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Sample records for homes-a randomized control

  1. A short-term, multicomponent infection control program in nursing homes: a cluster randomized controlled trial.

    PubMed

    Chami, Kathleen; Gavazzi, Gaëtan; Bar-Hen, Avner; Carrat, Fabrice; de Wazières, Benoît; Lejeune, Benoist; Armand, Nathalie; Rainfray, Muriel; Hajjar, Joseph; Piette, François; Rothan Tondeur, Monique

    2012-07-01

    To assess the impact of a hygiene-encouragement program on reducing infection rates (primary end point) by 5%. A cluster randomized study was carried out over a 5-month period. Fifty nursing homes (NHs) with 4345 beds in France were randomly assigned by stratified-block randomization to either a multicomponent intervention (25 NHs) or an assessment only (25 NHs). The multicomponent intervention was targeted to caregivers and consisted of implementing a bundle of infection prevention consensual measures. Interactive educational meetings using a slideshow were organized at the intervention NHs. The NHs were also provided with color posters emphasizing hand hygiene and a kit that included hygienic products such as alcoholic-based hand sanitizers. Knowledge surveys were performed periodically and served as reminders. The primary end point was the total infection rate (urinary, respiratory, and gastrointestinal infections) in those infection cases classified either as definite or probable. Analyses corresponded to the underlying design and were performed according to the intention-to-treat principle. This study was registered (#NCT01069497). Forty-seven NHs (4515 residents) were included and followed. The incidence rate of the first episode of infection was 2.11 per 1000 resident-days in the interventional group and 2.15 per 1000 resident-days in the control group; however, the difference between the groups did not reach statistical significance in either the unadjusted (Hazard Ratio [HR] = 1.00 [95% confidence interval (CI) 0.89-1.13]; P = .93]) or the adjusted (HR = 0.99 [95% CI 0.87-1.12]; P = .86]) analysis. Disentangling the impact of this type of intervention involving behavioral change in routine practice in caregivers from the prevailing environmental and contextual determinants is often complicated and confusing to interpret the results. Copyright © 2012 American Medical Directors Association. Published by Elsevier Inc. All rights reserved.

  2. Effect of specialized bathing systems on resident cleanliness and water quality in nursing homes: a randomized controlled trial.

    PubMed

    Sloane, Philip D; Cohen, Lauren W; Williams, Christianna S; Munn, Jean; Preisser, John S; Sobsey, Mark D; Wait, Douglas A; Zimmerman, Sheryl

    2007-06-01

    A randomized controlled trial evaluated the impact of different methods of water agitation on clinical and microbiological outcomes in 31 nursing home residents. Four conditions were tested: a) whirlpool tub, jets on, using standard soap products; b) ultrasound tub, ultrasound on, using the standard soap products; c) ultrasound tub, ultrasound on, using specialized soap and skin conditioner; and d) either tub (randomized), water circulation off, using standard soap products (the control condition). Outcomes of interest included skin microbial flora, water microbial flora, skin condition, time spent bathing, and staff satisfaction. Resident skin condition and skin microbial flora did not differ between the four treatments. The tubs also did not differ in terms of bacterial colonization; however, there was a non-statistically significant trend for the highest counts to occur in whirlpool tubs after being idle overnight. The ultrasound and whirlpool tubs were preferred by staff over the control treatment (still water) in terms of sound and overall suitability. In addition, staff reported that the ultrasound tub using enhanced skin cleansers made bathing residents easier and faster than the same tub using standard cleansers.

  3. Effect of yoga program on executive functions of adolescents dwelling in an orphan home: A randomized controlled study.

    PubMed

    Purohit, Satya Prakash; Pradhan, Balaram

    2017-01-01

    Executive function (EF) is important for physical and mental health of children. Studies have shown that children with poverty and early life stress have reduced EF. The aim of the study was to evaluate the effect of Yoga program on the EF of orphan adolescents. Seventy two apparently healthy orphan adolescents randomized and allocated into two groups as Yoga group (n = 40; 14 girls, age = 12.69 ± 1.35 yrs) and Wait List Control (WLC) group (n = 32, 13 girls, age = 12.58 ± 1.52 yrs). Yoga group underwent three months of Yoga program in a schedule of 90 min per day, four days per week whereas the WLC group followed the routine activities. They were assessed by Stroop Color-Word Task, Digit Symbol Substitution Test (DSST), Digits Span Test and Trial Making Test (TMT) at the beginning and end of the program. The repeated measures ANOVA showed significant difference in time and group interactions (p < 0.05) for all subtests of Stroop Color-Word Task and Digit Span Test and part-A of TMT whereas there were no significant difference found in DSST and TMT (part-B). The post-hoc test with Bonferroni adjustment also showed significant improvements (p < 0.001) within the Yoga group in all test scores while in wrong score of DSST did not exhibit significant reduction. Whereas the WLC group, showed significant improvement (p < 0.05) in Stroop Color, Color-Word score, net score of DSST, Digit Span forward and Digit Span Total. Three months Yoga program was found useful for the young orphan adolescents in improving their executive functions.

  4. Effectiveness of advance care planning with family carers in dementia nursing homes: A paired cluster randomized controlled trial.

    PubMed

    Brazil, Kevin; Carter, Gillian; Cardwell, Chris; Clarke, Mike; Hudson, Peter; Froggatt, Katherine; McLaughlin, Dorry; Passmore, Peter; Kernohan, W George

    2017-07-01

    In dementia care, a large number of treatment decisions are made by family carers on behalf of their family member who lacks decisional capacity; advance care planning can support such carers in the decision-making of care goals. However, given the relative importance of advance care planning in dementia care, the prevalence of advance care planning in dementia care is poor. To evaluate the effectiveness of advance care planning with family carers in dementia care homes. Paired cluster randomized controlled trial. The intervention comprised a trained facilitator, family education, family meetings, documentation of advance care planning decisions and intervention orientation for general practitioners and nursing home staff. A total of 24 nursing homes with a dementia nursing category located in Northern Ireland, United Kingdom. Family carers of nursing home residents classified as having dementia and judged as not having decisional capacity to participate in advance care planning discussions. The primary outcome was family carer uncertainty in decision-making about the care of the resident (Decisional Conflict Scale). There was evidence of a reduction in total Decisional Conflict Scale score in the intervention group compared with the usual care group (-10.5, 95% confidence interval: -16.4 to -4.7; p < 0.001). Advance care planning was effective in reducing family carer uncertainty in decision-making concerning the care of their family member and improving perceptions of quality of care in nursing homes. Given the global significance of dementia, the implications for clinicians and policy makers include them recognizing the importance of family carer education and improving communication between family carers and formal care providers.

  5. Need-based intervention is an effective strategy for improving the nutritional status of older people living in a nursing home: a randomized controlled trial.

    PubMed

    Lee, Li-Chin; Tsai, Alan C; Wang, Jiun-Yi; Hurng, Baai-Shyun; Hsu, Hui-Chuan; Tsai, Hsin-Jen

    2013-12-01

    Nutrition is a key element in geriatric health. Protein-energy malnutrition is common in institutionalized persons. This study examined the effectiveness of a need-based "routine screening and timely intervention" strategy in improving the nutritional status of persons living in nursing homes. A 24-week randomized, double-blind, controlled trial. A privately managed geriatric nursing home in Taiwan. Ninety-two ≥65-year old persons who were ≤25kg/m(2), >1 month residence, able to self-feed or receive oral feeding, without acute infection and non-bed-ridden. Prospective participants were stratified by gender and then randomly assigned to either the control group (n=45) or the intervention group (n=47). Each subject in the intervention group was given a 50g/day soy-protein-based nutritional supplement if he/she was rated as undernourished according to the Mini Nutritional Assessment (MNA, score ≤24) and BMI ≤24kg/m(2). The supplement contained 9.5g protein, 250kcal energy and all essential micro-nutrients. The supplementation would be suspended once either one of the "at risk" condition was corrected. Nutritional rating with the MNA took place at baseline and every 4 weeks during the trial. Biochemical indicators were measured at baseline, mid-point (week-12) and end-point (week-24). Results were analyzed with the two-sample t-test, and the generalized estimating equations (GEE) controlled for demographic and health-related variables. Of the 92 subjects, 82 completed the trial; 7 withdrew and 3 died during the trial. Results showed that the need-based intervention was an effective and appropriate strategy for improving the nutritional status of persons at risk of undernourishment. The intervention significantly improved body weight, BMI, mid-arm circumference, calf circumference, and serum albumin and cholesterol concentrations at all intervals (all p<0.05). However, the intervention did not significantly improve hematocrit, hemoglobin or lymphocyte count

  6. Effectiveness of short-term, enhanced, infection control support in improving compliance with infection control guidelines and practice in nursing homes: a cluster randomized trial.

    PubMed

    Gopal Rao, G; Jeanes, A; Russell, H; Wilson, D; Atere-Roberts, E; O'Sullivan, D; Donaldson, N

    2009-10-01

    In this prospective cluster randomized controlled trial we evaluated the impact of short-term provision of enhanced infection control support on infection control practice in nursing homes in South London. Twelve nursing homes were recruited, six each in intervention (300 residents) and control (265 residents) groups. Baseline observations of hand hygiene facilities, environmental cleanliness and safe disposal of clinical waste showed poor compliance in both groups. Post-intervention observations showed improvement in both groups. There was no statistical difference between the two groups in the compliance for hand hygiene facilities (P=0.69); environmental cleanliness (P=0.43) and safe disposal of clinical waste (P=0.96). In both groups, greatest improvement was in compliance with safe disposal of clinical waste and the least improvement was in hand hygiene facilities. Since infection control practice improved in intervention and control groups, we could not demonstrate that provision of short-term, enhanced, infection control support in nursing homes had a significant impact in infection control practice.

  7. Supervised versus non-supervised implementation of an oral health care guideline in (residential) care homes: a cluster randomized controlled clinical trial

    PubMed Central

    2010-01-01

    Background The increase of the proportion of elderly people has implications for health care services. Advances in oral health care and treatment have resulted in a reduced number of edentulous individuals. An increasing number of dentate elderly people have tooth wear, periodontal disease, oral implants, and sophisticated restorations and prostheses. Hence, they are in need of both preventive and curative oral health care continuously. Weakened oral health due to neglect of self care and professional care and due to reduced oral health care utilization is already present when elderly people are still community-dwelling. At the moment of (residential) care home admittance, many elderly people are in need of oral health care urgently. The key factor in realizing and maintaining good oral health is daily oral hygiene care. For proper daily oral hygiene care, many residents are dependent on nurses and nurse aides. In 2007, the Dutch guideline "Oral health care in (residential) care homes for elderly people" was developed. Previous implementation research studies have revealed that implementation of a guideline is very complicated. The overall aim of this study is to compare a supervised versus a non-supervised implementation of the guideline in The Netherlands and Flanders (Belgium). Methods/Design The study is a cluster randomized intervention trial with an institution as unit of randomization. A random sample of 12 (residential) care homes accommodating somatic as well as psycho-geriatric residents in The Netherlands as well as in Flanders (Belgium) are randomly allocated to an intervention or control group. Representative samples of 30 residents in each of the 24 (residential) care homes are monitored during a 6-months period. The intervention consists of supervised implementation of the guideline and a daily oral health care protocol. Primary outcome variable is the oral hygiene level of the participating residents. To determine the stimulating or inhibiting

  8. A multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention in nursing homes: a two-armed randomized controlled trial.

    PubMed

    Beeckman, Dimitri; Clays, Els; Van Hecke, Ann; Vanderwee, Katrien; Schoonhoven, Lisette; Verhaeghe, Sofie

    2013-04-01

    Frail older people admitted to nursing homes are at risk of a range of adverse outcomes, including pressure ulcers. Clinical decision support systems are believed to have the potential to improve care and to change the behaviour of healthcare professionals. To determine whether a multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention improves adherence to recommendations for pressure ulcer prevention in nursing homes. Two-armed randomized controlled trial in a nursing home setting in Belgium. The trial consisted of a 16-week implementation intervention between February and June 2010, including one baseline, four intermediate, and one post-testing measurement. Primary outcome was the adherence to guideline-based care recommendations (in terms of allocating adequate pressure ulcer prevention in residents at risk). Secondary outcomes were the change in resident outcomes (pressure ulcer prevalence) and intermediate outcomes (knowledge and attitudes of healthcare professionals). Random sample of 11 wards (6 experimental; 5 control) in a convenience sample of 4 nursing homes in Belgium. In total, 464 nursing home residents and 118 healthcare professionals participated. The experimental arm was involved in a multi-faceted tailored implementation intervention of a clinical decision support system, including interactive education, reminders, monitoring, feedback and leadership. The control arm received a hard-copy of the pressure ulcer prevention protocol, supported by standardized 30 min group lecture. Patients in the intervention arm were significantly more likely to receive fully adequate pressure ulcer prevention when seated in a chair (F=16.4, P=0.003). No significant improvement was observed on pressure ulcer prevalence and knowledge of the professionals. While baseline attitude scores were comparable between both groups [exp. 74.3% vs. contr. 74.5% (P=0.92)], the mean score after the intervention was

  9. Evaluation of the Efficiency of the Nursing Care Plan Applied Using NANDA, NOC, and NIC Linkages to Elderly Women with Incontinence Living in a Nursing Home: A Randomized Controlled Study.

    PubMed

    Gencbas, Dercan; Bebis, Hatice; Cicek, Hatice

    2017-05-30

    Evaluate the efficiency of the nursing care plan, applied with the use of NANDA-I, NOC, and NIC (NNN) linkages, for elderly women with incontinence who live in nursing homes. A randomized controlled experimental design was applied. NNN linkages were prepared and applied for 12 weeks in an experimental group. NOC scales were evaluated again for two groups. A 0.5 NOC point change targeted in all elderly in the experimental group were provided between pretest-posttest scores. The experimental group had higher life quality and lower incontinence severity/symptoms than the control group. It is important that NNN linkages effective for solving the problems are used in different groups and with larger samples to create further evidence linking NNN. © 2017 NANDA International, Inc.

  10. A relaxation technique enhances psychological well-being and immune parameters in elderly people from a nursing home: a randomized controlled study.

    PubMed

    Reig-Ferrer, Abilio; Ferrer-Cascales, Rosario; Santos-Ruiz, Ana; Campos-Ferrer, Adolfo; Prieto-Seva, Alvaro; Velasco-Ruiz, Irene; Fernandez-Pascual, Maria Dolores; Albaladejo-Blazquez, Natalia

    2014-08-23

    The aging process involves a decline in immune functioning that renders elderly people more vulnerable to disease. In residential programs for the aged, it is vital to diminish their risk of disease, promote their independence, and augment their psychological well-being and quality of life. We performed a randomized controlled study, evaluating the ability of a relaxation technique based on Benson's relaxation response to enhance psychological well-being and modulate the immune parameters of elderly people living in a geriatric residence when compared to a waitlist control group. The study included a 2-week intervention period and a 3-month follow-up period. The main outcome variables were psychological well-being and quality of life, biomedical variables, immune changes from the pre-treatment to post-treatment and follow-up periods. Our findings reveal significant differences between the experimental and control groups in CD19, CD71, CD97, CD134, and CD137 lymphocyte subpopulations at the end of treatment. Furthermore, there was a decrease in negative affect, psychological discomfort, and symptom perception in the treatment group, which increased participants' quality of life scores at the three-month follow-up. This study represents a first approach to the application of a passive relaxation technique in residential programs for the elderly. The method appears to be effective in enhancing psychological well-being and modulating immune activity in a group of elderly people. This relaxation technique could be considered an option for achieving health benefits with a low cost for residential programs, but further studies using this technique in larger samples of older people are needed to confirm the trends observed in the present study. International Standard Randomised Controlled Trial Number Register ISRCTN85410212.

  11. Water-filtered infrared A for the treatment of chronic venous stasis ulcers of the lower legs at home: a randomized controlled blinded study.

    PubMed

    Schumann, H; Calow, T; Weckesser, S; Müller, M L; Hoffmann, G

    2011-09-01

    Water-filtered infrared A (wIRA) radiation can improve the healing of acute and chronic wounds both by thermal and thermic as well as by nonthermal and nonthermic effects. wIRA increases tissue temperature, oxygen partial pressure and perfusion. Investigation of the influence of wIRA on chronic venous stasis ulcers in an investigator-initiated, randomized, controlled, blinded study. Fifty-one patients with nonhealing chronic venous stasis ulcers of the lower legs were treated with compression therapy, wound cleansing, nonadhesive wound dressings and 30 min irradiation [wIRA + visible light (VIS) or VIS alone], predominantly at home, five times per week over 9 weeks and an additional 4 weeks without irradiation. Compared with the control group with VIS alone, the group with wIRA + VIS showed better wound healing [after 9 weeks 85 vs. 67·5 on a 0-100 visual analogue scale (VAS), median difference 15, 95% confidence interval (CI) 3-30, P = 0·012], a higher percentage of patients with a healing trend [after 9 weeks 21 of 25 (84%) vs. 13 of 26 (50%), P = 0·023], better granulation (after 9 weeks 90 vs. 80 on a 0-100 VAS, median difference 10, 95% CI 0-30, P = 0·036), a trend to less exudation (after 5 weeks 30 vs. 55 on a 0-100 VAS, P = 0·075) and to faster reduction of the wound area (after 7 weeks 39% vs. 19·5% reduction of wound area, median difference 20·5%, 95% CI -4-49%, P = 0·10; for wounds with an initial area < 10 cm(2): after 13 weeks 92% vs. 47% reduction of wound area, median difference 30%, 95% CI 0-68%, P = 0·11). The main variable 'Integral of relative ulcer area for each individual patient over time, standardized to an initial size of 1' did not reach significance. The application of wIRA at home was easily manageable. For the treatment of chronic venous stasis ulcers, the application of wIRA combined with phlebological therapy, compression therapy and wound dressing can be useful and can be recommended. © 2011 The Authors. BJD © 2011 British

  12. Cost effectiveness of training incontinent elderly in nursing homes: a randomized clinical trial.

    PubMed Central

    Hu, T W; Kaltreider, D L; Igou, J F; Yu, L C; Rohner, T J

    1990-01-01

    This study used a randomized clinical trial with 133 incontinent elderly in seven nursing homes to evaluate the effectiveness of a behavioral training therapy and its cost implications. The training program lasted three months, and a 22-week follow-up period examined the durability of the treatment effect. The therapy became effective after six weeks of training. By the final months of training, the treatment participants' wet episodes had been reduced by 0.6 episode per day, or a 26 percent reduction over baseline, and improvement was maintained during the follow-up period. Trainees with a high frequency of incontinence during baseline, relatively more cognitive residents, and residents with a normal bladder capacity responded better to this behavioral program. The cost of training was the equivalent of about one hour of nursing aide time per patient day. The reduction in incontinence during the follow-up period resulted in some small savings in laundry costs and supplies used, and some quantitatively unmeasurable but detectable improvement in psychosocial well-being among the trainees. Since the central figure in implementing this training protocol is the nursing aide, it is important to find an organizational management scheme that will stimulate nursing aides to reduce incontinence among nursing home residents. PMID:2116385

  13. iPad technology for home rehabilitation after stroke (iHOME): a proof-of-concept randomized trial.

    PubMed

    Saposnik, Gustavo; Chow, Chi-Ming; Gladstone, David; Cheung, Donna; Brawer, Edward; Thorpe, Kevin E; Saldanha, Avon; Dang, Alice; Bayley, Mark; Schweizer, Tom A

    2014-10-01

    Tablets are a novel line of computers controlled by a multitouch screen. Fine motor movements are captured on the tablet computer through electrical fields and can be qualitatively and quantitatively assessed. Evidence is limited on tablet use for stroke rehabilitation. iHOME is an investigator-initiated randomized controlled pilot trial with a single-blinded outcome assessment. The intervention consists of iPad use (investigational group) vs. usual care (control group) among patients receiving conventional outpatient rehabilitation. Eligibility includes aged 18-85 years who experienced a mild ischemic or hemorrhagic stroke (as diagnosed on neuroimaging and determined by the Chedoke-McMaster score ≥3. The STROKE REHAB® software for the iPad was specifically designed for patients with fine motor weakness and/or neglect. Of the total 30 patients, 20 will be in iHOME Acute (enrolled within three-months of stroke onset) and 10 patients in iHOME Chronic (enrolled more than six-months from onset). The primary feasibility outcome is the proportion of the scheduled iPad time used (more than 70% (≥140 mins) of the total 'dose' of intervention intended will be considered successful). Efficacy in fine motor movements will be assessed using the nine-hole peg test; time to magnify and pop the balloons in the iPad software application, and improvement in Wolf Motor Function Test. iHOME is a randomized controlled trial assessing the feasibility, safety, and efficacy of tablet technology for home use in stroke rehabilitation. The results of this study will serve as the basis for a larger multicenter trial. © 2014 World Stroke Organization.

  14. The economics of dementia-care mapping in nursing homes: a cluster-randomised controlled trial.

    PubMed

    van de Ven, Geertje; Draskovic, Irena; van Herpen, Elke; Koopmans, Raymond T C M; Donders, Rogier; Zuidema, Sytse U; Adang, Eddy M M; Vernooij-Dassen, Myrra J F J

    2014-01-01

    Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units. 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05) than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02). DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they adopt the DCM method. Dutch Trials Registry NTR2314.

  15. Effect of Cranberry Capsules on Bacteriuria Plus Pyuria among Older Women in Nursing Homes: A Randomized Clinical Trial

    PubMed Central

    Juthani-Mehta, Manisha; Van Ness, Peter H.; Bianco, Luann; Rink, Andrea; Rubeck, Sabina; Ginter, Sandra; Argraves, Stephanie; Charpentier, Peter; Acampora, Denise; Trentalange, Mark; Quagliarello, Vincent; Peduzzi, Peter

    2017-01-01

    Importance Bacteriuria plus pyuria is highly prevalent among older women living in nursing homes. Cranberry capsules are an understudied, non-antimicrobial, prevention strategy used in this population. Objective To test the effect of two oral cranberry capsules once per day on presence of bacteriuria plus pyuria among women residing in nursing homes Design, Setting, and Participants This study was a double-blind, randomized, placebo-controlled efficacy trial with stratification by nursing home and surveillance of one year. 21 nursing homes with at least 90 beds and within 50 miles of New Haven, CT participated. 185 English-speaking, female, nursing home residents, age 65 or older, with or without bacteriuria and pyuria at baseline, were randomized. The study was conducted from 8/24/12-10/26/15. Intervention Two oral cranberry capsules, each capsule containing 36mg of the active ingredient proanthocyanidin (i.e., 72mg total, equivalent to 20 ounces of cranberry juice), versus placebo administered once per day in 92 treatment and 93 control group participants. Main Outcomes and Measures The primary outcome was the presence of bacteriuria (i.e., at least 105 cfu/mL of one or two microorganisms on urine culture) plus pyuria (i.e., any number of white blood cells on urinalysis) assessed every two months for a total of six assessments over the one year of surveillance; any positive finding was considered to meet the primary outcome. Secondary outcomes were symptomatic urinary tract infection (UTI), all-cause death, all-cause hospitalization, all multi-drug antibiotic resistant organisms, antibiotics administered for suspected UTI, and total antimicrobial administration. Results Among 185 women who were randomized (mean age 86.4 years [± 8.2], 90.3% white, 31.4% with bacteriuria plus pyuria at baseline), 147 completed the study. Overall adherence to capsule administration was 80.1%. Unadjusted results showed the presence of bacteriuria plus pyuria in 25.5% (95% CI 18

  16. An elastic band exercise program for older adults using wheelchairs in Taiwan nursing homes: a cluster randomized trial.

    PubMed

    Chen, Kuei-Min; Li, Chun-Huw; Chang, Ya-Hui; Huang, Hsin-Ting; Cheng, Yin-Yin

    2015-01-01

    The number of older adults using wheelchairs in nursing homes is over 50% of that population, and many of them use wheelchairs due to muscle weakness in the lower extremities. Muscles of older adults are trainable, and progressive resistance exercises using elastic bands can increase muscle strength in older adults. To test the effectiveness of six-month Wheelchair-bound Senior Elastic Band exercises on the functional fitness of older adults in nursing homes. Cluster randomized trial. Ten nursing homes, southern Taiwan. 127 participants were recruited, and 114 of them completed the study. Inclusion criteria were: (1) aged 65 and over, (2) using wheelchairs for mobility, (3) living in the facility for at least three months, (4) cognitively intact, and (5) heavily or moderate dependency in their activities of daily living. The mean age of the participants was 79.15 (7.03) years, and 98.20% of them had chronic illnesses. Participants were randomly assigned to the experimental (five nursing homes, n=59) or the control (five nursing homes, n=55) group based on the nursing homes where they stayed. A 40-min Wheelchair-bound Senior Elastic Band exercise program was implemented three times per week for six months for the experimental group participants. The functional fitness (activities of daily living, lung capacity, body flexibilities, muscle power and endurance) of the participants was examined at baseline, after three months, and at the end of the six months study. The mixed-design, two-way analysis of variance was used to detect the interaction effects, and one-way repeated measures analysis of variance and analysis of covariance were performed to analyze the within-group and between-group differences. At the end of the six-month study, the Wheelchair-bound Senior Elastic Band group had better performances in all of the functional fitness indicators than the control group (all p<0.05). The Wheelchair-bound Senior Elastic Band exercises significantly improved the

  17. Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes: A Randomized Clinical Trial.

    PubMed

    Juthani-Mehta, Manisha; Van Ness, Peter H; Bianco, Luann; Rink, Andrea; Rubeck, Sabina; Ginter, Sandra; Argraves, Stephanie; Charpentier, Peter; Acampora, Denise; Trentalange, Mark; Quagliarello, Vincent; Peduzzi, Peter

    2016-11-08

    Bacteriuria plus pyuria is highly prevalent among older women living in nursing homes. Cranberry capsules are an understudied, nonantimicrobial prevention strategy used in this population. To test the effect of 2 oral cranberry capsules once a day on presence of bacteriuria plus pyuria among women residing in nursing homes. Double-blind, randomized, placebo-controlled efficacy trial with stratification by nursing home and involving 185 English-speaking women aged 65 years or older, with or without bacteriuria plus pyuria at baseline, residing in 21 nursing homes located within 50 miles (80 km) of New Haven, Connecticut (August 24, 2012-October 26, 2015). Two oral cranberry capsules, each capsule containing 36 mg of the active ingredient proanthocyanidin (ie, 72 mg total, equivalent to 20 ounces of cranberry juice) vs placebo administered once a day in 92 treatment and 93 control group participants. Presence of bacteriuria (ie, at least 105 colony-forming units [CFUs] per milliliter of 1 or 2 microorganisms in urine culture) plus pyuria (ie, any number of white blood cells on urinalysis) assessed every 2 months over the 1-year study surveillance; any positive finding was considered to meet the primary outcome. Secondary outcomes were symptomatic urinary tract infection (UTI), all-cause death, all-cause hospitalization, all multidrug antibiotic-resistant organisms, antibiotics administered for suspected UTI, and total antimicrobial administration. Of the 185 randomized study participants (mean age, 86.4 years [SD, 8.2], 90.3% white, 31.4% with bacteriuria plus pyuria at baseline), 147 completed the study. Overall adherence was 80.1%. Unadjusted results showed the presence of bacteriuria plus pyuria in 25.5% (95% CI, 18.6%-33.9%) of the treatment group and in 29.5% (95% CI, 22.2%-37.9%) of the control group. The adjusted generalized estimating equations model that accounted for missing data and covariates showed no significant difference in the presence of bacteriuria

  18. Effect of Promoting High-Quality Staff Interactions on Fall Prevention in Nursing Homes: A Cluster-Randomized Trial.

    PubMed

    Colón-Emeric, Cathleen S; Corazzini, Kirsten; McConnell, Eleanor S; Pan, Wei; Toles, Mark; Hall, Rasheeda; Cary, Michael P; Batchelor-Murphy, Melissa; Yap, Tracey; Anderson, Amber L; Burd, Andrew; Amarasekara, Sathya; Anderson, Ruth A

    2017-10-02

    New approaches are needed to enhance implementation of complex interventions for geriatric syndromes such as falls. To test whether a complexity science-based staff training intervention (CONNECT) promoting high-quality staff interactions improves the impact of an evidence-based falls quality improvement program (FALLS). Cluster-randomized trial in 24 nursing homes receiving either CONNECT followed by FALLS (intervention), or FALLS alone (control). Nursing home staff in all positions were asked to complete surveys at baseline, 3, 6, and 9 months. Medical records of residents with at least 1 fall in the 6-month pre- and postintervention windows (n = 1794) were abstracted for fall risk reduction measures, falls, and injurious falls. CONNECT taught staff to improve their connections with coworkers, increase information flow, and use cognitive diversity in problem solving. Intervention components included 2 classroom sessions, relationship mapping, and self-monitoring. FALLS provided instruction in the Agency for Healthcare Research and Quality's Falls Management Program. Primary outcomes were (1) mean number of fall risk reduction activities documented within 30 days of falls and (2) median fall rates among residents with at least 1 fall during the study period. In addition, validated scales measured staff communication quality, frequency, timeliness, and safety climate. Surveys were completed by 1545 staff members, representing 734 (37%) and 811 (44%) of eligible staff in intervention and control facilities, respectively; 511 (33%) respondents were hands-on care workers. Neither the CONNECT nor the FALLS-only facilities improved the mean count of fall risk reduction activities following FALLS (3.3 [1.6] vs 3.2 [1.5] of 10); furthermore, adjusted median recurrent fall rates did not differ between the groups (4.06 [interquartile range {IQR}, 2.03-8.11] vs 4.06 [IQR, 2.04-8.11] falls/resident/y). A modest improvement in staff communication measures was observed

  19. Validation therapy (VT) in nursing home: a case-control study.

    PubMed

    Tondi, L; Ribani, L; Bottazzi, M; Viscomi, G; Vulcano, V

    2007-01-01

    VT is a method for communicating with elderly people with dementia. It has been applied since 2001 at the "Istituto Giovanni XXIII" in Bologna, a public trust, housing over 500 not self-sufficient elderly people. Around 75% of these subjects suffer from cognitive impairment, associated to behavioral and psychological symptoms of dementia (BPSD) in over 35%. To assess the effectiveness of VT, we carried out a study involving 50 subjects divided in two groups, of cases and controls, made up by 27 and 23 patients, respectively. In both groups neuropsychiatric inventory (NPI) and the Bedford Alzheimer nursing severity scale (BANSS) were used before the start and after the end of the study; the case group underwent both individual and group VT. The results show a marked decrease of the average NPI symptom score in the case group (from 22.0 to 9.5) vs. a rise in the control group (from 21.7 to 24.1). Agitation, apathy, irritability and nighttime behaviors were the most improved NPI items among the subjects who underwent the VT. In these patients also the NPI distress score turned out reduced, vs. a small increase in the control group. In the case group an improvement occurred with BANSS too, even if much slighter changes were registered vs. the control group. Although the small number of subjects enlisted does not allow to draw firm inferences, the study suggests that VT is able to reduce the severity and frequency of BPSD, thus improving the relationship with and the management of patients having diagnosis of dementia without any side effects.

  20. Understanding Infection Prevention and Control in Nursing Homes: A Qualitative Study

    PubMed Central

    Stone, Patricia W.; Herzig, Carolyn T.A.; Pogorzelska-Maziarz, Monika; Carter, Eileen; Bjarnadottir, Ragnhildur I.; Semeraro, Patricia K.; Cohen, Catherine C.; Travers, Jasmine; Schweon, Steven

    2015-01-01

    Infections have been identified as a priority issue in nursing homes (NHs). We conducted a qualitative study purposively sampling 10 NHs across the country where 6 to 8 employees were recruited (N = 73). Semi-structured, open-ended guides were used to conduct in-depth interviews. Data were audio-taped, transcribed and a content analysis was performed. Five themes emerged: ‘Residents’ Needs’, ‘Roles and Training’ ‘Using Infection Data’, ‘External Resources’ and ‘Focus on Hand Hygiene’. Infection prevention was a priority in the NHs visited. While all sites had hand hygiene programs, other recommended areas were not a focus and many sites were not aware of available resources. Developing ways to ensure effective, efficient and standardized infection prevention and control in NHs continues to be a national priority. PMID:25794923

  1. Initiation of home mechanical ventilation at home: a randomised controlled trial of efficacy, feasibility and costs.

    PubMed

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    2014-09-01

    Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-inferior to an in hospital based setting. Seventy-seven patients were included, of which 38 patients started HMV at home. All patients were diagnosed with chronic respiratory failure due to a neuromuscular or thoracic cage disease. Primary outcome was the arterial carbon dioxide (PaCO2) while quality of life and costs were secondary outcomes. Telemonitoring was used in the home group to provide therapeutic information, for example; transcutaneous carbon dioxide, oxygen saturation and ventilator information, to the caregivers. Follow-up was six months. PaCO2, improved by 0.72 (SE ± 0.16) kPa in the hospital group and by 0.91 (±0.20) in the home group, both improvements being significant and the latter clearly not inferior. There were also significant improvements in quality of life in both groups, again not being inferior with home treatment. This study is the first to show that initiation of HMV at home in a selective group of patients with chronic respiratory failure is as effective for gas exchange and quality of life as hospital initiation. In addition we found that it is safe, technically feasible and that more than € 3000 per patient can be saved compared to our standard care. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. Optimal Quantum Control Using Randomized Benchmarking

    NASA Astrophysics Data System (ADS)

    Kelly, J.; Barends, R.; Campbell, B.; Chen, Y.; Chen, Z.; Chiaro, B.; Dunsworth, A.; Fowler, A. G.; Hoi, I.-C.; Jeffrey, E.; Megrant, A.; Mutus, J.; Neill, C.; O'Malley, P. J. J.; Quintana, C.; Roushan, P.; Sank, D.; Vainsencher, A.; Wenner, J.; White, T. C.; Cleland, A. N.; Martinis, John M.

    2014-06-01

    We present a method for optimizing quantum control in experimental systems, using a subset of randomized benchmarking measurements to rapidly infer error. This is demonstrated to improve single- and two-qubit gates, minimize gate bleedthrough, where a gate mechanism can cause errors on subsequent gates, and identify control crosstalk in superconducting qubits. This method is able to correct parameters so that control errors no longer dominate and is suitable for automated and closed-loop optimization of experimental systems.

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

    NASA Astrophysics Data System (ADS)

    Nabi-Abdolyousefi, Marzieh

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

  4. ASSISTments Dataset from Multiple Randomized Controlled Experiments

    ERIC Educational Resources Information Center

    Selent, Douglas; Patikorn, Thanaporn; Heffernan, Neil

    2016-01-01

    In this paper, we present a dataset consisting of data generated from 22 previously and currently running randomized controlled experiments inside the ASSISTments online learning platform. This dataset provides data mining opportunities for researchers to analyze ASSISTments data in a convenient format across multiple experiments at the same time.…

  5. ASSISTments Dataset from Multiple Randomized Controlled Experiments

    ERIC Educational Resources Information Center

    Selent, Douglas; Patikorn, Thanaporn; Heffernan, Neil

    2016-01-01

    In this paper, we present a dataset consisting of data generated from 22 previously and currently running randomized controlled experiments inside the ASSISTments online learning platform. This dataset provides data mining opportunities for researchers to analyze ASSISTments data in a convenient format across multiple experiments at the same time.…

  6. 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…

  7. 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…

  8. Alternatives to the Randomized Controlled Trial

    PubMed Central

    West, Stephen G.; Duan, Naihua; Pequegnat, Willo; Gaist, Paul; Des Jarlais, Don C.; Holtgrave, David; Szapocznik, José; Fishbein, Martin; Rapkin, Bruce; Clatts, Michael; Mullen, Patricia Dolan

    2008-01-01

    Public health researchers are addressing new research questions (e.g., effects of environmental tobacco smoke, Hurricane Katrina) for which the randomized controlled trial (RCT) may not be a feasible option. Drawing on the potential outcomes framework (Rubin Causal Model) and Campbellian perspectives, we consider alternative research designs that permit relatively strong causal inferences. In randomized encouragement designs, participants are randomly invited to participate in one of the treatment conditions, but are allowed to decide whether to receive treatment. In quantitative assignment designs, treatment is assigned on the basis of a quantitative measure (e.g., need, merit, risk). In observational studies, treatment assignment is unknown and presumed to be nonrandom. Major threats to the validity of each design and statistical strategies for mitigating those threats are presented. PMID:18556609

  9. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study.

    PubMed

    Jouen, Anne-Lise; Narzisi, Antonio; Xavier, Jean; Tilmont, Elodie; Bodeau, Nicolas; Bono, Valentina; Ketem-Premel, Nabila; Anzalone, Salvatore; Maharatna, Koushik; Chetouani, Mohamed; Muratori, Filippo; Cohen, David

    2017-01-01

    To meet the required hours of intensive intervention for treating children with autism spectrum disorder (ASD), we developed an automated serious gaming platform (11 games) to deliver intervention at home (GOLIAH) by mapping the imitation and joint attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. Here, we report the results of a 6-month matched controlled exploratory study. From two specialized clinics, we included 14 children (age range 5-8 years) with ASD and 10 controls matched for gender, age, sites, and treatment as usual (TAU). Participants from the experimental group received in addition to TAU four 30-min sessions with GOLIAH per week at home and one at hospital for 6 months. Statistics were performed using Linear Mixed Models. Children and parents participated in 40% of the planned sessions. They were able to use the 11 games, and participants trained with GOLIAH improved time to perform the task in most JA games and imitation scores in most imitation games. GOLIAH intervention did not affect Parental Stress Index scores. At end-point, we found in both groups a significant improvement for Autism Diagnostic Observation Schedule scores, Vineland socialization score, Parental Stress Index total score, and Child Behavior Checklist internalizing, externalizing and total problems. However, we found no significant change for by time × group interaction. Despite the lack of superiority of TAU + GOLIAH versus TAU, the results are interesting both in terms of changes by using the gaming platform and lack of parental stress increase. A large randomized controlled trial with younger participants (who are the core target of ESDM model) is now discussed. This should be facilitated by computing GOLIAH for a web platform. Trial registration Clinicaltrials.gov NCT02560415.

  10. A pilot randomized controlled trial of deprescribing.

    PubMed

    Beer, Christopher; Loh, Poh-Kooi; Peng, Yan Gee; Potter, Kathleen; Millar, Alasdair

    2011-04-01

    Polypharmacy and adverse drug reactions are frequent and important among older people. Few clinical trials have evaluated systematic withdrawal of medications among older people. This small, open, study was conducted to determine the feasibility of a randomized controlled deprescribing trial. Ten volunteers living in the community (recruited by media advertising) and 25 volunteers living in residential aged-care facilities (RCFs) were randomized to intervention or control groups. The intervention was gradual withdrawal of one target medication. The primary outcome was the number of intervention participants in whom medication withdrawal could be achieved. Other outcomes measures were quality of life, medication adherence, sleep quality, and cognitive impairment. Participants were aged 80 ± 11 years and were taking 9 ± 2 medications. Fifteen participants commenced medication withdrawal and all ceased or reduced the dose of their target medication. Two subjects withdrew; one was referred for clinical review, and one participant declined further dose reductions. A randomized controlled trial of deprescribing was acceptable to participants. Recruitment in RCFs is feasible. Definitive trials of deprescribing are required.

  11. Recent randomized controlled trials in otolaryngology.

    PubMed

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  12. 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

  13. Enhancing adoptive parenting: a randomized controlled trial.

    PubMed

    Rushton, Alan; Monck, Elizabeth; Leese, Morven; McCrone, Paul; Sharac, Jessica

    2010-10-01

    The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a "services as usual" group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference (p < 0.007) was found for "satisfaction with parenting" in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters' satisfaction with parenting in the intervention group compared to the routine service group.

  14. Sham Electroacupuncture Methods in Randomized Controlled Trials

    PubMed Central

    Chen, Zi-xian; Li, Yan; Zhang, Xiao-guang; Chen, Shuang; Yang, Wen-ting; Zheng, Xia-wei; Zheng, Guo-qing

    2017-01-01

    Sham electroacupuncture (EA) control is commonly used to evaluate the specific effects of EA in randomized-controlled trials (RCTs). However, establishing an inert and concealable sham EA control remains methodologically challenging. Here, we aimed to systematically investigate the sham EA methods. Eight electronic databases were searched from their inception to April 2015. Ten out of the 17 sham EA methods were identified from 94 RCTs involving 6134 participants according to three aspects: needle location, depth of needle insertion and electrical stimulation. The top three most frequently used types were sham EA type A, type L and type O ordinally. Only 24 out of the 94 trials reported credibility tests in six types of sham EA methods and the results were mainly as follows: sham EA type A (10/24), type B (5/24) and type Q (5/24). Compared with sham EA controls, EA therapy in 56.2% trials reported the specific effects, of which the highest positive rate was observed in type N (3/4), type F (5/7), type D (4/6) and type M (2/3). In conclusion, several sham EA types were identified as a promising candidate for further application in RCTs. Nonetheless, more evidence for inert and concealable sham EA control methods is needed. PMID:28106094

  15. Neurosurgical Randomized Controlled Trials-Distance Travelled.

    PubMed

    Azad, Tej D; Veeravagu, Anand; Mittal, Vaishali; Esparza, Rogelio; Johnson, Eli; Ioannidis, John P A; Grant, Gerald A

    2017-06-21

    The evidence base for many neurosurgical procedures has been limited. We performed a comprehensive and systematic analysis of study design, quality of reporting, and trial results of neurosurgical randomized controlled trials (RCTs). To systematically assess the design and quality characteristics of neurosurgical RCTs. From January 1961 to June 2016, RCTs with >5 patients assessing any 1 neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library. The median sample size in the 401 eligible RCTs was 73 patients with a mean patient age of 49.6. Only 111 trials (27.1%) described allocation concealment, 140 (34.6%) provided power calculations, and 117 (28.9%) were adequately powered. Significant efficacy or trend for efficacy was claimed in 226 reports (56.4%), no difference between the procedures was found in 166 trials (41.4%), and significant harm was reported in 9 trials (2.2%). Trials with a larger sample size were more likely to report randomization mode, specify allocation concealment, and power calculations (all P < .001). Government funding was associated with better specification of power calculations ( P = .008) and of allocation concealment ( P = .026), while industry funding was associated with reporting significant efficacy ( P = .02). Reporting of funding, specification of randomization mode and primary outcomes, and mention of power calculations improved significantly (all, P < .05) over time. Several aspects of the design and reporting of RCTs on neurosurgical procedures have improved over time. Better powered and accurately reported trials are needed in neurosurgery to deliver evidence-based care and achieve optimal outcomes.

  16. 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

  17. How is diarrhoea managed in UK care homes? A survey with implications for recognition and control of Clostridium difficile infection.

    PubMed

    Henderson, Hazel J; Maddock, Liz; Andrews, Sue; Trail, Peter; Loades, Nancy; Purcell, Bernadette; Iversen, Angela; Llewelyn, Martin J; Cassell, Jackie A

    2010-12-01

    Policy and regulatory efforts to reduce Clostridium difficile infection (CDI) rates now focus increasingly on the community setting, especially residential and nursing homes for the elderly. We aimed to describe how potentially infectious diarrhoea is managed in care homes, and to explore related infection control and human waste management practices. A questionnaire was sent to all care homes in Sussex, asking about management of diarrhoea and related infection control practices. Response rate was 41%. Residents with diarrhoea were reported to be isolated promptly in 36% of homes, and 78.2% of homes reported always wearing appropriate personal protective equipment. Most homes waited over 24 h before sending stool samples for testing. Human waste was disposed of by automated sluice in only 26% of care homes. Bedpans were washed in residents' sinks in 20.7% of residential homes, and in communal baths in 9.6%. This study shows that most care homes are not fully compliant with current infection prevention and control guidance, and that some unacceptable practices are occurring. In order to reduce potential for transmission of CDI and other diarrhoeal infection in care homes, infection prevention and control practices must be improved, with early diagnosis and control.

  18. Reactions to a Remote-Controlled Video-Communication Robot in Seniors' Homes: A Pilot Study of Feasibility and Acceptance

    PubMed Central

    Seelye, Adriana M.; Larimer, Nicole; Maxwell, Shoshana; Kearns, Peter; Kaye, Jeffrey A.

    2012-01-01

    Abstract Objective: Remote telepresence provided by tele-operated robotics represents a new means for obtaining important health information, improving older adults' social and daily functioning and providing peace of mind to family members and caregivers who live remotely. In this study we tested the feasibility of use and acceptance of a remotely controlled robot with video-communication capability in independently living, cognitively intact older adults. Materials and Methods: A mobile remotely controlled robot with video-communication ability was placed in the homes of eight seniors. The attitudes and preferences of these volunteers and those of family or friends who communicated with them remotely via the device were assessed through survey instruments. Results: Overall experiences were consistently positive, with the exception of one user who subsequently progressed to a diagnosis of mild cognitive impairment. Responses from our participants indicated that in general they appreciated the potential of this technology to enhance their physical health and well-being, social connectedness, and ability to live independently at home. Remote users, who were friends or adult children of the participants, were more likely to test the mobility features and had several suggestions for additional useful applications. Conclusions: Results from the present study showed that a small sample of independently living, cognitively intact older adults and their remote collaterals responded positively to a remote controlled robot with video-communication capabilities. Research is needed to further explore the feasibility and acceptance of this type of technology with a variety of patients and their care contacts. PMID:23082794

  19. Randomized controlled trials - a matter of design.

    PubMed

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

    2016-01-01

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

  20. 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

  1. Infection prevention and control in nursing homes: a qualitative study of decision-making regarding isolation-based practices.

    PubMed

    Cohen, Catherine Crawford; Pogorzelska-Maziarz, Monika; Herzig, Carolyn T A; Carter, Eileen J; Bjarnadottir, Ragnhildur; Semeraro, Patricia; Travers, Jasmine L; Stone, Patricia W

    2015-10-01

    Isolation-based practices in nursing homes (NHs) differ from those in acute care. NHs must promote quality of life while preventing infection transmission. Practices used in NHs to reconcile these goals of care have not been characterised. To explore decision-making in isolation-based infection prevention and control practices in NHs. A qualitative study was conducted with staff (eg, staff nurses, infection prevention directors and directors of nursing) employed in purposefully sampled US NHs. Semistructured, role-specific interview guides were developed and interviews were digitally recorded, transcribed verbatim and analysed using directed content analysis. The research team discussed emerging themes in weekly meetings to confirm consensus. We inferred from 73 interviews in 10 NHs that there was variation between NHs in practices regarding who was isolated, when isolation-based practices took place, how they were implemented, and how they were tailored for each resident. Interviewees' decision-making depended on staff perceptions of acceptable transmission risk and resident quality of life. NH resources also influenced decision-making, including availability of private rooms, extent to which staff can devote time to isolation-based practices and communication tools. A lack of understanding of key infection prevention and control concepts was also revealed. Current clinical guidelines are not specific enough to ensure consistent practice that meets care goals and resource constraints in NHs. However, new epidemiological research regarding effectiveness of varying isolation practices in this setting is needed to inform clinical practice. Further, additional infection prevention and control education for NH staff may be required. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials

    PubMed Central

    2011-01-01

    Background Studies have shown that residents in nursing homes often are exposed to inappropriate medication. Particular concern has been raised about the consumption of psychoactive drugs, which are commonly prescribed for nursing home residents suffering from dementia. This review is an update of a Norwegian systematic review commissioned by the Norwegian Directorate of Health. The purpose of the review was to identify and summarise the effect of interventions aimed at reducing potentially inappropriate use or prescribing of drugs in nursing homes. Methods We searched for systematic reviews and randomised controlled trials in the Cochrane Library, MEDLINE, EMBASE, ISI Web of Knowledge, DARE and HTA, with the last update in April 2010. Two of the authors independently screened titles and abstracts for inclusion or exclusion. Data on interventions, participants, comparison intervention, and outcomes were extracted from the included studies. Risk of bias and quality of evidence were assessed using the Cochrane Risk of Bias Table and GRADE, respectively. Outcomes assessed were use of or prescribing of drugs (primary) and the health-related outcomes falls, physical limitation, hospitalisation and mortality (secondary). Results Due to heterogeneity in interventions and outcomes, we employed a narrative approach. Twenty randomised controlled trials were included from 1631 evaluated references. Ten studies tested different kinds of educational interventions while seven studies tested medication reviews by pharmacists. Only one study was found for each of the interventions geriatric care teams, early psychiatric intervening or activities for the residents combined with education of health care personnel. Several reviews were identified, but these either concerned elderly in general or did not satisfy all the requirements for systematic reviews. Conclusions Interventions using educational outreach, on-site education given alone or as part of an intervention package and

  3. Physical abuse of older adults in nursing homes: a random sample survey of adults with an elderly family member in a nursing home.

    PubMed

    Schiamberg, Lawrence B; Oehmke, James; Zhang, Zhenmei; Barboza, Gia E; Griffore, Robert J; Von Heydrich, Levente; Post, Lori A; Weatherill, Robin P; Mastin, Teresa

    2012-01-01

    Few empirical studies have focused on elder abuse in nursing home settings. The present study investigated the prevalence and risk factors of staff physical abuse among elderly individuals receiving nursing home care in Michigan. A random sample of 452 adults with elderly relatives, older than 65 years, and in nursing home care completed a telephone survey regarding elder abuse and neglect experienced by this elder family member in the care setting. Some 24.3% of respondents reported at least one incident of physical abuse by nursing home staff. A logistic regression model was used to estimate the importance of various risk factors in nursing home abuse. Limitations in activities of daily living (ADLs), older adult behavioral difficulties, and previous victimization by nonstaff perpetrators were associated with a greater likelihood of physical abuse. Interventions that address these risk factors may be effective in reducing older adult physical abuse in nursing homes. Attention to the contextual or ecological character of nursing home abuse is essential, particularly in light of the findings of this study.

  4. How chaosity and randomness control human health

    NASA Astrophysics Data System (ADS)

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

    2005-08-01

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

  5. Understanding and control of random lasing

    NASA Astrophysics Data System (ADS)

    Burin, Alexander L.; Cao, Hui; Ratner, Mark A.

    2003-10-01

    Random lasing attracts much attention because it helps to understand coherent phenomena in disordered media and can be used in optoelectronics due to easy preparation (no need in mirrors) and small size of random lasers down to few microns. Recently the remarkable progress in studying the material, geometry and external pumping dependences of laser properties and efficiency has been reached. Lasing emerges from the special random cavities of high quality formed within the active medium. They can be described as the decaying eigenoptical modes within the medium and the optical mode having the minimum decay rate is responsible for lasing. Numerical and analytical studies of the properties of these modes permit to interpret existing experiments and suggest the ways to optimize the performance of lasers.

