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Sample records for controlled trial 5-day

  1. Initiation of GnRH agonist treatment on 3-5 days postoperatively in endometriosis patients: a randomized controlled trial.

    PubMed

    Gong, Lili; Zhang, Shaofen; Han, Yi; Long, Qiqi; Zou, Shien; Cao, Yuankui

    2015-08-01

    Seventy patients with stage III or IV endometriosis were randomly assigned to 2 groups after conservative surgery. Group O (n = 35) received 3 cycles of a 28-day gonadotropin-releasing hormone agonist (GnRH-a) treatment (goserelin, 3.6 mg) starting 3-5 days postoperatively. Group M (n = 35) received the same treatment starting on days 1-5 of menstruation. Groups were further subdivided according to add-back treatment. Pre- and posttreated levels of estradiol (E2 ), follicle stimulating hormone (FSH), and luteinizing hormone (LH) and visual analog scale (VAS), Kupperman menopausal index (KMI), and bone mineral density (BMD) scores were recorded. The incidence of uterine bleeding was assessed. In both groups, serum levels of E2 , FSH, and LH and VAS scores decreased significantly after treatment. Spotting was the most frequent bleeding pattern. During cycle 1, the bleeding time in group M was much longer that than that in group O (P =.001), and the bleeding rate in group M was significantly higher than that in group O (P =.024, RR = 1.185). In patients with stage III or IV endometriosis, the efficacy of GnRH-a initiated 3-5 days postoperatively was equivalent to that of GnRH-a initiated on days 1-5 of menstruation. Female patients who initiated GnRH-a treatment 3-5 days postoperatively experienced less uterine bleeding during the first cycle of treatment.

  2. Impact of a fixed-dose combination of naproxen and esomeprazole magnesium on serum thromboxane B2 inhibition by low-dose aspirin over 5 days in healthy adults: a phase I, randomized, double-blind, placebo-controlled, noninferiority trial.

    PubMed

    Angiolillo, Dominick J; Hwang, Clara; Datto, Catherine; Desai, Bhaloo; Sostek, Mark

    2011-12-01

    Low-dose aspirin (LDA) and nonsteroidal anti-inflammatory drugs (NSAIDs) are often used concomitantly; however, some NSAIDs may interfere with LDA antiplatelet activity. We evaluated the impact of coadministered enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg (fixed-dose combination) on LDA-mediated platelet cyclooxygenase (COX)-1 inhibition. In this Phase I, single-center, double-blind, placebo-controlled study, healthy volunteers (50-75 years) received enteric-coated LDA 81 mg once daily (QD) on days 1 to 5 (open-label), then enteric-coated LDA 81 mg QD plus either naproxen/esomeprazole magnesium or placebo twice daily (BID) on days 6 to 10 (randomized). Serum thromboxane B(2) (TXB(2)) inhibition from baseline to day 11 was the primary end point. The primary analysis excluded volunteers with ≤95% inhibition at day 6. Assay sensitivity and noninferiority of naproxen/esomeprazole magnesium versus placebo were concluded if the 90% CI lower limit for percent inhibition of TXB(2) was >90.0% in both treatment groups (prespecified criterion). Tolerability was a secondary end point. Overall, 42 volunteers were enrolled, 40 randomized, and 32 included in the primary pharmacodynamic analysis (day 6 TXB(2) inhibition ≥95%). Most volunteers (86%) were white, and 57% were female. Mean age was 60 (7) years, and mean body mass index was 26.4 (2.6) kg/m(2). Day 11 mean serum TXB(2) inhibition was 99.1% (90% CI, 98.7-99.6) in the LDA plus placebo group (n = 18) versus 99.6% (90% CI, 99.4-99.8) in the LDA plus naproxen/esomeprazole magnesium group (n = 14). Noninferiority of naproxen/esomeprazole magnesium versus placebo was established (CI lower limit >90.0%). Adverse event (AE) incidence was 40% (n = 8/20) in the LDA plus placebo group and 15% (n = 3/20) in the LDA plus naproxen/esomeprazole magnesium group. No serious AEs or discontinuations due to AEs were observed. This pilot investigation suggests that LDA coadministered with naproxen

  3. Added Value of Avian Influenza (H5) Day-Old Chick Vaccination for Disease Control in Egypt.

    PubMed

    Peyre, Marisa; Choisy, Marc; Sobhy, Heba; Kilany, Walid H; Gély, Marie; Tripodi, Astrid; Dauphin, Gwenaëlle; Saad, Mona; Roger, François; Lubroth, Juan; Jobre, Yilma

    2016-05-01

    The immunity profile against H5N1 highly pathogenic avian influenza (HPAI) in the commercial poultry value chain network in Egypt was modeled with the use of different vaccination scenarios. The model estimated the vaccination coverage, the protective seroconversion level, and the duration of immunity for each node of the network and vaccination scenario. Partial budget analysis was used to compare the benefit-cost of the different vaccination scenarios. The model predicted that targeting day-old chick avian influenza (AI) vaccination in industrial and large hatcheries would increase immunity levels in the overall poultry population in Egypt and especially in small commercial poultry farms (from <30% to >60%). This strategy was shown to be more efficient than the current strategy of using inactivated vaccines. Improving HPAI control in the commercial poultry sector in Egypt would have a positive impact to improve disease control.

  4. Short, frequent, 5-days-per-week, in-center hemodialysis versus 3-days-per week treatment: a randomized crossover pilot trial through the Midwest Pediatric Nephrology Consortium.

    PubMed

    Laskin, Benjamin L; Huang, Guixia; King, Eileen; Geary, Denis F; Licht, Christoph; Metlay, Joshua P; Furth, Susan L; Kimball, Tom; Mitsnefes, Mark

    2017-08-01

    No controlled trials in children with end-stage kidney disease have assessed the benefits of more frequently administered hemodialysis (HD). We conducted a multicenter, crossover pilot trial to determine if short, more frequent (5 days per week) in-center HD was feasible and associated with improvements in blood pressure compared with three conventional HD treatments per week. Because adult studies have not controlled for the weekly duration of dialysis, we fixed the total treatment time at 12 h a week of dialysis during two 3-month study periods; only frequency varied from 5 to 3 days per week between study periods. Eight children (median age 16.7 years) consented at three children's hospitals. The prespecified primary composite outcome was a sustained 10% decrease in systolic blood pressure and/or a decrease in antihypertensive medications relative to each study period's baseline. Among the six patients completing both study periods, five (83.3%) experienced the primary outcome during HD performed 5 days per week but not 3 days per week; one of the six (16.7%) achieved that outcome during 3-day but not 5-day (p = 0.22) per week HD. During 5-day HD, all patients had significantly more treatments during which their pre-HD systolic (p = 0.01) or diastolic (p = 0.01) blood pressure was 10% lower than baseline. We observed that more frequent HD sessions per week was feasible and associated with improved blood pressure control, but barriers to changing thrice-weekly standard of care include financial reimbursement and the time demands associated with more frequent treatments.

  5. Comparison of 4- versus 5-day Co-Synch + controlled internal drug release (CIDR) + timed artificial insemination protocols in dairy heifers.

    PubMed

    Palomares, Roberto A; Fishman, Heidi J; Jones, Arthur L; Ferrer, Maria S; Jenerette, Mathews; Vaughn, Aimee

    2015-10-01

    The objective of this study was to compare the pregnancy rate after timed artificial insemination (P/TAI) in dairy heifers treated with 4- versus 5-day Co-Synch + controlled internal drug release (CIDR) protocols. A total of 120 Holstein heifers were randomly assigned to one of two groups. The heifers received an intravaginal CIDR insert containing 1.38 g of progesterone for 4 days (Monday-Friday 4-day Co-Synch + CIDR; n = 60) or 5 days (5-day Co-Synch + CIDR; n = 60). At the time of CIDR removal, 25 mg of PGF2α was injected intramuscularly, and 72 hours after CIDR removal, the heifers received 100 μg of GnRH intramuscularly and were artificially inseminated. Artificial insemination was performed by an experienced technician, using commercial frozen-thawed semen from a single sire. Pregnancy diagnosis was performed by ultrasonography per rectum 32 days after TAI. Categorical data were analyzed using proc logistic and the chi-square test, whereas continuous variables were analyzed using the t-test of Statistical Analysis Systems. Heifers in the 4-day Co-Synch + CIDR group had an acceptable P/TAI32 (55.0%, 33 of 60), which was not different (P = 0.35) from that observed in the 5-day Co-Synch + CIDR group (63.3%, 38 of 60). Progesterone concentration at CIDR insertion or estradiol concentration at TAI did not influence the pregnancy outcomes. Interestingly, estradiol concentration at TAI was greater in the 4-day Co-Synch + CIDR group compared to the 5-day Co-Synch + CIDR group (P < 0.01). In conclusion, the Monday to Friday 4-day Co-Synch + CIDR protocol resulted in adequate P/TAI in dairy heifers, which was similar to that of the 5-day Co-Synch + CIDR protocol. This novel protocol might represent a promising hormonal treatment for TAI in dairy heifers, facilitating their reproductive management routine, while maintaining an adequate fertility. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Evaluation of Biomarkers of Exposure in Smokers Switching to a Carbon-Heated Tobacco Product: A Controlled, Randomized, Open-Label 5-Day Exposure Study

    PubMed Central

    Haziza, Christelle; Weitkunat, Rolf; Magnette, John

    2016-01-01

    Introduction: Tobacco harm reduction aims to provide reduced risk alternatives to adult smokers who would otherwise continue smoking combustible cigarettes (CCs). This randomized, open-label, three-arm, parallel-group, single-center, short-term confinement study aimed to investigate the effects of exposure to selected harmful and potentially harmful constituents (HPHCs) of cigarette smoke in adult smokers who switched to a carbon-heated tobacco product (CHTP) compared with adult smokers who continued to smoke CCs and those who abstained from smoking for 5 days. Methods: Biomarkers of exposure to HPHCs, including nicotine and urinary excretion of mutagenic material, were measured in 24-hour urine and blood samples in 112 male and female Caucasian smokers switching from CCs to the CHTP ad libitum use. Puffing topography was assessed during product use. Results: Switching to the CHTP or smoking abstinence (SA) resulted in marked decreases from baseline to Day 5 in all biomarkers of exposure measured, including carboxyhemoglobin (43% and 55% decrease in the CHTP and SA groups, respectively). The urinary excretion of mutagenic material was also markedly decreased on Day 5 compared with baseline (89% and 87% decrease in the CHTP and SA groups, respectively). No changes in biomarkers of exposure to HPHCs or urinary mutagenic material were observed between baseline and Day 5 in the CC group. Conclusions: Our results provide clear evidence supporting a reduction in the level of exposure to HPHCs of tobacco smoke in smokers who switch to CHTP under controlled conditions, similar to that observed in SA. Implications: The reductions observed in biomarkers of exposure to HPHCs of tobacco smoke in this short-term study could potentially also reduce the incidence of cancer, cardiovascular and respiratory diseases in those smokers who switch to a heated tobacco product. PMID:26817490

  7. BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial.

    PubMed

    Butler, Karina; Inshaw, Jamie; Ford, Deborah; Bernays, Sarah; Scott, Karen; Kenny, Julia; Klein, Nigel; Turkova, Anna; Harper, Lynda; Nastouli, Eleni; Paparini, Sara; Choudhury, Rahela; Rhodes, Tim; Babiker, Abdel; Gibb, Diana

    2016-06-01

    For human immunodeficiency virus (HIV)-infected adolescents facing lifelong antiretroviral therapy (ART), short-cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity, better adherence and cost savings. To determine whether or not efavirenz (EFV)-based ART in short cycles of 5 days on and 2 days off is as efficacious (in maintaining virological suppression) as continuous EFV-based ART (continuous therapy; CT). Secondary objectives included the occurrence of new clinical HIV events or death, changes in immunological status, emergence of HIV drug resistance, drug toxicity and changes in therapy. Open, randomised, non-inferiority trial. Europe, Thailand, Uganda, Argentina and the USA. Young people (aged 8-24 years) on EFV plus two nucleoside reverse transcriptase inhibitors and with a HIV-1 ribonucleic acid level [viral load (VL)] of < 50 copies/ml for > 12 months. Young people were randomised to continue daily ART (CT) or change to SCT (5 days on, 2 days off ART). Follow-up was for a minimum of 48 weeks (0, 4 and 12 weeks and then 12-weekly visits). The primary outcome was the difference between arms in the proportion with VL > 50 copies/ml (confirmed) by 48 weeks, estimated using the Kaplan-Meier method (12% non-inferiority margin) adjusted for region and age. In total, 199 young people (11 countries) were randomised (n = 99 SCT group, n = 100 CT group) and followed for a median of 86 weeks. Overall, 53% were male; the median age was 14 years (21% ≥ 18 years); 13% were from the UK, 56% were black, 19% were Asian and 21% were Caucasian; and the median CD4% and CD4 count were 34% and 735 cells/mm(3), respectively. By week 48, only one participant (CT) was lost to follow-up. The SCT arm had a 27% decreased drug exposure as measured by the adherence questionnaire and a MEMSCap(™) Medication Event Monitoring System (MEMSCap Inc., Durham, NC, USA) substudy (median cap openings per week: SCT group

  8. A trial of levofloxacin 750 mg once daily for 5 days versus ciprofloxacin 400 mg and/or 500 mg twice daily for 10 days in the treatment of acute pyelonephritis.

    PubMed

    Klausner, Howard A; Brown, Patricia; Peterson, Janet; Kaul, Simrati; Khashab, Mohammed; Fisher, Alan C; Kahn, James B

    2007-11-01

    A double-blind, noninferiority trial was conducted to establish the safety and efficacy of a once-daily, 5-day course of levofloxacin 750 mg compared to a twice-daily, 10-day course of ciprofloxacin in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). This report focuses on subjects with AP. Adult male and female subjects with clinical signs and symptoms of AP and laboratory confirmation of their diagnosis were randomized to receive one dose of levofloxacin 750 mg once daily intravenously (i.v.) or orally and one dose of placebo for 5 days, followed by placebo; or ciprofloxacin 400 mg i.v. and/or 500 mg orally twice daily for 10 days. The primary, prospectively defined end point was microbiologic eradication at post-therapy (study days 15-22). Secondary outcomes included clinical response and safety and tolerability. In the modified intent-to-treat (mITT) population (levofloxacin 94, ciprofloxacin 98), 83% of levofloxacin-treated and 79.6% of ciprofloxacin-treated subjects achieved microbiological eradication (difference -3.4, 95% CI -14.4%, 7.6%). In the microbiologically evaluable (ME) population (levofloxacin 80, ciprofloxacin 76), 92.5% of levofloxacin-treated vs. 93.4% of ciprofloxacin-treated subjects (difference -0.9, 95% CI -7.1%, 8.9%) achieved microbiologic eradication. Clinical success was achieved in 86.2% vs. 80.6% (mITT) and in 92.5% vs. 89.5% (ME) of levofloxacin-treated and ciprofloxacin-treated subjects, respectively. Escherichia coli was the most commonly isolated uropathogen. Few (2.1%) of the pathogens were fluoroquinolone-resistant. Adverse events (AEs) were similar to those seen previously with both agents. Potential limitations are that this analysis is based on a subset of subjects from a larger study and, because of different durations of therapy, the results may be biased against levofloxacin. High-dose, short-course therapy with levofloxacin in subjects with AP is at least as effective as standard 10-day therapy

  9. Your Child's Development: 3-5 Days

    MedlinePlus

    ... Feeding Your 1- to 2-Year-Old Your Child’s Development: 3-5 Days KidsHealth > For Parents > Your Child’s Development: 3-5 Days A A A Though only ... the sole of the foot Social and Emotional Development soothed by a ... When to Talk to Your Doctor Every child develops at his or her own pace, but ...

  10. Your Child's Development: 3-5 Days

    MedlinePlus

    ... 2-Year-Old Your Child’s Development: 3-5 Days KidsHealth > For Parents > Your Child’s Development: 3-5 Days Print A A A en español El desarrollo ... hijo: 3-5 días Though only a few days old, your baby already is able to interact ...

