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Sample records for 12-month randomized controlled

  1. Randomized Controlled Trial of BASICS for Heavy Drinking Mandated and Volunteer Undergraduates: 12-Month Outcomes

    PubMed Central

    Terlecki, Meredith A.; Buckner, Julia D.; Larimer, Mary E.; Copeland, Amy L.

    2014-01-01

    This is the first randomized trial testing whether heavy drinking undergraduates mandated to the Brief Alcohol Screening and Intervention for College Students (BASICS) program following a campus alcohol violation would benefit as much as heavy drinking volunteers up to one year post-intervention using control groups with high-risk drinkers to model disciplinary-related and naturalistic changes in drinking. Participants (61% male; 51% mandated; 84% Caucasian; Mage = 20.14 years) were screened for heavy drinking and randomized to BASICS (n = 115) or assessment-only control (n = 110). Outcome measures (drinking, alcohol problems) were collected at baseline, 4 weeks, 3, 6, and 12 months post-intervention. At 4 weeks post-intervention, intent-to-treat multilevel longitudinal models showed that regardless of referral group (mandated or volunteer) BASICS significantly decreased weekly drinking, typical drinks, and peak drinks relative to controls (ds = .41-.92). BASICS had a large effect on decreases in alcohol problems (d = .87). At 12 months post-intervention, BASICS participants (regardless of referral group) reported significantly fewer alcohol problems (d = .56) compared to controls. Significant long-term intervention gains for peak and typical drinks were sustained in both referral groups relative to controls (ds = .42; .11). Referral group had no significant main effect and did not interact with intervention condition to predict outcomes. Given that BASICS was associated with less drinking and fewer alcohol problems (even among heavier drinking mandated students up to one year post-intervention), provision of BASICS-style programs within disciplinary settings may help reduce heavy and problematic drinking among at-risk students. PMID:25844834

  2. Peak Oxygen Uptake after Cardiac Rehabilitation: A Randomized Controlled Trial of a 12-Month Maintenance Program versus Usual Care

    PubMed Central

    Madssen, Erik; Arbo, Ingerid; Granøien, Ingrid; Walderhaug, Liv; Moholdt, Trine

    2014-01-01

    Background Exercise capacity is a strong predictor of survival in patients with coronary artery disease (CAD). Exercise capacity improves after cardiac rehabilitation exercise training, but previous studies have demonstrated a decline in peak oxygen uptake after ending a formal rehabilitation program. There is a lack of knowledge on how long-term exercise adherence can be achieved in CAD patients. We therefore assessed if a 12-month maintenance program following cardiac rehabilitation would lead to increased adherence to exercise and increased exercise capacity compared to usual care. Materials and Methods Two-centre, open, parallel randomized controlled trial with 12 months follow-up comparing usual care to a maintenance program. The maintenance program consisted of one monthly supervised high intensity interval training session, a written exercise program and exercise diary, and a maximum exercise test every third month during follow-up. Forty-nine patients (15 women) on optimal medical treatment were included following discharge from cardiac rehabilitation. The primary endpoint was change in peak oxygen uptake at follow-up; secondary endpoints were physical activity level, quality of life and blood markers of cardiovascular risk. Results There was no change in peak oxygen uptake from baseline to follow-up in either group (intervention group 27.9 (±4.7) to 28.8 (±5.6) mL·kg (-1) min (−1), control group 32.0 (±6.2) to 32.8 (±5.8) mL·kg (−1) min (−1), with no between-group difference, p = 0.22). Quality of life and blood biomarkers remained essentially unchanged, and both self-reported and measured physical activity levels were similar between groups after 12 months. Conclusions A maintenance exercise program for 12 months did not improve adherence to exercise or peak oxygen uptake in CAD patients after discharge from cardiac rehabilitation compared to usual care. This suggests that infrequent supervised high intensity interval training sessions are

  3. Miniscalpel-Needle versus Steroid Injection for Plantar Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-Up

    PubMed Central

    Li, Shuming; Shen, Tong; Liang, Yongshan; Zhang, Ying; Bai, Bo

    2014-01-01

    Plantar fasciitis is the most common cause of heel pain in adults. A novel alternative medical instrument, the miniscalpel-needle (MSN), which is based on an acupuncture needle, has been recently developed in China. The objective of this study was to evaluate the effectiveness of the MSN release treatment versus that of traditional steroid injection for plantar fasciitis. Patients with plantar fasciitis were randomly assigned to 2 groups and followed up for 12 months, with 29 receiving MSN treatment and 25 receiving steroid injection treatment. The results showed that visual analog scale scores for morning pain, active pain, and overall heel pain all were decreased significantly in the MSN group from 1 to 12 months after treatment. In contrast, treatment with steroid injection showed a significant effect only at the 1-month follow-up but not at 6 or 12 months after treatment. Moreover, the MSN group achieved more rapid and sustained improvements than the steroid group throughout the duration of this study. No severe side effects were observed with MSN treatment. Our data suggest that the MSN release treatment is safe and has a significant benefit for plantar fasciitis compared to steroid injection. PMID:25114704

  4. 12 month changes in dietary intake of adolescent girls attending schools in low-income communities following the NEAT Girls cluster randomized controlled trial.

    PubMed

    Collins, Clare E; Dewar, Deborah L; Schumacher, Tracy L; Finn, Tara; Morgan, Philip J; Lubans, David R

    2014-02-01

    Poor dietary habits and obesity are more prevalent in lower socio-economic status (SES) communities. The NEAT Girls cluster randomized controlled trial was a school-based obesity prevention program targeting adolescent girls in low SES schools in NSW, Australia. The aim was to evaluate the 12-month impact of key nutrition program messages on dietary intake and food behaviors. Diet was assessed using a validated semi-quantitative food frequency questionnaire (FFQ). Individual foods were categorized into nutrient-dense or energy-dense, nutrient-poor food groups and the percentage contribution to total energy intake calculated. Participants were aged 13.2±0.5years (n=330). There were no statistically significant group-by-time effects for dietary intake or food related behaviors, with 12-month trends suggesting more intervention group girls had improved water intakes (59% consuming⩽three glasses per day to 54% at 12 months vs. 50% to 61% in controls, p=0.052), with a greater proportion consuming < one sweetened beverage per day (24-41% vs. 34-37% in controls, p=0.057). Further research including more intensive nutrition intervention strategies are required to evaluate whether dietary intake in adolescent girls attending schools in low SES communities can be optimized. PMID:24239513

  5. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study

    PubMed Central

    Caponnetto, Pasquale; Campagna, Davide; Cibella, Fabio; Morjaria, Jaymin B.; Caruso, Massimo; Russo, Cristina; Polosa, Riccardo

    2013-01-01

    Background Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a ‘smoking’ experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science. Methods ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model (‘Categoria’; Arbi Group Srl, Italy) compared to its non-nicotine choice. GroupA (n = 100) received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n = 100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (n = 100) received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO) levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. Results Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p<0.001 vs baseline), with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants’ perception and acceptance of the product under investigation was satisfactory. Conclusion In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and

  6. Predictive significance of the overvaluation of shape/weight in obese patients with binge eating disorder: findings from a randomized controlled trial with 12-month follow-up

    PubMed Central

    Grilo, C. M.; White, M. A.; Gueorguieva, R.; Wilson, G. T.; Masheb, R. M.

    2013-01-01

    Background Undue influence of body shape or weight on self-evaluation – referred to as overvaluation – is considered a core feature across eating disorders, but is not a diagnostic requirement for binge eating disorder (BED). This study examined the concurrent and predictive significance of overvaluation of shape/weight in obese patients with BED participating in a randomized clinical trial testing cognitive behavioral therapy (CBT) and behavioral weight loss (BWL). Method A total of 90 participants were randomly assigned to 6-month group treatments of CBT or BWL. Assessments were performed at baseline, throughout- and post-treatment, and at 6- and 12-month follow-ups after completing treatments with reliably administered semi-structured interviews and established measures. Results Participants categorized with overvaluation (n=52, 58%) versus without overvaluation (n=38, 42%) did not differ significantly in demographic features (age, gender and ethnicity), psychiatric co-morbidity, body mass index or binge eating frequency. The overvaluation group had significantly greater levels of eating disorder psychopathology and poorer psychological functioning (higher depression and lower self-esteem) than the non-overvaluation group. Overvaluation of shape/weight significantly predicted non-remission from binge eating and higher frequency of binge eating at the 12-month follow-up, even after adjusting for group differences in depression and self-esteem levels. Conclusions Our findings suggest that overvaluation does not simply reflect concern commensurate with being obese or more frequent binge eating, but also is strongly associated with heightened eating-related psychopathology and psychological distress, and has negative prognostic significance for longer-term treatment outcomes. Overvaluation of shape/weight warrants consideration as a diagnostic specifier for BED as it provides important information about severity and treatment outcome. PMID:22967857

  7. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes

    PubMed Central

    Polly, David W.; Wine, Kathryn D.; Whang, Peter G.; Frank, Clay J.; Harvey, Charles F.; Lockstadt, Harry; Glaser, John A.; Limoni, Robert P.; Sembrano, Jonathan N.

    2015-01-01

    BACKGROUND: Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain. OBJECTIVE: To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction. METHODS: A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete. RESULTS: Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (≥ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P < .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31). CONCLUSION: This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment. ABBREVIATIONS: EQ-5D, EuroQoL-5D INSITE, Investigation of Sacroiliac Fusion Treatment MCS, mental component summary NSM, nonsurgical management ODI, Oswestry Disability Index PCS, physical component summary RFA, radiofrequency ablation SF

  8. Randomized controlled trial of a computer-tailored multiple health behaviour intervention in general practice: 12-month follow-up results

    PubMed Central

    2014-01-01

    Background Effective strategies to address risk factors of non-communicable diseases are required to curtail the expanding costs of health care. This trial tested the effectiveness over one year of a minimal intervention targeting multiple health behaviours (diet, physical activity, alcohol and smoking) in a general practice setting, through the provision of personalised, computer-tailored feedback. Methods Patients who had attended a general practice in the previous 6 months were recruited from 21 general practitioners in Brisbane, Australia. Baseline data were collected using self-reports on adherence to ten health behaviours and summarised into a health score from 0 to 10. This randomised controlled trial used a 2×2 factorial design, with one arm randomising subjects to the intervention or control group. The other arm was either feedback at baseline (single contact) or an additional assessment with feedback at 3 months (dual contact). As such, 4 study groups created were, to which participants were randomised blindly: A. Intervention with single contact; B. Intervention with dual contact; C. Control with single contact and D. Control with dual contact. All participants were assessed again at 12 months. Results Of the 4676 participants randomised, 3065 completed questionnaires at 12 months. Both single and dual contact groups improved their 10 item health scores (+0.31 and +0.49 respectively) relative to control group outcomes (+0.02; p < 0.01). Improvement in adherence to guidelines for fish intake, type of milk consumed, vegetable and fruit intake, and alcohol intake were observed in single and dual contact intervention groups (p < 0.01). Both intervention groups showed greater improvement than controls for individual health behaviours, apart from red meat intake, smoking behaviour, physical activity and body weight. Interestingly, there was an improvement in reported non-smoking rates in both intervention and control groups (3% single contact; 4

  9. Neighborhood walkability, fear and risk of falling and response to walking promotion: The Easy Steps to Health 12-month randomized controlled trial

    PubMed Central

    Merom, D.; Gebel, K.; Fahey, P.; Astell-Burt, T.; Voukelatos, A.; Rissel, C.; Sherrington, C.

    2015-01-01

    In older adults the relationships between health, fall-related risk factors, perceived neighborhood walkability, walking behavior and intervention impacts are poorly understood. To determine whether: i) health and fall-related risk factors were associated with perceptions of neighborhood walkability; ii) perceived environmental attributes, and fall-related risk factors predicted change in walking behavior at 12 months; and iii) perceived environmental attributes and fall-related risk factors moderated the effect of a self-paced walking program on walking behavior. Randomized trial on walking and falls conducted between 2009 and 2012 involving 315 community-dwelling inactive adults ≥ 65 years living in Sydney, Australia. Measures were: mobility status, fall history, injurious fall and fear of falling (i.e., fall-related risk factors), health status, walking self-efficacy and 11 items from the neighborhood walkability scale and planned walking ≥ 150 min/week at 12 months. Participants with poorer mobility, fear of falling, and poor health perceived their surroundings as less walkable. Walking at 12 months was significantly greater in “less greenery” (AOR = 3.3, 95% CI: 1.11–9.98) and “high traffic” (AOR = 1.98, 95% CI: 1.00–3.91) neighborhoods. The intervention had greater effects in neighborhoods perceived to have poorer pedestrian infrastructure (p for interaction = 0.036). Low perceived walkability was shaped by health status and did not appear to be a barrier to walking behavior. There appears to be a greater impact of, and thus, need for, interventions to encourage walking in environments perceived not to have supportive walking infrastructure. Future studies on built environments and walking should gather information on fall-related risk factors to better understand how these characteristics interact. PMID:26844140

  10. Nurse-Led, Telephone-Based, Secondary Preventive Follow-Up after Stroke or Transient Ischemic Attack Improves Blood Pressure and LDL Cholesterol: Results from the First 12 Months of the Randomized, Controlled NAILED Stroke Risk Factor Trial

    PubMed Central

    Irewall, Anna-Lotta; Ögren, Joachim; Bergström, Lisa; Laurell, Katarina; Söderström, Lars; Mooe, Thomas

    2015-01-01

    Background Enhanced secondary preventive follow-up after stroke or transient ischemic attack (TIA) is necessary for improved adherence to recommendations regarding blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) levels. We investigated whether nurse-led, telephone-based follow-up was more efficient than usual care at improving BP and LDL-C levels at 12 months after hospital discharge. Methods We randomized 537 patients to either nurse-led, telephone-based follow-up (intervention) or usual care (control). BP and LDL-C measurements were performed at 1 month (baseline) and 12 months post-discharge. Intervention group patients who did not meet target values at baseline received additional follow-up, including titration of medication and lifestyle counselling, to reach treatment goals (BP < 140/90 mmHg, LDL-C < 2.5 mmol/L). Results At 12 months, mean systolic BP, diastolic BP and LDL-C was 3.3 (95% CI 0.3 to 6.3) mmHg, 2.3 mmHg (95% CI 0.5 to 4.2) and 0.3 mmol/L (95% CI 0.1 to 0.4) lower in the intervention group compared to controls. Among participants with values above the treatment goal at baseline, the difference in systolic BP and LDL-C was more pronounced (8.0 mmHg, 95% CI 4.0 to 12.1, and 0.6 mmol/L, 95% CI 0.4 to 0.9). A larger proportion of the intervention group reached the treatment goal for systolic BP (68.5 vs. 56.8%, p = 0.008) and LDL-C (69.7% vs. 50.4%, p < 0.001). Conclusions Nurse-led, telephone-based secondary preventive follow-up, including medication adjustment, was significantly more efficient than usual care at improving BP and LDL-C levels by 12 months post-discharge. Trial Registration ISRCTN Registry ISRCTN23868518 PMID:26474055

  11. The Irritable Bowel Syndrome Outcome Study (IBSOS): Rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome

    PubMed Central

    Lackner, Jeffrey M.; Keefer, Laurie; Jaccard, James; Firth, Rebecca; Brenner, Darren; Bratten, Jason; Dunlap, Laura J.; Byroads, Mark

    2012-01-01

    Irritable bowel syndrome is a common, oftentimes disabling, gastrointestinal disorder whose full range of symptoms has no satisfactory medical or dietary treatment. One of the few empirically validated treatments includes a specific psychological therapy called cognitive behavior therapy which, if available, is typically administered over several months by trained practitioners in tertiary care settings. There is an urgent need to develop more efficient versions of CBT that require minimal professional assistance but retain the efficacy profile of clinic based CBT. The Irritable Bowel Syndrome Outcome Study (IBSOS) is a multicenter, placebo-controlled randomized trial to evaluate whether a self-administered version of CBT is, at least as efficacious as standard CBT and more efficacious than an attention control in reducing core GI symptoms of IBS and its burden (e.g. distress, quality of life impairment, etc) in moderately to severely affected IBS patients. Additional goals are to assess, at quarterly intervals, the durability of treatment response over a 12 month period; to identify clinically useful patient characteristics associated with outcome as a way of gaining an understanding of subgroups of participants for whom CBT is most beneficial; to identify theory-based change mechanisms (active ingredients) that explain how and why CBT works; and evaluate the economic costs and benefits of CBT. Between August 2010 when IBSOS began recruiting subjects and February 2012, the IBSOS randomized 171 of 480 patients. Findings have the potential to improve the health of IBS patients, reduce its social and economic costs, conserve scarce health care resources, and inform evidence-based practice guidelines. PMID:22846389

  12. The Irritable Bowel Syndrome Outcome Study (IBSOS): rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome.

    PubMed

    Lackner, Jeffrey M; Keefer, Laurie; Jaccard, James; Firth, Rebecca; Brenner, Darren; Bratten, Jason; Dunlap, Laura J; Ma, Changxing; Byroads, Mark

    2012-11-01

    Irritable bowel syndrome is a common, oftentimes disabling, gastrointestinal disorder whose full range of symptoms has no satisfactory medical or dietary treatment. One of the few empirically validated treatments includes a specific psychological therapy called cognitive behavior therapy which, if available, is typically administered over several months by trained practitioners in tertiary care settings. There is an urgent need to develop more efficient versions of CBT that require minimal professional assistance but retain the efficacy profile of clinic based CBT. The Irritable Bowel Syndrome Outcome Study (IBSOS) is a multicenter, placebo-controlled randomized trial to evaluate whether a self-administered version of CBT is, at least as efficacious as standard CBT and more efficacious than an attention control in reducing core GI symptoms of IBS and its burden (e.g. distress, quality of life impairment, etc.) in moderately to severely affected IBS patients. Additional goals are to assess, at quarterly intervals, the durability of treatment response over a 12 month period; to identify clinically useful patient characteristics associated with outcome as a way of gaining an understanding of subgroups of participants for whom CBT is most beneficial; to identify theory-based change mechanisms (active ingredients) that explain how and why CBT works; and evaluate the economic costs and benefits of CBT. Between August 2010 when IBSOS began recruiting subjects and February 2012, the IBSOS randomized 171 of 480 patients. Findings have the potential to improve the health of IBS patients, reduce its social and economic costs, conserve scarce health care resources, and inform evidence-based practice guidelines. PMID:22846389

  13. Root Coverage in Smokers with Acellular Dermal Matrix Graft and Enamel Matrix Derivative: A 12-Month Randomized Clinical Trial.

    PubMed

    Costa, Priscila Paganini; Alves, Luciana Bastos; Souza, Sérgio Luís; Grisi, Márcio Fernando; Palioto, Daniela Bazan; Taba, Mario; Novaes, Arthur Belém

    2016-01-01

    This study investigated whether enamel matrix derivative (EMD) contributes to root coverage of gingival recessions performed with acellular dermal matrix graft (ADMG) in smokers during a 12-month follow-up. A sample of 19 smokers presenting bilateral Miller Class I or II gingival recessions were included. Selected sites randomly received both ADMG and EMD (test) or ADMG alone (control). Probing depth, clinical attachment level, gingival recession height, keratinized tissue, and root coverage were evaluated. Mean gain in recession height (P < .05), sites with complete root coverage (P < .05), and percentage of root coverage (59.7% and 52.8%, respectively) favored the test group compared with the control group. PMID:27333010

  14. One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension

    PubMed Central

    Riddle, M C; Yki-Järvinen, H; Bolli, G B; Ziemen, M; Muehlen-Bartmer, I; Cissokho, S; Home, P D

    2015-01-01

    Aims To evaluate the maintenance of efficacy and safety of insulin glargine 300 U/ml (Gla-300) versus glargine 100 U/ml (Gla-100) in people with type 2 diabetes mellitus (T2DM) using basal plus meal-time insulin for 12 months in the EDITION 1 trial. Methods EDITION 1 was a multicentre, randomized, open-label, two-arm, phase IIIa study. Participants completing the initial 6-month treatment period continued to receive Gla-300 or Gla-100, as previously randomized, once daily for a further 6-month open-label extension phase. Changes in glycated haemoglobin (HbA1c) and fasting plasma glucose concentrations, insulin dose, hypoglycaemic events and body weight were assessed. Results Of 807 participants enrolled in the initial phase, 89% (359/404) assigned to Gla-300 and 88% (355/403) assigned to Gla-100 completed 12 months. Glycaemic control was sustained in both groups (mean HbA1c: Gla-300, 7.24%; Gla-100, 7.42%), with more sustained HbA1c reduction for Gla-300 at 12 months: least squares mean difference Gla-300 vs Gla-100: HbA1c −0.17 [95% confidence interval (CI) −0.30 to −0.05]%. The mean daily basal insulin dose at 12 months was 1.03 U/kg for Gla-300 and 0.90 U/kg for Gla-100. Lower percentages of participants had ≥1 confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemic event with Gla-300 than Gla-100 at any time of day [24 h; 86 vs 92%; relative risk 0.94 (95% CI 0.89–0.99)] and during the night [54 vs 65%; relative risk 0.84 (95% CI 0.75–0.94)], while the annualized rates of such hypoglycaemic events were similar. No between-treatment differences in adverse events were apparent. Conclusion During 12 months of treatment of T2DM requiring basal and meal-time insulin, glycaemic control was better sustained and fewer individuals reported hypoglycaemia with Gla-300 than with Gla-100. The mean basal insulin dose was higher with Gla-300 compared with Gla-100, but total numbers of hypoglycaemic events and overall tolerability did not differ between

  15. Randomized clinical trial of four adhesion strategies in cervical lesions: 12-month results.

    PubMed

    de Paula, Eloisa Andrade; Tay, Lidia Yileng; Kose, Carlos; Mena-Serrano, Alexandra; Reis, Alessandra; Perdigão, Jorge; Loguercio, Alessandro D

    2015-01-01

    The aim of this study was to evaluate the 6- and 12-month clinical performance of four adhesion strategies from the same manufacturer (Kerr) in non-carious cervical lesions (NCCLs) using two evaluation criteria. Thirty-five patients, with at least four NCCLs each, participated in this study. After samplesize calculation, 180 restorations were assigned to one of the following groups: OFL (Optibond FL), OSP (Optibond Solo Plus), XTR (Optibond XTR), and AIO (Optibond All-In-One). The composite resin Filtek Supreme Ultra (3M ESPE) was placed incrementally. The restorations were evaluated at baseline, after 6 months, and after 12 months, using both the FDI and the USPHS-modified criteria. Statistical analyses were performed with Friedman repeated measures, ANOVA by rank, and the McNemar test for significance in each pair (α=0.05). Six restorations (2 for OFL, 1 for OSP, 2 for XTR, and 1 for AIO) were lost at 12 months (P>0.05 for both evaluation criteria). Marginal staining was observed in seven restorations using the FDI criteria (P>0.05) and three restorations using the USPHSmodified criteria (P>0.05). Eight restorations (2 for OSP, 3 for XTR, and 3 for AIO) were classified as Bravo for marginal adaptation using the USPHSmodified criteria (P>0.05). However, 62 restorations (14 for OFL, 12 for OSP, 15 for XTR, and 21 for AIO) were classified as Bravo using the FDI criteria (P>0.05). The four adhesion strategies showed similar clinical retention at 6 and 12 months. The FDI evaluation criteria tend to be more sensitive than the USPHS-modified criteria. PMID:25625130

  16. A 12-month controlled trial of methadone medical maintenance integrated into an adaptive treatment model.

    PubMed

    King, Van L; Kidorf, Michael S; Stoller, Kenneth B; Schwartz, Robert; Kolodner, Kenneth; Brooner, Robert K

    2006-12-01

    Methadone medical maintenance (MMM) reduces the reporting schedule for stable and well-functioning methadone maintenance patients to once a month, with counseling provided by medical staff. We report on the 12-month outcomes of 92 highly stable methadone maintenance patients randomly assigned to one of three study conditions: routine care, MMM at the methadone maintenance program, and MMM at a physician's office. Methadone medical maintenance patients received a 28-day supply of methadone, whereas routine care patients received five or six take-home methadone doses each week. All patients performed a medication recall once a month and submitted two urine samples each month. An adaptive stepped-care system of treatment intensification was used for patients who failed recall or who had drug-positive urine specimens. Seventy-seven patients completed the 12-month study period. Dropout was caused primarily by problems with handling methadone and disliking the recall frequency. There were low rates of drug use or failed medication recall. Treatment satisfaction was high in all groups, but the MMM patients initiated more new employment or family/social activities than did routine care patients over the study period. The stepped-care approach was well tolerated and matched patients to an appropriate step of service within a continuum of treatment intensity. PMID:17084792

  17. Effectiveness of a 12-month randomized clinical trial to increase physical activity in multiethnic postpartum women: Results from Hawaii’s Nā Mikimiki Project

    PubMed Central

    Albright, Cheryl L.; Steffen, Alana D.; Wilkens, Lynne R.; White, Kami K.; Novotny, Rachel; Nigg, Claudio R.; Saiki, Kara; Brown, Wendy J.

    2015-01-01

    Objective Few postpartum ethnic minority women perform leisure-time moderate-to-vigorous physical activity (MVPA). The study tested the effectiveness of a 12-month tailored intervention to increase MVPA in women with infants 2–12 months old. Methods From 2008–2011, women (n=311) with infants (average age = 5.7 months) from Honolulu, Hawaii were randomly assigned to receive tailored telephone calls and access to a mom-centric website (n=154) or access to a standard PA website (n=157). MVPA was measured at baseline, 6, and 12 months using self-report and acclerometers. Results Controlling for covariates, the tailored condition significantly increased self-reported MVPA from an average of 44 to 246 minutes/week compared with 46 to 156 minutes/week for the standard condition (p=0.027). Mothers with ≥ 2 children had significantly greater increases in MVPA in response to the tailored intervention than those with one child (p=0.016). Accelerometer-measured MVPA significantly increased over time (p=0.0001), with no condition differences. There was evidence of reactivity to initially wearing accelerometers; the tailored intervention significantly increased MVPA among women with low baseline accelerometer MVPA minutes, but not among those with high minutes (pinteraction=0.053). Conclusion A tailored intervention effectively increased MVPA over 12 months in multiethnic women with infants, particularly those with more than one child. PMID:25285751

  18. Plasma CRP Levels in Premenopausal Women with Major Depression: A 12-Month Controlled Study

    PubMed Central

    Cizza, G.; Eskandari, F.; Coyle, M.; Krishnamurthy, P.; Wright, E. C.; Mistry, S.; Csako, G.

    2009-01-01

    C-reactive protein (CRP), an inflammatory marker of cardiovascular risk, is often elevated in major depressive disorder (MDD). The magnitude and consistency of this elevation have not been previously characterized in premenopausal women with MDD. The aim of the study was to prospectively assess plasma CRP levels, body composition, endocrine and metabolic parameters, and depressive status in premenopausal women with MDD (n = 77) and controls (n = 41), aged 21 to 45. Women were enrolled in a 12-month, controlled study of bone turnover, the P.O.W.E.R. (Premenopausal, Osteoporosis, Women, Alendronate, Depression) Study. Blood samples were taken at Baseline, Month 6, and Month 12. Most subjects with MDD were in clinical remission. These women tended to have consistently higher CRP levels than controls over 12 months (p = 0.077). BMI was positively related to log[CRP] in women with MDD only. Nine women with MDD had CRP levels greater than 10 mg/l, a value associated with a very high cardiovascular risk. This subset was obese and had significantly higher triglycerides, total cholesterol, LDL-cholesterol, fasting insulin, and HOMA-IR than the rest of women with MDD. The variations in CRP levels over time were high (intra- and inter-individual coefficients of variations of ∼30–50% and ∼70–140%, respectively). No control had CRP levels greater than 10 mg/l. Depression was associated with increased plasma CRP in women with MDD. The clinical significance of abnormal plasma CRP for cardiovascular risk needs to be assessed in large prospective studies of women with depression. PMID:19408214

  19. Kinematic Measurement of 12-week Head Control Correlates with 12-month Neurodevelopment in Preterm Infants

    PubMed Central

    Bentzley, Jessica P; Coker-Bolt, Patty; Moreau, Noelle; Hope, Kathryn; Ramakrishnan, Viswanathan; Brown, Truman; Mulvihill, Denise; Jenkins, Dorothea

    2015-01-01

    Background Although new interventions treating neonatal brain injury show great promise, our current ability to predict clinical functional outcomes is poor. Quantitative biomarkers of long-term neurodevelopmental outcome are critically needed to gauge treatment efficacy. Kinematic measures derived from commonly used developmental tasks may serve as early objective markers of future motor outcomes. Aim To develop reliable kinematic markers of head control at 12 weeks corrected gestational age (CGA) from two motor tasks: head lifting in prone and pull-to-sit Study design and subjects Prospective observational study of 22 preterm infants born between 24 and 34 weeks of gestation Outcome measures Bayley Scales of Infant Development III (Bayley) motor scores Results Intrarater and interrater reliability of prone head lift angles and pull-to-sit head angles were excellent. Prone head lift angles at 12 weeks CGA correlated with white matter NAA/Cho, concurrent Test of Infant Motor Performance (TIMP) scores, and 12-month Bayley motor scores. Head angles during pull-to-sit at 12-weeks CGA correlated with TIMP scores. Conclusions Poor ability to lift the head in prone and an inability to align the head with the trunk during the pull-to-sit task were associated with poorer future motor outcome scores. Kinematic measurements of head control in early infancy may serve as reliable objective quantitative markers of future motor impairment and neurodevelopmental outcome. PMID:25621433

  20. 12-Month Outcomes of Community Engagement Versus Technical Assistance to Implement Depression Collaborative Care: A Partnered, Cluster, Randomized, Comparative-Effectiveness Trial

    PubMed Central

    Chung, Bowen; Ong, Michael; Ettner, Susan L.; Jones, Felica; Gilmore, James; McCreary, Michael; Sherbourne, Cathy; Ngo, Victoria; Koegel, Paul; Tang, Lingqi; Dixon, Elizabeth; Miranda, Jeanne; Belin, Thomas R.; Wells, Kenneth B.

    2014-01-01

    Background Depression collaborative care implementation using community engagement and planning (CEP) across programs compared to technical assistance to individual programs (Resources for Services, RS) in minority communities improves 6-month client outcomes. However, 12-month outcomes are unknown. Objective To compare effects of CEP and RS collaborative care implementation interventions on depressed clients’ mental health-related quality of life (MHRQL) and services use at 12-months. Design Matched health and community programs (n=93) in two communities randomized to CEP or RS. Measurements Self-reported client MHRQL, and services use at baseline, 6, and 12-months. Setting Los Angeles. Patients Adults (n=1018) with depressive symptoms (8-item Patient Health Questionnaire [PHQ-8]≥10); 85% ethnic minority. Interventions CEP and RS to implement depression collaborative care. Measurements Primary outcome: Poor MHRQL (12-item Mental Composite Score [MCS-12]≤40) at baseline, 6, and 12-months; Secondary outcomes: 12-months services use. Results At 6-months, the finding that CEP outperformed RS to reduce poor MHRQL was significant, but sensitive to underlying statistical assumptions. Similarly, at 12-months, some analyses suggested that CEP was advantageous on MHRQL, while other analyses did not confirm a significant difference favoring CEP. The finding that CEP reduced behavioral health hospitalizations at 6-months was not clear at 12-months with findings sensitive to underlying statistical assumptions. Other services use was not significantly different between interventions at 12-months. Limitations Self-reported data. Findings are sensitive to modeling assumptions. Conclusions In contrast to 6-month results, our findings did not show consistent CEP effects on reducing the likelihood of poor client MHRQL and behavioral health hospitalizations at 12-months. Still given under-resourced communities’ needs, CEP's favorable profile, and the absence of evidence

  1. The developing cognitive substrate of sequential action control in 9- to 12-month-olds: evidence for concurrent activation models.

    PubMed

    Verschoor, S A; Paulus, M; Spapé, M; Biro, S; Hommel, B

    2015-05-01

    Nine-month-olds start to perform sequential actions. Yet, it remains largely unknown how they acquire and control such actions. We studied infants' sequential-action control by employing a novel gaze-contingent eye tracking paradigm. Infants experienced occulo-motor action sequences comprising two elementary actions. To contrast chaining, concurrent and integrated models of sequential-action control, we then selectively activated secondary actions to assess interactions with the primary actions. Behavioral and pupillometric results suggest 12-month-olds acquire sequential action without elaborate strategy through exploration. Furthermore, the inhibitory mechanisms ensuring ordered performance develop between 9 and 12 months of age, and are best captured by concurrent models. PMID:25704583

  2. Serum Cholinesterase Activities Distinguish between Stroke Patients and Controls and Predict 12-Month Mortality

    PubMed Central

    Ben Assayag, Einor; Shenhar-Tsarfaty, Shani; Ofek, Keren; Soreq, Lilach; Bova, Irena; Shopin, Ludmila; Berg, Ronan MG; Berliner, Shlomo; Shapira, Itzhak; Bornstein, Natan M; Soreq, Hermona

    2010-01-01

    To date there is no diagnostic biomarker for mild stroke, although elevation of inflammatory biomarkers has been reported at early stages. Previous studies implicated acetylcholinesterase (AChE) involvement in stroke, and circulating AChE activity reflects inflammatory response, since acetylcholine suppresses inflammation. Therefore, carriers of polymorphisms that modify cholinergic activity should be particularly susceptible to inflammatory damage. Our study sought diagnostic values of AChE and Cholinergic Status (CS, the total capacity for acetylcholine hydrolysis) in suspected stroke patients. For this purpose, serum cholinesterase activities, butyrylcholinesterase-K genotype and inflammatory biomarkers were determined in 264 ischemic stroke patients and matched controls during the acute phase. AChE activities were lower (P < 0.001), and butyrylcholinesterase activities were higher in patients than in controls (P = 0.004). When normalized to sampling time from stroke occurrence, both cholinergic parameters were correlated with multiple inflammatory biomarkers, including fibrinogen, interleukin-6 and C-reactive protein (r = 0.713, r = 0.607; r = 0.421, r = 0.341; r = 0.276, r = 0.255; respectively; all P values < 0.001). Furthermore, very low AChE activities predicted subsequent nonsurvival (P = 0.036). Also, carriers of the unstable butyrylcholinesterase-K variant were more abundant among patients than controls, and showed reduced activity (P < 0.001). Importantly, a cholinergic score combining the two cholinesterase activities discriminated between 94.3% matched pairs of patients and controls, compared with only 75% for inflammatory measures. Our findings present the power of circulation cholinesterase measurements as useful early diagnostic tools for the occurrence of stroke. Importantly, these were considerably more distinctive than the inflammatory biomarkers, albeit closely associated with them, which may open new venues for stroke diagnosis and treatment

  3. Bone mass and bone turnover in power athletes, endurance athletes, and controls: a 12-month longitudinal study.

    PubMed

    Bennell, K L; Malcolm, S A; Khan, K M; Thomas, S A; Reid, S J; Brukner, P D; Ebeling, P R; Wark, J D

    1997-05-01

    Strain magnitude may be more important than the number of loading cycles in controlling bone adaptation to loading. To test this hypothesis, we performed a 12 month longitudinal cohort study comparing bone mass and bone turnover in elite and subelite track and field athletes and less active controls. The cohort comprised 50 power athletes (sprinters, jumpers, hurdlers, multievent athletes; 23 women, 27 men), 61 endurance athletes (middle-distance runners, distance runners; 30 women, 31 men), and 55 nonathlete controls (28 women, 27 men) aged 17-26 years. Total bone mineral content (BMC), regional bone mineral density (BMD), and soft tissue composition were measured by dual-energy X-ray absorptiometry. Bone turnover was assessed by serum osteocalcin (human immunoradiometric assay) indicative of bone formation, and urinary pyridinium crosslinks (high-performance liquid chromatography) indicative of bone resorption. Questionnaires quantified menstrual, dietary and physical activity characteristics. Baseline results showed that power athletes had higher regional BMD at lower limb, lumbar spine, and upper limb sites compared with controls (p < 0.05). Endurance athletes had higher BMD than controls in lower limb sites only (p < 0.05). Maximal differences in BMD between athletes and controls were noted at sites loaded by exercise. Male and female power athletes had greater bone density at the lumbar spine than endurance athletes. Over the 12 months, both athletes and controls showed modest but significant increases in total body BMC and femur BMD (p < 0.001). Changes in bone density were independent of exercise status except at the lumbar spine. At this site, power athletes gained significantly more bone density than the other groups. Levels of bone formation were not elevated in athletes and levels of bone turnover were not predictive of subsequent changes in bone mass. Our results provide further support for the concept that bone response to mechanical loading depends

  4. The role of action effects in 12-month-olds' action control: a comparison of televised model and live model.

    PubMed

    Klein, Annette M; Hauf, Petra; Aschersleben, Gisa

    2006-12-01

    The present study investigated differences in infant imitation after watching a televised model and a live model and addressed the issue of whether action effects influence infants' action control in both cases. In a 2x2 design, 12-month-old infants observed a live or a televised model performing a three-step action sequence, in which either the 2nd or the 3rd action step was combined with an acoustical action effect. We assumed that infants would use the observed action-effect relations for their own action control in the test phase afterwards. Even though results exhibited differences in the absolute amount of imitation between the two demonstration groups, both groups showed similar result patterns regarding the action effect manipulation: infants imitated the action step that was followed by a salient action effect more often and mostly as the first target action, emphasizing the important role of action effects in infants' action control. PMID:17138306

  5. A Randomized Trial of Computerized vs. In-person Brief Intervention for Illicit Drug Use in Primary Care: Outcomes through 12 months

    PubMed Central

    Gryczynski, Jan; Mitchell, Shannon Gwin; Gonzales, Arturo; Moseley, Ana; Peterson, Thomas R.; Ondersma, Steven J.; O'Grady, Kevin E.; Schwartz, Robert P.

    2014-01-01

    This study examined outcomes through 12 months from a randomized trial comparing computerized brief intervention (CBI) vs. in-person brief intervention (IBI) delivered by behavioral health counselors for adult community health center patients with moderate-level drug misuse (N= 360). Data were collected at baseline, 3-, 6-, and 12-month follow-up, and included the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) and laboratory analysis of hair samples. Repeated measures analyses examined differential change over time. There were no significant differences in drug-positive hair tests over time or by condition. Global ASSIST scores decreased in both conditions (p< .001), but there were no significant differences between conditions in overall change across 12 months of follow-up (p= .13). CBI produced greater overall reductions in alcohol (p= .04) and cocaine (p= .02) ASSIST scores than IBI, with initial differences dissipating over time. Computerized brief interventions present a viable alternative to traditional in-person brief interventions. PMID:25282578

  6. Developmental milestones record - 12 months

    MedlinePlus

    Normal childhood growth milestones - 12 months; Growth milestones for children - 12 months; Childhood growth milestones - 12 months ... care provider. PHYSICAL AND MOTOR SKILLS A 12-month-old child is expected to: Be 3 times ...

  7. Frequency, Predictors and Consequences of Crossing Over to Revascularization within 12 months of Randomization to Optimal Medical Therapy in the COURAGE Trial

    PubMed Central

    Spertus, John A; Maron, David J; Cohen, David J; Kolm, Paul; Hartigan, Pam; Weintraub, William S.; Berman, Daniel S.; O'Rourke, Robert A.; Teo, Koon K; Shaw, Leslee J.; Sedlis, Steven; Knudtson, Merril; Aslan, Mihaela; Dada, Marcin; Boden, William E.; John Mancini, G.B.

    2013-01-01

    Background In COURAGE, some stable ischemic heart disease (SIHD) patients randomized to optimal medical therapy (OMT) crossed over to early revascularization. The predictors and outcomes of patients who crossed over from OMT to revascularization are unknown. Methods and Results We compared characteristics of OMT patients who did and did not undergo revascularization within 12 months and created a Cox regression model to identify predictors of early revascularization. Patients' health status was measured with the Seattle Angina Questionnaire (SAQ). To quantify the potential consequences of initiating OMT without percutaneous coronary intervention (PCI), we compared the outcomes of crossover patients with a matched cohort randomized to immediate PCI. Among 1148 patients randomized to OMT, 185 (16.1%) underwent early revascularization. Patient characteristics independently associated with early revascularization were worse baseline SAQ scores and healthcare system. Among 156 OMT patients undergoing early revascularization matched to 156 patients randomized to PCI, rates of mortality (HR= 0.51 (0.13, 2.1) and nonfatal MI (HR=1.9 (0.75-4.6) were similar, as were 1-year SAQ scores. OMT patients, however, experienced worse health status over the initial year of treatment and more unstable angina admissions (HR=2.8 (1.1, 7.5)). Conclusion Among COURAGE patients assigned to OMT alone, patients' angina, dissatisfaction with their current treatment and, to a lesser extent, their health system were associated with early revascularization. Since early crossover was not associated with an increase in irreversible ischemic events, or impaired 12-month health status, these findings support an initial trial of OMT in SIHD with close follow-up of the most symptomatic patients. PMID:23838107

  8. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

    PubMed Central

    Münch, Andreas; Bohr, Johan; Miehlke, Stephan; Benoni, Cecilia; Olesen, Martin; Öst, Åke; Strandberg, Lars; Hellström, Per M; Hertervig, Erik; Armerding, Peter; Stehlik, Jiri; Lindberg, Greger; Björk, Jan; Lapidus, Annika; Löfberg, Robert; Bonderup, Ole; Avnström, Sören; Rössle, Martin; Dilger, Karin; Mueller, Ralph; Greinwald, Roland; Tysk, Curt; Ström, Magnus

    2016-01-01

    Objective This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis. Design A prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase. Results Clinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days)). The maintenance of clinical remission at 1 year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1 year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious. Conclusions Budesonide at a mean dose of 4.5 mg/day maintained clinical remission for at least 1 year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1 year may be beneficial given the high relapse rate after budesonide discontinuation. Trial registration numbers http://www.clinicaltrials.gov (NCT01278082) and http

  9. Improved asthma control in patients with severe, persistent allergic asthma after 12 months of nightly temperature-controlled laminar airflow: an observational study with retrospective comparisons

    PubMed Central

    Schauer, Uwe; Bergmann, Karl-Christian; Gerstlauer, Michael; Lehmann, Sylvia; Gappa, Monika; Brenneken, Amelie; Schulz, Christian; Ahrens, Peter; Schreiber, Jens; Wittmann, Michael; Hamelmann, Eckard

    2015-01-01

    Introduction Continuous or episodic allergen exposure is a major risk factor of frequent symptoms and exacerbations for patients with allergic asthma. It has been shown that temperature-controlled laminar airflow (TLA) significantly reduced allergen exposure and airway inflammation and improved quality of life of patients with poorly controlled allergic asthma. Objective The objective was to evaluate the effects of nighttime TLA when used during real-life conditions for 12 consecutive months in addition to the patients’ regular medication. Methods This multicenter, pre- and postretrospective observational study included patients with inadequately controlled moderate-to-severe allergic asthma who received add-on treatment with TLA for 12 consecutive months. Data on medication use, asthma control, asthma symptoms, lung function, use of hospital resources, and exacerbations were collected after 4 and 12 months and compared with corresponding data collected retrospectively from medical records during the year prior to inclusion in the study. Results Data from 30 patients (mean age 28; range 8–70) completing 4 months and 27 patients completing 12 months of TLA use are presented. The mean number of exacerbations was reduced from 3.6 to 1.3 (p<0.0001), and the ratio of asthma-related emergency room visits or hospitalizations diminished from 72.4 to 23.3% (p=0.001) or from 44.8 to 20.0% (p<0.05), respectively, after 12 months of TLA use. The Asthma Control Test index increased from 14.1 to 18.5 (p<0.0001). After 4 months of TLA use, clear improvements can be shown for most variables in line with the data collected after 12 months. Conclusions The addition of TLA to the patients’ regular medication significantly reduced exacerbations, asthma symptoms, and the utilization of hospital resources. The data support that TLA may be an important new non-pharmacological approach in the management of poorly controlled allergic asthma. PMID:26557252

  10. Effect of Improving Dietary Quality on Arterial Stiffness in Subjects with Type 1 and Type 2 Diabetes: A 12 Months Randomised Controlled Trial

    PubMed Central

    Petersen, Kristina S.; Clifton, Peter M.; Lister, Natalie; Keogh, Jennifer B.

    2016-01-01

    People with diabetes have accelerated arterial stiffening. The aim of this study was to determine the effect of increasing fruit, vegetable and dairy intake for 12 months on carotid femoral pulse wave velocity (cfPWV), augmentation index (AIx), and central blood pressure (cBP), compared to a usual diet control, in people with type 1 and type 2 diabetes. In a 12 months randomised controlled trial, cfPWV, AIx and cBP were measured every 3 months. The intervention group received dietary counselling to increase consumption of fruit (+1 serving/day; 150 g/day), vegetables (+2 servings/day; 150 g/day) and dairy (+1 serving/day; 200–250 g/day) at baseline, 1, 3, 6 and 9 months. The control group continued on their usual diet. One hundred and nine participants were randomised and 92 (intervention n = 45; control n = 47) completed. At 3 months, fruit (184 g/day; p = 0.001) and dairy (83 g/day; p = 0.037) intake increased in the intervention group compared with the control group but this increase was not maintained at 12 months. After adjustment for baseline measurements there was no time by treatment effect for central systolic or diastolic BP, AIx or cfPWV. A time effect existed for AIx which modestly increased over time. Peripheral diastolic BP and central pulse pressure were improved in the intervention group compared with the control group at 12 months. In the cohort with type 1 and type 2 diabetes, improving dietary quality by increasing consumption of fruit, vegetables and dairy did not improve cBP, AIx or cfPWV, compared with a control group continuing on their usual diet, after 12 months. PMID:27338467

  11. Prospective Randomized Study Comparing Combined Phaco-ExPress and Phacotrabeculectomy in Open Angle Glaucoma Treatment: 12-Month Follow-Up

    PubMed Central

    Konopińska, Joanna; Deniziak, Marta; Saeed, Emil; Bartczak, Agnieszka; Zalewska, Renata; Mariak, Zofia; Rękas, Marek

    2015-01-01

    Purpose of the Study. To compare the efficacy and safety of phacotrabeculectomy (P-Trab) and phacoemulsification with the ExPress (P-ExPress) mini glaucoma shunt implantation. Study Plan. Prospective randomized study. Material and Methods. 85 eyes with cataract and unregulated open angle glaucoma. There were 46 eyes in the P-ExPress and 39 the P-Trab group. Intraocular pressure (IOP), the number of antiglaucoma medications, qualified and complete surgical success (defined as IOP ≤ 18.0 mmHg), visual acuity (CDVA), the number of endothelial cells, and postoperative complications and additional procedures were assessed. Results. After 12 months of observation, the average IOP in the P-Express group went from 26.4 ± 9.3 down to 17.1 ± 5 mmHg (P < 0.05) and from 27.9 ± 12.9 down to 15.9 ± 2.7 mmHg in the P-Trab group (P < 0.05). No significant differences in the amount of medications used after surgery and CDVA were discovered between the groups. In the P-ExPress group, greater loss of endothelial cells was noted (CDloss%), compared to the P-Trab group. Conclusions. Both P-ExPress and P-Trab have comparable efficacy and similar early postoperative complication profile. The presence of additional implant (as is the case of the ExPress mini glaucoma shunt implantation) may cause progressive loss of endothelial cells. PMID:26137318

  12. Clinical outcome and bone healing of implants placed with high insertion torque: 12-month results from a multicenter controlled cohort study.

    PubMed

    Grandi, T; Guazzi, P; Samarani, R; Grandi, G

    2013-04-01

    This study evaluated the clinical outcome and the crestal bone resorption of implants placed with high insertion torque (up to 80 N cm). 102 patients were treated with 156 tapered implants. 42 implants (control group) presented insertion torque between 30 and 45 N cm (mean=37.4 SD 8.2). 114 implants (experimental group) were placed with insertion torque between 50 and 80 N cm (mean=74.8 SD 7.9). All implants were early loaded after 2 months. Peri-implant marginal bone levels were assessed immediately after surgery, and at 6- and 12-month follow up examinations. At the 12-month follow up all implants were clinically stable. After 12 months, patients in the experimental group lost an average of 0.41 mm (CI 95% 0.522; 0.263) of crestal bone compared with 0.45 mm (CI 95% 0.561; 0.286) for those in the control group. There were no significant differences between the two groups. No direct or inverse relationship was observed between the insertion torque values and crestal bone resorption. The results show that the use of high insertion torque (up to 80 N cm) did not prevent osseointegration and did not increase bone resorption around tapered implants early loaded up to 1 year after implant placement. PMID:23159169

  13. Cluster Randomized Controlled Trial

    PubMed Central

    Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

    2015-01-01

    Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

  14. The effects of different levels of calcium supplementation on the bone mineral status of postpartum lactating Chinese women: a 12-month randomised, double-blinded, controlled trial.

    PubMed

    Zhang, Zhe-Qing; Chen, Yu-Ming; Wang, Ruo-Qin; Huang, Zhen-Wu; Yang, Xiao-Guang; Su, Yi-Xiang

    2016-01-14

    Increasing dietary Ca intake may prevent the excessive mobilisation of bone mineral in nursing mothers. We aimed to investigate whether higher Ca intake could positively modulate the bone mineral changes in Chinese postpartum lactating women. The study was a 12-month randomised, double-blinded, parallel group trial conducted over 12 months. A total of 150 postpartum women were randomly selected to receive either 40 g of milk powder containing 300 mg of Ca and 5 μg of vitamin D (Low-Ca group) or same milk powder additionally fortified with 300 mg of Ca (Mid-Ca group) or 600 mg of Ca (High-Ca group). Bone mineral density (BMD) for the whole body, the lumbar spine, the total left hip and its sub-regions was measured using dual-energy X-ray absorptiometry. A total of 102 subjects completed the whole trial. The duration of total lactating time was 7·9 (SD 2·8) months on average. The intention-to-treat analysis yielded the following mean percentage changes in BMD for the whole body, the lumbar spine and the total left hip, respectively: -0·93 (SD 1·97), 2·11 (SD 4·90) and -1·60 (SD 2·65)% for the Low-Ca group; -0·56 (SD 1·89), 2·21 (SD 3·77) and -1·43 (SD 2·30)% for the Mid-Ca group; and -0·44 (SD 1·67), 2·32 (SD 4·66) and -0·95 (SD 4·08)% for the High-Ca group. The differences between the groups were not statistically significant (P: 0·5-0·9). The results of the complete case analysis were similar. In sum, we found no significant differences in the bone mineral changes from baseline to 12 months in postpartum lactating women consuming milk powder fortified with different levels of Ca. PMID:26522081

  15. Randomized, Multicenter Trial on the Effect of Radiation Therapy on Plantar Fasciitis (Painful Heel Spur) Comparing a Standard Dose With a Very Low Dose: Mature Results After 12 Months' Follow-Up

    SciTech Connect

    Niewald, Marcus; Micke, Oliver; Graeber, Stefan; Schaefer, Vera; Scheid, Christine; Fleckenstein, Jochen; Licht, Norbert; Ruebe, Christian

    2012-11-15

    Purpose: To conduct a randomized trial of radiation therapy for painful heel spur, comparing a standard dose with a very low dose. Methods and Materials: Sixty-six patients were randomized to receive radiation therapy either with a total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy twice weekly (standard dose) or with a total dose of 0.6 Gy applied in 6 fractions of 0.1 Gy twice weekly (low dose). In all patients lateral opposing 4- to 6-MV photon beams were used. The results were measured using a visual analogue scale, the Calcaneodynia score, and the SF12 health survey. The fundamental phase of the study ended after 3 months, and the follow-up was continued up to 1 year. Patients with insufficient pain relief after 3 months were offered reirradiation with the standard dosage at any time afterward. Results: Of 66 patients, 4 were excluded because of withdrawal of consent or screening failures. After 3 months the results in the standard arm were highly significantly superior compared with those in the low-dose arm (visual analogue scale, P=.001; Calcaneodynia score, P=.027; SF12, P=.045). The accrual of patients was stopped at this point. Further evaluation after 12 months' follow-up showed the following results: (1) highly significant fewer patients were reirradiated in the standard arm compared with the low-dose arm (P<.001); (2) the results of patients in the low-dose arm who were reirradiated were identical to those in the standard arm not reirradiated (reirradiation as a salvage therapy if the lower dose was ineffective); (3) patients experiencing a favorable result after 3 months showed this even after 12 months, and some results even improved further between 3 and 12 months. Conclusions: This study confirms the superior analgesic effect of radiation therapy with 6-Gy doses on painful heel spur even for a longer time period of at least 1 year.

  16. Immunogenicity of reduced dose priming schedules of serogroup C meningococcal conjugate vaccine followed by booster at 12 months in infants: open label randomised controlled trial

    PubMed Central

    Khatami, Ameneh; McKenna, Jennifer; Campbell, Danielle; Attard-Montalto, Simon; Birks, Jacqueline; Voysey, Merryn; White, Catherine; Finn, Adam; Macloed, Emma; Faust, Saul N; Kent, Alison Louise; Heath, Paul T; Borrow, Ray; Snape, Matthew D; Pollard, Andrew J

    2015-01-01

    Objective To determine whether the immunogenicity of a single dose infant priming schedule of serogroup C meningococcal (MenC) conjugate vaccine is non-inferior to a two dose priming schedule when followed by a booster dose at age 12 months. Design Phase IV open label randomised controlled trial carried out from July 2010 until August 2013 Setting Four centres in the United Kingdom and one centre in Malta. Participants Healthy infants aged 6-12 weeks followed up until age 24 months. Interventions In the priming phase of the trial 509 infants were randomised in a 10:10:7:4 ratio into four groups to receive either a single MenC-cross reacting material 197 (CRM) dose at 3 months; two doses of MenC-CRM at 3 and 4 months; a single MenC-polysaccharide-tetanus toxoid (TT) dose at 3 months; or no MenC doses, respectively. Haemophilus influenzae type b (Hib)-MenC-TT vaccine was administered to all infants at 12 months of age. All infants also received the nationally routinely recommended vaccines. Blood samples were taken at age 5, 12, 13, and 24 months. Main outcome measure MenC serum bactericidal antibody assay with rabbit complement (rSBA) one month after the Hib-MenC-TT vaccine. Non-inferiority was met if the lower 95% confidence limit of the difference in the mean log10 MenC rSBA between the single dose MenC-CRM and the two dose MenC-CRM groups was >−0.35. Results The primary objective was met: after a Hib-MenC-TT booster dose at 12 months of age the MenC rSBA geometric mean titres induced in infants primed with a single MenC-CRM dose were not inferior to those induced in participants primed with two MenC-CRM doses in infancy (660 (95% confidence interval 498 to 876) v 295 (220 to 398)) with a corresponding difference in the mean log10 MenC rSBA of 0.35 (0.17 to 0.53) that showed superiority of the single over the two dose schedule). Exploration of differences between the priming schedules showed that one month after Hib-MenC-TT vaccination, MenC rSBA ≥1:8 was

  17. Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6–12 months) subpopulation of OVA-301 phase III randomized trial

    PubMed Central

    Poveda, A.; Vergote, I.; Tjulandin, S.; Kong, B.; Roy, M.; Chan, S.; Filipczyk-Cisarz, E.; Hagberg, H.; Kaye, S. B.; Colombo, N.; Lebedinsky, C.; Parekh, T.; Gómez, J.; Park, Y. C.; Alfaro, V.; Monk, B. J.

    2011-01-01

    Background: OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD) over PLD alone in relapsed ovarian cancer. The optimal management of patients with partially platinum-sensitive relapse [6–12 months platinum-free interval (PFI)] is unclear. Patients and methods: Within OVA-301, we therefore now report on the outcomes for the 214 cases in this subgroup. Results: Trabectedin/PLD resulted in a 35% risk reduction of disease progression (DP) or death [hazard ratio (HR) = 0.65, 95% confidence interval (CI), 0.45–0.92; P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43–0.82; P = 0.0015; median survival 23.0 versus 17.1 months). The safety of trabectedin/PLD in this subset mimicked that of the overall population. Similar proportions of patients received subsequent therapy in each arm (76% versus 77%), although patients in the trabectedin/PLD arm had a slightly lower proportion of further platinum (49% versus 55%). Importantly, patients in the trabectedin/PLD arm survived significantly longer after subsequent platinum (HR = 0.63; P = 0.0357; median 13.3 versus 9.8 months). Conclusion: This hypothesis-generating analysis demonstrates that superior benefits with trabectedin/PLD in terms of PFS and survival in the overall population appear particularly enhanced in patients with partially sensitive disease (PFI 6–12 months). PMID:20643862

  18. Early colonization of the oral cavity in 6- and 12-month-old infants by cariogenic and periodontal pathogens: a case-control study.

    PubMed

    Merglova, Vlasta; Polenik, Pavel

    2016-09-01

    The colonization of the oral cavity by cariogenic and periodontal pathogens occurs earlier than previously thought. This study aimed to identify the presence and quantity of representative cariogenic and periodontal pathogens in the oral cavities of 6- and 12-month olds and to evaluate the influence of C-section delivery on early Streptococcus mutans (Sm) colonization of the oral cavity. The research cohort was composed of 59 infants (35 infants were delivered vaginally and 24 via C-section) and their mothers. At 6 months of age, the infants were examined, and unstimulated saliva samples were collected. Variables concerning mothers were DMF index and salivary levels of Sm. Repeated saliva samples were taken 6 months later. The representative cariogenic and periodontal microorganisms were identified, and their quantities were measured using a polymerase chain reaction-based method. The relationships between the presence of detected microbes, the mode of delivery, and maternal variables were evaluated using paired t tests, chi-squared test, and ANOVAs. High rates of cariogenic bacteria, Aggregatibacter actinomycetemcomitans (Aa) and Fusobacterium nucleatum (Fn), were found in both infant cohorts. An analysis of the differences between delivery methods revealed that the group of 6-month-old vaginally delivered infants had a significantly higher amount of Sm. We conclude that the cariogenic bacteria, Aa and Fn, are present in edentulous infants. This presence increases in the months following the eruption of the deciduous teeth. Results did not confirm the influence of C-section delivery on the early Sm colonization of the oral cavity. PMID:26914065

  19. Language Development: 8 to 12 Months

    MedlinePlus

    ... Email Print Share Language Development: 8 to 12 Months Page Content Article Body Toward the end of ... notice the coos, gurgles, and screeches of earlier months now giving way to recognizable syllables, such as “ ...

  20. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN)

    PubMed Central

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-01-01

    Introduction Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. Methods We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethics and dissemination Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer

  1. Efficacy of baby-CIMT: study protocol for a randomised controlled trial on infants below age 12 months, with clinical signs of unilateral CP

    PubMed Central

    2014-01-01

    Background Infants with unilateral brain lesions are at high risk of developing unilateral cerebral palsy (CP). Given the great plasticity of the young brain, possible interventions for infants at risk of unilateral CP deserve exploration. Constraint-induced movement therapy (CIMT) is known to be effective for older children with unilateral CP but is not systematically used for infants. The development of CIMT for infants (baby-CIMT) is described here, as is the methodology of an RCT comparing the effects on manual ability development of baby-CIMT versus baby-massage. The main hypothesis is that infants receiving baby-CIMT will develop manual ability in the involved hand faster than will infants receiving baby-massage in the first year of life. Method and design The study will be a randomised, controlled, prospective parallel-group trial. Invited infants will be to be randomised to either the baby-CIMT or the baby-massage group if they: 1) are at risk of developing unilateral CP due to a known neonatal event affecting the brain or 2) have been referred to Astrid Lindgren Children’s Hospital due to asymmetric hand function. The inclusion criteria are age 3–8 months and established asymmetric hand use. Infants in both groups will receive two 6-weeks training periods separated by a 6-week pause, for 12 weeks in total of treatment. The primary outcome measure will be the new Hand Assessment for Infants (HAI) for evaluating manual ability. In addition, the Parenting Sense of Competence scale and Alberta Infant Motor Scale will be used. Clinical neuroimaging will be utilized to characterise the brain lesion type. To compare outcomes between treatment groups generalised linear models will be used. Discussion The model of early intensive intervention for hand function, baby-CIMT evaluated by the Hand Assessment for Infants (HAI) will have the potential to significantly increase our understanding of how early intervention of upper limb function in infants at risk of

  2. Breastfeeding beyond 12 months. An historical perspective.

    PubMed

    Piovanetti, Y

    2001-02-01

    A decade ago, child psychiatrist Coello-Novello, in her term as Surgeon General of the United States, said, "It's the lucky baby, I feel, who continues to nurse until he's two." The accumulated evidence supports her statement. The understanding of the benefits of breastfeeding beyond 12 months should support the cultural change in which eventually prolonged breastfeeding becomes normal. PMID:11236726

  3. Recovery 3 and 12 months after hysterectomy

    PubMed Central

    Theunissen, Maurice; Peters, Madelon L.; Schepers, Jan; Maas, Jacques W.M.; Tournois, Fleur; van Suijlekom, Hans A.; Gramke, Hans-Fritz; Marcus, Marco A.E.

    2016-01-01

    Abstract Chronic postsurgical pain (CPSP) is 1 important aspect of surgical recovery. To improve perioperative care and postoperative recovery knowledge on predictors of impaired recovery is essential. The aim of this study is to assess predictors and epidemiological data of CPSP, physical functioning (SF-36PF, 0–100), and global surgical recovery (global surgical recovery index, 0–100%) 3 and 12 months after hysterectomy for benign indication. A prospective multicenter cohort study was performed. Sociodemographic, somatic, and psychosocial data were assessed in the week before surgery, postoperatively up to day 4, and at 3- and 12-month follow-up. Generalized linear model (CPSP) and linear-mixed model analyses (SF-36PF and global surgical recovery index) were used. Baseline data of 468 patients were collected, 412 (88%) patients provided data for 3-month evaluation and 376 (80%) patients for 12-month evaluation. After 3 and 12 months, prevalence of CPSP (numeric rating scale ≥ 4, scale 0–10) was 10.2% and 9.0%, respectively, SF-36PF means (SD) were 83.5 (20.0) and 85.9 (20.2), global surgical recovery index 88.1% (15.6) and 93.3% (13.4). Neuropathic pain was reported by 20 (5.0%) patients at 3 months and 14 (3.9%) patients at 12 months. Preoperative pain, surgery-related worries, acute postsurgical pain on day 4, and surgery-related infection were significant predictors of CPSP. Baseline level, participating center, general psychological robustness, indication, acute postsurgical pain, and surgery-related infection were significant predictors of SF-36PF. Predictors of global surgical recovery were baseline expectations, surgery-related worries, American Society of Anesthesiologists classification, type of anesthesia, acute postsurgical pain, and surgery-related infection. Several predictors were identified for CPSP, physical functioning, and global surgical recovery. Some of the identified factors are modifiable and optimization of patients’ preoperative

  4. The 'Walking for Wellbeing in the West' randomised controlled trial of a pedometer-based walking programme in combination with physical activity consultation with 12 month follow-up: rationale and study design

    PubMed Central

    Fitzsimons, Claire F; Baker, Graham; Wright, Annemarie; Nimmo, Myra A; Ward Thompson, Catharine; Lowry, Ruth; Millington, Catherine; Shaw, Rebecca; Fenwick, Elisabeth; Ogilvie, David; Inchley, Joanna; Foster, Charlie E; Mutrie, Nanette

    2008-01-01

    Background Scotland has a policy aimed at increasing physical activity levels in the population, but evidence on how to achieve this is still developing. Studies that focus on encouraging real world participants to start physical activity in their settings are needed. The Walking for Well-being in the West study was designed to assess the effectiveness of a pedometer-based walking programme in combination with physical activity consultation. The study was multi-disciplinary and based in the community. Walking for Well-being in the West investigated whether Scottish men and women, who were not achieving the current physical activity recommendation, increased and maintained walking behaviour over a 12 month period. This paper outlines the rationale and design of this innovative and pragmatic study. Methods Participants were randomised into two groups: Group 1: Intervention (pedometer-based walking programme combined with a series of physical activity consultations); Group 2: Waiting list control for 12 weeks (followed by minimal pedometer-based intervention). Physical activity (primary outcome) was measured using pedometer step counts (7 day) and the International Physical Activity Questionnaire (long version). Psychological processes were measured using questionnaires relating to the Transtheoretical Model of Behaviour Change, mood (Positive and Negative Affect Schedule) and quality of life (Euroqol EQ-5D instrument). Physiological measures included anthropometric and metabolic outcomes. Environmental influences were assessed subjectively (Neighbourhood Quality of Life Survey) and objectively (neighbourhood audit tool and GIS mapping). The qualitative evaluation employed observation, semi-structured interviews and focus groups. A supplementary study undertook an economic evaluation. Discussion Data analysis is on-going. Walking for Well-being in the West will demonstrate if a pedometer based walking programme, in combination with physical activity consultation

  5. Coping Skills Training for Parents of Children with Type 1 Diabetes: 12-Month Outcomes

    PubMed Central

    Grey, Margaret; Jaser, Sarah S.; Whittemore, Robin; Jeon, Sangchoon; Lindemann, Evie

    2011-01-01

    Background Although it is recognized that caring for a child with type 1 diabetes (T1D) is stressful for parents, few interventions have been developed and tested for this population. Objectives To compare a group educational intervention for parents of children with T1D to a coping skills training intervention. Method Parents of children with T1D were randomized to the group educational (n = 106) or coping skills training (n = 75) conditions. Parents completed measures of family conflict, responsibility for treatment, coping, and quality of life at baseline and 3 months, 6 months, and 12 months postintervention. Clinical data (i.e., HbA1c) were collected from children’s medical records pre- and postintervention. Results There were no significant treatment effects 12 months postintervention, but parents in both groups reported improved coping (p < .001), less responsibility for treatment management (p < .001), and improved quality of life (p = .005). While children’s metabolic control worsened over time, mean values at 12 months were still within the recommended levels in this well-controlled sample (HbA1c < 8%). Discussion Group-based interventions for parents of children with T1D may lessen the impact of treatment management, improving coping and quality of life. PMID:21522034

  6. BRAVISSIMO: 12-month results from a large scale prospective trial.

    PubMed

    Bosiers, M; Deloose, K; Callaert, J; Maene, L; Beelen, R; Keirse, K; Verbist, J; Peeters, P; Schroë, H; Lauwers, G; Lansink, W; Vanslembroeck, K; D'archambeau, O; Hendriks, J; Lauwers, P; Vermassen, F; Randon, C; Van Herzeele, I; De Ryck, F; De Letter, J; Lanckneus, M; Van Betsbrugge, M; Thomas, B; Deleersnijder, R; Vandekerkhof, J; Baeyens, I; Berghmans, T; Buttiens, J; Van Den Brande, P; Debing, E; Rabbia, C; Ruffino, A; Tealdi, D; Nano, G; Stegher, S; Gasparini, D; Piccoli, G; Coppi, G; Silingardi, R; Cataldi, V; Paroni, G; Palazzo, V; Stella, A; Gargiulo, M; Muccini, N; Nessi, F; Ferrero, E; Pratesi, C; Fargion, A; Chiesa, R; Marone, E; Bertoglio, L; Cremonesi, A; Dozza, L; Galzerano, G; De Donato, G; Setacci, C

    2013-04-01

    The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery. PMID:23558659

  7. Clinical performance of Class II adhesive restorations in pulpectomized primary molars: 12-month results.

    PubMed

    Zulfikaroglu, Burcu Togay; Atac, Atila Stephan; Cehreli, Zafer C

    2008-01-01

    The purpose of this report was to present the 12-month results of a prospective, randomized study evaluating the clinical and radiographic success rates of Class II adhesive restorations in pulpectomized primary molars. A total of 75 restorations were placed over root canal-treated primary molars, filled with a calcium hydroxide paste. The restorative systems tested were: (1) group 1: amalgam (negative control); (2) group 2: a hybrid resin composite (TPH, Dentsply) with prior acid conditioning and bonding with an etch-and-rinse adhesive (Prime&Bond NT, Dentsply); (3) group 3: a polyacid-modified resin composite (Dyract, Dentsply) bonded with Prime&Bond NT; (4) group 4: Dyract with prior nonrinse conditioner (NRC) treatment and bonding with Prime&Bond NT; and (5) group 5: a polyacid-modified resin composite (F2000) in conjunction with a self-etch adhesive (Prompt-L-Pop, 3M/ESPE). The restorations were evaluated clinically using the modified USPHS/Ryge criteria at 1, 2, 3, 4, 5, 6, 9, and 12 months. Radiographic evaluations were made in accordance with predetermined criteria. During the evaluation period, 12 teeth (group1=4, group2=1, group3=4, group4=3, and group5=2) were extracted due to radiographic evidence of failure. There was no difference between groups regarding the clinical evaluation criteria (P>.05) except marginal discoloration at 9 and 12 months (P<.05). The overall success rate at 12 months was 81% (group 1=73%, group 2=93%, group 3=73%, group 4=80%, and group 5=87%). Teeth restored with the resin composite+total-etch/bonding (group 2), followed by those with F2000+self-etch adhesive (group 5) exhibited the highest clinical and radiographic success rates. Radiographic failures observed beneath failed restorations were strongly suggestive of coronal microleakage. PMID:18505646

  8. Increased periosteal circumference remains present 12 months after an exercise intervention in preschool children.

    PubMed

    Specker, Bonny; Binkley, Teresa; Fahrenwald, Nancy

    2004-12-01

    We previously reported that calcium intake enhanced the leg bone response to physical activity of preschool children in a 12-month randomized trial of calcium supplementation and physical activity. To determine whether the intervention-induced changes in leg bone mineral content and size were maintained through the subsequent 12-month follow-up period, total body bone measurements by DXA and 20% distal tibia pQCT bone measurements were obtained at 24 months (12 months post-intervention). Children also were measured for height and weight, and accelerometer readings were obtained in a subset of children at 18 and 24 months (6 and 12 months post-intervention). Regression analyses were performed controlling for covariates and indicated that increases from 12 to 24 months were greater in the gross motor (GM) activity group (bone loading, large muscle exercises) vs. fine motor (FM) activity group (arts and crafts program) for arm bone area (BA) (P <0.01), total body (P=0.04) and arm (P <0.01) bone mineral content (BMC). There were no differences in BA or BMC changes from 12 to 24 months by calcium supplementation. Differences in tibia periosteal circumference by pQCT persisted at 24 months (GM 51.4 +/- 0.4 mm vs. FM 50.2 +/- 0.4 mm, P=0.03) with a trend for greater endosteal circumferences in the children in the GM vs. FM groups at both 12 and 24 months (both, P=0.08). There were no significant differences in cortical area or thickness by activity or supplement group at 24 months. Children in the GM group had greater accelerometer counts/day (P=0.04) and more time in vigorous activity (P=0.05) at 18 months compared to FM group. No differences in accelerometer readings were noted at 24 months. In conclusion, we found higher activity levels in children randomized to gross motor vs. fine motor activities 6 months after the intervention program ceased. Whether the greater periosteal circumference that was observed 12 months post-intervention was a persistent biological bone

  9. A comparative study of diode laser and plasmakinetic in transurethral enucleation of the prostate for treating large volume benign prostatic hyperplasia: a randomized clinical trial with 12-month follow-up.