  6. A primer on randomized controlled trials.

    PubMed

    Likosky, Donald S

    2006-03-01

    Randomized Clinical Trials are held as the gold standard for quantifying the effect of an intervention across two or more groups. In such a trial an intervention is randomly allocated to one of two groups. The benefit of such a trial lies in its ability to establish nearly comparable groups of subjects in all manner except for the effect of the intervention. As such, the effect of a given intervention may be attributed solely to the intervention and not to any other extraneous factor. In the following editorial, we will discuss several issues that are important for understanding how to conduct and interpret randomized trials: choosing the study population, choosing the comparison group, choosing your outcome, study design, data analysis, and issues of inference. This editorial is intended to make the reader an educated consumer of such trial designs.

  7. Multiple Shaker Random Vibration Control--An Update

    SciTech Connect

    Smallwood, D.O.

    1999-02-18

    The theory of the control of multiple shakers driving a single test item is reviewed. Several improvements that have been introduced since the original papers on the subject will be discussed. The improvements include: (1) specification of the control spectra; (2) the control of non-square systems (the number of shakers does not have to be equal to the number of control points); (3) the connection between sine testing, waveform control, and random control; (4) improvements in feedback control; (5) overlap-add versus time domain randomization; and (6) reproduction of non-Gaussian waveforms.

  8. Analyzing Randomized Controlled Interventions: Three Notes for Applied Linguists

    ERIC Educational Resources Information Center

    Vanhove, Jan

    2015-01-01

    I discuss three common practices that obfuscate or invalidate the statistical analysis of randomized controlled interventions in applied linguistics. These are (a) checking whether randomization produced groups that are balanced on a number of possibly relevant covariates, (b) using repeated measures ANOVA to analyze pretest-posttest designs, and…

  9. Active control of multi-dimensional random sound in ducts

    NASA Technical Reports Server (NTRS)

    Silcox, R. J.; Elliott, S. J.

    1990-01-01

    Previous work has demonstrated how active control may be applied to the control of random noise in ducts. These implementations, however, have been restricted to frequencies where only plane waves are propagating in the duct. In spite of this, the need for this technology at low frequencies has progressed to the point where commercial products that apply these concepts are currently available. Extending the frequency range of this technology requires the extension of current single channel controllers to multi-variate control systems as well as addressing the problems inherent in controlling higher order modes. The application of active control in the multi-dimensional propagation of random noise in waveguides is examined. An adaptive system is implemented using measured system frequency response functions. Experimental results are presented illustrating attained suppressions of 15 to 30 dB for random noise propagating in multiple modes.

  10. RANDOM ACCESS CONTROL OF ELECTROLUMINESCENT ELEMENTS.

    DTIC Science & Technology

    Cadmium selenide (CdSe) switches were devised to control the luminous emittance of electroluminescent cells in a solid-state display. The technique...purpose of this contract was to establish the feasibility of utilizing the hysteretic effect in cadmium selenide to provide switching and storage to an...array of electroluminescent cells by investigating the cadmium selenide material, by studying panel structure, and by investigating the addressing of

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

    PubMed

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

    2016-05-01

    The University of Georgia maintains two meat-type chicken control strains: the Athens Random Bred (ARB) and the Athens Canadian Random Bred (ACRB). The Athens Random Bred was developed from colored plumage commercial meat chicken strains in 1956. The ACRB is a replicate population of the Ottawa Meat Control strain which was developed in 1955 from white plumage commercial meat-type chickens. These genetic lines have been extremely valuable research resources and have been used extensively to provide comparative context to modern meat-type strains. The ACRB may be the oldest pedigreed control commercial meat-type chicken still in existence today. This paper reviews the history of the breed backgrounds for both control populations and reviews research utilizing the ACRB. © 2016 Poultry Science Association Inc.

  12. 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.

  13. 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.

  14. 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…

  15. 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…

  16. Random allocation in controlled clinical trials: a review.

    PubMed

    Egbewale, Bolaji Emmanuel

    2014-01-01

    An allocation strategy that allows for chance placement of participants to study groups is crucial to the experimental nature of randomised controlled trials. Following decades of the discovery of randomisation considerable erroneous opinion and misrepresentations of its concept both in principle and practice still exists. In some circles, opinions are also divided on the strength and weaknesses of each of the random allocation strategies. This review provides an update on various random allocation techniques so as to correct existing misconceptions on this all important procedure. This is a review of literatures published in the Pubmed database on concepts of common allocation techniques used in controlled clinical trials. Allocation methods that use; case record number, date of birth, date of presentation, haphazard or alternating assignment are non-random allocation techniques and should not be confused as random methods. Four main random allocation techniques were identified. Minimisation procedure though not fully a random technique, however, proffers solution to the limitations of stratification at balancing for multiple prognostic factors, as the procedure makes treatment groups similar in several important features even in small sample trials. Even though generation of allocation sequence by simple randomisation procedure is easily facilitated, a major drawback of the technique is that treatment groups can by chance end up being dissimilar both in size and composition of prognostic factors. More complex allocation techniques that yield more comparable treatment groups also have certain drawbacks. However, it is important that whichever allocation technique is employed, unpredictability of random assignment should not be compromised.

  17. Antidepressants as analgesics: a review of randomized controlled trials.

    PubMed Central

    Lynch, M E

    2001-01-01

    This review provides an overview of 59 randomized placebo-controlled trials that examined the analgesic effect of antidepressants. To summarize, there is significant evidence that the tricyclic group of antidepressants is analgesic and that trazodone is not; the data regarding selective serotonin reuptake inhibitors are conflicting. To date, there are no randomized controlled trials examining the potential analgesic action of nefazodone or venlafaxine, but on the basis of initial clinical reports and its structural similarity to other analgesics, venlafaxine shows promise as an analgesic. PMID:11212591

  18. A randomized controlled trial of an electronic informed consent process.

    PubMed

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  19. Effects on leisure activities and social participation of a case management intervention for frail older people living at home: a randomised controlled trial.

    PubMed

    Granbom, Marianne; Kristensson, Jimmie; Sandberg, Magnus

    2017-07-01

    Frailty causes disability and restrictions on older people's ability to engage in leisure activities and for social participation. The objective of this study was to evaluate the effects of a 1-year case management intervention for frail older people living at home in Sweden in terms of social participation and leisure activities. The study was a randomised controlled trial with repeated follow-ups. The sample (n = 153) was consecutively and randomly assigned to intervention (n = 80) or control groups (n = 73). The intervention group received monthly home visits over the course of a year by nurses and physiotherapists working as case managers, using a multifactorial preventive approach. Data collections on social participation, leisure activities and rating of important leisure activities were performed at baseline, 3, 6, 9 and 12 months, with recruitment between October 2006 and April 2011. The results did not show any differences in favour of the intervention on social participation. However, the intervention group performed leisure activities in general, and important physical leisure activities, to a greater extent than the control group at the 3-month follow-up (median 13 vs. 11, P = 0.034 and median 3 vs. 3, P = 0.031 respectively). A statistically significantly greater proportion of participants from the intervention group had an increased or unchanged number of important social leisure activities that they performed for the periods from baseline to 3 months (93.2% vs. 75.4%, OR = 4.48, 95% CI: 1.37-14.58). Even though statistically significant findings in favour of the intervention were found, more research on activity-focused case management interventions is needed to achieve clear effects on social participation and leisure activities. © 2017 John Wiley & Sons Ltd.

  20. Adaptive adjustment of the randomization ratio using historical control data

    PubMed Central

    Hobbs, Brian P.; Carlin, Bradley P.; Sargent, Daniel J.

    2013-01-01

    Background Prospective trial design often occurs in the presence of “acceptable” [1] historical control data. Typically this data is only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al. [2], succeeded a similar trial reported by Saltz et al. [3], and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS) characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors [4] are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure leads to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal

  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. 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…

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

    ERIC Educational Resources Information Center

    Newman, Denis; Jaciw, Andrew P.

    2012-01-01

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

  4. 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…

  5. Can the Randomized Controlled Trial Literature Generalize to Nonrandomized Patients?

    ERIC Educational Resources Information Center

    Stirman, Shannon Wiltsey; DeRubeis, Robert J.; Crits-Christoph, Paul; Rothman, Allison

    2005-01-01

    To determine the extent to which published randomized controlled trials (RCTs) of psychotherapy can be generalized to a sample of outpatients, the authors matched information obtained from charts of patients who had been screened out of RCTs to inclusion and exclusion criteria from published RCT studies. Most of the patients in the sample who had…

  6. Asthma Self-Management Model: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  7. 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…

  8. Can the Randomized Controlled Trial Literature Generalize to Nonrandomized Patients?

    ERIC Educational Resources Information Center

    Stirman, Shannon Wiltsey; DeRubeis, Robert J.; Crits-Christoph, Paul; Rothman, Allison

    2005-01-01

    To determine the extent to which published randomized controlled trials (RCTs) of psychotherapy can be generalized to a sample of outpatients, the authors matched information obtained from charts of patients who had been screened out of RCTs to inclusion and exclusion criteria from published RCT studies. Most of the patients in the sample who had…

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

    ERIC Educational Resources Information Center

    Newman, Denis; Jaciw, Andrew P.

    2012-01-01

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

  10. Asthma Self-Management Model: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  11. 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…

  12. 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…

  13. 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…

  14. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    DTIC Science & Technology

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  15. 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

  16. 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.

  17. What's in placebos: who knows? Analysis of randomized, controlled trials.

    PubMed

    Golomb, Beatrice A; Erickson, Laura C; Koperski, Sabrina; Sack, Deanna; Enkin, Murray; Howick, Jeremy

    2010-10-19

    No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting. To assess how often investigators specify the composition of placebos in randomized, placebo-controlled trials. 4 English-language general and internal medicine journals with high impact factors. 3 reviewers screened titles and abstracts of the journals to identify randomized, placebo-controlled trials published from January 2008 to December 2009. Reviewers independently abstracted data from the introduction and methods sections of identified articles, recording treatment type (pill, injection, or other) and whether placebo composition was stated. Discrepancies were resolved by consensus. Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002). Journals with high impact factors may not be representative. Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.

  18. 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

  19. Review of Randomized Controlled Trials of Massage in Preterm Infants.

    PubMed

    Niemi, Anna-Kaisa

    2017-04-03

    Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  20. [Randomized controlled trials terminated prematurely: beneficial therapy effects].

    PubMed

    Kluth, L A; Rink, M; Ahyai, S A; Fisch, M; Shariat, S F; Dahm, P

    2013-08-01

    Randomized controlled trials (RCTs) stopped prematurely for beneficial therapy effects are becoming increasingly more prevalent in the urological literature and often receive great attention in the public and medical media. Urologists who practice evidence-based medicine should be aware of the potential bias and the different reasons why and how early termination of RCTs can and will affect the results. This review provides insights into the challenges clinical urologists face by interpreting the results of prematurely terminated RCTs.

  1. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia.

    PubMed

    Terevnikov, Viacheslav; Joffe, Grigori; Stenberg, Jan-Henry

    2015-05-19

    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. 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. 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. 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 the course of psychosis. Better designed

  2. 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

  3. Exposure to violence in relation to personality traits, coping abilities, and burnout among caregivers in nursing homes: a case-control study.

    PubMed

    Isaksson, Ulf; Graneheim, Ulla Hällgren; Richter, Jörg; Eisemann, Martin; Aström, Sture

    2008-12-01

    Although violence toward caregivers occurs often and caregivers' ability to interact and deal with difficult situations is relevant in preventing such violence, few studies have been conducted that focus on caregivers' characteristics. This study explores the relationship between perceived exposure to violence and demographical factors, parental rearing, personality traits including coping abilities, defence styles, and burnout among caregivers working in nursing homes. A total of 196 caregivers working in nursing homes were included. They were asked to complete questionnaires concerning demographical factors and exposure to violence. One group of female caregivers reporting no exposure to violence (n = 20) was matched with one group of exposed to violence (n = 20). Both groups were asked to complete questionnaires concerning parental rearing, personality traits, coping abilities, and burnout. Around 68.4% of the caregivers had been exposed to violence during the previous year and 22.4% several times a week. Caregivers 50 years of age or younger and employed in geriatric care for more than 3 years were more frequently exposed to violence. Inter-group differences were found regarding 'maternal rejection' and 'burnout'. No statistical differences could be found concerning defence styles, coping ability, temperament, or character aspects. Violence toward caregivers occurs frequently and appears to be influenced by several factors. 'Maternal rejection' and 'burnout' among caregivers exposed to violence might influence the communication between caregivers and residents, rendering more violence. However, personality traits among caregivers do not seem to be associated with exposure to violence.

  4. Randomized Algorithms for Systems and Control: Theory and Applications

    DTIC Science & Technology

    2008-05-01

    does not display a currently valid OMB control number . 1. REPORT DATE MAY 2008 2. REPORT TYPE 3. DATES COVERED 00-00-2008 to 00-00-2008 4...TITLE AND SUBTITLE Randomized Algorithms for Systems and Control: Theory and Applications 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT... NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) IEIIT-CNR

  5. 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.

  6. 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.

  7. 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

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

    PubMed

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

    2015-07-06

    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.

  9. A Randomized Controlled Trial of Caries Prevention in Dental Practice.

    PubMed

    Tickle, M; O'Neill, C; Donaldson, M; Birch, S; Noble, S; Killough, S; Murphy, L; Greer, M; Brodison, J; Verghis, R; Worthington, H V

    2017-07-01

    We conducted a parallel group randomized controlled trial of children initially aged 2 to 3 y who were caries free, to prevent the children becoming caries active over the subsequent 36 mo. The setting was 22 dental practices in Northern Ireland, and children were randomly assigned by a clinical trials unit (CTU) (using computer-generated random numbers, with allocation concealed from the dental practice until each child was recruited) to the intervention (22,600-ppm fluoride varnish, toothbrush, 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized, evidence-based prevention advice) or advice-only control at 6-monthly intervals. The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were number of decayed, missing, or filled teeth (dmfs) in caries-active children, number of episodes of pain, and number of extracted teeth. Adverse reactions were recorded. Calibrated external examiners, blinded to the child's study group, assessed the status of the children at baseline and after 3 y. In total, 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 intervention, 547 control) were included in the final analyses. Eighty-seven percent of intervention and 86% of control children attended every 6-mo visit ( P = 0.77). A total of 187 (34%) in the intervention group converted to caries active compared to 213 (39%) in the control group (odds ratio, 0.81; 95% confidence interval, 0.64-1.04; P = 0.11). Mean dmfs of those with caries in the intervention group was 7.2 compared to 9.6 in the control group ( P = 0.007). There was no significant difference in the number of episodes of pain between groups ( P = 0.81) or in the number of teeth extracted in caries-active children ( P = 0.95). Ten children in the intervention group had adverse reactions of a minor nature. This well-conducted trial failed to demonstrate that the intervention kept children caries free, but there was evidence that once

  10. 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

  11. Laser Acupuncture for Neonatal Abstinence Syndrome: A Randomized Controlled Trial.

    PubMed

    Raith, Wolfgang; Schmölzer, Georg M; Resch, Bernhard; Reiterer, Fritz; Avian, Alexander; Koestenberger, Martin; Urlesberger, Berndt

    2015-11-01

    Neonatal abstinence syndrome (NAS) is usually treated with opiate derivatives and supported with nonpharmacological treatment. This prospective, randomized, controlled, blinded, single-center study was carried out between March 2009 and November 2014. Newborn infants diagnosed with NAS after maternal opioid substitution therapy were eligible for inclusion. Infants were randomly allocated to the acupuncture group (combining laser acupuncture and pharmacological therapy of morphine and phenobarbital) or control group (pharmacological therapy alone). Laser acupuncture was performed with a LABpen MED 10 (675 nm/10 mW) at 5 ear and 4 body acupuncture points, bilaterally, and sessions were repeated every day. The primary outcome measure was duration of oral morphine therapy for NAS. Secondary outcomes included highest single Finnegan score, time to highest single Finnegan score, maximum amount of oral morphine solution (in milliliters per kilogram and milligrams per kilogram), time to maximum amount of oral morphine solution, and length of hospital stay. Twenty-eight newborns (14 in each group) were eligible for analysis. Duration of oral morphine therapy was significantly reduced in the acupuncture group compared with the control group (28 vs 39 days, respectively, P = .019). In addition, we observed a significantly reduced length of hospital stay in the acupuncture group compared with the control group (35 days [interquartile range 25 to 47] vs 50 days [36 to 66], P = .048). Adjunctive laser acupuncture significantly reduced the duration of morphine therapy in newborns with NAS. Copyright © 2015 by the American Academy of Pediatrics.

  12. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    PubMed

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    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. 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). 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. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  13. Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial.

    PubMed

    Smallwood, J; Brown, R; Coulter, F; Irvine, E; Copland, C

    2001-10-01

    A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size. Copyright 2001 John Wiley & Sons, Ltd.

  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. Testimony Therapy With Ritual: A Pilot Randomized Controlled Trial.

    PubMed

    Esala, Jennifer J; Taing, Sopheap

    2017-02-01

    Testimony therapy can provide low-cost, brief, simple, and culturally adaptable psychosocial services in low-income countries (Agger, Raghuvanshi, Khan, Polatin, & Laursen, 2009). Nonetheless, there have been no well-controlled studies of testimony therapy. We report the analyses of a randomized controlled trial designed to assess the effectiveness of testimony therapy plus a culturally adapted ceremony in reducing mental health symptoms among Khmer Rouge torture survivors from across Cambodia. Using multilevel modeling, we compared symptoms of posttraumatic stress disorder, anxiety, and depression between a treatment (n = 45) and a control group (n = 43) at baseline, 3 months, and 6 months. We found that testimony therapy plus ceremony significantly reduced symptoms of posttraumatic stress disorder (d = 0.49), anxiety (d = 0.44), and depression (d = 0.53).

  16. NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

    PubMed

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-12-01

    Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

  17. Partner randomized controlled trial: study protocol and coaching intervention.

    PubMed

    Garbutt, Jane M; Highstein, Gabrielle; Yan, Yan; Strunk, Robert C

    2012-04-02

    Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. This paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year

  18. Partner randomized controlled trial: study protocol and coaching intervention

    PubMed Central

    2012-01-01

    Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance

  19. Epicatechin, procyanidins, cocoa, and appetite: a randomized controlled trial.

    PubMed

    Greenberg, James A; O'Donnell, Ryan; Shurpin, Miriam; Kordunova, Dorina

    2016-09-01

    In 2 randomized controlled trials, it was reported that dark chocolate acutely decreased appetite in human subjects, but the authors did not assess the types or concentrations of cocoa compounds that are needed. Other studies have suggested that the cocoa compounds epicatechin and procyanidins may be involved. We sought to test the hypotheses that, compared with placebo (an alkalized cocoa mixture containing essentially no epicatechin or procyanidins), the following beverages cause a decrease in appetite: 1) a nonalkalized cocoa mixture; 2) epicatechin plus placebo; and 3) procyanidins plus placebo. We measured the concentrations of cocoa compounds in all beverages. We used a 4-way randomized, crossover, placebo-controlled trial that was balanced for period and carryover effects in 28 healthy, young-adult men. We also conducted a smaller (n = 14), parallel, secondary randomized trial in which we explored the effects of higher doses of epicatechin and procyanidins. Our primary measure of appetite was ad libitum pizza intake 150 min after beverage ingestion. We used a linear mixed-model analysis. Intakes of beverages with the nonalkalized cocoa mixture that contained 0.6 mg epicatechin, 0.2 mg catechin, and 2.9 mg monomer-decamer procyanidins/kg body weight did not decrease pizza intake significantly (P = 0.29) compared with intake of the placebo. In the smaller secondary trial, a combination of epicatechin and the nonalkalized cocoa mixture that contained 1.6 mg epicatechin/kg body weight significantly decreased pizza intake by 18.7% (P = 0.04). Our nonalkalized cocoa mixture was associated with an acute decrease in food intake only after being supplemented with epicatechin. It is possible that epicatechin at a dose of >1.6 mg/kg body weight, alone or in concert with appropriate catalytic cocoa compounds, may be useful for helping people control their food intakes. This trial was registered at clinicaltrials.gov as NCT02408289. © 2016 American Society for Nutrition.

  20. A Randomized Controlled Trial of Mentoring Interventions for Underrepresented Minorities.

    PubMed

    Lewis, Vivian; Martina, Camille A; McDermott, Michael P; Trief, Paula M; Goodman, Steven R; Morse, Gene D; LaGuardia, Jennifer G; Sharp, Daryl; Ryan, Richard M

    2016-07-01

    To conduct a randomized controlled trial to evaluate the effects of different mentoring interventions on the basic psychological need satisfaction of underrepresented minorities and women in academia. Participants were 150 mentor/protégé dyads from three academic medical centers and eight other colleges and universities in western and central New York, randomized from 2010 to 2013 into mentor training (using principles of self-determination theory); peer mentoring for protégés; mentor training and peer mentoring for protégés combined; or control/usual practice. Protégé participants were graduate students, fellows, and junior faculty who were from underrepresented groups based on race, ethnicity, gender, or disability.The primary analysis was a comparison of intervention effects on changes in protégés' satisfaction of their basic psychological needs (competence, autonomy, and relatedness) with their mentor. They completed a well-validated, online questionnaire every two months for one year. There was no significant effect at the end of one year of either mentor training or peer mentoring on protégés' psychological basic need satisfaction with mentor specifically or at work in general. Exploratory analyses showed a significant effect of the mentor-based intervention on the protégés' overall psychological need satisfaction with their mentor at two months, the time point closest to completing mentor training. This randomized controlled trial showed a potential short-term effect of mentor training on changing basic psychological need satisfaction of underrepresented scholars with their mentors. Despite the lack of sustained effect of either mentor training or peer mentoring, these short-term changes suggest feasibility and potential for future study.

  1. 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

  2. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    PubMed Central

    Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2015-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. PMID:25456014

  3. Medication reconciliation at patient admission: a randomized controlled trial

    PubMed Central

    Mendes, Antonio E.; Lombardi, Natália F.; Andrzejevski, Vânia S.; Frandoloso, Gibran; Correr, Cassyano J.; Carvalho, Mauricio

    2015-01-01

    Objective: To measure length of hospital stay (LHS) in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620). The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety. PMID:27011775

  4. Mental practice enhances surgical technical skills: a randomized controlled study.

    PubMed

    Arora, Sonal; Aggarwal, Rajesh; Sirimanna, Pramudith; Moran, Aidan; Grantcharov, Teodor; Kneebone, Roger; Sevdalis, Nick; Darzi, Ara

    2011-02-01

    To assess the effects of mental practice on surgical performance. Increasing concerns for patient safety have highlighted a need for alternative training strategies outside the operating room. Mental practice (MP), "the cognitive rehearsal of a task before performance," has been successful in sport and music to enhance skill. This study investigates whether MP enhances performance in laparoscopic surgery. After baseline skills testing, 20 novice surgeons underwent training on an evidence-based virtual reality curriculum. After randomization using the closed envelope technique, all participants performed 5 Virtual Reality (VR) laparoscopic cholecystectomies (LC). Mental practice participants performed 30 minutes of MP before each LC; control participants viewed an online lecture. Technical performance was assessed using video Objective Structured Assessment of Technical Skills-based global ratings scale (scored from 7 to 35). Mental imagery was assessed using a previously validated Mental Imagery Questionnaire. Eighteen participants completed the study. There were no intergroup differences in baseline technical ability. Learning curves were demonstrated for both MP and control groups. Mental practice was superior to control (global ratings) for the first LC (median 20 vs 15, P = 0.005), second LC (20.5 vs 13.5, P = 0.001), third LC (24 vs 15.5, P < 0.001), fourth LC (25.5 vs 15.5, P < 0.001) and the fifth LC (27.5 vs 19.5, P = 0.00). The imagery for the MP group was also significantly superior to the control group across all sessions (P < 0.05). Improved imagery significantly correlated with better quality of performance (ρ 0.51–0.62, Ps < 0.05). This is the first randomized controlled study to show that MP enhances the quality of performance based on VR laparoscopic cholecystectomy. This may be a time- and cost-effective strategy to augment traditional training in the OR thus potentially improving patient care.

  5. A randomized controlled trial of qigong for fibromyalgia

    PubMed Central

    2012-01-01

    Introduction Fibromyalgia is difficult to treat and requires the use of multiple approaches. This study is a randomized controlled trial of qigong compared with a wait-list control group in fibromyalgia. Methods One hundred participants were randomly assigned to immediate or delayed practice groups, with the delayed group receiving training at the end of the control period. Qigong training (level 1 Chaoyi Fanhuan Qigong, CFQ), given over three half-days, was followed by weekly review/practice sessions for eight weeks; participants were also asked to practice at home for 45 to 60 minutes per day for this interval. Outcomes were pain, impact, sleep, physical function and mental function, and these were recorded at baseline, eight weeks, four months and six months. Immediate and delayed practice groups were analyzed individually compared to the control group, and as a combination group. Results In both the immediate and delayed treatment groups, CFQ demonstrated significant improvements in pain, impact, sleep, physical function and mental function when compared to the wait-list/usual care control group at eight weeks, with benefits extending beyond this time. Analysis of combined data indicated significant changes for all measures at all times for six months, with only one exception. Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice. Conclusions This study demonstrates that CFQ, a particular form of qigong, provides long-term benefits in several core domains in fibromyalgia. CFQ may be a useful adjuvant self-care treatment for fibromyalgia. Trial registration clinicaltrials.gov NCT00938834. PMID:22863206

  6. Barbed suture for gastrointestinal closure: a randomized control trial.

    PubMed

    Demyttenaere, Sebastian V; Nau, Peter; Henn, Matthew; Beck, Catherine; Zaruby, Jeffrey; Primavera, Michael; Kirsch, David; Miller, Jeffrey; Liu, James J; Bellizzi, Andrew; Melvin, W Scott

    2009-09-01

    In an effort to make laparoscopic suturing more efficient, the V-Loc advanced wound closure device (Covidien, Mansfield, MA) has been produced. This device is a self-anchoring barbed suture that obviates the need for knot tying. The goal of this initial feasibility study was to investigate the use of the barbed suture in gastrointestinal enterotomy closure. A randomized study of 12 pigs comparing enterotomy closure with barbed versus a nonbarbed suture of similar tensile strength was performed. To this end, 25 mm enterotomies were made in the stomach (1 control, 1 treatment), jejunum (2 controls, 2 treatments), and descending colon (1 control, 1 treatment). Animals were killed at 3, 7, and 14 days postoperatively (4 each group) and their gastrointestinal tracts harvested; 6 of the 8 enterotomies from each pig underwent burst strength testing. The remaining 2 were fixed in formalin and sent for histological examination. All 12 pigs survived until they were killed without any major complications. Enterotomy closure with barbed suture revealed adhesion scores, burst strength pressures, and histology scores that were similar to those for the control. Jejunal closures resulted in 6 failures at 7 days (3 control, 3 barbed) and 4 failures at 14 days (2 control, 2 barbed). The barbed suture significantly reduced suturing time in the stomach, jejunum, and colon. The V-Loc wound closure device appears to offer comparable gastrointestinal closure to 3-0 Maxon while being significantly faster. Further studies with V-Loc are required to assess its use in laparoscopic surgery.

  7. IS “RESCUE” THERAPY ETHICAL IN RANDOMIZED CONTROLLED TRIALS?

    PubMed Central

    Holubkov, Richard; Michael Dean, J.; Berger, John; Anand, K. J. S.; Carcillo, Joseph; Meert, Kathleen; Zimmerman, Jerry; Newth, Christopher; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol

    2011-01-01

    Objective There is a commonly held belief that randomized, placebo-controlled trials in pediatric critical care should incorporate “rescue” therapy (open-label administration of active drug) when a child’s condition is deteriorating. The ethical, conceptual and analytic challenges related to “rescue” therapy in randomized trials can be misrepresented. Design Narrative review. Methods The ethical basis of “rescue” therapy, the equipoise concept, and intention-to-treat analysis are examined in the setting of a hypothetical randomized trial comparing corticosteroids versus placebo in pediatric septic shock. Findings The perceived need for “rescue” therapy may be partly motivated by the moral imperative to save a child’s life. However, allowing “rescue” therapy in a trial is misconceived and inconsistent with equipoise regarding the efficacy of the study drug. If “rescue” therapy is permitted, intention-to-treat analysis can only compare immediate versus delayed use of the study drug. When “rescue” therapy is beneficial, the observed treatment effect is substantially diminished from true effect of the study drug, leading to increased sample size and thereby placing more children at risk (18 “excess” placebo-arm deaths occur in our hypothetical example). Analysis of a trial incorporating “rescue” therapy cannot definitively assess overall efficacy of the agent, or distinguish beneficial or harmful treatment effects related to timing of drug use. Conclusions While a “rescue” therapy component in a randomized trial may be perceived as ethically desirable, inconsistency of “rescue” therapy with full equipoise may itself raise significant ethical concerns. Increased sample sizes expose more children to the risks of study participation, including death. Researchers should be aware that clinical trials designed with “rescue” therapy cannot definitively determine the beneficial or harmful effects of a treatment per se, and

  8. 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

  9. Exercise training in mitochondrial myopathy: a randomized controlled trial.

    PubMed

    Cejudo, Pilar; Bautista, Juan; Montemayor, Teodoro; Villagómez, Rafael; Jiménez, Luis; Ortega, Francisco; Campos, Yolanda; Sánchez, Hildegard; Arenas, Joaquín

    2005-09-01

    Patients with mitochondrial myopathies (MM) usually suffer from exercise intolerance due to their impaired oxidative capacity and physical deconditioning. We evaluated the effects of a 12-week supervised randomized rehabilitation program involving endurance training in patients with MM. Twenty MM patients were assigned to a training or control group. For three nonconsecutive days each week, patients combined cycle exercise at 70% of their peak work rate with three upper-body weight-lifting exercises performed at 50% of maximum capacity. Training increased maximal oxygen uptake (28.5%), work output (15.5%), and minute ventilation (40%), endurance performance (62%), walking distance in shuttle walking test (+95 m), and peripheral muscle strength (32%-62%), and improved Nottingham Health Profile scores (21.47%) and clinical symptoms. Control MM patients did not change from baseline. Results show that our exercise program is an adequate training strategy for patients with mitochondrial myopathy.

  10. Standardization for subgroup analysis in randomized controlled trials.

    PubMed

    Varadhan, Ravi; Wang, Sue-Jane

    2014-01-01

    Randomized controlled trials (RCTs) emphasize the average or overall effect of a treatment (ATE) on the primary endpoint. Even though the ATE provides the best summary of treatment efficacy, it is of critical importance to know whether the treatment is similarly efficacious in important, predefined subgroups. This is why the RCTs, in addition to the ATE, also present the results of subgroup analysis for preestablished subgroups. Typically, these are marginal subgroup analysis in the sense that treatment effects are estimated in mutually exclusive subgroups defined by only one baseline characteristic at a time (e.g., men versus women, young versus old). Forest plot is a popular graphical approach for displaying the results of subgroup analysis. These plots were originally used in meta-analysis for displaying the treatment effects from independent studies. Treatment effect estimates of different marginal subgroups are, however, not independent. Correlation between the subgrouping variables should be addressed for proper interpretation of forest plots, especially in large effectiveness trials where one of the goals is to address concerns about the generalizability of findings to various populations. Failure to account for the correlation between the subgrouping variables can result in misleading (confounded) interpretations of subgroup effects. Here we present an approach called standardization, a commonly used technique in epidemiology, that allows for valid comparison of subgroup effects depicted in a forest plot. We present simulations results and a subgroup analysis from parallel-group, placebo-controlled randomized trials of antibiotics for acute otitis media.

  11. Psychosocial Telephone Intervention for Dementia Caregivers: A Randomized, Controlled Trial

    PubMed Central

    Tremont, Geoffrey; Davis, Jennifer D.; Papandonatos, George D.; Ott, Brian R.; Fortinsky, Richard H.; Gozalo, Pedro; Yue, Mun Sang; Bryant, Kimberly; Christine, Grover; Bishop, Duane S.

    2014-01-01

    Background Identifying effective and accessible interventions for dementia caregivers is critical as dementia prevalence increases. Objective Examine the effects of a telephone-based intervention on caregiver well-being. Design Randomized, controlled trial. Setting Academic medical center. Participants 250 distressed, family, dementia caregivers. Intervention Caregivers randomized to receive 16 telephone contacts over 6 months of either the Family Intervention: Telephone Tracking–Caregiver (FITT-C) or Telephone Support (TS). Outcome Primary outcome variables were family caregivers’ depressive symptoms, burden, and reactions to care recipients’ behavior problems at 6 months. Results The FITT-C intervention resulted in significantly improved caregiver depressive symptoms (p = 0.003; 27% net improvement) and less severe reactions to care-recipient depressive behaviors (p = 0.009; 29% net improvement) compared to the control condition (TS). Conclusion An entirely telephone-based intervention improves caregivers’ depressive symptoms and reactions to behavior problems in the care recipient and is comparable to reported results of face-to-face interventions. PMID:25074341

  12. Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

    PubMed

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

    2013-12-01

    Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

  13. Random total antiepileptic drug levels and seizure control during pregnancy.

    PubMed

    Al-Bunyan, M A

    2001-04-01

    To study the correlation of randomly-tested total antiepileptic plasma levels and seizure control in a retrospectively collected group of pregnant epileptic Saudi women. The medical records of 30 Saudi epileptic female patients were reviewed during their subsequent pregnancies (total of 50). The type of antiepileptic drugs used during each pregnancy, the dose of each drug and the corresponding total plasma levels were noted. Antiepileptic drugs assay were carried out randomly during pregnancy either by TDX or a sensitive high performance liquid chromatography method. A total of 50 pregnancies were studied. The most common seizure type in these women was complex partial seizure followed by primary generalized epilepsy, myoclonic seizures and of least occurrence was the simple partial seizure with secondary generalization. All patients were received antiepileptic drugs, including either carbamazepine, phenytoin, valporic acid, phenobarbitone or clonazepam. In a total of 24 pregnancies (48%), the serum levels of antiepileptic drugs were subtherapeutic during the first trimester. Recurrent seizures occurred in a total of 20 pregnancies (40%) especially in the 3rd trimester. It is concluded that subtherapeutic serum levels of antiepileptic drugs correlated highly with the increased frequency of seizure in these pregnant women. Monitoring of state of seizure control in epileptic pregnant women should be made regularly during the course of their pregnancies.

  14. Random total antiepilectic drug levels and seizure control during pregnancy.

    PubMed

    Al-Bunyan, M A

    2001-04-01

    To study the correlation of randomly-tested total antiepileptic plasma levels and seizure control in a retrospectively collected group of pregnant epileptic Saudi women. The medical records of 30 Saudi epileptic female patients were reviewed during their subsequent pregnancies (total of 50). The type of antiepileptic drugs used during each pregnancy, the dose of each drug and the corresponding total plasma levels were noted. Antiepileptic drugs assay were carried out randomly during pregnancy either by TDX or a sensitive high performance liquid chromatography method. A total of 50 pregnancies were studied. The most common seizure type in these women was complex partial seizure followed by primary generalized epilepsy, myoclonic seizures and of least occurrence was the simple partial seizure with secondary generalization. All patients were received antiepileptic drugs, including either carbamazepine, phenytoin, valporic acid, phenobarbitone or clonazepam. In a total of 24 pregnancies (48%), the serum levels of antiepileptic drugs were subtherapeutic during the first trimester. Recurrent seizures occurred in a total of 20 pregnancies (40%) especially in the 3rd trimester. It is concluded that subtherapeutic serum levels of antiepileptic drugs correlated highly with the increased frequency of seizure in these pregnant women. Monitoring of state of seizure control in epileptic pregnant women should be made regularly during the course of their pregnancies.

  15. Bibliometric analysis of the literature of randomized controlled trials

    PubMed Central

    Tsay, Ming-yueh; Yang, Yen-hsu

    2005-01-01

    Objective: Evidence-based medicine (EBM) is a significant issue and the randomized controlled trial (RCT) literature plays a fundamental role in developing EBM. This study investigates the features of RCT literature based on bibliometric methods. Growth of the literature, publication types, languages, publication countries, and research subjects are addressed. The distribution of journal articles was also examined utilizing Bradford's law and Bradford-Zipf's law. Method: The MEDLINE database was searched for articles indexed under the publication type “Randomized Control Trial,” and articles retrieved were counted and analyzed using Microsoft Access, Microsoft Excel, and PERL. Results: From 1990 to 2001, a total of 114,850 citations dealing with RCTs were retrieved. The literature growth rate, from 1965 to 2001, is steadily rising and follows an exponential model. Journal articles are the predominant form of publication, and the multicenter study is extensively used. English is the most commonly used language. Conclusions: Generally, RCTs are found in publications concentrating on cardiovascular disease, cancer, asthma, postoperative conditon, health, and anesthetics. Zone analysis and graphical formulation from Bradford's law of scattering shows variations from the standard Bradford model. Forty-two core journals were identified using Bradford's law. PMID:16239941

  16. A randomized controlled trial of home tooth-whitening products.

    PubMed

    Lo, Edward C M; Wong, Anthony H H; McGrath, Colman

    2007-10-01

    To evaluate the effectiveness of two marketed home tooth-whitening products. A randomized controlled clinical trial involving 87 adults who were randomly allocated into one of three groups: (1) 6% hydrogen peroxide whitening strips, (2) 18% carbamide peroxide whitening gel, and (3) a placebo (fluoride toothpaste) control group. Subjects were instructed individually and then used the given product daily for 2 consecutive weeks. Color was determined in brightness (L*), yellowness (b*) and redness (a*) [color space] at baseline and 8 weeks after dispensing the product by employing a high resolution digital camera (Fuji HC1000 CCD) to image the subject's anterior maxillary teeth under standard polarized lighting conditions. The subjects also completed a questionnaire on self-satisfaction with the treatment outcome. One-way ANOVA (Bonferroni test) demonstrated significant differences in color between the three groups with changes in brightness (L*, P< 0.001), yellowness (b*, P< 0.001) and redness (a*, P < 0.001). Changes in L* a* b* was greatest among those who used the 6% hydrogen peroxide whitening strips. Subjects in the whitening strip group also rated that product significantly (P < 0.01) more favorably than other groups with respect to the amount of whiteness improvement, as well as whitening satisfaction and overall impression while there is no significant difference between the whitening gel and the placebo groups.

  17. Psychosocial telephone intervention for dementia caregivers: A randomized, controlled trial.

    PubMed

    Tremont, Geoffrey; Davis, Jennifer D; Papandonatos, George D; Ott, Brian R; Fortinsky, Richard H; Gozalo, Pedro; Yue, Mun Sang; Bryant, Kimberly; Grover, Christine; Bishop, Duane S

    2015-05-01

    Identifying effective and accessible interventions for dementia caregivers is critical as dementia prevalence increases. Examine the effects of a telephone-based intervention on caregiver well-being. Randomized, controlled trial. Academic medical center. Two hundred and fifty distressed, family, dementia caregivers. Caregivers randomized to receive 16 telephone contacts over 6 months of either the Family Intervention: Telephone Tracking-Caregiver (FITT-C) or Telephone Support (TS). Primary outcome variables were family caregivers' depressive symptoms, burden, and reactions to care recipients' behavior problems at 6 months. The FITT-C intervention resulted in significantly improved caregiver depressive symptoms (P = .003; 27% net improvement) and less severe reactions to care-recipient depressive behaviors (P = .009; 29% net improvement) compared with the control condition (TS). An entirely telephone-based intervention improves caregivers' depressive symptoms and reactions to behavior problems in the care recipient and is comparable with reported results of face-to-face interventions. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  18. 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

  19. Randomized Controlled Trial of Primary Care Pediatric Parenting Programs

    PubMed Central

    Mendelsohn, Alan L.; Dreyer, Benard P.; Brockmeyer, Carolyn A.; Berkule-Silberman, Samantha B.; Huberman, Harris S.; Tomopoulos, Suzy

    2011-01-01

    Objectives To determine whether pediatric primary care–based programs to enhance parenting and early child development reduce media exposure and whether enhanced parenting mediates the effects. Design Randomized controlled trial. Setting Urban public hospital pediatric primary care clinic. Participants A total of 410 mother-newborn dyads enrolled after childbirth. Interventions Patients were randomly assigned to 1 of 2 interventions, the Video Interaction Project (VIP) and Building Blocks (BB) interventions, or to a control group. The VIP intervention comprised 1-on-1 sessions with a child development specialist who facilitated interactions in play and shared reading through review of videotapes made of the parent and child on primary care visit days; learning materials and parenting pamphlets were also provided. The BB intervention mailed parenting materials, including age-specific newsletters suggesting activities to facilitate interactions, learning materials, and parent-completed developmental questionnaires (Ages and Stages questionnaires). Outcome Measures Electronic media exposure in the home using a 24-hour recall diary. Results The mean (SD) exposure at 6 months was 146.5 (125.0) min/d. Exposure to VIP was associated with reduced total duration of media exposure compared with the BB and control groups (mean [SD] min/d for VIP, 131.6 [118.7]; BB, 151.2 [116.7]; control, 155.4 [138.7]; P=.009). Enhanced parent-child interactions were found to partially mediate relations between VIP and media exposure for families with a ninth grade or higher literacy level (Sobel statistic=2.49; P=.01). Conclusion Pediatric primary care may represent an important venue for addressing the public health problem of media exposure in young children at a population level. Trial Registration clinicaltrials.gov Identifier: NCT00212576 PMID:21199979

  20. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

    PubMed

    Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-09-22

    Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .

  1. Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial.

    PubMed

    Hillier, Sharon L; Nyirjesy, Paul; Waldbaum, Arthur S; Schwebke, Jane R; Morgan, Franklin G; Adetoro, Nikki A; Braun, Carol J

    2017-08-01

    To evaluate secnidazole as a single oral dose treatment for bacterial vaginosis in a phase 2 randomized, double-blind, placebo-controlled study. In a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study, women with bacterial vaginosis who met all Amsel criteria (discharge; pH 4.7 or greater; 20% or greater clue cells; positive whiff test) were randomized one to one to one at 24 U.S. centers to 1 or 2 g secnidazole compared with placebo. The primary endpoint was clinical cure (normalization of discharge, amine odor, and clue cells) 21-30 days after treatment. Secondary endpoints included microbiologic cure, defined as a Nugent score of 0-3, and therapeutic cure, defined as meeting criteria for both clinical and microbiologic cure. The modified intent to treat was used for efficacy analyses and included all randomized patients who met the enrollment criteria. Assuming a clinical cure rate of 40% in the active groups and 15% in the placebo group, a sample size of 52 patients per group provided approximately 80% power to detect a significant difference between groups (.05 level [two-sided]) using a Cochran-Mantel-Haenszel test. Between May and September 2014, 215 patients were enrolled. In the intent-to-treat population, the clinical cure rate was 65.3% for the 2-g group, 49.3% for the 1-g group, and 19.4% for the placebo group. The modified intent-to-treat population included 188 women (median age 33 years; 32% with four or more bacterial vaginosis episodes in the previous year; 54% black) with baseline Nugent scores 4 or greater. Clinical, microbiologic, and therapeutic cure rates were 67.7%, 40.3%, and 40.3% for 2 g secnidazole and 51.6%, 23.4%, and 21.9% for 1 g secnidazole compared with 17.7%, 6.5%, and 6.5% for placebo, respectively (P<.05 for secnidazole compared with placebo; all endpoints). Both doses were well-tolerated. Oral granules containing 1 and 2 g secnidazole were superior to placebo in bacterial vaginosis treatment (P<.001 for

  2. Dynamic response analysis of closed-loop control system for random intelligent truss structure under random forces

    NASA Astrophysics Data System (ADS)

    Gao, Wei; Chen, Jianjun; Zhou, Yabin; Cui, Mingtao

    2004-07-01

    Considering the randomness of structural damping, physical parameters of structural materials, geometric dimensions of active bars and passive bars, applied loads and control forces simultaneously, the problems of dynamic response analysis of closed-loop control system based on probability for the random intelligent truss structures are studied in this paper. The computational expressions of numerical characteristics of structural dynamic response of closed-loop control system are derived by means of the mode superposition method. Through the engineering examples, the influences of the randomness of them on structural dynamic response are inspected and some significant conclusions are obtained.

  3. Classroom and simulation team training: a randomized controlled trial.

    PubMed

    Clay-Williams, Robyn; McIntosh, Catherine A; Kerridge, Ross; Braithwaite, Jeffrey

    2013-07-01

    To test the hypotheses that classroom and simulation-based crew resource management (CRM) training interventions improve teamwork attitudes and behaviours of participants and that classroom training combined with simulation-based training provide synergistic improvements. A randomized controlled trial. Area Health Service in New South Wales, Australia. A total of 157 doctors, nurses and midwives randomized into one of four groups, consisting of three intervention groups and a control group. One-day CRM-based classroom course; one-day CRM style simulation-based training or classroom training followed by simulation-based training. Pre- and post-test quantitative participant teamwork attitudes, and post-test quantitative trainee reactions, knowledge and behaviour. Ninety-four doctors, nurses and midwives completed pre-intervention attitude questionnaires and 60 clinicians completed post-intervention assessments. No positive changes in teamwork attitudes were found associated with classroom or simulation training. Positive changes were found in knowledge (mean difference 1.50, 95% confidence interval (CI) 0.58-2.43, P = 0.002), self-assessed teamwork behaviour (mean difference 2.69, 95% CI 0.90-6.13, P = 0.009) and independently observed teamwork behaviour (mean difference 2.30, 95% CI 0.30-4.30, P = 0.027) when classroom-only trained group was compared with control; however, these changes were not found in the group that received classroom followed by simulation training. Classroom-based training alone resulted in improvements in participant knowledge and observed teamwork behaviour. The study found no additional impact of simulation training.

  4. The role of parental control and modelling in predicting a child's diet and relationship with food after they leave home. A prospective study.

    PubMed

    Dickens, Emma; Ogden, Jane

    2014-05-01

    Research indicates that parental control and parental modelling are key factors in shaping a child's eating behaviour. To date, however, little is known about how these factors influence a child's diet once they have left home. This prospective study evaluated the extent to which a parent's own behaviour and their use of control over food whilst their child was still living at home predicted their child's relationship with food once they had begun to live independently. Parent/child dyads (n=93) took part in the study. Parents completed baseline measures of parental control practices (overt control, covert control and pressure to eat), their own diet (unhealthy snacks, unhealthy meals, healthy foods) and eating behaviours (emotional, uncontrolled and restrained eating). At one year follow up, once their child had left home, the child completed measures of their own diet and eating behaviours. The results showed a clear role for modelling with concordance between a child's intake of unhealthy snacks and emotional eating and their parents' own reports of these behaviours. Furthermore, the child's intake of healthy foods was also predicted by their parent's behaviour although there was both concordance and discordance between parents and their children. No role for parental control was found for any measure of diet or eating behaviour. It is concluded that a parent's own behaviour rather than parental control has a stronger longer lasting influence once a child has left home and that although this mostly involves a child copying their parent's behaviour (action) at times it also involves the opposite (reaction). Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. A randomized controlled trial of financial incentives for weight loss

    PubMed Central

    Volpp, Kevin G.; John, Leslie K; Troxel, Andrea B; Norton, Laurie; Fassbender, Jennifer; Loewenstein, George

    2012-01-01

    Context Identifying effective strategies for treating obesity is both a clinical challenge and a public health priority due to the health consequences of obesity. Objective To determine whether common decision errors identified by behavioral economists such as prospect theory, loss aversion, and regret could be used to design an effective weight loss intervention. Design 3-arm randomized controlled trial in which participants were randomized to either usual care (weigh ins once a month) or one of two financial incentives arms. One incentive arm used deposit contracts in which participants put their own money at risk (matched 1:1 by the study) which they would lose if they failed to lose weight. The second used lottery-based incentives in which participants who met the weight loss target had each day a 1 in 5 chance of winning a small reward ($10) and a 1 in 100 chance of winning a large reward ($100). All participants were given a weight loss goal of 1 pound per week for 16 weeks, and results were analyzed using intention-to-treat analysis of variance models. Setting Philadelphia Veterans Affairs Medical Center. Patients 57 patients with BMIs between 30-40 aged between 30 and 70, with no contraindications for study participation. Main Outcome Measures Weight loss after 16 weeks. Results Participants in both incentive groups lost significantly more weight than participants in the control group (3.9 pounds); (Lottery = 13.1 lbs; p-value for lottery vs. control .014; deposit contract = 14.0 lbs, p-value vs. control .003). 47.4% of deposit contract participants and 52.6% of lottery arm participants met the 16-pound weight loss goal compared to 10.5% in the control group (p-value 0.014.). By the end of 7 months, substantial amounts of weight were regained; however, incentive participants weighed significantly less than they did at the study start whereas controls did not. Low lost to follow-up rates (7.0%) during the weight loss phase of the study suggest that both

  6. Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment.

    PubMed

    Yin, H Shonna; Parker, Ruth M; Sanders, Lee M; Dreyer, Benard P; Mendelsohn, Alan L; Bailey, Stacy; Patel, Deesha A; Jimenez, Jessica J; Kim, Kwang-Youn A; Jacobson, Kara; Hedlund, Laurie; Smith, Michelle C J; Maness Harris, Leslie; McFadden, Terri; Wolf, Michael S

    2016-10-01

    Poorly designed labels and packaging are key contributors to medication errors. To identify attributes of labels and dosing tools that could be improved, we examined the extent to which dosing error rates are affected by tool characteristics (ie, type, marking complexity) and discordance between units of measurement on labels and dosing tools; along with differences by health literacy and language. Randomized controlled experiment in 3 urban pediatric clinics. English- or Spanish-speaking parents (n = 2110) of children ≤8 years old were randomly assigned to 1 of 5 study arms and given labels and dosing tools that varied in unit pairings. Each parent measured 9 doses of medication (3 amounts [2.5, 5, and 7.5 mL] and 3 tools [1 cup, 2 syringes (0.2- and 0.5-mL increments)]), in random order. Outcome assessed was dosing error (>20% deviation; large error defined as > 2 times the dose). A total of 84.4% of parents made ≥1 dosing error (21.0% ≥1 large error). More errors were seen with cups than syringes (adjusted odds ratio = 4.6; 95% confidence interval, 4.2-5.1) across health literacy and language groups (P < .001 for interactions), especially for smaller doses. No differences in error rates were seen between the 2 syringe types. Use of a teaspoon-only label (with a milliliter and teaspoon tool) was associated with more errors than when milliliter-only labels and tools were used (adjusted odds ratio = 1.2; 95% confidence interval, 1.01-1.4). Recommending oral syringes over cups, particularly for smaller doses, should be part of a comprehensive pediatric labeling and dosing strategy to reduce medication errors. Copyright © 2016 by the American Academy of Pediatrics.