  11. Birth Control in Clinical Trials

    PubMed Central

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  12. Nuclear criticality safety: 5-day training course

    SciTech Connect

    Schlesser, J.A.

    1992-11-01

    This compilation of notes is presented as a source reference for the criticality safety course. It represents the contributions of many people, particularly Tom McLaughlin, the course's primary instructor. At the completion of this training course, the attendee will: be able to define terms commonly used in nuclear criticality safety; be able to appreciate the fundamentals of nuclear criticality safety; be able to identify factors which affect nuclear criticality safety; be able to identify examples of criticality controls as used at Los Alamos; be able to identify examples of circumstances present during criticality accidents; be able to identify examples of computer codes used by the nuclear criticality safety specialist; be able to identify examples of safety consciousness required in nuclear criticality safety.

  13. Nuclear criticality safety: 5-day training course

    SciTech Connect

    Schlesser, J.A.

    1992-11-01

    This compilation of notes is presented as a source reference for the criticality safety course. It represents the contributions of many people, particularly Tom McLaughlin, the course`s primary instructor. At the completion of this training course, the attendee will: be able to define terms commonly used in nuclear criticality safety; be able to appreciate the fundamentals of nuclear criticality safety; be able to identify factors which affect nuclear criticality safety; be able to identify examples of criticality controls as used at Los Alamos; be able to identify examples of circumstances present during criticality accidents; be able to identify examples of computer codes used by the nuclear criticality safety specialist; be able to identify examples of safety consciousness required in nuclear criticality safety.

  14. Basic problems in controlled trials.

    PubMed Central

    Burkhardt, R; Kienle, G

    1983-01-01

    On the basis of critical discussions which have taken place in recent years in the Federal Republic of Germany, certain methodological, ethical and legal problems arising in relation to controlled trials are discussed. Because of methodological inconsistencies inherent in the experimental approach, the efficacy of a drug must in any case be judged by physicians. This leads to major ethical and even--at least in Germany--legal problems which impose considerable limits on the feasibility of controlled trials in Germany. Editor's note: This paper is written at the invitation of the journal, following the considerable controversy on the ethics of clinical trials in the European Journal of Clinical Pharmacology (8-11). A critical commentary follows the paper with a short response from the authors and a further response from the commentator. PMID:6876102

  15. 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…

  16. 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…

  17. Supported employment: randomised controlled trial*

    PubMed Central

    Howard, Louise M.; Heslin, Margaret; Leese, Morven; McCrone, Paul; Rice, Christopher; Jarrett, Manuela; Spokes, Terry; Huxley, Peter; Thornicroft, Graham

    2010-01-01

    Background There is evidence from North American trials that supported employment using the individual placement and support (IPS) model is effective in helping individuals with severe mental illness gain competitive employment. There have been few trials in other parts of the world. Aims To investigate the effectiveness and cost-effectiveness of IPS in the UK. Method Individuals with severe mental illness in South London were randomised to IPS or local traditional vocational services (treatment as usual) (ISRCTN96677673). Results Two hundred and nineteen participants were randomised, and 90% assessed 1 year later. There were no significant differences between the treatment as usual and intervention groups in obtaining competitive employment (13% in the intervention group and 7% in controls; risk ratio 1.35, 95% CI 0.95–1.93, P = 0.15), nor in secondary outcomes. Conclusions There was no evidence that IPS was of significant benefit in achieving competitive employment for individuals in South London at 1-year follow-up, which may reflect suboptimal implementation. Implementation of IPS can be challenging in the UK context where IPS is not structurally integrated with mental health services, and economic disincentives may lead to lower levels of motivation in individuals with severe mental illness and psychiatric professionals. PMID:20435968

  18. NASA Animation Shows Hurricane Otto Over 5 Days

    NASA Image and Video Library

    A 5-day movie of NOAA's GOES-East satellite infrared and visible imagery of Hurricane Otto was created by the NASA/NOAA GOES Project at NASA's Goddard Space Flight Center in Greenbelt, Maryland. Th...

  19. The Internet and randomised controlled trials.

    PubMed

    Kelly, M A; Oldham, J

    1997-11-01

    Several factors constrain the implementation of Randomised Controlled Trials (RCTs). To obtain large sample sizes a multicentred multinational trial may be necessary or a long sampling period. The larger the trial the larger is the unit cost. To allow larger sample sizes, shorter sampling periods and lower unit costs, new methods are needed. The Internet and in particular the WWW provides such an opportunity. The WWW can provide global access, fast interaction and automation. A prototype Internet Trials Service (ITS) is currently being tested with a real international clinical trial (the Growth Restriction Intervention Trial--GRIT). The ITS is hosted on a Web server. It provides a series of HTML documents that describe the GRIT protocol. Registered centres may enter patients into the GRIT trial via ITS. Java applets are used to collect trial data before returning the study number and randomisation. ITS assumes all trial data will be intercepted by a sniffer. Therefore no information is sent that could specifically identify a patient, this must be sent later by more secure means. ITS assumes that trial centres can be spoofed. To authenticate the patients entered into the trial and the trial data sent, a regular audit report is sent to each centre by secure means for confirmation. By using Java, a full functional data entry system can be developed that runs locally within any Java enabled browser. It can perform data validation locally and also provide a sophisticated user interface.

  20. Effect of visual biofeedback to acquire supraglottic swallow in healthy individuals: a randomized-controlled trial.

    PubMed

    Imada, Miho; Kagaya, Hitoshi; Ishiguro, Yuriko; Kato, Miho; Inamoto, Yoko; Tanaka, Takashi; Shibata, Seiko; Saitoh, Eiichi

    2016-06-01

    The aim of this study is to evaluate the effect of visual biofeedback therapy in acquiring supraglottic swallow (SGS) in a randomized-controlled trial with healthy individuals. Eighteen individuals (mean age, 26 years) who could not close or keep closed the vocal folds before and during the swallow in SGS were allocated randomly to either a visual biofeedback group (eight individuals) or a nonbiofeedback group (10 individuals). A videoendoscope was inserted intranasally and an SGS exercise, using 4 ml of green-colored water, was performed 30 times per day up to 5 days. When the participant failed to perform SGS, the result was provided only to the participants in the visual biofeedback group. The median length of time until acquiring SGS was 1.5 days in the visual biofeedback group and 3.5 days in the nonbiofeedback group (P=0.040). We concluded that visual biofeedback effectively enabled participants to acquire SGS earlier.

  1. Radiation-Free Weekend Rescued! Continuous Accelerated Irradiation of 7-Days per Week Is Equal to Accelerated Fractionation With Concomitant Boost of 7 Fractions in 5-Days per Week: Report on Phase 3 Clinical Trial in Head-and-Neck Cancer Patients

    SciTech Connect

    Skladowski, Krzysztof; Hutnik, Marcin; Wygoda, Andrzej; Golen, Maria; Pilecki, Boleslaw; Przeorek, Wieslawa; Rutkowski, Tomasz; Lukaszczyk-Widel, Beata; Heyda, Alicja; Suwinski, Rafal; Tarnawski, Rafal; Maciejewski, Boguslaw

    2013-03-01

    Purpose: To report long-term results of randomized trial comparing 2 accelerated fractionations of definitive radiation therapy assessing the need to irradiate during weekend in patients with head and neck squamous cell carcinoma. Methods and Materials: A total of 345 patients with SCC of the oral cavity, larynx, and oro- or hypo-pharynx, stage T2-4N0-1M0, were randomized to receive continuous accelerated irradiation (CAIR: once per day, 7 days per week) or concomitant accelerated boost (CB: once per day, 3 days per week, and twice per day, 2 days per week). Total dose ranged from 66.6-72 Gy, dose per fraction was 1.8 Gy, number of fractions ranged from 37-40 fractions, and overall treatment time ranged from 37-40 days. Results: No differences for all trial end-points were noted. At 5 and 10 years, the actuarial rates of local-regional control were 63% and 60% for CAIR vs 65% and 60% for CB, and the corresponding overall survival were 40% and 25% vs 44% and 25%, respectively. Confluent mucositis was the main acute toxicity, with an incidence of 89% in CAIR and 86% in CB patients. The 5-year rate of grade 3-4 late radiation morbidity was 6% for both regimens. Conclusions: Results of this trial indicate that the effects of accelerated fractionation can be achieve by delivering twice-per-day irradiation on weekday(s). This trial has also confirmed that an accelerated, 6-weeks schedule is a reasonable option for patients with intermediate-stage head-and-neck squamous cell carcinoma because of the associated high cure rate and minimal severe late toxicity.

  2. A randomised controlled trial of nurse-managed trial conclusion following early phase cancer trial participation.

    PubMed

    Cox, K; Wilson, E; Arthur, A; Elkan, R; Armstrong, S

    2005-07-11

    The effect of a nurse-managed intervention, for early phase cancer trial participants at trial conclusion, on psychosocial outcomes was evaluated at two cancer centres in the Midlands, England using a randomised controlled trial. It involved 117 patients who were participating in an early phase cancer clinical trial. It was a nurse-managed trial exit, which included a trial exit interview, trial feedback information leaflet and telephone follow-up compared with standard care at trial conclusion. Psychological distress at 1 week and 4-6 weeks post-trial conclusion, patient's knowledge and understanding and patient's satisfaction were assessed. The results showed there was no significant difference between the two groups regarding scores for anxiety and depression at time one and time two. There is some suggestion that the intervention reduced anxiety from trial conclusion to follow-up (P=0.27). Patients in both groups felt they had contributed to cancer research through trial participation. However, intervention patients were more likely to feel that they knew how the trial was going (P<0.001), knew how other people in the trial were doing (P=0.001), had all the feedback they needed about the trial they took part in (P<0.01) and knew how they would be followed up (P=0.02). Patient satisfaction with the intervention was high (median score=4.5 where 5 is greatest satisfaction). In conclusion, nurse-managed trial conclusion led to positive outcomes for patients who had recently completed a clinical trial.

  3. Swiss regulations for controlling clinical trials.

    PubMed

    Zanini, G M

    1998-04-01

    Switzerland has recently issued regulations designed to control all trials with drugs in human subjects, namely the 'Regolamento dell'Ufficio Intercantonale per il controllo dei medicamenti in fase di studio clinico' (Intercantonal Regulations Controlling Drugs used in Clinical Trials), which have been operating since 1st January 1995. These new regulations are generally consistent with other international regulations and have introduced the concept of good clinical practice (GCP) into Switzerland. There are other regulations in Switzerland, such as Federal regulations on immunobiological products, special rules governing the administration of radiolabelled drugs to humans, drugs of abuse and medical devices. Any gap in the central regulations must be filled by cantonal regulations, where they exist. This is a comprehensive review of the regulations governing clinical trials in Switzerland, with special attention being devoted to trials with therapeutic compounds and to compatibility between Swiss and international procedures.

  4. Razors versus clippers. A randomised controlled trial.

    PubMed

    Taylor, Tracy; Tanner, Judith

    2005-12-01

    The purpose of this randomised controlled trial was to determine if patients showed a preference for preoperative hair removal with razors or clippers and to identify if one method was associated with more trauma or postoperative infections. The trial took place in a day surgery unit with patients who were having a range of surgical procedures including hernias and varicose veins. This study was sponsored by an award from the NATN/3M Clinical Fellowship.

  5. 5-Day repeated inhalation and 28-day post-exposure study of graphene.

    PubMed

    Shin, Jae Hoon; Han, Sung Gu; Kim, Jin Kwon; Kim, Boo Wook; Hwang, Joo Hwan; Lee, Jong Seong; Lee, Ji Hyun; Baek, Jin Ee; Kim, Tae Gyu; Kim, Keun Soo; Lee, Heon Sang; Song, Nam Woong; Ahn, Kangho; Yu, Il Je

    2015-01-01

    Graphene has recently been attracting increasing attention due to its unique electronic and chemical properties and many potential applications in such fields as semiconductors, energy storage, flexible electronics, biosensors and medical imaging. However, the toxicity of graphene in the case of human exposure has not yet been clarified. Thus, a 5-day repeated inhalation toxicity study of graphene was conducted using a nose-only inhalation system for male Sprague-Dawley rats. A total of three groups (20 rats per group) were compared: (1) control (ambient air), (2) low concentration (0.68 ± 0.14 mg/m(3) graphene) and (3) high concentration (3.86 ± 0.94 mg/m(3) graphene). The rats were exposed to graphene for 6 h/day for 5 days, followed by recovery for 1, 3, 7 or 28 days. The bioaccumulation and macrophage ingestion of the graphene were evaluated in the rat lungs. The exposure to graphene did not change the body weights or organ weights of the rats after the 5-day exposure and during the recovery period. No statistically significant difference was observed in the levels of lactate dehydrogenase, protein and albumin between the exposed and control groups. However, graphene ingestion by alveolar macrophages was observed in the exposed groups. Therefore, these results suggest that the 5-day repeated exposure to graphene only had a minimal toxic effect at the concentrations and time points used in this study.

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

    PubMed Central

    2012-01-01

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

  7. 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.

  8. Tramadol versus codeine/acetaminophen after pediatric tonsillectomy: A prospective, double-blinded, randomized controlled trial.

    PubMed

    Friedrichsdorf, Stefan J; Postier, Andrea C; Foster, Laurie Pane; Lander, Timothy A; Tibesar, Robert J; Lu, Yi; Sidman, James D

    2015-01-01

    Tonsillectomy is one of the most common pediatric surgical procedures performed in the United States. The postoperative period can be particularly painful, and there is currently no consensus on an optimal analgesic regimen. The objective of this study was to evaluate efficacy and safety of the single drug tramadol versus codeine/acetaminophen post-tonsillectomy. Prospective, double-blinded, randomized controlled trial. Large, Midwestern US pediatric hospital. Eighty-four children aged 4-15 years who underwent a tonsillectomy (with or without adenoidectomy) procedure were randomized and 74 were included in the analysis. Group 1 received liquid codeine/acetaminophen for 10 days post-tonsillectomy (5 days scheduled, followed by 5 days as-needed). Group 2 received liquid tramadol for 10 days post-tonsillectomy (5 days scheduled, followed by 5 days as-needed). Efficacy and side effects were evaluated using a 10-day take-home diary that was completed by parents. Children in both study arms reported adequate post-tonsillectomy pain management without significant differences between groups in pain scores. Oversedation was significantly higher on the day of surgery in the codeine/acetaminophen group, and itching was experienced by significantly more children in the tramadol group during the postoperative period. As part of multimodal analgesia, scheduled plus as-needed tramadol may be considered for children in the postoperative setting due to its analgesic properties, low potential for side effects, and good safety profile.

  9. Pilot study: rapidly cycling hypobaric pressure improves pain after 5 days in adiposis dolorosa.

    PubMed

    Herbst, Karen L; Rutledge, Thomas

    2010-08-20

    Adiposis dolorosa (AD) is a rare disorder of painful nodular subcutaneous fat accompanied by fatigue, difficulty with weight loss, inflammation, increased fluid in adipose tissue (lipedema and lymphedema), and hyperalgesia. Sequential compression relieves lymphedema pain; we therefore hypothesized that whole body cyclic pneumatic hypobaric compression may relieve pain in AD. To avoid exacerbating hyperalgesia, we utilized a touch-free method, which is delivered via a high-performance altitude simulator, the Cyclic Variations in Altitude Conditioning™ (CVAC™) process. As a pilot study, 10 participants with AD completed pain and quality of life questionnaires before and after 20-40 minutes of CVAC process daily for 5 days. Participants lost weight (195.5 ± 17.6-193.8 ± 17.3 lb; P = 0.03), and bioimpedance significantly decreased (510 ± 36-490 ± 38 ohm; P = 0.01). There was a significant decrease in scores on the Pain Catastrophizing Scale (P = 0.039), in average (P = 0.002), highest (P = 0.029), lowest (P = 0.04), and current pain severity (P = 0.02) on the Visual Analogue Scale, but there was no change in pain quality by the McGill Pain Questionnaire. There were no significant changes in total and physical SF-36 scores, but the mental score improved significantly (P = 0.049). There were no changes in the Pain Disability Index or Pittsburgh Sleep Quality Index. These data present a potential, new, noninvasive means of treating pain in AD by whole body pneumatic compression as part of the CVAC process. Although randomized, controlled trials are needed to confirm these data, the CVAC process could potentially help in treating AD pain and other chronic pain disorders.

