactory results. PMID:24959235

Restorations in abrasion/erosion cervical lesions: 8-year results of a triple blind randomized controlled trial.

PubMed

Dall'Orologio, Giovanni Dondi; Lorenzi, Roberta

2014-10-01

An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer. 50 subjects, 21 males and 29 females aged between 21 and 65, were randomized to receive 150 restorations, 100 with the new restorative material, 50 with the composite as control, placed in non-carious cervical lesions with the same bonding system. The main outcome measure was the cause of failure at 8 years. Randomization was number table-generated, with allocation concealment by opaque sequentially numbered sealed and stapled envelopes. Subjects, examiner, and analyst were blinded to group assignment. Two interim analyses were performed. Data were analyzed by ANOVA and Cox test (P < 0.05). After 8 years, 40 subjects and 120 teeth were included in the analysis of the primary outcome. There were eight failures in the experimental group and four failures in the control group. The cumulative loss rate was 7% for both restorative materials, with the annual failure lower than 1%, without any statistically significant difference. There were two key elements of failure: the presence of sclerotic dentin and the relationship between lesion and gingival margin.

Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.

PubMed

Li, Lan; Chen, Dawei; Wang, Chun; Yuan, Nanbing; Wang, Yan; He, Liping; Yang, Yanzhi; Chen, Lihong; Liu, Guanjian; Li, Xiujun; Ran, Xingwu

2015-01-01

The purpose of the study is to examine the safety and effectiveness of topical autologous platelet-rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12-week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short-term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long-term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment (p < 0.05 in both total DUs and subgroup of DFUs). The subjects defined as healing grade 1 were 50/59 (84.8%) in total DUs and 41/48 (85.4%) in DFUs in the APG group compared with 40/58 (69.0%) and 37/55 (67.3%) in the control group from intent to treat population. The Kaplan-Meier time-to-healing were significantly different between the two groups (p < 0.05 in both total DUs and subgroup of DFUs). No side effects were identified after topical APG application. The long-term survival and recurrence rates were comparative between groups (p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment. © 2015 by the Wound Healing Society.

Long-term outcomes and costs of an integrated rehabilitation program for chronic knee pain: a pragmatic, cluster randomized, controlled trial.

PubMed

Hurley, M V; Walsh, N E; Mitchell, H; Nicholas, J; Patel, A

2012-02-01

Chronic joint pain is a major cause of pain and disability. Exercise and self-management have short-term benefits, but few studies follow participants for more than 6 months. We investigated the long-term (up to 30 months) clinical and cost effectiveness of a rehabilitation program combining self-management and exercise: Enabling Self-Management and Coping of Arthritic Knee Pain Through Exercise (ESCAPE-knee pain). In this pragmatic, cluster randomized, controlled trial, 418 people with chronic knee pain (recruited from 54 primary care surgeries) were randomized to usual care (pragmatic control) or the ESCAPE-knee pain program. The primary outcome was physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] function), with a clinically meaningful improvement in physical function defined as a ≥15% change from baseline. Secondary outcomes included pain, psychosocial and physiologic variables, costs, and cost effectiveness. Compared to usual care, ESCAPE-knee pain participants had large initial improvements in function (mean difference in WOMAC function -5.5; 95% confidence interval [95% CI] -7.8, -3.2). These improvements declined over time, but 30 months after completing the program, ESCAPE-knee pain participants still had better physical function (difference in WOMAC function -2.8; 95% CI -5.3, -0.2); lower community-based health care costs (£-47; 95% CI £-94, £-7), medication costs (£-16; 95% CI £-29, £-3), and total health and social care costs (£-1,118; 95% CI £-2,566, £-221); and a high probability (80-100%) of being cost effective. Clinical and cost benefits of ESCAPE-knee pain were still evident 30 months after completing the program. ESCAPE-knee pain is a more effective and efficient model of care that could substantially improve the health, well-being, and independence of many people, while reducing health care costs. Copyright © 2012 by the American College of Rheumatology.

Influence of visual and auditory biofeedback on partial body weight support treadmill training of individuals with chronic hemiparesis: a randomized controlled clinical trial.

PubMed

Brasileiro, A; Gama, G; Trigueiro, L; Ribeiro, T; Silva, E; Galvão, É; Lindquist, A

2015-02-01

Stroke is an important causal factor of deficiency and functional dependence worldwide. To determine the immediate effects of visual and auditory biofeedback, combined with partial body weight supported (PBWS) treadmill training on the gait of individuals with chronic hemiparesis. Randomized controlled trial. Outpatient rehabilitation hospital. Thirty subjects with chronic hemiparesis and ability to walk with some help. Participants were randomized to a control group that underwent only PBWS treadmill training; or experimental I group with visual biofeedback from the display monitor, in the form of symbolic feet as the subject took a step; or experimental group II with auditory biofeedback associated display, using a metronome at 115% of the individual's preferred cadence. They trained for 20 minutes and were evaluated before and after training. Spatio-temporal and angular gait variables were obtained by kinematics from the Qualisys Motion Analysis system. Increases in speed and stride length were observed for all groups over time (speed: F=25.63; P<0.001; stride length: F=27.18; P<0.001), as well as changes in hip and ankle range of motion - ROM (hip ROM: F=14.43; P=0.001; ankle ROM: F=4.76; P=0.038), with no time*groups interaction. Other spatio-temporal and angular parameters remain unchanged. Visual biofeedback and auditory biofeedback had no influence on PBWS treadmill training of individuals with chronic hemiparesis, in short term. Additional studies are needed to determine whether, in long term, the biofeedback will promote additional benefit to the PBWS treadmill training. The findings of this study indicate that visual and auditory biofeedback does not bring immediate benefits on PBWS treadmill training of individuals with chronic hemiparesis. This suggest that, for additional benefits are achieved with biofeedback, effects should be investigated after long-term training, which may determine if some kind of biofeedback is superior to another to improve the hemiparetic gait.

Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

Stapled technique for acute thrombosed hemorrhoids: a randomized, controlled trial with long-term results.

PubMed

Wong, J C H; Chung, C C; Yau, K K; Cheung, H Y S; Wong, D C T; Chan, O C Y; Li, M K W

2008-04-01

This study was designed to compare stapled vs. conventional hemorrhoidectomy for patients with acute thrombosed hemorrhoids. Forty-one patients with acute thrombosed hemorrhoids were randomized into: 1) stapled hemorrhoidectomy (PPH group; n = 21), and 2) open hemorrhoidectomy (open group; n = 20). Emergency surgery was performed with perioperative data and complications were recorded. Patients were followed up by independent assessors to evaluate pain, recurrence, continence function, and satisfaction at regular intervals. The median follow-up for the PPH group and open group were 59 and 56 weeks, respectively. There was no significant difference in terms of the hospital stay, complication rate, and continence function; however, the mean pain intensity in the first postoperative week was significantly less in the PPH group (4.1 vs. 5.7, P = 0.02). Patients in the PPH group recovered significantly faster in terms of the time to become analgesic-free (4 vs. 8.5 days, P < 0.01), time to become pain-free (9 vs. 20.5 days, P = 0.01), resumption of work (7 vs. 12.5 days, P = 0.01), and time for complete wound healing (2 vs. 4 weeks, P < 0.01). On long-term follow-up, significantly fewer patients in the PPH group complained of recurrent symptoms (0 vs. 5, P = 0.02). The overall symptom improvement and patients' satisfaction were significantly better in the PPH group (90 vs. 80 percent, P = 0.03 and +3 vs. +2, P < 0.01 respectively). Stapled hemorrhoidectomy is safe and effective for acute thrombosed hemorrhoids. Similar to elective stapled procedure, emergency stapled excision has greater short-term benefits compared with conventional excision: diminished pain, faster recovery, and earlier return to work. Long-term results and satisfaction were excellent.

The FABS trial: a randomised control trial of the effects of a 6-month physical activity intervention on adherence and long-term physical activity and self-efficacy in older adults with memory complaints.

PubMed

Cox, Kay L; Flicker, Leon; Almeida, Osvaldo P; Xiao, Jianguo; Greenop, Kathryn R; Hendriks, Jacqueline; Phillips, Michael; Lautenschlager, Nicola T

2013-12-01

The aim of this study is to assess in older adults with memory complaints, the effects of a 6-month home-based physical activity (PA) intervention on short-term adherence, short and long-term self-efficacy and the predictors of adherence. Participants with memory complaints with or without mild cognitive impairment (MCI) were recruited from Perth, Western Australia between May 2004 and July 2006 and randomly assigned to a control or an intervention group. The intervention group received a 6-month PA programme and recorded sessions on a diary. Pedometer readings, questionnaires, and physical and cognitive measures were completed at 0, 6, 12 and 18 months. One hundred and seventy participants started the study. Retention rates were similar for both groups at all time-points however retention was higher for men than women (P<0.01). Adherence to the prescribed PA was 72.8% (95% CI, 70.8 74.9%). Men had higher adherence rate than women (P<0.001). Those with and without MCI had similar adherence. Compared to controls self-efficacy was higher in the intervention group after 6 months only (P<0.01). Older adults with memory complaints, with or without MCI, can successfully participate in and enjoy home-based PA programmes. Long-term adherence to such interventions may require continued support and increased self-efficacy. ( ACTRN012605000136606.). © 2013.

The effect of massage on immune function and stress in women with breast cancer--a randomized controlled trial.

PubMed

Billhult, A; Lindholm, C; Gunnarsson, Ronny; Stener-Victorin, E

2009-10-05

To examine the short-term effects of light pressure effleurage on circulating lymphocytes by studying the number and activity of peripheral blood natural killer (NK) cells in patients with breast cancer compared to a control group. Furthermore, the effect of light pressure effleurage on salivary cortisol levels, heart rate and blood pressure was studied. Single centre, prospective, randomized and controlled study. Thirty women, aged 50 to 75 years (mean 61 sd=7.2) with breast cancer undergoing radiation therapy in a hospital in southwestern Sweden were enrolled in the study. They were allocated to either receive massage in the form of a full-body light pressure effleurage treatment, or a control visit where they were given an equal amount of attention. Blood samples, saliva, notation of heart rate and blood pressure were collected before and after massage/control visit. Differences in change over time between groups were analyzed by Student's t-test. Light pressure effleurage massage decreased the deterioration of NK cell activity occurring during radiation therapy. Furthermore it lowered heart rate and systolic blood pressure. No effects were demonstrated on cortisol and diastolic pressure. A single full-body light pressure effleurage massage has a short-term effect on NK cell activity, systolic blood pressure and heart rate in patients with breast cancer. However, the long-term clinical importance of these findings needs to be further investigated.

Long-term outcomes of surgical treatment for epilepsy in adults with regard to seizures, antiepileptic drug treatment and employment.

PubMed

Malmgren, Kristina; Edelvik, Anna

2017-01-01

There is Class I evidence for short-term efficacy of epilepsy surgery from two randomized controlled studies of temporal lobe resection. Long-term outcome studies are observational. The aim of this narrative review was to summarise long-term outcomes taking the study methodology into account. A PubMed search was conducted identifying articles on long-term outcomes of epilepsy surgery in adults with regard to seizures, antiepileptic drug treatment and employment. Definitions of seizure freedom were examined in order to identify the proportions of patients with sustained seizure freedom. The quality of the long-term studies was assessed. In a number of high-quality studies 40-50% of patients had been continuously free from seizures with impairment of consciousness 10 years after resective surgery, with a higher proportion seizure-free at each annual follow-up. The proportion of seizure-free adults in whom AEDs have been withdrawn varied widely across studies, from 19-63% after around 5 years of seizure freedom. Few long-term vocational outcome studies were identified and results were inconsistent. Some investigators found no postoperative changes, others found decreased employment for patients with continuing seizures, but no change or increased employment for seizure-free patients. Having employment at baseline and postoperative seizure freedom were the strongest predictors of employment after surgery. Long-term studies of outcomes after epilepsy surgery are by necessity observational. There is a need for more prospective longitudinal studies of both seizure and non-seizure outcomes, considering individual patient trajectories in order to obtain valid outcome data needed for counselling patients about epilepsy surgery. Copyright © 2016 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Extended treatment for cigarette smoking cessation: a randomized control trial.

PubMed

Laude, Jennifer R; Bailey, Steffani R; Crew, Erin; Varady, Ann; Lembke, Anna; McFall, Danielle; Jeon, Anna; Killen, Diana; Killen, Joel D; David, Sean P

2017-08-01

To test the potential benefit of extending cognitive-behavioral therapy (CBT) relative to not extending CBT on long-term abstinence from smoking. Two-group parallel randomized controlled trial. Patients were randomized to receive non-extended CBT (n = 111) or extended CBT (n = 112) following a 26-week open-label treatment. Community clinic in the United States. A total of 219 smokers (mean age: 43 years; mean cigarettes/day: 18). All participants received 10 weeks of combined CBT + bupropion sustained release (bupropion SR) + nicotine patch and were continued on CBT and either no medications if abstinent, continued bupropion + nicotine replacement therapy (NRT) if increased craving or depression scores, or varenicline if still smoking at 10 weeks. Half the participants were randomized at 26 weeks to extended CBT (E-CBT) to week 48 and half to non-extended CBT (no additional CBT sessions). The primary outcome was expired CO-confirmed, 7-day point-prevalence (PP) at 52- and 104-week follow-up. Analyses were based on intention-to-treat. PP abstinence rates at the 52-week follow-up were comparable across non-extended CBT (40%) and E-CBT (39%) groups [odds ratio (OR) = 0.99; 95% confidence interval (CI) = 0.55, 1.78]. A similar pattern was observed across non-extended CBT (39%) and E-CBT (33%) groups at the 104-week follow-up (OR = 0.79; 95% CI= 0.44, 1.40). Prolonging cognitive-behavioral therapy from 26 to 48 weeks does not appear to improve long-term abstinence from smoking. © 2017 Society for the Study of Addiction.

Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial.

PubMed

Jin, Yu; Jacobs, Lotte; Baelen, Marie; Thijs, Lutgarde; Renkin, Jean; Hammer, Frank; Kefer, Joelle; Petit, Thibault; Verhamme, Peter; Janssens, Stefan; Sinnaeve, Peter; Lengelé, Jean-Philippe; Persu, Alexandre; Staessen, Jan A

2014-06-01

The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20-69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTN(TM), SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. ClinicalTrials.gov Identifier: NCT 01505010.

Rationale and design of the Investigator-Steered Project on intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial

PubMed Central

Jin, Yu; Jacobs, Lotte; Baelen, Marie; Thijs, Lutgarde; Renkin, Jean; Hammer, Frank; Kefer, Joelle; Petit, Thibault; Verhamme, Peter; Janssens, Stefan; Sinnaeve, Peter; Lengelé, Jean-Philippe; Persu, Alexandre

2014-01-01

The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20–69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTNTM, SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. Trial registration: ClinicalTrials.gov Identifier: NCT 01505010. PMID:24742341

Purse-string double-layer closure: a novel technique for repairing the uterine incision during cesarean section.

PubMed

Turan, Cem; Büyükbayrak, Esra Esim; Yilmaz, Aylin Onan; Karsidag, Yasemin Karageyim; Pirimoglu, Meltem

2015-04-01

To compare the classical double-layer uterine closure to a double-layer purse-string uterine closure (Turan technique) in cesarean section regarding short- and long-term results. Patients were randomized into either the double-layer purse-string uterine closure arm (study group, 84 patients) or the classical double-layer uterine closure arm (control group, 84 patients). For short-term comparison, a detailed transvaginal ultrasound examination was planned in all patients 6 weeks after the operation and a wedge-shaped defect in the uterine incision scar was accepted as uterine scar defect and recorded. For the long-term comparison, subsequent pregnancies of these patients were followed up for any complication. The number of patients with ultrasonographically visible uterine scar defect was 12 (23.5% of all scar defects) in the study group whereas it was 39 (76.5% of all scar defects) in the control group (P < 0.001, χ(2) = 15.42). Demographic data, operation time, hospitalization time, preoperative and postoperative hemoglobin values were not significantly different between the groups. During the 2-year of the follow-up period, five patients in the study group and six patients in the control group became pregnant again. No complication during their pregnancies and second cesarean operation were encountered. With the Turan technique, the uterine incision length becomes shorter, and the frequency of uterine scar defect is lower regarding short-term results. More data is needed for long-term results. ClinicalTrials.gov NCT01287611. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

Effects of repetitive peripheral magnetic stimulation on upper-limb spasticity and impairment in patients with spastic hemiparesis: a randomized, double-blind, sham-controlled study.

PubMed

Krewer, Carmen; Hartl, Sandra; Müller, Friedemann; Koenig, Eberhard

2014-06-01

To investigate short-term and long-term effects of repetitive peripheral magnetic stimulation (rpMS) on spasticity and motor function. Monocentric, randomized, double-blind, sham-controlled trial. Neurologic rehabilitation hospital. Patients (N=66) with severe hemiparesis and mild to moderate spasticity resulting from a stroke or a traumatic brain injury. The average time ± SD since injury for the intervention groups was 26 ± 71 weeks or 37 ± 82 weeks. rpMS for 20 minutes or sham stimulation with subsequent occupational therapy for 20 minutes, 2 times a day, over a 2-week period. Modified Tardieu Scale and Fugl-Meyer Assessment (arm score), assessed before therapy, at the end of the 2-week treatment period, and 2 weeks after study treatment. Additionally, the Tardieu Scale was assessed after the first and before the third therapy session to determine any short-term effects. Spasticity (Tardieu >0) was present in 83% of wrist flexors, 62% of elbow flexors, 44% of elbow extensors, and 10% of wrist extensors. Compared with the sham stimulation group, the rpMS group showed short-term effects on spasticity for wrist flexors (P=.048), and long-term effects for elbow extensors (P<.045). Arm motor function (rpMS group: median 5 [4-27]; sham group: median 4 [4-9]) did not significantly change over the study period in either group, whereas rpMS had a positive effect on sensory function. Therapy with rpMS increases sensory function in patients with severe limb paresis. The magnetic stimulation, however, has limited effect on spasticity and no effect on motor function. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Long-term contraception in a small implant: A review of Suprelorin (deslorelin) studies in cats.

PubMed

Fontaine, Christelle

2015-09-01

Deslorelin (Suprelorin®; Virbac) is a gonadotropin-releasing hormone (GnRH) agonist licensed in select countries for the long-term suppression of fertility in adult male dogs and male ferrets. This article summarizes studies investigating the use of deslorelin implants for the long-term suppression of fertility in male and female domestic cats. Slow-release deslorelin implants have been shown to generate effective, safe and reversible long-term contraception in male and female cats. In pubertal cats, a 4.7 mg deslorelin implant suppressed steroid sex hormones for an average of approximately 20 months (range 15-25 months) in males and an average of approximately 24 months (range 16-37 months) in females. Reversibility has been demonstrated by fertile matings approximately 2 years post-treatment in both male and female adult cats. In prepubertal female cats of approximately 4 months of age, puberty was postponed to an average of approximately 10 months of age (range 6-15 months) by a 4.7 mg deslorelin implant. The large variability in the duration of suppression of gonadal activity makes the definition of the optimal time for reimplantation quite challenging. In addition, the temporary stimulation phase occurring in the weeks following deslorelin implantation can induce in adult female cats a fertile estrus that needs to be managed to avoid unwanted pregnancy. Longer duration and larger scale controlled field studies implementing blinding, a negative control group and a carefully controlled randomization to each group are needed. Furthermore, the effects of repeated treatment need to be investigated. Finally, the effect of treatment on growth and bone quality of prepubertal cats needs to be assessed. However, the ease of use, long-lasting effects and reversibility of deslorelin implants are strong positive points supporting their use for controlling feline reproduction. © The Author(s) 2015.

Attendance at cultural events, reading books or periodicals, and making music or singing in a choir as determinants for survival: Swedish interview survey of living conditions.

PubMed

Bygren, L O; Konlaan, B B; Johansson, S E

To investigate the possible influence of attendance at cultural events, reading books or periodicals, making music or singing in a choir as determinants for survival. A simple random sample was drawn of 15,198 individuals aged 16-74 years. Of these, 85% (12,982) were interviewed by trained non-medical interviewers between 1982 and 1983 about cultural activities. They were followed up with respect to survival until 31 December 1991. Swedish interview survey of living conditions comprising a random sample of the adult Swedish population. 12,675 people interviewed between 1982 and 1983. Survival of subjects after controlling for eight confounding variables: age, sex, education level, income, long term disease, social network, smoking, and physical exercise. 6,301 men and 6,374 women were followed up; 533 men and 314 women died during this period. The control variables influenced survival in the expected directions except for social network for men; a significant negative effective was found when the analysis was made separately for men and women. We found an influence on mortality when the eight control variables were controlled for in people who rarely attended events compared with those attending most often, the relative risk being 1.57 (95% confidence interval 1.18 to 2.09). Attendance at cultural events may have a positive influence on survival. Long term follow up of large samples with confounders that are well controlled for and with the cultural stimulation more highly specified should be used to try to falsify the hypothesis before experiments start.

The Long-Term Impact of Neurofeedback on Symptom Burden and Interference in Patients With Chronic Chemotherapy-Induced Neuropathy: Analysis of a Randomized Controlled Trial.

PubMed

Prinsloo, Sarah; Novy, Diane; Driver, Larry; Lyle, Randall; Ramondetta, Lois; Eng, Cathy; Lopez, Gabriel; Li, Yisheng; Cohen, Lorenzo

2018-05-01

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer treatment and may adversely affect quality of life (QOL) for years. We explored the long-term effects of electroencephalographic neurofeedback (NFB) as a treatment for CIPN and other aspects of QOL. Seventy-one cancer survivors (mean age 62.5; 87% females) with CIPN were randomized to NFB or to a waitlist control (WLC) group. The NFB group underwent 20 sessions of NFB where rewards were given for voluntary changes in electroencephalography. Measurements of pain, cancer-related symptoms, QOL, sleep, and fatigue were obtained at baseline, end of treatment, and one and four months later. Seventy one participants enrolled in the study. At the end of treatment, 30 in the NFB group and 32 in the WLC group completed assessments; at four months, 23 in the NFB group and 28 in the WLC completed assessments. Linear mixed model analysis revealed significant group × time interaction for pain severity. A general linear model determined that the NFB group had greater improvements in worst pain (primary outcome) and other symptoms such as numbness, cancer-related symptom severity, symptom interference, physical functioning, general health, and fatigue compared with the WLC group at the end of treatment and four months (all P < 0.05). Effect sizes were moderate or large for most measures. NFB appears to result in long-term reduction in multiple CIPN symptoms and improved postchemotherapy QOL and fatigue. Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

[Efficacy and security of electronic cigarette for tobacco harm reduction: Systematic review and meta-analysis].

PubMed

Vanderkam, Paul; Boussageon, Rémy; Underner, Michel; Langbourg, Nicolas; Brabant, Yann; Binder, Philippe; Freche, Bernard; Jaafari, Nematollah

2016-11-01

Smoking is the first cause of preventable death in France and in the world. Without help, it was shown that 80 % of smokers who try to quit smoking relapse after one month with a low long-term success rate. Smoking reduction can concern smokers who did not want to quit or failed in their attempt to weaning. The final aim is to increase attractiveness of drug therapies by developing new products, such as electronic cigarettes, that can compete cigarette without reproducing its harmful effects. Assess the capacity of electronic cigarettes to reduce or stop tobacco use among regular smokers. Consultations MEDLINE and COCHRANE databases. e-cigarette; electronic cigarettes; ENDD (electronic nicotine delivery system); ENDS (electronic nicotine delivery device); vaping were used. Randomized controlled trials (RCTs) comparing the electronic cigarette with nicotine versus placebo device. Two randomized controlled trials were included in the quantitative analysis. The nicotine electronic cigarette users have tobacco consumption significantly decreased compared to the placebo group (RR: 1.30, 95 % CI [1.02 to 1.66]) at 6 months. Smoking cessation rate at 3 months was greater with the electronic cigarette contains nicotine (RR: 2.55, 95 % CI [1.31 to 4.98]). The small number of RCTs included does not allow definitive conclusions about the effectiveness of electronic cigarettes, especially in the medium to long term. The use of electronic cigarette with nicotine decreases tobacco consumption among regular smokers. Further studies are needed to specify electronic cigarettes safety profile and its ability to cause a reduction in consumption and a long-term cessation in smokers. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

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.