  7. 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

  8. Individual placement and support in Sweden - a randomized controlled trial.

    PubMed

    Bejerholm, Ulrika; Areberg, Cecilia; Hofgren, Caisa; Sandlund, Mikael; Rinaldi, Miles

    2015-01-01

    Currently there is no evidence on the effectiveness of Individual Placement and Support (IPS) in Sweden. To determine the effectiveness of IPS on vocational outcomes among people with severe mental illness (SMI) in a Swedish context. A secondary aim was to evaluate a community integration effect. A randomized controlled trial with a parallel design was used. Mental health outpatients with SMI were randomized to IPS or traditional vocational rehabilitation (TVR) services. The allocation status was assessor-blinded. The primary outcome was competitive employment. All vocational outcomes were collected continuously, and socio-demographic and clinical variables at baseline, 6 and 18 months. The trial is registered with ClinicalTrials.gov: NCT00960024. One hundred and twenty participants were randomized. Eighty seven per cent were assessed after 6 months, and 73% after 18 months. IPS was more effective than TVR in terms of gaining employment at 18-month follow-up (46% vs. 11%; difference 36%, 95% CI 18-54), along with the amount of working hours and weeks, longer job tenure periods and income. Cox regression analysis showed that IPS participants gained employment five times quicker than those in TVR. Ninety per cent of the IPS participants became involved in work, internships or education, i.e. activities integrated in mainstream community settings, while 24% in the TVR group achieved this. IPS is effective in a Swedish context in terms of gaining employment and becoming integrated within the local community. The welfare system presented obstacles for gaining competitive employment directly and it was indicated that internships delayed time to first competitive employment.

  9. Meaninglessness in terminally ill cancer patients: a randomized controlled study.

    PubMed

    Morita, Tatsuya; Murata, Hisayuki; Kishi, Emi; Miyashita, Mitsunori; Yamaguchi, Takuhiro; Uchitomi, Yosuke

    2009-04-01

    Although recent empirical studies reveal that fostering patients' perception of meaning in their lives is an essential task for palliative care clinicians, few studies have reported the effects of training programs for nurses specifically aimed at improving these skills. The primary aim of this randomized controlled trial was to determine the effects of an educational workshop focusing on patients' feelings of meaninglessness on nurses' confidence, self-reported practice, and attitudes toward caring for such patients, in addition to burnout and meaning of life. The study was designed as a single-institution, randomized controlled trial using a waiting list control. The intervention consisted of eight 180-minute training sessions over four months, including lectures and exercises using structured assessment. A total of 41 nurses were randomly allocated to three groups, which were separately trained, and all were evaluated four times at three-month intervals (before intervention, between each intervention, and after the last intervention). Assessments included validated Confidence and Self-Reported Practice scales, the Attitudes Toward Caring for Patients Feeling Meaningless Scale (including willingness to help, positive appraisal, and helplessness items), the Maslach Burnout Scale, job satisfaction, and the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). One participant withdrew from the study before the baseline evaluation, and the remaining 40 nurses completed the study. The nurses were all female and had a mean age of 31+/-6.4, and mean clinical experience of 8.9+/-5.5 years. There were no significant differences in background among the groups. The intervention effects were statistically significant on the Confidence Scale, the Self-Reported Practice Scale, and the willingness to help, positive appraisal, and helplessness subscales, in addition to the overall levels of burnout, emotional exhaustion, personal accomplishment, job satisfaction

  10. 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

  11. Internet-enhanced management of fibromyalgia: a randomized controlled trial.

    PubMed

    Williams, David A; Kuper, David; Segar, Michelle; Mohan, Niveditha; Sheth, Manish; Clauw, Daniel J

    2010-12-01

    Both pharmacological and non-pharmacological interventions have demonstrated efficacy in the management of fibromyalgia (FM). Non-pharmacological interventions however are far less likely to be used in clinical settings, in part due to limited access. This manuscript presents the findings of a randomized controlled trail of an Internet-based exercise and behavioral self-management program for FM designed for use in the context of a routine clinical care. 118 individuals with FM were randomly assigned to either (a) standard care or (b) standard care plus access to a Web-Enhanced Behavioral Self-Management program (WEB-SM) grounded in cognitive and behavioral pain management principles. Individuals were assessed at baseline and again at 6 months for primary endpoints: reduction of pain and an improvement in physical functioning. Secondary outcomes included fatigue, sleep, anxiety and depressive symptoms, and a patient global impression of improvement. Individuals assigned to the WEB-SM condition reported significantly greater improvement in pain, physical functioning, and overall global improvement. Exercise and relaxation techniques were the most commonly used skills throughout the 6 month period. A no-contact, Internet-based, self-management intervention demonstrated efficacy on key outcomes for FM. While not everyone is expected to benefit from this approach, this study demonstrated that non-pharmacological interventions can be efficiently integrated into routine clinical practice with positive outcomes.

  12. Reiki for the Treatment of Fibromyalgia: A Randomized Controlled Trial

    PubMed Central

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack

    2008-01-01

    Abstract Objective Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. Design This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. Setting/location The study setting was private medical offices in the Seattle, Washington metropolitan area. Subjects The subjects were comprised 100 adults with fibromyalgia. Intervention Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). Outcome measures The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by selfreport. Improvement between groups was examined in an intention-to-treat analysis. Results Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Conclusion Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms. PMID:18991519

  13. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    PubMed

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  14. Postoperative pain relief following hysterectomy: A randomized controlled trial

    PubMed Central

    Raghvendra, K. P.; Thapa, Deepak; Mitra, Sukanya; Ahuja, Vanita; Gombar, Satinder; Huria, Anju

    2016-01-01

    Background: Women experience moderate to severe postoperative pain following total abdominal hysterectomy (TAH). The transversus abdominis plane (TAP) block is a new modality for providing postoperative pain relief in these patients. Materials and Methods: The present study was a single center, prospective randomized trial. After the Institutional Ethics Committee approval and informed consent, patients were randomized to either epidural group: Epidural block placement + general anesthesia (GA) or TAP group: Single shot TAP block + GA. Patients in both the groups received standard general anesthetic technique and intravenous tramadol patient-controlled analgesia in the postoperative period. Patients were monitored for tramadol consumption, visual analog scale (VAS) both at rest and on coughing, hemodynamics, and side effects at 0, 2, 4, 6, 8, 12, and 24 h postoperatively. Results: The total consumption of tramadol in 24 h was greater in TAP group as compared to epidural group (68.8 [25.5] vs. 5.3 [11.6] mg, P < 0.001). The VAS scores at rest and on coughing were higher in TAP group as compared to the epidural group at 6, 8, 12, and 24 h postoperatively (P < 0.05). None of the patients in either group had any adverse effects. Conclusion: Epidural analgesia provided greater tramadol-sparing effect with superior analgesia postoperatively as compared to TAP block in patients up to 24 h following TAH. PMID:27499592

  15. Improving pediatric prevention via the internet: a randomized, controlled trial.

    PubMed

    Christakis, Dimitri A; Zimmerman, Frederick J; Rivara, Frederick P; Ebel, Beth

    2006-09-01

    Innovations to improve the delivery of pediatric preventive care are needed. We enrolled children, 0 to 11 years of age, into a factorial, randomized, controlled trial of a tailored, evidence-based, Web site (MyHealthyChild) that provided information on prevention topics before a scheduled well-child visit. There were 2 components of the intervention, namely, parental Web content and provider notification. Parental Web content provided information to parents about prevention topics; provider notification communicated to physicians topics that were of interest to parents. We assigned 887 children randomly to 4 groups (usual care, content only, content and notification, or notification only). Outcomes were determined with telephone follow-up surveys conducted 2 to 4 weeks after the visit. Poisson regression analysis was used to determine the independent effects of each intervention on the number of topics discussed and the number of preventive practices implemented. Parents in the notification/content group and in the notification-only group reported discussing more MyHealthyChild topics with their provider. Parents in the notification/content group and in the content-only group reported implementing more MyHealthyChild topic suggestions (such as use of a safety device). A Web-based intervention can activate parents to discuss prevention topics with their child's provider. Delivery of tailored content can promote preventive practices.

  16. Nebulized Magnesium Sulfate in Acute Bronchiolitis: A Randomized Controlled Trial.

    PubMed

    Modaresi, Mohammad Reza; Faghihinia, Jamal; Kelishadi, Roya; Reisi, Mohsen; Mirlohi, Shahrokh; Pajhang, Farhad; Sadeghian, Majid

    2015-09-01

    To assess the efficacy of nebulized magnesium sulfate as a bronchodilator in infants hospitalized with acute bronchiolitis. This three-center double masked randomized clinical trial comprised 120 children with moderate to severe bronchiolitis. They were randomly assigned into two groups: the first group was treated with nebulized magnesium sulfate (40 mg/kg) and nebulized epinephrine (0.1 ml/kg) and the second group (control) was treated with nebulized epinephrine (0.1 ml/kg). The primary outcome was the length of hospital stay. The use of oxygen, temperature, oxygen saturation (SPO2), pulse rate (PR), respiratory rate (RR) and respiratory distress assessment instrument (RDAI) score were measured in the beginning of the study and during hospitalization. The mean (SD) age of 120 infants was 5.1(± 2.6) mo and 60% were boys. The length of hospital stay was not different between the two groups (P > 0.01). Use of oxygen supplementation, SPO2 and vital signs were similar in the two groups. Improvement in RDAI score was significantly better in infants treated with nebulized magnesium sulfate than in the other group (P 0.01). Thus, in infants with acute bronchiolitis, the effect of nebulized magnesium sulfate is comparable to nebulized epinephrine. However nebulized magnesium sulfate can improve the clinical score so it may have additive effect to reduce symptoms during hospitalization.

  17. When can I go home? A prospective case control study to improve communication with patients regarding their diagnosis, treatment plan and likely discharge date.

    PubMed

    Murphy, David; Crowley, Rebecca; Spencer, Anthony; Birch, Mark

    2015-04-17

    This study aimed to improve our ability to communicate with patients with regard to four key issues. Their diagnosis, treatment plan, clinical criteria for discharge and estimated discharge date. This was a prospective case control study. It involved 200 general medical patients admitted to Christchurch Public Hospital. Each day there were two general medical admitting teams. One team formed the control group and the other team the intervention group. The 100 patients in the control group had their consultant ward round as normal. The 100 patients in the intervention group had a consultant ward round and were provided with additional written information answering the following four points: (1) their diagnosis (2) management plan for the day (3) clinical criteria for discharge and (4) estimated date of discharge. This was a laminated sheet that remained attached to their bedside locker. At four or more hours after the ward round every new patient would undergo a questionnaire based interview addressing their ability to correctly answer the points listed above. A comparison was then made between the intervention and control groups. A subgroup (n=30) were selected to obtain feedback on the initiative. 90% of respondents from the intervention group knew their diagnosis versus 59% of the control group (p<0.01). 76% knew their treatment plan for the day versus 41% (p<0.01). 76% knew some of the clinical criteria for safe discharge versus 25% (p<0.01) and 83% of the intervention group knew their estimated discharge date versus 52% of the control group (p<0.01). The median age of the patients in the intervention group was 78 years of age and 74 for the control group (p>0.05). Of those that gave feedback 70% believed the intervention was helpful in helping them understand their diagnosis and 70% believed knowing their likely discharge date was useful. The use of a card with written information for the patient regarding their diagnosis, treatment plan, clinical criteria for

  18. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. Methods/Design A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. Discussion The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. Trial registration The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of

  19. [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.

  20. Treating depression and substance use: A randomized controlled trial

    PubMed Central

    Hunter, Sarah B.; Watkins, Katherine E.; Hepner, Kimberly A.; Paddock, Susan M.; Munjas, Brett; Osilla, Karen C.; Perry, Suzanne

    2012-01-01

    Few integrated substance use and depression treatments have been developed for delivery in outpatient substance abuse treatment settings. To meet the call for more ‘transportable’ interventions, we conducted a pilot study to test a group cognitive behavioral therapy (CBT) for depression and substance use that was designed for delivery by outpatient substance abuse treatment counselors. Seventy-three outpatient clients were randomized to usual care enhanced with group CBT or usual care alone, and assessed at three time points (baseline, three and six months post-baseline). Our results demonstrated that the treatment was acceptable and feasible for delivery by substance abuse treatment staff, despite challenges with recruiting clients. Both depressive symptoms and substance use were reduced by the intervention, but were not significantly different from the control group. These results suggest that further research is warranted to enhance the effectiveness of treatment for co-occurring disorders in these settings. PMID:22301087

  1. Randomized controlled trial quality in pediatric physical therapy.

    PubMed

    Paci, Matteo; Landi, Niccolò; Marchettini, Mariangela; Baccini, Marco

    2014-08-01

    The aim of this study is to describe the reported quality of randomized controlled trials (RCTs) in pediatric physical therapy (PPT) and changes with time. All RCTs sourced from PEDro database and scored using the PEDro scale were included. RCTs were classified as high- or low quality both with the original cut-off of 6 and a modified cut-off of 5. The relationship between PEDro scores and year of publication was also investigated. One thousand three hundred sixty-seven articles were analyzed. According to the PEDro scale original and modified cut-off, 29% and 56% of the articles were classified as high-quality studies, respectively. The number of RCTs and the average PEDro score increased between 1962 and 2012. However, since some items of the scale could be more frequently satisfied, a further improvement of the quality of RCTs in PPT is recommended.

  2. Family Caregiver Training Program (FCTP): A Randomized Controlled Trial.

    PubMed

    DiZazzo-Miller, Rosanne; Winston, Kristin; Winkler, Sandra L; Donovan, Mary L

    The purpose of this study was to examine the effectiveness of the Family Caregiver Training Program (FCTP) for caregivers of people with dementia. A random assignment control group research design with a 3-mo follow-up was implemented. Thirty-six family caregivers of people with dementia demonstrated an increase in activity of daily living (ADL) knowledge (p < .001) and maintenance of that knowledge 3 mo posttest. Caregiver confidence, regardless of group assignment, improved; however, it was not maintained. Burden, depression, and occupational performance and satisfaction remained unchanged for the intervention group; however, physical health as it pertained to quality of life improved 3 mo posttest (p < .001). Findings demonstrate that the FCTP can effectively provide knowledge to family caregivers on how to assist people with dementia with ADLs. Even when standard care was provided, there was limited information on ADLs that family caregivers faced daily.

  3. 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.

  4. [Insulin infusion in intensive care: randomized controlled trial].

    PubMed

    Miranda, Milena Penteado Ferraro; Crespo, Jeiel Carlos Lamonica; Secoli, Silvia Regina

    2013-06-01

    This randomized controlled trial compared the use of an intensive and conventional insulin protocol on clinical outcomes in patients with severe sepsis and septic shock, in the first 72 hours. It was conducted at a university hospital in the city of São Paulo. Patients (n=46) were allocated into two groups: intensive glycemic (blood glucose between 80-110mg/dl) and conventional (180-220mg/dl). The Student's t-test and chi-square test were used for data analysis. A statistically significant (p<0.001) difference was observed in mean glycemia, but there was no difference in the variables of mean minimum arterial pressure (p=0.06) or maximum (p=0.11), serum creatinine (p=0,33) or in mortality (p=0.11). Although there was no difference between the groups regarding mortality, hemodynamic instability in the conventional group was longer and the only deaths occurred in it.

  5. 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.

  6. 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.

  7. [Randomized controlled study on acupuncture treatment for chronic fatigue syndrome].

    PubMed

    Chen, Xing-Hua; Li, Lu-Qian; Zhang, Wen; Yang, Juan; Dai, Yi-Shuang; Xu, Dong-Hua; Tang, Chun-Zhi

    2010-07-01

    To observe the therapeutic effect of acpuncture treatment for chronic fatigue syndrome (CFS). Nighty cases of CFS were randomly divided into an observation group and a control group, 45 cases in each group. The observation group was treated with acupunture at Renying (ST 9), Fengfu (GV 16), Baihui (GV 20); the control group was treated with 250 mL 5% Glucose injectio combined with 20 mL Shenmai injectio. Fatigue Scale (FS) was used to compare the scores between the two groups after treatment. The total scores in the observation group were 9.37 +/- 2.33 and 5.41 +/- 1.96 before and after treatment respectively, and in the control group, they were 9.08 +/- 2.27 and 7.34 +/- 2.03 respectively. FS brainwork integral, physical fatigue integral, and total integral all decreased after treatment in two groups (all P < 0.001), and it decreased much more obviously in the observation group (P < 0.05, P < 0.01). Both of the acpuncture treatment and Shenmai injectio are able to decrease fatigue scale score, improve the fatigue symptoms of CFS patients, and the effect of acupucture treatment is obviously superior to that of Shenmai injectio.

  8. Biofeedback Training in Crisis Managers: A Randomized Controlled Trial.

    PubMed

    Janka, A; Adler, C; Brunner, B; Oppenrieder, S; Duschek, S

    2017-06-01

    Working in crisis environments represents a major challenge, especially for executive personnel engaged in directing disaster operations, i.e. crisis managers. Crisis management involves operating under conditions of extreme stress resulting, for instance, from high-level decision-making, principal responsibility for personnel, multitasking or working under conditions of risk and time pressure. The present study aimed to investigate the efficacy of a newly developed biofeedback training procedure based on electrodermal activity, especially designed for the target group of crisis managers. The training comprised exercises promoting acquisition of control over sympathetic arousal under resting conditions and during exposure to visual, acoustic and cognitive stressors resembling situations related to crisis management. In a randomized controlled design, 36 crisis managers were assigned to either a biofeedback training group or waiting list control group. Subjective stress was assessed using the Perceived Stress Scale. In the training group, stress level markedly decreased; the decrease remained stable at follow-up 2 months after the training. The results indicate that biofeedback training in crisis management is an effective method for stress management that may help to reduce vulnerability to stress-related performance decline and stress-related disease.

  9. 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.

  10. A Randomized Controlled Trial of Mentoring Interventions for Underrepresented Minorities

    PubMed Central

    Lewis, Vivian; Martina, Camille A.; McDermott, Michael P.; Trief, Paula; Goodman, Steven R.; Morse, Gene D.; LaGuardia, Jennifer G.; Sharp, Daryl; Ryan, Richard M.

    2015-01-01

    Purpose To conduct a randomized controlled trial (RCT) to evaluate the effects of different mentoring interventions on the basic psychological need satisfaction of underrepresented minorities and women in academia. Method Participants were 150 mentor/protégé dyads from three academic medical centers and eight other colleges and universities in western and central New York, randomized from 2010–2013 into: mentor training (using principles of self-determination theory); peer mentoring for protégés; mentor training and peer mentoring for protégés combined; or control/usual practice. Protégé participants were graduate students, fellows and junior faculty who were from underrepresented groups based on race, ethnicity, gender, or disability. The primary analysis was a comparison of intervention effects on changes in protégés’ satisfaction of their basic psychological needs (competence, autonomy and relatedness) with their mentor. They completed a well-validated, online questionnaire every 2 months for 1 year. Results There was no significant effect at the end of 1 year of either mentor training or peer mentoring on protégés’ psychological basic need satisfaction with mentor specifically or at work in general. Exploratory analyses showed a significant effect of the mentor-based intervention on the protégés’ overall psychological need satisfaction with their mentor at 2 months, the time point closest to completing mentor training. Conclusions This RCT showed a potential short-term effect of mentor training on changing basic psychological need satisfaction of underrepresented scholars with their mentors. Despite the lack of sustained effect of either mentor training or peer mentoring, these short-term changes suggest feasibility and potential for future study. PMID:26717501

  11. Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

    PubMed

    Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; De Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

    2017-07-17

    Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated: 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial; and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 weeks and 12 months. Male fans of 2 ice hockey teams (35-65 years; body-mass index ≥28 kg/m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (Wait-list Control). Hockey FIT includes a 12-week active phase (weekly, coach-led group meetings including provision of dietary information, practice of behaviour change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-week minimally-supported phase (smartphone app for sustaining physical activity; private online social network; standardized emails; booster session/reunion). Measurement at baseline and 12 weeks (both groups), and 12 months (intervention group only), included clinical outcomes (e.g., weight) and self-reported physical activity, diet, self-rated health. Eighty men were recruited in 4 weeks; trial retention was >80% at 12 weeks and >75% at 12 months. At 12 weeks, the intervention group lost 3.6 (95% CI: -5.26, -1.90) kg more than the comparator (p<0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet and self-rated health at 12 weeks; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and thus, evidence to proceed with a definitive trial.

  12. Randomized controlled trial of Anticipatory and Preventive multidisciplinary Team Care

    PubMed Central

    Hogg, William; Lemelin, Jacques; Dahrouge, Simone; Liddy, Clare; Armstrong, Catherine Deri; Legault, Frances; Dalziel, Bill; Zhang, Wei

    2009-01-01

    ABSTRACT OBJECTIVE T o examine whether quality of care (QOC) improves when nurse practitioners and pharmacists work with family physicians in community practice and focus their work on patients who are 50 years of age and older and considered to be at risk of experiencing adverse health outcomes. DESIGN Randomized controlled trial. SETTING A family health network with 8 family physicians, 5 nurses, and 11 administrative personnel serving 10 000 patients in a rural area near Ottawa, Ont. PARTICIPANTS Patients 50 years of age and older at risk of experiencing adverse health outcomes (N = 241). INTERVENTIONS At-risk patients were randomly assigned to receive usual care from their family physicians or Anticipatory and Preventive Team Care (APTCare) from a collaborative team composed of their physicians, 1 of 3 nurse practitioners, and a pharmacist. MAIN OUTCOME MEASURES Quality of care for chronic disease management (CDM) for diabetes, coronary artery disease, congestive heart failure, and chronic obstructive pulmonary disease. RESULTS Controlling for baseline demographic characteristics, the APTCare approach improved CDM QOC by 9.2% (P < .001) compared with traditional care. The APTCare intervention also improved preventive care by 16.5% (P < .001). We did not observe significant differences in other secondary outcome measures (intermediate clinical outcomes, quality of life [Short-Form 36 and health-related quality of life scales], functional status [instrumental activities of daily living scale] and service usage). CONCLUSION Additional resources in the form of collaborative multidisciplinary care teams with intensive interventions in primary care can improve QOC for CDM in a population of older at-risk patients. The appropriateness of this intervention will depend on its cost-effectiveness. TRIAL REGISTRATION NUMBER NCT00238836 (CONSORT) PMID:20008582

  13. Randomized controlled trials: who fails run-in?

    PubMed

    Rees, Judy R; Mott, Leila A; Barry, Elizabeth L; Baron, John A; Figueiredo, Jane C; Robertson, Douglas J; Bresalier, Robert S; Peacock, Janet L

    2016-07-29

    Early identification of participants at risk of run-in failure (RIF) may present opportunities to improve trial efficiency and generalizability. We conducted a partial factorial-design, randomized, controlled trial of calcium and vitamin D to prevent colorectal adenoma recurrence at 11 centers in the United States. At baseline, participants completed two self-administered questionnaires (SAQs) and a questionnaire administered by staff. Participants in the full factorial randomization (calcium, vitamin D, both, or neither) received a placebo during a 3-month single-blinded run-in; women electing to take calcium enrolled in a two-group randomization (calcium with vitamin D, or calcium alone) and received calcium during the run-in. Using logistic regression models, we examined baseline factors associated with RIF in three subgroups: men (N = 1606) and women (N = 301) in the full factorial randomization and women in the two-group randomization (N = 666). Overall, 314/2573 (12 %) participants failed run-in; 211 (67 %) took fewer than 80 % of their tablets (poor adherence), and 103 (33 %) withdrew or were uncooperative. In multivariable models, 8- to 13-fold variation was seen by study center in odds of RIF risk in the two largest groups. In men, RIF decreased with age (adjusted odds ratio [OR] per 5 years 0.85 [95 % confidence interval, CI; 0.76-0.96]) and was associated with being single (OR 1.65 [95 % CI; 1.10-2.47]), not graduating from high school (OR 2.77 [95 % CI; 1.58-4.85]), and missing SAQ data (OR 1.97 [1.40-2.76]). Among women, RIF was associated primarily with health-related factors; RIF risk was lower with higher physical health score (OR 0.73 [95 % CI; 0.62-0.86]) and baseline multivitamin use (OR 0.44 [95 % CI; 0.26-0.75]). Women in the 5-year colonoscopy surveillance interval were at greater risk of RIF than those with 3-year follow-up (OR 1.91 [95 % CI; 1.08-3.37]), and the number of prescription medicines taken was also

  14. A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection

    PubMed Central

    2016-01-01

    BACKGROUND Data from studies in nonhuman primates suggest that the triple monoclonal antibody cocktail ZMapp is a promising immune-based treatment for Ebola virus disease (EVD). METHODS Beginning in March 2015, we conducted a randomized, controlled trial of ZMapp plus the current standard of care as compared with the current standard of care alone in patients with EVD that was diagnosed in West Africa by polymerase-chain-reaction (PCR) assay. Eligible patients of any age were randomly assigned in a 1:1 ratio to receive either the current standard of care or the current standard of care plus three intravenous infusions of ZMapp (50 mg per kilogram of body weight, administered every third day). Patients were stratified according to baseline PCR cycle-threshold value for the virus (≤22 vs. >22) and country of enrollment. Oral favipiravir was part of the current standard of care in Guinea. The primary end point was mortality at 28 days. RESULTS A total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea, and the United States. Of the 71 patients who could be evaluated, 21 died, representing an overall case fatality rate of 30%. Death occurred in 13 of 35 patients (37%) who received the current standard of care alone and in 8 of 36 patients (22%) who received the current standard of care plus ZMapp. The observed posterior probability that ZMapp plus the current standard of care was superior to the current standard of care alone was 91.2%, falling short of the prespecified threshold of 97.5%. Frequentist analyses yielded similar results (absolute difference in mortality with ZMapp, −15 percentage points; 95% confidence interval, −36 to 7). Baseline viral load was strongly predictive of both mortality and duration of hospitalization in all age groups. CONCLUSIONS In this randomized, controlled trial of a putative therapeutic agent for EVD, although the estimated effect of ZMapp appeared to be beneficial, the result did not meet the prespecified

  15. A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection.

    PubMed

    Davey, Richard T; Dodd, Lori; Proschan, Michael A; Neaton, James; Neuhaus Nordwall, Jacquie; Koopmeiners, Joseph S; Beigel, John; Tierney, John; Lane, H Clifford; Fauci, Anthony S; Massaquoi, Moses B F; Sahr, Foday; Malvy, Denis

    2016-10-13

    Background Data from studies in nonhuman primates suggest that the triple monoclonal antibody cocktail ZMapp is a promising immune-based treatment for Ebola virus disease (EVD). Methods Beginning in March 2015, we conducted a randomized, controlled trial of ZMapp plus the current standard of care as compared with the current standard of care alone in patients with EVD that was diagnosed in West Africa by polymerase-chain-reaction (PCR) assay. Eligible patients of any age were randomly assigned in a 1:1 ratio to receive either the current standard of care or the current standard of care plus three intravenous infusions of ZMapp (50 mg per kilogram of body weight, administered every third day). Patients were stratified according to baseline PCR cycle-threshold value for the virus (≤22 vs. >22) and country of enrollment. Oral favipiravir was part of the current standard of care in Guinea. The primary end point was mortality at 28 days. Results A total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea, and the United States. Of the 71 patients who could be evaluated, 21 died, representing an overall case fatality rate of 30%. Death occurred in 13 of 35 patients (37%) who received the current standard of care alone and in 8 of 36 patients (22%) who received the current standard of care plus ZMapp. The observed posterior probability that ZMapp plus the current standard of care was superior to the current standard of care alone was 91.2%, falling short of the prespecified threshold of 97.5%. Frequentist analyses yielded similar results (absolute difference in mortality with ZMapp, -15 percentage points; 95% confidence interval, -36 to 7). Baseline viral load was strongly predictive of both mortality and duration of hospitalization in all age groups. Conclusions In this randomized, controlled trial of a putative therapeutic agent for EVD, although the estimated effect of ZMapp appeared to be beneficial, the result did not meet the prespecified

  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. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    PubMed

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p < 0.001). The distance center bifocal contact lenses tested in this study achieved greater control over myopia progression and axial elongation (>70%) compared with most published results with multifocal spectacles. Further

  19. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    PubMed Central

    2012-01-01

    Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes). However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-)environment interactions to obtain more insight into a) moderating effects of polymorphisms on the link between parenting and child behavior, and b) behavioral mechanisms that underlie these gene-(gene-)environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training). In a screening, families with children aged 4–8 who show mild to (sub)clinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest), after 6 months (i.e., posttest), and after 10 months (i.e., follow-up). Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-)environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s) received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and will manifest

  20. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    ERIC Educational Resources Information Center

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  1. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    ERIC Educational Resources Information Center

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  2. Control Capacity and A Random Sampling Method in Exploring Controllability of Complex Networks

    PubMed Central

    Jia, Tao; Barabási, Albert-László

    2013-01-01

    Controlling complex systems is a fundamental challenge of network science. Recent advances indicate that control over the system can be achieved through a minimum driver node set (MDS). The existence of multiple MDS's suggests that nodes do not participate in control equally, prompting us to quantify their participations. Here we introduce control capacity quantifying the likelihood that a node is a driver node. To efficiently measure this quantity, we develop a random sampling algorithm. This algorithm not only provides a statistical estimate of the control capacity, but also bridges the gap between multiple microscopic control configurations and macroscopic properties of the network under control. We demonstrate that the possibility of being a driver node decreases with a node's in-degree and is independent of its out-degree. Given the inherent multiplicity of MDS's, our findings offer tools to explore control in various complex systems. PMID:23912679

  3. Teaching children to cross streets safely: a randomized, controlled trial.

    PubMed

    Schwebel, David C; McClure, Leslie A; Severson, Joan

    2014-07-01

    Child pedestrian injury is a global public health challenge. This randomized, controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and Web sites, plus no-training control, to improve children's street-crossing ability. Pedestrian safety was evaluated among 231 7- and 8-year-olds using both streetside (field) and laboratory-based (virtual environment) trials before intervention group assignment, immediately posttraining, and 6 months posttraining. All training groups received 6 30-min sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior postintervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly posttraining than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in postintervention VR trials. Children showed minimal change in attention to traffic posttraining. Children trained with videos/websites showed minimal learning. Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds' street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly disseminated.

  4. Teaching Children to Cross Streets Safely: A Randomized Controlled Trial

    PubMed Central

    Schwebel, David C.; McClure, Leslie A.; Severson, Joan

    2014-01-01

    Objective Child pedestrian injury is a global public health challenge. This randomized controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and websites, plus no-training control, to improve children’s street-crossing ability. Methods Pedestrian safety was evaluated among 231 seven- and eight-year-olds using both streetside (field) and laboratory-based (virtual environment) trials prior to intervention group assignment, immediately post-training, and six months post-training. All training groups received six 30-minute sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior post-intervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly post-training than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in post-intervention VR trials. Children showed minimal change in attention to traffic post-training. Children trained with videos/websites showed minimal learning. Conclusion Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds’ street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly

  5. Cardiopulmonary resuscitation support application on a smartphone - randomized controlled trial.

    PubMed

    Sakai, Tomohiko; Kitamura, Tetsuhisa; Nishiyama, Chika; Murakami, Yukiko; Ando, Masahiko; Kawamura, Takashi; Tasaki, Osamu; Kuwagata, Yasuyuki; Shimazu, Takeshi; Iwami, Taku

    2015-01-01

    This simulation trial aimed to compare the quality of cardiopulmonary resuscitation (CPR) with and without the newly-developed CPR support application on smartphones. In this trial, participants were randomly assigned to either the CPR support application group or the control group, stratified by sex and previous CPR training. Participants' CPR skills were evaluated by a 2-min case-based scenario test using the Leardal Resusci Anne PC Skill reporting Manikin System(®). The outcome measures were the proportion of chest compressions performed in each group and the number of total chest compressions and appropriate chest compressions performed during the 2-min test period. A total of 84 participants were enrolled and completed the protocol. All participants in the CPR support application group performed chest compressions, compared with only 31 (75.6%) in the control group (P<0.001). Among participants who performed chest compressions during the 2-min test period, the number of total chest compressions was significantly higher in the CPR support application group than in the control group (211.6±29.5 vs. 77.0±43.3, P<0.001). The number of appropriate chest compressions tended to be greater in the CPR support application group than in the control group, although it was statistically insignificant (30.3±57.3 vs. 17.2±28.7, P=0.246). In this cohort of laypersons, the newly-developed CPR support application for smartphones contributed to increasing the implementation rate and the number of total chest compressions performed and may assist in improving the survival rate for out-of-hospital cardiac arrests (UMIN000004740).

  6. Behavioral neurocardiac training in hypertension: a randomized, controlled trial.

    PubMed

    Nolan, Robert P; Floras, John S; Harvey, Paula J; Kamath, Markad V; Picton, Peter E; Chessex, Caroline; Hiscock, Natalie; Powell, Jonathan; Catt, Michael; Hendrickx, Hilde; Talbot, Duncan; Chen, Maggie H

    2010-04-01

    It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks ("mental stress"). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (-2.4+/-0.9 mm Hg, P=0.009, and -2.1+/-0.9 mm Hg, P=0.03, respectively) and pulse pressures (-1.7+/-0.6 mm Hg, P=0.004, and -1.4+/-0.6 mm Hg, P=0.02, respectively). No effect was observed for controls (P>0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P=0.01) and RR interval (P<0.001) during cognitive tasks. Among controls, high-frequency power was unchanged (P=0.29), and RR interval decreased (P=0.03). Neither intervention altered spontaneous baroreflex sensitivity (P>0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.

  7. Mobile health, exercise and metabolic risk: a randomized controlled trial.

    PubMed

    Petrella, Robert J; Stuckey, Melanie I; Shapiro, Sheree; Gill, Dawn P

    2014-10-18

    It was hypothesized that a mobile health (mHealth) intervention would elicit greater improvements in systolic blood pressure and other cardiometabolic risk factors at 12 weeks, which would be better maintained over 52 weeks, compared to the active control intervention. Eligible participants (≥2 metabolic syndrome risk factors) were randomized to the mHealth intervention (n = 75) or the active control group (n = 74). Blood pressure and other cardiometabolic risk factors were measured at baseline and at 12, 24 and 52 weeks. Both groups received an individualized exercise prescription and the intervention group additionally received a technology kit for home monitoring of biometrics and physical activity. Analyses were conducted on 67 participants in the intervention group (aged 56.7 ± 9.7 years; 71.6% female) and 60 participants in the active control group (aged 59.1 ± 8.4 years; 76.7% female). At 12 weeks, baseline adjusted mean change in systolic blood pressure (primary outcome) was greater in the active control group compared to the intervention group (-5.68 mmHg; 95% CI -10.86 to -0.50 mmHg; p = 0.03), but there were no differences between groups in mean change for secondary outcomes. Over 52-weeks, the difference in mean change for systolic blood pressure was no longer apparent between groups, but remained significant across the entire population (time: p < 0.001). In participants with increased cardiometabolic risk, exercise prescription alone had greater short-term improvements in systolic blood pressure compared to the mHealth intervention, though over 52 weeks, improvements were equal between interventions. ClinicalTrials.gov http://NCT01944124.

  8. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

    PubMed

    Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

    2011-05-01

    To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

  9. Usual and Unusual Care: Existing Practice Control Groups In Randomized Controlled Trials of Behavioral Interventions

    PubMed Central

    Freedland, Kenneth E.; Mohr, David C.; Davidson, Karina W.; Schwartz, Joseph E.

    2011-01-01

    Objective To examine the use of existing practice control groups in randomized controlled trials of behavioral interventions, and the role of extrinsic healthcare services in the design and conduct of behavioral trials. Method Selective qualitative review. Results Extrinsic healthcare services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment as usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusion This review highlights the need for a scientific consensus statement on control groups in behavioral trials. PMID:21536837

  10. Acupuncture for posttraumatic stress disorder: a randomized controlled pilot trial.

    PubMed

    Hollifield, Michael; Sinclair-Lian, Nityamo; Warner, Teddy D; Hammerschlag, Richard

    2007-06-01

    The purpose of the study was to evaluate the potential efficacy and acceptability of accupuncture for posttraumatic stress disorder (PTSD). People diagnosed with PTSD were randomized to either an empirically developed accupuncture treatment (ACU), a group cognitive-behavioral therapy (CBT), or a wait-list control (WLC). The primary outcome measure was self-reported PTSD symptoms at baseline, end treatment, and 3-month follow-up. Repeated measures MANOVA was used to detect predicted Group X Time effects in both intent-to-treat (ITT) and treatment completion models. Compared with the WLC condition in the ITT model, accupuncture provided large treatment effects for PTSD (F [1, 46] = 12.60; p < 0.01; Cohen's d = 1.29), similar in magnitude to group CBT (F [1, 47] = 12.45; p < 0.01; d = 1.42) (ACU vs. CBT, d = 0.29). Symptom reductions at end treatment were maintained at 3-month follow-up for both interventions. Accupuncture may be an efficacious and acceptable nonexposure treatment option for PTSD. Larger trials with additional controls and methods are warranted to replicate and extend these findings.

  11. Prevention of pathological gambling: a randomized controlled trial.

    PubMed

    Doiron, Jason P; Nicki, Richard M

    2007-01-01

    Although the gambling industry is expanding rapidly throughout North America and around the world, there are only a few empirically evaluated programs aimed at the prevention of pathological gambling (PG). The purpose of this study was to measure the effectiveness of a new prevention program aimed at PG. The Stop & Think! program was designed to teach at-risk video lottery terminal (VLT) gamblers cognitive restructuring and problem-solving skills that may help to prevent the development of PG. These skills were taught through a variety of methods - including an automated educational presentation, video and text vignettes, audio training tapes, and skill rehearsal. The program was evaluated using a randomized, 2-group experimental design with a wait-list control group and pre-, post-, and follow-up measures. Results indicated that, compared with the control group, the experimental group was less at risk for developing a gambling problem after the program. The experimental group endorsed fewer gambling-related cognitive distortions, engaged in less VLT gambling, and had lower scores on a measure of PG. The results of this study provide the basis for the implementation of the Stop & Think! program in the province of Prince Edward Island, Canada, and perhaps other jurisdictions too.

  12. Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

    PubMed

    Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

    2014-03-01

    To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

  13. HealthLinks Randomized Controlled Trial: Design and Baseline Results

    PubMed Central

    Hammerback, Kristen; Allen, Claire L.; Parrish, Amanda T.; Chan, K. Gary; Kohn, Marlana J.; Teague, Sara; Beresford, Shirley A.A.; Helfrich, Christian D.; Harris, Jeffrey R.

    2016-01-01

    Small employers, especially those in low-wage industries, frequently lack the capacity and resources to implement evidence-based health promotion interventions without support and assistance. The purpose of this paper is to (a) describe the intervention design and study protocol of the HealthLinks Trial and (b) report baseline findings. This study is a three-arm randomized controlled trial testing the impact of the HealthLinks intervention on worksites’ adoption and implementation of evidence-based interventions. Group 1 will receive HealthLinks, Group 2 will receive HealthLinks plus wellness committees, and Group 3 will be a delayed control group. Seventy-eight employers are participating in the study; 3302 employees across the worksites participated in baseline data collection. Employers and employees will participate in follow-up surveys at one and two years after baseline to measure implementation (one year) and maintenance (two years) of HealthLinks interventions. Study outcomes will determine whether HealthLinks is an effective approach to increasing evidence-based health promotion in small, low-wage worksites and whether wellness committees are a capacity-building tool that increases HealthLinks’ effectiveness. PMID:26946121

  14. Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies.

    PubMed

    Balasingam, Shobana; Wilder-Smith, Annelies

    2016-08-01

    Controlled human infection, the intentional infection of healthy volunteers, allows disease pathogenesis to be studied and vaccines and therapeutic interventions to be evaluated in a controlled setting. A systematic review of randomized controlled trials of countermeasures for influenza that used the experimental human infection platform was performed. The primary objective was to document the scope of trials performed to date and the main efficacy outcome in the trials. The secondary objective was to assess safety and identify serious adverse events. The PubMed database was searched for randomized controlled influenza human challenge studies with predetermined search terms. Review papers, papers without outcomes, community-acquired infections, duplicated data, pathogenesis studies, and observational studies were excluded. Twenty-six randomized controlled trials published between 1947 and 2014 fit the study inclusion criteria. Two-thirds of these trials investigated antivirals and one-third investigated influenza vaccines. Among 2462 subjects inoculated with influenza virus, the incidence of serious adverse events was low (0.04%). These challenge studies helped to down-select three antivirals and one vaccine that were subsequently approved by the US Food and Drug Administration (FDA). Controlled human infection studies are an important research tool in assessing promising influenza vaccines and antivirals. These studies are performed quickly and are cost-effective and safe, with a low incidence of serious adverse events. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. Rural providers' access to online resources: a randomized controlled trial

    PubMed Central

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  16. Dextrose Prolotherapy for Knee Osteoarthritis: A Randomized Controlled Trial

    PubMed Central

    Rabago, David; Patterson, Jeffrey J.; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A.; Zgierska, Aleksandra

    2013-01-01

    PURPOSE Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises. PMID:23690322

  17. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial.

    PubMed

    Rabago, David; Patterson, Jeffrey J; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A; Zgierska, Aleksandra

    2013-01-01

    Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.

  18. [Chuzhen therapy for sub-health: a randomized controlled study].

    PubMed

    Hu, You-Ping; Xu, Zhen-Jie; Wu, Jia; Xing, Lin; Zhang, Lei-Xiao; Zhang, Jin-Xing; Tan, Hui; Mao, Shi-Zhi; Zhou, Cong-Quan

    2012-11-01

    To observe the effect on intervention of sub-health with pestle needle (Chuzhen). Randomized controlled trail was adopted for this research. One hundred and fifty-three cases were randomly divided into two groups of a Chuzhen group (79 cases) and a massage group (74 cases). Acupoint of Bazhen (Baihui Bazhen, Shendao Bazhen, Zhiyang Bazhen, Mingmen Bazhen, Yaoyangguan Bazhen), Hechelu on the head, the neck and the lumbar area were adopted in Chuzhen group. While regular whole-body massage was applied in the massage group. The human sub-health score, the cornell medical index (CMI) and thermal texture maps system (TTM) technology of the two groups before and after the intervention were observed. 1) After treatment, sub-health condition score, the CMI score, the M-R score and the TTM index were all increased in both groups (all P<0.01) 2) Comparison of D-value of the two groups before and after the intervention: the level of the sub-health score, the total score of CMI, and the index of sleep, pressure, Governor Vessel, Hukou (first web), blood lipid, viscosity of blood, microcirculation of TTM index of the Chuzhen group changed more obvious (all P<0.01), but there was no statistic significances in the M-R score and blood sugar of the TTM (both P>0.05). 3) The sub-health condition score in Chuzhen group was higher than that in the massage group (P<0.01). Chuzhen therapy has definite effect on intervention of sub-health, which is better than regular general massage.

  19. Exercise therapy in hip osteoarthritis--a randomized controlled trial.

    PubMed

    Krauß, Inga; Steinhilber, Benjamin; Haupt, Georg; Miller, Regina; Martus, Peter; Janßen, Pia

    2014-09-01

    Roughly one in ten persons in the industrialized world suffers from hip osteoarthritis, a disease for which there is no cure. The goal of conservative therapy is to relieve symptoms, preferably with methods that let patients assume responsibility for their own treatment, e.g., physical training. In a randomized controlled trial, we studied the effectiveness of twelve weeks of exercise therapy in patients with hip osteoarthritis (THüKo), compared to no treatment (control group) and placebo ultrasound treatment of the hip (placebo ultrasound group). The primary endpoint was a comparison of the pain scores of the intervention versus control groups on the generic SF-36 health questionnaire. Secondary endpoints included comparisons across all three study groups of scores on the 7 other scales of the SF-36 and on the pain, physical function, and stiffness scales of the osteoarthritis-specific WOMAC Index. The statistical analysis was performed with ANCOVA, with baseline values as a covariate. Between-group effects were subsequently tested pairwise (two-tailed t-tests, alpha = 0.05). As for the primary endpoint, pain reduction was significantly greater in the intervention than in the control group (mean difference 5.7 points, 95% confidence interval [CI] 0.4-11.1 points, p = 0.034). The comparisons across all three study groups (i.e., secondary endpoints, with 71 subjects in the intervention group, 68 in the control group, and 70 in the placebo group) revealed no significant between-group effects with respect to the SF-36. On the WOMAC Index, however, statistically significant differences were found for pain reduction between the intervention and control group (mean difference 7.4 points, 95% CI 3.0-11.8, p = 0.001) and between the intervention and placebo group (mean difference 5.1 points, 95% CI 0.7-9.4, p = 0.024). Comparable mean differences were also found for functional improvement. Twelve weeks of exercise therapy in hip osteoarthritis patients of normal vitality

  20. Acupuncture in Menopause (AIM) Study: a Pragmatic, Randomized Controlled Trial

    PubMed Central

    Avis, Nancy E.; Coeytaux, Remy R.; Isom, Scott; Prevette, Kristen; Morgan, Timothy

    2015-01-01

    Objective to evaluate the short- and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. Methods A total of 209 perimenopausal and postmenopausal women aged 45-60 experiencing ≥4 VMS per day recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. Results VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (p<0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (p<0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained post treatment. Statistically significant clinical improvement was observed after 3 acupuncture treatments and maximum clinical effects occurred after a median of 8 treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. Conclusions We found that a course of acupuncture treatments was associated with significant reduction in VMS, as well as several quality of life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment. PMID:27023860

  1. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial.

    PubMed

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  2. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial

    PubMed Central

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research. PMID:27703964

  3. A Randomized Controlled Study of Neurofeedback for Chronic PTSD

    PubMed Central

    van der Kolk, Bessel A.; Hodgdon, Hilary; Gapen, Mark; Musicaro, Regina; Suvak, Michael K.; Hamlin, Ed; Spinazzola, Joseph

    2016-01-01

    Introduction Brain/Computer Interaction (BCI) devices are designed to alter neural signals and, thereby, mental activity. This study was a randomized, waitlist (TAU) controlled trial of a BCI, EEG neurofeedback training (NF), in patients with chronic PTSD to explore the capacity of NF to reduce PTSD symptoms and increase affect regulation capacities. Study Design 52 individuals with chronic PTSD were randomized to either NF (n = 28) or waitlist (WL) (n = 24). They completed four evaluations, at baseline (T1), after week 6 (T2), at post-treatment (T3), and at one month follow up (T4). Assessment measures were:1. Traumatic Events Screening Inventory (T1); 2. the Clinician Administered PTSD Scale (CAPS; T1, T3, T4); 3. the Davidson Trauma Scale (DTS; T1-T4) and 4. the Inventory of Altered Self-Capacities (IASC; T1-T4). NF training occurred two times per week for 12 weeks and involved a sequential placement with T4 as the active site, P4 as the reference site. Results Participants had experienced an average of 9.29 (SD = 2.90) different traumatic events. Post-treatment a significantly smaller proportion of NF (6/22, 27.3%) met criteria for PTSD than the WL condition (15/22, 68.2%), χ2 (n = 44, df = 1) = 7.38, p = .007. There was a significant treatment condition x time interaction (b = -10.45, t = -5.10, p< .001). Measures of tension reduction activities, affect dysregulation, and affect instability exhibited a significant Time x Condition interaction. The effect sizes of NF (d = -2.33 within, d = - 1.71 between groups) are comparable to those reported for the most effective evidence based treatments for PTSD. Discussion Compared with the control group NF produced significant PTSD symptom improvement in individuals with chronic PTSD, as well as in affect regulation capacities. NF deserves further investigation for its potential to ameliorate PTSD and to improve affect regulation, and to clarify its mechanisms of action. PMID:27992435

  4. Worksite intervention effects on physical health: a randomized controlled trial.

    PubMed

    Atlantis, Evan; Chow, Chin-Moi; Kirby, Adrienne; Fiatarone Singh, Maria A

    2006-09-01

    Overweight and physical inactivity are risk factors for increased disease burden and health care expenditure. Well-designed studies are still needed to determine the treatment efficacy of worksite interventions targeting such risk factors. This randomized controlled trial was conducted at one of Australia's casinos in 2002-2003, to investigate the effects of a comprehensive exercise and lifestyle intervention on physical fitness. Only 6.4% of the workforce expressed interest in being study participants. Seventy-three employees (aged 32 +/- 8 years, 51% overweight/obese, 73% shift workers and 52% women) were recruited and randomized to treatment or wait-list control groups for 24 weeks, 44 of whom completed the intervention. Components of the intervention include supervised moderate-to-high intensity exercise including combined aerobic (at least 20 min duration 3 days/week) and weight-training (for an estimated 30 min completed 2-3 days/week), and dietary/health education (delivered via group seminars, one-on-one counselling and literature through the provision of a worksite manual). ANCOVA, by intention-to-treat and of study completers, found significant between-group differences in the mean waist circumference and predicted maximal oxygen uptake (VO2max), favouring the intervention, but effects were concentrated in one subject. For study completers, between-group differences in the mean waist circumference (82.3 +/- 9.2 versus 90.5 +/- 17.8 cm, p = 0.01) and predicted VO2max (47 versus 41 ml/kg/min, p < 0.001) remained significant without the outlier, favouring the intervention. Higher intervention compliance predicted greater improvements in physical fitness. No significant effects on body mass or body mass index were found. This worksite intervention significantly improved waist circumference and aerobic fitness in healthy but sedentary employees, most of whom were shift workers. Worksite interventions have the potential to counter the increasing burden of

  5. Rehabilitation in advanced, progressive, recurrent cancer: a randomized controlled trial.

    PubMed

    Jones, Louise; Fitzgerald, Gail; Leurent, Baptiste; Round, Jeffrey; Eades, Jane; Davis, Sarah; Gishen, Faye; Holman, Amanda; Hopkins, Katherine; Tookman, Adrian

    2013-09-01

    Two million people across the U.K. are living with cancer, often experienced as a long-term condition. They may have unmet needs after active treatment. Rehabilitation aims to address these needs, maximize psychological and physical function, and enable minimum dependency regardless of life expectancy. We aimed to test, in a randomized controlled trial, the clinical and cost effectiveness of a rehabilitation intervention for patients with advanced, recurrent cancer. We conducted a two-arm, wait-list control, randomized trial of a complex rehabilitation intervention delivered by a hospice-based multidisciplinary team vs. usual care for active, progressive, recurrent hematological and breast malignancies, with a follow-up at three months. The primary outcome was the psychological subscale of the Supportive Care Needs Survey (SCNS). Secondary outcomes were other domains of the SCNS, psychological status, continuity of care, quality of life, and resource use. Forty-one participants were enrolled and 36 completed the trial. The primary outcome was significantly lower in the intervention arm (adjusted difference -16.8, 95% CI -28.34 to -5.3; P = 0.006). The SCNS physical and patient care subscales (-14.2, 95% CI -26.2 to -2.2; P = 0.02 and -7.4, 95% CI -13.7 to -1.1; P = 0.02, respectively) and self-reported health state (12.8, 95% CI 3.2 to 22.4; P = 0.01) also differed significantly. The incremental cost-effectiveness ratio was £19,390 per quality-adjusted life year. This intervention significantly reduced the unmet needs of cancer survivors and it is likely that it is cost-effective. Despite small numbers, the main effect size was robust. We recommend implementation alongside evaluation in wider clinical settings and patient populations. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  6. Meditation for migraines: a pilot randomized controlled trial.