  10. Pilot study: rapidly cycling hypobaric pressure improves pain after 5 days in adiposis dolorosa

    PubMed Central

    Herbst, Karen L; Rutledge, Thomas

    2010-01-01

    Adiposis dolorosa (AD) is a rare disorder of painful nodular subcutaneous fat accompanied by fatigue, difficulty with weight loss, inflammation, increased fluid in adipose tissue (lipedema and lymphedema), and hyperalgesia. Sequential compression relieves lymphedema pain; we therefore hypothesized that whole body cyclic pneumatic hypobaric compression may relieve pain in AD. To avoid exacerbating hyperalgesia, we utilized a touch-free method, which is delivered via a high-performance altitude simulator, the Cyclic Variations in Altitude Conditioning™ (CVAC™) process. As a pilot study, 10 participants with AD completed pain and quality of life questionnaires before and after 20–40 minutes of CVAC process daily for 5 days. Participants lost weight (195.5 ± 17.6–193.8 ± 17.3 lb; P = 0.03), and bioimpedance significantly decreased (510 ± 36–490 ± 38 ohm; P = 0.01). There was a significant decrease in scores on the Pain Catastrophizing Scale (P = 0.039), in average (P = 0.002), highest (P = 0.029), lowest (P = 0.04), and current pain severity (P = 0.02) on the Visual Analogue Scale, but there was no change in pain quality by the McGill Pain Questionnaire. There were no significant changes in total and physical SF-36 scores, but the mental score improved significantly (P = 0.049). There were no changes in the Pain Disability Index or Pittsburgh Sleep Quality Index. These data present a potential, new, noninvasive means of treating pain in AD by whole body pneumatic compression as part of the CVAC process. Although randomized, controlled trials are needed to confirm these data, the CVAC process could potentially help in treating AD pain and other chronic pain disorders. PMID:21197318

  11. 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…

  12. 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…

  13. Ethical issues in naturalistic versus controlled trials

    PubMed Central

    Helmchen, Hanfried

    2011-01-01

    Ethical core issues in research with human subjects are related to informed consent and risk-benefit assessment. This is valid for all types of studies. However, there has been much greater focus of ethical considerations on controlled clinical trials than on naturalistic trials, probably because the former are interventional in nature and may have unknown and perhaps severe somatic risks, whereas naturalistic studies seem not to intervene but only to observe, and therefore are assumed to have fewer or almost no risks. However, there are also ethical implications in naturalistic trials, although their weight is differently accentuated, more with potential, more with potential psychological burdens of the observational procedures and more with potential physical risks in interventional trials. This will be elaborated with examples of placebo-controlled trials and of incidental findings in screenings, of marketing influences on observational studies, and of psychological burdens by survey interviews. The ethical implications wilt be analyzed within a more general framework, Finally, recommendations will be offered. PMID:21842614

  14. The Hawthorne Effect: a randomised, controlled trial

    PubMed Central

    McCarney, Rob; Warner, James; Iliffe, Steve; van Haselen, Robbert; Griffin, Mark; Fisher, Peter

    2007-01-01

    Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation) or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months). Our primary outcomes were cognitive functioning (ADAS-Cog) and participant and carer-rated quality of life (QOL-AD). Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT), with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group), and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group). There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048 PMID:17608932

  15. 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.

  16. 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.

  17. [Practice and thought for quality control of drug clinical trial institution for clinical trials].

    PubMed

    Zhao, Ting; Wu, Ping; Li, Yong; Lian, Feng-mei; Liu, Ping; Qiao, Jie

    2014-12-01

    The quality control of new drug cilnical trial is the effective guaranty for the pharmaceutical safety and effective after available on market. Enhancing the inspection and quality control of new drug clinical trials provide the crucial importance to achieve a persistent profitable standard. This paper mainly discussed the problems of current clinical trials based on annual check of drug clinical trial institution.

  18. 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

  19. Alterations in erythrocyte survival parameters in rats after 19.5 days aboard Cosmos 782

    NASA Technical Reports Server (NTRS)

    Leon, H. A.; Serova, L. V.; Cummins, J.; Landaw, S. A.

    1978-01-01

    Rats were subjected to 19.5 days of weightless space flight aboard the Soviet biosatellite, Cosmos 782. Based on the output of CO-14, survival parameters of a cohort of erythrocytes labeled 15.5 days preflight were evaluated upon return from orbit. These were compared to vivarium control rats injected at the same time. Statistical evaluation indicates that all survival factors were altered by the space flight. The mean potential lifespan, which was 63.0 days in the control rats, was decreased to 59.0 days in the flight rats, and random hemolysis was increased three-fold in the flight rats. The measured size of the cohort was decreased, lending further support to the idea that hemolysis was accelerated during some portion of the flight. A number of factors that might be contributory to these changes are discussed, including forces associated with launch and reentry, atmospheric and environmental parameters, dietary factors, radiation, and weightlessness.

  20. Alterations in erythrocyte survival parameters in rats after 19.5 days aboard Cosmos 782

    NASA Technical Reports Server (NTRS)

    Leon, H. A.; Serova, L. V.; Cummins, J.; Landaw, S. A.

    1978-01-01

    Rats were subjected to 19.5 days of weightless space flight aboard the Soviet biosatellite, Cosmos 782. Based on the output of CO-14, survival parameters of a cohort of erythrocytes labeled 15.5 days preflight were evaluated upon return from orbit. These were compared to vivarium control rats injected at the same time. Statistical evaluation indicates that all survival factors were altered by the space flight. The mean potential lifespan, which was 63.0 days in the control rats, was decreased to 59.0 days in the flight rats, and random hemolysis was increased three-fold in the flight rats. The measured size of the cohort was decreased, lending further support to the idea that hemolysis was accelerated during some portion of the flight. A number of factors that might be contributory to these changes are discussed, including forces associated with launch and reentry, atmospheric and environmental parameters, dietary factors, radiation, and weightlessness.

  1. The first documented controlled trial in history.

    PubMed

    Koren, Gideon

    2015-01-01

     The first reported controlled human trial was conducted 2500 years ago by the Biblical judge Gideon Ben Yoash, who challenged God's Angel: "I will put a fleece of wool on the threshing floor. If there is dew on the fleece only, and it is dry on all the ground, then I will know that Thou wilt deliver Israel through me, as Thou hast spoken". In the control part of the trial he asked the Angel to keep the wool dry while the ground around it will be soaked with morning dew. It is unfortunate that these principles were not practiced for thousands of years thereafter, as many medical challenges could have been solved earlier.  

  2. Increasing girls' physical activity during an organised youth sport basketball program: a randomised controlled trial protocol.

    PubMed

    Guagliano, Justin M; Lonsdale, Chris; Kolt, Gregory S; Rosenkranz, Richard R

    2014-04-21

    Participation in organised youth sports (OYS) has been recommended as an opportunity to increase young peoples' moderate-to-vigorous physical activity (MVPA) levels. Participants, however, spend a considerable proportion of time during OYS inactive. The purpose of this study, therefore, was to investigate whether coaches who attended coach education sessions (where education on increasing MVPA and decreasing inactivity during training was delivered) can increase players' MVPA during training sessions over a 5-day basketball program compared to coaches who did not receive coach education sessions. A convenience sample of 80 female players and 8 coaches were recruited into the UWS School Holiday Basketball Program in Greater Western Sydney, Australia. A two-arm, parallel-group randomised controlled trial was employed to investigate whether coaches who attended 2 coach education sessions (compared with a no-treatment control) can increase their players' MVPA during training sessions over a 5-day basketball program. Objectively measured physical activity, directly observed lesson context and leader behaviour, player motivation, players' perceived autonomy support, and coaching information (regarding training session planning, estimations on player physical activity and lesson context during training, perceived ability to modify training sessions, perceived importance of physical activity during training, intention to increase physical activity/reduce inactivity, and likelihood of increasing physical activity/reducing inactivity) were assessed at baseline (day 1) and at follow-up (day 5). Linear mixed models will be used to analyse between arm differences in changes from baseline to follow-up on all outcomes. The current trial protocol describes, to our knowledge, the first trial conducted in an OYS context to investigate the efficacy of an intervention, relative to a control, in increasing MVPA. This study's findings will provide evidence to inform strategies targeting

  3. A Pilot Randomized Controlled Trial of Novel Dressing and Securement Techniques in 101 Pediatric Patients.

    PubMed

    Kleidon, Tricia M; Ullman, Amanda J; Gibson, Victoria; Chaseling, Brett; Schoutrop, Jason; Mihalia, Gabor; Rickard, Claire M

    2017-09-08

    To evaluate feasibility of an efficacy trial comparing peripherally inserted central catheter (PICC) dressing and securement techniques to prevent complications and failure. This pilot, 3-armed, randomized controlled trial was undertaken at Royal Children's Hospital and Lady Cilento Children's Hospital, Brisbane, Australia, between April 2014 and September 2015. Pediatric participants (N = 101; age range, 0-18 y) were assigned to standard care (bordered polyurethane [BPU] dressing, sutureless securement device), tissue adhesive (TA) (plus BPU dressing), or integrated securement dressings (ISDs). Average PICC dwell time was 8.1 days (range, 0.2-27.7 d). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were PICC complications, dressing performance, and parent and staff satisfaction. Protocol feasibility was established. PICC failure was 6% (2/32) with standard care, 6% (2/31) with ISD, and 3% (1/32) with TA. PICC complications were 16% across all groups. TA provided immediate postoperative hemostasis, prolonging the first dressing change until 5.5 days compared with 3.5 days and 2.5 days with standard care and ISD respectively. Bleeding was the most common reason for first dressing change: standard care (n = 18; 75%), ISD (n = 11; 69%), TA (n = 4; 27%). Parental satisfaction (median 9.7/10; P = .006) and staff feedback (9.2/10; P = .002) were most positive for ISD. This research suggests safety and acceptability of different securement dressings compared with standard care; securement dressings may also reduce dressing changes after insertion. Further research is required to confirm clinically cost-effective methods to prevent PICC failure. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

  4. Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Laparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published. Methods/Design This is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management. The primary study endpoint is the length of postoperative hospital stay in days. Sample size was estimated based on preliminary retrospective cohort, which suggested that 102 patients would provide 80% power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05. Secondary endpoints include passage of stool, commencement of enteral nutrition, 30-day mortality, complications, postoperative pain, and the length of sick leave. Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up. Long-term follow-up by letter or telephone interview will take place at 1, 5, and 10 years. Discussion To the best of our knowledge, this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction. Trial registration ClinicalTrials.gov identifier: NCT01867528. Date of registration May 26th 2013. PMID:25306234

  5. Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol.

    PubMed

    Rose, Annika; Vinogradov, Sophia; Fisher, Melissa; Green, Michael F; Ventura, Joseph; Hooker, Christine; Merzenich, Michael; Nahum, Mor

    2015-07-03

    Schizophrenia is a severe and chronic medical condition, characterized by positive and negative symptoms, as well as pervasive social cognitive deficits. Despite the functional significance of the social cognition deficits affecting many aspects of daily living, such as social relationships, occupational status, and independent living, there is still no effective treatment option for these deficits, which is applied as standard of care. To address this need, we developed a novel, internet-based training program that targets social cognition deficits in schizophrenia (SocialVille). Preliminary studies demonstrate the feasibility and initial efficacy of Socialville in schizophrenia patients (Nahum et al., 2014). The purpose of the current trial (referred to as the TReatment of Social cognition in Schizophrenia Trial or TRuSST) is to compare SocialVille to an active control training condition, include a larger sample of patients, and assess both social cognitive functioning, and functional outcomes. We will employ a multi-site, longitudinal, blinded, randomized controlled trial (RCT) design with a target sample of 128 patients with schizophrenia. Patients will perform, at their home or in clinic, 40 sessions of either the SocialVille training program or an active control computer game condition. Each session will last for 40-45 minutes/day, performed 3-5 days a week, over 10-12 weeks, totaling to 30 hours of training. Patients will be assessed on a battery of social cognitive, social functioning and functional outcomes immediately before training, mid-way through training (after 20 training sessions) and at the completion of the 40 training sessions. The strengths of this protocol are that it tests an innovative, internet-based treatment that targets fundamental social cognitive deficits in schizophrenia, employs a highly sensitive and extensive battery of functional outcome measures, and incorporates a large sample size in an RCT design. ClinicalTrials.gov NCT

  6. 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.

  7. Relevance of randomised controlled trials in oncology.

    PubMed

    Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco

    2016-12-01

    Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing.

  8. 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

  9. Randomised controlled trial of mesalazine in IBS

    PubMed Central

    Barbara, Giovanni; Cremon, Cesare; Annese, Vito; Basilisco, Guido; Bazzoli, Franco; Bellini, Massimo; Benedetti, Antonio; Benini, Luigi; Bossa, Fabrizio; Buldrini, Paola; Cicala, Michele; Cuomo, Rosario; Germanà, Bastianello; Molteni, Paola; Neri, Matteo; Rodi, Marcello; Saggioro, Alfredo; Scribano, Maria Lia; Vecchi, Maurizio; Zoli, Giorgio; Corinaldesi, Roberto; Stanghellini, Vincenzo

    2016-01-01

    Objective Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS. Design We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time. Results A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI −12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI −2.7% to 26.0%) and 5.9% (p=0.404; 95% CI −7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule. Conclusions Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy. Trial registration number ClincialTrials.gov number, NCT00626288. PMID:25533646

  10. 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

  11. Administration of hCG 5 days after breeding and reproductive performance in nulliparous dairy goats.

    PubMed

    Fonseca, J F; Torres, C A A

    2005-12-01

    The objective of this study was to investigate the effect of hCG administration 5 days after breeding on plasma progesterone (P4) concentration and reproductive performance of oestrous-induced nulliparous dairy goats. A total of 59 nulliparous goats (36 Alpine and 23 Saanen) received intravaginal sponges with 60 mg medroxyprogesterone acetate for 9 days plus 200 IU equine chorionic gonadotrophin (eCG) and 22.5 microg d-cloprostenol 24 h before sponge removal. After detection of oestrus (day of oestrus = day 0) and breeding, 49 females were randomly assigned, according to the breed, into two treatments (T1 and T2). In T1 (n = 25) and T2 (n = 24), animals received intramuscular injection of 1 ml of saline solution (control) or 250 IU hCG, respectively, 5 days after breeding. Plasma P4 concentration (ng/ml) was determined from blood sampled on days 0, 5, 7, 13, 17, 21, 28 and 45 after breeding. Animals were scanned by transrectal ultrasound (5 MHz probe) on days 35 and 70 after breeding for detection of pregnancy. Plasma P4 concentration did not differ (p > 0.05) between treatments in all days, but it was increased (p < 0.05) in Saanen than in Alpine goats from days 13 to 45. Pregnancy and parturition rates, litter size and gestation period were similar (p > 0.05) to treatments and breeds. Results of this study indicate that human chorionic gonadotrophin (hCG) administration 5 days after breeding did not significantly alter reproductive performance in dairy nulliparous goats and that plasma P4 differed between Saanen and Alpine goats.