Long-term effect of population screening for diabetes on cardiovascular morbidity, self-rated health, and health behavior.

PubMed

Echouffo-Tcheugui, Justin B; Simmons, Rebecca K; Prevost, A Toby; Williams, Kate M; Kinmonth, Ann-Louise; Wareham, Nicholas J; Griffin, Simon J

2015-03-01

There is limited trial evidence concerning the long-term effects of screening for type 2 diabetes on population morbidity. We examined the effect of a population-based diabetes screening program on cardiovascular morbidity, self-rated health, and health-related behaviors. We conducted a pragmatic, parallel-group, cluster-randomized controlled trial of diabetes screening (the ADDITION-Cambridge study) including 18,875 individuals aged 40 to 69 years at high risk of diabetes in 32 general practices in eastern England (27 practices randomly allocated to screening, 5 to no-screening for control). Of those eligible for screening, 466 (2.9%) were diagnosed with diabetes. Seven years after randomization, a random sample of patients was sent a postal questionnaire: 15% from the screening group (including diabetes screening visit attenders and non-attenders) and 40% from the no-screening control group. Self-reported cardiovascular morbidity, self-rated health (using the SF-8 Health Survey and EQ-5D instrument), and health behaviors were compared between trial groups using an intention-to-screen analysis. Of the 3,286 questionnaires mailed out, 1,995 (61%) were returned, with 1,945 included in the analysis (screening: 1,373; control: 572). At 7 years, there were no significant differences between the screening and control groups in the proportion of participants reporting heart attack or stroke (OR = 0.90, 95% CI, 0.71-1.15); SF-8 physical health summary score as an indicator of self-rated health status (β -0.33, 95% CI, -1.80 to 1.14); EQ-5D visual analogue score (β: 0.80, 95% CI, -1.28 to 2.87); total physical activity (β 0.50, 95% CI, -4.08 to 5.07); current smoking (OR 0.97, 95% CI, 0.72 to 1.32); and alcohol consumption (β 0.14, 95% CI, -1.07 to 1.35). Invitation to screening for type 2 diabetes appears to have limited impact on population levels of cardiovascular morbidity, self-rated health status, and health behavior after 7 years. © 2015 Annals of Family Medicine, Inc.

Long-Term Effect of Population Screening for Diabetes on Cardiovascular Morbidity, Self-Rated Health, and Health Behavior

PubMed Central

Echouffo-Tcheugui, Justin B.; Simmons, Rebecca K.; Prevost, A. Toby; Williams, Kate M.; Kinmonth, Ann-Louise; Wareham, Nicholas J.; Griffin, Simon J.

2015-01-01

PURPOSE There is limited trial evidence concerning the long-term effects of screening for type 2 diabetes on population morbidity. We examined the effect of a population-based diabetes screening program on cardiovascular morbidity, self-rated health, and health-related behaviors. METHODS We conducted a pragmatic, parallel-group, cluster-randomized controlled trial of diabetes screening (the ADDITION-Cambridge study) including 18,875 individuals aged 40 to 69 years at high risk of diabetes in 32 general practices in eastern England (27 practices randomly allocated to screening, 5 to no-screening for control). Of those eligible for screening, 466 (2.9%) were diagnosed with diabetes. Seven years after randomization, a random sample of patients was sent a postal questionnaire: 15% from the screening group (including diabetes screening visit attenders and non-attenders) and 40% from the no-screening control group. Self-reported cardiovascular morbidity, self-rated health (using the SF-8 Health Survey and EQ-5D instrument), and health behaviors were compared between trial groups using an intention-to-screen analysis. RESULTS Of the 3,286 questionnaires mailed out, 1,995 (61%) were returned, with 1,945 included in the analysis (screening: 1,373; control: 572). At 7 years, there were no significant differences between the screening and control groups in the proportion of participants reporting heart attack or stroke (OR = 0.90, 95% CI, 0.71–1.15); SF-8 physical health summary score as an indicator of self-rated health status (β −0.33, 95% CI, −1.80 to 1.14); EQ-5D visual analogue score (β: 0.80, 95% CI, −1.28 to 2.87); total physical activity (β 0.50, 95% CI, −4.08 to 5.07); current smoking (OR 0.97, 95% CI, 0.72 to 1.32); and alcohol consumption (β 0.14, 95% CI, −1.07 to 1.35). CONCLUSIONS Invitation to screening for type 2 diabetes appears to have limited impact on population levels of cardiovascular morbidity, self-rated health status, and health behavior after 7 years. PMID:25755036

Long-term effects of earlier initiated continuous Kangaroo Mother Care (KMC) for low-birth-weight (LBW) infants in Madagascar.

PubMed

Nagai, Shuko; Yonemoto, Naohiro; Rabesandratana, Norotiana; Andrianarimanana, Diavolana; Nakayama, Takeo; Mori, Rintaro

2011-12-01

To examine the long-term effects of earlier initiated continuous Kangaroo Mother Care (KMC) for relatively stable low-birth-weight (LBW) infants in a resource-limited country. A randomized controlled trial with long-term follow-up was performed in LBW infants in Madagascar. Earlier continuous KMC (intervention group) was initiated as soon as possible within 24 h postbirth, and later continuous KMC (control group: conventional care) was initiated after complete stabilization. Outcome measures were mortality or readmission, nutritional indicators at 6-12 months postbirth and feeding condition at 6 months postbirth (ClinicalTrials.gov, NCT00531492). A total of 72 infants were followed for mortality or readmission at 6-12 months postbirth. There was no difference between the two groups (7/36 vs. 7/36, Risk ratio (RR), 1.00; 95% CIs, 0.39-2.56; p = 1.00). The proportion of exclusive breast feeding (EBF) at 6 months postbirth was significantly higher with earlier KMC than later KMC (12/29 vs. 4/26; RR 2.69; 95% CIs, 1.00-7.31; p = 0.04). There were no differences in nutritional indicators between the two groups at 6-12 months postbirth. Earlier initiated continuous KMC results in a significantly higher proportion of EBF at 6 months postbirth. Further larger-scale long-term evaluations of earlier initiated continuous KMC for LBW infants are needed. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

The effects of test-enhanced learning on long-term retention in AAN annual meeting courses.

PubMed

Larsen, Douglas P; Butler, Andrew C; Aung, Wint Y; Corboy, John R; Friedman, Deborah I; Sperling, Michael R

2015-02-17

We measured the long-term retention of knowledge gained through selected American Academy of Neurology annual meeting courses and compared the effects of repeated quizzing (known as test-enhanced learning) and repeated studying on that retention. Participants were recruited from 4 annual meeting courses. All participants took a pretest. This randomized, controlled trial utilized a within-subjects design in which each participant experienced 3 different postcourse activities with each activity performed on different material. Each key information point from the course was randomized in a counterbalanced fashion among participants to one of the 3 activities: repeated short-answer quizzing, repeated studying, and no further exposure to the materials. A final test covering all information points from the course was taken 5.5 months after the course. Thirty-five participants across the 4 courses completed the study. Average score on the pretest was 36%. Performance on the final test showed that repeated quizzing led to significantly greater long-term retention relative to both repeated studying (55% vs 46%; t[34] = 3.28, SEM = 0.03, p = 0.01, d = 0.49) and no further exposure (55% vs 44%; t[34] = 3.16, SEM = 0.03, p = 0.01, d = 0.58). Relative to the pretest baseline, repeated quizzing helped participants to retain almost twice as much of the knowledge acquired from the course compared to repeated studying or no further exposure. Whereas annual meeting continuing medical education (CME) courses lead to long-term gains in knowledge, when repeated quizzing is added, retention is significantly increased. CME planners may consider adding repeated quizzing to increase the impact of their courses. © 2015 American Academy of Neurology.

Long-term Effects on Cognitive Trajectories of Postmenopausal Hormone Therapy in Two Age Groups.

PubMed

Espeland, Mark A; Rapp, Stephen R; Manson, JoAnn E; Goveas, Joseph S; Shumaker, Sally A; Hayden, Kathleen M; Weitlauf, Julie C; Gaussoin, Sarah A; Baker, Laura D; Padula, Claudia B; Hou, Lifang; Resnick, Susan M

2017-06-01

Postmenopausal hormone therapy may have long-term effects on cognitive function depending on women's age. Postintervention follow-up was conducted with annual cognitive assessments of two randomized controlled clinical trial cohorts, beginning an average of 6-7 years after study medications were terminated: 1,376 women who had enrolled in the Women's Health Initiative when aged 50-54 years and 2,880 who had enrolled when aged 65-79 years. Women had been randomly assigned to 0.625mg/d conjugated equine estrogens (CEE) for those with prior hysterectomy (mean 7.1 years), CEE with 2.5mg/d medroxyprogesterone acetate for those without prior hysterectomy (mean 5.4 years), or matching placebos. Hormone therapy, when prescribed to women aged 50-54 years, had no significant long-term posttreatment effects on cognitive function and on changes in cognitive function. When prescribed to older women, it was associated with long-term mean (SE) relative decrements (standard deviation units) in global cognitive function of 0.081 (0.029), working memory of 0.070 (0.025), and executive function of 0.054 (0.023), all p < .05. These decrements were relatively stable over time. Findings did not vary depending on the hormone therapy regimen, prior use, or years from last menstrual period. Mean intervention effects were small; however, the largest were comparable in magnitude to those seen during the trial's active intervention phase. CEE-based hormone therapy delivered near the time of menopause provides neither cognitive benefit nor detriment. If administered in older women, it results in small decrements in several cognitive domains that remain for many years. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The effects of test-enhanced learning on long-term retention in AAN annual meeting courses

PubMed Central

Butler, Andrew C.; Aung, Wint Y.; Corboy, John R.; Friedman, Deborah I.; Sperling, Michael R.

2015-01-01

Objective: We measured the long-term retention of knowledge gained through selected American Academy of Neurology annual meeting courses and compared the effects of repeated quizzing (known as test-enhanced learning) and repeated studying on that retention. Methods: Participants were recruited from 4 annual meeting courses. All participants took a pretest. This randomized, controlled trial utilized a within-subjects design in which each participant experienced 3 different postcourse activities with each activity performed on different material. Each key information point from the course was randomized in a counterbalanced fashion among participants to one of the 3 activities: repeated short-answer quizzing, repeated studying, and no further exposure to the materials. A final test covering all information points from the course was taken 5.5 months after the course. Results: Thirty-five participants across the 4 courses completed the study. Average score on the pretest was 36%. Performance on the final test showed that repeated quizzing led to significantly greater long-term retention relative to both repeated studying (55% vs 46%; t[34] = 3.28, SEM = 0.03, p = 0.01, d = 0.49) and no further exposure (55% vs 44%; t[34] = 3.16, SEM = 0.03, p = 0.01, d = 0.58). Relative to the pretest baseline, repeated quizzing helped participants to retain almost twice as much of the knowledge acquired from the course compared to repeated studying or no further exposure. Conclusions: Whereas annual meeting continuing medical education (CME) courses lead to long-term gains in knowledge, when repeated quizzing is added, retention is significantly increased. CME planners may consider adding repeated quizzing to increase the impact of their courses. PMID:25609761

Providing intensive addiction/housing case management to homeless veterans enrolled in addictions treatment: A randomized controlled trial.

PubMed

Malte, Carol A; Cox, Koriann; Saxon, Andrew J

2017-05-01

This study sought to determine whether homeless veterans entering Veterans Affairs (VA) substance use treatment randomized to intensive addiction/housing case management (AHCM) had improved housing, substance use, mental health, and functional outcomes and lower acute health care utilization, compared to a housing support group (HSG) control. Homeless veterans (n = 181) entering outpatient VA substance use treatment were randomized to AHCM and HSG and received treatment for 12 months. AHCM provided individualized housing, substance use and mental health case management, life skills training, and community outreach. The control condition was a weekly drop-in housing support group. Adjusted longitudinal analyses compared groups on baseline to month 12 change in percentage of days housed and functional status, substance use, and mental health outcomes (36-Item Short-Form Health Survey; Addiction Severity Index [ASI]). Negative binomial regression models compared groups on health care utilization. Both conditions significantly increased percentage of days housed, with no differences detected between conditions. In total, 74 (81.3%) AHCM and 64 (71.1%) HSG participants entered long-term housing (odds ratio = 1.9, 95% confidence interval [0.9, 4.0], p = .088). HSG participants experienced a greater decrease in emergency department visits than AHCM (p = .037), whereas AHCM participants remained in substance use treatment 52.7 days longer (p = .005) and had greater study treatment participation (p < .001) than HSG. ASI alcohol composite scores improved more for HSG than AHCM (p = .006), and both conditions improved on ASI drug and psychiatric scores and alcohol/drug abstinence. AHCM did not demonstrate overarching benefits beyond standard VA housing and substance use care. For those veterans not entering or losing long-term housing, different approaches to outreach and ongoing intervention are required. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Long-term use of minimal footwear on pain, self-reported function, analgesic intake, and joint loading in elderly women with knee osteoarthritis: A randomized controlled trial.

PubMed

Trombini-Souza, Francis; Matias, Alessandra B; Yokota, Mariane; Butugan, Marco K; Goldenstein-Schainberg, Claudia; Fuller, Ricardo; Sacco, Isabel C N

2015-12-01

Efforts have been made to retard the progressive debilitating pain and joint dysfunction in patients with knee osteoarthritis. We aimed to evaluate the therapeutic effect of a low-cost minimalist footwear on pain, function, clinical and gait-biomechanical aspects of elderly women with knee osteoarthritis. Throughout a randomized, parallel and controlled clinical trial, fifty-six patients with medial knee osteoarthritis were randomly allocated to an intervention (n=28) or control group (n=28), and assessed at baseline and after three and six months. The intervention involved wearing Moleca(®) footwear for at least 6h/day, 7 days/week, over 6 months. The pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index was the primary outcome. The secondary outcomes were the other subscales, Lequesne score, distance walked in 6 min, knee oedema and effusion, knee adduction moment and paracetamol intake. Intention-to-treat analysis was performed using two-way casewise ANOVA (< .05) and Cohen's d coefficient. Intervention group showed improvement in pain (effect size: 1.41, p<.001), function (effect size: 1.22, p=.001), stiffness (effect size: 0.76, p=.001), Lequesne score (effect size: 1.07, p<.001), and reduction by 21.8% in the knee adduction moment impulse (p=.017) during gait wearing Moleca(®). The analgesic intake was lower in the intervention group. The long-term use of Moleca(®) footwear relieves pain, improves self-reported function, reduces the knee loading while wearing Moleca(®), refrains the increase of analgesic intake in elderly women with knee osteoarthritis and can be considered as a conservative mechanical treatment option. ClinicalTrials.gov (NCT01342458). Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

Long-Term Intermittent Hypoxia Elevates Cobalt Levels in the Brain and Injures White Matter in Adult Mice

PubMed Central

Veasey, Sigrid C.; Lear, Jessica; Zhu, Yan; Grinspan, Judith B.; Hare, Dominic J.; Wang, SiHe; Bunch, Dustin; Doble, Philip A.; Robinson, Stephen R.

2013-01-01

Study Objectives: Exposure to the variable oxygenation patterns in obstructive sleep apnea (OSA) causes oxidative stress within the brain. We hypothesized that this stress is associated with increased levels of redox-active metals and white matter injury. Design: Participants were randomly allocated to a control or experimental group (single independent variable). Setting: University animal house. Participants: Adult male C57BL/6J mice. Interventions: To model OSA, mice were exposed to long-term intermittent hypoxia (LTIH) for 10 hours/day for 8 weeks or sham intermittent hypoxia (SIH). Measurements and Results: Laser ablation-inductively coupled plasma-mass spectrometry was used to quantitatively map the distribution of the trace elements cobalt, copper, iron, and zinc in forebrain sections. Control mice contained 62 ± 7 ng cobalt/g wet weight, whereas LTIH mice contained 5600 ± 600 ng cobalt/g wet weight (P < 0.0001). Other elements were unchanged between conditions. Cobalt was concentrated within white matter regions of the brain, including the corpus callosum. Compared to that of control mice, the corpus callosum of LTIH mice had significantly more endoplasmic reticulum stress, fewer myelin-associated proteins, disorganized myelin sheaths, and more degenerated axon profiles. Because cobalt is an essential component of vitamin B12, serum methylmalonic acid (MMA) levels were measured. LTIH mice had low MMA levels (P < 0.0001), indicative of increased B12 activity. Conclusions: Long-term intermittent hypoxia increases brain cobalt, predominantly in the white matter. The increased cobalt is associated with endoplasmic reticulum stress, myelin loss, and axonal injury. Low plasma methylmalonic acid levels are associated with white matter injury in long-term intermittent hypoxia and possibly in obstructive sleep apnea. Citation: Veasey SC; Lear J; Zhu Y; Grinspan JB; Hare DJ; Wang S; Bunch D; Doble PA; Robinson SR. Long-term intermittent hypoxia elevates cobalt levels in the brain and injures white matter in adult mice. SLEEP 2013;36(10):1471-1481. PMID:24082306

Comparison of unilateral versus bilateral percutaneous kyphoplasty for the treatment of patients with osteoporosis vertebral compression fracture (OVCF): a systematic review and meta-analysis.

PubMed

Cheng, Xing; Long, Hou-Qing; Xu, Jing-Hui; Huang, Yang-Liang; Li, Fo-Bao

2016-11-01

To compare the short- and long-term clinical outcomes, operation times, restoration rate, dosage of polymethylmeth-acrylate (PMMA) injected, complications and X-rays exposure frequency between unilateral and bilateral kyphoplasty approaches for the treatment of OVCF. Systematic review and meta-analysis. Randomized or non-randomized controlled trials published up to April 2015 that compared the unilateral and bilateral PKP for the treatment of OVCF were acquired by a comprehensive search in the Cochrane Controlled Trial Register, PubMed, MEDLINE, EMBASE, Web of Science, OVID. Exclusion criteria were patients with neoplastic etiology (metastasis or myeloma), infection, neural compression syndrome, invasive and degenerative disease, traumatic fracture, re-operation, neurological deficits, significant scoliosis and spinal stenosis. The main end points included: operation times, the short- and long-term postoperative Visual Analogue Scale (VAS) scores, the short-term postoperative Oswestry Disability Index (ODI), restoration rate, dosage of PMMA injected, cement leakage, X-ray exposure frequency and postoperative adjacent-level fractures. A total of 8 studies involving 428 patients were included in the meta-analysis. The mean operative time was shorter in the unilateral groups compared with the bilateral groups [P < 0.05, weighted mean difference (WMD) -19.74 (-30.56, -8.92)]. There was no significant difference in the short-term postoperative VAS scores [P > 0.05, WMD 0.03 (-0.34, 0.40)], the long-term postoperative VAS scores between them [P > 0.05, WMD 0.01 (-0.42, 0.45)] and the short-term postoperative ODI [P > 0.05, WMD -0.33 (-2.36, 1.69)] between the two groups. The unilateral approaches required significantly less dosage of PMMA than the bipedicular approaches did [P < 0.05, WMD -1.56 (-1.59, -1.16)]. The restoration rate in the bilateral groups was higher than the unilateral groups [P < 0.05, WMD -7.82 (-12.23, -3.41)]. There was no significant difference in the risk ratio of cement leakage [P > 0.05, RR 0.86 (0.36, 2.06)] and postoperative adjacent-level fractures [P > 0.05, RR 0.91 (0.25, 3.26)] between the two methods. The mean X-ray exposure frequency in the unilateral groups was greater than the bilateral groups [P < 0.05, WMD -5.69 (-10.67, -0.70)]. A definitive verdict could not be reached regarding which approach is better for the treatment of OVCF. Although unilateral PKP was associated with shorter operative time, less X- ray exposure frequency and dosage of PMMA than bilateral PKP. There was no apparent difference in the short- and long-term clinical outcomes and complications between them. However, bilateral PKP approaches were higher than unilateral PKP in term of the restoration rate. But on account of lack of some high-quality evidence, we hold that amounts of high-quality randomized controlled trials should be required and more complications should be analysed to resolve which surgical approach is better for the treatment of OVCF in the future.

Training symmetry of weight distribution after stroke: a randomized controlled pilot study comparing task-related reach, Bobath and feedback training approaches.

PubMed

Mudie, M H; Winzeler-Mercay, U; Radwan, S; Lee, L

2002-09-01

To determine (1) the most effective of three treatment approaches to retrain seated weight distribution long-term after stroke and (2) whether improvements could be generalized to weight distribution in standing. Inpatient rehabilitation unit. Forty asymmetrical acute stroke subjects were randomly allocated to one of four groups in this pilot study. Changes in weight distribution were compared between the 10 subjects of each of three treatment groups (task-specific reach, Bobath, or Balance Performance Monitor [BPM] feedback training) and a no specific treatment control group. One week of measurement only was followed by two weeks of daily training sessions with the treatment to which the subject was randomly allocated. Measurements were performed using the BPM daily before treatment sessions, two weeks after cessation of treatment and 12 weeks post study. Weight distribution was calculated in terms of mean balance (percentage of total body weight) or the mean of 300 balance points over a 30-s data run. In the short term, the Bobath approach was the most effective treatment for retraining sitting symmetry after stroke (p = 0.004). Training with the BPM and no training were also significant (p = 0.038 and p = 0.035 respectively) and task-specific reach training failed to reach significance (p = 0.26). At 12 weeks post study 83% of the BPM training group, 38% of the task-specific reach group, 29% of the Bobath group and 0% of the untrained group were found to be distributing their weight to both sides. Some generalization of symmetry training in sitting to standing was noted in the BPM training group which appeared to persist long term. Results should be treated with caution due to the small group sizes. However, these preliminary findings suggest that it might be possible to restore postural symmetry in sitting in the early stages of rehabilitation with therapy that focuses on creating an awareness of body position.

Properties of a new small-world network with spatially biased random shortcuts

NASA Astrophysics Data System (ADS)

Matsuzawa, Ryo; Tanimoto, Jun; Fukuda, Eriko

2017-11-01

This paper introduces a small-world (SW) network with a power-law distance distribution that differs from conventional models in that it uses completely random shortcuts. By incorporating spatial constraints, we analyze the divergence of the proposed model from conventional models in terms of fundamental network properties such as clustering coefficient, average path length, and degree distribution. We find that when the spatial constraint more strongly prohibits a long shortcut, the clustering coefficient is improved and the average path length increases. We also analyze the spatial prisoner's dilemma (SPD) games played on our new SW network in order to understand its dynamical characteristics. Depending on the basis graph, i.e., whether it is a one-dimensional ring or a two-dimensional lattice, and the parameter controlling the prohibition of long-distance shortcuts, the emergent results can vastly differ.

Cellular phone use and brain tumor: a meta-analysis.

PubMed

Kan, Peter; Simonsen, Sara E; Lyon, Joseph L; Kestle, John R W

2008-01-01

The dramatic increase in the use of cellular phones has generated concerns about potential adverse effects, especially the development of brain tumors. We conducted a meta-analysis to examine the effect of cellular phone use on the risk of brain tumor development. We searched the literature using MEDLINE to locate case-control studies on cellular phone use and brain tumors. Odds ratios (ORs) for overall effect and stratified ORs associated with specific brain tumors, long-term use, and analog/digital phones were calculated for each study using its original data. A pooled estimator of each OR was then calculated using a random-effects model. Nine case-control studies containing 5,259 cases of primary brain tumors and 12,074 controls were included. All studies reported ORs according to brain tumor subtypes, and five provided ORs on patients with > or =10 years of follow up. Pooled analysis showed an overall OR of 0.90 (95% confidence interval [CI] 0.81-0.99) for cellular phone use and brain tumor development. The pooled OR for long-term users of > or =10 years (5 studies) was 1.25 (95% CI 1.01-1.54). No increased risk was observed in analog or digital cellular phone users. We found no overall increased risk of brain tumors among cellular phone users. The potential elevated risk of brain tumors after long-term cellular phone use awaits confirmation by future studies.