    PubMed

    Wu, Gang; Hong, Zhe; Li, Chao; Bian, Cuidong; Huang, Shengsong; Wu, Denglong

    2016-05-01

    The objective of this study is to compare the efficacy and safety of diode laser enucleation of the prostate (DiLEP) with plasmakinetic enucleation of the prostate (PKEP) for symptomatic benign prostatic hyperplasia (BPH) patients with large prostate (volume > 80 ml). From January 2013 to June 2014, 80 consecutive patients were randomized treated with DiLEP (n = 40) or PKEP (n = 40). Perioperative and postoperative outcome data were assessed during a 1-year follow-up. There were no significant preoperative differences between the two surgical groups. The mean prostate volumes in the DiLEP and PKEP groups were 98.6 and 93.3 ml, respectively. DiLEP was equivalent to PKEP in improvement in International Prostate Symptom Score (IPSS), quality of life scores, and maximum flow rate. Compared with PKEP, patients treated with DiLEP showed a lower risk of blood loss (P < 0.01), shorter bladder irrigation and catheterization times (P < 0.01), as well as shorter hospital stays (P < 0.01). Moreover, the DiLEP group was significantly superior to bipolar plasmakinetic group in the irritative symptoms. However, the operation time of the DiLEP group was longer than that of PKEP group (P = 0.02). Both DiLEP and PKEP are safe and effective methods for the treatment of BPH in large prostates (volume > 80 ml). Compared with PKEP, DiLEP provides a decreased risk of hemorrhage, reduced bladder irrigation, and catheterization times, as well as shorter hospital stays. PMID:26822403

  10. Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

    ERIC Educational Resources Information Center

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-01-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

  11. Medical Care and Your 8- to 12-Month-Old

    MedlinePlus

    ... Pregnancy Medical Care and Your 8- to 12-Month-Old KidsHealth > For Parents > Medical Care and Your 8- to 12-Month-Old Print A A A Text Size What's ... baby visits during this period, once at 9 months and again at 12 months . If you have ...

  12. Control theory for random systems

    NASA Technical Reports Server (NTRS)

    Bryson, A. E., Jr.

    1972-01-01

    A survey is presented of the current knowledge available for designing and predicting the effectiveness of controllers for dynamic systems which can be modeled by ordinary differential equations. A short discussion of feedback control is followed by a description of deterministic controller design and the concept of system state. The need for more realistic disturbance models led to the use of stochastic process concepts, in particular the Gauss-Markov process. A compensator controlled system, with random forcing functions, random errors in the measurements, and random initial conditions, is treated as constituting a Gauss-Markov random process; hence the mean-square behavior of the controlled system is readily predicted. As an example, a compensator is designed for a helicopter to maintain it in hover in a gusty wind over a point on the ground.

  13. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy

    PubMed Central

    2014-01-01

    Objective Assessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA). Methods In this 52-week, randomized, double-blind, placebo-controlled, parallel-group study, women 40–80 years with VVA and an intact uterus were randomized 6 : 1 to ospemifene 60 mg/day or placebo. The primary objective was 12-month safety, particularly endometrial; 12-week efficacy was assessed. Safety assessments included endometrial histology and thickness, and breast and gynecological examinations. Efficacy evaluations included changes from baseline to week 12 in percentage of superficial and parabasal cells and vaginal pH. Results Of 426 randomized subjects, 81.9% (n = 349) completed the study with adverse events the most common reason for discontinuation (ospemifene 9.5%; placebo 3.9%). Most (88%) treatment-emergent adverse events with ospemifene were considered mild or moderate. Three cases (1.0%) of active proliferation were observed in the ospemifene group. For one, active proliferation was seen at end of study week 52, and diagnosed as simple hyperplasia without atypia on follow-up biopsy 3 months after the last dose. This subsequently resolved with progestogen treatment and dilatation and curettage. In six subjects (five ospemifene (1.4%), one placebo (1.6%)) endometrial polyps were found (histopathology); however, only one (ospemifene) was confirmed as a true polyp during additional expert review. Endometrial histology showed no evidence of carcinoma. Statistically significant improvements were seen for all primary and secondary efficacy measures and were sustained through week 52 with ospemifene vs. placebo. Conclusions The findings of this 52-week study confirm the tolerance and efficacy of oral ospemifene previously reported in short- and long-term studies. PMID:23984673

  14. Feeding Your 8- to 12-Month-Old

    MedlinePlus

    ... About Zika & Pregnancy Feeding Your 8- to 12-Month-Old KidsHealth > For Parents > Feeding Your 8- to 12-Month-Old Print A A A Text Size What's ... Much Should My Baby Eat? By about 8 months old, most babies are pros at handling the ...

  15. Randomized Controlled Trial of Positive Affect Induction to Promote Physical Activity After Percutaneous Coronary Intervention

    PubMed Central

    Peterson, Janey C.; Charlson, Mary E.; Hoffman, Zachary; Wells, Martin T.; Wong, Shing-Chiu; Hollenberg, James P.; Jobe, Jared B.; Boschert, Kathryn A.; Isen, Alice M.; Allegrante, John P.

    2013-01-01

    Background Within 1 year after percutaneous coronary intervention, more than 20% of patients experience new adverse events. Physical activity confers a 25% reduction in mortality; however, physical activity is widely underused. Thus, there is a need for more powerful behavioral interventions to promote physical activity. Our objective was to motivate patients to achieve an increase in expenditure of 336 kcal/wk or more at 12 months as assessed by the Paffenbarger Physical Activity and Exercise Index. Methods Two hundred forty-two patients were recruited immediately after percutaneous coronary intervention between October 2004 and October 2006. Patients were randomized to 1 of 2 groups. The patient education (PE) control group (n=118) (1) received an educational workbook, (2) received a pedometer, and (3) set a behavioral contract for a physical activity goal. The positive affect/self-affirmation (PA) intervention group (n=124) received the 3 PE control components plus (1) a PA workbook chapter, (2) bimonthly induction of PA by telephone, and (3) small mailed gifts. All patients were contacted with standardized bimonthly telephone follow-up for 12 months. Results Attrition was 4.5%, and 2.1% of patients died. Significantly more patients in the PA intervention group increased expenditure by 336 kcal/wk or more at 12 months, our main outcome, compared with the PE control group (54.9% vs 37.4%, P=.007). The PA intervention patients were 1.7 times more likely to reach the goal of a 336-kcal/wk or more increase by 12 months, controlling for demographic and psychosocial measures. In multivariate analysis, the PA intervention patients had nearly double the improvement in kilocalories per week at 12 months compared with the PE control patients (602 vs 328, P=.03). Conclusion Patients who receive PA intervention after percutaneous coronary intervention are able to achieve a sustained and clinically significant increase in physical activity by 12 months. Trial Registration

  16. Effects of aromatase inhibition vs. testosterone in older men with low testosterone: randomized-controlled trial.

    PubMed

    Dias, J P; Melvin, D; Simonsick, E M; Carlson, O; Shardell, M D; Ferrucci, L; Chia, C W; Basaria, S; Egan, J M

    2016-01-01

    Aging in men is associated with loss of bone mass, impaired physical function and altered body composition. The objective of this proof-of-concept randomized, double-blind, placebo-controlled, parallel-group, single-center trial was to determine the relative effects of testosterone (T) and estradiol (E(2)) on bone mineral density, body composition, and physical performance in older men. The primary outcome was lumbar spine bone mineral density (BMD), and secondary outcomes were body composition, muscle strength, gait speed, and sex hormone concentrations. Forty three men (age range, 65-82 years; mean age 71 years) with low total T levels <350 ng/dL were randomized to one of three groups: 5 g transdermal testosterone gel (TT) (N = 16), anastrozole (AI) 1 mg (N = 14) or placebo daily (N = 13) for 12 months. Outcomes were assessed at baseline, 3, 6, and 12 months. Both TT and AI increased serum TT levels (>500 ng/dL, p < 0.05) compared to baseline; T values remained stable throughout the duration of the trial. At 12 months, TT improved the primary outcome of lumbar spine BMD (p < 0.01).Both interventions improved knee strength at 12 months compared to baseline (p < 0.05) while lean body mass significantly increased only in the AI group at 6 and 12 months (1.49 ± 0.38 kg, p < 0.01; 1.24 ± 0.39 kg, p < 0.05, respectively) compared to baseline. Interestingly, TT improved fast gait speed at 3 and 12 months (p < 0.01, p < 0.05, respectively). In summary, this proof-of-concept study confirms that aromatization of T is required for maintaining BMD in older men with low-T levels. The trial also uncovered the novel finding that aromatization of T is required for improvement in fast gait speed, an observation that needs to be verified in future studies. PMID:26588809

  17. Safety for Your Child: 6 to 12 Months

    MedlinePlus

    ... Share Safety for Your Child: 6 to 12 Months Page Content Article Body ​ Did you know that ... may climb before walking, or walk with support months before you expect. Your child will grasp at ...

  18. 12-Month-Olds Produce Others' Intended but Unfulfilled Acts

    ERIC Educational Resources Information Center

    Nielsen, Mark

    2009-01-01

    Following Meltzoff's (1995) behavioral reenactment paradigm, this study investigated the ability of 12-month-olds (N = 44) to reproduce a model's attempted-but-failed actions on objects. Testing was conducted using a novel set of objects designed to enable young infants to readily identify the potential outcome of the model's actions. Infants who…

  19. Perceptual Learning: 12-Month-Olds' Discrimination of Monkey Faces

    ERIC Educational Resources Information Center

    Fair, Joseph; Flom, Ross; Jones, Jacob; Martin, Justin

    2012-01-01

    Six-month-olds reliably discriminate different monkey and human faces whereas 9-month-olds only discriminate different human faces. It is often falsely assumed that perceptual narrowing reflects a permanent change in perceptual abilities. In 3 experiments, ninety-six 12-month-olds' discrimination of unfamiliar monkey faces was examined. Following…

  20. Walking and Eating Behavior of Toddlers at 12 Months Old

    ERIC Educational Resources Information Center

    Koda, Naoko; Akimoto, Yuko; Hirose, Toshiya; Hinobayashi, Toshihiko; Minami, Tetsuhiro

    2004-01-01

    Locomotive and eating behavior of 52 toddlers was observed at 12 months old in a nursery school and investigated in relation to the acquisition of independent walking. The toddlers who acquired walking ate more by themselves using the hands than the toddlers who did not start walking. This suggested that acquisition of walking was associated with…

  1. Improving Care for Depression in Obstetrics and Gynecology: A Randomized Controlled Trial

    PubMed Central

    Melville, Jennifer L.; Reed, Susan D.; Russo, Joan; Croicu, Carmen A.; Ludman, Evette; LaRocco-Cockburn, Anna; Katon, Wayne

    2014-01-01

    OBJECTIVE To evaluate an evidence-based collaborative depression care intervention adapted to obstetrics and gynecology clinics compared with usual care. METHODS Two-site randomized controlled trial included screen-positive women (Patient Health Questionnaire-9 of at least 10) who then met criteria for major depression, dysthymia or both (Mini-International Neuropsychiatric Interview). Women were randomized to 12-months of collaborative depression management or usual care; 6, 12 and 18-month outcomes were compared. The primary outcomes were change from baseline to 12-months on depression symptoms and functional status. Secondary outcomes included at least 50% decrease and remission in depressive symptoms, global improvement, treatment satisfaction, and quality of care. RESULTS Participants were on average 39 years old, 44% were non-white and 56% had posttraumatic stress disorder. Intervention (n= 102) compared to usual care (n=103) patients had greater improvement in depressive symptoms at 12 months (P< .001) and 18 months (P=.004). The intervention group compared with usual care had improved functioning over 18 months (P< .05), were more likely to have an at least 50% decrease in depressive symptoms at 12 months (relative risk [RR]=1.74, 95% confidence interval [CI] 1.11–2.73), greater likelihood of at least 4 specialty mental health visits (6 month RR=2.70, 95% CI1.73–4.20; 12 month RR=2.53, 95% CI 1.63–3.94), adequate dose of antidepressant (6-month RR=1.64, 95% CI 1.03–2.60; 12-month RR=1.71, 95%CI 1.08 2.73), and greater satisfaction with care (6-month RR=1.70, 95% CI 1.19–2.44; 12-month RR=2.26, 95% CI 1.52–3.36). CONCLUSION Collaborative depression care adapted to women’s health settings improved depressive and functional outcomes and quality of depression care. PMID:24807320

  2. Effect of periodontal therapy on arterial structure and function among aboriginal australians: a randomized, controlled trial.

    PubMed

    Kapellas, Kostas; Maple-Brown, Louise J; Jamieson, Lisa M; Do, Loc G; O'Dea, Kerin; Brown, Alex; Cai, Tommy Y; Anstey, Nicholas M; Sullivan, David R; Wang, Hao; Celermajer, David S; Slade, Gary D; Skilton, Michael R

    2014-10-01

    Observational studies and nonrandomized trials support an association between periodontal disease and atherosclerotic vascular disease. Both diseases occur frequently in Aboriginal Australians. We hypothesized that nonsurgical periodontal therapy would improve measures of arterial function and structure that are subclinical indicators of atherosclerotic vascular disease. This parallel-group, randomized, open label clinical trial enrolled 273 Aboriginal Australians aged ≥18 years with periodontitis. Intervention participants received full-mouth periodontal scaling during a single visit, whereas controls received no treatment. Prespecified primary end points measured 12-month change in carotid intima-media thickness, an indicator of arterial structure, and 3- and 12-month change in pulse wave velocity, an indicator of arterial function. ANCOVA used complete case data to evaluate treatment group differences. End points could be calculated for 169 participants with follow-up data at 3 months and 168 participants at 12 months. Intima-media thickness decreased significantly after 12 months in the intervention group (mean reduction=-0.023 [95% confidence interval {CI}, -0.038 to -0.008] mm) but not in the control group (mean increase=0.002 [95% CI, -0.017 to 0.022] mm). The difference in intima-media thickness change between treatment groups was statistically significant (-0.026 [95% CI, -0.048 to -0.003] mm; P=0.03). In contrast, there were no significant differences between treatment groups in pulse wave velocity at 3 months (mean difference, 0.06 [95% CI, -0.17 to 0.29] m/s; P=0.594) or 12 months (mean difference, 0.21 [95% CI, -0.01 to 0.43] m/s; P=0.062). Periodontal therapy reduced subclinical arterial thickness but not function in Aboriginal Australians with periodontal disease, suggesting periodontal disease and atherosclerosis are significantly associated. PMID:24958498

  3. Long-Term Propranolol Use in Severely Burned Pediatric Patients: A Randomized Controlled Study

    PubMed Central

    Herndon, David N.; Rodriguez, Noe A.; Diaz, Eva C.; Hegde, Sachin; Jennings, Kristofer; Mlcak, Ronald P.; Suri, Jaipreet S.; Lee, Jong O.; Williams, Felicia N.; Meyer, Walter; Suman, Oscar E.; Barrow, Robert E.; Jeschke, Marc G.; Finnerty, Celeste C.

    2012-01-01

    Objective To determine the safety and efficacy of propranolol given for 1 year on cardiac function, resting energy expenditure, and body composition in a prospective randomized single-center controlled study in pediatric patients with large burns. Summary Background Data Severe burns trigger a hypermetabolic response that persists for up to 2 years after burn. Propranolol given for 1 month post burn blunts this response. Whether propranolol administration for 1 year after injury provides a continued benefit is currently unclear. Methods One-hundred seventy nine pediatric patients with >30% total body surface area burns were randomized to receive control (n = 89) or 4 mg/kg/d propranolol (n = 90) for 12 months after burn. Changes in resting energy expenditure, cardiac function, and body composition were measured acutely at 3, 6, 9, and 12 months postburn. Statistical analyses included techniques that adjust for non-normality, repeated measures, and regression analyses. P <0.05 was considered significant. Results Long-term propranolol treatment significantly reduced the percent of the predicted heart rate and percent of the predicted resting energy expenditure, decreased accumulation of central mass and central fat, prevented bone loss, and improved lean body mass accretion. There were very few adverse effects from the dose of propranolol used. Conclusions Propranolol treatment for 12 months, following thermal injury, ameliorates the hyperdynamic, hypermetabolic, hypercatabolic, and osteopenic responses in pediatric patients. This study is registered at clinicaltrials.gov, NCT00675714. PMID:22895351

  4. African American community members sustain favorable blood pressure outcomes through 12-month telephone motivational interviewing (MI) maintenance

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Community approaches offer promise for addressing disparities experienced by African Americans in hypertension prevalence, treatment, and control. HUB City Steps, a community-based participatory research lifestyle intervention, tracked participants through a 12-month MI maintenance phase following a...

  5. Modifying Media Content for Preschool Children: A Randomized Controlled Trial

    PubMed Central

    Garrison, Michelle M.; Herrenkohl, Todd; Haggerty, Kevin; Rivara, Frederick P.; Zhou, Chuan; Liekweg, Kimberly

    2013-01-01

    BACKGROUND: Although previous studies have revealed that preschool-aged children imitate both aggression and prosocial behaviors on screen, there have been few population-based studies designed to reduce aggression in preschool-aged children by modifying what they watch. METHODS: We devised a media diet intervention wherein parents were assisted in substituting high quality prosocial and educational programming for aggression-laden programming without trying to reduce total screen time. We conducted a randomized controlled trial of 565 parents of preschool-aged children ages 3 to 5 years recruited from community pediatric practices. Outcomes were derived from the Social Competence and Behavior Evaluation at 6 and 12 months. RESULTS: At 6 months, the overall mean Social Competence and Behavior Evaluation score was 2.11 points better (95% confidence interval [CI]: 0.78–3.44) in the intervention group as compared with the controls, and similar effects were observed for the externalizing subscale (0.68 [95% CI: 0.06–1.30]) and the social competence subscale (1.04 [95% CI: 0.34–1.74]). The effect for the internalizing subscale was in a positive direction but was not statistically significant (0.42 [95% CI: −0.14 to 0.99]). Although the effect sizes did not noticeably decay at 12 months, the effect on the externalizing subscale was no longer statistically significant (P = .05). In a stratified analysis of the effect on the overall scores, low-income boys appeared to derive the greatest benefit (6.48 [95% CI: 1.60–11.37]). CONCLUSIONS: An intervention to reduce exposure to screen violence and increase exposure to prosocial programming can positively impact child behavior. PMID:23420911

  6. Disclosure of Genetic Information and Change in Dietary Intake: A Randomized Controlled Trial

    PubMed Central

    Nielsen, Daiva E.; El-Sohemy, Ahmed

    2014-01-01

    Background Proponents of consumer genetic tests claim that the information can positively impact health behaviors and aid in chronic disease prevention. However, the effects of disclosing genetic information on dietary intake behavior are not clear. Methods A double-blinded, parallel group, 2∶1 online randomized controlled trial was conducted to determine the short- and long-term effects of disclosing nutrition-related genetic information for personalized nutrition on dietary intakes of caffeine, vitamin C, added sugars, and sodium. Participants were healthy men and women aged 20–35 years (n = 138). The intervention group (n = 92) received personalized DNA-based dietary advice for 12-months and the control group (n = 46) received general dietary recommendations with no genetic information for 12-months. Food frequency questionnaires were collected at baseline and 3- and 12-months after the intervention to assess dietary intakes. General linear models were used to compare changes in intakes between those receiving general dietary advice and those receiving DNA-based dietary advice. Results Compared to the control group, no significant changes to dietary intakes of the nutrients were observed at 3-months. At 12-months, participants in the intervention group who possessed a risk version of the ACE gene, and were advised to limit their sodium intake, significantly reduced their sodium intake (mg/day) compared to the control group (−287.3±114.1 vs. 129.8±118.2, p = 0.008). Those who had the non-risk version of ACE did not significantly change their sodium intake compared to the control group (12-months: −244.2±150.2, p = 0.11). Among those with the risk version of the ACE gene, the proportion who met the targeted recommendation of 1500 mg/day increased from 19% at baseline to 34% after 12 months (p = 0.06). Conclusions These findings demonstrate that disclosing genetic information for personalized nutrition results in greater changes

  7. Breast Health Intervention Effects on Knowledge and Beliefs Over Time Among Chinese American Immigrants--a Randomized Controlled Study.

    PubMed

    Lee-Lin, Frances; Pedhiwala, Nisreen; Nguyen, Thuan; Menon, Usha

    2015-09-01

    Chinese American immigrant women, nonadherent with mammography in the past 12 months, (N = 300) were enrolled in a randomized controlled trial designed to change knowledge and beliefs and increase mammogram use. This report describes intervention effects on changes in knowledge and beliefs between the control and educational groups over four time points (baseline and 3, 6, and 12 months). Variables measured included knowledge, perceived susceptibility, perceived general barriers to mammography, perceived benefits to mammography, and four cultural barriers to mammography (crisis orientation, modesty, use of Eastern medicine, reliance on others). At all three post-intervention time points, women in the education group had significantly higher knowledge scores than those in the control group, regardless of whether they had completed a mammogram during the study. Women in the education group reported higher perceived susceptibility to breast cancer at 3-month post-intervention. At 3- and 6-month post-intervention, regardless of mammogram screening completion, women reported lower concerns about modesty related to mammography when compared to the control group. By the 12-month post-intervention, women in the education group reported significantly fewer perceived barriers than the control group. A targeted breast health program successfully changed breast health knowledge and beliefs that were sustained for up to 6-12 months. Education targeted to women's knowledge and beliefs has significant potential for decreasing disparity in mammogram use among Chinese American immigrant women. PMID:25200949

  8. A randomized controlled evaluation of a psychosocial intervention in adults with chronic lung disease.

    PubMed

    Blake, R L; Vandiver, T A; Braun, S; Bertuso, D D; Straub, V

    1990-01-01

    The effect of a stress management program on morbidity and psychosocial and physical function in patients with chronic lung disease was assessed. Adults attending either a VA pulmonary clinic or university hospital pulmonary rehabilitation clinic who met criteria for obstructive or restrictive pulmonary disease were randomly assigned to receive the intervention or to a control group. The intervention was provided by a nurse and included one to three teaching sessions, reading material, audiotapes, and telephone follow-up. The program focused on stress management techniques such as cognitive restructuring, progressive relaxation, breathing exercises, and visual imagery. The 45 experimental subjects were similar to the 49 controls with respect to baseline characteristics. Experimental and control subjects had similar rates of mortality, hospital days, bed-disability days, restricted-activity days, and physician visits during the 12-month follow-up. There were no differences between the two groups in physical or psychosocial function at six months or in levels of stressful life changes, social supports, and self-esteem at six and 12 months. Intervention recipients had better function at 12 months, suggesting a possible benefit of the intervention. PMID:2227172

  9. Positive aspects of caregiving as a moderator of treatment outcome over 12 months.

    PubMed

    Hilgeman, Michelle M; Allen, Rebecca S; DeCoster, Jamie; Burgio, Louis D

    2007-06-01

    The authors examined the influence of positive aspects of caregiving (PAC) as a moderator of treatment outcome across 12 months in 1 of the original sites of the Resources for Enhancing Alzheimer's Caregiver Health I project. They used multilevel random coefficients regression analysis to predict time-varying PAC, depression, behavioral bother, and daily care burden in Alzheimer's caregivers (N = 243; mean age = 60.89, SD = 14.19). They found that time-varying PAC was predicted by time-varying daily care burden. They also found significant effects of time-varying PAC for depression, behavioral bother, and daily care burden. Notably, a PAC x Phase x Treatment effect was found for daily care burden, such that individuals who endorsed less PAC benefited most from the intervention across 12 months. The tendency to positively appraise the caregiving experience (i.e., PAC) in response to chronic stressors such as Alzheimer's caregiving may affect individuals' responsiveness to, and benefit from, interventions, whereas only daily care burden affected the tendency to find enjoyment in caregiving across 12 months. Future intervention research should assess individual PAC in order to better tailor interventions to caregiving needs. PMID:17563191

  10. Maternal Antenatal Depression and Infant Disorganized Attachment at 12 months

    PubMed Central

    Hayes, Lisa J.; Goodman, Sherryl H.; Carlson, Elizabeth

    2012-01-01

    Although high rates of attachment disorganization have been observed in infants of depressed mothers, little is known about the role of antenatal depression as a precursor to infant attachment disorganization. The primary aim of this study was to examine associations between maternal antenatal depression and infant disorganization at 12 months in a sample of women (N = 79) at risk for perinatal depression. A secondary aim was to test the roles of maternal postpartum depression and maternal parenting quality as potential moderators of this predicted association. Among women with histories of major depressive episodes, maternal depressive symptoms were assessed at multiple times during pregnancy and the first year postpartum, maternal parenting quality was measured at 3 months postpartum, and attachment disorganization was assessed at 12 months postpartum. Results revealed that infants classified as disorganized had mothers with higher levels of depressive symptoms during pregnancy compared to infants classified as organized. Maternal parenting quality moderated this association, as exposure to higher levels of maternal depressive symptoms during pregnancy was only associated with higher rates of infant disorganized attachment when maternal parenting at 3 months was less optimal. These findings suggest that enhancing maternal parenting behaviors during this early period in development has the potential to alter pathways to disorganized attachment among infants exposed to antenatal maternal depressive symptoms, which could have enduring consequences for child wellbeing. PMID:23216358

  11. Qigong and fibromyalgia: randomized controlled trials and beyond.

    PubMed

    Sawynok, Jana; Lynch, Mary

    2014-01-01

    Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6-8 weeks) produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function) that are maintained at 4-6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6-12 months) indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects. PMID:25477991

  12. A cluster-randomized trial of insecticide-treated curtains for dengue vector control in Thailand.

    PubMed

    Lenhart, Audrey; Trongtokit, Yuwadee; Alexander, Neal; Apiwathnasorn, Chamnarn; Satimai, Wichai; Vanlerberghe, Veerle; Van der Stuyft, Patrick; McCall, Philip J

    2013-02-01

    The efficacy of insecticide-treated window curtains (ITCs) for dengue vector control was evaluated in Thailand in a cluster-randomized controlled trial. A total of 2,037 houses in 26 clusters was randomized to receive the intervention or act as control (no treatment). Entomological surveys measured Aedes infestations (Breteau index, house index, container index, and pupae per person index) and oviposition indices (mean numbers of eggs laid in oviposition traps) immediately before and after intervention, and at 3-month intervals over 12 months. There were no consistent statistically significant differences in entomological indices between intervention and control clusters, although oviposition indices were lower (P < 0.01) in ITC clusters during the wet season. It is possible that the open housing structures in the study reduced the likelihood of mosquitoes making contact with ITCs. ITCs deployed in a region where this house design is common may be unsuitable for dengue vector control. PMID:23166195

  13. A Cluster-Randomized Trial of Insecticide-Treated Curtains for Dengue Vector Control in Thailand

    PubMed Central

    Lenhart, Audrey; Trongtokit, Yuwadee; Alexander, Neal; Apiwathnasorn, Chamnarn; Satimai, Wichai; Vanlerberghe, Veerle; Van der Stuyft, Patrick; McCall, Philip J.

    2013-01-01

    The efficacy of insecticide-treated window curtains (ITCs) for dengue vector control was evaluated in Thailand in a cluster-randomized controlled trial. A total of 2,037 houses in 26 clusters was randomized to receive the intervention or act as control (no treatment). Entomological surveys measured Aedes infestations (Breteau index, house index, container index, and pupae per person index) and oviposition indices (mean numbers of eggs laid in oviposition traps) immediately before and after intervention, and at 3-month intervals over 12 months. There were no consistent statistically significant differences in entomological indices between intervention and control clusters, although oviposition indices were lower (P < 0.01) in ITC clusters during the wet season. It is possible that the open housing structures in the study reduced the likelihood of mosquitoes making contact with ITCs. ITCs deployed in a region where this house design is common may be unsuitable for dengue vector control. PMID:23166195

  14. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A.; Robinson, John W. . E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S.; Keats, Melanie R.

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  15. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study

    PubMed Central

    Fiore, Maria; La Vecchia, Carlo; Marzuillo, Carolina; Gualano, Maria Rosaria; Liguori, Giorgio; Cicolini, Giancarlo; Capasso, Lorenzo; D'Amario, Claudio; Boccia, Stefania; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo

    2015-01-01

    Objective To evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes (e-cigarettes), directly comparing users of e-cigarettes only, smokers of tobacco cigarettes only, and smokers of both. Design Prospective cohort study. Final results are expected in 2019, but given the urgency of data to support policies on electronic smoking, we report the results of the 12-month follow-up. Data Sources Direct contact and structured questionnaires by phone or via internet. Methods Adults (30–75 years) were included if they were smokers of ≥1 tobacco cigarette/day (tobacco smokers), users of any type of e-cigarettes, inhaling ≥50 puffs weekly (e-smokers), or smokers of both tobacco and e-cigarettes (dual smokers). Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence. Main Outcome Measures Sustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily. Data Synthesis We used linear and logistic regression, with region as cluster unit. Results Follow-up data were available for 236 e-smokers, 491 tobacco smokers, and 232 dual smokers (overall response rate 70.8%). All e-smokers were tobacco ex-smokers. At 12 months, 61.9% of the e-smokers were still abstinent from tobacco smoking; 20.6% of the tobacco smokers and 22.0% of the dual smokers achieved tobacco abstinence. Adjusting for potential confounders, tobacco smoking abstinence or cessation remained significantly more likely among e-smokers (adjusted OR 5.19; 95% CI: 3.35–8.02), whereas adding e-cigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption. E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers. Non significant differences were found in self-reported serious adverse events (eleven overall). Conclusions Adding e-cigarettes to tobacco smoking did not facilitate

  16. Language Differences at 12 Months in Infants Who Develop Autism Spectrum Disorder.

    PubMed

    Lazenby, DeWayne C; Sideridis, Georgios D; Huntington, Noelle; Prante, Matthew; Dale, Philip S; Curtin, Suzanne; Henkel, Lisa; Iverson, Jana M; Carver, Leslie; Dobkins, Karen; Akshoomoff, Natacha; Tagavi, Daina; Nelson, Charles A; Tager-Flusberg, Helen

    2016-03-01

    Little is known about early language development in infants who later develop autism spectrum disorder (ASD). We analyzed prospective data from 346 infants, some of whom were at high risk for developing ASD, to determine if language differences could be detected at 12 months of age in the infants who later were diagnosed with ASD. Analyses revealed lower receptive and expressive language scores in infants who later were diagnosed with ASD. Controlling for overall ability to understand and produce single words, a Rasch analysis indicated that infants who later developed ASD had a higher degree of statistically unexpected word understanding and production. At 12 months of age, quantitative and qualitative language patterns distinguished infants who later developed ASD from those who did not. PMID:26476738

  17. Risks and Benefits of Dual Antiplatelet Therapy Beyond 12 Months After Coronary Stenting

    PubMed Central

    Dadjou, Yahya; Safavi, Salar; Kojuri, Javad

    2016-01-01

    Abstract The optimal duration of dual antiplatelet therapy (DAT) after coronary stenting remains poorly define. The aim of this study was to evaluate the impact of longer than 24 months DAT in patients who received drug-eluting and bare-metal stents. A total of 1010 individuals who underwent elective, urgent or emergency coronary angioplasty with intended stent implantation at reference or specialized cardiac hospitals were randomized to receive long-term and short-term DAT to determine the benefits and adverse effects of long-term DAT. Total of 508 patients were randomized to long-term and 502 patients to <1 year DAT, and all of them were followed for more than 36 months for major adverse cardiac and cerebvascular events and bleeding major adverse cardiac and cerebvascular events (MACCE) Mean age of the 1010 patients (364 women and 646 men) was 60 years. Stent reocclusion occurred in 15 patients. Mean Syntax score was 23.00 ± 5.08 for whole samples, 25.00 ± 5.27 in 28 patients with MACCE and 23 ± 5.00 in 982 patients without MACCE (P = 0.057). According to all specified bleeding definitions, clopidogrel therapy for >12 months was not associated with a greater risk of hemorrhage. A regimen of >12 months of clopidogrel therapy in patients who had received drug-eluting or bare-metal stents did not differ significantly from a regimen of <12 months on clopidogrel with regard to MACCE. Long-term DAT might not significantly affect the reduction in the risk of death from any cause, myocardial infarction, or stroke, and not associated with minor or major bleeding events. PMID:27258494

  18. Randomized controlled trial of atorvastatin in clinically isolated syndrome

    PubMed Central

    Waubant, E.; Pelletier, D.; Mass, M.; Cohen, J.A.; Kita, M.; Cross, A.; Bar-Or, A.; Vollmer, T.; Racke, M.; Stüve, O.; Schwid, S.; Goodman, A.; Kachuck, N.; Preiningerova, J.; Weinstock-Guttman, B.; Calabresi, P.A.; Miller, A.; Mokhtarani, M.; Iklé, D.; Murphy, S.; Kopetskie, H.; Ding, L.; Rosenberg, E.; Spencer, C.; Zamvil, S.S.; Waubant, E.; Pelletier, D.; Mass, M.; Bourdette, D.; Egan, R.; Cohen, J.; Stone, L.; Kita, M.; Elliott, M.; Cross, A.; Parks, B.J.; Bar-Or, A.; Vollmer, T.; Campagnolo, D.; Racke, M.; Stüve, O.; Frohman, E.; Schwid, S.; Goodman, A.; Segal, B.; Kachuck, N.; Weiner, L.; Preiningerova, J.; Carrithers, M.; Weinstock-Guttman, B.; Calabresi, P.; Kerr, D.; Miller, A.; Lublin, F.; Sayre, Peter; Hayes, Deborah; Rosenberg, Ellen; Gao, Wendy; Ding, Linna; Adah, Steven; Mokhtarani, Masoud; Neuenburg, Jutta; Bromstead, Carolyn; Olinger, Lynn; Mullen, Blair; Jamison, Ross; Speth, Kelly; Saljooqi, Kerensa; Phan, Peter; Phippard, Deborah; Seyfert-Margolis, Vicki; Bourcier, Katarzyna; Debnam, Tracia; Romaine, Jennifer; Wolin, Stephanie; O'Dale, Brittany; Iklé, David; Murphy, Stacey; Kopetskie, Heather

    2012-01-01

    Objective: To test efficacy and safety of atorvastatin in subjects with clinically isolated syndrome (CIS). Methods: Subjects with CIS were enrolled in a phase II, double-blind, placebo-controlled, 14-center randomized trial testing 80 mg atorvastatin on clinical and brain MRI activity. Brain MRIs were performed quarterly. The primary endpoint (PEP) was development of ≥3 new T2 lesions, or one clinical relapse within 12 months. Subjects meeting the PEP were offered additional weekly interferon β-1a (IFNβ-1a). Results: Due to slow recruitment, enrollment was discontinued after 81 of 152 planned subjects with CIS were randomized and initiated study drug. Median (interquartile range) numbers of T2 and gadolinium-enhancing (Gd) lesions were 15.0 (22.0) and 0.0 (0.0) at baseline. A total of 53.1% of atorvastatin recipients (n = 26/49) met PEP compared to 56.3% of placebo recipients (n = 18/32) (p = 0.82). Eleven atorvastatin subjects (22.4%) and 7 placebo subjects (21.9%) met the PEP by clinical criteria. Proportion of subjects who did not develop new T2 lesions up to month 12 or to starting IFNβ-1a was 55.3% in the atorvastatin and 27.6% in the placebo group (p = 0.03). Likelihood of remaining free of new T2 lesions was significantly greater in the atorvastatin group compared with placebo (odds ratio [OR] = 4.34, p = 0.01). Likelihood of remaining free of Gd lesions tended to be higher in the atorvastatin group (OR = 2.72, p = 0.11). Overall, atorvastatin was well tolerated. No clear antagonistic effect of atorvastatin plus IFNβ-1a was observed on MRI measures. Conclusion: Atorvastatin treatment significantly decreased development of new brain MRI T2 lesion activity, although it did not achieve the composite clinical and imaging PEP. Classification of Evidence: This study provided Class II evidence that atorvastatin did not reduce the proportion of patients with CIS meeting imaging and clinical criteria for starting immunomodulating therapy after 12 months

  19. Depression 12-months after coronary artery bypass graft is predicted by cortisol slope over the day.

    PubMed

    Poole, Lydia; Kidd, Tara; Ronaldson, Amy; Leigh, Elizabeth; Jahangiri, Marjan; Steptoe, Andrew

    2016-09-01

    Alterations in the diurnal profile of cortisol have been associated with depressed mood in patients with coronary heart disease. The relationship between cortisol output and depressed mood has not been investigated prospectively in coronary artery bypass graft (CABG) patients before. We aimed to study the relationship between cortisol measured pre- and post-operatively and depression symptoms measured 12 months after CABG surgery. We analysed data from 171 patients awaiting first-time, elective CABG surgery from the pre-assessment clinic at St. George's Hospital, London. The Beck Depression Inventory (BDI) was used to assess depression symptoms and saliva samples were collected to measure diurnal cortisol. Baseline assessments of depression and cortisol were obtained an average 29days before surgery, short-term follow-up of cortisol occurred 60days after surgery and long-term follow-up of depression was assessed 378days after surgery. Baseline cortisol slope was not associated with depression at 12-month follow-up. However, a steeper cortisol slope measured 60days after surgery predicted reduced odds of depression (BDI≥10) 12 months after surgery (odds ratio 0.661, 95% confidence interval 0.437-0.998, p=0.049) after controlling for covariates. These findings suggest interventions aimed at improving adaptation in the early recovery period may have long-term benefits in this patient group. PMID:27281345

  20. Effect of soy isoflavone supplementation on vascular endothelial function and oxidative stress in postmenopausal women: a community randomized controlled trial.

    PubMed

    Pusparini; Dharma, Rahayuningsih; Suyatna, Fransiscus D; Mansyur, Muchtaruddin; Hidajat, Adi

    2013-01-01

    A 12-month randomized double blind controlled trial was conducted among 182 Indonesian postmenopausal women aged 47 to 60 years to determine the effect of 100 mg/day soy isoflavone supplementation on vascular endothelial function such as vascular cell adhesion molecule-1 (VCAM-1), nitric oxide (NO) and malondialdehyde (MDA) as oxidative stress marker. The subjects were randomized to the intervention group receiving tablets consisting of 100 mg soy isoflavones and calcium carbonate 500 mg, and to the control group receiving 500 mg calcium carbonate. The concentrations of VCAM-1, NO and MDA were measured at baseline, and postsupplementation at 6 months and 12 months. After supplementation, the MDA concentrations were significantly lower in the soy isoflavone group compared with the control group (p=0.001). The concentrations of VCAM-1 and NO were not affected (p=0.992 and p=0.759, respectively). In all group the MDA concentration increased compared with baseline concentrations but the relative change of MDA concentrations was significantly lower in the soy isoflavone group compared with the control group. This study demonstrates that supplemental intake of soy isoflavones for 6 months and 12 months had an effect on oxidative stress by decreasing MDA concentration, but did not improve vascular endothelial function. PMID:23945405

  1. A parent-adolescent intervention to increase sexual risk communication: results of a randomized controlled trial.

    PubMed

    Villarruel, Antonia M; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L; Zhou, Yan

    2008-10-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6- and 12-month follow-ups. Generalized estimation equation (GEE) analysis indicates parents in the HIV risk reduction intervention reported significantly more general communication (p < .005), more sexual risk communication (p < .001) and more comfort with communication (p < .001) than parents in the control intervention. Behavioral, normative, and control beliefs significantly mediated the effect of the intervention on all communication outcomes. This study demonstrates the efficacy of an intervention to increase the quality and quantity of parent-adolescent communication related to general and sex-specific communication. PMID:18956979

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

    PubMed

    Fonagy, Peter; Sleed, Michelle; Baradon, Tessa

    2016-01-01

    There is a dearth of good-quality research investigating the outcomes of psychoanalytic parent-infant psychotherapy (PIP). This randomized controlled trial investigated the outcomes of PIP for parents with mental health problems who also were experiencing high levels of social adversity and their young infants (<12 months). Dyads were clinically referred and randomly allocated to PIP or a control condition of standard secondary and specialist primary care treatment (n = 38 in each group). Outcomes were assessed at baseline and at 6-month and 12-month follow-ups. The primary outcome was infant development. Secondary outcomes included parent-infant interaction, maternal psychopathology, maternal representations, maternal reflective functioning, and infant attachment. There were no differential effects over time between the groups on measures of infant development, parent-infant interaction, or maternal reflective functioning. Infant attachment classifications, measured only at the 12-month follow-up, did not differ between the groups. There were favorable outcomes over time for the PIP-treated dyads relative to the control group on several measures of maternal mental health, parenting stress, and parental representations of the baby and their relationship. The findings indicate potential benefits of parent-infant psychotherapy for improving mothers' psychological well-being and their representations of their baby and the parent-infant relationship. PMID:26939716

  3. Laser Pulpotomy–An Effective Alternative to Conventional Techniques: A 12 Months Clinicoradiographic Study

    PubMed Central

    Rana, Vivek; Srivastava, Nikhil; Chandna, Preetika

    2015-01-01

    ABSTRACT Background: Vital pulpotomy is a single-stage procedure of surgical amputation of the coronal portion of exposed vital pulp, usually as a means of preserving the vitality and function of the remaining radicular portion. Aims and objectives: The aim of this study was to compare the clinical and radiographic success rates for ferric sulfate (FS), electrosurgery (ES) and laser pulpotomy in human primary molars. Materials and methods: In a randomized clinical trial, 30 primary molars indicated for pulpotomy in children aged 4 to 10 years were treated using either a FS (10 teeth), ES technique (10 teeth) and laser (10 teeth). Following the pulpotomy, the teeth were evaluated for clinical and radiographic success at 3, 6, 9 and 12 months on the basis of the presence of pain, sinus, mobility, internal and external resorption, periapical radiolucency, calcification in the canal and bone loss. Statistical analysis: The data were assessed with Chi-square test. Results: After 12 months of follow-up, both clinical and radiographic success rates were 100% in the laser group but only 80% in both ES and FS groups. There was statistically significant difference between the success rates of three groups (p < 0.05). Conclusion: Laser pulpotomy showed better clinical as well as radiographical results than ES and FS pulpotomy. Laser pulpotomy was also found superior in terms of operating time, patient cooperation, ease of use and pain. Although results of the study showed the failure rates for electrosurgical pulpotomy to be equal to those for FS pulpotomy, electrosurgical pulpotomy being a nonpharmacological technique considered more favorable. Further studies using larger sample size and longer evaluation periods are suggested. How to cite this article: Gupta G, Rana V, Srivastava N, Chandna P. Laser Pulpotomy–An Effective Alternative to Conventional Techniques: A 12 Months Clinicoradiographic Study. Int J Clin Pediatr Dent 2015;8(1):18-21. PMID:26124576

  4. Effects of major ozonated autohemotherapy in the treatment of dry age related macular degeneration: a randomized controlled clinical study

    PubMed Central

    Borrelli, Emma; Diadori, Angelica; Zalaffi, Alessandro; Bocci, Velio

    2012-01-01

    AIM To evaluate the effect of systemic ozonated major autohaemotherapy (O3-AHT) in patients affected by dry age related macular degeneration (AMD). METHODS This study was a randomized, controlled clinical study. One hundred and forty patients with the diagnosis of AMD in both eyes, with the study eye presenting dry AMD and soft drusen, were randomly assigned in a 1:1 ratio to either receive 27 major ozonated autohemotherapy treatments during 12-month period, or a standardized multi-vitamin therapy. Primary outcome was the change in best corrected visual acuity (mean logMar change) between the baseline and 6 and 12 months, end point of the study. In addition, to investigate the safety of prolonged ozonated autohaemotherapy, we measured the routine haematochemical parameters and biochemical oxidative stress values at baseline and after 12 months treatment time. RESULTS The mean baseline best corrected visual acuity in study eyes was 0.36 in the treatment group and 0.38 in the control group (difference not statistically significant). At the primary endpoint, 6 months post-baseline, the mean logMAR change in the treated group improved by 0.1 and the values of the control group at the same time impaired by 0.2 respect to the baseline. Four percent and twenty-five percent of eyes in the group treated with O3-AHT gained 1 or more lines after 6 and 12 months respectively compared to 0% in the eyes which received no treatment (P<0.05 at 12 months). None of the treated patients experienced a loss in visual acuity in their study eye at 6 and 12 months, compared to 16% and 40 % of patients in the control group who lost 2 lines or more at 6 months and 12 months respectively (P<0.05 treated vs control group)). Major ozonated autohemotherapy was shown to be safe and well- tolerated by the patients. Moreover, the haematochemical parameters showed a decrease in the Reactive Oxygen Metabolites (300±10.1 UCARR at 12 months compared to a baseline value of 380±10.4 UCARR, P<0.05) and

  5. Combining Seeking Safety with Sertraline for PTSD and Alcohol Use Disorders: A Randomized Controlled Trial

    PubMed Central

    Hien, Denise; Levin, Frances Rudnick; Ruglass, Lesia; López-Castro, Teresa; Papini, Santiago; Hu, Mei Chen; Cohen, Lisa; Herron, Abigail

    2015-01-01

    Objective The current study marks the first randomized controlled trial to test the benefit of combining Seeking Safety (SS), a present-focused cognitive behavioral therapy for co-occurring posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD), with sertraline, a front-line medication for PTSD shown to also impact drinking outcomes. Method Sixty-nine participants (81% female; 59% African American) with primarily childhood sexual (46%) and physical (39%) trauma exposure, and drug dependence in addition to AUD were randomized to receive a partial-dose (12 sessions) of SS with either sertraline (n = 32; M = 7 sessions) or placebo (n = 37; M = 6 sessions). Assessments conducted at baseline, end-of-treatment, 6- and 12-months posttreatment measured PTSD and AUD symptom severity. Results Both groups demonstrated significant improvement in PTSD symptoms. The SS plus sertraline group exhibited a significantly greater reduction in PTSD symptoms than the SS plus placebo group at end-of-treatment (M difference = −16.15, p = .04, d = 0.83), which was sustained at 6- and 12-month follow-up (M difference = −13.81, p = .04, d = 0.71, and M difference = −12.72, p = .05, d = 0.65, respectively). Both SS groups improved significantly on AUD severity at all posttreatment time points with no significant differences between SS plus sertraline and SS plus placebo. Conclusion Results support the combining of a cognitive behavioral therapy and sertraline for PTSD/AUD. Clinically significant reductions in both PTSD and AUD severity were achieved and sustained through 12-months follow-up, Moreover, greater mean improvement in PTSD symptoms was observed across all follow-up assessments in the SS plus sertraline group. PMID:25622199

  6. A Randomized Controlled Trial of Ecological Momentary Intervention Plus Brief Group Therapy for Generalized Anxiety Disorder

    PubMed Central

    Newman, Michelle G.; Przeworski, Amy; Consoli, Andrés J.; Taylor, C. Barr

    2015-01-01

    Momentary intervention has been proposed as a cost-effective, generalizable, and ecologically valid method to increase the efficiency of face-to-face cognitive– behavioral therapy (CBT). The purpose of the current pilot study was to evaluate the efficacy of a six-session palmtop computer-assisted Group CBT for generalized anxiety disorder (GAD) (CAGT6) in comparison with a six-session Group CBT for GAD without the computer (CBGT6) and typical (12 session) Group CBT for GAD (CBGT12) in a randomized controlled trial. Thirty-four individuals with a primary diagnosis of GAD were randomized to one of the three conditions and completed measures of GAD and anxiety before therapy, after therapy, and at 6-, and 12-month follow-ups. Results indicated that CAGT6 was superior to CBGT6 at posttreatment, but not significantly different from CBGT12. At 6- and 12-month follow-ups, CAGT6 was neither significantly different from CBGT6, nor from CBGT12. Percentages of individuals achieving reliable change on two of the three GAD measures favored CAGT6 over CBGT6 at posttreatment, suggesting promise for the added value of the mobile technology. PMID:24059730

  7. The effects of motivation feedback in patients with severe mental illness: a cluster randomized controlled trial

    PubMed Central

    Jochems, Eline C; van der Feltz-Cornelis, Christina M; van Dam, Arno; Duivenvoorden, Hugo J; Mulder, Cornelis L

    2015-01-01

    Objective To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness. Methods Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968). Participants: adult outpatients with a primary diagnosis of a psychotic disorder or a personality disorder and their clinicians, treated in 12 community mental health teams (the clusters) of two mental health institutions in the Netherlands. Interventions: monthly motivation feedback (MF) generated by clinicians additional to treatment as usual (TAU) and TAU by the community mental health teams. Primary outcome: treatment engagement at patient level, assessed at 12 months by clinicians. Randomization: teams were allocated to MF or TAU by a computerized randomization program that randomized each team to a single treatment by blocks of varying size. All participants within these teams received similar treatment. Clinicians and patients were not blind to treatment allocation at the 12-month assessment. Results The 294 randomized patients (148 MF, 146 TAU) and 57 clinicians (29 MF, 28 TAU) of 12 teams (6 MF, 6 TAU) were analyzed according to the intention-to-treat principle. No statistically significant differences between treatment groups on treatment engagement were found (adjusted mean difference =0.1, 95% confidence interval =−2.2 to 2.3, P=0.96, d=0). Preplanned ancillary analyses showed statistically significant interaction effects between treatment group and primary diagnosis on treatment motivation and quality of life (secondary outcomes), which were beneficial for patients with a primary diagnosis of a personality disorder but not for those with a psychotic disorder. There were no reports of adverse events. Conclusion The current findings imply that monitoring and discussing the patient’s motivation is insufficient to improve motivation and treatment engagement, and

  8. Changes in mental and physical well-being among problematic alcohol and drug users in 12-month Internet-based intervention trials.

    PubMed

    Berman, Anne H; Wennberg, Peter; Sinadinovic, Kristina

    2015-03-01

    Twelve-month well-being outcomes were investigated for 835 participants in 1 of 2 randomized controlled trials offering online assessment and brief intervention for either problematic alcohol (n = 633) or drug use (n = 202). The well-being of participants who had reduced their substance use to a less problematic level (regardless of intervention) over 12 months was compared with that of participants who had maintained or increased their use. At a 12-month follow-up, the 227 alcohol trial participants with reduced use showed better well-being in comparison to the 406 with stable or increased use, in physical health and sleep quality, as well as general well-being, ability to concentrate, lower stress, better social life satisfaction and sense of control, and a lower rate of depressed mood. Among the 70 drug trial participants who had reduced their drug use over 12 months, 80% had ceased all drug use, and at follow-up they had fewer alcohol-related problems than the stable group. No differences in well-being between these groups were identified. Self-reported access to additional treatment modalities beyond the trial interventions (e.g., speaking to someone about problematic use and accessing additional Internet-based interventions) was higher among participants in both cohorts with reduced substance use in comparison to those with stable/increased use. Drug users who reduced their use accessed prescribed medication to a larger extent than those whose use remained stable or increased. Points to consider when conducting future research on well-being and problematic substance use are discussed. PMID:25664387

  9. Brief psychosocial-behavioral intervention with antidepressant reduces post-stroke depression significantly more than usual care with antidepressant: Living Well with Stroke randomized controlled trial

    PubMed Central

    Mitchell, Pamela H.; Veith, Richard C.; Becker, Kyra J.; Buzaitis, Ann; Cain, Kevin C.; Fruin, Michael; Tirschwell, David; Teri, Linda

    2009-01-01

    Background and Purpose Depression following stroke is prevalent, diminishing recovery and quality of life. Brief behavioral intervention, adjunctive to antidepressant therapy has not been well evaluated for long-term efficacy in those with post-stroke depression. Methods 101 clinically depressed ischemic stroke patients within four months of index stroke were randomly assigned to an 8 week brief psychosocial-behavioral intervention plus antidepressant or usual care, including antidepressant. Primary endpoint was reduction in depressive symptom severity at 12 months following entry. Results Hamilton Rating Scale for Depression (HRSD) raw score in the intervention group was significantly lower immediately post-treatment (p = < 0.001) and at 12 months (p = 0.05) compared to controls. Remission (HRSD < 10), was significantly greater immediately post-treatment and at 12 months in the intervention group compared to usual care control. The mean percent decrease (47% ± 26% intervention versus 32% ± 36% control, p = .02) and the mean absolute decrease (-9.2 ± 5.7 intervention versus -6.2 ± 6.4 control, p = 0.023) in HRSD at 12 months were clinically important and statistically significant in the intervention group compared to control. Conclusion A brief psychosocial/behavioral intervention is highly effective in reducing depression in both the short and long term. PMID:19661478

  10. The Primary Prevention of PTSD in Firefighters: Preliminary Results of an RCT with 12-Month Follow-Up

    PubMed Central

    Rees, Clare S.; Mazzucchelli, Trevor G.; Kane, Robert T.

    2016-01-01

    Aim To develop and evaluate an evidence-based and theory driven program for the primary prevention of Post-traumatic Stress Disorder (PTSD). Design A pre-intervention / post-intervention / follow up control group design with clustered random allocation of participants to groups was used. The “control” group received “Training as Usual” (TAU). Method Participants were 45 career recruits within the recruit school at the Department of Fire and Emergency Services (DFES) in Western Australia. The intervention group received a four-hour resilience training intervention (Mental Agility and Psychological Strength training) as part of their recruit training school curriculum. Data was collected at baseline and at 6- and 12-months post intervention. Results We found no evidence that the intervention was effective in the primary prevention of mental health issues, nor did we find any significant impact of MAPS training on social support or coping strategies. A significant difference across conditions in trauma knowledge is indicative of some impact of the MAPS program. Conclusion While the key hypotheses were not supported, this study is the first randomised control trial investigating the primary prevention of PTSD. Practical barriers around the implementation of this program, including constraints within the recruit school, may inform the design and implementation of similar programs in the future. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12615001362583 PMID:27382968

  11. A 12 Months Clinical and Radiographic Study to Assess the Efficacy of Open Flap Debridement and Subepithelial Connective Tissue Graft in Management of Supracrestal Defects

    PubMed Central

    Chhina, Shivjot

    2015-01-01

    Background: An improvement in clinical parameters along with regeneration is the desired outcome of periodontal therapy. The aim of this study was to analyze and contrast the efficaciousness of combined open flap debridement (OFD) and subepithelial connective tissue graft (SECTG) to OFD in the management of periodontal supracrestal defects. Materials and Methods: Totally, 20 paired sites exhibiting supracrestal defects were subjected to surgical treatment adopting the split mouth design. The defects were divided randomly for treatment with OFD and SECTG (test) or OFD alone (control). The clinical effectiveness of the two arms of treatment was evaluated at 6 months and 12 months post-operatively by assessing clinical and radiographic parameters. The measurements carried out included probing pocket depth (PPD), relative attachment level (RAL), gingival marginal level, radiographic bone level (BL). Results: The mean reduction in PPD at 0-12 months was 3.20 ± 0.82 mm and RAL gain of 3.10 ± 1.51 mm was observed, the OFD and SECTG (test) group; corresponding observations for OFD (control) were 2.10 ± 0.63 mm and 1.90 ± 0.57 mm. However, BL changes did not follow the pattern of clinical improvement on the radiographic assessment of either treatment group. Post-operative evaluation was made. Improvement in different clinical parameters was statistically significant (P < 0.01). Conclusion: Treatment of supracrestal defects with a combination of OFD and SECTG led to significantly better clinical results compared to OFD alone. PMID:26464551

  12. Networked Dynamic Systems: Identification, Controllability, and Randomness

    NASA Astrophysics Data System (ADS)

    Nabi-Abdolyousefi, Marzieh

    The presented dissertation aims to develop a graph-centric framework for the analysis and synthesis of networked dynamic systems (NDS) consisting of multiple dynamic units that interact via an interconnection topology. We examined three categories of network problems, namely, identification, controllability, and randomness. In network identification, as a subclass of inverse problems, we made an explicit relation between the input-output behavior of an NDS and the underlying interacting network. In network controllability, we provided structural and algebraic insights into features of the network that enable external signal(s) to control the state of the nodes in the network for certain classes of interconnections, namely, path, circulant, and Cartesian networks. We also examined the relation between network controllability and the symmetry structure of the graph. Motivated by the analysis results for the controllability and observability of deterministic networks, a natural question is whether randomness in the network layer or in the layer of inputs and outputs generically leads to favorable system theoretic properties. In this direction, we examined system theoretic properties of random networks including controllability, observability, and performance of optimal feedback controllers and estimators. We explored some of the ramifications of such an analysis framework in opinion dynamics over social networks and sensor networks in estimating the real-time position of a Seaglider from experimental data.

  13. Recruiting Participants for Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Gallagher, H. Alix; Roschelle, Jeremy; Feng, Mingyu

    2014-01-01

    The objective of this study was to look across strategies used in a wide range of studies to build a framework for researchers to use in conceptualizing the recruitment process. This paper harvests lessons learned across 19 randomized controlled trials in K-12 school settings conducted by a leading research organization to identify strategies that…

  14. Reporting Randomized Controlled Trials in Education

    ERIC Educational Resources Information Center

    Mayo-Wilson, Evan; Grant, Sean; Montgomery, Paul

    2014-01-01

    Randomized controlled trials (RCTs) are increasingly used to evaluate programs and interventions in order to inform education policy and practice. High quality reports of these RCTs are needed for interested readers to understand the rigor of the study, the interventions tested, and the context in which the evaluation took place (Mayo-Wilson et…

  15. Community based intervention to optimize osteoporosis management: randomized controlled trial

    PubMed Central

    2010-01-01

    Background Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis are underutilized. This pragmatic randomised study was done to evaluate the impact of a multifaceted community-based care program aimed at optimizing evidence-based management in patients at risk for osteoporosis and fractures. Methods This was a 12-month randomized trial performed in Ontario, Canada. Eligible patients were community-dwelling, aged ≥55 years, and identified to be at risk for osteoporosis-related fractures. Two hundred and one patients were allocated to the intervention group or to usual care. Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing, patient education and patient-specific recommendations for osteoporosis treatment. The primary outcome was the implementation of appropriate osteoporosis management. Results 101 patients were allocated to intervention and 100 to control. Mean age of participants was 71.9 ± 7.2 years and 94% were women. Pharmacological treatment (alendronate, risedronate, or raloxifene) for osteoporosis was increased by 29% compared to usual care (56% [29/52] vs. 27% [16/60]; relative risk [RR] 2.09, 95% confidence interval [CI] 1.29 to 3.40). More individuals in the intervention group were taking calcium (54% [54/101] vs. 20% [20/100]; RR 2.67, 95% CI 1.74 to 4.12) and vitamin D (33% [33/101] vs. 20% [20/100]; RR 1.63, 95% CI 1.01 to 2.65). Conclusions A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00465387) PMID:20799973

  16. Randomized Controlled Open-Label Trial of Vitamin E-Bonded Polysulfone Dialyzer and Erythropoiesis-Stimulating Agent Response

    PubMed Central

    Mochizuki, Takahiro; Kinugasa, Eriko; Kusano, Eiji; Ohwada, Shigeru; Kuno, Tsutomu; Kojima, Kenichiro; Kobayashi, Shuzo; Satoh, Minoru; Shimada, Noriaki; Nakao, Kazushi; Nakazawa, Ryoichi; Nishimura, Hideki; Noiri, Eisei; Shigematsu, Takashi; Tomo, Tadashi; Maeda, Teiryo

    2013-01-01

    Summary Background and objectives A 1-year multicenter prospective randomized controlled study was conducted on the effects of vitamin E-bonded polysulfone dialyzers on erythropoiesis-stimulating agent response in hemodialysis patients. Design, setting, participants, & measurements Major inclusion criteria were use of high-flux polysulfone dialyzers with 50–70 ml/min β2-microglobulin clearance over 3 months, transferrin saturation over 20%, same erythropoiesis-stimulating agent for over 3 months, and hemoglobin at 10–12 g/dl. Hemodialysis patients were placed in four interventional groups: two hemoglobin ranges (10.0–10.9 or 11.0–11.9 g/dl) and two dialyzers. Patients were randomly assigned by central registration to a vitamin E-bonded polysulfone dialyzers or polysulfone control group. Primary end point was relative erythropoiesis resistance index at baseline between groups at 12 months. Erythropoiesis resistance index was defined as total weekly erythropoiesis-stimulating agent dose divided by hemoglobin. Results There were no statistically significant differences in age or sex. There was no significant difference in relative erythropoiesis resistance index between vitamin E-bonded polysulfone dialyzers and control groups at 12 months (vitamin E-bonded polysulfone dialyzers: 1.1, control: 1.3). The vitamin E-bonded polysulfone dialyzers group showed better relative erythropoiesis resistance index than the control group at 11.0–11.9 g/dl hemoglobin (vitamin E-bonded polysulfone dialyzers: 1.0, control: 1.4 at 12 months, significant difference) but no difference at 10.0–10.9 g/dl hemoglobin. Conclusions The overall relative erythropoiesis resistance index showed no difference between the vitamin E-bonded polysulfone dialyzers and control groups, although the change in relative erythropoiesis resistance index differed according to hemoglobin level. PMID:23599410

  17. Nurse-Led Psychological Intervention After Physical Traumas: A Randomized Controlled Trial

    PubMed Central

    Skogstad, Laila; Hem, Erlend; Sandvik, Leiv; Ekeberg, Oivind

    2015-01-01

    Background Emergency room nurses were trained to provide a short-term psychological intervention in physically injured patients with Impact of Event Scale (IES) scores > 20. The aims were to study the effects of the psychological intervention relative to usual care (UC). Methods In a randomized controlled trial, psychological distress, daily functioning and the personality traits optimism/pessimism were compared with patients who received the UC. The interventions were provided 1 - 3 months after discharge. Results The IES scores were significantly reduced in both groups at 3 months (intervention: 41.1 - 28.6, P < 0.001 vs. UC: 35.4 - 26.2, P < 0.001), but not significantly different between groups. Baseline IES score was a significant predictor of IES scores at 3 (β = 0.4, P < 0.05) and 12 months (β = 0.3, P < 0.05), whereas overall daily functioning at 3 months predicted IES scores at 12 months (β = -0.5, P < 0.001). Patients receiving intervention became significantly more optimistic during the year, and had an increase in overall daily functioning from 3 to 12 months (P < 0.001). Patients declining intervention were more pessimistic and had lower daily functioning. Patients who talked with nurses with more training in psychological processing had a larger reduction in IES symptoms at 3 months (β = -0.3, P = 0.081). Conclusion The nurse-led intervention had a significant effect on optimism and overall daily functioning. Nurses may become a low-cost option to perform short-term psychological interventions with physically injured hospitalized patients. PMID:25780483

  18. Nonperturbative dynamical decoupling with random control.

    PubMed

    Jing, Jun; Bishop, C Allen; Wu, Lian-Ao

    2014-01-01

    Parametric fluctuations or stochastic signals are introduced into the rectangular pulse sequence to investigate the feasibility of random dynamical decoupling. In a large parameter region, we find that the out-of-order control pulses work as well as the regular pulses for dynamical decoupling and dissipation suppression. Calculations and analysis are enabled by and based on a nonperturbative dynamical decoupling approach allowed by an exact quantum-state-diffusion equation. When the average frequency and duration of the pulse sequence take proper values, the random control sequence is robust, fault-tolerant, and insensitive to pulse strength deviations and interpulse temporal separation in the quasi-periodic sequence. This relaxes the operational requirements placed on quantum control devices to a great deal. PMID:25169735

  19. Mid- and long-term effects of family constellation seminars in a general population sample: 8- and 12-month follow-up.

    PubMed

    Hunger, Christina; Weinhold, Jan; Bornhäuser, Annette; Link, Leoni; Schweitzer, Jochen

    2015-06-01

    In a previous randomized controlled trial (RCT), short-term efficacy of family constellation seminars (FCSs) in a general population sample was demonstrated. In this article, we examined mid- and long-term stability of these effects. Participants were 104 adults (M = 47 years; SD = 9; 84% female) who were part of the intervention group in the original RCT (3-day FCS; 64 active participants and 40 observing participants). FCSs were carried out according to manuals. It was predicted that FCSs would improve psychological functioning (Outcome Questionnaire OQ-45.2) at 8- and 12-month follow-up. Additionally, we assessed the effects of FCSs on psychological distress, motivational incongruence, individuals' experience in their personal social systems, and overall goal attainment. Participants yielded significant improvement in psychological functioning (d = 0.41 at 8-month follow-up, p = .000; d = 0.40 at 12-month follow-up, p = .000). Results were confirmed for psychological distress, motivational incongruence, the participants' experience in their personal social systems, and overall goal attainment. No adverse events were reported. This study provides first evidence for the mid- and long-term efficacy of FCSs in a nonclinical population. The implications of the findings are discussed. PMID:25264190

  20. A Randomized Controlled Pilot Study of an HIV Risk-Reduction Intervention for Sub-Saharan African University Students

    PubMed Central

    Heeren, G. Anita; Jemmott, John B.; Ngwane, Zolani; Mandeya, Andrew; Tyler, Joanne C.