  12. Platelet function in reconstituted whole blood variants: An observational study over 5 days of storage time.

    PubMed

    Ponschab, Martin; Schlimp, Christoph J; Zipperle, Johannes; Gabriel, Christian; Süssner, Susanne; Cadamuro, Janne; Gratz, Johannes; Redl, Heinz; Schöchl, Herbert

    2015-11-01

    Platelet concentrates (PCs) are usually stored at room temperature under constant gentle agitation. Risk of bacterial contamination limits maximum storage time to 5 days. The objective of the study was to investigate platelet function with regard to storage time in different reconstituted whole blood (RWB) variants. Donated apheresis PCs were stored at 22°C over 5 days. To obtain RWB, apheresis PCs were mixed with plasma-free packed red blood cells (RBCs) and either prethawed fresh frozen plasma (PT) or solvent-detergent plasma (SD) [1:1:1 ratio], or with leukocyte- and platelet-depleted whole blood (LD-WB) as control. Platelet function in RWB variants was assessed by impedance aggregometry (Multiplate) on Days 0, 1, 3, and 5 following platelet donation. Platelet aggregometry did not reach the lower limits determined from healthy volunteers in any of the RWB variants. Platelet aggregability measured by ASPI test, ADP test, and COL test declined over storage time in all RWB variants. No differences were observed in the TRAP test. At most measurement time points, LD-RWB provided significantly higher platelet aggregability compared with SD-RWB and PT-RWB (p < 0.01). SD-RWB demonstrated higher platelet aggregability on Day 0 in the ASPI test, ADP test, and TRAP test compared with PT-RWB. Apheresis PCs stored for 5 days at 22°C demonstrated reduced platelet aggregability, as measured by multiple electrode aggregometry when mixed with RBCs and plasma. As platelet aggregation in LD-RWB was superior compared with SD-RWB and PT-RWB variants, it might be possible that additives in RBCs or plasma are responsible for the observed depressed platelet function. Critical evaluation of current massive transfusion recommendations proposing early platelet transfusion is indicated.

  13. The effect of a 5-day space flight on the immature rat spine.

    PubMed

    Sinha, Raj K; Shah, Suken A; Hume, Eric L; Tuan, Rocky S

    2002-01-01

    Spaceflight has many reported effects upon the musculoskeletal system structure and function. This study was designed to determine the effect of a 5-day flight on the rat spine. In September 1991, 8 neonatal rats were flown aboard the Space Shuttle Columbia flight STS-48 during a 5-day mission. Upon return to earth, the spines were dissected, frozen and shipped to our laboratory. Matched ground-based rats were used as controls. The spines were radiographed and then slowly thawed. Individual vertebrae were subjected to compressive biomechanical testing using an Instron tester (Instron Corp, Canton, MA, USA) and then processed for determination of calcium and phosphorus content. The intervertebral discs were placed in physiological saline and the stress-relaxation characteristics measured. The discs were then lyophilized and assayed for collagen and proteoglycan content. Disc height on radiographs was measured by image analysis. After space flight, the heights of the discs were found to be 150 to 200 microns greater, although the values were not statistically significant. There was no difference in the resiliency of the thoracic discs as determined by stress-relaxation. However, in the lumbar discs, space flight increased the resiliency (p<.01). There was no difference in water content. In both the thoracic and lumbar discs there was a 3.3-fold increase in hydroxyproline-proteoglycan ratio after space flight. However, because of the small sample size, these values were not statistically significant. In the vertebrae, there was no difference in calcium-phosphate ratio or compressive strength. These data suggest that even after a short 5-day flight, the spine begins to undergo biomechanical and biochemical changes. In addition, the weightless environment in space may provide a good model to study the effects of immobilization on earth.

  14. 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

  15. 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.

  16. Writing to patients: a randomised controlled trial.

    PubMed

    O'Reilly, Máire; Cahill, Mary R; Perry, Ivan J

    2006-01-01

    It has been suggested that consultants should consider writing directly to patients with a summary of their outpatient consultation. In a controlled trial involving consecutive new referrals to a haematology outpatient clinic, we randomised patients to receive either a personal letter from their consultant summarising their consultation (n = 77) or a brief note thanking them for attending the clinic (n = 73). Patients were assessed for recall of and satisfaction with the consultation by a single independent observer, using standardised methods. At the second visit to outpatients, the patients' median percentage recall of items discussed during the consultation was 67% (IQ range 50-80%) in the intervention group, versus 57% (IQ range 43-76%) in the control group (p = 0.3). Strongly positive views on the personal letter were expressed by patients and referring clinicians. The findings suggest that although personal letters do not substantially improve recall of the clinical encounter, they are feasible, highly valued by patients and acceptable to referring clinicians.

  17. Beyond trial-by-trial adaptation: A quantification of the time scale of cognitive control.

    PubMed

    Aben, Bart; Verguts, Tom; Van den Bussche, Eva

    2017-03-01

    The idea that adaptation to stimulus or response conflict can operate over different time scales takes a prominent position in various theories and models of cognitive control. The mechanisms underlying temporal variations in control are nevertheless poorly understood, which is partly due to a lack of appropriate empirical measures. Inspired by reinforcement learning models, we developed a method to quantify the time scale of control behaviorally, by computing trial-by-trial effects that go beyond the preceding trial. Briefly, we extended the congruency sequence effect from 1 trial to multiple trials into the past and quantified the influence of previous trials on current-trial performance as a function of trial distance. The rate at which this influence changes across trials was taken as a measure of the time scale of control. We applied the method to a flanker task with different conflict frequencies and volatility. Results showed that the time scale of control was smaller in rare-conflict and volatile contexts, compared to frequent-conflict and neutral contexts. This is in agreement with theories differentiating transient from sustained control. The method offers new opportunities to reveal temporal differences in control modes and can easily be applied to various empirical paradigms. (PsycINFO Database Record

  18. 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

  19. 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.

  20. A multicentre, randomised, double-blind, placebo-controlled trial of aminophylline for bronchiolitis in infants admitted to intensive care.

    PubMed

    Turner, Alastair; Shann, Frank; Delzoppo, Carmel; Henning, Robert; Slater, Anthony; Beca, John; Erickson, Simon; Butt, Warwick

    2014-09-01

    To determine whether aminophylline reduced the duration of respiratory support in children admitted to intensive care with bronchiolitis. A multicentre, randomised, double-blind, placebo controlled trial. Paediatric intensive care units in teaching hospitals. Forty-five children with severe bronchiolitis. Patients were randomly assigned to receive an infusion of aminophylline (23) or placebo (22). The primary outcome measure was the number of hours of respiratory support required in the 120 hours after randomisation; respiratory support was defined as either nasal continuous positive airways pressure or mechanical ventilation. The trial was stopped early due to poor recruitment. Respiratory support was required for a median of only 1.5 days (interquartile range [IQR], 0.4-3.5 days) in the aminophylline group compared with 1.9 days (IQR, 0.3-3.5) days in the placebo group. However, more patients in the placebo group were receiving respiratory support at the time of randomisation and, after adjustment for this, there was no suggestion of a beneficial effect of aminophylline among the small number of patients studied (P=0.54, exact log-rank test stratified by respiratory support at the time of randomisation and censored at the time of death in one child in the aminophylline group). Not enough children were recruited for the study to test the hypothesis that aminophylline reduces the need for respiratory support in severe bronchiolitis. Consequently, the role of aminophylline in the management of severe bronchiolitis remains unknown.

  1. [Placebo control and clinical trial of Chinese medicine].

    PubMed

    Wu, Jing

    2010-10-01

    World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

  2. Observations of the 5-day wave in the mesosphere and lower thermosphere

    NASA Technical Reports Server (NTRS)

    Wu, D. L.; Hays, P. B.; Skinner, W. R.

    1994-01-01

    The 5-day planetary wave has been detected in the winds measured by the High Resolution Doppler Imager (HRDI) on the Upper Atmosphere Research Satellite (UARS) in the mesosphere and lower thermosphere (50-110 km). The appearances of the 5-day wave are transient, with a lifetime of 10-20 days in the two-year data set. The structures of selected 5-day wave events are in generally good agreement with the (1,1) Rossby normal mode for both zonal and meridional components. A climatology of the 5-day wave is presented for an altitude of 95 km and latitudes mainly between 40 deg S and 40 deg N.

  3. Treatment of Severe Poison Ivy: A Randomized, Controlled Trial of Long Versus Short Course Oral Prednisone

    PubMed Central

    Curtis, Gabrielle; Lewis, Amy C.

    2014-01-01

    Background Toxidendron (poison ivy, oak, and sumac) contact dermatitis is a common complaint in the outpatient primary care setting with little evidence-based guidance on best treatment duration. Methods This randomized, controlled trial examined the efficacy and side effects of a 5-day regimen of 40 mg oral prednisone daily (short course) compared to the same 5-day regimen followed by a prednisone taper of 30 mg daily for 2 days, 20 mg daily for 2 days, 10 mg daily for 2 days, and 5 mg daily for 4 days over a total of 15 days (long course) in patients with severe poison ivy dermatitis. Results In 49 patients with severe poison ivy, non-adherence rates, rash return, medication side effects, and time to improvement and complete healing of the rash were not significantly different between the two groups. Patients receiving the long course regimen were significantly less likely to utilize other medications (22.7% vs. 55.6%, P = 0.02, number needed to treat 3.05). Conclusions This study suggests that a longer course prescription may save patients’ time and exposure to excess medication in the treatment of severe poison ivy. Application of this information to clinical practice will save return visits and reduce excess non-prescription medication administration to individual patients. PMID:25247016

  4. Effects of naproxen on experimental rhinovirus colds. A randomized, double-blind, controlled trial.

    PubMed

    Sperber, S J; Hendley, J O; Hayden, F G; Riker, D K; Sorrentino, J V; Gwaltney, J M

    1992-07-01

    To determine whether naproxen, a propionic acid inhibitor of cyclooxygenase, alters the course of experimental rhinovirus colds. A randomized, double-blind, controlled trial. Rhinovirus challenge model in volunteers cloistered in individual hotel rooms. Eighty-seven healthy young adults with serum neutralizing antibody titers of less than or equal to 1:2 to the challenge virus; 79 were evaluable. Thirty-nine participants received naproxen (loading dose, 400 mg or 500 mg followed by 200 mg or 500 mg three times daily for 5 days). Forty participants received placebo. Treatment was started 6 hours after viral challenge. Daily measurement of viral titers, symptoms, nasal mucus production, and nasal tissue use; incidence of infection and illness; and measurement of homotypic serum neutralizing antibody responses. Viral titers and serum homotypic antibody responses were similar in the naproxen and placebo groups. Significant reductions in headache, malaise, myalgia, and cough occurred in the naproxen group. A 29% reduction was noted in the total (5-day) symptom score in the naproxen group (95% CI, 16% to 42%). Naproxen treatment did not alter virus shedding or serum neutralizing antibody responses in participants with experimental rhinovirus colds, but it had a beneficial effect on the symptoms of headache, malaise, myalgia, and cough. Prostaglandins may be among the inflammatory mediators that play a role in the pathogenesis of rhinovirus colds.

  5. Treatment of severe poison ivy: a randomized, controlled trial of long versus short course oral prednisone.

    PubMed

    Curtis, Gabrielle; Lewis, Amy C

    2014-12-01

    Toxidendron (poison ivy, oak, and sumac) contact dermatitis is a common complaint in the outpatient primary care setting with little evidence-based guidance on best treatment duration. This randomized, controlled trial examined the efficacy and side effects of a 5-day regimen of 40 mg oral prednisone daily (short course) compared to the same 5-day regimen followed by a prednisone taper of 30 mg daily for 2 days, 20 mg daily for 2 days, 10 mg daily for 2 days, and 5 mg daily for 4 days over a total of 15 days (long course) in patients with severe poison ivy dermatitis. In 49 patients with severe poison ivy, non-adherence rates, rash return, medication side effects, and time to improvement and complete healing of the rash were not significantly different between the two groups. Patients receiving the long course regimen were significantly less likely to utilize other medications (22.7% vs. 55.6%, P = 0.02, number needed to treat 3.05). This study suggests that a longer course prescription may save patients' time and exposure to excess medication in the treatment of severe poison ivy. Application of this information to clinical practice will save return visits and reduce excess non-prescription medication administration to individual patients.

  6. Analysis of scientific truth status in controlled rehabilitation trials.

    PubMed

    Kerry, Roger; Madouasse, Aurélien; Arthur, Antony; Mumford, Stephen D

    2013-08-01

    Systematic reviews, meta-analyses and clinical guidelines (reviews) are intended to inform clinical practice, and in this sense can be thought of as scientific truthmakers. High-quality controlled trials should align to this truth, and method quality markers should predict truth status. We sought to determine in what way controlled trial quality relates to scientific truth, and to determine predictive utility of trial quality and bibliographic markers. A sample of reviews in rehabilitation medicine was examined. Two scientific truth dimensions were established based on review outcomes. Quality and bibliographic markers were extracted from associated trials for use in a regression analysis of their predictive utility for trial truth status. Probability analysis was undertaken to examine judgments of future trial truth status. Of the 93 trials included in contemporaneous reviews, overall, n = 45 (48%) were true. Randomization was found more in true trials than false trials in one truth dimension (P = 0.03). Intention-to-treat analysis was close to significant in one truth dimension (P = 0.058), being more commonly used in false trials. There were no other significant differences in quality or bibliographic variables between true and false trials. Regression analysis revealed no significant predictors of trial truth status. Probability analysis reported that the reasonable chance of future trials being true was between 2 and 5%, based on a uniform prior. The findings are at odds with what is considered gold-standard research methods, but in line with previous reports. Further work should focus on scientific dynamics within healthcare research and evidence-based practice constructs. © 2012 John Wiley & Sons Ltd.

  7. Reporting of statistically significant results at ClinicalTrials.gov for completed superiority randomized controlled trials.

    PubMed

    Dechartres, Agnes; Bond, Elizabeth G; Scheer, Jordan; Riveros, Carolina; Atal, Ignacio; Ravaud, Philippe

    2016-11-30

    Publication bias and other reporting bias have been well documented for journal articles, but no study has evaluated the nature of results posted at ClinicalTrials.gov. We aimed to assess how many randomized controlled trials (RCTs) with results posted at ClinicalTrials.gov report statistically significant results and whether the proportion of trials with significant results differs when no treatment effect estimate or p-value is posted. We searched ClinicalTrials.gov in June 2015 for all studies with results posted. We included completed RCTs with a superiority hypothesis and considered results for the first primary outcome with results posted. For each trial, we assessed whether a treatment effect estimate and/or p-value was reported at ClinicalTrials.gov and if yes, whether results were statistically significant. If no treatment effect estimate or p-value was reported, we calculated the treatment effect and corresponding p-value using results per arm posted at ClinicalTrials.gov when sufficient data were reported. From the 17,536 studies with results posted at ClinicalTrials.gov, we identified 2823 completed phase 3 or 4 randomized trials with a superiority hypothesis. Of these, 1400 (50%) reported a treatment effect estimate and/or p-value. Results were statistically significant for 844 trials (60%), with a median p-value of 0.01 (Q1-Q3: 0.001-0.26). For the 1423 trials with no treatment effect estimate or p-value posted, we could calculate the treatment effect and corresponding p-value using results reported per arm for 929 (65%). For 494 trials (35%), p-values could not be calculated mainly because of insufficient reporting, censored data, or repeated measurements over time. For the 929 trials we could calculate p-values, we found statistically significant results for 342 (37%), with a median p-value of 0.19 (Q1-Q3: 0.005-0.59). Half of the trials with results posted at ClinicalTrials.gov reported a treatment effect estimate and/or p-value, with significant

  8. A method of extracting the number of trial participants from abstracts describing randomized controlled trials.

    PubMed

    Hansen, Marie J; Rasmussen, Nana Ø; Chung, Grace

    2008-01-01

    We have developed a method for extracting the number of trial participants from abstracts describing randomized controlled trials (RCTs); the number of trial participants may be an indication of the reliability of the trial. The method depends on statistical natural language processing. The number of interest was determined by a binary supervised classification based on a support vector machine algorithm. The method was trialled on 223 abstracts in which the number of trial participants was identified manually to act as a gold standard. Automatic extraction resulted in 2 false-positive and 19 false-negative classifications. The algorithm was capable of extracting the number of trial participants with an accuracy of 97% and an F-measure of 0.84. The algorithm may improve the selection of relevant articles in regard to question-answering, and hence may assist in decision-making.

