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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. Replicating Reducing the Risk: 12-Month Impacts of a Cluster Randomized Controlled Trial

    PubMed Central

    Blocklin, Michelle; Layzer, Jean; Price, Cristofer; Juras, Randall; Freiman, Lesley

    2016-01-01

    Objectives. To test the effectiveness of Reducing the Risk, an evidence-based sexual health curriculum designed to help prevent adolescent pregnancy and sexually transmitted infections, on youth sexual behavior and intermediate outcomes thought to lead to these behaviors. Methods. Classes within schools in St. Louis, Missouri; Austin, Texas; and San Diego, California; were randomly assigned to receive Reducing the Risk or “business as usual.” Youths completed Web-based surveys at baseline (preintervention, August 2012–January 2014) and 12 months later (August 2013–January 2015). Intent-to-treat analyses were conducted across sites; we tested for differences in impacts between sites and other subgroups. Results. The program had no overall impact on sexual behaviors. However, at 1 site, program participants were significantly less likely to have engaged in recent sexual intercourse than were control group members. There were positive overall impacts on intermediate outcomes (e.g., knowledge, attitudes). Conclusions. After 12 months, Reducing the Risk was unsuccessful at changing sexual behaviors. Other results were mixed, but promising evidence (e.g., behavioral impacts at 1 site, impacts on intermediate outcomes) suggests potential for more widespread behavioral impacts over a longer term. PMID:27689492

  3. Effects of high-impact training on bone and articular cartilage: 12-month randomized controlled quantitative MRI study.

    PubMed

    Multanen, Juhani; Nieminen, Miika T; Häkkinen, Arja; Kujala, Urho M; Jämsä, Timo; Kautiainen, Hannu; Lammentausta, Eveliina; Ahola, Riikka; Selänne, Harri; Ojala, Risto; Kiviranta, Ilkka; Heinonen, Ari

    2014-01-01

    Osteoarthritis and osteoporosis often coexist in postmenopausal women. The simultaneous effect of bone-favorable high-impact training on these diseases is not well understood and is a topic of controversy. We evaluated the effects of high-impact exercise on bone mineral content (BMC) and the estimated biochemical composition of knee cartilage in postmenopausal women with mild knee osteoarthritis. Eighty women aged 50 to 66 years with mild knee osteoarthritis were randomly assigned to undergo supervised progressive exercise three times a week for 12 months (n = 40) or to a nonintervention control group (n = 40). BMC of the femoral neck, trochanter, and lumbar spine was measured by dual-energy X-ray absorptiometry (DXA). The biochemical composition of cartilage was estimated using delayed gadolinium-enhanced magnetic resonance imaging (MRI) cartilage (dGEMRIC), sensitive to cartilage glycosaminoglycan content, and transverse relaxation time (T2) mapping that is sensitive to the properties of the collagen network. In addition, we evaluated clinically important symptoms and physical performance-related risk factors of falling: cardiorespiratory fitness, dynamic balance, maximal isometric knee extension and flexion forces, and leg power. Thirty-six trainees and 40 controls completed the study. The mean gain in femoral neck BMC in the exercise group was 0.6% (95% CI, -0.2% to 1.4%) and the mean loss in the control group was -1.2% (95% CI, -2.1% to -0.4%). The change in baseline, body mass, and adjusted body mass change in BMC between the groups was significant (p = 0.005), whereas no changes occurred in the biochemical composition of the cartilage, as investigated by MRI. Balance, muscle force, and cardiorespiratory fitness improved significantly more (3% to 11%) in the exercise group than in the control group. Progressively implemented high-impact training, which increased bone mass, did not affect the biochemical composition of cartilage and may be feasible

  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.

  5. Regulatory competence and social communication in term and preterm infants at 12 months corrected age. Results from a randomized controlled trial.

    PubMed

    Olafsen, Kåre S; Rønning, John A; Handegård, Bjørn Helge; Ulvund, Stein Erik; Dahl, Lauritz Bredrup; Kaaresen, Per Ivar

    2012-02-01

    Temperamental regulatory competence and social communication in term and preterm infants at 12 months corrected age was studied in a randomized controlled intervention trial aimed at enhancing maternal sensitive responsiveness. Surviving infants <2000 g from a geographically defined area were randomized to an intervention (71) or a control group (69), and compared with term infants (74). The intervention was a modified version of the "Mother-Infant Transaction Program". Regulatory competence was measured with the Infant Behavior Questionnaire, and social communication with the Early Social Communication Scales. Preterm intervention infants with low regulatory competence had higher responding to joint attention than preterm control infants. A sensitizing intervention may moderate the association between temperament and social communication, and thus allow an alternative functional outlet for preterm infants low in regulatory competence. The finding may have implications for conceptualizations of the role of early sensitizing interventions in promoting important developmental outcomes for premature infants.

  6. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up.

    PubMed

    Rathleff, M S; Mølgaard, C M; Fredberg, U; Kaalund, S; Andersen, K B; Jensen, T T; Aaskov, S; Olesen, J L

    2015-06-01

    The aim of this study was to investigate the effectiveness of shoe inserts and plantar fascia-specific stretching vs shoe inserts and high-load strength training in patients with plantar fasciitis. Forty-eight patients with ultrasonography-verified plantar fasciitis were randomized to shoe inserts and daily plantar-specific stretching (the stretch group) or shoe inserts and high-load progressive strength training (the strength group) performed every second day. High-load strength training consisted of unilateral heel raises with a towel inserted under the toes. Primary outcome was the foot function index (FFI) at 3 months. Additional follow-ups were performed at 1, 6, and 12 months. At the primary endpoint, at 3 months, the strength group had a FFI that was 29 points lower [95% confidence interval (CI): 6-52, P = 0.016] compared with the stretch group. At 1, 6, and 12 months, there were no differences between groups (P > 0.34). At 12 months, the FFI was 22 points (95% CI: 9-36) in the strength group and 16 points (95% CI: 0-32) in the stretch group. There were no differences in any of the secondary outcomes. A simple progressive exercise protocol, performed every second day, resulted in superior self-reported outcome after 3 months compared with plantar-specific stretching. High-load strength training may aid in a quicker reduction in pain and improvements in function.

  7. A Cluster Randomized Controlled Trial of an Adolescent HIV Prevention Program among Bahamian Youth: Effect at 12 Months Post-Intervention

    PubMed Central

    Chen, Xinguang; Lunn, Sonya; Deveaux, Lynette; Li, Xioaming; Brathwaite, Nanika; Cottrell, Lesley; Stanton, Bonita

    2014-01-01

    Background Behavioral interventions based on the Protection Motivation Theory (PMT) have been demonstrated to reduce HIV risk behavior among mid- and older adolescents in different settings across the globe but have not been evaluated among Caribbean nations and have received limited evaluation among pre-adolescents. Objective To determine 1) the effectiveness among pre-adolescents in The Bahamas of a PMT-based HIV prevention program “Focus on Youth in the Caribbean” (FOYC) and 2) the role of the targeted PMT constructs in intervention effect. Methods 1,360 sixth grade youth (10-11 years of age) from 15 urban schools in New Providence, The Bahamas were randomized by school to receive either FOYC or a control condition. Data collected at baseline, six and 12 months post intervention were analyzed. A five-step scheme was used to assess sexual behavior progression, ranging from “1” = “a virgin without intention to have sex” to” 5″ = “having sex without a condom”. Group-based trajectory analysis was utilized in assessing the program effect. Results Two sexual behavior progression patterns were detected: slow progressors and quick progressors. Receiving FOYC reduced the likelihood for adolescents to become quick progressors (adjusted OR = 0.77, 95% CI: 0.64-1.00). The observed effectiveness was especially impacted by a subset of the targeted PMT constructs. Conclusion FOYC effectively delays sexual risk among Bahamian pre-adolescents. The group-based trajectory analysis provides an analytical approach for assessing interventions among adolescents with low rates and diverse progression patterns of sexual activity. PMID:19116781

  8. Technology-assisted balance and gait training reduces falls in patients with Parkinson's disease: a randomized controlled trial with 12-month follow-up.

    PubMed

    Shen, Xia; Mak, Margaret K Y

    2015-02-01

    Objective. To examine the effects of technology-assisted balance and gait training on reducing falls in patients with Parkinson's disease (PD). Methods. Eligible subjects were randomly allocated to an experimental group given technology-assisted balance and gait training (BAL, n = 26) and an active control group undertaking strengthening exercises (CON, n = 25). The training in each group lasted for 3 months. The number of fallers and fall rate were used as primary outcomes, and single-leg-stance-time, latency of postural response to perturbation, self-selected gait velocity, and stride length as secondary outcomes. Fall incidence was recorded over 15 months after the baseline assessment (Pre). Other tests were performed at Pre, after 3-month intervention (Post(3m)), at 3 months (Post(6m)), and 12 months (Post(15m)) after treatment completion. Results. Forty-five subjects who completed the 3-month training were included in the data analysis. There were fewer fallers in the BAL than in the CON group at Post(3m), Post(6m), and Post(15m) (P < .05). In addition, the BAL group had lower fall rate than the CON group at Post(3m) and Post(6m) (incidence rate ratio: 0.111-0.188, P < .05), and marginally so at Post(15m) (incidence rate ratio: 0.407, P = .057). Compared with the CON subjects, the BAL subjects demonstrated greater reduction in the postural response latency and increase in the stride length against baseline at each assessment interval (P < .05), and marginally more increases of single-leg-stance-time at Post(3m) (P = .064), Post(6m) (P = .041) and Post(15m) (P = .087). Conclusions. Our positive findings provide evidence for the clinical use of technology-assisted balance and gait training in reducing falls in people with PD. PMID:24961993

  9. 12-MONTH COST-EFFECTIVENESS OF TELEPHONE-DELIVERED COLLABORATIVE CARE FOR TREATING DEPRESSION FOLLOWING CABG SURGERY: A RANDOMIZED CONTROLLED TRIAL

    PubMed Central

    Donohue, Julie M.; Belnap, Bea Herbeck; Men, Aiju; He, Fanyin; Roberts, Mark S.; Schulberg, Herbert C.; Reynolds, Charles F.; Rollman, Bruce L.

    2014-01-01

    Objective To determine the 12-month cost-effectiveness of a collaborative care (CC) program for treating depression following coronary artery bypass graft (CABG) surgery versus physicians’ usual care (UC). Methods We obtained 12 continuous months of Medicare and private medical insurance claims data on 189 patients who screened positive for depression following CABG surgery, met criteria for depression when reassessed by telephone two-weeks following hospitalization (9-item Patient Health Questionnaire ≥10), and were randomized to either an 8-month centralized, nurse-provided, and telephone-delivered collaborative care (CC) intervention for depression or to their physicians’ usual care (UC). Results At 12-months following randomization, CC patients had $2,068 lower but statistically similar estimated median costs compared to UC (P=0.30) and a variety of sensitivity analyses produced no significant changes. The incremental cost effectiveness ratio of CC was −$9,889 (−$11,940 to −$7,838) per additional quality-adjusted life-year (QALY), and there was 90% probability it would be cost-effective at the willingness to pay threshold of $20,000 per additional QALY. A bootstrapped cost-effectiveness plane also demonstrated a 68% probability of CC “dominating” UC (more QALYs at lower cost). Conclusions Centralized, nurse-provided, and telephone-delivered CC for post-CABG depression is a quality-improving and cost-effective treatment that meets generally accepted criteria for high-value care. PMID:24973911

  10. Community participation and belonging among formerly homeless adults with mental illness after 12 months of Housing First in Vancouver, British Columbia: a randomized controlled trial.

    PubMed

    Patterson, Michelle L; Moniruzzaman, Akm; Somers, Julian M

    2014-07-01

    This study examines community integration among homeless adults with mental illness 6 and 12 months after random assignment to Housing First (independent apartments or congregate residence) with support services or to treatment as usual (TAU). Residence in independent apartments was associated with increased 'psychological integration' for participants with less severe needs; however, no significant improvement in 'physical integration' was observed among any of the intervention groups. Analysis of individual items on the Psychological Integration subscale revealed that, compared to TAU, participants assigned to independent apartments were more likely to endorse statements related to the emotional components of community but not statements related to neighboring. Participants assigned to the congregate residence were more likely to endorse knowing their neighbors, but not interacting with neighbors or the emotional components of community. Findings are discussed in terms of housing program as well as broader contextual factors.

  11. 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

  12. 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

  13. 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

  14. Effectiveness of a low-intensity home-based aftercare for patients with severe mental disorders: a 12-month randomized controlled study.

    PubMed

    Sharifi, Vandad; Tehranidoost, Mehdi; Yunesian, Masud; Amini, Homayoun; Mohammadi, Mohammadreza; Jalali Roudsari, Mohsen

    2012-12-01

    To examine the effectiveness of a low-intensity home-based aftercare service, 130 patients with schizophrenia, schizoaffective disorder or bipolar disorder were randomized to receive either home aftercare or treatment-as-usual. In home aftercare, a general practitioner and a social worker made home visits once in a month after discharge from the hospital wherein they provided education and treatment. In a 1-year follow-up, home aftercare led to greater reduction in rehospitalization rate, more improvement in psychotic symptoms and global illness severity, as well as greater service satisfaction. The implementation of this low-intensity aftercare is recommended, especially in less resourceful settings. PMID:22772746

  15. 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

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

    PubMed

    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.

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

    PubMed

    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

  18. Change in Body Fat Mass Is Independently Associated with Executive Functions in Older Women: A Secondary Analysis of a 12-Month Randomized Controlled Trial

    PubMed Central

    Dao, Elizabeth; Davis, Jennifer C.; Sharma, Devika; Chan, Alison; Nagamatsu, Lindsay S.; Liu-Ambrose, Teresa

    2013-01-01

    Objectives To investigate the independent contribution of change in sub-total body fat and lean mass to cognitive performance, specifically the executive processes of selective attention and conflict resolution, in community-dwelling older women. Methods This secondary analysis included 114 women aged 65 to 75 years old. Participants were randomly allocated to once-weekly resistance training, twice-weekly resistance training, or twice-weekly balance and tone training. The primary outcome measure was the executive processes of selective attention and conflict resolution as assessed by the Stroop Test. Sub-total body fat and lean mass were measured by dual-energy x-ray absorptiometry (DXA) to determine the independent association of change in both sub-total body fat and sub-total body lean mass with Stroop Test performance at trial completion. Results A multiple linear regression model showed reductions in sub-total body fat mass to be independently associated with better performance on the Stroop Test at trial completion after accounting for baseline Stroop performance, age, baseline global cognitive state, baseline number of comorbidities, baseline depression, and experimental group. The total variance explained was 39.5%; change in sub-total body fat mass explained 3.9% of the variance. Change in sub-total body lean mass was not independently associated with Stroop Test performance (P>0.05). Conclusion Our findings suggest that reductions in sub-total body fat mass – not sub-total lean mass – is associated with better performance of selective attention and conflict resolution. PMID:23308123

  19. 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

  20. 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.

  1. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study

    PubMed Central

    Krzeski, Piotr; Buckland-Wright, Chris; Bálint, Géza; Cline, Gary A; Stoner, Karen; Lyon, Robert; Beary, John; Aronstein, William S; Spector, Tim D

    2007-01-01

    We performed a randomized, double-blind, placebo-controlled, multicenter, parallel-group, dose-response study of the efficacy and safety of the oral administration of PG-116800, a matrix metalloproteinase (MMP) inhibitor, in patients with mild to moderate knee osteoarthritis. The primary efficacy endpoints included the progression of joint space narrowing in the osteoarthritic knee, as measured by microfocal radiography with fluoroscopic positioning, and the reduction of symptoms (pain and stiffness) and/or the improvement of function, as measured by the Western Ontario and McMaster Universities osteoarthritis index (WOMAC). Four hundred and one patients were randomly assigned to either placebo (n = 80) or one of fourdoses of PG-116800: 25 mg (n = 81), 50 mg (n = 80), 100 mg (n = 80), or 200 mg (n = 80) taken twice daily for 12 months. During the study, the 200-mg dose was discontinued based on an increased frequency of musculoskeletal adverse effects. After 1 year of treatment, no statistically significant difference was observed between placebo and PG-116800 with regard to mean changes in minimum joint space width of the knee or to WOMAC scores. The most frequent adverse effect was arthralgia (35%). Twenty-three percent of evaluable patients had at least a 30% decrease from baseline of at least onerange-of-motion measurement of either shoulder at a follow-up visit. The percentage of patients with reduction in range of motion was significantly greater in the twohighest dose groups relative to placebo. Thirteen percent of patients, half of whom were in the 200-mg group, reported hand adverse events (oedema, palmar fibrosis, Dupuytren contracture, or persistent tendon thickness or nodules). The threemost frequent shoulder adverse events were reversible arthralgia, stiffness, and myalgia, which mostly affected the twohighest dose groups. The unfavorable risk-benefit balance of the MMP inhibitor PG-116800 in patients with knee osteoarthritis precludes further

  2. 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

  3. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis

    PubMed Central

    Dirschka, T; Radny, P; Dominicus, R; Mensing, H; Brüning, H; Jenne, L; Karl, L; Sebastian, M; Oster-Schmidt, C; Klövekorn, W; Reinhold, U; Tanner, M; Gröne, D; Deichmann, M; Simon, M; Hübinger, F; Hofbauer, G; Krähn-Senftleben, G; Borrosch, F; Reich, K; Berking, C; Wolf, P; Lehmann, P; Moers-Carpi, M; Hönigsmann, H; Wernicke-Panten, K; Hahn, S; Pabst, G; Voss, D; Foguet, M; Schmitz, B; Lübbert, H; Szeimies, R-M

    2013-01-01

    Background Two phase III trials of photodynamic therapy (PDT) with BF-200 ALA, a recently approved nanoemulsion formulation of 5-aminolaevulinic acid (ALA) demonstrated high clearance rates in mild-to-moderate actinic keratosis (AK). The comparison to a registered methyl aminolaevulinate (MAL) cream demonstrated significantly superior total patient clearance rates. Objectives To evaluate long-term efficacy and safety of PDT for AK 6 and 12 months after the last PDT with BF-200 ALA, MAL or placebo. Methods The follow-up phase (FUP) was performed with patients of two phase III studies. Both studies compared BF-200 ALA with placebo, one of the studies additionally with MAL. Overall recurrence rates and various subgroups (light source, lesion severity, lesion location, complete responders after first PDT) were assessed 6 and 12 months after the last PDT. Results Recurrence rates were similar for BF-200 ALA and MAL, with a tendency to lower recurrence rates for BF-200 ALA. The proportion of patients who were fully cleared during PDT and remained completely clear for at least 12 months after PDT were 47% for BF-200 ALA (both studies) and 36% for MAL treatment. The subgroup that was illuminated with narrow wavelength LED lamps reached 69% and 53% for BF-200 ALA (both studies, respectively) and 41% for MAL. No safety concerns were reported. Conclusions The FUP data confirmed the high efficacy and safety of PDT with BF-200 ALA. The slightly lower recurrence rates after BF-200 ALA treatment compared with MAL treatment enhanced the better treatment outcome due to the significantly superior efficacy. PMID:23252768

  4. 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

  5. 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

  6. Evaluation of cervical posture following palatal expansion: a 12-month follow-up controlled study.

    PubMed

    Tecco, Simona; Caputi, Sergio; Festa, Felice

    2007-02-01

    This study evaluated the effects of rapid palatal expansion (RPE) on nasopharyngeal airway size, head posture, and cervical curvature angle in children with nasal obstruction. The patients were 45 female subjects (8-15 years of age) who had a reduced nasopharyngeal airway size and were subjectively assessed as being mouth breathers and requiring palatal expansion. They were randomly allocated to one of two groups: 23 subjects in the first group were treated with RPE, while the 22 subjects in the other group were monitored for approximately 14 months prior to commencing therapy, and became untreated controls. Lateral skull radiographs, taken in the natural head position, were obtained at the first visit (T0) and 6 (T1) and 12 (T2) months later for all subjects. The differences between the cephalometric variables at baseline and after 6 and 12 months were evaluated with a one-way repeated measures analysis of variance. Where significant interactions were found, a Bonferroni corrected paired Student's t-test was performed for pairwise comparisons. Changes in cephalometric variables within the experimental groups were tested by paired Student's t-tests as a post hoc procedure. Finally, a correlation matrix, using the Pearson correlation coefficient, was computed in order to evaluate the relationship between the change in airway adequacy and (1) the amount of maxillary expansion, (2) chronological age, (3) the amount of time that the appliance was activated, and (4) morphological and postural measurements of the face. At T1, children under active treatment showed a statistically significant increase in nasopharyngeal airway size, cervical curvature angle, and flexion of the head, together with a significant decrease in craniocervical angulation (all P < 0.05). These changes were all found to be stable at T2. No significant changes were seen in the control group. The correlation coefficients indicated a significant correlation between nasopharyngeal airway size and

  7. Risks and Benefits of Dual Antiplatelet Therapy Beyond 12 Months After Coronary Stenting: A Prospective Randomized Cohort Study.

    PubMed

    Dadjou, Yahya; Safavi, Salar; Kojuri, Javad

    2016-05-01

    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.

  8. Survival and success rates of immediately and early loaded implants: 12-month results from a multicentric randomized clinical study.

    PubMed

    Grandi, Tommaso; Garuti, Giovanna; Guazzi, Paolo; Tarabini, Luciano; Forabosco, Andrea

    2012-06-01

    Our objective was to compare survival and peri-implant bone levels of immediately nonocclusally vs early loaded implants in partially edentulous patients up to 12 months after implant placement. Eighty patients (inclusion criteria: general good health, good oral hygiene, 30-65 years old; exclusion criteria: head and neck irradiation/cancer, pregnancy, uncontrolled diabetes, substance abuse, bruxism, lack of opposing occluding dentition, smokers >10 cigarettes/day, need for bone augmentation procedures) were selected in 5 Italian study centers and randomized into 2 groups: 40 patients in the immediately loaded group (minimal insertion torque 30 Ncm) and 40 patients in the early loaded group. Immediately loaded implants were provided with nonoccluding temporary restorations. Final restorations were provided 2 months later. Early loaded implants were provided with a definitive restoration after 2 months. Peri-implant bone resorption was evaluated radiographically with software (ImageJ 1.42). No dropout occurred. Both groups gradually lost peri-implant bone. After 12 months, patients of both groups lost an average of 0.4 mm of peri-implant bone. There were no statistically significant differences (evaluated with t test) between the 2 loading strategies for peri-implant bone level changes at 2 (P = .6730), 6 (P = .6613) and 12 (P = .5957) months or for survival rates (100% in both groups). If adequate primary stability is achieved, immediate loading of dental implants can provide similar success rates, survival rates, and peri-implant bone resorption as compared with early loading, as evaluated in the present study. PMID:21480777

  9. Comparison of applying particulate demineralized bone matrix (DBM), putty DBM and open flap debridement in periodontal horizontal bone defects. A 12-month longitudinal, multi-centre, triple-blind, split-mouth, randomized, controlled clinical study. Part 2 - evaluation of the interdental soft tissue.

    PubMed

    Kaya, Y; Yalim, M; Bahçecitapar, M; Baloş, K

    2009-07-01

    To date, there have been many studies clinically evaluating periodontal regenerative procedures by the help of routinely used hard and soft tissue parameters; however, these parameters are not capable of assessing interdental soft tissue located above the regenerative periodontal surgery area. The purpose of this study was to assess interproximal soft tissue changes following application of (i) particulate form demineralized bone matrix (DBM), (ii) putty form DBM and (ii) open flap debridement (OFD, control), using modified curtain technique in the treatment of interproximal suprabony (horizontal) defects located in anterior maxillary region, as previously reported. Twenty-five chronic periodontitis patients with 125 interproximal surgery sites (radiologically >or=4 mm horizontal bone defect) were also participate in this second stage of the triple-blind, split mouth, randomized, controlled clinical trial. Surgery sites were assessed by (i) plaque index (PI), (ii) gingival index (GI), (iii) the presence of interdental soft tissue clefts or craters and (iv) the loss of interdental papilla height by using papilla presence index (PPI), during the healing period. At the baseline and 3, 6, 9 and 12 months after the operations, these measurements were repeated. In all groups, there is a significant increase in the prevalence of soft tissue cleft and crater formation (P < 0.01), with increase in PI and GI scores at interdental soft tissue defect areas (P < 0.001), 3 months after the operations. There was also an increase in PPI scores after the operations in all treatment groups (P < 0.01). Three procedures affected the interproximal soft tissues similarly. There was no significant difference among groups in terms of all parameters (P > 0.05). Particulate DBM, putty DBM and OFD demostrated similar interproximal soft tissue changes especially increasing interproximal PI and GI scores in 3 months follow-up. PMID:19453849

  10. 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

  11. A randomized trial of computerized vs. in-person brief intervention for illicit drug use in primary care: outcomes through 12 months.

    PubMed

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

    2015-03-01

    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.

  12. 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

  13. 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

  14. 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 ...

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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

  1. 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.

  2. Combination therapy with sitagliptin and lansoprazole in patients with recent-onset type 1 diabetes (REPAIR-T1D): 12-month results of a multicentre, randomised, placebo-controlled, phase 2 trial

    PubMed Central

    Griffin, Kurt J; Thompson, Paul A; Gottschalk, Michael; Kyllo, Jennifer H; Rabinovitch, Alex

    2014-01-01

    Summary Background Type 1 diabetes results from autoimmune destruction of pancreatic β cells. Findings from preclinical studies suggest that dipeptidyl peptidase-4 inhibitors and proton-pump inhibitors might enhance β-cell survival and regeneration. We postulated that sitagliptin and lansoprazole would preserve β-cell function in patients with recent-onset type 1 diabetes. Methods We did a double-blind, placebo-controlled, phase 2 trial (REPAIR-T1D). Participants aged 11–36 years, diagnosed with type 1 diabetes within the past 6 months were recruited from Sanford Health Systems (Sioux Falls, SD, USA; Fargo, ND, USA), Children's Hospitals and Clinics of Minnesota (St Paul, MN, USA), and Rady Children's Hospital (San Diego, CA, USA). Participants were randomly assigned (2:1) to receive oral sitagliptin (100 mg for participants ≥18 years, 50 mg for those <18 years) and lansoprazole (60 mg for participants ≥18 years, 30 mg for those <18 years) or matched placebo for 12 months. Randomisation was done by a blocked randomisation process (blocks of three and six), with separate streams for younger (<18 years) and older (≥18 years) participants, and males and females. All participants and personnel remained masked until after the completion of the final 12 month visit, at which time data were unmasked to the analysis team. The primary endpoint was C-peptide response to a mixed meal challenge at 12 months measured as 2 h area under curve. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01155284. Findings Between Sept 21, 2010, and May 29, 2012, 46 participants were randomly assigned to the treatment group and 22 to the placebo group; of whom 40 participants in the treatment group and 18 in the placebo group completed the 12-month treatment. At 12 months, the mean change in C-peptide area under curve was −229 pmol/L (95% CI −316 to −142) for the treatment group and −253 pmol/L (−383 to −123) for the

  3. 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

  4. 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

  5. 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

  6. Changes in hip and ankle range of motion and hip muscle strength in 8–11 year old novice female ballet dancers and controls: a 12 month follow up study

    PubMed Central

    Bennell, K; Khan, K; Matthews, B; Singleton, C

    2001-01-01

    Objectives—To evaluate in a 12 month longitudinal study changes in hip and ankle range of motion and hip muscle strength in young female novice ballet dancers. Methods—Fifty three of the original 77 (69%) female dancers aged 8–11 years and 40 of the original 49 (82%) controls returned for follow up measurements one year later. Supine right active hip external (ER) and internal (IR) rotation were measured using an inclinometer. A turnout protractor was used to assess standing active turnout range. Range of right weight bearing ankle dorsiflexion and calf muscle length were measured in a standing lunge position using an inclinometer. A manual muscle tester was used to assess right hip flexor, IR, ER, abductor and adductor strength. Results—The mean (SD) 12 month change in hip ER did not differ between dancers (11.7 (11.3)°) and controls (8.1 (17.6)°). Dancers gained 12.5 (13.5)° hip IR which was significantly greater than controls (0.5 (13.9)°). Greater IR change was associated with improved IR strength (r = 0.34, p<0.001). Dancers increased total turnout (12.0 (16.7)°) significantly more than controls (2.2 (20.0)°). There was no significant change in ankle dorsiflexion range in either group. Dancers and controls increased in all measures of hip muscle strength (p<0.001) and dancers achieved significantly greater gains in three out of five muscle groups (all, p<0.05). Conclusions—Total hip range of motion increased in both ballet students and controls at this young age. However, ankle dorsiflexion did not, which is probably due to this movement being blocked by bony apposition, rather than soft tissue stretch. This has implications for ballet teachers, as it has long been accepted that this movement could be improved with training. Dancers had greater increases in hip strength after 12 months compared with controls in muscles specific for ballet, suggesting that hip strength can be trained at this young age. Whether these gains are permanent requires

  7. 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

  8. Gist extraction and sleep in 12-month-old infants.

    PubMed

    Konrad, Carolin; Herbert, Jane S; Schneider, Silvia; Seehagen, Sabine

    2016-10-01

    Gist extraction is the process of excerpting shared features from a pool of new items. The present study examined sleep and the consolidation of gist in 12-month-old infants using a deferred imitation paradigm. Sixty infants were randomly assigned to a nap, a no-nap or a baseline control condition. In the nap and no-nap conditions, infants watched demonstrations of the same target actions on three different hand puppets that shared some features. During a 4-h delay, infants in the nap condition took a naturally scheduled nap while infants in the no-nap condition naturally stayed awake. Afterwards, infants were exposed to a novel forth hand puppet that combined some of the features from the previously encountered puppets. Only those infants who took a nap after learning produced a significantly higher number of target actions than infants in the baseline control condition who had not seen any demonstrations of target actions. Infants in the nap condition also produced significantly more target actions than infants in the no-nap condition. Sleep appears to support the storage of gist, which aids infants in applying recently acquired knowledge to novel circumstances. PMID:27587286

  9. Gist extraction and sleep in 12-month-old infants.

    PubMed

    Konrad, Carolin; Herbert, Jane S; Schneider, Silvia; Seehagen, Sabine

    2016-10-01

    Gist extraction is the process of excerpting shared features from a pool of new items. The present study examined sleep and the consolidation of gist in 12-month-old infants using a deferred imitation paradigm. Sixty infants were randomly assigned to a nap, a no-nap or a baseline control condition. In the nap and no-nap conditions, infants watched demonstrations of the same target actions on three different hand puppets that shared some features. During a 4-h delay, infants in the nap condition took a naturally scheduled nap while infants in the no-nap condition naturally stayed awake. Afterwards, infants were exposed to a novel forth hand puppet that combined some of the features from the previously encountered puppets. Only those infants who took a nap after learning produced a significantly higher number of target actions than infants in the baseline control condition who had not seen any demonstrations of target actions. Infants in the nap condition also produced significantly more target actions than infants in the no-nap condition. Sleep appears to support the storage of gist, which aids infants in applying recently acquired knowledge to novel circumstances.