    2012-01-01

    This pilot study used a randomized controlled trial to test the efficacy of an HIV risk-reduction intervention for university students in Eastern Cape Province, South Africa. Randomly selected second-year students were randomized to one of two interventions based on social cognitive theory and qualitative research: HIV risk-reduction, targeting sexual-risk behaviors; health-promotion control, targeting health behaviors unrelated to sexual risks. Participants completed behavioral assessments via audio computer-assisted self-interviewing pre-intervention, 6, and 12 months post intervention, with 97.2% retained at 12-month follow-up. Averaged over the 2 follow-ups, HIV risk-reduction intervention participants reported less unprotected vaginal intercourse and more frequent condom use than control participants, with greater efficacy in non-South Africans than South Africans. Positive changes were also observed on theoretical mediators of condom use that the intervention targeted. Interventions based on social cognitive theory integrated with qualitative information from the population may reduce sexual risk behaviors among university students in sub-Saharan Africa. PMID:22246515

  1. A new tetravalent canine leptospirosis vaccine provides at least 12 months immunity against infection.

    PubMed

    Klaasen, H L B M; van der Veen, M; Sutton, D; Molkenboer, M J C H

    2014-03-15

    A key success factor in the vaccination of dogs against leptospirosis is long term protection against establishment of the renal carrier state, in order to protect other dogs, as well as humans, against this re-emerging zoonotic disease. In this paper, we describe the ability of a new European tetravalent vaccine containing antigen from Leptospira interrogans (sensu lato) serogroups Icterohaemorrhagiae, Canicola, Grippotyphosa and Australis to control infection and renal excretion in dogs at 12 months after vaccination. In order to demonstrate the efficacy of all four vaccine components, four separate challenge studies were performed. For each study two groups of dogs were used (a group receiving the leptospirosis vaccine and a control group). Twelve months after the second vaccination all dogs in the vaccine and control groups were challenged, both intraperitoneally and conjunctivally, using a pathogenic challenge strain from one of four serogroups. Parameters recorded post-challenge were: clinical signs of disease, change in body temperature, total leucocyte count, thrombocyte count, presence of challenge organisms in blood, urine and kidney tissue, and evidence of interstitial nephritis at necropsy four weeks after challenge. The vaccine was able to either prevent or significantly reduce infection following challenge with the strains of all four serogroups. The vaccine was also able to prevent or significantly reduce renal infection following Canicola and Icterohaemorrhagiae challenge, and there was a trend of reduction of renal infection with Australis (serovar Bratislava). In the case of the Grippotyphosa study, challenge led to no detectable renal infection in any dog of the control group. In conclusion, in this study significant protective immunity was achieved in dogs 12 months after a basic vaccination schedule of two doses against strains of serogroups Canicola, Icterohaemorrhagiae, Grippotyphosa and Australis. PMID:24054091

  2. National High Blood Pressure 12-Month Kit. May 1988.

    ERIC Educational Resources Information Center

    National Heart and Lung Inst. (DHHS/NIH), Bethesda, MD. National High Blood Pressure Education Program.

    Part I of this kit provides information for program planners and health professionals on ways to overcome barriers to health care among the medically underserved, promote high blood pressure control through the media and other community channels, and improve adherence to treatment among hypertensive patients. It lists additional resources for…

  3. Slow rates of habituation predict greater zBMI gains over 12 months in lean children

    PubMed Central

    Epstein, Leonard H.; Robinson, Jodie L.; Roemmich, James N.; Marusewski, Angela

    2011-01-01

    Slow rates of habituation are related to greater energy intake, and cross-sectionally to body weight. The present study is designed to assess whether slow rates of habituation are prospectively related to zBMI change over a 12 month period in 66 lean 8–12 year-old children, and whether the rate of habituation is a stable behavioral phenotype. Results showed slower rates of habituation predicted greater zBMI change, controlling for child sex, age, initial zBMI, dietary awareness and minority status. In addition, the rate of habituation was stable over the year of observation. These data suggest that slow rates of habituation may be a risk factor for weight gain and the development of obesity. Future research is needed to understand the mechanism for this effect, and assess whether the habituation phenotype interacts with other behavioral phenotypes, such as food reinforcement, to influence increases in zBMI. PMID:21741020

  4. Early response to inhaled bronchodilators and corticosteroids as a predictor of 12-month treatment responder status and COPD exacerbations

    PubMed Central

    Calverley, Peter M; Postma, Dirkje S; Anzueto, Antonio R; Make, Barry J; Eriksson, Göran; Peterson, Stefan; Jenkins, Christine R

    2016-01-01

    Background Early treatment response markers, for example, improvement in forced expiratory volume in 1 second (FEV1) and St George’s Respiratory Questionnaire (SGRQ) total score, may help clinicians to better manage patients with chronic obstructive pulmonary disease (COPD). We investigated the prevalence of clinically important improvements in FEV1 and SGRQ scores after 2-month budesonide/formoterol or formoterol treatment and whether such improvements predict subsequent improvements and exacerbation rates. Methods This post hoc analysis is based on data from three double-blind, randomized studies in patients with moderate-to-very-severe COPD receiving twice-daily budesonide/formoterol or formoterol alone for 6 or 12 months. Prebronchodilator FEV1 and SGRQ total score were measured before treatment and at 2 and 12 months; COPD exacerbation rates were measured during months 2–12. Responders were defined by ≥100 mL improvement in prebronchodilator FEV1 and ≥4-point decrease in SGRQ total score. Results Overall, 2,331 and 1,799 patients were included in the 0–2- and 0–12-month responder analyses, respectively, and 2,360 patients in the 2–12-month exacerbation rate analysis. At 2 months, 35.1% of patients were FEV1 responders and 44.3% were SGRQ responders. The probability of response was significantly greater with budesonide/formoterol than with formoterol or placebo for both parameters. Two-month responders had a greater chance of 12-month response than 2-month nonresponders for both FEV1 (odds ratio, 5.57; 95% confidence interval, 4.14–7.50) and SGRQ (odds ratio, 3.87; 95% confidence interval, 2.83–5.31). Two-month response in FEV1 (P<0.001), but not SGRQ (P=0.11), was associated with greater reductions in exacerbation risk. Conclusion Early FEV1 and SGRQ treatment responses relate to their changes at 12 months. FEV1 response, but not SGRQ response, at 2 months predicts the risk of a future COPD exacerbation in some, but not all patients. This is

  5. 26 CFR 1.443-1 - Returns for periods of less than 12 months.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 26 Internal Revenue 6 2014-04-01 2014-04-01 false Returns for periods of less than 12 months. 1.443-1 Section 1.443-1 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Accounting Periods § 1.443-1 Returns for periods of less than 12 months. (a) Returns for...

  6. Motivational Interviewing Versus Cognitive Behavioral Group Therapy in the Treatment of Problem and Pathological Gambling: A Randomized Controlled Trial

    PubMed Central

    Carlbring, Per; Jonsson, Jakob; Josephson, Henrik; Forsberg, Lars

    2009-01-01

    Pathological gambling is a widespread problem with major implications for society and the individual. There are effective treatments, but little is known about the relative effectiveness of different treatments. The aim of this study was to test the effectiveness of motivational interviewing, cognitive behavioral group therapy, and a no-treatment control (wait-list) in the treatment of pathological gambling. This was done in a randomized controlled trial at an outpatient dependency clinic at Karolinska Institute (Stockholm, Sweden). A total of 150 primarily self-recruited patients with current gambling problems or pathological gambling according to an NORC DSM-IV screen for gambling problems were randomized to four individual sessions of motivational interviewing (MI), eight sessions of cognitive behavioral group therapy (CBGT), or a no-treatment wait-list control. Gambling-related measures derived from timeline follow-back as well as general levels of anxiety and depression were administered at baseline, termination, and 6 and 12 months posttermination. Treatment showed superiority in some areas over the no-treatment control in the short term, including the primary outcome measure. No differences were found between MI and CBGT at any point in time. Instead, both MI and CBGT produced significant within-group decreases on most outcome measures up to the 12-month follow-up. Both forms of intervention are promising treatments, but there is room for improvement in terms of both outcome and compliance. PMID:19967577

  7. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    PubMed

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise. PMID:25790454

  8. A Randomized Controlled Trial of Celecoxib to Prevent Recurrence of Non-Muscle–Invasive Bladder Cancer

    PubMed Central

    Sabichi, Anita L.; Lee, J. Jack; Grossman, H. Barton; Liu, Suyu; Richmond, Ellen; Czerniak, Bogdan A.; De la Cerda, Jorge; Eagle, Craig; Viner, Jaye L.; Palmer, J. Lynn; Lerner, Seth P.

    2014-01-01

    Significant morbidity and expense result from frequent recurrences of non-muscle invasive bladder cancer (NMIBC) after standard treatment, and carcinoma in situ (Tis) is a poor prognostic factor. Predicated on observational and preclinical data strongly supporting cyclooxygenase-2 (COX-2) in the pathogenesis, and the activity of COX-2 inhibitors, in bladder cancer, we conducted a randomized, double-blind, placebo-controlled trial to determine if celecoxib could reduce the time-to-recurrence (TTR) in NMIBC patients at high risk for recurrence. 146 patients were randomized to celecoxib (200 mg) or placebo orally twice daily for at least 12 months. The average treatment duration was 1.25 years. Primary intent-to-treat analysis revealed celecoxib did not statistically significantly prolong TTR compared with placebo (P = 0.17, log-rank). With a median follow-up of 2.49 years the relative risk of recurrence in the celecoxib vs placebo arms was 0.64 (95% CI, 0.38, 1.17). The recurrence-free rate at 12 months with celecoxib was 88% (95% CI, 0.81,0.96) versus 78% (95% CI, 0.69, 0.89) with placebo. After controlling for covariates with Cox regression analysis, recurrence rates did not differ between the two study arms (HR = 0.69; 95% CI, 0.37,1.29). Celecoxib had a marginally significant effect on reducing metachronous recurrences (vs. placebo) with hazard ratio of 0.56 (95% CI, 0.3,1.06; P=0.075). Celecoxib was well tolerated, with similar adverse events and quality-of-life in both arms. Our clinical trial results do not show a clinical benefit for celecoxib in preventing NMIBC recurrence but further investigation of COX-2 inhibitors in this setting is warranted. PMID:21881030

  9. Brief cognitive therapy for panic disorder: a randomized controlled trial.

    PubMed

    Clark, D M; Salkovskis, P M; Hackmann, A; Wells, A; Ludgate, J; Gelder, M

    1999-08-01

    Cognitive therapy (CT) is a specific and highly effective treatment for panic disorder (PD). Treatment normally involves 12-15 1-hr sessions. In an attempt to produce a more cost-effective version, a briefer treatment that made extensive use of between-sessions patient self-study modules was created. Forty-three PD patients were randomly allocated to full CT (FCT), brief CT (BCT), or a 3-month wait list. FCT and BCT were superior to wait list on all measures, and the gains obtained in treatment were maintained at 12-month follow-up. There were no significant differences between FCT and BCT. Both treatments had large (approximately 3.0) and essentially identical effect sizes. BCT required 6.5 hr of therapist time, including booster sessions. Patients' initial expectation of therapy success was negatively correlated with posttreatment panic-anxiety. Cognitive measures at the end of treatment predicted panic-anxiety at 12-month follow-up. PMID:10450630

  10. Reducing HIV-Related Stigma in Health Care Settings: A Randomized Controlled Trial in China

    PubMed Central

    Wu, Zunyou; Liang, Li-Jung; Guan, Jihui; Jia, Manhong; Rou, Keming; Yan, Zhihua

    2013-01-01

    Objectives. The objective of the intervention was to reduce service providers’ stigmatizing attitudes and behaviors toward people living with HIV. Methods. The randomized controlled trial was conducted in 40 county-level hospitals in 2 provinces of China between October 2008 and February 2010. Forty-four service providers were randomly selected from each hospital, yielding a total of 1760 study participants. We randomized the hospitals to either an intervention condition or a control condition. In the intervention hospitals, about 15% of the popular opinion leaders were identified and trained to disseminate stigma reduction messages. Results. We observed significant improvements for the intervention group in reducing prejudicial attitudes (P < .001), reducing avoidance intent towards people living with HIV (P < .001), and increasing institutional support in the hospitals (P = .003) at 6 months after controlling for service providers’ background factors and clinic-level characteristics. The intervention effects were sustained and strengthened at 12 months. Conclusions. The intervention reduced stigmatizing attitudes and behaviors among service providers. It has the potential to be integrated into the health care systems in China and other countries. PMID:23237175

  11. Sample controllability of impulsive differential systems with random coefficients

    NASA Astrophysics Data System (ADS)

    Zhang, Shuorui; Sun, Jitao

    2016-07-01

    In this paper, we investigate the controllability of impulsive differential systems with random coefficients. Impulsive differential systems with random coefficients are a different stochastic model from stochastic differential equations. Sufficient conditions of sample controllability for impulsive differential systems with random coefficients are obtained by using random Sadovskii's fixed-point theorem. Finally, an example is given to illustrate our results.

  12. A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

    ERIC Educational Resources Information Center

    Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

    2012-01-01

    Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

  13. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  14. Telephone Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Non-inferiority Trial

    PubMed Central

    Turner, Cynthia M.; Mataix-Cols, David; Lovell, Karina; Krebs, Georgina; Lang, Katie; Byford, Sarah; Heyman, Isobel

    2014-01-01

    Objective Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT. Method Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children’s Yale–Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up. Results Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received. Conclusion TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information–Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832. PMID:25457928

  15. The Breathe Easier through Weight Loss Lifestyle (BE WELL) Intervention: A randomized controlled trial

    PubMed Central

    2010-01-01

    Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI) and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT) of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324) are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke). The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical activity level and nutrient

  16. The penumbra of randomized control trials

    PubMed Central

    Nanivadekar, Arun S.

    2013-01-01

    Pre-occupation with randomized control trials as the basis of evidence-based medicine has increasingly shadowed other study designs over the last half a century. These include surveys, case-control studies, and case-cohort studies. They have the potential to overcome several ethical and cost constraints, but depend on the embedding of research in routine practice, emphasis on relevant but limited, accurate, and complete data, harnessing of information technology for this purpose, and epidemiological and statistical literacy among clinicians. Only then will it be possible to nurture and network research-oriented practices by therapeutic areas. Given these, the alternative study designs can pave the way to regulatory reforms that will ultimately benefit the discoverers, approvers and users of health-care tools. PMID:24010055

  17. Can attention control conditions have detrimental effects in behavioral medicine randomized trials?

    PubMed Central

    Pagoto, Sherry; McDermott, Mary M.; Reed, George; Greenland, Philip; Mazor, Kathy M.; Ockene, Judith K.; Whited, Matt; Schneider, Kristin; Appelhans, Brad; Leung, Kathy; Merriam, Philip; Ockene, Ira

    2012-01-01

    Objective Attention control conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance is available in the literature about which behavioral interventions and outcomes merit an attention control. The primary aim of the present paper is to demonstrate a scenario in which use of attention control in a behavioral randomized trial was unnecessary and possibly detrimental. Methods Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered telephone counseling (PC) intervention reduced low-density lipoprotein cholesterol (LDL-C) levels in 355 participants with peripheral arterial disease (PAD), compared to attention control (AC) and usual care (UC) conditions. The PC intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched phone-delivered health education, and the UC condition consisted of an educational pamphlet. Results At 12-month follow-up, mean LDL-C changes were −11.1, and −6.8 mg/dl in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased use or dose intensity of medication was significantly lower in AC than UC, 17.5% versus 30.5% (p=0.03). No significant difference between AC and UC were observed on other outcomes. Conclusions The AC had significantly worse medication outcomes and there was no indication of a therapeutic effect on other endpoints. Implications for use of attention control in behavioral randomized trials are discussed. PMID:23197844

  18. The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye

    PubMed Central

    Blackie, Caroline A; Coleman, Christy A; Holland, Edward J

    2016-01-01

    Purpose To evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye. Methods The prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group). Results At 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378). Conclusion A single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for

  19. Penile vibratory stimulation in the recovery of urinary continence and erectile function after nerve-sparing radical prostatectomy: a randomized, controlled trial

    PubMed Central

    Fode, Mikkel; Borre, Michael; Ohl, Dana A; Lichtbach, Jonas; Sønksen, Jens

    2014-01-01

    Objective To examine the effect of penile vibratory stimulation (PVS) in the preservation and restoration of erectile function and urinary continence in conjunction with nerve-sparing radical prostatectomy (RP). Patients and Methods The present study was conducted between July 2010 and March 2013 as a randomized prospective trial at two university hospitals. Eligible participants were continent men with an International Index of Erectile Function-5 (IIEF-5) score of at least 18, scheduled to undergo nerve-sparing RP. Patients were randomized to a PVS group or a control group. Patients in the PVS group were instructed in using a PVS device (FERTI CARE® vibrator). Stimulation was performed at the frenulum once daily by the patients in their own homes for at least 1 week before surgery. After catheter removal, daily PVS was re-initiated for a period of 6 weeks. Participants were evaluated at 3, 6 and 12 months after surgery with the IIEF-5 questionnaire and questions regarding urinary bother. Patients using up to one pad daily for security reasons only were considered continent. The study was registered at http://clinicaltrials.gov/ (NCT01067261). Results Data from 68 patients were available for analyses (30 patients randomized to PVS and 38 patients randomized to the control group). The IIEF-5 score was highest in the PVS group at all time points after surgery with a median score of 18 vs 7.5 in the control group at 12 months (P = 0.09), but the difference only reached borderline significance. At 12 months, 16/30 (53%) patients in the PVS group had reached an IIEF-5 score of at least 18, while this was the case for 12/38 (32%) patients in the control group (P = 0.07). There were no significant differences in the proportions of continent patients between groups at 3, 6 or 12 months. At 12 months 90% of the PVS patients were continent, while 94.7% of the control patients were continent (P = 0.46). Conclusion The present study did not document a significant effect of

  20. Percentage of People Who Used the Oral Care System in the Last 12 Months

    MedlinePlus

    ... Months Percentage of People who Used the Oral Care System in the Last 12 Months Oral diseases, ... Group Percentage of People Who Use the Oral Care System by Age Group uv9w-t62r Download these ...

  1. Randomized Controlled Trial of a Web-based Indoor Tanning Intervention: Acceptability and Preliminary Outcomes

    PubMed Central

    Stapleton, Jerod L.; Manne, Sharon L.; Darabos, Katie; Greene, Kathryn; Ray, Anne E.; Turner, Amber L.; Coups, Elliot J.

    2015-01-01

    Objective This manuscript describes the acceptability and preliminary behavioral outcomes from a pilot randomized control trial of a web-based indoor tanning intervention for young adult women. The intervention targets indoor tanning user’s perceptions of then benefits and value of tanning and addresses the role of body image-related constructs in indoor tanning. Methods Participants were 186 young adult women who reported indoor tanning at least once in the past 12 months. The study design was a 2-arm randomized controlled trial with pre and post assessments and random assignment to an intervention or control condition. Intervention acceptability was assessed by obtaining participants’ evaluation of the intervention. Regression analyses were used to test for intervention condition differences in preliminary behavioral outcomes measured at 6-weeks post-intervention. Results Participants provided favorable evaluations of the intervention on several dimensions and a highly positive overall rating. Intervention participants were more likely to report abstaining from indoor tanning and indicated a lower likelihood of using indoor tanning in the future compared to control participants on the post-intervention assessment. No differences were found for sunburns. Conclusions The results of this pilot randomized controlled trial provide evidence that the indoor tanning intervention is acceptable to participants and may encourage cessation of indoor tanning behavior. The findings provide preliminary support for an indoor tanning intervention that engages tanners to challenge their beliefs about the benefits of indoor tanning. The use of a web-based indoor tanning intervention is unique and provides strong potential for dissemination. PMID:26651469

  2. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field. PMID:26248094

  3. Effects of 12 Months Continuous Positive Airway Pressure on Sympathetic Activity Related Brainstem Function and Structure in Obstructive Sleep Apnea.

    PubMed

    Henderson, Luke A; Fatouleh, Rania H; Lundblad, Linda C; McKenzie, David K; Macefield, Vaughan G

    2016-01-01

    Muscle sympathetic nerve activity (MSNA) is greatly elevated in patients with obstructive sleep apnea (OSA) during normoxic daytime wakefulness. Increased MSNA is a precursor to hypertension and elevated cardiovascular morbidity and mortality. However, the mechanisms underlying the high MSNA in OSA are not well understood. In this study we used concurrent microneurography and magnetic resonance imaging to explore MSNA-related brainstem activity changes and anatomical changes in 15 control and 15 OSA subjects before and after 6 and 12 months of continuous positive airway pressure (CPAP) treatment. We found that following 6 and 12 months of CPAP treatment, resting MSNA levels were significantly reduced in individuals with OSA. Furthermore, this MSNA reduction was associated with restoration of MSNA-related brainstem activity and structural changes in the medullary raphe, rostral ventrolateral medulla, dorsolateral pons, and ventral midbrain. This restoration occurred after 6 months of CPAP treatment and was maintained following 12 months CPAP. These findings show that continual CPAP treatment is an effective long-term treatment for elevated MSNA likely due to its effects on restoring brainstem structure and function. PMID:27013952

  4. Effects of 12 Months Continuous Positive Airway Pressure on Sympathetic Activity Related Brainstem Function and Structure in Obstructive Sleep Apnea

    PubMed Central

    Henderson, Luke A.; Fatouleh, Rania H.; Lundblad, Linda C.; McKenzie, David K.; Macefield, Vaughan G.

    2016-01-01

    Muscle sympathetic nerve activity (MSNA) is greatly elevated in patients with obstructive sleep apnea (OSA) during normoxic daytime wakefulness. Increased MSNA is a precursor to hypertension and elevated cardiovascular morbidity and mortality. However, the mechanisms underlying the high MSNA in OSA are not well understood. In this study we used concurrent microneurography and magnetic resonance imaging to explore MSNA-related brainstem activity changes and anatomical changes in 15 control and 15 OSA subjects before and after 6 and 12 months of continuous positive airway pressure (CPAP) treatment. We found that following 6 and 12 months of CPAP treatment, resting MSNA levels were significantly reduced in individuals with OSA. Furthermore, this MSNA reduction was associated with restoration of MSNA-related brainstem activity and structural changes in the medullary raphe, rostral ventrolateral medulla, dorsolateral pons, and ventral midbrain. This restoration occurred after 6 months of CPAP treatment and was maintained following 12 months CPAP. These findings show that continual CPAP treatment is an effective long-term treatment for elevated MSNA likely due to its effects on restoring brainstem structure and function. PMID:27013952

  5. Xerostomia and quality of life after intensity-modulated radiotherapy vs. conventional radiotherapy for early-stage nasopharyngeal carcinoma: Initial report on a randomized controlled clinical trial

    SciTech Connect

    Pow, Edmond; Kwong, Dora; McMillan, Anne S. . E-mail: annemcmillan@hku.hk; Wong, May; Sham, Jonathan; Leung, Lucullus; Leung, W. Keung

    2006-11-15

    Purpose: To compare directly the effect of intensity-modulated radiotherapy (IMRT) vs. conventional radiotherapy (CRT) on salivary flow and quality of life (QoL) in patients with early-stage nasopharyngeal carcinoma (NPC). Methods and Materials: Fifty-one patients with T2, N0/N1, M0 NPC took part in a randomized controlled clinical study and received IMRT or CRT. Stimulated whole (SWS) and parotid (SPS) saliva flow were measured and Medical Outcomes Short Form 36 (SF-36), European Organization for Research and Treatment of Cancer (EORTC) core quetionnaire, and EORTC head-and-neck module (QLQ-H and N35) were completed at baseline and 2, 6, and 12 months after radiotherapy. Results: Forty-six patients (88%) were in disease remission 12 months after radiotherapy. At 12 months postradiotherapy, 12 (50.0%) and 20 patients (83.3%) in the IMRT group had recovered at least 25% of preradiotherapy SWS and SPS flow respectively, compared with 1 (4.8%) and 2 patients (9.5%), respectively, in the CRT group. Global health scores showed continuous improvement in QoL after both treatments (p < 0.001). However, after 12 months subscale scores for role-physical, bodily pain, and physical function were significantly higher in the IMRT group, indicating a better condition (p < 0.05). Dry mouth and sticky saliva were problems in both groups 2 months after treatment. In the IMRT group, there was consistent improvement over time with xerostomia-related symptoms significantly less common than in the CRT group at 12 months postradiotherapy. Conclusions: IMRT was significantly better than CRT in terms of parotid sparing and improved QoL for early-stage disease. The findings support the case for assessment of health-related QoL in relation to head-and-neck cancer using a site-specific approach.

  6. Accelerated Hepatitis B Vaccine Schedule among Drug Users – A Randomized Controlled Trial

    PubMed Central

    Hwang, Lu-Yu; Grimes, Carolyn Z.; Tran, Thanh Quoc; Clark, April; Xia, Rui; Lai, Dejian; Troisi, Catherine; Williams, Mark

    2010-01-01

    Background Hepatitis B vaccine provides a model for improving uptake and completion of multi-dose vaccinations in the drug-using community. Methods DASH project conducted randomized controlled trial among not-in-treatment current drug users in two urban neighborhoods. Neighborhoods were cluster-randomized to receive a standard (HIV information) or enhanced (HBV vaccine acceptance/adherence) behavioral intervention; participants within clusters were randomized to a standard (0, 1, 6 mo) or accelerated (0, 1, 2 mo) vaccination schedule. Outcomes were completion of three-dose vaccine and HBV seroprotection. Results Of those screening negative for HIV/HBV, 77% accepted HB vaccination and 75% of those received all 3 doses. Injecting drug users (IDUs) on the accelerated schedule were significantly more likely to receive 3 doses (76%) than those on the standard schedule (66%, p=.04), although for drug users as a whole the adherence was 77% and 73%. No difference in adherence was observed between behavioral intervention groups. Predictors of adherence were older age, African American race, stable housing, and alcohol use. Cumulative HBV seroprotection (≥10 mIU/mL) was gained by 12 months by 65% of those completing. Seroprotection at 6 months was greater for the accelerated schedule group. Conclusions The accelerated vaccine schedule improves hepatitis B vaccination adherence among IDU. PMID:20936979

  7. Unexpected Arrest-Related Deaths in America: 12 Months of Open Source Surveillance

    PubMed Central

    Ho, Jeffrey D.; Heegaard, William G.; Dawes, Donald M.; Natarajan, Sridhar; Reardon, Robert F.; Miner, James R.

    2009-01-01

    Introduction: Sudden, unexpected arrest-related death (ARD) has been associated with drug abuse, extreme delirium or certain police practices. There is insufficient surveillance and causation data available. We report 12 months of surveillance data using a novel data collection methodology. Methods: We used an open-source, prospective method to collect 12 consecutive months of data, including demographics, behavior, illicit substance use, control methods used, and time of collapse after law enforcement contact. Descriptive analysis and chi-square testing were applied. Results: There were 162 ARD events reported that met inclusion criteria. The majority were male with mean age 36 years, and involved bizarre, agitated behavior and reports of drug abuse just prior to death. Law enforcement control techniques included none (14%); empty-hand techniques (69%); intermediate weapons such as TASER® device, impact weapon or chemical irritant spray (52%); and deadly force (12%). Time from contact to subject collapse included instantaneous (13%), within the first hour (53%) and 1–48 hours (35%). Significant collapse time associations occurred with the use of certain intermediate weapons. Conclusion: This surveillance report can be a foundation for discussing ARD. These data support the premise that ARDs primarily occur in persons with a certain demographic and behavior profile that includes middle-aged males exhibiting agitated, bizarre behavior generally following illicit drug abuse. Collapse time associations were demonstrated with the use of TASER devices and impact weapons. We recommend further study in this area to validate our data collection method and findings. PMID:19561821

  8. Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial

    PubMed Central

    Broderick, Joan E.; Keefe, Francis J.; Bruckenthal, Patricia; Junghaenel, Doerte U.; Schneider, Stefan; Schwartz, Joseph E.; Kaell, Alan T.; Caldwell, David S.; McKee, Daphne; Reed, Shelby; Gould, Elaine

    2014-01-01

    A multisite, randomized, controlled clinical effectiveness trial was conducted for osteoarthritis patients with chronic pain of the knee or hip. Adult health nurse practitioners provided a 10-session intervention, pain coping skills training (PCST), in patients’ doctors’ offices (N = 129 patients); the control group received usual care (N = 127 patients). Primary outcomes assessed at baseline, posttreatment, 6-month follow-up, and 12-month follow-up were: pain intensity, physical functioning, psychological distress, self-efficacy, catastrophizing, use of coping strategies, and quality of life. Secondary measures included fatigue, social functioning, health satisfaction, and use of pain medication. Methods favoring external validity, consistent with pragmatic, effectiveness research, were utilized. Primary ITT and secondary per-protocol analyses were conducted. Attrition was within the expected range: 11% at posttreatment and 29% at 12-month follow-up; rates did not differ between groups. Omnibus ITT analyses across all assessment points indicated significant improvement for the PCST group compared with the control group for pain intensity, physical functioning, psychological distress, use of pain coping strategies, and self-efficacy, as well as fatigue, satisfaction with health, and reduced use of pain medication. Treatment effects were robust to covariates (demographics and clinical sites). Trends in the outcomes across the assessments were examined. All outcomes, except for self-efficacy, were maintained through the 12-month follow-up; effects for self-efficacy degraded over time. Per-protocol analyses did not yield greater effect sizes. Comparisons of PCST patients who were more vs less treatment adherent suggested greater effectiveness for patients with high adherence. Results support the effectiveness of nurse practitioner delivery of PCST for chronic osteoarthritis pain. PMID:24865795

  9. Twelve-month follow-up of advance provision of emergency contraception among teenage girls in Sweden—a randomized controlled trial

    PubMed Central

    Tydén, Tanja; Darj, Elisabeth; Larsson, Margareta

    2013-01-01

    Objective. The objective of this study was to evaluate the effect of an intervention with advance provision of emergency contraceptive pills (ECP), condoms, and extended information to a targeted group of teenage girls, compared with a control group, 12 months after intervention. Material and methods. A randomized controlled trial among 420 girls, 15–19 years old, requesting emergency contraception at a youth clinic in Sweden was carried out. Data were collected by a questionnaire at the initial visit and structured telephone interviews 12 months after enrolment. Differences between the intervention group and the control group regarding ECP use, time interval from unprotected intercourse to ECP intake, contraceptive use, and sexual risk-taking were analysed. Results. One year after the intervention 62% of the girls could be reached for follow-up. The girls in the intervention group reported a shorter time interval (mean 15.3 hours) from unprotected intercourse to ECP intake compared to the control group (mean 25.8 hours) (p = 0.019), without any evidence of decreased use of contraceptives or increased sexual risk-taking. Conclusion. Even up to 12 months following the intervention, advance provision of ECP at one single occasion, to a specific target group of adolescent girls, shortens the time interval from unprotected intercourse to pill intake, without jeopardizing contraceptive use or increasing sexual risk-taking. Considering the clinical relevance of these results, we suggest that advance provision of ECP could be implemented as a routine preventive measure for this target group. PMID:24102148

  10. A multicenter randomized controlled trial of tonsillectomy combined with steroid pulse therapy in patients with immunoglobulin A nephropathy

    PubMed Central

    Kawamura, Tetsuya; Yoshimura, Mitsuhiro; Miyazaki, Yoichi; Okamoto, Hidekazu; Kimura, Kenjiro; Hirano, Keita; Matsushima, Masato; Utsunomiya, Yasunori; Ogura, Makoto; Yokoo, Takashi; Okonogi, Hideo; Ishii, Takeo; Hamaguchi, Akihiko; Ueda, Hiroyuki; Furusu, Akira; Horikoshi, Satoshi; Suzuki, Yusuke; Shibata, Takanori; Yasuda, Takashi; Shirai, Sayuri; Imasawa, Toshiyuki; Kanozawa, Koichi; Wada, Akira; Yamaji, Izumi; Miura, Naoto; Imai, Hirokazu; Kasai, Kenji; Soma, Jun; Fujimoto, Shouichi; Matsuo, Seiichi; Tomino, Yasuhiko

    2014-01-01

    Background The study aim was, for the first time, to conduct a multicenter randomized controlled trial to evaluate the effect of tonsillectomy in patients with IgA nephropathy (IgAN). Methods Patients with biopsy-proven IgAN, proteinuria and low serum creatinine were randomly allocated to receive tonsillectomy combined with steroid pulses (Group A; n = 33) or steroid pulses alone (Group B; n = 39). The primary end points were urinary protein excretion and the disappearance of proteinuria and/or hematuria. Results During 12 months from baseline, the percentage decrease in urinary protein excretion was significantly larger in Group A than that in Group B (P < 0.05). However, the frequency of the disappearance of proteinuria, hematuria, or both (clinical remission) at 12 months was not statistically different between the groups. Logistic regression analyses revealed the assigned treatment was a significant, independent factor contributing to the disappearance of proteinuria (odds ratio 2.98, 95% CI 1.01–8.83, P = 0.049), but did not identify an independent factor in achieving the disappearance of hematuria or clinical remission. Conclusions The results indicate tonsillectomy combined with steroid pulse therapy has no beneficial effect over steroid pulses alone to attenuate hematuria and to increase the incidence of clinical remission. Although the antiproteinuric effect was significantly greater in combined therapy, the difference was marginal, and its impact on the renal functional outcome remains to be clarified. PMID:24596084

  11. Effects of Zinc Supplementation on the Incidence of Mortality in Preschool Children: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Fu, Wei; Ding, Li-Ren; Zhuang, Cheng; Zhou, Yu-Hao

    2013-01-01

    Background Previous trials have shown that zinc supplementation can decrease the risk of diarrhea, pneumonia, and malaria in children; however, the effects of zinc supplementation on mortality remain unclear. This study aimed at evaluating the benefits and risks of zinc supplementation on both total mortality and cause-specific mortality. Methodology and Principal Findings We searched PubMed, EmBase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials in preschool children reporting total mortality or cause-specific mortality. Relative risk (RR) was used as a measure of the effect of zinc supplementation on the risk of mortality using a random effect model. Of the 1,520 identified articles, we included 8 trials reporting data on 87,854 children. Overall, zinc supplementation had no effect on total mortality (RR, 0.76; 95% CI: 0.56–1.04; P = 0.084), diarrhea-related mortality (RR, 0.80; 95% CI: 0.53–1.20; P = 0.276), pneumonia-related mortality (RR, 0.52; 95% CI: 0.11–2.39; P = 0.399), malaria-related mortality (RR, 0.90; 95% CI: 0.77–1.06; P = 0.196), or other causes of mortality (RR, 0.98; 95% CI: 0.67–1.44; P = 0.917). Subgroup analysis indicated that zinc supplementation was associated with a reduction in total mortality risk if the participants were boys, aged greater than 12 months, and the duration of the follow-up period was less than 12 months. Conclusions/Significance Zinc supplementation does not have an effect on total mortality, diarrhea-related mortality, pneumonia-related mortality, malaria-related mortality, or other causes of mortality. Subgroup analysis suggested that zinc supplementation can effectively reduce the risk of total mortality if the participants were boys, aged greater than 12 months, and the duration of the follow-up period was less than 12 months. PMID:24244591

  12. Long Term Effects on Risk Factors for Cardiovascular Disease after 12-Months of Aerobic Exercise Intervention - A Worksite RCT among Cleaners

    PubMed Central

    Korshøj, Mette; Lidegaard, Mark; Krustrup, Peter; Jørgensen, Marie Birk; Søgaard, Karen; Holtermann, Andreas

    2016-01-01

    Objectives Occupational groups exposed to high occupational physical activity have an increased risk for cardiovascular disease (CVD). This may be explained by the high relative aerobic workload. Enhanced cardiorespiratory fitness reduces the relative aerobic workload. Thus, the aim was to evaluate the 12-months effects of worksite aerobic exercise on risk factors for CVD among cleaners. Methods One hundred and sixteen cleaners aged 18–65 years were randomized to a group performing aerobic exercise and a reference group receiving lectures. Outcomes were collected at baseline and after 12-months. A repeated measures 2×2 multi-adjusted mixed-model design was applied to compare the between-group differences using intention-to-treat analysis. Results Between-group differences (p<0.05) were found favouring the aerobic exercise group: cardiorespiratory fitness 2.15 (SE 1.03) mlO2/min/kg, aerobic workload -2.15 (SE 1.06) %HRR, resting HR -5.31 (SE 1.61) beats/min, high sensitive C-reactive protein -0.65 (SE 0.24) μg/ml. The blood pressure was unaltered. Stratified analyses on relative aerobic workload at baseline revealed that those with relative aerobic workloads ≥30% of HRR seems to impose a notable adverse effect on resting and ambulatory blood pressure. Conclusion This long-term worksite aerobic exercise intervention among cleaners led to several beneficial effects, but also potential adverse effects among those with high relative aerobic workloads. Trial Registration Controlled-Trials.com ISRCTN86682076 PMID:27513932

  13. Periodic or random nanostructures for light scattering control

    NASA Astrophysics Data System (ADS)

    Berginc, Gerard

    2016-04-01

    Our paper mainly focuses on the control of light scattering by periodic or randomly rough structures. First designed with bi-periodical structures, antireflective surfaces can be achieved with random patterns. We present some new structures with periodic or random patterns, which have been designed by rigorous numerical methods (FDTD) or analytical methods. We show that random interfaces offer new degrees of freedom and possibilities by control of their statistical properties.

  14. Effectiveness of a Worksite Mindfulness-Related Multi-Component Health Promotion Intervention on Work Engagement and Mental Health: Results of a Randomized Controlled Trial

    PubMed Central

    van Berkel, Jantien; Boot, Cécile R. L.; Proper, Karin I.; Bongers, Paulien M.; van der Beek, Allard J.

    2014-01-01

    Objectives The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness. Methods In a randomized controlled trial design, 257 workers of two research institutes participated. The intervention group (n = 129) received a targeted mindfulness-related training, followed by e-coaching. The total duration of the intervention was 6 months. Data on work engagement, mental health, need for recovery and mindfulness were collected using questionnaires at baseline and after 6 and 12 months follow-up. Effects were analyzed using linear mixed effect models. Results There were no significant differences in work engagement, mental health, need for recovery and mindfulness between the intervention and control group after either 6- or 12-months follow-up. Additional analyses in mindfulness-related training compliance subgroups (high and low compliance versus the control group as a reference) and subgroups based on baseline work engagement scores showed no significant differences either. Conclusions This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness after 6 and 12 months. Trial registration Netherlands Trial Register NTR2199 PMID:24489648

  15. Supervised exercise training reduces oxidative stress and cardiometabolic risk in adults with type 2 diabetes: a randomized controlled trial

    PubMed Central

    Vinetti, Giovanni; Mozzini, Chiara; Desenzani, Paolo; Boni, Enrico; Bulla, Laura; Lorenzetti, Isabella; Romano, Claudia; Pasini, Andrea; Cominacini, Luciano; Assanelli, Deodato

    2015-01-01

    To evaluate the effects of supervised exercise training (SET) on cardiometabolic risk, cardiorespiratory fitness and oxidative stress status in 2 diabetes mellitus (T2DM), twenty male subjects with T2DM were randomly assigned to an intervention group, which performed SET in a hospital-based setting, and to a control group. SET consisted of a 12-month supervised aerobic, resistance and flexibility training. A reference group of ten healthy male subjects was also recruited for baseline evaluation only. Participants underwent medical examination, biochemical analyses and cardiopulmonary exercise testing. Oxidative stress markers (1-palmitoyl-2-[5-oxovaleroyl]-sn-glycero-3-phosphorylcholine [POVPC]; 1-palmitoyl-2-glutaroyl-sn-glycero-3-phosphorylcholine [PGPC]) were measured in plasma and in peripheral blood mononuclear cells. All investigations were carried out at baseline and after 12 months. SET yielded a significant modification (p < 0.05) in the following parameters: V'O2max (+14.4%), gas exchange threshold (+23.4%), waist circumference (−1.4%), total cholesterol (−14.6%), LDL cholesterol (−20.2%), fasting insulinemia (−48.5%), HOMA-IR (−52.5%), plasma POVPC (−27.9%) and PGPC (−31.6%). After 12 months, the control group presented a V'O2max and a gas exchange threshold significantly lower than the intervention group. Plasma POVC and PGPC were significantly different from healthy subjects before the intervention, but not after. In conclusion, SET was effective in improving cardiorespiratory fitness, cardiometabolic risk and oxidative stress status in T2DM. PMID:25783765

  16. Changes over 12 months in eye glances during secondary task engagement among novice drivers.

    PubMed

    O'Brien, Fearghal; Klauer, Sheila G; Ehsani, Johnathon; Simons-Morton, Bruce G

    2016-08-01

    During their first year of driving, crash rates among novice drivers are very high but decline rapidly. However, it is not clear what skills or knowledge they are acquiring in this period. Secondary task engagement while driving is a contributing factor to many traffic collisions and some of the elevated crash risk among novices could be explained by greater prevalence or longer periods of eyes off the road while engaging in these non-driving tasks. The current study looked at the eye glances of novice teen drivers engaging in secondary tasks on a test track at 0 and 12 months of licensure and compared their performance with their parents. Novices improved from 0 to 12 months on their longest single glance off the forward roadway and total percentage of time for eyes off the forward roadway, but parents remained stable. Compared with their parents, the longest single glance off the forward roadway was longer for novices at 0 months, but by 12 months there was no difference between the groups. However, for total percentage of time for eyes off the forward roadway, novices performed the same as their parents at 0 months and actually had shorter times at 12 months. These findings could reflect the combined development of driving skills over 12 months and the relative experience that modern teenagers have with portable electronic devices. The results suggest that novice drivers are particularly poor at engaging with secondary tasks while driving. PMID:27177392

  17. Effect of denosumab on Japanese patients with rheumatoid arthritis: a dose–response study of AMG 162 (Denosumab) in patients with RheumatoId arthritis on methotrexate to Validate inhibitory effect on bone Erosion (DRIVE)—a 12-month, multicentre, randomised, double-blind, placebo-controlled, phase II clinical trial

    PubMed Central

    Takeuchi, Tsutomu; Tanaka, Yoshiya; Ishiguro, Naoki; Yamanaka, Hisashi; Yoneda, Toshiyuki; Ohira, Takeshi; Okubo, Naoki; Genant, Harry K

    2016-01-01

    Objectives To evaluate efficacy and safety of three different regimens of denosumab, a fully human monoclonal antibody to receptor activator of nuclear factor kappa B (RANK) ligand (RANKL), for Japanese patients with rheumatoid arthritis (RA). Methods In this multicentre, randomised, placebo-controlled phase II study, 350 Japanese patients with RA between 6 months and <5 years, stratified by glucocorticoid use and rheumatoid factor status, were randomly assigned to subcutaneous injections of placebo or denosumab 60 mg every 6 months (Q6M), every 3 months (Q3M) or every 2 months (Q2M). All patients basically continued methotrexate treatment and had a supplement of calcium and vitamin D throughout the study. The primary endpoint was change in the modified Sharp erosion score from baseline to 12 months. Results Denosumab significantly inhibited the progression of bone erosion at 12 months compared with the placebo, and the mean changes of the modified Sharp erosion score at 12 months from baseline were 0.99, 0.27 (compared with placebo, p=0.0082), 0.14 (p=0.0036) and 0.09 (p<0.0001) in the placebo, Q6M, Q3M and Q2M, respectively. Secondary endpoint analysis revealed that denosumab also significantly inhibited the increase of the modified total Sharp score compared with the placebo, with no obvious evidence of an effect on joint space narrowing for denosumab. As shown in previous studies, denosumab increased bone mineral density. No apparent difference was observed in the safety profiles of denosumab and placebo. Conclusions Addition of denosumab to methotrexate has potential as a new therapeutic option for patients with RA with risk factors of joint destruction. Trial registration number JapicCTI-101263. PMID:26585988

  18. Randomized controlled trials - a matter of design.

    PubMed

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial. PMID:27354804

  19. Effect of 12-month rehabilitation with low loading program on chronic respiratory disease

    PubMed Central

    Endo, Yasuhiro; Dobashi, Kunio; Uga, Daisuke; Kato, Daigo; Nakazawa, Rie; Sakamoto, Masaaki; Fueki, Makoto; Makino, Sohei

    2016-01-01

    [Purpose] The purpose of this study was to examine the effect of 12-month rehabilitation with low loading program on chronic respiratory disease. [Subjects and Methods] Twelve patients with chronic respiratory disease participated in this study, in which the effect of long-term rehabilitation for 12 months was assessed. Nine patients had chronic obstructive pulmonary disease, two had asthma, and one had interstitial pneumonia. In all patients, symptoms, lower-extremity strength, walking distance, activities of daily living, and quality of life were investigated to examine the effect of respiratory rehabilitation. [Results] After 12 months, the isometric knee extension strength and weight-bearing index both showed a significant increase. [Conclusion] The findings of this study suggested that improvement in lower-limb muscle strength can be achieved through long-term intervention, and indicated the validity of repetitive standing and walking exercises. PMID:27134407

  20. Employment-based reinforcement of adherence to oral naltrexone in unemployed injection drug users: 12-month outcomes.

    PubMed

    Dunn, Kelly; DeFulio, Anthony; Everly, Jeffrey J; Donlin, Wendy D; Aklin, Will M; Nuzzo, Paul A; Leoutsakos, Jeannie-Marie S; Umbricht, Annie; Fingerhood, Michael; Bigelow, George E; Silverman, Kenneth

    2015-06-01

    Oral naltrexone could be a promising relapse-prevention pharmacotherapy for recently detoxified opioid-dependent patients; however, interventions are often needed to promote adherence with this treatment approach. We recently conducted a study to evaluate a 26-week employment-based reinforcement intervention of oral naltrexone in unemployed injection drug users (Dunn et al., 2013). Participants were randomly assigned into a contingency (n = 35) group required to ingest naltrexone under staff observation to gain entry into a therapeutic workplace or a prescription (n = 32) group given a take-home supply of oral naltrexone and access to the workplace without observed ingestion. Monthly urine samples were collected and analyzed for evidence for naltrexone adherence, opioid use, and cocaine use. As previously reported, contingency participants provided significantly more naltrexone-positive urine samples than prescription participants during the 26-week intervention period. The goal of this current study is to report the 12-month outcomes, which occurred 6 months after the intervention ended. Results at the 12-month visit showed no between-groups differences in naltrexone-positive, opioid-negative, or cocaine-negative urine samples and no participant self-reported using naltrexone at the follow-up visit. These results show that even after a period of successfully reinforced oral naltrexone adherence, longer-term naltrexone use is unlikely to be maintained after reinforcement contingencies are discontinued. (PsycINFO Database Record PMID:25134047

  1. Early child care and obesity at 12 months of age in the Danish National Birth Cohort

    PubMed Central

    Neelon, Sara E Benjamin; Andersen, Camilla Schou; Morgen, Camilla Schmidt; Kamper-Jørgensen, Mads; Oken, Emily; Gillman, Matthew W; Sørensen, Thorkild IA

    2014-01-01

    Background/Objectives Evidence suggests that the child care environment may be more obesogenic than the family home, and previous studies have found that child care use may be associated with obesity in children. Few studies, however, have focused on child care during infancy, which may be an especially vulnerable period. This study examined child care use in infancy and weight status at 12 months of age in a country where paid maternity leave is common and early child care is not as prevalent as in other developed countries. Subjects/Methods We studied 27821 children born to mothers participating in the Danish National Birth Cohort (DNBC), a longitudinal study of pregnant women enrolled between 1997 and 2002, who were also included in the Childcare Database, a national record of child care use in Denmark. The exposure was days in child care from birth to 12 months. The outcomes were sex-specific body mass index (BMI) z-score and overweight/obesity (BMI ≥85th percentile based on the World Health Organization classification) at 12 months. We conducted multivariable linear and logistic regression analyses examining child care use and weight outcomes. Results A total of 17721 (63.7%) children attended child care during their first year of life. After adjustment for potential confounders, a 30-day increment of child care was associated with a modestly higher BMI z-score at 12 months (0.03 units; 95% CI: 0.01, 0.05; p=0.003). Similarly, child care use was associated with increased odds of being overweight/obese at 12 months of age (OR 1.05; 95% CI: 1.01, 1.10; p=0.047). Conclusions Child care in the first year of life was associated with slightly higher weight at 12 months, suggesting that child care settings may be important targets for obesity prevention in infancy. PMID:25233894

  2. Effects of a Rehabilitation Program on Perceived Environmental Barriers in Older Patients Recovering from Hip Fracture: A Randomized Controlled Trial

    PubMed Central

    Salpakoski, Anu; Arkela, Marja; Kallinen, Mauri; Rantanen, Taina; Sipilä, Sarianna

    2013-01-01

    Objectives. To study effects of a one-year multicomponent intervention on perceived environmental barriers in hip fracture patients. Design. Randomized controlled trial of a 12-month home-based rehabilitation aiming to improve mobility and function (ISRCTN53680197); secondary analyses. Subjects. Community-dwelling hip fracture patients on average 70 days after trauma (n = 81). Methods. Assessments at baseline, 3, 6, and 12 months later included perceived entrance-related barriers (e.g., indoor/outdoor stairs, lighting, floor surfaces, and storage for mobility devices) and perceived barriers in the outdoor environment (poor street condition, hilly terrain, long-distances, and lack of resting places). Sum scores for entrance-related and outdoor barriers were analyzed using general estimating equation models. Results. At baseline, 48% and 37% of the patients perceived at least one entrance-related barrier, and 62% and 60% perceived at least one outdoor barrier in the intervention and control group, respectively. Over time, (P = 0.003) the number of entrance-related barriers decreased in both groups (group P = 0.395; interaction P = 0.571). For outdoor barriers, time (P = 0.199), group (P = 0.911), and interaction effect (P = 0.430) were not significant. Conclusion. Our intervention had no additional benefit over standard care in hip fracture patients. Further study is warranted to determine whether perceived environmental barriers can be reduced by interventions targeted at the older individual. This trial is registered with ISRCTN53680197. PMID:23986910

  3. Two Novel Treatments to Reduce Overeating in Overweight Children: A Randomized Controlled Trial

    PubMed Central

    Boutelle, Kerri N.; Peterson, Carol B.; Rydell, Sarah A.; Zucker, Nancy L.; Cafri, Guy; Harnack, Lisa

    2014-01-01

    Objective Our purpose in this study was to examine 2 treatments targeted at reducing eating in the absence of hunger in overweight and obese children. Method Thirty-six overweight and obese 8- to 12-year-old children (58% female; mean age = 10.3 years, SD = 1.3), with high scores on eating in the absence of hunger, and their parents were randomly assigned to an 8-week children's appetite awareness training or cue exposure treatment–food. Children completed an eating in the absence of hunger (EAH) paradigm, an Eating Disorder Examination interview for children, and three 24-hr dietary recalls, and their height and weight were measured. Parents completed the EAH Questionnaire and the Binge Eating Scale, and their height and weight were measured. Assessments were conducted at baseline, posttreatment, and 6 and 12 months posttreatment. Results Results showed that both treatments resulted in significant decreases in binge eating in children over time. Additionally, children in the food cue exposure treatment showed significant decreases in EAH posttreatment and 6 months posttreatment, but children in the appetite awareness training showed no change in EAH. Neither treatment produced significant effects on caloric intake in children or on any of the parent outcomes. Conclusions This study demonstrates that training in food cue responsitivity and appetite awareness has the potential to be efficacious for reducing EAH and binge eating in children. Because these data are preliminary, further treatment development and randomized controlled studies are needed. PMID:22122291

  4. A Randomized Controlled Trial Testing the Efficacy of a Brief Cannabis Universal Prevention Program among Adolescents in Primary Care

    PubMed Central

    Walton, Maureen A.; Resko, Stella; Barry, Kristen L.; Chermack, Stephen T.; Zucker, Robert A.; Zimmerman, Marc A.; Booth, Brenda M.; Blow, Frederic C.

    2014-01-01

    Aims To examine the efficacy of a brief intervention delivered by a therapist (TBI) or a computer (CBI), in preventing cannabis use among adolescents in urban primary care clinics. Design A randomized controlled trial comparing: CBI and TBI versus control. Setting Urban primary care clinics in the United States. Participants Research staff recruited 714 adolescents (ages 12-18) who reported no lifetime cannabis use on a screening survey for this study, which included a baseline survey, randomization (stratified by gender and grade) to conditions (control; CBI; TBI), and 3, 6, and 12 month assessments. Measurements Using an intent to treat approach, primary outcomes were cannabis use (any, frequency); secondary outcomes included frequency of other drug use, severity of alcohol use, and frequency of delinquency (among 85% completing follow-ups). Findings Compared with controls, CBI participants had significantly lower rates of any cannabis use over 12 months (24.2%, 16.8%, respectively, p<.05), frequency of cannabis use at 3 and 6 months (p<.05) and other drug use at 3 months (p<.01). Compared with controls, TBI participants did not differ in cannabis use or frequency, but had significantly less other drug use at 3 months (p<.05), alcohol use at 6 months (p<.01), and delinquency at 3 months (p<.01). Conclusions Among adolescents in urban primary care in the United States, a computer brief intervention appeared to prevent and reduce cannabis use. Both computer and therapist delivered brief interventions appeared to have small effects in reducing other risk behaviors, but these dissipated over time. PMID:24372937

  5. JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes. Methods/Design Randomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up). Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets) and control group (Placebo); two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM) criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c). Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36); score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG), liver function (ALT) and renal function (BUN, Creatinine) test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs) will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others. Discussion The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes. Trial registration Chinese clinical trials register Chi

  6. Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial

    PubMed Central

    Lehr, Dirk; Ebert, David Daniel; Berking, Matthias; Riper, Heleen

    2016-01-01

    Background Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting. Objective This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees. Methods A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus’s transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only. Results An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F 1,261=58.08, P<.001; Cohen’s d=0.83) and at the 6-month follow-up (F 1,261=80.17, P<.001; Cohen’s d=1.02). The effects in the iSMI group were maintained at 12-month follow-up. Conclusions This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions. Trial Registration German Clinical Trials

  7. Neuropsychological Performance of Youth with Secondary Attention-Deficit/Hyperactivity Disorder 6- and 12-Months after Traumatic Brain Injury

    PubMed Central

    Ornstein, Tisha J.; Sagar, Sanya; Schachar, Russell J.; Ewing-Cobbs, Linda; Chapman, Sandra B.; Dennis, Maureen; Saunders, Ann E.; Yang, Tony T.; Levin, Harvey S.; Max, Jeffrey E.

    2016-01-01

    The present study compared executive dysfunction among children with attention-deficit/hyperactivity disorder (ADHD) after traumatic brain injury (TBI), also called secondary ADHD (S-ADHD), pre-injury ADHD and children with TBI only (i.e., no ADHD). Youth aged 6–16 years admitted for TBI to five trauma centers were enrolled (n = 177) and evaluated with a semi-structured psychiatric interview scheduled on three occasions (within 2 weeks of TBI, i.e., baseline assessment for pre-injury status; 6-months and 12-months post-TBI). This permitted the determination of 6- and 12-month post-injury classifications of membership in three mutually exclusive groups (S-ADHD; pre-injury ADHD; TBI-only). Several executive control measures were administered. Unremitted S-ADHD was present in 17/141 (12%) children at the 6-month assessment, and in 14/125 (11%) children at 12-months post-injury. The study found that children with S-ADHD exhibited deficient working memory, attention, and psychomotor speed as compared to children with pre-injury ADHD. Furthermore, the children with S-ADHD and the children with TBI-only were impaired compared to the children with pre-injury ADHD with regard to planning. No group differences related to response inhibition emerged. Age, but not injury severity, gender, or adaptive functioning was related to executive function outcome. Neuropsychological sequelae distinguish among children who develop S-ADHD following TBI and those with TBI only. Moreover, there appears to be a different pattern of executive control performance in those who develop S-ADHD than in children with pre-injury ADHD suggesting that differences exist in the underlying neural mechanisms that define each disorder, underscoring the need to identify targeted treatment interventions. PMID:25489810

  8. MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Ravn, Henrik; Batista, Celso Soares Pereira; Rodrigues, Amabelia

    2016-01-01

    Background Recent studies have revealed a low measles vaccination (MV) rate in the Republic of Guinea-Bissau (West Africa) that has not increased in accordance with the increasing coverage of other vaccinations. Measles is the deadliest of all childhood rash/fever illnesses and spreads easily, implying that if the vaccination coverage is declining there is a significant risk of new measles outbreaks [27]. Meanwhile, mobile health (mHealth; the use of mobile phones for health interventions) has generated much enthusiasm, and shown potential in improving health service delivery in other contexts. Objective The aim of this study is to evaluate the efficiency of mHealth as a tool for improving MV coverage while contributing to the mHealth evidence base. Methods This study will take place at three health centers in different regions of Guinea-Bissau. Participants, defined as mothers of the children receiving the MV, will be enrolled when they arrive with their children at the health center to receive the Bacillus Calmette-Guérin vaccination, usually within one month of the child’s birth. Enrolment will continue until a study population of 990 children has been reached. The participants will be randomly assigned to a control arm or one of two intervention arms. Each of the three groups will have 330 participants, distributed equally between health centers. Participants in the first intervention arm will receive a scheduled short message service (SMS) text message reminding them of the MV. Participants in the second intervention arm will receive a voice call in addition to the SMS message, while the control arm will receive no interventions. The MV is scheduled to be administered at 9 months of age. Although the vaccine would still be effective after 12 months, local policy in Guinea-Bissau prevents children aged >12 months from receiving the vaccination, and thus the study will follow-up with participants after the children reach 12 months of age. Children who have

  9. Estimating the minimum control count of random network models

    PubMed Central

    Ruths, Derek; Ruths, Justin

    2016-01-01

    The study of controllability of complex networks has introduced the minimum number of controls required for full controllability as a new network measure of interest. This network measure, like many others, is non-trivial to compute. As a result, establishing the significance of minimum control counts (MCCs) in real networks using random network null models is expensive. Here we derive analytic estimates for the expected MCCs of networks drawn from three commonly-used random network models. Our estimates show good agreement with exact control counts. Furthermore, the analytic expressions we derive offer insights into the structures within each random network model that induce the need for controls. PMID:26817434

  10. Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

    PubMed Central

    2009-01-01

    Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm (<30 weeks of gestational age) and their families, compared with standard medical follow-up. The aim of the program, delivered over nine sessions by a team comprising a physiotherapist and psychologist, is to improve infant development (cognitive, motor and language), behavioral regulation, caregiver-child interactions and caregiver mental health at 24 months' corrected age. The infants will be stratified by severity of brain white matter injury (assessed by magnetic resonance imaging) at term equivalent age, and then randomized. At 12 months' corrected age interim outcome measures will include motor development assessed using the Alberta Infant Motor Scale and the Neurological Sensory Motor Developmental Assessment. Caregivers will also complete a questionnaire at this time to obtain information on behavior, parenting, caregiver mental health, and social support. The primary outcomes are at 24 months' corrected age and include cognitive, motor and language development assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary outcomes at 24 months include caregiver-child interaction measured using an observational task, and infant behavior, parenting, caregiver mental health and social support measured via standardized parental questionnaires. Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program

  11. Determinants of Weight Gain Prevention in Young Adult and Midlife Women: Study Design and Protocol of a Randomized Controlled Trial

    PubMed Central

    2015-01-01

    Background Treatment of overweight and obesity through body weight reduction has been monumentally ineffective as few individuals are able to sustain weight loss. Rather than treating weight gain once it has become problematic, prevention of weight gain over time may be more effective. Objective The aim of this research is to preclude the burden of adult obesity in women by identifying the determinants of weight gain prevention. The objective of this randomized controlled trial (RCT) is to compare a weight gain prevention intervention delivered by the registered dietitian versus counselor. Methods This is a 12-month parallel-arm weight gain prevention RCT designed to increase self-efficacy, self-regulation, outcome expectations and family and social support through the use of a nutrition education intervention in women, aged 18-45 years, from the Urbana-Champaign (Illinois, USA) area. Women have been randomized to registered dietitian, counselor or wait-list control groups (August 2014) and are undergoing weekly nutrition education sessions for four months, followed by monthly sessions for eight months (through August 2015). Outcome measures, including: (1) dietary intake, (2) physical activity, (3) anthropometric and blood pressure measurements, (4) biochemical markers of health, (5) eating behaviors and health perceptions, and (6) mediators of behavior change, were collected before the intervention began (baseline) and will be collected at 3, 6, 9, and 12 months of the study. Results In total, 87 women have been randomized to intervention groups, and 81 women have completed first week of the study. Results are expected in early 2016. Conclusions This RCT is one of the first to examine weight gain prevention in women across normal, overweight, and obese body mass index categories. Results of this research are expected to have application to evidence-based practice in weight gain prevention for women and possibly have implication for policy regarding decreasing the

  12. The Closed Equilibrated Biological Aquatic System: A 12 months Test of an Artificial Aquatic Ecosystem

    NASA Astrophysics Data System (ADS)

    Blüm, V.; Andriske, M.; Ludwig, Ch.; Paaßen, U.; Voeste, D.

    1999-01-01

    The ``Closed Equilibrated Biological Aquatic System'' (C.E.B.A.S.) is finally disposed for long-term multi-generation experiments with aquatic organisms in a space station. Therefore a minimum operation time of three month is required. It is verified in three versions of laboratory prototypes. The third one passed successfully a 12 months mid-term test in 1995/96 thus demonstrating its high biological stability. The third version of the C.E.B.A.S. consists of a 100 l animal tank, two plant cultivators with a volume of 15 l each with independent illuminations, a 3.0 l semibiological ``mechanical'' filter, a 3.0 l bacteria filter, a heating/cooling device and a dummy filter unit. The live-bearing teleost Xiphophorus helleri is the vertebrate and the pulmonate water snail Biomphalaria glabrata the invertebrate experimental animal in the system. The rootless higher water plant Ceratophyllum demersum is the producer organism. Ammonia oxidizing bacteria and other microorganisms settle in the filters. A simple data acquisition is combined with temperature and plant illumination control. Besides of the space aspects the C.E.B.A.S. proved to be an extremely suitable tool to investigate the organism and subcomponent interactions in a well defined terrestrial aquatic closed ecosystem by providing physical, chemical and biological data which allow an approach to a comprehensive system analysis. Moreover the C.E.B.A.S. is the base for the development of innovative combined animal-plant aquaculture systems for human nutrition on earth which could be implemented into bioregenerative life support systems with a higher degree of complexity suitable for lunar or planetary bases.

  13. A 12-month prospective study of the relationship between stress fractures and bone turnover in athletes.

    PubMed

    Bennell, K L; Malcolm, S A; Brukner, P D; Green, R M; Hopper, J L; Wark, J D; Ebeling, P R

    1998-07-01

    Bone remodeling may be involved in the pathogenesis of stress fractures in athletes. We conducted a 12-month prospective study to evaluate bone turnover in 46 female and 49 male track and field athletes aged 17-26 years (mean age 20.3; SD 2.0) 20 of whom developed a stress fracture. Baseline levels of bone turnover were evaluated in all athletes and monthly bone turnover levels were evaluated in a subset consisting of the 20 athletes who sustained a stress fracture and a matched comparison group who did not sustain a stress fracture. Bone formation was assessed using serum osteocalcin (OC) measured by human immunoradiometric assay and bone resorption by urinary excretion of pyridinium cross-links (Pyr and D-Pyr); high performance liquid chromatography and N-telopeptides of type 1 collagen (NTx) using ELISA assay. Athletes who developed stress fractures had similar baseline levels of bone turnover compared with their nonstress fracture counterparts (P > 0.10). Results of serial measurements showed no differences in average levels of Pyr, D-Pyr, or OC in those who developed stress fractures (P = 0.10) compared with the control group. In the athletes with stress fractures, there was also no difference in bone turnover levels prior to or following the onset of bony pain. Our results show that single and multiple measurements of bone turnover are not clinically useful in predicting the likelihood of stress fractures in athletes. Furthermore, there were no consistent temporal changes in bone turnover associated with stress fracture development. However, our results do not negate the possible pathogenetic role of local changes in bone remodeling at stress fracture sites, given the high biological variability of bone turnover markers and the fact that levels of bone turnover reflect the integration of all bone remodeling throughout the skeleton. PMID:9632851

  14. 78 FR 40104 - Endangered and Threatened Wildlife; 12-Month Finding on Petitions To List the Northeastern...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    ...We, NMFS, announce a 12-month finding on two petitions to list the northeastern Pacific (NEP) population of white sharks (Carcharodon carcharias) as threatened or endangered under the Endangered Species Act (ESA). We have completed a status review of the NEP white shark population in response to these petitions using the best available scientific and commercial data. Based on this review, we......

  15. Speech Production in 12-Month-Old Children with and without Hearing Loss

    ERIC Educational Resources Information Center

    McGowan, Richard S.; Nittrouer, Susan; Chenausky, Karen

    2008-01-01

    Purpose: The purpose of this study was to compare speech production at 12 months of age for children with hearing loss (HL) who were identified and received intervention before 6 months of age with those of children with normal hearing (NH). Method: The speech production of 10 children with NH was compared with that of 10 children with HL whose…

  16. Will Any Doll Do? 12-Month-Olds' Reasoning about Goal Objects

    ERIC Educational Resources Information Center

    Spaepen, Elizabet; Spelke, Elizabeth

    2007-01-01

    Infants as young as 5 months of age view familiar actions such as reaching as goal-directed (Woodward, 1998), but how do they construe the goal of an actor's reach? Six experiments investigated whether 12-month-old infants represent reaching actions as directed to a particular individual object, to a narrowly defined object category (e.g., an…

  17. Metacognitive functioning predicts positive and negative symptoms over 12 months in first episode psychosis.

    PubMed

    McLeod, Hamish J; Gumley, Andrew I; Macbeth, Angus; Schwannauer, Matthias; Lysaker, Paul H

    2014-07-01

    The negative symptoms of schizophrenia are a major source of impairment and distress but both pharmacological and psychological treatment options provide only modest benefit. Developing more effective psychological treatments for negative symptoms will require a more sophisticated understanding of the psychological processes that are implicated in their development and maintenance. We extended previous work by demonstrating that metacognitive functioning is related to negative symptom expression across the first 12 months of first episode psychosis (FEP). Previous studies in this area have either been cross-sectional or have used much older participants with long-standing symptoms. In this study, forty-five FEP participants were assessed three times over 12 months and provided data on PANSS rated symptoms, premorbid adjustment, metacognitive functioning, and DUP. Step-wise linear regression showed that adding metacognition scores to known predictors of negative symptoms (baseline symptom severity, gender, DUP, and premorbid academic and social adjustment) accounted for 62% of the variance in PANSS negative symptom scores at six months and 38% at 12 months. The same predictors also explained 47% of the variance in positive symptoms at both six and 12 months. However, exploration of the simple correlations between PANSS symptom scores and metacognition suggests a stronger univariate relationship between metacognition and negative symptoms. Overall, the results indicate that problems with mental state processing may be important determinants of negative symptom expression from the very early stages of psychosis. These results provide further evidence that metacognitive functioning is a potentially relevant target for psychological interventions. PMID:24725651

  18. PREVALENCE OF CRYPTOSPORIDIUM SPECIES AND GENOTYPES IN A 12-MONTH LONGITUDINAL STUDY IN DAIRY CALVES

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fecal specimens were collected regularly from 30 calves from birth until 12 months of age at a dairy farm in Maryland to determine the prevalence of Cryptosporidium species/genotypes. Samples were collected weekly the first 8 weeks after calves were born, biweekly for calves 3 to 5 months of age, an...

  19. Infants Show a Facilitation Effect for Native Language Phonetic Perception between 6 and 12 Months

    ERIC Educational Resources Information Center

    Kuhl, Patricia K.; Stevens, Erica; Hayashi, Akiko; Deguchi, Toshisada; Kiritani, Shigeru; Iverson, Paul

    2006-01-01

    Patterns of developmental change in phonetic perception are critical to theory development. Many previous studies document a decline in nonnative phonetic perception between 6 and 12 months of age. However, much less experimental attention has been paid to developmental change in native-language phonetic perception over the same time period. We…

  20. Biological Motion Displays Elicit Social Behavior in 12-Month-Olds

    ERIC Educational Resources Information Center

    Yoon, Jennifer M. D.; Johnson, Susan C.