  9. 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

  10. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    PubMed

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  11. Publication status of contemporary oncology randomised controlled trials worldwide.

    PubMed

    Chen, Yu-Pei; Liu, Xu; Lv, Jia-Wei; Li, Wen-Fei; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2016-10-01

    Little is known about the extent of selective publication in contemporary oncology randomised controlled trials (RCTs) worldwide. This study aimed to evaluate the rates of publication and timely publication (within 24 months) for contemporary oncology RCTs from all over the world. We also investigated the trial characteristics associated with publication and timely publication. We identified all phase III oncology RCTs registered on ClinicalTrials.gov with a primary completion date between January 2008 and December 2012. We searched PubMed and EMBASE to identify publications. The final search date was 31 December 2015. Our primary outcome measure was the time to publication from the primary completion date to the date of primary publication in a peer-reviewed journal. We identified 598 completed oncology RCTs; overall, 398 (66.6%) had been published. For published trials, the median time to publication was 25 months (interquartile range, 16-37 months). Only 192 trials (32.1%) were published within 24 months. Timely publication was independently associated with trials completed late in 2012. Trials conducted in Asia and other regions were less likely to have timely publication, but trials conducted in different locations were all equally likely to be published. Industry- and NIH-funded trials were equally likely to be published timely or at any time after trial completion. Among 391 published trials with clear primary outcomes, there was a trend for timely publication of positive trials compared with negative trials. Despite the ethical obligations and societal expectations of disclosing findings promptly, oncology RCTs performed poorly. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods

    PubMed Central

    Wiljer, David; Cafazzo, Joseph A

    2016-01-01

    Background Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Objective Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. Methods We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Results Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study

  13. Continuing Assessment of the 5-Day Sodium Carbonate-Ammonium Nitrate Extraction Assay as an Indicator Test for Silicon Fertilizers.

    PubMed

    Zellner, Wendy; Friedrich, Russell L; Kim, Sujin; Sturtz, Douglas; Frantz, Jonathan; Altland, James; Krause, Charles

    2015-01-01

    The 5-day sodium carbonate-ammonium nitrate extraction assay (5-day method) has been recognized by the American Association of Plant Food Control Officials as a validated test method to identify fertilizers or beneficial substances that provide plant-available silicon (Si). The test method used the molybdenum blue colorimetric assay to quantify percentage Si; however, laboratories may use inductively coupled plasma optical emission spectroscopy (ICP-OES) for elemental analysis. To examine the use of either colorimetric or ICP-OES methods for Si determination, the 5-day method was performed on the following Si-containing compounds; wollastonite, sand, biochar, and a basic oven furnace (BOF) slag. Grow-out studies using Zinnia elegans were also performed using varying rates of the wollastonite, biochar, and BOF slag. Our results show using the 5-day method, wollastonite had the highest extracted amounts of silicic acid (H4SiO4) at 4% followed by biochar (2%), BOF slag (1%), and sand (0%). Extraction values calculated using either the molybdenum blue colorimetric assay or ICP-OES for detection of the H4SiO4 had a significant correlation, supporting the application of either detection method for this type of analysis. However, when extracted values were compared to amounts of Si taken up by the plants, the 5-day method overestimated both wollastonite and biochar. While this method is a valid indicator test for determining a soluble Si source, other plant species and methods should be perused to potentially provide more quantitative analyses for plant-available Si content of all materials.

  14. Shoot growth in aseptically cultivated daylily and haplopappus plantlets after a 5-day spaceflight

    NASA Technical Reports Server (NTRS)

    Levine, H. G.; Krikorian, A. D.

    1992-01-01

    Plantlets of daylily (Hemerocallis cv. Autumn Blaze) regenerated from cell suspensions, and 4 clonal populations of Haplopappus gracilis were aseptically cultivated aboard the Shuttle "Discovery" during a 5-day mission within NASA's Plant Growth Unit (PGU) apparatus. Daylily was selected as a representative herbaceous perennial monocotyledon and the haplopappus clones represented an annual dicotyledon. The latter included 4 strains with different physiological and morphological characteristics: two aseptic seedling clones (each generated from a single seedling) and two tissue culture-derived lines. Mean daily growth rates for the primary shoots of all plantlets averaged 4.13 mm day-1 (SD = 2.20) for the flight experiment and 4.68 mm day-1 (SD = 2.59) for the ground control. Comparable growth rates calculated by summing both the primary and secondary shoots for all plantlets were 5.94 mm day-1 (SD = 2.89) for the flight experiment and 6.38 mm day-1 (SD = 3.71) for the control. Statistically significant differences existed between: (1) flight vs control primary shoot growth (the controls growing more than plantlets subjected to spaceflight conditions), (2) the different populations (the daylily gaining more shoot material than any of the haplopappus populations and the haplopappus seedling clones outperforming the tissue culture-derived haplopappus lines), and (3) the individual Plant Growth Chambers contained within the PGU. The data suggest that some spaceflight-associated factor(s) increased the tendency for primary shoot apices to degrade or senesce, resulting in the release of apical dominance and permitting the emergence of axillary branches, which subsequently partially compensated for the reduced primary axis growth. In addition to spaceflight-associated factors, the physiologically diverse nature of the experimental material as well as environmental heterogeneities within the culture apparatus contributed to the variation in growth results. The findings

  15. The 6.5-day wave and its seasonal variability in the middle and upper atmosphere

    NASA Astrophysics Data System (ADS)

    Liu, H.-L.; Talaat, E. R.; Roble, R. G.; Lieberman, R. S.; Riggin, D. M.; Yee, J.-H.

    2004-11-01

    The zonal wave number 1 planetary wave of period near 6.5 days is a robust feature in the mesosphere and lower thermosphere (MLT) region with prominent seasonal variability as revealed by ground based and satellite observations. This wave and its seasonal variability are well reproduced in a recent one model year run of the National Center for Atmospheric Research thermosphere-ionosphere-mesosphere-electrodynamics general circulation model (TIME-GCM) with its lower boundary specified according to the National Centers for Environmental Prediction analysis (year 1993). Wavelet analysis of the model output shows that in the MLT region the wave maximizes before and after the equinoxes and minimizes at solstices. The wave amplitudes at the equinoxes are smaller than the peaks before and after but are still larger than the wave amplitudes at solstices. However, at the lower boundary near 30 km the wave peaks are predominantly between fall and the following spring. By examining the episodes of maximum and minimum wave amplitude and by conducting additional control experiments using the TIME-GCM, the structure of this planetary wave and the factors determining the wave characteristics and seasonal variability are studied in detail. It is found that the wave source, mean wind structure, instability, and the critical layers of the wave can all affect the wave response in the MLT region and can have a strong seasonal dependence. Before and after equinox, the wave follows the waveguide and propagates from the stratosphere to the summer mesosphere/mesopause, where it may amplify due to baroclinic/barotropic instability. Such instability is usually absent from the equinoctial atmosphere, so that there is no wave amplification at equinox. At solstice the wave decays significantly when propagating away from its winter source due to the strong eastward winter stratospheric jet. In the summer side the westward jet is also strong, and the meridional and vertical extension of the

  16. Preosteoblast production 55 hours after a 12.5-day spaceflight on Cosmos 1887

    NASA Technical Reports Server (NTRS)

    Garetto, L. P.; Gonsalves, M. R.; Morey, E. R.; Durnova, G.; Roberts, W. E.; Morey-Holton, E. (Principal Investigator)

    1990-01-01

    The influence of 12.5 days of spaceflight and a 55 h stressful recovery period (at 1 g) on fibroblastlike osteoblast precursor cells was assessed in the periodontal ligament (PDL) of rats that were 91 days old at launch. Nuclear morphometry was used as a marker for precursor cell differentiation in 3 microns sections cut in the midsagittal plane from the maxillary first molar. According to nuclear volume, cells were classified as preosteoblasts (C + D cells, greater than or equal to 120 microns 3) and less differentiated progenitor cells (A + A' cells, 40-79 microns 3). Compared with synchronous controls (simulated flight conditions), the 55 h postflight recovery period at 1 g resulted in a 40% decrease in the A + A' cell population, a 42% increase in the C + D cells, and a 39% increase in the number of PDL fibroblastlike cells near the bone surface. These results are consistent with a postflight osteogenic response in PDL. This recovery response occurred despite physiological stress in the flight animals that resulted in a highly significant (P less than or equal to 0.001) increase in adrenal weight. The data suggest that after spaceflight there is a strong and rapid recovery mechanism for osteoblast differentiation that is not suppressed by physiological stress.

  17. Preosteoblast production 55 hours after a 12.5-day spaceflight on Cosmos 1887.

    PubMed

    Garetto, L P; Gonsalves, M R; Morey, E R; Durnova, G; Roberts, W E

    1990-01-01

    The influence of 12.5 days of spaceflight and a 55 h stressful recovery period (at 1 g) on fibroblastlike osteoblast precursor cells was assessed in the periodontal ligament (PDL) of rats that were 91 days old at launch. Nuclear morphometry was used as a marker for precursor cell differentiation in 3 microns sections cut in the midsagittal plane from the maxillary first molar. According to nuclear volume, cells were classified as preosteoblasts (C + D cells, greater than or equal to 120 microns 3) and less differentiated progenitor cells (A + A' cells, 40-79 microns 3). Compared with synchronous controls (simulated flight conditions), the 55 h postflight recovery period at 1 g resulted in a 40% decrease in the A + A' cell population, a 42% increase in the C + D cells, and a 39% increase in the number of PDL fibroblastlike cells near the bone surface. These results are consistent with a postflight osteogenic response in PDL. This recovery response occurred despite physiological stress in the flight animals that resulted in a highly significant (P less than or equal to 0.001) increase in adrenal weight. The data suggest that after spaceflight there is a strong and rapid recovery mechanism for osteoblast differentiation that is not suppressed by physiological stress.

  18. Randomized controlled trials of malaria intervention trials in Africa, 1948 to 2007: a descriptive analysis.

    PubMed

    Lutje, Vittoria; Gerritsen, Annette; Siegfried, Nandi

    2011-03-15

    Nine out of ten deaths from malaria occur in sub-Saharan Africa. Various control measures have achieved some progress in the control of the disease, but malaria is still a major public health problem in Africa. Randomized controlled trials (RCTs) are universally considered the best study type to rigorously assess whether an intervention is effective. The study reported here provides a descriptive analysis of RCTs reporting interventions for the prevention and treatment of malaria conducted in Africa, with the aim of providing detailed information on their main clinical and methodological characteristics, that could be used by researchers and policy makers to help plan future research. Systematic searches for malaria RCTs were conducted using electronic databases (Medline, Embase, the Cochrane Library), and an African geographic search filter to identify RCTs conducted in Africa was applied. Results were exported to the statistical package STATA 8 to obtain a random sample from the overall data set. Final analysis of trial characteristics was done in a double blinded fashion by two authors using a standardized data extraction form. A random sample of 92 confirmed RCTs (from a total of 943 reports obtained between 1948 and 2007) was prepared. Most trials investigated drug treatment in children with uncomplicated malaria. Few trials reported on treatment of severe malaria or on interventions in pregnant women. Most trials were of medium size (100-500 participants), individually randomized and based in a single centre. Reporting of trial quality was variable. Although three-quarter of trials provided information on participants' informed consent and ethics approval, more details are needed. The majority of malaria RCT conducted in Africa report on drug treatment and prevention in children; there is need for more research done in pregnant women. Sources of funding, informed consent and trial quality were often poorly reported. Overall, clearer reporting of trials is

  19. Randomized controlled trials of malaria intervention trials in Africa, 1948 to 2007: a descriptive analysis

    PubMed Central

    2011-01-01

    Background Nine out of ten deaths from malaria occur in sub-Saharan Africa. Various control measures have achieved some progress in the control of the disease, but malaria is still a major public health problem in Africa. Randomized controlled trials (RCTs) are universally considered the best study type to rigorously assess whether an intervention is effective. The study reported here provides a descriptive analysis of RCTs reporting interventions for the prevention and treatment of malaria conducted in Africa, with the aim of providing detailed information on their main clinical and methodological characteristics, that could be used by researchers and policy makers to help plan future research. Methods Systematic searches for malaria RCTs were conducted using electronic databases (Medline, Embase, the Cochrane Library), and an African geographic search filter to identify RCTs conducted in Africa was applied. Results were exported to the statistical package STATA 8 to obtain a random sample from the overall data set. Final analysis of trial characteristics was done in a double blinded fashion by two authors using a standardized data extraction form. Results A random sample of 92 confirmed RCTs (from a total of 943 reports obtained between 1948 and 2007) was prepared. Most trials investigated drug treatment in children with uncomplicated malaria. Few trials reported on treatment of severe malaria or on interventions in pregnant women. Most trials were of medium size (100-500 participants), individually randomized and based in a single centre. Reporting of trial quality was variable. Although three-quarter of trials provided information on participants' informed consent and ethics approval, more details are needed. Conclusions The majority of malaria RCT conducted in Africa report on drug treatment and prevention in children; there is need for more research done in pregnant women. Sources of funding, informed consent and trial quality were often poorly reported

  20. 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.

  1. 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

  2. Clinical trials: active control vs placebo--what is ethical?

    PubMed

    Spławiński, Jacek; Kuźniar, Jerzy

    2004-01-01

    The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs, superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of micro (the difference between a tested drug and comparator) < or = 0 against micro > 0; the latter tests the null hypothesis of micro < or = - delta against, micro > - delta, where delta is the clinical difference from the comparator. In a superiority trial, a new drug is tested against a placebo; in a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with placebo to a non-inferiority trial with an active-control--following the latest revision of Declaration of Helsinki--is in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical: to violate patients' rights or to produce results without scientific value. All presented considerations lead to the conclusion that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation of patients, and the ancient quest for effective medicines. In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is fruitless.

  3. 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.

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

    PubMed

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

    2016-12-01

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

  5. Safety of placebo controls in pediatric hypertension trials.

    PubMed

    Smith, P Brian; Li, Jennifer S; Murphy, M Dianne; Califf, Robert M; Benjamin, Daniel K

    2008-04-01

    Many clinical trials, including those in pediatric populations, use a placebo arm for medical conditions for which there are readily available therapeutic interventions. Several short-term efficacy trials of antihypertensive medications performed in response to Food and Drug Administration-issued written requests have used a placebo arm; whether the use of a placebo arm is safe in children with hypertension is unknown. We sought to define the rates of adverse events in 10 short-term antihypertensive trials to determine whether these trials resulted in increased risk to pediatric patients receiving placebo. We combined patient-level data from 10 antihypertensive efficacy trials performed in pediatric patients that were submitted to the Food and Drug Administration from 1998 to 2005. We determined the number and type of all of the adverse events reported during the placebo-controlled portion of the clinical trials and compared these numbers between the patients who received placebo and those who received active drug. Among the 1707 children in the 10 studies, we observed no differences in the rates of adverse events reported between the patients who received placebo and those who received active drug. Only 5 patients suffered a serious adverse event during the trials; none were thought by the investigators to be related to study drug, and only 1 occurred in a patient receiving placebo. Short-term exposure to placebo in pediatric trials of antihypertensive medications appears to be safe.