  10. 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

  11. 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

  12. Ethosuximide, Valproic Acid and Lamotrigine in Childhood Absence Epilepsy: Initial Monotherapy Outcomes at 12 months

    PubMed Central

    Glauser, Tracy A.; Cnaan, Avital; Shinnar, Shlomo; Hirtz, Deborah G.; Dlugos, Dennis; Masur, David; Clark, Peggy O.; Adamson, Peter C.

    2012-01-01

    Purpose Determine the optimal initial monotherapy for children with newly diagnosed childhood absence epilepsy based on 12 months of double blind therapy. Methods A double-blind, randomized controlled clinical trial compared the efficacy, tolerability and neuropsychological effects of ethosuximide, valproic acid and lamotrigine in children with newly diagnosed childhood absence epilepsy. Study medications were titrated to clinical response and subjects remained in the trial unless they reached a treatment failure criterion. Maximal target doses were ethosuximide 60 mg/kg/day or 2000 mg/day, valproic acid 60 mg/kg/day or 3000 mg/day and lamotrigine 12 mg/kg/day or 600 mg/day. Original primary outcome was at 16–20 weeks and included a video EEG assessment. For this report, the main effectiveness outcome was the freedom from failure rate 12 months after randomization and included a video EEG assessment; differential drug effects were determined by pairwise comparisons. The main cognitive outcome was the percentage of subjects experiencing attentional dysfunction at the Month 12 visit. Key Findings A total of 453 children were enrolled and randomized; seven were deemed ineligible and 446 subjects comprised the overall efficacy cohort. There were no demographic differences between the three cohorts. By 12 months after starting therapy, only 37% of all enrolled subjects were free from treatment failure on their first medication. At the Month 12 visit, the freedom-from-failure rates for ethosuximide and valproic acid were similar (45% and 44%, respectively; odds ratio with valproic acid vs. ethosuximide, 0.94; 95% confidence interval [CI], 0.60 to 1.48; P = 0.82) and were higher than the rate for lamotrigine (21%; odds ratio with ethosuximide vs. lamotrigine, 3.09; 95% CI, 1.86 to 5.13; odds ratio with valproic acid vs. lamotrigine, 2.90; 95% CI, 1.74 to 4.83; P<0.001 for both comparisons). The frequency of treatment failures due to lack of seizure control (p < 0

  13. 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

  14. 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 ...

  15. 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…

  16. 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.

  17. 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

  18. 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 ...

  19. Alcohol Interventions Among Underage Drinkers in the ED: A Randomized Controlled Trial

    PubMed Central

    Chermack, Stephen T.; Ehrlich, Peter F.; Carter, Patrick M.; Booth, Brenda M.; Blow, Frederic C.; Barry, Kristen L.; Walton, Maureen A.

    2015-01-01

    OBJECTIVES: This study examined the efficacy of emergency department (ED)-based brief interventions (BIs), delivered by a computer or therapist, with and without a post-ED session, on alcohol consumption and consequences over 12 months. METHODS: Patients (ages 14–20 years) screening positive for risky drinking were randomized to: BI (n = 277), therapist BI (n = 278), or control (n = 281). After the 3-month follow-up, participants were randomized to receive a post-ED BI session or control. Incorporating motivational interviewing, the BIs addressed alcohol consumption and consequences, including driving under the influence (DUI), and alcohol-related injury, as well as other concomitant drug use. The computer BI was an offline, Facebook-styled program. RESULTS: Among 4389 patients screened, 1054 patients reported risky drinking and 836 were enrolled in the randomized controlled trial. Regression models examined the main effects of the intervention conditions (versus control) and the interaction effects (ED condition × post-ED condition) on primary outcomes. The therapist and computer BIs significantly reduced consumption at 3 months, consequences at 3 and 12 months, and prescription drug use at 12 months; the computer BI reduced the frequency of DUI at 12 months; and the therapist BI reduced the frequency of alcohol-related injury at 12 months. The post-ED session reduced alcohol consequences at 6 months, benefiting those who had not received a BI in the ED. CONCLUSIONS: A single-session BI, delivered by a computer or therapist in the ED, shows promise for underage drinkers. Findings for the fully automated stand-alone computer BI are particularly appealing given the ease of future implementation. PMID:26347440

  20. 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 ...

  1. SURGICAL CROWN LENGTHENING: A 12-MONTH STUDY - RADIOGRAPHIC RESULTS*

    PubMed Central

    Diniz, Daniela Eleutério; Okuda, Kalizia Marcela; Fonseca, Clarissa Ribeiro; Gonzalez, Marly Kimie Sonohara; Greghi, Sebastião Luiz Aguiar; do Valle, Accácio Lins; Lauris, José Roberto Pereira

    2007-01-01

    Objective The purpose of this study was to perform a radiographic follow-up evaluation after a 12-month healing period, following crown lengthening surgery. Material and methods Twenty-three periodontally healthy subjects (mean age 32.5 years) that required crown lengthening surgery in premolars were recruited. In a total of 30 premolars, full thickness flaps, osseous resection, and flap suturing were performed. The restorative margin was defined in the pre-surgical phase and maintained unaltered during the healing period, serving as a reference point. Standardized bitewing radiographs were taken before and after osseous reduction, and at 2, 3, 6, and 12-month healing periods. Results Intact lamina dura was observed at both mesial and distal alveolar crests only from the 3rd month. At 12-months, all alveolar crests presented lamina dura. The overall mean distance from the restorative margin to the alveolar crest achieved after osseous resection was 3.28±0.87 mm at mesial and 2.81±0.51 mm at distal sites. No significant radiographic changes in the bone crest were observed during a 12-month healing period. Conclusion The findings of this study suggest that the radiographic proximal bone level observed on bitewing radiographs following crown lengthening surgery can be used as a reference to predict the future level of the healed alveolar crest. PMID:19089145

  2. Earmuff effectiveness against chainsaw noise over a 12-month period.

    PubMed

    Kirk, P

    1993-08-01

    A study measuring the ability of new Peltor H7P3 Grade 4 helmet-mounted earmuffs to reduce the level of chainsaw noise reaching forestry workers' ears was undertaken over a one-year period. The objective was to establish effective replacement guidelines for earmuffs. The results showed that the earmuffs provided effective hearing protection for the subjects over the one-year test period. There were no statistically significant changes in field attenuation levels during the first 9 months. While the following three-month period (9-12 months) did experience a significant 3 dB(A) decrease, mean inside microphone noise level measured at the 12-month stage was 78.8 +/- 3.0 dB(A). This level is well under the damage risk criterion of Leq (8 hour) not exceeding 85 dB(A). It was noted during the study that a large proportion of the earmuffs would normally have been replaced before the 12-month stage owing to the discomfort associated with cushion deterioration. Results suggest that Peltor H7P3 grade 4 helmet-mounted earmuffs could be safely used as an effective form of chainsaw noise protection in a production forestry environment for a maximum period of 12 months before cushion replacement.

  3. 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…

  4. 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…

  5. Prime Time: 12-Month Sexual Health Outcomes of a Clinic-Based Intervention to Prevent Pregnancy Risk Behaviors

    PubMed Central

    Sieving, Renee E.; McMorris, Barbara J.; Beckman, Kara J.; Pettingell, Sandra L.; Secor-Turner, Molly; Kugler, Kari; Garwick, Ann W.; Resnick, Michael D.; Bearinger, Linda H.

    2010-01-01

    Purpose Prime Time, a youth development intervention, aims to reduce pregnancy risk among adolescent girls seeking clinic services who are at high risk for pregnancy. This paper examines sexual risk behaviors and hypothesized psychosocial mediators after 12 months of the Prime Time intervention. Methods Randomized controlled trial with 253 girls ages 13-17 years meeting specified risk criteria. Intervention participants were involved in Prime Time programming plus usual clinic services for 18 months, control participants received usual clinic services. The intervention employed a combination of case management and peer leadership programs. Participants in this interim outcomes study completed self-report surveys at baseline and 12 months following enrollment. Surveys assessed sexual risk behaviors and psychosocial factors targeted for change by Prime Time. Results At the 12-month interim, the intervention group reported more consistent use of condoms, hormonal contraception and dual contraceptive methods with their most recent partner than did the control group. The intervention group also reported greater stress management skills with trends towards higher levels of pro-social connectedness at school and with family. No between-group differences were noted in psychosocial measures specific to sex and contraceptive use. Conclusions Preventing early pregnancy among high-risk adolescents requires multifaceted, sustained approaches. An important research focus involves testing youth development interventions offered through clinic settings, where access to high-risk adolescents is plentiful and few efforts have emphasized a dual approach of building protective factors while addressing risk. Findings suggest that youth development interventions through clinic settings hold promise in reducing pregnancy risk among high-risk youth. PMID:21783050

  6. [Clinical, microbiological and immunological findings in peri-implantitis patients with bar-retained lower removable partial dentures, compared to a healthy control group (12-month-follow-up)].

    PubMed

    Mesmer, Christian; Forster, András; Antal, Márk; Nagy, Katalin

    2012-06-01

    Cause, treatment strategies and prognosis of peri-implantitis is not well understood. The aim of this study was to followup clinical, microbiological and immunological findings in individuals wearing bar-retained lower partial dentures with and without peri-implantitis, pre and post treatment. From the Tuebingen Implant Registry recall program 16 peri-implantitis patients were compared to 16 healthy individuals in a prospective, unblinded study. Peri-implantitis was treated with a single anti-inflammatory therapy according to the CIST protocol while the controls received professional implant cleaning. The following findings were recorded at four time points before treatment (T1) and 30, 90, 360 days post treatment (T2-T4): sulcular fluid flow rate, probing depth, plaque and bleeding index, implant stability (Periotest); sulcular concentrations of interleukin-1 beta, plasminogen activator inhibitor 2, prostaglandin E2, and the sum score of five periodonto-pathogenic bacteria species by PCR (Hain Microldent test). Statistically significant differences between healthy and diseased implants were found for probing depth, bleeding on probing, bacterial load, and implant stability. For the first three, a significant decrease in severity was observed after treatment, but reached initial pre-treatment values within one year. No changes could be observed in the individuals without peri-implantitis. The results of the present study confirm marked differences in peri-implant findings between healthy and diseased sites. They demonstrate that a single anti-inflammatory intervention can initially--but not sustained--reduce probing depth, bleeding on probing, and the total bacterial load as evident from PCR diagnostics. Further immunological diagnostic measures do not seem to provide more information in the patients investigated.

  7. 12-Month-Old Infants Represent Probable Endings of Motion Events

    ERIC Educational Resources Information Center

    Wagner, Laura; Carey, Susan

    2005-01-01

    This experiment investigated 12-month-old infants' ability to link an event's beginning to its probable ending. Following Csibra, Biro, Koos, and Gergely (2003), infants were habituated to a simple chasing event involving animated balls, and at test saw 2 possible endings: either 1 ball caught the other or failed to do so. Two controls were added…

  8. 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.

  9. 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

  10. 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...

  11. A Randomized Controlled Trial of the embrace Advanced Scar Therapy Device to Reduce Incisional Scar Formation

    PubMed Central

    Longaker, Michael T.; Rohrich, Rod J.; Greenberg, Lauren; Furnas, Heather; Wald, Robert; Bansal, Vivek; Seify, Hisham; Tran, Anthony; Weston, Jane; Korman, Joshua M.; Chan, Rodney; Kaufman, David; Dev, Vipul R.; Mele, Joseph A.; Januszyk, Michael; Cowley, Christy; McLaughlin, Peggy; Beasley, Bill; Gurtner, Geoffrey C.; Longaker, Michael T.; Gurtner, Geoffrey C.

    2015-01-01

    Background Scarring represents a significant biomedical burden in clinical medicine. Mechanomodulation has been linked to scarring through inflammation, but until now a systematic approach to attenuate mechanical force and reduce scarring has not been possible. Methods The authors conducted a 12-month, prospective, open-label, randomized, multicenter clinical trial to evaluate abdominoplasty scar appearance following postoperative treatment with the embrace Advanced Scar Therapy device to reduce mechanical forces on healing surgical incisions. Incisions from 65 healthy adult subjects were randomized to receive embrace treatment on one half of an abdominoplasty incision and control treatment (surgeon's optimal care methods) on the other half. The primary endpoint for this study was the difference between assessments of scar appearance for the treated and control sides using the visual analogue scale scar score. Results Final 12-month study photographs were obtained from 36 subjects who completed at least 5 weeks of dressing application. The mean visual analogue scale score for embrace-treated scars (2.90) was significantly improved compared with control-treated scars (3.29) at 12 months (difference, 0.39; 95 percent confidence interval, 0.14 to 0.66; p = 0.027). Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale evaluation (p = 0.02 and p < 0.001, respectively). No serious adverse events were reported. Conclusions These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery. To the authors’ knowledge, this represents the first level I evidence for postoperative scar reduction. PMID:24804638

  12. Meta-analysis of randomized controlled trials on efficacy and safety of extended thienopyridine therapy after drug-eluting stent implantation

    PubMed Central

    Tang, Wenyi; Yeh, James; Chen, Jian; Liu, Mao; Ke, Jianting; Tan, Guangyi; Lin, Xiufang

    2016-01-01

    Background The potential benefits and risks of extended thienopyridine therapy beyond 12 months after drug-eluting stent (DES) implantation remain unclear. Methods Randomized controlled trials (RCTs) were searched in PubMed, EMBASE, the Cochrane Library and China National Knowledge Infrastructure databases. The adverse clinical endpoints were compared between 12 months group (aspirin alone) and >12 months group (additional thienopyridine plus aspirin after 12-month dual antiplatelet therapy). Odds ratios (ORs) with 95% confidence intervals (95% CIs) were used as summary statistics. A random-effect model was used in the meta-analysis process. Results Finally, three RCTs incorporating 16,265 participants were included in this meta-analysis. The results indicated that the incidences of myocardial infarction (1.55% vs. 2.90%; OR =0.58; 95% CI, 0.40–0.84; P=0.004) and stent thrombosis (0.32% vs. 0.98%; OR =0.35; 95% CI, 0.20–0.62; P<0.001) in the >12 months group were significantly lower than the 12 months group. However, compared to the 12 months group, the extended thienopyridine therapy markedly increased the risk of bleeding events (2.09% vs. 1.28%; OR =1.64; 95% CI, 1.23–2.17; P<0.001). The risks of stroke (0.78% vs. 0.84%; P=0.67) and cardiac death (0.94% vs. 0.89%; P=0.61) were similar between the two groups. Conclusions The synthesis of available evidence indicates that a regimen of extended thienopyridine therapy beyond 12 months may significantly reduce the risks of myocardial infarction and stent thrombosis but increase the risk of bleeding events in the patients who have received DESs implantation. PMID:27747163

  13. 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

  14. A test of cognitive mediation in a 12-month physical activity workplace intervention: does it explain behaviour change in women?

    PubMed Central

    2010-01-01

    Background Attempts to demonstrate the efficacy of interventions aimed at increasing physical activity (PA) have been mixed. Further, studies are seldom designed in a manner that facilitates the understanding of how or why a treatment is effective or ineffective and PA intervention designs should be guided by a heavier reliance upon behavioral theory. The use of a mediating variable framework offers a systematic methodological approach to testing the role of theory, and could also identify the effectiveness of specific intervention components. The primary purpose of this paper was to test the mediating role that cognitive constructs may have played in regards to the positive effect that a workplace behavioral intervention had on leisure-time PA for women. A subsidiary purpose was to examine the cross-sectional relationships of these cognitive constructs with PA behavior. Methods The Physical Activity Workplace Study was a randomized controlled trial which compared the effects of stage-matched and standard print materials upon self-reported leisure-time PA, within a workplace sample at 6 and 12-months. In this secondary analysis we examined the mediation effects of 14 psychosocial constructs across 3 major social-cognitive theories which were operationalized for the intervention materials and measured at baseline, 6 and 12-months. We examined change in PA and change in the psychological constructs employing a mediation strategy proposed by Baron and Kenny for: (1) the first 6-months (i.e., initial change), (2) the second 6-months (i.e., delayed change), and (3) the entire 12-months (overall change) of the study on 323 women (n = 213 control/standard materials group; n = 110 stage-matched materials group). Results Of the 14 constructs and 42 tests (including initial, delayed and overall change) two positive results were identified (i.e., overall change in pros, initial change in experiential powerful intervention approaches processes), with very small effect sizes

  15. 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

  16. 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.

  17. 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

  18. Nurse Navigators in Early Cancer Care: A Randomized, Controlled Trial

    PubMed Central

    Wagner, Edward H.; Ludman, Evette J.; Aiello Bowles, Erin J.; Penfold, Robert; Reid, Robert J.; Rutter, Carolyn M.; Chubak, Jessica; McCorkle, Ruth

    2014-01-01

    Purpose To determine whether a nurse navigator intervention improves quality of life and patient experience with care for people recently given a diagnosis of breast, colorectal, or lung cancer. Patients and Methods Adults with recently diagnosed primary breast, colorectal, or lung cancer (n = 251) received either enhanced usual care (n = 118) or nurse navigator support for 4 months (n = 133) in a two-group cluster randomized, controlled trial with primary care physicians as the units of randomization. Patient-reported measures included the Functional Assessment of Cancer Therapy–General (FACT-G) Quality of Life scale, three subscales of the Patient Assessment of Chronic Illness Care (PACIC), and selected subscales from a cancer adaptation of the Picker Institute's patient experience survey. Self-report measures were collected at baseline, 4 months, and 12 months. Automated administrative data were used to assess time to treatment and total health care costs. Results There were no significant differences between groups in FACT-G scores. Nurse navigator patients reported significantly higher scores on the PACIC and reported significantly fewer problems with care, especially psychosocial care, care coordination, and information, as measured by the Picker instrument. Cumulative costs after diagnosis did not differ significantly between groups, but lung cancer costs were $6,852 less among nurse navigator patients. Conclusion Compared with enhanced usual care, nurse navigator support for patients with cancer early in their course improves patient experience and reduces problems in care, but did not differentially affect quality of life. PMID:24276777

  19. Hypoglossal Nerve Stimulation Improves Obstructive Sleep Apnea: 12 Month Outcomes

    PubMed Central

    Kezirian, Eric J.; Goding, George S.; Malhotra, Atul; O'Donoghue, Fergal J.; Zammit, Gary; Wheatley, John R.; Catcheside, Peter G.; Smith, Philip L.; Schwartz, Alan R.; Walsh, Jennifer H.; Maddison, Kathleen J.; Claman, David M.; Huntley, Tod; Park, Steven Y.; Campbell, Matthew C.; Palme, Carsten E.; Iber, Conrad; Eastwood, Peter R.; Hillman, David R.; Barnes, Maree

    2013-01-01

    Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnoea (OSA) pathogenesis. Hypoglossal nerve stimulation (HGNS) activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce OSA severity. The objective of this study was to examine the safety, feasibility, and efficacy of a novel HGNS system (HGNS®, Apnex Medical, Inc., St. Paul, MN) in treating OSA at 12 months following implantation. Thirty-one subjects (35% female, age 52·4±9·4 years) with moderate to severe OSA and unable to tolerate positive airway pressure underwent surgical implantation and activation of the HGNS system in a prospective single-arm interventional trial. Primary outcomes were changes in OSA severity (apnoea-hypopnoea index, AHI, from in-laboratory polysomnogram) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ). HGNS was used on 86±16% of nights for 5·4±1·4 hours per night. There was a significant improvement (p < 0·001) from baseline to 12 months in AHI (45.4±17·5 to 25·3±20·6 events/h) and FOSQ score (14·2±2·0 to 17·0±2·4) as well as other polysomnogram and symptom measures. Outcomes were stable compared to 6 months following implantation. Three serious device-related adverse events occurred: an infection requiring device removal and two stimulation lead cuff dislodgements requiring replacement. There were no significant adverse events with onset later than 6 months following implantation. HGNS demonstrated favourable safety, feasibility, and efficacy. PMID:24033656

  20. In vivo measurements of tooth wear over 12 months.

    PubMed

    Rodriguez, J M; Austin, R S; Bartlett, D W

    2012-01-01

    The aim of this study was to measure the progression of tooth wear in a cohort of 63 patients, 43 males and 20 females with a mean age of 39.1 years. Recruitment followed referral from general practice to Guy's Hospital for advice/management of tooth wear. Addition silicone impressions were taken at 6-month intervals for a total of 12 months; impressions were subsequently poured in type IV gypsum. Casts were scanned using a non-contacting laser profilometer and then superimposed using Geomagic® Qualify 11. Wear was measured in μm by tooth per time interval. A questionnaire highlighting dietary, parafunctional and gastric risk factors was obtained from each participant. Clustered multiple regression analysis was used to determine the relationship between tooth wear progression and risk factors. Maximum follow-up times were 6 months for 63 participants and 12 months for 30 participants. The measurement error was 15 μm. At the tooth level, 72.2% of 1,078 teeth wore <15 μm over a 6-month period. At the subject level, 77.7% of 63 participants showed median wear <15 μm over a 6-month period. There was a statistical trend towards tooth wear progression being associated with gastric risk factors (p < 0.05). The lower molars and the upper anterior teeth were the most commonly affected teeth; the lower molars and the upper central incisors were the most severely affected teeth. Tooth wear progression was slow in this cohort, suggesting that tooth wear may be cyclical and inactive in the majority of participants.

  1. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial.

    PubMed

    Praga, M; Barrio, V; Juárez, G Fernández; Luño, J

    2007-05-01

    Membranous nephropathy is a common cause of nephrotic syndrome in adults. Although some patients with membranous nephropathy achieve a spontaneous remission, renal function continues to deteriorate in others. We conducted a prospective randomized trial evaluating monotherapy with tacrolimus to achieve complete or partial remission in patients with biopsy-proven membranous nephropathy. Twenty-five patients received tacrolimus (0.05 mg/kg/day) over 12 months with a 6-month taper, whereas 23 patients were in the control group. The probability of remission in the treatment group was 58, 82, and 94% after 6, 12, and 18 months but only 10, 24, and 35%, respectively in the control group. The decrease in proteinuria was significantly greater in the treatment group. Notably, six patients in the control group and only one in the treatment group reached the secondary end point of a 50% increase in their serum creatinine. No patient in the tacrolimus group showed a relapse during the taper period. Nephrotic syndrome reappeared in almost half of the patients who were in remission by the 18th month after tacrolimus withdrawal. We conclude that tacrolimus is a very useful therapeutic option for patients with membranous nephropathy and preserved renal function. The majority of patients experienced remission with a significant reduction in the risk for deteriorating renal function.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

  7. Weight lifting and appendicular skeletal muscle mass among breast cancer survivors: a randomized controlled trial.

    PubMed

    Brown, Justin C; Schmitz, Kathryn H

    2015-06-01

    Low appendicular skeletal muscle mass (ASMM) is associated with premature mortality, hyperinsulinemia, frailty, disability, and low bone mineral density. We explored the potential efficacy of slowly progressive weight lifting to attenuate the decline of ASMM among breast cancer survivors by conducting a post hoc analysis of data from the Physical Activity and Lymphedema trial. Between October 2005 and August 2008, we conducted a single-blind, randomized controlled trial of twice weekly slowly progressive weight lifting or standard care among 295 non-metastatic breast cancer survivors. ASMM was quantified using dual-energy X-ray absorptiometry. Changes in ASMM were evaluated from baseline to 12 months between the weight lifting and control groups using repeated measures linear mixed effects regression models. Over 12 months, participants in the weight lifting group experienced attenuated declines in muscle mass compared to the control group, as reflected by relative ASMM (-0.01 ± 0.02 kg/m(2) vs -0.08 ± 0.03 kg/m(2); P = 0.041) and absolute ASMM (-0.02 ± 0.06 kg vs -0.22 ± 0.07 kg; P = 0.038), respectively. Weight lifting did not alter other body composition outcomes including body mass index, total body mass, body fat percentage, and fat mass compared to the control group. Weight lifting significantly increased upper and lower body muscle strength compared to the control group. The intervention was well tolerated with no serious adverse events related to weight lifting. Slowly progressive weight lifting attenuated the decline of ASMM among breast cancer survivors compared to standard care over 12 months. These data are hypothesis generating. Future studies should examine the efficacy of weight lifting to improve distal health outcomes among breast cancer survivors. PMID:25935584

  8. Weight Lifting and Appendicular Skeletal Muscle Mass among Breast Cancer Survivors: A Randomized Controlled Trial

    PubMed Central

    Brown, Justin C.; Schmitz, Kathryn H.

    2015-01-01

    Purpose Low appendicular skeletal muscle mass (ASMM) is associated with premature mortality, hyperinsulinemia, frailty, disability, and low bone mineral density. We explored the potential efficacy of slowly-progressive weight lifting to attenuate the decline of ASMM among breast cancer survivors by conducting a post hoc analysis of data from the Physical Activity and Lymphedema trial. Methods Between October 2005 and August 2008 we conducted a single-blind, randomized controlled trial of twice-weekly slowly-progressive weight lifting or standard care among 295 non-metastatic breast cancer survivors. ASMM was quantified using dual-energy x-ray absorptiometry. Changes in ASMM were evaluated from baseline to 12-months between the weight lifting and control groups using repeated-measures linear mixed-effects regression models. Results Over 12-months, participants in the weight lifting group experienced attenuated declines in muscle mass compared to the control group, as reflected by relative ASMM (−0.01±0.02 kg/m2 versus −0.08±0.03 kg/m2; P=0.041) and absolute ASMM (−0.02±0.06 kg versus −0.22±0.07 kg; P=0.038), respectively. Weight lifting did not alter other body composition outcomes including body mass index, total body mass, body fat percentage, and fat mass compared to the control group. Weight lifting significantly increased upper- and lower-body muscle strength compared to the control group. The intervention was well-tolerated with no serious adverse events related to weight lifting. Conclusions Slowly-progressive weight lifting attenuated the decline of ASMM among breast cancer survivors compared to standard care over 12-months. These data are hypothesis generating. Future studies should examine the efficacy of weight lifting to improve distal health outcomes among breast cancer survivors. PMID:25935584

  9. Laparoscopically assisted ventriculoperitoneal shunt placement: a prospective randomized controlled trial.

    PubMed

    Schucht, Philippe; Banz, Vanessa; Trochsler, Markus; Iff, Samuel; Krähenbühl, Anna Katharina; Reinert, Michael; Beck, Jürgen; Raabe, Andreas; Candinas, Daniel; Kuhlen, Dominique; Mariani, Luigi

    2015-05-01

    OBJECT In ventriculoperitoneal (VP) shunt surgery, laparoscopic assistance can be used for placement of the peritoneal catheter. Until now, the efficacy of laparoscopic shunt placement has been investigated only in retrospective and nonrandomized prospective studies, which have reported decreased distal shunt dysfunction rates in patients undergoing laparascopic placement compared with mini-laparotomy cohorts. In this randomized controlled trial the authors compared rates of shunt failure in patients who underwent laparoscopic surgery for peritoneal catheter placement with rates in patients who underwent traditional mini-laparotomy. METHODS One hundred twenty patients scheduled for VP shunt surgery were randomized to laparoscopic surgery or mini-laparotomy for insertion of the peritoneal catheter. The primary endpoint was the rate of overall shunt complication or failure within the first 12 months after surgery. Secondary endpoints were distal shunt failure, overall complication/ failure, duration of surgery and hospitalization, and morbidity. RESULTS The overall shunt complication/failure rate was 15% (9 of 60 cases) in the laparoscopic group and 18.3% (11 of 60 cases) in the mini-laparotomy group (p = 0.404). Patients in the laparoscopic group had no distal shunt failures; in contrast, 5 (8%) of 60 patients in the mini-laparotomy group experienced distal shunt failure (p = 0.029). Intraoperative complications occurred in 2 patients (both in the laparoscopic group), and abdominal pain led to catheter removal in 1 patient per group. Infections occurred in 1 patient in the laparoscopic group and 3 in the mini-laparotomy group. The mean durations of surgery and hospitalization were similar in the 2 groups. CONCLUSIONS While overall shunt failure rates were similar in the 2 groups, the use of laparoscopic shunt placement significantly reduced the rate of distal shunt failure compared with mini-laparotomy.

  10. 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

  11. Language development at 18 months is related to multimodal communicative strategies at 12 months.

    PubMed

    Igualada, Alfonso; Bosch, Laura; Prieto, Pilar

    2015-05-01

    The present study investigated the degree to which an infants' use of simultaneous gesture-speech combinations during controlled social interactions predicts later language development. Nineteen infants participated in a declarative pointing task involving three different social conditions: two experimental conditions (a) available, when the adult was visually attending to the infant but did not attend to the object of reference jointly with the child, and (b) unavailable, when the adult was not visually attending to neither the infant nor the object; and (c) a baseline condition, when the adult jointly engaged with the infant's object of reference. At 12 months of age measures related to infants' speech-only productions, pointing-only gestures, and simultaneous pointing-speech combinations were obtained in each of the three social conditions. Each child's lexical and grammatical output was assessed at 18 months of age through parental report. Results revealed a significant interaction between social condition and type of communicative production. Specifically, only simultaneous pointing-speech combinations increased in frequency during the available condition compared to baseline, while no differences were found for speech-only and pointing-only productions. Moreover, simultaneous pointing-speech combinations in the available condition at 12 months positively correlated with lexical and grammatical development at 18 months of age. The ability to selectively use this multimodal communicative strategy to engage the adult in joint attention by drawing his attention toward an unseen event or object reveals 12-month-olds' clear understanding of referential cues that are relevant for language development. This strategy to successfully initiate and maintain joint attention is related to language development as it increases learning opportunities from social interactions.