    PubMed

    Wells, Rebecca Erwin; Burch, Rebecca; Paulsen, Randall H; Wayne, Peter M; Houle, Timothy T; Loder, Elizabeth

    2014-10-01

    Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines. Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga. Preliminary research has shown MBSR to be effective for chronic pain syndromes, but it has not been evaluated for migraines. We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR (n = 10) or usual care (n = 9). Our primary outcome was change in migraine frequency from baseline to initial follow-up. Secondary outcomes included change in headache severity, duration, self-efficacy, perceived stress, migraine-related disability/impact, anxiety, depression, mindfulness, and quality of life from baseline to initial follow-up. MBSR was safe (no adverse events), with 0% dropout and excellent adherence (daily meditation average: 34 ± 11 minutes, range 16-50 minutes/day). Median class attendance from 9 classes (including retreat day) was 8 (range [3, 9]); average class attendance was 6.7 ± 2.5. MBSR participants had 1.4 fewer migraines/month (MBSR: 3.5 to 1.0 vs control: 1.2 to 0 migraines/month, 95% confidence interval CI [-4.6, 1.8], P = .38), an effect that did not reach statistical significance in this pilot sample. Headaches were less severe, although not significantly so (-1.3 points/headache on 0-10 scale, [-2.3, 0.09], P = .053) and shorter (-2.9 hours/headache, [-4.6, -0.02], P = .043) vs control. Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control (-12.6, [-22.0, -1.0], P = .017 and -4.8, [-11.0, -1.0], P = .043, respectively). Self-efficacy and mindfulness improved in MBSR vs control (13.2 [1.0, 30.0], P

  7. Placebo Effects and the Common Cold: A Randomized Controlled Trial

    PubMed Central

    Barrett, Bruce; Brown, Roger; Rakel, Dave; Rabago, David; Marchand, Lucille; Scheder, Jo; Mundt, Marlon; Thomas, Gay; Barlow, Shari

    2011-01-01

    PURPOSE We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open-label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODS We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTS Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were −0.16 days (95% CI, −0.90 to 0.58 days) for illness duration and −22 severity points (95% CI, −70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, −0.28 to 1.12 days) and 22 severity points (95% CI, −19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group

  8. Women's experiences as members of attention control and experimental intervention groups in a randomized controlled trial.

    PubMed

    Beal, Claudia C; Stuifbergen, Alexa; Volker, Deborah; Becker, Heather

    2009-12-01

    Attention control groups are often used in research testing the efficacy of psychosocial and behavioural interventions in order to control for placebo effects. The authors conducted a descriptive qualitative study to investigate how participants viewed their experiences in attention control and experimental intervention groups following a randomized controlled trial for women with fibromyalgia syndrome. Moderately structured interviews were conducted with 18 women (12 from the experimental intervention group and 6 from the attention control group). Members of the control group reported some benefits but few behavioural changes as a result of participating in the RCT, and some participants expressed disappointment at not receiving the intervention. Perceptions of changes in attitudes towards fibromyalgia syndrome and behaviours reported by the intervention group appear to be consistent with the theory underlying the intervention. Possible placebo effects identified in both groups include negative and positive social interactions with other participants.

  9. Norfloxacin therapy for hepatopulmonary syndrome: a pilot randomized controlled trial.

    PubMed

    Gupta, Samir; Faughnan, Marie E; Lilly, Les; Hutchison, Stuart; Fowler, Robert; Bayoumi, Ahmed M

    2010-12-01

    The hepatopulmonary syndrome occurs in up to one-third of patients with cirrhosis. Animal models of this disease suggest that endotoxemia might cause nitric oxide-mediated vascular dilatation that can be inhibited by the antibiotic norfloxacin. We sought to test this hypothesis in humans. We conducted a pilot randomized, controlled crossover trial of norfloxacin 400 mg twice daily for 4 weeks with a 4-week washout period to assess the feasibility of a larger trial. The primary clinical end point was change in alveolar-arterial oxygen gradient (AaDO₂). Recruitment was challenging, and change in AaDO₂ was highly variable. We recruited 9 adults (1 woman; age, 60 ± 9 years; AaDO₂, 50 ± 22 mm Hg). AaDO₂ decreased by 0.8 ± 4.8 and 3.4 ± 12.4 mm Hg while on norfloxacin and placebo, respectively (P = .59). Recruitment difficulties and variability of the primary outcome measure suggest the need for a multicenter clinical research network for future therapeutic trials in this disease. There was no major effect of norfloxacin on gas exchange in patients with hepatopulmonary syndrome. Copyright © 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

  10. Validating Obstetric Emergency Checklists using Simulation: A Randomized Controlled Trial.

    PubMed

    Bajaj, Komal; Rivera-Chiauzzi, Enid Y; Lee, Colleen; Shepard, Cynthia; Bernstein, Peter S; Moore-Murray, Tanya; Smith, Heather; Nathan, Lisa; Walker, Katie; Chazotte, Cynthia; Goffman, Dena

    2016-10-01

    Background The World Health Organization's Surgical Safety Checklist has demonstrated significant reduction in surgical morbidity. The American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative (SMI) safety bundles include eclampsia and postpartum hemorrhage (PPH) checklists. Objective To determine whether use of the SMI checklists during simulated obstetric emergencies improved completion of critical actions and to elicit feedback to facilitate checklist revision. Study Design During this randomized controlled trial, teams were assigned to use a checklist during one of two emergencies: eclampsia and PPH. Raters scored teams on critical step completion. Feedback was elicited through structured debriefing. Results In total, 30 teams completed 60 scenarios. For eclampsia, trends toward higher completion were noted for blood pressure and airway management. For PPH, trends toward higher completion rates were noted for PPH stage assessment and fundal massage. Feedback resulted in substantial checklist revision. Participants were enthusiastic about using checklists in a clinical emergency. Conclusion Despite trends toward higher rates of completion of critical tasks, teams using checklists did not approach 100% task completion. Teams were interested in the application of checklists and provided feedback necessary to substantially revise the checklists. Intensive implementation planning and training in use of the revised checklists will result in improved patient outcomes.

  11. Validation of a MIMO Random Control Tool Using the CUBE™

    NASA Astrophysics Data System (ADS)

    Carrella, Alex; Janssens, Joris; Debille, Jan; Faignet, Eddy; Peetrs, Bart

    2012-07-01

    Environmental testing is an important engineering discipline which aims at simulating the effect of the environmnet on a given structure, item or system. A particular environment is the vibratory one. From development to qualification, engineering systems subject to harsh dynamic environments have to be tested in order to ensure their capability to withstand vibrations. To this end, there exist a wealth of test stadards which impose strict pass/fail criteria. However, these methods are rather dated and the testing community is constantly striving to update the standards to account for new technologies and ever more stringent requirements. Currently, the standard specify to carry out vibration tests along one axis at the time, that is using a Single-Input-Single-Ouput (SISO) or a Single-Input- Multiple-Ouput (SIMO) approach. However, there are a number of significant advanteges in using a Multiple- Input-Multiple-Ouput (MIMO) apporach. In this paper are presented the results of an experimental campaign aimed at assessing the capabilty of the new MIMO Random control developed at LMS.

  12. Randomized controlled trials – a matter of design

    PubMed Central

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

    2016-01-01

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

  13. Custom-tailored spatial mode sorting by controlled random scattering

    NASA Astrophysics Data System (ADS)

    Fickler, Robert; Ginoya, Manit; Boyd, Robert W.

    2017-04-01

    The need to increase data transfer rates constitutes a key challenge in modern information-driven societies. Taking advantage of the transverse spatial modes of light to encode more information is a promising avenue for both classical and quantum photonics. However, to ease access to the encoded information, it is essential to be able to sort spatial modes into different output channels. Here, we introduce a way to customize the sorting of arbitrary spatial light modes. Our method relies on the high degree of control over random scattering processes by preshaping of the phase structure of the incident light. We demonstrate experimentally that various sets of modes, irrespective of their specific modal structure, can be transformed to a broad range of output channel arrangements. Thus, our method enables full access to all of the information encoded in the transverse structure of the field; for example, azimuthal and radial modes. We also demonstrate that coherence is retained in this complex mode transformation, which opens up applications in quantum and classical information science.

  14. Randomized controlled trial of ionization and photoelectric smoke alarm functionality.

    PubMed

    Mueller, B A; Sidman, E A; Alter, H; Perkins, R; Grossman, D C

    2008-04-01

    To compare functionality, reasons for non-function, and nuisance alarm levels of two common types of smoke alarms after installation in low- to mid-level income households in King County, Washington. Randomized controlled trial of 761 households. An ionization or photoelectric smoke alarm was installed between June 1, 2000 and July 31, 2002. Main outcome measures were: percentage of study alarms that were working, observed reasons for non-functional status, and self-reported frequency of nuisance alarms at 9 and 15 months of follow-up. At 9 months after installation, 20% of ionization, vs 5% of photoelectric alarms were non-functional, a difference that persisted at 15 months, with the most common reasons for both types being a disconnected or absent battery. The risk ratio for ionization, relative to photoelectric alarms, being non-functional or removed was 2.7 (95% CI 1.8 to 4.1) at 15 months of follow-up. These findings were not altered by educational level, or the presence of smokers, children <5 years, or adults > or =65 years. Burn prevention efforts are geared towards increasing smoke alarm ownership and improving maintenance of functional status. Results suggest that the selective use of photoelectric alarms by fire injury prevention programs or consumers may provide longer-term protection in similar populations. Designing smoke alarms that minimize nuisance alarming may also result in longer term functionality.

  15. Carnosine Treatment for Gulf War Illness: A Randomized Controlled Trial

    PubMed Central

    Baraniuk, James N.; El-Amin, Suliman; Corey, Rebecca; Rayhan, Rakib U.; Timbol, Christian R.

    2013-01-01

    About 25% of 1990-1991 Persian Gulf War veterans experience disabling fatigue, widespread pain, and cognitive dysfunction termed Gulf War illness (GWI) or Chronic Multisymptom Illness (CMI). A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species (ROS) and central nervous system injury. The endogenous antioxidant L-carnosine (β-alanyl-L-histidine) is a potential treatment since it is a free radical scavenger in nervous tissue. To determine if nutritional supplementation with L-carnosine would significantly improve pain, cognition and fatigue in GWI, a randomized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed. L-carnosine was given as 500, 1000, and 1500 mg increasing at 4 week intervals. Outcomes included subjective fatigue, pain and psychosocial questionnaires, and instantaneous fatigue and activity levels recorded by ActiWatch Score devices. Cognitive function was evaluated by WAIS-R digit symbol substitution test. Carnosine had 2 potentially beneficial effects: WAIS-R scores increased significantly, and there was a decrease in diarrhea associated with irritable bowel syndrome. No other significant incremental changes were found. Therefore, 12 weeks of carnosine (1500 mg) may have beneficial cognitive effects in GWI. Fatigue, pain, hyperalgesia, activity and other outcomes were resistant to treatment. PMID:23618477

  16. Randomized controlled trials to assess therapies for multiple sclerosis.

    PubMed

    Wingerchuk, Dean M; Noseworthy, John H

    2002-04-23

    MS poses formidable challenges to clinical investigators. Obstacles to the study of MS therapies include disease chronicity, an unpredictable clinical course, radiologic and pathologic heterogeneity, and limited understanding of the underlying pathophysiology. Randomized controlled trials (RCTs) provide a means to assess therapeutic efficacy while reducing the risks of study bias and confounding factors that influence interpretation of results. RCTs have demonstrated that type 1 interferons and glatiramer acetate alter the short-term natural history of MS and have served as the basis of approval for the marketing of these treatments. Improvements and optimization of trial methodology may hasten the discovery of effective therapies and facilitate better comparisons of the results of individual drug trials. The most urgent need is for improved surrogate end points for clinical outcome with predictive validity for long-term disability. Even if RCT methodology is optimal, however, several limitations inherent to MS trials threaten to impede further progress, including obstacles to long-term studies (e.g., costs), patient withdrawal, and escalating sample size requirements to detect partial therapeutic benefit. There is a crucial need to develop alternative investigative methods, possibly through enhanced collaboration across centers and with industry, and by exploring innovative techniques to use existing RCT and natural history databases to greater advantage.

  17. Evaluating cognitive effort in a randomized controlled trial.

    PubMed

    Turner, Travis H; Renfroe, Jenna B; Morella, Kristen; Marriott, Bernadette P

    2016-09-01

    Many randomized controlled trials (RCTs) of neuropsychiatric conditions involve cognitive outcome measures; however, validity of cognitive data relies on adequate effort during testing, and such screening is seldom performed. Given well-established rates of 10 to 30% poor effort in clinical settings, this is not a trivial concern. This preliminary study evaluated effort during cognitive testing in an RCT of omega-3 supplementation to reduce suicidality in a high-risk psychiatric population. An interim analysis of sustained attentions measures from the Connors Performance Test (CPT-2) at baseline for the first 60 participants was conducted. Previously validated cut points to detect insufficient effort on the CPT-2 were applied. At baseline, 12% (7) were identified as giving poor effort. Follow-up analyses indicated less psychiatric distress and suicidality among those who gave poor effort. Results suggest comparable likelihood of a poor effort on cognitive testing in clinical and RCT participation. Reduced psychiatric distress in the poor effort group raises concern regarding interpretation of other measures. The importance of screening cognitive data for effort in RCTs is highlighted. Future studies will examine effort at follow-up visits, and explore relationships to attrition, adherence, and response to treatment. Copyright © 2016 John Wiley & Sons, Ltd.

  18. Working on asymmetry in Parkinson's disease: randomized, controlled pilot study.

    PubMed

    Ricciardi, Lucia; Ricciardi, Diego; Lena, Francesco; Plotnik, Meir; Petracca, Martina; Barricella, Simona; Bentivoglio, Anna Rita; Modugno, Nicola; Bernabei, Roberto; Fasano, Alfonso

    2015-08-01

    Posture, gait and balance problems are very disabling symptoms in Parkinson's disease (PD). An increased stride-to-stri de variability, reduction of automaticity and asymmetry of lower limbs function characterize parkinsonian gait. These features predispose to freezing of gait (FOG), which often leads to falls. The aim of this study was to evaluate how the modulation of asymmetry through physiotherapy might improve gait and reduce FOG, thus preventing falls. Twenty-eight PD patients entered a double-blind pilot feasibility controlled study and were evaluated at baseline and after 3 months of a rehabilitative program (performed twice a week) by means of the motor part of the Unified Parkinson's Disease Rating Scale (UPDRS-III), Gait and Falls Questionnaire, Tinetti balance and gait scale, Short Physical Performance Battery (SPPB), European Quality of Life questionnaire. Patients were randomly assigned to three treatment arms: (1) worst side improvement; (2) best side improvement; (3) standard therapy. All study arms showed a significant improvement of the Tinetti and SPPB scores. BSI led to a greater improvement than ST in terms of UPDRS-III (p = 0.01); Tinetti total score (p = 0.05) and Tinetti gait subscore (p = 0.01). Our study confirms the efficacy of physical therapy in the treatment of PD and, more importantly, suggests that specific intervention tailored on individual feature (e.g., asymmetry of motor condition) might be even more effective than standard rehabilitative programs.

  19. Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial.

    PubMed

    Titov, Nickolai; Andrews, Gavin; Johnston, Luke; Robinson, Emma; Spence, Jay

    2010-09-01

    Clinician-guided Internet-based cognitive behavioural therapy (iCBT) programs are clinically effective at treating specific anxiety disorders. The present study examined the efficacy of a transdiagnostic Internet-based cognitive behavioural treatment (iCBT) program to treat more than one anxiety disorder within the same program (the Anxiety Program). Eighty six individuals meeting diagnostic criteria for generalized anxiety disorder (GAD), panic disorder, and/or social phobia were randomly assigned to a treatment group, or to a waitlist control group. Treatment consisted of CBT based online educational lessons and homework assignments, weekly email or telephone contact from a clinical psychologist, access to a moderated online discussion forum, and automated emails. An intention-to-treat model using the baseline-observation-carried-forward principle was employed for data analyses. Seventy-five percent of treatment group participants completed all 6 lessons within the 8 week program. Post-treatment data was collected from 38/40 treatment group and 38/38 control group participants, and 3-month follow-up data was collected from 32/40 treatment group participants. Relative to controls, treatment group participants reported significantly reduced symptoms of anxiety as measured by the Generalized Anxiety Disorder - 7 Item, Social Phobia Screening Questionnaire, and the Panic Disorder Severity Rating Scale - Self Report Scale, but not on the Penn State Worry Questionnaire, with corresponding between-groups effect sizes (Cohen's d) at post-treatment of 0.78, 0.43, 0.43, and 0.20, respectively. The clinician spent a total mean time of 46min per person over the program, participants rated the procedure as moderately acceptable, and gains were sustained at follow-up. Modifications to the Anxiety program, based on post-treatment feedback from treatment group participants, were associated with improved outcomes in the control group. These results indicate that transdiagnostic

  20. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial.

    PubMed

    Morris, Jill K; Vidoni, Eric D; Johnson, David K; Van Sciver, Angela; Mahnken, Jonathan D; Honea, Robyn A; Wilkins, Heather M; Brooks, William M; Billinger, Sandra A; Swerdlow, Russell H; Burns, Jeffrey M

    2017-01-01

    There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer's disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. ClinicalTrials.gov NCT01128361.

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

    PubMed Central

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

    2013-01-01

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

  2. Modifying media content for preschool children: a randomized controlled trial.

    PubMed

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

    2013-03-01

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

  3. Efficacy of Exercise for Menopausal Symptoms: A Randomized Controlled Trial

    PubMed Central

    Sternfeld, Barbara; Guthrie, Katherine A.; Ensrud, Kristine E.; LaCroix, Andrea Z.; Larson, Joseph C.; Dunn, Andrea L.; Anderson, Garnet L.; Seguin, Rebecca A.; Carpenter, Janet S.; Newton, Katherine M.; Reed, Susan D.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Roberts, Melanie; Caan, Bette J.

    2013-01-01

    OBJECTIVE To determine efficacy of exercise training for alleviating vasomotor and other menopausal symptoms. METHODS Late-peri and post-menopausal, sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted at three sites: 106 to exercise and 142 to usual activity. The exercise intervention consisted of individual, facility-based aerobic exercise training 3 times/week for 12 weeks. VMS frequency and bother were recorded on daily diaries at baseline and weeks 6 and 12. Intent to treat analyses compared between group differences in changes in VMS frequency and bother, sleep symptoms (Insomnia Severity Index, Pittsburgh Sleep Quality Index) and mood (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7 questionnaire). RESULTS At the end of week 12, changes in VMS frequency in the exercise group (mean change of −2.4/day, 95% CI −3.0, −1.7) and VMS bother (mean change of −0.5 on a 4 point scale, 95% CI −0.6, −0.4) were not significantly different from those in the control group (−2.6 VMS/day, 95% CI −3.2, −2.0, p=0.43; −0.5 points, 95% CI −0.6, −0.4, p=0.75). The exercise group reported greater improvement in insomnia symptoms (p=0.03), subjective sleep quality (p=0.01), and depressive symptoms (p=0.04), but differences were small and not statistically significant when p values were adjusted for multiple comparisons. Results were similar when considering treatment-adherent women only. CONCLUSION These findings provide strong evidence that 12-weeks of moderate-intensity aerobic exercise does not alleviate VMS but may result in small improvements in sleep quality, insomnia and depression in midlife, sedentary women. PMID:23899828

  4. Acceptance and commitment therapy for fibromyalgia: a randomized controlled trial.

    PubMed

    Wicksell, R K; Kemani, M; Jensen, K; Kosek, E; Kadetoff, D; Sorjonen, K; Ingvar, M; Olsson, G L

    2013-04-01

    Fibromyalgia (FM) is characterized by widespread pain and co-morbid symptoms such as fatigue and depression. For FM, medical treatments alone appear insufficient. Recent meta-analyses point to the utility of cognitive behaviour therapy (CBT), but effects are moderate. Within the continuous development of CBT, the empirical support for acceptance and commitment therapy (ACT) has increased rapidly. ACT focuses on improving functioning by increasing the patient's ability to act in accordance with personal values also in the presence of pain and distress (i.e., psychological flexibility). However, no study has yet explored the utility of ACT in FM. To evaluate the efficacy of ACT for FM and the role of psychological inflexibility as a mediator of improvement. In this randomized controlled trial, ACT was evaluated in comparison to a waiting list control condition. Forty women diagnosed with FM participated in the study. Assessments were made pre- and post-treatment and at 3 months of follow-up. The ACT intervention consisted of 12 weekly group sessions. Significant differences in favour of ACT were seen in pain-related functioning, FM impact, mental health-related quality of life, self-efficacy, depression, anxiety and psychological inflexibility. Changes in psychological inflexibility during the course of treatment were found to mediate pre- to follow-up improvements in outcome variables. The results correspond with previous studies on ACT for chronic pain and suggest the utility of ACT for FM as well as the role of psychological inflexibility as a mediator of improvement. © 2012 European Federation of International Association for the Study of Pain Chapters.

  5. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial

    PubMed Central

    Van Sciver, Angela; Mahnken, Jonathan D.; Honea, Robyn A.; Brooks, William M.; Billinger, Sandra A.; Swerdlow, Russell H.; Burns, Jeffrey M.

    2017-01-01

    Background There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer’s disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. Methods and findings This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Conclusions Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. Trial registration ClinicalTrials.gov NCT01128361 PMID:28187125

  6. Parent Mentors and Insuring Uninsured Children: A Randomized Controlled Trial

    PubMed Central

    Lin, Hua; Walker, Candy; Lee, Michael; Currie, Janet M.; Allgeyer, Rick; Fierro, Marco; Henry, Monica; Portillo, Alberto; Massey, Kenneth

    2016-01-01

    BACKGROUND: Six million US children are uninsured, despite two-thirds being eligible for Medicaid/Children’s Health Insurance Program (CHIP), and minority children are at especially high risk. The most effective way to insure uninsured children, however, is unclear. METHODS: We conducted a randomized trial of the effects of parent mentors (PMs) on insuring uninsured minority children. PMs were experienced parents with ≥1 Medicaid/CHIP-covered child who received 2 days of training, then assisted families for 1 year with insurance applications, retaining coverage, medical homes, and social needs; controls received traditional Medicaid/CHIP outreach. The primary outcome was obtaining insurance 1 year post-enrollment. RESULTS: We enrolled 237 participants (114 controls; 123 in PM group). PMs were more effective (P< .05 for all comparisons) than traditional methods in insuring children (95% vs 68%), and achieving faster coverage (median = 62 vs 140 days), high parental satisfaction (84% vs 62%), and coverage renewal (85% vs 60%). PM children were less likely to have no primary care provider (15% vs 39%), problems getting specialty care (11% vs 46%), unmet preventive (4% vs 22%) or dental (18% vs 31%) care needs, dissatisfaction with doctors (6% vs 16%), and needed additional income for medical expenses (6% vs 13%). Two years post-PM cessation, more PM children were insured (100% vs 76%). PMs cost $53.05 per child per month, but saved $6045.22 per child insured per year. CONCLUSIONS: PMs are more effective than traditional Medicaid/CHIP methods in insuring uninsured minority children, improving health care access, and achieving parental satisfaction, but are inexpensive and highly cost-effective. PMID:27244706

  7. Phytothermotherapy in osteoarthritis: a randomized controlled clinical trial.

    PubMed

    Fioravanti, Antonella; Bellisai, Barbara; Iacoponi, Francesca; Manica, Patrizia; Galeazzi, Mauro

    2011-05-01

    The aim of this study was to assess the efficacy of adding a cycle of phytothermotherapy (a traditional treatment with fermenting grass used in Trentino-Alto Adige, Italy) to the usual drug treatment, in patients with primary symptomatic osteoarthritis (OA) of the knee, hip, or lumbar spine. In this randomized, single-blind, controlled trial, 218 outpatients were enrolled; 109 patients were treated with a cycle of phytothermotherapy at the thermal resort of Garniga Terme (Trento, Italy) for 10 days; the other 109 patients continued regular outpatient care. Patients were assessed at baseline, after 2 weeks, and after 3 months from the beginning of the study and were evaluated using a visual analogue scale (VAS) for spontaneous pain, a Health Assessment Questionnaire, the Lequesne index for hip and knee osteoarthritis, and the Rolland Morris Questionnaire for lumbar spine OA and symptomatic drug consumption. In patients treated with phytothermotherapy, a significant improvement of VAS and a reduction of nonsteroidal anti-inflammatory drug consumption at the end of treatment and 3 months later were observed. In the control group, no significant differences were noted. The analyses performed separately for each subgroup for OA localization showed that the best results were evident in lumbar spine OA. Concerning tolerability, in the group treated with phytothermotherapy 10% of patients presented side-effects due to treatment, but these were of low intensity and did not interrupt the therapy. In conclusion, the results show beneficial effects of a cycle of phytothermotherapy in patients with OA of the hip, knee, or lumbar spine. Phytothermotherapy may therefore be a useful aid alongside the usual pharmacologic and physiokinesic therapies, or may be used as a valid alternative for patients who do not tolerate pharmacologic treatments.

  8. The selection and design of control conditions for randomized controlled trials of psychological interventions.

    PubMed

    Mohr, David C; Spring, Bonnie; Freedland, Kenneth E; Beckner, Victoria; Arean, Patricia; Hollon, Steven D; Ockene, Judith; Kaplan, Robert

    2009-01-01

    The randomized controlled trial (RCT) provides critical support for evidence-based practice using psychological interventions. The control condition is the principal method of removing the influence of unwanted variables in RCTs. There is little agreement or consistency in the design and construction of control conditions. Because control conditions have variable effects, the results of RCTs can depend as much on control condition selection as on the experimental intervention. The aim of this paper is to present a framework for the selection and design of control conditions for these trials. Threats to internal validity arising from modern RCT methodology are reviewed and reconsidered. The strengths and weaknesses of several categories of control conditions are examined, including the ones that are under experimental control, the ones that are under the control of clinical service providers, and no-treatment controls. Considerations in the selection of control conditions are discussed and several recommendations are proposed. The aim of this paper is to begin to define principles by which control conditions can be selected or developed in a manner that can assist both investigators and grant reviewers. Copyright 2009 S. Karger AG, Basel.

  9. Amoxicillin for acute rhinosinusitis: A randomized controlled trial

    PubMed Central

    Garbutt, Jane M.; Banister, Christina; Spitznagel, Edward; Piccirillo, Jay F.

    2013-01-01

    Context Evidence to support antibiotic treatment for acute rhinosinusitis is scant, yet antibiotics are commonly used. Objective To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with clinically diagnosed acute rhinosinusitis. Design Randomized placebo-controlled trial Participants and Setting Adults with uncomplicated, acute rhinosinusitis were recruited from 10 community practices in Missouri between November 1st 2006 and May 1st 2009 Interventions Ten-day course of either amoxicillin (1500mg/day) or placebo administered in three doses/day. All patients received a 5-7-day supply of symptomatic treatments for pain, fever, cough and nasal congestion to use as needed. Main Outcome Measures The primary outcome was improvement in the disease-specific quality of life after 3–4 days of treatment assessed with the SNOT-16 (minimally important difference 0.5 on 0 to 3 scale). Secondary outcomes included the patients' retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, satisfaction with and adverse effects of treatment. Outcomes were assessed by telephone interview at Days 3, 7, 10 and 28. Results 166 adults (36% male, 78% Caucasian) were randomized to amoxicillin (85) or placebo (81); 92% concurrently used ≥1 symptomatic treatment (amoxicillin, 94%, placebo 90%, p=0.34). The mean change in SNOT-16 scores was not significantly different between groups on Day 3 (mean difference between groups 0.03, 95% CI −0.12 to 0.19) and Day 10, but differed at Day 7 favoring amoxicillin (mean difference between groups 0.19, 95% CI 0.024 to 0.35). At Day 7 more participants treated with amoxicillin reported symptom improvement (74% vs. 56%, p=0.0205; NNT = 6, 95% CI 3 to 34), with no difference at Day-3 or Day-10. No between group differences were found for any other secondary outcomes. No serious adverse events occurred. Conclusion Among patients with acute rhinosinusitis, a 10-day

  10. Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial

    PubMed Central

    Featherstone, Katie; Donovan, Jenny L

    1998-01-01

    Objectives To explore trial participants’ understandings of randomisation. Design In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews were recorded on audio tape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes, using a grounded theory approach. Setting The CLasP study comprises three linked multicentre, pragmatic randomised controlled trials evaluating the effectiveness and cost effectiveness of laser therapy, standard surgery, and conservative management for men with lower urinary tract symptoms or urinary retention, or both, related to benign prostatic disease. Subjects 20 participants in the CLasP study were interviewed. Sampling was purposeful: men were included from each of the treatment arms, the two major centres, and at different points in the trial. Interventions and outcome measures Interviews used a checklist of topics to encourage participants to describe their experiences. Narratives concerning randomisation were compared to identify common themes, retaining the context of the discussion to allow detailed interpretation. Results Most participants recalled and described aspects of randomisation, such as the involvement of chance, comparison, and concealed allocation. Many found the concept of randomisation difficult, however, and developed alternative lay explanations to make sense of their experiences. Inaccurate patient information and lay interpretations of common trial terms caused confusion. Conclusions The provision of clear and accurate patient information is important, but this alone will not ensure consistent interpretation of concepts such as randomisation. Patients may need to discuss the purposes of randomisation in order to understand them fully enough to give truly informed consent. Key messagesMost trial participants were able to recall and

  11. A pilot randomized controlled trial to improve geriatric frailty.

    PubMed

    Chan, Ding-Cheng Derrick; Tsou, Hsiao-Hui; Yang, Rong-Sen; Tsauo, Jau-Yih; Chen, Ching-Yu; Hsiung, Chao Agnes; Kuo, Ken N

    2012-09-25

    Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome. This RCT enrolled 117 older adults (65-79 years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ≥1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n = 55 or problem solving therapy, PST, n = 57) or controls (non-EN, n = 62 or non-PST, n = 60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3 month. Subjects were followed at 3, 6, and 12 months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions. Mean age was 71.4 ± 3.7 years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p = 0.008) at 3 months, but not 6 or 12 months. They also had more increase of serum 25(OH) vitamin D level (4.9 ± 7.7 vs 1.2 ± 5.4, p = 0.006) and lower percentage of osteopenia (74% vs 89% p = 0.042) at 12 months. PST group subjects had better improvement (2.7 ± 6.1 vs 0.2 ± 6.7, p = 0.035, 6-month) and less deterioration (-3.5 ± 9.7 vs -7.1 ± 8.7, p = 0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also

  12. Postural control and shoulder steadiness in F-16 pilots: a randomized controlled study.

    PubMed

    Lange, Britt; Murray, Mike; Chreiteh, Shadi S; Toft, Palle; Jørgensen, Marie B; Søgaard, Karen; Sjøgaard, Gisela

    2014-04-01

    During maneuvering, fighter pilots experience loads of up to 50-70 kg on their necks. Neck disorders are common and have been linked to impairment in muscle control. We conducted an intervention study introducing targeted training for 24 wk that reduced neck pain. The current study reports the results of the secondary objective, which was to increase the understanding of possible mechanisms underlying such neck pain and its intervention-related relief. In a parallel, single-blinded, randomized controlled study, 55 F-16 pilots were evaluated at baseline and randomized to a control group (CG; N = 28) or training group (TG; N = 27). Postural control was tested in four different settings: Romberg with open and closed eyes, unilateral stance, and perturbation. Maximal voluntary contraction and force steadiness was measured for shoulder elevation. At follow-up, there was a significant between-group difference in the Romberg test with closed eyes only (95% confidence ellipse area; CG: 761 +/- 311 mm2; TG: 650 +/- 405 mm2). Prior to randomization, there were no significant differences in postural control and steadiness between 30 pilots who experienced neck pain within the previous 3 mo and 25 pilots without such pain. Impaired postural control and steadiness may only be quantifiable in individuals experiencing acute neck pain of certain intensity, and there may be a ceiling effect in the ability to improve these parameters. For individuals with highly developed physiological capacity, a battery of tests with more stringent demands should be considered, e.g., increased number of repetitions, prolonged duration of the tests, or testing with eyes closed.

  13. Fundamental movement skills in preschoolers: a randomized controlled trial targeting object control proficiency.

    PubMed

    Donath, L; Faude, O; Hagmann, S; Roth, R; Zahner, L

    2015-11-01

    Adequately developed fundamental movement skills, particularly object control dimensions, are considered essential to learn more complex movement patterns and to increase the likelihood to successfully participate in organized and non-organized sports during later years. Thus, the present randomized controlled trial aimed at improving object control dimensions at an early state in a kindergarten setting. Catching, throwing, kicking, rolling and stationary dribbling were assessed via gross motor development 2 (TGMD-2) testing in 41 normally developed preschoolers. On a cluster-randomized basis [strata: age, sex and body mass index (BMI)], three kindergartens were randomly assigned to an intervention group (n = 22, INT, age: 4.6 ± 1.0 years; BMI: 16.2 ± 1.1 kg/m(2) ) and three to a control group (n = 19, CON: age: 4.5 ± 1.2 years; BMI: 16.8 ± 1.2 kg/m(2) ). Twelve structured training sessions were given within 6 weeks (12 sessions). The total training volume was 330 min. Moderate time × group interaction were observed for the total sum score (Δ+22%, P = 0.05) and dribbling (Δ+41%, P = 0.002). Adjusting for baseline differences analyses of covariance did not affect these results. Interestingly, likely to most likely practically worthwhile effects were detected for the total sum score, catching and dribbling. Object control dimensions such as dribbling and catching that apparently rely on rhythmical movement patterns and anticipatory eye-hand coordination seem to benefit from short-term object control training. These skills are considered important for successful team-sport participation and appropriate sportive motor development. © 2015 John Wiley & Sons Ltd.

  14. Randomized controlled trials: still the backbone of vascular surgery?

    PubMed

    Naylor, A R

    Prior to the introduction of evidence-based medicine, decision-making was largely based upon 'intuitive reasoning', whereby senior clinicians dictated practice based upon personal dogma, personal experience and (often) biased observational studies. This era began to end (in vascular surgery) following completion of the landmark randomized trials in carotid disease, which recruited patients throughout the 1980s. Despite scepticism amongst some surgeons of the time these particular randomized trials have stood the test of time and remain the cornerstone of virtually every guideline of practice to this day. The carotid randomized trials became a beacon for using 'evidence' rather than 'intuitive reasoning' and randomized trials have now been used to determine optimal practice in a plethora of carotid surgery and stenting trials, lower limb revascularization and numerous aortic aneurysm based studies. The literature abounds with situations where practice (previously based on observational study data) was changed overnight following publication of a well-designed randomized trial. However, while observational studies are prone to selection bias, randomized trials bring their own unique limitations including problems with external validity, they take too long to complete, they are very expensive, they are notorious for problems with recruitment and they can frequently become obsolete. This has led to a (not unreasonable) call for more observational studies to be used in the development of practice guidelines. Unfortunately, the principle guideline bodies around the world, e.g. National Institute for Health and Care Excellence (NICE) and the American Heart Association (AHA), prioritize randomized trial evidence above all else. Until that changes, guideline makers will find it very difficult to deviate from using historical randomized trial evidence, even when high quality observational data suggest that 'real world' practice bears little comparison to that reported in the

  15. Prenatal Docosahexaenoic Acid Supplementation and Infant Morbidity: Randomized Controlled Trial

    PubMed Central

    Imhoff-Kunsch, Beth; Stein, Aryeh D.; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle

    2011-01-01

    OBJECTIVE: Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. METHODS: In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. RESULTS: Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58–1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P < .0001). At 6 months, infants in the DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and “other illness,” respectively, but 74% longer duration of vomiting (all P < .05). CONCLUSIONS: DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months. PMID:21807696

  16. Randomized Controlled Trials of Pediatric Massage: A Review

    PubMed Central

    Moyer, Christopher A.

    2007-01-01

    The existing reviews of massage therapy (MT) research are either limited to infants, adults, or were conducted prior to the publication of the most recent studies using pediatric samples. Randomized controlled trials (RCTs) of pediatric MT are reviewed. A literature search yielded 24 RCTs of pediatric MT, defined as the manual manipulation of soft tissue intended to promote health and well-being in recipients between 2 and 19 years of age. Because RCTs of pediatric MT varied considerably in the amount and types of data reported, quantitative and narrative review methods were both used. Single-dose and multiple-dose effects were examined separately. Among single-dose effects, significant reductions of state anxiety were observed at the first session (g = 0.59, P < 0.05) and the last session (g = 1.10, P < 0.01) of a course of treatment. Effects for salivary cortisol (g = 0.28), negative mood (g = 0.52) and behavior (g = 0.37) were non-significant. Three of eleven multiple-dose effects were statistically significant. These were trait anxiety (g = 0.94, P < 0.05), muscle tone (g = 0.90, P < 0.01) and arthritis pain (g = 1.33, P < 0.01). Results of studies not permitting effect size calculation were judged to be generally consistent with quantitative results. MT benefits pediatric recipients, though not as universally as sometimes reported. Numerous weaknesses endemic to MT research (e.g. low statistical power, frequent failure to report basic descriptive statistics) are identified, and recommendations for future pediatric MT research are discussed. PMID:17342238

  17. Clinical randomized controlled trial of chemomechanical caries removal (Carisolv).

    PubMed

    Lozano-Chourio, M A; Zambrano, O; González, H; Quero, M

    2006-05-01

    The purpose of this study was to compare the chemomechanical caries-removal system (Carisolv) with high-speed excavation in cavitated occlusal caries of primary molars. Design and setting. The study was a randomized controlled, clinical trial in which the two techniques were compared in each subject. Participants were chosen from public schools, in Maracaibo County, Zulia State, Venezuela. The sample consisted of 80 primary molars selected from 40 children (mean age 7.7+/-0.7 years). Each patient had at least two contralateral primary molars with cavitated occlusal caries and approximately equal-size access to lesions. The outcome variables were: clinically complete caries removal, size of the opening of the cavity, volume of carious tissue removed, pain during caries removal, anaesthesia requested by the patient, caries-removal time, and behaviour and preference of patients. All treated molars were clinically caries free whichever caries-removal procedure was used. When Carisolv' was used the final cavity entrance sizes were smaller (P<0.001) and the estimated volume of tissue removed was less (P<0.001). The time taken for caries removal was three times longer (7.51+/-1.83 min, P<0.001). Some pain was reported by seven (17.5%) participants when Carisolv was used, compared with 16 (40%) when high-speed excavation was used (P<0.05). Using the Carisolv method there was a higher proportion of patients with positive behaviour (P<0.01), and 71.0% (P<0.05) preferred this treatment. Carisolv is an effective clinical alternative treatment for the removal of occlusal dentinal caries in cavitated primary molars; it is more conservative of dental tissue and appeared to be more comfortable for most patients, although the clinical time spent is longer than when using high-speed excavation.

  18. Design and Validity of Randomized Controlled Dental Restorative Trials

    PubMed Central

    Göstemeyer, Gerd; Blunck, Uwe; Paris, Sebastian; Schwendicke, Falk

    2016-01-01

    Background: The evidence stemming from trials on restorative materials is shaped not only by trial findings, but also trial design and validity. We aimed to evaluate both aspects in randomized controlled dental restorative trials published from 2005–2015. Methods: Using systematic review methodology, we retrieved trials comparing restorative or adhesive dental materials. Two authors independently assessed design, risk of bias, registration status, and findings of trials. Descriptive and regression analyses were performed. Results: 114 studies on 15,321 restorations placed mainly in permanent teeth of 5232 patients were included. Per trial, the median number of patients was 37 (25th/75th percentiles: 30/51). Follow-up was 24 (20/48) months. Seventeen percent of trials reported on sample size calculations, 2% had been registered. Most trials (90%) used US Public Health Service (USPHS) criteria, and had a high risk of bias. More recent trials were more likely to have been registered, to have reported on sample size calculations, to be of low risk of bias, and to use other than USPHS-criteria. Twenty-three percent of trials yielded significant differences between groups. The likelihood of such differences was significantly increased in older studies, studies with potential reporting bias, published in journals with high impact factor (>2), longer follow-up periods, and not using USPHS-criteria. Conclusions: The majority of dental restorative trials published from 2005–2015 had limited validity. Risk of bias decreased in more recent trials. Future trials should aim for high validity, be registered, and use defined and appropriate sample sizes, follow-up periods, and outcome measures. PMID:28773493

  19. Internet-based randomized controlled trials: a systematic review

    PubMed Central

    Mathieu, Erin; McGeechan, Kevin; Barratt, Alexandra; Herbert, Robert

    2013-01-01

    Background The internet is increasingly being used to conduct randomized controlled trials (RCTs). Knowledge of the types of interventions evaluated and the methodological quality of these trials could inform decisions about whether to conduct future trials using conventional methods, fully online or a mixture of the two. Objective To identify and describe the scope of internet-based RCTs for human health condition interventions and evaluate their methodological quality. Methods A systematic review of RCTs of any health intervention conducted fully or primarily on the internet was carried out. Results 23 fully and 27 primarily internet-based RCTs were identified. The first was conducted in 2000. The majority of trials evaluated interventions that involved providing health information to participants, but a few evaluated self-administered interventions (eg, valerian, stretching). Methodological quality was variable and the methods were generally poorly reported. The risk of bias was low in only a small number of trials; most had substantial methodological shortcomings. Only one trial was identified as meeting all criteria for adequate methodological quality. A particular problem was high rates of loss to follow-up (fully online: mean 47%; primarily online: mean 36%). Conclusions It is theoretically possible but perhaps difficult to test the effectiveness of health interventions rigorously with RCTs conducted fully or primarily over the internet. The use of the internet to conduct trials is more suited to pragmatic rather than explanatory trials. The main limitation of these trials is that they typically experience high rates of loss to follow-up. Methodological standards now accepted for traditional RCTs needs to be evident for online RCTs as well, especially in reporting of their methods. PMID:23065196

  20. The HONEYPOT randomized controlled trial statistical analysis plan.

    PubMed

    Pascoe, Elaine Mary; Lo, Serigne; Scaria, Anish; Badve, Sunil V; Beller, Elaine Mary; Cass, Alan; Hawley, Carmel Mary; Johnson, David W

    2013-01-01

    The HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients. To make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial. Statisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes. A statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Making public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results.

  1. The HONEYPOT Randomized Controlled Trial Statistical Analysis Plan

    PubMed Central

    Pascoe, Elaine Mary; Lo, Serigne; Scaria, Anish; Badve, Sunil V.; Beller, Elaine Mary; Cass, Alan; Hawley, Carmel Mary; Johnson, David W.

    2013-01-01

    ♦ Background: The HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients. ♦ Objective: To make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial. ♦ Methods: Statisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes. ♦ Results: A statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ♦ Conclusions: Making public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results. PMID:23843589

  2. Sample size in orthodontic randomized controlled trials: are numbers justified?

    PubMed

    Koletsi, Despina; Pandis, Nikolaos; Fleming, Padhraig S

    2014-02-01

    Sample size calculations are advocated by the Consolidated Standards of Reporting Trials (CONSORT) group to justify sample sizes in randomized controlled trials (RCTs). This study aimed to analyse the reporting of sample size calculations in trials published as RCTs in orthodontic speciality journals. The performance of sample size calculations was assessed and calculations verified where possible. Related aspects, including number of authors; parallel, split-mouth, or other design; single- or multi-centre study; region of publication; type of data analysis (intention-to-treat or per-protocol basis); and number of participants recruited and lost to follow-up, were considered. Of 139 RCTs identified, complete sample size calculations were reported in 41 studies (29.5 per cent). Parallel designs were typically adopted (n = 113; 81 per cent), with 80 per cent (n = 111) involving two arms and 16 per cent having three arms. Data analysis was conducted on an intention-to-treat (ITT) basis in a small minority of studies (n = 18; 13 per cent). According to the calculations presented, overall, a median of 46 participants were required to demonstrate sufficient power to highlight meaningful differences (typically at a power of 80 per cent). The median number of participants recruited was 60, with a median of 4 participants being lost to follow-up. Our finding indicates good agreement between projected numbers required and those verified (median discrepancy: 5.3 per cent), although only a minority of trials (29.5 per cent) could be examined. Although sample size calculations are often reported in trials published as RCTs in orthodontic speciality journals, presentation is suboptimal and in need of significant improvement.

  3. Exercise training and habitual physical activity: a randomized controlled trial.

    PubMed

    Swift, Damon L; Johannsen, Neil M; Tudor-Locke, Catrine; Earnest, Conrad P; Johnson, William D; Blair, Steven N; Sénéchal, Martin; Church, Timothy S

    2012-12-01

    Exercise training reduces adiposity and risk of cardiovascular disease. However, the combined effects of habitual free-living physical activity and aerobic training on waist circumference, weight, fitness, and blood pressure in postmenopausal women are unknown. To evaluate the effects of habitual physical activity levels during aerobic training on weight, waist circumference, fitness, and blood pressure. Secondary analysis of an RCT. Original data collected April 2001 to June 2005 and analyzed in 2012. Postmenopausal women in a supervised exercise trial. Women (n=325) were randomized to 4, 8, or 12 kcal/kg per week of aerobic training or a control group for 6 months. All outcome measures were collected at baseline and follow-up. Changes in dependent variables within each training group were evaluated across tertiles of pedometer-determined habitual physical activity outside exercise training sessions. Changes in waist circumference and weight. Reductions in waist circumference were significantly greater with higher steps/day accumulated outside exercise training compared to lower levels in the 4 (high: -4.8 cm vs low: -1.4 cm, p=0.03); 8 (high: -4.2 cm vs low: -0.4 cm, p=0.03), and 12 kcal/kg per week groups (high: -4.1 cm vs low: -0.7 cm, p=0.05). For all groups, p-trend≤0.03. A trend was observed for greater weight reduction with higher steps/day in the 4 kcal/kg per week group (p-trend=0.04) but not for the other exercise doses. No effects were observed for blood pressure or fitness measures (all p>0.05). In postmenopausal women, higher habitual physical activity while participating in aerobic training was associated with greater reductions in central adiposity, and was supportive of weight loss compared to lower levels. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  4. Personal health records and hypertension control: a randomized trial.

    PubMed

    Wagner, Peggy J; Dias, James; Howard, Shalon; Kintziger, Kristina W; Hudson, Matthew F; Seol, Yoon-Ho; Sodomka, Pat

    2012-01-01

    To examine the impact of a personal health record (PHR) in patients with hypertension measured by changes in biological outcomes, patient empowerment, patient perception of quality of care, and use of medical services. A cluster-randomized effectiveness trial with PHR and no PHR groups was conducted in two ambulatory clinics. 453 of 1686 (26.4%) patients approached were included in the analyses. A PHR tethered to the patient's electronic medical record (EMR) was the primary intervention and included security measures, patient control of access, limited transmission of EMR data, blood pressure (BP) tracking, and appointment assistance. BP was the main outcome measure. Patient empowerment was assessed using the Patient Activation Measure and Patient Empowerment Scale. Quality of care was assessed using the Clinician and Group Assessment Score (CAHPS) and the Patient Assessment of Chronic Illness Care. Frequency of use of medical services was self-reported. No impact of the PHR was observed on BP, patient activation, patient perceived quality, or medical utilization in the intention-to-treat analysis. Sub-analysis of intervention patients self-identified as active PHR users (25.7% of those with available information) showed a 5.25-point reduction in diastolic BP. Younger age, self-reported computer skills, and more positive provider communication ratings were associated with frequency of PHR use. Few patients provided with a PHR actually used the PHR with any frequency. Thus simply providing a PHR may have limited impact on patient BP, empowerment, satisfaction with care, or use of health services without additional education or clinical intervention designed to increase PHR use. http://ClinicalTrials.gov Identifier: NCT01317537.

  5. Randomized controlled trial of Cassia alata Linn. for constipation.

    PubMed

    Thamlikitkul, V; Bunyapraphatsara, N; Dechatiwongse, T; Theerapong, S; Chantrakul, C; Thanaveerasuwan, T; Nimitnon, S; Boonroj, P; Punkrut, W; Gingsungneon, V

    1990-04-01

    Cassia alata Linn. is a medical plant. Its leaves have been claimed to be effective as a laxative. The studies done so far have shown no toxicity as a result of consuming Cassia alata Linn. leaves. The plant has been found to contain anthraquinones, presumed to be the active ingredient causing the laxative effect. The objective of the study was to test efficacy of Cassia alata Linn. leaves for treatment of constipation compared with a placebo and mist. alba in a multicenter randomized controlled trial carried out in one provincial and 5 community hospitals. Eighty adult patients admitted to 5 community hospitals and one provincial hospital with at least 72 hours of constipation were included in the study. Twenty-eight patients were in the placebo group, 28 in the mist. alba group, and 24 in Cassia alata Linn. group. Each patient was given 120 ml of fluid with caramel color, mist. alba, or Cassia alata Linn. infusion at bed time. Evaluation was performed after 24 hours whether the patient defecated or not. The characteristics of the patients among the three groups were not different. Eighteen per cent of patients in the placebo group passed stools within 24 hours, whereas, 86 and 83 per cent of patients in mist. alba and Cassia alata Linn. groups respectively, passed stools. The differences observed between placebo and mist. alba, placebo and Cassia alata Linn. were statistically highly significant, P less than 0.001 and clinically important. Minimal self-limited side effects, i.e., nausea, dyspepsia, abdominal pain and diarrhea were noted in 16-25 per cent of the patients.(ABSTRACT TRUNCATED AT 250 WORDS)

  6. Mortality in the randomized, controlled lung intergroup trial of isotretinoin.

    PubMed

    Lee, J Jack; Feng, Lei; Reshef, Daniel S; Sabichi, Anita L; Williams, Brendell; Rinsurongkawong, Waree; Wistuba, Ignacio I; Lotan, Reuben; Lippman, Scott M

    2010-06-01

    In 2001, we reported that mortality may have been higher with isotretinoin (30 mg/d for 3 years) than with placebo in the subgroup of current smokers among the 1,166 patients with definitively resected early-stage non-small cell lung cancer who participated in the randomized, controlled Lung Intergroup Trial. We report the overall and cause (cancer, cardiovascular disease, or other)-specific mortality associated with long-term isotretinoin after an extended median follow-up of 6.2 years that included the capture of cause-of-death data from 428 deceased patients. Overall mortality was 36.7% in each of the two trial arms, about two thirds related to cancer and one third to other or unknown causes. Overall and cancer deaths increased in current smokers in the isotretinoin arm during the treatment and the extended follow-up period. No mortality end point increased among never smokers and former smokers taking isotretinoin, and cancer deaths decreased marginally in this combined subgroup. Isotretinoin also increased deaths from cardiovascular disease in current smokers. The present analysis supports the safety of protracted isotretinoin use in the combined group of never smokers and former smokers, which has important public health implications, for example, for treating acne in young people. The increased mortality in current smokers in this study is further evidence of the multifaceted danger of active smoking. The overall indications of this study have public health implications for treating acne in young people and other uses of retinoids in smokers.