  6. Veterinary clinical research database for homeopathy: placebo-controlled trials.

    PubMed

    Clausen, J; Albrecht, H; Mathie, R T

    2013-04-01

    Veterinary homeopathy has led a somewhat shadowy existence since its first introduction. Only in the last three decades has the number of clinical trials increased considerably. This literature is generally not well perceived, which may be partly a consequence of the diffuse and somewhat inaccessible nature of some of the relevant research publications. The Veterinary Clinical Research Database for Homeopathy (VetCR) was launched in 2006 to provide information on existing clinical research in veterinary homeopathy and to facilitate the preparation of systematic reviews. The aim of the present report is to provide an overview of this first database on clinical research in veterinary homeopathy, with a special focus on its content of placebo controlled clinical trials and summarising what is known about placebo effects in animals. In April 2012, the VetCR database contained 302 data records. Among these, 203 controlled trials were identified: 146 randomised and 57 non-randomised. In 97 of those 203 trials, the homeopathic medical intervention was compared to placebo. A program of formal systematic reviews of peer-reviewed randomised controlled trials in veterinary homeopathy is now underway; detailed findings from the program's data extraction and appraisal approach, including the assessment of trial quality (risk of bias), will be reported in due course. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. 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…

  8. 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…

  9. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

    PubMed Central

    Gluud, Christian; Nikolova, Dimitrinka

    2007-01-01

    Background The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study. Methods We searched the 454,449 records on publications in The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, Issue 3, 2005 (CD-ROM version) for possible country of origin. We inspected a random sample of 906 records for information on country and type of trial. Results There was an exponential growth of publications on randomised controlled trials and controlled clinical trials since 1946, but the growth seems to have seized since 2000. We identified the possible country of origin of 210,974 publications (46.4%). The USA is leading with about 46,789 publications followed by UK, Germany, Italy, the Netherlands, Canada, and France. Sweden becomes the leader with 891 publications per million inhabitants during the last 60 years followed by Denmark (n = 864), New Zealand (n = 791), Finland (n = 781), the Netherlands (n = 570), Switzerland (n = 547), and Norway (n = 543). In depth assessment of the random sample backed these findings. Conclusion Many records lacked country of origin, even after the additional scrutiny. The number of publications on clinical trials increased exponentially until the turn of the century. Rather small, democratic, and wealthy countries take the lead when the number of publications on clinical trials is calculated based on million inhabitants. If all countries produced the same number of trials as these countries, this could mean thousands of new effective treatments during the next 60 years. PMID:17326823

  10. Efficacy and tolerability of 5-day azacytidine dose-intensified regimen in higher-risk MDS.

    PubMed

    Pierdomenico, Francesca; Esteves, Susana; Almeida, Antonio

    2013-09-01

    Higher-risk myelodysplastic syndromes (MDS) are aggressive disorders with rapid progression to AML and short survival. Azacitidine has shown unprecedented survival advantage in these patients but its treatment schedule involves daily hospital administrations for 7 days every 4 weeks. Due to patient and staffing constraints, we have treated 50 patients with a 5-day dose-intensified (500 mg/m(2) total monthly dose divided in 5 days) azacitidine schedule in our center. The regimen was well tolerated, with Grade 3/4 adverse events seen in 24 % patients and only two discontinuations due to toxicity. The response rate was similar to that reported with the 7-day schedule: 16 % complete remissions, 32 % partial remissions, and 62 % transfusion independence. The median survival was 19.2 months from diagnosis. In addition, this regimen reduced hospital visits by 28 % and drug use by 30 %. Our results demonstrate the safety and efficacy of a dose-intensified 5-day regimen.

  11. Chest physical therapy for children hospitalised with acute pneumonia: a randomised controlled trial.

    PubMed

    Paludo, C; Zhang, L; Lincho, C S; Lemos, D V; Real, G G; Bergamin, J A

    2008-09-01

    The indication for chest physical therapy as an adjunct to the treatment of children hospitalised with acute pneumonia remains controversial and there is a lack of robust scientific evidence for the effectiveness of this modality in these patients. A randomised controlled trial was conducted in two tertiary hospitals in southern Brazil. Children aged 29 days to 12 years hospitalised with pneumonia between February and October 2006 were recruited; 51 were randomly allocated to the intervention group (chest physical therapy plus standard treatment for pneumonia) and 47 to the control group (standard treatment for pneumonia alone). The primary outcome was time to clinical resolution. The secondary outcomes were length of stay in hospital and duration of respiratory symptoms and signs. There were no significant differences in terms of median time to clinical resolution (4.0 vs 4.0 days, p = 0.84) and median length of hospital stay (6.0 vs 6.0 days, p = 0.76) between the intervention and control groups. The intervention group had a longer median duration of coughing (5.0 vs 4.0 days, p = 0.04) and of rhonchi on lung auscultation (2.0 vs 0.5 days, p = 0.03) than the control group. Chest physical therapy as an adjunct to standard treatment does not hasten clinical resolution of children hospitalised with acute pneumonia and may prolong duration of coughing and rhonchi.

  12. Impact and Costs of Incentives to Reduce Attrition in Online Trials: Two Randomized Controlled Trials

    PubMed Central

    Murray, Elizabeth; Kalaitzaki, Eleftheria; White, Ian R; McCambridge, Jim; Thompson, Simon G; Wallace, Paul; Godfrey, Christine

    2011-01-01

    Background Attrition from follow-up is a major methodological challenge in randomized trials. Incentives are known to improve response rates in cross-sectional postal and online surveys, yet few studies have investigated whether they can reduce attrition from follow-up in online trials, which are particularly vulnerable to low follow-up rates. Objectives Our objective was to determine the impact of incentives on follow-up rates in an online trial. Methods Two randomized controlled trials were embedded in a large online trial of a Web-based intervention to reduce alcohol consumption (the Down Your Drink randomized controlled trial, DYD-RCT). Participants were those in the DYD pilot trial eligible for 3-month follow-up (study 1) and those eligible for 12-month follow-up in the DYD main trial (study 2). Participants in both studies were randomly allocated to receive an offer of an incentive or to receive no offer of an incentive. In study 1, participants in the incentive arm were randomly offered a £5 Amazon.co.uk gift voucher, a £5 charity donation to Cancer Research UK, or entry in a prize draw for £250. In study 2, participants in the incentive arm were offered a £10 Amazon.co.uk gift voucher. The primary outcome was the proportion of participants who completed follow-up questionnaires in the incentive arm(s) compared with the no incentive arm. Results In study 1 (n = 1226), there was no significant difference in response rates between those participants offered an incentive (175/615, 29%) and those with no offer (162/611, 27%) (difference = 2%, 95% confidence interval [CI] –3% to 7%). There was no significant difference in response rates among the three different incentives offered. In study 2 (n = 2591), response rates were 9% higher in the group offered an incentive (476/1296, 37%) than in the group not offered an incentive (364/1295, 28%) (difference = 9%, 95% CI 5% to 12%, P < .001). The incremental cost per extra successful follow-up in the incentive

  13. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

    PubMed Central

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Background Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. Methods We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Results Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Conclusion Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients. PMID:28192509

  14. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.

    PubMed

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients.

  15. Effect of Transcutaneous Electric Nerve Stimulation on Pain after Total Knee Arthroplasty: A Blind Randomized Controlled Trial.

    PubMed

    Beckwée, David; Bautmans, Ivan; Lefeber, Nina; Lievens, Pierre; Scheerlinck, Thierry; Vaes, Peter

    2017-05-01

    Transcutaneous electric nerve stimulation (TENS) has proven to be effective for postsurgical pain relief. However, there is a lack of well-constructed clinical trials investigating the effect of TENS after total knee arthroplasty (TKA). In addition, previous investigations reported that low- and high-frequency TENSs produced analgesic tolerance after 4 or 5 days of treatment. The aim of this study is to explore the effect of burst TENS on pain during hospitalization after TKA and to investigate whether burst TENS produces analgesic tolerance after 4 or 5 days of treatment. This stratified, triple blind, randomized controlled trial was approved by the University Hospital Brussels. Sixty-eight subjects were screened for eligibility before surgery; 54 were found eligible and 53 were included in the analyses. Patients were allocated to either a burst TENS or sham burst TENS group. TENS was applied daily during continuous passive mobilization. Knee pain intensity, knee range of motion, and analgesic consumption were assessed daily. Patients received burst TENS (N = 25) or sham burst TENS (N = 28). No significant differences in knee pain intensity were found between the groups (p > 0.05). Within the TENS and the sham TENS groups, the difference in knee pain before and after treatment did not evolve over time (p > 0.05). This study found no effects of burst TENS compared with sham burst TENS on pain during hospitalization after TKA. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  16. Preventive Antibacterial Therapy in Acute Ischemic Stroke: A Randomized Controlled Trial

    PubMed Central

    Klehmet, Juliane; Rogge, Witold; Drenckhahn, Christoph; Göhler, Jos; Bereswill, Stefan; Göbel, Ulf; Wernecke, Klaus Dieter; Wolf, Tilo; Arnold, Guy; Halle, Elke; Volk, Hans-Dieter; Dirnagl, Ulrich; Meisel, Andreas

    2008-01-01

    Background Pneumonia is a major risk factor of death after acute stroke. In a mouse model, preventive antibacterial therapy with moxifloxacin not only prevents the development of post-stroke infections, it also reduces mortality, and improves neurological outcome significantly. In this study we investigate whether this approach is effective in stroke patients. Methods Preventive ANtibacterial THERapy in acute Ischemic Stroke (PANTHERIS) is a randomized, double-blind, placebo-controlled trial in 80 patients with severe, non-lacunar, ischemic stroke (NIHSS>11) in the middle cerebral artery (MCA) territory. Patients received either intravenous moxifloxacin (400 mg daily) or placebo for 5 days starting within 36 hours after stroke onset. Primary endpoint was infection within 11 days. Secondary endpoints included neurological outcome, survival, development of stroke-induced immunodepression, and induction of bacterial resistance. Findings On intention-to treat analysis (79 patients), the infection rate at day 11 in the moxifloxacin treated group was 15.4% compared to 32.5% in the placebo treated group (p = 0.114). On per protocol analysis (n = 66), moxifloxacin significantly reduced infection rate from 41.9% to 17.1% (p = 0.032). Stroke associated infections were associated with a lower survival rate. In this study, neurological outcome and survival were not significantly influenced by treatment with moxifloxacin. Frequency of fluoroquinolone resistance in both treatment groups did not differ. On logistic regression analysis, treatment arm as well as the interaction between treatment arm and monocytic HLA-DR expression (a marker for immunodepression) at day 1 after stroke onset was independently and highly predictive for post-stroke infections. Interpretation PANTHERIS suggests that preventive administration of moxifloxacin is superior in reducing infections after severe non-lacunar ischemic stroke compared to placebo. In addition, the results emphasize the

  17. 5-Day versus 10-Day Course of Fluoroquinolones in Outpatient Males with a Urinary Tract Infection (UTI).

    PubMed

    Mospan, Geoffrey A; Wargo, Kurt A

    Current guidelines classify urinary tract infections (UTIs) in males as complicated and recommend longer treatment than for UTIs in females. The objective of this study is to demonstrate that males with UTIs may be successfully treated with an outpatient 5-day course of levofloxacin. Data were obtained from a previously conducted clinical trial (www.clinicaltrials.gov identifier NCT00210886), a multicenter, double-blind, randomized, noninferiority study comparing levofloxacin 750 mg intravenously/by mouth once daily for 5 days and ciprofloxacin 400/500 mg intravenously/by mouth twice daily for 10 days in complicated UTI (cUTI). The current study was a post hoc, subgroup analysis of male and female subjects with cUTI. Subjects were stratified into groups based on sex and antibiotic received. The subjects were analyzed at the end of therapy (EOT) and post therapy (PT) for clinical success rates, defined as no further need for antimicrobial treatment. Totals of 427 patients (224 male, 203 female) and 350 patients (189 male, 161 female) were included in the modified intent-to-treat (mITT) population and microbiologically evaluable (ME) populations, respectively. Clinical success rates between males and females were not statistically different between antibiotic groups in either the mITT or ME populations at EOT or PT. This study demonstrates that males with UTI may be treated with a shorter course of antimicrobial therapy for UTI than previously recommended. © Copyright 2016 by the American Board of Family Medicine.

  18. Chemotherapeutic trial to control enterobiasis in schoolchildren.

    PubMed

    Yang, Y S; Kim, S W; Jung, S H; Huh, S; Lee, J H

    1997-12-01

    To assess several chemotherapeutic schemes for control of enterobiasis, 738 children in five primary schools in Chunchon, Korea, were studied from May 1994 to June 1995. They were divided into 6 groups by the schemes: treatment of once or twice a year; treatment of positive cases or of whole class students; treatment with or without family members. The overall egg positive rate before intervention was 17.5% out of 789 children. Treating all individuals in a class together with family members of positive cases brought better control efficacy than other schemes (p = 0.000). However, when egg positive rate is less than 30%, treating only egg positive cases also can reduce egg positive rate. The confounding factors for the enterobiasis control in primary schoolchildren were new-comer to a class and familial infection.

  19. 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

  20. 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

  1. Weed Control Trials in Cottonwood Plantations

    Treesearch

    R. M. Krinard

    1964-01-01

    Weed control in the first year is essential for establishing a cottonwood plantation, for the young trees can neither survive nor grow well if they must compete with other plants. Once the light and moisture conditions are established in its favor, cottonwood becomes the fastest growing tree in the South.

  2. Does Visceral Osteopathic Treatment Accelerate Meconium Passage in Very Low Birth Weight Infants?- A Prospective Randomized Controlled Trial

    PubMed Central

    Haiden, Nadja; Pimpel, Birgit; Kreissl, Alexandra; Jilma, Bernd; Berger, Angelika

    2015-01-01

    Background To determine whether the complementary approach of visceral manipulative osteopathic treatment accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants. Methods This study was a prospective, randomized, controlled trial in premature infants with a birth weight <1500 g and a gestational age <32 weeks who received a visceral osteopathic treatment 3 times during their first week of life or no treatment. Results Passage of the last meconium occurred after a median of 7.5 days (95% confidence interval: 6–9 days, n = 21) in the intervention group and after 6 days (95% confidence interval: 5-9 days, n = 20,) in the control group (p = 0.11). However, osteopathic treatment was associated with a 8 day longer time to full enteral feedings (p = 0.02), and a 34 day longer hospital stay (Median = 66 vs. 100 days i.e.; p=0.14). Osteopathic treatment was tolerated well and no adverse events were observed. Conclusions Visceral osteopathic treatment of the abdomen did not accelerate meconium excretion in VLBW (very low birth weight)-infants. However infants in the osteopathic group had a longer time to full enteral feedings and a longer hospital stay, which could represent adverse effects. Based on our trial results, we cannot recommend visceral osteopathic techniques in VLBW-infants. Trial registration Clinical trials.gov: NCT02140710 PMID:25875011

  3. Effectiveness of short-course therapy (5 days) with grepafloxacin in the treatment of acute bacterial exacerbations of chronic bronchitis.