  12. 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

  13. Effect of duodenal-jejunal bypass surgery on glycemic control in type 2 diabetes: a randomized controlled trial

    PubMed Central

    Petry, Tarissa Z.; Fabbrini, Elisa; Otoch, Jose P.; Carmona, Murilo A.; Caravatto, Pedro P.; Salles, João E.; Sarian, Thais; Correa, Jose L.; Schiavon, Carlos A.; Patterson, Bruce W.; Cohen, Ricardo; Klein, Samuel

    2015-01-01

    Objective To determine whether upper gastrointestinal tract (UGI) bypass itself has beneficial effects on the factors involved in regulating glucose homeostasis in patients with type 2 diabetes (T2D). Methods A 12-month randomized controlled trial was conducted in 17 overweight/obese subjects with T2D, who received standard medical care (SC, n=7, BMI=31.7±3.5 kg/m2) or duodenal-jejunal bypass surgery with minimal gastric resection (DJBm) (n=10; BMI=29.7±1.9 kg/m2). A 5-h modified oral glucose tolerance test (OGTT) was performed at baseline and at 1, 6 and 12 months after surgery or starting SC. Results Body weight decreased progressively after DJBm (7.9±4.1%, 9.6±4.2%, and 10.2±4.3% at 1, 6, and 12 months, respectively), but remained stable in the SC group (P<0.001). DJBm, but not SC, improved: 1) oral glucose tolerance (decreased 2-hr glucose concentration, P=0.039), 2) insulin sensitivity (decreased Homeostatic Model Assessment of Insulin Resistance, P=0.013), 3) early insulin response to a glucose load (increased insulinogenic index, P=0.022), and 4) overall glycemic control (reduction in HbA1c with less diabetes medications). Conclusions DJBm causes moderate weight loss and improves metabolic function in T2D. However, our study cannot separate the benefits of moderate weight loss from the potential therapeutic effect of UGI tract bypass itself on the observed metabolic improvements. PMID:26414562

  14. 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

  15. 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…

  16. 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…

  17. A calcium-collagen chelate dietary supplement attenuates bone loss in postmenopausal women with osteopenia: a randomized controlled trial.

    PubMed

    Elam, Marcus L; Johnson, Sarah A; Hooshmand, Shirin; Feresin, Rafaela G; Payton, Mark E; Gu, Jennifer; Arjmandi, Bahram H

    2015-03-01

    Menopause leads to an increased risk for osteoporosis in women. Although drug therapies exist, increasing numbers of people prefer alternative therapies such as dietary supplements, for example, calcium, vitamin D, and collagen hydrolysates for the prevention and treatment of osteoporosis. We have previously shown that a 3-month intervention using a calcium-collagen chelate (CC) dietary supplement was efficacious in improving bone mineral density (BMD) and blood biomarkers of bone turnover in osteopenic postmenopausal women. This study reports the long-term efficacy of CC in reducing bone loss in postmenopausal women with osteopenia. Thirty-nine women were randomly assigned to one of two groups: 5 g of CC containing 500 mg of elemental calcium and 200 IU vitamin D (1,25-dihydroxyvitamin D3) or control (500 mg of calcium and 200 IU vitamin D) daily for 12 months. Total body, lumbar, and hip BMD were evaluated at baseline, 6 and 12 months using dual-energy X-ray absorptiometry. Blood was collected at baseline, 6 and 12 months to assess levels of blood biomarkers of bone turnover. Intent-to-treat (ITT) analysis was performed using repeated measures analysis of variance pairwise comparisons and multivariate analysis to assess time and group interactions. The loss of whole body BMD in women taking CC was substantially lower than that of the control group at 12 months in those who completed the study and the ITT analysis, respectively (CC: -1.33% and -0.33% vs. control: -3.75% and -2.17%; P=.026, P=.035). The CC group had significantly reduced levels of sclerostin and tartrate-resistant acid phosphatase isoform 5b (TRAP5b) (P<.05), and higher bone-specific alkaline phosphatase/TRAP5b ratio (P<.05) than control at 6 months. These results support the use of CC in reducing bone loss in osteopenic postmenopausal women.

  18. 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…

  19. 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

  20. Psychological and social predictors of changes in fruit and vegetable consumption over 12 months following behavioral and nutrition education counseling.

    PubMed

    Steptoe, Andrew; Perkins-Porras, Linda; Rink, Elisabeth; Hilton, Sean; Cappuccio, Francesco P

    2004-11-01

    This study assessed psychological and social factors predicting 12-month changes in fruit and vegetable consumption achieved by 271 men and women from a low-income population randomized to brief behavioral and nutrition education counseling. Greater increases in fruit and vegetable intake were achieved in the behavioral than in the nutrition education condition (1.49 vs. 0.87 portions per day, p=.021). Increases were predicted by baseline social support for dietary change but not by baseline psychological measures. However, short-term (8-week) changes in dietary self-efficacy, encouragement, anticipated regret, perceived benefits, and knowledge of recommended intake predicted 12-month changes in fruit and vegetable consumption independently of gender, age, ethnicity, income, and baseline intake. These factors accounted for 51% of the superiority of behavioral counseling over nutrition education.

  1. 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.

  2. 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

  3. Associations between positive and negative affect and 12-month physical disorders in a national sample.

    PubMed

    Weiser, Eric B

    2012-06-01

    Associations between positive and negative affect and a range of 12-month physical disorders were investigated in the Midlife Development in the United States Survey, a nationally representative sample of 3,032 adults ages 25-74. These associations were examined, controlling for relevant sociodemographic and psychiatric covariates. High positive affect was associated with decreased risk of physical disorders, whereas high negative affect was associated with increased risk. However, associations between positive affect and physical disorders were partially attenuated following adjustment for concurrent negative affect. Additionally, high affect balance was associated with decreased risk of physical disorders before and after adjustments. These findings underscore the relevance of affective disposition in health status, suggesting that both positive and negative affect may serve as viable health risk parameters.

  4. Topiramate-induced psychosis: the picture at 12 months.

    PubMed

    Watkin, Anna; Alam, Faouzi; Javed, Qaiser

    2010-01-01

    A 19-year-old white British man, not previously known to psychiatric services, presented with acute onset of florid psychotic symptoms. His symptoms included auditory hallucinations, misidentification of family members, thought interference and delusions of control. His level of distress was high and did not respond to verbal or medical de-escalation; therefore, he required nursing in seclusion. It was noted that he recently had an increase of his anti-epileptic medication to 100 mg topiramate twice per day. Topiramate was thought to be the cause of his psychosis and, consequently, was changed to phenytoin. Since discontinuation of the topiramate, his psychotic symptoms settled within 4 days and he was discharged shortly afterwards. He was monitored by the Early Intervention services. At 15-months post-discharge, there was no recurrence of any symptoms despite not receiving antipsychotic medication. To our knowledge, this is the first report that describes the progress of a patient past the initial psychotic episode. Therefore, we believe this is an important finding to report.

  5. Thoracic sympathetic block for the treatment of complex regional pain syndrome type I: a double-blind randomized controlled study.

    PubMed

    Rocha, Roberto de Oliveira; Teixeira, Manoel Jacobsen; Yeng, Lin Tchia; Cantara, Mirlene Gardin; Faria, Viviane Gentil; Liggieri, Victor; Loduca, Adrianna; Müller, Barbara Maria; Souza, Andrea C M S; de Andrade, Daniel Ciampi

    2014-11-01

    Pain relief in complex regional pain syndrome (CRPS) remains a major challenge, in part due to the lack of evidence-based treatment trials specific for this condition. We performed a long-term randomized, double-blinded active-control study to evaluate the efficacy of thoracic sympathetic block (TSB) for upper limb type I CRPS. The study objective was to evaluate the analgesic effect of TSB in CRPS. Patients with CRPS type I were treated with standardized pharmacological and physical therapy and were randomized to either TSB or control procedure as an add-on treatment. Clinical data, pain intensity, and interference (Brief Pain Inventory), pain dimensions (McGill Pain Questionnaire [MPQ]), neuropathic characteristics (Neuropathic Pain Symptom Inventory [NPSI]), mood, upper limb function (Disabilities of Arm, Shoulder and Hand), and quality of life were assessed before, and at 1 month and 12 months after the procedure. Thirty-six patients (19 female, 44.7 ± 11.1 years of age) underwent the procedure (17 in the TSB group). Average pain intensity at 1 month was not significantly different after TSB (3.5 ± 3.2) compared to control procedure (4.8 ± 2.7; P=0.249). At 12 months, however, the average pain item was significantly lower in the TSB group (3.47 ± 3.5) compared to the control group (5.86 ± 2.9; P=0.046). Scores from the MPQ, evoked-pain symptoms subscores (NPSI), and depression scores (Hospital Anxiety and Depression Scale) were significantly lower in the TSB group compared to the control group at 1 and at 12 months. Other measurements were not influenced by the treatment. Quality of life was only slightly improved by TSB. No major adverse events occurred. Larger, multicentric trials should be performed to confirm these original findings.

  6. 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

  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. 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.

  9. Extracorporeal shock wave lithotripsy in infants less than 12-month old.

    PubMed

    Turna, Burak; Tekin, Ali; Yağmur, İsmail; Nazlı, Oktay

    2016-10-01

    There is a lack of literature on children compared to adults regarding the long-term effects of extracorporeal shock wave lithotripsy (SWL), specifically in infants. The aim of the present study was to analyze the efficacy and safety of SWL in infants and also evaluate its potential adverse effects in the mid-term. Between May 1999 and December 2013, 36 infants with 39 renal units underwent SWL treatment for kidney stones with an electrohydraulic lithotripter (Dornier MPL 9000/ELMED Multimed Classic). All children were less than 12-month old. The mid-term effects of SWL were examined at the last follow-up by measuring arterial blood pressure, random blood glucose level and ipsilateral kidney size. Evaluation of treatment and its consequences was based on clinical examination, blood tests and conventional imaging (plain abdominal radiography and ultrasound). Overall stone-free rate was 84.6 % after 3-month follow-up without any major complications. Mid-term follow-up was available in 20 of 36 children with a mean follow-up of 3.2 ± 2.8 years (range 0.5-15.3). None of the infants were found to develop new onset of hypertension or diabetes. All treated infant kidneys' sizes were in the normal percentile range. SWL for management of infant kidney stones is effective and safe in the mid-term.

  10. 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

  11. Three Randomized Controlled Trials of Early Long-Chain Polyunsaturated Fatty Acid Supplementation on Means-End Problem Solving in Nine-Month Olds

    PubMed Central

    Drover, James R.; Hoffman, Dennis R.; Castañeda, Yolanda S.; Morale, Sarah E.; Birch, Eileen E.

    2009-01-01

    This study examines whether feeding infants formula supplemented with long-chain polyunsaturated fatty acids (LCPUFA) improves cognitive function of 9-month olds. Participants included 229 infants from 3, randomized controlled trials. Children received either formula supplemented with docosahexaenoic acid and arachidonic acid, or a control formula beginning at 1 to 5 d (12 month feeding study), or following 6 weeks (6-week weaning study) or 4 to 6 months of breastfeeding (4-to 6-month weaning study). Infants were assessed with a two-step problem solving task. In the 12-month feeding and 6-week weaning studies, supplemented children had more intentional solutions (successful task completions) and higher intention scores (goal-directed behaviors) than controls. These results suggest that LCPUFA-supplementation improves means-end problem solving. PMID:19765006

  12. Sociodemographic and smoking behavioral predictors associated with smoking cessation according to follow-up periods: a randomized, double-blind, placebo-controlled trial of transdermal nicotine patches.

    PubMed

    Myung, Seung Kwon; Seo, Hong Gwan; Park, Sohee; Kim, Yeol; Kim, Dong Jin; Lee, Do Hoon; Seong, Moon Woo; Nam, Myung Hyun; Oh, Seung Won; Kim, Ji Ae; Kim, Mi Young

    2007-12-01

    This study investigated sociodemographic and smoking behavioral factors associated with smoking cessation according to follow-up periods. In this randomized, double-blind, placebo-controlled trial of transdermal nicotine patches, subjects were a total of 118 adult male smokers, who were followed up for 12 months. Univariable logistic regression analysis and stepwise multiple logistic regression analyses were performed to identify the predictors of smoking cessation. The overall self-reported point prevalence rates of abstinence were 20% (24/118) at 12 months follow-up, and there was no significant difference in abstinence rates between placebo and nicotine patch groups. In the univariable logistic regression analysis, predictors of successful smoking cessation were the low consumption of cigarettes per day and the low Fagerstrom Test for Nicotine Dependence (FTND) scores (p<0.05) at 3, 6, and 12 months follow-up. In the stepwise multiple logistic regression analyses, predictors of successful smoking cessation, which were different according to the follow- up periods, were found to be the low consumption of cigarettes per day at the short-term and midterm follow-up (< or =6 months), older age, and the low consumption of cigarettes per day at the long-term follow-up (12 months).

  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. 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…

  15. Meta-analyses of randomized controlled trials.

    PubMed

    Sacks, H S; Berrier, J; Reitman, D; Ancona-Berk, V A; Chalmers, T C

    1987-02-19

    A new type of research, termed meta-analysis, attempts to analyze and combine the results of previous reports. We found 86 meta-analyses of reports of randomized controlled trials in the English-language literature. We evaluated the quality of these meta-analyses, using a scoring method that considered 23 items in six major areas--study design, combinability, control of bias, statistical analysis, sensitivity analysis, and application of results. Only 24 meta-analyses (28 percent) addressed all six areas, 31 (36 percent) addressed five, 25 (29 percent) addressed four, 5 (6 percent) addressed three, and 1 (1 percent) addressed two. Of the 23 individual items, between 1 and 14 were addressed satisfactorily (mean +/- SD, 7.7 +/- 2.7). We conclude that an urgent need exists for improved methods in literature searching, quality evaluation of trials, and synthesizing of the results.

  16. 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 ...

  17. 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

  18. 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

  19. 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

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

    PubMed

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

    2014-02-01

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

  1. 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

  2. Randomized Control Trial of Composite Cuspal Restorations

    PubMed Central

    Fennis, W.M.; Kuijs, R.H.; Roeters, F.J.; Creugers, N.H.; Kreulen, C.M.

    2014-01-01

    The objective of this randomized control trial was to compare the five-year clinical performance of direct and indirect resin composite restorations replacing cusps. In 157 patients, 176 restorations were made to restore maxillary premolars with Class II cavities and one missing cusp. Ninety-two direct and 84 indirect resin composite restorations were placed by two operators, following a strict protocol. Treatment technique and operator were assigned randomly. Follow-up period was at least 4.5 yrs. Survival rates were determined with time to reparable failure and complete failure as endpoints. Kaplan-Meier five-year survival rates were 86.6% (SE 0.27%) for reparable failure and 87.2% (SE 0.27%) for complete failure. Differences between survival rates of direct and indirect restorations [89.9% (SE 0.34%) vs. 83.2% (SE 0.42%) for reparable failure and 91.2% (SE 0.32%) vs. 83.2% (SE 0.42%) for complete failure] were not statistically significant (p = .23 for reparable failure; p = .15 for complete failure). Mode of failure was predominantly adhesive. The results suggest that direct and indirect techniques provide comparable results over the long term (trial registration number: ISRCTN29200848). PMID:24155264

  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. 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

  6. Infant feeding and allergy: 12-month prospective study of 500 babies born into allergic families.

    PubMed

    Merrett, T G; Burr, M L; Butland, B K; Merrett, J; Miskelly, F G; Vaughan-Williams, E

    1988-12-01

    This investigation studied 487 babies for symptoms of allergic disease during their first year of life. Because of their positive family histories all the babies are at high risk of becoming allergic. The babies were randomly divided such that cows' milk was deliberately withheld from one group; infants in this group were fed with a soya substitute where required. No benefit resulted from withholding cows' milk, indeed symptoms were more usually associated with this group. Breast feeding, even for a short period, was clearly associated with a lower incidence of wheeze, prolonged colds, diarrhoea, and vomiting. It seemed that the duration of breast feeding was less important than whether or not the child had been breast-fed at all. Wheezing was both more common among boys than girls (P less than .05) and if the mother was a smoker. Other environmental features related to wheezing were social class, month of birth, lack of breast feeding, exposure to dampness, mould and coal fires, but not to domestic pets nor to the numbers of mites found in bedding and carpets. Mite exposure was, however, associated with prolonged colds. Eczema was the only allergic symptom not positively associated with any environmental factor; moreover, it was neither associated with a lack of breast feeding nor with inclusion of cows' milk in the diet. Eczema was associated with the incidence of positive skin prick tests and IgE antibodies to egg white. IgE and IgG4 antibodies were estimated at birth (mothers' and cord bloods) and 3 and 12 months later.(ABSTRACT TRUNCATED AT 250 WORDS)

  7. 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

  8. 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.

  9. 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

  10. A Randomized Controlled Trial of Positive-Affect Intervention and Medication Adherence in Hypertensive African Americans

    PubMed Central

    Ogedegbe, Gbenga O.; Boutin-Foster, Carla; Wells, Martin T.; Allegrante, John P.; Isen, Alice M.; Jobe, Jared B.; Charlson, Mary E.

    2015-01-01

    Background Poor adherence explains poor blood pressure (BP) control; however African Americans suffer worse hypertension-related outcomes. Methods This randomized controlled trial evaluated whether a patient education intervention enhanced with positive-affect induction and self-affirmation (PA) was more effective than patient education (PE) alone in improving medication adherence and BP reduction among 256 hypertensive African Americans followed up in 2 primary care practices. Patients in both groups received a culturally tailored hypertension self-management workbook, a behavioral contract, and bimonthly telephone calls designed to help them overcome barriers to medication adherence. Also, patients in the PA group received small gifts and bimonthly telephone calls to help them incorporate positive thoughts into their daily routine and foster self-affirmation. The main outcome measures were medication adherence (assessed with electronic pill monitors) and within-patient change in BP from baseline to 12 months. Results The baseline characteristics were similar in both groups: the mean BP was 137/82 mm Hg; 36% of the patients had diabetes; 11% had stroke; and 3% had chronic kidney disease. Based on the intention-to-treat principle, medication adherence at 12 months was higher in the PA group than in the PE group (42% vs 36%, respectively; P =.049). The within-group reduction in systolic BP (2.14 mm Hg vs 2.18 mm Hg; P =.98) and diastolic BP (−1.59 mm Hg vs −0.78 mm Hg; P=.45) for the PA group and PE group, respectively, was not significant. Conclusions A PE intervention enhanced with PA led to significantly higher medication adherence compared with PE alone in hypertensive African Americans. Future studies should assess the cost-effectiveness of integrating such interventions into primary care. Trial Registration clinicaltrials.gov Identifier: NCT00227175 PMID:22269592

  11. 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.

  12. 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

  13. 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.

  14. School-based intervention to reduce anxiety in children: study protocol for a randomized controlled trial (PACES)

    PubMed Central

    2012-01-01

    Background Emotional problems such as anxiety and low mood in children are common, impair everyday functioning and increase the risk of severe mental health disorders in adulthood. Relatively few children with emotional health problems are identified and referred for treatment indicating the need to investigate preventive approaches. Methods/Design The study is designed to be a pragmatic cluster randomized controlled trial evaluating the effectiveness of an efficacious school-based cognitive behavior therapy (CBT) prevention program (FRIENDS) on symptoms of anxiety and low mood in children 9 to 10 years of age. The unit of allocation is schools which are assigned to one of three conditions: school-led FRIENDS, health-led FRIENDS or treatment as usual. Assessments will be undertaken at baseline, 6 months and 12 months. The primary outcome measure is change on the Revised Child Anxiety and Depression Scale. Secondary outcome measures assess changes in self-esteem, worries, bullying and life satisfaction. An economic evaluation will be undertaken. Discussion As of September 2011, 41 schools have been recruited and randomized. Final 12-month assessments are scheduled to be completed by May 2013. Trial Registration ISRCTN23563048 PMID:23186118

  15. 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

  16. 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

  17. The effect of a structured intervention on caregivers of patients with dementia and problem behaviors: a randomized controlled pilot study.

    PubMed

    Nobili, Alessandro; Riva, Emma; Tettamanti, Mauro; Lucca, Ugo; Liscio, Mariarosaria; Petrucci, Bianca; Porro, Gabriella Salvini

    2004-01-01

    The objective was to assess the effect of a structured intervention on caregiver stress and the institutionalization rate of patients with dementia and problem behaviors. Caregivers contacting the Federazione Alzheimer Italia (AI) to receive help, advice, or information in relation to problem behaviors of outpatients were enrolled. Eligible caregiver-patient dyads were randomized to receive either a structured intervention or the counseling AI usually provides (control group). After basal assessment, families were reassessed at 6 and 12 months. Problem behavior (particularly agitation) was the only variable significantly correlated (P = 0.006) with the baseline caregivers' stress score. Thirty-nine families completed the 12-month follow-up; the mean problem behavior score was significantly lower in the intervention than the control group (p < 0.03); the time needed for care of the patient increased by 0.5 +/- 9.7 hours/day in the control group and decreased by 0.3 +/- 4.1 in the intervention group (p = 0.4, Wilcoxon test). The main determinant of institutionalization seemed to be the level of caregiver stress (p = 0.03). In patients of the intervention group, there was a significant reduction in the frequency of delusions. This pilot study suggests that caregiver stress is relieved by a structured intervention. The number of families lost to follow-up, the relatively short duration of the study, and the ceiling effect due to the severity of the clinical characteristics of patients probably all partly dilute the observed findings.

  18. 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

  19. Pediatric Nephrologists’ Beliefs Regarding Randomized Controlled Trials

    PubMed Central

    Wightman, Aaron G; Oron, Assaf P; Symons, Jordan M; Flynn, Joseph T

    2014-01-01

    Background Pediatrics and pediatric nephrology lag behind adult medicine in producing randomized controlled trials (RCTs). Physician attitudes have been shown to play a significant role in RCT enrollment. Methods We surveyed members of the American Society of Pediatric Nephrology regarding beliefs about RCTs and factors influencing decisions to recommend RCT enrollment. Regression analyses were used to identify effects of variables on an aggregate score summarizing attitudes toward RCTs. Results 130 replies were received. 66% had enrolled patients in RCTs. Respondents in practice >15 years were more likely to have recruited a patient to a RCT than those in practice <5 years. Respondents were more willing to recommend RCT enrollment if the study was multicenter, patients were sicker or had a poorer prognosis, or if the parent or participant received a financial incentive versus the provider. In multiple regression analysis, history of enrolling patients in a RCT was the only significant predictor of higher aggregate RCT-friendly attitude. Conclusions Many pediatric nephrologists have never enrolled a patient in a RCT, particularly those in practice <5 years. Respondents who have not enrolled patients in RCTs have a less RCT-friendly attitude. Provision of improved training and resources might increase participation of junior providers in RCTs. PMID:24379023

  20. 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

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

    PubMed

    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

  2. Weight Lifting and Physical Function Among Survivors of Breast Cancer: A Post Hoc Analysis of a Randomized Controlled Trial

    PubMed Central

    Brown, Justin C.; Schmitz, Kathryn H.

    2015-01-01

    Purpose Survivors of breast cancer may experience deterioration of physical function. This is important because poor physical function may be associated with premature mortality, injurious falls, bone fracture, and disability. We conducted a post hoc analysis to explore the potential efficacy of slowly progressive weight lifting to reduce the incidence of physical function deterioration among survivors of breast cancer. Methods Between October 2005 and August 2008, we conducted a single-blind, 12-month, randomized controlled trial of twice-per-week slowly progressive weight lifting or standard care among 295 survivors of nonmetastatic breast cancer. In this post hoc analysis of data from the Physical Activity and Lymphedema Trial, we examined incident deterioration of physical function after 12 months, defined as a ≥ 10-point decrease in the physical function subscale of the Medical Outcomes Short-Form 36-item questionnaire. Results The proportion of participants who experienced incident physical function deterioration after 12 months was 16.3% (24/147) in the control group and 8.1% (12/148) in the weight lifting group (relative risk, 0.49; 95% CI, 0.25 to 0.96; P = .04). No serious or unexpected adverse events occurred that were related to weight lifting. Conclusion Slowly progressive weight lifting compared with standard care reduced the incidence of physical function deterioration among survivors of breast cancer. These data are hypothesis generating. Future studies should directly compare the efficacy of weight lifting with other modalities of exercise, such as brisk walking, to appropriately inform the development of a confirmatory study designed to preserve physical function among survivors of breast cancer. PMID:25964257

  3. 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

  4. 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

  5. The moderation of Mindfulness-based stress reduction effects by trait mindfulness: results from a randomized controlled trial.

    PubMed

    Shapiro, Shauna L; Brown, Kirk Warren; Thoresen, Carl; Plante, Thomas G

    2011-03-01

    Mindfulness-based stress reduction (MBSR) has shown effectiveness for a variety of mental health conditions. However, it is not known for whom the intervention is most effective. In a randomized controlled trial (N = 30), we explored whether individuals with higher levels of pretreatment trait mindfulness would benefit more from MBSR intervention. Results demonstrated that relative to a control condition (n = 15), MBSR treatment (n = 15) had significant effects on several outcomes, including increased trait mindfulness, subjective well-being, and empathy measured at 2 and 12 months after treatment. However, relative to controls, MBSR participants with higher levels of pretreatment mindfulness showed a larger increase in mindfulness, subjective well-being, empathy, and hope, and larger declines in perceived stress up to 1 year after treatment.

  6. 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

  7. 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.

  8. The closed equilibrated biological aquatic system: a 12 months test of an artificial aquatic ecosystem.

    PubMed

    Blum, V; Andriske, M; Ludwig, C h; 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 months 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 Biomphalana 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 sample 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.

  9. 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

  10. Adherence to Glaucoma Medications Over 12 Months in Two US Community Pharmacy Chains

    PubMed Central

    Feehan, Michael; Munger, Mark A.; Cooper, Daniel K.; Hess, Kyle T.; Durante, Richard; Jones, Gregory J.; Montuoro, Jaime; Morrison, Margaux A.; Clegg, Daniel; Crandall, Alan S.; DeAngelis, Margaret M.

    2016-01-01

    This study determined the degree of adherence to medications for glaucoma among patients refilling prescriptions in community pharmacies. Methods: Data abstracted from the dispensing records for 3615 adult patients (18 years or older, predominantly over 45) receiving glaucoma medications from two retail pharmacy chains (64 stores in total) were analyzed. From a 24-month historic data capture period, the 12-month levels of adherence were determined using standard metrics, the proportion of days covered (PDC) and the medication possession ratio (MPR). The overall 12-month mean PDC was only 57%, and the mean MPR was 71%. Using a criterion by which 80% coverage was considered satisfactory adherence, only 30% had satisfactory overall 12-month PDC coverage, and only 37% had satisfactory overall 12-month MPR coverage. Refill adherence increased with age and was highest in the 65-and-older age group (p < 0.001). Differential adherence was found across medication classes, with the highest satisfactory coverage seen for those taking alpha2-adrenergic agonists (PDC = 36.0%; MPR = 47.6%) down to those taking direct cholinergic agonists (PDC = 25.0%; MPR = 31.2%) and combination products (PDC = 22.7%; MPR = 31.0%). Adherence to glaucoma medications in the community setting, as measured by pharmacy refill data, is very poor and represents a critical target for intervention. Community pharmacists are well positioned to monitor and reinforce adherence in this population. PMID:27618115

  11. 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…

  12. 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…

  13. Upper limb module in non-ambulant patients with spinal muscular atrophy: 12 month changes.

    PubMed

    Sivo, Serena; Mazzone, Elena; Antonaci, Laura; De Sanctis, Roberto; Fanelli, Lavinia; Palermo, Concetta; Montes, Jacqueline; Pane, Marika; Mercuri, Eugenio

    2015-03-01

    Recent studies have suggested that in non-ambulant patients affected by spinal muscular atrophy the Upper Limb Module can increase the range of activities assessed by the Hammersmith Functional Motor Scale Expanded. The aim of this study was to establish 12-month changes in the Upper Limb Module in a cohort of non-ambulant spinal muscular atrophy patients and their correlation with changes on the Hammersmith Functional Motor Scale Expanded. The Upper Limb Module scores ranged between 0 and 17 (mean 10.23, SD 4.81) at baseline and between 1 and 17 at 12 months (mean 10.27, SD 4.74). The Hammersmith Functional Motor Scale Expanded scores ranged between 0 and 34 (mean 12.43, SD 9.13) at baseline and between 0 and 34 at 12 months (mean 12.08, SD 9.21). The correlation betweeen the two scales was 0.65 at baseline and 0.72 on the 12 month changes. Our results confirm that the Upper Limb Module can capture functional changes in non-ambulant spinal muscular atrophy patients not otherwise captured by the other scale and that the combination of the two measures allows to capture changes in different subgroups of patients in whom baseline scores and functional changes may be influenced by several variables such as age.

  14. 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…

  15. 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

  16. 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.…

  17. 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…

  18. 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…

  19. 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.

  20. Time to 12-month remission and treatment failure for generalised and unclassified epilepsy

    PubMed Central

    Bonnett, Laura J; Tudur Smith, Catrin; Smith, David; Williamson, Paula R; Chadwick, David; Marson, Anthony G

    2014-01-01

    Objectives To develop prognostic models for time to 12-month remission and time to treatment failure after initiating antiepileptic drug monotherapy for generalised and unclassified epilepsy. Methods We analysed data from the Standard and New Antiepileptic Drug (arm B) study, a randomised trial that compared initiating treatment with lamotrigine, topiramate and valproate in patients diagnosed with generalised or unclassified epilepsy. Multivariable regression modelling was used to investigate how clinical factors affect the probability of achieving 12-month remission and treatment failure. Results Significant factors in the multivariable model for time to 12-month remission were having a relative with epilepsy, neurological insult, total number of tonic-clonic seizures before randomisation, seizure type and treatment. Significant factors in the multivariable model for time to treatment failure were treatment history (antiepileptic drug treatment prior to randomisation), EEG result, seizure type and treatment. Conclusions The models described within this paper can be used to identify patients most likely to achieve 12-month remission and most likely to have treatment failure, aiding individual patient risk stratification and the design and analysis of future epilepsy trials. PMID:24292995

  1. 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…

  2. School-Based Interventions for Anxious Children: 3-, 6-, and 12-Month Follow-Ups

    ERIC Educational Resources Information Center

    Bernstein, Gail A.; Bernat, Debra H.; Victor, Andrea M.; Layne, Ann E.

    2008-01-01

    The study followed participants aged 7 to 11 years from a previous study that compared three school-based cognitive-behavioral therapy (CBT) interventions for anxious children to determine long-term post-treatment benefits. Results indicate school-based CBT decreases anxiety symptoms up to 12 months post-treatment.

  3. 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.