  7. Generating and controlling homogeneous air turbulence using random jet arrays

    NASA Astrophysics Data System (ADS)

    Carter, Douglas; Petersen, Alec; Amili, Omid; Coletti, Filippo

    2016-12-01

    The use of random jet arrays, already employed in water tank facilities to generate zero-mean-flow homogeneous turbulence, is extended to air as a working fluid. A novel facility is introduced that uses two facing arrays of individually controlled jets (256 in total) to force steady homogeneous turbulence with negligible mean flow, shear, and strain. Quasi-synthetic jet pumps are created by expanding pressurized air through small straight nozzles and are actuated by fast-response low-voltage solenoid valves. Velocity fields, two-point correlations, energy spectra, and second-order structure functions are obtained from 2D PIV and are used to characterize the turbulence from the integral-to-the Kolmogorov scales. Several metrics are defined to quantify how well zero-mean-flow homogeneous turbulence is approximated for a wide range of forcing and geometric parameters. With increasing jet firing time duration, both the velocity fluctuations and the integral length scales are augmented and therefore the Reynolds number is increased. We reach a Taylor-microscale Reynolds number of 470, a large-scale Reynolds number of 74,000, and an integral-to-Kolmogorov length scale ratio of 680. The volume of the present homogeneous turbulence, the largest reported to date in a zero-mean-flow facility, is much larger than the integral length scale, allowing for the natural development of the energy cascade. The turbulence is found to be anisotropic irrespective of the distance between the jet arrays. Fine grids placed in front of the jets are effective at modulating the turbulence, reducing both velocity fluctuations and integral scales. Varying the jet-to-jet spacing within each array has no effect on the integral length scale, suggesting that this is dictated by the length scale of the jets.

  8. Oxytocin and autism: a systematic review of randomized controlled trials.

    PubMed

    Preti, Antonio; Melis, Mariangela; Siddi, Sara; Vellante, Marcello; Doneddu, Giuseppe; Fadda, Roberta

    2014-03-01

    Little is known about the effectiveness of pharmacological interventions on autism spectrum disorder (ASD). This is a systematic review of the randomized controlled trials (RCTs) of oxytocin interventions in autism, made from January 1990 to September 2013. A search of computerized databases was supplemented by manual search in the bibliographies of key publications. The methodological quality of the studies included in the review was evaluated independently by two researchers, according to a set of formal criteria. Discrepancies in scoring were resolved through discussion. The review yielded seven RCTs, including 101 subjects with ASD (males=95) and 8 males with Fragile X syndrome. The main categories of target symptoms tested in the studies were repetitive behaviors, eye gaze, and emotion recognition. The studies had a medium to high risk of bias. Most studies had small samples (median=15). All the studies but one reported statistically significant between-group differences on at least one outcome variable. Most findings were characterized by medium effect size. Only one study had evidence that the improvement in emotion recognition was maintained after 6 weeks of treatment with intranasal oxytocin. Overall, oxytocin was well tolerated and side effects, when present, were generally rated as mild; however, restlessness, increased irritability, and increased energy occurred more often under oxytocin. RCTs of oxytocin interventions in autism yielded potentially promising findings in measures of emotion recognition and eye gaze, which are impaired early in the course of the ASD condition and might disrupt social skills learning in developing children. There is a need for larger, more methodologically rigorous RCTs in this area. Future studies should be better powered to estimate outcomes with medium to low effect size, and should try to enroll female participants, who were rarely considered in previous studies. Risk of bias should be minimized. Human long

  9. A Randomized Controlled Trial of Storytelling as a Communication Tool

    PubMed Central

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

    2013-01-01

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

  10. Massage Therapy and Labor Outcomes: a Randomized Controlled Trial

    PubMed Central

    Janssen, Patricia; Shroff, Farah; Jaspar, Paula

    2012-01-01

    Introduction Massage is a time-honored method by which women have received comfort throughout the millennia, yet it has not been rigorously evaluated in the modern day delivery suite. No study to date that we are aware of has evaluated the effect of massage therapy by a regulated massage therapist on labor pain. The purpose of this study was to evaluate the effectiveness of massage therapy provided by registered massage therapists in managing pain among women in active labor. Methods BC Women’s Hospital, Vancouver, BC. Research Design: a randomized controlled trial. Participants: 77 healthy nulliparous women presenting in spontaneous labor. Intervention: Swedish massage administered for up to five hours by a registered massage therapist during labor vs. standard care. Main outcome measures include: cervical dilation at the time of administration of epidural, compared using estimated marginal means in an analysis of covariance. We also compared perception of pain at three time periods during labor according to cervical dilation at 3–4 cm, 5–7 cm, and 8–10 cm using the McGill Present Pain Intensity Scale. Results The mean cervical dilation at the time of epidural insertion after adjustment for station of the presenting part, cervical dilation, and status of membranes on admission to hospital was 5.9 cm (95% CI 5.2–6.7) compared to 4.9 in the control group (95% CI 4.2–5.8). Scores on the McGill Pain Scale were consistently lower in the massage therapy group (13.3 vs. 16.9 at 3–4 cm, 13.3 vs. 15.8 at 5–6 cm, and 19.4 vs. 28.3 at 7–8 cm), although these differences were not statistically significant. Conclusions Our findings from this pilot study suggest that massage therapy by a registered massage therapist has the potential to be an effective means of pain management that may be associated with delayed use of epidural analgesia. It may therefore have the potential to reduce exposure to epidural analgesia during labor and decrease rates of associated

  11. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  12. Family dietary coaching to improve nutritional intakes and body weight control: a randomized controlled trial.

    PubMed

    Paineau, Damien L; Beaufils, François; Boulier, Alain; Cassuto, Dominique-Adèle; Chwalow, Judith; Combris, Pierre; Couet, Charles; Jouret, Béatrice; Lafay, Lionel; Laville, Martine; Mahe, Sylvain; Ricour, Claude; Romon, Monique; Simon, Chantal; Tauber, Maïté; Valensi, Paul; Chapalain, Véronique; Zourabichvili, Othar; Bornet, Francis

    2008-01-01

    To test the hypothesis that family dietary coaching would improve nutritional intakes and weight control in free-living (noninstitutionalized) children and parents. Randomized controlled trial. Fifty-four elementary schools in Paris, France. One thousand thirteen children (mean age, 7.7 years) and 1013 parents (mean age, 40.5 years). Families were randomly assigned to group A (advised to reduce fat and to increase complex carbohydrate intake), group B (advised to reduce both fat and sugar and to increase complex carbohydrate intake), or a control group (given no advice). Groups A and B received monthly phone counseling and Internet-based monitoring for 8 months. Changes in nutritional intake, body mass index (calculated as weight in kilograms divided by height in meters squared), fat mass, physical activity, blood indicators, and quality of life. Compared with controls, participants in the intervention groups achieved their nutritional targets for fat intake and to a smaller extent for sugar and complex carbohydrate intake, leading to a decrease in energy intake (children, P < .001; parents, P = .02). Mean changes in body mass index were similar among children (group A, + 0.05, 95% confidence interval [CI], - 0.06 to 0.16; group B, + 0.10, 95% CI, - 0.03 to 0.23; control group, + 0.13, 95% CI, 0.04-0.22; P = .45), but differed in parents (group A, + 0.13, 95% CI, - 0.01 to 0.27; group B, - 0.02, 95% CI, - 0.14 to 0.11; control group, + 0.24, 95% CI, 0.13-0.34; P = .001), with a significant difference between group B and the control group (P = .01). Family dietary coaching improves nutritional intake in free-living children and parents, with beneficial effects on weight control in parents. Trial Registration clinicaltrials.gov Identifier: NCT00456911.

  13. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    PubMed Central

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  14. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States.

    PubMed

    Olson, Ryan; Wipfli, Brad; Thompson, Sharon V; Elliot, Diane L; Anger, W Kent; Bodner, Todd; Hammer, Leslie B; Perrin, Nancy A

    2016-09-01

    To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = -0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers.

  15. Individual and contextual determinants of resident-on-resident abuse in nursing homes: a random sample telephone survey of adults with an older family member in a nursing home.

    PubMed

    Schiamberg, Lawrence B; von Heydrich, Levente; Chee, Grace; Post, Lori A

    2015-01-01

    Few empirical investigations of elder abuse in nursing homes address the frequency and determinants of resident-on-resident abuse (RRA). A random sample of 452 adults with an older adult relative, ≥65 years of age, in a nursing home completed a telephone survey regarding elder abuse experienced by that elder family member. Using a Linear Structural Relations (LISREL) modeling design, the study examined the association of nursing home resident demographic characteristics (e.g., age, gender), health and behavioral characteristics (e.g., diagnosis of Alzheimer's Disease, Activities of Daily Living (ADLs), Instrumental Activities of Daily Living (IADLs), types of staff abuse (e.g., physical, emotional), and factors beyond the immediate nursing home setting (e.g., emotional closeness of resident with family members) with RRA. Mplus statistical software was used for structural equation modeling. Main findings indicated that resident-on-resident mistreatment of elderly nursing home residents is associated with the age of the nursing home resident, all forms of staff abuse, all ADLs and IADLs, and emotional closeness of the older adult to the family. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  16. Costing and cost analysis in randomized controlled trials: caveat emptor.

    PubMed

    Polsky, Daniel; Glick, Henry

    2009-01-01

    This article provides an overview of the central issues regarding cost valuation and analysis for a decision maker's evaluation of costing performed within randomized controlled trials (RCTs). Costing involves specific choices for valuation and analysis that involve trade-offs. Understanding these choices and their implications is necessary for proper evaluation of how costs are valued and analyzed within an RCT and cannot be assessed through a checklist of adherence to general principles. Resource costing, the most common method of costing, involves measuring medical service use in study case report forms and translating this use into a cost by multiplying the number of units of each medical service by price weights for those services. A choice must be made as to how detailed the measurement of resources will be. Micro-costing improves the specificity of the cost estimate, but it is often impractical to precisely measure resources at this level and the price weights for these micro-units may not be available. Gross-costing may be more practical, and price weights are often easier to find and are more reliable, but important resource differences between treatment groups may be lost in the bundling of resources. Price weights can either be nationally determined or centre specific, but the appropriate price weight will depend on perspective, convenience, completeness and accuracy. Identifying the resource types and the appropriate price weights for these resources are the essential elements to an accurate valuation of costs. Once medical services are valued, the resulting individual patient cost estimates must be analysed. The difference in the mean cost between treatment groups is the important summary statistic for cost-effectiveness analysis from both the budgetary and the social perspectives. The statistical challenges with cost data typically stem from its skewed distribution and the resulting possibility that the sample mean may be inefficient and possibly

  17. The reporting quality of randomized controlled trials in orthodontics.

    PubMed

    Lempesi, Evangelia; Koletsi, Despina; Fleming, Padhraig S; Pandis, Nikolaos

    2014-06-01

    Accurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting. The 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling. 128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values. The reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions. Copyright

  18. Echinacea for treating the common cold: A randomized controlled trial

    PubMed Central

    Barrett, Bruce; Brown, Roger; Rakel, Dave; Mundt, Marlon; Bone, Kerry; Barlow, Shari; Ewers, Tola

    2011-01-01

    Background Echinacea is widely used to treat common cold. Objective To assess potential benefits of echinacea as common cold treatment. Design Randomized controlled trial with four parallel groups: 1) no pills, 2) placebo pills (blinded), 3) echinacea pills (blinded), or 4) echinacea pills (open-label). (NCT00065715) Setting Community-based trial. Participants People aged 12 to 80 years with new onset common cold. Interventions Extracts of Echinacea purpurea and E. angustifolia root were used to make tablets standardized to alkamide content. Indistinguishable placebo tablets contained only inert ingredients. Measurements The primary outcome was area-under-the-curve global severity, with severity assessed twice daily by self report on the Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Secondary outcomes included interleukin-8 and neutrophil count from nasal wash assessed at intake and two days later. Results Of 719 enrolled, 713 completed the protocol. Participants were 64% female and 88% white, with mean age 33.7 years. Mean global severity was 236 and 258 for blinded and unblinded echinacea, 264 for blinded placebo, and 286 for those without pills. Contrasting the two blinded groups yields a 28 point (95% CI = −69 to 13) trend toward benefit for echinacea (p=0.089). Mean illness duration for the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared to 6.87 days for blinded placebo and 7.03 for no pills. Contrasting blinded groups yields a 0.53 day (95% CI = −1.25 to 0.19) trend toward benefit (p = 0.075). Median change interleukin-8 (pg/mL) and neutrophil cell count were: no pills (30, 1), blinded placebo (39, 1), blinded echinacea (58, 2), and open-label echinacea (70, 1), also not statistically significant. Limitations Higher-than-expected variability limited power to detect small-but-potentially-important benefits. Conclusions The observed shorter illness duration and lower severity seen in the echinacea groups were

  19. The talking card: Randomized controlled trial of a novel audio-recording tool for asthma control.

    PubMed

    Cowden, John D; Wilkerson-Amendell, Sharon; Weathers, Laura; Gonzalez, Emma D; Dinakar, Chitra; Westbrook, David H; Williams, Arthur R

    2015-01-01

    Asthma care plans typically include complicated written instructions. Customized, audio-recorded instructions may bridge health literacy gaps and improve treatment plan understanding. To measure the effects of a recordable greeting card-style tool (Talking Card) on asthma control and parental care of children with asthma. Multisite randomized trial in two primary care clinics, including children 4-11 years old with uncontrolled asthma and their parents. Parent-child dyads were randomized to usual care of asthma or usual care plus the Talking Card. Dyads completed three asthma-focused visits over 3 months. At the visit, card recipients received customized instructions recorded by the pediatrician onto an audio chip in the card. Asthma control was measured by using the Childhood Asthma Control Test. Card use and parental satisfaction were measured by parental survey (card arm only). Outcomes were analyzed by using generalized estimating equations and frequency distributions. Sixty-four dyads participated and attended 166 clinic visits. Card use was associated with a 1.6-point increase in Childhood Asthma Control Test score (p = 0.02) and a clinic visit regardless of card use with a three-point increase (p < 0.001). Satisfaction and self-efficacy were high among the card users. The mean satisfaction score was 8.9 of 10, with 96% agreeing or strongly agreeing that the card helped them take better care of asthma. The Talking Card, a novel audio communication tool, was associated with improved asthma control and deemed highly desirable by parents and children struggling to control asthma. This inexpensive portable tool may be useful in other chronic disorders and in locales with low literacy and poor access to digital technology.

  20. Intention-to-Treat Analysis in Partially Nested Randomized Controlled Trials with Real-World Complexity

    ERIC Educational Resources Information Center

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

    Demands for scientific knowledge of what works in educational policy and practice has driven interest in quantitative investigations of educational outcomes, and randomized controlled trials (RCTs) have proliferated under these conditions. In educational settings, even when individuals are randomized, both experimental and control students are…

  1. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  2. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  3. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    ERIC Educational Resources Information Center

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  4. The Walking School Bus and children's physical activity: A pilot cluster randomized controlled trial

    USDA-ARS?s Scientific Manuscript database

    To evaluate the impact of a "walking school bus" program on children's rates of active commuting to school and physical activity. We conducted a pilot cluster randomized controlled trial among 4th-graders from 8 schools in Houston, Texas (N = 149). Random allocation to treatment or control condition...

  5. Key Items to Get Right When Conducting a Randomized Controlled Trial in Education

    ERIC Educational Resources Information Center

    Coalition for Evidence-Based Policy, 2005

    2005-01-01

    This is a checklist of key items to get right when conducting a randomized controlled trial to evaluate an educational program or practice ("intervention"). It is intended as a practical resource for researchers and sponsors of research, describing items that are often critical to the success of a randomized controlled trial. A significant…

  6. A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

    ERIC Educational Resources Information Center

    Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

    2012-01-01

    This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

  7. Meta-Analysis of Randomized, Controlled Treatment Trials for Pediatric Obsessive-Compulsive Disorder

    ERIC Educational Resources Information Center

    Watson, Hunna J.; Rees, Clare S.

    2008-01-01

    Objective: To conduct a meta-analysis on randomized, controlled treatment trials of pediatric obsessive-compulsive disorder (OCD). Method: Studies were included if they employed randomized, controlled methodology and treated young people (19 years or under) with OCD. A comprehensive literature search identified 13 RCTs containing 10…

  8. Intention-to-Treat Analysis in Partially Nested Randomized Controlled Trials with Real-World Complexity

    ERIC Educational Resources Information Center

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

    Demands for scientific knowledge of what works in educational policy and practice has driven interest in quantitative investigations of educational outcomes, and randomized controlled trials (RCTs) have proliferated under these conditions. In educational settings, even when individuals are randomized, both experimental and control students are…

  9. Meta-Analysis of Randomized, Controlled Treatment Trials for Pediatric Obsessive-Compulsive Disorder

    ERIC Educational Resources Information Center

    Watson, Hunna J.; Rees, Clare S.

    2008-01-01

    Objective: To conduct a meta-analysis on randomized, controlled treatment trials of pediatric obsessive-compulsive disorder (OCD). Method: Studies were included if they employed randomized, controlled methodology and treated young people (19 years or under) with OCD. A comprehensive literature search identified 13 RCTs containing 10…

  10. A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

    ERIC Educational Resources Information Center

    Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

    2012-01-01

    This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

  11. Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial.

    PubMed

    Chen, Jyun-Hong; Ou, Huang-Tz; Lin, Tzu-Chieh; Lai, Edward Chia-Cheng; Kao, Yea-Huei Yang

    2016-02-01

    Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider. To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes. A 421-bed district hospital in Nantou City, Taiwan. We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann–Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P < 0.05. The change in the mean HbA1c level from the baseline to the next level within 6 months after recruiting. Nonparametric data (Mann–Whitney test) showed that the mean HbA1c level significantly decreased (0.83 %) after 6 months for the intervention group compared with an increase of 0.43 % for the control group (P ≤ 0.001). Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups. The pharmacist intervention program provided

  12. Effect of diclofenac suppository on pain control during flexible cystoscopy-A randomized controlled trial

    PubMed Central

    Nadeem, Mehwash; Ather, M Hammad

    2016-01-01

    TRIAL DESIGN: To compare the difference in pain score during flexible cystoscopy between patients undergoing the procedure with plain lubricating gel  only and plain gel with diclofenac suppository in a randomized control trial. METHODS:  A total of 60 male patients with an indication of flexible cystoscopy were enrolled in a prospective, randomized controlled study. Patients were randomized in two groups. In group “A”, patients received diclofenac suppository one hour prior to the procedure while group “B” did not receive diclofenac suppository. Both groups received 10 ml of intra-urethral  plain gel for lubrication during flexible cystoscopy. Pain score was recorded immediately after the procedure using the visual analogue scale (VAS). Pre- and post-procedure pulse rate and systolic blood pressure was also recorded. Statistical analyses were performed using chi-square test and student t-test. Regression analysis was performed to address the confounding variables. RESULTS: Both groups were comparable for variables including age, duration of procedure, level of operating surgeon and indication of procedure. Most common indication for flexible cystoscopy was removal of double J stent. There was a statistically significant difference in the mean pain score between two groups ( p = 0.012).  The difference in post-procedure mean pulse rate in the two groups was statistically significant ( p= 0.01) however there was no difference observed in mean post procedure systolic blood pressure. Regression analysis showed that none of the confounding variables were significantly affecting pain perception. CONCLUSIONS: Intra rectal diclofenac suppository is simple and effective pre-emptive analgesia. We recommend its routine use during flexible cystoscopy for better pain control.

  13. Computer Control of a Random Access Slide Projector.

    ERIC Educational Resources Information Center

    Barker, Philip G.

    1982-01-01

    A description of a simple interface to enable the interconnection of a random access slide projector and a microcomputer is provided, as well as summaries of the role of slide images as a means of implementing graphic communication and the new activity in graphics as an area of information processing. The microcomputer interface is then detailed,…

  14. Building Kindergartners' Number Sense: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-01-01

    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 1 of 3 groups (n = 44 in each…

  15. Building Kindergartners' Number Sense: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-01-01

    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 1 of 3 groups (n = 44 in each…

  16. Randomized, Controlled Trial of CBT Training for PTSD Providers

    DTIC Science & Technology

    2015-10-01

    902-909. Shapiro, F. (2001). Eye movement desensitization and reprocessing (EMDR): Basic principles, protocols, and procedures (2nd ed.) (2nd ed...A randomized clinical trial of eye movement desensitization and reprocessing (EMDR), fluoxetine, and pill placebo in the treatment of

  17. Randomized, Controlled Trial of CBT Training for PTSD Providers

    DTIC Science & Technology

    2013-10-01

    and Therapy, 47, 902-909. Shapiro, F. (2001). Eye movement desensitization and reprocessing ( EMDR ): Basic principles...Hopper, E. K., Korn, D. L., & Simpson, W. B. (2007). A randomized clinical trial of eye movement desensitization and reprocessing ( EMDR ), fluoxetine...Josef Ruzek, Ph.D. CONTRACTING ORGANIZATION: Palo Alto Institute for Research and Education Palo Alto, CA 94304 REPORT

  18. Randomized, Controlled Trial of CBT Training for PTSD Providers

    DTIC Science & Technology

    2013-10-01

    and Therapy, 47, 902-909. Shapiro, F. (2001). Eye movement desensitization and reprocessing ( EMDR ): Basic principles, protocols, and procedures...Simpson, W. B. (2007). A randomized clinical trial of eye movement desensitization and reprocessing ( EMDR ), fluoxetine, and pill placebo in the...21702 DISTRIBUTION STATEMENT: Approved for Public Release; Distribution Unlimited The views, opinions

  19. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

    PubMed Central

    2012-01-01

    Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost effectiveness of remifentanil as

  20. Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design.

    PubMed

    Bian, Zhao-Xiang; Moher, David; Dagenais, Simon; Li, You-Ping; Liu, Liang; Wu, Tai-Xiang; Miao, Jiang-Xia

    2006-03-01

    To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical

  1. A meta-analysis of randomized controlled trials of telmisartan for flow-mediated dilatation.

    PubMed

    Takagi, Hisato; Umemoto, Takuya

    2014-09-01

    There have been a number of small-sized underpowered randomized controlled trials to assess effects of telmisartan on flow-mediated dilatation (FMD). To determine whether telmisartan increases FMD, we performed a meta-analysis of these trials. MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched through December 2013. Eligible studies were prospective randomized controlled trials of telmisartan reporting FMD as an outcome. Search terms included: telmisartan; endothelial function/dysfunction; flow-mediated dilation/dilatation/vasodilation/vasodilatation; and randomized, randomly or randomization. Included studies were reviewed to determine the number of patients randomized, mean duration of treatment and percent changes of FMD. Of 25 potentially relevant articles screened initially, seven reports of randomized trials enrolling a total of 398 patients were identified and included. A pooled analysis of the seven trials demonstrated a statistically significant increase in FMD by 48.7%, with telmisartan relative to control in the random-effects model (mean difference, 48.72%; 95% confidence interval, 15.37-82.08%; P for effect=0.004; P for heterogeneity <0.00001). Exclusion of any single trial from the analysis did not substantively alter the overall result of our analysis. There was no evidence of significant publication bias. In conclusion, the present meta-analysis of seven randomized controlled trials enrolling a total of 398 patients confirmed the evidence of a significant increase in FMD with telmisartan, which suggests that telmisartan may improve endothelial dysfunction.

  2. Meta-analysis of Placebo-Controlled Randomized Controlled Trials on the Prevalence of Statin Intolerance.

    PubMed

    Riaz, Haris; Khan, Abdur Rahman; Khan, Muhammad Shahzeb; Rehman, Karim Abdur; Alansari, Shehab Ahmad Redha; Gheyath, Bashaer; Raza, Sajjad; Barakat, Amr; Luni, Faraz Khan; Ahmed, Haitham; Krasuski, Richard A

    2017-09-01

    The prevalence of intolerance varies widely. Stopping statin therapy is associated with worse outcomes in patients with cardiovascular disease. Despite extensive studies, the benefits and risks of statins continue to be debated by clinicians and the lay public. We searched the PubMed, Medline, and Cochrane Central Register of Controlled Trials (CENTRAL) databases for all randomized controlled trials of statins compared with placebo. Studies were included if they had ≥1,000 participants, had patients who were followed up for ≥1 year, and reported rates of drug discontinuation. Studies were pooled as per the random effects model. A total of 22 studies (statins = 66,024, placebo = 63,656) met the inclusion criteria. The pooled analysis showed that, over a mean follow-up of 4.1 years, the rates of discontinuation were 13.3% (8,872 patients) for statin-treated patients and 13.9% (8,898 patients) for placebo-treated patients. The random effects model showed no significant difference between the placebo and statin arms (odds ratio [OR] = 0.99, 95% confidence interval [CI] = 0.93 to 1.06). The results were similar for both primary prevention (OR = 0.98, 95% CI = 0.92 to 1.05, p = 0.39) and secondary prevention (OR = 0.92, 95% CI = 0.83 to 1.05, p = 0.43) studies. The pooled analysis suggested that the rates of myopathy were also similar between the statins and placebos (OR = 1.2, 95% CI = 0.88 to 1.62, p = 0.25). In conclusion, this meta-analysis of >125,000 patients suggests that the rate of drug discontinuation and myopathy does not significantly differ between statin- and placebo-treated patients in randomized controlled trials. These findings are limited by the heterogeneity of results, the variable duration of follow-up, and the lower doses of statins compared with contemporary clinical practice. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Controlling Random Lasing with Three-Dimensional Plasmonic Nanorod Metamaterials.

    PubMed

    Wang, Zhuoxian; Meng, Xiangeng; Choi, Seung Ho; Knitter, Sebastian; Kim, Young L; Cao, Hui; Shalaev, Vladimir M; Boltasseva, Alexandra

    2016-04-13

    Plasmonics has brought revolutionary advances to laser science by enabling deeply subwavelength nanolasers through surface plasmon amplification. However, the impact of plasmonics on other promising laser systems has so far remained elusive. Here, we present a class of random lasers enabled by three-dimensional plasmonic nanorod metamaterials. While dense metallic nanostructures are usually detrimental to laser performance due to absorption losses, here the lasing threshold keeps decreasing as the volume fraction of metal is increased up to ∼0.07. This is ∼460 times higher than the optimal volume fraction reported thus far. The laser supports spatially confined lasing modes and allows for efficient modulation of spectral profiles by simply tuning the polarization of the pump light. Full-field speckle-free imaging at micron-scales has been achieved by using plasmonic random lasers as the illumination sources. Our findings show that plasmonic metamaterials hold potential to enable intriguing coherent optical sources.

  4. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP).

    PubMed

    Allison, David B; Gadde, Kishore M; Garvey, William Timothy; Peterson, Craig A; Schwiers, Michael L; Najarian, Thomas; Tam, Peter Y; Troupin, Barbara; Day, Wesley W

    2012-02-01

    A 56-week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled-release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI ≥ 35 kg/m(2)) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced-energy diet. Primary end points were percent WL and proportions of patients achieving 5% WL. Secondary end points included waist circumference (WC), systolic and diastolic blood pressure (BP), fasting glucose, and lipid measures. In the primary analysis (randomized patients with at least one postbaseline weight measurement who took at least one dose of assigned drug or placebo), patients in the placebo, 3.75/23, and 15/92 groups lost 1.6%, 5.1%, and 10.9% of baseline body weight (BW), respectively, at 56 weeks (P < 0.0001). In categorical analysis, 17.3% of placebo patients, 44.9% of 3.75/23 patients, and 66.7% of 15/92 patients, lost at least 5% of baseline BW at 56 weeks (P < 0.0001). The 15/92 group had significantly greater changes relative to placebo for WC, systolic and diastolic BP, fasting glucose, triglycerides, total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL). The most common adverse events were paresthesia, dry mouth, constipation, dysgeusia, and insomnia. Dropout rate from the study was 47.1% for placebo patients, 39.0% for 3.75/23 patients, and 33.6% of 15/92 patients. PHEN/TPM CR demonstrated dose-dependent effects on weight and metabolic variables in the direction expected to be beneficial with no evidence of serious adverse events induced by treatment.

  5. A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

    DTIC Science & Technology

    2014-10-01

    Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and...COVERED 30 Sep 2013 - 29 Sep 2014 4. TITLE AND SUBTITLE A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education... Meditation (TM) vs. Prolonged Exposure (PE) and PTSD health education control (EC), using the Clinician Administered PTSD Scale (CAPS) (primary

  6. The debate: a case for randomized controls in invasive aspergillosis.

    PubMed

    Bennett, John E

    2006-09-01

    Randomized trials in invasive aspergillosis have evolved over the past decade. Definitions of disease now include specifics of the underlying disease and how this affects interpretation of certain tests, including high resolution computed tomography and smears or cultures of sputum and bronchoalveolar lavage. Study hypotheses have changed from underpowered superiority trials to adequately powered noninferiority trials. Consensus building between Europe and North America has allowed trials to be conducted with the same protocol in both regions, thereby increasing study enrollment. In aggregate, the following outcomes can be drawn from randomized trials: (i) Liposomal amphotericin B is possibly superior to conventional amphotericin B at 14 days and less toxic. Whether the dose of liposomal amphotericin is 1 or 4 mg/kg daily is not as important as other factors in determining outcome of possible aspergillosis; (ii) amphotericin B colloidal dispersion is less nephrotoxic but has more acute infusion-related reactions than conventional amphotericin B; (iii) starting treatment with voriconazole is superior to starting with conventional amphotericin B. In an era of increasing cost containment, it will be the randomized trials that provide the clinician with the information needed to avoid inappropriate use of expensive drugs and drug combinations.

  7. The Effectiveness of Pregabalin for Post-Tonsillectomy Pain Control: A Randomized Controlled Trial

    PubMed Central

    Park, Soo Seog; Kim, Dong-Hyun; Nam, In-Chul; Lee, Il-Hwan; Hwang, Jae-Woong

    2015-01-01

    Background Although various analgesics have been used, postoperative pain remains one of the most troublesome aspects of tonsillectomy for patients. Objective The aim of the present study was to evaluate the effectiveness of premedication using pregabalin compared with placebo (diazepam) on postoperative pain control in patients undergoing tonsillectomy. Methods Forty-eight adult patients were randomly divided into a control group and a pregabalin group. Preoperatively, patients in the control group received 4 mg diazepam orally as placebo, whereas those in the pregabalin group received 300 mg pregabalin orally. All participants were provided with patient-controlled analgesia using fentanyl for 24 hours after surgery. Postoperative pain treatment included acetaminophen 650 mg three times daily for 8 postoperative days. The primary outcome measure was the total amount of patient-controlled fentanyl consumption after tonsillectomy. Secondary outcome measures were the number of injections of ketorolac tromethamine (each 30 mg) requested by patients, pain scores, overall satisfaction scores, drowsiness, nausea, dizziness, headache, and vomiting after the surgery. P < 0.05 was considered statistically significant. Results The total amount of fentanyl demanded decreased significantly in the pregabalin group (P < 0.001). There were no significant differences in the number of ketorolac tromethamine injections, pain scores, overall satisfaction scores, drowsiness, nausea, dizziness, headache, and vomiting between the two groups. Conclusion Administration of 300 mg pregabalin prior to tonsillectomy decreases fentanyl consumption compared with that after 4 mg diazepam, without an increased incidence of adverse effects. Trial Registration KCT0001215 PMID:25706948

  8. A visual medication schedule to improve anticoagulation control: a randomized, controlled trial.

    PubMed

    Machtinger, Edward L; Wang, Frances; Chen, Lay-Leng; Rodriguez, Maytrella; Wu, Sandy; Schillinger, Dean

    2007-10-01

    Misunderstanding between clinicians and patients may lead to medication-related errors and poor clinical outcomes, particularly in anticoagulant care. One hundred forty-seven chronic warfarin users were randomized to receive a visual medication schedule at each visit, along with brief counseling, versus standard care, and followed for 90 days. At baseline, patient and clinician reports of the prescribed warfarin regimen were recorded to identify patients as "discordant" versus "concordant" to determine whether the effect of the intervention varied with clinician-patient discordance. At baseline, clinician-patient warfarin regimen discordance was common in intervention and control groups (38% versus 42%). Intervention subjects achieved anticoagulation control more rapidly than control subjects (median 28 versus 42 days; hazard ratio [HR], 1.43; confidence interval [CI], 1.00, 2.06). The benefit of the intervention was significant among subjects with baseline regimen discordance (median, 28 versus 49 days; HR, 1.92; CI, 1.08, 3.39) but not among subjects with baseline concordance (median 28 versus 35 days; HR, 1.14; CI, 0.71,1.83). Among patients in poor anticoagulant control whose understanding of their warfarin regimen is discordant with their providers', a visual medication schedule, combined with brief counseling, reduced time to anticoagulation control. The study suggests a simple strategy to enhance medication safety and efficacy for at-risk patients.

  9. Kinesio Taping for pain control during labor: Protocol of a randomized, controlled trial.

    PubMed

    Miquelutti, Maria Amelia; Cecatti, José Guilherme

    2017-03-01

    This study protocol will evaluate the effectiveness and safety during labor and delivery of the Kinesio Taping bandage for pain sensation, satisfaction of patients, and obstetric and neonatal outcomes. A randomized controlled trial with 60 participants divided into two groups will be conducted. The intervention group will receive bandage application on the vertebral regions corresponding to uterine dermatomes - from T10 to L1 and from S2 to S4. The control group will receive bandage application away from uterine dermatomes, from T1 to T4. The primary endpoint is pain during labor. Secondary endpoints are perinatal outcomes and patient satisfaction with the bandage and with her labor. Pain levels will be evaluated on an hourly basis during labor, and intention-to-treat analysis will be performed. Risk ratios and 95% confidence intervals will be calculated. Findings on effectiveness of pain control with no adverse effects to both the mother and neonate are the first step in evaluating the systematic use of Kinesio Taping during labor. Since self-control may affect birthing experience satisfaction, discovering new alternatives for pain control may allow for a better experience. © 2017 John Wiley & Sons Australia, Ltd.

  10. Interference control training for PTSD: A randomized controlled trial of a novel computer-based intervention

    PubMed Central

    Bomyea, Jessica; Stein, Murray B.; Lang, Ariel J.

    2015-01-01

    Post-traumatic stress disorder (PTSD) is a chronic and debilitating condition characterized by persistent intrusive memories. Although effective treatments exist for PTSD, there is a need for development of alternative treatments. Diminished ability to control proactive interference may contribute to re-experiencing symptoms and may be a novel intervention target. The present study tested an intervention designed to modify proactive interference control. Forty-two women with PTSD were randomly assigned to a computerized cognitive training or a control condition. The impact of these programs on cognitive performance and symptoms was assessed. PTSD re-experiencing symptoms and interference control performance improved significantly more for individuals in the training group relative to those in the control group. Other PTSD and general distress symptoms improved equally over time in both groups. Cognitive training of this type may hold promise as a novel intervention for reducing PTSD symptoms, although the mechanism of action and implications for models of PTSD requires future study. PMID:26114901

  11. Telerehabilitation Versus Traditional Care Following Total Hip Replacement: A Randomized Controlled Trial Protocol

    PubMed Central

    Bourke, Michael; Crossley, Kay; Russell, Trevor

    2017-01-01

    Background Total hip replacement (THR) is the gold standard treatment for severe hip osteoarthritis. Effectiveness of physical rehabilitation for THR patients following discharge from hospital is supported by evidence; however, barriers such as geographical location and transport can limit access to appropriate health care. One solution to this issue is using an alternative model of care using telerehabilitation technology to deliver rehabilitation programs directly into patients’ homes. A telerehabilitation model may also have potential health care cost savings for health care providers. Objective This study aims to determine if a telerehabilitation model of care delivered remotely is as effective as face-to-face rehabilitation in the THR population and cost effective for health care providers and patients. Methods A total of 70 people undergoing THR will be recruited to participate in a randomized, single-blind, controlled noninferiority clinical trial. The trial will compare a technology-based THR rehabilitation program to in-person care. On discharge from hospital, participants randomized to the in-person group will receive usual care, defined as a paper home exercise program (HEP) targeting strengthening exercises for quadriceps, hip abductors, extensors, and flexors; they will be advised to perform their HEP 3 times per day. At 2, 4, and 6 weeks postoperatively, they will receive a 30-minute in-person physiotherapy session with a focus on gait retraining and reviewing and progressing their HEP. The telerehabilitation protocol will involve a program similar in content to the in-person rehabilitation program, except delivery will be directly into the homes of the participants via telerehabilitation technology on an iPad. Outcomes will be evaluated preoperatively, day of discharge from in-patient physiotherapy, 6 weeks and 6 months postoperatively. The primary outcome will be the quality of life subscale of the hip disability and osteoarthritis outcome score

  12. Significance of patient-controlled sedation during colonoscopy. Results from a prospective randomized controlled study.

    PubMed

    Crepeau, Thomas; Poincloux, Laurent; Bonny, Corinne; Lighetto, Sylvie; Jaffeux, Patricia; Artigue, Fabrice; Walleckx, Pierre; Bazin, Jean Etienne; Dapoigny, Michel; Bommelaer, Gilles

    2005-11-01

    In France, general anesthesia is given to more than 90% of patients undergoing colonoscopy although in several countries sedation is limited to intolerant patients. This study was carried out to determine whether Patient-Controlled Sedation (PCS) could provide a lighter sedation than general anesthesia adapted to the patient's individual requirement. Patients aged from 18 to 80 scheduled for elective colonoscopy were prospectively randomized to receive either standard sedation (control group) or patient-controlled-sedation (PCS). In the control group, patients received a continuous infusion of propofol. Patients in the PCS group were connected to an infusion pump containing propofol and self-administered 20-mg boluses as often as they required. An anesthetist was present throughout the procedure. Patient satisfaction measured on a visual analog scale four hours after colonoscopy was the main outcome criterion. From December 2002 to September 2003, 402 patients underwent elective colonoscopy, 173 of them were eligible and were asked to participate in the study. Seventy-two gave their informed consent and were prospectively randomized. The patients' mean satisfaction scores were not statistically different between the two groups: 84.7 mm (PCS group) vs. 91.5 mm (control group); P = 0.24. Mean doses of propofol (60 mg vs. 248 mg; P <0.001), depth of sedation and time before discharge (1.75 hours vs. 4.45 hours) were significantly lower for patients in the PCS group; nine of them (25.7%) did not use the pump and had total colonoscopy without sedation. There were no statistically significant differences between the two groups regarding total duration of colonoscopy (19.4 min (PCS) vs. 18 min (control)) difficulty and therapeutic procedures (biopsy or polypectomy). Two weeks after the procedure, 96.5% of patients in the PCS group were willing to repeat the examination under the same conditions vs. 72.5% of patients in the control group (P = 0.03). Our results demonstrate

  13. The Copenhagen Triage Algorithm: a randomized controlled trial.

    PubMed

    Hasselbalch, Rasmus Bo; Plesner, Louis Lind; Pries-Heje, Mia; Ravn, Lisbet; Lind, Morten; Greibe, Rasmus; Jensen, Birgitte Nybo; Rasmussen, Lars S; Iversen, Kasper

    2016-10-10

    Crowding in the emergency department (ED) is a well-known problem resulting in an increased risk of adverse outcomes. Effective triage might counteract this problem by identifying the sickest patients and ensuring early treatment. In the last two decades, systematic triage has become the standard in ED's worldwide. However, triage models are also time consuming, supported by limited evidence and could potentially be of more harm than benefit. The aim of this study is to develop a quicker triage model using data from a large cohort of unselected ED patients and evaluate if this new model is non-inferior to an existing triage model in a prospective randomized trial. The Copenhagen Triage Algorithm (CTA) study is a prospective two-center, cluster-randomized, cross-over, non-inferiority trial comparing CTA to the Danish Emergency Process Triage (DEPT). We include patients ≥16 years (n = 50.000) admitted to the ED in two large acute hospitals. Centers are randomly assigned to perform either CTA or DEPT triage first and then use the other triage model in the last time period. The CTA stratifies patients into 5 acuity levels in two steps. First, a scoring chart based on vital values is used to classify patients in an immediate category. Second, a clinical assessment by the ED nurse can alter the result suggested by the score up to two categories up or one down. The primary end-point is 30-day mortality and secondary end-points are length of stay, time to treatment, admission to intensive care unit, and readmission within 30 days. If proven non-inferior to standard DEPT triage, CTA will be a faster and simpler triage model that is still able to detect the critically ill. Simplifying triage will lessen the burden for the ED staff and possibly allow faster treatment. Clinicaltrials.gov: NCT02698319 , registered 24. of February 2016, retrospectively registered.

  14. Robotic Compared With Laparoscopic Sacrocolpopexy: A Randomized Controlled Trial

    PubMed Central

    Anger, Jennifer T.; Mueller, Elizabeth R.; Tarnay, Christopher; Smith, Bridget; Stroupe, Kevin; Rosenman, Amy; Brubaker, Linda; Bresee, Catherine; Kenton, Kimberly

    2014-01-01

    Objective: Laparoscopic and robotic sacrocolpopexy are widely used for pelvic organ prolapse (POP) treatment. Evidence comparing outcomes and costs is lacking. We compared costs and clinically relevant outcomes in women randomized to laparoscopic sacrocolpopexy compared with robotic sacrocolpopexy. Methods: Participants with symptomatic stage POP II or greater, including significant apical support loss, were randomized to either laparoscopic or robotic sacrocolpopexy. We compared surgical costs (including costs for robot, initial hospitalization) and re-hospitalization within 6 weeks. Secondary outcomes included postoperative pain, POP quantification, symptom severity and quality of life, and adverse events. Results: We randomized 78 women [mean age 59 years]: laparoscopic (n=38), robotic (n=40). The robotic sacrocolpopexy group had higher initial hospital costs ($19,616 vs. $11,573, p < 0.001) and over 6 weeks, hospital costs remained higher for robotic sacrocolpopexy ($20,898 vs. $12,170, p < 0.001). When we excluded costs of robot purchase and maintenance, we did not detect a statistical difference in initial day of surgery costs of robotic vs. laparoscopic ($12,586 vs. $11,573; p = 0.160) or hospital costs over 6 weeks ($13,867 vs. $12,170; p = 0.060). The robotic group had longer operating room times (202.8 min vs. 178.4 min, p = 0.030) and higher pain scores 1-week after surgery (3.5 ± 2.1 vs. 2.6 ± 2.2; p = 0.044). There were no group differences in symptom bother by Pelvic Floor Distress Inventory, POP stage, or rate of adverse events. Conclusion: Costs of robotic sacrocolpopexy are higher than laparoscopic, while short-term outcomes and complications are similar. Primary cost differences resulted from robot maintenance and purchase costs. PMID:24463657

  15. Timer watch assisted urotherapy in children: a randomized controlled trial.

    PubMed

    Hagstroem, Søren; Rittig, Søren; Kamperis, Konstantinos; Djurhuus, Jens Christian

    2010-10-01

    We evaluated the effect of timer watch treatment in addition to standard urotherapy in children with overactive bladder and daytime urinary incontinence. A total of 60 children with daytime urge incontinence were included in the study. Following a 4-week run-in period of standard urotherapy children were randomized to 12 weeks of standard urotherapy with or without a timer watch. Incontinence episodes were registered and 48-hour bladder diaries were obtained before randomization, and at weeks 1, 11 and 12. Long-term response was evaluated at 7 months. Two children became continent during the run-in period. Before intervention children in the timer group were slightly more wet than children in the standard urotherapy group (median 7 [IQR 25% to 75% 6 to 7] vs 6 [3 to 7] wet days per week, p <0.05). Following 12 weeks of standard urotherapy children randomized to timer assisted urotherapy had significantly fewer wet days per week (median 2, IQR 25% to 75% 0 to 5) vs those undergoing standard urotherapy alone (5, 2.75 to 6.75, p <0.01). In the timer group 18 children (60%) achieved a greater than 50% decrease in incontinence episodes, compared to only 5 (18%) treated without timer assistance. Nine patients (30%) in the timer group and no child in the standard urotherapy group achieved complete daytime continence. The timer increased compliance with the timed voiding regimen. At 7 months of followup 60% of children in the timer group were still continent in the daytime. A programmable timer watch significantly improves the effect of standard urotherapy. When using the timer watch as a supplement to standard urotherapy 60% of the children obtained complete and sustainable daytime continence. Copyright © 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  16. Effects of the FITKids randomized controlled trial on executive control and brain function.

    PubMed

    Hillman, Charles H; Pontifex, Matthew B; Castelli, Darla M; Khan, Naiman A; Raine, Lauren B; Scudder, Mark R; Drollette, Eric S; Moore, Robert D; Wu, Chien-Ting; Kamijo, Keita

    2014-10-01

    To assess the effect of a physical activity (PA) intervention on brain and behavioral indices of executive control in preadolescent children. Two hundred twenty-one children (7-9 years) were randomly assigned to a 9-month afterschool PA program or a wait-list control. In addition to changes in fitness (maximal oxygen consumption), electrical activity in the brain (P3-ERP) and behavioral measures (accuracy, reaction time) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility. Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control (1.3 mL/kg per minute, 95% confidence interval [CI]: 0.3 to 2.4; d = 0.34 for group difference in pre-to-post change score). Intervention participants exhibited greater improvements from pretest to posttest in inhibition (3.2%, 95% CI: 0.0 to 6.5; d = 0.27) and cognitive flexibility (4.8%, 95% CI: 1.1 to 8.4; d = 0.35 for group difference in pre-to-post change score) compared with control. Only the intervention group increased attentional resources from pretest to posttest during tasks requiring increased inhibition (1.4 µV, 95% CI: 0.3 to 2.6; d = 0.34) and cognitive flexibility (1.5 µV, 95% CI: 0.6 to 2.5; d = 0.43). Finally, improvements in brain function on the inhibition task (r = 0.22) and performance on the flexibility task correlated with intervention attendance (r = 0.24). The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control. These findings demonstrate a causal effect of a PA program on executive control, and provide support for PA for improving childhood cognition and brain health. Copyright © 2014 by the American Academy of Pediatrics.

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

    PubMed

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

    2016-07-01

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

  18. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial.

    PubMed

    Mercier, Rebecca J; Liberty, Abigail

    2014-12-01

    To determine if intrauterine administration of 5 cc of 2% lidocaine in addition to paracervical block reduces pain during laminaria insertion, when compared with paracervical block and saline placebo. This was a randomized, double blind placebo-controlled trial. Women presenting for abortion by dilation and evacuation (D&E) at 14-24 weeks gestational age were randomized to receive an intrauterine instillation of either 5 mL of 2% lidocaine or 5 mL of normal saline, in addition to standard paracervical block with 20 cc of 0.25% bupivacaine. Our primary outcome was self-reported pain scores on a 100mm Visual Analogue Scale (VAS) immediately following laminaria insertion. Secondary outcome was self-reported VAS pain score indicating the maximum level of pain experienced during the 24-48-h interval between laminaria insertion and D&E procedure. Seventy-two women were enrolled, and data for 67 women were analyzed, only two of whom were more than 21 weeks on gestation. The range of pain scores at both time points was large (1-90 mm at laminaria insertion; 0-100mm in laminaria-D&E interval). Mean pain scores were not different between treatment groups at laminaria insertion, (33 vs. 32, p=.8) or in the laminaria - D&E interval (43 vs. 44, p=.9). Intrauterine administration of 5 cc of 2% lidocaine in addition to paracervical block did not reduce pain with laminaria insertion when compared to paracervical block with saline placebo. Intrauterine lidocaine combined with paracervical block does not improve pain control at laminaria insertion when compared with paracervical block and saline placebo. Wide variation in pain scores and persistent pain after laminaria insertion suggests patient would benefit from more effective methods of pain control at laminaria insertion and during the post-laminaria interval. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. Social status and energy intake: a randomized controlled experiment.

    PubMed

    Pavela, G; Lewis, D W; Dawson, J A; Cardel, M; Allison, D B

    2017-10-01

    While the inverse association between socioeconomic status (SES) and obesity in high gross domestic product countries is well established using observational data, the extent to which the association is due to a true causal effect of SES and, if so, the mechanisms of this effect remain incompletely known. To assess the influence of social status on obesity via energy intake, we randomized individuals to a higher or lower social status and observed subsequent energy intake. College students between the ages of 18 and 25 were randomized to social status and were operationalized as being a leader or follower in a partner activity as purportedly determined by a (bogus) test of leadership ability. Investigators were blinded to treatment assignment. Immediately after being told their leadership assignment, paired participants were provided with platters of food. Energy intake was objectively measured in kilocalories (kcal) consumed, and paired t-tests were used to test for significant differences in intake between leaders and followers. A total of 60 participants were included in the final analysis (males = 28, females = 32). Overall, no difference in energy intake was observed between leaders and followers, consuming an average of 575.3 and 579.8 kcal, respectively (diff = 4.5 kcal, P = 0.94). The null hypothesis of no effect of social status, operationalized as assignment to a leadership position in a small-group activity, on energy intake was not rejected. © 2017 World Obesity Federation.

  20. Control problem for diffusion-type random fields

    SciTech Connect

    Knopov, P.S.; Derieva, E.N.

    1995-09-01

    Sufficient existence conditions are given for optimal control in a system described by a stochastic differential equations. These conditions are derived by Girsanov`s method of transformation of measures. Existence of {epsilon}-optimal controls is proved and a method of their construction is described.

  1. A Randomized Controlled Trial of Brief Interventions for Body Dissatisfaction

    ERIC Educational Resources Information Center

    Wade, Tracey; George, Wing Man; Atkinson, Melissa

    2009-01-01

    The authors examined the relative effectiveness of 3 different approaches to the experience of body dissatisfaction compared to a control and ruminative attention control condition, with respect to increasing weight and appearance satisfaction. One hundred female undergraduates (mean age = 24.38, SD = 9.39) underwent a body dissatisfaction…

  2. A Randomized Controlled Trial of Brief Interventions for Body Dissatisfaction

    ERIC Educational Resources Information Center

    Wade, Tracey; George, Wing Man; Atkinson, Melissa

    2009-01-01

    The authors examined the relative effectiveness of 3 different approaches to the experience of body dissatisfaction compared to a control and ruminative attention control condition, with respect to increasing weight and appearance satisfaction. One hundred female undergraduates (mean age = 24.38, SD = 9.39) underwent a body dissatisfaction…

  3. Effects of an anger management and stress control program on smoking cessation: a randomized controlled trial.

    PubMed

    Yalcin, Bektas Murat; Unal, Mustafa; Pirdal, Hasan; Karahan, Tevfik Fikret

    2014-01-01

    The purpose of this study was to investigate the effects of a cognitive behavioral therapy-oriented anger management and stress control program on smokers' quit rates. Of 2348 smokers, 350 were randomly allocated into study and control groups (n = 175 each). An individualized therapy cessation technique was selected for each participant (combination of behavioral counseling, nicotine replacement therapy, and/or pharmacotherapy). The participants in the control group attended a standard quit program, whereas the study group also received an additional 5-session (90 minutes each) cognitive behavioral therapy-oriented program aimed at improving their anger and stress coping skills. At the beginning of the study, both groups were asked to complete the Trait Anger Scale (TAS) of the State and Trait Anger Scale and the Self-Confident (SCS) and Hopeless (HS) subscales of the Stress Coping Styles Inventory; pretest smoking status of both groups and their coping skills were compared with each other as soon as the program ended (post-test results) and after 3 and 6 months (first and second follow-up tests). Although there was no difference between pretest scores on the TAS (P = .234), SCS (P = .130), and HS (P = .148) subscales, post-test results indicate that the study groups' TAS and HS scores decreased and SCS scores increased (P < .001), whereas there was no change in the control group (P > .05). The study group had a better quit level after 6 months compared with the control group (44% vs 27.4%; P < .001). The anger management and stress control program was found to have a significant effect on cessation (odds ratio, 2.09; 95% confidence interval, 1.14-3.85). The anger and stress coping skills program may increase the success of quitting smoking. © Copyright 2014 by the American Board of Family Medicine.