    2009-01-01

    To test the hypothesis that biological motion perception is developmentally integrated with important social cognitive abilities, 12-month-olds (N = 36) were shown a display of a human point-light figure turning to observe a target. Infants spontaneously and reliably followed the figure's "gaze" despite the absence of familiar and socially…

  1. Case Study Analyses of Play Behaviors of 12-Month-Old Infants Later Diagnosed with Autism

    ERIC Educational Resources Information Center

    Mulligan, Shelley

    2015-01-01

    Case study research methodology was used to describe the play behaviors of three infants at 12 months of age, who were later diagnosed with an autism spectrum disorder. Data included standardized test scores, and analyses of video footage of semi-structured play sessions from infants identified as high risk for autism, because of having a sibling…

  2. The Flexibility of 12-Month-Olds' Preferences for Phonologically Appropriate Object Labels

    ERIC Educational Resources Information Center

    MacKenzie, Heather K.; Graham, Susan A.; Curtin, Suzanne; Archer, Stephanie L.

    2014-01-01

    We explored 12-month-olds' flexibility in accepting phonotactically illegal or ill-formed word forms in a modified associative-learning task. Sixty-four English-learning infants were presented with a training phase that either clarified the purpose of a sound--object association task or left the task ambiguous. Infants were then habituated to…

  3. 5 CFR 550.705 - Criteria for meeting the requirement for 12 months of continuous employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of continuous employment is met if, on the date of separation, an employee has held one or more... 12 months of continuous employment. 550.705 Section 550.705 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PAY ADMINISTRATION (GENERAL) Severance Pay § 550.705...

  4. FedEx Express Gasoline Hybrid Electric Delivery Truck Evaluation: 12-Month Report

    SciTech Connect

    Barnitt, R.

    2011-01-01

    This report summarizes the data obtained in a 12-month comparison of three gasoline hybrid electric delivery vehicles with three comparable diesel vehicles. The data show that there was no statistical difference between operating cost per mile of the two groups of vehicles. As expected, tailpipe emissions were considerably lower across all drive cycles for the gHEV than for the diesel vehicle.

  5. Intention to Leave, Anticipated Reasons for Leaving, and 12-Month Turnover of Child Care Center Staff.

    ERIC Educational Resources Information Center

    Manlove, Elizabeth E.; Guzell, Jacqueline R.

    1997-01-01

    Job turnover among a sample of child care workers was examined in relation to demographic, work-related, and nonwork-related factors. Findings indicated that the perceived choice of other jobs and job tenure both have an impact on intention to leave, as well as on actual 12-month turnover. (Author)

  6. Understanding the Abstract Role of Speech in Communication at 12 Months

    ERIC Educational Resources Information Center

    Martin, Alia; Onishi, Kristine H.; Vouloumanos, Athena

    2012-01-01

    Adult humans recognize that even unfamiliar speech can communicate information between third parties, demonstrating an ability to separate communicative function from linguistic content. We examined whether 12-month-old infants understand that speech can communicate before they understand the meanings of specific words. Specifically, we test the…

  7. Evidence for a Unitary Goal Concept in 12-Month-Old Infants

    ERIC Educational Resources Information Center

    Biro, Szilvia; Verschoor, Stephan; Coenen, Lot

    2011-01-01

    We investigated whether infants can transfer their goal attribution between situations that contain different types of information about the goal. We found that 12-month-olds who had attributed a goal based on the causal efficacy of a means-end action generated expectations about the actor's action in another scenario in which the actor could…

  8. Atypical Object Exploration at 12 Months of Age Is Associated with Autism in a Prospective Sample

    ERIC Educational Resources Information Center

    Ozonoff, Sally; Macari, Suzanne; Young, Gregory S.; Goldring, Stacy; Thompson, Meagan; Rogers, Sally J.

    2008-01-01

    This prospective study examined object exploration behavior in 66 12-month-old infants, of whom nine were subsequently diagnosed with an autism spectrum disorder. Previous investigations differ on when the repetitive behaviors characteristic of autism are first present in early development. A task was developed that afforded specific opportunities…

  9. Preliminary Clinical Evaluation of Short Fiber-Reinforced Composite Resin in Posterior Teeth: 12-Months Report

    PubMed Central

    Garoushi, S; Tanner, J; Vallittu, PK; Lassila, L

    2012-01-01

    This preliminary clinical trial evaluated 12 month clinical performance of novel filling composite resin system which combines short fiber-reinforced composite resin and conventional particulate filler composite resin in high stress bearing applications. A total of 37 class I and II restorations (compound and complex type) were placed in 6 premolars and 31 molars. The restorations were reviewed clinically at 6 months (baseline) and 12 months using modified USPHS codes change criteria for marginal adaptation, post-operative sensitivity, pulpal pain and secondary caries criteria. Photographs and x-rays were obtained for restorative analysis. Results of 12 months evaluation showed 5 restorations having little marginal leakage (B score) and 1 patient had minor pulpal symptom and post-operative sensitivity (B score). No secondary caries or bulk fracture was detected. The majority of restorations exhibited A scores of the evaluated criteria. After 12 months, restorations combining base of short fiber reinforced composite resin as substructure and surface layer of hybrid composite resin displayed promising performance in high load bearing areas. PMID:22408696

  10. 12-Month-Olds' Phonotactic Knowledge Guides Their Word-Object Mappings

    ERIC Educational Resources Information Center

    MacKenzie, Heather; Curtin, Suzanne; Graham, Susan A.

    2012-01-01

    This study examined whether 12-month-olds will accept words that differ phonologically and phonetically from their native language as object labels in an associative learning task. Sixty infants were presented with sets of English word-object (N = 30), Japanese word-object (N = 15), or Czech word-object (N = 15) pairings until they habituated.…

  11. 12-Month Follow-Up of Fluoxetine and Cognitive Behavioral Therapy for Binge Eating Disorder

    ERIC Educational Resources Information Center

    Grilo, Carlos M.; Crosby, Ross D.; Wilson, G. Terence; Masheb, Robin M.

    2012-01-01

    Objective: The longer term efficacy of medication treatments for binge-eating disorder (BED) remains unknown. This study examined the longer term effects of fluoxetine and cognitive behavioral therapy (CBT) either with fluoxetine (CBT + fluoxetine) or with placebo (CBT + placebo) for BED through 12-month follow-up after completing treatments.…

  12. Class Matters: 12-Month-Olds' Word-Object Associations Privilege Content over Function Words

    ERIC Educational Resources Information Center

    MacKenzie, Heather; Curtin, Suzanne; Graham, Susan A.

    2012-01-01

    A fundamental step in learning words is the development of an association between a sound pattern and an element in the environment. Here we explore the nature of this associative ability in 12-month-olds, examining whether it is constrained to privilege particular word forms over others. Forty-eight infants were presented with sets of novel…

  13. Suicide Attempts within 12 Months of Treatment for Substance Use Disorders

    ERIC Educational Resources Information Center

    Britton, Peter C.; Conner, Kenneth R.

    2010-01-01

    There are limited prospective data on suicide attempts (SA) during the months following treatment for substance use disorders (SUD), a period of high risk. In an analysis of the Drug Abuse Treatment Outcomes Study, a longitudinal naturalistic multisite study of treated SUDs, variables associated with SA in the 12 months following SUD treatment…

  14. Reduction of left ventricular ejection fraction after 12-month follow-up in hemodialysis patients

    PubMed Central

    Momeni, Ali; Khaledi, Arsalan; Hasanzadeh, Katayoun

    2016-01-01

    Introduction: Cardiovascular disease is the most common cause of morbidity and mortality in hemodialysis patients. Objectives: The aim of this study was to detect echocardiographic abnormality in the beginning and after 12-month follow-up in the hemodialysis patients. Patients and Methods: In a cross-sectional study, 60 hemodialysis patients older than 18 years and the dialysis duration longer than three months were enrolled. At the beginning of the study, echocardiography was done and after 12 months was repeated in all of the patients by the same cardiologist. At the end of the study, data were analyzed using SPSS software (version 19). Results: From the total of cases 37 were male and 23 female. At the beginning of the study, mitral regurgitation, tricuspid regurgitation and aortic insufficiency were found in 54, 47 and 11 patients respectively. After 12 months left ventricular ejection fraction (LVEF) decreased significantly, however there was no significant difference between other echocardiographic findings at the beginning and after 12 months. Conclusion: Decrease in LVEF over time in hemodialysis patients may be due to negative effect of uremia on cardiac function, so it seems that periodical cardiac evaluation of these patients is essential and beneficial. PMID:27069961

  15. Gastrointestinal tract development in red deer (Cervus elaphus) calves from 1 to 12 months of age.

    PubMed

    Hammond, K J; Hoskin, S O; Jopson, N B; Mackintosh, C G; Hofstra, G; Thompson, B R; Stevens, D R

    2013-11-01

    This study provides a detailed description of the development of the gastrointestinal tract (GIT) of farmed red deer (Cervus elaphus) calves over the first 12 months of age. GIT development was measured using a combination of computerised tomography (CT) scanning and traditional slaughter plus dissection techniques. Red deer calves of a known birth date were randomly assigned to two treatment groups. A group of five animals were repeatedly CT scanned at 31, 63, 92, 135, 207, 275 and 351 days of age to identify GIT organs and determine their volume. From a group of 20 animals, subsets of four individuals were also scanned at corresponding ages (except 135 days of age). They were immediately euthanised and dissected after CT scanning to compare CT-scanned results with actual anatomical measurements. Individual organ weights were compared with their respective organ volumes determined by CT scanning and were found to have a strong, positive relationship. The combined rumen and reticulum (RR) CT-scanned volume was compared with its volume determined by the water-displacement technique and this also showed good correlation between the two techniques (R = 0.92). The allometric growth rates of organs, relative to animal live weight gains, in descending order, were the rumen, omasum, reticulum, abomasum, caecum blind sac, kidneys, spleen and liver. The red deer GIT was continuing to grow and develop when the last measurement was taken at 351 days of age. The greatest growth of the RR, when expressed in terms of empty weight, was between 31 and 92 days of age. Compared with sheep and cattle, it appears that the red deer have a similar or greater rate of RR development up until approximately 60 to 90 days of age; however, the final increments of GIT maturity in deer may take longer to complete, with the empty weight of the RR gaining 7.5 g/day between 275 and 351 days of age. CT scanning was validated in this study as a viable technique to follow GIT development in the same

  16. Comparison of measures of comorbidity for predicting disability 12-months post-injury

    PubMed Central

    2013-01-01

    Background Understanding the factors that impact on disability is necessary to inform trauma care and enable adequate risk adjustment for benchmarking and monitoring. A key consideration is how to adjust for pre-existing conditions when assessing injury outcomes, and whether the inclusion of comorbidity is needed in addition to adjustment for age. This study compared different approaches to modelling the impact of comorbidity, collected as part of the routine hospital episode data, on disability outcomes following orthopaedic injury. Methods 12-month Glasgow Outcome Scale – Extended (GOS-E) outcomes for 13,519 survivors to discharge were drawn from the Victorian Orthopaedic Trauma Outcomes Registry, a prospective cohort study of admitted orthopaedic injury patients. ICD-10-AM comorbidity codes were mapped to four comorbidity indices. Cases with a GOS-E score of 7–8 were considered “recovered”. A split dataset approach was used with cases randomly assigned to development or test datasets. Logistic regression models were fitted with “recovery” as the outcome and the performance of the models based on each comorbidity index (adjusted for injury and age) measured using calibration (Hosmer-Lemshow (H-L) statistics and calibration curves) and discrimination (Area under the Receiver Operating Characteristic (AUC)) statistics. Results All comorbidity indices improved model fit over models with age and injuries sustained alone. None of the models demonstrated acceptable model calibration (H-L statistic p < 0.05 for all models). There was little difference between the discrimination of the indices for predicting recovery: Charlson Comorbidity Index (AUC 0.70, 95% CI: 0.68, 0.71); number of ICD-10 chapters represented (AUC 0.70, 95% CI: 0.69, 0.72); number of six frequent chronic conditions represented (AUC 0.70, 95% CI: 0.69, 0.71); and the Functional Comorbidity Index (AUC 0.69, 95% CI: 0.68, 0.71). Conclusions The presence of ICD-10 recorded comorbid

  17. Skeletal findings in the first 12 months following initiation of glucocorticoid therapy for pediatric nephrotic syndrome

    PubMed Central

    Phan, V; Blydt-Hansen, T; Feber, J; Alos, N; Arora, S; Atkinson, S; Bell, L; Clarson, C; Couch, R; Cummings, EA; Filler, G; Grant, RM; Grimmer, J; Hebert, D; Lentle, B; Ma, J; Matzinger, M; Midgley, J; Pinsk, M; Rodd, C; Shenouda, N; Stein, R; Stephure, D; Taback, S; Williams, K; Rauch, F; Siminoski, K; Ward, LM

    2014-01-01

    Introduction Vertebral fracture (VF) incidence following glucocorticoid (GC) initiation has not been previously reported in pediatric nephrotic syndrome. Methods VF were assessed on radiographs (Genant method); lumbar spine bone mineral density (LS BMD) was evaluated by dual-energy x-ray absorptiometry. Results Sixty-five children were followed to 12 months post-GC initiation (median age: 5.4 years, range 2.3 to 17.9). Three of 54 children with radiographs (6%, 95% CI 2 to 15%) had incident VF at 1 year. The mean LS BMD Z-score was below the healthy average at baseline (mean ± SD −0.5 ± 1.1 p=0.001) and at 3 months (−0.6 ± 1.1 p<0.001), but not at 6 months (−0.3 ± 1.3, p=0.066) or 12 months (−0.3 ± 1.2, p=0.066). Mixed effect modeling showed a significant increase in LS BMD Z-scores between 3 and 12 months (0.22 SD, 95% CI 0.08 to 0.36, p=0.003). A sub-group (N=16; 25%) had LS BMD Z-scores that were ≤ −1.0 at 12 months. In these children, each additional 1000 mg/m2 of GC received in the first 3 months was associated with a decrease in LS BMD Z-score by 0.39 at 12 months (95% CI, −0.71 to −0.07; p=0.017). Conclusions The incidence of VF at 1 year was low and LS BMD Z-scores improved by 12 months in the majority. Twenty-five percent of children had LS BMD Z-scores ≤ −1.0 at 12 months. In these children, LS BMD Z-scores were inversely associated with early GC exposure, despite similar GC exposure compared to the rest of the cohort. PMID:23948876

  18. A brief intervention for weight management in primary care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Obesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment. Methods/design We propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n = 60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n = 1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up. Discussion Trial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop

  19. How chaosity and randomness control human health

    NASA Astrophysics Data System (ADS)

    Yulmetyev, Renat M.; Yulmetyeva, Dinara; Gafarov, Fail M.

    2005-08-01

    We discuss the fundamental role that chaosity and randomness play in the determination of quality and efficiency of medical treatment. The statistical parameter of non-Markovity from non-equilibrium statistical physics of condensed matters is offered as a quantitative information measure of chaosity and randomness. The role of chaosity and randomness is determined by the phenomenological property, which includes quantitative informational measures of chaosity and randomness and pathology (disease) in a covariant form. Manifestations of the statistical informational behavior of chaosity and randomness are examined while analyzing the chaotic dynamics of RR intervals from human ECG's, the electric signals of a human muscle's tremor of legs in a normal state and at Parkinson disease, the electric potentials of the human brain core from EEG's during epileptic seizure and a human hand finger tremor in Parkinson's disease. The existence of the above stated informational measure allows to introduce the quantitative factor of the quality of treatment. The above-stated examples confirm the existence of new phenomenological property, which is important not only for the decision of medical problems, but also for the analysis of the wide range of problems of physics of complex systems of life and lifeless nature.

  20. Randomized Controlled Trial of Web-Based Decisional Balance Feedback and Personalized Normative Feedback for College Drinkers

    PubMed Central

    Collins, Susan E; Kirouac, Megan; Lewis, Melissa A; Witkiewitz, Katie; Carey, Kate B

    2014-01-01

    Objective: Web-based personalized feedback interventions, particularly personalized normative feedback (PNF), are efficacious in improving college drinking outcomes; however, no personalized feedback interventions to date have provided college drinkers with feedback about their own decisional balance. This study tested the relative efficacy of a novel decisional balance feedback (DBF) intervention, PNF, and an assessment-only control condition. Method: Participants (N = 724; 56% female) were undergraduate students at a 4-year university in the U.S. Pacific Northwest and were randomized to receive one-time exposure to web-based DBF, PNF, or assessment only. Web-based assessment occurred at baseline and at 1-, 6-, and 12-month follow-ups and included measures of motivation to change, drinking quantity norms, drinking frequency/quantity, and alcohol-related problems. Results: At the 1-month follow-up, DBF and PNF participants reported reductions in alcohol-related problems; however, only PNF participants reduced their drinking frequency and quantity. At the 6-month follow-up, only DBF participants showed significant reductions in drinking quantity and alcohol-related problems. Neither group maintained reductions in alcohol use or alcohol-related problems at the 12-month follow-up. Conclusions: This study provided preliminary evidence that web-based DBF and PNF are efficacious interventions for college drinkers, with DBF having somewhat longer lasting effects. PMID:25343656

  1. Comparing different boosters of planning interventions on changes in fat consumption in overweight and obese individuals: a randomized controlled trial.

    PubMed

    Scholz, Urte; Ochsner, Sibylle; Luszczynska, Aleksandra

    2013-01-01

    Single planning interventions have been found to promote short-term dietary change. Repeated planning interventions may foster long-term effects on behavior change. It remains unknown whether there is a critical number of boosters to establish long-term maintenance of behavioral changes. This study aimed at investigating what social-cognitive variables mediate the effects of the interventions on dietary behavior change. Overall, 373 participants (n = 270 women, 72.4%; age M = 52.42, SD = 12.79) were randomly allocated to one of five groups: a control group, a single planning group, and three groups with 3, 6, or 9 weeks' repeated planning interventions. Follow-ups took place 4, 6, and 12 months after baseline. Change in fat consumption was not promoted by any of the interventions. In terms of social-cognitive variables, intentions, self-efficacy and coping planning displayed a time × group interaction, with the 9 weeks' planning group showing the most beneficial effects. Effect sizes, however, were very small. None of the tested planning interventions successfully promoted change in fat consumption across the 12 month period. This, however, could not be explained by problems with adherence to the intervention protocol. Potential explanations for this unexpected result are discussed. PMID:22519565

  2. Percutaneous osseointegrated prostheses for amputees: Limb compensation in a 12-month ovine model.

    PubMed

    Shelton, Trevor J; Beck, J Peter; Bloebaum, Roy D; Bachus, Kent N

    2011-10-13

    Percutaneous osseointegrated prostheses are being investigated as an alternative strategy to attach prosthetic limbs to patients. Although the use of these implants has shown to be promising in clinical trials, the ability to maintain a skin seal around an osseointegrated implant interface is a major challenge to prevent superficial and deep periprosthetic infections. The specific aim of this study was to establish a translational load-bearing ovine model to assess postoperative limb compensation and gait symmetry following a percutaneous osseointegrated implant. We tested the following hypotheses: (1) the animals would return to pre-amputation limb loads within 12-months; (2) the animals would return to a symmetrical gait pattern (stride length and time in stance) within 12-months. The results demonstrated that one month following surgery, the sheep loaded their amputated limb to a mean value of nearly 80% of their pre-amputation loading condition; by 12-months, this mean had dropped to approximately 74%. There was no statistical differences between the symmetry of the amputated forelimb and the contralateral forelimb at any time point for the animals stride length or the time spent in the stance phase of their gait cycle. Thus, the data showed that while the animals maintained symmetric gait patterns, they did not return to full weight-bearing after 12-months. The results of this study showed that a large animal load-bearing model had a symmetric gait and was weight bearing for up to 12 months. While the current investigation utilizes an ovine model, the data show that osseointegrated implant technology with postoperative follow-up can help our human patients return to symmetric gait and maintain an active lifestyle, leading to an improvement in their quality of life following amputation. PMID:21920525

  3. Percutaneous Osseointegrated Prostheses for Amputees: Limb Compensation in a 12-Month Ovine model

    PubMed Central

    Shelton, Trevor J.; Beck, J. Peter; Bloebaum, Roy D.; Bachus, Kent N.

    2011-01-01

    Percutaneous osseointegrated prostheses are being investigated as an alternative strategy to attach prosthetic limbs to patients. Although the use of these implants has shown to be promising in clinical trials; the ability to maintain a skin seal around an osseointegrated implant interface is a major challenge to prevent superficial and deep periprosthetic infections. The specific aim of this study was to establish a translational load-bearing ovine model to assess postoperative limb compensation and gait symmetry following a percutaneous integrated implant. We tested the following hypotheses: (1) the animals would return to pre-amputation limb loads within 12-months; (2) the animals would return to a symmetrical gait pattern (stride length and time in stance) within 12-months. The results demonstrated that one month following surgery, the sheep loaded their amputated limb to a mean value of nearly 80% of their pre-amputation loading condition; by 12-months, this mean had dropped to approximately 74%. There were no statistical differences between the symmetry of the amputated forelimb and the contralateral forelimb at any time point for the animals stride length or the time spent in the stance phase of their gait cycle. Thus, the data showed that while the animals maintained symmetric gait patterns, they did not return to full weight-bearing after 12-months. The results of this study showed that a large animal load-bearing model had a symmetric gait and was weight bearing for up to 12 months. While the current investigation utilizes an ovine model, there data show that osseointegrated implant technology with postoperative follow-up can help our human patients return to symmetric gait and maintain an active lifestyle, leading to an improvement in their quality of life following amputation. PMID:21920525

  4. The Effect of Deworming on Growth in One-Year-Old Children Living in a Soil-Transmitted Helminth-Endemic Area of Peru: A Randomized Controlled Trial

    PubMed Central

    Joseph, Serene A.; Casapía, Martín; Montresor, Antonio; Rahme, Elham; Ward, Brian J.; Marquis, Grace S.; Pezo, Lidsky; Blouin, Brittany; Maheu-Giroux, Mathieu; Gyorkos, Theresa W.

    2015-01-01

    Background Appropriate health and nutrition interventions to prevent long-term adverse effects in children are necessary before two years of age. One such intervention may include population-based deworming, recommended as of 12 months of age by the World Health Organization in soil-transmitted helminth (STH)-endemic areas; however, the benefit of deworming has been understudied in early preschool-age children. Methodology/Principal Findings A randomized, double-blind, placebo-controlled trial was conducted to determine the effect of deworming (500 mg single-dose crushed mebendazole tablet) on growth in one-year-old children in Iquitos, Peru. Children were enrolled during their routine 12-month growth and development clinic visit and followed up at their 18 and 24-month visits. Children were randomly allocated to: Group 1: deworming at 12 months and placebo at 18 months; Group 2: placebo at 12 months and deworming at 18 months; Group 3: deworming at both 12 and 18 months; or Group 4: placebo at both 12 and 18 months (i.e. control group). The primary outcome was weight gain at the 24-month visit. An intention-to-treat approach was used. A total of 1760 children were enrolled between September 2011 and June 2012. Follow-up of 1563 children (88.8%) was completed by July 2013. STH infection was of low prevalence and predominantly light intensity in the study population. All groups gained between 1.93 and 2.05 kg on average over 12 months; the average difference in weight gain (kg) compared to placebo was: 0.05 (95% CI: -0.05, 0.17) in Group 1; -0.07 (95%CI: -0.17, 0.04) in Group 2; and 0.04 (95%CI: -0.06, 0.14) in Group 3. There was no statistically significant difference in weight gain in any of the deworming intervention groups compared to the control group. Conclusions Overall, with one year of follow-up, no effect of deworming on growth could be detected in this population of preschool-age children. Low baseline STH prevalence and intensity and/or access to

  5. Coping and Parenting: Mediators of 12-Month Outcomes of a Family Group Cognitive-Behavioral Preventive Intervention with Families of Depressed Parents

    PubMed Central

    Compas, Bruce E.; Champion, Jennifer E.; Forehand, Rex; Cole, David A.; Reeslund, Kristen L.; Fear, Jessica; Hardcastle, Emily J.; Keller, Gary; Rakow, Aaron; Garai, Emily; Merchant, Mary Jane; Roberts, Lorinda

    2011-01-01

    In a randomized clinical trial with 111 families of parents with a history of major depressive disorder (86% mothers; 86% Caucasian), changes in adolescents’ (mean age 11 years; 42% female) coping and parents’ parenting skills were examined as mediators of the effects of a family group cognitive behavioral preventive intervention on adolescents’ internalizing and externalizing symptoms. Changes in hypothesized mediators were assessed at 6-months and changes in adolescents’ symptoms were measured at 12-month follow-up. Significant differences favoring the family intervention as compared with a written information comparison condition were found for changes in composite measures of parent-adolescent reports of adolescents’ use of secondary control coping skills and direct observations of parents’ positive parenting skills. Changes in adolescents’ secondary control coping and positive parenting mediated the effects of the intervention on depressive, internalizing and externalizing symptoms accounting for approximately half of the effect of the intervention on the outcomes. Further, reciprocal relations between children’s internalizing symptoms and parenting were found from baseline to 6-month follow-up. Implications for the prevention of psychopathology in offspring of depressed parents are highlighted. PMID:20873898

  6. Esthetic Outcomes of Single-Tooth Implant-Supported Restorations Using Metal-Ceramic Restorations with Zirconia or Titanium Abutments: A Randomized Controlled Clinical Study.

    PubMed

    Baldini, Nicola; D'Elia, Chiara; Clementini, Marco; Carrillo de Albornoz, Ana; Sanz, Mariano; De Sanctis, Massimo

    2016-01-01

    The aim of this study was to test whether zirconia abutments exhibit the same clinical and esthetic outcomes as titanium abutments in single-tooth implant restorations in the esthetic area. The 24 treated patients were randomly assigned to a test (zirconia abutment) or control (titanium abutment) group. Objective evaluations were carried out using the Implant Crown Aesthetic Index (ICAI) and the Papilla Index (PI) at the 1-month and 12-month follow-up examinations after crown cementation. No significant differences, either in ICAI or in other periodontal or radiographic measurements, were observed. At 1 year, zirconia and titanium abutments exhibited the same esthetic outcomes. PMID:27333019

  7. The association between self-reported racial discrimination and 12-month DSM-IV mental disorders among Asian Americans nationwide

    PubMed Central

    Spencer, Michael; Chen, Juan; Yip, Tiffany; Takeuchi, David T.

    2007-01-01

    Growing research finds that reports of discrimination are associated with mental health. However, many US studies are focused on regional samples and do not control for important confounders such as other stressors and health conditions. The present study examines the association between self-reported racial discrimination and DSM-IV defined mental disorders among Asian respondents to the 2002–2003 US National Latino and Asian American Study (n=2,047). Logistic regression analyses indicated that self-reported racial discrimination was associated with greater odds of having any DSM-IV disorder, depressive disorder, or anxiety disorder within the past 12 months -- controlling for sociodemographic characteristics, acculturative stress, family cohesion, poverty, self-rated health, chronic physical conditions, and social desirability. Further, multinomial logistic regression found that individuals who reported discrimination were at a twofold greater risk of having one disorder within the past 12 months, and a threefold greater risk of having two or more disorders. Thus, self-reported discrimination was associated with increased risk of mental disorders among Asian Americans across the United States and this relationship was not explained by social desirability, physical health, other stressors, and sociodemographic factors. Should these associations ultimately be shown enduring and causal, they suggest that policies designed to reduce discrimination may help improve mental health. PMID:17374553

  8. Digital servo control of random sound fields

    NASA Technical Reports Server (NTRS)

    Nakich, R. B.

    1973-01-01

    It is necessary to place number of sensors at different positions in sound field to determine actual sound intensities to which test object is subjected. It is possible to determine whether specification is being met adequately or exceeded. Since excitation is of random nature, signals are essentially coherent and it is impossible to obtain true average.

  9. An Internet Intervention to Improve Asthma Management: Rationale and Protocol of a Randomized Controlled Trial

    PubMed Central

    Lau, Annie YS; Dennis, Sarah; Liaw, Siaw-Teng; Coiera, Enrico

    2013-01-01

    Background Many studies have shown the effectiveness of self-management for patients with asthma. In particular, possession and use of a written asthma action plan provided by a doctor has shown to significantly improve patients’ asthma control. Yet, uptake of a written asthma action plan and preventative asthma management is low in the community, especially amongst adults. Objective A Web-based personally controlled health management system (PCHMS) called Healthy.me will be evaluated in a 2010 CONSORT-compliant 2-group (static websites verse PCHMS) parallel randomized controlled trial (RCT) (allocation ratio 1:1). Methods The PCHMS integrates an untethered personal health record with consumer care pathways and social forums. After eligibility assessment, a sample of 300 adult patients with moderate persistent asthma will be randomly assigned to one of these arms. After 12 months of using either Healthy.me or information websites (usual care arm), a post-study assessment will be conducted. Results The primary outcome measure is possession of or revision of an asthma action plan during the study. Secondary outcome measures include: (1) adherence to the asthma action plan, (2) rate of planned and unplanned visits to healthcare providers for asthma issues, (3) usage patterns of Healthy.me and attrition rates, (4) asthma control and asthma exacerbation scores, and (5) impact of asthma on life and competing demands, and days lost from work. Conclusions This RCT will provide insights into whether access to an online PCHMS will improve uptake of a written asthma action plan and preventative asthma actions. Trial Registration Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12612000716864; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362714 (Archived by WebCite at http://www.webcitation.org/6IYBJGRnW). PMID:23942523

  10. Nurse Case Management and Housing Interventions Reduce Allergen Exposures: The Milwaukee Randomized Controlled Trial

    PubMed Central

    Breysse, Jill; Wendt, Jean; Dixon, Sherry; Murphy, Amy; Wilson, Jonathan; Meurer, John; Cohn, Jennifer; Jacobs, David E.

    2011-01-01

    Objective We examined the impact of a combination of home environmental interventions and nurse case management services on total settled dust loadings and on allergen concentrations in the homes of asthmatic children. Methods Using a randomized longitudinal controlled trial study design, we randomly assigned homes of asthmatic children in Milwaukee to either a control (n=64) or an intervention (n=57) group. Control group homes received a visual assessment, education, bed/pillow dust mite encasings, and treatment of lead-based paint hazards. The intervention group received these same services plus nurse case management that included tailored, individual asthma action plans, provision of minor home repairs, home cleaning using special vacuuming and wet washing, and integrated pest management. Dust vacuum samples were collected from measured surface areas of floors in the TV room, kitchen, and child's bedroom at baseline and at three-, six-, and 12-month follow-up visits. Dust loading (mass per surface area) is a means of measuring total dust and the total amount of allergen present. Results For the intervention group, geometric mean dust loadings declined significantly from baseline (39 milligrams per square foot [mg/ft2]) to post-intervention (11 mg/ft2) (p<0.001). Baseline dust loading, treatment group, visit, and season were significant predictors of follow-up dust loadings. Mean post-intervention dust loadings were 72% higher in the control group. The total amount of allergen in settled house dust declined significantly following the intervention because total dust loading declined; the concentration of allergens in settled dust did not change significantly. Conclusion The combination of nurse case management and home environmental interventions promotes collaboration between health and housing professionals and is effective in reducing exposures to allergens in settled dust. PMID:21563716

  11. Improving district facility readiness: a 12-month evaluation of a data-driven health systems strengthening intervention in rural Rwanda

    PubMed Central

    Iyer, Hari S.; Kamanzi, Emmanuel; Mugunga, Jean Claude; Finnegan, Karen; Uwingabiye, Alice; Shyaka, Edward; Niyonzima, Saleh; Hirschhorn, Lisa R.; Drobac, Peter C.

    2015-01-01

    Background While health systems strengthening (HSS) interventions are recommended by global health policy experts to improve population health in resource-limited settings, few examples exist of evaluations of HSS interventions conducted at the district level. In 2009, a partnership between Partners In Health (PIH), a non-governmental organization, and the Rwandan Ministry of Health (RMOH) was provided funds to implement and evaluate a district-level HSS intervention in two rural districts of Rwanda. Design The partnership provided limited funds to 14 health centers for targeted systems support in 2010; six others received support prior to the intervention (reference). RMOH health systems norms were mapped across the WHO HSS framework, scored from 0 to 10 and incorporated into a rapid survey assessing 11 domains of facility readiness. Stakeholder meetings allowed partnership leaders to review results, set priorities, and allocate resources. Investments included salary support, infrastructure improvements, medical equipment, and social support for patients. We compared facility domain scores from the start of the intervention to 12 months and tested for correlation between change in score and change in funding allocation to assess equity in our approach. Results We found significant improvements among intervention facilities from baseline to 12 months across several domains [infrastructure (+4, p=0.0001), clinical services (+1.2, p=0.03), infection and sanitation control (+0.6, p=0.03), medical equipment (+1.0, p=0.02), information use (+2, p=0.002)]. Composite score across domains improved from 6.2 at baseline to 7.4 at 12 months (p=0.002). Across facilities, 50% had composite scores greater than the average score among reference facilities (7.4) at 12 months compared to none at baseline. Conclusions Rapid facility surveys, stakeholder engagement, and information feedback can be used for gap analysis and resource allocation. This approach can achieve effective use

  12. Parent-Infant Vocalisations at 12 Months Predict Psychopathology at 7 Years

    ERIC Educational Resources Information Center

    Allely, C. S.; Purves, D.; McConnachie, A.; Marwick, H.; Johnson, P.; Doolin, O.; Puckering, C.; Golding, J.; Gillberg, C.; Wilson, P.

    2013-01-01

    This study investigated the utility of adult and infant vocalisation in the prediction of child psychopathology. Families were sampled from the Avon Longitudinal Study of Parents and Children (ALSPAC) birth cohort. Vocalisation patterns were obtained from 180 videos (60 cases and 120 randomly selected sex-matched controls) of parent-infant…

  13. Randomized controlled trial of parental responsiveness intervention for toddlers at high risk for autism.

    PubMed

    Kasari, Connie; Siller, Michael; Huynh, Linh N; Shih, Wendy; Swanson, Meghan; Hellemann, Gerhard S; Sugar, Catherine A

    2014-11-01

    This study tested the effects of a parent-mediated intervention on parental responsiveness with their toddlers at high risk for an autism spectrum disorder (ASD). Participants included caregivers and their 66 toddlers at high risk for ASD. Caregivers were randomized to 12 sessions of an individualized parent education intervention aimed at improving parental responsiveness or to a monitoring control group involving 4 sessions of behavioral support. Parental responsiveness and child outcomes were measured at three time points: at beginning and end of the 3-month treatment and at 12-months post-study entry. Parental responsiveness improved significantly in the treatment group but not the control group. However, parental responsiveness was not fully maintained at follow up. There were no treatment effects on child outcomes of joint attention or language. Children in both groups made significant developmental gains in cognition and language skills over one year. These results support parental responsiveness as an important intervention target given its general association with child outcomes in the extant literature; however, additional supports are likely needed to fully maintain the treatment effect and to affect child outcomes. PMID:25260191

  14. Intervention for infants with brain injury: Results of a randomized controlled study

    PubMed Central

    Badr, Lina Kurdahi; Garg, Meena; Kamath, Meghna

    2009-01-01

    A randomized clinical trail (RCT) employed a 12-month individualized cognitive/sensorimotor stimulation program to look at the efficacy of the intervention on 62 infants with suspected brain injury. The control group infants received the State-funded follow-up program provided by the Los Angeles (LA) Regional Centers while the intervention group received intensive stimulation using the Curriculum and Monitoring System (CAMS) taught by public health nurses (PHNs). The developmental assessments and outcome measures were performed at 6, 12 and 18 months corrected age and included the Bayley motor and mental development, the Home, mother–infant interaction (Nursing Child Assessment Feeding Scale (NCAFS) and Nursing Child Assessment Teaching Scale (NCATS)), parental stress and social support. At 18 months, 43 infants remained in the study. The results indicate that the intervention had minimal positive effects on the Bayley mental and motor development scores of infants in the intervention group. Likewise, the intervention did not contribute to less stress or better mother–infant interaction at 12 or 18 months although there were significant differences in the NCAFS scores favoring the intervention group at 6 months. There was a significant trend, however, for the control group to have a significant decrease over time on the Bayley mental scores. Although the sample was not large and attrition was at 31%, this study provides further support to the minimal effects of stimulation and home intervention for infants with brain injury and who may have more significant factors contributing to their developmental outcome. PMID:17138264

  15. Research Aimed at Improving Both Mood and Weight (RAINBOW) in Primary Care: A Type 1 hybrid design randomized controlled trial

    PubMed Central

    Ma, Jun; Yank, Veronica; Lv, Nan; Goldhaber-Fiebert, Jeremy D.; Lewis, Megan A.; Kramer, M. Kaye; Snowden, Mark B.; Rosas, Lisa G.; Xiao, Lan; Blonstein, Andrea C.

    2015-01-01

    Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n=404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system’s services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance™). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE’s cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated—through a new model of accessible and integrative lifestyle medicine and mental health expertise—in primary care. PMID:26096714

  16. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial.

    PubMed

    Ma, Jun; Yank, Veronica; Lv, Nan; Goldhaber-Fiebert, Jeremy D; Lewis, Megan A; Kramer, M Kaye; Snowden, Mark B; Rosas, Lisa G; Xiao, Lan; Blonstein, Andrea C

    2015-07-01

    Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n = 404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system's services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance(™)). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE's cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated-through a new model of accessible and integrative lifestyle medicine and mental health expertise-in primary care. PMID:26096714

  17. Complementary feeding: a Global Network cluster randomized controlled trial

    PubMed Central

    2011-01-01

    Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale

  18. Narrative exposure therapy for 7- to 16-year-olds: a randomized controlled trial with traumatized refugee children.

    PubMed

    Ruf, Martina; Schauer, Maggie; Neuner, Frank; Catani, Claudia; Schauer, Elisabeth; Elbert, Thomas

    2010-08-01

    The authors examined the effectiveness of narrative exposure therapy for children (KIDNET) in treating posttraumatic stress disorder (PTSD) in refugee children living in exile. Twenty-six children traumatized by organized violence were randomly assigned to KIDNET or to a waiting list. Significant treatment by time interactions on all PTSD-relevant variables indicated that the KIDNET group, but not the controls, showed a clinically significant improvement in symptoms and functioning. Success of the KIDNET group remained stable at 12-month follow-up. This study confirms previous findings that, if left untreated, PTSD in children may persist for an extended period. However, it also shows that it is possible to effectively treat chronic PTSD and restore functioning in traumatized refugee children in only 8 treatment sessions. PMID:20684019

  19. Adding a Motivational Interviewing Pretreatment to Cognitive Behavioral Therapy for Generalized Anxiety Disorder: A Preliminary Randomized Controlled Trial

    PubMed Central

    Westra, Henny A.; Arkowitz, Hal; Dozois, David J.A.

    2009-01-01

    Seventy six individuals with a principal diagnosis of generalized anxiety disorder (GAD) were randomly assigned to receive either an MI pretreatment or no pretreatment (NPT), prior to receiving CBT. Significant group differences favoring the MI-CBT group were observed on the hallmark GAD symptom of worry and on therapist-rated homework compliance, which mediated the impact of treatment group on worry reduction. Adding MI pretreatment to CBT was specifically and substantively beneficial for individuals with high worry severity at baseline. There was evidence of relapse at 6-month follow-up for high severity individuals who received MI-CBT, but significant moderator effects favoring the high severity MI-CBT group were again apparent at 12-months post-treatment. Pending replication in a more controlled test, these findings suggest that MI may be a promising adjunct to CBT for GAD for those of high severity, a group which has been less responsive to CBT in past research. PMID:19665347

  20. Angiotensin II Receptor Blockers and Cancer Risk: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Zhao, Yun-Tao; Li, Peng-Yang; Zhang, Jian-Qiang; Wang, Lei; Yi, Zhong

    2016-05-01

    Angiotensin II receptor blockers (ARB) are widely used drugs that are proven to reduce cardiovascular disease events; however, several recent meta-analyses yielded conflicting conclusions regarding the relationship between ARB and cancer incidence, especially when ARB are combined with angiotensin-converting enzyme inhibitors (ACEI).We investigated the risk of cancer associated with ARB at different background ACEI levels.Search of PubMed and EMBASE (1966 to December 17, 2015) without language restriction.Randomized, controlled trials (RCTs) had at least 12 months of follow-up data and reported cancer incidence was included.Study characteristics, quality, and risk of bias were assessed by 2 reviewers independently.Nineteen RCTs including 148,334 patients were included in this study. Random-effects model meta-analyses were used to estimate the risk ratio (RR) of cancer risk. No excessive cancer risk was observed in our analyses of ARB alone versus placebo alone without background ACEI use (risk ratio [RR] 1.08, 95% confidence interval [CI] 1.00-1.18, P = 0.05); ARB alone versus ACEI alone (RR 1.03, 95%CI 0.94-1.14, P = 0.50); ARB plus partial use of ACEI versus placebo plus partial use of ACEI (RR 0.97, 95%CI 0.90-1.04, P = 0.33); and ARB plus ACEI versus ACEI (RR 0.99, 95%CI 0.79-1.24, P = 0.95).Lack of long-term data, inadequate reporting of safety data, significant heterogeneity in underlying study populations, and treatment regimens.ARB have a neutral effect on cancer incidence in randomized trials. We observed no significant differences in cancer incidence when we compared ARB alone with placebo alone, ARB alone with ACEI alone, ARB plus partial use of ACEI with placebo plus partial use of ACEI, or ARB plus ACEI combination with ACEI. PMID:27149494

  1. The flexibility of 12-month-olds' preferences for phonologically appropriate object labels.

    PubMed

    MacKenzie, Heather K; Graham, Susan A; Curtin, Suzanne; Archer, Stephanie L

    2014-02-01

    We explored 12-month-olds' flexibility in accepting phonotactically illegal or ill-formed word forms in a modified associative-learning task. Sixty-four English-learning infants were presented with a training phase that either clarified the purpose of a sound-object association task or left the task ambiguous. Infants were then habituated to sets of Czech words with onsets that are illegal in English (e.g., ptak), consonantal sounds (e.g., /l/), or novel functionlike words (e.g., iv). When infants were provided with a training phase that highlighted the purpose of the task, they associated the phonotactically illegal Czech words, but not the consonantal sounds or novel functionlike words, with objects. Thus, English-learning 12-month-old infants' flexibility in associating various sound forms with novel objects is limited to labels that share the structural shape of well-formed nounlike words. PMID:23815699

  2. Randomized controlled trials: what are they and who needs them?

    PubMed

    Pihlstrom, Bruce L; Curran, Alice E; Voelker, Helen T; Kingman, Albert

    2012-06-01

    Dentistry is rapidly entering a new era of evidence-based practice, and society is demanding prevention and treatment that has been proven to be effective in terms of meaningful health outcomes. Practitioners, individual patients and the public need randomized controlled trials because they provide the highest level of scientific evidence to change clinical practice and inform public health policy. Well-designed randomized controlled trials are conceptually simple but deceptively complex to design, implement and translate into clinical practice. Randomized controlled trials are fundamentally different from observational clinical research because they randomly assign volunteers to receive test or control interventions, they are prospective and the success of the test intervention is based on a meaningful clinical outcome that is specified before the trial begins. To be successful, randomized controlled trials must be carefully designed and powered to answer a specific question that will be generalizable to the population under study. Randomized controlled trials can be designed to evaluate efficacy, effectiveness, superiority, equivalence or noninferiority. Prominent issues and challenges in designing and conducting randomized controlled trials include carefully defining enrollment criteria, establishing an organizational infrastructure, use of a data-coordinating center, developing a manual of procedures, obtaining informed consent, recruiting and ensuring the safety of volunteer subjects, ensuring data quality, analysis and publication of trial outcomes, and translating results into clinical practice. PMID:22507057

  3. An online guided ACT intervention for enhancing the psychological wellbeing of university students: A randomized controlled clinical trial.

    PubMed

    Räsänen, Panajiota; Lappalainen, Päivi; Muotka, Joona; Tolvanen, Asko; Lappalainen, Raimo

    2016-03-01

    Stress, anxiety and depression are relatively common problems among university students. This study examined whether an online psychological intervention aiming at enhancing the wellbeing of university students could be an effective and practical alternative for meeting the needs of a university population. University students (N = 68; 85% female; 19-32 years old) were randomly assigned to either a guided seven-week online Acceptance and Commitment Therapy (iACT) intervention or a waiting list control condition (WLC). A between-groups pre-post (iACT vs WLC) design with 12-month follow-up for the iACT participants was conducted. The intervention participants were offered two face-to-face meetings, completed online exercises during a five-week period, and received personal weekly written feedback via the website from their randomly assigned, trained student coaches. Waitlist participants were offered the intervention program soon after the post measurements. Results in this small efficacy trial showed that the iACT participants had significantly higher gains in wellbeing (between group, d = 0.46), life satisfaction (d = 0.65), and mindfulness skills (d = 0.49). In addition, iACT participants' self-reported stress (d = 0.54) and symptoms of depression (d = 0.69) were significantly reduced compared to the participants in the control group. These benefits were maintained over a 12-month follow-up period (within iACT group, d = 0.65-0.69, for primary measures). The results suggest that an online-based, coach-guided ACT program with blended face-to-face and online sessions could be an effective and well-accepted alternative for enhancing the wellbeing of university students. PMID:26848517

  4. 26 CFR 1.443-1 - Returns for periods of less than 12 months.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 26 Internal Revenue 6 2013-04-01 2013-04-01 false Returns for periods of less than 12 months. 1.443-1 Section 1.443-1 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED... period ($18,836×1/12) 1,570 Example 3. The Y Corporation makes a re- turn for the six-month period...

  5. 26 CFR 1.443-1 - Returns for periods of less than 12 months.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 26 Internal Revenue 6 2012-04-01 2012-04-01 false Returns for periods of less than 12 months. 1.443-1 Section 1.443-1 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED... period ($18,836×1/12) 1,570 Example 3. The Y Corporation makes a re- turn for the six-month period...

  6. 26 CFR 1.443-1 - Returns for periods of less than 12 months.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 26 Internal Revenue 6 2010-04-01 2010-04-01 false Returns for periods of less than 12 months. 1.443-1 Section 1.443-1 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED... period ($18,836×1/12) 1,570 Example 3. The Y Corporation makes a re- turn for the six-month period...

  7. 26 CFR 1.443-1 - Returns for periods of less than 12 months.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 26 Internal Revenue 6 2011-04-01 2011-04-01 false Returns for periods of less than 12 months. 1.443-1 Section 1.443-1 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED... period ($18,836×1/12) 1,570 Example 3. The Y Corporation makes a re- turn for the six-month period...

  8. 77 FR 60509 - Endangered and Threatened Wildlife and Plants; 12-Month Finding for the Lemmon Fleabane...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list as an endangered or threatened species Erigeron lemmonii (Lemmon fleabane). After a review of the best available scientific information we find that listing the Lemmon fleabane as an endangered or threatened species is no longer warranted, and therefore we are removing this species from the......

  9. Quit and Smoking Reduction Rates in Vape Shop Consumers: A Prospective 12-Month Survey

    PubMed Central

    Polosa, Riccardo; Caponnetto, Pasquale; Cibella, Fabio; Le-Houezec, Jacques

    2015-01-01

    Aims: Here, we present results from a prospective pilot study that was aimed at surveying changes in daily cigarette consumption in smokers making their first purchase at vape shops. Modifications in products purchase were also noted. Design: Participants were instructed how to charge, fill, activate and use their e-cigarettes (e-cigs). Participants were encouraged to use these products in the anticipation of reducing the number of cig/day smoked. Settings: Staff from LIAF contacted 10 vape shops in the province of the city of Catania (Italy) that acted as sponsors to the 2013 No Tobacco Day. Participants: 71 adult smokers (≥18 years old) making their first purchase at local participating vape shops were asked by professional retail staff to complete a form. Measurements: Their cigarette consumption was followed-up prospectively at 6 and 12 months. Details of products purchase (i.e., e-cigs hardware, e-liquid nicotine strengths and flavours) were also noted. Findings: Retention rate was elevated, with 69% of participants attending their final follow-up visit. At 12 month, 40.8% subjects could be classified as quitters, 25.4% as reducers and 33.8% as failures. Switching from standard refillables (initial choice) to more advanced devices (MODs) was observed in this study (from 8.5% at baseline to 18.4% at 12 month) as well as a trend in decreasing the e-liquid nicotine strength, with more participants adopting low nicotine strength (from 49.3% at baseline to 57.1% at 12 month). Conclusions: We have found that smokers purchasing e-cigarettes from vape shops with professional advice and support can achieve high success rates. PMID:25811767

  10. Stress fracture injury in female endurance athletes in the United Kingdom: A 12-month prospective study.

    PubMed

    Duckham, R L; Brooke-Wavell, K; Summers, G D; Cameron, N; Peirce, N

    2015-12-01

    Studies of stress fracture (SF) incidence are limited in number and geographical location; this study determined the incidence of SF injury in female endurance athletes based in the United Kingdom. A total of 70 athletes aged between 18 and 45 years were recruited and prospectively monitored for 12 months. Questionnaires at baseline and 12 months assessed SF, menstrual and training history, eating psychopathology, and compulsive exercise. Peak lower leg muscle strength was assessed in both legs using an isometric muscle rig. Bone mineral density (BMD) of total body, spine, hip, and radius was assessed using dual X-ray absorptiometry. Among the 61 athletes who completed the 12-month monitoring, two sustained a SF diagnosed by magnetic resonance imaging, giving an incidence rate (95% confidence intervals) of 3.3 (0.8, 13.1) % of the study population sustaining a SF over 12 months. The SF cases were 800 m runners aged 19 and 22 years, training on average 14.2 h a week, eumenorrheic with no history of menstrual dysfunction. Case 1 had a higher than average energy intake and low eating psychopathology and compulsive exercise scores, while the reverse was true in case 2. BMD in both cases was similar to mean values in the non-SF group. The incidence of SF in our female endurance athlete population based in the United Kingdom was 3.3%, which is lower than previously reported. Further work is needed to confirm the current incidence of SF and evaluate the associated risk factors. PMID:25892560

  11. Reduced Cognitive Function Predicts Functional Decline in Patients with Heart Failure over 12 months

    PubMed Central

    Alosco, Michael L.; Spitznagel, Mary Beth; Cohen, Ronald; Sweet, Lawrence H.; Colbert, Lisa H.; Josephson, Richard; Hughes, Joel; Rosneck, Jim; Gunstad, John

    2016-01-01

    Background Impaired activities of daily living (ADL) are common in heart failure (HF) patients and contribute to the elevated mortality and hospitalization rates in this population. Cognitive impairment is also prevalent in HF, though its ability to predict functional decline over time is unknown. Aims This study examined the longitudinal pattern of activities of daily living in HF persons and whether reduced baseline cognitive status predicts functional decline in this population. Methods 110 persons with HF completed the Lawton-Brody Activities of Daily Living Scale and were administered the Modified Mini-Mental Status Examination (3MS) at baseline and a 12-month follow-up. Three composite scores were derived from the Lawton-Brody, including total, instrumental, and basic ADLs. Results HF patients reported high rates of baseline impairments in instrumental ADLs, including shopping, food preparation, housekeeping duties, laundry, among others. Repeated measures analyses showed significant declines in total and instrumental ADLs from baseline to the 12-month follow-up in HF (p < .05). Hierarchical regression analyses showed that poorer baseline performance on the 3MS predicted worse total ADL performance at 12-months (β = .15, p = .049), including greater dependence in shopping, driving, feeding, and physical ambulation (p < .05 for all). Conclusion The current results show that HF patients report significant functional decline over a 12-month period and brief cognitive tests can identify those patients at highest risk for decline. If replicated, such findings encourage the use of cognitive screening measures to identify HF patients most likely to require assistance with ADL tasks. PMID:23754840

  12. 6 Minute Walk Test in Duchenne MD Patients with Different Mutations: 12 Month Changes

    PubMed Central

    Pane, Marika; Mazzone, Elena S.; Sormani, Maria Pia; Messina, Sonia; Vita, Gian Luca; Fanelli, Lavinia; Berardinelli, Angela; Torrente, Yvan; D'Amico, Adele; Lanzillotta, Valentina; Viggiano, Emanuela; D'Ambrosio, Paola; Cavallaro, Filippo; Frosini, Silvia; Bello, Luca; Bonfiglio, Serena; Scalise, Roberta; De Sanctis, Roberto; Rolle, Enrica; Bianco, Flaviana; Van der Haawue, Marlene; Magri, Francesca; Palermo, Concetta; Rossi, Francesca; Donati, Maria Alice; Alfonsi, Chiara; Sacchini, Michele; Arnoldi, Maria Teresa; Baranello, Giovanni; Mongini, Tiziana; Pini, Antonella; Battini, Roberta; Pegoraro, Elena; Previtali, Stefano C.; Napolitano, Sara; Bruno, Claudio; Politano, Luisa; Comi, Giacomo P.; Bertini, Enrico; Morandi, Lucia; Gualandi, Francesca; Ferlini, Alessandra; Goemans, Nathalie; Mercuri, Eugenio

    2014-01-01

    Objective In the last few years some of the therapeutical approaches for Duchenne muscular dystrophy (DMD) are specifically targeting distinct groups of mutations, such as deletions eligible for skipping of individual exons. The aim of this observational study was to establish whether patients with distinct groups of mutations have different profiles of changes on the 6 minute walk test (6MWT) over a 12 month period. Methods The 6MWT was performed in 191 ambulant DMD boys at baseline and 12 months later. The results were analysed using a test for heterogeneity in order to establish possible differences among different types of mutations (deletions, duplications, point mutations) and among subgroups of deletions eligible to skip individual exons. Results At baseline the 6MWD ranged between 180 and 560,80 metres (mean 378,06, SD 74,13). The 12 month changes ranged between −325 and 175 (mean −10.8 meters, SD 69.2). Although boys with duplications had better results than those with the other types of mutations, the difference was not significant. Similarly, boys eligible for skipping of the exon 44 had better baseline results and less drastic changes than those eligible for skipping exon 45 or 53, but the difference was not significant. Conclusions even if there are some differences among subgroups, the mean 12 month changes in each subgroup were all within a narrow Range: from the mean of the whole DMD cohort. This information will be of help at the time of designing clinical trials with small numbers of eligible patients. PMID:24421885

  13. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

    PubMed Central

    Azar, Kristen MJ; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

    2015-01-01

    Background In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions The randomized trial will provide rigorous evidence regarding the efficacy of

  14. Alendronate Effect on the Prevention of Bone loss in Early Stages of Ankylosing Spondylitis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

    PubMed Central

    Khabbazi, Alireza; Noshad, Hamid; Gafarzadeh, Sevil; Hajialiloo, Mehrzad; Kolahi, Susan

    2014-01-01

    Background: Ankylosing spondylitis (AS) is an inflammatory rheumatic disease that leads to a progressive ankylosis of vertebras and ossification of paravertebral ligaments. Bone loss and osteoporosis are amongst the important complications of AS, treatment of which is a challenging issue. Objectives: This study aimed to clarify the effect of alendronate on the prevention of bone loss in patients with early AS. Patients and Methods: In a randomized, double-blind, placebo-controlled study, 24 patients with early stages of AS were recruited in Emam Reza Hospital, Tabriz University of Medical Sciences. The diagnostic criteria of early AS were Schober’s index ≥ 5, normal hip joint in pelvic radiography, and absence or rarity of syndesmophytes in spine radiography (Taylor index ≤ 1). The participants were randomly allocated to the treatment and control groups and received 70 mg/week of alendronate and the same dose of placebo, respectively, for 12 months. Before and 12 months after the intervention, bone densitometry was performed from lumbar and pelvic region using the dual-energy X-ray absorptiometry (DEXA) method with Hologic QDR model instrument. Patients, physicians who prescribed the medications and those who interpreted the outcomes, and densitometry technicians were unaware of the assigned medication to each patient. Both groups received supplemental calcium (1000 mg/day) and vitamin D (400 mg/day). Results: After 12 months of treatment, hip and lumbar bone mineral density differences were not statistically significant between study groups (P = 0.061 and P = 0.112, respectively). No case of clinically apparent vertebral and nonvertebral fracture were observed in the treatment and control groups. Conclusions: Our results suggested that applying alendronate was ineffective in preventing bone loss in patients with early stages of AS. PMID:25068053

  15. Noninvasive Positive Airway Pressure Treatment in Children Less Than 12 Months of Age

    PubMed Central

    Adeleye, Adetayo; Nettel-Aguirre, Alberto; Buchhalter, Jeffrey; Kirk, Valerie

    2016-01-01

    Study Objectives. We identified the associated conditions of patients less than 12 months of age who were referred for polysomnogram (PSG) studies. We collated PSG findings and physician interpretation. We determined the correlation between the recommended treatment by the PSG interpreting physician and actual prescribed treatment by the referring or subjects' physician. We determined adherence with noninvasive positive airway pressure (PAP) treatment. Methods. This was a retrospective cohort study. Participants included children less than 12 months of age referred for PSG studies between 2007 and 2012. Results. 92 patients under the age of 12 months were included in the study analysis. Mean (standard deviation, SD) age in days at time of the PSG study was 208.5 (101.2). 35 (38%) patients had a diagnosis of Trisomy 21. Seven (8%) patients had no prior diagnosis. Median (Q1, Q3) apnea hypopnea index (AHI) was 22.5 (11.3–37.0). Agreement between the PSG interpreting physician's recommendation and actual prescribed treatment by the referring or subjects' physician was 85.9% [95% CI 77.1–91.6]. Mean (SD) percentage days with PAP therapy usage more than 4 hours was 25.2% (32). Conclusions. In our experience, despite consistent physician messaging to families, adherence with noninvasive PAP treatment is low. PMID:27445563

  16. Weight change among people randomized to minimal intervention control groups in weight loss trials

    PubMed Central

    Johns, David J.; Hartmann‐Boyce, Jamie; Jebb, Susan A.; Aveyard, Paul

    2016-01-01

    Objective Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Methods Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12‐month mean weight change using baseline observation carried forward. Meta‐regression was conducted in STATA v12. Results Thirty studies met the inclusion criteria, twenty‐nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was −0.8 kg (95% CI −1.1 to −0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of −0.53 kg (95% CI −0.96 to −0.09). Also in an unadjusted model, each additional weigh‐in was associated with a weight change of −0.42 kg (95% CI −0.81 to −0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh‐ins was associated with weight change. Conclusions Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow‐up. PMID:27028279

  17. Reducing psychotropic pharmacotherapy in patients with severe mental illness: a cluster-randomized controlled intervention study

    PubMed Central

    Kilian, Reinhold; Sørensen, Helle Østermark; Eriksen, Susan Engelbrechsen; Davidsen, Annette Sofie; Jensen, Signe Olrik Wallenstein; Munk-Jørgensen, Povl

    2015-01-01

    Background: Many patients with mental illness receive psychotropic medicine in high dosages and from more than one drug. One of the consequences of this practice is obesity, which is a contributing factor to increased physical morbidity and premature death. Methods: Our study was a cluster-randomized intervention study involving 6 facilities and 174 patients diagnosed with severe mental illnesses (73% schizophrenia). The intervention period was 12 months and consisted of teaching sessions with the staff and evaluating the patients’ intake of psychotropic medication. At index, 44% met criteria for obesity and 76% met criteria for overweight. Waist circumferences were 108 cm for men and 108 cm for women. Olanzapine, clozapine and quetiapine were the most common prescribed antipsychotics. Mean values of daily doses of antipsychotic were 2.5. Results: The intervention showed no significant differences between the intervention and control group regarding psychotropic treatment. At follow up, independent of intervention, patients receiving antipsychotic polypharmacy had a larger waist circumference compared with patients receiving antipsychotic monotherapy of 9.8 cm (1.5–18.1) (p = 0.028). Discussion and conclusion: We found both a high prevalence of obesity and that the patients received treatment with antipsychotic polypharmaceutics in high dosages. Active awareness did not change practice and we must think of other ways to restrict treatment with psychotropics in this group of patients. PMID:26240746

  18. The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Patients with chronic autoimmune thyroiditis have impaired health-related quality of life. The thyroid gland has a high selenium concentration, and specific selenoprotein enzyme families are crucial to immune function, and catalyze thyroid hormone metabolism and redox processes in thyroid cells. Previous randomized controlled trials have found that selenium supplementation decreases thyroid-disease-specific antibody levels. We hypothesize that selenium might be beneficial in the treatment of chronic autoimmune thyroiditis. Methods/Design The CATALYST trial is an investigator-initiated randomized, blinded, multicentre clinical trial of selenium supplementation versus placebo in patients with chronic autoimmune thyroiditis. Inclusion criteria: age ≥18 years; serum thyroid peroxidase antibody level ≥100 IU/ml within the previous 12 months; treatment with levothyroxine and written informed consent. Exclusion criteria: previous diagnosis of toxic nodular goitre, Graves’ hyperthyroidism, postpartum thyroiditis, Graves’ orbitopathy; previous antithyroid drug treatment, radioiodine therapy or thyroid surgery; immune-modulatory or other medication affecting thyroid function; pregnancy, planned pregnancy or breastfeeding; allergy towards any intervention or placebo component; intake of selenium supplementation >55 μg/day; inability to read or understand Danish or lack of informed consent. The trial will include 2 × 236 participants. The experimental intervention and control groups will receive 200 μg selenium-enriched yeast or matching placebo tablets daily for 12 months. The experimental supplement will be SelenoPrecise®. The primary outcome is thyroid-related quality of life assessed by the Thyroid Patient-Reported Outcome (ThyPRO) questionnaire. Secondary outcomes include serum thyroid peroxidase antibody concentration; serum triiodothyronine/thyroxine ratio; levothyroxine dosage; adverse reactions and serious adverse reactions and events

  19. The Tracking Study: Description of a randomized controlled trial of variations on weight tracking frequency in a behavioral weight loss program

    PubMed Central

    Linde, Jennifer A.; Jeffery, Robert W.; Crow, Scott J.; Brelje, Kerrin L.; Pacanowski, Carly R.; Gavin, Kara L.; Smolenski, Derek J.

    2014-01-01

    Observational evidence from behavioral weight control trials and community studies suggests that greater frequency of weighing oneself, or tracking weight, is associated with better weight outcomes. Conversely, it has also been suggested that frequent weight tracking may have a negative impact on mental health and outcomes during weight loss, but there are minimal experimental data that address this concern in the context of an active weight loss program. To achieve the long-term goal of strengthening behavioral weight loss programs, the purpose of this randomized controlled trial (the Tracking Study) is to test variations on frequency of self-weighing during a behavioral weight loss program, and to examine psychosocial and mental health correlates of weight tracking and weight loss outcomes. Three hundred thirty-nine overweight and obese adults were recruited and randomized to one of three variations on weight tracking frequency during a 12-month weight loss program with a 12-month follow-up: daily weight tracking, weekly weight tracking, or no weight tracking. The primary outcome is weight in kilograms at 24 months. The weight loss program integrates each weight tracking instruction with standard behavioral weight loss techniques (goal setting, self-monitoring, stimulus control, dietary and physical activity enhancements, lifestyle modifications); participants in weight tracking conditions were provided with wireless Internet technology (Wi-Fi-enabled digital scales and touchscreen personal devices) to facilitate weight tracking during the study. This paper describes the study design, intervention features, recruitment, and baseline characteristics of participants enrolled in the Tracking Study. PMID:25533727

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

    PubMed

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

    2012-02-01

    Achieving satisfactory retention in online HIV prevention trials typically has proven 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 online, 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

  1. Differences in homeostatic model assessment (HOMA) values and insulin levels after vitamin D supplementation in healthy men: a double-blind randomized controlled trial.

    PubMed

    Tepper, S; Shahar, D R; Geva, D; Ish-Shalom, S

    2016-06-01

    Vitamin D is thought to play a role in glucose metabolism. The aim of the present study was to determine the effect of vitamin D supplementation on markers of insulin sensitivity and inflammation in men without diabetes with vitamin D deficiency/insufficiency. In this 1-year double-blind randomized controlled trial, 130 men aged 20-65 years (mean age 47.52 ± 11.84 years) with serum 25-hydroxyvitamin D levels <50 nmol/l (mean 38.89 ± 8.64 nmol/l) were randomized to treatment (100 000 IU vitamin D bimonthly) or placebo. Anthropometric measurements, demographic questionnaires, and blood indices (fasting glucose, insulin, high-sensitivity C-reactive protein, lipids) were collected and repeated after 6 and 12 months. The compliance rate was 98.5%. Multivariate models, adjusted for baseline levels, age, body mass index, sun exposure, physical activity and LDL, showed significant differences in insulin and homeostatic model assessment of insulin resistance (HOMA-IR) values between groups. Levels of insulin and HOMA-IR values remained steady during the study period in the treatment group but increased by 16% in the control group (p = 0.038 and p = 0.048, respectively). Vitamin D supplementation administered for 12 months in healthy men maintained insulin levels and HOMA-IR values relative to the increase in the control group. Further studies are needed to establish the long-term effect of vitamin D supplementation on the risk of diabetes. PMID:26890031

  2. 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

  3. Web Intervention for Adolescents Affected by Disaster: Population-Based Randomized Controlled Trial

    PubMed Central

    Ruggiero, Kenneth J.; Price, Matthew; Adams, Zachary; Stauffacher, Kirstin; McCauley, Jenna; Danielson, Carla Kmett; Knapp, Rebecca; Hanson, Rochelle F.; Davidson, Tatiana M.; Amstadter, Ananda B.; Carpenter, Matthew J.; Saunders, Benjamin E.; Kilpatrick, Dean G.; Resnick, Heidi S.

    2015-01-01

    Objective To assess the efficacy of Bounce Back Now (BBN), a modular, web-based intervention for disaster-affected adolescents and their parents. Method A population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study web portal irrespective of mental health status at baseline. Families who accessed the web portal were assigned randomly to 3 groups: (1) BBN, which featured modules for adolescents and parents targeting adolescents’ mental health symptoms; (2) BBN plus additional modules targeting parents’ mental health symptoms; or (3) assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression. Results Nearly 50% of families accessed the web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B=−0.24, SE=0.08, p<.01) and depressive symptoms (B=−0.23, SE=0.09, p<.01). Post-hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental vs. control conditions at 12-month follow-up (PTSD: B=−0.36, SE=0.19, p=.06; depressive symptoms: B=−0.42, SE=0.19, p=0.03). A time × condition interaction also was found favoring the BBN vs. BBN + parent self-help condition for PTSD symptoms (B=0.30, SE=0.12, p=.02), but not depressive symptoms (B=0.12, SE=0.12, p=.33). Conclusion Results supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters. PMID:26299292

  4. Is Personality a Key Predictor of Missing Study Data? An Analysis From a Randomized Controlled Trial

    PubMed Central

    Jerant, Anthony; Chapman, Benjamin P.; Duberstein, Paul; Franks, Peter

    2009-01-01

    PURPOSE Little is known regarding the effects of psychological factors on data collection in research studies. We examined whether Five Factor Model (FFM) personality factors—Neuroticism, Extraversion, Openness, Agreeableness, and Conscientiousness—predicted missing data in a randomized controlled trial (RCT). METHODS Individuals (N = 415) aged 40 years and older with various chronic conditions, plus basic activity impairment, depressive symptoms, or both, were recruited from a primary care network and enrolled in a 6-week RCT of an illness self-management intervention, delivered by means of home visits or telephone calls or usual care. Random effects logistic regression modeling was used to examine whether FFM factors predicted missing illness management self-efficacy data at any scheduled follow-up (2, 4, and 6 weeks, and 6 and 12 months), controlling for disease burden, study arm, and sociodemographic characteristics. RESULTS Across all follow-up points, the missing data rate was 4.5%. Higher levels of Openness (adjusted odds ratio [AOR] for 1-SD increase = 0.24; 95% CI, 0.12–0.46; P <.001), Agreeableness (AOR = 0.29; CI 0.14–0.60; P=.001), and Conscientiousness (AOR = 0.24; CI 0.15–0.50; P <.001) were independently associated with fewer missing data. Accuracy of the missing data prediction model increased when personality variables were added (change in area under the receiver operating characteristic curve from 0.71 to 0.77; χ21=6.6; P=.01). CONCLUSIONS Personality was a powerful predictor of missing study data in this RCT. Assessing personality could inform efforts to enhance data completion and adjust analyses for bias caused by missing data. PMID:19273870

  5. Impact of Pre-Stage II Hemodynamics and Pulmonary Artery Anatomy on 12-Month Outcome in the Single Ventricle Reconstruction Trial

    PubMed Central

    Aiyagari, Ranjit; Rhodes, John F.; Shrader, Peter; Radtke, Wolfgang A.; Bandisode, Varsha M.; Bergersen, Lisa; Gillespie, Matthew J.; Gray, Robert G.; Guey, Lin T.; Hill, Kevin D.; Hirsch, Russel; Kim, Dennis W.; Lee, Kyong-Jin; Pelech, Andrew N.; Ringewald, Jeremy; Takao, Cheryl; Vincent, Julie A.; Ohye, Richard G.