An Effectiveness Trial of a Selected Dissonance-Based Eating Disorder Prevention Program for Female High School Students: Long-Term Effects

PubMed Central

Stice, Eric; Rohde, Paul; Shaw, Heather; Gau, Jeff

2011-01-01

Objective Efficacy trials found that a dissonance-based eating disorder prevention program in which female high school and college students with body image concerns critique the thin-ideal reduced eating disorder risk factors, eating disorder symptoms, and future eating disorder onset. The present effectiveness trial tested whether this program produces effects through long-term follow-up when high school clinicians recruit students and deliver the intervention under real-world conditions. Method Female high school students with body image concerns (N = 306; M age = 15.7 SD = 1.1) were randomized to the dissonance intervention or an educational brochure control condition and completed assessments through 3-year follow-up. Results Dissonance participants showed significantly greater decreases in body dissatisfaction at 2-year follow-up and eating disorder symptoms at 3-year follow-up than controls; effects on other risk factors, risk for eating disorder onset, and other outcomes (e.g., body mass) were marginal or non-significant. Conclusions Although it was encouraging that some key effects persisted over long-term follow-up, effects were on average smaller in this effectiveness trial than previous efficacy trials, which could be due to (a) facilitator selection, training, and supervision, (b) the lower risk status of participants, or (c) the use of a control condition that produces some effects. PMID:21707136

EFFECT OF A NOVEL ESSENTIAL OIL MOUTHRINSE WITHOUT ALCOHOL ON GINGIVITIS: A DOUBLE-BLINDED RANDOMIZED CONTROLLED TRIAL

PubMed Central

Botelho, Marco Antonio; Bezerra, José Gomes; Correa, Luciano Lima; Fonseca, Said Gonçalves da Cruz; Montenegro, Danusa; Gapski, Ricardo; Brito, Gerly Anne Castro; Heukelbach, Jörg

2007-01-01

Several different plant extracts have been evaluated with respect to their antimicrobial effects against oral pathogens and for reduction of gingivitis. Given that a large number of these substances have been associated with significant side effects that contraindicate their long-term use, new compounds need to be tested. The aim of this study was to assess the short-term safety and efficacy of a Lippia sidoides ("alecrim pimenta")-based essential oil mouthrinse on gingival inflammation and bacterial plaque. Fifty-five patients were enrolled into a pilot, double-blinded, randomized, parallel-armed study. Patients were randomly assigned to undergo a 7-day treatment regimen with either the L. sidoides-based mouthrinse or 0.12% chlorhexidine mouthrinse. The results demonstrated decreased plaque index, gingival index and gingival bleeding index scores at 7 days, as compared to baseline. There was no statistically significance difference (p>0.05) between test and control groups for any of the clinical parameters assessed throughout the study. Adverse events were mild and transient. The findings of this study demonstrated that the L. sidoides-based mouthrinse was safe and efficacious in reducing bacterial plaque and gingival inflammation. PMID:19089126

A randomized, controlled trial of diathermy hemorrhoidectomy vs. stapled hemorrhoidectomy in an intended day-care setting with longer-term follow-up.

PubMed

Cheetham, M J; Cohen, C R G; Kamm, M A; Phillips, R K S

2003-04-01

Hemorrhoidectomy is the most effective long-term treatment for hemorrhoids. Although it is possible to perform hemorrhoidectomy as a day case with a high degree of patient satisfaction, patients take an average of 14 days off work after surgery. Stapled hemorrhoidectomy is believed to be less painful than conventional hemorrhoidectomy and should allow an earlier return to work. The aim of this study was to compare both the immediate and the long-term results of stapled hemorrhoidectomy with diathermy hemorrhoidectomy in patients with prolapsing internal hemorrhoids in an intended day-care setting. Thirty-one patients were randomly assigned to undergo diathermy hemorrhoidectomy (n = 16) or stapled hemorrhoidectomy performed with a purpose-designed endoluminal stapling device, PPH01T (n = 15). All operations were planned as day or short-stay cases. All patients received lactulose, commenced preoperatively, together with postoperative topical glyceryl trinitrate and oral metronidazole. Patients were assessed by structured interview to assess their symptoms before and after surgery, with an intended follow-up of six months. All patients completed a 10-cm visual analog pain scale daily for the first ten days after surgery. The total pain score (sum of all pain scores) was significantly higher in the diathermy group (50 (range, 9.8-79.9) vs. 19.6 (range, 1.3-89.5), P = 0.03). Patients took a median of 14 (range, 3-21) days off work after diathermy hemorrhoidectomy compared with 10 (range, 3-38) days for the patients undergoing stapled hemorrhoidectomy (P = 0.15). At long-term follow-up, three patients (all in the stapled group) developed new symptoms of fecal urgency and anal pain, and three patients required further surgery to remove symptomatic external hemorrhoids after stapled hemorrhoidectomy. Although stapled hemorrhoidectomy is less painful in the short term, this does not lead to a significantly earlier return to work, and some patients develop new symptoms at long-term follow-up.

A randomized controlled trial of laparoscopic nissen fundoplication versus proton pump inhibitors for treatment of patients with chronic gastroesophageal reflux disease: One-year follow-up.

PubMed

Anvari, Mehran; Allen, Christopher; Marshall, John; Armstrong, David; Goeree, Ron; Ungar, Wendy; Goldsmith, Charles

2006-12-01

A randomized controlled trial conducted in patients with gastroesophageal reflux disease compared optimized medical therapy using proton pump inhibitor (n = 52) with laparoscopic Nissen fundoplication (n = 52). Patients were monitored for 1 year. The primary end point was frequency of gastroesophageal reflux dis-ease symptoms. Surgical patients had improved symptoms, pH control, and overall quality of life health index after surgery at 1 year compared with the medical group. The overall gastroesophageal reflux disease symptom score at 1 year was unchanged in the medical patients, but improved in the surgical patients. Fourteen patients in the medical arm experienced symptom relapse requiring titration of the proton pump inhibitor dose, but 6 had satisfactory symptom remission. No surgical patients required additional treatment for symptom control. Patients controlled on long-term proton pump inhibitor therapy for chronic gastroesophageal reflux disease are excellent surgical candidates and should experience improved symptom control after surgery at 1 year.

Questioning short-term memory and its measurement: Why digit span measures long-term associative learning.

PubMed

Jones, Gary; Macken, Bill

2015-11-01

Traditional accounts of verbal short-term memory explain differences in performance for different types of verbal material by reference to inherent characteristics of the verbal items making up memory sequences. The role of previous experience with sequences of different types is ostensibly controlled for either by deliberate exclusion or by presenting multiple trials constructed from different random permutations. We cast doubt on this general approach in a detailed analysis of the basis for the robust finding that short-term memory for digit sequences is superior to that for other sequences of verbal material. Specifically, we show across four experiments that this advantage is not due to inherent characteristics of digits as verbal items, nor are individual digits within sequences better remembered than other types of individual verbal items. Rather, the advantage for digit sequences stems from the increased frequency, compared to other verbal material, with which digits appear in random sequences in natural language, and furthermore, relatively frequent digit sequences support better short-term serial recall than less frequent ones. We also provide corpus-based computational support for the argument that performance in a short-term memory setting is a function of basic associative learning processes operating on the linguistic experience of the rememberer. The experimental and computational results raise questions not only about the role played by measurement of digit span in cognition generally, but also about the way in which long-term memory processes impact on short-term memory functioning. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

[GERD: endoscopic antireflux therapies].

PubMed

Caca, K

2006-08-02

A couple of minimally-invasive, endoscopic antireflux procedures have been developed during the last years. Beside endoscopic suturing these included injection/implantation technique of biopolymers and application of radiofrequency. Radiofrequency (Stretta) has proved only a very modest effect, while implantation techniques have been abandoned due to lack of long-term efficacy (Gatekeeper) or serious side effects (Enteryx). While first generation endoluminal suturing techniques (EndoCinch, ESD) demonstrated a proof of principle their lack of durability, due to suture loss, led to the development of a potentially durable transmural plication technique (Plicator). In a prospective-randomized, sham-controlled trial the Plicator procedure proved superiority concerning reflux symptoms, medication use and esophageal acid exposure (24-h-pH-metry). While long-term data have to be awaited to draw final conclusions, technical improvements will drive innovation in this field.

A randomised controlled trial of the use of aromatherapy and hand massage to reduce disruptive behaviour in people with dementia.

PubMed

Fu, Chieh-Yu; Moyle, Wendy; Cooke, Marie

2013-07-10

Aromatherapy and hand massage therapies have been reported to have some benefit for people with dementia who display behavioural symptoms; however there are a number of limitations of reported studies. The aim is to investigate the effect of aromatherapy (3% lavender oil spray) with and without hand massage on disruptive behaviour in people with dementia living in long-term care. In a single blinded randomised controlled trial 67 people with a diagnosis of dementia and a history of disruptive behaviour, from three long-term care facilities were recruited and randomised using a random number table into three groups: (1) Combination (aromatherapy and hand massage) (n = 22), (2) Aromatherapy (n = 23), (3) Placebo control (water spray) (n = 22). The intervention was given twice daily for six weeks. Data on residents' behaviour (CMAI) and cognition (MMSE) were collected before, during and after the intervention. Despite a downward trend in behaviours displayed not one of the interventions significantly reduced disruptive behaviour. Further large-scale placebo controlled studies are required where antipsychotic medication is controlled and a comparison of the methods of application of aromatherapy are investigated. ACTRN12612000917831.

Effects of a long-term psychosocial nursing intervention on adolescents exposed to catastrophic stress.

PubMed

Hardin, Sally Brosz; Weinrich, Sally; Weinrich, Martin; Garrison, Carol; Addy, Cheryl; Hardin, Thomas L

2002-09-01

This research tested the effects of a long-term psychosocial nursing intervention designed to decrease mental distress in adolescents following a catastrophic event. Advanced Practice Psychiatric Nurses conducted the Catastrophic Stress Intervention (CSI) in two South Carolina high schools for three years following Hurricane Hugo. The CSI consisted of nine protocols designed to decrease adolescents' mental distress by increasing their understanding of stress and by enhancing their self-efficacy and social support. Adolescents (N = 1030) were randomized to intervention or control groups and completed one baseline and five postintervention measures of mental distress, self-efficacy, and social support. The hypothesis was that intervention adolescents would have less mental distress than control adolescents. The research also addressed the particular time points at which differences between intervention and control adolescents might be shown. Repeated measures multivariate analysis of variance, with exposure to the hurricane, self-efficacy, and social support as control variables, showed that intervention adolescents reported less mental distress than control adolescents at 12, 18, and 24 months but that this difference dissipated by 30 and 36 months. Implications for the CSI and timing of interventions with adolescents after a catastrophic event are discussed.

Cognitive behavioral therapy positively affects fatigue in patients with multiple sclerosis: Results of a randomized controlled trial.

PubMed

van den Akker, Lizanne E; Beckerman, Heleen; Collette, Emma H; Twisk, Jos Wr; Bleijenberg, Gijs; Dekker, Joost; Knoop, Hans; de Groot, Vincent

2017-10-01

Fatigue is a common symptom in multiple sclerosis (MS) and often restricts societal participation. Cognitive behavioral therapy (CBT) may alleviate MS-related fatigue, but evidence in literature is inconclusive. To evaluate the effectiveness of CBT to improve MS-related fatigue and participation. In a multi-center, assessor-masked, randomized controlled trial, participants with severe MS-related fatigue were assigned to CBT or control treatment. CBT consisted of 12 individual sessions with a psychologist trained in CBT, the control treatment consisted of three consultations with a MS nurse, both delivered over 16 weeks. Assessments were at baseline, 8, 16 (i.e. post-intervention), 26, and 52 weeks post-baseline. Primary outcomes were the Checklist Individual Strength-fatigue subscale (CIS20r fatigue) and the Impact on Participation and Autonomy questionnaire (IPA). Data were analyzed according to the intention-to-treat principle, using mixed-model analysis. Between 2011 and 2014, 91 patients were randomized (CBT: n = 44; control: n = 47). Between-group analysis showed a positive post-intervention effect for CBT on CIS20r fatigue (T16: -6.7 (95% confidence interval (CI) = -10.7; -2.7) points) that diminished during follow-up (T52: 0.5 (95% CI = -3.6; 4.4)). No clinically relevant effects were found on societal participation. Severe MS-related fatigue can be reduced effectively with CBT in the short term. More research is needed on how to maintain this effect over the long term.

Long-Term Outcomes of the ATHENA (Athletes Targeting Healthy Exercise & Nutrition Alternatives) Program for Female High School Athletes

ERIC Educational Resources Information Center

Elliot, Diane L.; Goldberg, Linn; Moe, Esther L.; DeFrancesco, Carol A.; Durham, Melissa B.; McGinnis, Wendy; Lockwood, Chondra

2008-01-01

Adolescence and emerging adulthood are critical windows for establishing life-long behaviors. We assessed long-term outcomes of a prospective randomized harm reduction/health promotion program for female high school athletes. The intervention's immediate beneficial effects on diet pill use and unhealthy eating behaviors have been reported;…

Comparative study of oncologic outcomes for laparoscopic vs. open surgery in transverse colon cancer

PubMed Central

Kim, Woo Ram; Baek, Se Jin; Kim, Chang Woo; Jang, Hyun A; Cho, Min Soo; Bae, Sung Uk; Hur, Hyuk; Min, Byung Soh; Lee, Kang Young; Kim, Nam Kyu; Sohn, Seung Kuk

2014-01-01

Purpose Laparoscopic resection for transverse colon cancer is a technically challenging procedure that has been excluded from various large randomized controlled trials of which the long-term outcomes still need to be verified. The purpose of this study was to evaluate long-term oncologic outcomes for transverse colon cancer patients undergoing laparoscopic colectomy (LAC) or open colectomy (OC). Methods This retrospective review included patients with transverse colon cancer who received a colectomy between January 2006 and December 2010. Short-term and five-year oncologic outcomes were compared between these groups. Results A total of 131 patients were analyzed in the final study (LAC, 84 patients; OC, 47 patients). There were no significant differences in age, gender, body mass index, tumor location, operative procedure, or blood loss between groups, but the mean operative time in LAC was significantly longer (LAC, 246.8 minutes vs. OC, 213.8 minutes; P = 0.03). Hospital stay was much shorter for LAC than OC (9.1 days vs. 14.5 days, P < 0.01). Postoperative complication rates were not statistically different between the two groups. In terms of long-term oncologic data, the 5-year disease-free survival and overall survival were not statistically different between both groups, and subgroup analysis according to cancer stage also revealed no differences. Conclusion LAC for transverse colon cancer is feasible and safe with comparable short- and long-term outcomes. PMID:24761404

Comparative study of oncologic outcomes for laparoscopic vs. open surgery in transverse colon cancer.

PubMed

Kim, Woo Ram; Baek, Se Jin; Kim, Chang Woo; Jang, Hyun A; Cho, Min Soo; Bae, Sung Uk; Hur, Hyuk; Min, Byung Soh; Baik, Seung Hyuk; Lee, Kang Young; Kim, Nam Kyu; Sohn, Seung Kuk

2014-01-01

Laparoscopic resection for transverse colon cancer is a technically challenging procedure that has been excluded from various large randomized controlled trials of which the long-term outcomes still need to be verified. The purpose of this study was to evaluate long-term oncologic outcomes for transverse colon cancer patients undergoing laparoscopic colectomy (LAC) or open colectomy (OC). This retrospective review included patients with transverse colon cancer who received a colectomy between January 2006 and December 2010. Short-term and five-year oncologic outcomes were compared between these groups. A total of 131 patients were analyzed in the final study (LAC, 84 patients; OC, 47 patients). There were no significant differences in age, gender, body mass index, tumor location, operative procedure, or blood loss between groups, but the mean operative time in LAC was significantly longer (LAC, 246.8 minutes vs. OC, 213.8 minutes; P = 0.03). Hospital stay was much shorter for LAC than OC (9.1 days vs. 14.5 days, P < 0.01). Postoperative complication rates were not statistically different between the two groups. In terms of long-term oncologic data, the 5-year disease-free survival and overall survival were not statistically different between both groups, and subgroup analysis according to cancer stage also revealed no differences. LAC for transverse colon cancer is feasible and safe with comparable short- and long-term outcomes.

Effects of postoperative administration of ketoprofen or carprofen on short- and long-term results of femoral head and neck excision in dogs.

PubMed

Grisneaux, Emmanuelle; Dupuis, Jacques; Pibarot, Philippe; Bonneau, Norbert H; Charette, Benoît; Blais, Diane

2003-10-01

To determine whether postoperative administration of ketoprofen or carprofen had any effects on short- or long-term results of femoral head and neck excision (FHNE) in dogs. Prospective randomized controlled trial. 40 client-owned, large-breed dogs undergoing FHNE and 15 healthy large-breed dogs used as controls for hip joint angle measurements and force plate analyses. Dogs undergoing FHNE were treated with ketoprofen, carprofen, or a placebo for 21 days after surgery. Hip joint abduction and extension angles were measured at the end of surgery and 120 days later. Lameness scores were assigned, and force plate analyses were performed on days 3, 15, and 120. There were no significant differences among treatment groups in regard to hip joint angles or lameness scores. Force plate analysis revealed that dogs in all 3 treatment groups bore consistently less weight on the operated limb than did control dogs for the duration of the study. Dogs receiving ketoprofen had greater peak propulsive force at a walk on day 3 and greater peak vertical force at a walk on day 15 than did dogs receiving the placebo. Treatment of an acute condition and preservation of the lesser trochanter, but not postoperative analgesic administration, were positively associated with ground reaction forces on day 120. Owners of 12 of 31 dogs indicated that the dog's gait worsened for a few days after discontinuation of analgesic administration. Administration of ketoprofen or carprofen after surgery was not associated with long-term results of FHNE, probably because of the impact of other factors. Because some owners noticed worsening of the lameness following cessation of analgesic administration in the present study, it is possible that longer administration would have improved long-term results.

Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal.

PubMed

Pozzilli, Paolo; Raz, Itamar; Peled, Dana; Elias, Dana; Avron, Ann; Tamir, Merana; Eren, Rachel; Dagan, Shlomo; Cohen, Irun R

2014-01-01

Endogenous insulin secretion, measured by C-peptide area under the curve (AUC), can be tested using both the glucagon stimulation test (GST) and the mixed-meal tolerance test (MMTT). This study compares these two stimulation methods using long-term data from patients newly diagnosed with type 1 diabetes or with latent autoimmune diabetes. A recently completed phase 3 intervention study with DiaPep277 demonstrated improved glycemic control and a significant treatment effect of glucagon-stimulated C-peptide secretion. Unexpectedly, MMTT failed to detect differences between the treated and control groups. Data from 343 patients in two balanced-randomized, double-blind, placebo-controlled, parallel-group trials of DiaPep277 were used to compare and correlate between GST- and MMTT-derived C-peptide AUC. Pearson's correlations were calculated for absolute C-peptide AUC at baseline and 12 and 24 months and for long-term changes in AUC (AUC). The absolute AUC values obtained at any single time point by the two tests were well correlated in both data sets (r = 0.74-0.9). However, the correlations between the AUC were much weaker (r = 0.39-0.58). GST-stimulated C-peptide secretion was stable over the fasting glucose range permitted for the test (4-11.1 mmol/L), but MMTT-stimulated C-peptide secretion decreased over the same range, implying differences in sensitivity to glucose. Measurement of long-term changes in stimulated C-peptide, reflecting endogenous insulin secretion, during the course of intervention trials may be affected by the method of stimulation, possibly reflecting different sensitivities to the physiological status of the tested subject.

The area postrema does not modulate the long-term salt sensitivity of arterial pressure.

PubMed

Collister, J P; Osborn, J W

1998-10-01

The hindbrain circumventricular organ, the area postrema (AP), receives multiple signals linked to body fluid homeostasis. In addition to baroreceptor input, AP cells contain receptors for ANG II, vasopressin, and atrial natriuretic peptide. Hence, it has been proposed that the AP is critical in long-term adjustments in sympathetic outflow in response to changes in dietary NaCl. The present study was designed to test the hypothesis that long-term control of arterial pressure over a range of dietary NaCl requires an intact AP. Male Sprague-Dawley rats were randomly selected for lesion of the AP (APx) or sham lesion. Three months later, rats were instrumented with radiotelemetry transmitters for continuous monitoring of mean arterial pressure (MAP) and heart rate and were placed in individual metabolic cages. Rats were given 1 wk postoperative recovery. The dietary salt protocol consisted of a 7-day period of 1.0% NaCl (control), 14 days of 4.0% NaCl (high), 7 days of 1.0% NaCl, and finally 14 days of 0.1% NaCl (low). The results are reported as the average arterial pressure observed on the last day of the given dietary salt period: APx (n = 7) 114 +/- 2 (1.0%), 110 +/- 3 (4.0%), 110 +/- 3 (1.0%), and 114 +/- 4 (0.1%) mmHg; sham (n = 6) 115 +/- 2 (1.0%), 114 +/- 3 (4.0%), 111 +/- 3 (1. 0%), and 113 +/- 2 (0.1%) mmHg. Neither group of rats demonstrated significant changes in MAP throughout the entire dietary salt protocol. Furthermore, no significant differences in MAP were detected between groups throughout the protocol. All lesions were histologically verified. These results suggest that the area postrema plays no role in long-term control of arterial pressure during chronic changes in dietary salt.

Fall Preventive Exercise With or Without Behavior Change Support for Community-Dwelling Older Adults: A Randomized Controlled Trial With Short-Term Follow-up.

PubMed

Arkkukangas, Marina; Söderlund, Anne; Eriksson, Staffan; Johansson, Ann-Christin

2017-02-27

In Western countries, falls and fall-related injuries are a well-known threat to health in the aging population. Studies indicate that regular exercise improves strength and balance and can therefore decrease the incidence of falls and fall-related injuries. The challenge, however, is to provide exercise programs that are safe, effective, and attractive to the older population. The aim of this study was to investigate the short-term effect of a home-based exercise program with or without motivational interviewing (MI) compared with standard care on physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency. A total of 175 older adults participated in this randomized controlled study. They were randomly allocated for the Otago Exercise Program (OEP) (n = 61), OEP combined with MI (n = 58), or a control group (n = 56). The participants' mean age was 83 years. The recruitment period was from October 2012 to May 2015. Measurements of physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency were done before and 12 weeks after randomization. A total of 161 participants were followed up, and there were no significant differences between groups after a period of 12 weeks of regular exercise. Within the OEP + MI group, physical performance, fall self-efficacy, physical activity level, and handgrip strength improved significantly; likewise, improved physical performance and fall self-efficacy were found in the control group. A corresponding difference did not occur in the OEP group. Adherence to the exercise was generally high in both exercise groups. In the short-term perspective, there were no benefits of an exercise program with or without MI regarding physical performance, fall self-efficacy, activity level, handgrip strength, adherence to the exercise, and fall frequency in comparison to a control group. However, some small effects occurred within the OEP + MI group, indicating that there may be some possible value in behavioral change support combined with exercise in older adults that requires further evaluation in both short- and long-term studies.

Long-term Clinical Outcomes of Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Sasso, Willa R; Smucker, Joseph D; Sasso, Maria P; Sasso, Rick C

2017-02-15

Prospective, randomized, single-center, clinical trial. To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF). Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change. Cervical disc arthroplasty has been designed to mitigate some of the challenges associated with arthrodesis whereas providing for a similar positive neurological outcome. As data has been collected from numerous prospective US FDA IDE trials, longer term outcomes regarding adjacent segment change may be examined. As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty. Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055). At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy. 1.

Sensory-specific satiety is intact in rats made obese on a high-fat high-sugar choice diet.

PubMed

Myers, Kevin P

2017-05-01

Sensory-specific satiety (SSS) is the temporary decreased pleasantness of a recently eaten food, which inhibits further eating. Evidence is currently mixed whether SSS is weaker in obese people, and whether such difference precedes or follows from the obese state. Animal models allow testing whether diet-induced obesity causes SSS impairment. Female rats (n = 24) were randomly assigned to an obesogenic high-fat, high-sugar choice diet or chow-only control. Tests of SSS involved pre-feeding a single palatable, distinctively-flavored food (cheese- or cocoa-flavored) prior to free choice between both foods. Rats were tested for short-term SSS (2 h pre-feeding immediately followed by 2 h choice) and long-term SSS (3 day pre-feeding prior to choice on day 4). In both short- and long-term tests rats exhibited SSS by shifting preference towards the food not recently eaten. SSS was not impaired in obese rats. On the contrary, in the long-term tests they showed stronger SSS than controls. This demonstrates that neither the obese state nor a history of excess energy consumption fundamentally causes impaired SSS in rats. The putative impaired SSS in obese people may instead reflect a specific predisposition, properties of the obesogenic diet, or history of restrictive dieting and bingeing. Copyright © 2017 Elsevier Ltd. All rights reserved.