    PubMed

    DeAbate, C A; Bettis, R; Munk, Z M; Fleming, H; Munn, N J; Riffer, E; Bagby, B; Giguere, G; Collins, J J

    1999-01-01

    Three hundred eighty-nine patients were enrolled in a double-masked, multicenter, randomized clinical trial comparing the clinical and bacteriologic efficacies and safety of a 5-day course (n = 195) versus a 10-day course (n = 194) of grepafloxacin 400 mg once daily in the treatment of acute bacterial exacerbations of chronic bronchitis (ABECB). Patients in the 5-day treatment group received placebo on days 6 through 10. Bacteriologic assessments were based on cultures of sputum specimens obtained before and, when possible, during and after treatment. Organisms were isolated from the pretreatment sputum specimens of 332 of 388 (86%) patients, the primary pathogens being Haemophilus parainfluenzae, Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, and Staphylococcus aureus (29%, 19%, 4%, 5%, and 5% of isolates, respectively). Among isolates tested for beta-lactamase production, results were positive in 25% of H influenzae isolates and 90% of M catarrhalis isolates. Forty-two percent of S pneumoniae isolates demonstrated reduced susceptibility (intermediate or high-level resistance) to penicillin. A satisfactory clinical outcome (cure or improvement) was achieved in 83% (128 of 155) and 81% (122 of 150) of clinically evaluable patients treated with grepafloxacin for 5 or 10 days, respectively. Pathogens were eradicated or presumed eradicated in 77% (106 of 138) and 80% (98 of 123) of bacteriologically evaluable patients treated with grepafloxacin for 5 or 10 days, respectively. The 2 treatment groups were equivalent with respect to both clinical and bacteriologic efficacy, and no statistically significant differences in the incidence of drug-related adverse events were seen between the 2 groups. Substantial symptom relief was evident with both treatment regimens by the first during-treatment measurement, which occurred between days 3 through 5. These results indicate that treatment with 400 mg grepafloxacin once daily for 5 days is as well

  4. An Uncontrolled Examination of a 5-Day Intensive Treatment for Pediatric OCD

    ERIC Educational Resources Information Center

    Whiteside, Stephen P.; Jacobsen, Amy Brown

    2010-01-01

    This study examined the feasibility of a 5-day intensive treatment for pediatric obsessive-compulsive disorder (OCD). Fifteen children with OCD received a week-long treatment based on exposure and response prevention (ERP). The intervention also emphasized teaching children and parents how to conduct ERP independently at home. All families…

  5. An Uncontrolled Examination of a 5-Day Intensive Treatment for Pediatric OCD

    ERIC Educational Resources Information Center

    Whiteside, Stephen P.; Jacobsen, Amy Brown

    2010-01-01

    This study examined the feasibility of a 5-day intensive treatment for pediatric obsessive-compulsive disorder (OCD). Fifteen children with OCD received a week-long treatment based on exposure and response prevention (ERP). The intervention also emphasized teaching children and parents how to conduct ERP independently at home. All families…

  6. The Sexunzipped Trial: Young People’s Views of Participating in an Online Randomized Controlled Trial

    PubMed Central

    Nicholas, Angela; Stevenson, Fiona; Murray, Elizabeth

    2013-01-01

    Background Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants’ experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement. Objective Our goal was to determine participants’ views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention. Methods We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology. Results Interview participants found the trial design, including online recruitment via Facebook, online registration, email

  7. Enhancing Cognitive Abilities with Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial

    PubMed Central

    Hardy, Joseph L.; Nelson, Rolf A.; Thomason, Moriah E.; Sternberg, Daniel A.; Katovich, Kiefer; Farzin, Faraz; Scanlon, Michael

    2015-01-01

    Background A variety of studies have demonstrated gains in cognitive ability following cognitive training interventions. However, other studies have not shown such gains, and questions remain regarding the efficacy of specific cognitive training interventions. Cognitive training research often involves programs made up of just one or a few exercises, targeting limited and specific cognitive endpoints. In addition, cognitive training studies typically involve small samples that may be insufficient for reliable measurement of change. Other studies have utilized training periods that were too short to generate reliable gains in cognitive performance. Methods The present study evaluated an online cognitive training program comprised of 49 exercises targeting a variety of cognitive capacities. The cognitive training program was compared to an active control condition in which participants completed crossword puzzles. All participants were recruited, trained, and tested online (N = 4,715 fully evaluable participants). Participants in both groups were instructed to complete one approximately 15-minute session at least 5 days per week for 10 weeks. Results Participants randomly assigned to the treatment group improved significantly more on the primary outcome measure, an aggregate measure of neuropsychological performance, than did the active control group (Cohen’s d effect size = 0.255; 95% confidence interval = [0.198, 0.312]). Treatment participants showed greater improvements than controls on speed of processing, short-term memory, working memory, problem solving, and fluid reasoning assessments. Participants in the treatment group also showed greater improvements on self-reported measures of cognitive functioning, particularly on those items related to concentration compared to the control group (Cohen’s d = 0.249; 95% confidence interval = [0.191, 0.306]). Conclusion Taken together, these results indicate that a varied training program composed of a number of

  8. The CRASH trial: the first large-scale, randomised, controlled trial in head injury

    PubMed Central

    Roberts, Ian

    2001-01-01

    The global epidemic of head injuries is just beginning. Many are caused by road traffic crashes. It is estimated that, by 2020, road traffic crashes will have moved from its present position of ninth to third in the world disease burden ranking, as measured in disability adjusted life years. In developing countries, it will have moved to second. The Corticosteroid Randomisation After Significant Head Injury (CRASH) trial is a large-scale, randomised, controlled trial, among adults with head injury and impaired consciousness, of the effects of a short-term infusion of corticosteroids on death and on neurological disability. Following a successful pilot phase, which included over 1000 randomised participants, the main phase of the trial is now underway. Over the next 5 years, the trial aims to recruit a total of 20,000 patients. Such large numbers will only be possible if hundreds of doctors and nurses can collaborate in emergency departments all over the world. The trial is currently recruiting, and new collaborators are welcome to join the trial (see ). PMID:11737908

  9. Effect of N-acetylcysteine on inflammation biomarkers in pediatric acute pyelonephritis: a randomized controlled trial.

    PubMed

    Allameh, Zahra; Karimi, Abdollah; Rafiei Tabatabaei, Seddigheh; Sharifian, Mostafa; Salamzadeh, Jamshid

    2015-11-01

    This study was designed to investigate the effect of N-acetylcysteine (NAC), as a potent and safe antioxidant, on inflammatory biomarkers of acute pyelonephritis in pediatric patients. Children (< 15 years old) admitted with a diagnosis of pyelonephritis were recruited in a randomized placebo-controlled trial. They were randomly allocated to 2 groups and recieved placebo or NAC effervescent tablets with daily dose based on their weight, for 5 days. The children were evaluated for serum procalcitonin level, leukocyte count, C-reactive protein (CRP), serum creatinine, and clinical symptoms on the 1st and the 5th days. Seventy patients, 35 in each group, with a mean age of 5.54 ± 3.10 years completed the study. There was no significant difference between the two groups in the amount of changes in procalcitonin levels after 5 days (P = .90). Within-group analysis confirmed CRP reduction in both groups (P < .001); however, between-group analysis did not show significant difference in CRP reductions, either (P = .65). No significant differences were found between the two groups in the day of resolving pyuria (P = .46), day of resolving bacteriuria (P = .81), or reductions in leukocyte count (P = .64) and neutrophil count (P = .49). A short period of NAC administration with the recommended doses could not lead to a significant decrease in inflammation biomarkers. Studies on higher doses and longer duration of NAC administration along with evaluation of the long-term effects of the intervention by tools such as renal scntigraphy are suggested.

  10. Zonal Wave Number 2 Rossby Wave (3.5-day oscillation) Over The Martian Lower Atmosphere

    NASA Astrophysics Data System (ADS)

    Ghosh, P.; Thokuluwa, R. K.

    2013-12-01

    Over the Mars, height (800-50 Pascal pressure coordinate) profiles of temperature (K), measured by radio occultation technique during the MGS (Mars Global Surveyor) mission, obtained for the period of 1-10 January 2006 at the Martian latitude of ~63N in almost all the longitudes are analyzed to study the characteristics of the 3.5-day oscillation. To avoid significant data gaps in a particular longitude sector, we selected a set of 7 Mars longitude regions with ranges of 0-30E, 35-60E, 65-95E, 190-230E, 250-280E, 290-320E, and 325-360E to study the global characteristics of the 3.5-day oscillation. The 3.5-day oscillation is not selected as a-priori but observed as a most significant oscillation during this period of 1-10 January 2006. It is observed that in the longitude of 0-30E, the 3.5-day oscillation shows statistically significant power (above the 95% confidence level white noise) from the lowest height (800 Pascal, 8 hPa) itself and up to the height of 450 Pascal level with the maximum power of ~130 K^2 at the 600 & 650 Pascal levels. It started to grow from the power of ~ 50 K^2 at the lowest height of 800 Pascal level and reached the maximum power in the height of 600-650 Pascal level and then it started to get lessened monotonously up to the height of 450 Pascal level where its power is ~ 20 K^2. Beyond this height and up to the height of 50 Pascal level, the wave amplitude is below the white noise level. As the phase of the wave is almost constant at all the height levels, it seems that the observed 3.5-day oscillation is a stationary wave with respect to the height. In the 35-60 E longitude sector, the vertical structure of the 3.5-day oscillation is similar to what observed for the 0-30 E longitude region but the power is statistically insignificant at all the heights. However in the 65-95E longitude sector, the wave grows from the lowest level (70 K^2) of 800 Pascal to its maximum power of 280 K^2 in the height of 700 Pascal level and then it started

  11. 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.

  12. Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

    ERIC Educational Resources Information Center

    Torgerson, Carole J.

    2009-01-01

    The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

  13. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    PubMed

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  14. Surgical trials in oncology. the importance of quality control in the TME trial.

    PubMed

    Klein Kranenbarg, E; van de Velde, C J H

    2002-05-01

    Results from randomised trials provide the best scientific evidence of efficacy or inefficacy of the therapy. The evaluation of surgical procedures involves problems in addition to those associated with medical experimentation. Surgery, unlike a pill, is not a standardised, reproducible entity, but a unique product whose details are defined by, for example, the skill of the surgeon. Quality assurance is important for treatment and also for data handling. The different treatments (surgery, pathology, radiotherapy, etc.) should be familiar to all participating physicians prior to the start of the trial. Instructions can be given by means of a well-written protocol, videotapes, workshops and instructors at the dissection table. The data collection and data check should be done by data managers and co-ordinators for the separate disciplines. Errors and missing data should be completed and feedback to the physician is essential. Close contact between an active co-ordinating data centre, including co-ordinators for the separate disciplines, and all participating physicians is essential to conduct a quality controlled multicentre, multidisciplinary trial. Continuous enthusiasm can be maintained by the organisation of regular workshops, distribution of newsletters and trial up-dates at scientific meetings. The efforts from all of the involved co-ordinators, data managers, instructors and physicians have resulted in a very successful trial with rapid accrual, good quality treatments and procedures, good quality data, and a high participation rate among hospitals and patients. Quality control is expensive and labour-intensive, but it is worthwhile.

  15. 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

  16. Effects of Gentle Human Touch and Field Massage on Urine Cortisol Level in Premature Infants: A Randomized, Controlled Clinical Trial

    PubMed Central

    Asadollahi, Malihe; Jabraeili, Mahnaz; Mahallei, Majid; Asgari Jafarabadi, Mohammad; Ebrahimi, Sakine

    2016-01-01

    Introduction: Hospitalization in neonatal intensive care unit may leads to many stresses for premature infants. Since premature infants cannot properly process stressors, identifying interventions that reduce the stress level for them is seems necessary. The aim of present study was to compare the effects of Field massage and Gentle Human Touch (GHT) techniques on the urine level of cortisol, as an indicator of stress in preterm infants. Methods: This randomized, controlled clinical trial was carried out in Al-Zahra hospital, Tabriz. A total of 84 premature infants were randomly assigned into three groups. First groups were touched by their mothers three times a day (15 minutes in each session) for 5 days by GHT technique. The second group was received 15 minutes Field massage with sunflower oil three times a day by their mothers for 5 days. The third group received routine care. In all groups, 24-hours urine samples were collected in the first and sixth day after the intervention and analyzed for cortisol level. Data were analyzed by SPSS software. Results: There were significant differences between mean of changes in cortisol level between GHT and control groups and Field massage and control groups (0.026). Conclusion: Although the massage with Field technique resulted in a significant reduction in blood cortisol level, but the GHT technique have also a similar effect. So, both methods are recommended for decreasing of stress in preterm infants. PMID:27752484

  17. Randomized controlled trials in schizophrenia: opportunities, limitations, and trial design alternatives

    PubMed Central

    Correll, Christoph U.; Kishimoto, Taishiro; Kane, John M.

    2011-01-01

    State-of-the art clinical trial design and methodology are enormously important for the advancement of the field. In contrast, the critical relevance of trial conduct and implementation have only more recently been the focus of discussion and research. Although randomized controlled trials are generally considered the gold standard for the assessment of pharmacologic and nonpharmacologic interventions in medicine, trials are vulnerable to complications and influences that can seriously compromise their success, Like interventions, trial design and conduct are also contextual. They need to be individualized and adapted to a number of relevant variables, such as setting, population, illness phase, interventions, patient and rater expectations and biases, and the overall aims of the investigation. While this means that there is no unified approach possible, certain general principles and guidelines require careful consideration. Knowledge of basic solutions and alternatives, and the recognition of the complex challenges that need to be addressed proactively can help to minimize unwanted outcomes, including trial failure and uninformative or falsely negative outcomes. Moreover, novel design alternatives need to be explored that target sample enrichment according to the study question and enhancement of precision in the measurement of relevant outcomes. We propose two novel design strategies that take advantage of the recently validated early antipsychotic response paradigm (that has also been observed with antidepressants and mood stabilizers). In the “early responder randomized discontinuation design” all patients are assigned to the active drug, and only those who had at least a minimal response at 2 weeks are enrolled in a double-blind, placebo-controlled discontinuation trial, enriching the placebo controlled trial portion with true drug responders. In the mirror image “early nonresponder randomized dose increase or augmentation design,” early nonresponders

  18. Directional sensitivity of "first trial" reactions in human balance control.

    PubMed

    Oude Nijhuis, Lars B; Allum, John H J; Borm, George F; Honegger, Flurin; Overeem, Sebastiaan; Bloem, Bastiaan R

    2009-06-01

    Support-surface movements are commonly used to examine balance control. Subjects typically receive a series of identical or randomly interspersed multidirectional balance perturbations and the atypical "first trial reaction" (evoked by the first perturbation) is often excluded from further analysis. However, this procedure may obscure vital information about neurophysiological mechanisms associated with the first perturbation and, by analogy, fully unexpected falls. We studied first trial reactions, aiming to clarify their directional impact on postural control and to characterize the underlying neurophysiological substrate. We instructed 36 subjects to maintain balance following support-surface rotations in six different directions. Perturbations in each direction were delivered in blocks, consisting of 10 serial stimuli. Full body kinematics, surface reactive forces, and electromyographic (EMG) responses were recorded. Regardless of direction, for the very first rotation, displacement of the center of mass was 15% larger compared with the ensuing nine identical rotations (P < 0.0001). This first trial reaction immediately reemerged whenever a new perturbation direction was introduced. First trial reactions (and near-falls) were greatest for backward-directed rotations and smallest for laterally directed rotations. This directional dependence coincided with early changes in vertical head accelerations. First trial reactions in EMG responses involved larger amplitudes in general and earlier muscle response onsets in upper body muscles. These findings show that first trial reactions are associated with significantly increased postural instability, mainly due to increased response amplitudes. Although rapid habituation occurs following presentation of identical stimuli, subjects immediately become unstable again when the perturbation direction suddenly changes. Excessive responses due to a failure to combine proprioceptive and vestibular cues effectively may explain

  19. 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…

  20. 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"…

  1. 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…

  2. 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…

  3. 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…

  4. Outcomes in a Randomised Controlled Trial of Mathematics Tutoring

    ERIC Educational Resources Information Center

    Topping, K. J.; Miller, D.; Murray, P.; Henderson, S.; Fortuna, C.; Conlin, N.

    2011-01-01

    Background: Large-scale randomised controlled trials (RCT) are relatively rare in education. The present study was an attempt to scale up previous small peer tutoring projects, while investing only modestly in continuing professional development for teachers. Purpose: A two-year RCT of peer tutoring in mathematics was undertaken in one local…

  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. 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"…

  7. 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…

  8. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    PubMed

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial.

  9. 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…

  10. Outcomes in a Randomised Controlled Trial of Mathematics Tutoring

    ERIC Educational Resources Information Center

    Topping, K. J.; Miller, D.; Murray, P.; Henderson, S.; Fortuna, C.; Conlin, N.