  4. 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.…

  5. 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…

  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. A First Step in Form-Based Category Abstraction by 12-Month-Old Infants

    ERIC Educational Resources Information Center

    Gomez, Rebecca L.; Lakusta, Laura

    2004-01-01

    The present experiments investigate how young language learners begin to acquire form-based categories and the relationships between them. We investigated this question by exposing 12-month-olds to auditory structure of the form aX and bY (infants had to learn that a-elements grouped with Xs and not Ys). Infants were then tested on strings from…

  8. 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

  9. 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

  10. 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

  11. 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

  12. Mindfulness meditation and cognitive behavioral therapy for insomnia: a naturalistic 12-month follow-up.

    PubMed

    Ong, Jason C; Shapiro, Shauna L; Manber, Rachel

    2009-01-01

    A unique intervention combining mindfulness meditation with cognitive behavioral therapy for insomnia (CBT-I) has been shown to have acute benefits at posttreatment in an open label study. The aim of the present study was to examine the long-term effects of this integrated intervention on measures of sleep and sleep-related distress in an attempt to characterize the natural course of insomnia following this treatment and to identify predictors of poor long-term outcome. Analyses were conducted on 21 participants, who provided follow-up data at six and 12 months posttreatment. At each time point, participants completed one week of sleep and meditation diaries and questionnaires related to mindfulness, sleep, and sleep-related distress, including the Pre-Sleep Arousal Scale, the Glasgow Sleep Effort Scale, the Kentucky Inventory of Mindfulness Skills, and the Insomnia Episode Questionnaire. Analyses examining the pattern of change across time (baseline, end of treatment, six months, and 12 months) revealed that several sleep-related benefits were maintained during the 12-month follow-up period. Participants who reported at least one insomnia episode (>or=1 month) during the follow-up period had higher scores on the Pre-Sleep Arousal Scale (P < .05) and the Glasgow Sleep Effort Scale (P < .05) at end of treatment compared with those with no insomnia episodes. Correlations between mindfulness skills and insomnia symptoms revealed significant negative correlations (P < .05) between mindfulness skills and daytime sleepiness at each of the three time points but not with nocturnal symptoms of insomnia. These results suggest that most sleep-related benefits of an intervention combining CBT-I and mindfulness meditation were maintained during the 12-month follow-up period, with indications that higher presleep arousal and sleep effort at end of treatment constitute a risk for occurrence of insomnia during the 12 months following treatment.

  13. Growth of very low birth weight infants at 12 months corrected age in southern Brazil.

    PubMed

    Oliveira, Mariana G; Silveira, Rita C; Procianoy, Renato S

    2008-02-01

    The objective of this article is to describe growth of very low birth weight infants born in southern Brazil. All infants weighing < or =1500 g were followed up until 12 months corrected age (CA). Growth was recorded at 40 weeks, 6 and 12 months CA. Catch up was considered if the measures were > or =-2 SD of World Health Organization growth charts for weight and length; and of National Center for Health Statistics for head circumference. One hundred and ninety three infants born were followed up for the study. At 40 weeks CA, 57.8% patients achieved catch-up in weight and 50.9% in length. At 6 months CA, 82.2% achieved catch-up for weight and length and at 1 year CA, 92% achieved catch-up in weight and 86.9% in length. Catch-up in head circumference was achieved for 93.4%, 85.9% and 85% patients at 40 weeks, 6 months and 12 months CA, respectively. At 12 months CA, no catch-up in weight, length and head circumference was related to higher SNAPPE-II (P = 0.046) and periventricular leukomalacia (PVL) (P = 0.003); longer time to achieve full enteral nutrition at the neonatal intensive care unit (NICU) (P = 0.037), lower maternal education (P = 0.018) and PVL (P = 0,003); higher SNAPPE-II (P = 0,004), PVL (P = 0.005) and longer time to achieve full enteral nutrition at the NICU (P = 0.044), respectively. In conclusion, PVL and higher SNAPPE-II were important factors to catch-up delay. Catch-up growth was high at 12 months CA.

  14. Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548

    PubMed Central

    Ersek, Mary; Turner, Judith A; Cain, Kevin C; Kemp, Carol A

    2004-01-01

    Background Chronic pain is a common and frequently disabling problem in older adults. Clinical guidelines emphasize the need to use multimodal therapies to manage persistent pain in this population. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples. This training includes education about pain as well as instruction and practice in several management techniques, including relaxation, physical exercise, modification of negative thoughts, and goal setting. Few studies have examined the effectiveness of this therapy in older adult samples. Methods/Design This is a randomized, controlled trial to assess the effectiveness of a pain self-management training group intervention, as compared with an education-only control condition. Participants are recruited from retirement communities in the Pacific Northwest of the United States and must be 65 years or older and experience persistent, noncancer pain that limits their activities. The primary outcome is physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes are depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurs by facility to minimize cross-contamination between groups. The target sample size is 273 enrolled, which assuming a 20% attrition rate at 12 months, will provide us with 84% power to detect a moderate effect size of .50 for the primary outcome. Discussion Few studies have investigated the effects of multimodal pain self-management training among older adults. This randomized controlled trial is designed to assess the efficacy of a pain self-management program that incorporates physical and psychosocial pain coping skills among adults in the mid-old to old-old range. PMID:15285783

  15. 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

  16. Greater weight loss among men participating in a commercial weight loss program: a pooled analysis of 2 randomized controlled trials.

    PubMed

    Barraj, Leila M; Murphy, Mary M; Heshka, Stanley; Katz, David L

    2014-02-01

    Being overweight and obese are significant health concerns for men and women, yet despite comparable needs for effective weight loss and maintenance strategies, little is known about the success of commercial weight loss programs in men. This study tests the hypothesis that men participating in a commercial weight loss program (Weight Watchers) had significantly greater weight loss than men receiving limited support from health professionals for weight loss (controls). A pooled analysis of weight loss and related physiologic parameter data from 2 randomized clinical trials was conducted. After 12 months, analysis of covariance tests showed that men in the commercial program group (n = 85) lost significantly more weight (P < .01) than men in the control group (n = 84); similar significant differences were observed for body mass index and waist circumference. These results suggest that participation in a commercial weight loss program may be a more effective means to lose weight and maintain weight loss.

  17. Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial

    PubMed Central

    Wolf, Michael S.; Kaiser, Darren; Morrow, Daniel G.

    2016-01-01

    Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™) implemented via an electronic medical record to improve patients' medication knowledge, adherence, and glycemic control compared to usual care. Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months. Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients' knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients' demonstrated medication use, regimen adherence, or glycemic control (HbA1c). Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.gov NCT01296633.

  18. Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial

    PubMed Central

    Wolf, Michael S.; Kaiser, Darren; Morrow, Daniel G.

    2016-01-01

    Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™) implemented via an electronic medical record to improve patients' medication knowledge, adherence, and glycemic control compared to usual care. Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months. Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients' knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients' demonstrated medication use, regimen adherence, or glycemic control (HbA1c). Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.gov NCT01296633. PMID:27699179

  19. Clinical Research Methodology 3: Randomized Controlled Trials.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  20. 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

  1. A Micro-Analysis of Mother-Infant Interaction. Behavior Regulating Social Contact Between a Mother and her 3 1/2 Month-Old Twins

    ERIC Educational Resources Information Center

    Stern, Daniel N.

    1971-01-01

    An example of controlling" maternal behavior with 3 1/2-month-old twins is studied by a method of frame-by-frame film analysis. Characteristic infant behaviors regulating social contact with the mother are identified and followed through 15 months. (Author)

  2. 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

  3. 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…

  4. 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

  5. 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

  6. 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

  7. 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

  8. Short-Term Effect of Autologous Bone Marrow Stem Cells to Treat Acute Myocardial Infarction: A Meta-Analysis of Randomized Controlled Clinical Trials.

    PubMed

    Cong, Xiao-Qiang; Li, Ying; Zhao, Xin; Dai, Yan-Jian; Liu, Ya

    2015-06-01

    Bone marrow stem cells (BMSCs) have been used to treat patient with ST-segment elevation myocardial infarction (STEMI) via intracoronary route. We performed a meta-analysis to evaluate the short-term efficacy and safety of this modality. Seventeen randomized controlled trials (RCTs) of BMSC-based therapy for STEMI, delivered with 9 days of reperfusion and followed up shorter than 12 months, were identified by systematic review. Intracoronary BMSC therapy resulted in an overall significant improvement in left ventricular ejection fraction (LVEF) by 2.74 % (95 % confidence interval (CI) 2.09-3.39, P < 0.00001, I(2) = 84 %) at 3-6-month follow-up and 5.1 % (95 % CI 4.16-6.03, P < 0.00001 and I(2) = 85 %) at 12 months. The left ventricular end-systolic volume (LVESV) and wall motion score index (WMSI) were also reduced at 3-6 months. At 12 months, left ventricular end-diastolic volume (LVEDV), LVESV, and WMSI were significantly reduced in BMSC group. In conclusion, intracoronary BMSC therapy at post-STEMI is safe and effective in patient with acute STEMI.

  9. Random transitions and cell cycle control.

    PubMed

    Brooks, R F

    1981-01-01

    Differences between the cycle times of sister cells are exponentially distributed, which means that these differences can be explained entirely by the existence of a single critical step in the cell cycle which occurs at random. Cycle times as a whole are not exponentially distributed, indicating an additional source of variation in the cell cycle. It follows that this additional variation must affect sister cells identically; ie, sister cell cycle times are correlated. This correlation and the overall distribution of cycle times can be predicted quantitatively by a model that was developed initially in order to explain certain problematic features of the response of quiescent cells to mitogenic stimulation - in particular, the significance of the lag that almost invariably occurs between stimulation and the onset of DNA synthesis. This model proposes that each cell cycle depends not on one but two random transitions, one of which (at reasonably high growth rates) occurs in the mother cell, its effects being inherited equally by the two daughter cells. The fundamental timing element in the cell cycle is proposed to be a lengthy process, called L, which accounts for most of the lag on mitogenic stimulation and also for the minimum cycle time in growing cultures. One of the random transitions is concerned with the initiation of L, whereas the other becomes possible on completion of L. The latter transition has two consequences: the first is the initiation of a sequence of events which includes S, G2 and M; the second is the restoration of the state from which L may be initiated once more. As a result, L may begin (at random) at any stage of the conventional cycle, ie, S, G2, M, or G1. There are marked similarities between the hypothetical process L and the biogenesis of mitotic centres - the structures responsible for organising the spindle poles. PMID:7312875

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  16. 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

  17. A sensitivity analysis for subverting randomization in controlled trials.

    PubMed

    Marcus, S M

    2001-02-28

    In some randomized controlled trials, subjects with a better prognosis may be diverted into the treatment group. This subverting of randomization results in an unobserved non-compliance with the originally intended treatment assignment. Consequently, the estimate of treatment effect from these trials may be biased. This paper clarifies the determinants of the magnitude of the bias and gives a sensitivity analysis that associates the amount that randomization is subverted and the resulting bias in treatment effect estimation. The methods are illustrated with a randomized controlled trial that evaluates the efficacy of a culturally sensitive AIDS education video.

  18. 12-Month Outcome and Predictors of Recurrence in Psychiatric Treatment of Depression: A Retrospective Study.

    PubMed

    Johansson, Olof; Lundh, Lars-Gunnar; Bjärehed, Jonas

    2015-09-01

    Many individuals treated for depression suffer relapse or recurrence after treatment. Known risk factors include number of previous depressive episodes and residual symptoms after treatment. Both relapse/recurrence rates and predictors of relapse/recurrence, however, may differ between various settings. To perform a naturalistic evaluation of the sustained effectiveness of treatment for adult clinical depression in a psychiatric out-patient setting and to examine psychosocial and clinical predictors of relapse/recurrence. 51 individuals, who were successfully treated/discharged from psychiatric care 12 months prior, were assessed regarding current depressive status and regarding relapse and recurrence. Logistic regression was used to assess the predictive impact of the variables measured. At the 12-month follow-up, 26% of the participants were in complete remission, 45% were in partial remission, and 29% were clinically depressed. In 1 year, 61% suffered a new depressive episode. Having a greater number of previous episodes and having no partner significantly increased the risk of relapse or recurrence. A high prevalence of depression and partially remitted depression is reported at 12-month follow up, and a large proportion of the sample would likely benefit from active treatment. Relapse/recurrence rates are higher in this study than in many other studies, and it may be hypothesized that they are generally higher in psychiatric settings than in primary care. If so, this would indicate the need for a different treatment strategy in the psychiatric care of depression, with emphasis on long-term management of depression.

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

    PubMed

    Adeleye, Adetayo; Ho, Alice; 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

  20. 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

  1. Effect of exercise on bone structural traits, physical performance and body composition in breast cancer patients--a 12-month RCT.

    PubMed

    Nikander, R; Sievänen, H; Ojala, K; Kellokumpu-Lehtinen, P-L; Palva, T; Blomqvist, C; Luoto, R; Saarto, T

    2012-09-01

    In this 12-month RCT, we examined whether aerobic impact exercise training (3x/week) could facilitate breast cancer survivors' recovery by enhancing their bone structural strength, physical performance and body composition. After the adjuvant chemo- and/ or radiotherapy, 86 patients were randomly assigned into the training or control group. Structural bone traits were assessed with pQCT at the tibia and with DXA at the femoral neck. Agility (figure-8 running), jump force and power (force platform), grip strength and cardiovascular fitness (2-km walk test) were also assessed. Training effects on outcome variables were estimated by two-way factorial ANCOVA using the study group and menopausal status as fixed factors. Bone structural strength was better maintained among the trainees. At the femoral neck, there was a small but significant 2% training effect in the bone mass distribution (p=0.05). At the tibial diaphysis, slight 1% to 2% training effects (p=0.03) in total cross-sectional area and bone structural strength were observed (p=0.03) among the postmenopausal trainees. Also, 3% to 4% training effects were observed in the figure-8 running time (p=0.03) and grip strength (p=0.01). In conclusion, vigorous aerobic impact exercise training has potential to maintain bone structural strength and improve physical performance among breast cancer survivors.

  2. 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

  3. Similar immunogenicity of measles-mumps-rubella (MMR) vaccine administrated at 8 months versus 12 months age in children.

    PubMed

    He, Hanqing; Chen, Enfu; Chen, Haiping; Wang, Zhifang; Li, Qian; Yan, Rui; Guo, Jing; Zhou, Yang; Pan, Jinren; Xie, Shuyun

    2014-06-30

    Two doses of measles-mumps-rubella (MMR) strategy has been recommended by World Health Organization and is also widely adopted in many countries. In order to provide the evidence for perfecting the immunization strategy of MMR, this study evaluated the safety and immunogenicity of MMR with different two-dose schedule in infants. 280 participants were enrolled and randomly allocated to Group 1 (first dose at 8 months) or Group 2 (first dose at 12 months), and both groups administered the second dose at 10 months later. Solicited local and general symptoms after each vaccination with MMR were mild and infrequent in all participants of two groups. After administration of the first dose of MMR, seropositive rates were 100% in both groups for measles, 89.3% in Group 1 and 87.1% in Group 2 for mumps (P=0.578), 92.0% in Group 1 and 92.9% in Group 2 (P=0.393). The seropositive rates of mumps decreased significantly (from >86% to <65%) both in two groups (P<0.001) 10 months after the first dose of MMR, but no significant change was found in measles and rubella. All children get the positive titer for three vaccines in two groups after given the second dose MMR, higher seroconversion rate was found for mumps both in two groups (71.7% vs 77.2%, P=0.370). In conclusion, this study indicated that the MMR was well tolerated and immunogenic against measles, mumps and rubella with schedule of first dose both at 8 months and 12 months age. Our findings strongly supported that two doses of MMR can be introduced by replacing the first dose of MR in current EPI with MMR at 8 months age and the second dose at 18 months in China.

  4. Nifedipine improves immediate, and 6- and 12-month graft function in cyclosporin A (CyA) treated renal allograft recipients.

    PubMed

    Harper, S J; Moorhouse, J; Veitch, P S; Horsburgh, T; Walls, J; Bell, P R; Donnelly, P K; Feehally, J

    1992-01-01

    To investigate the effect of oral nifedipine, a calcium channel blocker known not to modify cyclosporin A (CyA) pharmacokinetics, on immediate transplant function and CyA nephrotoxicity, 68 adult renal transplant recipients were pre-operatively randomized to one of three regimes: A (high-dose CyA, initial dose 17 mg/kg per day, maintenance dose 7 mg/kg per day); B (regime A plus oral nifedipine); C low-dose CyA, initial dose 10 mg/kg per day, maintenance 4 mg/kg per day plus azathioprine 1 mg/kg per day). All three groups received identical steroid regimes. Calcium channel blockers of all types were avoided in groups A and C. Delayed graft function (dialysis dependence by day 4) was seen least frequently in group B (P < 0.02). Group B had improved graft function at 6 months compared with group A, identified by differences in serum creatinine (P < 0.05), GFR (P < 0.01) and ERPF (P < 0.05). Similar differences in serum creatinine (P < 0.05) and GFR (P < 0.05) were also identified at 12 months. Group C also had better 6- and 12-month GFR values than group A (P < 0.05 each). The three groups did not differ in donor or recipient age, HLA matching, ischaemic or anastomosis times, frequency of early rejection or whole-blood CyA levels. These results indicate that nifedipine significantly improves immediate and medium-term graft function.

  5. 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

  6. 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.

  7. 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

  8. Preventing Smoking Relapse via Web-Based Computer-Tailored Feedback: A Randomized Controlled Trial

    PubMed Central

    Bolman, Catherine; Candel, Math J.J.M; Wiers, Reinout W; de Vries, Hein

    2012-01-01

    Background Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation. However, the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored. The Stay Quit for You (SQ4U) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group. Objectives To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group. The action planning (AP) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments (the first 3 assignments prior to quit date and the final 3 assignments after quit date). The action planning plus (AP+) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt. Respondents in the control group only filled out questionnaires. The study also assessed possible dose–response relationships between abstinence and adherence to the programs. Methods The study was a randomized controlled trial with three conditions: the control group, the AP program, and the AP+ program. Respondents were daily smokers (N = 2031), aged 18 to 65 years, who were motivated and willing to quit smoking within 1 month. The primary outcome was self-reported continued abstinence 12 months after baseline. Logistic regression analyses were conducted using three samples: (1) all respondents as randomly assigned, (2) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol, and (3) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements. Observed case analyses and conservative analyses were conducted. Results In the

  9. 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

  10. Selection of intervention components in an internet stop smoking participant preference trial: beyond randomized controlled trials.

    PubMed

    Schueller, Stephen M; Leykin, Yan; Pérez-Stable, Eliseo J; Muñoz, Ricardo F

    2013-01-30

    To address health problems that have a major impact on global health requires research designs that go beyond randomized controlled trials. One such design, the participant preference trial, provides additional information in an ecologically valid manner, once intervention efficacy has been demonstrated. The current study presents illustrative data from a participant preference trial of an internet-based smoking cessation intervention. Participants (N=7763) from 124 countries accessed the intervention and were allowed to choose from nine different site components to aid their quit attempt. Of consenting participants, 36.7% completed at least one follow-up assessment. Individuals with depression were more likely to choose a mood management module and participants who smoked a higher number of cigarettes were more likely to choose a cigarette counter and a nicotine replacement therapy guide. Furthermore, depressed participants selecting the mood management component were more likely to report at least one successful 7 day quit (37.2% vs. 22.2%) in the 12 months following the intervention. Thus, participants with depressive symptoms appear to make choices on the basis of their needs and to benefit from these decisions. This suggests that providing the ability to customize previously validated resources may be a successful way to widely disseminate interventions.

  11. Randomized Controlled Trial of Personalized Motivational Interventions in Substance Using Patients With Facial Injuries

    PubMed Central

    Shetty, Vivek; Murphy, Debra A.; Zigler, Corwin; Yamashita, Dennis-Duke R.; Belin, Thomas R.

    2011-01-01

    Purpose The proximate use of illicit drugs or alcohol (substance use) is the most common precipitator of facial injuries among socioeconomically disadvantaged populations. Reducing these risky behaviors could minimize adverse health sequelae and potential reinjury. The objective of our study was to test whether a culturally competent, personalized motivational intervention incorporated into surgical care could significantly reduce existing substance use behaviors in facial injury patients. Patients and Methods Substance-using subjects (n = 218) presenting with facial injuries to a level 1 trauma center were randomly assigned to either a personalized motivational intervention (PMI) condition or a health-information (HI) control condition. After a brief assessment of the individual’s substance use severity and willingness to change these behaviors, both groups attended 2 counseling sessions with a trained interventionist. The PMI subjects (n = 118) received individualized, motivational interventions, whereas the HI subjects (n = 100) received only general health information. Both groups were reassessed at 6 and 12 months postinjury, and changes in substance-use patterns were measured to assess the effects of intervention. Results The PMI and HI groups were closely matched on their sociodemographic and substance use characteristics. Subjects in the PMI group showed statistically significant declines in drug use at both the 6- and 12-month assessments. The intervention’s effect on lowering illicit drug use was greatest at the 6-month assessment but had weakened by the 1-year follow-up. The efficacy of the PMI was moderated by an individual’s initial drug use severity; individuals with greater drug use dependency at baseline were seen to have larger intervention effects, as did individuals who were most aware of their drug problem and willing to change their substance use behaviors. Unlike illicit drug use, changes in alcohol use did not differ significantly

  12. 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

  13. 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

  14. 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

  15. Saving and Empowering Young Lives in Europe (SEYLE): a randomized controlled trial

    PubMed Central

    2010-01-01

    Background There have been only a few reports illustrating the moderate effectiveness of suicide-preventive interventions in reducing suicidal behavior, and, in most of those studies, the target populations were primarily adults, whereas few focused on adolescents. Essentially, there have been no randomized controlled studies comparing the efficacy, cost-effectiveness and cultural adaptability of suicide-prevention strategies in schools. There is also a lack of information on whether suicide-preventive interventions can, in addition to preventing suicide, reduce risk behaviors and promote healthier ones as well as improve young people's mental health. The aim of the SEYLE project, which is funded by the European Union under the Seventh Framework Health Program, is to address these issues by collecting baseline and follow-up data on health and well-being among European adolescents and compiling an epidemiological database; testing, in a randomized controlled trial, three different suicide-preventive interventions; evaluating the outcome of each intervention in comparison with a control group from a multidisciplinary perspective; as well as recommending culturally adjusted models for promoting mental health and preventing suicidal behaviors. Methods and design The study comprises 11,000 adolescents emitted from randomized schools in 11 European countries: Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain, with Sweden serving as the scientific coordinating center. Each country performs three active interventions and one minimal intervention as a control group. The active interventions include gatekeeper training (QPR), awareness training on mental health promotion for adolescents, and screening for at-risk adolescents by health professionals. Structured questionnaires are utilized at baseline, 3- and 12-month follow-ups in order to assess changes. Discussion Although it has been reported that suicide

  16. 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

  17. A Randomized Controlled Trial of Clinician-Supported Problem-Solving Bibliotherapy for Family Caregivers of People With First-Episode Psychosis

    PubMed Central

    Chien, Wai Tong; Thompson, David R.; Lubman, Dan I.; McCann, Terence V.

    2016-01-01

    Family interventions for first-episode psychosis (FEP) are an integral component of treatment, with positive effects mainly on patients’ mental state and relapse rate. However, comparatively little attention has been paid to the effects of family interventions on caregivers’ stress coping and well-being, especially in non-Western countries. We aimed to test the effects of a 5-month clinician-supported problem-solving bibliotherapy (CSPSB) for Chinese family caregivers of people with FEP in improving family burden and carers’ problem-solving and caregiving experience, and in reducing psychotic symptoms and duration of re-hospitalizations, compared with those only received usual outpatient family support (UOFS). A randomized controlled trial was conducted across 2 early psychosis clinics in Hong Kong, where there might be inadequate usual family support services for FEP patients. A total of 116 caregivers were randomly selected, and after baseline measurement, randomly assigned to the CSPSB or UOFS. They were also assessed at 1-week and 6- and 12-month post-intervention. Intention-to-treat analyses were applied and indicated that the CSPSB group reported significantly greater improvements in family burden and caregiving experience, and reductions in severity of psychotic symptoms and duration of re-hospitalizations, than the UOFS group at 6- and 12-month follow-up. CSPSB produces moderate long-term benefits to caregivers and FEP patients, and is a low-cost adjunct to UOFS. PMID:27147450

  18. Sociodemographic, perinatal, behavioral, and psychosocial predictors of weight retention at 3 and 12 months postpartum.

    PubMed

    Siega-Riz, Anna Maria; Herring, Amy H; Carrier, Kathryn; Evenson, Kelly R; Dole, Nancy; Deierlein, Andrea

    2010-10-01

    Postpartum weight retention plays an important role in the pathway leading to obesity among women of childbearing age. The objective of this study was to examine predictors of moderate (1-10 pounds) and high (>10 pounds) postpartum weight retention using data from a prospective pregnancy cohort that followed women into the postpartum period; n = 688 and 550 women at 3 and 12 months, respectively. Analysis included descriptive statistics and predictive modeling using log-binomial techniques. The average weight retained at 3 and 12 months postpartum in this population was 9.4 lb (s.d. = 11.4) and 5.7 lb (s.d. = 13.2), respectively. At 3 months postpartum, prepregnancy weight, gestational weight gain, and hours slept during the night were associated with moderate or high weight retention, whereas having an infant hospitalized after going home and scoring in the upper 75th percentile of the Eating Attitudes Test (EAT) were associated only with high weight retention. At 12 months postpartum, prepregnancy weight, gestational weight gain, and maternal education were associated with moderate weight retention; and gestational weight gain, maternal age, race, employment status, and having an infant hospitalized at birth were associated with high weight retention. The results of this study illustrate the importance of prepregnancy weight and gestational weight gain in predicting postpartum weight retention. Furthermore, given the lack of successful intervention studies that exist to date to help women lose weight in the postpartum period, the results of this study may help to inform future interventions that focus on such aspects as hours of sleep, dealing with stress associated with a hospitalized infant, and nonclinical eating disorder symptomatology.

  19. Sociodemographic, Perinatal, Behavioral, and Psychosocial Predictors of Weight Retention at 3 and 12 months Postpartum

    PubMed Central

    Siega-Riz, Anna Maria; Herring, Amy H.; Carrier, Kathryn; Evenson, Kelly R.; Dole, Nancy; Deierlein, Andrea

    2010-01-01

    Postpartum weight retention plays an important role in the pathway leading to obesity among women of childbearing age. The objective of this study was to examine predictors of moderate (1–10 pounds) and high (>10 pounds) postpartum weight retention using data from a prospective pregnancy cohort that followed women into the postpartum period; n=688 and 550 women at 3 and 12 months, respectively. Analysis included descriptive statistics and predictive modeling using log-binomial techniques. The average weight retained at 3 and 12 months postpartum in this population was 9.4 lbs (SD=11.4) and 5.7 lbs (SD=13.2) respectively. At 3- months postpartum, prepregnancy weight, gestational weight gain, and hours slept during the night were associated with moderate or high weight retention while having an infant hospitalized after going home and scoring in the upper 75th percentile of the eating attitudes test were associated only with high weight retention. At 12- months postpartum, prepregnancy weight, gestational weight gain and maternal education were associated with moderate weight retention and gestational weight gain, maternal age, race, employment status, and having an infant hospitalized at birth were associated with high weight retention. The results of this study illustrate the importance of prepregnancy weight and gestational weight gain in predicting postpartum weight retention. Furthermore, given the lack of successful intervention studies that exist to date to help women lose weight in the postpartum period, the results of this study may help to inform future interventions that focus on such aspects as hours of sleep, dealing with stress associated with a hospitalized infant, and non-clinical eating disorder symptomatology. PMID:20035283

  20. 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

  1. Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial

    PubMed Central

    Michaelson, Peter; Gard, Gunvor; Eriksson, Margareta K

    2016-01-01

    Background Web-based interventions with a focus on behavior change have been used for pain management, but studies of Web-based interventions integrated in clinical practice are lacking. To emphasize the development of cognitive skills and behavior, and to increase activity and self-care in rehabilitation, the Web Behavior Change Program for Activity (Web-BCPA) was developed and added to multimodal pain rehabilitation (MMR). Objective The objective of our study was to evaluate the effects of MMR in combination with the Web-BCPA compared with MMR among persons with persistent musculoskeletal pain in primary health care on pain intensity, self-efficacy, and copying, as part of a larger collection of data. Web-BCPA adherence and feasibility, as well as treatment satisfaction, were also investigated. Methods A total of 109 participants, mean age 43 (SD 11) years, with persistent pain in the back, neck, shoulder, and/or generalized pain were recruited to a randomized controlled trial with two intervention arms: (1) MMR+WEB (n=60) and (2) MMR (n=49). Participants in the MMR+WEB group self-guided through the eight modules of the Web-BCPA: pain, activity, behavior, stress and thoughts, sleep and negative thoughts, communication and self-esteem, solutions, and maintenance and progress. Data were collected with a questionnaire at baseline and at 4 and 12 months. Outcome measures were pain intensity (Visual Analog Scale), self-efficacy to control pain and to control other symptoms (Arthritis Self-Efficacy Scale), general self-efficacy (General Self-Efficacy Scale), and coping (two-item Coping Strategies Questionnaire; CSQ). Web-BCPA adherence was measured as minutes spent in the program. Satisfaction and Web-BCPA feasibility were assessed by a set of items. Results Of 109 participants, 99 received the allocated intervention (MMR+WEB: n=55; MMR: n=44); 88 of 99 (82%) completed the baseline and follow-up questionnaires. Intention-to-treat analyses were performed with a sample

  2. 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

  3. 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

  4. 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…

  5. 76 FR 38503 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List a Distinct...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ... FR 19925). The notice of a 90-day finding and commencement of a 12- month status review for the USNRMs DPS was published in the annual Candidate Notice of Review on November 10, 2010 (75 FR 69222... initiated a 12-month status review (68 FR 41169). On April 8, 2004, we published a warranted...

  6. 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…

  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

    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.