Nonpharmacological Treatments of Insomnia for Long-Term Painful Conditions: A Systematic Review and Meta-analysis of Patient-Reported Outcomes in Randomized Controlled Trials

PubMed Central

Tang, Nicole K.Y.; Lereya, S. Tanya; Boulton, Hayley; Miller, Michelle A.; Wolke, Dieter; Cappuccio, Francesco P.

2015-01-01

Study Objectives: Insomnia is a debilitating comorbidity of chronic pain. This study evaluated the effect of nonpharmacological sleep treatments on patient-reported sleep quality, pain, and well-being in people with long-term cancer and non-cancer (e.g., back pain, arthritis, fibromyalgia) pain conditions. Design: We systematically searched Cochrane CENTRAL, MEDLINE, Embase, and PsychINFO for relevant studies. Search period was set to inception of these databases to March 2014. Studies were included if they were: original randomized controlled trials (RCTs); testing a nonpharmacological intervention; that targets sleep; in adults; with painful health conditions; that has a control group; includes a measure of sleep quality; and at least one other health and well-being outcome. Measurement and Findings: Means and standard deviations of sleep quality, pain, fatigue, depression, anxiety, physical and psychological functioning were extracted for the sleep treatment and control groups at baseline, posttreatment and final follow-up. Methodological details concerning the treatment, participants, and study design were abstracted to guide heterogeneity and subgroup analyses. Eleven RCTs involving 1,066 participants (mean age 45–61 years) met the criteria for the meta-analysis. There was no systematic evidence of publication bias. Nonpharmacological sleep treatments in chronic pain patients were associated with a large improvement in sleep quality (standardized mean difference = 0.78, 95% Confidence Interval [0.42, 1.13]; P < 0.001), small reduction in pain (0.18 [0, 0.36] P < 0.05), and moderate improvement in fatigue (0.38 [0.08, 0.69]; P < 0.01) at posttreatment. The effects on sleep quality and fatigue were maintained at follow-up (up to 1 year) when a moderate reduction in depression (0.31, [0.09, 0.53]; P < 0.01) was also observed. Both cancer and non-cancer pain patients benefited from nonpharmacological sleep treatments. Face-to-face treatments achieved better outcomes than those delivered over the phone/internet. Conclusions: Although the body of evidence was small, nonpharmacological sleep interventions may represent a fruitful avenue for optimizing treatment outcomes in patients with chronic pain. Registration: PROSPERO registration: CRD42013004131. Citation: Tang NK, Lereya T, Boulton H, Miller MA, Wolke D, Cappuccio FP. Nonpharmacological treatments of insomnia for long-term painful conditions: a systematic review and meta-analysis of patient-reported outcomes in randomized controlled trials. SLEEP 2015;38(11):1751–1764. PMID:25902806

Effect of Short- and Long-Term Play Therapy Services on Teacher-Child Relationship Stress

ERIC Educational Resources Information Center

Ray, Dee C.; Henson, Robin K.; Schottelkorb, April A.; Brown, April Garofano; Muro, Joel

2008-01-01

The purpose of the present study was to explore the effect of both short- and long term Child-Centered Play Therapy on teacher-student relationship stress. Teachers identified 58 students exhibiting emotional and behavioral difficulties who were randomly assigned to one of two treatment groups. Students in the short-term intensive play therapy…

Long-term effect of presurgical nasoalveolar molding on growth of maxillary arch in unilateral cleft lip and palate: randomized controlled trial.

PubMed

Shetty, V; Agrawal, R K; Sailer, H F

2017-08-01

The objective of this study was to investigate the long-term effect of presurgical nasoalveolar molding (PNAM) on growth of the maxillary arch through early childhood until 6 years of age in complete unilateral cleft lip and palate (UCLP) patients presenting for PNAM at different ages. Complete UCLP patients who were treated at our centre were divided into two groups. The study group underwent PNAM and was further subdivided into three subgroups (PNAM initiated within 1 month, between 1 and 6 months, and between 6 and 12 months of age in subgroup I, II, and III, respectively). The control group did not undergo PNAM and was further subdivided into three subgroups. Patients were evaluated at T1 (first visit), T2 (before cheiloplasty), and T3 (at 6 years). Between T1and T2, the intersegment distance (ISD) reduced significantly in the study group but increased in the control group, whereas the intercanine width (ICW) in both the study and control groups did not show significant change. Between T2 and T3, ISD and ICW were reduced significantly in the control group due to arch collapse, whereas in the study group, ISD reduced slightly with ICW remaining almost similar to noncleft norms. We conclude that reduced ISD following PNAM improves arch symmetry and stability, and thus may prevent arch collapse in the long term. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Effectiveness trial of an indicated cognitive-behavioral group adolescent depression prevention program versus bibliotherapy and brochure control at 1- and 2-year follow-up.

PubMed

Rohde, Paul; Stice, Eric; Shaw, Heather; Gau, Jeff M

2015-08-01

The main goal of this study was to evaluate the long-term effects of a brief group cognitive-behavioral (CB) adolescent depression indicated prevention program through 2-year follow-up, relative to CB bibliotherapy and brochure control, when high school personnel recruited students and delivered the program. Three hundred seventy-eight adolescents (M age = 15.5, SD = 1.2; 68% female, 72% White) with elevated self-assessed depressive symptoms who were randomized to CB group, CB bibliotherapy, or educational brochure control were assessed at pretest, posttest, and 6-, 12-, 18-, and 24-month follow-up. By 2 years postintervention, CB group participants showed significantly lower major depressive disorder (MDD) onset versus CB bibliotherapy (10% vs. 25%, respectively; hazard ratio = 2.48, p = .006), but the incidence difference relative to brochure controls (17%) was nonsignificant; MDD incidence for bibliotherapy and brochure controls did not differ. Although CB group participants showed lower depressive symptoms at posttest versus brochure controls, there were no effects for this outcome or for social adjustment or substance use over 2-year follow-up. Moderator analyses suggested that participants with higher baseline depressive symptoms showed greater long-term symptom reductions in the CB group intervention versus bibliotherapy. The evidence that a brief CB group intervention delivered by real-world providers significantly reduced MDD onset versus CB bibliotherapy is potentially encouraging. However, the lack of MDD prevention effects relative to brochure control and lack of long-term symptom effects (though consistent with results from other depression prevention trials), suggest that the delivery of the CB group should be refined to strengthen its effectiveness. (c) 2015 APA, all rights reserved).

Long-term clinical effects of epalrestat, an aldose reductase inhibitor, on diabetic peripheral neuropathy: the 3-year, multicenter, comparative Aldose Reductase Inhibitor-Diabetes Complications Trial.

PubMed

Hotta, Nigishi; Akanuma, Yasuo; Kawamori, Ryuzo; Matsuoka, Kempei; Oka, Yoshitomo; Shichiri, Motoaki; Toyota, Takayoshi; Nakashima, Mitsuyoshi; Yoshimura, Isao; Sakamoto, Nobuo; Shigeta, Yukio

2006-07-01

We sought to evaluate the long-term efficacy and safety of epalrestat, an aldose reductase inhibitor, on diabetic peripheral neuropathy. Subjects with diabetic neuropathy, median motor nerve conduction velocity (MNCV) >or=40 m/s, and HbA(1c)

Long-term follow-up effects of the HomeStyles randomized controlled trial in families with preschool children on social cognitive theory constructs associated with physical activity cognitions and behaviors.

PubMed

Quick, Virginia; Martin-Biggers, Jennifer; Povis, Gayle Alleman; Worobey, John; Hongu, Nobuko; Byrd-Bredbenner, Carol

2018-05-01

This study examined long-term follow-up effects of participation in the HomeStyles RCT, using Social Cognitive Theory constructs, on physical activity cognitions, home environment, and lifestyle behavioral practices of families with preschool children (ages 2 to 5 years). Parents were systematically randomized to experimental or attention control group at baseline. Those completing all surveys that comprised of valid, reliable measures were the analytic sample (n = 61 experimental, n = 63 control; mean age 32.8 ± 5.9SD years). Repeated measures ANCOVA, controlling for prognostic variables (e.g., parent sex) revealed that variables assessing modeling of physical activity for children increased significantly (P ≤ .01) in both groups with no significant time by group effects. Paired t-tests indicated the experimental group's self-efficacy for keeping children's weight healthy and performing health promoting behaviors increased significantly over time whereas the control group did not but with no significant time by group effects. Self-regulation paired t-test findings indicated that total screentime the experimental group allowed children decreased significantly over time with no significant time by group effect. The value parents placed on physical activity for children increased over time in both groups with a significant time effect. The experimental group over time had significantly greater increases in the availability of physical activity space and supports inside the home than the control group. Improvements noted have the potential to help protect children and parents from excess weight gain, yet findings indicate considerable opportunity for continued improvement as well as elucidation of factors affecting concomitant changes in both study groups. Copyright © 2018 Elsevier Inc. All rights reserved.

Body-composition changes in the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE)-2 study: A 2-y randomized controlled trial of calorie restriction in nonobese humans

USDA-ARS?s Scientific Manuscript database

Calorie restriction (CR) retards aging and increases longevity in many animal models. However, it is unclear whether CR can be implemented in humans without adverse effects on body composition. We evaluated the effect of a 2-year CR regimen on body composition including the influence of sex and body...

Motor Learning Curve and Long-Term Effectiveness of Modified Constraint-Induced Movement Therapy in Children with Unilateral Cerebral Palsy: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Geerdink, Yvonne; Aarts, Pauline; Geurts, Alexander C.

2013-01-01

The goal of this study was to determine the progression of manual dexterity during 6 weeks (54 h) (modified) constraint-induced movement therapy ((m)CIMT) followed by 2 weeks (18 h) bimanual training (BiT) in children with unilateral spastic cerebral palsy (CP), to establish whether and when a maximal training effect was reached and which factors…

Aripiprazole in schizophrenia and schizoaffective disorder: A review.

PubMed

Stip, Emmanuel; Tourjman, Valérie

2010-01-01

During the past decade, there has been some progress in the pharmacotherapy of schizophrenia and schizoaffective disorder. Current evidence supports the use of various second-generation, or atypical, antipsychotic medications, although few of these agents have been associated with long-term efficacy and tolerability. Aripiprazole is an atypical antipsychotic that has been found to improve positive and negative symptoms of schizophrenia with a favorable adverse-effect profile. This article reviews the efficacy and tolerability of aripiprazole in the context of recommended management strategies for schizophrenia and schizoaffective disorder, and in comparison with first-generation and other second-generation antipsychotics. A search of MEDLINE (1999-May 2009) was conducted for reports of short- and long-term clinical studies of atypical antipsychotics (including aripiprazole) and meta-analyses of randomized controlled trials comparing first- and second-generation antipsychotics (including aripiprazole) in the treatment of schizophrenia or schizoaffective disorder. The search terms were schizophrenia; schizoaffective disorder; pharmacogenetics; adverse effects; tardive dyskinesia AND atypical antipsychotics; aripiprazole; aripiprazole, schizophrenia, AND double-blind studies; and atypical antipsychotics AND adverse effects. The reference lists of identified articles were reviewed for additional relevant publications. Only full study publications were included. Based on the clinical evidence, including data from short-term (4-8 weeks) and long-term (26-52 weeks) randomized, double-blind clinical trials, aripiprazole has been associated with improvements in positive, negative, cognitive, and affective symptoms of schizophrenia and schizoaffective disorder. It has been associated with long-term (up to 52 weeks) symptom control in schizophrenia, as well as with efficacy in treatment-resistant schizophrenia. Common adverse effects associated with aripiprazole were nausea, insomnia, and agitation. These effects were usually transient. The evidence suggests that aripiprazole is unlikely to be associated with clinically significant weight gain or dyslipidemia, increased prolactin levels, or prolongation of the QTc interval. Compared with placebo, aripiprazole has been reported to have a relatively low potential for inducing metabolic syndrome. Based on the evidence reviewed, aripiprazole monotherapy appears to be effective and well tolerated in treating the positive, negative, and cognitive symptoms of schizophrenia and schizoaffective disorder. It was associated with a low risk for the common adverse effects of antipsychotic therapy, including metabolic and endocrine alterations. 2010 Excerpta Medica Inc. All rights reserved.

Short and long-term effects of supervised versus unsupervised exercise training on health-related quality of life and functional outcomes following lung cancer surgery - a randomized controlled trial.

PubMed

Brocki, Barbara Cristina; Andreasen, Jane; Nielsen, Lene Rodkjaer; Nekrasas, Vytautas; Gorst-Rasmussen, Anders; Westerdahl, Elisabeth

2014-01-01

Surgical resection enhances long-term survival after lung cancer, but survivors face functional deficits and report on poor quality of life long time after surgery. This study evaluated short and long-term effects of supervised group exercise training on health-related quality of life and physical performance in patients, who were radically operated for lung cancer. A randomized, assessor-blinded, controlled trial was performed on 78 patients undergoing lung cancer surgery. The intervention group (IG, n=41) participated in supervised out-patient exercise training sessions, one hour once a week for ten weeks. The sessions were based on aerobic exercises with target intensity of 60-80% of work capacity, resistance training and dyspnoea management. The control group (CG, n=37) received one individual instruction in exercise training. Measurements consisted of: health-related quality of life (SF36), six minute walk test (6MWT) and lung function (spirometry), assessed three weeks after surgery and after four and twelve months. Both groups were comparable at baseline on demographic characteristic and outcome values. We found a statistically significant effect after four months in the bodily pain domain of SF36, with an estimated mean difference (EMD) of 15.3 (95% CI:4 to 26.6, p=0.01) and a trend in favour of the intervention for role physical functioning (EMD 12.04, 95% CI: -1 to 25.1, p=0.07) and physical component summary (EMD 3.76, 95% CI:-0.1 to 7.6, p=0.06). At 12 months, the tendency was reversed, with the CG presenting overall slightly better measures. We found no effect of the intervention on 6MWT or lung volumes at any time-point. Supervised compared to unsupervised exercise training resulted in no improvement in health-related quality of life, except for the bodily pain domain, four months after lung cancer surgery. No effects of the intervention were found for any outcome after one year. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

A randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux disease (GERD): 3-year outcomes.

PubMed

Anvari, Mehran; Allen, Christopher; Marshall, John; Armstrong, David; Goeree, Ron; Ungar, Wendy; Goldsmith, Charles

2011-08-01

A randomized controlled trial (RCT) investigated patients with gastroesophageal reflux disease (GERD) who were stable and symptomatically controlled with long-term medical therapy to compare ongoing optimized medical therapy with laparoscopic Nissen fundoplication (LNF). Of the 180 patients eligible for randomization, 104 gave informed consent, and 3 withdrew from the study immediately after randomization. The patients randomized to medical therapy received optimized treatment with proton pump inhibitors (PPIs) using a standardized management protocol based on best evidence and published guidelines. The surgical patients underwent LNF by one of four surgeons using a previously published technique. The patients underwent symptom evaluation using the GERD symptom scale (GERSS) and the global visual analog scale (VAS) for overall symptom control. They had 24-h esophageal pH monitoring at baseline and after 3 years. The medical patients were evaluated receiving PPI, and the surgical patients were evaluated not receiving PPI. For the 3-year follow-up assessment, 93 patients were available. At 3 years, surgery was associated with more heartburn-free days, showing a mean difference of -1.35 days per week (p = 0.0077) and a lower VAS score (p = 0.0093) than medical management. Surgical patients reported improved quality of life on the general health subscore of the Medical Outcomes Survey Short Form 36 (SF-36) at 3 years, with a mean difference of -12.19 (p = 0.0124). The groups did not differ significantly in terms of GERSS or acid exposure on 24-h esophageal pH monitoring at 3 years. There were six treatment failures (11.8%) in the surgical group and eight treatment failures (16%) in the medical group by 3 years. For patients whose GERD symptoms are stable and controlled with PPI, continuing medical therapy and laparoscopic antireflux surgery are equally effective, although surgery may result in better symptom control and quality of life.

Long-term outcomes and predictors of internet-delivered cognitive behavioral therapy for childhood anxiety disorders.

PubMed

Vigerland, Sarah; Serlachius, Eva; Thulin, Ulrika; Andersson, Gerhard; Larsson, Jan-Olov; Ljótsson, Brjánn

2017-03-01

This study investigated the long-term outcomes of internet-delivered cognitive behavior therapy (ICBT) for children with anxiety disorders, and potential pre-treatment predictors of treatment outcome. The sample included eighty-four children (8-12 years old) with anxiety disorders, from both a treatment group and a waitlist control (after participants had crossed over to treatment) of a previous randomized controlled study. Participants were assessed at post-treatment and three- and twelve-months after treatment using a semi-structured interview and parent ratings. Pre-treatment data were used to investigate predictors of treatment outcome at three-month follow-up. Intention-to-treat analysis showed that treatment gains were maintained at twelve-month follow-up, including clinician rated severity of the principal anxiety disorder, parent rated anxiety symptoms and global functioning, with mainly large effect sizes (Cohen's d = 0.63-2.35). Completer analyses showed that suspected autism spectrum disorder was associated with less change in symptom severity. No other pre-treatment measures significantly predicted treatment outcome. This study suggests that internet-delivered CBT can have long-term beneficial effects for children with anxiety disorders. Predictors of treatment outcome need to be evaluated further. Clinicaltrials.gov; NCT01533402. Copyright © 2016 Elsevier Ltd. All rights reserved.

Clinical relevance of the effects of reach-to-grasp training using trunk restraint in individuals with hemiparesis poststroke: A systematic review.

PubMed

Greisberger, Andrea; Aviv, Hanna; Garbade, Sven F; Diermayr, Gudrun

2016-04-28

To evaluate the evidence for, and clinical relevance of, immediate and long-term effects of trunk restraint during reach-to-grasp training poststroke on movement patterns and functional abilities within the framework of the International Classification of Functioning, Disability and Health. PubMed, Web of Science, CINAHL, Embase, PEDro, Cochrane Library (publication dates January 1985 to March 2015). Randomized controlled trials comparing training using trunk restraint with any other exercise training. Data were extracted by one researcher and checked by two other researchers. The Cochrane Collaboration's tool for assessing risk of bias and the Physiotherapy Evidence Database scale were used by two researchers to assess study quality and risk of bias. Eight studies met the inclusion criteria. Five studies found better recovery of movement patterns (trunk displacement, elbow extension, and/or shoulder flexion - body function/structure) at post-test in the experimental compared with the control groups. Functional abilities (activity/participation) improved more in the experimental groups in 3 studies at post-test. Long-term effects were found in one study after 4 weeks. Trunk restraint has immediate and some long-term effects in adults with chronic stroke. However, these effects are not consistently clinically relevant when referring to minimal detectable change or minimal clinically important difference values.

Obesity in pregnancy: implications for the mother and lifelong health of the child. A consensus statement.

PubMed

Poston, Lucilla; Harthoorn, Lucien F; Van Der Beek, Eline M

2011-02-01

Obesity among pregnant women is becoming one of the most important women's health issues. Obesity is associated with increased risk of almost all pregnancy complications: gestational hypertension, preeclampsia, gestational diabetes mellitus, delivery of large-for-GA infants, and higher incidence of congenital defects all occur more frequently than in women with a normal BMI. Evidence shows that a child of an obese mother may suffer from exposure to a suboptimal in utero environment and that early life adversities may extend into adulthood. In September 2009, ILSI Europe convened a workshop with multidisciplinary expertise to review practices and science base of health and nutrition of obese pregnant women, with focus on the long-term health of the child. The consensus viewpoint of the workshop identified gaps and gave recommendations for future research on gestational weight gain, gestational diabetes, and research methodologies. The evidence available on short- and long-term health impact for mother and child currently favors actions directed at controlling prepregnancy weight and preventing obesity in women of reproductive ages. More randomized controlled trials are needed to evaluate the effects of nutritional and behavioral interventions in pregnancy outcomes. Moreover, suggestions that maternal obesity may transfer obesity risk to child through non-Mendelian (e.g. epigenetic) mechanisms require more long-term investigation.

Long-term outcomes of brief, intensive CBT for specific phobias: The negative impact of ADHD symptoms.

PubMed

Halldorsdottir, Thorhildur; Ollendick, Thomas H

2016-05-01

The objectives were twofold: (a) examine long-term treatment effects in youth receiving 1-session treatment (OST) or educational support (EST) for a specific phobia (SP) and (b) examine the differential predictive and moderation effects of attention-deficit/hyperactivity disorder (ADHD) symptoms on immediate and long-term outcomes following the interventions. Eighty-three children (ages 6-15, 47% female, 89% White) with a SP were randomly assigned to receive OST or EST. Follow up assessments occurred at 1 week, 6 months, 1 year, and 4 years. Hierarchical linear growth modeling (HLGM) was used to explore the association of parent-reported ADHD symptoms, the 2 treatment conditions (i.e., OST vs. EST), and the trajectory of change in the severity of the SP from pretreatment to the 4-year follow-up. Age, conduct problems and learning problems were controlled for in all analyses. A greater immediate reduction in severity rating of the SP was observed in the OST compared to EST, whereas the trajectory of long-term outcomes was similar across conditions over time. Higher levels of ADHD symptoms predicted poor immediate and long-term treatment outcomes across treatment conditions. ADHD symptoms, however, did not moderate the relationship between treatment condition and immediate or long-term treatment outcomes. The results of the study need to be interpreted in light of several study limitations. However, if confirmed, the findings suggest that anxious youth with comorbid ADHD symptoms are less likely to benefit from brief, intensive psychotherapy and may require either longer, standard CBT treatment or adjunctive pharmacotherapy. (c) 2016 APA, all rights reserved).

Dyadic planning of health-behavior change after prostatectomy: a randomized-controlled planning intervention.

PubMed

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

2011-09-01

In this study, we investigated the role of dyadic planning for health-behavior change. Dyadic planning refers to planning health-behavior change together with a partner. We assumed that dyadic planning would affect the implementation of regular pelvic-floor exercise (PFE), with other indicators of social exchange and self-regulation strategies serving as mediators. In a randomized-controlled trial at a German University Medical Center, 112 prostatectomy-patients with partners were randomly assigned to a dyadic PFE-planning condition or one of three active control conditions. Questionnaire data were assessed at multiple time points within six months post-surgery, measuring self-reported dyadic PFE-planning and pelvic-floor exercise as primary outcomes and social exchange (support, control) and a self-regulation strategy (action control) as mediating mechanisms. There were no specific intervention effects with regard to dyadic PFE-planning or pelvic-floor exercise, as two active control groups also showed increases in either of these variables. However, results suggested that patients instructed to plan dyadically still benefited from self-reported dyadic PFE-planning regarding pelvic-floor exercise. Cross-sectionally, received negative control from partners was negatively related with PFE only in control groups and individual action control mediated between self-reported dyadic PFE-planning and PFE for participants instructed to plan PFE dyadically. Longitudinally, action control mediated between self-reported dyadic PFE-planning and pelvic-floor exercise for all groups. Findings provide support for further investigation of dyadic planning in health-behavior change with short-term mediating effects of behavior-specific social exchange and long-term mediating effects of better self-regulation. Copyright © 2011 Elsevier Ltd. All rights reserved.

Advice to Stay Active or Structured Exercise in the Management of Sciatica: A Systematic Review and Meta-analysis.