  4. Controlled-release misoprostol vaginal insert in parous women for labor induction: a randomized controlled trial.

    PubMed

    Ewert, Karine; Powers, Barbara; Robertson, Steve; Alfirevic, Zarko

    2006-11-01

    To assess the ability of a controlled-release misoprostol vaginal insert to induce labor using dose reservoirs of 25, 50, 100, and 200 microg. This double-blind, dose ranging, randomized study was carried out in parous women requiring induction of labor at term. Each woman was randomly assigned to receive a single misoprostol vaginal insert that could remain in place for up to 24 hours and was removed for onset of active labor, an adverse event, or having reached 24 hours in situ. The primary outcome measure was time from insertion of the misoprostol vaginal insert to vaginal delivery of the neonate. A total of 124 women participated in the study. The median time to vaginal delivery was 27.5, 19.1, 13.1, and 10.6 hours for the 25-, 50-, 100-, and 200-microg doses, respectively. The percentage of women who delivered vaginally within 12 hours was 9%, 14%, 47%, and 53% (P<.001 using the 25-microg group as the comparator) and within 24 hours was 42%, 79%, 81%, and 70% (P=.003). Uterine hyperstimulation syndrome occurred in one woman who received the 25-mug, two women who received the 100-microg, and three women who received the 200-microg dose reservoirs. Misoprostol vaginal inserts effectively induced labor in pregnant parous women at term. I.

  5. Evaluation of random plasma glucose for assessment of glycaemic control in type 2 diabetes mellitus.

    PubMed

    Ain, Qurratul; Latif, Atif; Jaffar, Syed Raza; Ijaz, Aamir

    2017-09-01

    To evaluate the accuracy of random plasma glucose in outpatients with type 2 diabetes mellitus for assessing glycaemic control. This comparative, cross-sectional study was conducted at the chemical pathology department of PNS Shifa Hospital, Karachi, from August 2015 to March 2016, and comprised data of subjects with type 2 diabetes mellitus who reported for evaluation of glycaemic control in non-fasting state. All blood samples were analysed for random plasma glucose and glycated haemoglobin. Random plasma glucose was compared as an index test with glycated haemoglobin considering it as reference standard at a value of less than 7% for good glycaemic control. SPSS 20 was used for data analysis. Of the 222 subjects, 93(42%) had good glycaemic control. Random plasma glucose showed strong positive correlation with glycated haemoglobin (p=0.000).Area under curve for random plasma glucose as determined by plotting receiver operating characteristic curve against glycated haemoglobin value of 7% was 0.89 (95% confidence interval: 0.849-0.930). Random plasma glucose at cut-off value of 150 mg/dl was most efficient for ruling out poor glycaemic control among patients with type 2 diabetes mellitus with 90.7% sensitivity and69.9% specificity and Youden's index of 0.606. Random plasma glucose may be used to reflect glycaemic control in adults with type 2 diabetes mellitus in areas where glycated haemoglobin is not feasible.

  6. Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

    ERIC Educational Resources Information Center

    Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

    2017-01-01

    Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

  7. Preventing Relapse/Recurrence in Recurrent Depression With Cognitive Therapy: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bockting, Claudi L. H.; Schene, Aart H.; Spinhoven, Philip; Koeter, Maarten W. J.; Wouters, Luuk F.; Huyser, Jochanan; Kamphuis, Jan H.

    2005-01-01

    This article reports on the outcome of a randomized controlled trial of cognitive group therapy (CT) to prevent relapse/recurrence in a group of high-risk patients diagnosed with recurrent depression. Recurrently depressed patients (N = 187) currently in remission following various types of treatment were randomized to treatment as usual,…

  8. After-School Multifamily Groups: A Randomized Controlled Trial Involving Low-Income, Urban, Latino Children

    ERIC Educational Resources Information Center

    McDonald, Lynn; Moberg, D. Paul; Brown, Roger; Rodriguez-Espiricueta, Ismael; Flores, Nydia I.; Burke, Melissa P.; Coover, Gail

    2006-01-01

    This randomized controlled trial evaluated a culturally representative parent engagement strategy with Latino parents of elementary school children. Ten urban schools serving low-income children from mixed cultural backgrounds participated in a large study. Classrooms were randomly assigned either either to an after-school, multifamily support…

  9. Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

    ERIC Educational Resources Information Center

    Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

    2009-01-01

    When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

  10. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  11. What to Do when Data Are Missing in Group Randomized Controlled Trials. NCEE 2009-0049

    ERIC Educational Resources Information Center

    Puma, Michael J.; Olsen, Robert B.; Bell, Stephen H.; Price, Cristofer

    2009-01-01

    This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups of students such as entire classrooms or schools are randomized. Missing outcome data are a…

  12. Effect of Art Production on Negative Mood: A Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Bell, Chloe E.; Robbins, Steven J.

    2007-01-01

    Art therapists have long held that art production causes reductions in stress and elevations in mood (Rubin, 1999). The authors examined this claim in a randomized, controlled trial. Fifty adults between the ages of 18 and 30 were randomly assigned to either create an art work or to view and sort a series of art prints. Three measures of overall…

  13. Efficacy of Parent-Child Interaction Therapy with Chinese ADHD Children: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Ng, Gene S. H.; Choi, S. Y.

    2017-01-01

    Purpose: This study aimed to evaluate the efficacy of Parent-Child Interaction Therapy (PCIT) in Chinese children with attention-deficit/hyperactivity disorder (ADHD) or ADHD features. Methods: This study adopted a randomized controlled trial design without blinding. Participants were randomized into either the intervention group (n = 32) and…

  14. Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

    ERIC Educational Resources Information Center

    Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

    2015-01-01

    Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

  15. Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

    ERIC Educational Resources Information Center

    Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

    2017-01-01

    Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

  16. Efficacy of Parent-Child Interaction Therapy with Chinese ADHD Children: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Ng, Gene S. H.; Choi, S. Y.

    2017-01-01

    Purpose: This study aimed to evaluate the efficacy of Parent-Child Interaction Therapy (PCIT) in Chinese children with attention-deficit/hyperactivity disorder (ADHD) or ADHD features. Methods: This study adopted a randomized controlled trial design without blinding. Participants were randomized into either the intervention group (n = 32) and…

  17. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  18. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    ERIC Educational Resources Information Center

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  19. Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

    ERIC Educational Resources Information Center

    Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

    2009-01-01

    When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

  20. The Late Pretest Problem in Randomized Control Trials of Education Interventions

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2010-01-01

    Pretest-posttest experimental designs often are used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data often are collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  1. The Late Pretest Problem in Randomized Control Trials of Education Interventions. NCEE 2009-4033

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2008-01-01

    Pretest-posttest experimental designs are often used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data are often collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  2. Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Campbell, Melissa; Decker, Kathleen P.; Kruk, Kerry; Deaver, Sarah P.

    2016-01-01

    This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans (N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual…

  3. Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Campbell, Melissa; Decker, Kathleen P.; Kruk, Kerry; Deaver, Sarah P.

    2016-01-01

    This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans (N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual…

  4. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    ERIC Educational Resources Information Center

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  5. Improving preschoolers' mathematics achievement with tablets: a randomized controlled trial

    NASA Astrophysics Data System (ADS)

    Schacter, John; Jo, Booil

    2017-09-01

    With a randomized field experiment of 433 preschoolers, we tested a tablet mathematics program designed to increase young children's mathematics learning. Intervention students played Math Shelf, a comprehensive iPad preschool and year 1 mathematics app, while comparison children received research-based hands-on mathematics instruction delivered by their classroom teachers. After 22 weeks, there was a large and statistically significant effect on mathematics achievement for Math Shelf students (Cohen's d = .94). Moderator analyses demonstrated an even larger effect for low achieving children (Cohen's d = 1.27). These results suggest that early education teachers can improve their students' mathematics outcomes by integrating experimentally proven tablet software into their daily routines.

  6. Improving preschoolers' mathematics achievement with tablets: a randomized controlled trial

    NASA Astrophysics Data System (ADS)

    Schacter, John; Jo, Booil

    2017-04-01

    With a randomized field experiment of 433 preschoolers, we tested a tablet mathematics program designed to increase young children's mathematics learning. Intervention students played Math Shelf, a comprehensive iPad preschool and year 1 mathematics app, while comparison children received research-based hands-on mathematics instruction delivered by their classroom teachers. After 22 weeks, there was a large and statistically significant effect on mathematics achievement for Math Shelf students (Cohen's d = .94). Moderator analyses demonstrated an even larger effect for low achieving children (Cohen's d = 1.27). These results suggest that early education teachers can improve their students' mathematics outcomes by integrating experimentally proven tablet software into their daily routines.

  7. Randomized controlled trials for Alzheimer disease and Parkinson disease.

    PubMed

    Lauretani, Fulvio; Ticinesi, Andrea; Meschi, Tiziana; Teresi, Giulio; Ceda, Gian Paolo; Maggio, Marcello

    2016-06-01

    The continuous increase in elderly and oldest-old population, and subsequent rise in prevalence of chronic neurological diseases like Alzheimer's disease (AD) and Parkinson's disease (PD), are a major challenge for healthcare systems. These two conditions are the most prevalent neurodegenerative diseases in older persons and physicians should engage treatment for these patients. In this field, Randomized Clinical Trials (RCTs) specifically focused on elderly populations are still lacking. The aim of this study was to identify RCTs conducted among AD and PD and to examine the difference between mean age of enrollment and incidence of these two neurodegenerative diseases. We found that the scenario is different between PD and AD. In particular, the enrollment for PD trials seems to include younger persons than AD, although the incidence of both diseases is similar and highest after 80 years old. The consequence of these results could influence conclusive guidelines of treatment in older parkinsonian patients.

  8. Fluticasone or montelukast in preschool wheeze: a randomized controlled trial.

    PubMed

    Krawiec, Marta; Strzelak, Agnieszka; Krenke, Katarzyna; Modelska-Wozniak, Izabela; Jaworska, Joanna; Kulus, Marek

    2015-03-01

    Approximately 30% of children younger than 3 years experience at least 1 episode of wheezing. Antiasthmatic medication is routinely prescribed, but its effectiveness remains unclear. Our study was aimed to evaluate the effect of anti-inflammatory treatment on frequency and severity of preschool wheeze episodes (PWEs). Children aged 6 to 36 months with the first up to the third PWE were randomly assigned to receive montelukast, fluticasone, or no treatment for 12 weeks. The outcome measures were the number of PWEs, the number of hospitalizations due to PWE, and the severity of respiratory symptoms. results: There were no significant differences in outcome measures between the groups. However, tobacco-exposed children treated with fluticasone had significantly fewer PWEs (P = .01). Neither montelukast nor fluticasone has proven effective in the prevention of PWE recurrence. Children of smoking parents may benefit from fluticasone treatment after PWE. This observation requires confirmation in larger studies. © The Author(s) 2014.

  9. Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial

    PubMed Central

    Spillane, Nichea S.; Day, Anne M.; Cioe, Patricia A.; Parks, Acacia; Leventhal, Adam M.; Brown, Richard A.

    2015-01-01

    Objective: Greater depressive symptoms and low positive affect (PA) are associated with poor smoking cessation outcomes. Smoking cessation approaches that incorporate a focus on PA may benefit smokers trying to quit. The purpose of this study was to conduct a pilot randomized clinical trial to compare standard smoking cessation treatment (ST) with smoking cessation treatment that targets positive affect, termed positive psychotherapy for smoking cessation (PPT-S). Method: Smokers who were seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8 weeks of nicotine replacement therapy, either ST (n = 31) or PPT-S (n = 35). Seven-day point prevalence smoking abstinence was biochemically confirmed at 8, 16, and 26 weeks. Results: Compared to ST, a greater percentage of participants in PPT-S were abstinent at 8 weeks, 16 weeks, and 26 weeks, but these differences were nonsignificant. In a more statistically powerful longitudinal model, participants in PPT-S had a significantly higher odds of abstinence (adjusted odds ratio [AOR] = 2.75; 95% CI = 1.02, 7.42; p = .046) across follow-ups compared to those in ST. The positive effect of PPT-S was stronger for those higher in PA (OR = 6.69, 95% CI = 1.16, 38.47, p = .03). Greater use of PPT-S strategies during the initial 8 weeks of quitting was associated with a less steep decline in smoking abstinence rates over time (OR = 2.64, 95% CI = 1.06, 6.56, p =.04). Conclusion: This trial suggests substantial promise for incorporating PPT into smoking cessation treatment. PMID:25646352

  10. Randomized controlled trial of sealed in-office bleaching effectiveness.

    PubMed

    Santana, Mário Artur Pereira; Nahsan, Flávia Pardo Salata; Oliveira, Alaíde Hermínia de Aguiar; Loguércio, Alessandro Dourado; Faria-e-Silva, André Luis

    2014-01-01

    Regardless of the high success rate, patients commonly report the occurrence of tooth sensitivity during the in-office bleaching procedures. Recently, it has been demonstrated that using a customized tray (called sealed in-office bleaching technique) reduces peroxide penetration. The aim of this randomized clinical study was to evaluate tooth sensitivity and bleaching efficacy of sealed bleaching, in comparison with a conventional in-office technique. Twenty patients were randomized allocated in two groups in which 35% hydrogen peroxide gel was used in a single 45-min application. For the sealed technique, a customized bleaching tray was fabricated and carefully positioned over the bleaching agent during the session. The color was recorded at a baseline, 7 and 28 days after the bleaching session, using Vita Easy Shade spectrophotometer. Tooth sensitivity was recorded during (20 and 40 min) and immediately after the treatment using a visual analogue scale. The bleaching efficacy was evaluated by repeated-measures ANOVA, while the absolute risk of tooth sensitivity and its intensity were evaluated by Fisher's exact and Mann-Whitney tests, respectively (α=0.05). No significant difference on bleaching efficacy was observed between the conventional (7.4 and 8.1 ΔE) and sealed techniques (7.8 and 8.3 ΔE) at both evaluation periods. No significant difference was observed regarding the absolute risk of tooth sensitivity (p=0.15). Sealed technique showed a significant decrease of sensitivity intensity after 40 min (p=0.03). Sealed bleaching technique was able to reduce the sensitivity intensity during the bleaching procedure, without jeopardizing the bleaching efficacy.

  11. Sentence retrieval for abstracts of randomized controlled trials

    PubMed Central

    2009-01-01

    Background The practice of evidence-based medicine (EBM) requires clinicians to integrate their expertise with the latest scientific research. But this is becoming increasingly difficult with the growing numbers of published articles. There is a clear need for better tools to improve clinician's ability to search the primary literature. Randomized clinical trials (RCTs) are the most reliable source of evidence documenting the efficacy of treatment options. This paper describes the retrieval of key sentences from abstracts of RCTs as a step towards helping users find relevant facts about the experimental design of clinical studies. Method Using Conditional Random Fields (CRFs), a popular and successful method for natural language processing problems, sentences referring to Intervention, Participants and Outcome Measures are automatically categorized. This is done by extending a previous approach for labeling sentences in an abstract for general categories associated with scientific argumentation or rhetorical roles: Aim, Method, Results and Conclusion. Methods are tested on several corpora of RCT abstracts. First structured abstracts with headings specifically indicating Intervention, Participant and Outcome Measures are used. Also a manually annotated corpus of structured and unstructured abstracts is prepared for testing a classifier that identifies sentences belonging to each category. Results Using CRFs, sentences can be labeled for the four rhetorical roles with F-scores from 0.93–0.98. This outperforms the use of Support Vector Machines. Furthermore, sentences can be automatically labeled for Intervention, Participant and Outcome Measures, in unstructured and structured abstracts where the section headings do not specifically indicate these three topics. F-scores of up to 0.83 and 0.84 are obtained for Intervention and Outcome Measure sentences. Conclusion Results indicate that some of the methodological elements of RCTs are identifiable at the sentence

  12. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    PubMed Central

    Chmiel, Corinne; Senn, Oliver; Rosemann, Thomas; Del Prete, Valerio; Steurer-Stey, Claudia

    2014-01-01

    Background Inadequate blood pressure (BP) control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP) improves BP control and adherence with home BP measurement. Methods In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg), and adherence with home BP measurement after 6 months. Results One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7). BP control (treatment target <140/90 mmHg) was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5). Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1) Conclusion Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months), but no significant between-group difference was observed in BP change. A markedly higher percentage of patients achieved BP values in the normal range. This simple, inexpensive approach of color-coded BP self-monitoring is user-friendly and applicable in primary care

  13. Comparing Adrenaline with Tranexamic Acid to Control Acute Endobronchial Bleeding: A Randomized Controlled Trial

    PubMed Central

    Fekri, Mitra Samareh; Hashemi-Bajgani, Seyed Mehdy; Shafahi, Ahmad; Zarshenas, Rozita

    2017-01-01

    Background: Hemoptysis occurs due to either pulmonary diseases or bronchoscopy interventions. The aim of the present study was to compare the efficacy of the endobronchial instillation of adrenaline with that of tranexamic acid. Methods: Fifty patients were randomly selected as 2 double-blinded sample groups (n=25). In these patients, bleeding could not be controlled with cold saline lavage during bronchoscopy and they, therefore, required prescription of another medicine. Adrenaline (1 mg) in one group and tranexamic acid (500 mg) in the other group were diluted in 20 mL of normal saline and instilled through the bronchoscope. This technique was repeated 3 times at 90-second intervals, if necessary. In the case of persistent bleeding, 90 seconds after the last dose, a second medicine was given for bleeding control. Observation of clot through the bronchoscope meant that the bleeding had stopped. The efficacy of tranexamic acid and adrenaline was evaluated and then compared using the Mann–Whitney test. Results: The time of bleeding control had no significant difference between tranexamic acid and adrenaline (P=0.908). Another analysis was done to evaluate bleeding control with a second medicine; the results showed that 1 (4%) patient in the tranexamic acid and 8 (32%) in the adrenaline group needed the second medicine and there was no significant difference between the 2 groups (P=0.609). Conclusion: Our results suggested that tranexamic acid by endobronchial instillation was as efficient as adrenaline in controlling hemoptysis and required less frequent use of a second medicine. Trial Registration Number: IRCT2014120220188 PMID:28360438

  14. 77 FR 26789 - Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... From the Federal Register Online via the Government Publishing Office ] INTERNATIONAL TRADE COMMISSION Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and Products Containing Same; Determination Rescinding the Exclusion Order and Cease and Desist Orders AGENCY...

  15. Stochastic Control for a Class of Random Evolution Models

    SciTech Connect

    Hongler, Max-Olivier Soner, Halil Mete Streit, Ludwig

    2004-03-15

    We construct the explicit connection existing between a solvable model of the discrete velocities non-linear Boltzmann equation and the Hamilton-Bellman-Jacobi equation associated with a simple optimal control of a piecewise deterministic process. This study extends the known relation that exists between the Burgers equation and a simple controlled diffusion problem. In both cases the resulting partial differential equations can be linearized via a logarithmic transformation and hence offer the possibility to solve physically relevant non-linear field models in full generality.

  16. Amitriptyline vs divalproate in migraine prophylaxis: a randomized controlled trial.

    PubMed

    Kalita, J; Bhoi, S K; Misra, U K

    2013-07-01

    This study compares efficacy and safety of divalproate extended release (DVA-ER) and amitriptyline (AMT) in migraine. Three hundred migraineurs having >4 attacks monthly were randomized into DVA-ER or AMT. The primary end points were >50% reduction in frequency, ≥1 grade improvement in the severity, and >50% improvement in a visual analogue scale (VAS). Secondary end points were functional disability, rescue medication, and adverse events. The median age was 32 years, and 241 were women. 150 patients each received DVA-ER and AMT. At 3 months, 74.7% in DVA-ER and 62% patients in AMT group improved in headache frequency (P = 0.02) and at 6 months, 65.3% and 54%, respectively (P = 0.90). At 3 months, the VAS score improved by >50% in 80.7% in DVA-ER and 64% in AMT (P = 0.005). At 6 months, there was no significant difference between the two groups in VAS score (69.3% vs 56%; P = 0.47) and other outcome parameters. The composite side effects were also not different between the two groups (68% vs 81%); however, hair fall, menstrual irregularity, polycystic ovary, and weight gain were commoner in DVA-ER group. Divalproate extended release is more effective at 3 months than AMT; however, at 6 months, both are equally effective in migraine prophylaxis. © 2013 John Wiley & Sons A/S.

  17. Training Significantly Improves Fetoscopy Performance: A Pilot Randomized Controlled Trial.

    PubMed

    Mietzsch, Stefan; Boettcher, Johannes; Yang, Sisi; Chantereau, Pierre; Romero, Philip; Bergholz, Robert; Reinshagen, Konrad; Boettcher, Michael

    2016-10-01

    Background Implementation of complex fetoscopic procedures that included intracorporeal suturing has been limited due to technical difficulties that might be surmounted with adequate training. Evaluating the impact of laparoscopic or fetoscopic training on fetoscopic performance was the aim of this study. Methods To evaluate fetoscopic performance after either laparoscopic or fetoscopic training, subjects were asked to perform four surgeon's square knots fetoscopically prior and post 2 hours of hands-on training. All subjects were medical students and novice in laparoscopic and fetoscopic interventions. Total time, knot stability (evaluated via tensiometer), suture accuracy, knot quality, and fetoscopic performance were assessed. Results Forty-six subjects were included in the study; after simple randomization, 24 were trained fetoscopically and 22 laparoscopically. Both groups had comparable baseline characteristics and improved after training significantly regarding all aspects assessed in this study. Subjects who trained fetoscopically were superior in terms of suturing and knot-tying performance. Conclusion Training significantly improves fetoscopic performance and may indeed be the keystone for future complex fetoscopic interventions. It seems advisable to train rather fetoscopically than laparoscopically resulting in higher suture and knot-tying quality. Georg Thieme Verlag KG Stuttgart · New York.

  18. Electroacupuncture for Functional Constipation: A Multicenter, Randomized, Control Trial

    PubMed Central

    Zheng, Cuihong; Ding, Pei; Tian, Man; Wang, Ying; Dong, Haoxu; Zhang, Mingmin; Wang, Wei; Xu, Shabei; Xie, Minjie

    2017-01-01

    Background and Aim. To investigate the efficacy and safety of electroacupuncture (EA) with different current intensities for functional constipation (FC) and to assess whether the effects of EA with different current intensities are superior to the mosapride. Methods. Patients with FC were randomly divided into low current intensity group (LCI), high current intensity group (HCI), and mosapride group (MC). The primary outcome was three or more spontaneous bowel movements (SBMs) per week and an increase of one or more SBMs from baseline during at least 3 of the 4 weeks. Results. The primary outcome was reached by 53.45%, 66.15%, and 52.24% of the patients who received LCI, HCI, and mosapride, respectively. EA can significantly improve the weekly SBMs and stool consistency and reduce straining severity (p < 0.0001, all). HCI improved the quality of life better than mosapride (p < 0.05) and reduced the proportion of severe constipation more than LCI and mosapride (p < 0.05, both). Conclusions. EA is effective and safe at both current intensities for FC; therapeutic effects of LCI and HCI are not superior to mosapride. EA is superior to mosapride in improving patients' life quality and satisfaction level of treatment; EA has fewer adverse events than mosapride. PMID:28250788

  19. Patient agenda setting in respiratory outpatients: A randomized controlled trial.

    PubMed

    Early, Frances; Everden, Angharad Jt; O'Brien, Cathy M; Fagan, Petrea L; Fuld, Jonathan P

    2015-11-01

    Soliciting a patient's agenda (the reason for their visit, concerns and expectations) is fundamental to health care but if not done effectively outcomes can be adversely affected. Forms to help patients consider important issues prior to a consultation have been tested with mixed results. We hypothesized that using an agenda form would impact the extent to which patients felt their doctor discussed the issues that were important to them. Patients were randomized to receive an agenda form to complete whilst waiting or usual care. The primary outcome measure was the proportion of patients agreeing with the statement 'My doctor discussed the issues that were important to me' rated on a four-point scale. Secondary outcomes included other experience and satisfaction measures, consultation duration and patient confidence. There was no significant effect of agenda form use on primary or secondary outcomes. Post hoc exploratory analyses suggested possible differential effects for new compared to follow-up patients. There was no overall benefit from the form and a risk of detrimental impact on patient experience for some patients. There is a need for greater understanding of what works for whom in supporting patients to get the most from their consultation.

  20. Sham Control Methods Used in Ear-Acupuncture/Ear-Acupressure Randomized Controlled Trials: A Systematic Review

    PubMed Central

    Zhang, Claire Shuiqing; Yang, Angela Weihong; Zhang, Anthony Lin; May, Brian H.

    2014-01-01

    Abstract Ear-acupuncture/ear-acupressure (EAP) has been used for a range of health conditions with numerous randomized controlled trials (RCTs) investigating its efficacy and safety. However, the design of sham interventions in these RCTs varied significantly. This study systematically reviewed RCTs on EAP for all clinical conditions involving a number of sham EAPs as a control intervention. The review is guided by the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 and investigated the types and differences of sham EAP interventions. Four electronic English databases (The Cochrane Library, PubMed, Embase, CINAHL®) and two Chinese databases (CQVIP, CNKI) were searched in December 2012 and 55 published RCTs comparing real and sham EAP for any clinical condition were included. Characteristics of participants, real and sham interventions, and outcomes were extracted. Four types of sham methods were identified. Among the 55 RCTs, 25 studies involved treatment on nonspecific ear acupoints as the sham method; seven studies used nonacupoints on the ear; nine studies selected placebo needles or placebo ear-acupressure on the same ear acupoints for the real treatment; 10 studies employed pseudo-intervention; and five studies combined two of the above methods to be the sham control. Other factors of treatment such as number of points, treatment duration, and frequency also varied greatly. Risk of bias assessment suggests that 32 RCTs were “high risk” in terms of participants blinding, and 45 RCTs were “high risk” in terms of personnel blinding. Meta-analysis was not conducted due to the high clinical heterogeneity across included studies. No relationship was found between the sham designs and efficacy outcomes, or between the sham types and dropout rate. No solid conclusion of which design is the most appropriate sham control of EAP could be drawn in this review. PMID:24138333

  1. Wavelength control of random polymer fiber laser based on adaptive disorder.

    PubMed

    Hu, Zhijia; Gao, Pengfei; Xie, Kang; Liang, Yunyun; Jiang, Haiming

    2014-12-15

    We demonstrate the realization of two different kinds of random polymer optical fiber lasers to control the random lasing wavelength by changing the disorder of polymer optical fibers (POFs). One is a long-range disorder POF based on copolymer refractive-index inhomogeneity, and the other is a short-range disorder POF based on polyhedral oligomeric silsesquioxanes scattering. By end pumped both disorder POFs, the coherent random lasing for both is observed. Meanwhile, the random lasing wavelength of the short-range disorder POF because of a small scattering mean-free path has been found to be blue shifted with respect to the long-range disorder POF, which will give a way to control the random lasing wavelength.

  2. Behavior Therapy for Pediatric Trichotillomania: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Franklin, Martin E.; Edson, Aubrey L.; Ledley, Deborah A.; Cahill, Shawn P.

    2011-01-01

    Objective: To examine the efficacy and durability of a behavioral therapy (BT) protocol for pediatric TTM compared with a minimal attention control (MAC) condition. It was hypothesized that the BT condition would be superior to MAC at the end of acute treatment, and would also demonstrate durability of gains through the maintenance treatment…

  3. Does Playworks Work? Findings from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    James-Burdumy, Susanne; Bleeker, Martha; Beyler, Nicholas; London, Rebecca A.; Westrich, Lisa; Stokes-Guinan, Katie; Castrechini, Sebastian

    2013-01-01

    Most school principals believe recess has a positive impact on the development of students' social skills and academic achievement. Research also suggests that physical activity and play during recess may be linked to improvements in both academic and prosocial behaviors (Centers for Disease Control and Prevention 2010). Recess, however, has been…

  4. Behavior Therapy for Pediatric Trichotillomania: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Franklin, Martin E.; Edson, Aubrey L.; Ledley, Deborah A.; Cahill, Shawn P.

    2011-01-01

    Objective: To examine the efficacy and durability of a behavioral therapy (BT) protocol for pediatric TTM compared with a minimal attention control (MAC) condition. It was hypothesized that the BT condition would be superior to MAC at the end of acute treatment, and would also demonstrate durability of gains through the maintenance treatment…

  5. Effects of RYGB on energy expenditure, appetite and glycaemic control: a randomized controlled clinical trial.

    PubMed

    Schmidt, J B; Pedersen, S D; Gregersen, N T; Vestergaard, L; Nielsen, M S; Ritz, C; Madsbad, S; Worm, D; Hansen, D L; Clausen, T R; Rehfeld, J F; Astrup, A; Holst, J J; Sjödin, A

    2016-02-01

    Increased energy expenditure (EE) has been proposed as an important mechanism for weight loss following Roux-en-Y gastric bypass (RYGB). However, this has never been investigated in a controlled setting independent of changes in energy balance. Similarly, only few studies have investigated the effect of RYGB on glycaemic control per se. Here, we investigated the effect of RYGB on EE, appetite, glycaemic control and specific signalling molecules compared with a control group in comparable negative energy balance. Obese normal glucose-tolerant participants were randomized to receive RYGB after 8 (n=14) or 12 weeks (n=14). The protocol included a visit at week 0 and three visits (weeks 7, 11 and 78) where 24-h EE, appetite and blood parameters were assessed. Participants followed a low-calorie diet from weeks 0-11, with those operated at week 12 serving as a control group for those operated at week 8. Compared with controls, RYGB-operated participants had lower body composition-adjusted 24-h EE and basal EE 3 weeks postoperatively (both P<0.05) but EE parameters at week 78 were not different from preoperative values (week 7). Surgery changed the postprandial response of glucagon-like peptide-1 (GLP-1), peptide YY3-36 (PYY), ghrelin, cholecystokinin, fibroblast growth factor-19 and bile acids (all P<0.05). Particularly, increases in GLP-1, PYY and decreases in ghrelin were associated with decreased appetite. None of HOMA-IR (homeostasis model assessment-estimated insulin resistance), Matsuda index, the insulinogenic index, the disposition index and fasting hepatic insulin clearance were different between the groups, but RYGB operated had lower fasting glucose (P<0.05) and the postprandial glucose profile was shifted to the left (P<0.01). Our data do not support that EE is increased after RYGB. More likely, RYGB promotes weight loss by reducing appetite, partly mediated by changes in gastrointestinal hormone secretion. Furthermore, we found that the early changes in

  6. Morning compared with evening induction of labor: a nested randomized controlled trial. A nested randomized controlled trial.

    PubMed

    Dodd, Jodie M; Crowther, Caroline A; Robinson, Jeffrey S

    2006-08-01

    To test the hypothesis that commencing induction of labor in the morning more closely reflects the physiologic timing of onset of labor and is associated with fewer women who remain undelivered 24 hours after cervical ripening and induction begins. This was a nested randomized clinical trial, conducted between April 2001 and December 2004. Pregnant women at more than 36+6 weeks gestation with a cephalic presentation who were scheduled for prostaglandin induction of labor were eligible to participate. Women were randomly assigned to either admission in the morning (0800 hours) or admission in the evening (2,000 hours). The primary outcome measures were vaginal birth not achieved in 24 hours, uterine hyperstimulation with associated fetal heart rate changes, and cesarean delivery. A total of 620 women were entered in the trial, with 280 women in the morning admission group and 340 women in the evening admission group. There were no statistically significant differences between the timing of admission for induction and the primary trial outcomes. However, women admitted in the morning were less likely to require oxytocin infusion (morning admission 126 of 280 [45.0%] compared with evening admission 184 of 340 [54.1%]; relative risk 0.83, 95% confidence interval 0.70-0.97; P=.022). Nulliparous women admitted in the morning were less likely to require operative vaginal birth (morning admission 10 of 62 [16.1%] compared with evening admission 28 of 82 [34.2%]; relative risk 0.47, 95% confidence interval 0.25-0.90; P=.015). For women who require induction of labor, consideration should be given to admission in the morning rather than admission in the evening. Australian Clinical Trials Registry, www.actr.org.au, 12606000156583.

  7. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

    PubMed

    Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

    2014-05-24

    The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

  8. Multisite Randomized Controlled Trial to Compare Two Methods of Tinnitus Intervention to Two Control Conditions.

    PubMed

    Henry, James A; Stewart, Barbara J; Griest, Susan; Kaelin, Christine; Zaugg, Tara L; Carlson, Kathleen

    In this four-site clinical trial, we evaluated whether tinnitus masking (TM) and tinnitus retraining therapy (TRT) decreased tinnitus severity more than the two control groups: an attention-control group that received tinnitus educational counseling (and hearing aids if needed; TED), and a 6-month-wait-list control (WLC) group. The authors hypothesized that, over the first 6 months of treatment, TM and TRT would decrease tinnitus severity in Veterans relative to TED and WLC, and that TED would decrease tinnitus severity relative to WLC. The authors also hypothesized that, over 18 months of treatment, TM and TRT would decrease tinnitus severity relative to TED. Treatment effectiveness was hypothesized not to be different across the four sites. Across four Veterans affairs medical center sites, N = 148 qualifying Veterans who experienced sufficiently bothersome tinnitus were randomized into one of the four groups. The 115 Veterans assigned to TM (n = 42), TRT (n = 34), and TED (n = 39) were considered immediate-treatment subjects; they received comparable time and attention from audiologists. The 33 Veterans assigned to WLC were, after 6 months, randomized to receive delayed treatment in TM, TRT, or TED. Assessment of outcomes took place using the Tinnitus Handicap Inventory (THI) at 0, 3, 6, 12, and 18 months. Results of a repeated measures analysis of variance using an intention-to-treat approach showed that the tinnitus severity of Veterans receiving TM, TRT, and TED significantly decreased (p < 0.05) relative to Veterans in the WLC group at 3 months (effect sizes = 0.44, 0.52, and 0.27, respectively) and at 6 months (effect sizes = 0.52, 0.56, and 0.40, respectively). Analyses comparing effectiveness of TM, TRT, and TED over 18 months revealed that the three conditions were not significantly different, but that tinnitus severity in the combined groups significantly decreased (p < 0.01) from baseline to 3 months (5.6 THI points) and from 3 to 6 months (3.7 THI

  9. Temperature-Controlled Continuous Cold Flow Device after Total Knee Arthroplasty: A Randomized Controlled Trial Study.

    PubMed

    Ruffilli, Alberto; Castagnini, Francesco; Traina, Francesco; Corneti, Isabella; Fenga, Domenico; Giannini, Sandro; Faldini, Cesare

    2016-11-30

    Total knee arthroplasty (TKA) is a widely accepted and successful procedure for end-stage arthritis. Nevertheless, fast-track may be compromised by many factors, such as pain, edema, and blood loss. Cryotherapy has been advocated as a safe and effective strategy to improve the postoperative results, acting on pain, edema, and blood loss. This study is a prospective randomized controlled study, involving 50 patients after primary TKA. A power analysis was performed preoperatively. Twenty-four patients were addressed to a postoperative treatment with a continuous cold flow device (Hilotherm, Hilotherm GmbH, Germany). Twenty-six patients represented the control group, treated with crushed ice packs. All the patients shared the same analgesic strategy and the same rehabilitation protocol. Pain, analgesic consumption, active knee range of motion, drain output, transfusion requirement, and total blood loss were evaluated at different follow-ups (postoperative first, third, and seventh days). The two groups were homogenous for preoperative and intraoperative features. The groups showed no statistically significant differences in all the evaluated parameters. A modest reduction of knee volume was evident after 7 days from surgery (trend). No differences in blood loss were noticed. Continuous cold flow device in the acute postoperative setting after TKA did not show superiority in reducing edema, pain, and blood loss, compared with traditional icing regimen. Thus, due to the costs, it should be reserved to selected cases.

  10. How well are randomized controlled trials reported in the dermatology literature?

    PubMed

    Adetugbo, K; Williams, H

    2000-03-01

    To assess the methodological quality of the design and reporting of randomized controlled trials published in one major dermatology specialty journal. In a survey of all published parallel group randomized controlled trials, we found 73 reports with allocation described as randomized from all issues of Clinical and Experimental Dermatology from its inception in 1976 through 1997. Direct and indirect measures of the adequacy of randomization, trial sample size, baseline comparisons, and intention-to-treat analysis. Hand searching identified 73 randomized controlled trials, but only 31 of these were found by searching MEDLINE for the publication type clinical trials. Of the 73 randomized controlled trials, 68 contained sufficient information to include in the analysis. Only 1 study (1%) reported the method of random sequence generation, and only 5 studies (7%) reported adequate concealment of allocation. Among 38 trials that used simple randomization, the sample sizes in the comparison groups were identical in 22 occasions, raising the possibility that simple randomization might not have been adequately generated or concealed. Most trials (88%) excluded some randomized participants from their analysis. The median sample size was 23 per trial. Only 1 trial reported sample size and statistical power considerations and had an a priori main hypothesis. Hand searching is important for locating all relevant trials. There is the need for higher methodological quality in clinical trial reporting in dermatology journals. The adoption of the CONSORT (Consolidated Standards of Reporting Trials) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports.

  11. Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial.

    PubMed

    Featherstone, K; Donovan, J L

    1998-10-31

    To explore trial participants' understandings of randomisation. In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews were recorded on audio tape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes, using a grounded theory approach. The CLasP study comprises three linked multicentre, pragmatic randomised controlled trials evaluating the effectiveness and cost effectiveness of laser therapy, standard surgery, and conservative management for men with lower urinary tract symptoms or urinary retention, or both, related to benign prostatic disease. 20 participants in the CLasP study were interviewed. Sampling was purposeful: men were included from each of the treatment arms, the two major centres, and at different points in the trial. Interviews used a checklist of topics to encourage participants to describe their experiences. Narratives concerning randomisation were compared to identify common themes, retaining the context of the discussion to allow detailed interpretation. Most participants recalled and described aspects of randomisation, such as the involvement of chance, comparison, and concealed allocation. Many found the concept of randomisation difficult, however, and developed alternative lay explanations to make sense of their experiences. Inaccurate patient information and lay interpretations of common trial terms caused confusion. The provision of clear and accurate patient information is important, but this alone will not ensure consistent interpretation of concepts such as randomisation. Patients may need to discuss the purposes of randomisation in order to understand them fully enough to give truly informed consent.

  12. Pilates in heart failure patients: a randomized controlled pilot trial.

    PubMed

    Guimarães, Guilherme Veiga; Carvalho, Vitor Oliveira; Bocchi, Edimar Alcides; d'Avila, Veridiana Moraes

    2012-12-01

    Conventional cardiac rehabilitation program consist of 15 min of warm-up, 30 min of aerobic exercise and followed by 15 min calisthenics exercise. The Pilates method has been increasingly applied for its therapeutic benefits, however little scientific evidence supports or rebukes its use as a treatment in patients with heart failure (HF). Investigate the effects of Pilates on exercise capacity variables in HF. Sixteen pts with HF, left ventricular ejection fraction 27 ± 14%, NYHA class I-II were randomly assigned to conventional cardiac rehabilitation program (n = 8) or mat Pilates training (n = 8) for 16 weeks of 30 min of aerobic exercise followed by 20 min of the specific program. At 16 weeks, pts in the mat Pilates group and conventional group showed significantly increase on exercise time 11.9 ± 2.5 to 17.8 ± 4 and 11.7 ± 3.9 to 14.2 ± 4 min, respectively. However, only the Pilates group increased significantly the ventilation (from 56 ± 20 to 69 ± 17 L/min, P = 0.02), peak VO(2) (from 20.9 ± 6 to 24.8 ± 6 mL/kg/min, P = 0.01), and O(2) pulse (from 11.9 ± 2 to 13.8 ± 3 mL/bpm, P = 0.003). The Pilates group showed significantly increase in peak VO(2) when compared with conventional group (24.8 ± 6 vs. 18.3 ± 4, P = 0.02). The result suggests that the Pilates method may be a beneficial adjunctive treatment that enhances functional capacity in patients with HF who are already receiving standard medical therapy. © 2011 Blackwell Publishing Ltd.

  13. A randomized controlled trial of four precolonoscopy bowel cleansing regimens

    PubMed Central

    Kao, Dina; Lalor, Eoin; Sandha, Gurpal; Fedorak, Richard N; van der Knoop, Bloeme; Doornweerd, Stieneke; van Kooten, Harmke; Schreuders, Eline; Midodzi, William; van Zanten, Sander Veldhuyzen

    2011-01-01

    BACKGROUND: The ideal bowel cleansing regimen for colonoscopy has yet to be determined. OBJECTIVE: To compare the cleansing efficacy, and patient tolerability and safety of four bowel preparation regimens. METHODS: A total of 834 patients undergoing outpatient colonoscopy were randomly assigned to one of four regimens: 4 L polyethylene glycol (PEG); 2 L PEG + 20 mg bisacodyl; 90 mL of sodium phosphate (NaP); or two sachets of a commercially available bowel cleansing solution (PSMC) + 300 mL of magnesium citrate (M). The primary outcome measure was cleansing efficacy, which was scored by blinded endoscopists using the Ottawa Bowel Preparation Scale. Secondary outcome measures were bowel preparation quality according to time of colonoscopy, and patient tolerability and safety. RESULTS: The mean total cleansing score was significantly worse in the NaP group compared with the other three groups (P<0.0001). The mean cleansing scores were worse in patients who underwent morning versus afternoon colonoscopy, a finding that was consistent in all four groups. PSMC + M was the best tolerated regimen. No clinically significant mean changes in creatinine or electrolyte levels were identified, although a significantly higher proportion of patients in the NaP group developed hypokelemia (P<0.0001). CONCLUSIONS: 2 L PEG + 20 mg bisacodyl, or PSMC + M was as efficacious as 4 L PEG and superior to NaP for bowel cleansing. A short interval between the completion of bowel preparation and the start of colonoscopy (ie, ‘runway time’), irrespective of bowel preparation regimen, appeared to be a more important predictor of bowel cleanliness than the cathartic agents used. PMID:22175055

  14. A randomized controlled trial of four precolonoscopy bowel cleansing regimens.

    PubMed

    Kao, Dina; Lalor, Eoin; Sandha, Gurpal; Fedorak, Richard N; van der Knoop, Bloeme; Doornweerd, Stieneke; van Kooten, Harmke; Schreuders, Eline; Midodzi, William; Veldhuyzen van Zanten, Sander

    2011-12-01

    The ideal bowel cleansing regimen for colonoscopy has yet to be determined. To compare the cleansing efficacy, and patient tolerability and safety of four bowel preparation regimens. A total of 834 patients undergoing outpatient colonoscopy were randomly assigned to one of four regimens: 4 L polyethylene glycol (PEG); 2 L PEG + 20 mg bisacodyl; 90 mL of sodium phosphate (NaP); or two sachets of a commercially available bowel cleansing solution (PSMC) + 300 mL of magnesium citrate (M). The primary outcome measure was cleansing efficacy, which was scored by blinded endoscopists using the Ottawa Bowel Preparation Scale. Secondary outcome measures were bowel preparation quality according to time of colonoscopy, and patient tolerability and safety. The mean total cleansing score was significantly worse in the NaP group compared with the other three groups (P<0.0001). The mean cleansing scores were worse in patients who underwent morning versus afternoon colonoscopy, a finding that was consistent in all four groups. PSMC + M was the best tolerated regimen. No clinically significant mean changes in creatinine or electrolyte levels were identified, although a significantly higher proportion of patients in the NaP group developed hypokelemia (P<0.0001). 2 L PEG + 20 mg bisacodyl, or PSMC + M was as efficacious as 4 L PEG and superior to NaP for bowel cleansing. A short interval between the completion of bowel preparation and the start of colonoscopy (ie, 'runway time'), irrespective of bowel preparation regimen, appeared to be a more important predictor of bowel cleanliness than the cathartic agents used.

  15. Betamethasone in hernia surgery: a randomized controlled trial.

    PubMed

    Simsa, J; Magnusson, N; Hedberg, M; Lorentz, T; Gunnarsson, U; Sandblom, G

    2013-11-01

    Post-operative pain and nausea may be a problem in day-case surgery. This study aims to investigate the effect of betamethasone on pain and nausea in inguinal hernia surgery. Patients aged 18-70 years scheduled for open inguinal hernia surgery at two Swedish hospitals, March 2005-December 2009, were eligible for inclusion. Patients were randomized, to either treatment with 12 mg betamethasone intravenously or placebo. Post-operative pain was assessed using a visual analogue scale on the recovery ward, each day the first post-operative week and at 1 month after surgery. One year after surgery, residual pain was estimated by the Inguinal Pain Questionnaire. A total of 398 patients were included (21 women, 377 men). Pain at rest on the day of surgery was significantly lower in the treatment group (p = 0.012). The pain was also significantly lower in the treatment group the day after surgery (p < 0.001), but not during the remaining part of the first post-operative week. Bleeding complications were reported by 17 patients (8.5%) in the Betamethasone group and seven (3.5%) in the placebo group (p = 0.028). One month after surgery, 21 out of 173 (12%) in the betamethasone group still had pain, compared to 33 out of 159 (21%) in the placebo arm (p = 0.049). After 1 year, no significant difference in pain was seen. A 12 mg betamethasone reduced pain during the first 24 h and at 1 month after inguinal hernia surgery. If combined with diclofenac, however, this dose may increase the risk for bleeding complications. © 2013 European Federation of International Association for the Study of Pain Chapters.

  16. Randomized controlled trial of deutetrabenazine for tardive dyskinesia

    PubMed Central

    Factor, Stewart A.; Hauser, Robert A.; Jimenez-Shahed, Joohi; Ondo, William G.; Jarskog, L. Fredrik; Meltzer, Herbert Y.; Woods, Scott W.; Bega, Danny; LeDoux, Mark S.; Shprecher, David R.; Davis, Charles; Davis, Mat D.; Stamler, David; Anderson, Karen E.

    2017-01-01

    Objective: To determine the efficacy and safety of deutetrabenazine as a treatment for tardive dyskinesia (TD). Methods: One hundred seventeen patients with moderate to severe TD received deutetrabenazine or placebo in this randomized, double-blind, multicenter trial. Eligibility criteria included an Abnormal Involuntary Movement Scale (AIMS) score of ≥6 assessed by blinded central video rating, stable psychiatric illness, and stable psychoactive medication treatment. Primary endpoint was the change in AIMS score from baseline to week 12. Secondary endpoints included treatment success at week 12 on the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change. Results: For the primary endpoint, deutetrabenazine significantly reduced AIMS scores from baseline to week 12 vs placebo (least-squares mean [standard error] −3.0 [0.45] vs −1.6 [0.46], p = 0.019). Treatment success on CGIC (48.2% vs 40.4%) favored deutetrabenazine but was not significant. Deutetrabenazine and placebo groups showed low rates of psychiatric adverse events: anxiety (3.4% vs 6.8%), depressed mood/depression (1.7% vs 1.7%), and suicidal ideation (0% vs 1.7%, respectively). In addition, no worsening in parkinsonism, as measured by the Unified Parkinson's Disease Rating Scale motor subscale, was noted from baseline to week 12 in either group. Conclusions: In patients with TD, deutetrabenazine was well tolerated and significantly reduced abnormal movements. Classification of evidence: This study provides Class I evidence that in patients with TD, deutetrabenazine reduces AIMS scores. PMID:28446646

  17. A Randomized Controlled Trial of Compression Rates during Cardiopulmonary Resuscitation.

    PubMed

    Hwang, Sung Oh; Cha, Kyoung Chul; Kim, Kyuseok; Jo, You Hwan; Chung, Sung Phil; You, Je Sung; Shin, Jonghwan; Lee, Hui Jai; Park, Yoo Seok; Kim, Seunghwan; Choi, Sang Cheon; Park, Eun Jung; Kim, Won Young; Seo, Dong Woo; Moon, Sungwoo; Han, Gapsu; Choi, Han Sung; Kang, Hyunggoo; Park, Seung Min; Kwon, Woon Yong; Choi, Eunhee

    2016-09-01

    The objective of this study was to compare the efficacy of cardiopulmonary resuscitation (CPR) with 120 compressions per minute (CPM) to CPR with 100 CPM in patients with non-traumatic out-of-hospital cardiac arrest. We randomly assigned patients with non-traumatic out-of-hospital cardiac arrest into two groups upon arrival to the emergency department (ED). The patients received manual CPR either with 100 CPM (CPR-100 group) or 120 CPM (CPR-120 group). The primary outcome measure was sustained restoration of spontaneous circulation (ROSC). The secondary outcome measures were survival discharge from the hospital, one-month survival, and one-month survival with good functional status. Of 470 patients with cardiac arrest, 136 patients in the CPR-100 group and 156 patients in the CPR-120 group were included in the final analysis. A total of 69 patients (50.7%) in the CPR-100 group and 67 patients (42.9%) in the CPR-120 group had ROSC (absolute difference, 7.8% points; 95% confidence interval [CI], -3.7 to 19.2%; P = 0.183). The rates of survival discharge from the hospital, one-month survival, and one-month survival with good functional status were not different between the two groups (16.9% vs. 12.8%, P = 0.325; 12.5% vs. 6.4%, P = 0.073; 5.9% vs. 2.6%, P = 0.154, respectively). We did not find differences in the resuscitation outcomes between those who received CPR with 100 CPM and those with 120 CPM. However, a large trial is warranted, with adequate power to confirm a statistically non-significant trend toward superiority of CPR with 100 CPM. ( www.cris.nih.go.kr, cris.nih.go.kr number, KCT0000231).