    2014-01-01

    Objective To compare interstage cardiac catheterization hemodynamic and angiographic findings between shunt types for Single Ventricle Reconstruction (SVR) trial. Background The SVR trial, which randomized subjects to modified Blalock-Taussig shunt (MBTS) or right ventricle-to-pulmonary artery shunt (RVPAS) for the Norwood procedure, demonstrated RVPAS was associated with smaller pulmonary artery diameter, but superior 12-month transplant-free survival. Methods We analyzed pre-stage II catheterization data for SVR trial subjects. Hemodynamic variables and shunt and pulmonary angiography were compared between shunt types; their association with 12-month transplant-free survival was also evaluated. Results Of 549 randomized subjects, 389 underwent pre-stage II catheterization. Smaller size, lower aortic and superior vena cava saturation, and higher ventricular end-diastolic pressure (EDP) were associated with worse 12-month transplant-free survival. MBTS subjects had lower coronary perfusion pressure (27mmHg vs. 32mmHg, P<0.001) and higher Qp:Qs ratio (1.1 vs. 1.0, P=0.009). Higher Qp:Qs ratio increased the risk of death or transplant only in the RVPAS group (P=0.01). MBTS subjects had fewer shunt (14% vs. 28%, P=0.004) and severe left pulmonary artery stenoses (0.7% vs. 9.2%, P=0.003), larger mid-main branch pulmonary artery diameters and higher Nakata index (164 vs. 134, P<0.001). Conclusions Compared with RVPAS subjects, MBTS subjects had more hemodynamic abnormalities related to shunt physiology, while RVPAS subjects had more shunt or pulmonary obstruction of a severe degree, and inferior pulmonary artery growth at pre-stage II catheterization. Lower BSA, higher ventricular EDP, and lower SVC saturation were associated with worse 12-month transplant-free survival. PMID:24332668

  6. Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers.

    PubMed

    Lynch, Elizabeth B; Liebman, Rebecca; Ventrelle, Jennifer; Keim, Kathryn; Appelhans, Bradley M; Avery, Elizabeth F; Tahsin, Bettina; Li, Hong; Shapera, Merle; Fogelfeld, Leon

    2014-11-01

    The Lifestyle Improvement through Food and Exercise (LIFE) study is a community-based randomized-controlled trial to measure the effectiveness of a lifestyle intervention to improve glycemic control among African Americans with type 2 diabetes attending safety net clinics. The study enrolled African American adults with a diagnosis of type 2 diabetes and HbA1c ≥ 7.0 who had attended specific safety net community clinics in the prior year. 210 patients will be enrolled and randomized to either the LIFE intervention or a standard of care control group, which consists of two dietitian-led diabetes self-management classes. The LIFE intervention was delivered in 28 group sessions over 12 months and focused on improving diet through dietitian-led culturally-tailored nutrition education, increasing physical activity through self-monitoring using an accelerometer, increasing ability to manage blood sugar through modifications to lifestyle, and providing social support for behavior change. In addition to the group sessions, peer supporters made regular telephone calls to participants to monitor progress toward behavioral goals and provide social support. The 12-month intervention phase was followed by a six-month maintenance phase consisting of two group sessions. The primary outcome of the study is change in A1C from baseline to 12 months, and an additional follow-up will occur at 18 months. The hypothesis of the study is that the participants in the LIFE intervention will show a greater improvement in glycemic control over 12 months than participants in the control group. PMID:25245954

  7. Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: A randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers

    PubMed Central

    Liebman, Rebecca; Ventrelle, Jennifer; Keim, Kathryn; Appelhans, Bradley M.; Avery, Elizabeth F.; Tahsin, Bettina; Li, Hong; Shapera, Merle; Fogelfeld, Leon

    2014-01-01

    The Lifestyle Improvement through Food and Exercise (LIFE) study is a community-based randomized-controlled trial to measure the effectiveness of a lifestyle intervention to improve glycemic control among African Americans with type 2 diabetes attending safety net clinics. The study enrolled African American adults with a diagnosis of type 2 diabetes and HbA1c ≥ 7.0 who had attended specific safety net community clinics in the prior year. 210 patients will be enrolled and randomized to either the LIFE intervention or a standard of care control group, which consists of two dietitian-led diabetes self-management classes. The LIFE intervention was delivered in 30 group sessions over 12-months and focused on improving diet through dietitian-led culturally-tailored nutrition education, increasing physical activity through self-monitoring using an accelerometer, increasing ability to manage blood sugar through modifications to lifestyle, and providing social support for behavior change. In addition to the group sessions, peer supporters made regular telephone calls to participants to monitor progress towards behavioral goals and provide social support. The 12-month intervention phase was followed by a six-month maintenance phase consisting of two group sessions. The primary outcome of the study is change in A1C from baseline to 12-months, and an additional follow-up will occur at 18-months. The hypothesis of the study is that the participants in the LIFE intervention will show a greater improvement in glycemic control over 12-months than participants in the control group. PMID:25245954

  8. Contact force-guided catheter ablation for the treatment of atrial fibrillation: a meta-analysis of randomized, controlled trials

    PubMed Central

    Qi, Z.; Luo, X.; Wu, B.; Shi, H.; Jin, B.; Wen, Z.

    2016-01-01

    Contact force (CF) sensing technology allows real-time monitoring during catheter ablation for atrial fibrillation (AF). However, the effect of CF sensing technology on procedural parameters and clinical outcomes still needs clarification. Because of the inconsistent results thus far in this area, we performed a meta-analysis to determine whether CF sensing technology can improve procedural parameters and clinical outcomes for the treatment of AF. Studies examining the benefits of CF sensing technology were identified in English-language articles by searching the MEDLINE, Web of Science, and Cochrane Library databases (inception to May 2015). Ten randomized, controlled trials involving 1834 patients (1263 males, 571 females) were included in the meta-analysis (681 in the CF group, 1153 in the control group). Overall, the ablation time was significantly decreased by 7.34 min (95%CI=-12.21 to -2.46; P=0.003, Z test) in the CF group compared with the control group. CF sensing technology was associated with significantly improved freedom from AF after 12 months (OR=1.55, 95%CI=1.20 to 1.99; P=0.0007) and complications were significantly lower in the CF group than in the control group (OR=0.50, 95%CI=0.29 to 0.87; P=0.01). However, fluoroscopy time analysis showed no significantly decreased trend associated with CF-guided catheter ablation (weighted mean difference: -2.59; 95%CI=-9.06 to 3.88; P=0.43). The present meta-analysis shows improvement in ablation time and freedom from AF after 12 months in AF patients treated with CF-guided catheter ablation. However, CF-guided catheter ablation does not decrease fluoroscopy time. PMID:26840711

  9. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    PubMed Central

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K.; Cole, David A.

    2010-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9–15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; by parent reports on internalizing and externalizing problems; and by child and parent reports on a standardized diagnostic interview. Parent depressive symptoms and parent episodes of major depression also were assessed. Evidence emerged for significant differences favoring the family group intervention on both child and parent outcomes; strongest effects for child outcomes were found at the 12-month assessment with medium effect sizes on most measures. Implications for the prevention of adverse outcomes in children of depressed parents are highlighted. PMID:19968378

  10. Randomized controlled trial of a family cognitive-behavioral preventive intervention for children of depressed parents.

    PubMed

    Compas, Bruce E; Forehand, Rex; Keller, Gary; Champion, Jennifer E; Rakow, Aaron; Reeslund, Kristen L; McKee, Laura; Fear, Jessica M; Colletti, Christina J M; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K; Cole, David A

    2009-12-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9-15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; by parent reports on internalizing and externalizing problems; and by child and parent reports on a standardized diagnostic interview. Parent depressive symptoms and parent episodes of major depression also were assessed. Evidence emerged for significant differences favoring the family group intervention on both child and parent outcomes; strongest effects for child outcomes were found at the 12-month assessment with medium effect sizes on most measures. Implications for the prevention of adverse outcomes in children of depressed parents are highlighted. PMID:19968378

  11. Effect of Biocompatible Peritoneal Dialysis Solution on Residual Renal Function: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Seo, Eun-Young; An, Sook Hee; Cho, Jang-Hee; Suh, Hae Sun; Park, Sun-Hee; Gwak, Hyesun; Kim, Yong-Lim; Ha, Hunjoo

    2014-01-01

    ♦ Introduction: Residual renal function (RRF) plays an important role in outcome of peritoneal dialysis (PD) including mortality. It is, therefore, important to provide a strategy for the preservation of RRF. The objective of this study was to evaluate relative protective effects of new glucose-based multicompartmental PD solution (PDS), which is well known to be more biocompatible than glucose-based conventional PDS, on RRF compared to conventional PDS by performing a systematic review (SR) of randomized controlled trials. ♦ Methods: We searched studies presented up to January 2014 in MEDLINE, EMBASE, the COCHRANE library, and local databases. Three independent reviewers reviewed and extracted prespecified data from each study. The random effects model, a more conservative analysis model, was used to combine trials and to perform stratified analyses based on the duration of follow-up. Study quality was assessed using the Cochrane Handbook for risk of bias. Eleven articles with 1,034 patients were identified for the SR. ♦ Results: The heterogeneity of the studies under 12 months was very high, and the heterogeneity decreased substantially when we stratified studies by the duration of follow-up. The mean difference of the studies after 12 months was 0.46 mL/min/1.73 m2 (95% confidence interval = 0.25 to + 0.67). ♦ Conclusion: New PDS showed the effect to preserve and improve RRF for long-term use compared to conventional PDS, even though it did not show a significant difference to preserve RRF for short-term use. PMID:25185015

  12. Use of a 12 months' self-referral reminder to facilitate uptake of bowel scope (flexible sigmoidoscopy) screening in previous non-responders: a London-based feasibility study

    PubMed Central

    Kerrison, Robert S; McGregor, Lesley M; Marshall, Sarah; Isitt, John; Counsell, Nicholas; Wardle, Jane; von Wagner, Christian

    2016-01-01

    Background: In March 2013, NHS England extended its national Bowel Cancer Screening Programme to include ‘one-off' Flexible Sigmoidoscopy screening (NHS Bowel Scope Screening, BSS) for men and women aged 55. With less than one in two people currently taking up the screening test offer, there is a strong public health mandate to develop system-friendly interventions to increase uptake while the programme is rolling out. This study aimed to assess the feasibility of sending a reminder to previous BSS non-responders, 12 months after the initial invitation, with consideration for its potential impact on uptake. Method: This study was conducted in the ethnically diverse London Boroughs of Brent and Harrow, where uptake is below the national average. Between September and November 2014, 160 previous non-responders were randomly selected to receive a reminder of the opportunity to self-refer 12 months after their initial invitation. The reminder included instructions on how to book an appointment, and provided options for the time and day of the appointment and the gender of the endoscopist performing the test. To address barriers to screening, the reminder was sent with a brief locally tailored information leaflet designed specifically for this study. Participants not responding within 4 weeks were sent a follow-up reminder, after which there was no further intervention. Self-referral rates were measured 8 weeks after the delivery of the follow-up reminder and accepted as final. Results: Of the 155 participants who received the 12 months' reminder (returned to sender, n=5), 30 (19.4%) self-referred for an appointment, of which 24 (15.5%) attended and were successfully screened. Attendance rates differed by gender, with significantly more women attending an appointment than men (20.7% vs 8.8%, respectively; OR=2.73, 95% CI=1.02–7.35, P=0.05), but not by area (Brent vs Harrow) or area-level deprivation. Of the 30 people who self-referred for an appointment, 27 (90

  13. Family-Based Cluster Randomized Controlled Trial Enhancing Physical Activity and Motor Competence in 4–7-Year-Old Children

    PubMed Central

    Laukkanen, Arto; Pesola, Arto Juhani; Heikkinen, Risto; Sääkslahti, Arja Kaarina; Finni, Taija

    2015-01-01

    Little is known of how to involve families in physical activity (PA) interventions for children. In this cluster randomized controlled trial, we recruited families with four- to seven-year-old children to participate in a year-long study where parents in the intervention group families (n = 46) received tailored counseling to increase children’s PA. Structured PA was not served. Control group families (n = 45) did not receive any counseling. PA in all children (n = 91; mean age 6.16 ± 1.13 years at the baseline) was measured by accelerometers at the baseline and after three, six, nine and 12 months. Motor competence (MC) (n = 89) was measured at the baseline and after six and 12 months by a KTK (KörperkoordinationsTest für Kinder) and throwing and catching a ball (TCB) protocols. The effect of parental counseling on study outcomes was analyzed by a linear mixed-effects model fit by REML and by a Mann-Whitney U test in the case of the TCB. As season was hypothesized to affect counseling effect, an interaction of season on the study outcomes was examined. The results show significant decrease of MVPA in the intervention group when compared to the control group (p < .05). The TCB showed a nearly significant improvement at six months in the intervention group compared to the controls (p = .051), but not at 12 months. The intervention group had a steadier development of the KTK when the interaction of season was taken into account. In conclusion, more knowledge of family constructs associating with the effectiveness of counseling is needed for understanding how to enhance PA in children by parents. However, a hypothesis may be put forward that family-based counseling during an inactive season rather than an active season may provide a more lasting effect on the development of KTK in children. Trial Registration Controlled-Trials.com ISRCTN28668090 PMID:26502183

  14. History of the Athens Canadian Random Bred and the Athens Random Bred control populations.

    PubMed

    Collins, K E; Marks, H L; Aggrey, S E; Lacy, M P; Wilson, J L

    2016-05-01

    The University of Georgia maintains two meat-type chicken control strains: the Athens Random Bred (ARB) and the Athens Canadian Random Bred (ACRB). The Athens Random Bred was developed from colored plumage commercial meat chicken strains in 1956. The ACRB is a replicate population of the Ottawa Meat Control strain which was developed in 1955 from white plumage commercial meat-type chickens. These genetic lines have been extremely valuable research resources and have been used extensively to provide comparative context to modern meat-type strains. The ACRB may be the oldest pedigreed control commercial meat-type chicken still in existence today. This paper reviews the history of the breed backgrounds for both control populations and reviews research utilizing the ACRB. PMID:26976904

  15. Tissue Kallikrein Prevents Restenosis After Stenting of Severe Atherosclerotic Stenosis of the Middle Cerebral Artery: A Randomized Controlled Trial.

    PubMed

    Shi, Ruifeng; Zhang, Renliang; Yang, Fang; Lin, Min; Li, Min; Liu, Ling; Yin, Qin; Lin, Hang; Xiong, Yunyun; Liu, Wenhua; Fan, Xiaobing; Dai, Qiliang; Zhou, Lizhi; Lan, Wenya; Cao, Qinqin; Chen, Xin; Xu, Gelin; Liu, Xinfeng

    2016-02-01

    In-stent restenosis (ISR) following intracranial artery stenting affects long-term clinical outcome. This randomized controlled trial sought to identify the long-term efficacy of exogenous tissue kallikrein (TK) for preventing ISR after intracranial stenting of symptomatic middle cerebral artery (MCA) atherosclerotic stenosis.Sixty-one patients successfully treated with intracranial stenting for symptomatic MCA M1 segment stenosis (>70%) were enrolled and randomized into 2 groups: control group and TK group. Patients in the TK group received human urinary kallidinogenase for 7 days, followed by maintenance therapy of pancreatic kallikrein for 6 months. The primary end point was angiographically verified ISR at 6 months, and secondary end points included vascular events and death within 12 months. Endogenous TK plasma concentrations of patients were measured before stenting and at the 6-month follow-up time-point.Patients in the TK group had lower occurrence rates of ISR and vascular events than patients in the control group. There was no difference in endogenous TK levels in plasma at 6 months postoperatively between the TK and control groups. Further subgroup analysis revealed that patients without ISR had higher endogenous TK levels at baseline and lower concentrations at 6 months postoperatively compared with patients who underwent ISR.Exogenous TK is effective for the prevention of ISR after intracranial stenting. PMID:26871851

  16. A randomized, controlled trial of everolimus-based dual immunosuppression versus standard of care in de novo kidney transplant recipients.

    PubMed

    Chadban, Steven J; Eris, Josette Marie; Kanellis, John; Pilmore, Helen; Lee, Po Chang; Lim, Soo Kun; Woodcock, Chad; Kurstjens, Nicol; Russ, Graeme

    2014-03-01

    Kidney transplant recipients receiving calcineurin inhibitor-based immunosuppression incur increased long-term risks of cancer and kidney fibrosis. Switch to mammalian target of rapamycin (mTOR) inhibitors may reduce these risks. Steroid or Cyclosporin Removal After Transplant using Everolimus (SOCRATES), a 36-month, prospective, multinational, open-label, randomized controlled trial for de novo kidney transplant recipients, assessed whether everolimus switch could enable elimination of mycophenolate plus either steroids or CNI without compromising efficacy. Patients received cyclosporin, mycophenolate and steroids for the first 14 days then everolimus with mycophenolate and CNIwithdrawal (CNI-WD); everolimus with mycophenolate and steroid withdrawal (steroid-WD); or cyclosporin, mycophenolate and steroids (control). 126 patients were randomized. The steroid WD arm was terminated prematurely because of excess discontinuations. Mean eGFR at month 12 for CNI-WD versus control was 65.1 ml/min/1.73 m2 vs. 67.1 ml/min/1.73 m2 by ITT, which met predefined noninferiority criteria (P=0.026). The CNI-WD group experienced a higher rate of BPAR(31% vs. control 13%, P=0.048) and showed a trend towards higher composite treatment failure (BPAR, graft loss, death, loss to follow-up). The 12 month results from SOCRATES show noninferiority in eGFR, but a significant excess of acute rejection when everolimus was commenced at week 2 to enable a progressive withdrawal of mycophenolate and cyclosporin in kidney transplant recipients. PMID:24279685

  17. Home-Based Psychiatric Outpatient Care Through Videoconferencing for Depression: A Randomized Controlled Follow-Up Trial

    PubMed Central

    Rössler, Wulf

    2016-01-01

    Background There is a tremendous opportunity for innovative mental health care solutions such as psychiatric care through videoconferencing to increase the number of people who have access to quality care. However, studies are needed to generate empirical evidence on the use of psychiatric outpatient care via videoconferencing, particularly in low- and middle-income countries and clinically unsupervised settings. Objective The objective of this study was to evaluate the effectiveness and feasibility of home-based treatment for mild depression through psychiatric consultations via videoconferencing. Methods A randomized controlled trial with a 6- and 12-month follow-up including adults with mild depression treated in an ambulatory setting was conducted. In total, 107 participants were randomly allocated to the videoconferencing intervention group (n=53) or the face-to-face group (F2F; n=54). The groups did not differ with respect to demographic characteristics at baseline. The F2F group completed monthly follow-up consultations in person. The videoconferencing group received monthly follow-up consultations with a psychiatrist through videoconferencing at home. At baseline and after 6 and 12 months, in-person assessments were conducted with all participants. Clinical outcomes (severity of depression, mental health status, medication course, and relapses), satisfaction with treatment, therapeutic relationship, treatment adherence (appointment compliance and dropouts), and medication adherence were assessed. Results The severity of depression decreased significantly over the 12-month follow-up in both the groups. There was a significant difference between groups regarding treatment outcomes throughout the follow-up period, with better results in the videoconferencing group. There were 4 relapses in the F2F group and only 1 in the videoconferencing group. No significant differences between groups regarding mental health status, satisfaction with treatment, therapeutic

  18. Efficacy of theory-based HIV behavioral prevention among rural-to-urban migrants in China: a randomized controlled trial.

    PubMed

    Li, Xiaoming; Lin, Danhua; Wang, Bo; Du, Hongfei; Tam, Cheuk Chi; Stanton, Bonita

    2014-08-01

    Our objective was to evaluate the efficacy of a cultural adaptation of a social cognitive theory-based HIV behavioral prevention program among young rural-to-urban migrants in China. The intervention design and assessment were guided by the Protection Motivation Theory (PMT). The intervention was evaluated through a randomized controlled trial with 6-month and 12-month follow-ups. The primary behavioral outcome was the use of condoms. Other outcome measures include HIV knowledge, condom use knowledge, HIV-related perceptions (PMT constructs), and intention to use condom. The mixed-effects regression models for condom use with regular partners indicated that overall frequency of condom use, condom use in last three sexual acts and proper condom use increased over time for the participants but the increases were significantly greater among the intervention group than the control group at 6-month and 12-month follow-ups. The mixed-effects models for HIV-related perceptions indicated that extrinsic rewards, intrinsic rewards, and response costs decreased while vulnerability, severity, response efficacy, and self-efficacy increased over time for the intervention group. The increases in HIV knowledge, condom use knowledge, and intention to use condom were also significantly greater among the intervention group than the control group. The data in the current study suggested efficacy of a social cognitive theory-based behavioral intervention in increasing condom use among young migrants in China. The intervention also increased protective perceptions and decreased risk perception posited by the theory (i.e., PMT). PMID:25068178

  19. The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals. As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program ‘Life! Taking action on diabetes’ (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program. Methods/design We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only. The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow

  20. Random and Targeted Interventions for Epidemic Control in Metapopulation Models

    NASA Astrophysics Data System (ADS)

    Tanaka, Gouhei; Urabe, Chiyori; Aihara, Kazuyuki

    2014-07-01

    In general, different countries and communities respond to epidemics in accordance with their own control plans and protocols. However, owing to global human migration and mobility, strategic planning for epidemic control measures through the collaboration of relevant public health administrations is gaining importance for mitigating and containing large-scale epidemics. Here, we present a framework to evaluate the effectiveness of random (non-strategic) and targeted (strategic) epidemic interventions for spatially separated patches in metapopulation models. For a random intervention, we analytically derive the critical fraction of patches that receive epidemic interventions, above which epidemics are successfully contained. The analysis shows that the heterogeneity of patch connectivity makes it difficult to contain epidemics under the random intervention. We demonstrate that, particularly in such heterogeneously connected networks, targeted interventions are considerably effective compared to the random intervention. Our framework is useful for identifying the target areas where epidemic control measures should be focused.

  1. A Blinded Randomized Controlled Trial of Motivational Interviewing to Improve Adherence with Osteoporosis Medications: Design of the OPTIMA Trial

    PubMed Central

    Solomon, Daniel H.; Gleeson, Timothy; Iversen, Maura; Avorn, Jerome; Brookhart, M. Alan; Lii, Joyce; Losina, Elena; May, Frank; Patrick, Amanda; Shrank, William H.; Katz, Jeffrey N.

    2010-01-01

    Purpose While many effective treatments exist for osteoporosis, most people do not adhere to such treatments long-term. No proven interventions exist to improve osteoporosis medication adherence. We report here on the design and initial enrollment in an innovative randomized controlled trial aimed at improving adherence to osteoporosis treatments. Methods The trial represents a collaboration between academic researchers and a state-run pharmacy benefits program for low-income older adults. Beneficiaries beginning treatment with a medication for osteoporosis are targeted for recruitment. We randomize consenting individuals to receive 12-months of mailed education (control arm) or an intervention consisting of one-on-one telephone-based counseling and the mailed education. Motivational Interviewing forms the basis for the counseling program which is delivered by seven trained and supervised health counselors over ten telephone calls. The counseling sessions include scripted dialogue, open-ended questions about medication adherence and its barriers, as well as structured questions. The primary endpoint of the trial is medication adherence measured over the 12-month intervention period. Secondary endpoints include fractures, nursing home admissions, health care resource utilization, and mortality. Results During the first 7 months of recruitment, we have screened 3,638 potentially eligible subjects. After an initial mailing, 1,115 (30.6%) opted out of telephone recruitment and 1,019 (28.0%) could not be successfully contacted. Of the remaining, 879 (24.2%) consented to participate and were randomized. Women comprise over 90% of all groups, mean ages range from 77–80 years old, and the majority in all groups was white. The distribution of osteoporosis medications was comparable across groups and the median number of different prescription drugs used in the prior year was 8–10. Conclusions We have developed a novel intervention for improving osteoporosis medication

  2. Course and Determinants of Anosognosia in Alzheimer's Disease: A 12-Month Follow-up.

    PubMed

    Turró-Garriga, Oriol; Garre-Olmo, Josep; Calvó-Perxas, Laia; Reñé-Ramírez, Ramón; Gascón-Bayarri, Jordi; Conde-Sala, Josep Lluís

    2016-01-01

    Anosognosia in Alzheimer's disease (AD) has been associated with greater cognitive impairment and more behavioural and psychological symptoms of dementia (BPSD). This study examines the incidence, persistence, and remission rates of anosognosia over a 12-month period, as well as the related risk factors. This was an observational 12-month prospective study. The longitudinal sample comprised 177 patients with mild or moderate AD, and their respective caregivers. Anosognosia was assessed using the Anosognosia Questionnaire in Dementia, and we also evaluated cognitive status (Mini-Mental State Examination), functional disability (Disability Assessment in Dementia), and the presence of BPSD (Neuropsychiatric Inventory). Multinomial logistic regression was used to determine the variables associated with the incidence, persistence and remission of anosognosia. The prevalence of anosognosia was 39.5% (95% CI = 32.1-47.1) at baseline. At 12 months, incidence was 38.3% (95% CI = 28.6-48.0), persistence was 80.0% (95% CI = 69.9-90.1) and remission was 20.0% (95% CI = 9.9-30.1). The regression model identified lower age, more education, and the presence of delusions as variables associated with incidence, and more education, lower instrumental DAD score, and disinhibition as variables associated with persistence. No variables were associated with remission (n = 14). The presence of anosognosia in AD patients is high. Education and certain neuropsychiatric symptoms may explain a greater and earlier incidence of anosognosia. However, anosognosia also increases with greater cognitive impairment and disease severity. PMID:26890611

  3. Community participation of patients 12 months post-stroke in Johannesburg, South Africa

    PubMed Central

    Stewart, Aimee; Musenge, Eustasius

    2013-01-01

    Abstract Background Improvement in health-related quality of life (HRQL) is the main goal of rehabilitation. The ability of the stroke-patient to participate in various situations signifies successful rehabilitation. The aim of the study was to establish the extent of community participation and the barriers and facilitators to the participation for stroke patients after their discharge. Method This study formed part of a larger study focusing on the impact of caregiver education on stroke survivors and their careers. This was a longitudinal study comprising 200 patients with first-time ischaemic stroke. Although the patients were followed up at home at 3 months, 6 months and 12 months post-stroke, this paper focuses on the 12-months follow-up participation results. Patient functional ability was measured by using the Barthel Index (BI) and the Rivermead Mobility Index (RMI), whereas participation was measured by using the International Classification of Functioning, Disability and Health (ICF) checklist. Descriptive statistics were used to analyse the data. Results Patients experienced severe to complete difficulty when undertaking single and multiple tasks without help 12-months post-discharge. They struggled with the preparation of meals, household work and interpersonal interactions, and they had difficulties with community life and partaking in recreation and leisure activities. Immediate family and societal attitudes were viewed as facilitators to community participation whereas friends, transportation services and social security services were viewed as barriers to community participation. Conclusion The patient-ability to socialise and participate in community issues is currently poor. The identified barriers to community participation need to be addressed in order to improve patient-participation in the community post-stroke.

  4. Services for adolescent psychiatric disorders: 12-month data from the National Comorbidity Survey-Adolescent

    PubMed Central

    Costello, E. Jane; He, Jian-ping; Sampson, Nancy A; Kessler, Ronald C.; Merikangas, Kathleen Ries

    2014-01-01

    Objective This report examined data on 12-month rates of service use for adolescent mental, emotional, and behavioral disorders. Methods The National Comorbidity Survey Adolescent Supplement (NCS-A) is a national survey of DSM-IV mental, emotional, and behavioral disorders and service use among U.S. adolescents. Results In the 12 months up to the interview, 45% of adolescents with psychiatric disorders received some form of professional help. Youth with mood disorders were most likely to receive services (60.1%), and those with anxiety disorders least likely (41.4%). Services were more likely to be provided in a school setting (23.6% of those with disorders) or by specialty mental health providers (22.8%) than by general medical practitioners (10.1%). Juvenile justice (4.5%), complementary and alternative medicine (CAM) (5.3%), and human services (7.9%) also provided mental health care. Although pediatricians treated a higher proportion of youth with mood disorders than of those with behavior disorders, they were more likely to treat youth with behavior disorders because of the larger number of the latter (11.5% of 1,465 vs. 13.9% of 820). Black youth were significantly less likely than white youth to receive specialty mental health or pediatric services for mental disorders. Conclusions The 12-month findings from the NCS-A confirm those of earlier, smaller studies, that only a minority of youth with psychiatric disorders received recent treatment of any sort. Much of this treatment was provided in service settings in which few of the providers were likely to have specialist mental health training. PMID:24233052

  5. Paliperidone Palmitate and Metabolic Syndrome in Patients With Schizophrenia: A 12-Month Observational Prospective Cohort Study.

    PubMed

    Rosso, Gianluca; Pessina, Enrico; Martini, Azzurra; Di Salvo, Gabriele; Maina, Giuseppe

    2016-06-01

    Oral and long-acting injectable second-generation antipsychotics are known to be associated with a high risk of metabolic adverse effects. Together with other drug treatments, poor lifestyle choices, and genetic liability, they contribute to development of metabolic syndrome (MetS), which occurs in nearly one third of patients with schizophrenia.The primary objective of this multicenter prospective observational study was to explore the prevalence of MetS in a sample of 60 real-world patients treated with paliperidone palmitate (PP) over a period of 12 months. The secondary objectives were to assess other tolerability aspects and the efficacy of PP on schizophrenic symptoms.The proportion of patients with MetS at baseline (33%) did not significantly change neither at 6 (39.0%) nor at 12 months (29.5%) of PP treatment. The same applies to each individual component of MetS. We found a slight but statistically significant increase in body mass index (26.3 ± 6.0 vs 27.1 ± 4.6, P = 0.031) and of waist circumference (98.2 ± 17.9 vs 100.3 ± 15.9, P = 0.021) from baseline to end point. Weight gain was detected in approximately 15% of patients.At least 1 mild or moderate adverse event was found in 71.3%, 88.0%, and 52.1% of patients, respectively, at baseline, 6 months, and 12 months. A significant improvement in schizophrenic symptoms emerged by means of Positive and Negative Syndrome Scale total and subscale scores.Together with previous literature findings, our results seem to indicate that PP could be a valid therapeutic option for patients with a severe disorder and with a high metabolic risk profile. PMID:27043122

  6. CUMULATIVE TRAUMAS AND RISK THRESHOLDS: 12-MONTH PTSD IN THE WORLD MENTAL HEALTH (WMH) SURVEYS

    PubMed Central

    Karam, Elie G.; Friedman, Matthew J.; Hill, Eric D.; Kessler, Ronald C.; McLaughlin, Katie A.; Petukhova, Maria; Sampson, Laura; Shahly, Victoria; Angermeyer, Matthias C.; Bromet, Evelyn J.; de Girolamo, Giovanni; de Graaf, Ron; Demyttenaere, Koen; Ferry, Finola; Florescu, Silvia E.; Haro, Josep Maria; He, Yanling; Karam, Aimee N.; Kawakami, Norito; Kovess-Masfety, Viviane; Medina-Mora, María Elena; Browne, Mark A. Oakley; Posada-Villa, José A.; Shalev, Arieh Y.; Stein, Dan J.; Viana, Maria Carmen; Zarkov, Zahari; Koenen, Karestan C.

    2014-01-01

    Background Clinical research suggests that posttraumatic stress disorder (PTSD) patients exposed to multiple traumatic events (TEs) rather than a single TE have increased morbidity and dysfunction. Although epidemiological surveys in the United States and Europe also document high rates of multiple TE exposure, no population-based cross-national data have examined this issue. Methods Data were analyzed from 20 population surveys in the World Health Organization World Mental Health Survey Initiative (n 51,295 aged 18+). The Composite International Diagnostic Interview (3.0) assessed 12-month PTSD and other common DSM-IV disorders. Respondents with 12-month PTSD were assessed for single versus multiple TEs implicated in their symptoms. Associations were examined with age of onset (AOO), functional impairment, comorbidity, and PTSD symptom counts. Results 19.8% of respondents with 12-month PTSD reported that their symptoms were associated with multiple TEs. Cases who associated their PTSD with four or more TEs had greater functional impairment, an earlier AOO, longer duration, higher comorbidity with mood and anxiety disorders, elevated hyper-arousal symptoms, higher proportional exposures to partner physical abuse and other types of physical assault, and lower proportional exposure to unexpected death of a loved one than cases with fewer associated TEs. Conclusions A risk threshold was observed in this large-scale cross-national database wherein cases who associated their PTSD with four or more TEs presented a more “complex” clinical picture with substantially greater functional impairment and greater morbidity than other cases of PTSD. PTSD cases associated with four or more TEs may merit specific and targeted intervention strategies. Depression and Anxiety 31:130–142, 2014. PMID:23983056

  7. Prevention of Bone Loss with Risedronate in Breast Cancer Survivors: A Randomized, Controlled Clinical Trial

    PubMed Central

    Greenspan, Susan L.; Vujevich, Karen T.; Brufsky, Adam; Lembersky, Barry C.; van Londen, G.J.; Jankowitz, Rachel C.; Puhalla, Shannon L.; Rastogi, Priya; Perera, Subashan

    2016-01-01

    Purpose Aromatase inhibitors (AIs), adjuvant endocrine therapy for postmenopausal women with hormone receptor positive breast cancer, are associated with bone loss and fractures. Our objectives were to determine if 1) oral bisphosphonate therapy can prevent bone loss in women on an AI and, 2) early changes in bone turnover markers (BTM) can predict later changes in bone mineral density (BMD). Methods We conducted a 2 year double-blind, placebo-controlled, randomized trial in 109 postmenopausal women with low bone mass on an aromatase inhibitor (AI-anastrozole, letrozole, or exemestane) for hormone receptor positive breast cancer. Participants were randomized to once weekly risedronate 35 mg or placebo and all received calcium plus vitamin D. The main outcome measures included BMD, BTM [carboxy-terminal collagen crosslinks (CTX) and N-terminal propeptide of type 1 procollagen (P1NP)] and safety. Results Eighty-seven percent completed 24 months. BMD increased more in the active treatment group compared to placebo with an adjusted difference at 24 months of 3.9 ± 0.7 percentage points at the spine and 3.2 ± 0.5 percentage points at the hip (both p<0.05). The adjusted difference between the active treatment and placebo groups were 0.09 ± 0.04 nmol/LBCE for CTX and 23.3 ± 4.8 µg/mL for P1NP (both p<0.05). Women with greater 12-month decreases in CTX and P1NP in the active treatment group had a greater 24-month increase in spinal BMD (p<0.05). The oral therapy was safe and well tolerated. Conclusion In postmenopausal women with low bone mass and breast cancer on an AI, the oral bisphosphonate risedronate maintained skeletal health. PMID:25792492

  8. The 12-Month Prevalence of DSM-IV Anxiety Disorders among Nigerian Secondary School Adolescents Aged 13-18 Years

    ERIC Educational Resources Information Center

    Adewuya, Abiodun O.; Ola, Bola A.; Adewumi, Tomi A.

    2007-01-01

    Aims: To estimate the 12-month prevalence of DSM-IV-specific anxiety disorders among Nigerian secondary school adolescents aged 13-18 years. Method: A representative sample of adolescents (n=1090) from senior secondary schools in a semi-urban town in Nigeria was assessed for the 12-month prevalence of DSM-IV-specific anxiety. Results: The 12-month…

  9. Identification of Infants at Risk for Autism Spectrum Disorder and Developmental Language Delay Prior to 12 Months

    ERIC Educational Resources Information Center

    Samango-Sprouse, Carole A.; Stapleton, Emily J.; Aliabadi, Farhad; Graw, Robert; Vickers, Rebecca; Haskell, Kathryn; Sadeghin, Teresa; Jameson, Robert; Parmele, Charles L.; Gropman, Andrea L.

    2015-01-01

    Studies have shown an increased head circumference and the absence of the head tilt reflex as possible risk factors for autism spectrum disorder, allowing for early detection at 12 months in typically developing population of infants. Our aim was to develop a screening tool to identify infants prior to 12 months at risk for autism spectrum…

  10. Gender and relational differences in sensitivity to internal and external cues at 12 months.

    PubMed

    Watson, John S; Futo, Judit; Fonagy, Peter; Gergely, Gyorgy

    2011-03-01

    Gender differences favoring women in relation to awareness of the subjective (internal) world are well demonstrated but their origins are poorly understood. We trained 173 12-month-olds to visually fixate a video image in response to an internal cue (opening own mouth), external cue (seeing a face open its mouth), or both cues. Female infants showed significantly greater sensitivity than males to the internal cues suggesting that prioritization of internally accessible experience is already evident at one year of age. PMID:21500960

  11. Effects of a Web-Based Patient Activation Intervention to Overcome Clinical Inertia on Blood Pressure Control: Cluster Randomized Controlled Trial

    PubMed Central

    Thiboutot, Jeffrey; Falkner, Bonita; Kephart, Donna K; Stuckey, Heather L; Adelman, Alan M; Curry, William J; Lehman, Erik B

    2013-01-01

    Background Only approximately half of patients with hypertension have their blood pressure controlled, due in large part to the tendency of primary care providers (PCPs) not to intensify treatment when blood pressure values are elevated. Objective This study tested the effect of an intervention designed to help patients ask questions at the point of care to encourage PCPs to appropriately intensify blood pressure treatment. Methods PCPs and their patients with hypertension (N=500) were recruited by letter and randomized into 2 study groups: (1) intervention condition in which patients used a fully automated website each month to receive tailored messages suggesting questions to ask their PCP to improve blood pressure control, and (2) control condition in which a similar tool suggested questions to ask about preventive services (eg, cancer screening). The Web-based tool was designed to be used during each of the 12 study months and before scheduled visits with PCPs. The primary outcome was the percentage of patients in both conditions with controlled blood pressure. Results Of 500 enrolled patients (intervention condition: n=282; control condition: n=218), 418 (83.6%) completed the 12-month follow-up visit. At baseline, 289 (61.5%) of participants had controlled blood pressure. Most (411/500, 82.2%) participants used the intervention during at least 6 of 12 months and 222 (62.5%) reported asking questions directly from the Web-based tool. There were no group differences in asking about medication intensification and there were no differences in blood pressure control after 12 months between the intervention condition (201/282, 71.3%) and control condition (143/218, 65.6%; P=.27) groups. More intervention condition participants discussed having a creatinine test (92, 52.6% vs 49, 35.5%; P=.02) and urine protein test (81, 44.8% vs 21, 14.6%; P<.001), but no group differences were observed in the rate of testing. The control condition participants reported more

  12. Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial.

    PubMed

    Mason, Ashley E; Epel, Elissa S; Aschbacher, Kirstin; Lustig, Robert H; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M; Daubenmier, Jennifer

    2016-05-01

    Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β = -0.06, SE(β) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414). PMID:26867697

  13. Cutting-Balloon Angioplasty Versus Balloon Angioplasty as Treatment for Short Atherosclerotic Lesions in the Superficial Femoral Artery: Randomized Controlled Trial

    SciTech Connect

    Poncyljusz, Wojciech Falkowski, Aleksander; Safranow, Krzysztof Rac, Monika; Zawierucha, Dariusz

    2013-12-15

    Purpose: To evaluate the treatments of a short-segment atherosclerotic stenosis in the superficial femoral arteries with the cutting balloon angioplasty (CBA) versus conventional balloon angioplasty [percutaneous transluminal angioplasty (PTA)] in a randomized controlled trial. Material and Methods: The study group comprised 60 patients (33 men, 27 women; average age 64 years) with a short ({<=}5 cm) focal SFA de novo atherosclerotic stenosis associated with a history of intermittent claudication or rest pain. The primary end point of this study was the rate of binary restenosis in the treated segment 12 months after the intervention. All patients were evenly randomized to either the PTA or CBA treatment arms. Follow-up angiograms and ankle-brachial index (ABI) measurements were performed after 12 months. The evaluation of the restenosis rates and factors influencing its occurrence were calculated by logistic regression analysis. Results: In the intention-to-treat analysis, restenosis rates after 2-month follow-up were 9 of 30 (30 %) in the PTA group and 4 of 30 (13 %) in the CBA group (p = 0.117). In the actual treatment analysis, after exclusion of patients who required nitinol stent placement for a suboptimal result after angioplasty alone (5 patients in the PTA group and none in the CBA group), restenosis rates were 9 of 25 (36 %) and 4 of 30 (13 %), respectively (p = 0.049). In the intention-to-treat analysis there were also significant differences in ABI values between the PTA and CBA groups at 0.77 {+-} 0.11 versus 0.82 {+-} 0.12, respectively (p = 0.039), at 12 months. Conclusion: Based on the presented results of the trial, CBA seems to be a safer and more effective than PTA for treatment of short atherosclerotic lesions in the superior femoral artery.

  14. Sociopsychological Tailoring to Address Colorectal Cancer Screening Disparities: A Randomized Controlled Trial

    PubMed Central

    Jerant, Anthony; Kravitz, Richard L.; Sohler, Nancy; Fiscella, Kevin; Romero, Raquel L.; Parnes, Bennett; Tancredi, Daniel J.; Aguilar-Gaxiola, Sergio; Slee, Christina; Dvorak, Simon; Turner, Charles; Hudnut, Andrew; Prieto, Francisco; Franks, Peter

    2014-01-01

    PURPOSE Interventions tailored to sociopsychological factors associated with health behaviors have promise for reducing colorectal cancer screening disparities, but limited research has assessed their impact in multiethnic populations. We examined whether an interactive multimedia computer program (IMCP) tailored to expanded health belief model sociopsychological factors could promote colorectal cancer screening in a multiethnic sample. METHODS We undertook a randomized controlled trial, comparing an IMCP tailored to colorectal cancer screening self-efficacy, knowledge, barriers, readiness, test preference, and experiences with a nontailored informational program, both delivered before office visits. The primary outcome was record-documented colorectal cancer screening during a 12-month follow-up period. Secondary outcomes included postvisit sociopsychological factor status and discussion, as well as clinician recommendation of screening during office visits. We enrolled 1,164 patients stratified by ethnicity and language (49.3% non-Hispanic, 27.2% Hispanic/English, 23.4% Hispanic/Spanish) from 26 offices around 5 centers (Sacramento, California; Rochester and the Bronx, New York; Denver, Colorado; and San Antonio, Texas). RESULTS Adjusting for ethnicity/language, study center, and the previsit value of the dependent variable, compared with control patients, the IMCP led to significantly greater colorectal cancer screening knowledge, self-efficacy, readiness, test preference specificity, discussion, and recommendation. During the followup period, 132 (23%) IMCP and 123 (22%) control patients received screening (adjusted difference = 0.5 percentage points, 95% CI −4.3 to 5.3). IMCP effects did not differ significantly by ethnicity/language. CONCLUSIONS Sociopsychological factor tailoring was no more effective than nontailored information in encouraging colorectal cancer screening in a multiethnic sample, despite enhancing sociopsychological factors and visit

  15. Immediate loading of zygomatic implants using the intraoral welding technique: a 12-month case series.

    PubMed

    Degidi, Marco; Nardi, Diego; Piattelli, Adriano; Malevez, Chantal

    2012-10-01

    The aim of this prospective study was to evaluate the concept of intraoral welding as a suitable technique for fabricating a fixed restoration for the edentulous maxilla the day of surgery using standard and zygomatic implants. Ten consecutive patients (four men, six women; mean age, 62.3 ± 11.6 years) were involved in this study, each of whom had an edentulous atrophic maxilla and received two standard and two zygomatic implants. All implants were loaded immediately with a fixed prosthesis supported by an intraorally welded titanium framework. Definitive abutments were connected to the implants, and a titanium bar was welded to them using an intraoral welding unit. This framework was used to support the definitive prosthesis, which was fitted the day of implant placement. Patients were checked for swelling, pain, and framework stability at 1, 3, 6, and 12 months. A total of 20 immediately loaded standard and 20 zygomatic implants were used. The cases included in this study achieved a 100% prosthetic success rate at the 12-month follow-up. No fracture or radiographically detectable alteration of the welded frameworks was noticed. It is possible to successfully rehabilitate the edentulous atrophic maxilla with a permanently fixed prosthesis supported by an intraorally welded titanium framework attached to standard and zygomatic implants the day of surgery. PMID:22754908

  16. Spoken Language Benefits of Extending Cochlear Implant Candidacy Below 12 Months of Age

    PubMed Central

    Nicholas, Johanna G.; Geers, Ann E.

    2013-01-01

    Objective To test the hypothesis that cochlear implantation surgery before 12 months of age yields better spoken language results than surgery between 12–18 months of age. Study Design Language testing administered to children at 4.5 years of age (± 2 months). Setting Schools, speech-language therapy offices, and cochlear implant (CI) centers in the US and Canada. Participants 69 children who received a cochlear implant between ages 6–18 months of age. All children were learning to communicate via listening and spoken language in English-speaking families. Main Outcome Measure Standard scores on receptive vocabulary, expressive and receptive language (includes grammar). Results Children with CI surgery at 6–11 months (N=27) achieved higher scores on all measures as compared to those with surgery at 12–18 months (N=42). Regression analysis revealed a linear relationship between age of implantation and language outcomes throughout the 6–18 month surgery-age range. Conclusion For children in intervention programs emphasizing listening and spoken language, cochlear implantation before 12 months of age appears to provide a significant advantage for spoken language achievement observed at 4.5 years of age. PMID:23478647

  17. Acoustic changes in student actors' voices after 12 months of training.

    PubMed

    Walzak, Peta; McCabe, Patricia; Madill, Cate; Sheard, Christine

    2008-05-01

    This study was to evaluate acoustic changes in student actors' voices after 12 months of actor training. The design used was a longitudinal study. Eighteen students enrolled in an Australian tertiary 3-year acting program (nine male and nine female) were assessed at the beginning of their acting course and again 12 months later using a questionnaire, interview, maximum phonation time (MPT), reading, spontaneous speaking, sustained phonation tasks, and a pitch range task. Samples were analyzed for MPT, fundamental frequency across tasks, pitch range for speaking and reading, singing pitch range, noise-to-harmonic ratio, shimmer, and jitter. After training, measures of shimmer significantly increased for both male and female participants. Female participants' pitch range significantly increased after training, with a significantly lower mean frequency for their lowest pitch. The finding of limited or negative changes for some measures indicate that further investigation is required into the long-term effects of actor voice training and which parameters of voicing are most targeted and valued in training. Particular investigation into the relationship between training targets and outcomes could more reliably inform acting programs about changes in teaching methodologies. Further research into the relationship between specific training techniques, physiological changes, and vocal changes may also provide information on implementing more evidence-based training methods. PMID:17512170

  18. Self‐help educational booklets for the prevention of smoking relapse following smoking cessation treatment: a randomized controlled trial

    PubMed Central

    Blyth, Annie; Brown, Tracey J.; Barton, Garry R.; Notley, Caitlin; Aveyard, Paul; Holland, Richard; Bachmann, Max O.; Sutton, Stephen; Leonardi‐Bee, Jo.; Brandon, Thomas H.; Song, Fujian

    2015-01-01

    Abstract Aims Most people who quit smoking for a short term will return to smoking again in 12 months. We tested whether self‐help booklets can reduce relapse in short‐term quitters after receiving behavioural and pharmacological cessation treatment. Design A parallel‐arm, pragmatic individually randomized controlled trial. Setting Smoking cessation clinics in England. Participants People who stopped smoking for 4 weeks after receiving cessation treatment in stop smoking clinics. Intervention Participants in the experimental group (n = 703) were mailed eight booklets, each of which taught readers how to resist urges to smoke. Participants in the control group (n = 704) received a leaflet currently used in practice. Measurements The primary outcome was prolonged, carbon monoxide‐verified abstinence from months 4 to 12. The secondary outcomes included 7‐day self#x02010;reported abstinence at 3 and 12 months. Mixed‐effects logistic regression was used to estimate treatment effects and to investigate possible effect modifying variables. Findings There were no statistically significant differences between the groups in prolonged abstinence from months 4 to 12 (36.9% versus 38.6%; odds ratio 0.93, 95% confidence interval 0.75–1.16; P = 0.524). In addition, there were no significant differences between the groups in any secondary outcomes. However, people who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse. Conclusions In people who stop smoking successfully with behavioural support, a comprehensive self‐help educational programme to teach people skills to identify and respond to high‐risk situations for return to smoking did not reduce relapse. PMID:26235659

  19. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    PubMed Central

    Law, Mary; Darrah, Johanna; Pollock, Nancy; Rosenbaum, Peter; Russell, Dianne; Walter, Stephen D; Petrenchik, Theresa; Wilson, Brenda; Wright, Virginia

    2007-01-01

    Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care

  20. Multiple input/output random vibration control system

    NASA Technical Reports Server (NTRS)

    Unruh, James F.

    1988-01-01

    A multi-input/output random vibration control algorithm was developed based on system identification concepts derived from random vibration spectral analysis theory. The unique features of the algorithm are: (1) the number of input excitors and the number of output control responses need not be identical; (2) the system inverse response matrix is obtained directly from the input/output spectral matrix; and (3) the system inverse response matrix is updated every control loop cycle to accommodate system amplitude nonlinearities. A laboratory demonstration case of two imputs with three outputs is presented to demonstrate the system capabilities.

  1. Affectionate Writing Reduces Total Cholesterol: Two Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Floyd, Kory; Mikkelson, Alan C.; Hesse, Colin; Pauley, Perry M.

    2007-01-01

    In two 5-week trials, healthy college students were randomly assigned either to experimental or control groups. Participants in the experimental groups wrote about their affection for significant friends, relatives, and/or romantic partners for 20 minutes on three separate occasions; on the same schedule, those in the control groups wrote about…

  2. The Use of Control in Non-Randomized Designs.

    ERIC Educational Resources Information Center

    Halperin, Si; Jorgensen, Randall

    The concept of control is fundamental to comparative research. In research designs where randomization of observational units is not possible, control has been exercised statistically from a single covariate by a process of residualization. The alternative, known as subclassification on the propensity score, was developed primarily for…

  3. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study

    PubMed Central

    2012-01-01

    Background Total knee arthroplasty (TKA) is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy. The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA. Methods A prospective, randomized, controlled study in 30 patients undergoing TKA was conducted. Patients were randomized into experimental PEMFs or a control group. Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days. Postoperatively, all patients received the same rehabilitation program. Treatment outcome was assessed using the Knee Society Score, SF-36 Health-Survey and VAS. Patients were evaluated pre-operatively and one, two, six and 12 months after TKA. Joint swelling and Non Steroidal Anti Inflammatory Drug (NSAID) consumption were recorded. Comparisons between the two groups were carried out using a two-tail heteroschedastic Student’s t-test. Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons, applied on each group, and a Dunnet post hoc test. A p value < 0.05 was considered statistically significant. Results Pre-operatively, no differences were observed between groups in terms of age, sex, weight, height, Knee-Score, VAS, SF-36 and joint swelling, with the exception of the Functional Score. The Knee-Score, SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups. In the I

  4. Peer-Led, Empowerment-Based Approach to Self-Management Efforts in Diabetes (PLEASED): A Randomized Controlled Trial in an African American Community

    PubMed Central

    Tang, Tricia S.; Funnell, Martha M.; Sinco, Brandy; Spencer, Michael S.; Heisler, Michele

    2015-01-01

    PURPOSE We compared a 3-month diabetes self-management education (DSME) program followed by a 12-month peer support intervention with a 3-month DSME program alone in terms of initial and sustained improvements in glycated hemoglobin (HbA1c). Secondary outcomes were risk factors for cardiovascular disease (CVD), diabetes distress, and social support. METHODS We randomized 106 community-dwelling African American adults with type 2 diabetes to a 3-month DSME program followed by 12 months of weekly group sessions and supplementary telephone support delivered by peer leaders or to a 3-month DSME program with no follow-up peer support. Assessments were conducted at baseline, 3, 9, and 15 months. RESULTS No changes in HbA1c were observed at 3 months or at 15 months for either group. The peer support group either sustained improvement in key CVD risk factors or stayed the same while the control group worsened at 15 months. At 15 months, the peer-support group had significantly lower low-density lipoprotein cholesterol levels (−15 mg/dL, P = .03), systolic blood pressure (−10 mm Hg, P = .01), diastolic blood pressure (−8.3 mm Hg, P = .001), and body mass index (−0.8 kg/m2, P = .032) than the DSME-alone group. CONCLUSIONS In this population of African American adults, an initial DSME program, whether or not followed by 12 months of peer support, had no effect on glycemic control. Participants in the peer-support arm of the trial did, however, experience significant improvements in some CVD risk factors or stay approximately the same while the control group declined. PMID:26304969

  5. Is there a role of pulsed electromagnetic fields in management of patellofemoral pain syndrome? Randomized controlled study at one year follow-up.

    PubMed

    Servodio Iammarrone, Clemente; Cadossi, Matteo; Sambri, Andrea; Grosso, Eugenio; Corrado, Bruno; Servodio Iammarrone, Fernanda

    2016-02-01

    Patellofemoral pain syndrome (PFPS) is a common cause of recurrent or chronic knee pain in young adults, generally located in the retropatellar region. Etiology is controversial and includes several factors, such as anatomical defects, muscular imbalance, or joint overuse. Good results have been reported with exercise therapy, including home exercise program (HEP). Joint inflammation with increase of pro-inflammatory cytokines levels in the synovial fluid might be seen especially when chondromalacia becomes evident. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has shown anti-inflammatory effects and anabolic chondrocyte activity. The purpose of this randomized controlled study was to evaluate if the combination of HEP with PEMFs was more effective than HEP alone in PFPS treatment. Thirty-one PFPS patients were enrolled in this study. All patients were instructed to train with HEP. Patients in the PEMFs group associated HEP with PEMFs. Function and pain were assessed with Victorian Institute of Sport Assessment score (VISA), Visual Analog Scale (VAS), and Feller's Patella Score at baseline at 2, 6, and 12 months of follow-up. Drug assumption was also recorded. Increase in VISA score was significantly higher in PEMFs group compared to controls at 6 and 12 months, as well as the increase in the Feller's Patella Score at 12 months. VAS score became significantly lower in the PEMFs group with respect to control group since 6 month follow-up. Pain reduction obtained with PEMFs enhanced practicing therapeutic exercises leading to a better recovery process; this is extremely important in addressing the expectations of young patients, who wish to return to sporting activities. PMID:26756278

  6. A Randomized Controlled Trial Comparing Suture-Fixation Mucopexy and Doppler-Guided Hemorrhoidal Artery Ligation in Patients with Grade III Hemorrhoids.

    PubMed

    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

  7. 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

  8. Design and Rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): A Cluster Randomized Trial

    PubMed Central

    Margolis, Karen L.; Kerby, Tessa J.; Asche, Stephen E.; Bergdall, Anna R.; Maciosek, Michael V.; O’Connor, Patrick J.; Sperl-Hillen, Joann

    2012-01-01

    Background Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. Objectives The Home Blood Pressure Telemonitoring and Case Management to Control Hypertension study (HyperLink) is a clinic-randomized trial designed to determine whether an intervention that combines home BP telemonitoring with pharmacist case management improves BP control compared to usual care at 6 and 12 months in patients with uncontrolled hypertension. Secondary outcomes are maintenance of BP control at 18 months, patient satisfaction with their health care, and costs of care. Methods HyperLink enrolled 450 hypertensive patients with uncontrolled BP from 16 primary care clinics. Eight clinics were randomized to provide usual care (UC) to their patients (n = 222) and 8 were randomized to provide the telemonitoring intervention (TI) (n = 228). TI patients received home BP telemonitors that internally store and electronically transmit BP data to a secure database. Pharmacist case managers adjust antihypertensive therapy based on the home BP data under a collaborative practice agreement with the clinics’ primary care teams. The length of the intervention is 12 months, with follow-up to 18 months to determine the durability of the intervention. Conclusions We will test in a real primary care setting whether combining BP telemonitoring and pharmacist case management can achieve and maintain high rates of BP control compared to usual care. PMID:22498720

  9. The effects of office ergonomic training on musculoskeletal complaints, sickness absence, and psychological well-being: a cluster randomized control trial.

    PubMed

    Mahmud, Norashikin; Kenny, Dianna T; Md Zein, Raemy; Hassan, Siti Nurani

    2015-03-01

    This study explored whether musculoskeletal complaints can be reduced by the provision of ergonomics education. A cluster randomized controlled trial study was conducted in which 3 units were randomized to intervention and received training and 3 units were given a leaflet. The effect of intervention on knowledge, workstation practices, musculoskeletal complaints, sickness absence, and psychological well-being were assessed at 6 and 12 months. Although there was no increment of knowledge among workers, significant improvements in workstation practices in the use of monitor, keyboard, and chair were observed. There were significant reductions in neck and upper and lower back complaints among workers but these did not translate into fewer days lost from work. Workers' stress was found to be significantly reduced across the studies. In conclusion, office ergonomics training can be beneficial in reducing musculoskeletal risks and stress among workers. PMID:21878465

  10. Efficacy, Safety and Cost of Insecticide Treated Wall Lining, Insecticide Treated Bed Nets and Indoor Wall Wash with Lime for Visceral Leishmaniasis Vector Control in the Indian Sub-continent: A Multi-country Cluster Randomized Controlled Trial

    PubMed Central

    Das, Pradeep; Ghosh, Debashis; Priyanka, Jyoti; Matlashewski, Greg; Kroeger, Axel; Upfill-Brown, Alexander

    2016-01-01

    Background We investigated the efficacy, safety and cost of lime wash of household walls plus treatment of sand fly breeding places with bleach (i.e. environmental management or EM), insecticide impregnated durable wall lining (DWL), and bed net impregnation with slow release insecticide (ITN) for sand fly control in the Indian sub-continent. Methods This multi-country cluster randomized controlled trial had 24 clusters in each three sites with eight clusters per high, medium or low sand fly density stratum. Every cluster included 45–50 households. Five households from each cluster were randomly selected for entomological measurements including sand fly density and mortality at one, three, nine and twelve months post intervention. Household interviews were conducted for socioeconomic information and intervention acceptability assessment. Cost for each intervention was calculated. There was a control group without intervention. Findings Sand fly mortality [mean and 95%CI] ranged from 84% (81%-87%) at one month to 74% (71%-78%) at 12 months for DWL, 75% (71%-79%) at one month to 49% (43%-55%) at twelve months for ITN, and 44% (34%-53%) at one month to 22% (14%-29%) at twelve months for EM. Adjusted intervention effect on sand fly density measured by incidence rate ratio ranged from 0.28 (0.23–0.34) at one month to 0.62 (0.51–0.75) at 12 months for DWL; 0.72 (0.62–0.85) at one month to 1.02 (0.86–1.22) at 12 months for ITN; and 0.89 (0.76–1.03) at one months to 1.49 (1.26–1.74) at 12 months for EM. Household acceptance of EM was 74% compared to 94% for both DWL and ITN. Operational cost per household in USD was about 5, 8, and 2 for EM, DWL and ITN, respectively. Minimal adverse reactions were reported for EM and ITN while 36% of households with DWL reported transient itching. Interpretation DWL is the most effective, durable and acceptable control method followed by ITN. The Visceral Leishmaniasis (VL) Elimination Program in the Indian sub

  11. Cluster-Randomized Controlled Trial of an HIV/Sexually Transmitted Infection Risk-Reduction Intervention for South African Men

    PubMed Central

    Jemmott, Loretta S.; O’Leary, Ann; Ngwane, Zolani; Icard, Larry D.; Heeren, G. Anita; Mtose, Xoliswa; Carty, Craig

    2014-01-01

    Objectives. We tested the efficacy of a sexual risk-reduction intervention for men in South Africa, where heterosexual exposure is the main mode of HIV transmission. Methods. Matched-pairs of neighborhoods in Eastern Cape Province, South Africa, were randomly selected and within pairs randomized to 1 of 2 interventions based on social cognitive theory and qualitative research: HIV/sexually transmitted infection (STI) risk-reduction, targeting condom use, or attention-matched control, targeting health issues unrelated to sexual risks. Sexually active men aged 18 to 45 years were eligible. The primary outcome was consistent condom use in the past 3 months. Results. Of 1181 participants, 1106 (93.6%) completed the 12-month follow-up. HIV and STI risk-reduction participants had higher odds of reporting consistent condom use (odds ratio [OR] = 1.32; 95% confidence interval [CI] = 1.03, 1.71) and condom use at last vaginal intercourse (OR = 1.40; 95% CI = 1.08, 1.82) than did attention-control participants, adjusting for baseline prevalence. No differences were observed on unprotected intercourse or multiple partnerships. Findings did not differ for sex with steady as opposed to casual partners. Conclusions. Behavioral interventions specifically targeting men can contribute to efforts to reduce sexual risk behaviors in South Africa. PMID:24432923

  12. Environmental and genetic determinants of vitamin D insufficiency in 12-month-old infants.

    PubMed

    Suaini, Noor H A; Koplin, Jennifer J; Ellis, Justine A; Peters, Rachel L; Ponsonby, Anne-Louise; Dharmage, Shyamali C; Matheson, Melanie C; Wake, Melissa; Panjari, Mary; Tan, Hern-Tze Tina; Martin, Pamela E; Pezic, Angela; Lowe, Adrian J; Martino, David; Gurrin, Lyle C; Vuillermin, Peter J; Tang, Mimi L K; Allen, Katrina J

    2014-10-01

    We aimed to investigate the relationship between genetic and environmental exposure and vitamin D status at age one, stratified by ethnicity. This study included 563 12-month-old infants in the HealthNuts population-based study. DNA from participants' blood samples was genotyped using Sequenom MassARRAY MALDI-TOF system on 28 single nucleotide polymorphisms (SNPs) in six genes. Using logistic regression, we examined associations between environmental exposure and SNPs in vitamin D pathway and filaggrin genes and vitamin D insufficiency (VDI). VDI, defined as serum 25-hydroxyvitamin D3(25(OH)D3) level ≤50nmol/L, was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Infants were stratified by ethnicity determined by parent's country of birth. Infants formula fed at 12 months were associated with reduced odds of VDI compared to infants with no current formula use at 12 months. This association differed by ethnicity (Pinteraction=0.01). The odds ratio (OR) of VDI was 0.29 for Caucasian infants (95% CI, 0.18-0.47) and 0.04 for Asian infants (95% CI, 0.006-0.23). Maternal vitamin D supplementation during pregnancy and/or breastfeeding were associated with increased odds of infants being VDI (OR, 2.39; 95% CI, 1.11-5.18 and OR, 2.5; 95% CI, 1.20-5.24 respectively). Presence of a minor allele for any GC SNP (rs17467825, rs1155563, rs2282679, rs3755967, rs4588, rs7041) was associated with increased odds of VDI. Caucasian infants homozygous (AA) for rs4588 had an OR of 2.49 of being associated with VDI (95% CI, 1.19-5.18). In a country without routine infant vitamin D supplementation or food chain fortification, formula use is strongly associated with a reduced risk of VDI regardless of ethnicity. There was borderline significance for an association between filaggrin mutations and VDI. However, polymorphisms in vitamin D pathway related genes were associated with increased likelihood of being VDI in infancy. PMID:25174667

  13. Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression: A Randomized Controlled Trial

    PubMed Central

    Robinson, Robert G.; Jorge, Ricardo E.; Moser, David J.; Acion, Laura; Solodkin, Ana; Small, Steven L.; Fonzetti, Pasquale; Hegel, Mark; Arndt, Stephan

    2009-01-01

    Context Depression occurs in more than half of patients who have experienced a stroke. Poststroke depression has been shown in numerous studies to be associated with both impaired recovery in activities of daily living and increased mortality. Prevention of depression thus represents a potentially important goal. Objective To determine whether treatment with escitalopram or problem-solving therapy over the first year following acute stroke will decrease the number of depression cases that develop compared with placebo medication. Design, Setting, and Participants A multisite randomized controlled trial for prevention of depression among 176 nondepressed patients was conducted within 3 months following acute stroke from July 9, 2003, to October 1, 2007. The 12-month trial included 3 groups: a double-blind placebo-controlled comparison of escitalopram (n=59) with placebo (n=58), and a nonblinded problem-solving therapy group (n=59). Main Outcome Measures The main outcome measure was the development of major or minor poststroke depression based on symptoms elicited by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) and the diagnostic criteria from DSM-IV for depression due to stroke with major depressivelike episode or minor depression (ie, research criteria). Results Patients who received placebo were significantly more likely to develop depression than individuals who received escitalopram (11 major and 2 minor cases of depression [22.4%] vs 3 major and 2 min or cases of depression [8.5%], adjusted hazard ratio [HR], 4.5; 95% confidence interval [CI], 2.4–8.2; P<.001) and also more likely than individuals who received problem-solving therapy (5 major and 2 minor cases of depression [11.9%], adjusted HR, 2.2; 95% CI, 1.4–3.5; P<.001). These results were adjusted for history of mood disorders and remained significant after considering possible confounders such as age, sex, treatment site

  14. Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    practice. All patients have a CT scan at 5 days (+/−2 days) to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients. Trial registration Current Controlled Trials ISRCTN19321911 PMID:23072576

  15. Randomized Controlled Trials for the Treatment of Hidradenitis Suppurativa.

    PubMed

    van Rappard, Dominique C; Mekkes, Jan R; Tzellos, Thrasivoulos

    2016-01-01

    Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. Several treatment modalities are available, but most of them lack high-quality evidence. A systematic search was performed to identify all randomized controlled trials for the treatment of HS in order to review and evaluate the evidence. Recommendations for future randomized controlled trials include using validated scores, inclusion of patient rated outcomes, and thorough report of side effects. Evidence for long-term treatment and benefit/risk ratio of available treatment modalities is needed in order to enhance evidence-based treatment in daily clinical practice. Combining surgery with antiinflammatory treatment warrants further investigation. PMID:26617360

  16. Minimally Invasive Surgical Technique in Periodontal Regeneration: A Randomized Controlled Clinical Trial Pilot Study.

    PubMed

    Ghezzi, Carlo; Ferrantino, Luca; Bernardini, Luigi; Lencioni, Margherita; Masiero, Silvia

    2016-01-01

    The purpose of this study was to compare two minimally invasive surgical techniques (MISTs) for the treatment of periodontal defects: (1) guided tissue regeneration (GTR) using resorbable minimembrane and particulate xenograft (DBBM); and (2) inductive periodontal regeneration (IPR) using enamel matrix derivatives and DBBM. A sample of 20 infrabony periodontal defects in 20 patients were randomly assigned to either the GTR or the IPR group. A follow-up was performed at 12 months postoperative. Significant improvement in clinical parameters was observed in both groups, although no intergroup differences were found. MIST with GTR or IPR demonstrated very good outcomes 1 year after surgery, with no differences between treatment groups. PMID:27333004

  17. Preventing Obesity Among Adolescent Girls: One-Year Outcomes of the Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) Cluster Randomized Controlled Trial.