PubMed

Fernandez, Matt; Hartvigsen, Jan; Ferreira, Manuela L; Refshauge, Kathryn M; Machado, Aryane F; Lemes, Ítalo R; Maher, Chris G; Ferreira, Paulo H

2015-09-15

A systematic review and meta-analysis. To evaluate the evidence on comparative effectiveness of advice to stay active versus supervised structured exercise in the management of sciatica. Conservative management of sciatica usually includes interventions to promote physical activity in the form of advice to stay active or exercise, but there has been no systematic review directly comparing the effectiveness of these 2 approaches. Data Sources included MEDLINE, CINAHL, EMBASE, and PEDro databases. Studies were randomized controlled trials comparing advice with exercise. Two independent reviewers extracted data and assessed methodological quality using the PEDro scale. Pain and disability data were extracted for all time points and converted to a common 0 to 100 scale. Data were pooled with a random effects model for short, intermediate, and long-term follow-ups. The GRADE approach was used to summarize the strength of evidence. Five trials were included in the meta-analysis, which showed a significant, although small effect favoring exercise over advice for reducing leg pain intensity in the short term (weighted mean difference: 11.43 [95% confidence interval, 0.71-22.16]) but no difference for disability (weighted mean difference: 1.45 [95% confidence interval, -2.86 to 5.76]). Furthermore, there was no difference at intermediate and long-term follow-ups between advice and exercise for patient-relevant outcomes. There is low-quality evidence (GRADE) that exercise provides small, superior effects compared with advice to stay active on leg pain in the short term for patients experiencing sciatica. However, there is moderate-quality evidence showing no difference between advice to stay active and exercise on leg pain and disability status in people with sciatica in the long term. 1.

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

PubMed

Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

2014-02-24

The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. ClinicalTrials.gov identifier NCT01232764.

Five Year Follow-Up of a Randomized Controlled Trial on Warming and Humidification of Insufflation Gas in Laparoscopic Colonic Surgery—Impact on Small Bowel Obstruction and Oncologic Outcomes

PubMed Central

Sammour, Tarik; Hill, Andrew G.

2015-01-01

Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA. PMID:25875541

Five year follow-up of a randomized controlled trial on warming and humidification of insufflation gas in laparoscopic colonic surgery--impact on small bowel obstruction and oncologic outcomes.

PubMed

Sammour, Tarik; Hill, Andrew G

2015-04-01

Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA.

Effect of Acarbose on Long-Term Prognosis in Acute Coronary Syndromes Patients with Newly Diagnosed Impaired Glucose Tolerance.

PubMed

Yun, Peng; Du, Ai-ming; Chen, Xue-jun; Liu, Jing-cheng; Xiao, Hu

2016-01-01

To investigate the effect of acarbose therapy on the long-term prognosis of patients with acute coronary syndromes (ACS) complicating newly diagnosed impaired glucose tolerance (IGT). 135 patients hospitalized for ACS who had been newly diagnosed with IGT were randomly assigned to acarbose group (150 mg/day, n = 67) or control group (no acarbose, n = 68). All cases in each group were given the same elementary treatment. Mean follow-up was 2.3 years. The incidence of major adverse cardiovascular event (MACE) and carotid intima-middle thickness (CIMT) were statistically analyzed. During the mean follow-up of 2.3 years, the risk of recurrent MACE in acarbose group was decreased significantly compared with that in control group (26.67% versus 46.88%, P < 0.05); at the same time, thickening of the CIMT was significantly slower than the control group ((1.28 ± 0.42) mm versus (1.51 ± 0.64) mm, P < 0.05). Acarbose can effectively reduce the risk of MACE in ACS patients with newly diagnosed IGT, simultaneously retarding the progression of carotid intima-media thickness.

Age-related Cataract in a Randomized Trial of Vitamins E and C in Men

PubMed Central

Christen, William G.; Glynn, Robert J.; Sesso, Howard D.; Kurth, Tobias; MacFadyen, Jean; Bubes, Vadim; Buring, Julie E.; Manson, JoAnn E.; Michael Gaziano, J.

2010-01-01

Objective To test whether supplementation with alternate day vitamin E or daily vitamin C affects the incidence of age-related cataract in a large-scale randomized trial of men. Design Randomized, double-masked, placebo-controlled trial. Participants Eleven thousand five hundred forty-five apparently healthy US male physicians aged 50 years or older who were without a diagnosis of cataract at baseline. Intervention Participants were randomly assigned to receive 400 IU of vitamin E or placebo on alternate days, and 500 mg of vitamin C or placebo daily. Main Outcome Measure Incident cataract responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-report confirmed by medical record review. Results After 8 years of treatment and follow-up, a total of 1,174 incident cataracts were confirmed. There were 579 cataracts in the vitamin E treated group and 595 in the vitamin E placebo group (hazard ratio [HR], 0.99; 95 percent confidence interval [CI], 0.88 to 1.11). For vitamin C, there were 593 cataracts in the treated group and 581 in the placebo group (HR, 1.02; CI, 0.91 to 1.14). Conclusions In a large-scale randomized trial of US male physicians, long-term alternate day use of 400 IU of vitamin E and/or daily use of 500 mg of vitamin C had no significant beneficial or harmful effect on the risk of cataract. Application to Clinical Practice Long-term use of vitamin E and/or vitamin C supplements has no appreciable effect on cataract. PMID:21060040

A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

PubMed

Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

2015-01-01

Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

PubMed Central

Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S.

2015-01-01

Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

Three Randomized Controlled Trials of Early Long-Chain Polyunsaturated Fatty Acid Supplementation on Means-End Problem Solving in 9-Month-Olds

ERIC Educational Resources Information Center

Drover, James; Hoffman, Dennis R.; Castaneda, Yolanda S.; Morale, Sarah E.; Birch, Eileen E.

2009-01-01

This study examines whether feeding infants formula supplemented with long-chain polyunsaturated fatty acids (LCPUFA) improves cognitive function of 9-month-olds. Participants included 229 infants from 3 randomized controlled trials. Children received either formula supplemented with docosahexaenoic acid and arachidonic acid, or a control formula…

Chronic non-cancer pain: Focus on once-daily tramadol formulations

PubMed Central

Coluzzi, Flaminia; Mattia, Consalvo

2007-01-01

Despite progress in pain management, chronic non-cancer pain (CNCP) represents still a clinical challenge. The efficacy and safety profile of tramadol make it suitable as a long-term treatment in a variety of CNCP conditions. New once-daily (OD) formulations of tramadol have been marketed in various countries, in order to offer the advantage of a reduced dosing regimen and to improve patients’ compliance. This review focuses on the technology, pharmacology, clinical efficacy, and safety of different once-daily tramadol formulations. Hydrophilic vs hydrophobic matrix systems and newer technologies used in once-daily formulations to control drug delivery are discussed. Three randomized controlled trials (RCTs) established OD tramadol analgesic efficacy to be superior to that of placebo for pain management and functional improvement in patients with osteoarthritis. Three RCTs demonstrated similar rates of efficacy between OD tramadol and immediate-release (IR) or sustained-release (SR) formulations, with a better adverse events profile. An open trial on long term tolerability showed that OD tramadol is generally safe in rheumatological pain treatment. PMID:18473006

Behavior Therapy for Tics in Children: Acute and Long-Term Effects on Psychiatric and Psychosocial Functioning

PubMed Central

Woods, Douglas W.; Piacentini, John C.; Scahill, Lawrence; Peterson, Alan L.; Wilhelm, Sabine; Chang, Susanna; Deckersbach, Thilo; McGuire, Joseph; Specht, Matt; Conelea, Christine A.; Rozenman, Michelle; Dzuria, James; Liu, Haibei; Levi-Pearl, Sue; Walkup, John T.

2014-01-01

Children (n = 126) ages 9 to 17 years with chronic tic or Tourette disorder were randomly assigned to receive either behavior therapy or a control treatment over 10 weeks. This study examined acute effects of behavior therapy on secondary psychiatric symptoms and psychosocial functioning and long-term effects on these measures for behavior therapy responders only. Baseline and end point assessments conducted by a masked independent evaluator assessed several secondary psychiatric symptoms and measures of psychosocial functioning. Responders to behavior therapy at the end of the acute phase were reassessed at 3-month and 6-month follow-up. Children in the behavior therapy and control conditions did not differentially improve on secondary psychiatric or psychosocial outcome measures at the end of the acute phase. At 6-month posttreatment, positive response to behavior therapy was associated with decreased anxiety, disruptive behavior, and family strain and improved social functioning. Behavior therapy is a tic-specific treatment for children with tic disorders. PMID:21555779

Reductions of intimate partner violence resulting from supplementing children with omega-3 fatty acids: A randomized, double-blind, placebo-controlled, stratified, parallel-group trial.

PubMed

Portnoy, Jill; Raine, Adrian; Liu, Jianghong; Hibbeln, Joseph R

2018-05-20

Omega-3 supplementation has been found to reduce externalizing behavior in children. Reciprocal models of parent-child behavior suggest that improving child behavior could lead to improvements in parent behavior, however no study has examined whether omega-3 supplementation in children could reduce intimate partner violence or child maltreatment by their adult caregivers. In this randomized, double-blind, placebo-controlled, stratified, parallel group trial, a community sample of children were randomized to receive either a fruit drink containing 1 gm of omega-3 fats (Smartfish Recharge; Omega-3 group, n = 100) or the same fruit drink without omega-3's (Placebo group, n = 100). Child participants, adult caregivers, and research staff were blinded to group assignment. Adult caregivers reported inter-partner and child-directed physical assault and psychological aggression at baseline, 6 months (end of treatment) and 12 months (6 months post-treatment) using the Conflicts Tactics Scale. Caregivers of children in the omega-3 group reported long-term reductions in psychological aggression in a group × time interaction. Improvements in adult psychological aggression were correlated with improvements in child externalizing behavior scores. No differences were reported for child maltreatment. This study is the first to show that omega-3 supplementation in children can reduce inter-partner psychological aggression among adult caregivers not receiving supplements. Findings suggest that improving child behavior through omega-3 supplementation could have long-term benefits to the family system as a whole. © 2018 Wiley Periodicals, Inc.

A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan.

PubMed

Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Itamura, Rio; Asami, Yuko; Kuribayashi, Kazuhiko; Imaeda, Takayuki

2016-01-01

The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75-225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery-Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (-10.76; P=0.031), but not in the flexible-dose (-10.37; P=0.106) group compared with placebo (-9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan.

A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan

PubMed Central

Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Asami, Yuko; Kuribayashi, Kazuhiko; Imaeda, Takayuki

2016-01-01

The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75–225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery–Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (−10.76; P=0.031), but not in the flexible-dose (−10.37; P=0.106) group compared with placebo (−9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan. PMID:26513202

Zonisamide and renal calculi in patients with epilepsy: how big an issue?

PubMed

Wroe, Stephen

2007-08-01

To determine the prevalence of renal calculi in patients treated with zonisamide during randomized, controlled and open-label clinical trials, and from post-marketing surveillance data. Reports of renal calculi from four placebo-controlled double-blind trials of zonisamide, their long-term open-label treatment extension phases, and the US/European zonisamide clinical trial programme were reviewed. One double-blind study and its extension included routine ultrasound screening to identify asymptomatic calculi. Post-marketing surveillance data were also investigated, as was concomitant treatment with topiramate. No symptomatic renal calculi were reported during four randomized double-blind, placebo-controlled trials involving 848 subjects (including 498 zonisamide recipients) treated for up to 3 months. In long-term extension studies with treatment for up to 24 months, symptomatic renal calculi were reported in 9/626 (1.4%) patients. Pooled safety data from all US/European clinical trials identified 15/1296 (1.2%) patients with symptomatic renal calculi during treatment for up to 8.7 years. Post-marketing surveillance revealed nine cases from 59 667 patient-years of exposure in the USA, and 14 from 709 294 patient-years of exposure in Japan; only one case occurred during concomitant topiramate and zonisamide treatment. No imbalance in electrolyte levels was found from 35 patients receiving such co-treatment in clinical trials. The available data suggest that the risk of developing renal calculi during zonisamide treatment is low. Data are insufficient to determine whether concomitant treatment with topiramate increases the risk of renal stones.

Research to encourage exercise for fibromyalgia (REEF): use of motivational interviewing, outcomes from a randomized-controlled trial.

PubMed

Ang, Dennis C; Kaleth, Anthony S; Bigatti, Silvia; Mazzuca, Steven A; Jensen, Mark P; Hilligoss, Janna; Slaven, James; Saha, Chandan

2013-04-01

Regular exercise is associated with important benefits in patients with fibromyalgia (FM). Unfortunately, long-term maintenance of exercise after a structured program is rare. The present study tested the efficacy of Motivational Interviewing (MI) to promote exercise and improve symptoms in patients with FM. A total of 216 patients with FM were randomized to 6 MI sessions (n=107) or an equal number of FM self-management lessons (education control/EC, n=109). Co-primary endpoints were an increase of 30 minutes in moderate-vigorous physical activity and improvement in the Fibromyalgia Impact Questionnaire (FIQ)-Physical Impairment score, assessed at pretreatment, posttreatment, and 3-month and 6-month follow-up. Secondary outcomes included clinically meaningful improvements in FIQ score, pain severity ratings, and a 6-minute walk test. There were no significant treatment group differences in either co-primary endpoint at 6-month follow-up. However, more MI participants than controls exhibited meaningful improvements in FIQ score at 6-month follow-up (62.9% vs. 49.5%, P=0.06). Compared with EC participants, MI participants also displayed a larger increment in their 6-minute walk test (43.9 vs. 24.8 m, P=0.03). In addition, MI was superior to EC in increasing the number of hours of physical activity immediately postintervention and in reducing pain severity both immediately after the intervention and at 3-month follow-up. Despite a lack of benefits on long-term outcome, MI seems to have short-term benefits with respect to self-report physical activity and clinical outcomes. This is the first study in FM that explicitly addresses exercise maintenance as a primary aim.

Melatonin for sedative withdrawal in older patients with primary insomnia: a randomized double-blind placebo-controlled trial

PubMed Central

Lähteenmäki, Ritva; Puustinen, Juha; Vahlberg, Tero; Lyles, Alan; Neuvonen, Pertti J; Partinen, Markku; Räihä, Ismo; Kivelä, Sirkka-Liisa

2014-01-01

Aim We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here ‘BZD’) use. Methods A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted. Results There were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups. Conclusions Gradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstinence. CRM showed no withdrawal benefit compared with placebo. PMID:24286360

Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes

PubMed Central

Dahabreh, Issa J.; Sheldrick, Radley C.; Paulus, Jessica K.; Chung, Mei; Varvarigou, Vasileia; Jafri, Haseeb; Rassen, Jeremy A.; Trikalinos, Thomas A.; Kitsios, Georgios D.

2012-01-01

Aims Randomized controlled trials (RCTs) are the gold standard for assessing the efficacy of therapeutic interventions because randomization protects from biases inherent in observational studies. Propensity score (PS) methods, proposed as a potential solution to confounding of the treatment–outcome association, are widely used in observational studies of therapeutic interventions for acute coronary syndromes (ACS). We aimed to systematically assess agreement between observational studies using PS methods and RCTs on therapeutic interventions for ACS. Methods and results We searched for observational studies of interventions for ACS that used PS methods to estimate treatment effects on short- or long-term mortality. Using a standardized algorithm, we matched observational studies to RCTs based on patients’ characteristics, interventions, and outcomes (‘topics’), and we compared estimates of treatment effect between the two designs. When multiple observational studies or RCTs were identified for the same topic, we performed a meta-analysis and used the summary relative risk for comparisons. We matched 21 observational studies investigating 17 distinct clinical topics to 63 RCTs (median = 3 RCTs per observational study) for short-term (7 topics) and long-term (10 topics) mortality. Estimates from PS analyses differed statistically significantly from randomized evidence in two instances; however, observational studies reported more extreme beneficial treatment effects compared with RCTs in 13 of 17 instances (P = 0.049). Sensitivity analyses limited to large RCTs, and using alternative meta-analysis models yielded similar results. Conclusion For the treatment of ACS, observational studies using PS methods produce treatment effect estimates that are of more extreme magnitude compared with those from RCTs, although the differences are rarely statistically significant. PMID:22711757

Who Recommends Long-Term Care Matters

ERIC Educational Resources Information Center

Kane, Robert L.; Bershadsky, Boris; Bershadsky, Julie

2006-01-01

Purpose: Making good consumer decisions requires having good information. This study compared long-term-care recommendations among various types of health professionals. Design and Methods: We gave randomly varied scenarios to a convenience national sample of 211 professionals from varying disciplines and work locations. For each scenario, we…

Effectiveness of perioperative antiepileptic drug prophylaxis for early and late seizures following oncologic neurosurgery: a meta-analysis.

PubMed

Joiner, Evan F; Youngerman, Brett E; Hudson, Taylor S; Yang, Jingyan; Welch, Mary R; McKhann, Guy M; Neugut, Alfred I; Bruce, Jeffrey N

2018-04-27

OBJECTIVE The purpose of this meta-analysis was to evaluate the impact of perioperative antiepileptic drug (AED) prophylaxis on short- and long-term seizure incidence among patients undergoing brain tumor surgery. It is the first meta-analysis to focus exclusively on perioperative AED prophylaxis among patients undergoing brain tumor surgery. METHODS The authors searched PubMed/MEDLINE, Embase, Cochrane Central Register of Controlled Trials, clinicaltrials.gov, and the System for Information on Gray Literature in Europe for records related to perioperative AED prophylaxis for patients with brain tumors. Risk of bias in the included studies was assessed using the Cochrane risk of bias tool. Incidence rates for early seizures (within the first postoperative week) and total seizures were estimated based on data from randomized controlled trials. A Mantel-Haenszel random-effects model was used to analyze pooled relative risk (RR) of early seizures (within the first postoperative week) and total seizures associated with perioperative AED prophylaxis versus control. RESULTS Four RCTs involving 352 patients met the criteria of inclusion. The results demonstrated that perioperative AED prophylaxis for patients undergoing brain tumor surgery provides a statistically significant reduction in risk of early postoperative seizures compared with control (RR = 0.352, 95% confidence interval 0.130-0.949, p = 0.039). AED prophylaxis had no statistically significant effect on the total (combined short- and long-term) incidence of seizures. CONCLUSIONS This meta-analysis demonstrates for the first time that perioperative AED prophylaxis for brain tumor surgery provides a statistically significant reduction in early postoperative seizure risk.

Is the authoritative parenting model effective in changing oral hygiene behavior in adolescents?

PubMed

Brukienė, Vilma; Aleksejūnienė, Jolanta

2012-12-01

This study examined whether the authoritative parenting model (APM) is more effective than conventional approaches for changing adolescent oral hygiene behavior. A total of 247 adolescents were recruited using a cluster random-sampling method. Subject groups were randomly allocated into an intervention group (APM-based interventions), a Control Group 1 (conventional dental education and behavior modification) or a Control Group 2 (conventional behavior modification). The results were assessed after 3 and 12 months. Oral hygiene level was assessed as percent dental plaque and the ratio of plaque percent change (RPC). At the 3-month follow-up, there were significant differences among the groups; the APM group had the largest decrease in plaque levels (24.5%), Control Group 1 showed a decrease in plaque levels of 15.4% and Control Group 2 showed an increase in plaque levels of 2.8%. At the 12-month follow-up, an improvement was observed in all groups, but there were no statistically significant differences among the groups. In the short term, the intervention based on the APM was more effective in changing adolescent oral hygiene behavior compared with the conventional approaches. The reasons for long-term positive change after discontinued interventions in control groups need to be explored in future studies.

Esophageal replacement in children: Challenges and long-term outcomes.

PubMed

Soccorso, Giampiero; Parikh, Dakshesh H

2016-01-01

Replacement of a nonexistent or damaged esophagus continues to pose a significant challenge to pediatric surgeons. Various esophageal replacement grafts and techniques have not produced consistently good outcomes to emulate normal esophagus. Therefore, many techniques are still being practiced and recommended with no clear consensus. We present a concise literature review of the currently used techniques and with discussions on the advantages and anticipated morbidity. There are no randomized controlled pediatric studies to compare different types of esophageal replacements. Management and graft choice are based on geographical and personal predilections rather than on any discernible objective data. The biggest series with long-term outcome are reported for gastric transposition and colonic replacement. Comparison of different studies shows no significant difference in early (graft necrosis and anastomotic leaks) or late complications (strictures, poor feeding, gastro-esophageal reflux, tortuosity of the graft, and Barrett's esophagus). The biggest series seem to have lower complications than small series reflecting the decennials experience in their respective centers. Long-term follow-up is recommended following esophageal replacement for the development of late strictures, excessive tortuosity, and Barrett's changes within the graft. Once child overcomes initial morbidity and establishes oral feeding, long-term consequences and complications of pediatric esophageal replacement should be monitored and managed in adult life.

Esophageal replacement in children: Challenges and long-term outcomes

PubMed Central

Soccorso, Giampiero; Parikh, Dakshesh H.

2016-01-01

Replacement of a nonexistent or damaged esophagus continues to pose a significant challenge to pediatric surgeons. Various esophageal replacement grafts and techniques have not produced consistently good outcomes to emulate normal esophagus. Therefore, many techniques are still being practiced and recommended with no clear consensus. We present a concise literature review of the currently used techniques and with discussions on the advantages and anticipated morbidity. There are no randomized controlled pediatric studies to compare different types of esophageal replacements. Management and graft choice are based on geographical and personal predilections rather than on any discernible objective data. The biggest series with long-term outcome are reported for gastric transposition and colonic replacement. Comparison of different studies shows no significant difference in early (graft necrosis and anastomotic leaks) or late complications (strictures, poor feeding, gastro-esophageal reflux, tortuosity of the graft, and Barrett's esophagus). The biggest series seem to have lower complications than small series reflecting the decennials experience in their respective centers. Long-term follow-up is recommended following esophageal replacement for the development of late strictures, excessive tortuosity, and Barrett's changes within the graft. Once child overcomes initial morbidity and establishes oral feeding, long-term consequences and complications of pediatric esophageal replacement should be monitored and managed in adult life. PMID:27365900

Shared weight and dietary changes in parent-child dyads following family-based obesity treatment.

PubMed

Best, John R; Goldschmidt, Andrea B; Mockus-Valenzuela, Danyte S; Stein, Richard I; Epstein, Leonard H; Wilfley, Denise E

2016-01-01

The primary objective was to determine whether children and their participating parents undergoing family-based behavioral treatment (FBT) for obesity show similar dietary changes following treatment, and if so, whether these shared dietary changes explain the similarity in weight change within the parent-child dyad. Data come from a randomized controlled trial of 148 parent-child dyads who completed FBT and were followed over a 2-year maintenance phase. Energy-dense, nutrient-poor foods ("RED" foods) and fruit and vegetable intake were assessed across time. Maintenance of lower RED food intake following FBT predicted weight maintenance in children and in parents (ps < .01), and dietary and weight changes were correlated within parent-child dyads (ps < .01). Most interesting, the similarity in long-term weight maintenance between children and their parents was predicted by the similarity in long-term changes in RED food intake between children and their parents (p < .001). These findings point to the important role of maintaining low energy-dense, nutrient-poor food intake for long-term weight maintenance in children and parents. Furthermore, these results suggest that the correlation between parent and child weight maintenance can be explained in part by similar long-term changes in energy-dense, nutrient-poor food intake. (c) 2015 APA, all rights reserved).

Role of Fixation and Postoperative Regimens in the Long-Term Outcomes of Distal Chevron Osteotomy: A Randomized Controlled Two-by-Two Factorial Trial of 100 Patients.

PubMed

Pentikäinen, Ilkka; Piippo, Jouni; Ohtonen, Pasi; Junila, Juhani; Leppilahti, Juhana

2015-01-01

The necessity of chevron osteotomy fixation is controversial and evidence for the effectiveness of postoperative regimens is limited. In a prospective, randomized study, we compared the long-term results of 2 operative techniques (osteotomy fixation versus no fixation) and 2 postoperative regimens (a soft cast versus an elastic bandage) in 100 patients who underwent surgery for hallux valgus. Clinical evaluations with the American Orthopaedic Foot and Ankle Society (AOFAS) scale scoring were performed at baseline and 6 weeks, 6 months, 1 year, and a mean of 7.9 years postoperatively. The mean AOFAS function score were better in the group treated without osteotomy fixation and with an elastic bandage at 6 weeks postoperatively, but the differences then disappeared. The total AOFAS scores improved significantly in all 4 subgroups during the first 12 months; however, in the long term, some deterioration occurred. In the AOFAS scores, the average function, alignment, and total points were significantly worse when the preoperative hallux valgus angles exceeded 30°. The incidence of complication was low (1%); there was 1 superficial wound infection. The AOFAS score did not differ statistically among the groups in our population. An elastic bandage for postoperative treatment is recommended. The risk of recurrence is greater and functional result worse if the preoperative hallux valgus angle exceeds 30°. Copyright © 2015 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

Predicting Long-Term Cognitive Outcome Following Breast Cancer with Pre-Treatment Resting State fMRI and Random Forest Machine Learning.