  8. We Should Really Keep In Touch: Predictors of the Ability to Maintain Contact With Contraception Clinical Trial Participants Over 12 Months

    PubMed Central

    Torres, Leah N.; Turok, David K.; Sanders, Jessica N.; Jacobson, Janet C.; Dermish, Amna I.; Ward, Katherine

    2014-01-01

    Objectives This study assesses the ability to maintain contact with participants enrolled in an emergency contraception (EC) trial with 12 months of follow-up based on the modes of contact they provided at enrollment. Study Design Data came from a clinical trial offering women the copper intrauterine device (IUD) or oral levonorgestrel (LNG) for EC. A modified Poisson regression was used to assess predictors associated with the ability to contact study participants 12 months after enrollment. Results Data were available for 542 participants; 443 (82%) could be contacted at 12 months. Contact at 12 months was greatest for those whose preferred method of contact was text messaging, email, or any (62/68 91% contacted) and worst for the 18 who had a landline phone (only 7 contacted, 39%). After controlling for age, having an email address, text messaging, language preference, type of EC chosen, and insurance, preferred contact other than phone increased the likelihood of follow-up by 10% (RR 1.1 95% CI 1.0-1.2), while having a landline reduced a woman's likelihood of being contacted at 12 months by 50% compared to women with a contract cell (RR 0.5; 95% CI 0.3-1.0). Conclusion The few women with a landline for contact had poor follow-up at one year while women who preferred email or text had the highest rate of follow-up. Implications Understanding how best to reduce loss to follow-up is an essential component of conducting a contraceptive clinical trial. Improved participant retention maximizes internal validity and allows for important clinical outcomes, such as pregnancy, to be assessed. PMID:25242443

  9. Reduction in urinary albumin excretion with a moderate low-carbohydrate diet in patients with type 2 diabetes: a 12-month intervention

    PubMed Central

    Haimoto, Hajime; Sasakabe, Tae; Umegaki, Hiroyuki; Wakai, Kenji

    2012-01-01

    Introduction Urinary albumin excretion (UAE) is a marker of the early phase of diabetic nephropathy. Although a low-carbohydrate diet (LCD) has been shown to effectively improve glycemic control in patients with type 2 diabetes (T2DM), its effects on UAE remain unknown. Patients and methods A total of 124 patients (mean age ± standard deviation, 61.6 ± 9.2 years) with T2DM were instructed to consume a moderate LCD (1734 ± 416 kcal/d; % carbohydrate:fat:protein = 38:37:19) for 12 months. We measured the levels of UAE, hemoglobin A1c, fasting plasma glucose, fasting serum insulin (IRI), and the serum lipid profiles in the patients and recorded their dosages of antidiabetic drugs during this 12-month period. Results Of the 124 patients, 68 were normoalbuminuric, 50 were microalbuminuric, and six were macroalbuminuric at baseline. The patients had relatively good compliance with the moderate LCD diet. After 12 months, the mean levels of hemoglobin A1c, fasting plasma glucose, IRI, homeostasis model assessment-estimated insulin resistance, and the body mass index of all participants significantly decreased (P = 0.003 for IRI and P < 0.001 for the other parameters). Among the microalbuminuric patients (n = 50), remission to normoalbuminuria was frequently achieved (52%) and the geometric mean UAE significantly decreased by 53% (95% confidence interval: 43, 62) over 12 months (P < 0.001). After patients taking an angiotensin 2 receptor blocker were excluded, the UAE significantly decreased by 41% (n = 26, 95% confidence interval: 25, 54; P < 0.001). Moreover, the reduction in UAE was significantly and positively correlated with a reduction in homeostasis model assessment-estimated insulin resistance levels (rs = 0.308; P = 0.031). Conclusion A moderate LCD (38% carbohydrate diet) achieved a remarkable reduction in UAE over 12 months in microalbuminuric patients with T2DM. PMID:22924004

  10. 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

  11. 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

  12. Cause or effect: what matters? How 12-month-old infants learn to categorize artifacts.

    PubMed

    Träuble, Birgit; Pauen, Sabina

    2011-09-01

    This paper investigates the role of cause and effect relations for infants' learning about artifacts. Two experiments tested whether 12-month-olds categorized a given set of unfamiliar artifacts according to overall similarity and/or according to part similarity, depending on what kind of video demonstration was presented before the start of the categorization task. In both experiments, the actions performed with objects were accompanied by interesting effects but the causal relation between object-structure and effects was teased apart. In one video demonstration (Expt 1), the experimenter used the object part to produce some kind of effect in a causally plausible way. In another video demonstration (Expt 2), the experimenter performed similar actions with the same objects as in Expt 1, followed by the same effects as before. Importantly, however, no plausible cause-effect relation was provided this time. Only infants participating in Expt 1 categorized the set of unfamiliar objects according to part similarity. This finding suggests that 12-month-olds attend to the causal relation between specific object parts and their functional use when categorizing artifacts, rather than merely associating form-characteristics with an interesting effect.

  13. Incidence of Disability Among Children 12 Months After Traumatic Brain Injury

    PubMed Central

    Koepsell, Thomas D.; Wang, Jin; Temkin, Nancy; Dorsch, Andrea; Vavilala, Monica S.; Durbin, Dennis; Jaffe, Kenneth M.

    2012-01-01

    Objectives. We examined the burden of disability resulting from traumatic brain injuries (TBIs) among children younger than 18 years. Methods. We derived our data from a cohort study of children residing in King County, Washington, who were treated in an emergency department for a TBI or for an arm injury during 2007–2008. Disabilities 12 months after injury were assessed according to need for specialized educational and community-based services and scores on standardized measures of adaptive functioning and social–community participation. Results. The incidence of children receiving new services at 12 months was about 10-fold higher among those with a mild TBI than among those with a moderate or severe TBI. The population incidence of disability (defined according to scores below the norm means on the outcome measures included) was also consistently much larger (2.8-fold to 28-fold) for mild TBIs than for severe TBIs. Conclusions. The burden of disability caused by TBIs among children is primarily accounted for by mild injuries. Efforts to prevent these injuries as well as to decrease levels of disability following TBIs are warranted. PMID:22994196

  14. Effects of a 12-Month Pedometer-Based Walking Intervention in Women of Low Socioeconomic Status

    PubMed Central

    Hornbuckle, Lyndsey M.; Kingsley, J. Derek; Kushnick, Michael R.; Moffatt, Robert J.; Haymes, Emily M.; Miles, Rebecca; Toole, Tonya; Panton, Lynn B.

    2016-01-01

    This study examined the effects of a 12-month walking intervention in overweight/obese, low socioeconomic women. Forty-six women (48.2 ± 8.0 years) entered the study. Outcomes included weight, waist and hip circumferences, body mass index (BMI), blood pressure, glycosylated hemoglobin, blood lipids, fibrinogen, and high-sensitivity C-reactive protein (hsCRP). Both intention-to-treat analyses in all participants and group analyses in study completers only (3K group = increased steps/day by ≥3,000; No Δ group = did not increase steps/day by ≥3,000) were conducted. Group × time ANOVA was used. In study completers, 3K significantly increased steps/day (6,903 ± 3,328 to 12,323 ± 5,736) compared to No Δ (4,926 ± 3,374 to 5,174 ± 3,095) from baseline to 12 months. There was a significant time effect for weight (P = 0.030), BMI (P = 0.029), and hsCRP (P = 0.044). Low socioeconomic women who adhere to a long-term, pedometer-based walking intervention significantly increased steps/day and may improve body weight, BMI, and hsCRP. This could help reduce health disparities in this population over time. PMID:27746679

  15. 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

  16. Adaptive pumping for spectral control of random lasers

    NASA Astrophysics Data System (ADS)

    Bachelard, Nicolas; Gigan, Sylvain; Noblin, Xavier; Sebbah, Patrick

    2014-06-01

    A laser is not necessarily a sophisticated device: pumping an amplifying medium randomly filled with scatterers makes a perfectly viable `random laser'. The absence of mirrors greatly simplifies laser design, but control over the emission wavelength and directionality is lost, seriously hindering prospects for this otherwise simple laser. Recently, we proposed an approach to tame random lasers, inspired by coherent light control in complex media. Here, we implement this method in an optofluidic random laser where modes are spatially extended and overlap, making individual mode selection impossible, a priori. We show experimentally that control over laser emission can be regained even in this extreme case. By actively shaping the optical pump within the random laser, single-mode operation at any selected wavelength is achieved with spectral selectivity down to 0.06 nm and more than 10 dB side-lobe rejection. This method paves the way towards versatile tunable and controlled random lasers as well as the taming of other laser sources.

  17. 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

  18. Taming random lasers through active spatial control of the pump.

    PubMed

    Bachelard, N; Andreasen, J; Gigan, S; Sebbah, P

    2012-07-20

    Active control of the spatial pump profile is proposed to exercise control over random laser emission. We demonstrate numerically the selection of any desired lasing mode from the emission spectrum. An iterative optimization method is employed, first in the regime of strong scattering where modes are spatially localized and can be easily selected using local pumping. Remarkably, this method works efficiently even in the weakly scattering regime, where strong spatial overlap of the modes precludes spatial selectivity. A complex optimized pump profile is found, which selects the desired lasing mode at the expense of others, thus demonstrating the potential of pump shaping for robust and controllable single mode operation of a random laser.

  19. Taming Random Lasers through Active Spatial Control of the Pump

    NASA Astrophysics Data System (ADS)

    Bachelard, N.; Andreasen, J.; Gigan, S.; Sebbah, P.

    2012-07-01

    Active control of the spatial pump profile is proposed to exercise control over random laser emission. We demonstrate numerically the selection of any desired lasing mode from the emission spectrum. An iterative optimization method is employed, first in the regime of strong scattering where modes are spatially localized and can be easily selected using local pumping. Remarkably, this method works efficiently even in the weakly scattering regime, where strong spatial overlap of the modes precludes spatial selectivity. A complex optimized pump profile is found, which selects the desired lasing mode at the expense of others, thus demonstrating the potential of pump shaping for robust and controllable single mode operation of a random laser.

  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. 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…

  2. 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…

  3. Simulation of random wind fluctuations. [space shuttle ascent control

    NASA Technical Reports Server (NTRS)

    Perlmutter, M.

    1974-01-01

    A technique was developed for the simulation of random wind fluctuations for use in computer studies of the space shuttle ascent control. The simulated wind fluctuations were generated using the techniques of control theory that have statistical characteristics similar to the characteristics obtained from wind data at Kennedy Space Center.

  4. 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.

  5. Challenges of randomized controlled trial design in plastic surgery.

    PubMed

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  6. Prevalence, correlates, and comorbidity of 12-Month tobacco dependence among ever-smokers in South Korea, during 1984-2001.

    PubMed

    Jeon, Hong Jin; Hahm, Bong-Jin; Lee, Hae-Woo; Hong, Jin Pyo; Bae, Jae-Nam; Park, Jong Ik; Kim, Jang-Kyu; Bae, Ahn; Park, Jong Han; Chung, Eun-Kee; Shin, Jong-Ho; Choi, Yong-Seoung; Chung, In-Won; Lee, Hyo Jung; Cho, Maeng Je

    2008-04-01

    The rate of dependence among ever-users of a drug indicates the risk of developing dependence once an individual has been exposed to the drug. This is the first study to investigate 12-month tobacco dependence (TD) among ever-smokers in a community-based population. Analyses were based on two national studies of representative samples aged 18-64 in 1984 (n=5,025) and in 2001 (n=6,275), conducted with household visits and face-to-face interviews. The rates of 12-month TD among ever-smokers in men showed no significant difference between 51.6% in 1984 and 50.6% in 2001. On the contrary, the rates in women significantly increased from 33.3% in 1984 to 52.8% in 2001. After adjusting for the sociodemographic variables, 'male gender' was significantly associated with 12-month TD among eversmokers in 1984, but not in 2001. 'Unmarried' was significantly associated in 2001 but not in 1984. 'Alcohol dependence' was the only psychiatric disorder associated with 12-month TD in both study years. In conclusion, 12-month TD was found in about 50% of ever-smokers, and gender differences between the rates of 12-month TD which was observed in 1984 disappeared in 2001. Individuals with 12-month TD showed higher comorbidity with alcohol dependence than ever-smokers without TD.

  7. Management based on exhaled nitric oxide levels adjusted for atopy reduces asthma exacerbations in children: A dual centre randomized controlled trial.

    PubMed

    Petsky, Helen L; Li, Albert M; Au, Chun T; Kynaston, Jennifer A; Turner, Catherine; Chang, Anne B

    2015-06-01

    While several randomized control trials (RCTs) have evaluated the use of fractional exhaled nitric oxide (FeNO) to improve asthma outcomes, none used FeNO cut-offs adjusted for atopy, a determinant of FeNO levels. In a dual center RCT, we assessed whether a treatment strategy based on FeNO levels, adjusted for atopy, reduces asthma exacerbations compared with the symptoms-based management (controls). Children with asthma from hospital clinics of two hospitals were randomly allocated to receive an a-priori determined treatment hierarchy based on symptoms or FeNO levels. There was a 2-week run-in period and they were then reviewed 10 times over 12-months. The primary outcome was the number of children with exacerbations over 12-months. Sixty-three children were randomized (FeNO = 31, controls = 32); 55 (86%) completed the study. Although we did achieve our planned sample size, significantly fewer children in the FeNO group (6 of 27) had an asthma exacerbation compared to controls (15 of 28), P = 0.021; number to treat for benefit = 4 (95% CI 3-24). There was no difference between groups for any secondary outcomes (quality of life, symptoms, FEV1 ). The final daily inhaled corticosteroids (ICS) dose was significantly (P = 0.037) higher in the FeNO group (median 400 µg, IQR 250-600) compared to the controls (200, IQR100-400). Taking atopy into account when using FeNO to tailor asthma medications is likely beneficial in reducing the number of children with severe exacerbations at the expense of increased ICS use. However, the strategy is unlikely beneficial for improving asthma control. A larger study is required to confirm or refute our findings.

  8. Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: study protocol for two linked randomized controlled trials

    PubMed Central

    2014-01-01

    Background As the population ages, more people are suffering from long-term health conditions (LTCs). Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth: technologies such as the Internet, telephone and home self-monitoring. Methods/Design This study aims to evaluate the effectiveness and cost-effectiveness of a telehealth intervention delivered by NHS Direct to support patients with LTCs. Two randomized controlled trials will be conducted in parallel, recruiting patients with two exemplar LTCs: depression or raised cardiovascular disease (CVD) risk. A total of 1,200 patients will be recruited from approximately 42 general practices near Bristol, Sheffield and Southampton, UK. Participants will be randomly allocated to either usual care (control group) or usual care plus the NHS Direct Healthlines Service (intervention group). The intervention is based on a conceptual model incorporating promotion of self-management, optimisation of treatment, coordination of care and engagement of patients and general practitioners. Participants will be provided with tailored help, combining telephone advice from health information advisors with support to use a range of online resources. Participants will access the service for 12 months. Outcomes will be collected at baseline, four, eight and 12 months for the depression trial and baseline, six and 12 months for the CVD risk trial. The primary outcome will be the proportion of patients responding to treatment, defined in the depression trial as a PHQ-9 score <10 and an absolute reduction in PHQ-9 ≥5 after 4 months, and in the CVD risk trial as maintenance or reduction of 10-year CVD risk after 12 months. The study will also assess whether the intervention is cost-effective from the perspective of the NHS and personal social services. An embedded qualitative interview study will explore healthcare professionals’ and patients’ views of

  9. Health Coaching by Medical Assistants to Improve Control of Diabetes, Hypertension, and Hyperlipidemia in Low-Income Patients: A Randomized Controlled Trial

    PubMed Central

    Willard-Grace, Rachel; Chen, Ellen H.; Hessler, Danielle; DeVore, Denise; Prado, Camille; Bodenheimer, Thomas; Thom, David H.

    2015-01-01

    PURPOSE Health coaching by medical assistants could be a financially viable model for providing self-management support in primary care if its effectiveness were demonstrated. We investigated whether in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care. METHODS We conducted a 12-month randomized controlled trial of 441 patients at 2 safety net primary care clinics in San Francisco, California. The primary outcome was a composite measure of being at or below goal at 12 months for at least 1 of 3 uncontrolled conditions at baseline as defined by hemoglobin A1c, systolic blood pressure, and low-density lipoprotein (LDL) cholesterol. Secondary outcomes were meeting all 3 goals and meeting individual goals. Data were analyzed using χ2 tests and linear regression models. RESULTS Participants in the coaching arm were more likely to achieve both the primary composite measure of 1 of the clinical goals (46.4% vs 34.3%, P = .02) and the secondary composite measure of reaching all clinical goals (34.0% vs 24.7%, P = .05). Almost twice as many coached patients achieved the hemoglobin A1c goal (48.6% vs 27.6%, P = .01). At the larger study site, coached patients were more likely to achieve the LDL cholesterol goal (41.8% vs 25.4%, P = .04). The proportion of patients meeting the systolic blood pressure goal did not differ significantly. CONCLUSIONS Medical assistants serving as in-clinic health coaches improved control of hemoglobin A1c and LDL levels, but not blood pressure, compared with usual care. Our results highlight the need to understand the relationship between patients’ clinical conditions, interventions, and the contextual features of implementation. PMID:25755034

  10. 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

  11. Influence of chlorhexidine concentration on the durability of etch-and-rinse dentin bonds: a 12-month in vitro study

    PubMed Central

    Breschi, Lorenzo; Cammelli, Federica; Visintini, Erika; Mazzoni, Annalisa; Vita, Francesca; Carrilho, Marcela; Cadenaro, Milena; Foulger, Stephen; Tay, Franklin R; Pashley, David; Di Lenarda, Roberto

    2013-01-01

    Objective To investigate the effect of 0.2% and 2% chlorhexidine (CHX) used as a therapeutic primer on the long-term bond strengths of two etch-and-rinse adhesive systems. Methods Adper Scotchbond 1XT (SB1) and XP-Bond (XPB) were evaluated. Etched dentin substrates were assigned to six treatment groups: (1) 0.2% CHX + SB1; (2) 2% CHX + SB1; (3) SB1 (control); (4) 0.2% CHX + XPB; (5) 2% CHX + XPB; (6) XPB (control). Composite build-ups were made and beams prepared for microtensile bond strength test. Beams were divided in three subgroups and either immediately pulled to failure or stored in artificial saliva for 6 or 12 months prior to testing. Data were evaluated by three-way ANOVA. Additional adhesive interfaces were prepared to investigate nanoleakage expression by TEM. Results SB1 and XPB showed similar immediate bond strength values with or without CHX pre-treatment (p>0.05). After 12 months, bonds fell from 43.9 ± 9.5 MPa to 20.1 ± 5.4 MPa and from 39.6 ± 9.4 MPa to 14.2 ± 5.0 MPa in control specimens for SB1 and XPB respectively, while bond fell only from 41.9±9.6MPa to 33.2 ± 8.3 MPa and 38.3 ± 8.9 MPa to 26.5 ± 10.9 (for SB1 and XPB respectively) when 0.2% CHX was previously used. CHX concentration did not affect bond strength values (0.2% vs 2%, p>.05). Nanoleakage increased during aging in controls, but reduced silver deposits were found in CHX-treated specimens. Conclusions Chlorhexidine significantly reduced the loss of bond strength seen in control bonds. Since no bacterial growth was present in the aging conditions, the results of this study suggest that endogenous factors thought to degrade the adhesive interface can be inhibited by CHX. Further in vivo trials should confirm the role of CHX in bond durability. PMID:19603582

  12. 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

  13. 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

  14. A 12-month prospective comparison of court-diverted with self-referred heroin users.

    PubMed

    Desland, M L; Batey, R G

    1992-01-01

    Forty-seven heroin users referred by the Drug and Alcohol Court Assessment Programme (DACAP) were compared with 45 self-referred heroin users at 12 months post-presentation. Data at presentation indicated distinct subpopulations were generated by each referral source. Differences were recorded in age, heroin use, marital status, educational level, employment history and age of onset of anti-social behaviour. The DACAP scheme exerted an earlier health intervention effect in a sample experiencing dysfunction in other areas, principally legally and socially. Prospective data demonstrated that both samples reported significant reductions in the proportion using heroin. Differences between samples evident at presentation were expressed prospectively, in rates of employment, incarceration and involvement in methadone maintenance programmes. The limitations of diverting clientele from the legal system to the treatment system is discussed in light of these results.

  15. Words (but not Tones) Facilitate Object Categorization: Evidence From 6- and 12-Month-Olds

    PubMed Central

    Fulkerson, Anne L.; Waxman, Sandra R.

    2007-01-01

    Recent studies reveal that naming has powerful conceptual consequences within the first year of life. Naming distinct objects with the same word highlights commonalities among the objects and promotes object categorization. In the present experiment, we pursued the origin of this link by examining the influence of words and tones on object categorization in infants at 6 and 12 months. At both ages, infants hearing a novel word for a set of distinct objects successfully formed object categories; those hearing a sequence of tones for the same objects did not. These results support the view that infants are sensitive to powerful and increasingly nuanced links between linguistic and conceptual units very early in the process of lexical acquisition. PMID:17064677

  16. Gender and discipline in 5-12-month-old infants: a longitudinal study.

    PubMed

    Ahl, Richard Evan; Fausto-Sterling, Anne; García-Coll, Cynthia; Seifer, Ronald

    2013-04-01

    We examined the effects of infant age and gender on the behaviors of infants and mothers during discipline interactions using longitudinal, naturalistic, home-based, taped observations of 16 mother-infant dyads (eight males and eight females). These observations were conducted between the child ages of 5 and 12 months and used a devised Maternal Discipline Coding System to code for the occurrence of discipline events. During discipline interactions, mothers vocalized longer, used harsher tones, and used more explanations with older compared to younger infants. Male infants were more likely than female infants to cry or whine during discipline events. Mothers of male infants used longer vocalizations, more words, and more affectionate terms than mothers of female infants. Male infants were more difficult during discipline interactions than female infants, but it appeared that mothers of males responded to this difficulty by using milder discipline techniques.

  17. Risk factors associated with exertional medial tibial pain: a 12 month prospective clinical study

    PubMed Central

    Burne, S; Khan, K; Boudville, P; Mallet, R; Newman, P; Steinman, L; Thornton, E

    2004-01-01

    Objective: To investigate in a military setting the potential role of intrinsic biomechanical and anthropometric risk factors for, and the incidence of, exertional medial tibial pain (EMTP). Methods: A prospective clinical outcome study in a cohort of 122 men and 36 women at the Australian Defence Force Academy. Each cadet underwent measurements of seven intrinsic variables: hip range of motion, leg length discrepancy, lean calf girth, maximum ankle dorsiflexion range, foot type, rear foot alignment, and tibial alignment. Test–retest reliability was undertaken on each variable. A physician recorded any cadet presenting with diagnostic criteria of EMTP. Records were analysed at 12 months for EMTP presentation and for military fitness test results. Results: 23 cadets (12 men, 11 women) met the criteria for EMTP after 12 months, with a cross gender (F/M) odds ratio of 3.1. In men, both internal and external range of hip motion was greater in those with EMTP: left internal (12°, p = 0.000), right internal (8°, p = 0.014), left external (8°, p = 0.042), right external (9°, p = 0.026). Lean calf girth was lower by 4.2% for the right leg (p = 0.040) but by only 2.9% for the left leg (p = 0.141). No intrinsic risk factor was associated with EMTP in women. EMTP was the major cause for non-completion of the run component of the ADFA fitness test in both men and women. Conclusions: Greater internal and external hip range of motion and lower lean calf girth were associated with EMTP in male military cadets. Women had high rates of injury, although no intrinsic factor was identified. Reasons for this sex difference need to be identified. PMID:15273181

  18. 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

  19. 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.

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics.

    PubMed

    Chien, Wai-Tong; Bressington, Daniel

    2015-09-30

    This study aimed to test the effectiveness of a nurse-led structured psychosocial intervention program in Chinese patients with first-onset mental illness. A single-blind, parallel group, randomized controlled trial design was used. The study involved 180 participants with mild to moderate-severe symptoms of psychotic or mood disorders who were newly referred to two psychiatric outpatient clinics in Hong Kong. Patients were randomly assigned to either an eight-session nurse-led psychosocial intervention program (plus usual care) or usual psychiatric outpatient care (both n=90). The primary outcome was psychiatric symptoms. Outcomes were measured at recruitment, one week and 12 months post-intervention. Patients in the psychosocial intervention group reported statistically significant improvements in symptoms compared to treatment as usual. There were also significant improvements in illness insight and perceived quality of life and reduction in length of re-hospitalizations over the 12-month follow-up. The findings provide evidence that the nurse-led psychosocial intervention program resulted in improved health outcomes in Chinese patients with first-onset mental illness.

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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

  11. Efficacy and safety of desvenlafaxine treatment for hot flashes associated with menopause: a meta-analysis of randomized controlled trials.

    PubMed

    Sun, Zheng; Hao, Yanqing; Zhang, Min

    2013-01-01

    Vasomotor symptoms, such as daytime hot flashes and nighttime awakenings due to hot flashes, are commonly associated with menopausal women. The aim of this study was to assess desvenlafaxine in moderate to severe hot flashes in postmenopausal women. Electronic databases were searched for relevant randomized controlled trials that compared desvenlafaxine to placebo for postmenopausal women affected with hot flashes. The main outcomes were mean differences (MD) or standardized mean differences (SMD) and 95% confidence interval (CI) for change of the hot flashes. Six randomized controlled trials were identified in the meta-analysis. Pooled change of moderate and severe hot flashes frequency reduced SMD of -0.49 (95% CI -0.91 to -0.07) in desvenlafaxine 100 mg and -0.36 (95% CI -0.54 to -0.19) in desvenlafaxine 150 mg at week 12. Desvenlafaxine 100 mg reduced moderate and severe hot flashes frequency SMD of -0.74 (95% CI -1.05 to -0.44) within 26 weeks. There is no evidence for an increased risk of cardiovascular, cerebrovascular, or hepatic events associated with desvenlafaxine 100 mg/day. The meta-analysis suggests that treatment with desvenlafaxine 100 mg/day is associated with a significant reduction of moderate to severe hot flashes in postmenopausal women. Desvenlafaxine appears both safe and effective for treating hot flushes for up to 12 months.

  12. Randomized controlled trial to test a computerized psychosocial cancer assessment and referral program: methods and research design.

    PubMed

    O'Hea, Erin L; Cutillo, Alexandra; Dietzen, Laura; Harralson, Tina; Grissom, Grant; Person, Sharina; Boudreaux, Edwin D

    2013-05-01

    The National Cancer Coalition Network, National Cancer Institute, and American College of Surgeons all emphasize the need for oncology providers to identify, address, and monitor psychosocial needs of their patients. The Mental Health Assessment and Dynamic Referral for Oncology (MHADRO) is a patient-driven, computerized, psychosocial assessment that identifies, addresses, and monitors physical, psychological, and social issues faced by oncology patients. This paper presents the methodology of a randomized controlled trial (RCT) that tested the impact of the MHADRO on patient outcomes at 2, 6, and 12 months. Patient outcomes including overall psychological distress, depression, anxiety, functional disability, and use of psychosocial resources will be presented in future publications after all follow-up data is gathered. Eight hundred and thirty six cancer patients with heterogeneous diagnoses, across three comprehensive cancer centers in different parts of the United States, were randomized to the MHADRO (intervention) or an assessment-only control group. Patients in the intervention group were provided detailed, personalized reports and, when needed, referrals to mental health services; their oncology provider received detailed reports designed to foster clinical decision making. Those patients who demonstrated high levels of psychosocial problems were given the option to authorize that a copy of their report be sent electronically to a "best match" mental health professional. Demographic and patient cancer-related data as well as comparisons between patients who were enrolled and those who declined enrollment are presented. Challenges encountered during the RCT and strategies used to address them are discussed.

  13. Telephone-delivered behavioral intervention among blacks with sleep apnea and metabolic syndrome: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Lack of adherence to recommended treatment for obstructive sleep apnea remains an ongoing public health challenge. Despite evidence that continuous positive airway pressure (CPAP) is effective and improves overall quality of life, adherence with the use of CPAP in certain racial/ethnic groups, especially blacks, is suboptimal. Evidence indicates that the incidence and prevalence of obstructive sleep apnea are higher among blacks, relative to whites, and blacks are less likely to adhere to recommended treatment compared with other racial/ethnic groups. Methods Using a two-arm randomized controlled design, this study will evaluate the effectiveness of a culturally and linguistically tailored telephone-delivered intervention to promote adherence to physician-recommended sleep apnea assessment and treatment among blacks with metabolic syndrome, versus an attention-control arm. The intervention is designed to foster adherence to recommended sleep apnea care using the stages-of-change model. The intervention will be delivered entirely over the telephone. Participants in the intervention arm will receive 10 phone calls to address challenges and barriers to recommended care. Outcomes will be assessed at baseline, and at 6- and 12-months post-randomization. Discussion This tailored behavioral intervention will improve adherence to sleep apnea assessment and treatment among blacks with metabolic syndrome. We expect to demonstrate that this intervention modality is feasible in terms of time and cost and can be replicated in populations with similar racial/ethnic backgrounds. Trial registration The study is registered at clinicaltrials.gov NCT01946659 (February 2013) PMID:24925227

  14. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    PubMed Central

    Stegink-Jansen, Caroline W.

    2015-01-01

    Introduction. Patients with chronic lateral elbow (LE) tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1) to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE) for patients with chronic LE tendinopathy, and (2) to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment. Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities. Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows) were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows) or EE treatment (56 elbows). Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments. Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047) and in maximum grip strength (p = 0.008) than EE subjects. Astym therapy also resolved 20/21 (95.7%) of the EE non-responders, who showed improvements in DASH scores (p < 0.005), pain with activity (p = 0.002), and function (p = 0.004) following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported. Conclusion. This study

  15. 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

  16. 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

  17. Non-clinical immuno-toxicological evaluation of HER1 cancer vaccine in non-human primates: a 12-month study.

    PubMed

    Barro, Ana M Bada; Rivero, Arianna Iglesias; Goñi, Avelina León; Navarro, Bárbara O González; Angarica, Meilis Mesa; Ramírez, Belinda Sánchez; Bedoya, Darel Martínez; Triana, Consuelo González; Rodríguez, Axel Mancebo; Parada, Ángel Casacó

    2012-12-17

    Human epidermal growth factor receptor (HER1) constitutes a tumor associated antigen. Its overexpression in many epithelial tumors has been associated with bad prognosis and poor survival. Cancer vaccine based on the extracellular domain (ECD) of HER1 and adjuvated in very small sized proteoliposomes (VSSP) and Montanide ISA 51-VG is a new and complementary approach for the treatment of epithelial tumors. The present study deals with the immunogenicity of this vaccine in Macaca fascicularis monkeys and evaluation of its toxicity during 12 months. Twelve monkeys were randomized into two groups of 3 animals per sex: control and vaccinated. Treated monkeys received 9 doses of vaccination and were daily inspected for clinical signs. Body weight, rectal temperature, cardiac and respiratory rates were measured during the study. Humoral immune response, clinical pathology parameters and delayed type hypensensitivity were analyzed. Skin biopsy was performed at the end of the study in all animals. Animal's survival in the study was 100% (n=12). Local reactions were observed at the administration site of four treated animals (n=6), with two showing slight inflammatory cutaneous damage. Clinical pathology parameters were not affected. HER1 vaccine induced high IgG antibodies titers in the treated animals even when DTH was not observed. The induced antibodies recognized HER1+ tumor cell lines, decreased HER1 phosphorylation and showed anti-proliferative and pro-apoptotic effects in H125 cells. In general the present study showed that HER1 vaccine induced specific immune response in M. fascicularis monkeys and was well tolerated, suggesting it could be safely used in clinical studies in epithelial cancer patients.

  18. Web-based acceptance and commitment therapy for depressive symptoms with minimal support: a randomized controlled trial.