  18. Telephone recruitment into a randomized controlled trial of quitline support.

    PubMed

    Tzelepis, Flora; Paul, Christine L; Walsh, Raoul A; Wiggers, John; Knight, Jenny; Lecathelinais, Christophe; Daly, Justine; Neil, Amanda; Girgis, Afaf

    2009-10-01

    Only 1%-7% of adult smokers use quitlines annually. Active telephone recruitment may increase utilization and enroll new groups of quitline users. This study aimed to (1) determine the proportion of adult daily smokers actively recruited by telephone to quitline support; (2) calculate the cost per smoker recruited; and (3) compare the characteristics of participants to smokers in the New South Wales (NSW, Australia) general population. Between September 2005 and April 2007, 1562 adult daily smokers randomly selected from the electronic NSW telephone directory were recruited into an RCT. The proportion of smokers and the cost per smoker recruited were examined. Participants were compared to NSW adult daily smokers from the NSW Population Health Survey and the Centre for Health Research & Psycho-oncology Smoking Community Survey. Analysis was completed in 2008. More than half (52%) of eligible smokers contacted by telephone were recruited into cessation support. The cost per smoker recruited was AU$71 (US$59). Active telephone recruitment successfully enrolled smokers who are currently under-represented among quitline users. For instance, more than two thirds (68%) of participants were not intending to quit within 1 month. Compared with NSW adult daily smokers, participants were significantly more likely to be older; more highly educated; married/living with partner or divorced/separated; a nonmetropolitan resident; more nicotine dependent; more ready to quit; and have fewer household members. Participants were significantly less likely to live with a smoker than were NSW adult daily smokers. Active telephone recruitment has the potential to substantially increase the proportion of smokers using quitline services at a reasonable cost. This method also engages smokers currently under-represented in quitline populations.

  19. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study.

    PubMed

    De Vito, Andrea; Agnoletti, Vanni; Berrettini, Stefano; Piraccini, Emanuele; Criscuolo, Armando; Corso, Ruggero; Campanini, Aldo; Gambale, Giorgio; Vicini, Claudio

    2011-03-01

    Understanding the sites of pharyngeal collapse is mandatory for surgical treatment decision-making in obstructive sleep-apnea-hypopnea syndrome patients. Drug-induced sleep endoscopy (DISE) allows for the direct observation of the upper airway during sedative-induced sleep. In order to re-create snoring and apnea patterns related to a spontaneous sleep situation, the authors used a target-controlled infusion (TCI) sleep endoscopy (DISE-TCI), comparing this technique to conventional DISE, in which sedation was reached by a manual bolus injection. The authors conducted a prospective, randomized, unicenter study. The apneic event observation and its correlation with pharyngeal collapse patterns is the primary endpoint; secondary endpoints are defined as stability and safety of sedation plans of DISE-TCI technique. From January 2009 to June 2009, 40 OSAHS patients were included in the study and randomized allocated in two groups: the bolus injection conventional DISE group and the DISE-TCI group. We recorded the complete apnea event at the oropharynx and hypopharynx levels in 4 patients of the conventional DISE group (20%) and in 17 patients of the DISE-TCI group (85%) (P < 0.0001). Two patients needed oxygen in the conventional DISE group because of severe desaturation that resulted from the first bolus of propofol (1 mg/kg) (P = 0.4872 ns). We recorded the instability of the sedation plan in 13 patients from the conventional DISE group (65%) and 1 patient from the DISE-TCI group (5%) (P = 0.0001). Our results suggest that the DISE-TCI technique should be the first choice in performing sleep endoscopy because of its increased accuracy, stability and safety.

  20. Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

    DTIC Science & Technology

    2016-03-01

    any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN...September 2015. The cause of death was amphetamine intoxication complicating a cardiovascular condition, not study related. One SAE was reported and... death was blunt force trauma not related to the study. At NMCSD one SAE was reported and acknowledged on 26 May 2015. The cause of death is unknown

  1. Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

    DTIC Science & Technology

    2017-03-01

    further contact , the Caring Letters group had a significantly lower suicide rate for the first two years of the trial. These “caring letters” are one of...Compared to a control group (usual care) with no further contact , the Caring Letters group had a significantly lower suicide rate for the first two...is completing request to obtain the SSA Death Master File. Dr. Luxton co-authored a caring contacts implementation paper (in press, Professional

  2. Model predictive control for tracking randomly varying references

    NASA Astrophysics Data System (ADS)

    Falugi, Paola

    2015-04-01

    This paper proposes a model predictive control scheme for tracking a-priori unknown references varying in a wide range and analyses its performance. It is usual to assume that the reference eventually converges to a constant in which case convergence to zero of the tracking error can be established. In this note we remove this simplifying assumption and characterise the set to which the tracking error converges and the associated region of convergence.

  3. Do children with cerebral palsy benefit from computerized working memory training? Study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Cerebral palsy (CP) is the most common motor disability in childhood (2 to 3 per 1000 live births), and is frequently accompanied by cognitive impairments and behavioural problems. Children with CP are at increased risk of attention deficit disorder with or without hyperactivity (Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD)) including working memory deficits. The primary aim of this study is to evaluate if cognitive training may improve working memory in children with CP. Methods/Designs The study is an investigator-blinded, randomized controlled trial with a stepped-wedge design that will include 115 schoolchildren with CP. Eligible for participation are children with CP, aged 7 to 15 years, who are able to follow instructions and handle a computer mouse. Exclusion criteria are the presence of photosensitive epilepsy, Gross Motor Function Classification System (GMFCS) level V (most severe CP) (Phys Ther 80: 974-985, 2000) and severe visual or hearing impairments. Following assessment of eligibility and baseline cognitive assessment the participants will be randomized to either cognitive working memory training or treatment-as-usual (‘control group’). The intervention is a computer-based working memory training program consisting of 25 daily sessions to be performed over a 5 to 6-week period at home. A neuropsychological assessment will be performed before and 4 to 6 weeks after completed training. When the latter assessment has been completed in the intervention group, the ‘control group’ will start on the same training program. Both groups will meet for a final neuropsychological assessment six months after completed training by an examiner unaware of group adherence. Discussion There is limited evidence for the effect of most interventions in children with CP, and evidence is completely lacking for interventions aiming to improve deficits in cognition, learning and behaviour. The proposed multicenter study

  4. A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

    DTIC Science & Technology

    2016-10-01

    Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in...Exposure Therapy and Education Control on PTSD in Veterans 5a. CONTRACT NUMBER W81XWH-12-1-0576 5b. GRANT NUMBER PT110413 & PT110413A 5c...blinded, RCT will: 1) evaluate effects of Transcendental Meditation (TM) vs. Prolonged Exposure (PE) and PTSD health education control (EC), using the

  5. A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

    DTIC Science & Technology

    2016-10-01

    Award Number: W81XWH-12-1-0577 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in...NUMBER Therapy and Education Control on PTSD in Veterans 5b. GRANT NUMBER W81XWH-12-1-0577 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Thomas Rutledge...Prolonged Exposure (PE) and education control (EC) groups in Veterans diagnosed with clinically significant PTSD by way of a validated structured

  6. Determining optimal approaches for weight maintenance: a randomized controlled trial

    PubMed Central

    Dale, Kelly S.; McAuley, Kirsten A.; Taylor, Rachael W.; Williams, Sheila M.; Farmer, Victoria L.; Hansen, Paul; Vorgers, Sue M.; Chisholm, Alexandra W.; Mann, Jim I.

    2009-01-01

    Background Weight regain often occurs after weight loss in overweight individuals. We aimed to compare the effectiveness of 2 support programs and 2 diets of different macronutrient compositions intended to facilitate long-term weight maintenance. Methods Using a 2 × 2 factorial design, we randomly assigned 200 women who had lost 5% or more of their initial body weight to an intensive support program (implemented by nutrition and activity specialists) or to an inexpensive nurse-led program (involving “weigh-ins” and encouragement) that included advice about high-carbohydrate diets or relatively high-monounsaturated-fat diets. Results In total, 174 (87%) participants were followed-up for 2 years. The average weight loss (about 2 kg) did not differ between those in the support programs (0.1 kg, 95% confidence interval [CI] −1.8 to 1.9, p = 0.95) or diets (0.7 kg, 95% CI −1.1 to 2.4, p = 0.46). Total and low-density lipoprotein (LDL) cholesterol levels were significantly higher among those on the high-monounsaturated-fat diet (total cholesterol: 0.17 mmol/L, 95% CI 0.01 to 0.33; p = 0.040; LDL cholesterol: 0.16 mmol/L, 95% CI 0.01 to 0.31; p = 0.039) than among those on the high-carbohydrate diet. Those on the high-monounsaturated-fat diet also had significantly higher intakes of total fat (5% total energy, 95% CI 3% to 6%, p < 0.001) and saturated fat (2% total energy, 95% CI 1% to 2%, p < 0.001). All of the other clinical and laboratory measures were similar among those in the support programs and diets. Interpretation A relatively inexpensive program involving nurse support is as effective as a more resource-intensive program for weight maintenance over a 2-year period. Diets of different macronutrient composition produced comparable beneficial effects in terms of weight loss maintenance. ClinicalTrials.gov trial register no. NCT00128336. PMID:19433812

  7. A randomized, controlled trial of an aerosolized vaccine against measles.

    PubMed

    Low, Nicola; Bavdekar, Ashish; Jeyaseelan, Lakshmanan; Hirve, Siddhivinayak; Ramanathan, Kavitha; Andrews, Nicholas J; Shaikh, Naseem; Jadi, Ramesh S; Rajagopal, Arunachalam; Brown, Kevin E; Brown, David; Fink, James B; John, Oommen; Scott, Pippa; Riveros-Balta, A Ximena; Greco, Michel; Dhere, Rajeev; Kulkarni, Prasad S; Henao Restrepo, Ana Maria

    2015-04-16

    Aerosolized vaccine can be used as a needle-free method of immunization against measles, a disease that remains a major cause of illness and death. Data on the immunogenicity of aerosolized vaccine against measles in children are inconsistent. We conducted an open-label noninferiority trial involving children 9.0 to 11.9 months of age in India who were eligible to receive a first dose of measles vaccine. Children were randomly assigned to receive a single dose of vaccine by means of either aerosol inhalation or a subcutaneous injection. The primary end points were seropositivity for antibodies against measles and adverse events 91 days after vaccination. The noninferiority margin was 5 percentage points. A total of 1001 children were assigned to receive aerosolized vaccine, and 1003 children were assigned to receive subcutaneous vaccine; 1956 of all the children (97.6%) were followed to day 91, but outcome data were missing for 331 children because of thawed specimens. In the per-protocol population, data on 1560 of 2004 children (77.8%) could be evaluated. At day 91, a total of 662 of 775 children (85.4%; 95% confidence interval [CI], 82.5 to 88.0) in the aerosol group, as compared with 743 of 785 children (94.6%; 95% CI, 92.7 to 96.1) in the subcutaneous group, were seropositive, a difference of -9.2 percentage points (95% CI, -12.2 to -6.3). Findings were similar in the full-analysis set (673 of 788 children in the aerosol group [85.4%] and 754 of 796 children in the subcutaneous group [94.7%] were seropositive at day 91, a difference of -9.3 percentage points [95% CI, -12.3 to -6.4]) and after multiple imputation of missing results. No serious adverse events were attributable to measles vaccination. Adverse-event profiles were similar in the two groups. Aerosolized vaccine against measles was immunogenic, but, at the prespecified margin, the aerosolized vaccine was inferior to the subcutaneous vaccine with respect to the rate of seropositivity. (Funded by the

  8. Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial.

    PubMed

    McAlister, Finlay A; Majumdar, Sumit R; Padwal, Raj S; Fradette, Miriam; Thompson, Ann; Buck, Brian; Dean, Naeem; Bakal, Jeffrey A; Tsuyuki, Ross; Grover, Steven; Shuaib, Ashfaq

    2014-05-13

    Optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke, but there are substantial gaps in care, which could be addressed by nurse- or pharmacist-led care. We compared 2 types of case management (active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians) in addition to usual care. We performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets. Participants in both groups had a monthly visit for 6 months with either a nurse or pharmacist. Nurses measured cardiovascular risk factors, counselled patients and faxed results to primary care physicians (active control). Pharmacists did all of the above as well as prescribed according to treatment algorithms (intervention). Most of the 279 study participants (mean age 67.6 yr, mean systolic blood pressure 134 mm Hg, mean low-density lipoprotein [LDL] cholesterol 3.23 mmol/L) were already receiving treatment at baseline (antihypertensives: 78.1%; statins: 84.6%), but none met guideline targets (systolic blood pressure ≤ 140 mm Hg, fasting LDL cholesterol ≤ 2.0 mmol/L). Substantial improvements were observed in both groups after 6 months: 43.4% of participants in the pharmacist case manager group met both systolic blood pressure and LDL guideline targets compared with 30.9% in the nurse-led group (12.5% absolute difference; number needed to treat = 8, p = 0.03). Compared with nurse-led case management (risk factor evaluation, counselling and feedback to primary care providers), active case management by pharmacists substantially improved risk factor control at 6 months among patients who had experienced a stroke. ClinicalTrials.gov, no. NCT00931788.

  9. Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial

    PubMed Central

    McAlister, Finlay A.; Majumdar, Sumit R.; Padwal, Raj S.; Fradette, Miriam; Thompson, Ann; Buck, Brian; Dean, Naeem; Bakal, Jeffrey A.; Tsuyuki, Ross; Grover, Steven; Shuaib, Ashfaq

    2014-01-01

    Background: Optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke, but there are substantial gaps in care, which could be addressed by nurse- or pharmacist-led care. We compared 2 types of case management (active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians) in addition to usual care. Methods: We performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets. Participants in both groups had a monthly visit for 6 months with either a nurse or pharmacist. Nurses measured cardiovascular risk factors, counselled patients and faxed results to primary care physicians (active control). Pharmacists did all of the above as well as prescribed according to treatment algorithms (intervention). Results: Most of the 279 study participants (mean age 67.6 yr, mean systolic blood pressure 134 mm Hg, mean low-density lipoprotein [LDL] cholesterol 3.23 mmol/L) were already receiving treatment at baseline (antihypertensives: 78.1%; statins: 84.6%), but none met guideline targets (systolic blood pressure ≤ 140 mm Hg, fasting LDL cholesterol ≤ 2.0 mmol/L). Substantial improvements were observed in both groups after 6 months: 43.4% of participants in the pharmacist case manager group met both systolic blood pressure and LDL guideline targets compared with 30.9% in the nurse-led group (12.5% absolute difference; number needed to treat = 8, p = 0.03). Interpretation: Compared with nurse-led case management (risk factor evaluation, counselling and feedback to primary care providers), active case management by pharmacists substantially improved risk factor control at 6 months among patients who had experienced a stroke. Trial registration: ClinicalTrials.gov, no. NCT00931788 PMID:24733770

  10. Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial.

    PubMed

    Hume, Megan P; Nicolucci, Alissa C; Reimer, Raylene A

    2017-02-22

    Background: Prebiotics have been shown to improve satiety in adults with overweight and obesity; however, studies in children are limited.Objective: We examined the effects of prebiotic supplementation on appetite control and energy intake in children with overweight and obesity.Design: This study was a randomized, double-blind, placebo-controlled trial. Forty-two boys and girls, ages 7-12 y, with a body mass index (BMI) of ≥85th percentile were randomly assigned to 8 g oligofructose-enriched inulin/d or placebo (maltodextrin) for 16 wk. Objective measures of appetite included energy intake at an ad libitum breakfast buffet, 3-d food records, and fasting satiety hormone concentrations. Subjective appetite ratings were obtained from visual analog scales before and after the breakfast. Children's Eating Behavior Questionnaires were also completed by caregivers.Results: Compared with placebo, prebiotic intake resulted in significantly higher feelings of fullness (P = 0.04) and lower prospective food consumption (P = 0.03) at the breakfast buffet at 16 wk compared with baseline. Compared with placebo, prebiotic supplementation significantly reduced energy intake at the week 16 breakfast buffet in 11- and 12-y-olds (P = 0.04) but not in 7- to 10-y-olds. Fasting adiponectin (P = 0.04) and ghrelin (P = 0.03) increased at 16 wk with the prebiotic compared with placebo. In intent-to-treat analysis, there was a trend for prebiotic supplementation to reduce BMI z score to a greater extent than placebo (-3.4%; P = 0.09) and a significant -3.8% reduction in per-protocol analysis (P = 0.043).Conclusions: Independent of other lifestyle changes, prebiotic supplementation in children with overweight and obesity improved subjective appetite ratings. This translated into reduced energy intake in a breakfast buffet in older but not in younger children. This simple dietary change has the potential to help with appetite regulation in children with obesity. This trial was registered at

  11. Control of Phlebotomus argentipes (Diptera: Psychodidae) sand fly in Bangladesh: A cluster randomized controlled trial.

    PubMed

    Chowdhury, Rajib; Faria, Shyla; Huda, M Mamun; Chowdhury, Vashkar; Maheswary, Narayan Prosad; Mondal, Dinesh; Akhter, Shireen; Akter, Sakila; Khan, Rajaul Karim; Nabi, Shah Golam; Kroeger, Axel; Argaw, Daniel; Alvar, Jorge; Dash, Aditya Prasad; Banu, Qamar

    2017-09-05

    A number of studies on visceral leishmaniasis (VL) vector control have been conducted during the past decade, sometimes came to very different conclusion. The present study on a large sample investigated different options which are partially unexplored including: (1) indoor residual spraying (IRS) with alpha cypermethrin 5WP; (2) long lasting insecticide impregnated bed-net (LLIN); (3) impregnation of local bed-nets with slow release insecticide K-O TAB 1-2-3 (KOTAB); (4) insecticide spraying in potential breeding sites outside of house using chlorpyrifos 20EC (OUT) and different combinations of the above. The study was a cluster randomized controlled trial where 3089 houses from 11 villages were divided into 10 sections, each section with 6 clusters and each cluster having approximately 50 houses. Based on vector density (males plus females) during baseline survey, the 60 clusters were categorized into 3 groups: (1) high, (2) medium and (3) low. Each group had 20 clusters. From these three groups, 6 clusters (about 300 households) were randomly selected for each type of intervention and control arms. Vector density was measured before and 2, 4, 5, 7, 11, 14, 15, 18 and 22 months after intervention using CDC light traps. The impact of interventions was measured by using the difference-in-differences regression model. A total of 17,434 sand flies were collected at baseline and during the surveys conducted over 9 months following the baseline measurements. At baseline, the average P. argentipes density per household was 10.6 (SD = 11.5) in the control arm and 7.3 (SD = 8.46) to 11.5 (SD = 20.2) in intervention arms. The intervention results presented as the range of percent reductions of sand flies (males plus females) and rate ratios in 9 measurements over 22 months. Among single type interventions, the effect of IRS with 2 rounds of spraying (applied by the research team) ranged from 13% to 75% reduction of P. argentipes density compared to the control arm (rate

  12. Surface segregation of fluorinated moieties on random copolymer films controlled by random-coil conformation of polymer chains in solution.

    PubMed

    Xue, Dongwu; Wang, Xinping; Ni, Huagang; Zhang, Wei; Xue, Gi

    2009-02-17

    The relationship between solution properties, film-forming methods, and the solid surface structures of random copolymers composed of butyl methacrylate and dodecafluorheptyl methylacrylate (DFHMA) was investigated by contact angle measurements, X-ray photoelectron spectroscopy, sum frequency generation vibrational spectroscopy, and surface tension measurements. The results, based on thermodynamic considerations, demonstrated that the random copolymer chain conformation at the solution/air interface greatly affected the surface structure of the resulting film, thereby determining the surface segregation of fluorinated moieties on films obtained by various film-forming techniques. When the fluorinated monomer content of the copolymer solution was low, entropic forces dominated the interfacial structure, with the perfluoroalkyl groups unable to migrate to the solution/air interface and thus becoming buried in a random-coil chain conformation. When employing this copolymer solution for film preparation by spin-coating, the copolymer chains in solution were likely extended due to centrifugal forces, thereby weakening the entropy effect of the polymer chains. Consequently, this resulted in the segregation of the fluorinated moieties on the film surface. For the films prepared by casting, the perfluoroalkyl groups were, similar to those in solution, incapable of segregating at the film surface and were thus buried in the random-coil chains. When the copolymers contained a high content of DFHMA, the migration of perfluoroalkyl groups at the solution/air interface was controlled by enthalpic forces, and the perfluoroalkyl groups segregated at the surface of the film regardless of the film-forming technique. The aim of the present work was to obtain an enhanced understanding of the formation mechanism of the chemical structure on the surface of the polymer film, while demonstrating that film-forming methods may be used in practice to promote the segregation of fluorinated

  13. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    ERIC Educational Resources Information Center

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  14. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    ERIC Educational Resources Information Center

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

  15. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    ERIC Educational Resources Information Center

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

  16. Distributed reservation control protocols for random access broadcasting channels

    NASA Astrophysics Data System (ADS)

    Greene, E. P.; Ephremides, A.

    1981-05-01

    Attention is given to a communication network consisting of an arbitrary number of nodes which can communicate with each other via a time-division multiple access (TDMA) broadcast channel. The reported investigation is concerned with the development of efficient distributed multiple access protocols for traffic consisting primarily of single packet messages in a datagram mode of operation. The motivation for the design of the protocols came from the consideration of efficient multiple access utilization of moderate to high bandwidth (4-40 Mbit/s capacity) communication satellite channels used for the transmission of short (1000-10,000 bits) fixed length packets. Under these circumstances, the ratio of roundtrip propagation time to packet transmission time is between 100 to 10,000. It is shown how a TDMA channel can be adaptively shared by datagram traffic and constant bandwidth users such as in digital voice applications. The distributed reservation control protocols described are a hybrid between contention and reservation protocols.

  17. Distributed reservation control protocols for random access broadcasting channels

    NASA Technical Reports Server (NTRS)

    Greene, E. P.; Ephremides, A.

    1981-01-01

    Attention is given to a communication network consisting of an arbitrary number of nodes which can communicate with each other via a time-division multiple access (TDMA) broadcast channel. The reported investigation is concerned with the development of efficient distributed multiple access protocols for traffic consisting primarily of single packet messages in a datagram mode of operation. The motivation for the design of the protocols came from the consideration of efficient multiple access utilization of moderate to high bandwidth (4-40 Mbit/s capacity) communication satellite channels used for the transmission of short (1000-10,000 bits) fixed length packets. Under these circumstances, the ratio of roundtrip propagation time to packet transmission time is between 100 to 10,000. It is shown how a TDMA channel can be adaptively shared by datagram traffic and constant bandwidth users such as in digital voice applications. The distributed reservation control protocols described are a hybrid between contention and reservation protocols.

  18. Worksite intervention effects on sleep quality: a randomized controlled trial.

    PubMed

    Atlantis, Evan; Chow, Chin-Moi; Kirby, Adrienne; Singh, Maria A Fiatarone

    2006-10-01

    Employees with sleep disturbance are at increased risk of disease. Exercise is believed to be effective for improving sleep quality, but few studies have been conducted. This study investigated the effects of a 24-week worksite exercise/behavioral intervention on self-rated sleep quality, via the Pittsburgh Sleep Quality Index (PSQI), in 73 employees. Greater post-test improvements in the PSQI (-2.0 +/- 2.6 vs. -1.3 +/- 2.7 points, p = .006, and -16 +/- 61 vs. -1 +/- 76%, p = .02) were found in treatment versus controls, and in women versus men (by -2.7 points [-5.0 to -0.3 points, p = .03], and by -72% [-142 to -2%, p = .04]). Similar results were found in the shift worker subgroup. Changes in sleep scores were not significantly related to baseline characteristics, changes in psychological health or quality-of-life scores, or level of exercise compliance.

  19. Fetal response to abbreviated relaxation techniques. A randomized controlled study.

    PubMed

    Fink, Nadine S; Urech, Corinne; Isabel, Fornaro; Meyer, Andrea; Hoesli, Irène; Bitzer, Johannes; Alder, Judith

    2011-02-01

    stress during pregnancy can have adverse effects on the course of pregnancy and on fetal development. There are few studies investigating the outcome of stress reduction interventions on maternal well-being and obstetric outcome. this study aims (1) to obtain fetal behavioral states (quiet/active sleep, quiet/active wakefulness), (2) to investigate the effects of maternal relaxation on fetal behavior as well as on uterine activity, and (3) to investigate maternal physiological and endocrine parameters as potential underlying mechanisms for maternal-fetal relaxation-transferral. the behavior of 33 fetuses was analyzed during laboratory relaxation/quiet rest (control group, CG) and controlled for baseline fetal behavior. Potential associations between relaxation/quiet rest and fetal behavior (fetal heart rate (FHR), FHR variation, FHR acceleration, and body movements) and uterine activity were studied, using a computerized cardiotocogram (CTG) system. Maternal heart rate, blood pressure, cortisol, and norepinephrine were measured. intervention (progressive muscle relaxation, PMR, and guided imagery, GI) showed changes in fetal behavior. The intervention groups had higher long-term variation during and after relaxation compared to the CG (p=.039). CG fetuses had more FHR acceleration, especially during and after quiet rest (p=.027). Women in the PMR group had significantly more uterine activity than women in the GI group (p=.011) and than CG women. Maternal heart rate, blood pressure, and stress hormones were not associated with fetal behavior. this study indicates that the fetus might participate in maternal relaxation and suggests that GI is superior to PMR. This could especially be true for women who tend to direct their attention to body sensations such as abdominal activity. 2010 Elsevier Ltd. All rights reserved.

  20. Early Intensive Leg Training to Enhance Walking in Children With Perinatal Stroke: Protocol for a Randomized Controlled Trial.

    PubMed

    Hurd, Caitlin; Livingstone, Donna; Brunton, Kelly; Teves, Michelle; Zewdie, Ephrem; Smith, Allison; Ciechanski, Patrick; Gorassini, Monica A; Kirton, Adam; Watt, Man-Joe; Andersen, John; Yager, Jerome; Yang, Jaynie F

    2017-08-01

    Development of motor pathways is modulated by activity in these pathways, when they are maturing (ie, critical period). Perinatal stroke injures motor pathways, including the corticospinal tracts, reducing their activity and impairing motor function. Current intervention for the lower limb emphasizes passive approaches (stretching, braces, botulinum toxin injections). The study hypothesis was that intensive, early, child-initiated activity during the critical period will enhance connectivity of motor pathways to the legs and improve motor function. The study objective was to determine whether early intervention with intensive activity is better than standard care, intervention delivered during the proposed critical period is better than after, and the outcomes are different when the intervention is delivered by a physical therapist in an institution vs. a parent at home. A prospective, delay-group, single-blind, randomized controlled trial (RCT) and a parallel, cohort study of children living beyond commuting distance and receiving an intervention delivered by their parent. The RCT intervention was provided in university laboratories, and parent training was provided in the childs home. Children 8 months to 3 years old with MRI-confirmed perinatal ischemic stroke and early signs of hemiparesis. Intensive, play-based leg activity with weights for the affected leg and foot, 1 hour/day, 4 days/week for 12 weeks. The primary outcome was the Gross Motor Function Measure-66 score. Secondary outcomes were motion analysis of walking, full-day step counts, motor evoked potentials from transcranial magnetic stimulation, and patellar tendon reflexes. Inter-individual heterogeneity in the severity of the stroke and behavioral differences are substantial but measurable. Differences in intervention delivery and assessment scoring are minimized by standardization and training. The intervention, contrary to current practice, could change physical therapy interventions for children

  1. Controlling memory impairment in elderly adults using virtual reality memory training: a randomized controlled pilot study.

    PubMed

    Optale, Gabriele; Urgesi, Cosimo; Busato, Valentina; Marin, Silvia; Piron, Lamberto; Priftis, Konstantinos; Gamberini, Luciano; Capodieci, Salvatore; Bordin, Adalberto

    2010-05-01

    Memory decline is a prevalent aspect of aging but may also be the first sign of cognitive pathology. Virtual reality (VR) using immersion and interaction may provide new approaches to the treatment of memory deficits in elderly individuals. The authors implemented a VR training intervention to try to lessen cognitive decline and improve memory functions. The authors randomly assigned 36 elderly residents of a rest care facility (median age 80 years) who were impaired on the Verbal Story Recall Test either to the experimental group (EG) or the control group (CG). The EG underwent 6 months of VR memory training (VRMT) that involved auditory stimulation and VR experiences in path finding. The initial training phase lasted 3 months (3 auditory and 3 VR sessions every 2 weeks), and there was a booster training phase during the following 3 months (1 auditory and 1 VR session per week). The CG underwent equivalent face-to-face training sessions using music therapy. Both groups participated in social and creative and assisted-mobility activities. Neuropsychological and functional evaluations were performed at baseline, after the initial training phase, and after the booster training phase. The EG showed significant improvements in memory tests, especially in long-term recall with an effect size of 0.7 and in several other aspects of cognition. In contrast, the CG showed progressive decline. The authors suggest that VRMT may improve memory function in elderly adults by enhancing focused attention.

  2. Citalopram controls phobic symptoms in patients with panic disorder: randomized controlled trial.

    PubMed Central

    Leinonen, E; Lepola, U; Koponen, H; Turtonen, J; Wade, A; Lehto, H

    2000-01-01

    OBJECTIVE: To examine the effects of long-term treatment with citalopram or clomipramine on subjective phobic symptoms in patients with panic disorder. DESIGN: Double-blind, parallel-group, five-arm study. PATIENTS: Patients aged 18 to 65 years with panic disorder (DMS-III-R diagnosis) and with no major depressive symptoms. INTERVENTIONS: Four hundred and seventy-five patients were randomized to 8 weeks of treatment with either citalopram (10 to 15 mg per day; 20 to 30 mg per day; or 40 to 60 mg per day), clomipramine (60 to 90 mg per day) or placebo. Two hundred and seventy-nine patients continued treatment after the 8-week acute phase. OUTCOME MEASURES: Phobic symptoms were assessed using the Phobia Scale and the Symptom Checklist's (SCL-90) phobia-related factors. RESULTS: At all dosages, citalopram was more efficacious than placebo, with 20 to 30 mg generally being the most effective dosage. Citalopram (20 to 30 mg) generally decreased phobic symptoms significantly more than placebo after Month 3. Interpersonal sensitivity decreased when measured on the respective SCL-90 sub-scale. Alleviation of phobic symptoms generally continued to increase towards the end of the treatment. The effect of clomipramine was not as consistent. CONCLUSIONS: All active treatment groups, especially the group receiving 20 to 30 mg per day of citalopram, effectively controlled phobic symptoms in patients with panic disorder. Long-term treatment with citalopram further decreased phobic symptoms. PMID:10721681

  3. Evaluation of influenza prevention in the workplace using a personally controlled health record: randomized controlled trial.

    PubMed

    Bourgeois, Florence T; Simons, William W; Olson, Karen; Brownstein, John S; Mandl, Kenneth D

    2008-03-14

    Personally controlled health records (PCHRs) are accessible over the Internet and allow individuals to maintain and manage a secure copy of their medical data. These records provide a new opportunity to provide customized health recommendations to individuals based on their record content. Health promotion programs using PCHRs can potentially be used in a variety of settings and target a large range of health issues. The aim was to assess the value of a PCHR in an employee health promotion program for improving knowledge, beliefs, and behavior around influenza prevention. We evaluated a PCHR-based employee health promotion program using a randomized controlled trial design. Employees at Hewlett Packard work sites who reported reliable Internet access and email use at least once every 2 days were recruited for participation. PCHRs were provided to all participants for survey administration, and tailored, targeted health messages on influenza illness and prevention were delivered to participants in the intervention group. Participants in the control group received messages addressing cardiovascular health and sun protection. The main outcome measure was improvement in knowledge, beliefs, and behavior around influenza prevention. Secondary outcomes were influenza vaccine rates among household members, the impact of cardiovascular health and sun protection messages on the control group, and the usability and utility of the PCHR-based program for employees. The intervention did not have a statistically significant effect on the influenza knowledge elements we assessed but did impact certain beliefs surrounding influenza. Participants in the intervention group were more likely to believe that the influenza vaccine was effective (OR = 5.6; 95% CI = 1.7-18.5), that there were actions they could take to prevent the flu (OR = 3.2; 95% CI = 1.1-9.2), and that the influenza vaccine was unlikely to cause a severe reaction (OR = 4.4; 95% CI = 1.3-15.3). Immunization rates did

  4. A comparison of handsearching versus MEDLINE searching to identify reports of randomized controlled trials.

    PubMed

    Hopewell, S; Clarke, M; Lusher, A; Lefebvre, C; Westby, M

    2002-06-15

    This study aims to compare handsearching to a basic MEDLINE search for the identification of reports of randomized trials in specialized health care journals. Twenty-two specialized health care journals, published in the U.K., were handsearched for all reports of controlled trials (as defined by the Cochrane Collaboration). The reports of trials, which were judged to be definitely randomized, were identified from a random sample of three years per journal and form one element of this study. A MEDLINE search using the publication type terms 'randomized controlled trial' and 'controlled clinical trial' was also performed for the same journal years. The reports of trials retrieved by handsearching were then compared against those retrieved from the MEDLINE search, to identify differences in retrieval between the two techniques. Reports of randomized trials identified by the MEDLINE search but not found by handsearching were individually assessed to see if they met the Cochrane eligibility criteria for a report of a randomized trial. A total of 714 reports of randomized trials were found by using a combination of both handsearching and MEDLINE searching. Of these, 369 (52 per cent) were identified only by handsearching and 32 (4 per cent) were identified only by MEDLINE searching. Of the reports identified only by handsearching, 252 had no MEDLINE record, of which 232 (92 per cent) were meeting abstracts or published in supplements; 117 (25 per cent) of the 462 reports of randomized trials which had a MEDLINE record were missed by the electronic search because they did not have either of the publication type terms 'randomized controlled trial' or 'controlled clinical trial'. This proportion varied depending on when the reports of randomized trials were published (that is, before or after the introduction of the MEDLINE publication type terms above). The highest additional yield from handsearching compared to MEDLINE searching was for reports of randomized trials

  5. Randomized controlled trial of intravenous acetaminophen for postcesarean delivery pain control.

    PubMed

    Altenau, Brie; Crisp, Catrina C; Devaiah, C Ganga; Lambers, Donna S

    2017-09-01

    Cesarean delivery is a common surgery in the United States, with 1.3 million performed during 2009.(1) Obstetricians must balance the growing concern with opioid abuse, dependence, and side effects with optimal postoperative pain control. Intravenous acetaminophen may represent an additional method to decrease the reliance on opioid medications and improve postoperative pain following cesarean delivery. The objective of the study was to determine whether the administration of intravenous acetaminophen following routine scheduled cesarean delivery would decrease the need for narcotic medications to control postoperative pain. This was an institutional review board-approved, double-blind, placebo-controlled, randomized trial, registered on clinicaltrials.gov (number 02046382). Women scheduled to undergo cesarean delivery with regional anesthesia at term were recruited. All perioperative and postpartum care was standardized via study order sets. Study patients were given all medications in a standardized manner receiving either acetaminophen 1000 mg intravenously or 100 mL saline (placebo) every 8 hours for 48 hours for a total of 6 doses. The pharmacy prepared intravenous acetaminophen and saline in identical administration bags labeled study drug to ensure blinding. The initial dose of study drug was given within 60 minutes of skin incision. Quantity of breakthrough and scheduled analgesic medications and self-reported pain levels on the Faces Pain Scale (0-10) before and after study drug administration were collected. Patient demographics were extracted from the chart. Power calculation determined that 45 patients per arm were required to detect a 30% reduction in postcesarean narcotic requirement with 80% power and a significance level of P = .05. A total of 133 patients were consented for the study. Twenty-nine were excluded and 104 patients completed the study: 57 received intravenous acetaminophen and 47 received placebo. There were no differences in baseline

  6. Neostigmine Decreases Bupivacaine Use by Patient-Controlled Epidural Analgesia During Labor: A Randomized Controlled Study

    PubMed Central

    Ross, Vernon H.; Pan, Peter H.; Owen, Medge D; Seid, Melvin H.; Harris, Lynne; Clyne, Brittany; Voltaire, Misa; Eisenach, James C.

    2009-01-01

    Background Intrathecal neostigmine produces analgesia, but also severe nausea. In contrast, epidural neostigmine enhances opioid and local anesthetic analgesia without causing nausea. Previous studies examined only single epidural neostigmine bolus administration and did not assess the efficacy of continuous epidural infusion or several aspects of maternal and fetal safety. We therefore tested the hypothesis that epidural neostigmine in combination with bupivacaine by continuous infusion during labor would reduce the amount of bupivacaine required. Methods Twelve healthy women scheduled for elective cesarean delivery were assigned to receive epidural neostigmine, 40 μg (first 6 subjects) or 80 μg (second 6 subjects) as a single bolus, with fetal heart rate and uterine contractions monitored for 20 minutes. In a subsequent experiment, 40 healthy laboring women were randomized to receive bupivacaine 1.25 mg/mL alone or with neostigmine 4 μg/mL by patient-controlled epidural analgesia. The primary outcome measure was hourly bupivacaine use. Results Epidural neostigmine bolus did not alter baseline fetal heart rate, induce contractions or produce nausea. Epidural neostigmine infusion reduced bupivacaine requirement by 19% in all patients and 25% in those with > 4 hours of treatment (P<0.05 for both), but might have contributed to the incidence of mild sedation. Mode of delivery, incidence of maternal nausea and fetal heart rate abnormality were similar between groups. Conclusions These data show that adding epidural neostigmine 4 μg/mL reduces the hourly bupivacaine requirement by 19% to 25% with patient-controlled epidural analgesia during labor. Administered as a bolus and by continuous infusion at the studied doses, epidural neostigmine does not cause nausea and does not induce uterine contractions or fetal heart rate abnormalities, but mild sedation can occur. PMID:19377050

  7. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial

    PubMed Central

    Ngo, Lynn L.; Ward, Kristy K.; Mody, Sheila K.

    2015-01-01

    Objective To evaluate intramuscular ketorolac compared to placebo saline injection for pain control with intrauterine device (IUD) placement. Methods We conducted a randomized, double-blind, placebo controlled trial between July 2012 and March 2014. Patients received ketorolac 30mg or placebo saline intramuscular injection 30 minutes prior to IUD placement. The primary outcome was pain with IUD placement on a 10cm visual analog scale (VAS). Sample size was calculated to provide 80% power to show a 2.0cm difference (α=0.05) in the primary outcome. Secondary outcomes included pain with study drug injection, speculum insertion, tenaculum placement, uterine sounding, and at 5 and 15 minutes after IUD placement. Results A total of 67 women participated in the study, 33 in the ketorolac arm and 34 in the placebo arm. There were no differences in baseline demographics including age, BMI, and race. There were no differences in median pain scores for IUD placement in the placebo versus ketorolac groups (5.2cm vs 3.6cm, p=0.99). There was a decrease in median pain scores at 5 minutes (2.2cm vs 0.3cm, p=<0.001) and 15 minutes (1.6cm vs 0.1cm, p=<0.001) after IUD placement but no difference for all other time points. Nulliparous participants (n=16, 8 per arm) had a decrease in pain scores with IUD placement (8.1cm vs 5.4cm, p=0.02). In this study, 22% of participants in the placebo group and 18% in the ketorolac group reported injection pain was as painful as IUD placement. Conclusions Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement. PMID:26241253

  8. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial.

    PubMed

    Ngo, Lynn L; Ward, Kristy K; Mody, Sheila K

    2015-07-01

    To evaluate intramuscular ketorolac compared with placebo saline injection for pain control with intrauterine device (IUD) placement. We conducted a randomized, double-blind, placebo-controlled trial between July 2012 and March 2014. Patients received 30 mg ketorolac or placebo saline intramuscular injection 30 minutes before IUD placement. The primary outcome was pain with IUD placement on a 10-cm visual analog scale. Sample size was calculated to provide 80% power to show a 2.0-cm difference (α=0.05) in the primary outcome. Secondary outcomes included pain with study drug injection, speculum insertion, tenaculum placement, uterine sounding, and at 5 and 15 minutes after IUD placement. A total of 67 women participated in the study, 33 in the ketorolac arm and 34 in the placebo arm. There were no differences in baseline demographics including age, body mass index, and race. There were no differences in median pain scores for IUD placement in the placebo compared with ketorolac groups (5.2 compared with 3.6 cm, P=.99). There was a decrease in median pain scores at 5 minutes (2.2 compared with 0.3 cm, P≤.001) and 15 minutes (1.6 compared with 0.1 cm, P≤.001) after IUD placement but no difference for all other time points. Nulliparous participants (n=16, eight per arm) had a decrease in pain scores with IUD placement (8.1 compared with 5.4 cm, P=.02). In this study, 22% of participants in the placebo group and 18% in the ketorolac group reported injection pain was as painful as IUD placement. Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement. ClinicalTrials.gov; www.clinicaltrials.gov, NCT01664559. I.

  9. Randomized sham-controlled trial of acupuncture for postoperative pain control after stapled haemorrhoidopexy.

    PubMed

    Langenbach, M R; Aydemir-Dogruyol, K; Issel, R; Sauerland, S

    2012-08-01

    Haemorrhoidectomy usually causes moderate to strong postoperative pain. Chinese studies have found that acupuncture may have an analgesic effect in posthaemorrhoidectomy patients. This is the first Western study aiming assess the efficacy of acupuncture as an adjunct analgesic therapy after stapled haemorrhoidopexy. In a randomized controlled trial, 50 patients were allocated to three groups. Conventional drug therapy (oral diclofenac and metamizol, local lidocaine) served as baseline analgesia. In the control group (n = 17) only this regimen was used. In addition to baseline analgesia, 17 patients received verum acupuncture. Sham acupuncture was performed on 16 patients. Being the primary outcome measure, pain was measured twice daily using the numerical rating scale (NRS) and compared statistically by repeated-measures analysis of variance. The study was registered (DRKS00003116). Results  After verum acupuncture, pain intensity was not significantly lower when compared with conventional analgesia (primary hypothesis, P = 0.057), but was when compared to sham acupuncture (P = 0.007). In the afternoon of postoperative day 1, for example, NRS was 2.7 (SD 1.5) in the verum group, but 4.0 (1.0) in the sham group and 4.1 (1.9) under conventional analgesia. Furthermore, significantly fewer rescue analgesics were necessary if verum acupuncture was applied. Cardiovascular parameters were stable in all three groups, and no complications were recorded. In posthaemorrhoidectomy patients, acupuncture appears to be an effective adjunct to conventional analgesia. Further studies are necessary to confirm these observations and to refine the acupuncture technique. © 2012 The Authors. Colorectal Disease © 2012 The Association of Coloproctology of Great Britain and Ireland.

  10. Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group.

    PubMed

    MacKinnon, Christopher J; Smith, Nathan Grant; Henry, Melissa; Milman, Evgenia; Chochinov, Harvey M; Körner, Annette; Berish, Mel; Farrace, Amanda Jessica; Liarikos, Nikoleta; Cohen, S Robin

    2015-01-01

    More effective psychosocial interventions that target uncomplicated bereavement are needed for those actively seeking support. The objective of this study was to assess the feasibility of evaluating a unique meaning-based group counseling (MBGC) intervention with a randomized controlled trial (RCT) design. Twenty-six bereft individuals were randomly assigned to either MBGC or a control bereavement support group. Twenty participants (11 experimental, nine control) completed all aspects of the study including self-report measures at baseline, postintervention, and 3-month follow-up of meaning in life, anxiety, depression, and grief. Results support the feasibility of an RCT with MBGC.

  11. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    ERIC Educational Resources Information Center

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  12. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    ERIC Educational Resources Information Center

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  13. Effectiveness of "Primary Bereavement Care" for Widows: A Cluster Randomized Controlled Trial Involving Family Physicians

    ERIC Educational Resources Information Center

    García, Jesus A.; Landa, Victor; Grandes, Gonzalo; Pombo, Haizea; Mauriz, Amaia

    2013-01-01

    Thirty-one family physicians, from 19 primary care teams in Biscay (Spain), were randomly assigned to intervention or control group. The 15 intervention family physicians, after training in primary bereavement care, saw 43 widows for 7 sessions, from the 4th to 13th month after their loss. The 16 control family physicians, without primary…

  14. Strength and Agility Training in Adolescents with Down Syndrome: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lin, Hsiu-Ching; Wuang, Yee-Pay

    2012-01-01

    The purpose of this study was to investigate the effects of a proposed strength and agility training program of adolescents with Down syndrome. Ninety-two adolescents were recruited and evenly randomized to two intervention groups (exercise group vs. control group). The mean age for the exercise and the control group was 10.6 plus or minus 3.2 and…

  15. Parent Training for Young Children with Developmental Disabilities: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group…

  16. A Randomized Controlled Trial of Hanen's "More than Words" in Toddlers with Early Autism Symptoms

    ERIC Educational Resources Information Center

    Carter, Alice S.; Messinger, Daniel S.; Stone, Wendy L.; Celimli, Seniz; Nahmias, Allison S.; Yoder, Paul

    2011-01-01

    Background: This randomized controlled trial compared Hanen's "More than Words" (HMTW), a parent-implemented intervention, to a "business as usual" control group. Methods: Sixty-two children (51 boys and 11 girls; M age = 20 months; SD = 2.6) who met criteria for autism spectrum disorders (ASD) and their parents participated in the study. The HMTW…

  17. Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

    ERIC Educational Resources Information Center

    Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

    2013-01-01

    The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

  18. Strength and Agility Training in Adolescents with Down Syndrome: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lin, Hsiu-Ching; Wuang, Yee-Pay

    2012-01-01

    The purpose of this study was to investigate the effects of a proposed strength and agility training program of adolescents with Down syndrome. Ninety-two adolescents were recruited and evenly randomized to two intervention groups (exercise group vs. control group). The mean age for the exercise and the control group was 10.6 plus or minus 3.2 and…

  19. Neural network based adaptive control of nonlinear plants using random search optimization algorithms

    NASA Technical Reports Server (NTRS)

    Boussalis, Dhemetrios; Wang, Shyh J.

    1992-01-01

    This paper presents a method for utilizing artificial neural networks for direct adaptive control of dynamic systems with poorly known dynamics. The neural network weights (controller gains) are adapted in real time using state measurements and a random search optimization algorithm. The results are demonstrated via simulation using two highly nonlinear systems.

  20. Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

    ERIC Educational Resources Information Center

    Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

    2013-01-01

    The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

  1. Effectiveness of "Primary Bereavement Care" for Widows: A Cluster Randomized Controlled Trial Involving Family Physicians

    ERIC Educational Resources Information Center

    García, Jesus A.; Landa, Victor; Grandes, Gonzalo; Pombo, Haizea; Mauriz, Amaia

    2013-01-01

    Thirty-one family physicians, from 19 primary care teams in Biscay (Spain), were randomly assigned to intervention or control group. The 15 intervention family physicians, after training in primary bereavement care, saw 43 widows for 7 sessions, from the 4th to 13th month after their loss. The 16 control family physicians, without primary…

  2. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    ERIC Educational Resources Information Center

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  3. Neural network based adaptive control of nonlinear plants using random search optimization algorithms

    NASA Technical Reports Server (NTRS)

    Boussalis, Dhemetrios; Wang, Shyh J.

    1992-01-01

    This paper presents a method for utilizing artificial neural networks for direct adaptive control of dynamic systems with poorly known dynamics. The neural network weights (controller gains) are adapted in real time using state measurements and a random search optimization algorithm. The results are demonstrated via simulation using two highly nonlinear systems.

  4. A Randomized Controlled Trial of Hanen's "More than Words" in Toddlers with Early Autism Symptoms

    ERIC Educational Resources Information Center

    Carter, Alice S.; Messinger, Daniel S.; Stone, Wendy L.; Celimli, Seniz; Nahmias, Allison S.; Yoder, Paul

    2011-01-01

    Background: This randomized controlled trial compared Hanen's "More than Words" (HMTW), a parent-implemented intervention, to a "business as usual" control group. Methods: Sixty-two children (51 boys and 11 girls; M age = 20 months; SD = 2.6) who met criteria for autism spectrum disorders (ASD) and their parents participated in the study. The HMTW…

  5. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    ERIC Educational Resources Information Center

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  6. Searching for control: priming randomness increases the evaluation of ritual efficacy.

    PubMed

    Legare, Cristine H; Souza, André L

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual action and a desired outcome. Two experiments were conducted (one in Brazil [n = 40] and another in the United States [n = 94]) to evaluate how the perceived efficacy of rituals is affected by feelings of randomness. In a between-subjects design, the Scramble Sentence Task was used as a priming procedure in three conditions (i.e., randomness, negativity, and neutral) and participants were then asked to rate the efficacy of rituals used for problem-solving purposes. The results demonstrate that priming randomness increased participants' perception of ritual efficacy relative to negativity and neutral conditions. Implications for increasing our understanding of the relationship between perceived control and ritualistic behavior are discussed.

  7. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

    PubMed Central

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

    2014-01-01

    Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

  8. [Randomized controlled trials for the prevention and treatment of glucocorticoid-induced osteoporosis].

    PubMed

    Suzuki, Yasuo

    2006-11-01

    The effectiveness of drug therapy for the prevention or treatment of glucocorticoid-induced osteoporosis has been reported. Especially, the beneficial effects of bisphosphonates (etidoronate, alendronate, and risedronate) to prevent bone loss and fractures have been confirmed by the large-scale, multicenter, double-blind, randomized controlled trials in terms of both primary and secondary prevention. This article reviews the results of recent randomized prospective trials using bisphosphonates in glucocorticoid-induced osteoporosis.

  9. Solution to the variation problem for information path functional of a controlled random process

    NASA Astrophysics Data System (ADS)

    Lerner, Vladimir S.

    2007-10-01

    The paper introduces a new approach to dynamic modeling, using the variation principle, applied to a functional on trajectories of a controlled random process, and its connection to the process' information functional. In [V.S. Lerner, Dynamic approximation of a random information functional, J. Math. Anal. Appl. 327 (1) (2007) 494-514, available online 5-24-06], we presented the information path functional with the Lagrangian, determined by the parameters of a controlled stochastic equation. In this paper, the solution to the path functional's variation problem provides both a dynamic model of a random process and the model's optimal control, which allows us to build a two-level information model with a random process at the microlevel and a dynamic process at the macrolevel. A wide class of random objects, modeled by the Markov diffusion process and a common structure of the process' information functional, leads to a universal information structure of the dynamic model, which is specified and identified on a particular object with the applied optimal control functions. The developed mathematical formalism, based on classical methods, is aimed toward the solution of problems identification, combined with an optimal control synthesis, which is practically implemented and also demonstrated in the paper's example.

  10. Daily Text Messaging for Weight Control Among Racial and Ethnic Minority Women: Randomized Controlled Pilot Study

    PubMed Central

    Levine, Erica L; Askew, Sandy; Foley, Perry; Bennett, Gary G

    2013-01-01

    Background Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations. Objective This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women. Methods Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. Results The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference –2.41 kg, 95% CI –5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=–.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence. Conclusions Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention. Trial Registration Clinicaltrials.gov: NCT00939081; http://clinicaltrials.gov/show/NCT00939081 (Archived by WebCite at http://www.webcitation.org/6Ki

  11. Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial.