PubMed

Kesler, Shelli R; Rao, Arvind; Blayney, Douglas W; Oakley-Girvan, Ingrid A; Karuturi, Meghan; Palesh, Oxana

2017-01-01

We aimed to determine if resting state functional magnetic resonance imaging (fMRI) acquired at pre-treatment baseline could accurately predict breast cancer-related cognitive impairment at long-term follow-up. We evaluated 31 patients with breast cancer (age 34-65) prior to any treatment, post-chemotherapy and 1 year later. Cognitive testing scores were normalized based on data obtained from 43 healthy female controls and then used to categorize patients as impaired or not based on longitudinal changes. We measured clustering coefficient, a measure of local connectivity, by applying graph theory to baseline resting state fMRI and entered these metrics along with relevant patient-related and medical variables into random forest classification. Incidence of cognitive impairment at 1 year follow-up was 55% and was predicted by classification algorithms with up to 100% accuracy ( p < 0.0001). The neuroimaging-based model was significantly more accurate than a model involving patient-related and medical variables ( p = 0.005). Hub regions belonging to several distinct functional networks were the most important predictors of cognitive outcome. Characteristics of these hubs indicated potential spread of brain injury from default mode to other networks over time. These findings suggest that resting state fMRI is a promising tool for predicting future cognitive impairment associated with breast cancer. This information could inform treatment decision making by identifying patients at highest risk for long-term cognitive impairment.

Predicting Long-Term Cognitive Outcome Following Breast Cancer with Pre-Treatment Resting State fMRI and Random Forest Machine Learning

PubMed Central

Kesler, Shelli R.; Rao, Arvind; Blayney, Douglas W.; Oakley-Girvan, Ingrid A.; Karuturi, Meghan; Palesh, Oxana

2017-01-01

We aimed to determine if resting state functional magnetic resonance imaging (fMRI) acquired at pre-treatment baseline could accurately predict breast cancer-related cognitive impairment at long-term follow-up. We evaluated 31 patients with breast cancer (age 34–65) prior to any treatment, post-chemotherapy and 1 year later. Cognitive testing scores were normalized based on data obtained from 43 healthy female controls and then used to categorize patients as impaired or not based on longitudinal changes. We measured clustering coefficient, a measure of local connectivity, by applying graph theory to baseline resting state fMRI and entered these metrics along with relevant patient-related and medical variables into random forest classification. Incidence of cognitive impairment at 1 year follow-up was 55% and was predicted by classification algorithms with up to 100% accuracy (p < 0.0001). The neuroimaging-based model was significantly more accurate than a model involving patient-related and medical variables (p = 0.005). Hub regions belonging to several distinct functional networks were the most important predictors of cognitive outcome. Characteristics of these hubs indicated potential spread of brain injury from default mode to other networks over time. These findings suggest that resting state fMRI is a promising tool for predicting future cognitive impairment associated with breast cancer. This information could inform treatment decision making by identifying patients at highest risk for long-term cognitive impairment. PMID:29187817

Non-invasive ventilation during cycle exercise training in patients with chronic respiratory failure on long-term ventilatory support: A randomized controlled trial.

PubMed

Vitacca, Michele; Kaymaz, Dicle; Lanini, Barbara; Vagheggini, Guido; Ergün, Pınar; Gigliotti, Francesco; Ambrosino, Nicolino; Paneroni, Mara

2018-02-01

The role of non-invasive ventilation (NIV) during exercise training (ET) in patients with chronic respiratory failure (CRF) is still unclear. The aim of this study was to test whether NIV during ET had an additional effect in increasing the 6-min walking distance (6MWD) and cycle endurance time compared with ET alone. All patients underwent 20 sessions of cycle training over 3 weeks and were randomly assigned to ET with NIV or ET alone. Outcome measures were 6MWD (primary outcome), incremental and endurance cycle ergometer exercise time, respiratory muscle function, quality of life by the Maugeri Respiratory Failure questionnaire (MRF-28), dyspnoea (Medical Research Council scale) and leg fatigue at rest. Forty-two patients completed the study. Following training, no significant difference in 6MWD changes were found between groups. Improvement in endurance time was significantly greater in the NIV group compared with the non-NIV training group (754 ± 973 vs 51 ± 406 s, P = 0.0271); dyspnoea improved in both groups, while respiratory muscle function and leg fatigue improved only in the NIV ET group. MRF-28 improved only in the group training without NIV. In CRF patients on long-term NIV and long-term oxygen therapy (LTOT), the addition of NIV to ET sessions resulted in an improvement in endurance time, but not in 6MWD. © 2017 Asian Pacific Society of Respirology.

Variation of Care Time Between Nursing Units in Classification-Based Nurse-to-Resident Ratios: A Multilevel Analysis

PubMed Central

Planer, Katarina; Hagel, Anja

2018-01-01

A validity test was conducted to determine how care level–based nurse-to-resident ratios compare with actual daily care times per resident in Germany. Stability across different long-term care facilities was tested. Care level–based nurse-to-resident ratios were compared with the standard minimum nurse-to-resident ratios. Levels of care are determined by classification authorities in long-term care insurance programs and are used to distribute resources. Care levels are a powerful tool for classifying authorities in long-term care insurance. We used observer-based measurement of assignable direct and indirect care time in 68 nursing units for 2028 residents across 2 working days. Organizational data were collected at the end of the quarter in which the observation was made. Data were collected from January to March, 2012. We used a null multilevel model with random intercepts and multilevel models with fixed and random slopes to analyze data at both the organization and resident levels. A total of 14% of the variance in total care time per day was explained by membership in nursing units. The impact of care levels on care time differed significantly between nursing units. Forty percent of residents at the lowest care level received less than the standard minimum registered nursing time per day. For facilities that have been significantly disadvantaged in the current staffing system, a higher minimum standard will function more effectively than a complex classification system without scientific controls. PMID:29442533

Variation of Care Time Between Nursing Units in Classification-Based Nurse-to-Resident Ratios: A Multilevel Analysis.

PubMed

Brühl, Albert; Planer, Katarina; Hagel, Anja

2018-01-01

A validity test was conducted to determine how care level-based nurse-to-resident ratios compare with actual daily care times per resident in Germany. Stability across different long-term care facilities was tested. Care level-based nurse-to-resident ratios were compared with the standard minimum nurse-to-resident ratios. Levels of care are determined by classification authorities in long-term care insurance programs and are used to distribute resources. Care levels are a powerful tool for classifying authorities in long-term care insurance. We used observer-based measurement of assignable direct and indirect care time in 68 nursing units for 2028 residents across 2 working days. Organizational data were collected at the end of the quarter in which the observation was made. Data were collected from January to March, 2012. We used a null multilevel model with random intercepts and multilevel models with fixed and random slopes to analyze data at both the organization and resident levels. A total of 14% of the variance in total care time per day was explained by membership in nursing units. The impact of care levels on care time differed significantly between nursing units. Forty percent of residents at the lowest care level received less than the standard minimum registered nursing time per day. For facilities that have been significantly disadvantaged in the current staffing system, a higher minimum standard will function more effectively than a complex classification system without scientific controls.

Lessons from writing sessions: a school-based randomized trial with adolescent orphans in Rwanda

PubMed Central

Unterhitzenberger, Johanna; Rosner, Rita

2014-01-01

Background Treatments for adolescents affected by long-term loss in low- and middle-income countries are lacking. As school-based interventions are cost-efficient and easy to disseminate, an evaluation of this treatment setting for adolescents is worthwhile. Objective Examining the effect of a school-based unstructured emotional writing intervention (sensu Pennebaker, group 1) about the loss of a parent to reduce adaptation problems to loss, compared to writing about a hobby (group 2), and non-writing (group 3). Method We randomly assigned 14–18-year-old Rwandan orphans to one of the three conditions (n=23 per condition). Before and after the intervention, subjects completed the Prolonged Grief Questionnaire for Adolescents and the Mini International Neuropsychiatric Interview for Children and Adolescents, Part A, on depression as self-report measures of long-term effects of early parental loss. Results Repeated measures analyses of variance showed no differential effect for any of the three conditions but revealed a significant effect of time at posttest regarding grief severity. Reduction of grief symptoms was significantly higher in subjects with elevated grief. Depressive symptoms showed no significant change from pre- to posttest in the emotional writing condition, whereas they significantly decreased in the control condition. Conclusions Results imply that unstructured, brief emotional writing might not be indicated in adolescents affected by early parental loss who show severe and long-term distress; a more structured approach seems recommendable. PMID:25537814

Ramipril and Losartan Exert a Similar Long-Term Effect upon Markers of Heart Failure, Endogenous Fibrinolysis, and Platelet Aggregation in Survivors of ST-Elevation Myocardial Infarction: A Single Centre Randomized Trial.

PubMed

Marinšek, Martin; Sinkovič, Andreja

2016-01-01

Blocking the renin-angiotensin-aldosterone system in ST-elevation myocardial infarction (STEMI) patients prevents heart failure and recurrent thrombosis. Our aim was to compare the effects of ramipril and losartan upon the markers of heart failure, endogenous fibrinolysis, and platelet aggregation in STEMI patients over the long term. After primary percutaneous coronary intervention (PPCI), 28 STEMI patients were randomly assigned ramipril and 27 losartan, receiving therapy for six months with dual antiplatelet therapy (DAPT). We measured N-terminal proBNP (NT-proBNP), ejection fraction (EF), plasminogen-activator-inhibitor type 1 (PAI-1), and platelet aggregation by closure times (CT) at the baseline and after six months. Baseline NT-proBNP ≥ 200 pmol/mL was observed in 48.1% of the patients, EF < 55% in 49.1%, and PAI-1 ≥ 3.5 U/mL in 32.7%. Six-month treatment with ramipril or losartan resulted in a similar effect upon PAI-1, NT-proBNP, EF, and CT levels in survivors of STEMI, but in comparison to control group, receiving DAPT alone, ramipril or losartan treatment with DAPT significantly increased mean CT (226.7 ± 80.3 sec versus 158.1 ± 80.3 sec, p < 0.05). Ramipril and losartan exert a similar effect upon markers of heart failure and endogenous fibrinolysis, and, with DAPT, a more efficient antiplatelet effect in long term than DAPT alone.

Asthma Medicines: Long-Term Control

MedlinePlus

... Size Email Print Share Asthma Medicines: Long-term Control Page Content Article Body Corticosteroids Synthetic versions of ... form, they are used exclusively for long-term control; they are not very effective for acute symptoms. ...

Adding Celecoxib With or Without Zoledronic Acid for Hormone-Naïve Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial

PubMed Central

Mason, Malcolm D.; Clarke, Noel W.; James, Nicholas D.; Dearnaley, David P.; Spears, Melissa R.; Ritchie, Alastair W.S.; Attard, Gerhardt; Cross, William; Jones, Rob J.; Parker, Christopher C.; Russell, J. Martin; Thalmann, George N.; Schiavone, Francesca; Cassoly, Estelle; Matheson, David; Millman, Robin; Rentsch, Cyrill A.; Barber, Jim; Gilson, Clare; Ibrahim, Azman; Logue, John; Lydon, Anna; Nikapota, Ashok D.; O’Sullivan, Joe M.; Porfiri, Emilio; Protheroe, Andrew; Srihari, Narayanan Nair; Tsang, David; Wagstaff, John; Wallace, Jan; Walmsley, Catherine; Parmar, Mahesh K.B.; Sydes, Matthew R.

2017-01-01

Purpose Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally advanced or metastatic prostate cancer who were initiating long-term hormone therapy. We report survival data for two celecoxib (Cel)-containing comparisons, which stopped accrual early at interim analysis on the basis of failure-free survival. Patients and Methods Standard of care (SOC) was hormone therapy continuously (metastatic) or for ≥ 2 years (nonmetastatic); prostate (± pelvic node) radiotherapy was encouraged for men without metastases. Cel 400 mg was administered twice a day for 1 year. Zoledronic acid (ZA) 4 mg was administered for six 3-weekly cycles, then 4-weekly for 2 years. Stratified random assignment allocated patients 2:1:1 to SOC (control), SOC + Cel, or SOC + ZA + Cel. The primary outcome measure was all-cause mortality. Results were analyzed with Cox proportional hazards and flexible parametric models adjusted for stratification factors. Results A total of 1,245 men were randomly assigned (Oct 2005 to April 2011). Groups were balanced: median age, 65 years; 61% metastatic, 14% N+/X M0, 25% N0M0; 94% newly diagnosed; median prostate-specific antigen, 66 ng/mL. Median follow-up was 69 months. Grade 3 to 5 adverse events were seen in 36% SOC-only, 33% SOC + Cel, and 32% SOC + ZA + Cel patients. There were 303 control arm deaths (83% prostate cancer), and median survival was 66 months. Compared with SOC, the adjusted hazard ratio was 0.98 (95% CI, 0.80 to 1.20; P = .847; median survival, 70 months) for SOC + Cel and 0.86 (95% CI, 0.70 to 1.05; P =.130; median survival, 76 months) for SOC + ZA + Cel. Preplanned subgroup analyses in men with metastatic disease showed a hazard ratio of 0.78 (95% CI, 0.62 to 0.98; P = .033) for SOC + ZA + Cel. Conclusion These data show no overall evidence of improved survival with Cel. Preplanned subgroup analyses provide hypotheses for future studies. PMID:28300506

Adding Celecoxib With or Without Zoledronic Acid for Hormone-Naïve Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial.

PubMed

Mason, Malcolm D; Clarke, Noel W; James, Nicholas D; Dearnaley, David P; Spears, Melissa R; Ritchie, Alastair W S; Attard, Gerhardt; Cross, William; Jones, Rob J; Parker, Christopher C; Russell, J Martin; Thalmann, George N; Schiavone, Francesca; Cassoly, Estelle; Matheson, David; Millman, Robin; Rentsch, Cyrill A; Barber, Jim; Gilson, Clare; Ibrahim, Azman; Logue, John; Lydon, Anna; Nikapota, Ashok D; O'Sullivan, Joe M; Porfiri, Emilio; Protheroe, Andrew; Srihari, Narayanan Nair; Tsang, David; Wagstaff, John; Wallace, Jan; Walmsley, Catherine; Parmar, Mahesh K B; Sydes, Matthew R

2017-05-10

Purpose Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally advanced or metastatic prostate cancer who were initiating long-term hormone therapy. We report survival data for two celecoxib (Cel)-containing comparisons, which stopped accrual early at interim analysis on the basis of failure-free survival. Patients and Methods Standard of care (SOC) was hormone therapy continuously (metastatic) or for ≥ 2 years (nonmetastatic); prostate (± pelvic node) radiotherapy was encouraged for men without metastases. Cel 400 mg was administered twice a day for 1 year. Zoledronic acid (ZA) 4 mg was administered for six 3-weekly cycles, then 4-weekly for 2 years. Stratified random assignment allocated patients 2:1:1 to SOC (control), SOC + Cel, or SOC + ZA + Cel. The primary outcome measure was all-cause mortality. Results were analyzed with Cox proportional hazards and flexible parametric models adjusted for stratification factors. Results A total of 1,245 men were randomly assigned (Oct 2005 to April 2011). Groups were balanced: median age, 65 years; 61% metastatic, 14% N+/X M0, 25% N0M0; 94% newly diagnosed; median prostate-specific antigen, 66 ng/mL. Median follow-up was 69 months. Grade 3 to 5 adverse events were seen in 36% SOC-only, 33% SOC + Cel, and 32% SOC + ZA + Cel patients. There were 303 control arm deaths (83% prostate cancer), and median survival was 66 months. Compared with SOC, the adjusted hazard ratio was 0.98 (95% CI, 0.80 to 1.20; P = .847; median survival, 70 months) for SOC + Cel and 0.86 (95% CI, 0.70 to 1.05; P =.130; median survival, 76 months) for SOC + ZA + Cel. Preplanned subgroup analyses in men with metastatic disease showed a hazard ratio of 0.78 (95% CI, 0.62 to 0.98; P = .033) for SOC + ZA + Cel. Conclusion These data show no overall evidence of improved survival with Cel. Preplanned subgroup analyses provide hypotheses for future studies.

Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial.

PubMed

Legemate, Catherine M; Goei, Harold; Middelkoop, Esther; Oen, Irma M M H; Nijhuis, Tim H J; Kwa, Kelly A A; van Zuijlen, Paul P M; Beerthuizen, Gerard I J M; Nieuwenhuis, Marianne K; van Baar, Margriet E; van der Vlies, Cornelis H

2018-04-19

Deep dermal burns require tangential excision of non-viable tissue and skin grafting to improve wound healing and burn-scar quality. Tangential excision is conventionally performed with a knife, but during the last decade hydrosurgery has become popular as a new tool for tangential excision. Hydrosurgery is generally thought to be a more precise and controlled manner of burn debridement leading to preservation of viable tissue and, therefore, better scar quality. Although scar quality is considered to be one of the most important outcomes in burn surgery today, no randomized controlled study has compared the effect of these two common treatment modalities with scar quality as a primary outcome. The aim of this study is, therefore, to compare long-term scar quality after hydrosurgical versus conventional tangential excision in deep dermal burns. A multicenter, randomized, intra-patient, controlled trial will be conducted in the Dutch burn centers of Rotterdam, Beverwijk, and Groningen. All patients with deep dermal burns that require excision and grafting are eligible. Exclusion criteria are: a burn wound < 50 cm 2 , total body surface area (TBSA) burned > 30%, full-thickness burns, chemical or electrical burns, infected wounds (clinical symptoms in combination with positive wound swabs), insufficient knowledge of the Dutch or English language, patients that are unlikely to comply with requirements of the study protocol and follow-up, and patients who are (temporarily) incompetent because of sedation and/or intubation. A total of 137 patients will be included. Comparable wound areas A and B will be appointed, randomized and either excised conventionally with a knife or with the hydrosurgery system. The primary outcome is scar quality measured by the observer score of the Patient and Observer Scar Assessment Scale (POSAS); a subjective scar-assessment instrument, consisting of two separate six-item scales (observer and patient) that are both scored on a 10-point rating scale. This study will contribute to the optimal surgical treatment of patients with deep dermal burn wounds. Dutch Trial Register, NTR6232 . Registered on 23 January 2017.

Effect of forced exercise and exercise withdrawal on memory, serum and hippocampal corticosterone levels in rats.

PubMed

Radahmadi, Maryam; Alaei, Hojjatallah; Sharifi, Mohammad Reza; Hosseini, Nasrin

2015-10-01

Evidence suggests that there are positive effects of exercise on learning and memory. Moreover, some studies have demonstrated that forced exercise plays the role of a stressor. This study was aimed at investigating the effects of different timing of exercise and exercise withdrawal on memory, and serum and hippocampal corticosterone (CORT) levels. Wistar rats were randomly divided into five groups: control, sham, exercise-rest (exercise withdrawal), rest-exercise (exercised group), and exercise-exercise (continuous exercise). Rats were forced to run on a treadmill for 1 h/day at a speed 20-21-m/min. Memory function was evaluated by the passive avoidance test in different intervals (1, 7 and 21 days) after foot shock. Findings showed that after the exercise withdrawal, short-term and mid-term memories, had significant enhancement compared to the control group, while the long-term memory did not present this result. In addition, the serum and hippocampal CORT levels were at the basal levels after the rest period in the exercise-rest group. In the rest-exercise group, exercise improved mid- and long-term memories, whereas continuous exercise improved all types short-, mid- and long-term memories, particularly the mid-term memory. Twenty-one and forty-two days of exercise significantly decreased the serum and hippocampal CORT levels. It seems that exercise for at least 21 days with no rest could affect biochemical factors in the brain. Also, regular continuous exercise plays an important role in memory function. Hence, the duration and withdraw of exercise are important factors for the neurobiological aspects of the memory responses.

Intravenous lipid emulsions in term infants: impact on laboratory and clinical outcomes and long-term consequences.

PubMed

Hartman, Corina; Shamir, Raanan

2015-01-01

Parenteral nutrition (PN) in term newborns and older infants is often required for nutritional support for temporary or permanent intestinal failure from any reason. Lipid emulsions (LEs) are an essential source of high-density energy, essential fatty acids, and fat-soluble vitamins. Depending on the fatty acid type, LEs may also have significant immunomodulatory effects. All LEs, starting with soybean oil-based LE and subsequently with medium-chain triglycerides-, olive oil- and fish oil-based LEs, have been investigated in newborns and infants. Laboratory data (mainly liver enzymes, plasma lipid profiles and some metabolic markers) have been investigated for some LEs. The outcome of intestinal failure-associated liver disease after switching to new fish oil-based LEs has been sporadically reported. Long-term outcome data have only looked at the relationship between PN and mortality/morbidity, especially liver disease, and a few studies have looked at growth. There are no controlled studies in this age group that investigated the relationship between different types of LEs and long-term outcomes. In spite of their contribution to understanding the use and indications of various LEs as well as their advantages and adverse effects, most studies in newborns and infants have been observational or retrospective, and the investigated population has been heterogeneous, either in terms of the degree of maturation, age or diagnoses. High-quality studies, preferably randomized and controlled, in this particular population are needed, especially with the widespread use of PN and the emergence of new LEs. © 2015 S. Karger AG, Basel.

A comparison of two endoscopic closures: over-the-scope clip (OTSC) versus KING closure (endoloop + clips) in a randomized long-term experimental study.

PubMed

Dolezel, R; Ryska, O; Kollar, M; Juhasova, J; Kalvach, J; Ryska, M; Martinek, J

2016-11-01

Both over-the-scope clip (OTSC) and KING (endoloop + clips) closures provide reliable and safe full-thickness endoscopic closure. Nevertheless, OTSC clip demonstrated significantly inferior histological healing in the short-term follow-up. To compare OTSC versus KING closure of a perforation with regard to long-term effectiveness and macroscopic and histological quality of healing. We performed a randomized experimental study with 16 mini-pigs (mean weight 43.2 ± 11.2 kg). A standardized perforation was performed on the anterior sigmoid wall. KING closure (n = 8) was attained by approximation of an endoloop fixed to the margins of a perforation with endoclips. OTSC closure (n = 8) was performed by deploying OTSC (OVESCO) over the defect. Pigs underwent a control sigmoidoscopy 8 months after the closure to assess the macroscopic quality of healing. Then, autopsy was performed and the rectosigmoid was sent for histopathological assessment. All closures were completed successfully without air leaks. The duration of closure was similar in both techniques (OTSC 17.8 ± 7.6 min vs. KING 19.6 ± 8.8 min). At autopsy, all KING closures (100 %) were healed with a flat scar without signs of leakage. Microscopically, no inflammatory changes were observed after KING closure. In the OTSC group, microscopic ulcers were present in two pigs (25 %), cryptal abscesses in three pigs (38 %) and significant neutrophil accumulation in all eight pigs (P < 0.01). Giant cell granulomas, dysplasia or abundant scarification was not observed in either group. Both OTSC and KING closures offer a long-term reliable seal of a gastrointestinal perforation without stenosis or fistulas. KING closure provides long-term histologically superior healing.

77 FR 46058 - Utility Scale Wind Towers From the Socialist Republic of Vietnam: Preliminary Determination of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-02

... Sale, Comment 1. Sales during the POI were made pursuant to long-term contracts, and/or purchase orders..., the material terms appear to be fixed, pursuant to the long-term agreement, and are reflected in the...: Dynamic Random Access Memory Semiconductors of One Megabit and Above From the Republic of Korea, 57 FR...

Effect of a diet intervention during pregnancy on dietary behavior in the randomized controlled Norwegian Fit for Delivery study.