    PubMed

    Lubans, David R; Morgan, Philip J; Okely, Anthony D; Dewar, Deborah; Collins, Clare E; Batterham, Marijka; Callister, Robin; Plotnikoff, Ronald C

    2012-09-01

    OBJECTIVE To evaluate the impact of a 12-month multicomponent school-based obesity prevention program, Nutrition and Enjoyable Activity for Teen Girls among adolescent girls. DESIGN Group randomized controlled trial with 12-month follow-up. SETTING Twelve secondary schools in low-income communities in the Hunter and Central Coast regions of New South Wales, Australia. PARTICIPANTS Three hundred fifty-seven adolescent girls aged 12 to 14 years. INTERVENTION A multicomponent school-based intervention program tailored for adolescent girls. The intervention was based on social cognitive theory and included teacher professional development, enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity sessions, handbooks and pedometers for self-monitoring, parent newsletters, and text messaging for social support. MAIN OUTCOME MEASURES Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), BMI z score, body fat percentage, physical activity, screen time, dietary intake, and self-esteem. RESULTS After 12 months, changes in BMI (adjusted mean difference, -0.19; 95% CI, -0.70 to 0.33), BMI z score (mean, -0.08; 95% CI, -0.20 to 0.04), and body fat percentage (mean, -1.09; 95% CI, -2.88 to 0.70) were in favor of the intervention, but they were not statistically different from those in the control group. Changes in screen time were statistically significant (mean, -30.67 min/d; 95% CI, -62.43 to -1.06), but there were no group by time effects for physical activity, dietary behavior, or self-esteem. CONCLUSIONS A school-based intervention tailored for adolescent girls from schools located in low-income communities did not significantly reduce BMI gain. However, changes in body composition were of a magnitude similar to previous studies and may be associated with clinically important health outcomes. TRIAL REGISTRATION anzctr.org.au Identifier: 12610000330044. PMID:22566517

  18. Preventive effect of vitamin D3 supplementation on conversion of optic neuritis to clinically definite multiple sclerosis: a double blind, randomized, placebo-controlled pilot clinical trial.

    PubMed

    Derakhshandi, Hajar; Etemadifar, Masoud; Feizi, Awat; Abtahi, Seyed-Hossein; Minagar, Alireza; Abtahi, Mohammad-Ali; Abtahi, Zahra-Alsadat; Dehghani, Alireza; Sajjadi, Sepideh; Tabrizi, Nasim

    2013-09-01

    Multiple sclerosis (MS) presents with optic neuritis (ON) in 20 % of cases and 50 % of ON patients develop MS within 15 years. In this study, we evaluated the preventive effects of vitamin D3 administration on the conversion of ON to MS (primary outcome) and on the MRI lesions (secondary outcome) of ON patients with low serum 25 (OH) D levels. Thirty ON patients (15 in each of 2 groups, aged 20-40 years) with serum 25 (OH) D levels of less than 30 ng/ml were enrolled in a double blind, randomized, parallel-group trial. The treatment group (cases) received 50,000 IU of vitamin D3 weekly for 12 months and the control group (controls) received a placebo weekly for 12 months. Finally, the subsequent relapse rate and changes in MRI plaques were compared between the two groups. Risk reduction was 68.4 % for the primary outcome in the treatment group (relative risk = 0.316, p = 0.007). After 12 months, patients in the treatment group had a significantly lower incidence rate of cortical, juxtacortical, corpus callosal, new T2, new gadolinium-enhancing lesions and black holes. The mean number of total plaques showed a marginally significant decrease in the group receiving vitamin D3 supplementation as compared with the placebo group (p = 0.092). Administration of vitamin D3 supplements to ON patients with low serum vitamin 25 (OH) D levels may delay the onset of a second clinical attack and the subsequent conversion to MS. PMID:23250818

  19. Infant neurological examination from 3 to 12 months: predictive value of the single items.

    PubMed

    Pizzardi, A; Romeo, D M M; Cioni, M; Romeo, M G; Guzzetta, A

    2008-12-01

    The prognostic value of the single items of a standardised neurological examination, the Hammersmith Infant Neurologic Examination (HINE), was explored longitudinally in 658 infants at 3, 6, 9 and 12 months post-term age. ROC curves were built based on the presence/absence of cerebral palsy at 2 years of age. Global HINE scores showed very high prediction (ROC curve areas above 0.9) at all ages. The items with the highest predictive value were always movement quality and quantity. In the first semester, among the most predictive items were those assessing tone, while beyond that time they were reflexes and reactions. Our results show that the high predictive value of the HINE across the first year of life is granted by the successful combination of different groups of items for each age-period. This should be recognised in clinical practice when assessing the significance of individual neurological profiles. PMID:19568999

  20. Pointing as Epistemic Request: 12-month-olds Point to Receive New Information

    PubMed Central

    Kovács, Ágnes M.; Tauzin, Tibor; Téglás, Ernő; Gergely, György; Csibra, Gergely

    2015-01-01

    Infants start pointing systematically to objects or events around their first birthday. It has been proposed that infants point to an event in order to share their appreciation of it with others. In the current study, we tested another hypothesis, according to which infants' pointing could also serve as an epistemic request directed to the adult. Thus, infants' motivation for pointing could include the expectation that adults would provide new information about the referent. In two experiments, an adult reacted to 12-month-olds’ pointing gestures by exhibiting 'informing' or 'sharing' behavior. In response, infants pointed more frequently across trials in the informing than in the sharing condition. This suggests that the feedback that contained new information matched infants' expectations more than mere attention sharing. Such a result is consistent with the idea that not just the comprehension but also the production of early communicative signals is tuned to assist infants' learning from others. PMID:26568703

  1. Agricultural accidents: A study of 132 patients seen at addenbrooke's hospital, Cambridge, in 12 months

    PubMed Central

    Cooper, D. K. C.

    1969-01-01

    In a 12-month study 132 patients injured in agricultural accidents were treated at the Accident Service of Addenbrooke's Hospital, Cambridge. Agricultural machinery and implements were concerned in 50% of the accidents and animals in 10%. The state of immunity against tetanus of these patients was found to be extremely low, only 9% being fully immunized, and 56% having never received a course of prophylactic adsorbed tetanus toxoid. While prevention is obviously the only real solution to accidents of any nature, legislation is not enough to achieve this, and the final responsibility lies with the farmworker to ensure that all safety precautions are followed. ImagesFig. 1Fig. 2Fig. 3 PMID:5388731

  2. Repetitive Behavior in 12-Month-Olds Later Classified With Autism Spectrum Disorder

    PubMed Central

    Elison, Jed T.; Wolff, Jason J.; Reznick, J. Steven; Botteron, Kelly N.; Estes, Annette M.; Gu, Hongbin; Hazlett, Heather C.; Meadows, Adriane J.; Paterson, Sarah J.; Zwaigenbaum, Lonnie; Piven, Joseph

    2014-01-01

    Objective As compared to the utility of early emerging social communicative risk markers for predicting a later diagnosis of autism spectrum disorder (ASD), less is known about the relevance of early patterns of restricted and repetitive behaviors. We examined patterns of stereotyped motor mannerisms and repetitive manipulation of objects in 12-month-olds at high and low risk for developing ASD, all of whom were assessed for ASD at 24 months. Method Observational coding of repetitive object manipulation and stereotyped motor behaviors in digital recordings of the Communication and Symbolic Behavior Scales was conducted using the Repetitive and Stereotyped Movement Scales for three groups of 12-month-olds: 1) low-risk infants (LR, n = 53); 2) high-familial-risk infants who did not meet diagnostic criteria for ASD at 24-months (HR-negative, n = 75); and 3) high-familial-risk infants who met diagnostic criteria for ASD at 24 months (HR-ASD, n = 30). Results The HR-ASD group showed significantly more stereotyped motor mannerisms than both the HR-negative group (p = .025) and the LR group (p = .001). The HR-ASD and HR-negative groups demonstrated statistically equivalent repetitive object manipulation scores (p = .431), and both groups showed significantly more repetitive object manipulation than the LR group (p’s < 0.040). Combining the motor and object stereotypy scores into an RSMS composite yielded a disorder-continuum effect such that each group was significantly different from one another (LR < HR-negative < HR-ASD). Conclusion These results suggest that targeted assessment of repetitive behavior during infancy may augment early identification efforts. PMID:25440311

  3. Mild pituitary phenotype in 3- and 12-month-old Aip-deficient male mice.

    PubMed

    Lecoq, Anne-Lise; Zizzari, Philippe; Hage, Mirella; Decourtye, Lyvianne; Adam, Clovis; Viengchareun, Say; Veldhuis, Johannes D; Geoffroy, Valérie; Lombès, Marc; Tolle, Virginie; Guillou, Anne; Karhu, Auli; Kappeler, Laurent; Chanson, Philippe; Kamenický, Peter

    2016-10-01

    Germline mutations in the aryl hydrocarbon receptor-interacting protein (AIP) gene predispose humans to pituitary adenomas, particularly of the somatotroph lineage. Mice with global heterozygous inactivation of Aip (Aip(+/-)) also develop pituitary adenomas but differ from AIP-mutated patients by the high penetrance of pituitary disease. The endocrine phenotype of these mice is unknown. The aim of this study was to determine the endocrine phenotype of Aip(+/-) mice by assessing the somatic growth, ultradian pattern of GH secretion and IGF1 concentrations of longitudinally followed male mice at 3 and 12 months of age. As the early stages of pituitary tumorigenesis are controversial, we also studied the pituitary histology and somatotroph cell proliferation in these mice. Aip(+/-) mice did not develop gigantism but exhibited a leaner phenotype than wild-type mice. Analysis of GH pulsatility by deconvolution in 12-month-old Aip(+/-) mice showed a mild increase in total GH secretion, a conserved GH pulsatility pattern, but a normal IGF1 concentration. No pituitary adenomas were detected up to 12 months of age. An increased ex vivo response to GHRH of pituitary explants from 3-month-old Aip(+/-) mice, together with areas of enlarged acini identified on reticulin staining in the pituitary of some Aip(+/-) mice, was suggestive of somatotroph hyperplasia. Global heterozygous Aip deficiency in mice is accompanied by subtle increase in GH secretion, which does not result in gigantism. The absence of pituitary adenomas in 12-month-old Aip(+/-) mice in our experimental conditions demonstrates the important phenotypic variability of this congenic mouse model. PMID:27621108

  4. The effect of ulipristal acetate treatment on symptomatic uterine fibroids within 12-months follow-up

    PubMed Central

    Woźniak, Sławomir; Szkodziak, Piotr; Czuczwar, Piotr; Woźniakowska, Ewa; Paszkowski, Maciej; Milart, Paweł

    2014-01-01

    Aim of the study The purpose of the study was to monitor the effect of ulipristal acetate treatment on symptomatic uterine fibroids within 12-months follow-up. Material and methods Fifty six patients with symptomatic uterine fibroids qualified for surgical treatment were included in the prospective observational study. All patients received preoperative oral UPA treatment for 3 months (1 × 5 mg). Patients that refused surgical treatment after UPA therapy were followed-up for the next 9 months. The volume of the intramural fibroid was estimated by TV-US using and integrated VOCAL 3D imaging program at baseline, after 3 months of UPA treatment and further at 3-months intervals. Results Before UPA mean dominant fibroid volume was estimated to be 216.0 cm3 (38.4-768.2 cm3) and decreased to 117.6 cm3 (12.6-668.0 cm3) after 3 months of UPA therapy. Mean percentage volume reduction was 45.6%. Mean hemoglobin level increased from an initial 10.1 g/dL (6.8-12.9 g/dL) to 12.6 g/dL (10.1-14.8) after 3 months of UPA therapy. At 12 months after initiating UPA treatment mean dominant fibroid volume decreased by 43.9%. In one third of followed-up patients the effect of 3 month UPA therapy persisted for the next 9 months. Conclusions Three month UPA therapy decreases fibroid volume and improves hemoglobin level before planned surgical treatment. In one third of followed-up patients the effect of 3 month UPA therapy persisted for the next 9 months. PMID:26327823

  5. The Origins of 12-Month Attachment: A Microanalysis of 4-Month Mother-Infant Interaction

    PubMed Central

    Beebe, Beatrice; Jaffe, Joseph; Markese, Sara; Buck, Karen; Chen, Henian; Cohen, Patricia; Bahrick, Lorraine; Andrews, Howard; Feldstein, Stanley

    2013-01-01

    A detailed microanalysis of 4-month mother-infant face-to-face communication revealed a fine-grained specification of essential communication processes that predicted 12-month insecure attachment outcomes, particularly resistant and disorganized classifications. An urban community sample of 84 dyads were videotaped at 4 months during a face-to-face interaction, and at 12 months during the Ainsworth Strange Situation. Four-month mother and infant communication modalities of attention, affect, touch, and spatial orientation were coded from split-screen videotape on a 1s time base; mother and infant facial-visual “engagement” variables were constructed. We used contingency measures (multi-level time-series modeling) to examine the dyadic temporal process over time, and specific rates of qualitative features of behavior to examine the content of behavior. Self-contingency (auto-correlation) measured the degree of stability/lability within an individual’s own rhythms of behavior; interactive contingency (lagged cross-correlation) measured adjustments of the individual’s behavior that were correlated with the partner’s previous behavior. We documented that both self- and interactive contingency, as well as specific qualitative features, of mother and infant behavior were mechanisms of attachment formation by 4 months, distinguishing 12-month insecure, resistant, and disorganized attachment classifications from secure; avoidant were too few to test. All communication modalities made unique contributions. The separate analysis of different communication modalities identified intermodal discrepancies or conflict, both intrapersonal and interpersonal, that characterized insecure dyads. Contrary to dominant theories in the literature on face-to-face interaction, measures of maternal contingent coordination with infant yielded the fewest associations with 12-month attachment, whereas mother and infant self-contingency, and infant contingent coordination with mother

  6. The origins of 12-month attachment: a microanalysis of 4-month mother-infant interaction.

    PubMed

    Beebe, Beatrice; Jaffe, Joseph; Markese, Sara; Buck, Karen; Chen, Henian; Cohen, Patricia; Bahrick, Lorraine; Andrews, Howard; Feldstein, Stanley

    2010-01-01

    A microanalysis of 4-month mother-infant face-to-face communication revealed a fine-grained specification of communication processes that predicted 12-month insecure attachment outcomes, particularly resistant and disorganized classifications. An urban community sample of 84 dyads were videotaped at 4 months during a face-to-face interaction, and at 12 months during the Ainsworth Strange Situation. Four-month mother and infant communication modalities of attention, affect, touch, and spatial orientation were coded from split-screen videotape on a 1 s time base; mother and infant facial-visual "engagement" variables were constructed. We used contingency measures (multi-level time-series modeling) to examine the dyadic temporal process over time, and specific rates of qualitative features of behavior to examine the content of behavior. Self-contingency (auto-correlation) measured the degree of stability/lability within an individual's own rhythms of behavior; interactive contingency (lagged cross-correlation) measured adjustments of the individual's behavior that were correlated with the partner's previous behavior. We documented that both self- and interactive contingency, as well as specific qualitative features, of mother and infant behavior were mechanisms of attachment formation by 4 months, distinguishing 12-month insecure, resistant, and disorganized attachment classifications from secure; avoidant were too few to test. All communication modalities made unique contributions. The separate analysis of different communication modalities identified intermodal discrepancies or conflict, both intrapersonal and interpersonal, that characterized insecure dyads. Contrary to dominant theories in the literature on face-to-face interaction, measures of maternal contingent coordination with infant yielded the fewest associations with 12-month attachment, whereas mother and infant self-contingency, and infant contingent coordination with mother, yielded comparable numbers

  7. Outcomes of a 12-Month Technology-Based Intervention to Promote Weight Loss in Adolescents at Risk for Type 2 Diabetes

    PubMed Central

    Patrick, Kevin; Norman, Gregory J.; Davila, Evelyn P.; Calfas, Karen J.; Raab, Fred; Gottschalk, Michael; Sallis, James F.; Godbole, Suni; Covin, Jennifer R.

    2013-01-01

    Background: Obese adolescents are at risk for type 2 diabetes mellitus (T2DM). Obesity interventions delivered through media, such as the web and text messages [short message service (SMS)] may be beneficial when targeting obese adolescents. Methods: A randomized controlled trial, Pace-Internet for Diabetes Prevention Intervention (PACEi-DP), compared three forms of an obesity intervention to usual care (UC): (a) website only (W); (b) website, monthly group sessions, and follow-up calls (WG); and (c) website and SMS (WSMS). Participants were overweight or obese adolescents at risk for T2DM (n = 101; age 12–16 years; mean body mass index (BMI) percentile = 97.6; 74.3% Hispanic). In addition to the website, WSMS participants received SMS supporting intervention goals and behavioral strategies and communicated via SMS with a case manager. WG participants had additional group activities related to weight loss and received follow-up calls from a health coach. UC participants were given printed materials and encouraged to attend three initial group sessions. Repeated measures mixed model regression analyses tested treatment effects for anthropometric, behavioral, and behavioral change strategy outcomes. Results: There were no treatment effects for BMI, adiposity, physical activity, or diet at 12 months. Treatment effects were observed for sedentary behavior, with the W arm having a greater decrease in sedentary behavior (4.9 to 2.8 h/day) than the UC arm (p =.006). Conclusion: Although not sufficient to produce weight loss, the combination of web intervention and group sessions with telephone follow-up yielded improvements in sedentary behavior and in the use of behavior change strategies expected to lead to behavior change. PMID:23759410

  8. Single-blind, randomized controlled trial of effectiveness of Naikan therapy as an adjunctive treatment for schizophrenia over a one-year follow-up period

    PubMed Central

    ZHANG, Hong; LI, Chenhu; ZHAO, Liyu; ZHAN, Guilai

    2015-01-01

    Background Current treatments for schizophrenia are often only partially effective. Aims Assess the possible benefit of using adjunctive Naikan therapy, a cognitive approach based on self-reflection that originated in Japan for the treatment of schizophrenia. Methods After resolution of acute psychotic symptoms, 235 psychiatric inpatients with schizophrenia who had a middle school education or higher were randomly assigned to a control group (n=112) that received routine medication and inpatient rehabilitative treatment or an intervention group (n=123) that also received adjunctive Naikan therapy for 2 hours daily, 5 days a week for 4 weeks. The patients were then discharged and followed up for 12 months. The Positive and Negative Syndrome Scale (PANSS), Personal and Social Performance scale (PSP), and Insight and Attitude Questionnaire (ITAQ) were used to assess patients at enrollment, after the 1-month intervention, and after the 12-month follow-up. Evaluators were blind to the group assignment of patients. Results Only 13 (10.6%) of the intervention group participants relapsed over the 12-month follow-up, but 23 (20.5%) control group participants relapsed (X2=4.50, p=0.034). Using a modified intention-to-treat analysis and a repeated measure analysis of variance, the PANSS, PSP, and ITAQ total scores all showed significantly greater improvement over the 12-month follow-up in the Naikan group than in the control group. The drop in mean chlorpromazine-equivalent dosage from enrollment to the end of follow-up was significantly different in the intervention group but not in the control group, though the change in dosage over time between groups was not statistically significant. Conclusions This study provides robust support for the effectiveness of Naikan therapy as an adjunctive treatment during the recovery period of schizophrenia. Compared to treatment as usually, adjunctive Naikan therapy can sustain the improvement in psychotic symptoms achieved during acute

  9. A new interdisciplinary treatment strategy versus usual medical care for the treatment of subacromial impingement syndrome: a randomized controlled trial

    PubMed Central

    Dorrestijn, Oscar; Stevens, Martin; Diercks, Ron L; van der Meer, Klaas; Winters, Jan C

    2007-01-01

    Background Subacromial impingement syndrome (SIS) is the most frequently recorded shoulder disorder. When conservative treatment of SIS fails, a subacromial decompression is warranted. However, the best moment of referral for surgery is not well defined. Both early and late referrals have disadvantages – unnecessary operations and smaller improvements in shoulder function, respectively. This paper describes the design of a new interdisciplinary treatment strategy for SIS (TRANSIT), which comprises rules to treat SIS in primary care and a well-defined moment of referral for surgery. Methods/Design The effectiveness of an arthroscopic subacromial decompression versus usual medical care will be evaluated in a randomized controlled trial (RCT). Patients are eligible for inclusion when experiencing a recurrence of SIS within one year after a first episode of SIS which was successfully treated with a subacromial corticosteroid injection. After inclusion they will receive injection treatment again by their general practitioner. When, after this treatment, there is a second recurrence within a year post-injection, the participants will be randomized to either an arthroscopic subacromial decompression (intervention group) or continuation of usual medical care (control group). The latter will be performed by a general practitioner according to the Dutch National Guidelines for Shoulder Problems. At inclusion, at randomization and three, six and 12 months post-randomization an outcome assessment will take place. The primary outcome measure is the patient-reported Shoulder Disability Questionnaire. The secondary outcome measures include both disease-specific and generic measures, and an economic evaluation. Treatment effects will be compared for all measurement points by using a GLM repeated measures analyses. Discussion The rationale and design of an RCT comparing arthroscopic subacromial decompression with usual medical care for subacromial impingement syndrome are

  10. Screening and brief interventions for hazardous and harmful alcohol use among university students in South Africa: results from a randomized controlled trial.

    PubMed

    Pengpid, Supa; Peltzer, Karl; van der Heever, Hendry; Skaal, Linda

    2013-05-01

    The aim of this study was to assess the effectiveness of Screening and Brief Intervention (SBI) for alcohol problems among university students in South Africa. The study design for this efficacy study is a randomized controlled trial with 6- and 12-month follow-ups to examine the effects of a brief alcohol intervention to reduce alcohol use by hazardous and harmful drinkers in a university setting. The unit of randomization is the individual university student identified as a hazardous or harmful drinker attending public recruitment venues in a university campus. University students were screened for alcohol problems, and those identified as hazardous or harmful drinkers were randomized into an experimental or control group. The experimental group received one brief counseling session on alcohol risk reduction, while the control group received a health education leaflet. Results indicate that of the 722 screened for alcohol and who agreed to participate in the trial 152 (21.1%) tested positive for the Alcohol Use Disorder Identification Test (AUDIT) (score 8 or more). Among the 147 (96.7%) university students who also attended the 12-month follow-up session, the intervention effect on the AUDIT score was -1.5, which was statistically significant (P = 0.009). Further, the depression scores marginally significantly decreased over time across treatment groups, while other substance use (tobacco and cannabis use), self-rated health status and Posttraumatic Stress Disorder (PTSD) scores did not change over time across treatment groups. The study provides evidence of effective brief intervention by assistant nurses with hazardous and harmful drinkers in a university setting in South Africa. The short duration of the brief intervention makes it a realistic candidate for use in a university setting. PMID:23698697

  11. Multicenter randomized, controlled study of intramuscular administration of interferon-beta for the treatment of chronic hepatitis C.

    PubMed

    Castro, A; Suárez, D; Inglada, L; Carballo, E; Domínguez, A; Diago, M; Such, J; Del Olmo, J A; Pérez-Mota, A; Pedreira, J; Quiroga, J A; Carreño, V

    1997-01-01

    The intramuscular administration of interferon-beta (IFN-beta) at a dosage of 6 million units three times per week for 6 months has been evaluated in 90 patients included in a multicenter, randomized, controlled trial for the treatment of chronic hepatitis C. Transaminase levels were significantly reduced in IFN-beta-treated patients (p = 0.015) and were significantly lower with respect to those of the untreated controls (p = 0.040 at 6 months). Four treated (8%) and one untreated (2.5%) patients had normal transaminase values after 6 months. At study end (12 months), three quarters of the IFN-beta-treated patients had sustained transaminase normalization, whereas the untreated case had relapsed. Hepatitis C viremia was cleared in 6 (12%) treated patients but in none of the untreated controls (p = 0.058). Side effects of IFN-beta were infrequent (a mild flu-like syndrome in < 10%, asthenia in 16%, anorexia in 8%, headaches and weight loss in 8%, and hair loss in 4%). Leukocyte and platelet counts decreased during IFN-beta treatment, but no dose modifications were necessary. Such decreases were not statistically significant when compared with the levels in the untreated controls. Intramuscular IFN-beta at the dosage used has little efficacy in the treatment of chronic hepatitis C. Because of IFN-beta tolerance, higher doses and alternate routes of injection might prove beneficial for the treatment of this disease. PMID:9041468

  12. In School Settings, Are All RCTs (Randomized Control Trials) Exploratory?

    ERIC Educational Resources Information Center

    Newman, Denis; Jaciw, Andrew P.

    2012-01-01

    The motivation for this paper is the authors' recent work on several randomized control trials in which they found the primary result, which averaged across subgroups or sites, to be moderated by demographic or site characteristics. They are led to examine a distinction that the Institute of Education Sciences (IES) makes between "confirmatory"…

  13. A Randomized Controlled Trial of Two Online Mathematics Curricula

    ERIC Educational Resources Information Center

    Wang, Haiwen; Woodworth, Katrina

    2011-01-01

    This study applies a randomized controlled trial to examine the effects of supplemental instruction using two online mathematics curricula--DreamBox and Reasoning Mind. It is an independent evaluation intended to generate unbiased results that will help inform the ongoing development of a charter school network's hybrid instructional model, which…

  14. Pedometer Use in University Freshmen: A Randomized Controlled Pilot Study

    ERIC Educational Resources Information Center

    LeCheminant, James D.; Smith, John D.; Covington, N. Kay; Hardin-Renschen, Tracie; Heden, Tim

    2011-01-01

    Objectives: To describe activity patterns associated with a pedometer intervention in university freshmen and compare the intervention participants to controls for several health outcomes. Methods: Forty-six university freshmen were randomized to a group that wore a pedometer across the academic year with a goal of 10,000 steps/day or to a control…

  15. Improving Balance in Subacute Stroke Patients: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Goljar, Nika; Burger, Helena; Rudolf, Marko; Stanonik, Irena

    2010-01-01

    The aim of the study was to compare the efficacy of balance training in a balance trainer, a newly developed mechanical device for training balance, with conventional balance training in subacute stroke patients. This was a randomized controlled study. Fifty participants met the inclusion criteria and 39 finished the study. The participants were…

  16. A double-blind randomized control trial of diazepam

    PubMed Central

    1983-01-01

    A double-blind randomized controlled trial of diazepam against placebo in the management of minor conditions seen in general practice demonstrated that administration of either diazepam or placebo was associated with a substantial reduction in symptomatology three weeks later. There was no demonstrable difference between diazepam and placebo. PMID:6358487

  17. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  18. A Systematic Review of Randomized Controlled Studies of Art Therapy

    ERIC Educational Resources Information Center

    Maujean, Annick; Pepping, Christopher A.; Kendall, Elizabeth

    2014-01-01

    This review article examines current knowledge about the efficacy of art therapy based on the findings of 8 randomized controlled trials (RCTs) conducted with adult populations from 2008-2013 that met a high standard of rigor. Of these studies, all but one reported beneficial effects of art therapy. Review findings suggest that art therapy may…

  19. Teacher Awareness Program on Child Abuse: A Randomized Controlled Trial.

    ERIC Educational Resources Information Center

    McGrath, Patrick; And Others

    1987-01-01

    Because teachers lack knowledge of the law, of school board policies, and of issues regarding child abuse and neglect, a professional development workshop was developed and presented to all teachers in the Ottawa Public Schools. Evaluation by a randomized controlled trial showed the workshop effective in increasing and maintaining knowledge.…

  20. Additional Saturday rehabilitation improves functional independence and quality of life and reduces length of stay: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Many inpatients receive little or no rehabilitation on weekends. Our aim was to determine what effect providing additional Saturday rehabilitation during inpatient rehabilitation had on functional independence, quality of life and length of stay compared to 5 days per week of rehabilitation. Methods This was a multicenter, single-blind (assessors) randomized controlled trial with concealed allocation and 12-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in Melbourne, Australia. Patients were eligible if they were adults (aged ≥18 years) admitted for rehabilitation for any orthopedic, neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management. Participants were randomly allocated to usual care Monday to Friday rehabilitation (control) or to Monday to Saturday rehabilitation (intervention). The additional Saturday rehabilitation comprised physiotherapy and occupational therapy. The primary outcomes were functional independence (functional independence measure (FIM); measured on an 18 to 126 point scale), health-related quality of life (EQ-5D utility index; measured on a 0 to 1 scale, and EQ-5D visual analog scale; measured on a 0 to 100 scale), and patient length of stay. Outcome measures were assessed on admission, discharge (primary endpoint), and at 6 and 12 months post discharge. Results We randomly assigned 996 adults (mean (SD) age 74 (13) years) to Monday to Saturday rehabilitation (n = 496) or usual care Monday to Friday rehabilitation (n = 500). Relative to admission scores, intervention group participants had higher functional independence (mean difference (MD) 2.3, 95% confidence interval (CI) 0.5 to 4.1, P = 0.01) and health-related quality of life (MD 0.04, 95% CI 0.01 to 0.07, P = 0.009) on discharge and may have had a shorter length of stay by 2 days (95% CI 0 to 4, P = 0.1) when compared to

  1. Long-Term DHEA Replacement in Primary Adrenal Insufficiency: A Randomized, Controlled Trial

    PubMed Central

    Gurnell, Eleanor M.; Hunt, Penelope J.; Curran, Suzanne E.; Conway, Catherine L.; Pullenayegum, Eleanor M.; Huppert, Felicia A.; Compston, Juliet E.; Herbert, Joseph; Chatterjee, V. Krishna K.

    2008-01-01

    Context: Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison’s disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failure of DHEA synthesis is not typically corrected. Objective and Design: In a double-blind trial, we randomized 106 subjects (44 males, 62 females) with Addison’s disease to receive either 50 mg daily of micronized DHEA or placebo orally for 12 months to evaluate its longer-term effects on bone mineral density, body composition, and cognitive function together with well-being and fatigue. Results: Circulating DHEAS and androstenedione rose significantly in both sexes, with testosterone increasing to low normal levels only in females. DHEA reversed ongoing loss of bone mineral density at the femoral neck (P < 0.05) but not at other sites; DHEA enhanced total body (P = 0.02) and truncal (P = 0.017) lean mass significantly with no change in fat mass. At baseline, subscales of psychological well-being in questionnaires (Short Form-36, General Health Questionnaire-30), were significantly worse in Addison’s patients vs. control populations (P < 0.001), and one subscale of SF-36 improved significantly (P = 0.004) after DHEA treatment. There was no significant benefit of DHEA treatment on fatigue or cognitive or sexual function. Supraphysiological DHEAS levels were achieved in some older females who experienced mild androgenic side effects. Conclusion: Although further long-term studies of DHEA therapy, with dosage adjustment, are desirable, our results support some beneficial effects of prolonged DHEA treatment in Addison’s disease. PMID:18000094

  2. A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

    ERIC Educational Resources Information Center

    Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.

    2010-01-01

    Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

  3. The Effectiveness of Lifestyle Triple P in the Netherlands: A Randomized Controlled Trial

    PubMed Central

    Gerards, Sanne M. P. L.; Dagnelie, Pieter C.; Gubbels, Jessica S.; van Buuren, Stef; Hamers, Femke J. M.; Jansen, Maria W. J.; van der Goot, Odilia H. M.; de Vries, Nanne K.; Sanders, Matthew R.; Kremers, Stef P. J.

    2015-01-01

    Introduction Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children. The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherlands. Method We used a parallel randomized controlled design to test the effectiveness of the intervention. In total, 86 child-parent triads (children 4–8 years old, overweight or obese) were recruited and randomly assigned (allocation ratio 1:1) to the Lifestyle Triple P intervention or the control condition. Parents in the intervention condition received a 14-week intervention consisting of ten 90-minute group sessions and four individual telephone sessions. Primary outcome measure was the children’s body composition (BMI z-scores, waist circumference and skinfolds). The research assistant who performed the measurements was blinded for group assignment. Secondary outcome measures were the children’s dietary behavior and physical activity level, parenting practices, parental feeding style, parenting style, and parental self-efficacy. Outcome measures were assessed at baseline and 4 months (short-term) and 12 months (long-term) after baseline. Multilevel multiple regression analyses were conducted to determine the effect of the intervention on primary and secondary outcome measures. Results No intervention effects were found on children’s body composition. Analyses of secondary outcomes showed positive short-term intervention effects on children’s soft-drink consumption and parental responsibility regarding physical activity, encouragement to eat, psychological control, and efficacy and satisfaction with parenting. Longer-term intervention effects were found on parent’s report of children’s time spent on sedentary behavior and playing outside, parental monitoring food intake, and responsibility regarding nutrition. Conclusion Although the Lifestyle Triple P intervention showed

  4. Randomized Placebo-Controlled Phase II Trial of Autologous Mesenchymal Stem Cells in Multiple Sclerosis

    PubMed Central

    Blanco, Yolanda; Marín, Pedro; Moreno, Beatriz; Berenguer, Joan; Gabilondo, Iñigo; Martínez-Heras, Eloy; Sola-Valls, Nuria; Arnaiz, Joan-Albert; Andreu, Enrique J.; Fernández, Begoña; Bullich, Santi; Sánchez-Dalmau, Bernardo; Graus, Francesc; Villoslada, Pablo; Saiz, Albert

    2014-01-01

    Objective Uncontrolled studies of mesenchymal stem cells (MSCs) in multiple sclerosis suggested some beneficial effect. In this randomized, double-blind, placebo-controlled, crossover phase II study we investigated their safety and efficacy in relapsing-remitting multiple sclerosis patients. Efficacy was evaluated in terms of cumulative number of gadolinium-enhancing lesions (GEL) on magnetic resonance imaging (MRI) at 6 months and at the end of the study. Methods Patients unresponsive to conventional therapy, defined by at least 1 relapse and/or GEL on MRI scan in past 12 months, disease duration 2 to 10 years and Expanded Disability Status Scale (EDSS) 3.0–6.5 were randomized to receive IV 1–2×106 bone-marrow-derived-MSCs/Kg or placebo. After 6 months, the treatment was reversed and patients were followed-up for another 6 months. Secondary endpoints were clinical outcomes (relapses and disability by EDSS and MS Functional Composite), and several brain MRI and optical coherence tomography measures. Immunological tests were explored to assess the immunomodulatory effects. Results At baseline 9 patients were randomized to receive MSCs (n = 5) or placebo (n = 4). One patient on placebo withdrew after having 3 relapses in the first 5 months. We did not identify any serious adverse events. At 6 months, patients treated with MSCs had a trend to lower mean cumulative number of GEL (3.1, 95% CI = 1.1–8.8 vs 12.3, 95% CI = 4.4–34.5, p = 0.064), and at the end of study to reduced mean GEL (−2.8±5.9 vs 3±5.4, p = 0.075). No significant treatment differences were detected in the secondary endpoints. We observed a non-significant decrease of the frequency of Th1 (CD4+ IFN-γ+) cells in blood of MSCs treated patients. Conclusion Bone-marrow-MSCs are safe and may reduce inflammatory MRI parameters supporting their immunomodulatory properties. ClinicalTrials.gov NCT01228266 PMID:25436769

  5. Verapamil is Less Effective than Triamcinolone for Prevention of Keloid Scar Recurrence After Excision in a Randomized Controlled Trial.

    PubMed

    Danielsen, Patricia L; Rea, Suzanne M; Wood, Fiona M; Fear, Mark W; Viola, Helena M; Hool, Livia C; Gankande, Thilanee U; Alghamdi, Mansour; Stevenson, Andrew W; Manzur, Mitali; Wallace, Hilary J

    2016-08-23

    A double-blind randomized controlled trial with a paired split-scar design compared verapamil, an L-type Ca2+ channel antagonist, and triamcinolone for prevention of keloid recurrence after excision. Ca2+ channel blocking activity of verapamil in keloid cells was explored. One keloid was excised per subject and each wound half randomized to receive intralesional injections of triamcinolone (10 mg/ml) or verapamil (2.5 mg/ml) at monthly intervals (4 doses). Interim analysis was performed after 14 subjects were completed. Survival analysis demonstrated significantly higher keloid recurrence with verapamil compared to triamcinolone 12 months post-surgery (log-rank test, p = 0.01) and higher overall risk of recurrence with verapamil (hazard ratio 8.44, 95% CI 1.62-44.05). The study was terminated early according to the stopping guideline (p < 0.05). Verapamil is safe but not as effective as triamcinolone in preventing keloid recurrence after excision. Further study is necessary to determine if clinical response to verapamil is linked to modulation of intracellular Ca2+. PMID:26911400

  6. Lifestyle modification and weight reduction among low-income patients with the metabolic syndrome: the CHARMS randomized controlled trial.

    PubMed

    Chirinos, Diana A; Goldberg, Ronald B; Llabre, Maria M; Gellman, Marc; Gutt, Miriam; McCalla, Judith; Mendez, Armando; Schneiderman, Neil

    2016-06-01

    Although weight is an important intervention target among patients with metabolic syndrome, few trials have recruited low-income minority populations. The Community Health and Risk-reduction for Metabolic Syndrome randomized controlled trial aimed to examine the effects of a lifestyle intervention on weight and metabolic syndrome components among low-income minority adults. We randomized 120 adults with metabolic syndrome to standard medical care (N = 60) or a lifestyle intervention (N = 60). Using an intent-to-treat approach, we found significant intervention effects on weight [B = -0.452; SE = 0.122; 95 % confidence intervals (CI) -0.653 to -0.251) and glucose levels at 6-months (B = -0.522, SE = 0.234, 95 % CI -0.907 to -0.138). These changes were maintained through the 12-month assessment. No significant effects were observed on insulin resistance or other metabolic syndrome components. Our intervention was successful in achieving modest but significant weight loss and reduction in fasting glucose among low-income minority subjects with metabolic syndrome. PMID:26846133

  7. Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Pulp necrosis is one of the main complications of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling. The aim of this prospective randomized clinical trial is to compare Mineral Trioxide Aggregate(MTA)with Calcium Hydroxide(CH)as materials used to induce root-end closure in necrotic permanent immature incisors. Methods/Design This study, promoted by AP-HP, was approved by the ethics committee(CPP Paris Ile de France IV). 34 children aged from 6 to 18 years and presenting a non-vital permanent incisor are selected. Prior to treatment, an appropriate written consent has to be obtained from both parents and from children. Patients are then randomly assigned to either the MTA(experimental)or CH(control)groups. Recalls are performed after 3, 6 and 12 months to determine the presence or absence of a calcified apical barrier through the use of clinical and radiographic exams. Additional criteria such as clinical symptoms, apical radiolucencies, periapical index(PAI)are also noted. Trial registration ClinicalTrials.gov no. NCT00472173 (First inclusion: May 10, 2007; Last inclusion: April 23, 2009; study completed: April 15, 2010) PMID:21752247

  8. Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508

    PubMed Central

    2011-01-01

    Background Care management programmes are an effective approach to care for high risk patients with complex care needs resulting from multiple co-occurring medical and non-medical conditions. These patients are likely to be hospitalized for a potentially "avoidable" cause. Nurse-led care management programmes for high risk elderly patients showed promising results. Care management programmes based on health care assistants (HCAs) targeting adult patients with a high risk of hospitalisation may be an innovative approach to deliver cost-efficient intensified care to patients most in need. Methods/Design PraCMan is a cluster randomized controlled trial with primary care practices as unit of randomisation. The study evaluates a complex primary care practice-based care management of patients at high risk for future hospitalizations. Eligible patients either suffer from type 2 diabetes mellitus, chronic obstructive pulmonary disease, chronic heart failure or any combination. Patients with a high likelihood of hospitalization within the following 12 months (based on insurance data) will be included in the trial. During 12 months of intervention patients of the care management group receive comprehensive assessment of medical and non-medical needs and resources as well as regular structured monitoring of symptoms. Assessment and monitoring will be performed by trained HCAs from the participating practices. Additionally, patients will receive written information, symptom diaries, action plans and a medication plan to improve self-management capabilities. This intervention is addition to usual care. Patients from the control group receive usual care. Primary outcome is the number of all-cause hospitalizations at 12 months follow-up, assessed by insurance claims data. Secondary outcomes are health-related quality of life (SF12, EQ5D), quality of chronic illness care (PACIC), health care utilisation and costs, medication adherence (MARS), depression status and severity (PHQ-9

  9. Adherence to Self-Monitoring via Interactive Voice Response Technology in an eHealth Intervention Targeting Weight Gain Prevention Among Black Women: Randomized Controlled Trial

    PubMed Central

    2014-01-01

    Background eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. Objective This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. Methods The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. Results Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =−.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate <80% (−1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference −0.94 kg, 95% CI −1.64 to −0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring. Conclusions Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence

  10. Effectiveness of depression and anxiety prevention in adolescents with high familial risk: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Depression and anxiety disorders during adolescence can have detrimental consequences. Both disorders are related to negative outcome in various areas during adolescence and are also predictive of depression and anxiety disorders later in life. Especially parental psychopathology and being female are risk factors that increase the probability of developing one of these disorders during adolescence. Research has shown that prevention programs have promising results, especially for adolescents who have these risk factors. Therefore, in this study, we will focus on the effectiveness of a prevention program ‘A jump forward’ that has been developed for adolescent girls with a familial risk of depression and/or anxiety. Methods/Design We designed a randomized controlled trial to test the effectiveness of an indicated and selective prevention program aimed at depression and anxiety in adolescent girls. Adolescents aged between 11 and 15 years old with depressive and/or anxiety symptoms and with parents who show indicators of parental psychopathology will be randomly assigned to the experimental (N = 80) or control groups (N = 80). Participants in the experimental group will follow a preventive intervention, consisting of six sessions of 90 minutes each. All participants will complete baseline, intervention phase 1 (after session 2), intervention phase 2 (after session 4), post-intervention, 6 month follow-up, and 12 month follow-up assessments. Furthermore, parents will be asked to complete assessments at baseline, post-intervention, and 12-month follow-up. Primary outcome will be depressive symptoms. Secondary outcomes will be anxiety symptoms, suicidal ideation, response style, negative cognitive errors, parental emotional support and parental control, parental psychopathology, parenting stress and adolescents’ depression and anxiety symptoms according to the parents. Discussion This paper described the study designed to evaluate a program

  11. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    PubMed Central

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  12. The quality of randomized controlled trials in major anesthesiology journals.

    PubMed

    Greenfield, Mary Lou V H; Rosenberg, Andrew L; O'Reilly, Michael; Shanks, Amy M; Sliwinski, Michelle J; Nauss, Michael D

    2005-06-01

    Increased attention has been directed at the quality of randomized controlled trials (RCTs) and how they are being reported. We examined leading anesthesiology journals to identify if there were specific areas for improvement in the design and analysis of published clinical studies. All RCTs that appeared between January 2000 and December 2000 in leading anesthesiology journals (Anesthesiology,Anesthesia & Analgesia,Anaesthesia, and Canadian Journal of Anaesthesia) were retrieved by a MEDLINE search. We used a previously validated assessment tool, including 14 items associated with study quality, to determine a quality score for each article. The overall mean weighted quality score was 44% +/- 16%. Overall average scores were relatively high for appropriate controls (77% +/- 7%) and discussions of side effects (67% +/- 6%). Scores were very low for randomization blinding (5% +/- 2%), blinding observers to results (1% +/- 1%), and post-beta estimates (16% +/- 13%). Important pretreatment clinical predictors were absent in 32% of all studies. Significant improvement in the reporting and conduct of RCTs is required and should focus on randomization methodology, the blinding of investigators, and sample size estimates. Repeat assessments of the literature may improve the adoption of guidelines for the improvement of the quality of randomized controlled trials. PMID:15920210

  13. A randomized controlled trial of a home-visiting intervention aimed at preventing relationship problems in depressed mothers and their infants.

    PubMed

    van Doesum, Karin T M; Riksen-Walraven, J Marianne; Hosman, Clemens M H; Hoefnagels, Cees

    2008-01-01

    This study examined the effect of a mother-baby intervention on the quality of mother-child interaction, infant-mother attachment security, and infant socioemotional functioning in a group of depressed mothers with infants aged 1-12 months. A randomized controlled trial compared an experimental group (n = 35) receiving the intervention (8-10 home visits) with a control group (n = 36) receiving parenting support by telephone. There were assessments pre, post, and follow-up after 6 months. The intervention had positive effects on the quality of mother-infant interaction. Infants in the experimental group had higher scores for attachment security and for one aspect of socioemotional functioning, namely, competence. The intervention proved successful in preventing deterioration of the quality of mother-child interaction. PMID:18489412

  14. Brief Client-Centered Motivational and Behavioral Intervention to Promote HPV Vaccination in a Hard-to-Reach Population: A Pilot Randomized Controlled Trial.

    PubMed

    Joseph, Natalie Pierre; Bernstein, Judith; Pelton, Steve; Belizaire, Myrdell; Goff, Ginette; Horanieh, Nour; Freund, Karen M

    2016-08-01

    Objective To evaluate the impact of a client-centered behavioral intervention (Brief Negotiated Interviewing) on mothers' human papillomavirus (HPV) vaccine knowledge and vaccination initiation for their adolescent daughters. Methods We randomized mothers to intervention (n = 100) and control (n = 100) groups, and followed them over 12 months. Electronic medical records were reviewed to determine vaccination status. The primary outcome was receipt of the first vaccine. The secondary outcome was HPV vaccine knowledge among mothers. Results Brief Negotiated Interviewing intervention mothers demonstrated increased knowledge about HPV (pre/post mean score of 5 to 10 out of a possible 11; P < .001) and significantly higher mean knowledge scores (10 vs 6, P < .001) than control mothers. However, initiation and completion rates of the vaccine were not significantly different between groups. Conclusions Increasing HPV vaccine knowledge did not translate into increased vaccine uptake or completion of vaccination series. Future intervention must explore vaccine reminders to increase HPV vaccination rates. PMID:26968631

  15. Randomized controlled trials in diving and hyperbaric medicine.

    PubMed

    Bennett, Michael H

    2013-01-01

    Randomized controlled trials (RCTs) are widely accepted as the most appropriate methodology available for the investigation of health interventions. This is because of the low potential for systematic bias and the ability to assume causality. Well-designed RCTs, often modified by the addition of blinding participants to the treatment allocated, greatly assist physicians and funding agencies in deciding on the most effective and cost-efficient methods available to prevent and treat ill health. One of the problems for hyperbaric physicians is the widely scattered nature of the evidence, making retrieval and appraisal problematic. This review assembles the randomized evidence in order to assist practitioners, discusses the nature of randomized trials and explores approaches to designing and performing powerful and convincing trials in this area. It is extracted from the UHMS Report Hyperbaric Oxygen Therapy Indications. PMID:24224286

  16. Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. Methods/Design This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. Discussion This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been

  17. Control with a random access protocol and packet dropouts

    NASA Astrophysics Data System (ADS)

    Wang, Liyuan; Guo, Ge

    2016-08-01

    This paper investigates networked control systems whose actuators communicate with the controller via a limited number of unreliable channels. The access to the channels is decided by a so-called group random access protocol, which is modelled as a binary Markov sequence. Data packet dropouts in the channels are modelled as independent Bernoulli processes. For such systems, a systematic characterisation for controller synthesis is established and stated in terms of the transition probabilities of the Markov protocol and the packet dropout probabilities. The results are illustrated via a numerical example.

  18. Background frequency of Bacillus species at the Canberra Airport: A 12 month study.

    PubMed

    Gahan, Michelle E; Thomas, Rory; Rossi, Rebecca; Nelson, Michelle; Roffey, Paul; Richardson, Michelle M; McNevin, Dennis

    2015-12-01

    Anthrax, caused by Bacillus anthracis, is a naturally occurring disease in Australia. Whilst mainly limited to livestock in grazing regions of Victoria and New South Wales, movement of people, stock and vehicles means B. anthracis could be present outside this region. Of particular interest is the "background" prevalence of B. anthracis at transport hubs including airports. The aim of this study was to determine the background frequency of B. anthracis and the commonly used hoax agent Bacillus thuringiensis at the Canberra Airport over a 12 month period. Samples were collected daily for seven days each month from August 2011-July 2012 and analyzed using species specific real-time polymerase chain reaction. Fourteen samples (of a total of 575) were positive for the B. anthracis PL3 genomic marker, 24 for the cya (pXO1) plasmid marker and five for the capB (pXO2) plasmid marker. Whilst five samples were positive for both PL3 and cya, no samples were positive for all three markers hence there is no evidence to suggest the presence of pathogenic B. anthracis strains. B. anthracis targets were detected primarily in February 2012 and B. thuringiensis peaked in October and November 2011 and again in April and May 2012. This study provides a rapid method to screen for, and differentiate, Bacillus species. Armed with this information investigators will be able to discriminate a "threat" from "background" frequencies should the need arise. PMID:26298416

  19. Day Hospital Treatment for Anorexia Nervosa: A 12-Month Follow-up Study.

    PubMed

    Abbate-Daga, Giovanni; Marzola, Enrica; De-Bacco, Carlotta; Buzzichelli, Sara; Brustolin, Annalisa; Campisi, Stefania; Amianto, Federico; Migliaretti, Giuseppe; Fassino, Secondo

    2015-09-01

    Day hospitals (DHs) represent a treatment option for anorexia nervosa (AN), a mental disorder that is difficult to treat and has no evidence-based treatments available. We aimed to determine the effectiveness of a DH treatment that was specifically focused on the emotions of severe AN patients. Body mass index and eating psychopathology were the primary outcome measures. Fifty-six adult patients with AN were assessed upon admission, at the end of treatment (EOT) and at a 12-month follow-up evaluation (T18) using Eating Disorders Inventory-2, Beck Depression Inventory, Hamilton Rating Scale for Anxiety and Brief Social Phobia Scale. All participants received a multidisciplinary treatment programme that focused on psychodynamic psychotherapy. Seventy-eight per cent of participants reported positive outcomes at EOT and 68% at T18. Moreover, 82.1% and 65.4% of long-standing patients showed positive outcomes at EOT and T18, respectively. All measures of psychopathology were significantly improved at EOT and were maintained at follow-up. Our DH was effective at treating severe AN patients; however, further investigations of the processes of change are warranted. PMID:25974364

  20. Determinants of return to work 12 months after total hip and knee arthroplasty.

    PubMed

    Leichtenberg, C S; Tilbury, C; Kuijer, Ppfm; Verdegaal, Shm; Wolterbeek, R; Nelissen, Rghh; Frings-Dresen, Mhw; Vliet Vlieland, Tpm

    2016-07-01

    Introduction A substantial number of patients undergoing total hip or knee arthroplasty (THA or TKA) do not or only partially return to work. This study aimed to identify differences in determinants of return to work in THA and TKA. Methods We conducted a prospective, observational study of working patients aged <65 years undergoing THA or TKA for osteoarthritis. The primary outcome was full versus partial or no return to work 12 months postoperatively. Factors analysed included preoperative sociodemographic and work characteristics, alongside the Hip Disability and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS), and Oxford Hip and Knee Scores. Results Of 67 THA and 56 TKA patients, 9 (13%) and 10 (19%), respectively, returned partially and 5 (7%) and 6 (11%), respectively, did not return to work 1 year postoperatively. Preoperative factors associated with partial or no return to work in THA patients were self-employment, absence from work and a better HOOS Activities of Daily Living (ADL) subscale score, whereas only work absence was relevant in TKA patients. Type of surgery modified the impact of ADL scores on return to work. Conclusions In both THA and TKA, absence from work affected return to work, whereas self-employment and better preoperative ADL subscale scores were also associated in THA patients. The impact of ADL scores on return to work was modified by type of surgery. These results suggest that strategies aiming to influence modifiable factors should consider THA and TKA separately. PMID:27138849

  1. The Tasmanian Insulin-treated Diabetes Register. Inception and progress in the first 12 months.

    PubMed

    King, H; Senator, G; Zimmet, P; Harris, A

    1986-04-14

    A Statewide register of insulin-treated diabetic patients has been established in Tasmania. The register is the first of its kind in Australasia. Insulin treatment was chosen as the criterion for admission to the register because it was a suitably "hard" end-point, and because the completeness of the register could be validated easily by insulin prescription statistics. Both subjects with insulin-dependent diabetes mellitus and those with non-insulin-dependent diabetes mellitus (who happened to be treated with insulin as of the prevalence date, May l, 1984) are eligible for registration in the prevalent population. Furthermore, no age restrictions have been placed upon entry. It is to be hoped that this all-inclusive policy will assist in the development of an epidemiological definition of insulin-dependent diabetes mellitus. Access to cases has been by hospital records, general practitioners, lay bodies and general publicity. Of over 600 diabetic subjects who were contacted during the first 12 months of the study (approximately one-half of the estimated prevalent population), only three declined to join the register. Once fully established and validated, the register will be used to test aetiological hypotheses in addition to providing descriptive cross-sectional information about diabetes in Tasmania. It is intended that a longitudinal study of insulin-treated diabetes will follow once the cross-sectional information is complete. PMID:3959970

  2. Infant feeding in the first year. 2: feeding practices from 6-12 months of life.

    PubMed

    Meyer, Rosan

    2009-01-01

    The mainstay of nutrition in infants below six months of age is breast and/or formula milk. Infants aged between six and 12 months require additional sources of nutrition and numerous oral and developmental milestones have to be achieved to support normal development of feeding skills. Requirements increase during this period for protein, vitamin D, thiamin, niacin, vitamin B6, vitamin B12, zinc, iron and magnesium. This increased demand is met through weaning foods and breast-feeding, and, if breast milk is not available, through a suitable milk formula. The choice of milk formula above the age of six months is very much dependent on the individual infant and the stage of weaning. One of the principal factors in choosing a suitable formula at this age is the depleting iron stores. Infant formulae suitable from birth along with age-appropriate weaning foods will provide adequate iron for the majority of infants. However, iron-fortified formula may be useful to reduce iron deficiency in some vulnerable infants. Weaning should be commenced by six months of age, but not earlier than 17 weeks. Delaying wheat, egg, soy, fish and dairy beyond six months of age does not prevent the development of allergies and these foods contribute significantly to nutrients required for growth and development. It is important that parents receive evidence-based guidance on what constitutes optimal nutrition during this period of increased requirements and rapid development. PMID:19517945

  3. Social looking, social referencing and humor perception in 6- and-12-month-old infants.

    PubMed

    Mireault, Gina C; Crockenberg, Susan C; Sparrow, John E; Pettinato, Christine A; Woodard, Kelly C; Malzac, Kirsten

    2014-11-01

    Social referencing refers to infants' use of caregivers as emotional referents in ambiguous situations (Walden, 1993). Studies of social referencing typically require ambulation, thereby over-looking younger, non-ambulatory infants (i.e., ≤8-months) and resulting in a widespread assumption that young infants do not employ this strategy. Using a novel approach that does not require mobility, we found that when parents provided unsolicited affective cues during an ambiguous-absurd (i.e., humorous) event, 6-month-olds employ one component of social referencing, social looking Additionally, 6-month-olds who did not laugh at the event were significantly more likely to look toward parents than their counterparts who found the event funny. Sequential analyses revealed that, following a reference to a smiling parent, 6-month olds were more likely to smile at the parent, but by 12 months were more likely to smile at the event suggesting that older infants are influenced by parental affect in humorous situations. The developmental implications of these findings are discussed, as well as the usefulness of studying humor for understanding important developmental phenomena. PMID:25061893

  4. Surviving social assistance: 12-month prevalence of depression in sole-support parents receiving social assistance

    PubMed Central

    Byrne, C; Browne, G; Roberts, J; Ewart, B; Schuster, M; Underwood, J; Flynn-Kingston, S; Rennick, K; Bell, B; Gafni, A; Watt, S; Ashford, Y; Jamieson, E

    1998-01-01

    BACKGROUND: Although it is generally recognized that poverty and depression can coexist among single parents receiving social assistance, there is insufficient research on this topic. The goals of this study therefore were to investigate the prevalence, correlates and health care expenditures associated with depression among sole-support parents receiving social assistance. METHODS: Sole-support parents who had applied for social assistance in 2 regions of southwestern Ontario were included in the study. Depression was diagnosed with the 1994 University of Michigan Composite International Diagnostic Interview short forms. RESULTS: The 12-month prevalence rate of depressive disorder among the parents interviewed was 45.4% (345/760). A total of 247 (32.5%) had major depressive disorder alone, 19 (2.5%) had dysthymia, and 79 (10.4%) had both major depressive disorder and dysthymia ("double depression"). Those with major depressive disorder, particularly double depression, had significantly higher rates of coexisting psychiatric disorder than those without depressive disorders. Parents with depression reported higher rates of developmental delay and behaviour problems in their children than parents without depression. Expenditures for health care services were higher for parents with depression and for their children than for parents without depressive disorder and their children. INTERPRETATION: Single parents receiving social assistance have high rates of depression. Such parents with depression also have higher rates of other psychiatric disorders and higher expenditures for health care services, and their children have higher rates of developmental delay and behaviour problems. PMID:9559013

  5. [Effect of breast feeding and psychosocial variables upon psychomotor development of 12-month-old infants].

    PubMed

    De Andraca, I; Salas, M I; López, C; Cayazzo, M S; Icaza, G

    1999-09-01

    This study evaluates the participation of psychosocial variables in the relation between breast feeding (BF) and psychomotor development (PMD) in dyads with different BF duration. We assessed 138 mother-infant dyads, divided in two groups: 86 received BF as unique source of milk feeding for at least 6 months (prolonged BF group) and 52 were weaned before 45 days of age (early weaning group). General information about pregnancy, delivery and feeding was collected in a non experimental prospective design. At 6-7 months of age a milk feeding situation was observed at home, and mother-infant interactional patterns were recorded through a specially designed scale. At 12 months of age the PMD was assessed (Bayley Scales of Infant Development). Infant temperament, home stimulation, mother depression and family stress were also measured. Similar family characteristics were observed in both study groups. Early bonding and first feeding experiences were different, both reported as better in the prolonged BF group. Moreover, dyads of this group showed a higher variety and quality of mother-infant interactional patterns during feeding, with a higher synchrony and reciprocity in the relationship. Mean Mental Development Index (MDI) and Psychomotor Developmental Index (PDI) were similar in both groups. Explicatory variables for MDI and PDI are different in both study groups. Dyads who attained prolonged BF conform from a psychosocial perspective--a different group than the early weaned. PMID:10667261

  6. Perceptions of Massage Therapists Participating in a Randomized Controlled Trial

    PubMed Central

    Perlman, Adam; Dreusicke, Mark; Keever, Teresa; Ali, Ather

    2015-01-01

    Background Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider–patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. Methods Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. Results Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. Conclusions Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials. PMID:26388961

  7. Meeting Postpartum Women’s Family Planning Needs Through Integrated Family Planning and Immunization Services: Results of a Cluster-Randomized Controlled Trial in Rwanda

    PubMed Central

    Dulli, Lisa S; Eichleay, Marga; Rademacher, Kate; Sortijas, Steve; Nsengiyumva, Théophile

    2016-01-01

    ABSTRACT Objective The primary objective of this study was to test the effectiveness of integrating family planning service components into infant immunization services to increase modern contraceptive method use among postpartum women. Methods The study was a separate sample, parallel, cluster-randomized controlled trial. Fourteen randomly selected primary health facilities were equally allocated to intervention (integrated family planning and immunization services at the same time and location) and control groups (standard immunization services only). At baseline (May–June 2010), we interviewed postpartum women attending immunization services for their infant aged 6 to 12 months using a structured questionnaire. A separate sample of postpartum women was interviewed 16 months later after implementation of the experimental health service intervention. We used linear mixed regression models to test the study hypothesis that postpartum women attending immunization services for their infants aged 6–12 months in the intervention facilities will be more likely to use a modern contraceptive method than postpartum women attending immunization services for their infants aged 6–12 months in control group facilities. Results We interviewed and analyzed data for 825 women from the intervention group and 829 women from the control group. Results showed the intervention had a statistically significant, positive effect on modern contraceptive method use among intervention group participants compared with control group participants (regression coefficient, 0.15; 90% confidence interval [CI], 0.04 to 0.26). Although we conducted a 1-sided significance test, this effect was also significant at the 2-sided test with alpha = .05. Among those women who did not initiate a contraceptive method, awaiting the return of menses was the most common reason cited for non-use of a method. Women in both study groups overwhelmingly supported the concept of integrating family planning

  8. Field trial of a vaccine against New World cutaneous leishmaniasis in an at-risk child population: safety, immunogenicity, and efficacy during the first 12 months of follow-up.

    PubMed

    Armijos, R X; Weigel, M M; Aviles, H; Maldonado, R; Racines, J

    1998-05-01

    The safety, immunogenicity, and efficacy of a vaccine against cutaneous leishmaniasis in rural Ecuadorian children was assessed in a randomized, controlled, double-blinded study. Vaccine group subjects received 2 intradermal doses of a whole, killed promastigote vaccine cocktail plus bacille Calmette-Guérin (BCG) adjuvant. Control subjects got 2 doses of BCG only. The subjects who received both vaccination doses, 438 in the vaccine group (79.3%) and 406 in the control group (83.4%), were followed for 12 months. No serious adverse side effects were identified in either group. Significantly more vaccine group subjects than controls converted to a positive Montenegro skin test (85.1% vs. 20.1%; chi2 = 279; P < .001). The incidence of cutaneous leishmaniasis was significantly reduced in the vaccine compared with the control group (2.1% vs. 7.6%; chi2 = 8.95; P < .003). The protective efficacy of the vaccine was 72.9% (95% confidence interval = 36.1%-88.5%). PMID:9593024

  9. Disclosing Pleiotropic Effects during Genetic Risk Assessment for Alzheimer’s Disease: A Randomized, Controlled Trial

    PubMed Central

    Christensen, Kurt D.; Roberts, J. Scott; Whitehouse, Peter J.; Royal, Charmaine D. M.; Obisesan, Thomas O.; Cupples, L. Adrienne; Vernarelli, Jacqueline A.; Bhatt, Deepak L.; Linnenbringer, Erin; Butson, Melissa B.; Fasaye, Grace-Ann; Uhlmann, Wendy R.; Hiraki, Susan; Wang, Na; Cook-Deegan, Robert; Green, Robert C.

    2016-01-01

    Background Increasing use of genetic testing raises questions about disclosing secondary findings, including pleiotropic information. Objective To determine the safety and behavioral impact of disclosing modest associations between APOE genotype and coronary artery disease (CAD) risk during APOE-based genetic risk assessments for Alzheimer’s disease (AD). Design Randomized, multicenter equivalence clinical trial Setting Four teaching hospitals Participants 257 asymptomatic adults enrolled, 69% with one AD-affected first degree relative Intervention Disclosing AD and CAD genetic risk information (AD+CAD) versus disclosing only AD genetic risk (AD-only) Measurements Co-primary outcomes were Beck Anxiety Index (BAI) and Center for Epidemiologic Studies Depression Scale (CES-D) scores at 12 months. Secondary outcomes included test-related distress at 12 months, all measures at 6 weeks and 6 months, and health behavior changes at 12 months. Results 12 months after disclosure, mean BAI scores were 3.5 and 3.5 in AD-only and AD+CAD arms (Δ=0.0, 95%CI: −1.0 to 1.0), and mean CES-D scores were 6.4 and 7.1 in AD-only and AD+CAD arms (Δ=0.7, 95%CI: −1.0 to 2.4). Both confidence bounds fell within the equivalence margin of +/−5 points. Among ε4-positive participants, distress was lower in AD+CAD arms than AD-only arms (Δ=−4.8, 95%CI: −8.6 to −1.0) (p=0.031 for disclosure arm x APOE genotype). AD+CAD participants also reported more health behavior changes, regardless of APOE genotype. Limitations Outcomes were self-reported from volunteers without severe anxiety, severe depression, or cognitive problems. Analyses omitted 33 randomized participants. Conclusion Disclosing pleiotropic information did not increase anxiety or depression, and may have decreased distress among those at increased risk for two conditions. Providing risk modification information regarding CAD improved health behaviors. Findings highlight potential benefits of secondary genetic findings

  10. Adverse Events from a Randomized, Multi-Arm, Placebo-Controlled Trial of Mebendazole in Children 12-24 Months of Age.

    PubMed

    Joseph, Serene A; Montresor, Antonio; Casapía, Martín; Pezo, Lidsky; Gyorkos, Theresa W

    2016-07-01

    Large-scale deworming interventions, using anthelminthic drugs, are recommended in areas where the prevalence of soil-transmitted helminth infection is high. Anthelminthic safety has been established primarily in school-age children. Our objective was to provide evidence on adverse events from anthelminthic use in early childhood. A randomized multi-arm, placebo-controlled trial of mebendazole, administered at different times and frequencies, was conducted in children 12 months of age living in Iquitos, Peru. Children were followed up to 24 months of age. The association between mebendazole administration and the occurrence of a serious or minor adverse event was determined using logistic regression. There was a total of 1,686 administrations of mebendazole and 1,676 administrations of placebo to 1,760 children. Eighteen serious adverse events (i.e., 11 deaths and seven hospitalizations) and 31 minor adverse events were reported. There was no association between mebendazole and the occurrence of a serious adverse event (odds ratio [OR] = 1.21; 95% confidence interval [CI] = 0.47, 3.09) or a minor adverse event (OR = 0.84; 95% CI = 0.41, 1.72). Results from our trial support evidence of safety in administering mebendazole during early childhood. These results support World Health Organization deworming policy and the scaling up of interventions to reach children as of 12 months of age in endemic areas. PMID:27139441

  11. Outcome From a Randomized Controlled Trial of Group Therapy for Binge Eating Disorder: Comparing Dialectical Behavior Therapy Adapted for Binge Eating to an Active Comparison Group Therapy

    PubMed Central

    Safer, Debra L.; Robinson, Athena Hagler; Jo, Booil

    2011-01-01

    Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED) aims to reduce binge eating by improving adaptive emotion-regulation skills. Preliminary findings have been promising but have only compared DBT-BED to a wait-list. To control for the hypothesized specific effects of DBT-BED, the present study compared DBT-BED to an active comparison group therapy (ACGT). Men and women (n = 101) meeting DSM-IV BED research criteria were randomly assigned to 20 group sessions of DBT-BED (n = 50) or ACGT (n = 51). DBT-BED had a significantly lower dropout rate (4%) than ACGT (33.3%). Linear Mixed Models revealed that posttreatment binge abstinence and reductions in binge frequency were achieved more quickly for DBT-BED than for ACGT (posttreatment abstinence rate = 64% for DBT-BED vs. 36% for ACGT) though differences did not persist over the 3-, 6-, and 12-month follow-up assessments (e.g., 12-month follow-up abstinence rate = 64% for DBT-BED vs. 56% for ACGT). Secondary outcome measures revealed no sustained impact on emotion regulation. Although both DBT-BED and ACGT reduced binge eating, DBT-BED showed significantly fewer dropouts and greater initial efficacy (e.g., at posttreatment) than ACGT. The lack of differential findings over follow-up suggests that the hypothesized specific effects of DBT-BED do not show long-term impact beyond those attributable to nonspecific common therapeutic factors. PMID:20171332

  12. Observer-based controller design for networked control systems with sensor quantisation and random communication delay

    NASA Astrophysics Data System (ADS)

    Liu, Ming; You, Jia

    2012-10-01

    This article addresses the study of observer-based controller design for network-based control systems in the presence of output quantisation and random communication delay simultaneously. In the communication channel, the output measurement are quantised before transmission, and two kinds of network-induced delays are taken into account simultaneously: (i) random delay from sensor to controller and (ii) random delay from controller to actuator. These two types of random delays are modelled as two independent Bernoulli distributed white sequences. The observer-based controller is synthesised to stabilise the networked closed-loop system in the sense of stochastic stability. Sufficient conditions for the existence of the controller are provided by stochastic Lyapunov method. An illustrative numerical example is employed to demonstrate the applicability and flexibility of the proposed design strategy.

  13. Constraint-Induced Aphasia Therapy for Treatment of Chronic Post-Stroke Aphasia: A Randomized, Blinded, Controlled Pilot Trial

    PubMed Central

    Szaflarski, Jerzy P.; Ball, Angel L.; Vannest, Jennifer; Dietz, Aimee R.; Allendorfer, Jane B.; Martin, Amber N.; Hart, Kimberly; Lindsell, Christopher J.