    PubMed

    Lappalainen, Päivi; Langrial, Sitwat; Oinas-Kukkonen, Harri; Tolvanen, Asko; Lappalainen, Raimo

    2015-11-01

    Low-intensity interventions for people suffering from depressive symptoms are highly desirable. The aim of the present study was to investigate the outcomes of a web-based acceptance and commitment therapy (ACT)-based intervention without face-to-face contact for people suffering from depressive symptoms. Participants (N = 39) with depressive symptoms were randomly assigned to an Internet-delivered acceptance and commitment therapy (iACT) intervention or a waiting list control condition (WLC). Participants were evaluated with standardized self-reporting measures (Beck Depression Inventory [BDI-II], Symptom Checklist-90 [SCL-90], Acceptance and Action Questionnaire [AAQ-2], Five Facet Mindfulness Questionnaire [FFMQ], Automatic Thoughts Questionnaire [ATQ], and White Bear Suppression Inventory [WBSI]) at pre- and post-measurement. Long-term effects in the iACT group were examined using a 12-month follow-up. The iACT program comprised home assignments, online feedback given by master's-level students of psychology over a 7-week intervention period, and automated email-based reminders. Significant effects were observed in favor of the iACT group on depression symptomatology (between effect sizes [ESs] at post-treatment, iACT/WLC, g = .83), psychological and physiological symptoms (g = .60), psychological flexibility (g = .67), mindfulness skills (g = .53), and frequency of automatic thoughts (g = .57) as well as thought suppression (g = .53). The treatment effects in the iACT group were maintained over the 12-month follow-up period (within-iACT ES: BDI-II, g = 1.33; SCL-90, g = 1.04; ATQF/B [Frequency/Believability], FFMQ, WBSI, AAQ-II, g = .74-1.08). The iACT participants stated that they would be happy to recommend the same intervention to others with depressive symptoms. We conclude that an ACT-based guided Internet-delivered treatment with minimal contact can be effective for people with depressive symptoms.

  19. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes

    PubMed Central

    Carrasquillo, Olveen; Patberg, Elizabeth; Alonzo, Yisel; Li, Hua; Kenya, Sonjia

    2014-01-01

    Background Type 2 diabetes mellitus disproportionately affects the Latino community. Latinos with diabetes are also less likely to have adequate control of cardiovascular risk factors such as cholesterol and blood pressure. Community health workers (CHWs) are increasingly being used to address various health disparity conditions, including diabetes. However, evidence of their effectiveness from randomized controlled trials is limited. Methods The Miami Health Heart Initiative is a randomized controlled trial of 300 Latino patients with diabetes. Patients with hemoglobin A1c (HbA1c) ≥8.0% were recruited from Miami-Dade’s public hospital system. At baseline, all patients underwent phlebotomy, physical examination, and a structured 90-minute research interview. They were then randomized to either usual care or a CHW intervention called Cariño. For participants in the Cariño arm of the study, CHW services included assistance with nonmedical social services, health education, and patient navigation in which the CHWs serve as a bridge between patients and the health care system. These services were delivered through home visits, phone calls, and group visits. At 12 months, all subjects had a follow-up examination. The primary outcomes at 1 year are changes in systolic blood pressure, low-density lipoprotein, and HbA1c. Secondary outcomes include medication adherence, medication intensification, diabetes self-efficacy, physical activity, and self-reported fruit and vegetable intake. Discussion The Miami Healthy Heart Initiative is one of the first rigorously conducted randomized controlled trials to provide evidence on the impact of CHWs on diabetes intermediate outcomes among Latinos. If the data support our primary hypotheses, the study would lend added support to ongoing efforts to incorporate CHWs as part of our national efforts to reduce and ultimately eliminate health disparities. PMID:24600243

  20. 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

  1. 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…

  2. 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…

  3. 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…

  4. 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…

  5. 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…

  6. Reducing child conduct disordered behaviour and improving parent mental health in disadvantaged families: a 12-month follow-up and cost analysis of a parenting intervention.

    PubMed

    McGilloway, Sinead; NiMhaille, Grainne; Bywater, Tracey; Leckey, Yvonne; Kelly, Paul; Furlong, Mairead; Comiskey, Catherine; O'Neill, Donal; Donnelly, Michael

    2014-09-01

    The effectiveness of the Incredible Years Basic parent programme (IYBP) in reducing child conduct problems and improving parent competencies and mental health was examined in a 12-month follow-up. Pre- to post-intervention service use and related costs were also analysed. A total of 103 families and their children (aged 32-88 months), who previously participated in a randomised controlled trial of the IYBP, took part in a 12-month follow-up assessment. Child and parent behaviour and well-being were measured using psychometric and observational measures. An intention-to-treat analysis was carried out using a one-way repeated measures ANOVA. Pairwise comparisons were subsequently conducted to determine whether treatment outcomes were sustained 1 year post-baseline assessment. Results indicate that post-intervention improvements in child conduct problems, parenting behaviour and parental mental health were maintained. Service use and associated costs continued to decline. The results indicate that parent-focused interventions, implemented in the early years, can result in improvements in child and parent behaviour and well-being 12 months later. A reduced reliance on formal services is also indicated.

  7. Randomized Controlled Trial of Education and Feedback for Implementation of Guidelines for Acute Low Back Pain

    PubMed Central

    Schectman, Joel M; Schroth, W Scott; Verme, Dante; Voss, John D

    2003-01-01

    OBJECTIVE The effect of clinical guidelines on resource utilization for complex conditions with substantial barriers to clinician behavior change has not been well studied. We report the impact of a multifaceted guideline implementation intervention on primary care clinician utilization of radiologic and specialty services for the care of acute low back pain. DESIGN Physician groups were randomized to receive guideline education and individual feedback, supporting patient education materials, both, or neither. The impact on guideline adherence and resource utilization was evaluated during the 12-month period before and after implementation. PARTICIPANTS Fourteen physician groups with 120 primary care physician and associate practitioners from 2 group model HMO practices. INTERVENTIONS Guideline implementation utilized an education/audit/feedback model with local peer opinion leaders. The patient education component included written and videotaped materials on the care of low back pain. MAIN RESULTS The clinician intervention was associated with an absolute increase in guideline-consistent behavior of 5.4% in the intervention group versus a decline of 2.7% in the control group (P = .04). The patient education intervention produced no significant change in guideline-consistent behavior, but was poorly adopted. Patient characteristics including duration of pain, prior history of low back pain, and number of visits during the illness episode were strong predictors of service utilization and guideline-consistent behavior. CONCLUSIONS Implementation of an education and feedback-supported acute low back pain care guideline for primary care clinicians was associated with an increase in guideline-consistent behavior. Patient education materials did not enhance guideline effectiveness. Implementation barriers could limit the utility of this approach in usual care setttings. PMID:14521638

  8. 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

  9. Enhancing a sustainable healthy working life: design of a clustered randomized controlled trial

    PubMed Central

    2010-01-01

    Background To improve a sustainable healthy working life, we have developed the intervention 'Staying healthy at work', which endeavours to enhance work participation of employees aged 45 years and older by increasing their problem-solving capacity and stimulating their awareness of their role and responsibility towards a healthy working life. This research study aims to evaluate the process and the effectiveness of the intervention compared with care as usual. Methods/design The study is a cluster-randomized controlled trial design (randomized at the supervisor level), with a 1-year follow-up. Workers aged 45 years and older have been enrolled in the study. Workers in the intervention group are receiving the intervention 'Staying healthy at work'. The main focus of the intervention is to promote a healthy working life of ageing workers by: (1) changing workers awareness and behaviour, by emphasizing their own decisive role in attaining goals; (2) improving the supervisors' ability to support workers in taking the necessary action, by means of enhancing knowledge and competence; and (3) enhancing the use of the human resource professionals and the occupational health tools available within the organization. The supervisors in the intervention group have been trained how to present themselves as a source of support for the worker. Workers in the control group are receiving care as usual; supervisors in the control group have not participated in the training. Measurements have been taken at baseline and will be followed up at 3, 6 and 12 months. The primary outcome measures are vitality, work ability and productivity. The secondary outcomes measures include fatigue, job strain, work attitude, self-efficacy and work engagement. A process evaluation will be conducted at both the supervisor and the worker levels, and satisfaction with the content of the intervention will be assessed. Discussion The intervention 'Staying healthy at work' has the potential to provide

  10. 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

  11. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial.

    PubMed

    Jeyamohan, Shiveindra B; Kenning, Tyler J; Petronis, Karen A; Feustel, Paul J; Drazin, Doniel; DiRisio, Darryl J

    2015-08-01

    OBJECT Anterior cervical discectomy and fusion (ACDF) is an effective procedure for the treatment of cervical radiculopathy and/or myelopathy; however, postoperative dysphagia is a significant concern. Dexamethasone, although potentially protective against perioperative dysphagia and airway compromise, could inhibit fusion, a generally proinflammatory process. The authors conducted a prospective, randomized, double-blinded, controlled study of the effects of steroids on swallowing, the airway, and arthrodesis related to multilevel anterior cervical reconstruction in patients who were undergoing ACDF at Albany Medical Center between 2008 and 2012. The objective of this study was to determine if perioperative steroid use improves perioperative dysphagia and airway edema. METHODS A total of 112 patients were enrolled and randomly assigned to receive saline or dexamethasone. Data gathered included demographics, functional status (including modified Japanese Orthopaedic Association myelopathy score, neck disability index, 12-Item Short-Form Health Survey score, and patient-reported visual analog scale score of axial and radiating pain), functional outcome swallowing scale score, interval postoperative imaging, fusion status, and complications/reoperations. Follow-up was performed at 1, 3, 6, 12, and 24 months, and CT was performed 6, 12, and 24 months after surgery for fusion assessment. RESULTS Baseline demographics were not significantly different between the 2 groups, indicating adequate randomization. In terms of patient-reported functional and pain-related outcomes, there were no differences in the steroid and placebo groups. However, the severity of dysphagia in the postoperative period up to 1 month proved to be significantly lower in the steroid group than in the placebo group (p = 0.027). Furthermore, airway difficulty and a need for intubation trended toward significance in the placebo group (p = 0.057). Last, fusion rates at 6 months proved to be

  12. 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

  13. The acceptance of three simultaneous vaccine injections recommended at 12 months of age.

    PubMed

    Hanna, Jeffrey N; Bullen, Ruth C; Andrews, Debora E

    2004-01-01

    Since January 2003, vaccination with Meningococcal C conjugate vaccine (MenCCV) is recommended at 12 months of age, at the same time as the measles-mumps-rubella (MMR) and Haemophilus influenzae type b (Hib) vaccines. Most (83%) of a cohort of 751 children in north Queensland born in January 2003 received the three injectable vaccines simultaneously. Of the 122 children who had not received MenCCV with the other two vaccines, 88 (72%) had received it by 18 months of age. The median age of receipt of MenCCV in the children who had received the three vaccines simultaneously was 12.3 months, whereas the median age in the children who had not received it at the same time as the other two vaccines was 14.0 months. This study suggests that non-simultaneous vaccination puts children at-risk of receiving MenCCV late, or not at all, and has implications for the introduction of universal infant pneumococcal vaccination program, starting in January 2005.

  14. Social Looking, Social Referencing and Humor Perception in 6-and-12-month-old Infants

    PubMed Central

    Mireault, Gina C.; Crockenberg, Susan C.; Sparrow, John E.; Pettinato, Christine A.; Woodard, Kelly C.; Malzac, Kirsten

    2014-01-01

    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-mos) 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

  15. 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

  16. A pandemic influenza vaccine in India: from strain to sale within 12 months.

    PubMed

    Dhere, Rajeev; Yeolekar, Leena; Kulkarni, Prasad; Menon, Ravi; Vaidya, Vivek; Ganguly, Milan; Tyagi, Parikshit; Barde, Prajakt; Jadhav, Suresh

    2011-07-01

    In the event of a highly pathogenic influenza pandemic, the Indian subcontinent would need 1.2 billion doses of vaccine to immunize its entire population, double if two doses were required to assure immunity. Serum Institute of India Limited (SII) thus became one of six initial grantees of the World Health Organization (WHO) technology transfer initiative to create capacity in developing countries to manufacture H5N1 pandemic influenza vaccine. At the outbreak of the A(H1N1) 2009 influenza pandemic, experience gained from the H5N1 project was used to develop a live attenuated influenza vaccine (LAIV), since this was the only option for the level of surge capacity required for a large-scale immunization campaign in India. SII took <12 months to develop and market its LAIV intranasal vaccine from receipt of the seed strain from WHO. As of November 2010, over 2.5 million persons have been vaccinated with Nasovac(®) with no serious adverse reactions or vaccine failure after 3 months' post-marketing surveillance. The product has been submitted for prequalification by WHO for purchase by United Nations agencies. In parallel, SII also developed an inactivated influenza vaccine, and is currently looking to ensure the sustainability of its influenza vaccine manufacturing capacity.

  17. Incidences of new prescribing by British child and adolescent psychiatrists: a prospective study over 12 months.

    PubMed

    Clark, Andrew F

    2004-03-01

    Little is known about the epidemiology of pharmacotherapy in the treatment of child psychiatric disorder. This study reports on the systematic prospective collection of instances of new prescribing by child and adolescent mental health services serving a population of approximately four million people in North West England. Diagnostic and demographic information regarding new prescribing by child and adolescent mental health services within Greater Manchester and Lancashire was systematically collected prospectively over two 6-month periods between 2000 and 2002. Within the 12 months studied, there were 845 instances of a drug being newly prescribed to a child or adolescent in the treatment of a psychiatric disorder. In total, 48 different drugs were prescribed for 25 different diagnoses. The eight most commonly prescribed drugs were methylphenidate, methylphenidate/placebo trial, paroxetine, fluoxetine, risperidone, imipramine, dexamphetamine and melatonin, accounting for 73% of all prescribing. There was marked variation between services in the amount of prescribing with significant correlation between prescription of stimulants and prescription of selective serotonin reuptake inhibitor antidepressants. Prescription of medications in the treatment of child psychiatric disorder has become a significant part of child and adolescent mental health practice. However, the evidence base underpinning this usage remains limited, and further high quality therapeutic clinical trials are urgently needed.

  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.

  19. 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.

  20. 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

  1. 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.

  2. 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

  3. The probable and the possible at 12 months: intuitive reasoning about the uncertain future.

    PubMed

    Cesana-Arlotti, Nicolò; Téglás, Erno; Bonatti, Luca L

    2012-01-01

    How do infants predict the next future event, when such a prediction requires estimating the event's probability? The literature suggests that adult humans often fail this task because their probability estimates are affected by heuristics and biases or because they can reason about the frequency of classes of events but not about the probability of single events. Recent evidence suggests instead that already at 12 months infants have an intuitive notion of probability that applies to single, never experienced events and that they may use it to predict what will happen next. We present a theory according to which infants' intuitive grasp of the probability of future events derives from their representation of logically consistent future possibilities. We compare it and other theories against the currently available data. Although the evidence does not speak uniquely in favor of one theory, the results presented and the theories currently being developed to account for them suggest that infants have surprisingly sophisticated reasoning abilities. These conclusions are incompatible with most current theories of adult logical and probabilistic reasoning. PMID:23205406

  4. 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

  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. A randomized controlled trial of home visits by neighborhood mentor mothers to improve children's nutrition in South Africa

    PubMed Central

    le Roux, Ingrid M.; le Roux, Karl; Mbeutu, Kwanie; Comulada, W. Scott; Desmond, Katherine A.; Rotheram-Borus, Mary Jane

    2011-01-01

    Malnourished children and babies with birth weights under 2500 g are at high risk for negative outcomes over their lifespans. Philani, a paraprofessional home visiting program, was developed to improve nutritional outcomes for young children in South Africa. One “mentor mother” was recruited from each of 37 neighborhoods in Cape Town, South Africa. Mentor mothers were trained to conduct home visits to weigh children under six years old and to support mothers to problem-solve life challenges, especially around nutrition. Households with underweight children were assigned randomly on a 2:1 ratio to the Philani program (n = 500) or to a standard care condition (n = 179); selection effects occurred and children in the intervention households weighed less at recruitment. Children were evaluated over a one-year period (n = 679 at recruitment and n = 638 with at least one follow-up; 94%). Longitudinal random effects models indicated that, over 12 months, the children in the intervention condition gained significantly more weight than children in the control condition. Mentor mothers who are positive peer deviants may be a viable strategy that is efficacious and can build community, and the use of mentor mothers for other problems in South Africa is discussed. PMID:22299019

  7. 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.

  8. 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

  9. Shamba Maisha: Randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes in Kenya

    PubMed Central

    WEISER, Sheri D.; BUKUSI, Elizabeth A.; STEINFELD, Rachel L.; FRONGILLO, Edward A.; WEKE, Elly; DWORKIN, Shari L.; PUSATERI, Kyle; SHIBOSKI, Stephen; SCOW, Kate; BUTLER, Lisa M.; COHEN, Craig R.

    2015-01-01

    Objectives Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. Design Pilot cluster randomized controlled trial Methods The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for one year. Data were collected on nutritional parameters, CD4 T lymphocyte counts, and HIV RNA. Difference in difference fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. Results We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/mm3, p<0.001) and proportion virologically suppressed in the intervention arm compared to the control arm (comparative improvement in proportion of 0.33 suppressed, OR 7.6, 95% CI: 2.2–26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, p<0.001) and frequency of food consumption (9.4 times per week greater frequency, p=0.013) compared to controls. Conclusion Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity. PMID:26214684

  10. De novo therapy with everolimus and reduced-exposure cyclosporine following pediatric kidney transplantation: a prospective, multicenter, 12-month study.

    PubMed

    Grushkin, Carl; Mahan, John D; Mange, Kevin C; Hexham, J Mark; Ettenger, Robert

    2013-05-01

    Prospective data regarding the de novo use of everolimus following kidney transplantation in children are sparse. In a prospective, 12-month, single-arm, open-label study, pediatric kidney transplant patients received everolimus (target trough concentration ≥3 ng/mL) with reduced-exposure CsA and corticosteroids, with or without basiliximab induction. Sixteen of the 18 patients completed the study on-treatment. Age range was 2-16 yr (mean 10.9 yr); eight patients received a living donor graft. Mean (s.d.) everolimus level was 7.4 (3.1) ng/mL during the first 12 months post-transplant. There were no cases of BPAR, graft loss, or death during the study. Protocol biopsies were performed at month 12 in seven patients, with subclinical (untreated) acute rejection diagnosed in one case. Mean (s.d.) estimated GFR (Schwartz formula) was 98 (34) mL/min/1.73 m(2) at month 12. Three patients experienced one or more serious adverse events with a suspected relation to study medication. One patient discontinued study medication due to post-transplant lymphoproliferative disease (5.6%). Everolimus with reduced-dose CsA and corticosteroids achieved good efficacy and renal function and was well tolerated in this small cohort of pediatric kidney transplant patients. Controlled trials are required to answer remaining questions about the optimal use of everolimus in this setting.

  11. 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

  12. Patient navigation and financial incentives to promote smoking cessation in an underserved primary care population: A randomized controlled trial protocol.

    PubMed

    Quintiliani, Lisa M; Russinova, Zlatka L; Bloch, Philippe P; Truong, Ve; Xuan, Ziming; Pbert, Lori; Lasser, Karen E

    2015-11-01

    Despite the high risk of tobacco-related morbidity and mortality among low-income persons, few studies have connected low-income smokers to evidence-based treatments. We will examine a smoking cessation intervention integrated into primary care. To begin, we completed qualitative formative research to refine an intervention utilizing the services of a patient navigator trained to promote smoking cessation. Next, we will conduct a randomized controlled trial combining two interventions: patient navigation and financial incentives. The goal of the intervention is to promote smoking cessation among patients who receive primary care in a large urban safety-net hospital. Our intervention will encourage patients to utilize existing smoking cessation resources (e.g., quit lines, smoking cessation groups, discussing smoking cessation with their primary care providers). To test our intervention, we will conduct a randomized controlled trial, randomizing 352 patients to the intervention condition (patient navigation and financial incentives) or an enhanced traditional care control condition. We will perform follow-up at 6, 12, and 18 months following the start of the intervention. Evaluation of the intervention will target several implementation variables: reach (participation rate and representativeness), effectiveness (smoking cessation at 12 months [primary outcome]), unintended consequences (e.g., purchase of illicit substances with incentive money), adoption (use of intervention across primary care suites), implementation (delivery of intervention), and maintenance (smoking cessation after conclusion of intervention). Improving the implementation of smoking cessation interventions in primary care settings serving large underserved populations could have substantial public health impact, reducing cancer-related morbidity/mortality and associated health disparities. PMID:26362691

  13. 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…

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. Verifying a multiprocessor cache controller using random case generation

    SciTech Connect

    Wood, D.A.; Gibson, G.A.; Katz, R.H. )

    1989-01-01

    The newest generation of cache controller chips provide coherency to support multiprocessor systems, i.e., the controllers coordinate access to the cache memories to guarantee a single global view of memory. The cache coherency protocols they implement complicate the controller design, making design verification difficult. In the design of the cache controller for SPUR, a shared memory multiprocessor designed and built at U.C. Berkeley, the authors developed a random tester to generate and verify the complex interactions between multiple processors in the the functional simulation. Replacing the CPU model, the tester generates memory references by randomly selecting from a script of actions and checks. The checks verify correct completion of their corresponding actions. The tester was easy to develop, and detected over half of the functional bugs uncovered during simulation. They used an assembly language version of the random tester to verify the prototype hardware. A multiprocessor system is operational; it runs the Sprite operating system and is being used for experiments in parallel programming.

  19. 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

  20. A Cluster Randomized Controlled Trial Evaluating the Efficacy of Peer Mentors to Support South African Women Living with HIV and Their Infants

    PubMed Central

    Rotheram-Borus, Mary Jane; Richter, Linda M.; van Heerden, Alastair; van Rooyen, Heidi; Tomlinson, Mark; Harwood, Jessica M.; Comulada, W. Scott; Stein, Alan

    2014-01-01

    Objective We evaluate the effect of clinic-based support by HIV-positive Peer Mentors, in addition to standard clinic care, on maternal and infant well-being among Women Living with HIV (WLH) from pregnancy through the infant's first year of life. Methods In a cluster randomized controlled trial in KwaZulu-Natal, South Africa, eight clinics were randomized for pregnant WLH to receive either: a Standard Care condition (SC; 4 clinics; n = 656 WLH); or an Enhanced Intervention (EI; 4 clinics; n = 544 WLH). WLH in the EI were invited to attend four antenatal and four postnatal meetings led by HIV-positive Peer Mentors, in addition to SC. WLH were recruited during pregnancy, and at least two post-birth assessment interviews were completed by 57% of WLH at 1.5, 6 or 12 months. EI's effect was ascertained on 19 measures of maternal and infant well-being using random effects regressions to control for clinic clustering. A binomial test for correlated outcomes evaluated EI's overall efficacy. Findings WLH attended an average of 4.1 sessions (SD = 2.0); 13% did not attend any sessions. Significant overall benefits were found in EI compared to SC using the binomial test. Secondarily, over time, WLH in the EI reported significantly fewer depressive symptoms and fewer underweight infants than WLH in the SC condition. EI WLH were significantly more likely to use one feeding method for six months and exclusively breastfeed their infants for at least 6 months. Conclusions WLH benefit by support from HIV-positive Peer Mentors, even though EI participation was partial, with incomplete follow-up rates from 6–12 months. Trial Registration ClinicalTrials.gov NCT00972699 PMID:24465444

  1. Extrinsic stain removal with a toothpowder: A randomized controlled trial

    PubMed Central

    Khan, Muhammad Khalil; Bokhari, Syed Akhtar Hussain; Haleem, Abdul; Kareem, Abdul; Khan, Ayyaz Ali; Hosein, Tasleem; Khan, Muhammad Usama

    2014-01-01

    Objectives The efficacy of a commercially available toothpowder was compared with toothpaste in removing extrinsic dental stains. Methods In this single-blind, randomized controlled trial, 77 volunteers were included from a residential professional college. All study subjects (control toothpaste users and test toothpowder users) plaque control measures. All study subjects were instructed to rinse with 5 ml 0.12% chlorhexidine mouthwash for 1 minute, twice and one cup of double tea bag solution three times daily for three weeks. Subjects were randomized into test (n=36) and control (n=36) groups. Toothpaste (control) and toothpowder (test) was used for two weeks to see the effects on removing stains on the labial surfaces of 12 anterior teeth. For measuring dental extrinsic stains Lobene Stain Index (SI) was used. Results The amount of stain following the use of toothpaste and toothpowder was more controlled with the experimental toothpowder. For all sites combined, there was evidence that the experimental toothpowder was significantly superior to toothpaste in reducing stain area (p<.001), stain intensity (p<.001) and composite/product (area × intensity) (p<.001). Conclusion Stain removing efficacy of toothpowder was significantly higher as compared with toothpaste. A toothpowder may be expected to be of benefit in controlling and removing extrinsic dental staining. PMID:25505862

  2. Outcome of anthroposophic medication therapy in chronic disease: A 12-month prospective cohort study

    PubMed Central

    Hamre, Harald J; Witt, Claudia M; Glockmann, Anja; Ziegler, Renatus; Kienle, Gunver S; Willich, Stefan N; Kiene, Helmut

    2008-01-01

    Background Anthroposophic medications (AMED) are prescribed in 56 countries. Objective To study clinical outcomes in patients prescribed AMED for chronic disease. Design Prospective cohort study. Setting 110 medical practices in Germany. Participants 665 consecutive outpatients aged 1–71 years, prescribed AMED for mental, respiratory, musculoskeletal, neurological, genitourinary, and other chronic diseases. Main outcomes Disease and Symptom Scores (physicians’ and patients’ assessment, 0–10) and SF-36. Results During the first six months, an average of 1.5 AMED per patient was used, in total 652 different AMED. Origin of AMED was mineral (8.0% of 652 AMED), botanical (39.0%), zoological (7.2%), chemically defined (13.0%), and mixed (33.0%). From baseline to six-month-follow-up, all outcomes improved significantly: Disease Score improved by mean 3.15 points (95% confidence interval 2.97–3.34, p < 0.001), Symptom Score by 2.43 points (2.23–2.63, p < 0.001), SF-36 Physical Component Summary by 3.04 points (2.16–3.91, p < 0.001), and SF-36 Mental Component Summary by 5.75 points (4.59–6.92, p < 0.001). All improvements were maintained at 12-month follow-up. Improvements were similar in adult men and women, in children, and in patients not using adjunctive therapies. Conclusion Outpatients using AMED for chronic disease had long-term reduction of disease severity and improvement of quality of life. PMID:19920891

  3. 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

  4. 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

  5. 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

  6. Rituximab in Children with Steroid-Dependent Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial

    PubMed Central

    Rossi, Roberta; Bonanni, Alice; Quinn, Robert R.; Sica, Felice; Bodria, Monica; Pasini, Andrea; Montini, Giovanni; Edefonti, Alberto; Belingheri, Mirco; De Giovanni, Donatella; Barbano, Giancarlo; Degl’Innocenti, Ludovica; Scolari, Francesco; Murer, Luisa; Reiser, Jochen; Fornoni, Alessia; Ghiggeri, Gian Marco

    2015-01-01

    Steroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from steroids or steroid-sparing agents. This open-label, noninferiority, randomized controlled trial at four sites in Italy tested whether rituximab is noninferior to steroids in maintaining remission in juvenile SDNS. We enrolled children age 1–16 years who had developed SDNS in the previous 6–12 months and were maintained in remission with high prednisone doses (≥0.7 mg/kg per day). We randomly assigned participants to continue prednisone alone for 1 month (control) or to add a single intravenous infusion of rituximab (375 mg/m2; intervention). Prednisone was tapered in both groups after 1 month. For noninferiority, rituximab had to permit steroid withdrawal and maintain 3-month proteinuria (mg/m2 per day) within a prespecified noninferiority margin of three times the levels among controls (primary outcome). We followed participants for ≥1 year to compare risk of relapse (secondary outcome). Fifteen children per group (21 boys; mean age, 7 years [range, 2.6–13.5 years]) were enrolled and followed for ≤60 months (median, 22 months). Three-month proteinuria was 42% lower in the rituximab group (geometric mean ratio, 0.58; 95% confidence interval, 0.18 to 1.95 [i.e., within the noninferiority margin of three times the levels in controls]). All but one child in the control group relapsed within 6 months; median time to relapse in the rituximab group was 18 months (95% confidence interval, 9 to 32 months). In the rituximab group, nausea and skin rash during infusion were common; transient acute arthritis occurred in one child. In conclusion, rituximab was noninferior to steroids for the treatment of juvenile SDNS. PMID:25592855

  7. Randomized Controlled Trials in Health Technology Assessment: Overkill or Overdue?

    PubMed Central

    Bentzen, Søren M.

    2012-01-01

    Evidence-based medicine has become a cornerstone in the development of radiation oncology and the randomized controlled phase III trial remains the gold standard for assessing differential benefits in clinical outcome between therapies. Health technologies aimed at improving treatment quality should primarily be tested using process measures or operational characteristics, the reason being that the sensitivity and specificity of clinical outcome is low for detecting quality improvements. The ongoing discussion of the relative merits of intensity modulated photon vs. proton radiotherapy is used to illustrate these concepts. Concerns over clinical and individual equipoise as well as the potential limitations of health economics considerations in this setting are also discussed. Working in a technology and science based medical discipline, radiation oncology researchers need to further develop methodology for critical assessment of health technologies as a complement to randomized controlled trials. PMID:18237799

  8. Randomized controlled trial of motivational enhancement therapy with nontreatment-seeking adolescent cannabis users: a further test of the teen marijuana check-up.

    PubMed

    Walker, Denise D; Stephens, Robert; Roffman, Roger; Demarce, Josephine; Lozano, Brian; Towe, Sheri; Berg, Belinda

    2011-09-01

    Cannabis use adversely affects adolescents and interventions that are attractive to adolescents are needed. This trial compared the effects of a brief motivational intervention for cannabis use with a brief educational feedback control and a no-assessment control. Participants were randomized into one of three treatment conditions: Motivational Enhancement Therapy (MET), Educational Feedback Control (EFC), or Delayed Feedback Control (DFC). Those who were assigned to MET and EFC were administered a computerized baseline assessment immediately following randomization and completed assessments at the 3- and 12-month follow-up periods. Participants in the DFC condition were not assessed until the 3-month follow-up. Following the completion of treatment sessions, all participants were offered up to four optional individual treatment sessions aimed at cessation of cannabis use. The research was conducted in high schools in Seattle, Washington. The participant s included 310 self-referred adolescents who smoked cannabis regularly. The main outcome measures included days of cannabis use, associated negative consequences, and engagement in additional treatment. At the 3-month follow-up, participants in both the MET and EFC conditions reported significantly fewer days of cannabis use and negative consequences compared to those in the DFC. The frequency of cannabis use was less in MET relative to EFC at 3 months, but it did not translate to differences in negative consequences. Reductions in use and problems were sustained at 12 months, but there were no differences between MET and EFC interventions. Engagement in additional treatment was minimal and did not differ by condition. Brief interventions can attract adolescent cannabis users and have positive impacts on them, but the mechanisms of the effects are yet to be identified.

  9. 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

  10. 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

  11. The Impact of Vitamin D3 Supplementation on Muscle Function among HIV-Infected Children and Young Adults: A Randomized Controlled Trial

    PubMed Central

    Brown, Justin C.; Schall, Joan I.; Rutstein, Richard M.; Leonard, Mary B.; Zemel, Babette S.; Stallings, Virginia A.