PubMed

Hillesund, E R; Bere, E; Sagedal, L R; Vistad, I; Øverby, N C

2016-10-01

A mother's diet during pregnancy has the potential to influence both her own and her child's short- and long-term health. This paper reports the effects of a randomized controlled diet intervention during pregnancy on dietary behavior post-intervention as reported in late pregnancy. The diet intervention was part of a lifestyle intervention targeting both diet and physical activity behaviors among nulliparous women participating in the randomized controlled Norwegian Fit for Delivery study (NFFD). Eligible women were enrolled in early pregnancy from eight healthcare clinics in southern Norway between 2009 and 2013. The diet intervention was based on 10 dietary recommendations that were conveyed during two counseling sessions by phone and in a pamphlet describing the recommendations and their simplified rationale. A diet score was constructed from a 43-item food frequency questionnaire (FFQ) and used to assess intervention effect on dietary behavior (score range 0-10). Between-group dietary differences post-intervention were estimated with analysis of covariance, with adjustment for baseline diet. A total of 508 women completed the FFQ both at baseline and post-intervention. There were no between-group differences in diet score and subscales at baseline. Post-intervention, the intervention group had higher overall diet score (control: 4.61, intervention: 5.04, P=0.013) and favorable dietary behavior in seven of the 10 dietary domains: 'consumption of water relative to total beverage consumption' (P=0.002), 'having vegetables with dinner' (P=0.027), 'choosing fruits and vegetables for between-meal snacks' (P=0.023), 'buying small portion sizes of unhealthy foods' (P=0.010), 'limiting sugar intake' (P=0.005), 'avoiding eating beyond satiety' (P=0.009) and 'reading food labels' (P=0.011). The NFFD diet intervention improved dietary behavior. Potential long-term clinical influence in mother and child will be investigated in further studies.

Real-time optimized biofeedback utilizing sport techniques (ROBUST): a study protocol for a randomized controlled trial.

PubMed

Taylor, Jeffrey B; Nguyen, Anh-Dung; Paterno, Mark V; Huang, Bin; Ford, Kevin R

2017-02-07

Anterior cruciate ligament (ACL) injuries in female athletes lead to a variety of short- and long-term physical, financial, and psychosocial ramifications. While dedicated injury prevention training programs have shown promise, ACL injury rates remain high as implementation has not become widespread. Conventional prevention programs use a combination of resistance, plyometric, balance and agility training to improve high-risk biomechanics and reduce the risk of injury. While many of these programs focus on reducing knee abduction load and posture during dynamic activity, targeting hip extensor strength and utilization may be more efficacious, as it is theorized to be an underlying mechanism of injury in adolescent female athletes. Biofeedback training may complement traditional preventive training, but has not been widely studied in connection with ACL injuries. We hypothesize that biofeedback may be needed to maximize the effectiveness of neuromuscular prophylactic interventions, and that hip-focused biofeedback will improve lower extremity biomechanics to a larger extent than knee-focused biofeedback during dynamic sport-specific tasks and long-term movement strategies. This is an assessor-blind, randomized control trial of 150 adolescent competitive female (9-19 years) soccer players. Each participant receives 3x/week neuromuscular preventive training and 1x/week biofeedback, the mode depending on their randomization to one of 3 biofeedback groups (hip-focused, knee-focused, sham). The primary aim is to assess the impact of biofeedback training on knee abduction moments (the primary biomechanical predictor of future ACL injury) during double-leg landings, single-leg landings, and unplanned cutting. Testing will occur immediately before the training intervention, immediately after the training intervention, and 6 months after the training intervention to assess the long-term retention of modified biomechanics. Secondary aims will assess performance changes, including hip and core strength, power, and agility, and the extent to which maturation effects biofeedback efficacy. The results of the Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) trial will help complement current preventive training and may lead to clinician-friendly methods of biofeedback to incorporate into widespread training practices. Date of publication in ClinicalTrials.gov: 20/04/2016. ClinicalTrials.gov Identifier: NCT02754700 .

A double-blind randomized placebo-controlled withdrawal trial comparing memantine and antipsychotics for the long-term treatment of function and neuropsychiatric symptoms in people with Alzheimer's disease (MAIN-AD).

PubMed

Ballard, Clive; Thomas, Alan; Gerry, Stephen; Yu, Ly-Mee; Aarsland, Dag; Merritt, Claire; Corbett, Anne; Davison, Christopher; Sharma, Narenda; Khan, Zunera; Creese, Byron; Loughlin, Paul; Bannister, Carol; Burns, Alistair; Win, Soe Nyunt; Walker, Zuzana

2015-04-01

Neuropsychiatric symptoms in Alzheimer disease (AD) cause significant distress and present a complex clinical challenge for treatment. Pharmacological treatment options are limited to antipsychotics, which carry extensive safety issues. There is emerging evidence to support the potential benefits of memantine, currently licensed for moderate to severe AD, in the prophylaxis of neuropsychiatric symptoms. The MAIN-AD study is a double-blind randomized placebo-controlled withdrawal trial comparing memantine with antipsychotics for the treatment of neuropsychiatric symptoms over 24 weeks. A total of 199 people with probable AD living in care homes already receiving an antipsychotic were randomized to receive either memantine or to continue an antipsychotic. The primary outcomes were function (Bristol Activities of Daily Living Scale [BADLS]) and agitation (Cohen-Mansfield Agitation Inventory [CMAI]). Secondary outcomes were Neuropsychiatric Inventory (NPI), Mini-Mental State Examination (MMSE), and mortality. There was no significant difference between groups on the BADLS or CMAI. At 24 weeks, there was a nonsignificant adjusted difference in favor of memantine on the BADLS of 0.23 (95% CI -1.80-2.27; P = .82) and in favor of antipsychotic on the CMAI of 0.09 (95% CI -0.35-8.53; P = .07). Although there were no significant differences in total NPI, there were 5.01 (95% CI -1.68-11.70; P = .05) and 3.63 (95% CI -1.40-8.67; P = .16) point advantages favoring antipsychotics at weeks 12 and 24, respectively. In addition, in an exploratory analysis, individuals allocated to antipsychotics were significantly less likely to experience relapse of neuropsychiatric symptoms at all time points. The group receiving memantine had a nonsignificant 1.3-point advantage on the MMSE at 24 weeks. This study indicates no benefits for memantine in the long-term treatment and prophylaxis of clinically significant neuropsychiatric symptoms. The results did indicate some benefits for antipsychotic medications in reducing the relapse of neuropsychiatric symptoms, but this must be balanced against increased mortality risk. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Etanercept provides an effective, safe and flexible short- and long-term treatment regimen for moderate-to-severe psoriasis: a systematic review of current evidence.

PubMed

Strohal, Robert; Chimenti, Sergio; Vena, Gino Antonio; Girolomoni, Giampiero

2013-06-01

The treatment of psoriasis requires long-lasting intervention. Conventional treatments for psoriasis comprise topical, phototherapeutic and systemic modalities, such as methotrexate or cyclosporine. Biological therapies are advocated by treatment guidelines for the use in moderate-to-severe psoriasis, when conventional treatments have failed, are contraindicated or are associated with severe adverse events. Etanercept is an anti-TNF recombinant fusion protein that has emerged as a standard biologic treatment option for moderate-to-severe psoriasis. The present review summarizes data from pivotal and post-marketing randomized controlled etanercept trials to treat moderate-to-severe psoriasis for 24 weeks and longer. During the first 12 weeks, etanercept can be administered in different dosing regimens: 50 mg twice weekly (BIW) and 50 mg once weekly. Although both regimens are effective, it has been shown that the 50 mg BIW dosage leads to higher response rates at week 24. In addition, after 24 weeks' treatment etanercept provides the unique possibility of continuous or intermittent long-term treatment programmes. The medium- to long-term efficacy of etanercept was consistent, regardless of whether etanercept therapy was interrupted or continuous. Taking the chronic nature of psoriasis into account, this flexibility in dosing regimen bestows a key advantage in facilitating individualisation of long-term treatment according to patient needs.

Epinephrine in Out-of-hospital Cardiac Arrest: Helpful or Harmful?

PubMed Central

Shao, Huan; Li, Chun-Sheng

2017-01-01

Objective: Epinephrine is the primary drug administered during cardiopulmonary resuscitation (CPR) to reverse cardiac arrest. The evidence for the use of adrenaline in out-of-hospital cardiac arrest (OHCA) and in-hospital resuscitation is inconclusive. We conducted a systematic review on the clinical efficacy of adrenaline in adult OHCA patients to evaluate whether epinephrine provides any overall benefit for patients. Data Sources: The EMBASE and PubMed databases were searched with the key words “epinephrine,” “cardiac arrest,” and variations of these terms. Study Selection: Data from clinical randomized trials, meta-analyses, guidelines, and recent reviews were selected for review. Results: Sudden cardiac arrest causes 544,000 deaths in China each year, with survival occurring in <1% of cases (compared with 12% in the United States). The American Heart Association recommends the use of epinephrine in patients with cardiac arrest, as part of advanced cardiac life support. There is a clear evidence of an association between epinephrine and increased return of spontaneous circulation (ROSC). However, there are conflicting results regarding long-term survival and functional recovery, particularly neurological outcome, after CPR. There is currently insufficient evidence to support or reject epinephrine administration during resuscitation. We believe that epinephrine may have a role in resuscitation, as administration of epinephrine during CPR increases the probability of restoring cardiac activity with pulses, which is an essential intermediate step toward long-term survival. Conclusions: The administration of adrenaline was associated with improved short-term survival (ROSC). However, it appears that the use of adrenaline is associated with no benefit on survival to hospital discharge or survival with favorable neurological outcome after OHCA, and it may have a harmful effect. Larger placebo-controlled, double-blind, randomized control trials are required to definitively establish the effect of epinephrine. PMID:28836556

Epinephrine in Out-of-hospital Cardiac Arrest: Helpful or Harmful?

PubMed

Shao, Huan; Li, Chun-Sheng

2017-09-05

Epinephrine is the primary drug administered during cardiopulmonary resuscitation (CPR) to reverse cardiac arrest. The evidence for the use of adrenaline in out-of-hospital cardiac arrest (OHCA) and in-hospital resuscitation is inconclusive. We conducted a systematic review on the clinical efficacy of adrenaline in adult OHCA patients to evaluate whether epinephrine provides any overall benefit for patients. The EMBASE and PubMed databases were searched with the key words "epinephrine," "cardiac arrest," and variations of these terms. Data from clinical randomized trials, meta-analyses, guidelines, and recent reviews were selected for review. Sudden cardiac arrest causes 544,000 deaths in China each year, with survival occurring in <1% of cases (compared with 12% in the United States). The American Heart Association recommends the use of epinephrine in patients with cardiac arrest, as part of advanced cardiac life support. There is a clear evidence of an association between epinephrine and increased return of spontaneous circulation (ROSC). However, there are conflicting results regarding long-term survival and functional recovery, particularly neurological outcome, after CPR. There is currently insufficient evidence to support or reject epinephrine administration during resuscitation. We believe that epinephrine may have a role in resuscitation, as administration of epinephrine during CPR increases the probability of restoring cardiac activity with pulses, which is an essential intermediate step toward long-term survival. The administration of adrenaline was associated with improved short-term survival (ROSC). However, it appears that the use of adrenaline is associated with no benefit on survival to hospital discharge or survival with favorable neurological outcome after OHCA, and it may have a harmful effect. Larger placebo-controlled, double-blind, randomized control trials are required to definitively establish the effect of epinephrine.

Ursodiol in patients with parenteral nutrition-associated cholestasis.

PubMed

San Luis, Valerie A; Btaiche, Imad F

2007-11-01

To review the role of ursodeoxycholic acid (ursodiol) in treating parenteral nutrition-associated cholestasis (PNAC). A MEDLINE (1950-May 2007) search was performed using the key terms parenteral nutrition, cholestasis, ursodeoxycholic acid, and ursodiol. All English-language articles that evaluated the safety and efficacy of ursodiol for PNAC were included in this review. The benefits of exogenous ursodiol administration in the treatment of cholestasis can be explained by its alteration of effects on bile composition and flow and provision of cytoprotective, membrane stabilizing, and immunomodulatory effects. Two animal studies, 2 case reports, and 6 human studies (2 prospective and 3 retrospective pediatric studies, 1 adult prospective study) evaluated the efficacy of ursodiol in patients with PNAC. Ursodiol 10-30 mg/kg/day in children and 10-15 mg/kg/day in adults administered in 2-3 doses improved the biochemical and clinical signs and symptoms of PNAC. However, short-term improvement in biochemical parameters may not necessarily predict the outcome of PNAC patients. At recommended doses, ursodiol may not be effective in patients with short bowel syndrome or in those with resected terminal ileum because of reduced ursodiol absorption. Studies supporting the efficacy of ursodiol in treatment of PNAC are limited by small sample size, absence of randomization and controls, short duration, and lack of accountancy to confounding variables. Large, prospective, randomized, placebo-controlled, long-term follow-up studies evaluating the efficacy and optimal dosing and duration of ursodiol therapy for PNAC are not yet available. Ursodiol may improve the biochemical signs and clinical symptoms of PNAC. However, optimal dosing, timing, duration of therapy, and long-term effects on PNAC outcome and prognosis require further studies.

Effects of Vitex agnus and Flaxseed on cyclic mastalgia: A randomized controlled trial.

PubMed

Mirghafourvand, Mojgan; Mohammad-Alizadeh-Charandabi, Sakineh; Ahmadpour, Parivash; Javadzadeh, Yousef

2016-02-01

Evidence on the effect of Vitex agnus and Flaxseed on cyclical mastalgia is not enough. This study aimed to assess the efficacy of V. agnus and Flaxseed on cyclical mastalgia. This randomized controlled trial was conducted on 159 women referred to health centers of Tabriz, Iran. Subjects were allocated into three groups (n=53 per group) using block randomization. Group I received 25g daily Flaxseed powder and placebo of V. agnus; group II received daily 3.2-4.8mg V. agnus tablet and placebo of Flaxseed and control group received both placebo. Nominal day breast pain was applied at baseline, first, and second month after the intervention. Data was analyzed using general linear model. There was no statistical significant difference between the three groups in terms of socio-demographic characteristics and baseline values. The breast pain improved significantly in both intervention groups during the first and second month after intervention. Mean NDBP score was significantly lower than that in the control group at the first month after the intervention in the Flaxseed [adjusted mean difference: -3.1 (95% CI: -4.2 to -2.0)] and V. agnus groups [-3.3 (-4.3 to -2.2)] and the second month after the intervention in Flaxseed [-7.0 (-8.1 to -5.9)] and V. agnus groups [-6.4 (-7.5 to -5.3)]. Flaxseed and V. agnus are effective in short-term period in decreasing cyclical mastalgia. However, further studies are needed to examine the long-term effectiveness and sustainability of the effects after stopping the treatment in order to decide whether these alternative treatments are suitable to treat mastalgia or not. Copyright © 2015 Elsevier Ltd. All rights reserved.

Long term effects of self-determination theory and motivational interviewing in a web-based physical activity intervention: randomized controlled trial.

PubMed

Friederichs, Stijn A H; Oenema, Anke; Bolman, Catherine; Lechner, Lilian

2015-08-18

Our main objective in the current study was to evaluate the long-term effectiveness (12 months from baseline) of I Move (a web-based computer tailored physical activity intervention, based on self-determination theory and motivational interviewing). To this end, we compared I Move to a web-based computer tailored physical activity intervention based on traditional health behavior theories (Active Plus), and to a no-intervention control group. As a secondary objective, the present study aimed to identify participant characteristics that moderate the long term effects of I Move and Active Plus. A randomized controlled trial was conducted, comparing three research conditions: 1) the I Move condition, participants in this condition received I Move; 2) the Active Plus condition, participants in this condition received Active Plus; 3) the control condition; participants in this condition received no intervention and were placed on a waiting list. Main outcome measures were weekly minutes of moderate to vigorous physical activity and weekly days with minimal 30 min of physical activity. All measurements were taken by web-based questionnaires via the study website. Intervention effects were analyzed using multilevel linear regression analyses. At 12 months from baseline, I Move was found to be effective in increasing weekly minutes of moderate to vigorous physical activity (ES = .13), while Active Plus was not. In contrast, Active Plus was found to be effective in increasing weekly days with ≥ 30 min PA at 12 months (ES = .11), while I Move was not. No moderators of the effects of I Move were found. The results suggest that web-based computer tailored physical activity interventions might best include elements based on both self-determination theory/motivational interviewing and traditional health behavioral theories. To be more precise, it is arguable that the focus of the theoretical foundations, used in new web-based PA interventions should depend on the intended program outcome. In order to draw firm conclusions, however, more research on the effects of self-determination theory and motivational interviewing in web-based physical activity promotion is needed. Dutch Trial Register NTR4129.

Effects of programmed exercise on depressive symptoms in midlife and older women: A meta-analysis of randomized controlled trials.

PubMed

Pérez-López, Faustino R; Martínez-Domínguez, Samuel J; Lajusticia, Héctor; Chedraui, Peter

2017-12-01

To perform a systematic review and meta-analysis to clarify the effect of programmed exercise on depressive symptoms (DSs) in midlife and older women. We carried out a structured search of PubMed-Medline, Web of Science, Scopus, Embase, Cochrane Library and Scielo, from database inception through June 29, 2017, without language restriction. The search included the following terms: "depression", "depressive symptoms", "exercise", "physical activity", "menopause", and "randomized controlled trial" (RCTs) in midlife and older women. The US, UK and Australian Clinical Trials databases were also searched. We assessed randomized controlled trials (RCTs) that compared the effect of exercise for at least 6 weeks versus no intervention on DSs as the outcome (as defined by trial authors). Exercise was classified according to duration as "mid-term exercise intervention" (MTEI; lasting for 12 weeks to 4 months), and "long-term exercise intervention" (LTEI; lasting for 6-12 months). Mean changes (±standard deviations) in DSs, as assessed with different questionnaires, were extracted to calculate Hedges' g and then used as the effect size for meta-analysis. Standardized mean differences (SMDs) of DSs after intervention were pooled using a random-effects model. Eleven publications were included for analysis related to 1943 midlife and older women (age range 44-55 years minimum to 65.5±4.0 maximum), none of whom was using a hormone therapy. Seven MTEIs were associated with a significant reduction in DSs (SMD=-0.44; 95% CI -0.69, -0.18; p=0.0008) compared with controls. The reduction in DSs was also significant in six LTEIs (SMD=- 0.29; 95% CI -0.49; -0.09; p=0.005). Heterogeneity of effects among studies was moderate to high. Less perceived stress and insomnia (after exercise) were also found as secondary outcomes. Exercise of low to moderate intensity reduces depressive symptoms in midlife and older women. Copyright © 2017. Published by Elsevier B.V.

Effects of a prevention program for divorced families on youth cortisol reactivity 15 years later.

PubMed

Luecken, Linda J; Hagan, Melissa J; Mahrer, Nicole E; Wolchik, Sharlene A; Sandler, Irwin N; Tein, Jenn-Yun

2015-01-01

We examined whether an empirically based, randomised controlled trial of a preventive intervention for divorced mothers and children had a long-term impact on offspring cortisol regulation. Divorced mothers and children (age 9-12) were randomly assigned to a literature control condition or the 11-week New Beginnings Program, a family-focused group preventive intervention for mothers and children in newly divorced families. Fifteen years after the trial, offspring salivary cortisol (n = 161) was measured before and after a social stress task. Multilevel mixed models were used to predict cortisol from internalizing symptoms, externalizing symptoms, group assignment and potential moderators of intervention effects. Across the sample, higher externalizing symptoms were associated with lower cortisol reactivity. There was a significant group-by-age interaction such that older offspring in the control group had higher reactivity relative to the intervention group, and younger offspring in the control group exhibited a decline across the task relative to younger offspring in the intervention group. Preventive interventions for youth from divorced families may have a long-term impact on cortisol reactivity to stress. Results highlight the importance of examining moderators of program effects.

Long-term safety of early consumption of Lactobacillus fermentum CECT5716: A 3-year follow-up of a randomized controlled trial.

PubMed

Maldonado-Lobón, J A; Gil-Campos, M; Maldonado, J; López-Huertas, E; Flores-Rojas, K; Valero, A D; Rodríguez-Benítez, M V; Bañuelos, O; Lara-Villoslada, F; Fonollá, J; Olivares, M

2015-01-01

Lactobacillus fermentum CECT5716 is a probiotic strain originally isolated from human breast milk. Previous clinical studies in infants showed that the early administration of a milk formula containing this probiotic strain was safe and may be useful for the prevention of community-acquired infections. This is a 3-year follow-up study aimed at evaluating the long-term effects produced by the early consumption of an infant formula supplemented with L. fermentum CECT5716 (experimental group, EG) compared with a control formula without the probiotic (control group, CG). The infants included in this follow-up study had previously completed a 5-month randomized double-blind controlled trial (from 1 to 6 months of age), where the safety and tolerance of the probiotic formula was evaluated. The main outcome of the follow-up study was the growth of the children. The secondary outcomes included the incidence of infectious and non-infectious diseases, parameters related with intestinal function and faecal microbiota. At 3 years, the mean values of weight, length and head circumference were similar in children of the EG compared with those of the CG. No differences were observed in the incidence of infectious and non-infectious diseases or disorders related with intestinal function. The pattern of faecal microbiota was also similar between both groups. In conclusion, this 3-year study shows that the early administration of the probiotic of L. fermentum CECT5716 in an infant formula is safe and it does not produce measurable differences in children compared with a control formula. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effects of high-intensity exercise and protein supplement on muscle mass in ADL dependent older people with and without malnutrition: a randomized controlled trial.

PubMed

Carlsson, M; Littbrand, H; Gustafson, Y; Lundin-Olsson, L; Lindelöf, N; Rosendahl, E; Håglin, L

2011-08-01

Loss of muscle mass is common among old people living in institutions but trials that evaluate interventions aimed at increasing the muscle mass are lacking. Objective, participants and intervention: This randomized controlled trial was performed to evaluate the effect of a high-intensity functional exercise program and a timed protein-enriched drink on muscle mass in 177 people aged 65 to 99 with severe physical or cognitive impairments, and living in residential care facilities. Three-month high-intensity exercise was compared with a control activity and a protein-enriched drink was compared with a placebo drink. A bioelectrical impedance spectrometer (BIS) was used in the evaluation. The amount of muscle mass and body weight (BW) were followed-up at three and six months and analyzed in a 2 x 2 factorial ANCOVA, using the intention to treat principle, and controlling for baseline values. At 3-month follow-up there were no differences in muscle mass and BW between the exercise and the control group or between the protein and the placebo group. No interaction effects were seen between the exercise and nutritional intervention. Long-term negative effects on muscle mass and BW was seen in the exercise group at the 6-month follow-up. A three month high-intensity functional exercise program did not increase the amount of muscle mass and an intake of a protein-enriched drink immediately after the exercise did not induce any additional effect on muscle mass. There were negative long-term effects on muscle mass and BW, indicating that it is probably necessary to compensate for an increased energy demand when offering a high-intensity exercise program.

Attendance at cultural events, reading books or periodicals, and making music or singing in a choir as determinants for survival: Swedish interview survey of living conditions.

PubMed Central

Bygren, L. O.; Konlaan, B. B.; Johansson, S. E.

1996-01-01

OBJECTIVES: To investigate the possible influence of attendance at cultural events, reading books or periodicals, making music or singing in a choir as determinants for survival. DESIGN: A simple random sample was drawn of 15,198 individuals aged 16-74 years. Of these, 85% (12,982) were interviewed by trained non-medical interviewers between 1982 and 1983 about cultural activities. They were followed up with respect to survival until 31 December 1991. SETTING: Swedish interview survey of living conditions comprising a random sample of the adult Swedish population. SUBJECTS: 12,675 people interviewed between 1982 and 1983. MAIN OUTCOME MEASURES: Survival of subjects after controlling for eight confounding variables: age, sex, education level, income, long term disease, social network, smoking, and physical exercise. RESULTS: 6,301 men and 6,374 women were followed up; 533 men and 314 women died during this period. The control variables influenced survival in the expected directions except for social network for men; a significant negative effective was found when the analysis was made separately for men and women. We found an influence on mortality when the eight control variables were controlled for in people who rarely attended events compared with those attending most often, the relative risk being 1.57 (95% confidence interval 1.18 to 2.09). CONCLUSION: Attendance at cultural events may have a positive influence on survival. Long term follow up of large samples with confounders that are well controlled for and with the cultural stimulation more highly specified should be used to try to falsify the hypothesis before experiments start. PMID:8990990

Long-term follow-up of a randomized controlled trial on additional core stability exercises training for improving dynamic sitting balance and trunk control in stroke patients.