    2015-01-01

    Background Few studies have documented the possibility of treatment-induced improvements in language functions 12 months or longer after stroke. The purpose of the current study was to provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to provide the data needed to design an appropriately powered trial. Material/Methods This was a randomized, controlled, single-blinded, pilot trial. We identified 32 patients with chronic post-stroke aphasia. Of these, 27 were offered participation, and 24 were randomized (CONSORT diagram): 14 to CIAT and to 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours of therapy). Outcomes were assessed within 1 week of intervention and at 1 and 12 weeks after intervention and included several linguistic measures and a measure of overall subjective communication abilities (mini-Communicative Abilities Log (mini-CAL)). To maintain blinding, clinicians treating patients (CIAT group) did not communicate with other team members and the testing team members were blinded to treatment group assignment. Results Overall, the results of this pilot trial support the results of previous observational studies that CIAT may lead to improvements in linguistic abilities. At 12 weeks, the treatment group reported better subjective communication abilities (mini-CAL) than the no-intervention group (p=0.019). Other measures trended towards better performance in the CIAT group. Conclusions In this randomized, controlled, and blinded pilot study, intensive language therapy (CIAT) led to an improvement in subjective language abilities. The effects demonstrated allow the design of a definitive trial of CIAT in patients with a variety of post-stroke aphasia types. In addition, our experiences have identified important considerations for designing subsequent trial

  14. Parent-infant vocalisations at 12 months predict psychopathology at 7 years.

    PubMed

    Allely, C S; Purves, D; McConnachie, A; Marwick, H; Johnson, P; Doolin, O; Puckering, C; Golding, J; Gillberg, C; Wilson, P

    2013-03-01

    This study investigated the utility of adult and infant vocalisation in the prediction of child psychopathology. Families were sampled from the Avon Longitudinal Study of Parents and Children (ALSPAC) birth cohort. Vocalisation patterns were obtained from 180 videos (60 cases and 120 randomly selected sex-matched controls) of parent-infant interactions when infants were one year old. Cases were infants who had been subsequently diagnosed aged seven years, with at least one psychiatric diagnostic categorisation using the Development and Wellbeing Assessment. Psychopathologies included in the case group were disruptive behaviour disorders, oppositional-conduct disorders, Attention Deficit Hyperactivity Disorder, pervasive development disorder, and emotional disorders. Associations between infant and parent vocalisations and later psychiatric diagnoses were investigated. Low frequencies of maternal vocalisation predicted later development of infant psychopathology. A reduction of five vocalisations per minute predicted a 44% (95%CI: 11-94%; p-value=0.006) increase in the odds of an infant being a case. No association was observed between infant vocalisations and overall case status. In sum, altered vocalisation frequency in mother-infant interactions at one year is a potential risk marker for later diagnosis of a range of child psychopathologies. PMID:23291516

  15. Association between Substance Use Disorder Status and Pain-Related Function Following 12 Months of Treatment in Primary Care Patients with Musculoskeletal Pain

    PubMed Central

    Morasco, Benjamin J.; Corson, Kathryn; Turk, Dennis C.; Dobscha, Steven K.

    2010-01-01

    The goal of this study was to examine relationships between substance use disorder (SUD) history and 12-month outcomes among primary care patients with chronic noncancer pain (CNCP). Patients were enrolled in a randomized trial of collaborative care intervention (CCI) versus treatment-as-usual (TAU) to improve pain-related physical and emotional function. At baseline, 72 of 362 patients (20.0%) had a history of SUD. Compared to CNCP patients without SUD, those with comorbid SUD had poorer pain-related function and were more likely to meet criteria for current major depression and posttraumatic stress disorder (all p-values<0.05). Logistic regression analyses were conducted to examine whether SUD status was associated with clinically significant change over 12 months in pain-related function (30% reduction in Roland Morris Disability Questionnaire Score). The overall model was not significant in the CCI group. However, within the TAU group, participants with a SUD history were significantly less likely to show improvements in pain-related function (OR=0.30, 95% CI=0.11–0.82). CNCP patients with comorbid SUD reported greater functional impairment at baseline. Patients with SUD who received usual care were 70% less likely to have clinically significant improvements in pain-related function 12 months post-baseline, and SUD status did not impede improvement for the CCI group. Perspective Chronic non-cancer pain patients with a history of a substance use disorder (SUD) report poorer pain-related functioning and are less likely to experience clinically significant improvements from usual pain treatment. Providers should assess for SUD status and provide more intensive interventions for these patients. PMID:20851057

  16. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia

    PubMed Central

    Joffe, Grigori; Stenberg, Jan-Henry

    2015-01-01

    Background: Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. Methods: To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. Results: There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors’ efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Conclusions: Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups—plausibly due to differences in the mechanisms of action. Antidepressants may not worsen

  17. Teacher awareness program on child abuse: a randomized controlled trial.

    PubMed

    McGrath, P; Cappelli, M; Wiseman, D; Khalil, N; Allan, B

    1987-01-01

    Teachers have a significant role in preventing, detecting and reporting child abuse and neglect. They are hindered in fulfilling this role by a serious lack of knowledge of the law, of school board policies, and of maltreatment. A comprehensive professional development workshop was developed and presented to elementary school teachers. The package was evaluated by means of a randomized controlled trial. The workshop proved to be effective in increasing and maintaining knowledge. PMID:3828866

  18. Validity of 12-Month Falls Recall in Community-Dwelling Older Women Participating in a Clinical Trial

    PubMed Central

    Sanders, Kerrie M.; Stuart, Amanda L.; Scott, David; Kotowicz, Mark A.; Nicholson, Geoff C.

    2015-01-01

    Objectives. To compare 12-month falls recall with falls reported prospectively on daily falls calendars in a clinical trial of women aged ≥70 years. Methods. 2,096 community-dwelling women at high risk of falls and/or fracture completed a daily falls calendar and standardised interviews when falls were recorded, for 12 months. Data were compared to a 12-month falls recall question that categorised falls status as “no falls,” “a few times,” “several,” and “regular” falls. Results. 898 (43%) participants reported a fall on daily falls calendars of whom 692 (77%) recalled fall(s) at 12 months. Participants who did not recall a fall were older (median 79.3 years versus 77.8 years, P = 0.028). Smaller proportions of fallers who sustained an injury or accessed health care failed to recall a fall (all P < 0.04). Among participants who recalled “no fall,” 85% reported zero falls on daily calendars. Few women selected falls categories of “several times” or “regular” (4.1% and 0.4%, resp.) and the sensitivity of these categories was low (30% to 33%). Simply categorising participants into fallers or nonfallers had 77% sensitivity and 94% specificity. Conclusion. For studies where intensive ascertainment of falls is not feasible, 12-month falls recall questions with fewer responses may be an acceptable alternative. PMID:26273292

  19. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0–6–12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient’s nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. Discussion The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet

  20. Randomized controlled trial of standard versus double dose cotrimoxazole for childhood pneumonia in Pakistan.

    PubMed Central

    Rasmussen, Zeba A.; Bari, Abdul; Qazi, Shamim; Rehman, Gul; Azam, Iqbal; Khan, SherBaz; Aziz, Farida; Rafi, Sadia; Roghani, Mehr Taj; Iqbal, Imran; Nagi, Abdul Ghaffar; Hussain, Waqar; Bano, Nahida; van Latum, Late J. C.; Khan, Mushtaq

    2005-01-01

    OBJECTIVE: Increasing concern over bacterial resistance to cotrimoxazole, which is recommended by WHO as a first-line drug for treating non-severe pneumonia, led to the suggestion that this might not be optimal therapy. However, changing to alternative antimicrobial agents, such as amoxicillin, is costly. We compared the clinical efficacy of twice-daily cotrimoxazole in standard versus double dosage for treating non-severe pneumonia in children. METHODS: A randomized controlled multicentre trial was implemented in seven hospital outpatient departments and two community health programmes. A total of 1143 children aged 2-59 months with non-severe pneumonia were randomly allocated to receive 4 mg trimethoprim plus 20 mg sulfamethoxazole/kg of body weight or 8 mg trimethoprim plus 40 mg sulfamethoxazole/kg of body weight orally twice-daily for 5 days Treatment failure occurred when a child required a change of therapy, died or was lost to follow-up. Children required a change of therapy if their condition worsened (they developed chest indrawing or danger signs) or if at 48 hours after enrollment, their clinical condition was the same (defined as having a respiratory rate that was 5 breaths/minute higher or lower than at the time of enrollment). FINDINGS: The results of 1134 children were analysed: 578 were assigned to the standard dose of cotrimoxazole and 556 to the double dose. Treatment failed in 112 children (19.4%) in the standard group and 118 (21.2%) in the double-dose group (relative risk 1.10; 95% confidence interval = 0.87-1.37). Using multivariate analysis we found that treatment was more likely to fail in children who were not given the medicine correctly (P = 0.001), in those younger than 12 months (P = 0.004), those who had used antibiotics previously (P = 0.002), those whose respiratory rate was > or =20 breaths/minute above the age-specific cut-off point (P = 0.006), and those from urban areas (P = 0.042). CONCLUSION: Both standard and double strength

  1. Sailing for Rehabilitation of Patients with Severe Mental Disorders: Results of a Cross Over Randomized Controlled Trial

    PubMed Central

    Carta, Mauro G; Maggiani, Federica; Pilutzu, Laura; Moro, Maria F; Mura, Gioia; Cadoni, Federica; Sancassiani, Federica; Vellante, Marcello; Machado, Sergio; Preti, Antonio

    2014-01-01

    This study set out to evaluate the effectiveness of a sailing and learning-to-sail rehabilitation protocol in a sample of patients diagnosed with severe mental disorders. The study was a randomized, crossover, waiting-list controlled trial, following recruitment in the Departments of Mental Health of South Sardinia. Participants were outpatients diagnosed with severe mental disorders, recruited through announcements to the directors of the Departments of Mental Health of South Sardinia. Out of the 40 patients enrolled in the study, those exposed to rehabilitation with sailing during a series of guided and supervised sea expeditions near the beach of Cagliari (Sardinia), where the aim to explore the marine environment while sailing was emphasized, showed a statistically significant improvement of their clinical status (measured by BPRS) and, as well, of their general functioning (measured by HoNOS Scale) against the control group. The improvement was maintained at follow-up for some months only: after 12 months, the patients returned to their baseline values on the measures of psychopathology and showed a worsening trend of their quality of life. Sailing can represent a substitute of important experiences that the patients with severe mental disorders miss because of their illness. PMID:25191520

  2. The Effects of Acupressure Training on Sleep Quality and Cognitive Function of Older Adults: A 1-Year Randomized Controlled Trial.

    PubMed

    Zeng, Hui; Liu, Mengjiao; Wang, Ping; Kang, Jiaxun; Lu, Fenghua; Pan, Lu

    2016-10-01

    We explored the effects of acupressure training on older adults' sleep quality and cognitive function. Ninety older adults with impaired sleep quality were selected from screened volunteers and randomly divided into equal control and experimental groups; 82 completed the 1-year follow-up. Participants in the control group were given instructions on sleep health, while those in the experimental group received sleep health instructions plus individual and small group acupressure training sessions and support to practice the intervention on their own each day. All participants were assessed by trained assistants blind to study group allocation using Chinese versions of the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Mini-Mental State Examination, and four subscales from the revised Chinese version of the Wechsler Memory Scale, at baseline and at 3, 6, and 12 months. Repeated measures analysis of variance showed that acupressure training improved older adults' sleep quality and cognitive function, but the mediating effect of sleep on the relationship between acupressure training and cognitive function was not supported. Given the ease, simplicity, and safety of acupressure training observed with community-dwelling older adults in China, attempts should be made to replicate these preliminary positive findings with larger samples. © 2016 Wiley Periodicals, Inc. PMID:27327537

  3. Sailing can improve quality of life of people with severe mental disorders: results of a cross over randomized controlled trial.

    PubMed

    Carta, Mauro Giovanni; Maggiani, Federica; Pilutzu, Laura; Moro, Maria Francesca; Mura, Gioia; Sancassiani, Federica; Vellante, Vellante; Migliaccio, Gian Mario; Machado, Sergio; Nardi, Antonio Egidio; Preti, Antonio

    2014-01-01

    The aim of this study was to evaluate the impact of a sailing rehabilitation program on the quality of life (QoL) in a sample of patients with severe mental disorders. The study adopted a randomized, crossover, waiting-list controlled design. The participants enrolled in the study were outpatients diagnosed with severe chronic mental disorders. The participants (N=40) exposed to rehabilitation with sailing took part in a series of supervised cruises near the gulf of Cagliari, South Sardinia, and showed a statistically significant improvement of their quality of life compared to the control group. This improvement was comparable to the improvement in psychopathologic status and social functioning as shown in a previous report of the same research project. The improvement was maintained at follow-up only during the trial and for a few months later: after 12 months, patients returned to their baseline values and their quality of life showed a worsening trend. This is the first study to show that rehabilitation with sailing may improve the quality of life of people with severe chronic mental disorders. In all likelihood, a program grounded on learning how to manage a sailing vessel - during which patients perform cruises that emphasize the exploration of the marine environment by sailing - might be interesting enough and capture the attention of the patients so as to favour greater effectiveness of standard rehabilitation protocols, but this should be specifically tested. PMID:25191521

  4. Sailing for rehabilitation of patients with severe mental disorders: results of a cross over randomized controlled trial.

    PubMed

    Carta, Mauro G; Maggiani, Federica; Pilutzu, Laura; Moro, Maria F; Mura, Gioia; Cadoni, Federica; Sancassiani, Federica; Vellante, Marcello; Machado, Sergio; Preti, Antonio

    2014-01-01

    This study set out to evaluate the effectiveness of a sailing and learning-to-sail rehabilitation protocol in a sample of patients diagnosed with severe mental disorders. The study was a randomized, crossover, waiting-list controlled trial, following recruitment in the Departments of Mental Health of South Sardinia. Participants were outpatients diagnosed with severe mental disorders, recruited through announcements to the directors of the Departments of Mental Health of South Sardinia. Out of the 40 patients enrolled in the study, those exposed to rehabilitation with sailing during a series of guided and supervised sea expeditions near the beach of Cagliari (Sardinia), where the aim to explore the marine environment while sailing was emphasized, showed a statistically significant improvement of their clinical status (measured by BPRS) and, as well, of their general functioning (measured by HoNOS Scale) against the control group. The improvement was maintained at follow-up for some months only: after 12 months, the patients returned to their baseline values on the measures of psychopathology and showed a worsening trend of their quality of life. Sailing can represent a substitute of important experiences that the patients with severe mental disorders miss because of their illness. PMID:25191520

  5. Maternal Efficacy and Safety Outcomes in a Randomized, Controlled Trial Comparing Insulin Detemir With NPH Insulin in 310 Pregnant Women With Type 1 Diabetes

    PubMed Central

    Mathiesen, Elisabeth R.; Hod, Moshe; Ivanisevic, Marina; Duran Garcia, Santiago; Brøndsted, Lise; Jovanovič, Lois; Damm, Peter; McCance, David R.

    2012-01-01

    OBJECTIVE This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Patients were randomized and exposed to IDet or NPH up to 12 months before pregnancy or at 8–12 weeks gestation. The primary analysis aimed to demonstrate noninferiority of IDet to NPH with respect to A1C at 36 gestational weeks (GWs) (margin of 0.4%). The data were analyzed using linear regression, taking several baseline factors and covariates into account. RESULTS A total of 310 type 1 diabetic women were randomized and exposed to IDet (n = 152) or NPH (n = 158) up to 12 months before pregnancy (48%) or during pregnancy at 8–12 weeks (52%). The estimated A1C at 36 GWs was 6.27% for IDet and 6.33% for NPH in the full analysis set (FAS). IDet was declared noninferior to NPH (FAS, –0.06% [95% CI –0.21 to 0.08]; per protocol, –0.15% [–0.34 to 0.04]). Fasting plasma glucose (FPG) was significantly lower with IDet versus NPH at both 24 GWs (96.8 vs. 113.8 mg/dL, P = 0.012) and 36 GWs (85.7 vs. 97.4 mg/dL, P = 0.017). Major and minor hypoglycemia rates during pregnancy were similar between groups. CONCLUSIONS Treatment with IDet resulted in lower FPG and noninferior A1C in late pregnancy compared with NPH insulin. Rates of hypoglycemia were comparable. PMID:22851598

  6. Long-Term Patterns of Online Evidence Retrieval Use in General Practice: A 12-Month Study

    PubMed Central

    Westbrook, Johanna I; Kidd, Michael R; Day, Richard O; Coiera, Enrico

    2008-01-01

    Background Provision of online evidence at the point of care is one strategy that could provide clinicians with easy access to up-to-date evidence in clinical settings in order to support evidence-based decision making. Objective The aim was to determine long-term use of an online evidence system in routine clinical practice. Methods This was a prospective cohort study. 59 clinicians who had a computer with Internet access in their consulting room participated in a 12-month trial of Quick Clinical, an online evidence system specifically designed around the needs of general practitioners (GPs). Patterns of use were determined by examination of computer logs and survey analysis. Results On average, 9.9 searches were conducted by each GP in the first 2 months of the study. After this, usage dropped to 4.4 searches per GP in the third month and then levelled off to between 0.4 and 2.6 searches per GP per month. The majority of searches (79.2%, 2013/2543) were conducted during practice hours (between 9 am and 5 pm) and on weekdays (90.7%, 2315/2543). The most frequent searches related to diagnosis (33.6%, 821/2291) and treatment (34.5%, 844/2291). Conclusion GPs will use an online evidence retrieval system in routine practice; however, usage rates drop significantly after initial introduction of the system. Long-term studies are required to determine the extent to which GPs will integrate the use of such technologies into their everyday clinical practice and how this will affect the satisfaction and health outcomes of their patients. PMID:18353750

  7. Temporal dynamics of arousal and attention in 12-month-old infants.

    PubMed

    Wass, S V; Clackson, K; de Barbaro, K

    2016-07-01

    Research from the animal literature suggests that dynamic, ongoing changes in arousal lead to dynamic changes in an individual's state of anticipatory readiness, influencing how individuals distribute their attention to the environment. However, multiple peripheral indices exist for studying arousal in humans, each showing change on different temporal scales, challenging whether arousal is best characterized as a unitary or a heterogeneous construct. Here, in 53 typical 12-month-olds, we recorded heart rate (HR), head movement patterns, electrodermal activity (EDA), and attention (indexed via look duration) during the presentation of 20 min of mixed animations and TV clips. We also examined triggers for high arousal episodes. Using cross-correlations and auto-correlations, we found that HR and head movement show strong covariance on a sub-minute scale, with changes in head movement consistently preceding changes in HR. EDA showed significant covariance with both, but on much larger time-scales. HR and head movement showed consistent relationships with look duration, but the relationship is temporally specific: relations are observed between head movement, HR and look duration at 30 s time-lag, but not at larger time intervals. No comparable relationships were found for EDA. Changes in head movement and HR occurred before changes in look duration, but not for EDA. Our results suggest that consistent patterns of covariation between heart rate, head movement and EDA can be identified, albeit on different time-scales, and that associations with look duration are present for head movement and heart rate, but not for EDA. Our results suggests that there is a single construct of arousal that can identified across multiple measures, and that phasic changes in arousal precede phasic changes in look duration. © 2016 Wiley Periodicals, Inc. Dev Psychobiol 58: 623-639, 2016. PMID:26999073

  8. Beneficial effects of multisensory and cognitive stimulation in institutionalized elderly: 12-months follow-up

    PubMed Central

    Dias E Dias de Macedo, Liliane; De Oliveira, Thaís Cristina Galdino; Soares, Fernanda Cabral; Bento-Torres, João; Bento-Torres, Natáli Valim Oliver; Anthony, Daniel Clive; Picanço-Diniz, Cristovam Wanderley

    2015-01-01

    We previously demonstrated the beneficial effects of a multisensory and cognitive stimulation program, consisting of 48 sessions, twice a week, to improve the cognition of elderly subjects living either in long-term care institutions (institutionalized – I) or in communities with their families (noninstitutionalized – NI). In the present study, we evaluated these subjects after the end of the intervention and compared the rate of age-related cognitive decline of those living in an enriched community environment (NI group, n=15, 74.1±3.9 years old) with those living in the impoverished environment of long-term care institutions (I group, n=20, 75.1±6.8 years old). Both groups participated fully in our stimulation program. Over 1 year, we conducted revaluations at five time points (2 months, 4 months, 6 months, 8 months, and 12 months) after the completion of the intervention. Both elderly groups were evaluated with the mini-mental state examination and selected language tests. Progressive cognitive decline was observed in both groups over the period. Indeed, it took only 4–6 months after the end of the stimulation program for significant reductions in language test scores to become apparent. However, earlier reductions in test scores were mainly associated with I group, and linguistic prosody test scores were significantly affected by institutionalization and time, two variables that interacted and reduced these scores. Moreover, I group reduced the Montréal cognitive assessment battery language tests scores 4 months before NI group. It remains to be investigated what mechanisms may explain the earlier and more intense language losses in institutionalized elderly. PMID:26316730

  9. Three-dimensional analysis of cranial growth from 6 to 12 months of age.

    PubMed

    Meyer-Marcotty, P; Böhm, H; Linz, C; Kochel, J; Stellzig-Eisenhauer, A; Schweitzer, T

    2014-10-01

    The aim of this study was to generate three-dimensional data of the physiological growth of the infant's cranium in the significant growth phase from 6 to 12 months of age. In a longitudinal observational study non-invasive 3D data using an optical surface scanner were generated of the entire head of 52 Caucasian infants (27 females and 25 males) between the ages of 6 (T1) and 12 (T2) months. The circumference of the head increased by 6.51 per cent (from 43.50 to 46.33cm). Analysis of width and length showed that the head grows 2.84 per cent more in length, resulting in a decrease in the cranial index of 2.52 per cent (from 83.87 to 81.76 per cent). The highest increment observed was in the total volume of the cranium, with an increase of 18.76 per cent (from 1229.01 to 1459.57cm(3)). Comparison of the left and right sides of the head by measuring the diagonal symmetry difference showed a difference of only 0.37cm. Overall, the symmetry-related parameters showed an almost symmetric development of the cranium in infants. The findings should provide valuable information on physiological growth and development of the infant's cranium. Therefore the high growth rate of the cranium in the first year of life suggests that this period is a critical period in which the disruption of developmental processes may have long-lasting effects on the morphology of the cranium with a prognostically unfavourable effect of the further growth of the viscerocranium. PMID:25257925

  10. Effects of an HIV peer prevention intervention on sexual and injecting risk behaviors among injecting drug users and their risk partners in Thai Nguyen, Vietnam: A randomized controlled trial

    PubMed Central

    Go, Vivian F.; Frangakis, Constantine; Le Minh, Nguyen; Latkin, Carl A.; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy; Zelaya, Carla; Vu, Pham The; Chen, Yong; Celentano, David D.; Quan, Vu Minh

    2014-01-01

    Globally, 30% of new HIV infections outside sub-Saharan Africa involve injecting drug users (IDU) and in many countries, including Vietnam, HIV epidemics are concentrated among IDU. We conducted a randomized controlled trial in Thai Nguyen, Vietnam, to evaluate whether a peer oriented behavioral intervention could reduce injecting and sexual HIV risk behaviors among IDU and their network members. 419 HIV-negative index IDU aged 18 years or older and 516 injecting and sexual network members were enrolled. Each index participant was randomly assigned to receive a series of six small group peer educator-training sessions and three booster sessions in addition to HIV testing and counseling (HTC) (intervention; n = 210) or HTC only (control; n = 209). Follow-up, including HTC, was conducted at 3, 6, 9 and 12 months post-intervention. The proportion of unprotected sex dropped significantly from 49% to 27% (SE (difference) = 3%, p < 0.01) between baseline and the 3-month visit among all index-network member pairs. However, at 12 months, post-intervention, intervention participants had a 14% greater decline in unprotected sex relative to control participants (Wald test = 10.8, df = 4, p = 0.03). This intervention effect is explained by trial participants assigned to the control arm who missed at least one standardized HTC session during follow-up and subsequently reported increased unprotected sex. The proportion of observed needle/syringe sharing dropped significantly between baseline and the 3-month visit (14% vs. 3%, SE (difference) = 2%, p < 0.01) and persisted until 12 months, but there was no difference across trial arms (Wald test = 3.74, df = 3, p = 0.44). PMID:24034963

  11. Effects of an HIV peer prevention intervention on sexual and injecting risk behaviors among injecting drug users and their risk partners in Thai Nguyen, Vietnam: a randomized controlled trial.

    PubMed

    Go, Vivian F; Frangakis, Constantine; Le Minh, Nguyen; Latkin, Carl A; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy; Zelaya, Carla; Vu, Pham The; Chen, Yong; Celentano, David D; Quan, Vu Minh

    2013-11-01

    Globally, 30% of new HIV infections outside sub-Saharan Africa involve injecting drug users (IDU) and in many countries, including Vietnam, HIV epidemics are concentrated among IDU. We conducted a randomized controlled trial in Thai Nguyen, Vietnam, to evaluate whether a peer oriented behavioral intervention could reduce injecting and sexual HIV risk behaviors among IDU and their network members. 419 HIV-negative index IDU aged 18 years or older and 516 injecting and sexual network members were enrolled. Each index participant was randomly assigned to receive a series of six small group peer educator-training sessions and three booster sessions in addition to HIV testing and counseling (HTC) (intervention; n = 210) or HTC only (control; n = 209). Follow-up, including HTC, was conducted at 3, 6, 9 and 12 months post-intervention. The proportion of unprotected sex dropped significantly from 49% to 27% (SE (difference) = 3%, p < 0.01) between baseline and the 3-month visit among all index-network member pairs. However, at 12 months, post-intervention, intervention participants had a 14% greater decline in unprotected sex relative to control participants (Wald test = 10.8, df = 4, p = 0.03). This intervention effect is explained by trial participants assigned to the control arm who missed at least one standardized HTC session during follow-up and subsequently reported increased unprotected sex. The proportion of observed needle/syringe sharing dropped significantly between baseline and the 3-month visit (14% vs. 3%, SE (difference) = 2%, p < 0.01) and persisted until 12 months, but there was no difference across trial arms (Wald test = 3.74, df = 3, p = 0.44). PMID:24034963

  12. Analysis of correlation between initial alveolar bone density and apical root resorption after 12 months of orthodontic treatment without extraction

    PubMed Central

    Scheibel, Paula Cabrini; Ramos, Adilson Luiz; Iwaki, Lilian Cristina Vessoni; Micheletti, Kelly Regina

    2014-01-01

    OBJECTIVE: The aim of the present study was to investigate the correlation between initial alveolar bone density of upper central incisors (ABD-UI) and external apical root resorption (EARR) after 12 months of orthodontic movement in cases without extraction. METHODS: A total of 47 orthodontic patients 11 years old or older were submitted to periapical radiography of upper incisors prior to treatment (T1) and after 12 months of treatment (T2). ABD-UI and EARR were measured by means of densitometry. RESULTS: No statistically significant correlation was found between initial ABD-UI and EARR at T2 (r = 0.149; p = 0.157). CONCLUSION: Based on the present findings, alveolar density assessed through periapical radiography is not predictive of root resorption after 12 months of orthodontic treatment in cases without extraction. PMID:25715722

  13. Mobile Technology for Vegetable Consumption: A Randomized Controlled Pilot Study in Overweight Adults

    PubMed Central

    Mathur, Maya; King, Abby C

    2016-01-01

    Background Mobile apps present a potentially cost-effective tool for delivering behavior change interventions at scale, but no known studies have tested the efficacy of apps as a tool to specifically increase vegetable consumption among overweight adults. Objective The purpose of this pilot study was to assess the initial efficacy and user acceptability of a theory-driven mobile app to increase vegetable consumption. Methods A total of 17 overweight adults aged 42.0 (SD 7.3) years with a body mass index (BMI) of 32.0 (SD 3.5) kg/m2 were randomized to the use of Vegethon (a fully automated theory-driven mobile app enabling self-monitoring of vegetable consumption, goal setting, feedback, and social comparison) or a wait-listed control condition. All participants were recruited from an ongoing 12-month weight loss trial (parent trial). Researchers who performed data analysis were blinded to condition assignment. The primary outcome measure was daily vegetable consumption, assessed using an adapted version of the validated Harvard Food Frequency Questionnaire administered at baseline and 12 weeks after randomization. An analysis of covariance was used to assess differences in 12-week vegetable consumption between intervention and control conditions, controlling for baseline. App usability and satisfaction were measured via a 21-item post-intervention questionnaire. Results Using intention-to-treat analyses, all enrolled participants (intervention: 8; control: 9) were analyzed. Of the 8 participants randomized to the intervention, 5 downloaded the app and logged their vegetable consumption a mean of 0.7 (SD 0.9) times per day, 2 downloaded the app but did not use it, and 1 never downloaded it. Consumption of vegetables was significantly greater among the intervention versus control condition at the end of the 12-week pilot study (adjusted mean difference: 7.4 servings; 95% CI 1.4-13.5; P=.02). Among secondary outcomes defined a priori, there was significantly greater

  14. Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial

    PubMed Central

    Carey, Michael P.; Senn, Theresa E.; Walsh, Jennifer L.; Coury-Doniger, Patricia; Urban, Marguerite A.; Fortune, Thierry; Vanable, Peter A.; Carey, Kate B.

    2014-01-01

    We report results from a randomized controlled trial designed to evaluate the efficacy of a video-based sexual risk reduction intervention and to measure assessment reactivity. Patients (N = 1010; 56 % male; 69 % African American) receiving care at a sexually transmitted infection (STI) clinic were assigned to one of four conditions formed by crossing assessment condition (i.e., sexual health vs. general health) with intervention condition (i.e., sexual risk reduction intervention vs. general health promotion). After completing their assigned baseline assessment, participants received their assigned intervention, and subsequently returned for follow-up assessments at 3, 6, 9, and 12 months. Participants in all conditions reduced their self-reported sexual risk behavior, and the incidence of new STIs declined from baseline through the follow-ups; however, there was no effect of intervention or assessment condition. We conclude that further risk reduction will require more intensive interventions, especially in STI clinics that already provide excellent clinical care. PMID:25433653

  15. Predictors of outcome after 6 and 12 months following anthroposophic therapy for adult outpatients with chronic disease: a secondary analysis from a prospective observational study

    PubMed Central

    2010-01-01

    Background Anthroposophic medicine is a physician-provided complementary therapy system involving counselling, artistic and physical therapies, and special medications. The purpose of this analysis was to identify predictors of symptom improvement in patients receiving anthroposophic treatment for chronic diseases. Methods 913 adult outpatients from Germany participated in a prospective cohort study. Patients were starting anthroposophic treatment for mental (30.4% of patients, n = 278/913), musculoskeletal (20.2%), neurological (7.6%), genitourinary (7.4%) or respiratory disorders (7.2%) or other chronic indications. Stepwise multiple linear regression analysis was performed with the improvement of Symptom Score (patients' assessment, 0: not present, 10: worst possible) after 6 and 12 months as dependent variables. 61 independent variables pertaining to socio-demographics, life style, disease status, co-morbidity, health status (SF-36), depression, and therapy factors were analysed. Results Compared to baseline, Symptom Score improved by average 2.53 points (95% confidence interval 2.39-2.68, p < 0.001) after six months and by 2.49 points (2.32-2.65, p < 0.001) after 12 months. The strongest predictor for improvement after six months was baseline Symptom Score, which alone accounted for 25% of the variance (total model 32%). Improvement after six months was also positively predicted by better physical function, better general health, shorter disease duration, higher education level, a diagnosis of respiratory disorders, and by a higher therapy goal documented by the physician at baseline; and negatively predicted by the number of physiotherapy sessions in the pre-study year and by a diagnosis of genitourinary disorders. Seven of these nine variables (not the two diagnoses) also predicted improvement after 12 months. When repeating the 0-6 month analysis on two random subsamples of the original sample, three variables (baseline Symptom Score, physical function

  16. Uteroplacental insufficiency leads to hypertension, but not glucose intolerance or impaired skeletal muscle mitochondrial biogenesis, in 12-month-old rats

    PubMed Central

    Tran, Melanie; Young, Margaret E; Jefferies, Andrew J; Hryciw, Deanne H; Ward, Michelle M; Fletcher, Erica L; Wlodek, Mary E; Wadley, Glenn D

    2015-01-01

    Growth restriction impacts on offspring development and increases their risk of disease in adulthood which is exacerbated with “second hits.” The aim of this study was to investigate if blood pressure, glucose tolerance, and skeletal muscle mitochondrial biogenesis were altered in 12-month-old male and female offspring with prenatal or postnatal growth restriction. Bilateral uterine vessel ligation induced uteroplacental insufficiency and growth restriction in offspring (Restricted). A sham surgery was also performed during pregnancy (Control) and some litters from sham mothers had their litter size reduced (Reduced litter), which restricted postnatal growth. Growth-restricted females only developed hypertension at 12 months, which was not observed in males. In Restricted females only homeostasis model assessment for insulin resistance was decreased, indicating enhanced hepatic insulin sensitivity, which was not observed in males. Plasma leptin was increased only in the Reduced males at 12 months compared to Control and Restricted males, which was not observed in females. Compared to Controls, leptin, ghrelin, and adiponectin were unaltered in the Restricted males and females, suggesting that at 12 months of age the reduction in body weight in the Restricted offspring is not a consequence of circulating adipokines. Skeletal muscle PGC-1α levels were unaltered in 12-month-old male and female rats, which indicate improvements in lean muscle mass by 12 months of age. In summary, sex strongly impacts the cardiometabolic effects of growth restriction in 12-month-old rats and it is females who are at particular risk of developing long-term hypertension following growth restriction. PMID:26416974

  17. Uteroplacental insufficiency leads to hypertension, but not glucose intolerance or impaired skeletal muscle mitochondrial biogenesis, in 12-month-old rats.

    PubMed

    Tran, Melanie; Young, Margaret E; Jefferies, Andrew J; Hryciw, Deanne H; Ward, Michelle M; Fletcher, Erica L; Wlodek, Mary E; Wadley, Glenn D

    2015-09-01

    Growth restriction impacts on offspring development and increases their risk of disease in adulthood which is exacerbated with "second hits." The aim of this study was to investigate if blood pressure, glucose tolerance, and skeletal muscle mitochondrial biogenesis were altered in 12-month-old male and female offspring with prenatal or postnatal growth restriction. Bilateral uterine vessel ligation induced uteroplacental insufficiency and growth restriction in offspring (Restricted). A sham surgery was also performed during pregnancy (Control) and some litters from sham mothers had their litter size reduced (Reduced litter), which restricted postnatal growth. Growth-restricted females only developed hypertension at 12 months, which was not observed in males. In Restricted females only homeostasis model assessment for insulin resistance was decreased, indicating enhanced hepatic insulin sensitivity, which was not observed in males. Plasma leptin was increased only in the Reduced males at 12 months compared to Control and Restricted males, which was not observed in females. Compared to Controls, leptin, ghrelin, and adiponectin were unaltered in the Restricted males and females, suggesting that at 12 months of age the reduction in body weight in the Restricted offspring is not a consequence of circulating adipokines. Skeletal muscle PGC-1α levels were unaltered in 12-month-old male and female rats, which indicate improvements in lean muscle mass by 12 months of age. In summary, sex strongly impacts the cardiometabolic effects of growth restriction in 12-month-old rats and it is females who are at particular risk of developing long-term hypertension following growth restriction. PMID:26416974

  18. Self-help smoking cessation and maintenance programs: a comparative study with 12-month follow-up by the American Lung Association.

    PubMed

    Davis, A L; Faust, R; Ordentlich, M

    1984-11-01

    One thousand two hundred thirty seven smokers responding to lung association announcements in five geographic areas were randomly assigned to one of four groups and mailed American Lung Association materials: 1) leaflets (L); 2) leaflets plus maintenance manual (L + M); 3) cessation manual (C); and 4) cessation and maintenance manuals (C + M). Five telephone interviews over one year achieved a 95 per cent follow-up completion rate. Nonrespondents as well as exclusive cigar and pipe users were classified as smokers. Twenty per cent quit initially, with 5 per cent continually abstinent in (C + M) at 12 months vs 2 per cent in (L) (p less than .05). Nonsmoking prevalence rates (no tobacco smoking in the past month), on the other hand, gradually increased after six months; at 12 months those with the maintenance component, (L + M) and (C + M), had higher rates (18 per cent) than (L) (12 per cent) or (C) (15 per cent). Leaflets and manual alone were least cost effective. Rising nonsmoking prevalence rates observed in all groups suggest that successful attempts to quit increased over time and that a contributing factor might have been the follow-up method. Although achieving lower quit rates than methods requiring attendance at a course, the self-help intervention has the advantages of greater availability, flexibility, and in some instances lower cost. PMID:6437257

  19. Active control of tensegrity structures under random excitation

    NASA Astrophysics Data System (ADS)

    Ganesh Raja, M.; Narayanan, S.

    2007-06-01

    In this paper we consider vibration control of tensegrity structures under stationary and nonstationary random excitations. These excitations may be representative of many physical loading conditions, such as earthquake, wind, aerodynamic and acoustic excitations. The optimal control theory based on H2 and \\mathrm {H}_{\\infty } controller with full state and limited state feedback is used for the control. The response of the tensegrity structure is represented by the zero lag covariance matrix and the same is obtained by solving the matrix Lyapunov equation. The force generated by the electro-mechanical coupling of the piezoelectric actuator is used in the formulation. A tensegrity structure of class-1 comprising of two modules, with 24 pretension cables and six struts with piezoelectric actuators, is considered.

  20. Respecting the circle of life: one year outcomes from a randomized controlled comparison of an HIV risk reduction intervention for American Indian adolescents.

    PubMed

    Tingey, Lauren; Mullany, Britta; Chambers, Rachel; Hastings, Ranelda; Lee, Angelita; Parker, Anthony; Barlow, Allison; Rompalo, Anne

    2015-01-01

    Potential for widespread transmission of HIV/AIDS among American Indian (AI) adolescents exists, yet no evidence-based interventions (EBIs) have been adapted and evaluated with this population. Intensive psychoeducation may improve knowledge and decision-making which could potentially translate to reductions in HIV risk behaviors. A peer group randomized controlled comparison of an adapted EBI vs. control was delivered over an eight-day summer basketball camp in one reservation-based tribal community to adolescents ages 13-19. Outcome data were gathered immediately post-camp and at 6 and 12 months follow-up. Self-selected peer groups were randomized to intervention (n = 138) or control (n = 129) conditions for a total sample of 267 participants (56.2% female), mean age 15.1 years (SD = 1.7). Intervention participants had better condom use self-efficacy post-camp (Adjusted Mean Difference [AMD] = -0.75, p < 0.005) and at 6 (AMD = -0.44, p < 0.005) and 12 months (AMD = -0.23, p < 0.05) follow-up. Intervention participants also had higher HIV prevention and transmission knowledge (post-camp: AMD = 0.07, p < 0.01; 6 months: AMD = 0.06, p < 0.01) were more likely to believe condoms prevent sexually transmitted infections (post-camp: RR = 1.41, p < 0.005; 6 months: RR = 1.34, p < 0.05), to talk with an adult about HIV/AIDS (post-camp: RR=1.78, p < 0.005; 6 months: RR = 1.14, p < 0.005), had higher partner negotiation efficacy related to substance use during sex (post-camp: AMD = 0.37, p < 0.01), and were more likely to intend to use a condom (post-camp: RR = 1.39, p < 0.01). The adapted intervention had short- and medium-term impacts on AI adolescent risk for HIV/AIDS, but attenuated at 12 months. Intervention delivery through a community-based camp is feasible and acceptable with strong retention. Additional study is needed to evaluate the adapted intervention's impact on sexual risk behaviors and if booster sessions and parent involvement translate to long-term impacts

  1. Effects of 12-month valsartan therapy on glycation and oxidative stress markers in type 2 diabetic subjects with hypertension.

    PubMed

    Komiya, Naoko; Hirose, Hiroshi; Saisho, Yoshifumi; Saito, Ikuo; Itoh, Hiroshi

    2008-11-01

    Although it has been reported that angiotensin II receptor blockers inhibited the formation and accumulation of advanced glycation endproducts (AGEs) in vitro and in vivo, whether they can do so clinically is not clear. We investigated the effects of 12-month valsartan therapy on various markers of inflammation, glycation, and oxidation in type 2 diabetic subjects with hypertension. We started 40 mg/day valsartan treatment in 15 type 2 diabetic patients with hypertension. In 6 patients, the dose of valsartan was increased to 80 mg/day after 6 months and maintained until 12 months. Metabolic parameters including BMI and serum high molecular weight (HMW)-adiponectin, high-sensitivity C-reactive protein (hs-CRP) as an inflammation marker, AGEs, paraoxonase activity, platelet-activating factor (PAF)- acetylhydrolase activity, and urine 8-isoprostane levels were measured at baseline and after 6 and 12 months of treatment. Urine microalbumin level and carotid artery intima-media thickness (IMT) were also measured. Even after valsartan therapy, the blood pressure levels of the patients were not decreased significantly. Serum AGEs and urine 8-isoprostane levels decreased at both 6 and 12 months (P < 0.05 for both), although other metabolic and oxidative markers were unchanged. Though urine microalbumin levels tended to be decreased after 6 and 12 months of valsartan treatment, the changes were not significant. Mean IMT at 12 months was not changed from the baseline value. In conclusion, the findings suggest that treatment with valsartan, even at a low dose, may ameliorate some glycation and oxidative stress markers independently of an effect on blood pressure in hypertensive type 2 diabetic subjects. PMID:19075484

  2. Prediction model for outcome after low-back surgery: individualized likelihood of complication, hospital readmission, return to work, and 12-month improvement in functional disability.

    PubMed

    McGirt, Matthew J; Sivaganesan, Ahilan; Asher, Anthony L; Devin, Clinton J

    2015-12-01

    OBJECT Lumbar spine surgery has been demonstrated to be efficacious for many degenerative spine conditions. However, there is wide variability in outcome after spine surgery at the individual patient level. All stakeholders in spine care will benefit from identification of the unique patient or disease subgroups that are least likely to benefit from surgery, are prone to costly complications, and have increased health care utilization. There remains a large demand for individual patient-level predictive analytics to guide decision support to optimize outcomes at the patient and population levels. METHODS One thousand eight hundred three consecutive patients undergoing spine surgery for various degenerative lumbar diagnoses were prospectively enrolled and followed for 1 year. A comprehensive patient interview and health assessment was performed at baseline and at 3 and 12 months after surgery. All predictive covariates were selected a priori. Eighty percent of the sample was randomly selected for model development, and 20% for model validation. Linear regression was performed with Bayesian model averaging to model 12-month ODI (Oswestry Disability Index). Logistic regression with Bayesian model averaging was used to model likelihood of complications, 30-day readmission, need for inpatient rehabilitation, and return to work. Goodness-of-fit was assessed via R(2) for 12-month ODI and via the c-statistic, area under the receiver operating characteristic curve (AUC), for the categorical endpoints. Discrimination (predictive performance) was assessed, using R(2) for the ODI model and the c-statistic for the categorical endpoint models. Calibration was assessed using a plot of predicted versus observed values for the ODI model and the Hosmer-Lemeshow test for the categorical endpoint models. RESULTS On average, all patient-reported outcomes (PROs) were improved after surgery (ODI baseline vs 12 month: 50.4 vs 29.5%, p < 0.001). Complications occurred in 121 patients (6

  3. Randomly Sampled-Data Control Systems. Ph.D. Thesis

    NASA Technical Reports Server (NTRS)

    Han, Kuoruey

    1990-01-01

    The purpose is to solve the Linear Quadratic Regulator (LQR) problem with random time sampling. Such a sampling scheme may arise from imperfect instrumentation as in the case of sampling jitter. It can also model the stochastic information exchange among decentralized controllers to name just a few. A practical suboptimal controller is proposed with the nice property of mean square stability. The proposed controller is suboptimal in the sense that the control structure is limited to be linear. Because of i. i. d. assumption, this does not seem unreasonable. Once the control structure is fixed, the stochastic discrete optimal control problem is transformed into an equivalent deterministic optimal control problem with dynamics described by the matrix difference equation. The N-horizon control problem is solved using the Lagrange's multiplier method. The infinite horizon control problem is formulated as a classical minimization problem. Assuming existence of solution to the minimization problem, the total system is shown to be mean square stable under certain observability conditions. Computer simulations are performed to illustrate these conditions.

  4. Effectiveness of a facebook-delivered physical activity intervention for post-partum women: a randomized controlled trial protocol

    PubMed Central

    2013-01-01

    Background Physical activity is reduced during the post-partum period. Facebook is frequently used by Australian mothers, and offers flexibility, high levels of engagement and the ability to disseminate information and advice via social contacts. The Mums Step it Up Program is a newly developed 50 day team-based physical activity intervention delivered via a Facebook app. The program involves post-partum women working in teams of 4–8 friends aiming to achieve 10,000 steps per day measured by a pedometer. Women are encouraged to use the app to log their daily steps and undertake social and supportive interactions with their friends and other participants. This study aims to determine the effectiveness of the Mums Step it Up Program. Method/design A sample of 126 women up to 12 months post-partum will be recruited through community-based health and family services. Participants will be randomly allocated into one of three groups: control, pedometer only and the Mums Step it Up Program. Assessments will be completed at baseline, 6 weeks and 6 months. The primary outcome (objective physical activity) and the secondary outcomes (sleep quality and quantity, depressive symptoms, weight and quality of life) will be used to determine the effectiveness of the Mums Step it Up Program compared with the control and pedometer only groups. Analyses will be undertaken on an intention-to-treat-basis using random effects mixed modeling. The effect of theorized mediators (physical activity attitudes, subjective norms and perceived behavioral control) will also be examined. Discussion This study will provide information about the potential of a Facebook app for the delivery of health behavior interventions. If this intervention proves to be effective it will be released on a mass scale and promoted to the general public. Trial registration Australia and New Zealand Clinical Trials Register: ACTRN12613000069752 PMID:23714411

  5. Three phase III randomized controlled trials of topical resiquimod 0.01-percent gel to reduce anogenital herpes recurrences.

    PubMed

    Mark, Karen E; Spruance, Spotswood; Kinghorn, George R; Sacks, Stephen L; Slade, Herbert B; Meng, Tze-Chiang; Selke, Stacy; Magaret, Amalia; Wald, Anna

    2014-09-01

    Resiquimod, a Toll-like receptor 7 and 8 agonist, stimulates production of cytokines that promote an antigen-specific T helper type 1 acquired immune response. Animal and phase II human trials showed posttreatment efficacy in reducing recurrent herpes lesion days and/or time to first recurrence. Three phase III randomized, double-blind, vehicle-controlled trials of topical resiquimod to reduce anogenital herpes recurrences were conducted in healthy adults with ≥4 recurrences within the prior year. Participants applied resiquimod 0.01% gel or vehicle gel 2 times per week for 3 weeks to each recurrence for 12 months. Trials 1 and 2 had 2:1 resiquimod-vehicle randomization. Trial 3 had 1:1:1 randomization for resiquimod and 500 mg valacyclovir orally twice daily for 5 days (RESI-VAL), resiquimod and oral placebo (RESI-PLA), and vehicle and oral placebo (VEH-PLA). The median time to first recurrence was similar for resiquimod and vehicle (trial 1, 60 and 56 days, P=0.7; trial 2, 54 and 48 days, P=0.47; trial 3, 51 [RESI-VAL], 55 [RESI-PLA], and 44 [VEH-PLA] days, P=not significant [NS]). The median time to healing of initial treated recurrence was longer for resiquimod (trial 1, 18 compared to 10 days, P<0.001; trial 2, 19 compared to 13 days, P=0.16; trial 3, 14 [RESI-VAL], 16 [RESI-PLA], and 8 [VEH-PLA] days, P<0.001). In trials 1 and 2, moderate to severe erythema and erosion/ulceration at the application site were more common in resiquimod recipients. In conclusion, no posttreatment efficacy of resiquimod 0.01% gel was observed. Increased application site reactions and initial recurrence healing time are consistent with resiquimod-induced cytokine effects. PMID:24709264

  6. Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial.

    PubMed

    Smallwood, J; Brown, R; Coulter, F; Irvine, E; Copland, C

    2001-10-01

    A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size. PMID:11607948

  7. Benzodiazepine Discontinuation among Adults with GAD: A Randomized Trial of Cognitive-Behavioral Therapy

    ERIC Educational Resources Information Center

    Gosselin, Patrick; Ladouceur, Robert; Morin, Charles M.; Dugas, Michel J.; Baillargeon, Lucie

    2006-01-01

    This study evaluated the specific effectiveness of cognitive-behavior therapy (CBT) combined with medication tapering for benzodiazepine discontinuation among generalized anxiety disorder (GAD) patients by using a nonspecific therapy control group. Sixty-one patients who had used benzodiazepines for more than 12 months were randomly assigned to…

  8. The Effectiveness of Propolis on Gingivitis: A Randomized Controlled Trial

    PubMed Central

    Paulino, Niraldo; Nör, Jacques E.; Moreira, Alexandre

    2014-01-01

    Abstract Background: A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Methods: Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days −14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). Results: The 38 persons who completed the study (age 13–22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Conclusions: Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period. PMID:25380344

  9. Effects of a couple-based intervention to reduce risks for HIV, HCV, and STIs among drug-involved heterosexual couples in Kazakhstan: A randomized controlled trial

    PubMed Central

    El-Bassel, Nabila; Gilbert, Louisa; Terlikbayeva, Assel; Beyrer, Chris; Wu, Elwin; Chang, Mingway; Hunt, Tim; Ismayilova, Leyla; Shaw, Stacey A.; Primbetova, Sholpan; Rozental, Yelena; Zhussupov, Baurzhan; Tukeyev, Marat

    2014-01-01

    Objective Project Renaissance is a randomized controlled trial of an HIV/HCV/STI prevention intervention conducted in Almaty, Kazakhstan. We hypothesized that couples assigned to the intervention of interest will have lower incidence of HIV, HCV, sexually transmitted infections (STI), rates of unprotected sex, and unsafe injection over the 12-month follow up period compared to those assigned to an attention control arm. Design A total of 300 couples (600 participants) where one or both partners reported injecting drugs in the past 90 days were randomized to one of two arms: (1) a five-session HIV/HCV/STI prevention intervention (Risk Reduction: RR), or (2) a five-session Wellness Promotion (WP) intervention. Results Over the 12-month follow up period, assignment to RR compared to WP significantly lowered the incidence of HCV infection by 69% (IRR=0.31, 95% CI=0.10 – 0.90, p=0.031). Although differences were not statistically significant, RR participants had a lower incidence of HIV infection by 51% (IRR=0.49, 95% CI=0.16 – 1.48, p=0.204) and any STI by 37% (IRR=0.63, 95%=0.21 – 1.93, p=0.418) than WP participants. RR participants reported significantly fewer numbers of unprotected vaginal sex acts with their study partners (IRR=0.58, 95% CI=0.36 – 0.93, p=0.024) and more consistent condom use (OR=2.30, 95% CI=1.33 – 4.00, p=0.003) over the entire follow-up period compared to WP participants. Conclusion Project Renaissance demonstrated a significant effect for biological and behavioral endpoints. Findings draw attention to an HIV/HCV/STI prevention intervention strategy that can be scaled up for drug-involved couples in harm reduction programs, drug treatment, and criminal justice settings. PMID:24991973

  10. The Effect of a Physical Activity Program on the Total Number of Primary Care Visits in Inactive Patients: A 15-Month Randomized Controlled Trial

    PubMed Central

    Giné-Garriga, Maria; Martin-Borràs, Carme; Puig-Ribera, Anna; Martín-Cantera, Carlos; Solà, Mercè; Cuesta-Vargas, Antonio

    2013-01-01

    Background Effective promotion of exercise could result in substantial savings in healthcare cost expenses in terms of direct medical costs, such as the number of medical appointments. However, this is hampered by our limited knowledge of how to achieve sustained increases in physical activity. Objectives To assess the effectiveness of a Primary Health Care (PHC) based physical activity program in reducing the total number of visits to the healthcare center among inactive patients, over a 15-month period. Research Design Randomized controlled trial. Subjects Three hundred and sixty-two (n = 362) inactive patients suffering from at least one chronic condition were included. One hundred and eighty-three patients (n = 183; mean (SD); 68.3 (8.8) years; 118 women) were randomly allocated to the physical activity program (IG). One hundred and seventy-nine patients (n = 179; 67.2 (9.1) years; 106 women) were allocated to the control group (CG). The IG went through a three-month standardized physical activity program led by physical activity specialists and linked to community resources. Measures The total number of medical appointments to the PHC, during twelve months before and after the program, was registered. Self-reported health status (SF-12 version 2) was assessed at baseline (month 0), at the end of the intervention (month 3), and at 12 months follow-up after the end of the intervention (month 15). Results The IG had a significantly reduced number of visits during the 12 months after the intervention: 14.8 (8.5). The CG remained about the same: 18.2 (11.1) (P = .002). Conclusions Our findings indicate that a 3-month physical activity program linked to community resources is a short-duration, effective and sustainable intervention in inactive patients to decrease rates of PHC visits. Trial Registration ClinicalTrials.gov NCT00714831 PMID:23805219

  11. Building Kindergartners’ Number Sense: A Randomized Controlled Study

    PubMed Central

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2015-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

  12. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

    PubMed

    Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

    2012-07-01

    We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia. PMID:21461716

  13. Cervical Lidocaine for IUD Insertional Pain: a Randomized Controlled Trial

    PubMed Central

    McNicholas, Colleen P.; Madden, Tessa; Zhao, Qiuhong; Secura, Gina; Allsworth, Jenifer E.; Peipert, Jeffrey F.

    2012-01-01

    Objective Anticipated pain with intrauterine device (IUD) insertion may be a barrier to widespread use. Our objective was to evaluate the efficacy of intracervical 2% lidocaine gel for pain relief with IUD insertion. Study Design We performed a double-blind, randomized controlled trial of women undergoing IUD insertion. Participants were randomly assigned to 2% lidocaine or placebo gel. Study gel (3ccs) wase placed 3 minutes prior to IUD insertion. Pain scores were measured at various time points using a 10-point visual analog scale. Results Of the 200 participants randomized, 199 completed the study. Pain scores among lidocaine and placebo arms were similar at tenaculum placement (lidocaine and placebo; median 4, range 0–10 p=0.15) as well as with insertion (lidocaine: median 5 range 1–10, placebo: median 6 range 0–10 p=0.16). These results did not differ by parity. Conclusions Topical or intracervical 2% lidocaine gel prior to IUD insertion does not decrease pain scores. PMID:23107081

  14. Medication reconciliation at patient admission: a randomized controlled trial

    PubMed Central

    Mendes, Antonio E.; Lombardi, Natália F.; Andrzejevski, Vânia S.; Frandoloso, Gibran; Correr, Cassyano J.; Carvalho, Mauricio

    2015-01-01

    Objective: To measure length of hospital stay (LHS) in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620). The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety. PMID:27011775

  15. Shallow Semantic Parsing of Randomized Controlled Trial Reports

    PubMed Central

    Paek, Hyung; Kogan, Yacov; Thomas, Prem; Codish, Seymour; Krauthammer, Michael

    2006-01-01

    In this work, we are measuring the performance of Propbank-based Machine Learning (ML) for automatically annotating abstracts of Randomized Controlled Trials (RCTs) with semantically meaningful tags. Propbank is a resource of annotated sentences from the Wall Street Journal (WSJ) corpus, and we were interested in assessing performance issues when porting this resource to the medical domain. We compare intra-domain (WSJ/WSJ) with cross-domain (WSJ/medical abstracts) performance. Although the intra-domain performance is superior, we found a reasonable cross-domain performance. PMID:17238412

  16. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    PubMed Central

    Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2015-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. PMID:25456014

  17. Delivery of Evidence-Based Treatment for Multiple Anxiety Disorders in Primary Care: A Randomized Controlled Trial

    PubMed Central

    Roy-Byrne, Peter; Craske, Michelle G.; Sullivan, Greer; Rose, Raphael D.; Edlund, Mark J.; Lang, Ariel J.; Bystritsky, Alexander; Welch, Stacy Shaw; Chavira, Denise A.; Golinelli, Daniela; Campbell-Sills, Laura; Sherbourne, Cathy D.; Stein, Murray B.

    2010-01-01

    Context Improving the quality of mental health care requires moving clinical interventions from controlled research settings into “real world” practice settings. While such advances have been made for depression, little work has been done for anxiety disorders. Objective To determine whether a flexible treatment-delivery model for multiple primary care anxiety disorders (panic, generalized anxiety, social anxiety, and/or posttraumatic stress disorders) would be superior to usual care. Design, Setting, and Participants Randomized controlled effectiveness trial of CALM (“Coordinated Anxiety Learning and Management”) compared to usual care (UC) in 17 primary care clinics in 4 US cities. Between June 2006 and April 2008, 1004 patients with anxiety disorders (with or without major depression), age 18–75, English- or Spanish-speaking, enrolled and subsequently received treatment for 3–12 months. Blinded follow-up assessments at 6, 12, and 18 months after baseline were completed in October 2009. Intervention(s) CALM allowed choice of cognitive behavioral therapy (CBT), medication, or both; included real-time web-based outcomes monitoring to optimize treatment decisions and a computer-assisted program to optimize delivery of CBT by non-expert care managers who also assisted primary care providers in promoting adherence and optimizing medications. Main Outcome Measure(s) 12-item Brief Symptom Inventory (anxiety and somatic symptoms) score. Secondary outcomes: Proportion of responders (≥ 50% reduction from pre-treatment BSI-12 score) and remitters (total BSI-12 score < 6). Results Significantly greater improvement for CALM than UC in global anxiety symptoms: BSI-12 group differences of −2.49 (95% CI, −3.59 to −1.40), −2.63 (95% CI, −3.73 to −1.54), and −1.63 (95% CI, −2.73 to −0.53) at 6, 12, and 18 months, respectively. At 12 months, response and remission rates (CALM vs. UC) were 63.66% (58.95–68.37) vs. 44.68% (39.76–49.59), and 51

  18. Low intensity vs. self-guided Internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study

    PubMed Central

    2013-01-01

    Background Major depression will become the second most important cause of disability in 2020. Computerized cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy has been carried out. The aim of this study is to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system. Methods The study is made up of 3 phases: 1.- Development of a computerized cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed. Discussion The comparisons between low intensity and self-guided are infrequent, and also a comparative economic evaluation between them and compared with usual treatment in primary. The strength of the study is that it is a multicenter, randomized, controlled trial of low intensity and self-guided Internet-delivered psychotherapy for depression in primary care, being the treatment completely integrated in primary care setting. Trial registration Clinical Trials NCT01611818 PMID:23312003

  19. Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial

    PubMed Central

    2009-01-01

    Background Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings. Design E-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240) recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided α level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up. Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level) and moderators (e.g., age, gender, race/ethnicity, baseline mental status) of the intervention's effect on weight change also will be examined. Discussion This study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care. Trial registration NCT00842426

  20. Patient Empowerment Improved Perioperative Quality of Care in Cancer Patients Aged ≥ 65 Years – A Randomized Controlled Trial

    PubMed Central

    Schmidt, Maren; Eckardt, Rahel; Scholtz, Kathrin; Neuner, Bruno; von Dossow-Hanfstingl, Vera; Sehouli, Jalid; Stief, Christian G.; Wernecke, Klaus-Dieter; Spies, Claudia D.

    2015-01-01

    Purpose This randomized controlled, clinical prospective interventional trial was aimed at exploring the effect of patient empowerment on short- and long-term outcomes after major oncologic surgery in elderly cancer patients. Methods This trial was performed from February 2011 to January 2014 at two tertiary medical centers in Germany. The study included patients aged 65 years and older undergoing elective surgery for gastro-intestinal, genitourinary, and thoracic cancer. The patients were randomly assigned to the intervention group, i.e. patient empowerment through information booklet and diary keeping, or to the control group, which received standard care. Randomization was done by block randomization in blocks of four in order of enrollment. The primary outcome were 1,postoperative length of hospital stay (LOS) and 2. long-term global health-related quality of life (HRQoL) one year postoperatively. HRQoL was assessed using the EORTC QLQ C30 questionnaire. Secondary outcomes encompassed postoperative stress and complications. Further objectives were the identification of predictors of LOS, and HRQoL at 12 months. Results Overall 652 patients were included. The mean age was 72 ± 4.9 years, and the majority of patients were male (68.6%, n = 447). The ^median of postoperative length of stay was 9 days (IQR 7–14 day). There were no significant differences between the intervention and the control groups in postoperative LOS (p = 0.99) or global HRQoL after one year (women: p = 0.54, men: p = 0.94). While overall complications and major complications occurred in 74% and 24% of the cases, respectively, frequency and severity of complications did not differ significantly between the groups. Patients in the intervention group reported significantly less postoperative pain (p = 0.03) than the control group. Independent predictors for LOS were identified as severity of surgery, length of anesthesia, major postoperative complications, nutritional state, and pre

  1. 76 FR 62503 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Black...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the black-footed albatross (Phoebastria nigripes) as endangered or threatened under the Endangered Species Act of 1973, as amended (Act). The petitioners provided three listing options for consideration by the Service: Listing the black- footed albatross throughout its range; listing the......

  2. The Role of Intersensory Redundancy in the Emergence of Social Referencing in 5 1/2-Month-Old Infants

    ERIC Educational Resources Information Center

    Vaillant-Molina, Mariana; Bahrick, Lorraine E.

    2012-01-01

    Early evidence of social referencing was examined in 5 1/2-month-old infants. Infants were habituated to 2 films of moving toys, one toy eliciting a woman's positive emotional expression and the other eliciting a negative expression under conditions of bimodal (audiovisual) or unimodal visual (silent) speech. It was predicted that intersensory…

  3. 76 FR 9991 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Thorne's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ... Hermes copper butterflies in the Federal Register (71 FR 44980 and 71 FR 44966, respectively). The... FR 44980). On March 17, 2009, Center for Biological Diversity (CBD) and David Hogan filed a complaint... butterfly as endangered may be warranted (75 FR 17062). This notice constitutes the 12-month finding on...

  4. Effectiveness and Predictors of Continuation of Paliperidone Palmitate Long-Acting Injection Treatment: A 12-Month Naturalistic Cohort Study.

    PubMed

    Whale, Richard; Pereira, Marco; Cuthbert, Sharon; Fialho, Renata

    2015-10-01

    Antipsychotic long-acting injectable (LAI) medication has an important place as a treatment option in schizophrenia with evolving evidence to support clinical benefit over oral medication. Paliperidone palmitate is recently licensed as an LAI. We studied a naturalistic cohort of all identifiable patients who initiated paliperidone LAI in a specific United Kingdom region (Sussex) from first availability up to January 2013 (n = 179). Favorably, 60% of the cohort continued paliperidone LAI beyond 12 months from initiation. Schizophrenia diagnosis was significantly associated with 12-month continuation on univariate analysis (65% continuation rate at 12 months in this diagnostic subgroup). No baseline variables were identified as independently associated with 12-month continuation. However, fewer inpatient days after initiation (odds ratio [OR], 1.01; 95% confidence interval [CI], 1.003-1.011; P = 0.002), dose adjustment up or down (OR, 3.46; 95% CI, 1.26-9.51; P = 0.016), and a higher maintenance dose (OR, 8.31; 95% CI, 1.84-37.51; P = 0.006) during treatment course were all independently associated with continuation on multivariate analysis. Our findings support the importance of a collaborative approach with the LAI recipient in treatment decision making to enhance treatment effectiveness. PMID:26267419

  5. 76 FR 37706 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Castanea...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    ... publish these 12-month findings in the Federal Register. Previous Federal Actions On July 1, 1975 (40 FR... Service for listing as an endangered species under the Act in 1976 (June 16, 1976, 41 FR 24524). However... Wildlife Service 1988). Ozark chinquapin became a category 2 candidate on December 15, 1980 (45 FR...

  6. 75 FR 13909 - Endangered and Threatened Wildlife and Plants; 12-Month Findings for Petitions to List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... finding in the Federal Register (69 FR 21484) that these petitions taken collectively, as well as... finding, until July 30, 2004 (69 FR 41445). In accordance with section 4(b)(3)(A) of the Act, we completed... January 12, 2005, we announced our not-warranted 12-month finding in the Federal Register (70 FR 2243)....

  7. 78 FR 68659 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ..., 2008, we published a 12-month finding on the petition to list the Gunnison's prairie dog (73 FR 6660... published a 90-day finding in the Federal Register (71 FR 6241) determining that the petition did not... notice of review process (73 FR 75175, December 20, 2008; 74 FR 57804, November 9, 2009; 75 FR...

  8. 75 FR 30338 - Endangered and Threatened Wildlife and Plants; 12-month Finding on a Petition to List the White...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... may be warranted. On November 9, 2004, we announced our 90-day finding (69 FR 64889) that the petition... Finding on a Petition to List the White-tailed Prairie Dog as Endangered or Threatened AGENCY: Fish and... Wildlife Service announce a 12-month finding on a petition to list the white-tailed prairie dog...

  9. Cancers in Australia in 2010 attributable to total breastfeeding durations of 12 months or less by parous women

    PubMed Central

    Jordan, Susan J; Wilson, Louise F; Nagle, Christina M; Green, Adele C; Olsen, Catherine M; Bain, Christopher J; Pandeya, Nirmala; Whiteman, David C; Webb, Penelope M

    2015-01-01

    Objectives To estimate the proportion and number of cancers occurring in Australia in 2010 attributable to parous women having breastfed for total durations of ≤12 months. Methods We estimated the population attributable fraction (PAF) of breast cancers (the only cancer site with convincing evidence of causal association) associated with women breastfeeding for ≤12 months in total, using standard formulae incorporating breastfeeding prevalence data, relative risks associated with breastfeeding and cancer incidence. We also estimated the proportion change in disease incidence (potential impact fraction [PIF]) that might have occurred under two hypothetical scenarios of women breastfeeding for longer durations. Results An estimated 235 (1.7%) breast cancer cases that occurred in Australian in 2010 could be attributed to women breastfeeding for total durations of ≤12 months. Assuming a hypothetical increase in breastfeeding, we estimated that the number of breast cancers prevented would range from 36 to 51 (prevented fraction = 0.3% to 0.4%). Conclusions More than 200 breast cancers were attributable to women breastfeeding for total durations of ≤12 months. Implications Policies to increase breastfeeding duration may help prevent breast cancers in the future. PMID:26437725

  10. 76 FR 46251 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Redrock...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ... Register on December 16, 2009 (74 FR 66866). This notice constitutes the 12-month finding on the June 18... levels, on their own, do not affect aquatic invertebrates (Spindler 2010b, p. 1), and we do not expect... an important food source and foraging area for stream invertebrates (Wallace and Webster 1996, p....

  11. 76 FR 42631 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Pinus...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... January 27, 1994 (59 FR 3824). On December 9, 2008, we received a petition dated December 8, 2008, from... published in the Federal Register on July 20, 2010 (75 FR 42033). In that finding we determined that the... Pinus albicaulis (75 FR 42033), and received 20 letters from the public. This 12-month finding is...

  12. Correlation of serum KL-6 and CC16 levels with neurodevelopmental outcome in premature infants at 12 months corrected age.