    2015-01-01

    Objectives We tested the hypothesis that daily vitD3 supplementation increases neuromuscular motor skills, jump power, jump energy, muscular force, and muscular strength. Methods This was a secondary analysis of a randomized controlled trial of 12-months of oral 7,000 IU/day vitD3 supplementation or placebo among 56 persons living with HIV aged 9–25 years. Neuromuscular motor skills were quantified using the Bruininks-Oseretsky Test of Motor Proficiency. Power was quantified using peak jump power, and energy was quantified using peak jump height. Muscular force was quantified using isometric ankle plantar- and dorsiflexion, isokinetic knee flexion and extension. Muscular strength was quantified using isometric handgrip strength. Results After 12-months, serum 25-hydroxyvitamin D [25(OH)D] was higher with supplementation versus placebo (β=12.1 ng/mL; P<0.001). In intention-to-treat analyses, supplementation improved neuromuscular motor skills versus placebo (β=1.14; P=0.041). We observed no effect of supplementation on jump power, jump energy, muscular force, or muscular strength outcomes versus placebo. Conclusions Among HIV-infected children and young adults supplementation with daily high-dose vitD3 increased concentration of serum 25(OH)D and improved neuromuscular motor skills versus placebo. PMID:26032206

  12. 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.

  13. 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

  14. 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

  15. Immunogenicity of poliovirus vaccines in chronically malnourished infants: a randomized controlled trial in Pakistan.

    PubMed

    Saleem, Ali Faisal; Mach, Ondrej; Quadri, Farheen; Khan, Asia; Bhatti, Zaid; Rehman, Najeeb Ur; Zaidi, Sohail; Weldon, William C; Oberste, Steven M; Salama, Maha; Sutter, Roland W; Zaidi, Anita K M

    2015-06-01

    Reaching high population immunity against polioviruses (PV) is essential to achieving global polio eradication. Efficacy of oral poliovirus vaccine (OPV) varies and is lower among children living in tropical areas with impoverished environments. Malnutrition found as a risk factor for lower serological protection against PV. We compared whether inactivated polio vaccine (IPV) can be used to rapidly close the immunity gap among chronically malnourished (stunted) infants in Pakistan who will not be eligible for the 14 week IPV dose in routine EPI schedule. A phase 3, multicenter 4-arm randomized controlled trial conducted at five Primary Health Care (PHC) centers in Karachi, Pakistan. Infants, 9-12 months were stratified by length for age Z score into chronically malnourished and normally nourished. Infants were randomized to receive one dose of either bivalent OPV (bOPV) alone or bOPV+IPV. Baseline seroprevalence of PV antibodies and serum immune response to study vaccine dose were assessed by neutralization assay. Vaccine PV shedding in stool was evaluated 7 days after a bOPV challenge dose. Sera and stool were analyzed from 852/928 (92%) enrolled children. At baseline, the seroprevalence was 85.6% (n=386), 73.6% (n=332), and 70.7% (n=319) in malnourished children against PV types 1, 2 and 3 respectively; and 94.1% (n=448), 87.0% (n=441) and 83.6% (n=397) in the normally nourished group (p<0.05). Children had previously received 9-10 doses of bOPV (80%) or tOPV (20%). One dose of IPV+bOPV given to malnourished children increased their serological protection (PV1, n=201, 97.6%; PV2, n=198, 96.1% and PV3, n=189, 91.7%) to parity with normally nourished children who had not received IPV (p=<0.001). Seroconversion and boosting for all three serotypes was significantly more frequent in children who received IPV+bOPV than in those with bOPV only (p<0.001) in both strata. Shedding of polioviruses in stool did not differ between study groups and ranged from 2.4% (n=5) to 7

  16. 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

  17. 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

  18. 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.

  19. 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.

  20. 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

  1. 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

  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. 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

  4. 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

  5. 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

  6. A randomized controlled trial to promote volunteering in older adults.

    PubMed

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention.

  7. 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.

  8. 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

  9. Validation of Placebo in a Manual Therapy Randomized Controlled Trial

    PubMed Central

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

    2015-01-01

    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months. PMID:26145718

  10. 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.

  11. 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

  12. 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

  13. Cognitive behavioral therapy for orthodontic pain control: a randomized trial.

    PubMed

    Wang, J; Jian, F; Chen, J; Ye, N S; Huang, Y H; Wang, S; Huang, R H; Pei, J; Liu, P; Zhang, L; Zhao, Z H; Chen, Q M; Lai, W L; Lin, Y F

    2012-06-01

    The objective of this study was to evaluate the efficacy of cognitive behavioral therapy intervention for patients who experienced pain during orthodontic treatment. The baseline characteristics were assessed via questionnaires and oral examinations. Four hundred and fifty eligible individuals were recruited and randomized by computer-generated block randomization into three groups: cognitive behavioral therapy intervention (n = 150), ibuprofen intervention (n = 150), and no intervention (control; n = 150). Primary outcomes were the change from baseline in pain intensity measured with 100-mm Visual Analog Scale (VAS) scores at 1, 2, 3, 7, 14, and 30 days after initial archwire placement. Outcomes assessment was blinded and followed the intention-to-treat principle. One hundred forty-three (95.30%), 145 (96.70%), and 141 (94.00%) individuals in the cognitive behavioral therapy, the ibuprofen, and the control groups, respectively, completed the one-month follow-up evaluations. Those in the cognitive behavioral therapy group showed a greater decrease in mean VAS scores than did those in the control group over the previous five time-points (p < 0.001). Cognitive behavioral therapy was shown to be effective in pain control during the initial stage of orthodontic treatment. The study registration number was ChiCTR-TRC-00000556.

  14. Biomimetic propulsion under random heaving conditions, using active pitch control

    NASA Astrophysics Data System (ADS)

    Politis, Gerasimos; Politis, Konstantinos

    2014-05-01

    Marine mammals travel long distances by utilizing and transforming wave energy to thrust through proper control of their caudal fin. On the other hand, manmade ships traveling in a wavy sea store large amounts of wave energy in the form of kinetic energy for heaving, pitching, rolling and other ship motions. A natural way to extract this energy and transform it to useful propulsive thrust is by using a biomimetic wing. The aim of this paper is to show how an actively pitched biomimetic wing could achieve this goal when it performs a random heaving motion. More specifically, we consider a biomimetic wing traveling with a given translational velocity in an infinitely extended fluid and performing a random heaving motion with a given energy spectrum which corresponds to a given sea state. A formula is invented by which the instantaneous pitch angle of the wing is determined using the heaving data of the current and past time steps. Simulations are then performed for a biomimetic wing at different heave energy spectra, using an indirect Source-Doublet 3-D-BEM, together with a time stepping algorithm capable to track the random motion of the wing. A nonlinear pressure type Kutta condition is applied at the trailing edge of the wing. With a mollifier-based filtering technique, the 3-D unsteady rollup pattern created by the random motion of the wing is calculated without any simplifying assumptions regarding its geometry. Calculated unsteady forces, moments and useful power, show that the proposed active pitch control always results in thrust producing motions, with significant propulsive power production and considerable beneficial stabilizing action to ship motions. Calculation of the power required to set the pitch angle prove it to be a very small percentage of the useful power and thus making the practical application of the device very tractable.

  15. 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

  16. 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).

  17. Once-yearly zoledronic acid and days of disability, bed rest, and back pain: randomized, controlled HORIZON Pivotal Fracture Trial.

    PubMed

    Cauley, Jane A; Black, Dennis; Boonen, Steven; Cummings, Steven R; Mesenbrink, Peter; Palermo, Lisa; Man, Zulema; Hadji, Peyman; Reid, Ian R

    2011-05-01

    The objective of this study was to determine the effect of once-yearly zoledronic acid on the number of days of back pain and the number of days of disability (ie, limited activity and bed rest) owing to back pain or fracture in postmenopausal women with osteoporosis. This was a multicenter, randomized, double-blind, placebo-controlled trial in 240 clinical centers in 27 countries. Participants included 7736 postmenopausal women with osteoporosis. Patients were randomized to receive either a single 15-minute intravenous infusion of zoledronic acid (5 mg) or placebo at baseline, 12 months, and 24 months. The main outcome measures were self-reported number of days with back pain and the number of days of limited activity and bed rest owing to back pain or a fracture, and this was assessed every 3 months over a 3-year period. Our results show that although the incidence of back pain was high in both randomized groups, women randomized to zoledronic acid experienced, on average, 18 fewer days of back pain compared with placebo over the course of the trial (p = .0092). The back pain among women randomized to zoledronic acid versus placebo resulted in 11 fewer days of limited activity (p = .0017). In Cox proportional-hazards models, women randomized to zoledronic acid were about 6% less likely to experience 7 or more days of back pain [relative risk (RR) = 0.94, 95% confidence interval (CI) 0.90-0.99] or limited activity owing to back pain (RR = 0.94, 95% CI 0.87-1.00). Women randomized to zoledronic acid were significantly less likely to experience 7 or more bed-rest days owing to a fracture (RR = 0.58, 95% CI 0.47-0.72) and 7 or more limited-activity days owing to a fracture (RR = 0.67, 95% CI 0.58-0.78). Reductions in back pain with zoledronic acid were independent of incident fracture. Our conclusion is that in women with postmenopausal osteoporosis, a once-yearly infusion with zoledronic acid over a 3-year period significantly reduced the

  18. 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.

  19. Choline-stabilized orthosilicic acid supplementation as an adjunct to Calcium/Vitamin D3 stimulates markers of bone formation in osteopenic females: a randomized, placebo-controlled trial

    PubMed Central

    Spector, Tim D; Calomme, Mario R; Anderson, Simon H; Clement, Gail; Bevan, Liisa; Demeester, Nathalie; Swaminathan, Rami; Jugdaohsingh, Ravin; Berghe, Dirk A Vanden; Powell, Jonathan J

    2008-01-01

    Background Mounting evidence supports a physiological role for silicon (Si) as orthosilicic acid (OSA, Si(OH)4) in bone formation. The effect of oral choline-stabilized orthosilicic acid (ch-OSA) on markers of bone turnover and bone mineral density (BMD) was investigated in a double-blind placebo-controlled trial. Methods Over 12-months, 136 women out of 184 randomized (T-score spine < -1.5) completed the study and received, daily, 1000 mg Ca and 20 μg cholecalciferol (Vit D3) and three different ch-OSA doses (3, 6 and 12 mg Si) or placebo. Bone formation markers in serum and urinary resorption markers were measured at baseline, and after 6 and 12 months. Femoral and lumbar BMD were measured at baseline and after 12 months by DEXA. Results Overall, there was a trend for ch-OSA to confer some additional benefit to Ca and Vit D3 treatment, especially for markers of bone formation, but only the marker for type I collagen formation (PINP) was significant at 12 months for the 6 and 12 mg Si dose (vs. placebo) without a clear dose response effect. A trend for a dose-corresponding increase was observed in the bone resorption marker, collagen type I C-terminal telopeptide (CTX-I). Lumbar spine BMD did not change significantly. Post-hoc subgroup analysis (baseline T-score femur < -1) however was significant for the 6 mg dose at the femoral neck (T-test). There were no ch-OSA related adverse events observed and biochemical safety parameters remained within the normal range. Conclusion Combined therapy of ch-OSA and Ca/Vit D3 had a potential beneficial effect on bone collagen compared to Ca/Vit D3 alone which suggests that this treatment is of potential use in osteoporosis. NTR 1029 PMID:18547426

  20. Three Phase III Randomized Controlled Trials of Topical Resiquimod 0.01-Percent Gel To Reduce Anogenital Herpes Recurrences

    PubMed Central

    Spruance, Spotswood; Kinghorn, George R.; Sacks, Stephen L.; Slade, Herbert B.; Meng, Tze-Chiang; Selke, Stacy; Magaret, Amalia; Wald, Anna

    2014-01-01

    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

  1. Predictors of 12-Month Outcome in Bulimia Nervosa and the Influence of Attitudes to Shape and Weight.

    ERIC Educational Resources Information Center

    Fairburn, Christopher G.; And Others

    1993-01-01

    Patients with bulimia nervosa were treated with either cognitive behavioral, behavioral, or a form of interpersonal psychotherapy for 19 sessions in an 18-week period. Assessments were made at pretreatment; posttreatment; and 4-, 8-, and 12-month follow-up. The nature of the relationship between attitudinal disturbance and outcome was complex and…

  2. 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

  3. 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...

  4. 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...

  5. 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...) crayfish, (4) wildfires, (5) prescribed fires, (6) recreation, and (7) urban and rural development. The potential impacts of nonnative crayfish are discussed here related to habitat alterations, and other...

  6. Disruptions in brain networks of older fallers are associated with subsequent cognitive decline: a 12-month prospective exploratory study.

    PubMed

    Hsu, Chun Liang; Voss, Michelle W; Handy, Todd C; Davis, Jennifer C; Nagamatsu, Lindsay S; Chan, Alison; Bolandzadeh, Niousha; Liu-Ambrose, Teresa

    2014-01-01

    Cognitive impairment and impaired mobility are major public health concerns. There is growing recognition that impaired mobility is an early biomarker of cognitive impairment and dementia. The neural basis for this association is currently unclear. We propose disrupted functional connectivity as a potential mechanism. In this 12-month prospective exploratory study, we compared functional connectivity of four brain networks- the default mode network (DMN), fronto-executive network (FEN), fronto-parietal network (FPN), and the primary motor sensory network (SMN)--between community-dwelling older adults with ≥ two falls in the last 12 months and their non-falling counterparts (≤ one fall in the last 12 months). Functional connectivity was examined both at rest and during a simple motor tapping task. Compared with non-fallers, fallers showed more connectivity between the DMN and FPN during right finger tapping (p  = 0.04), and significantly less functional connectivity between the SMN and FPN during rest (p ≤ 0.05). Less connectivity between the SMN and FPN during rest was significantly associated with greater decline in both cognitive function and mobility over the12-month period (r =  -0.32 and 0.33 respectively; p ≤ 0.04). Thus, a recent history of multiple falls among older adults without a diagnosis of dementia may indicate sub-clinical changes in brain function and increased risk for subsequent decline.

  7. 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…

  8. 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

  9. 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...

  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. 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.

  12. 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...

  13. 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

    ... published a 90-day finding in the Federal Register (71 FR 6241) determining that the petition did not..., 2008, we published a 12-month finding on the petition to list the Gunnison's prairie dog (73 FR 6660... notice of review process (73 FR 75175, December 20, 2008; 74 FR 57804, November 9, 2009; 75 FR...

  14. 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…

  15. 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…

  16. 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…

  17. 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…

  18. 76 FR 61895 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    .... ACTION: Notice of 12-month petition finding. SUMMARY: We, the U.S. Fish and Wildlife Service, announce a... finding is available for public inspection, by appointment, during normal business hours at the U.S. Fish... the Act (16 U.S.C. 1531 et seq.), requires that, for any petition to revise the Federal Lists...

  19. 76 FR 61855 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Cactus...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ...), pygmy-owls still occupy suitable habitat in northeastern Mexico and the pygmy-owl's distribution remains... Service, Interior. ACTION: Notice of 12-month petition finding. SUMMARY: We, the U.S. Fish and Wildlife... public inspection, by appointment, during normal business hours at the U.S. Fish and Wildlife...

  20. 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)....

  1. 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

    ...), who described the habitat as a dry, deciduous forest. After 1992, six additional populations of... 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...

  2. 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

    ..., diseased, rarely reproductive,'' and from only ``Deciduous Forest.'' Chapman et al. (2006) describe long... 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)....

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. Coblation tonsillectomy: a double blind randomized controlled study.

    PubMed

    Timms, M S; Temple, R H

    2002-06-01

    Tonsillectomy has been performed by a number of techniques. This double blind randomized controlled study compares the technique of tissue coblation with bipolar dissection for the removal of tonsils in 10 adult patients with a history of chronic tonsillitis. A significant reduction in post-operative pain and more rapid healing of the tonsillar fossae were found in the side removed by tissue coblation. There were no episodes of primary or secondary haemorrhage on either side. This new technique for tonsil removal warrants further study.

  10. Randomized controlled trial design in rheumatoid arthritis: the past decade

    PubMed Central

    Strand, Vibeke; Sokolove, Jeremy

    2009-01-01

    Much progress has occurred over the past decade in rheumatoid arthritis trial design. Recognized challenges have led to the establishment of a clear regulatory pathway to demonstrate efficacy of a new therapeutic. The use of pure placebo beyond 12 to 16 weeks has been demonstrated to be unethical and thus background therapy and/or early rescue has become regular practice. Goals of remission and 'treating to targets' may prove more relevant to identify real-world use of new and existing therapeutics. Identification of rare adverse events associated with new therapies has resulted in intensive safety evaluation during randomized controlled trials and emphasis on postmarketing surveillance and use of registries. PMID:19232061

  11. A Randomized Controlled Trial of Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in HIV-infected Individuals

    PubMed Central

    Safren, Steven A.; O’Cleirigh, Conall; Tan, Judy; Raminani, Sudha; Reilly, Laura C.; Otto, Michael W.; Mayer, Kenneth H.

    2008-01-01

    Objective To evaluate cognitive behavioral therapy to enhance medication adherence and reduce depression (CBT-AD) in individuals with HIV. Design A two arm, randomized, controlled, cross-over trial comparing CBT-AD, to enhanced treatment as usual only (ETAU). ETAU, which both groups received, included a single-session intervention for adherence and a letter to the patient’s provider documenting her or his continued depression. The intervention group also received 10 to 12 sessions of CBT-AD. Main Outcome Measures Adherence to antiretroviral therapy as assessed by Medication Event Monitoring Systems (MEMs) and depression as assessed by blinded structured evaluation. Results At the acute outcome assessment (3-months), those who received CBT-AD evidenced significantly greater improvements in medication adherence and depression relative to the comparison group. Those who were originally assigned to the comparison group who chose to cross over to CBT-AD showed similar improvements in both depression and adherence outcomes. Treatment gains for those in the intervention group were generally maintained at 6 and 12-month follow-up assessments. By the end of the follow-up period, those originally assigned CBT-AD demonstrated improvements in plasma HIV RNA concentrations, though these differences did not emerge before the cross-over, and hence there were not between-group differences. Conclusions CBT-AD is a potentially efficacious approach for individuals with HIV struggling with depression and adherence. Replication and extension in larger efficacy trials are needed. PMID:19210012

  12. Factors associated with high use of a workplace web-based stress management program in a randomized controlled intervention study.

    PubMed

    Hasson, H; Brown, C; Hasson, D

    2010-08-01

    In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program including health screening tool, diary and information about stress was offered to the control group. Additional materials, i.e. interactive, cognitive-based and classical stress management exercises and a chat room, were offered to the intervention group. Baseline data regarding participants' demographics, health (self-ratings and biological measures), lifestyle, work-related factors and group membership were analyzed to study determinants of employees' participation in the program during a period of 12 months. Multiple logistic regression analysis was used and found intervention group membership, being a woman, having at most a secondary education, regular physical exercise habits and having positive expectations of the program were significant predictors of high use. The findings demonstrate that the interactivity of a web-based program is an important factor for determining participation in a web-based worksite stress management program. Implications for those developing and implementing future web-based health promotion activities are discussed. PMID:20150531

  13. 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

  14. 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…

  15. 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

  16. A multicomponent behavioral intervention to reduce stroke risk factor behaviors: The SHARE Cluster-Randomized Controlled Trial

    PubMed Central

    Brown, Devin L.; Conley, Kathleen M.; Sánchez, Brisa N.; Resnicow, Kenneth; Cowdery, Joan E.; Sais, Emma; Murphy, Jillian; Skolarus, Lesli E.; Lisabeth, Lynda D.; Morgenstern, Lewis B.

    2015-01-01

    Background and Purpose The Stroke Health and Risk Education (SHARE) Project was a cluster-randomized, faith-based, culturally-sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Methods Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the three outcomes was significant at the 0.05/3 level. Results Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53; 84% were Hispanic/Latino; 64% were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day (95% CI: 0.08, 0.42), p = 0.002), a greater decrease in sodium intake (−123.17 mg/day (−194.76, −51.59), p=0.04), but no difference in change in moderate or greater intensity physical activity (−27 MET-minutes per week (−526, 471), p=0.56). Conclusions This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary endpoint. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. PMID:26374480

  17. 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

  18. Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial.

    PubMed

    Taverner, Murray; Loughnan, Terence

    2014-02-01

    Shoulder pain is the third most common musculoskeletal problem and accounts for 5% of general practitioner consultations. Although many treatments are described, there is no consensus on optimal treatment and up to 40% of patients still have pain 12 months after initially seeking help for pain. Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT. Patients were assessed at 4 and 12 weeks by a blinded observer and compared with baseline. We observed sustained reductions in pain at night, pain with activity, and functional improvement at 4 and 12 weeks with active but not sham TCPRFT. The 25 subjects who received active treatment showed statistically significant reductions of 24/100 in pain at night and 20/100 of pain with activity at 4 weeks and 18/100 and 19/100, respectively, at 12 weeks from baseline. Statistically significant lower Brief Pain Inventory pain and function scores (4 and 12 weeks), improved pain self-efficacy (4 weeks), Oxford Shoulder scores (12 weeks), and internal rotation (12 weeks) were seen. Pain at both rest and shoulder elevation were not improved by active treatment. No complications were seen. This study of a simple, low risk, outpatient treatment confirms the findings of our earlier study of TCPRFT for knee pain and shoulder pain audit that transcutaneous pulsed radiofrequency treatment may help some people with painful shoulders.

  19. Brief Intervention Decreases Drinking Frequency in HIV-Infected, Heavy Drinking Women: Results of a Randomized Controlled Trial

    PubMed Central

    Chander, Geetanjali; Hutton, Heidi E.; Lau, Bryan; Xu, Xiaoqiang; McCaul, Mary E.

    2015-01-01

    Objective Hazardous alcohol use by HIV-infected women is associated with poor HIV outcomes and HIV transmission risk behaviors. We examined the effectiveness of brief alcohol intervention (BI) among hazardous drinking women receiving care in an urban, HIV clinic. Methods Women were randomized to a 2-session BI or usual care. Outcomes assessed at baseline, 3, 6 and 12 months included 90-day frequency of any alcohol use and heavy/binge drinking (≥4 drinks per occasion), and average drinks per drinking episode. Secondary outcomes included HIV medication and appointment adherence, HIV1-RNA suppression, and days of unprotected vaginal sex. We examined intervention effectiveness using generalized mixed effect models and quantile regression. Results Of 148 eligible women, 74 were randomized to each arm. In mixed effects models, 90-day drinking frequency decreased among intervention group compared to control, with women in the intervention condition less likely to have a drinking day (OR: 0.42 (95% CI: 0.23–0.75). Heavy/binge drinking days and drinks per drinking day did not differ significantly between groups. Quantile regression demonstrated a decrease in drinking frequency in the middle to upper ranges of the distribution of drinking days and heavy/binge drinking days that differed significantly between intervention and control conditions. At follow-up, the intervention group had significantly fewer episodes of unprotected vaginal sex. No intervention effects were observed for other outcomes. Conclusions Brief alcohol intervention reduces frequency of alcohol use and unprotected vaginal sex among HIV-infected women. More intensive services may be needed to lower drinks per drinking day and enhance care for more severely affected drinkers. PMID:25967270

  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. 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

  2. Online psychoeducational support for infertile women: a randomized controlled trial

    PubMed Central

    Cousineau, Tara M.; Green, Traci C.; Corsini, Evelyn; Seibring, A; Showstack, Marianne T.; Applegarth, Linda; Davidson, Marie; Perloe, Mark

    2008-01-01

    BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress (P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices. PMID:18089552

  3. 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

  4. 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

  5. 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

  6. Effect of block-periodized exercise training on bone and coronary heart disease risk factors in early post-menopausal women: a randomized controlled study.

    PubMed

    Kemmler, W; Bebenek, M; von Stengel, S; Engelke, K; Kalender, W A

    2013-02-01

    The purpose of this 12 month randomized exercise intervention was to determine the effect of a block-periodized multipurpose exercise program on bone mineral density (BMD) and parameters of the metabolic syndrome (MetS) in early post-menopausal women. Eighty-five subjects (52.3 ± 2.4 years) living in the area of Erlangen (Germany) were randomly assigned into an exercise (EG, n=43) or a wellness-control group (CG: n=42). The EG performed a periodized multipurpose exercise program with 4-6-week blocks of high-intensity bone-specific exercise intermitted by 10-12 weeks of exercise dedicated to increase endurance and reduce cardiac and metabolic risk factors. The CG performed a low-volume/low-intensity "wellness" program to increase well-being. After 12 months, significant exercise effects were observed for the lumbar spine (LS) BMD as assessed by quantitative computed tomography [total BMD (EG: -0.3 ± 2.1% vs CG: -2.1 ± 2.2%, P=0.015); trabecular BMD (EG: -0.7 ± 3.4% vs CG: -4.7 ± 4.9%, P=0.001) and dual-energy x-ray absorptiometry (DXA) (EG: -0.1 ± 2.2% vs CG: -2.0 ± 2.0%, P=0.002)]. However, no significant effects were observed for total hip BMD as assessed by DXA (P=0.152). Although all MetS parameters were favorably affected among the EG, only the effect for waist circumference was significant. In summary, short periods of bone-specific intervention embedded in longer periods of exercises dedicated to improve cardiovascular and metabolic risk factors positively affected BMD at the LS.

  7. 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.

  8. Randomized Controlled Trial of Calcitriol in Severe Sepsis

    PubMed Central

    Raed, Anas; Donnino, Michael W.; Ginde, Adit A.; Waikar, Sushrut S.

    2014-01-01

    Rationale: Vitamin D and its metabolites have potent immunomodulatory effects in vitro, including up-regulation of cathelicidin, a critical antimicrobial protein. Objectives: We investigated whether administration of 1,25-dihydroxyvitamin D (calcitriol) to critically ill patients with sepsis would have beneficial effects on markers of innate immunity, inflammation, and kidney injury. Methods: We performed a double-blind, randomized, placebo-controlled, physiologic study among 67 critically ill patients with severe sepsis or septic shock. Patients were randomized to receive a single dose of calcitriol (2 μg intravenously) versus placebo. The primary outcome was plasma cathelicidin protein levels assessed 24 hours after study drug administration. Secondary outcomes included leukocyte cathelicidin mRNA expression, plasma cytokine levels (IL-10, IL-6, tumor necrosis factor-α, IL-1β, and IL-2), and urinary kidney injury markers. Measurements and Main Results: Patients randomized to calcitriol (n = 36) versus placebo (n = 31) had similar plasma cathelicidin protein levels at 24 hours (P = 0.16). Calcitriol-treated patients had higher cathelicidin (P = 0.04) and IL-10 (P = 0.03) mRNA expression than placebo-treated patients 24 hours after study drug administration. Plasma cytokine levels (IL-10, IL-6, tumor necrosis factor-α, IL-1β, and IL-2) and urinary kidney injury markers were similar in calcitriol- versus placebo-treated patients (P > 0.05 for all comparisons). Calcitriol had no effect on clinical outcomes nor were any adverse effects observed. Conclusions: Calcitriol administration did not increase plasma cathelicidin protein levels in critically ill patients with sepsis and had mixed effects on other immunomodulatory markers. Additional phase II trials investigating the dose and timing of calcitriol as a therapeutic agent in specific sepsis phenotypes may be warranted. Clinical trial registered with www.clinicaltrials.gov (NCT 01689441). PMID:25029202

  9. 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

  10. Effects of salt substitute on pulse wave analysis among individuals at high cardiovascular risk in rural China: a randomized controlled trial.

    PubMed

    Hu, Jihong; Jiang, Xiongjing; Li, Nicole; Yu, Xuequn; Perkovic, Vlado; Chen, Bailing; Zhao, Liancheng; Neal, Bruce; Wu, Yangfeng

    2009-04-01

    Reduced-sodium, increased-potassium salt substitutes lower blood pressure but may also have direct effects on vascular structure and arterial function. This study aimed to test the effects of long-term salt substitution on indices of these outcomes. The China Salt Substitute Study was a randomized, controlled trial designed to establish the effects of salt substitute (65% sodium chloride, 25% potassium chloride, 10% magnesium sulfate) compared with regular salt (100% sodium chloride) on blood pressure among 600 high-risk individuals living in six rural areas in northern China over a 12-month intervention period. Data on central aortic blood pressure, aortic pressure augmentation (AUG), augmentation index (AIx), the differences of the peak of first and baseline waves (P(1)-P(0)) and pulse wave reflection time (RT) were collected at randomization and at the completion of follow-up in 187 participants using the Sphygmocor pulse wave analysis system. Mean baseline blood pressure was 150.1/91.4 mm Hg, mean age was 58.4 years, 41% were male and three quarters had a history of vascular disease. After 12 months of intervention, there were significant net reductions in peripheral (7.4 mm Hg, P=0.009) and central (6.9 mm Hg, P=0.011) systolic blood pressure levels and central pulse pressure (4.5 mm Hg, P=0.012) and correspondingly there was a significant net reduction in P(1)-P(0) (3.0 mm Hg, P=0.007), borderline significant net reduction in AUG (1.5 mm Hg, P=0.074) and significant net increase in RT (2.59 ms, P=0.001). There were no detectable reductions in peripheral (2.8 mm Hg, P=0.14) or central (2.4 mm Hg, P=0.13) diastolic blood pressure levels or AIx (0.06%, P=0.96). In conclusion, over the 12-month study period the salt substitute significantly reduced not only peripheral and central systolic blood pressure but also reduced arterial stiffness.