PubMed

Cabanas-Valdés, Rosa; Bagur-Calafat, Caritat; Girabent-Farrés, Montserrat; Caballero-Gómez, Fernanda Mª; du Port de Pontcharra-Serra, Helena; German-Romero, Ana; Urrútia, Gerard

2017-11-01

Analyse the effect of core stability exercises in addition to conventional physiotherapy training three months after the intervention ended. A randomized controlled trial. Outpatient services. Seventy-nine stroke survivors. In the intervention period, both groups underwent conventional physiotherapy performed five days/week for five weeks, and in addition the experimental group performed core stability exercises for 15 minutes/day. Afterwards, during a three-month follow-up period, both groups underwent usual care that could eventually include conventional physiotherapy or physical exercise but not in a controlled condition. Primary outcome was trunk control and dynamic sitting balance assessed by the Spanish-Version of Trunk Impairment Scale 2.0 and Function in Sitting Test. Secondary outcomes were standing balance and gait evaluated by the Berg Balance Scale, Tinetti Test, Brunel Balance Assessment, Spanish-Version of Postural Assessment Scale for Stroke and activities of daily living using the Barthel Index. A total of 68 subjects out of 79 completed the three-month follow-up period. The mean difference (SD) between groups was 0.78 (1.51) points ( p = 0.003) for total score on the Spanish-Version of Trunk Impairment Scale 2.0, 2.52 (6.46) points ( p = 0.009) for Function in Sitting Test, dynamic standing balance was 3.30 (9.21) points ( p= 0.009) on the Berg Balance Scale, gait was 0.82 (1.88) points ( p = 0.002) by Brunel Balance Assessment (stepping), and 1.11 (2.94) points ( p = 0.044) by Tinetti Test (gait), all in favour of core stability exercises. Core stability exercises plus conventional physiotherapy have a positive long-term effect on improving dynamic sitting and standing balance and gait in post-stroke patients.

Circumferential fusion is dominant over posterolateral fusion in a long-term perspective: cost-utility evaluation of a randomized controlled trial in severe, chronic low back pain.

PubMed

Soegaard, Rikke; Bünger, Cody E; Christiansen, Terkel; Høy, Kristian; Eiskjaer, Søren P; Christensen, Finn B

2007-10-15

Cost-utility evaluation of a randomized, controlled trial with a 4- to 8-year follow-up. To investigate the incremental cost per quality-adjusted-life-year (QALY) when comparing circumferential fusion to posterolateral fusion in a long-term, societal perspective. The cost-effectiveness of circumferential fusion in a long-term perspective is uncertain but nonetheless highly relevant as the ISSLS prize winner 2006 in clinical studies reported the effect of circumferential fusion superior to the effect of posterolateral fusion. A recent trial found no significant difference between posterolateral and circumferential fusion reporting cost-effectiveness from a 2-year viewpoint. A total of 146 patients were randomized to posterolateral or circumferential fusion and followed 4 to 8 years after surgery. The mean age of the cohort was 46 years (range, 20-65 years); 61% were females, 49% were smokers, 30% had primary diagnosis of isthmic spondylolisthesis, 35% had disc degeneration and no previous surgery, and 35% had disc degeneration and previous surgery. Eighty-two percent of patients have had symptoms for more than 2 years and 50% were out of the labor market due to sickness. The EQ-5D instrument was applied for the measurement of health-related quality of life and costs (2004 U.S. dollars) were measured in a full-scale societal perspective. Productivity costs were valued by the Friction Cost method, and both costs and effects were discounted. Arithmetic means and 95% bias-corrected, bootstrapped confidence intervals were reported. Nonparametric statistics were used for tests of statistical significance. Comprehensive sensitivity analysis was conducted and reported using cost-effectiveness acceptability curves. The circumferential group demonstrated clinical superiority over the posterolateral fusion group in functional outcome (P < 0.01), fusion rate (P < 0.04), and number of reoperations (P < 0.01) among others. Cost-utility analysis demonstrated circumferential fusion dominant over posterolateral fusion, that is, for each QALY gained performing circumferential fusion, the incremental saving was estimated at U.S. $49,306 (95% confidence interval, $27,183-$2,735,712). Results proved to be strong to various sensitivity analyses; only a differentiated underestimation of patients' need for postoperative household help against the circumferential approach could alter the dominance; however, still the probability of cost-effectiveness was >0.85 given a threshold for willingness to pay of U.S. $50,000 per QALY. Circumferential fusion is dominant over instrumented posterolateral fusion, that is, both being significantly cheaper and significantly better in a long-term, societal perspective.

The immediate and long-term effects of exercise and patient education on physical, functional, and quality-of-life outcome measures after single-level lumbar microdiscectomy: a randomized controlled trial protocol.

PubMed

Selkowitz, David M; Kulig, Kornelia; Poppert, Elizabeth M; Flanagan, Sean P; Matthews, Ndidiamaka D; Beneck, George J; Popovich, John M; Lona, Jose R; Yamada, Kimiko A; Burke, Wendy S; Ervin, Carolyn; Powers, Christopher M

2006-08-25

Low back pain remains a costly quality-of-life-related health problem. Microdiscectomy is often the surgical procedure of choice for a symptomatic, single-level, lumbar disc herniation in younger and middle-aged adults. The question of whether a post-microdiscectomy exercise program enhances function, quality of life, and disability status has not been systematically explored. Thus, the overall purpose of this study is to assess immediate and long-term outcomes of an exercise program, developed at University of Southern California (USC), targeting the trunk and lower extremities (USC Spine Exercise Program) for persons who have undergone a single-level microdiscectomy for the first time. One hundred individuals between the ages of 18 and 60 who consent to undergo lumbar microdiscectomy will be recruited to participate in this study. Subjects will be randomly assigned to one of two groups: 1) one session of back care education, or 2) a back care education session followed by the 12-week USC Spine Exercise Program. The outcome examiners (evaluators), as well as the data managers, will be blinded to group allocation. Education will consist of a one-hour "one-on-one" session with the intervention therapist, guided by an educational booklet specifically designed for post-microdiscectomy care. This session will occur four to six weeks after surgery. The USC Spine Exercise Program consists of two parts: back extensor strength and endurance, and mat and upright therapeutic exercises. This exercise program is goal-oriented, performance-based, and periodized. It will begin two to three days after the education session, and will occur three times a week for 12 weeks. Primary outcome measures include the Oswestry Disability Questionnaire, Roland-Morris Disability Questionnaire, SF-36 quality of life assessment, Subjective Quality of Life Scale, 50-foot Walk, Repeated Sit-to-Stand, and a modified Sorensen test. The outcome measures in the study will be assessed before and after the 12-week post-surgical intervention program. Long-term follow up assessments will occur every six months beginning one year after surgery and ending five years after surgery. Immediate and long-term effects will be assessed using repeated measures multivariate analysis of variance (MANOVA). If significant interactions are found, one-way ANOVAs will be performed followed by post-hoc testing to determine statistically significant pairwise comparisons. We have presented the rationale and design for a randomized controlled trial evaluating the effectiveness of a treatment regimen for people who have undergone a single-level lumbar microdiscectomy.

Substitution of sugar-sweetened beverages with other beverage alternatives: a review of long-term health outcomes.

PubMed

Zheng, Miaobing; Allman-Farinelli, Margaret; Heitmann, Berit Lilienthal; Rangan, Anna

2015-05-01

Excessive consumption of sugar-sweetened beverages (SSBs) has become an intractable public health concern worldwide, making investigation of healthy beverage alternatives for SSBs imperative. To summarize the available evidence on the effects of replacing SSBs with beverage alternatives on long-term health outcomes. We systematically retrieved studies from six electronic databases from inception to November 2013. Prospective cohort studies and randomized controlled trials (RCTs) examining the effects of substituting beverage alternatives for SSBs on long-term health outcomes in both children and adults were included. The quality of included studies was assessed using the Scottish Intercollegiate Guidelines Network 50 methodology checklists. Six cohort studies and four RCTs were included in the systematic review with the quality rating ranging from acceptable to high. Evidence from both cohort studies and RCTs showed substitution of SSBs by various beverage alternatives was associated with long-term lower energy intake and lower weight gain. However, evidence was insufficient to draw conclusions regarding the effect of beverage substitution on other health outcomes, and which beverage alternative is the best choice. Although studies on this topic are sparse, the available evidence suggests a potential beneficial effect on body weight outcomes when SSBs are replaced by water or low-calorie beverages. Further studies in this area are warranted to fully understand the long-term health implications of beverage substitutions. Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

General inattentiveness is a long-term reliable trait independently predictive of psychological health: Danish validation studies of the Mindful Attention Awareness Scale.

PubMed

Jensen, Christian Gaden; Niclasen, Janni; Vangkilde, Signe Allerup; Petersen, Anders; Hasselbalch, Steen Gregers

2016-05-01

The Mindful Attention Awareness Scale (MAAS) measures perceived degree of inattentiveness in different contexts and is often used as a reversed indicator of mindfulness. MAAS is hypothesized to reflect a psychological trait or disposition when used outside attentional training contexts, but the long-term test-retest reliability of MAAS scores is virtually untested. It is unknown whether MAAS predicts psychological health after controlling for standardized socioeconomic status classifications. First, MAAS translated to Danish was validated psychometrically within a randomly invited healthy adult community sample (N = 490). Factor analysis confirmed that MAAS scores quantified a unifactorial construct of excellent composite reliability and consistent convergent validity. Structural equation modeling revealed that MAAS scores contributed independently to predicting psychological distress and mental health, after controlling for age, gender, income, socioeconomic occupational class, stressful life events, and social desirability (β = 0.32-.42, ps < .001). Second, MAAS scores showed satisfactory short-term test-retest reliability in 100 retested healthy university students. Finally, MAAS sample mean scores as well as individuals' scores demonstrated satisfactory test-retest reliability across a 6 months interval in the adult community (retested N = 407), intraclass correlations ≥ .74. MAAS scores displayed significantly stronger long-term test-retest reliability than scores measuring psychological distress (z = 2.78, p = .005). Test-retest reliability estimates did not differ within demographic and socioeconomic strata. Scores on the Danish MAAS were psychometrically validated in healthy adults. MAAS's inattentiveness scores reflected a unidimensional construct, long-term reliable disposition, and a factor of independent significance for predicting psychological health. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Behavioral intervention to promote smoking cessation and prevent weight gain: A systematic review and meta-analysis

PubMed Central

Spring, Bonnie; Howe, Dorothea; Berendsen, Mark; McFadden, H. Gene; Hitchcock, Kristin; Rademaker, Alfred W.; Hitsman, Brian

2009-01-01

Aims The prospect of weight gain discourages many cigarette smokers from quitting. Practice guidelines offer varied advice about managing weight gain after quitting smoking, but no systematic review and meta-analysis have been available. We reviewed evidence to determine whether behavioral weight control intervention compromises smoking cessation attempts, and if it offers an effective way to reduce post-cessation weight gain. Methods We identified randomized controlled trials that compared combined smoking treatment and behavioral weight control to smoking treatment alone for adult smokers. English-language studies were identified through searches of PubMed, Ovid MEDLINE, CINAHL, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials. Of 779 articles identified and 35 potentially relevant RCTs screened, 10 met criteria and were included in the meta-analysis. Results Patients who received both smoking treatment and weight treatment showed increased abstinence (OR=1.29, 95% CI=1.01,1.64) and reduced weight gain (g = -0.30, 95% CI=-0.63, -0.04) in the short term (<3 months) compared with patients who received smoking treatment alone. Differences in abstinence (OR=1.23, 95% CI=0.85, 1.79) and weight control (g= -0.17, 95% CI=-0.42, 0.07) were no longer significant in the long term (>6 months). Conclusions Findings provide no evidence that combining smoking treatment and behavioral weight control produces any harm and significant evidence of short-term benefit for both abstinence and weight control. However, the absence of long-term enhancement of either smoking cessation or weight control by the time-limited interventions studied to date provides insufficient basis to recommend societal expenditures on weight gain prevention treatment for patients who are quitting smoking. PMID:19549058

Regional analgesia for improvement of long-term functional outcome after elective large joint replacement

PubMed Central

Atchabahian, Arthur; Schwartz, Gary; Hall, Charles B; Lajam, Claudette M; Andreae, Michael H

2015-01-01

Background Regional analgesia is more effective than conventional analgesia for controlling pain and may facilitate rehabilitation after large joint replacement in the short term. It remains unclear if regional anaesthesia improves functional outcomes after joint replacement beyond three months after surgery. Objectives To assess the effects of regional anaesthesia and analgesia on long-term functional outcomes 3, 6 and 12 months after elective major joint (knee, shoulder and hip) replacement surgery. Search methods We performed an electronic search of several databases (CENTRAL, MEDLINE, EMBASE, CINAHL), and handsearched reference lists and conference abstracts. We updated our search in June 2015. Selection criteria We included randomized controlled trials (RCTs) comparing regional analgesia versus conventional analgesia in patients undergoing total shoulder, hip or knee replacement. We included studies that reported a functional outcome with a follow-up of at least three months after surgery. Data collection and analysis We used standard methodological procedures expected by Cochrane. We contacted study authors for additional information. Main results We included six studies with 350 participants followed for at least three months. All of these studies enrolled participants undergoing total knee replacement. Studies were at least partially blinded. Three studies had a high risk of performance bias and one a high risk of attrition bias, but the risk of bias was otherwise unclear or low. Only one study assessed joint function using a global score. Due to heterogeneity in outcome and reporting, we could only pool three out of six RCTs, with range of motion assessed at three months after surgery used as a surrogate for joint function. All studies had a high risk of detection bias. Using the random-effects model, there was no statistically significant difference between the experimental and control groups (mean difference 3.99 degrees, 95% confidence interval (CI) − 2.23 to 10.21; P value = 0.21, 3 studies, 140 participants, very low quality evidence). We did not perform further analyses because immediate adverse effects were not part of the explicit outcomes of any of these typically small studies, and long-term adverse events after regional anaesthesia are rare. None of the included studies elicited or reported long-term adverse effects like persistent nerve damage. Authors’ conclusions More high-quality studies are needed to establish the effects of regional analgesia on function after major joint replacement, as well as on the risk of adverse events (falls). PMID:26269416

[Mid- to long-term outcomes of cervical disc arthroplasty for symptomatic cervical disc disease: a meta-analysis].

PubMed

Kan, S L; Yang, B; Ning, G Z; Gao, S J; Sun, J C; Feng, S Q

2016-12-01

Objective: To compare the benefits and harms of cervical disc arthroplasty (CDA) with anterior cervical discectomy and fusion(ACDF) for symptomatic cervical disc disease at mid- to long-term follow-up. Methods: Electronic searches were made in PubMed, EMBASE, and the Cochrane Library for randomized controlled trials with at least 48 moths follow-up.Outcomes were reported as relative risk or standardized mean difference.Meta-analysis was carried out using Revman version 5.3 and Stata version 12.0. Results: Seven trials were included, involving 2 302 participants.The results of this meta-analysis indicated that CDA brought about fewer secondary surgical procedures, lower neck disability index (NDI) scores, lower neck and arm pain scores, greater SF-36 Physical Component Summary (PCS) and Mental Component Summary(MCS) scores, greater range of motion (ROM) at the operative level and less superior adjacent-segment degeneration( P <0.05) than ACDF.CDA was not statistically different from ACDF in inferior adjacent-segment degeneration, neurological success, and adverse events ( P >0.05). Conclusions: CDA can significantly reduce the rates of secondary surgical procedures compared with ACDF.Meanwhile, CDA is superior or equivalent to ACDF in other aspects.As some studies without double-blind are included and some potential biases exites, more randomized controlled trials with high quality are required to get more reliable conclusions.

Long-term survival after traumatic brain injury: a population-based analysis controlled for nonhead trauma.

PubMed

Brown, Allen W; Leibson, Cynthia L; Mandrekar, Jay; Ransom, Jeanine E; Malec, James F

2014-01-01

To examine the contribution of co-occurring nonhead injuries to hazard of death after traumatic brain injury (TBI). A random sample of Olmsted County, Minnesota, residents with confirmed TBI from 1987 through 1999 was identified. Each case was assigned an age- and sex-matched, non-TBI "regular control" from the population. For "special cases" with accompanying nonhead injuries, 2 matched "special controls" with nonhead injuries of similar severity were assigned. Vital status was followed from baseline (ie, injury date for cases, comparable dates for controls) through 2008. Cases were compared first with regular controls and second with regular or special controls, depending on case type. In total, 1257 cases were identified (including 221 special cases). For both cases versus regular controls and cases versus regular or special controls, the hazard ratio was increased from baseline to 6 months (10.82 [2.86-40.89] and 7.13 [3.10-16.39], respectively) and from baseline through study end (2.92 [1.74-4.91] and 1.48 [1.09-2.02], respectively). Among 6-month survivors, the hazard ratio was increased for cases versus regular controls (1.43 [1.06-2.15]) but not for cases versus regular or special controls (1.05 [0.80-1.38]). Among 6-month survivors, accounting for nonhead injuries resulted in a nonsignificant effect of TBI on long-term mortality.

The efficacy of early treatment of seasonal allergic rhinitis with benifuuki green tea containing O-methylated catechin before pollen exposure: an open randomized study.

PubMed

Maeda-Yamamoto, Mari; Ema, Kaori; Monobe, Manami; Shibuichi, Ikuo; Shinoda, Yuki; Yamamoto, Tomohiro; Fujisawa, Takao

2009-09-01

We previously reported that 'benifuuki' green tea containing O-methylated catechin significantly relieved the symptoms of perennial or seasonal rhinitis compared with a placebo green tea that did not contain O-methylated catechin in randomized double-blind clinical trials. In this study we assessed the effects of 'benifuuki' green tea on clinical symptoms of seasonal allergic rhinitis. An open-label, single-dose, randomized, parallel-group study was performed on 38 subjects with Japanese cedar pollinosis. The subjects were randomly assigned to long-term (December 27, 2006-April 8, 2007, 1.5 months before pollen exposure) or short-term (February 15, 2007: after cedar pollen dispersal--April 8, 2007) drinking of a 'benifuuki' tea drink containing 34 mg O-methylated catechin per day. Each subject recorded their daily symptom scores in a diary. The primary efficacy variable was the mean weekly nasal symptom medication score during the study period. The nasal symptom medication score in the long-term intake group was significantly lower than that of the short-term intake group at the peak of pollen dispersal. The symptom scores for throat pain, nose-blowing, tears, and hindrance to activities of daily living were significantly better in the long-term group than the short-term group. In particular, the differences in the symptom scores for throat pain and nose-blowing between the 2 groups were marked. We conclude that drinking 'benifuuki' tea for 1.5 months prior to the cedar pollen season is effective in reducing symptom scores for Japanese cedar pollinosis.

Effects of clopidogrel with or without aspirin on the generation of extracellular vesicles in the microcirculation and in venous blood: A randomized placebo controlled trial.

PubMed

Traby, L; Kaider, A; Kollars, M; Eichinger, S; Wolzt, M; Kyrle, P A

2018-05-17

Dual-antiplatelet therapy (DAPT) is a standard strategy in acute coronary heart disease; however, it confers a considerable bleeding risk. Single-antiplatelet therapy (SAPT) inhibits haemostatic system activation ex vivo to a similar extent as DAPT. Extracellular vesicles (EV) are procoagulant and contribute to haemostatic system activation. We aimed to investigate the effect of DAPT compared with SAPT on EV. In a randomized, double-blind, placebo-controlled trial, 44 healthy volunteers received DAPT (clopidogrel + aspirin) or SAPT (clopidogrel + placebo) for 7 days. Blood was obtained from a standardized microvascular injury and through venipuncture at baseline (BL) and at 2 h, 24 h, and 8 days after treatment initiation. The number, origin, and surface expression of EV were assessed using flow cytometry. Data are given as median (quartiles). Non-parametric tests were used to evaluate the short-term (BL vs 2 h) and long-term differences (2 h to 8 days), as well as the differences between treatment groups. There was no difference either in the short-term effects on the number (×10 3  mL -1 ) of EV in microvascular blood between DAPT [BL: 1433 (653; 3184) vs 2 h: 862 (545; 2026), p = 0.39] and SAPT [(BL: 614 (552; 1402) vs 2 h: 1079 (781; 1538), p = 0.75)] or in the long-term effects. DAPT and SAPT did not exhibit differential short-term effects on the number and proportion (36% and 27% vs 55% and 36%) of platelet-derived EV. DAPT and SAPT resulted in a significant short-term increase in phosphatidylserine expression in microvascular blood. The effects of DAPT and SAPT on EV in venous blood were similar to those in microvascular blood. DAPT and SAPT have comparable effects on the amount, origin, and surface characteristics of EV. Copyright © 2018. Published by Elsevier Ltd.

Long-Term Effects of CBT on Social Impairment in Adolescents with ASD.

PubMed

Maddox, Brenna B; Miyazaki, Yasuo; White, Susan W

2017-12-01

Anxiety interventions involving social skills training and CBT for youth with ASD have shown promise, but few studies have examined the effects on social functioning or the maintenance of treatment gains. This study evaluated change in social skills during a randomized controlled trial of CBT and during the 1-year follow-up for 25 adolescents with ASD and anxiety. We examined the effect of pretreatment social anxiety and loneliness on treatment response. Social impairment improved during treatment and continued to improve through the 3-month follow-up. Although adolescents with higher social anxiety had greater pretreatment social impairment, they showed steeper improvement in social skills during treatment. Loneliness was not a significant predictor of change during treatment. CBT targeting social skills and anxiety can lead to long-term improvements in social functioning.

Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial.

PubMed

Li, Yan; Ma, Hongli; Zhang, Yuehui; Kuang, Hongying; Ng, Ernest Hung Yu; Hou, Lihui; Wu, Xiaoke

2013-07-18

Insulin resistance and hyperinsulinemia play a key role in the pathogenesis of polycystic ovary syndrome (PCOS), which is characterized by hyperandrogenism, ovulatory dysfunction, and presence of polycystic ovaries on pelvic scanning. Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Berberine has effects on insulin resistance but its use in women with PCOS has not been fully investigated. In this paper, we present a research design evaluating the effects of berberine on insulin resistance in women with PCOS. This is a multicenter, randomized, placebo-controlled and double-blind trial. A total of 120 patients will be enrolled in this study and will be randomized into two groups. Berberine or placebo will be taken orally for 12 weeks. The primary outcome is the whole body insulin action assessed with the hyperinsulinemic-euglycemic clamp. We postulate that women with PCOS will have improved insulin resistance following berberine administration. This study is registered at ClinicalTrials.gov, NCT01138930.

Benefits of commercial weight-loss programs on blood pressure and lipids: a systematic review.

PubMed

Mehta, Ambereen K; Doshi, Ruchi S; Chaudhry, Zoobia W; Jacobs, David K; Vakil, Rachit M; Lee, Clare J; Bleich, Sara N; Clark, Jeanne M; Gudzune, Kimberly A

2016-09-01

Our objective was to compare the effect of commercial weight-loss programs on blood pressure and lipids to control/education or counseling among individuals with overweight/obesity. We conducted a systematic review by searching MEDLINE and Cochrane Database of Systematic Reviews from inception to November 2014 and references identified by the programs. We included randomized, controlled trials ≥12weeks in duration. Two reviewers extracted information on study design, interventions, and mean change in systolic blood pressure (SBP), diastolic blood pressure (DBP), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), triglycerides, and total cholesterol and assessed risk of bias. We included 27 trials. Participants' blood pressure and lipids were normal at baseline in most trials. At 12months, Weight Watchers showed little change in blood pressure or lipid outcomes as compared to control/education (2 trials). At 12months, Atkins' participants had higher HDL-c and lower triglycerides than counseling (4 trials). Other programs had inconsistent effects or lacked long-term studies. Risk of bias was high for most trials of all programs. In conclusion, limited data exist regarding most commercial weight-loss programs' long-term effects on blood pressure and lipids. Clinicians should be aware that Weight Watchers has limited data that demonstrate CVD risk factor benefits relative to control/education. Atkins may be a reasonable option for patients with dyslipidemia. Additional well-designed, long-term trials are needed to confirm these conclusions and evaluate other commercial programs. Copyright © 2016 Elsevier Inc. All rights reserved.