    PubMed

    Zhang, Zhiqun; Lu, Hui; Zhu, Yunxia; Xiang, Junhua; Huang, Xianmei

    2015-01-01

    The aim of this study was to evaluate KL-6 and CC16 levels and their correlation with neurodevelopmental outcome among very low birth weight pre-term infants at 12 months corrected age. This prospective cohort study was performed from 2011 to 2013 by enrolling pre-term neonates of gestational age ≤ 32 weeks and birth weight ≤ 1500 g. Serum KL-6 and CC16 levels were determined 7 days after birth and their correlation with neurodevelopment was evaluated using Gesell Mental Developmental Scales. Of the 86 eligible pre-term infants, 63 completed follow-up, of which 15 had bronchopulmonary dysplasia. At 12 months corrected age, 49 infants had favorable outcomes and 14 infants had poor neurodevelopmental outcome. KL-6 levels were higher and CC16 levels were lower in infants with poor neurodevelopmental outcome compared with those infants who had favourable neurodevelopmental outcome. Serum KL-6 levels less than 90.0 ng/ml and CC16 levels greater than 320.0 pg/ml at 7 days of life were found to be predictive of a favourable outcome at 12 months corrected age. These biological markers could predict neurodevelopmental outcome at 12 months corrected age in very low birth weight premature infants, and help the clinician plan early therapeutic interventions to minimize or avoid poor neurodevelopmental outcome. PMID:25631862

  13. Immunogenicity and safety of a trivalent inactivated 2010-2011 influenza vaccine in Taiwan infants aged 6-12 months.

    PubMed

    Hwang, Kao-Pin; Hsu, Yu-Lung; Hsieh, Tsung-Hsueh; Lin, Hsiao-Chuan; Yen, Ting-Yu; Wei, Hsiu-Mei; Lin, Hung-Chih; Chen, An-Chyi; Chow, Julie Chi; Huang, Li-Min

    2014-05-01

    This prospective study aimed to investigate the immune responses and safety of an influenza vaccine in vaccine-naïve infants aged 6-12 months, and was conducted from November 2010 to May 2011. Fifty-nine infants aged 6-12 months received two doses of trivalent inactivated influenza vaccine 4 weeks apart. Hemagglutination inhibition titers were measured 4 weeks after the two doses of study vaccine. Based on the assumption that a hemagglutination inhibition titer of 1:40 or greater against the antigen would be protective in adults, two doses of the study vaccine generated a protective immune response of 63.2% against influenza A(H1N1), 82.5% against influenza A(H3N2) and 38.6% against influenza B viruses in infants aged 6-12 months. The geometric mean fold rises against influenza type A and B viruses also met the European Medicines Agency criteria for flu vaccines. The solicited events within 7 days after vaccination were mild in intensity. No deaths or adverse events such as optic neuritis, cranial neuropathy, and brachial neuropathy or Guillain-Barre syndrome were reported. Two doses of inactivated influenza vaccine were well tolerated and induced a protective immune response against influenza in infants aged 6-12 months. PMID:24625341

  14. Social and Object Mastery Play in 12-Month Olds with Depressed and Non-Depressed Mothers: Developmental Changes and Correlates.

    ERIC Educational Resources Information Center

    Popper, Sally D.; And Others

    As part of a longitudinal study of postpartum adjustment and infant development, this study examined whether securely attached 12-month-old infants show greater object mastery motivation and social-object mastery motivation than do insecurely attached infants. Object mastery relates to infants' goal-directed behavior that is oriented toward…

  15. 77 FR 59357 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Spring...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-27

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Spring Mountains acastus checkerspot butterfly (Chlosyne acastus robusta) as an endangered species under the Endangered Species Act of 1973, as amended (Act). After review of the best available scientific and commercial information, we find that listing the Spring Mountains acastus......

  16. Structural neural correlates of impaired mobility and subsequent decline in executive functions: A 12-month prospective study

    PubMed Central

    Hsu, Chun Liang; Best, John R.; Chiu, Bryan K.; Nagamatsu, Lindsay S; Voss, Michelle W.; Handy, Todd C.; Bolandzadeh, Niousha; Liu-Ambrose, Teresa

    2016-01-01

    Impaired mobility, such as falls, may be an early biomarker of subsequent cognitive decline and is associated with subclinical alterations in both brain structure and function. In this 12-month prospective study, we examined whether there are volumetric differences in gray matter and subcortical regions, as well as cerebral white matter, between older fallers and non-fallers. In addition, we assessed whether these baseline volumetric differences are associated with changes in cognitive function over 12 months. A total of 66 community-dwelling older adults were recruited and categorized by their falls status. Magnetic resonance imaging occurred at baseline and participants’ physical and cognitive performances were assessed at baseline and 12-months. At baseline, fallers showed significantly lower volumes in gray matter, subcortical regions, and cerebral white matter compared with non-fallers. Notably, fallers had significantly lower left lateral orbitofrontal white matter volume. Moreover, lower left lateral orbitofrontal white matter volume at baseline was associated with greater decline in set-shifting performance over 12 months. Our data suggest that falls may indicate subclinical alterations in regional brain volume that are associated with subsequent decline in executive functions. PMID:27079333

  17. Health-related quality of life and functional changes in DMD: A 12-month longitudinal cohort study

    PubMed Central

    Messina, Sonia; Vita, Gian Luca; Sframeli, Maria; Mondello, Stefania; Mazzone, Elena; D'Amico, Adele; Berardinelli, Angela; La Rosa, Matteo; Bruno, Claudio; Distefano, Maria Grazia; Baranello, Giovanni; Barcellona, Costanza; Scutifero, Marianna; Marcato, Sonia; Palmieri, Arianna; Politano, Luisa; Morandi, Lucia; Mongini, Tiziana; Pegoraro, Elena; D'Angelo, Maria Grazia; Pane, Marika; Rodolico, Carmelo; Minetti, Carlo; Bertini, Enrico; Vita, Giuseppe; Mercuri, Eugenio

    2016-01-01

    In Duchenne muscular dystrophy (DMD) little has been reported on the association between clinical outcome measures and patient health-related quality of life (HRQOL) tools. Our study evaluated the relationship between 12 month changes on the Generic Core Scales (GCS), the Multidimensional Fatigue Scale and the Neuromuscular Module of the PedsQLTM with several outcome measures (6 minute walk test, North Star Ambulatory Assessment and timed items) in ambulatory DMD. Ninety-eight ambulatory DMD in a multicentric setting were included in the study. At baseline, the PedsQLTM inventories correlated with almost all the functional measures On the Child Self-Report there was a significant decrease between baseline and 12 months on the PedsQLTM GCS and its first domain, in parallel with the decrement in the functional outcome measures. Correlation between the 12 month changes on the PedsQLTM inventories and functional measures were almost all negligible. Similar results were obtained on the Parent Proxy-Report. In conclusion, PedsQLTM correlates with the level of impairment at baseline, but this does not hold true when 12 month changes are considered. Further studies comparing different tools are needed to better elucidate the complexity of the relationship between HRQOL and functional performances. PMID:26916554

  18. Infants' Vocal Engagement Oriented towards Mother versus Stranger at 3 Months and Avoidant Attachment Behavior at 12 Months

    ERIC Educational Resources Information Center

    Volker, Susanne

    2007-01-01

    The aim of the present study was to demonstrate that mother avoidance in infants at the age of 12 months can be predicted by the infants' differential vocal engagement to mother versus a female stranger at the age of 3 months. Differential engagement in favor of the mother was supposed to relate to low future avoidance. The vocal behavior of 26…

  19. Is Visual Reference Necessary? Contributions of Facial versus Vocal Cues in 12-Month-Olds' Social Referencing Behavior

    ERIC Educational Resources Information Center

    Vaish, Amrisha; Striano, Tricia

    2004-01-01

    To examine the influences of facial versus vocal cues on infants' behavior in a potentially threatening situation, 12-month-olds on a visual cliff received positive facial-only, vocal-only, or both facial and vocal cues from mothers. Infants' crossing times and looks to mother were assessed. Infants crossed the cliff faster with multimodal and…

  20. Child-Centered Behaviors of Caregivers with 12-Month-Old Infants: Associations with Passive Joint Engagement and Later Language

    ERIC Educational Resources Information Center

    Trautman, Carol Hamer; Rollins, Pamela Rosenthal

    2006-01-01

    This study investigates three aspects of social communication in 12-month-old infants and their caregivers: (a) caregiver conversational style, (b) caregiver gesture, and (c) infant engagement. Differences in caregiver behavior during passive joint engagement were associated with language outcomes. Although total mean duration of infant time in…

  1. 75 FR 78029 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the North...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ..., 1995, we published a finding (60 FR 19567) that a previous petition, submitted by the Predator Project... scientific and commercial information indicating that listing may be warranted (68 FR 60112). On September 29... published a 12-month finding of ``not warranted'' for the wolverine in the contiguous United States (73...

  2. 75 FR 19592 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List the Wyoming...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-15

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Wyoming pocket gopher (Thomomys clusius) as endangered or threatened and to designate critical habitat under the Endangered Species Act of 1973, as amended. After review of all available scientific and commercial information, we find that listing the Wyoming pocket gopher as either......

  3. 75 FR 53615 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List the White...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... warranted, and initiated a status review (74 FR 36152). This notice constitutes the 12-month finding on the... species under the Act in the 1982 Candidate Notice of Review (47 FR 58454, December 30, 1982). Category 2... for possible addition to the ] Lists of Endangered and Threatened Wildlife and Plants (61 FR...

  4. Validity of the Fine Motor Area of the 12-Month Ages and Stages Questionnaire in Infants Following Major Surgery

    ERIC Educational Resources Information Center

    Smith, Cally; Wallen, Margaret; Walker, Karen; Bundy, Anita; Rolinson, Rachel; Badawi, Nadia

    2012-01-01

    The Ages and Stages Questionnaires (ASQ) are parent-report screening tools to identify infants at risk of developmental difficulties. The purpose of this study was to examine validity and internal reliability of the fine motor developmental area of the ASQ, 2nd edition (ASQ2-FM) for screening 12-month-old infants following major surgery. The…

  5. IMPACT OF A 12-MONTH EXPOSURE TO A DIURNAL PATTERN OF OZONE ON PULMONARY FUNCTION, ANTIOXIDANT BIOCHEMISTRY AND IMMUNOLOGY

    EPA Science Inventory

    Rats were exposed for 12 months, 13 hr/day, 7 days/week to 0.06 ppm O3; Monday through Friday, the animals received a 9 hr spike reaching a maximum concentration of 0.25 ppm. An increase in the rate of lung nitrogen washout was observed in the O3-exposed rats. Residual volume and...

  6. Correlation of serum KL-6 and CC16 levels with neurodevelopmental outcome in premature infants at 12 months corrected age

    PubMed Central

    Zhang, Zhiqun; Lu, Hui; Zhu, Yunxia; Xiang, Junhua; Huang, Xianmei

    2015-01-01

    The aim of this study was to evaluate KL-6 and CC16 levels and their correlation with neurodevelopmental outcome among very low birth weight pre-term infants at 12 months corrected age. This prospective cohort study was performed from 2011 to 2013 by enrolling pre-term neonates of gestational age ≤ 32 weeks and birth weight ≤ 1500 g. Serum KL-6 and CC16 levels were determined 7 days after birth and their correlation with neurodevelopment was evaluated using Gesell Mental Developmental Scales. Of the 86 eligible pre-term infants, 63 completed follow-up, of which 15 had bronchopulmonary dysplasia. At 12 months corrected age, 49 infants had favorable outcomes and 14 infants had poor neurodevelopmental outcome. KL-6 levels were higher and CC16 levels were lower in infants with poor neurodevelopmental outcome compared with those infants who had favourable neurodevelopmental outcome. Serum KL-6 levels less than 90.0 ng/ml and CC16 levels greater than 320.0 pg/ml at 7 days of life were found to be predictive of a favourable outcome at 12 months corrected age. These biological markers could predict neurodevelopmental outcome at 12 months corrected age in very low birth weight premature infants, and help the clinician plan early therapeutic interventions to minimize or avoid poor neurodevelopmental outcome. PMID:25631862

  7. The First Year Inventory: A Longitudinal Follow-Up of 12-Month-Old to 3-Year-Old Children

    ERIC Educational Resources Information Center

    Turner-Brown, Lauren M.; Baranek, Grace T.; Reznick, J Steven; Watson, Linda R.; Crais, Elizabeth R.

    2013-01-01

    The First Year Inventory is a parent-report measure designed to identify 12-month-old infants at risk for autism spectrum disorder. First Year Inventory taps behaviors that indicate risk in the developmental domains of sensory--regulatory and social--communication functioning. This longitudinal study is a follow-up of 699 children at 3 years of…

  8. 76 FR 9722 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Solanum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-22

    ... FR 63659) our finding that the petition to list A. eggersiana and S. conocarpum presented substantial... February 28, 2006. On March 7, 2006, we published our 12-month finding (71 FR 11367) that listing of A... Number The Service adopted guidelines on September 21, 1983 (48 FR 43098), to establish a rational...

  9. Structural neural correlates of impaired mobility and subsequent decline in executive functions: a 12-month prospective study.

    PubMed

    Hsu, Chun Liang; Best, John R; Chiu, Bryan K; Nagamatsu, Lindsay S; Voss, Michelle W; Handy, Todd C; Bolandzadeh, Niousha; Liu-Ambrose, Teresa

    2016-07-01

    Impaired mobility, such as falls, may be an early biomarker of subsequent cognitive decline and is associated with subclinical alterations in both brain structure and function. In this 12-month prospective study, we examined whether there are volumetric differences in gray matter and subcortical regions, as well as cerebral white matter, between older fallers and non-fallers. In addition, we assessed whether these baseline volumetric differences are associated with changes in cognitive function over 12months. A total of 66 community-dwelling older adults were recruited and categorized by their falls status. Magnetic resonance imaging occurred at baseline and participants' physical and cognitive performances were assessed at baseline and 12-months. At baseline, fallers showed significantly lower volumes in gray matter, subcortical regions, and cerebral white matter compared with non-fallers. Notably, fallers had significantly lower left lateral orbitofrontal white matter volume. Moreover, lower left lateral orbitofrontal white matter volume at baseline was associated with greater decline in set-shifting performance over 12months. Our data suggest that falls may indicate subclinical alterations in regional brain volume that are associated with subsequent decline in executive functions. PMID:27079333

  10. 12-Month and Lifetime Prevalence of Suicide Attempts among Black Adolescents in the National Survey of American Life

    ERIC Educational Resources Information Center

    Joe, Sean; Baser, Raymond S.; Neighbors, Harold W.; Caldwell, Cleopatra H.; Jackson, James S.

    2009-01-01

    The data from the National Survey of American life on the suicidal behavior of 1,170 African American and Caribbean black adolescents aged 13 to 17 shows that black adolescents report having a lifetime prevalence of 7.5 percent for suicidal ideation and 2.7 percent for attempts. The 12-month prevalence of suicidal ideation is 3.2 percent and…

  11. Efficacy of Yoga for Vasomotor Symptoms: A Randomized Controlled Trial

    PubMed Central

    Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2013-01-01

    Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673

  12. A randomized controlled trial of qigong for fibromyalgia

    PubMed Central

    2012-01-01

    Introduction Fibromyalgia is difficult to treat and requires the use of multiple approaches. This study is a randomized controlled trial of qigong compared with a wait-list control group in fibromyalgia. Methods One hundred participants were randomly assigned to immediate or delayed practice groups, with the delayed group receiving training at the end of the control period. Qigong training (level 1 Chaoyi Fanhuan Qigong, CFQ), given over three half-days, was followed by weekly review/practice sessions for eight weeks; participants were also asked to practice at home for 45 to 60 minutes per day for this interval. Outcomes were pain, impact, sleep, physical function and mental function, and these were recorded at baseline, eight weeks, four months and six months. Immediate and delayed practice groups were analyzed individually compared to the control group, and as a combination group. Results In both the immediate and delayed treatment groups, CFQ demonstrated significant improvements in pain, impact, sleep, physical function and mental function when compared to the wait-list/usual care control group at eight weeks, with benefits extending beyond this time. Analysis of combined data indicated significant changes for all measures at all times for six months, with only one exception. Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice. Conclusions This study demonstrates that CFQ, a particular form of qigong, provides long-term benefits in several core domains in fibromyalgia. CFQ may be a useful adjuvant self-care treatment for fibromyalgia. Trial registration clinicaltrials.gov NCT00938834. PMID:22863206

  13. Predicting the Onset of Anxiety Syndromes at 12 Months in Primary Care Attendees. The PredictA-Spain Study

    PubMed Central

    Moreno-Peral, Patricia; Luna, Juan de Dios; Marston, Louise; King, Michael; Nazareth, Irwin; Motrico, Emma; GildeGómez-Barragán, María Josefa; Torres-González, Francisco; Montón-Franco, Carmen; Sánchez-Celaya, Marta; Díaz-Barreiros, Miguel Ángel; Vicens, Catalina; Muñoz-Bravo, Carlos; Bellón, Juan Ángel

    2014-01-01

    Background There are no risk algorithms for the onset of anxiety syndromes at 12 months in primary care. We aimed to develop and validate internally a risk algorithm to predict the onset of anxiety syndromes at 12 months. Methods A prospective cohort study with evaluations at baseline, 6 and 12 months. We measured 39 known risk factors and used multilevel logistic regression and inverse probability weighting to build the risk algorithm. Our main outcome was generalized anxiety, panic and other non-specific anxiety syndromes as measured by the Primary Care Evaluation of Mental Disorders, Patient Health Questionnaire (PRIME-MD-PHQ). We recruited 3,564 adult primary care attendees without anxiety syndromes from 174 family physicians and 32 health centers in 6 Spanish provinces. Results The cumulative 12-month incidence of anxiety syndromes was 12.2%. The predictA-Spain risk algorithm included the following predictors of anxiety syndromes: province; sex (female); younger age; taking medicines for anxiety, depression or stress; worse physical and mental quality of life (SF-12); dissatisfaction with paid and unpaid work; perception of financial strain; and the interactions sex*age, sex*perception of financial strain, and age*dissatisfaction with paid work. The C-index was 0.80 (95% confidence interval = 0.78–0.83) and the Hedges' g = 1.17 (95% confidence interval = 1.04–1.29). The Copas shrinkage factor was 0.98 and calibration plots showed an accurate goodness of fit. Conclusions The predictA-Spain risk algorithm is valid to predict anxiety syndromes at 12 months. Although external validation is required, the predictA-Spain is available for use as a predictive tool in the prevention of anxiety syndromes in primary care. PMID:25184313

  14. High Incidence of Vertebral Fractures in Children with Acute Lymphoblastic Leukemia 12 Months After the Initiation of Therapy

    PubMed Central

    Alos, Nathalie; Grant, Ronald; Ramsay, Timothy; Halton, Jacqueline; Cummings, Elizabeth A.; Miettunen, Paivi M.; Abish, Sharon; Atkinson, Stephanie; Barr, Ronald; Cabral, David A.; Cairney, Elizabeth; Couch, Robert; Dix, David B.; Fernandez, Conrad V.; Hay, John; Israels, Sara; Laverdière, Caroline; Lentle, Brian; Lewis, Victor; Matzinger, MaryAnn; Rodd, Celia; Shenouda, Nazih; Stein, Robert; Stephure, David; Taback, Shayne; Wilson, Beverly; Williams, Kathryn; Rauch, Frank; Siminoski, Kerry; Ward, Leanne M.

    2014-01-01

    Purpose Vertebral fractures due to osteoporosis are a potential complication of childhood acute lymphoblastic leukemia (ALL). To date, the incidence of vertebral fractures during ALL treatment has not been reported. Patient and Methods We prospectively evaluated 155 children with ALL during the first 12 months of leukemia therapy. Lateral thoracolumbar spine radiographs were obtained at baseline and 12 months. Vertebral bodies were assessed for incident vertebral fractures using the Genant semi-quantitative method, and relevant clinical indices such as spine bone mineral density (BMD), back pain and the presence of vertebral fractures at baseline were analyzed for association with incident vertebral fractures. Results Of the 155 children, 25 (16%, 95% Confidence Interval (CI) 11% to 23%) had a total of 61 incident vertebral fractures, of which 32 (52%) were moderate or severe. Thirteen of the 25 children with incident vertebral fractures (52%) also had fractures at baseline. Vertebral fractures at baseline increased the odds of an incident fracture at 12 months by an odds ratio of 7.3 (95% CI 2.3 to 23.1, p = 0.001). In addition, for every one standard deviation reduction in spine BMD Z-score at baseline, there was 1.8-fold increased odds of incident vertebral fracture at 12 months (95% CI 1.2 to 2.7, p = 0.006). Conclusion Children with ALL have a high incidence of vertebral fractures after 12 months of chemotherapy, and the presence of vertebral fractures and reductions in spine BMD Z-scores at baseline are highly associated clinical features. PMID:22734031

  15. Patterns of mother-infant interaction from 3 to 12 months among dyads with substance abuse and psychiatric problems.

    PubMed

    Siqveland, Torill S; Haabrekke, Kristin; Wentzel-Larsen, Tore; Moe, Vibeke

    2014-11-01

    The aim of this study was to investigate the development of mother-infant interaction patterns from 3 to 12 months among three groups of mother-baby pairs recruited during pregnancy: one group from residential substance abuse treatment (n=28), a second group from psychiatric outpatient treatment (n=22), and a third group from well-baby clinics (n=30). The mother-infant interaction at 3 and 12 months was assessed by the Parent-Child Early Relational Assessment (PCERA), which consists of maternal, child and dyadic subscales (Clark, 2006). Linear mixed effects models were used to analyze group differences and the changes in mother-infant interaction from 3 to 12 months. At 3 months, pairwise comparisons showed that the group with psychiatric problems had significantly more difficulties in the mother-infant interaction than the two other groups. The group with substance abuse problems was not significantly different from the two other groups. At 12 months, the mother-infant pairs in the substance abuse group showed significantly more relational disturbances than the non-clinical pairs, as well as a poorer affective quality of interaction than the dyads in the group with psychiatric problems. Analysis of change from 3 to 12 months showed that difficulties in the interaction increased among the mother-baby pairs in the substance abuse group, while improvements were displayed in the two other groups. These results underline that mother-infant pairs at double risk due to maternal substance abuse and other non-optimal factors, are in need for long-term follow up in order to prevent the development of negative interactional patterns. PMID:25459795

  16. Northern Eurasia Earth Science Partnership Initiative in the past 12 months: An Update

    NASA Astrophysics Data System (ADS)

    Groisman, Pavel; Lowford, Richard

    2013-04-01

    Eight years ago Northern Eurasia Earth Science Partnership Initiative (NEESPI) was launched with the release of its Science Plan (http://neespi.org). Gradually, the Initiative was joined by numerous international projects launched in EU, Russia, the United States, Canada, Japan, and China. Throughout its duration, NEESPI served and is serving as an umbrella for more than 155 individual international research projects. Currently, the total number of the ongoing NEESPI projects (as on January 2013) is 48 and has changed but slightly compared to its peak (87 in 2008). The past 12 months (from the previous EGU Assembly) were extremely productive in the NEESPI outreach. We organized three Open Science Sessions at the three major Geoscience Unions/Assembly Meetings (JpGU, AGU, and this EGU Session) and three International NEESPI Workshops. The programs of two of these Workshops (in Yoshkar Ola and Irkutsk, Russia) included Summer Schools for early career scientists. More than 150 peer-reviewed papers, books, and/or book chapters were published in 2012 or are in press (this list was still incomplete at the time of preparation of this abstract). In particular, a suite of 25 peer-reviewed NEESPI articles was published in the Forth Special NEESPI Issue of "Environmental Research Letters" (ERL) http://iopscience.iop.org/1748-9326/focus/NEESPI3 (this is the third ERL Issue). In December 2012, the next Special ERL NEESPI Issue was launched http://iopscience.iop.org/1748-9326/focus/NEESPI4. Northern Eurasia is a large study domain. Therefore, it was decided to describe the latest findings related to its environmental changes in several regional monographs in English. Three books on Environmental Changes in the NEESPI domain were published by the University of Helsinki (Groisman et al. 2012), "Akademperiodyka" (Groisman and Lyalko 2012), and Springer Publishing House (Groisman and Gutman 2013) being devoted to the high latitudes of Eurasia, to Eastern Europe, and to Siberia

  17. Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group.

    PubMed

    Bourmaud, Aurelie; Soler-Michel, Patricia; Oriol, Mathieu; Regnier, Véronique; Tinquaut, Fabien; Nourissat, Alice; Bremond, Alain; Moumjid, Nora; Chauvin, Franck

    2016-03-15

    Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated. PMID:26883201

  18. Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group

    PubMed Central

    Bourmaud, Aurelie; Soler-Michel, Patricia; Oriol, Mathieu; Regnier, Véronique; Tinquaut, Fabien; Nourissat, Alice; Bremond, Alain; Moumjid, Nora; Chauvin, Franck

    2016-01-01

    Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated. PMID:26883201

  19. Comparative effectiveness of next generation genomic sequencing for disease diagnosis: Design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes✩

    PubMed Central

    Gallego, Carlos J.; Bennette, Caroline S.; Heagerty, Patrick; Comstock, Bryan; Horike-Pyne, Martha; Hisama, Fuki; Amendola, Laura M.; Bennett, Robin L.; Dorschner, Michael O.; Tarczy-Hornoch, Peter; Grady, William M.; Fullerton, S. Malia; Trinidad, Susan B.; Regier, Dean A.; Nickerson, Deborah A.; Burke, Wylie; Patrick, Donald L.; Jarvik, Gail P.; Veenstra, David L.

    2014-01-01

    Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effectiveness and patient-centered outcomes research. We designed a randomized controlled trial that incorporates these research methods to evaluate whole exome sequencing compared to usual care in patients being evaluated for hereditary colorectal cancer and polyposis syndromes. Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings. Patients will receive findings associated with colorectal cancer in a first return of result visit, and findings not associated with colorectal cancer (incidental findings) during a second return of result visit. The primary outcome is efficacy to detect mutations associated with these syndromes; secondary outcomes include psychosocial impact, cost-effectiveness and comparative costs. The secondary outcomes will be obtained via surveys before and after each return visit. The expected challenges in conducting this randomized controlled trial include the relatively low prevalence of genetic disease, difficult interpretation of some genetic variants, and uncertainty about which incidental findings should be returned to patients. The approaches utilized in this study may help guide other investigators in clinical genomics to identify useful outcome measures and strategies to address comparative effectiveness questions about the clinical implementation of genomic sequencing in clinical care. PMID:24997220

  20. Snoezelen, structured reminiscence therapy and 10-minutes activation in long term care residents with dementia (WISDE): study protocol of a cluster randomized controlled trial

    PubMed Central

    2010-01-01

    Background People with dementia are often inapproachable due to symptoms of their illness. Therefore nurses should establish relationships with dementia patients via their remaining resources and facilitate communication. In order to achieve this, different targeted non-pharmacological interventions are recommended and practiced. However there is no sufficient evidence about the efficacy of most of these interventions. A number of publications highlight the urgent need for methodological sound studies so that more robust conclusions may be drawn. Methods/Design The trial is designed as a cluster randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany) as the units of randomization. Nursing homes will be randomly allocated into 4 study groups consisting of 5 clusters and 90 residents: snoezelen, structured reminiscence therapy, 10-minutes activation or unstructured verbal communication (control group). The purpose is to determine whether the interventions are effective to reduce apathy in long-term care residents with dementia (N = 360) as the main outcome measure. Assessments will be done at baseline, 3, 6 and 12 months after beginning of the interventions. Discussion This trial will particularly contribute to the evidence on efficacy of non-pharmacological interventions in dementia care. Trial Registration ClinicalTrials.gov NCT00653731 PMID:20113526

  1. Resistance to Erythropoiesis Stimulating Agents in Patients Treated with Online Hemodiafiltration and Ultrapure Low-Flux Hemodialysis: Results from a Randomized Controlled Trial (CONTRAST)

    PubMed Central

    van der Weerd, Neelke C.; Den Hoedt, Claire H.; Blankestijn, Peter J.; Bots, Michiel L.; van den Dorpel, Marinus A.; Lévesque, Renée; Mazairac, Albert H. A.; Nubé, Menso J.; Penne, E. Lars; ter Wee, Pieter M.; Grooteman, Muriel P. C.

    2014-01-01

    Resistance to erythropoiesis stimulating agents (ESA) is common in patients undergoing chronic hemodialysis (HD) treatment. ESA responsiveness might be improved by enhanced clearance of uremic toxins of middle molecular weight, as can be obtained by hemodiafiltration (HDF). In this analysis of the randomized controlled CONvective TRAnsport STudy (CONTRAST; NCT00205556), the effect of online HDF on ESA resistance and iron parameters was studied. This was a pre-specified secondary endpoint of the main trial. A 12 months' analysis of 714 patients randomized to either treatment with online post-dilution HDF or continuation of low-flux HD was performed. Both groups were treated with ultrapure dialysis fluids. ESA resistance, measured every three months, was expressed as the ESA index (weight adjusted weekly ESA dose in daily defined doses [DDD]/hematocrit). The mean ESA index during 12 months was not different between patients treated with HDF or HD (mean difference HDF versus HD over time 0.029 DDD/kg/Hct/week [−0.024 to 0.081]; P = 0.29). Mean transferrin saturation ratio and ferritin levels during the study tended to be lower in patients treated with HDF (−2.52% [−4.72 to −0.31]; P = 0.02 and −49 ng/mL [−103 to 4]; P = 0.06 respectively), although there was a trend for those patients to receive slightly more iron supplementation (7.1 mg/week [−0.4 to 14.5]; P = 0.06). In conclusion, compared to low-flux HD with ultrapure dialysis fluid, treatment with online HDF did not result in a decrease in ESA resistance. Trial Registration ClinicalTrials.gov NCT00205556 PMID:24743493

  2. Effects of insecticide-treated bednets during early infancy in an African area of intense malaria transmission: a randomized controlled trial.

    PubMed Central

    Müller, Olaf; Traoré, Corneille; Kouyaté, Bocar; Yé, Yazoumé; Frey, Claudia; Coulibaly, Boubacar; Becher, Heiko

    2006-01-01

    OBJECTIVE: Insecticide-impregnated bednets and curtains have been shown by many studies to be effective against malaria. However, because of possible interactions with immunity development, treated bednets may cause no effect at all or even an increase in malaria morbidity and mortality in areas of high transmission. To clarify this issue, we did a randomized controlled trial to assess the long-term effects of bednet protection during early infancy. METHODS: A total of 3387 neonates from 41 villages in rural Burkina Faso were individually randomized to receive either bednet protection from birth (group A) or from age 6 months (group B). Primary outcomes were all-cause mortality in all study children and incidence of falciparum malaria in a representative subsample of the study population. FINDINGS: After a mean follow-up of 27 months, there were 129 deaths in group A and 128 deaths in group B rate ratio (RR) 1.0 (95% confidence interval (CI): 0.78-1.27)). Falciparum malaria incidence was lower in group A than in group B, during early (0-5 months) and late infancy (6-12 months) (RR 3.1, 95% CI: 2.0-4.9; RR 1.3, 95% CI: 1.1-1.6) and rates of moderate to severe anaemia were significantly lower during late infancy (11.5% vs 23.3%, P = 0.008), but there were no differences between groups in these parameters in children older than 12 months. CONCLUSION: The findings from this study provide additional evidence for the efficacy of insecticide-treated nets in young children living in areas of intense malaria transmission. PMID:16501729

  3. Efficacy of an HIV Intervention in Reducing High-Risk HPV, Non-viral STIs, and Concurrency among African-American Women: A Randomized Controlled Trial

    PubMed Central

    Wingood, Gina M.; DiClemente, Ralph J.; Robinson-Simpson, LaShun; Lang, Delia L.; Caliendo, Angela; Hardin, James W.

    2013-01-01

    Objective This trial evaluated the efficacy of an HIV intervention condition, relative to a health promotion condition, in reducing incidence of non-viral STIs (Chlamydia, gonorrhea, trichomoniasis), oncogenic HPV subtypes 16 and 18, sexual concurrency, and other HIV-associated behaviors over a 12-month period. Design Randomized controlled trial. Data analysts blinded to treatment allocation. Setting Kaiser Permanente Georgia Subjects A random sample of 848 African American women Intervention The two 4-hour HIV intervention sessions were based on Social Cognitive Theory and the Theory of Gender and Power. The intervention was designed to enhance participants’ self sufficiency and attitudes and skills associated with condom use. The HIV intervention also encouraged STI testing and treatment of male sex partners, and reducing vaginal douching and individual and male partner concurrency. Main Outcome Measure Incident non-viral STIs. Results In GEE analyses, over the 12-month follow-up, participants in the HIV intervention, relative to the comparison, were less likely to have non-viral incident STIs (OR=0.62; 95% CI, 0.40-0.96; P =.033); and incident high-risk HPV infection (OR=0.37; 95% CI, 0.18-0.77; P = .008), or concurrent male sex partners (OR=0.55; 95% CI, 0.37-0.83; P = .005). Additionally, intervention participants were less likely to report multiple male sex partners, more likely to use condoms during oral sex, more likely to inform their main partner of their STI test results, encourage their main partner to seek STI testing, report that their main partner was treated for STIs, and report not douching. Conclusion This is the first trial to demonstrate that an HIV intervention can achieve reductions in non-viral STIs, high-risk HPV, and individual concurrency. PMID:23673884

  4. Enhancing antiepileptic drug adherence: a randomized controlled trial.

    PubMed

    Brown, Ian; Sheeran, Paschal; Reuber, Markus

    2009-12-01

    Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (P<0.01). The implementation intention intervention may be an easy-to-administer and effective means of promoting AED adherence. PMID:19864187

  5. Effects of comprehensive therapy based on traditional Chinese medicine patterns in stable chronic obstructive pulmonary disease: a four-center, open-label, randomized, controlled study

    PubMed Central

    2012-01-01

    Background Traditional Chinese medicine (TCM) has been used to treat chronic obstructive pulmonary disease (COPD) for many years. This study aimed to evaluate the efficacy and safety of the comprehensive therapy based on the three common TCM patterns in stable COPD patients. Methods A four-center, open-label randomized controlled method was conducted. A total of 352 patients were divided into the trial group (n = 176, treated with conventional Western medicine and Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules, and Yi-Qi Zi-Shen granules based on the TCM patterns respectively) and the control group (n = 176, treated with conventional Western medicine). The frequency and duration of acute exacerbation, lung function, clinical symptoms, 6-minute walking distance (6MWD), dyspnea scale and quality of life were observed during a 6-month treatment period and at a further 12-month follow-up. Results A total of 306 patients completed the study fully. The full analysis set (FAS) population was 350 and the per-protocol analysis set (PPS) population was 306. After the 6-month treatment and 12-month follow-up, there were significant differences between the trial and control group in the following: frequency of acute exacerbation (FAS: P = 0.000; PPS: P = 0.000); duration of acute exacerbation (FAS: P = 0.000; PPS: P = 0.001); FEV1 (FAS: P = 0.007; PPS: P = 0.008); symptoms (FAS: P = 0.001; PPS: P = 0.001); 6MWD (FAS: P = 0.045; PPS: P = 0.042); dyspnea scale (FAS: P = 0.002; PPS: P = 0.004); and physical domain (FAS: P = 0.000; PPS: P = 0.000), psychological domain (FAS: P = 0.008; PPS: P = 0.011), social domain (FAS: P = 0.001; PPS: P = 0.000) and environment domain (FAS: P = 0.015; PPS: P = 0.009) of the WHOQOL-BREF questionnaire. There were no differences between the trial and control group in FVC, FEV1% and adverse events. Conclusions Based on the TCM patterns, Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules and Yi-Qi Zi-Shen granules have beneficial effects on measured

  6. Cognitive Stimulation in Patients with Dementia: Randomized Controlled Trial

    PubMed Central

    Mapelli, Daniela; Di Rosa, Elisa; Nocita, Rosaria; Sava, Donatella

    2013-01-01

    Background/Aims This study explores the effective outcomes of a structured cognitive stimulation treatment to improve cognition and behavioral symptoms in people with dementia (PWDs), using a randomized controlled clinical trial. Methods Thirty PWDs were divided into three groups: experimental (treated with cognitive stimulation), placebo (treated with occupational therapy), and control (continuing with the usual activities of the nursing home). Assessment, at baseline and after a period of 8 weeks, was performed using the Clinical Dementia Rating Scale, activities of daily living, Mini-Mental State Examination, Esame Neuropsicologico Breve 2, Geriatric Depression Scale and Behavioral Pathology in Alzheimer's Disease Scale. Results Only the experimental group improved its performance in cognitive tests (p < 0.05) and showed a significant decrease in behavioral symptoms (p < 0.01) after the treatment. Conclusions The results suggest that a cognitive stimulation treatment for PWDs would improve not only their cognition, but also behavioral symptoms. PMID:24052800

  7. Facilitators and Barriers to Employment Among Veterans with Spinal Cord Injury Receiving 12 Months of Evidence-Based Supported Employment Services

    PubMed Central

    Njoh, Eni N.; Trainor, John K.; O’Connor, Danielle R.; Barnett, Scott D.; Ottomanelli, Lisa

    2015-01-01

    Background: Return to work is associated with positive rehabilitation outcomes for persons with spinal cord injury (SCI); however, more research is needed on vocational support for persons with disabilities seeking employment. Objective: The association between facilitators and barriers of employment and employment outcome was examined among Veterans with SCI who participated in an evidence-based supported employment (EBSE) program. Methods: Using a mixed-methods, nested case-control design, data on facilitators and barriers to employment were extracted from qualitative interviews and quantitative measures administered in person to 34 Veterans with SCI who completed 12 months of an EBSE program. Participants who did (case) and did not (control) obtain competitive employment were matched on time since SCI. Facilitators and barriers to employment were compared between the groups. Results: Self-report measures administered at baseline were examined; there were no statistically significant factors that predicted employment outcomes after 12 months of EBSE program participation. Qualitative interview data revealed program-specific facilitators and Veteran characteristics that were associated with employment outcomes. Conclusions: Qualitative data illustrate how the integration of the vocational rehabilitation specialist on the medical team is helpful for addressing identified disability-specific barriers, including practical matters such as transportation and caregiving schedules, to facilitate employment outcomes. PMID:25762857

  8. On the Efficacy and Mediation of a One-on-One HIV Risk-Reduction Intervention for African American Men Who Have Sex with Men: A Randomized Controlled Trial.

    PubMed

    Jemmott, John B; Jemmott, Loretta Sweet; O'Leary, Ann; Icard, Larry D; Rutledge, Scott E; Stevens, Robin; Hsu, Janet; Stephens, Alisa J

    2015-07-01

    We examined the efficacy and mediation of Being Responsible for Ourselves (BRO), an HIV/STI risk-reduction intervention for African American men who have sex with men (MSM), the population with the highest HIV-diagnosis rate in the US. We randomized African American MSM to one of two interventions: BRO HIV/STI risk-reduction, targeting condom use; or attention-matched control, targeting physical activity and healthy diet. The interventions were based on social cognitive theory, the reasoned-action approach, and qualitative research. Men reporting anal intercourse with other men in the past 90 days were eligible and completed pre-intervention, immediately post-intervention, and 6 and 12 months post-intervention surveys. Of 595 participants, 503 (85 %) completed the 12-month follow-up. Generalized-estimating-equations analysis indicated that, compared with the attention-matched control intervention, the BRO intervention did not increase consistent condom use averaged over the 6- and 12-month follow-ups, which was the primary outcome. Although BRO did not affect the proportion of condom-protected intercourse acts, unprotected sexual intercourse, multiple partners, or insertive anal intercourse, it did reduce receptive anal intercourse compared with the control, a behavior linked to incident HIV infection. Mediation analysis using the product-of-coefficients approach revealed that although BRO increased seven of nine theoretical constructs it was designed to affect, it increased only one of three theoretical constructs that predicted consistent condom use: condom-use impulse-control self-efficacy. Thus, BRO indirectly increased consistent condom use through condom-use impulse-control self-efficacy. In conclusion, although BRO increased several theoretical constructs, most of those constructs did not predict consistent condom use; hence, the intervention did not increase it. Theoretical constructs that interventions should target to increase African American MSM

  9. Effectiveness of an intervention at construction worksites on work engagement, social support, physical workload, and need for recovery: results from a cluster randomized controlled trial

    PubMed Central

    2012-01-01

    Background To prolong sustainable healthy working lives of construction workers, a worksite prevention program was developed which aimed to improve the health and work ability of construction workers. The aim of the current study was to investigate the effectiveness of this program on social support at work, work engagement, physical workload and need for recovery. Methods Fifteen departments from six construction companies participated in this cluster randomized controlled trial; 8 departments (n=171 workers) were randomized to an intervention group and 7 departments (n=122 workers) to a control group. The intervention consisted of two individual training sessions of a physical therapist to lower the physical workload, a Rest-Break tool to improve the balance between work and recovery, and two empowerment training sessions to increase the influence of the construction workers at the worksite. Data on work engagement, social support at work, physical workload, and need for recovery were collected at baseline, and at three, six and 12 months after the start of the intervention using questionnaires. Results No differences between the intervention and control group were found for work engagement, social support at work, and need for recovery. At 6 months follow-up, the control group reported a small but statistically significant reduction of physical workload. Conclusion The intervention neither improved social support nor work engagement, nor was it effective in reducing the physical workload and need for recovery among construction workers. Trial registration NTR1278 PMID:23171354

  10. The impact of two workplace-based health risk appraisal interventions on employee lifestyle parameters, mental health and work ability: results of a randomized controlled trial.

    PubMed

    Addley, K; Boyd, S; Kerr, R; McQuillan, P; Houdmont, J; McCrory, M

    2014-04-01

    Health risk appraisals (HRA) are a common type of workplace health promotion programme offered by American employers. In the United Kingdom, evidence of their effectiveness for promoting health behaviour change remains inconclusive. This randomized controlled trial examined the effects of two HRA interventions on lifestyle parameters, mental health and work ability in a UK context. A total of 180 employees were randomized into one of three groups: Group A (HRA augmented with health promotion and education activities), Group B (HRA only) and Group C (control, no intervention). After 12 months, changes in mean scoring in 10 lifestyle, mental health and work ability indices were compared, Groups A and B demonstrated non-significant improvements in 70% and 80%, respectively, compared with controls (40%). Odds ratios revealed that, compared with the control group, Group A was 29.2 (95% CI: 9.22-92.27) times more likely to report a perceived change in lifestyle behaviour; Group B 4.4 times (95% CI: 1.65-11.44). In conclusion, participation in the HRA was associated with a higher likelihood of perceived lifestyle behaviour change which was further increased in the augmented HRA group, thereby providing preliminary evidence that HRA and augmented HRA in particular may help UK employees make positive healthy lifestyle changes. PMID:24399261

  11. Study protocol: the effect of vitamin D supplements on cardiometabolic risk factors among urban premenopausal women in a tropical country - a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Besides its classical role in musculoskeletal diseases, vitamin D deficiency has recently been found to be associated with cardiometabolic risks such as hypertension, diabetes mellitus and hypercholesterolemia. Although Malaysia is a sunshine-abundant country, recent studies found that vitamin D deficiency prevalence was significantly high. However, few published studies that measured its effect on cardiometabolic risk factors were found in Malaysia. There are also limited clinical trials carried out globally that tried to establish the causality of vitamin D and cardiometabolic risks. Therefore, a double blind, parallel, randomized controlled trial on vitamin D and cardiometabolic risks is planned to be carried out. The objective of this study is to investigate whether vitamin D supplements can reduce the cardiometabolic risk and improve the quality of life in urban premenopausal women with vitamin D deficiency. Methods/design Three hundred and twenty premenopausal women working in a public university in Kuala Lumpur, Malaysia will be randomized to receive either vitamin D supplement (50,000 IU weekly for 8 weeks and 50,000 IU monthly for 10 months) or placebo for 12 months. At baseline, all participants are vitamin D deficient (≤ 20 ng/ml or 50 nmol/l). Both participants and researchers will be blinded. The serum vitamin D levels of all participants collected at various time points will only be analysed at the end of the trial. Outcome measures such as 25(OH) D3, HOMA-IR, blood pressure, full lipid profiles will be taken at baseline, 6 months and 12 months. Health related quality of life will be measured at baseline and 12 months. The placebo group will be given delayed treatment for six months after the trial. Discussion This trial will be the first study investigating the effect of vitamin D supplements on both the cardiometabolic risk and quality of life among urban premenopausal women in Malaysia. Our findings will contribute to the growing body

  12. Histological Predictors of Maximum Failure Loads Differ Between the Healing ACL and ACL Grafts After 6 and 12 Months In Vivo

    PubMed Central

    Proffen, Benedikt L.; Fleming, Braden C.; Murray, Martha M.

    2013-01-01

    Background: Bioenhanced anterior cruciate ligament (ACL) repair, where the suture repair is supplemented with a biological scaffold, is a promising novel technique to stimulate healing after ACL rupture. However, the histological properties of a successfully healing ACL and how they relate to the mechanical properties have not been fully described. Purpose: To determine which histological features best correlate with the mechanical properties of the healing ACL repairs and ACL grafts in a porcine model at 6 and 12 months after injury. Study Design: Controlled laboratory study. Methods: A total of 48 Yucatan mini-pigs underwent ACL transection followed by: (1) conventional ACL reconstruction with bone–patellar tendon–bone (BPTB) allograft, (2) bioenhanced ACL reconstruction with BPTB allograft using a bioactive scaffold, or (3) bioenhanced ACL repair using the same bioactive scaffold. After 6 and 12 months of healing, structural properties of the ACL or graft (yield and failure load, linear stiffness) were measured. Following mechanical testing, ACL specimens were histologically analyzed for cell and vascular density and qualitatively assessed using the advanced Ligament Maturity Index. Results: After 6 months of healing, the cellular organization subscore was most predictive of yield load (r 2 = 0.98), maximum load (r 2 = 0.89), and linear stiffness (r 2 = 0.95) of the healing ACL, while at 12 months, the collagen subscore (r 2 = 0.68) became the best predictor of maximum load. For ACL grafts, the reverse was true, with the collagen subscore predictive of yield and maximum loads at 6 months (r 2 = 0.55) and graft cellularity predictive of maximum load of the graft at 12 months (r 2 = 0.50). Conclusion: These findings suggest there may be key biological differences in development and maintenance of ACL tissue after repair or reconstruction, with early ligament function dependent on cellular population of the repair but early graft function dependent on the

  13. Effect of recent spinal cord injury on wnt signaling antagonists (sclerostin and dkk-1) and their relationship with bone loss. A 12-month prospective study.

    PubMed

    Gifre, Laia; Vidal, Joan; Carrasco, Josep L; Filella, Xavier; Ruiz-Gaspà, Silvia; Muxi, Africa; Portell, Enric; Monegal, Ana; Guañabens, Nuria; Peris, Pilar

    2015-06-01

    Spinal cord injury (SCI) has been associated with a marked increase in bone loss and bone remodeling, especially short-term after injury. The absence of mechanical load, mediated by osteocyte mechanosensory function, seems to be a causative factor related to bone loss in this condition. However, the pathogenesis and clinical management of this process remain unclear. Therefore, the aim of the study was to analyze the effect of recent SCI on the Wnt pathway antagonists, sclerostin and Dickkopf (Dkk-1), and their relationship with bone turnover and bone mineral density (BMD) evolution. Forty-two patients (aged 35 ± 14yrs) with a recent (<6months) complete SCI were prospectively included. Sclerostin and Dkk-1, bone turnover markers (bone formation: PINP, bone ALP; resorption: sCTx) and BMD (lumbar spine, proximal femur, total body and lower extremities [DXA]) were assessed at baseline and at 6 and 12 months. The results were compared with a healthy control group. 22/42 patients completed the 12-month follow-up. At baseline, SCI patients showed a marked increase in bone markers (PINP and sCTx), remaining significantly increased at up to 6 months of follow-up. Additionally, they presented significantly increased Dkk-1 values throughout the study, whereas sclerostin values did not significantly change. BMD markedly decreased at the proximal femur (-20.2 ± 5.4%, p < 0.01), total body (-5.7 ± 2.2%, p = 0.02) and lower extremities (-13.1 ± 4.5%, p = 0.01) at 12 months. Consequently, 59% of patients developed densitometric osteoporosis at 12 months. Patients with higher Dkk-1 values (>58 pmol/L) at baseline showed higher sublesional BMD loss. In conclusion, this study shows that short-term after SCI there is a marked increase in bone turnover and bone loss, the latter associated with an increase in Dkk-1 serum levels. The persistence of increased levels of this Wnt antagonist throughout the study and their relationship with the magnitude of

  14. Buffering Syndemic Effects in a Sexual Risk-Reduction Intervention for Male Clients of Female Sex Workers: Results From a Randomized Controlled Trial

    PubMed Central

    Strathdee, Steffanie A.; Semple, Shirley J.; Chavarin, Claudia V.; Magis-Rodriguez, Carlos; Patterson, Thomas L.

    2015-01-01

    Objectives. We sought to test the efficacy of a sexual risk intervention for male clients of female sex workers (FSWs) and examine whether efficacy was moderated by syndemic risk. Methods. From 2010 to 2014, we conducted a 2-arm randomized controlled trial (60-minute, theory-based, safer sex intervention versus a didactic time-equivalent attention control) that included 400 male clients of FSWs on the US–Mexico border with follow-up at 4, 8, and 12 months. We measured 5 syndemic risk factors, including substance use and depression. Primary outcomes were sexually transmitted infections incidence and total unprotected sex with FSWs. Results. Although participants in both groups became safer, there was no significant difference in behavior change between groups. However, baseline syndemic risk moderated intervention efficacy. At baseline, there was a positive association between syndemic risk and unprotected sex. Then at 12 months, longitudinal analyses showed the association depended on intervention participation (B = −0.71; 95% confidence interval [CI] = –1.22, –0.20; P = .007). Among control participants there still existed this modest association (B = 0.36; 95% CI = –0.49, 1.22; P = .09); among intervention participants there was a significant negative association (B = −0.35; 95% CI = –0.63, –0.06; P = .02). Conclusion. A brief intervention might attenuate syndemic risks among clients of FSWs. Other populations experiencing syndemic problems may also benefit from such programs. PMID:25713953

  15. A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results.

    PubMed

    Saccà, Francesco; Quarantelli, Mario; Rinaldi, Carlo; Tucci, Tecla; Piro, Raffaele; Perrotta, Gaetano; Carotenuto, Barbara; Marsili, Angela; Palma, Vincenzo; De Michele, Giuseppe; Brunetti, Arturo; Brescia Morra, Vincenzo; Filla, Alessandro; Salvatore, Marco

    2012-01-01

    Amyotrophic lateral sclerosis (ALS) is a fatal neurological disease with motor neuron degeneration. Riluzole is the only available treatment. Two-thirds of ALS patients present with growth hormone (GH) deficiency. The aim of this study is to determine if add-on of GH to riluzole, with an individually regulated dose based on Insulin-like growth factor 1 (IGF-I) production, was able to reduce neuronal loss in the motor cortex, reduce mortality, and improve motor function of ALS patients. Patients with definite/probable ALS, in treatment with riluzole, aged 40-85 years, and with disease duration ≤3 years were enrolled. The study was randomized, placebo controlled, and double blind. Before treatment, patients were tested with a GH releasing hormone (GHRH) + arginine test. The initial dose of GH was 2 IU s.c. every other day, and was progressively increased to a maximum of 8 IU. Primary endpoint was N-acetylaspartate/(creatine + choline) (NAA/Cre + Cho) ratio in motor cortex assessed by magnetic resonance spectroscopy performed at months 0, 6, and 12. Secondary endpoints were mortality and ALS functional rating scale revised (ALSFRS-R). The NAA/(Cre + Cho) ratio decreased in all patients who completed the trial. No significant difference was noted between treated and placebo group. At baseline, although IGF-I levels were within the normal range, 73% of patients had GH deficiency, being severe in half of them. Compared with bulbar onset, spinal-onset patients showed more depressed GH response to the GHRH + arginine stimulation test (10.4 ± 7.0 versus 15.5 ± 8.1 ng/mL; p < 0.05). Insulin resistance [homeostasis model assessment of insulin resistance (HOMA-IR)] increased from 2.1 ± 1.0 at baseline to 4.6 ± 1.9 at 12 months (p < 0.001). Insulin-like growth factor (IGF) binding protein 3 (IGFBP-3) decreased from 8,435 ± 4,477 ng/mL at baseline to 3,250 ± 1,780 ng/mL at 12 months (p < 0.001). The results show that GH exerted no effect on cerebral NAA or clinical

  16. Endoscopic Enucleation versus Open Prostatectomy for Treating Large Benign Prostatic Hyperplasia: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Hou, Qi; Wang, Dejuan; Huang, Wentao; Hu, Cheng; Li, Ke; Gao, Xin

    2015-01-01

    Objectives To evaluate the overall efficacy and safety of endoscopic enucleation of the prostate (EP) vs open prostatectomy (OP) for large benign prostatic hyperplasia (BPH). Methods We conducted an electronic search of PubMed/Medline, EMBASE, The Cochrane Library, and Web of Science to detect all relevant randomized controlled trials (RCTs) comparing EP with OP. A meta-analysis was performed using Review Manager 5.3. Results Seven RCTs (735 patients) were included. At the 3-, 6- and 12-month follow-up, there were no significant differences in the International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), quality of life (QoL) score and post-void residual urine volume (PVR) between EP and OP. The International Index of Erectile Function (IIEF-5) was higher with EP (weighted mean difference [WMD]: 1.00, 95% confidence interval [CI]: 0.21 to 1.78, p=0.01) at the 12-month follow-up. The catheterization time (WMD: 3.80 d, 95%CI: -5.11 to -2.48, P<0.00001) and hospital stay (WMD: 4.93 d, 95%CI: -5.96 to -3.89, P<0.00001) were shorter with EP. The duration of operation was longer for EP compared with OP (WMD: 16.21 min, 95%CI: 3.72 to 28.70, P=0.01). The resected tissue weight (WMD: -9.63 g, 95%CI: -14.46 to -4.81, P<0.0001) and decrease in hemoglobin (WMD: -1.14 g/dL, 95%CI: -1.81 to -0.47, P=0.0008) were less with EP. EP was associated with fewer blood transfusions (risk ratio: 0.22, 95%CI: 0.10 to 0.47, P=0.0001). There were no significant differences between EP and OP when comparing other complications. Conclusions Although only a limited number of RCTs with relatively limited follow-up are available, EP is shown to have a similar postoperative profile and comparable safety to OP. By contrast, EP may have a more desirable perioperative profile. EP appears to be an effective and safe minimally invasive option for treating large prostates that requires only brief convalescence. PMID:25826453

  17. Vivamos Activos: A Randomized Controlled Trial of Two Community-Based Weight Loss Strategies among Obese, Low-income Latinos

    PubMed Central

    Rosas, Lisa Goldman; Thiyagarajan, Sreedevi; Goldstein, Benjamin Alan; Drieling, Rebecca Lucia; Romero, Priscilla Padilla; Ma, Jun; Yank, Veronica; Stafford, Randall Scott

    2015-01-01

    Background Latino immigrants have high rates of obesity and face barriers to weight loss. Objective Evaluate the effectiveness of a case-management (CM) intervention with and without community health workers (CHWs) for weight loss. Design Two-year, randomized controlled trial comparing two interventions to each other and to usual care (UC). Participants/setting Eligible participants included Latinos with a Body Mass Index of 30-60 and one or more heart disease risk factors. The 207 participants recruited from 2009-2011 had a mean age of 47 years and were mostly female (77%). At 24 months, 86% of the sample was assessed. Intervention The CM+CHW (n=82) and CM (n=84) interventions were compared to each other and to UC (n=41). Both included an intensive 12 month phase followed by 12 months of maintenance. The CM+CHW group received home visits. Main outcome measures Weight change at 24 months. Statistical Analyses Generalized estimating equations using intent-to-treat. Results At 6 months, mean weight loss in the CM+CHW arm was −2.1 kg (95% CI −2.8, −1.3) or −2% of baseline weight (−1%, −2%) compared to −1.6 kg (−2.4, −0.7; % weight change: −2%, −1%, −3%) in CM and −0.9 kg (−1.8, 0.1; % weight change: −1%, 0%, −2%) in UC. By 12 and 24 months, differences narrowed and CM+CHW was no longer statistically distinct. Men achieved greater weight loss than women in all groups at each time point (p<0.05). At 6 months, men in the CM+CHW arm lost more weight (−4.4 kg, −6.0, −2.7) compared to UC (−0.4 kg, −2.4, 1.5), but by 12 and 24 months differences were not significant. Conclusions Incorporation of CHWs may help promote early weight loss, especially among men, but it did not achieve weight maintenance. Social and environmental influences may need to be addressed to achieve sustained weight loss in Latino immigrant populations. PMID:25578925

  18. Standards of Reporting of Randomized Controlled Trials in General Surgery

    PubMed Central

    Balasubramanian, Sabapathy P.; Wiener, Martin; Alshameeri, Zeiad; Tiruvoipati, Ravindranath; Elbourne, Diana; Reed, Malcolm W.

    2006-01-01

    Objective: To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality. Summary Background Data: Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels. Methods: Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose. Results: Of the 69 RCTs analyzed, only 37.7% had a Jadad score of ≥3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022). Conclusion: The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology. PMID:17060756

  19. Efficacy and oncologic safety of nerve-sparing radical hysterectomy for cervical cancer: a randomized controlled trial

    PubMed Central

    Roh, Ju-Won; Lee, Dong Ock; Lim, Myong Cheol; Seo, Sang-Soo; Chung, Jinsoo; Lee, Sun

    2015-01-01

    Objective A prospective, randomized controlled trial was conducted to evaluate the efficacy of nerve-sparing radical hysterectomy (NSRH) in preserving bladder function and its oncologic safety in the treatment of cervical cancer. Methods From March 2003 to November 2005, 92 patients with cervical cancer stage IA2 to IIA were randomly assigned for surgical treatment with conventional radical hysterectomy (CRH) or NSRH, and 86 patients finally included in the analysis. Adequacy of nerve sparing, radicality, bladder function, and oncologic safety were assessed by quantifying the nerve fibers in the paracervix, measuring the extent of paracervix and harvested lymph nodes (LNs), urodynamic study (UDS) with International Prostate Symptom Score (IPSS), and 10-year disease-free survival (DFS), respectively. Results There were no differences in clinicopathologic characteristics between two groups. The median number of nerve fiber was 12 (range, 6 to 21) and 30 (range, 17 to 45) in the NSRH and CRH, respectively (p<0.001). The extent of resected paracervix and number of LNs were not different between the two groups. Volume of residual urine and bladder compliance were significantly deteriorated at 12 months after CRH. On the contrary, all parameters of UDS were recovered no later than 3 months after NSRH. Evaluation of the IPSS showed that the frequency of long-term urinary symptom was higher in CRH than in the NSRH group. The median duration before the postvoid residual urine volume became less than 50 mL was 11 days (range, 7 to 26 days) in NSRH group and was 18 days (range, 10 to 85 days) in CRH group (p<0.001). No significant difference was observed in the 10-year DFS between two groups. Conclusion NSRH appears to be effective in preserving bladder function without sacrificing oncologic safety. PMID:25872890

  20. Bilateral Administration of Autologous CD133+ Cells in Ambulatory Patients with Refractory Critical Limb Ischemia: Lessons Learned from a Pilot Randomized, Double blind, Placebo-controlled Trial

    PubMed Central

    Raval, Amish N.; Schmuck, Eric; Tefera, Girma; Leitzke, Cathlyn; Ark, Cassondra Vander; Hei, Derek; Centanni, John M.; de Silva, Ranil; Koch, Jill; Chappell, Richard; Hematti, Peiman

    2014-01-01

    Introduction CD133+ cells confer angiogenic potential and may be beneficial for the treatment of critical limb ischemia (CLI). However, patient selection, blinding methods and endpoints for clinical trials is challenging. We hypothesized that bilateral intramuscular administration of cytokine mobilized CD133+ cells in ambulatory patients with refractory CLI would be feasible and safe. Methods In this double-blind, randomized, sham-controlled trial, subjects received subcutaneous injections of granulocyte colony stimulating factor (10 mcg/kg/d) for 5 days, followed by leukapheresis, and intramuscular administration of 50-400 million sorted CD133+ cells delivered into both legs. Control subjects received normal saline injections, sham leukapheresis and intramuscular injection of placebo buffered solution. Subjects were followed for 1 year. An aliquot of CD133+ cells was collected from each subject to test for genes associated with cell senescence. Results 70 subjects were screened, of whom 10 were eligible. Subject enrollment was suspended due to a high rate of mobilization failure in subjects randomized to treatment. Of 10 subjects enrolled (7 randomized to treatment, 3 randomized to control), there were no differences in serious adverse events at 12 months and blinding was preserved. There were non-significant trends toward improved amputation free survival, 6 minute walk distance, walking impairment questionnaire and quality of life in subjects randomized to treatment. Successful CD133+ mobilizers expressed fewer senescence associated genes compared to poor mobilizers. Conclusion Bilateral administration of autologous CD133+ cell in ambulatory CLI subjects was safe and blinding was preserved. However, poor mobilization efficiency combined with high CD133+ senescence suggests futility in this approach. PMID:25239491

  1. Preconception maternal nutrition: a multi-site randomized controlled trial

    PubMed Central

    2014-01-01

    Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of

  2. Effects of Miniscalpel-Needle Release on Chronic Neck Pain: A Retrospective Analysis with 12-Month Follow-Up

    PubMed Central

    Li, Shuming; Shen, Tong; Liang, Yongshan; Zhang, Ying; Bai, Bo

    2015-01-01

    Objective Chronic neck pain is a highly prevalent condition, and is often treated with non-steroidal anti-inflammatory drugs. Limited clinical studies with short-term follow-up have shown promising efficacy of acupuncture as well as miniscalpel-needle (MSN) release. In this retrospective study, we examined whether MSN release could produce long-lasting relief in patients with chronic neck pain. Methods We retrieved the medical records of all patients receiving weekly MSN release treatment for chronic neck pain at this institution during a period from May 2012 to December 2013. Only cases with the following information at prior to, and 1, 6, and 12 months after the treatment, were included in the analysis: neck disability index (NDI), numerical pain rating scale (NPRS), and active cervical range of motion (CROM). The primary analysis of interest is comparison of the 12-month measures with the baseline. Patients who took analgesic drugs or massage within 2 weeks prior to assessment were excluded from the analysis. For MSN release, tender points were identified manually by an experienced physician, and did not necessarily follow the traditional acupuncture system. MSN was inserted vertically (parallel to the spine) until breaking through resistance and patient reporting of distention, soreness or heaviness. The depth of the needling ranged from 10 to 50 mm. The release was carried out by moving the MSN up and down 3–5 times without rotation. Results A total of 559 cases (patients receiving weekly MSN release treatment for chronic neck pain) were screened. The number of cases with complete information (NDI, NPRS, and CROM at baseline, 1, 6 and 12 months after last treatment) was 180. After excluding the cases with analgesic treatment or massage within 2 weeks of assessment (n = 53), a total of 127 cases were included in data analysis. The number of MSN release session was 7 (range: 4–11). At 12 months after the treatment, both NPRS and NDI were significantly lower

  3. Sustained Uptake of a Hospital-Based Handwashing with Soap and Water Treatment Intervention (Cholera-Hospital-Based Intervention for 7 Days [CHoBI7]): A Randomized Controlled Trial.

    PubMed

    George, Christine Marie; Jung, Danielle S; Saif-Ur-Rahman, K M; Monira, Shirajum; Sack, David A; Mahamud-ur Rashid; Mahmud, Md Toslim; Mustafiz, Munshi; Rahman, Zillur; Bhuyian, Sazzadul Islam; Winch, Peter J; Leontsini, Elli; Perin, Jamie; Begum, Farzana; Zohura, Fatema; Biswas, Shwapon; Parvin, Tahmina; Sack, R Bradley; Alam, Munirul

    2016-02-01

    Diarrhea is the second leading cause of death in children under 5 years of age globally. The time patients and caregivers spend at a health facility for severe diarrhea presents the opportunity to deliver water, sanitation, and hygiene (WASH) interventions. We recently developed Cholera-Hospital-Based Intervention for 7 days (CHoBI7), a 1-week hospital-based handwashing with soap and water treatment intervention, for household members of cholera patients. To investigate if this intervention could lead to sustained WASH practices, we conducted a follow-up evaluation of 196 intervention household members and 205 control household members enrolled in a randomized controlled trial of the CHoBI7 intervention 6 to 12 months post-intervention. Compared with the control arm, the intervention arm had four times higher odds of household members' handwashing with soap at a key time during 5-hour structured observation (odds ratio [OR]: 4.71, 95% confidence interval [CI]: 2.61, 8.49) (18% versus 50%) and a 41% reduction in households in the World Health Organization very high-risk category for stored drinking water (OR: 0.38, 95% CI: 0.15, 0.96) (58% versus 34%) 6 to 12 months post-intervention. Furthemore, 71% of observed handwashing with soap events in the intervention arm involved the preparation and use of soapy water, which was promoted during the intervention, compared to 9% of control households. These findings demonstrate that the hospital-based CHoBI7 intervention can lead to significant increases in handwashing with soap practices and improved stored drinking water quality 6 to 12 months post-intervention. PMID:26728766

  4. Postoperative pain relief following hysterectomy: A randomized controlled trial

    PubMed Central

    Raghvendra, K. P.; Thapa, Deepak; Mitra, Sukanya; Ahuja, Vanita; Gombar, Satinder; Huria, Anju

    2016-01-01

    Background: Women experience moderate to severe postoperative pain following total abdominal hysterectomy (TAH). The transversus abdominis plane (TAP) block is a new modality for providing postoperative pain relief in these patients. Materials and Methods: The present study was a single center, prospective randomized trial. After the Institutional Ethics Committee approval and informed consent, patients were randomized to either epidural group: Epidural block placement + general anesthesia (GA) or TAP group: Single shot TAP block + GA. Patients in both the groups received standard general anesthetic technique and intravenous tramadol patient-controlled analgesia in the postoperative period. Patients were monitored for tramadol consumption, visual analog scale (VAS) both at rest and on coughing, hemodynamics, and side effects at 0, 2, 4, 6, 8, 12, and 24 h postoperatively. Results: The total consumption of tramadol in 24 h was greater in TAP group as compared to epidural group (68.8 [25.5] vs. 5.3 [11.6] mg, P < 0.001). The VAS scores at rest and on coughing were higher in TAP group as compared to the epidural group at 6, 8, 12, and 24 h postoperatively (P < 0.05). None of the patients in either group had any adverse effects. Conclusion: Epidural analgesia provided greater tramadol-sparing effect with superior analgesia postoperatively as compared to TAP block in patients up to 24 h following TAH. PMID:27499592

  5. Treatment of bulimia nervosa with sertraline: a randomized controlled trial.

    PubMed

    Milano, W; Petrella, C; Sabatino, C; Capasso, A

    2004-01-01

    Bulimia nervosa (BN) is one of the most frequently encountered eating disorders in industrialized societies. It has been suggested that reduced serotonin activity may trigger some of the cognitive and mood disturbances associated with BN. Thus, pharmacologic treatment of BN is mainly based on the use of selective serotonin reuptake inhibitors, which have proved effective. At present, the biological basis of this disorder is not completely clear. The aim of this randomized, controlled trial was to verify the efficacy of sertraline, a selective serotonin reuptake inhibitor, in a group of patients with a diagnosis of BN. Twenty female outpatients, with an age range of 24 to 36 years and a diagnosis of purging type BN as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV), were assigned randomly to two treatment groups. The first group received sertraline 100 mg/day for 12 weeks; the second group received placebo. The study was conducted for 12 weeks, with weekly clinical assessments. At the end of the observation period, the group treated with sertraline had a statistically significant reduction in the number of binge eating crises and purging compared with the group who received placebo. In no case was treatment interrupted because of side effects. This study confirms that sertraline is well tolerated and effective in reducing binge-eating crises and purging in patients with BN. PMID:15605617

  6. Treatment of bulimia nervosa with fluvoxamine: a randomized controlled trial.

    PubMed

    Milano, W; Siano, C; Putrella, C; Capasso, A

    2005-01-01

    Bulimia nervosa (BN) is one of the most common eating disorders in industrialized societies. It has been suggested that reduced serotonin activity triggers some of the cognitive and mood disturbances associated with BN. For this reason, the pharmacologic treatment of BN consists mainly of selective serotonin reuptake inhibitors (SSRIs), which have been proven effective. At present, the physiologic bases of this disorder are not yet completely understood. We conducted a randomized controlled trial to verify the efficacy of the SSRI fluvoxamine in patients with a diagnosis of BN. Twelve female outpatients aged 21 to 34 years with a diagnosis of BN-binge purging (as defined by the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) were randomly assigned to 2 treatment groups: the fluvoxamine 200 mg/day group and the placebo group. The patients underwent weekly clinical assessments for 12 weeks. At the end of the observation period, there was a statistically significant reduction in the number of binge-eating crises and purging episodes in the fluvoxamine group compared with placebo. In no case was treatment interrupted because of emergent side effects. These findings support the hypothesis that fluvoxamine is well tolerated and effe