    PubMed

    Lazarov, Amit; Pine, Daniel S; Bar-Haim, Yair

    2017-07-01

    Patients with social anxiety disorder exhibit increased attentional dwelling on social threats, providing a viable target for therapeutics. This randomized controlled trial examined the efficacy of a novel gaze-contingent music reward therapy for social anxiety disorder designed to reduce attention dwelling on threats. Forty patients with social anxiety disorder were randomly assigned to eight sessions of either gaze-contingent music reward therapy, designed to divert patients' gaze toward neutral stimuli rather than threat stimuli, or to a control condition. Clinician and self-report measures of social anxiety were acquired pretreatment, posttreatment, and at 3-month follow-up. Dwell time on socially threatening faces was assessed during the training sessions and at pre- and posttreatment. Gaze-contingent music reward therapy yielded greater reductions of symptoms of social anxiety disorder than the control condition on both clinician-rated and self-reported measures. Therapeutic effects were maintained at follow-up. Gaze-contingent music reward therapy, but not the control condition, also reduced dwell time on threat, which partially mediated clinical effects. Finally, gaze-contingent music reward therapy, but not the control condition, also altered dwell time on socially threatening faces not used in training, reflecting near-transfer training generalization. This is the first randomized controlled trial to examine a gaze-contingent intervention in social anxiety disorder. The results demonstrate target engagement and clinical effects. This study sets the stage for larger randomized controlled trials and testing in other emotional disorders.

  12. A compound herbal preparation (CHP) in the treatment of children with ADHD: a randomized controlled trial.

    PubMed

    Katz, M; Levine, A Adar; Kol-Degani, H; Kav-Venaki, L

    2010-11-01

    Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. A randomized, double-blind, placebo-controlled trial. University-affiliated tertiary medical center. 120 children newly diagnosed with ADHD, meeting DSM-IV criteria. Random assignment to the herbal treatment group (n = 80) or control group (placebo; n = 40); 73 patients in the treatment group (91%) and 19 in the control group (48%) completed the 4-month trial. Test of Variables of Attention (TOVA) administered before and after the treatment period; overall score and 4 subscales. The treatment group showed substantial, statistically significant improvement in the 4 subscales and overall TOVA scores, compared with no improvement in the control group, which persisted in an intention-to-treat analysis. The well-tolerated CHP demonstrated improved attention, cognition, and impulse control in the intervention group, indicating promise for ADHD treatment in children.

  13. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial.

    PubMed

    Ngo, Lynn L; Braaten, Kari P; Eichen, Eva; Fortin, Jennifer; Maurer, Rie; Goldberg, Alisa B

    2016-12-01

    To evaluate whether 550 mg oral naproxen sodium given 1 hour before intrauterine device (IUD) insertion is effective for pain relief as compared with placebo. This was a randomized, double-blind, placebo-controlled trial. The primary outcome was pain with IUD insertion measured on a 100-mm visual analog scale (VAS). Our sample size was calculated to detect a 15-mm difference in VAS scores with 80% power (α=0.05). Secondary outcomes included pain with tenaculum placement, uterine sounding, and 5 and 15 minutes postinsertion. A total of 118 women were enrolled and analyzed (58 in the naproxen sodium arm, 60 in the placebo arm, 97% nulliparous) between May 11, 2015, and March 25, 2016. There were no differences in baseline demographics or reproductive characteristics between arms. There were no differences in median VAS pain scores for the primary outcome of pain with IUD insertion between the naproxen sodium arm compared with the placebo arm (69 compared with 66 mm, P=.89). There were no differences in the secondary outcomes of median VAS pain scores with tenaculum placement (37 compared with 32 mm, P=.97) or uterine sounding (60 compared with 58 mm, P=.66). However, median pain scores postprocedure were lower in the naproxen arm as compared with the placebo arm: 17 compared with 26 mm (P=.01) at 5 minutes and 13 compared with 24 mm (P=.01) at 15 minutes postinsertion. Oral naproxen sodium does not reduce pain with IUD insertion but does reduce pain after insertion and should be considered as a premedication. ClinicalTrials.gov, http://clinicaltrials.gov, NCT02388191.

  14. Field-based random sampling without a sampling frame: control selection for a case-control study in rural Africa.

    PubMed

    Crampin, A C; Mwinuka, V; Malema, S S; Glynn, J R; Fine, P E

    2001-01-01

    Selection bias, particularly of controls, is common in case-control studies and may materially affect the results. Methods of control selection should be tailored both for the risk factors and disease under investigation and for the population being studied. We present here a control selection method devised for a case-control study of tuberculosis in rural Africa (Karonga, northern Malawi) that selects an age/sex frequency-matched random sample of the population, with a geographical distribution in proportion to the population density. We also present an audit of the selection process, and discuss the potential of this method in other settings.

  15. Analysis of random drop for gateway congestion control. M.S. Thesis

    NASA Technical Reports Server (NTRS)

    Hashem, Emam Salaheddin

    1989-01-01

    Lately, the growing demand on the Internet has prompted the need for more effective congestion control policies. Currently No Gateway Policy is used to relieve and signal congestion, which leads to unfair service to the individual users and a degradation of overall network performance. Network simulation was used to illustrate the character of Internet congestion and its causes. A newly proposed gateway congestion control policy, called Random Drop, was considered as a promising solution to the pressing problem. Random Drop relieves resource congestion upon buffer overflow by choosing a random packet from the service queue to be dropped. The random choice should result in a drop distribution proportional to the bandwidth distribution among all contending TCP connections, thus applying the necessary fairness. Nonetheless, the simulation experiments demonstrate several shortcomings with this policy. Because Random Drop is a congestion control policy, which is not applied until congestion has already occurred, it usually results in a high drop rate that hurts too many connections including well-behaved ones. Even though the number of packets dropped is different from one connection to another depending on the buffer utilization upon overflow, the TCP recovery overhead is high enough to neutralize these differences, causing unfair congestion penalties. Besides, the drop distribution itself is an inaccurate representation of the average bandwidth distribution, missing much important information about the bandwidth utilization between buffer overflow events. A modification of Random Drop to do congestion avoidance by applying the policy early was also proposed. Early Random Drop has the advantage of avoiding the high drop rate of buffer overflow. The early application of the policy removes the pressure of congestion relief and allows more accurate signaling of congestion. To be used effectively, algorithms for the dynamic adjustment of the parameters of Early Random Drop

  16. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

    PubMed Central

    Tan, Jing-Yu; Suen, Lorna K. P.; Wang, Tao; Molassiotis, Alexander

    2015-01-01

    Objectives To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. Methods Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes. Results Sixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and “non-acupoint” stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes. Conclusions A great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes

  17. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks

  18. Digital servo control of random sound test excitation. [in reverberant acoustic chamber

    NASA Technical Reports Server (NTRS)

    Nakich, R. B. (Inventor)

    1974-01-01

    A digital servocontrol system for random noise excitation of a test object in a reverberant acoustic chamber employs a plurality of sensors spaced in the sound field to produce signals in separate channels which are decorrelated and averaged. The average signal is divided into a plurality of adjacent frequency bands cyclically sampled by a time division multiplex system, converted into digital form, and compared to a predetermined spectrum value stored in digital form. The results of the comparisons are used to control a time-shared up-down counter to develop gain control signals for the respective frequency bands in the spectrum of random sound energy picked up by the microphones.

  19. Joint Random Access and Power Control Game in Ad Hoc Networks with Noncooperative Users

    NASA Astrophysics Data System (ADS)

    Long, Chengnian; Guan, Xinping

    We consider a distributed joint random access and power control scheme for interference management in wireless ad hoc networks. To derive decentralized solutions that do not require any cooperation among the users, we formulate this problem as non-cooperative joint random access and power control game, in which each user minimizes its average transmission cost with a given rate constraint. Using supermodular game theory, the existence and uniqueness of Nash equilibrium are established. Furthermore, we present an asynchronous distributed algorithm to compute the solution of the game based on myopic best response updates, which converges to Nash equilibrium globally.

  20. Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

    PubMed

    Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

    2017-08-01

    This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Chiropractic spinal manipulative therapy for cervicogenic headache: a single-blinded, placebo, randomized controlled trial.

    PubMed

    Chaibi, Aleksander; Knackstedt, Heidi; Tuchin, Peter J; Russell, Michael Bjørn

    2017-07-24

    Cervicogenic headache is a disabling headache where pharmacological management have limited effect. Thus, non-pharmacological management is warranted. Our objective was therefore to investigate the efficacy of chiropractic spinal manipulative therapy versus placebo (sham manipulation) and control (continued usual but non-manual management) for cervicogenic headache in a prospective 3-armed single-blinded, placebo, randomized controlled trial of 17 months' duration. Nineteen participants were equally randomized into the three groups, and 12 participants completed the randomized controlled trial. Headache frequency improved at all time points in the chiropractic spinal manipulative therapy and the placebo group. Headache index improved in the chiropractic spinal manipulative therapy group at all time points, while it improved at 6 and 12 months' follow-up in the placebo group. The control group remained unchanged during the whole study period. Adverse events were few, mild and transient. Blinding was concealed throughout the RCT. Thus, our results suggest that manual-therapy might be a safe treatment option for participants with cervicogenic headache, but data need to be confirmed in a randomized controlled trial with sufficient sample size and statistical power. Trial registration ClinicalTrials.gov identifier: NCT01687881, 11 September 2012.

  2. PDE-based random-valued impulse noise removal based on new class of controlling functions.

    PubMed

    Wu, Jian; Tang, Chen

    2011-09-01

    This paper is concerned with partial differential equation (PDE)-based image denoising for random-valued impulse noise. We introduce the notion of ENI (the abbreviation for "edge pixels, noisy pixels, and interior pixels") that denotes the number of homogeneous pixels in a local neighborhood and is significantly different for edge pixels, noisy pixels, and interior pixels. We redefine the controlling speed function and the controlling fidelity function to depend on ENI. According to our two controlling functions, the diffusion and fidelity process at edge pixels, noisy pixels, and interior pixels can be selectively carried out. Furthermore, a class of second-order improved and edge-preserving PDE denoising models is proposed based on the two new controlling functions in order to deal with random-valued impulse noise reliably. We demonstrate the performance of the proposed PDEs via application to five standard test images, corrupted by random-valued impulse noise with various noise levels and comparison with the related second-order PDE models and the other special filtering methods for random-valued impulse noise. Our two controlling functions are extended to automatically other PDE models.

  3. Electrically controllable liquid crystal random lasers below the Fréedericksz transition threshold.

    PubMed

    Lee, Chia-Rong; Lin, Jia-De; Huang, Bo-Yuang; Lin, Shih-Hung; Mo, Ting-Shan; Huang, Shuan-Yu; Kuo, Chie-Tong; Yeh, Hui-Chen

    2011-01-31

    This investigation elucidates for the first time electrically controllable random lasers below the threshold voltage in dye-doped liquid crystal (DDLC) cells with and without adding an azo-dye. Experimental results show that the lasing intensities and the energy thresholds of the random lasers can be decreased and increased, respectively, by increasing the applied voltage below the Fréedericksz transition threshold. The below-threshold-electric-controllability of the random lasers is attributable to the effective decrease of the spatial fluctuation of the orientational order and thus of the dielectric tensor of LCs by increasing the electric-field-aligned order of LCs below the threshold, thereby increasing the diffusion constant and decreasing the scattering strength of the fluorescence photons in their recurrent multiple scattering. This can result in the decrease in the lasing intensity of the random lasers and the increase in their energy thresholds. Furthermore, the addition of an azo-dye in DDLC cell can induce the range of the working voltage below the threshold for the control of the random laser to reduce.

  4. A multifactorial fall prevention programme in home-dwelling elderly people: a randomized-controlled trial.

    PubMed

    Sjösten, N M; Salonoja, M; Piirtola, M; Vahlberg, T; Isoaho, R; Hyttinen, H; Aarnio, P; Kivelä, S-L

    2007-04-01

    To describe the implementation and the effects of a multifactorial fall prevention trial on the specified risk factors of falling, incidence of falls and injurious falls, and on specified secondary outcome measures; to describe the design of the study and to assess the success of randomization. Randomized-controlled trial. Recruitment started in March 2003 and lasted until the end of January 2005, when a total number of 591 participants was reached. Participants were randomized into two age groups (65-74 years and 75 years and over), then into an intensive multifactorial risk-based prevention programme or into a one-time counselling on fall prevention. The intervention included individual geriatric assessment, guidance and treatment, individual guidance on fall prevention, physical exercise in small groups, psychosocial group activities, lectures, home-exercises and home hazards assessment. A total of 293 people were randomized into the 1-year prevention programme and 298 into the control condition. The mean age was 73.5 years in both groups; 84% of the participants were women. The groups were well balanced at baseline in relation to risk factors of falls, and the only statistically significant difference was found in the amount of regularly taken medicines, which was significantly lower in the control group: mean 3.7 (SD 3.0) vs. 4.2 (SD 3.1), P=0.028. Participants were successfully randomized into a multifactorial fall prevention trial.

  5. Tuning of an optimal fuzzy PID controller with stochastic algorithms for networked control systems with random time delay.

    PubMed

    Pan, Indranil; Das, Saptarshi; Gupta, Amitava

    2011-01-01

    An optimal PID and an optimal fuzzy PID have been tuned by minimizing the Integral of Time multiplied Absolute Error (ITAE) and squared controller output for a networked control system (NCS). The tuning is attempted for a higher order and a time delay system using two stochastic algorithms viz. the Genetic Algorithm (GA) and two variants of Particle Swarm Optimization (PSO) and the closed loop performances are compared. The paper shows that random variation in network delay can be handled efficiently with fuzzy logic based PID controllers over conventional PID controllers.

  6. Use of Kampo Diagnosis in Randomized Controlled Trials of Kampo Products in Japan: A Systematic Review

    PubMed Central

    Motoo, Yoshiharu; Arai, Ichiro; Tsutani, Kiichiro

    2014-01-01

    Background The Committee for Evidence-based Medicine (EBM) of the Japan Society for Oriental Medicine started compiling Evidence Reports of Kampo Treatment (EKAT) in 2007. EKAT is a compilation of structured abstracts of randomized controlled trials (RCTs), along with comments by a third party reviewer. As of 31 December, 2012, there were 378 RCTs of Kampo medicines in Japan. The primary research question of this study is “How frequently is Kampo diagnosis used in RCTs of Kampo medicines?” The secondary research question is “When is Kampo diagnosis used in RCTs?” Materials and Methods The structured abstract (SA) of each RCT article was reviewed to examine how Kampo diagnosis was used in RCTs, especially how Kampo diagnosis was used in the randomization process. Results Kampo diagnosis was used before randomization in 27 RCTs (7.1%), after randomization in 31 RCTs (8.2%), and not used in 320 RCTs (84.7%). Before randomization, Kampo diagnosis was used as a criterion for inclusion in 10 RCTs, criterion for exclusion in 9 RCTs, and criteria for both inclusion and exclusion in 2 RCTs. Kampo formulas were determined according to Kampo diagnosis in 7 RCTs. After randomization, subgroup analyses according to Kampo diagnosis were done in 27 RCTs, and grade of disease severity at Kampo diagnosis was used for analysis as an endpoint in 4 RCTs. Conclusions Kampo diagnosis was used before randomization only in approximately 15% of RCTs, and the number of RCT articles using Kampo diagnosis after randomization was almost the same as that before randomization. Further studies to determine the good RCTs conforming to CONSORT requirements and good systematic reviews conforming to PRISMA requirements are needed to clarify the significance of Kampo diagnosis. PMID:25119187

  7. Online distribution channel increases article usage on Mendeley: a randomized controlled trial.

    PubMed

    Kudlow, Paul; Cockerill, Matthew; Toccalino, Danielle; Dziadyk, Devin Bissky; Rutledge, Alan; Shachak, Aviv; McIntyre, Roger S; Ravindran, Arun; Eysenbach, Gunther

    2017-01-01

    Prior research shows that article reader counts (i.e. saves) on the online reference manager, Mendeley, correlate to future citations. There are currently no evidenced-based distribution strategies that have been shown to increase article saves on Mendeley. We conducted a 4-week randomized controlled trial to examine how promotion of article links in a novel online cross-publisher distribution channel (TrendMD) affect article saves on Mendeley. Four hundred articles published in the Journal of Medical Internet Research were randomized to either the TrendMD arm (n = 200) or the control arm (n = 200) of the study. Our primary outcome compares the 4-week mean Mendeley saves of articles randomized to TrendMD versus control. Articles randomized to TrendMD showed a 77% increase in article saves on Mendeley relative to control. The difference in mean Mendeley saves for TrendMD articles versus control was 2.7, 95% CI (2.63, 2.77), and statistically significant (p < 0.01). There was a positive correlation between pageviews driven by TrendMD and article saves on Mendeley (Spearman's rho r = 0.60). This is the first randomized controlled trial to show how an online cross-publisher distribution channel (TrendMD) enhances article saves on Mendeley. While replication and further study are needed, these data suggest that cross-publisher article recommendations via TrendMD may enhance citations of scholarly articles.

  8. Search Control Algorithm Based on Random Step Size Hill-Climbing Method for Adaptive PMD Compensation

    NASA Astrophysics Data System (ADS)

    Tanizawa, Ken; Hirose, Akira

    Adaptive polarization mode dispersion (PMD) compensation is required for the speed-up and advancement of the present optical communications. The combination of a tunable PMD compensator and its adaptive control method achieves adaptive PMD compensation. In this paper, we report an effective search control algorithm for the feedback control of the PMD compensator. The algorithm is based on the hill-climbing method. However, the step size changes randomly to prevent the convergence from being trapped at a local maximum or a flat, unlike the conventional hill-climbing method. The randomness depends on the Gaussian probability density functions. We conducted transmission simulations at 160Gb/s and the results show that the proposed method provides more optimal compensator control than the conventional hill-climbing method.

  9. [Intervention to reduce adolescents sexual risk behaviors: a randomized controlled trial].

    PubMed

    Gallegos, Esther C; Villarruel, Antonia M; Loveland-Cherry, Carol; Ronis, David L; Yan Zhou, Ms

    2008-01-01

    To test the efficacy of a behavioral intervention designed to decrease risk sexual behaviors for HIV/AIDS and unplanned pregnancies in Mexican adolescents. Randomized controlled trial with four follow ups; 832 adolescents recruited from high schools, age 14-17, were randomly assigned to the experimental or control group. The six hour intervention used active learning strategies, and was delivered in two sessions on two consecutive Saturdays. The study was carried out in Monterrey, Mexico, 2002-2005. GEE analysis indicated no differences in sexual relationships intentions between the two conditions, however, the experimental group had higher intentions to use condoms and contraceptives (mean differences 0.15 and 0.16, CI 95%) in the next three months, as compared with the control group. Theoretical variables, such as control beliefs, were significant mediators of the intervention. The behavioral intervention represents an important effort in promoting safe sexual behaviors among Mexican adolescents.

  10. Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

    PubMed

    Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

    2014-08-01

    Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Randomized controlled trial of the effectiveness of chlorhexidine showers before elective plastic surgical procedures.

    PubMed

    Veiga, Daniela Francescato; Damasceno, Carlos Américo Veiga; Veiga-Filho, Joel; Figueiras, Ricardo Góes; Vieira, Roberto Bezerra; Garcia, Edgard Silva; Silva, Virgínia Vilasboas; Novo, Neil Ferreira; Ferreira, Lydia Masako

    2009-01-01

    This randomized controlled trial was designed to assess the effect of preoperative chlorhexidine showers on skin colonization and postoperative infection rates associated with plastic surgical procedures involving the trunk. Chlorhexidine showers were effective in reducing skin colonization with coagulase-negative staphylococci and yeasts, but there was no difference in postoperative infection rates.

  12. Lower extremity power training in elderly subjects with moderate mobility limitations: A randomized controlled trial

    USDA-ARS?s Scientific Manuscript database

    Fifty-seven community-dwelling older adults were randomized to either high-velocity high-power training (POW), slow-velocity progressive resistance training (STR) or a control group of lower extremity stretching (CON). Training was performed three times per week for 12 weeks and subjects completed t...

  13. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    ERIC Educational Resources Information Center

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  14. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

    ERIC Educational Resources Information Center

    Braam, W.; Didden, R.; Smits, M.; Curfs, L.

    2008-01-01

    Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

  15. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  16. Randomized, Controlled Trial of a Comprehensive Program for Young Students with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Young, Helen E.; Falco, Ruth A.; Hanita, Makoto

    2016-01-01

    This randomized, controlled trial, comparing the Comprehensive Autism Program (CAP) and business as usual programs, studied outcomes for 3-5 year old students with autism spectrum disorder (ASD). Participants included 84 teachers and 302 students with ASD and their parents. CAP utilized specialized curricula and training components to implement…

  17. Reconsidering Findings of "No Effects" in Randomized Control Trials: Modeling Differences in Treatment Impacts

    ERIC Educational Resources Information Center

    Chaney, Bradford

    2016-01-01

    The primary technique that many researchers use to analyze data from randomized control trials (RCTs)--detecting the average treatment effect (ATE)--imposes assumptions upon the data that often are not correct. Both theory and past research suggest that treatments may have significant impacts on subgroups even when showing no overall effect.…

  18. Reconsidering Findings of "No Effects" in Randomized Control Trials: Modeling Differences in Treatment Impacts

    ERIC Educational Resources Information Center

    Chaney, Bradford

    2016-01-01

    The primary technique that many researchers use to analyze data from randomized control trials (RCTs)--detecting the average treatment effect (ATE)--imposes assumptions upon the data that often are not correct. Both theory and past research suggest that treatments may have significant impacts on subgroups even when showing no overall effect.…

  19. Searching for Control: Priming Randomness Increases the Evaluation of Ritual Efficacy

    ERIC Educational Resources Information Center

    Legare, Cristine H.; Souza, André L.

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual…

  20. Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

    USDA-ARS?s Scientific Manuscript database

    Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

  1. Attachment-Based Family Therapy for Adolescents with Suicidal Ideation: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Diamond, Guy S.; Wintersteen, Matthew B.; Brown, Gregory K.; Diamond, Gary M.; Gallop, Robert; Shelef, Karni; Levy, Suzanne

    2010-01-01

    Objective: To evaluate whether Attachment-Based Family Therapy (ABFT) is more effective than Enhanced Usual Care (EUC) for reducing suicidal ideation and depressive symptoms in adolescents. Method: This was a randomized controlled trial of suicidal adolescents between the ages of 12 and 17, identified in primary care and emergency departments. Of…

  2. Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

    ERIC Educational Resources Information Center

    Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

    2010-01-01

    Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

  3. Evaluation of Parent and Child Enhancement (PACE) Program: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Lo, Cyrus

    2017-01-01

    Objective: This study examined the efficacy of the Parent and Child Enhancement (PACE) program on child learning, child behavior problems, and parental stress, using randomized controlled trial design, in social services centers. Methods: Eligibility criteria were (1) children aged 2 years at program commencement, (2) low-income, new immigrant, or…

  4. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  5. Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

    ERIC Educational Resources Information Center

    Drits-Esser, Dina; Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K-12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The…

  6. Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

    ERIC Educational Resources Information Center

    Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

    2014-01-01

    This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

  7. Attention Training in Individuals with Generalized Social Phobia: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Amir, Nader; Beard, Courtney; Taylor, Charles T.; Klumpp, Heide; Elias, Jason; Burns, Michelle; Chen, Xi

    2009-01-01

    The authors conducted a randomized, double-blind placebo-controlled trial to examine the efficacy of an attention training procedure in reducing symptoms of social anxiety in 44 individuals diagnosed with generalized social phobia (GSP). Attention training comprised a probe detection task in which pictures of faces with either a threatening or…

  8. Randomized Controlled Non-Inferiority Trial of a Telehealth Treatment for Chronic Stuttering: The Camperdown Program

    ERIC Educational Resources Information Center

    Carey, Brenda; O'Brian, Sue; Onslow, Mark; Block, Susan; Jones, Mark; Packman, Ann

    2010-01-01

    Background: Although there are treatments that can alleviate stuttering in adults for clinically significant periods, in Australia there are barriers to the accessibility and availability of best-practice treatment. Aims: This parallel group, non-inferiority randomized controlled trial with multiple blinded outcome assessments investigated whether…

  9. Benefits and Harms of Sick Leave: Lack of Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Axelsson, Inge; Marnetoft, Sven-Uno

    2010-01-01

    The aim of this study was to try to identify those randomized controlled trials that compare sick leave with no sick leave or a different duration or degree of sick leave. A comprehensive, systematic, electronic search of Clinical Evidence, the Cochrane Library and PubMed, and a manual search of the Campbell Library and a journal supplement was…

  10. A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally.

    PubMed

    Solomon, Todd M; Leech, Jarrett; deBros, Guy B; Murphy, Cynthia A; Budson, Andrew E; Vassey, Elizabeth A; Solomon, Paul R

    2016-03-01

    Alpha BRAIN® is a nootropic supplement that purports to enhance cognitive functioning in healthy adults. The goal of this study was to investigate the efficacy of this self-described cognitive enhancing nootropic on cognitive functioning in a group of healthy adults by utilizing a randomized, double blind, placebo-controlled design. A total of 63-treatment naïve individuals between 18 and 35 years of age completed the randomized, double-blind, placebo controlled trial. All participants completed a 2-week placebo run in before receiving active product, Alpha BRAIN® or new placebo, for 6 weeks. Participants undertook a battery of neuropsychological tests at randomization and at study completion. Primary outcome measures included a battery of neuropsychological tests and measures of sleep. Compared with placebo, Alpha BRAIN® significantly improved on tasks of delayed verbal recall and executive functioning. Results also indicated significant time-by-group interaction in delayed verbal recall for the Alpha BRAIN® group. The use of Alpha BRAIN® for 6 weeks significantly improved recent verbal memory when compared with controls, in a group of healthy adults. While the outcome of the study is encouraging, this is the first randomized controlled trial of Alpha BRAIN®, and the results merit further study. Copyright © 2016 John Wiley & Sons, Ltd.

  11. Installing the Communities that Care Prevention System: Implementation Progress and Fidelity in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Quinby, Rose K.; Hanson, Koren; Brooke-Weiss, Blair; Arthur, Michael W.; Hawkins, J. David; Fagan, Abigail A.

    2008-01-01

    This article describes the degree to which high fidelity implementation of the Communities That Care (CTC) prevention operating system was reached during the first 18 months of intervention in 12 communities in the Community Youth Development Study, a 5-year group randomized controlled trial designed to test the efficacy of the CTC system. CTC…

  12. Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

    ERIC Educational Resources Information Center

    Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

    2010-01-01

    Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

  13. Efficacy of a Universal Parent Training Program (HOPE-20): Cluster Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Kwan, H. W.

    2017-01-01

    Objective: This study examined the efficacy of Hands-On Parent Empowerment-20 (HOPE-20) program. Methods: Eligible participants were parents residing in Hong Kong with target children aged 2 years attending nursery schools. Cluster randomized control trial was adopted, with 10 schools (110 participants) assigned to intervention group and 8 schools…

  14. The Results of a Randomized Control Trial Evaluation of the SPARK Literacy Program

    ERIC Educational Resources Information Center

    Jones, Curtis J.; Christian, Michael; Rice, Andrew

    2016-01-01

    The purpose of this report is to present the results of a two-year randomized control trial evaluation of the SPARK literacy program. SPARK is an early grade literacy program developed by Boys & Girls Clubs of Greater Milwaukee. In 2010, SPARK was awarded an Investing in Innovation (i3) Department of Education grant to further develop the…

  15. Learning What Works in ITS from Non-Traditional Randomized Controlled Trial Data

    ERIC Educational Resources Information Center

    Pardos, Zachary A.; Dailey, Matthew D.; Heffernan, Neil T.

    2011-01-01

    The well established, gold standard approach to finding out what works in education research is to run a randomized controlled trial (RCT) using a standard pre-test and post-test design. RCTs have been used in the intelligent tutoring community for decades to determine which questions and tutorial feedback work best. Practically speaking, however,…

  16. Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Goodkind, Jessica R.; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian L.; Baca, Brandon; Ndayisenga, Martin; Greene, R. Neil; Shantzek, Cece

    2017-01-01

    Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants' intervention experiences, and their…

  17. Vestibular Stimulation for ADHD: Randomized Controlled Trial of Comprehensive Motion Apparatus

    ERIC Educational Resources Information Center

    Clark, David L.; Arnold, L. Eugene; Crowl, Lindsay; Bozzolo, Hernan; Peruggia, Mario; Ramadan, Yaser; Bornstein, Robert; Hollway, Jill A.; Thompson, Susan; Malone, Krista; Hall, Kristy L.; Shelton, Sara B.; Bozzolo, Dawn R.; Cook, Amy

    2008-01-01

    Objective: This research evaluates effects of vestibular stimulation by Comprehensive Motion Apparatus (CMA) in ADHD. Method: Children ages 6 to 12 (48 boys, 5 girls) with ADHD were randomized to thrice-weekly 30-min treatments for 12 weeks with CMA, stimulating otoliths and semicircular canals, or a single-blind control of equal duration and…

  18. Randomized Controlled Trial of Transdermal Secretin on Behavior of Children with Autism

    ERIC Educational Resources Information Center

    Ratliff-Schaub, Karen; Carey, Tracy; Reeves, Gretchen; Rogers, Mary

    2005-01-01

    Previous trials of secretin for the treatment of autism have utilized a single or double dose administered intravenously. This is a report of a double-blind, randomized, controlled crossover trial of transdermally applied secretin in 15 children diagnosed with autism or pervasive developmental delay. Secretin or placebo was applied daily, in…

  19. Moderators of Theory-Based Interventions to Promote Physical Activity in 77 Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Bernard, Paquito; Carayol, Marion; Gourlan, Mathieu; Boiché, Julie; Romain, Ahmed Jérôme; Bortolon, Catherine; Lareyre, Olivier; Ninot, Gregory

    2017-01-01

    A meta-analysis of randomized controlled trials (RCTs) has recently showed that theory-based interventions designed to promote physical activity (PA) significantly increased PA behavior. The objective of the present study was to investigate the moderators of the efficacy of these theory-based interventions. Seventy-seven RCTs evaluating…

  20. Thinking outside the Randomized Controlled Trials Experimental Box: Strategies for Enhancing Credibility and Social Justice

    ERIC Educational Resources Information Center

    Hesse-Biber, Sharlene

    2013-01-01

    Some evaluators employ randomized controlled trials (RCTs) as the gold standard of evidence-based practice (EBP). Critics of RCT designs argue that RCTs do not include the complexity of program participants' experiences or clinical expertise, and couple this with criticisms that it is difficult to transfer RCT findings from the laboratory to…

  1. Training Anxious Children to Disengage Attention from Threat: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bar-Haim, Yair; Morag, Inbar; Glickman, Shlomit

    2011-01-01

    Background: Threat-related attention biases have been implicated in the etiology and maintenance of anxiety disorders. As a result, attention bias modification (ABM) protocols have been employed as treatments for anxious adults. However, they have yet to emerge for children. A randomized, double-blind placebo-controlled trial was conducted to…

  2. 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…

  3. Service Learning in Medical and Nursing Training: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, A. Y. M.; Chan, S. S. C.; Kwan, C. W.; Cheung, M. K. T.; Leung, S. S. K.; Fong, D. Y. T.

    2012-01-01

    The purpose of this study was to explore the long term effect of a service learning project on medical and nursing students' knowledge in aging and their attitudes toward older adults. A total of 124 students were recruited and then randomized to intervention group (IG) and control group (CG). A pre-and-post-intervention design measured students'…

  4. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

    ERIC Educational Resources Information Center

    Braam, W.; Didden, R.; Smits, M.; Curfs, L.

    2008-01-01

    Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

  5. An Empirical Comparison of Randomized Control Trials and Regression Discontinuity Estimations

    ERIC Educational Resources Information Center

    Barrera-Osorio, Felipe; Filmer, Deon; McIntyre, Joe

    2014-01-01

    Randomized controlled trials (RCTs) and regression discontinuity (RD) studies both provide estimates of causal effects. A major difference between the two is that RD only estimates local average treatment effects (LATE) near the cutoff point of the forcing variable. This has been cited as a drawback to RD designs (Cook & Wong, 2008).…

  6. Theory of Mind Training in Children with Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Begeer, Sander; Gevers, Carolien; Clifford, Pamela; Verhoeve, Manja; Kat, Kirstin; Hoddenbach, Elske; Boer, Frits

    2011-01-01

    Many children with Autism Spectrum Disorders (ASD) participate in social skills or Theory of Mind (ToM) treatments. However, few studies have shown evidence for their effectiveness. The current study used a randomized controlled design to test the effectiveness of a 16-week ToM treatment in 8-13 year old children with ASD and normal IQs (n = 40).…

  7. Fraction Intervention for Students with Mathematics Difficulties: Lessons Learned from Five Randomized Control Trials

    ERIC Educational Resources Information Center

    Fuchs, Lynn S.; Malone, Amelia S.; Schumacher, Robin F.; Namkung, Jessica; Wang, Amber

    2016-01-01

    The purpose of this article was to summarize results from 5 randomized control trials assessing the effects of intervention to improve the fraction performance of 4th-grade students at-risk for difficulty in learning about fractions. We begin by explaining the importance of competence with fractions and why an instructional focus on fractions…

  8. A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches

    DTIC Science & Technology

    2009-05-01

    Medical Therapies for Chronic Post- Traumatic Headaches PRINCIPAL INVESTIGATOR: Jay Erickson, M.D., Ph.D...4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches 5b. GRANT...of propranolol, topiramate, and amitriptyline as treatments for chronic post-traumatic headaches secondary to combat-related mild head injury. The

  9. Randomized Controlled Caregiver Mediated Joint Engagement Intervention for Toddlers with Autism

    ERIC Educational Resources Information Center

    Kasari, Connie; Gulsrud, Amanda C.; Wong, Connie; Kwon, Susan; Locke, Jill

    2010-01-01

    This study aimed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism. The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later. Compared to caregivers and toddlers randomized to the waitlist control group the immediate treatment (IT)…

  10. A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

    ERIC Educational Resources Information Center

    Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

    2014-01-01

    Objective: To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants: Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods: Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list…

  11. Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-01-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

  12. Determinants of glycemic control in youth with type 2 diabetes at randomization in the TODAY study

    USDA-ARS?s Scientific Manuscript database

    The purpose of this study was to investigate insulin sensitivity and secretion indices and determinants of glycemic control in youth with recent-onset type 2 diabetes (T2DM) at randomization in the TODAY study, the largest study of youth with T2DM to date. We examined estimates of insulin sensitivit...

  13. Effectiveness of a Parent Training Program in (Pre)Adolescence: Evidence from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leijten, Patty; Overbeek, Geertjan; Janssens, Jan M. A. M.

    2012-01-01

    The present randomized controlled trial examined the effectiveness of the parent training program Parents and Children Talking Together (PCTT) for parents with children in the preadolescent period who experience parenting difficulties. The program is focused on reducing child problem behavior by improving parents' communication and problem solving…

  14. Interpretation Training in Individuals with Generalized Social Anxiety Disorder: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Amir, Nader; Taylor, Charles T.

    2012-01-01

    Objective: To examine the efficacy of a multisession computerized interpretation modification program (IMP) in the treatment of generalized social anxiety disorder (GSAD). Method: The sample comprised 49 individuals meeting diagnostic criteria for GSAD who were enrolled in a randomized, double-blind placebo-controlled trial comparing IMP (n = 23)…

  15. Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

    2012-01-01

    This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

  16. Theory of Mind Training in Children with Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Begeer, Sander; Gevers, Carolien; Clifford, Pamela; Verhoeve, Manja; Kat, Kirstin; Hoddenbach, Elske; Boer, Frits

    2011-01-01

    Many children with Autism Spectrum Disorders (ASD) participate in social skills or Theory of Mind (ToM) treatments. However, few studies have shown evidence for their effectiveness. The current study used a randomized controlled design to test the effectiveness of a 16-week ToM treatment in 8-13 year old children with ASD and normal IQs (n = 40).…

  17. 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…

  18. Improving residents' end-of-life communication skills with a short retreat: a randomized controlled trial.

    PubMed

    Szmuilowicz, Eytan; el-Jawahri, Areej; Chiappetta, Laurel; Kamdar, Mihir; Block, Susan

    2010-04-01

    Internal medicine residents are largely unprepared to carry out end-of-life (EOL) conversations. There is evidence that these skills can be taught, but data from randomized controlled trials are lacking. We studied whether a day-long communication skills training retreat would lead to enhanced performance of and confidence with specific EOL conversations. We also studied the effect of the retreat on residents' ability to respond to patient emotions. PGY-2 resident volunteers were randomly assigned to a retreat group or a control group. The retreat involved a combination of teaching styles and skills practice with standardized patients. All participants completed questionnaires and were evaluated carrying out two types of conversations (breaking bad news or discussing direction of care) with a standardized patient before (T1) and after (T2) the intervention phase. Conversations were audio-taped and later rated by a researcher blinded to group assignment and time of assessment. Forty-nine residents agreed to randomization (88%) with 23 residents randomized to the retreat group and 26 to the control group. Compared to controls, retreat participants demonstrated higher T2 scores for breaking bad news, discussing direction of care, and responding to emotion. Comparing T2 to T1, the retreat group's improvement in responding to emotion was statistically significant. The retreat group's confidence improved significantly only for the breaking bad news construct. A short course for residents can significantly improve specific elements of resident EOL conversation performance, including the ability to respond to emotional cues.

  19. Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction

    ERIC Educational Resources Information Center

    Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C.

    2016-01-01

    Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard…

  20. Fluoxetine, Smoking, and History of Major Depression: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Spring, Bonnie; Doran, Neal; Pagoto, Sherry; McChargue, Dennis; Cook, Jessica Werth; Bailey, Katherine; Crayton, John; Hedeker, Donald

    2007-01-01

    The study was a randomized placebo-controlled trial testing whether fluoxetine selectively enhances cessation for smokers with a history of depression. Euthymic smokers with (H+, n = 109) or without (H-, n = 138) a history of major depression received 60 mg fluoxetine or placebo plus group behavioral quit-smoking treatment for 12 weeks. Fluoxetine…

  1. Searching for Control: Priming Randomness Increases the Evaluation of Ritual Efficacy

    ERIC Educational Resources Information Center

    Legare, Cristine H.; Souza, André L.

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual…

  2. Training Anxious Children to Disengage Attention from Threat: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bar-Haim, Yair; Morag, Inbar; Glickman, Shlomit

    2011-01-01

    Background: Threat-related attention biases have been implicated in the etiology and maintenance of anxiety disorders. As a result, attention bias modification (ABM) protocols have been employed as treatments for anxious adults. However, they have yet to emerge for children. A randomized, double-blind placebo-controlled trial was conducted to…

  3. Ice Hockey Players Using a Weighted Implement when Training on the Ice: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Stark, Timothy W.; Tvoric, Bojan; Walker, Bruce; Noonan, Dom; Sibla, Janeene

    2009-01-01

    The purpose of this study was to investigate the potential for improving hockey players' performance using a weighted implement on the ice. Forty-eight players were tested using a grip strength dynamometer. They also were assessed on their abilities to stick-handle. The participants were randomly placed into a control or research group. The…

  4. Randomized controlled trial to assess the effectiveness of a videotape about radiotherapy

    PubMed Central

    Harrison, R; Dey, P; Slevin, N J; Eardley, A; Gibbs, A; Cowan, R; Logue, J P; Leidecker, V; Hopwood, P

    2001-01-01

    In a randomized controlled trial, the additional provision of information on videotape was no more effective than written information alone in reducing pre-treatment worry about radiotherapy. Images of surviving cancer patients, however, may provide further reassurance to patients once therapy is completed. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11139305

  5. Evaluation of Parent and Child Enhancement (PACE) Program: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Lo, Cyrus

    2017-01-01

    Objective: This study examined the efficacy of the Parent and Child Enhancement (PACE) program on child learning, child behavior problems, and parental stress, using randomized controlled trial design, in social services centers. Methods: Eligibility criteria were (1) children aged 2 years at program commencement, (2) low-income, new immigrant, or…

  6. Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

    ERIC Educational Resources Information Center

    Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

    2010-01-01

    Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

  7. Management of Hypertension in Private Practice: A Randomized Controlled Trial in Continuing Medical Education.

    ERIC Educational Resources Information Center

    Gullion, David S.; And Others

    1988-01-01

    A randomized control trial was used to evaluate a physician education program designed to improve physician management of patients' hypertension, hypertension-related behaviors, and diastolic blood pressure. It was suggested that more intensive continuing medical education programs are needed to improve physician performance and patient outcome.…

  8. A Randomized Placebo-Controlled Trial of a School-Based Depression Prevention Program.

    ERIC Educational Resources Information Center

    Merry, Sally; McDowell, Heather; Wild, Chris J.; Bir, Julliet; Cunliffe, Rachel

    2004-01-01

    Objective: To conduct a placebo-controlled study of the effectiveness of a universal school-based depression prevention program. Method: Three hundred ninety-two students age 13 to 15 from two schools were randomized to intervention (RAP-Kiwi) and placebo programs run by teachers. RAP-Kiwi was an 11-session manual-based program derived from…

  9. Service Learning in Medical and Nursing Training: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, A. Y. M.; Chan, S. S. C.; Kwan, C. W.; Cheung, M. K. T.; Leung, S. S. K.; Fong, D. Y. T.

    2012-01-01

    The purpose of this study was to explore the long term effect of a service learning project on medical and nursing students' knowledge in aging and their attitudes toward older adults. A total of 124 students were recruited and then randomized to intervention group (IG) and control group (CG). A pre-and-post-intervention design measured students'…

  10. A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1

    ERIC Educational Resources Information Center

    Savage, Robert S.; Abrami, Philip; Hipps, Geoffrey; Deault, Louise

    2009-01-01

    This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http://grover.concordia.ca/abra/version1/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental…

  11. Learning What Works in ITS from Non-Traditional Randomized Controlled Trial Data

    ERIC Educational Resources Information Center

    Pardos, Zachary A.; Dailey, Matthew D.; Heffernan, Neil T.

    2011-01-01

    The well established, gold standard approach to finding out what works in education research is to run a randomized controlled trial (RCT) using a standard pre-test and post-test design. RCTs have been used in the intelligent tutoring community for decades to determine which questions and tutorial feedback work best. Practically speaking, however,…

  12. The Efficiency and Efficacy of Equivalence-Based Learning: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Zinn, Tracy E.; Newland, M. Christopher; Ritchie, Katie E.

    2015-01-01

    Because it employs an emergent-learning framework, equivalence-based instruction (EBI) is said to be highly efficient, but its presumed benefits must be compared quantitatively with alternative techniques. In a randomized controlled trial, 61 college students attempted to learn 32 pairs of proprietary and generic drug names using computer-based…

  13. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  14. Improving the General Language Skills of Second-Language Learners in Kindergarten: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rogde, Kristin; Melby-Lervåg, Monica; Lervåg, Arne

    2016-01-01

    Second-language learners display poorer general language skills in the language used at school than their monolingual peers, which is a concern because general language skills (vocabulary, grammar, language expression, and comprehension) provide the foundation for later academic success. In a randomized controlled trial, we examined the efficacy…

  15. Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Goodkind, Jessica R.; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian L.; Baca, Brandon; Ndayisenga, Martin; Greene, R. Neil; Shantzek, Cece

    2017-01-01

    Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants' intervention experiences, and their…

  16. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    ERIC Educational Resources Information Center

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  17. Randomized controlled trials of antibiotics for neonatal infections: a systematic review

    PubMed Central

    Kaguelidou, Florentia; Turner, Mark A; Choonara, Imti; van Anker, John; Manzoni, Paolo; Alberti, Corinne; Langhendries, Jean-Paul; Jacqz-Aigrain, Evelyne

    2013-01-01

    Aims Antibiotics are a key resource for the management of infectious diseases in neonatology and their evaluation is particularly challenging. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials on antibiotics in neonatal infections. Methods We performed a systematic search of PubMed, Embase and the Cochrane Library from January 1995 to March 2010. Bibliographies of relevant articles were also hand-searched. We included all randomized controlled trials that involved neonates and evaluated the use of an antibiotic agent in the context of a neonatal infectious disease. Methodological quality was evaluated using the Jadad scale and the Cochrane Risk of Bias Tool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality. Results A total of 35 randomized controlled trials were evaluated. The majority were conducted in a single hospital institution, without funding. Median sample size was 63 (34–103) participants. The most frequently evaluated antibiotic was gentamicin. Respectively, 18 (51%) and 17 (49%) trials evaluated the therapeutic or prophylactic use of antibiotics in various neonatal infections. Overall, the methodological quality was poor and did not improve over the years. Risk of bias was high in 66% of the trials. Conclusions Design and reporting of randomized controlled trials of antibacterial agents in neonates should be improved. Nevertheless, the necessity of implementing such trials when antibacterial efficacy has already been established in other age groups may be questioned and different methods of evaluation should be further developed. PMID:23488627

  18. Quantity and quality assessment of randomized controlled trials on orthodontic practice in PubMed.

    PubMed

    Shimada, Tatsuo; Takayama, Hisako; Nakamura, Yoshiki

    2010-07-01

    To find current high-quality evidence for orthodontic practice within a reasonable time, we tested the performance of a PubMed search. PubMed was searched using publication type randomized controlled trial and medical subject heading term "orthodontics" for articles published between 2003 and 2007. The PubMed search results were compared with those from a hand search of four orthodontic journals to determine the sensitivity of PubMed search. We evaluated the precision of the PubMed search result and assessed the quality of individual randomized controlled trials using the Jadad scale. Sensitivity and precision were 97.46% and 58.12%, respectively. In PubMed, of the 277 articles retrieved, 161 (58.12%) were randomized controlled trials on orthodontic practice, and 115 of the 161 articles (71.42%) were published in four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics. Assessment by the Jadad scale revealed 60 high-quality randomized controlled trials on orthodontic practice, of which 45 (75%) were published in these four journals. PubMed is a highly desirable search engine for evidence-based orthodontic practice. To stay current and get high-quality evidence, it is reasonable to look through four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics.

  19. Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

    ERIC Educational Resources Information Center

    Drits-Esser, Dina; Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K-12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The…

  20. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  1. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

    ERIC Educational Resources Information Center

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

    The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

  2. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  3. Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

    ERIC Educational Resources Information Center

    Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

    2014-01-01

    This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

  4. Covariate Adjustment Strategy Increases Power in the Randomized Controlled Trial With Discrete-Time Survival Endpoints

    ERIC Educational Resources Information Center

    Safarkhani, Maryam; Moerbeek, Mirjam

    2013-01-01

    In a randomized controlled trial, a decision needs to be made about the total number of subjects for adequate statistical power. One way to increase the power of a trial is by including a predictive covariate in the model. In this article, the effects of various covariate adjustment strategies on increasing the power is studied for discrete-time…

  5. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

    ERIC Educational Resources Information Center

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

    The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

  6. Randomized Controlled Trial of Transdermal Secretin on Behavior of Children with Autism

    ERIC Educational Resources Information Center

    Ratliff-Schaub, Karen; Carey, Tracy; Reeves, Gretchen; Rogers, Mary

    2005-01-01

    Previous trials of secretin for the treatment of autism have utilized a single or double dose administered intravenously. This is a report of a double-blind, randomized, controlled crossover trial of transdermally applied secretin in 15 children diagnosed with autism or pervasive developmental delay. Secretin or placebo was applied daily, in…

  7. Working Memory Training in Young Children with ADHD: A Randomized Placebo-Controlled Trial

    ERIC Educational Resources Information Center

    Dongen-Boomsma, Martine; Vollebregt, Madelon A.; Buitelaar, Jan K.; Slaats-Willemse, Dorine

    2014-01-01

    Background: Until now, working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD; for young children with ADHD, no studies are available. To this end, a triple-blind, randomized, placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training…

  8. Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-01-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

  9. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    ERIC Educational Resources Information Center

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  10. Treatment Preferences Affect the Therapeutic Alliance: Implications for Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Iacoviello, Brian M.; McCarthy, Kevin Scott; Barrett, Marna S.; Rynn, Moira; Gallop, Robert; Barber, Jacques P.

    2007-01-01

    The influence of treatment preferences on the development of the therapeutic alliance was investigated. Seventy-five patients were followed while participating in a randomized controlled trial comparing supportive-expressive psychotherapy with sertraline or pill placebo in the treatment of major depressive disorder. Therapeutic alliance was…

  11. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  12. Ice Hockey Players Using a Weighted Implement when Training on the Ice: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Stark, Timothy W.; Tvoric, Bojan; Walker, Bruce; Noonan, Dom; Sibla, Janeene

    2009-01-01

    The purpose of this study was to investigate the potential for improving hockey players' performance using a weighted implement on the ice. Forty-eight players were tested using a grip strength dynamometer. They also were assessed on their abilities to stick-handle. The participants were randomly placed into a control or research group. The…

  13. Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

    This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

  14. A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

    ERIC Educational Resources Information Center

    Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

    2014-01-01

    Objective: To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants: Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods: Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list…

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  16. Randomized, Controlled Trial of a Comprehensive Program for Young Students with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Young, Helen E.; Falco, Ruth A.; Hanita, Makoto

    2016-01-01

    This randomized, controlled trial, comparing the Comprehensive Autism Program (CAP) and business as usual programs, studied outcomes for 3-5 year old students with autism spectrum disorder (ASD). Participants included 84 teachers and 302 students with ASD and their parents. CAP utilized specialized curricula and training components to implement…

  17. Management of Hypertension in Private Practice: A Randomized Controlled Trial in Continuing Medical Education.

    ERIC Educational Resources Information Center

    Gullion, David S.; And Others

    1988-01-01

    A randomized control trial was used to evaluate a physician education program designed to improve physician management of patients' hypertension, hypertension-related behaviors, and diastolic blood pressure. It was suggested that more intensive continuing medical education programs are needed to improve physician performance and patient outcome.…

  18. Covariate Adjustment Strategy Increases Power in the Randomized Controlled Trial With Discrete-Time Survival Endpoints

    ERIC Educational Resources Information Center

    Safarkhani, Maryam; Moerbeek, Mirjam

    2013-01-01

    In a randomized controlled trial, a decision needs to be made about the total number of subjects for adequate statistical power. One way to increase the power of a trial is by including a predictive covariate in the model. In this article, the effects of various covariate adjustment strategies on increasing the power is studied for discrete-time…

  19. Scaling Academic Planning in Community College: A Randomized Controlled Trial. REL 2017-204

    ERIC Educational Resources Information Center

    Visher, Mary G.; Mayer, Alexander K.; Johns, Michael; Rudd, Timothy; Levine, Andrew; Rauner, Mary

    2016-01-01

    Community college students often lack an academic plan to guide their choices of coursework to achieve their educational goals, in part because counseling departments typically lack the capacity to advise students at scale. This randomized controlled trial tests the impact of guaranteed access to one of two alternative counseling sessions (group…

  20. Plasticity-Based Adaptive Cognitive Remediation (PACR) for OIF/OEF Veterans: A Randomized Controlled Trial

    DTIC Science & Technology

    2013-10-01

    Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Henry W. Mahncke, Ph.D. CONTRACTING ORGANIZATION: Brain Plasticity, Inc...WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Brain Plasticity Inc. AND ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT...TERMS traumatic brain injury, tbi, concussion, persistent post-concussive symptoms, cognition, cognitive function, cognitive rehabilitation