  11. 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

  12. 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

  13. The Saving and Empowering Young Lives in Europe (SEYLE) Randomized Controlled Trial (RCT): methodological issues and participant characteristics

    PubMed Central

    2013-01-01

    Background Mental health problems and risk behaviours among young people are of great public health concern. Consequently, within the VII Framework Programme, the European Commission funded the Saving and Empowering Young Lives in Europe (SEYLE) project. This Randomized Controlled Trial (RCT) was conducted in eleven European countries, with Sweden as the coordinating centre, and was designed to identify an effective way to promote mental health and reduce suicidality and risk taking behaviours among adolescents. Objective To describe the methodological and field procedures in the SEYLE RCT among adolescents, as well as to present the main characteristics of the recruited sample. Methods Analyses were conducted to determine: 1) representativeness of study sites compared to respective national data; 2) response rate of schools and pupils, drop-out rates from baseline to 3 and 12 month follow-up, 3) comparability of samples among the four Intervention Arms; 4) properties of the standard scales employed: Beck Depression Inventory, Second Edition (BDI-II), Zung Self-Rating Anxiety Scale (Z-SAS), Strengths and Difficulties Questionnaire (SDQ), World Health Organization Well-Being Scale (WHO-5). Results Participants at baseline comprised 12,395 adolescents (M/F: 5,529/6,799; mean age=14.9±0.9) from Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain. At the 3 and 12 months follow up, participation rates were 87.3% and 79.4%, respectively. Demographic characteristics of participating sites were found to be reasonably representative of their respective national population. Overall response rate of schools was 67.8%. All scales utilised in the study had good to very good internal reliability, as measured by Cronbach’s alpha (BDI-II: 0.864; Z-SAS: 0.805; SDQ: 0.740; WHO-5: 0.799). Conclusions SEYLE achieved its objective of recruiting a large representative sample of adolescents within participating European countries. Analysis

  14. 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

  15. 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

  16. The influence of infant-directed speech on 12-month-olds' intersensory perception of fluent speech.

    PubMed

    Kubicek, Claudia; Gervain, Judit; Hillairet de Boisferon, Anne; Pascalis, Olivier; Lœvenbruck, Hélène; Schwarzer, Gudrun

    2014-11-01

    The present study examined whether infant-directed (ID) speech facilitates intersensory matching of audio-visual fluent speech in 12-month-old infants. German-learning infants' audio-visual matching ability of German and French fluent speech was assessed by using a variant of the intermodal matching procedure, with auditory and visual speech information presented sequentially. In Experiment 1, the sentences were spoken in an adult-directed (AD) manner. Results showed that 12-month-old infants did not exhibit a matching performance for the native, nor for the non-native language. However, Experiment 2 revealed that when ID speech stimuli were used, infants did perceive the relation between auditory and visual speech attributes, but only in response to their native language. Thus, the findings suggest that ID speech might have an influence on the intersensory perception of fluent speech and shed further light on multisensory perceptual narrowing.

  17. Screening for Autism Spectrum Disorders in 12-Month-Old High-Risk Siblings by Parental Report

    PubMed Central

    Macari, Suzanne; Chen, Grace; Campbell, Daniel; Leventhal, John M.; Weitzman, Carol; Chawarska, Katarzyna

    2014-01-01

    This study examines whether parental report of social-communicative and repetitive behaviors at 12 months can be helpful in identifying autism spectrum disorder (ASD) in younger siblings of children with ASD [high-risk (HR)-siblings]. Parents of HR-siblings and infants without a family history of ASD completed the First Year Inventory at 12 months. Developmental outcomes were based on 24- or 36-month assessments. HR-siblings later diagnosed with ASD showed greater impairments in social communication than those with other developmental outcomes based on parental and clinician ratings. Parental report of decline in play and communication and impaired vocal imitation correctly classified a majority of ASD cases with high specificity. These preliminary findings have important implications for the development of early screening instruments for ASD in HR-siblings. PMID:25149178

  18. Development of socio-communicative skills in 9- to 12-month-old individuals with fragile X syndrome.

    PubMed

    Marschik, Peter B; Bartl-Pokorny, Katrin D; Sigafoos, Jeff; Urlesberger, Leo; Pokorny, Florian; Didden, Robert; Einspieler, Christa; Kaufmann, Walter E

    2014-03-01

    We investigated the early socio-communicative development of individuals with fragile X syndrome (FXS) by undertaking a retrospective analysis of family videos. Videos were analyzed to identify existing communicative forms and functions. Analyses were undertaken on seven children who were later diagnosed with FXS. The children were filmed when they were 9-12 months old and before being diagnosed. Fourteen different communicative forms and six different communicative functions were observed. All participants were observed to express the functions of 'Attention to self' and 'Answering', but none indicated 'Requesting action', 'Requesting information', 'Choice making', or 'Imitating'. Results suggest that children with FXS may have a limited range of communicative forms and functions when they are from 9 to 12 months of age. However, further research is necessary to gain a specific developmental profile of socio-communicative forms and functions in FXS.

  19. Diabetes Prevention in Hispanics: Report From a Randomized Controlled Trial

    PubMed Central

    Carosso, Elizabeth; Mariscal, Norma; Islas, Ilda; Ibarra, Genoveva; Holte, Sarah; Copeland, Wade; Linde, Sandra; Thompson, Beti

    2014-01-01

    Introduction Hispanics are at increased risk of developing type 2 diabetes. Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation. Methods We recruited Hispanic men and women (N = 320) who were residents of the Lower Yakima Valley, Washington, aged 18 years or older with hemoglobin A1c (HbA1c) levels higher than 6% to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012. The trial compared participants in the intervention arm, who received an immediate educational curriculum (n = 166), to participants in the control arm, who received a delayed educational curriculum (n = 154). The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes, diabetes treatment, and healthy dietary and physical activity behaviors. Participants were randomly assigned to the intervention and control arms, and analysts were blinded as to participant arm. We evaluated intervention effects on HbA1c levels; frequency (times per week) of fruit and vegetable consumption; and frequency (times per week) of mild, moderate, and strenuous leisure-time physical activity. At baseline, 3 months, and 6 months after randomization, participants completed a questionnaire and provided a blood sample. Analysts were blinded to intervention arm. Results The immediate intervention group (−0.64% [standard error (SE) 0.10]) showed a significant improvement in HbA1c scores (–37.5%, P = .04) compared with the delayed intervention group (–0.44%, P = .14). No significant changes were seen for dietary end points or changes in physical activity. We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group. Conclusion This home-based intervention delivered by CHWs was associated with a clinically and statistically

  20. 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

  1. Implementing lessons learned from previous bronchial biopsy trials in a new randomized controlled COPD biopsy trial with roflumilast

    PubMed Central

    2014-01-01

    Background Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease mediated by an array of inflammatory cells and mediators, but above all, CD8+ T-lymphocytes, macrophages and neutrophils are important players in disease pathogenesis. Roflumilast, a first-in-class, potent and selective phosphodiesterase 4 (PDE4) inhibitor, reduces the rate of exacerbations in patients with a high risk of future exacerbations and has been shown to reduce inflammatory cells and mediators in induced sputum, a surrogate of airway inflammation. However, these anti-inflammatory effects are yet to be confirmed in another robust study directly assessing inflammatory markers in bronchial sub-mucosa. Methods/Design An international, 16-week, randomized, double-blind, placebo-controlled, parallel-group study investigating the effects of roflumilast 500 μg once-daily versus placebo on inflammatory parameters in bronchial biopsy tissue specimens, sputum and blood serum. One hundred and fifty patients with COPD and chronic bronchitis for at least 12 months will be recruited into the study and randomized in a 1:1 ratio to receive either roflumilast or placebo. The primary endpoint will be the number of CD8+ cells (cell counts per mm2) in bronchial biopsy tissue specimens (sub-mucosa) and the key secondary endpoint will be the number of CD68+ cells (cell counts per mm2), assessed by indirect immunohistochemistry. Discussion It is hypothesized that treatment with roflumilast reduces the characteristic inflammation found in the airways of patients with moderate-to-severe COPD, compared with placebo. The design of the present study has built on the work of previous bronchial biopsy studies available in the literature. It is hoped that it will reveal the cellular mechanisms underlying the anti-inflammatory effects of roflumilast and identify potentially important biomarkers and other surrogate endpoints in patients with COPD. The design and rationale for this trial are

  2. 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

  3. Effect of Collaborative Care for Depression on Risk of Cardiovascular Events: Data from the IMPACT Randomized Controlled Trial

    PubMed Central

    Stewart, Jesse C.; Perkins, Anthony J.; Callahan, Christopher M.

    2014-01-01

    Objective Although depression is a risk and prognostic factor for cardiovascular disease (CVD), depression trials involving cardiac patients have not observed the anticipated cardiovascular benefits. To test our hypothesis that depression treatment delivered before clinical CVD onset reduces risk of CVD events, we conducted an 8-year follow-up study of the Indiana sites of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) randomized controlled trial. Methods Participants were 235 primary care patients aged ≥60 years with major depression or dysthymia who were randomized to a 12-month collaborative care program involving antidepressants and psychotherapy (85 without and 35 with baseline CVD) or usual care (83 without and 32 with baseline CVD). Hard CVD events (fatal/nonfatal) were identified using electronic medical record and Medicare/Medicaid data. Results 119 patients (51%) had a hard CVD event. As hypothesized, the Treatment x Baseline CVD interaction was significant (p = .021). IMPACT patients without baseline CVD had a 48% lower risk of an event than Usual Care patients (28% vs. 47%, HR = 0.52, 95% CI: 0.31–0.86). The number needed to treat to prevent one event over five years was 6.1. The likelihood of an event did not differ between IMPACT and Usual Care patients with baseline CVD (86% vs. 81%, HR = 1.19, 95% CI: 0.70–2.03). Conclusions Collaborative depression care delivered before CVD onset halved the excess risk of hard CVD events among older, depressed patients. Our findings raise the possibility that the IMPACT intervention could be used as a CVD primary prevention strategy. Trial Registration clinicaltrials.gov Identifier: NCT01561105 (http://clinicaltrials.gov/ct2/show/NCT01561105) PMID:24367124

  4. Results of a second year of therapy with the 12-month histrelin implant for the treatment of central precocious puberty.

    PubMed

    Rahhal, Samar; Clarke, William L; Kletter, Gad B; Lee, Peter A; Neely, E Kirk; Reiter, Edward O; Saenger, Paul; Shulman, Dorothy; Silverman, Lawrence; Eugster, Erica A

    2009-01-01

    Background. Gonadotropin releasing hormone analogs (GnRHas) are standard of care for central precocious puberty (CPP). The histrelin subcutaneous implant is safe and effective in the treatment of CPP for one year. Objective. The study evaluates a second year of therapy in children with CPP who received a new implant after one year of treatment. Methods. A prospective one-year study following an initial 12-month treatment period was conducted. Results. Thirty-one patients (29 girls) aged 7.7 +/- 1.5 years received a second implant. Eighteen were naïve to GnRHa therapy at first implantation. Peak LH declined from 0.92 +/- 0.58 mIU/mL at 12 months to 0.51 +/- 0.33 mIU/mL at 24 months (P < .0001) in naïve subjects, and from 0.74 +/- 0.50 mIU/mL at 12 months to 0.45 +/- 0.35 mIU/mL at 24 months (P = .0081) in previously treated subjects. Predicted adult height increased by 5.1 cm at 24 months (P = .0001). Minor implant site reactions occurred in 61%, while minor difficulties with explantation occurred in 32.2% of subjects. Conclusion. The histrelin implant demonstrates profound hypothalamic-pituitary-gonadal axis suppression when a new implant is placed for a second year of treatment. Prospective follow-up of this therapeutic modality for the treatment of CPP is needed.

  5. A comparison of the carcass and meat quality of Martina Franca donkey foals aged 8 or 12 months.

    PubMed

    Polidori, Paolo; Pucciarelli, Stefania; Ariani, Ambra; Polzonetti, Valeria; Vincenzetti, Silvia

    2015-08-01

    The effects of slaughter age (8 vs 12 months) were investigated on meat and carcass quality obtained from Martina Franca donkey foals. Sixteen male foals were used, eight were slaughtered at 8 months of age with a mean (±s.e.) final body weight of 101±18kg and the remaining 8 foals slaughtered at 12 months of age with a mean final body weight of 122±13kg. Carcass weight and dressing percentage were higher (P<0.05) in older foals. Shear force value was lower (P<0.05) in donkeys slaughtered at 8 months of age (54.03N) compared to the same muscle Longissimus Thoracis et Lumborum (LTL) collected in older animals (62.66N). Muscle glycogen content was higher (P<0.05) in foals slaughtered at 12months of age. Donkey foal meat showed an interesting content of essential amino acids and a notable percentage of unsaturated fatty acids in both groups of animals, giving a high nutritional value to this alternative red meat.

  6. Identification of infants at risk for autism spectrum disorder and developmental language delay prior to 12 months.

    PubMed

    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

    2015-04-01

    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 disorder and developmental learning delay, not affected by literacy or primary parental language, and provide immediate determination of risk for autism spectrum disorder. An abrupt head circumference acceleration and the absence of head tilt reflex by 9 months were used to identify infants at risk for autism spectrum disorder. Stability of early findings was then investigated when compared to comprehensive standardized neurodevelopmental assessment results and complete neurological and genetics evaluations. A total of 1024 typically developing infants were enrolled by 9 months, with 14 identified as at risk for autism spectrum disorder and 33 for developmental learning delay. There was a good positive predictive value for the identification of autism spectrum disorder prior to 12 months. This study demonstrates an efficient means to identify infants at risk for autism spectrum disorder by 9 months of age and serves to alert primary care providers of infants who are vulnerable for autism spectrum disorder before symptoms are discernible by clinical judgment of primary care providers, parental concerns, or by screening questionnaires.

  7. The impact of sport and active recreation injuries on physical activity levels at 12 months post-injury.

    PubMed

    Andrew, N; Wolfe, R; Cameron, P; Richardson, M; Page, R; Bucknill, A; Gabbe, B

    2014-04-01

    The aim of this study was to evaluate the impact of serious sport and active recreation injury on 12-month physical activity levels. Adults admitted to hospital with sport and active recreation-related injuries, and captured by the Victorian Orthopaedic Trauma Outcomes Registry were recruited to the study. Changes between preinjury and 12 month post-injury physical activity was assessed using the short International Physical Activity Questionnaire (IPAQ). Independent demographic, injury, and hospital variables were assessed for associations with changes in physical activity levels, using multivariate linear regression. A total of 324 patients were recruited, of which 98% were followed up at 12 months. Mean short IPAQ scores decreased from 7650 METS (95% CI: 7180, 8120) preinjury to 3880 METS; (95% CI: 3530, 4250) post-injury, independent of functional recovery. Education level and occupation group were the only variables independently associated with changes in physical activity levels post-injury. These results highlighted that sport and active recreation injuries lead to significant reductions in physical activity levels. Hence, the prevention of sport and active recreation injuries is important when considering promotion of activity at a population level.

  8. Maternal prenatal felt security and infant health at birth interact to predict infant fussing and crying at 12 months postpartum.

    PubMed

    Sawada, Natsumi; Gagné, Faby M; Séguin, Louise; Kramer, Michael S; McNamara, Helen; Platt, Robert W; Goulet, Lise; Meaney, Michael J; Lydon, John E

    2015-08-01

    Infants born with medical problems are at risk for less optimal developmental outcomes. This may be, in part, because neonatal medical problems are associated with maternal distress, which may adversely impact infants. However, the reserve capacity model suggests that an individual's bank of psychosocial resources buffers the adverse effects of later-encountered stressors. This prospective longitudinal study examined whether preexisting maternal psychosocial resources, conceptualized as felt security in close relationships, moderate the association between neonatal medical problems and infant fussing and crying 12 months postpartum. Maternal felt security was measured by assessing its indicators in 5,092 pregnant women. At birth, infants were classified as healthy or having a medical problem. At 12 months, experience sampling was used to assess daily maternal reports of fussing and crying in 135 mothers of infants who were healthy or had medical problems at birth. Confirmatory factor analyses revealed that attachment, relationship quality, self-esteem, and social support can be conceptualized as indicators of a single felt security factor. Multiple regression analyses revealed that prenatal maternal felt security interacts with infant health at birth to predict fussing and crying at 12 months. Among infants born with medical problems, higher felt security predicted decreased fussing and crying. Maternal felt security assessed before birth dampens the association between neonatal medical problems and subsequent infant behavior. This supports the hypothesis that psychosocial resources in reserve can be called upon in the face of a stressor to reduce its adverse effects on the self or others. PMID:25528180

  9. Maternal prenatal felt security and infant health at birth interact to predict infant fussing and crying at 12 months postpartum.

    PubMed

    Sawada, Natsumi; Gagné, Faby M; Séguin, Louise; Kramer, Michael S; McNamara, Helen; Platt, Robert W; Goulet, Lise; Meaney, Michael J; Lydon, John E

    2015-08-01

    Infants born with medical problems are at risk for less optimal developmental outcomes. This may be, in part, because neonatal medical problems are associated with maternal distress, which may adversely impact infants. However, the reserve capacity model suggests that an individual's bank of psychosocial resources buffers the adverse effects of later-encountered stressors. This prospective longitudinal study examined whether preexisting maternal psychosocial resources, conceptualized as felt security in close relationships, moderate the association between neonatal medical problems and infant fussing and crying 12 months postpartum. Maternal felt security was measured by assessing its indicators in 5,092 pregnant women. At birth, infants were classified as healthy or having a medical problem. At 12 months, experience sampling was used to assess daily maternal reports of fussing and crying in 135 mothers of infants who were healthy or had medical problems at birth. Confirmatory factor analyses revealed that attachment, relationship quality, self-esteem, and social support can be conceptualized as indicators of a single felt security factor. Multiple regression analyses revealed that prenatal maternal felt security interacts with infant health at birth to predict fussing and crying at 12 months. Among infants born with medical problems, higher felt security predicted decreased fussing and crying. Maternal felt security assessed before birth dampens the association between neonatal medical problems and subsequent infant behavior. This supports the hypothesis that psychosocial resources in reserve can be called upon in the face of a stressor to reduce its adverse effects on the self or others.

  10. Effect of inbreeding on weight gain of offspring from birth to 12 months after birth: a study from Iran.

    PubMed

    Nafissi, Samane; Ansari-Lari, Maryam; Saadat, Mostafa

    2010-03-01

    Consanguinity, the marriage between relatives, has been associated with adverse child health outcomes. The objective of the present study was to assess the effect of consanguinity on offspring weight gain from birth to 12 months after birth. Data were collected on 250 consecutive live-born singleton newborns referred to a local health centre in Shiraz (Fars province, southern Iran). Collected data covered socio-demographic characteristics (such as parental age at delivery and parental education), sex, birth order, weights from birth to 12 months after birth and consanguinity of marriages of parents. Considering the low prevalence of double first cousin, first cousin once removed, second cousin, and beyond second cousin marriages, only first cousin and unrelated marriages were included in the study. The study population consisted of a total of 207 newborns (57 offspring of first cousins, 150 offspring of unrelated marriages). Based on the results of repeated measurements analysis of variance, weight gain was associated with type of marriage (p=0.018), sex of offspring (p=0.001) and paternal education (p<0.001). There was no interaction between type of marriage and sex (p=0.831). Birth weight was not affected by type of marriage (p=0.46). There was significant interaction between inbreeding and time (p=0.034). Offspring of consanguineous marriages showed lower weight gain in comparison with those of unrelated marriages during 3-12 months after birth.

  11. Randomized controlled trials in environmental health research: ethical issues.

    PubMed

    Resnik, David B

    2008-01-01

    Randomized controlled trials (RCTs) are becoming increasingly common in environmental health research. Like all studies involving human subjects, environmental health RCTs raise many ethical challenges, ranging from obtaining informed consent to minimizing risks to protecting privacy and confidentiality. One of the most important issues raised by these studies is whether it is ethical to withhold effective environmental health interventions from research subjects in order to satisfy scientific objectives. Although environmental health investigators usually do not have professional obligations to provide medical care to research subjects, they have ethical obligations to avoid exploiting them. Withholding interventions from research subjects can be ethical, provided that it does not lead to exploitation of individuals or groups. To avoid exploiting individuals or groups, investigators should ensure that research subjects and study populations receive a fair share of the benefits of research.

  12. [Critical of the additive model of the randomized controlled trial].

    PubMed

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  13. Ameliorating children's reading-comprehension difficulties: a randomized controlled trial.

    PubMed

    Clarke, Paula J; Snowling, Margaret J; Truelove, Emma; Hulme, Charles

    2010-08-01

    Children with specific reading-comprehension difficulties can read accurately, but they have poor comprehension. In a randomized controlled trial, we examined the efficacy of three interventions designed to improve such children's reading comprehension: text-comprehension (TC) training, oral-language (OL) training, and TC and OL training combined (COM). Children were assessed preintervention, midintervention, postintervention, and at an 11-month follow-up. All intervention groups made significant improvements in reading comprehension relative to an untreated control group. Although these gains were maintained at follow-up in the TC and COM groups, the OL group made greater gains than the other groups did between the end of the intervention and follow-up. The OL and COM groups also demonstrated significant improvements in expressive vocabulary compared with the control group, and this was a mediator of the improved reading comprehension of the OL and COM groups. We conclude that specific reading-comprehension difficulties reflect (at least partly) underlying oral-language weaknesses that can be effectively ameliorated by suitable teaching.

  14. Regression of Fibroadenomas with Centchroman: a Randomized Controlled Trial.

    PubMed

    Tejwani, Prakash Laxmichand; Nerkar, Hrishikesh; Dhar, Anita; Kataria, Kamal; Hari, Smriti; Thulkar, Sanjay; Chumber, Sunil; Kumar, Sunesh; Srivastava, Anurag

    2015-12-01

    Fibroadenoma is a common cause of breast lump in young girls. Nearly 10-15 % of lesions regress spontaneously over the period of 6 to 60 months. The aim of study was to investigate the role of Centchroman in regression of fibroadenoma in comparison to natural observation and to study the association of hormonal receptors with degree of regression. The study was carried out at the outpatient clinic of Department of Surgery, All India Institute of Medical Sciences, New Delhi, from November 2004 to November 2007. Patients aged ≤30 years with fibroadenoma were included. Patients with fibroadenoma equal to or larger than 5 cm and with polycystic ovarian disease were excluded. Patients were randomized in two groups. Patients in active therapy arm were prescribed Centchroman 30 mg daily for 12 weeks, and another group was observed without any intervention (control group). Patients were followed at weeks 4, 8, 12, and 24 to assess response to therapy. Twenty-two (31.88 %) fibroadenomas in Centchroman arm disappeared completely as compared to four (7.69 %) in control arm over a period of 6 months. There was a decrease in the volume of fibroadenoma in ten (19.23 %) patients in control arm and 36 (52.17 %) patients in Centchroman arm. Centchroman therapy allowed 31 % fibroadenoma to regress completely with scanty menses or amenorrhea as the only side effect. PMID:26730050

  15. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    PubMed

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; p<0.05) and -2.84 mmHg (CI, -5.33 to -0.33 mmHg; p<0.05), respectively, after the 8-week intervention. The corresponding net change in renin activity was -1.17 ng/mL/h for the nattokinase group compared with the control group (p<0.05). In conclusion, nattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  16. Electroacupuncture for Primary Insomnia: A Randomized Controlled Trial

    PubMed Central

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Shi-Ping; Yap, Tuan-Gee; Law, Andrew C.K.

    2009-01-01

    Study Objectives: To evaluate the short-term efficacy and safety of electroacupuncture for the treatment of primary insomnia. Design: Randomized, single-blind, placebo-controlled, parallel-group. Setting: A university-based sleep clinic. Participants: Community sample of 60 Chinese adult volunteers who report having insomnia 3 or more nights per week, whose symptoms meet the DSM-IV criteria for primary insomnia for at least 3 months, and who have an Insomnia Severity Index total score of at least 15. Participants were screened with polysomnography and the Structured Clinical Interview for the DSM-IV prior to randomization. Intervention: Electroacupuncture at Yintang (EX-HN3), Baihui (GV20), bilateral ear Shenmen, Sishencong (EX-HN1), and Anmian (EX) 3 times per week for 3 weeks or placebo acupuncture using Streitberger needles at the same points. Measurements and Results: Self-reported questionnaires, 1-week sleep diaries, and 3-day actigraphy were collected at baseline and 1 week after treatment. The Insomnia Severity Index was used as the primary outcome measure. Both groups showed significant improvement compared with the pretreatment baseline. One-way analysis of covariance adjusted for baseline scores showed that there were significantly greater improvements in sleep efficiency by sleep diary and actigraphy in the electroacupuncture group. However, no significant between-group differences were observed in the Insomnia Severity Index and other outcome measures. The proportions of subjects having less than 30 minutes of wake after sleep onset and a sleep efficiency of at least 85% at the posttreatment visit were significantly higher in the electroacupuncture group. All adverse events were mild in severity. Conclusion: We found a slight advantage of electroacupuncture over placebo acupuncture in the short-term treatment of primary insomnia. Because of some limitations of the current study, further studies are necessary to verify the effectiveness of acupuncture

  17. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    PubMed Central

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y

  18. Emphasized warning reduces salt intake: a randomized controlled trial.

    PubMed

    Pinjuh Markota, Nina; Rumboldt, Mirjana; Rumboldt, Zvonko

    2015-03-01

    Excessive salt intake is a major cardiovascular risk factor. At variance to the developed countries, the main source of sodium in transitional and developing countries is salt added while cooking and/or at the table. The objective of this trial was to examine the impact of warning labels placed on home salt containers on daily salt intake.A sample of treated hypertensives (n = 150) was randomized in two subgroups, one receiving just a leaflet about the harmful effects of excessive salt intake (control; n = 74), and the other one receiving in addition warning stickers for household salt containers (intervention; n = 76). Arterial blood pressure (BP) and 24-hour urinary sodium excretion (Na24) were measured in all the subjects at the start of the trial, and 1 month and 2 months later. The average starting Na24 was 207 ± 71 mmol in the control group and 211 ± 85 mmol in the intervention group (P = .745). One month and 2 months later, a significant decrease was observed in the intervention group (to 183 ± 63 mmol and 176 ± 55 mmol; P < .0001), as opposed to the control group (203 ± 60 mmol and 200 ± 58 mmol; P = .1466). Initial BP was 143.7/84.1 mm Hg in the control, and 142.9/84.7 mm Hg in the intervention group (P = .667). One month and 2 months later, a significant drop in BP, by 5.3/2.9 mm Hg, was observed in the intervention group as opposed to the control group (0.4/0.9 mm Hg). Decrease in Na24 positively correlated to BP lowering (r(2) = 0.5989; P < .0001). A significant reduction in 24Na and BP is achieved with warning labels on harmful effects of excessive salt intake. Decreasing daily salt input by 35 mmol may result in an extra BP lowering by some 5-6/2-3 mm Hg.

  19. 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

  20. 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.

  1. Randomized Control Trials on Otago Exercise Program (OEP) to Reduce Falls Among Elderly Community Dwellers in Shahroud, Iran

    PubMed Central

    Dadgari, Ali; Aizan Hamid, Tengku; Hakim, Mohammad Nazrul; Chaman, Reza; Mousavi, Seyed Abbas; Poh Hin, Lim; Dadvar, Leila

    2016-01-01

    Background Fall is a worldwide health problem among elderly people and a known leading cause of disabilities. Fall prevention programs have been implemented in various forms. The Otago exercise program (OEP) is one of the most recent home-base exercise training program. Objectives This study was conducted to examine the effectiveness of OEP to reduce falls among elderly people in Shahroud, IR Iran. Materials and Methods This randomised control trial was conducted among the elderly community dwellers in Shahroud city of the Semnan province, IR Iran, with experience of falls in the last 12 months. Subjects of the study (n = 317) were recruited from elderly senior citizens at public health centers. Block systematic random sampling was applied to categorize the subjects in experimental and control groups. The experimental group (n = 160) received OEP for six months and was compared with the control group (n = 157) who received general health training. This study was registered with the following ID, IRCT2014012016285N1. Results The findings of the study showed that OEP improved physical performance (Berg-Balance-Score with P > 0.025, and Timed-Up-Go-Test with P > 0.017) and functional capacity (Arm-Curl-Test with P > 0.00 and Chair-Stand-Test with P > 0.01). In addition, OEP significantly reduced the incidence of falls (P ≤ 0.00) among senior citizens in the experimental group. Discussion The OEP as a home-based exercise is effective for the reduction of the incidence of falls among senior citizens with a history of falls. The OEP can be recommended for elderly homebound people who do not have access to facilities. PMID:27478629

  2. Reduction in sick leave by a workplace educational low back pain intervention: A cluster randomized controlled trial

    PubMed Central

    Ree, Eline; Lie, Stein Atle; Eriksen, Hege R.; Malterud, Kirsti; Indahl, Aage; Samdal, Oddrun; Harris, Anette

    2016-01-01

    Aims: The aim of this study was to investigate whether a workplace educational low back pain intervention had an effect on sick leave at the individual level and to identify possible predictors of the effect of intervention. Methods: Work units in two municipalities were cluster randomized to (a) educational meetings and peer support (45 units), (b) educational meetings, peer support and access to an outpatient clinic if needed (48 units) or (c) a control group (42 units). Both intervention groups attended educational meetings with information about back pain based on a non-injury model. A peer adviser was selected from among their colleagues. The outcome was days of sick leave at the individual level at 3, 6, 9 and 12 months, adjusting for previous sick leave at the unit level. As a result of similar effects on sick leave, the two intervention groups were merged (n=646) and compared with the control group (n=211). The predictors were different levels of belief in back pain myths, pain-related fear, helplessness/hopelessness and low back pain. Results: The intervention group had significantly less days of sick leave at the three month (4.9 days, p=0.001) and six month (4.4 days, p=0.016) follow ups compared with the control group. At three months, a low level of pain-related fear was the only predictor for the intervention effect (8.0 less days of sick leave, p<0.001). Conclusions: A workplace educational back pain intervention had an effect on sick leave for up to six months. A low score on pain-related fear was a predictor of the intervention effect. PMID:27307465

  3. Impact of Text Message Reminders on Caregivers’ Adherence to a Home Fortification Program Against Child Anemia in Rural Western China: A Cluster-Randomized Controlled Trial

    PubMed Central

    Zhou, Huan; Sun, Shuai; Sylvia, Sean; Yue, Ai; Shi, Yaojiang; Zhang, Linxiu; Medina, Alexis; Rozelle, Scott

    2016-01-01

    Objectives. To test whether text message reminders sent to caregivers improve the effectiveness of a home micronutrient fortification program in western China. Methods. We carried out a cluster-randomized controlled trial in 351 villages (clusters) in Shaanxi Province in 2013 and 2014, enrolling children aged 6 to 12 months. We randomly assigned each village to 1 of 3 groups: free delivery group, text messaging group, or control group. We collected information on compliance with treatments and hemoglobin concentrations from all children at baseline and 6-month follow-up. We estimated the intent-to-treat effects on compliance and child anemia using a logistic regression model. Results. There were 1393 eligible children. We found that assignment to the text messaging group led to an increase in full compliance (marginal effect = 0.10; 95% confidence interval [CI] = 0.03, 0.16) compared with the free delivery group and decrease in the rate of anemia at end line relative to the control group (marginal effect = −0.07; 95% CI = −0.12, −0.01), but not relative to the free delivery group (marginal effect = −0.03; 95% CI = −0.09, 0.03). Conclusions. Text messages improved compliance of caregivers to a home fortification program and children’s nutrition. PMID:27077354

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

    PubMed Central

    Kotela, Andrzej; Lorkowski, Jacek; Kucharzewski, Marek; Wilk-Frańczuk, Magdalena; Śliwiński, Zbigniew; Frańczuk, Bogusław; Łęgosz, Paweł  ; Kotela, Ireneusz

    2015-01-01

    Total knee arthroplasty (TKA) is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA. PMID:26301241

  5. Attention Demands Influence 10- and 12-Month-Old Infants' Perseverative Behavior

    ERIC Educational Resources Information Center

    Watanabe,