    2011-01-01

    Background: Large-scale randomised controlled trials (RCT) are relatively rare in education. The present study was an attempt to scale up previous small peer tutoring projects, while investing only modestly in continuing professional development for teachers. Purpose: A two-year RCT of peer tutoring in mathematics was undertaken in one local…

  11. Randomized controlled trial of the effect of regular paracetamol on influenza infection

    PubMed Central

    Jefferies, Sarah; Walker, Steven; Weatherall, Mark; Jennings, Lance; Luck, Michelle; Barrett, Kevin; Siebers, Robert; Blackmore, Timothy; Beasley, Richard; Perrin, Kyle

    2015-01-01

    Abstract Background and objective Anti‐pyretic treatment is recommended in the management of influenza infection. In animal models anti‐pyretic treatment increases mortality from influenza. We investigated the effects of paracetamol on viral and clinical outcomes in adults with influenza infection. Methods This is a randomized, double‐blind, placebo‐controlled trial of adults aged 18–65 years with influenza‐like illness and positive influenza rapid antigen test. Treatments were 1 g paracetamol four times a day, or matching placebo, for 5 days. Pernasal swabs were taken for influenza quantitative RT‐PCR at Baseline and Days 1, 2 and 5. Temperature and symptom scores were recorded for 5–14 days or time of resolution respectively. The primary outcome variable was area under the curve (AUC) for quantitative PCR log10 viral load from Baseline to Day 5. Results A total of 80 participants were randomized: no one was lost to follow up, and one withdrew after 4 days. There were 22 and 24 participants who were influenza PCR‐positive in placebo and in paracetamol groups respectively. Mean (SD) AUC PCR log10 viral load was 4.40 (0.91) in placebo and 4.64 (0.88) in paracetamol; difference was −0.24, 95% CI: −0.78 to 0.29, P = 0.36. In all participants there were no differences in symptom scores, temperature, time to resolution of illness and health status, with no interaction between randomized treatment and whether influenza was detected by PCR. Conclusion Regular paracetamol had no effect on viral shedding, temperature or clinical symptoms in patients with PCR‐confirmed influenza. There remains an insufficient evidence base for paracetamol use in influenza infection. Clinical trial registration: ACTRN12611000497909 at the Australian New Zealand Clinical Trials Registry. PMID:26638130

  12. 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

  13. Placebo-controlled trials and the Declaration of Helsinki.

    PubMed

    Lewis, John A; Jonsson, Bertil; Kreutz, Gottfried; Sampaio, Cristina; van Zwieten-Boot, Barbara

    2002-04-13

    A revised version of the Declaration of Helsinki, issued in October, 2000, remains a vital expression of medical ethics, and deserves unanimous support. A strict interpretation of the declaration seems to rule out clinical trials that use a placebo control group whenever licensed therapeutic methods already exist, preferring active controls. Although the efficacy of some new medicines can be satisfactorily established without the use of a placebo, for others the judicious use of placebo remains essential to establish their effectiveness.

  14. Calculating sample size in trials using historical controls.

    PubMed

    Zhang, Song; Cao, Jing; Ahn, Chul

    2010-08-01

    Makuch and Simon [Sample size considerations for non-randomised comparative studies. J Chronic Dis 1980; 33: 175-81.] developed a sample size formula for historical control trials. When assessing power, they assumed the true control treatment effect to be equal to the observed effect from the historical control group. Many researchers have pointed out that the Makuch-Simon approach does not preserve the nominal power and type I error when considering the uncertainty in the true historical control treatment effect. To develop a sample size formula that properly accounts for the underlying randomness in the observations from the historical control group. We reveal the extremely skewed nature in the distributions of power and type I error, obtained over all the random realizations of the historical control data. The skewness motivates us to derive a sample size formula that controls the percentiles, instead of the means, of the power and type I error. A closed-form sample size formula is developed to control arbitrary percentiles of power and type I error for historical control trials. A simulation study further demonstrates that this approach preserves the operational characteristics in a more realistic scenario where the population variances are unknown and replaced by sample variances. The closed-form sample size formula is derived for continuous outcomes. The formula is more complicated for binary or survival time outcomes. We have derived a closed-form sample size formula that controls the percentiles instead of means of power and type I error in historical control trials, which have extremely skewed distributions over all the possible realizations of historical control data.

  15. 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

  16. Sham surgery trial controls: perspectives of patients and their relatives.

    PubMed

    Swift, Teresa L

    2012-07-01

    This study reports on qualitative research conducted in the UK with people with Parkinson's Disease and their relatives on the subject of "sham surgery." It explores attitudes toward sham surgery and reasoning about hypothetical participation in a sham-controlled trial. Results showed that attitudes toward sham surgery may not necessarily predict trial participation behavior. A small majority of interviewees deemed sham surgery ethically acceptable with certain provisos, but hypothetical participation was driven primarily by disease severity and a lack of standard treatment options, with a preference for receiving the real surgery over sham. Ethical implications for patient equipoise and the autonomy of patients' research participation decisions are discussed.

  17. 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

  18. The Sexunzipped trial: optimizing the design of online randomized controlled trials.

    PubMed

    Bailey, Julia V; Pavlou, Menelaos; Copas, Andrew; McCarthy, Ona; Carswell, Ken; Rait, Greta; Hart, Graham; Nazareth, Irwin; Free, Caroline; French, Rebecca; Murray, Elizabeth

    2013-12-11

    Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions. Evaluations of digital interventions are increasingly conducted online. Trial administration and data collection online offers many advantages, but concerns remain over fraudulent registration to obtain compensation, the quality of self-reported data, and high attrition. This study addresses the feasibility of several dimensions of online trial design-recruitment, online consent, participant identity verification, randomization and concealment of allocation, online data collection, data quality, and retention at 3-month follow-up. Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the "Sexunzipped" online trial between November 2010 and March 2011 (n=2036). Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website. Participants were also randomly allocated to a postal request (or no request) for a urine sample for genital chlamydia testing and receipt of a lower (£10/US$16) or higher (£20/US$32) value shopping voucher compensation for 3-month outcome data. The majority of the 2006 valid participants (90.98%, 1825/2006) were aged between 18 and 20 years at enrolment, from all four countries in the United Kingdom. Most were white (89.98%, 1805/2006), most were in school or training (77.48%, 1545/1994), and 62.81% (1260/2006) of the sample were female. In total, 3.88% (79/2036) of registrations appeared to be invalid and another 4.00% (81/2006) of participants gave inconsistent responses within the questionnaire. The higher value compensation (£20/US$32) increased response rates by 6-10%, boosting retention at 3 months to 77.2% (166/215) for submission of online self-reported sexual health

  19. TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial.

    PubMed

    Watson, Gillian; O'Hara, James; Carding, Paul; Lecouturier, Jan; Stocken, Deborah; Fouweather, Tony; Wilson, Janet

    2016-04-01

    Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for attendance at a secondary care throat or voice clinic. There is a growing trend to treat throat symptom patients with proton pump inhibitors (PPIs) to suppress stomach acid, but most controlled studies fail to demonstrate a significant benefit of PPI over placebo. In addition, patient views on PPI use vary widely. A UK multi-centre, randomised, controlled trial for adults with persistent throat symptoms to compare the effectiveness of treatment with the proton pump inhibitor (PPI) lansoprazole versus placebo. The trial includes a six-month internal pilot, during which three sites will recruit 30 participants in total, to assess the practicality of the trial and assess the study procedures and willingness of the patient population to participate. If the pilot is successful, three additional sites will be opened to recruitment, and a further 302 participants recruited across the six main trial sites. Further trial sites may be opened, as necessary. The main trial will continue for a further 18 months. Participants will be followed up for 12 months from randomisation, throughout which both primary and secondary outcome data will be collected. The primary outcome is change in Reflux Symptom Index (RSI) score, the 'area standard' for this type of assessment, after 16 weeks (four months) of treatment. Secondary outcomes are RSI changes at 12 months after randomisation, Quality of Life assessment at four and 12 months, laryngeal mucosal changes, assessments of compliance and side effects, and patient-reported satisfaction. TOPPITS is designed to evaluate the relative effectiveness of treatment with a proton pump inhibitor versus placebo in patients with persistent throat symptoms. This will provide valuable information to clinicians and GPs regarding the treatment and management of care for these patients, on changes in symptoms, and in Quality of Life, over time. ISRCTN

  20. Trial-to-trial adaptation in control of arm reaching and standing posture.

    PubMed

    Pienciak-Siewert, Alison; Horan, Dylan P; Ahmed, Alaa A

    2016-12-01

    Classical theories of motor learning hypothesize that adaptation is driven by sensorimotor error; this is supported by studies of arm and eye movements that have shown that trial-to-trial adaptation increases with error. Studies of postural control have shown that anticipatory postural adjustments increase with the magnitude of a perturbation. However, differences in adaptation have been observed between the two modalities, possibly due to either the inherent instability or sensory uncertainty in standing posture. Therefore, we hypothesized that trial-to-trial adaptation in posture should be driven by error, similar to what is observed in arm reaching, but the nature of the relationship between error and adaptation may differ. Here we investigated trial-to-trial adaptation of arm reaching and postural control concurrently; subjects made reaching movements in a novel dynamic environment of varying strengths, while standing and holding the handle of a force-generating robotic arm. We found that error and adaptation increased with perturbation strength in both arm and posture. Furthermore, in both modalities, adaptation showed a significant correlation with error magnitude. Our results indicate that adaptation scales proportionally with error in the arm and near proportionally in posture. In posture only, adaptation was not sensitive to small error sizes, which were similar in size to errors experienced in unperturbed baseline movements due to inherent variability. This finding may be explained as an effect of uncertainty about the source of small errors. Our findings suggest that in rehabilitation, postural error size should be considered relative to the magnitude of inherent movement variability.

  1. Von Willebrand factor availability in platelet concentrates stored for 5 days.

    PubMed

    Cesar, J M; García-Avello, A; Monteagudo, J; Espinosa, J I; Lodos, J C; Castillo, R; Navarro, J L

    1994-02-01

    Von Willebrand factor (vWF) availability was assessed in platelet concentrates (PCs). After 5 days of storage, 82 +/- 9% of basal levels of ristocetin cofactor activity (vWF:RCo) remained in PCs. vWF antigen (vWF:Ag) increased up to 166 +/- 38% (P < 0.05) in the same period. Autoradiograph pattern of vW:Ag showed an increase in low molecular weight multimers, and fast migrating multimeric forms were visualized by crossed immunoelectrophoresis on day 5. Studies carried out in platelet free plasma stored as PCs showed similar changes in vWF:RCo but increments in vWF:Ag were not detected. These data indicate that PCs maintain vWF:RCo levels of clinical value even after 5 days of storage and suggest that vWF comes out from platelets to plasma during storage.

  2. Biochemical changes in rat liver after 18.5 days of spaceflight (41566)

    NASA Technical Reports Server (NTRS)

    Abraham, S.; Lin, C.Y.; Volkmann, C. M.; Klein, H. P.

    1983-01-01

    The effect of weightlessness on liver metabolism was investigated using tissue from rats flown in earth orbit for 18.5 days on the Soviet Cosmos 936 biosatellite and the changes in the activities of 28 carbohydrate and lipid enzymes were determined. The activities of two enzymes, palmitoyl-CoA desaturase and lactate dehydrogenase, increased, while the activities of five, glycogen phosphorylase, 6-phosphogluconate dehydrogenase, both acyltransferases which act on alpha-glycerolphosphate and diglycerides, and and aconitate hydratase decreased. The other enzyme activities were found to be unchanged. In addition, increased levels of liver glycogen and palmitoleate were detected which probably resulted from the lowered glycogen phosphorylase and increased palmitoyl-CoA desaturase activities, respectively, in those animals that experienced weightlessness. All of the changes observed in the rats after 18.5 days of spaceflight disappear by 25 days after the flight.

  3. Biochemical changes in rat liver after 18.5 days of spaceflight (41566)

    NASA Technical Reports Server (NTRS)

    Abraham, S.; Lin, C.Y.; Volkmann, C. M.; Klein, H. P.

    1983-01-01

    The effect of weightlessness on liver metabolism was investigated using tissue from rats flown in earth orbit for 18.5 days on the Soviet Cosmos 936 biosatellite and the changes in the activities of 28 carbohydrate and lipid enzymes were determined. The activities of two enzymes, palmitoyl-CoA desaturase and lactate dehydrogenase, increased, while the activities of five, glycogen phosphorylase, 6-phosphogluconate dehydrogenase, both acyltransferases which act on alpha-glycerolphosphate and diglycerides, and and aconitate hydratase decreased. The other enzyme activities were found to be unchanged. In addition, increased levels of liver glycogen and palmitoleate were detected which probably resulted from the lowered glycogen phosphorylase and increased palmitoyl-CoA desaturase activities, respectively, in those animals that experienced weightlessness. All of the changes observed in the rats after 18.5 days of spaceflight disappear by 25 days after the flight.

  4. Microbiological evaluation of octenidine dihydrochloride mouth rinse after 5 days' use in orthodontic patients.

    PubMed

    Dogan, Alev Aksoy; Cetin, Emel Sesli; Hüssein, Emad; Adiloglu, Ali Kudret

    2009-07-01

    To determine the absolute and relative antibacterial activity of octenidine dihydrochloride (OCT) against total and cariogenic bacteria in saliva samples of patients with fixed orthodontic appliances during 5 days of usage. The study group consisted of 5 male and 13 female subjects who were selected from patients in the Clinic of Orthodontics. Each patient was given physiologic saline (PS), chlorhexidine gluconate (CHX), polyvinylpyrrolidone-iodine complex (PVP-I), and OCT every morning for 5 days, each separated by a 2-week interval. Total and cariogenic bacteria in saliva samples of orthodontically treated patients with fixed appliances were collected during 5 days of usage. Unstimulated saliva was collected as a baseline sample. Saliva samples were collected at 15 minutes, and on the second, third, and fifth day after rinsing the mouth with any of the solutions for 30 seconds, and bacterial counts were detected. OCT showed an ultimate reduction of total viable oral bacteria, Lactobacillus species, and Streptococcus mutans in vivo. OCT also had a significantly greater inhibitory effect than 0.2% CHX and 7.5% PVP-I, from the beginning of the study until the fifth day after the orthodontic appliances were bonded (P < .1). OCT compared favorably with respect to CHX and PVP-I complex in orthodontically treated patients with fixed appliances (P

  5. 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

  6. 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.

  7. 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

  8. 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

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

    PubMed Central

    Joffe, Grigori; Stenberg, Jan-Henry

    2015-01-01

    Background: Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. Methods: To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. Results: There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors’ efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Conclusions: Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups—plausibly due to differences in the mechanisms of action. Antidepressants may not worsen

  10. Sequential therapy compared with standard triple therapy for Helicobacter pylori eradication in children: a double-blind, randomized, controlled trial.

    PubMed

    Albrecht, Piotr; Kotowska, Maria; Szajewska, Hania

    2011-07-01

    To determine the effectiveness of sequential therapy compared with standard triple therapy for Helicobacter pylori eradication in children. In 107 children with H pylori infection confirmed with 2 of 3 tests ((13)C-urea breath test, histopathology, rapid urease test), we conducted a double-blind, randomized, controlled trial comparing a sequential treatment (amoxicillin and omeprazole for 5 days followed by clarithromycin, tinidazole, and omeprazole for 5 days) to a 7-day standard triple eradication regimen (amoxicillin and clarithromycin plus omeprazole) followed by placebo for 3 days. In the experimental group (n=52) compared with the control group (n=51), there was a significant difference in the H pylori eradication rate at 6 to 8 weeks after the completion of treatment (primary outcome), as confirmed with negative results on (13)C-urea breath test (45/52 or 86.5% versus 35/51 or 68.6%; relative risk, 1.26; 95% CI, 1.02-1.60). Groups did not differ in any of the secondary outcomes (ie, adverse effects, the need for discontinuation of the H pylori therapy, compliance with therapy). In children with H pylori infection, sequential eradication therapy compared with standard triple therapy resulted in a higher eradication rate, although the difference was of borderline statistical significance. Copyright © 2011 Mosby, Inc. All rights reserved.

  11. Cognitive analytic therapy for personality disorder: randomised controlled trial.

    PubMed

    Clarke, Susan; Thomas, Peter; James, Kirsty

    2013-02-01

    Cognitive analytic therapy (CAT) is a theoretically coherent approach developed to address common processes underlying personality disorders, but is supported by limited empirical evidence. To investigate the effectiveness of time-limited CAT for participants with personality disorder. A service-based randomised controlled trial (trial registration: ISRCTN79596618) comparing 24 sessions of CAT (n = 38) and treatment as usual (TAU) (n = 40) over 10 months for individuals with personality disorder. Primary outcomes were measures of psychological symptoms and interpersonal difficulties. Participants receiving CAT showed reduced symptoms and experienced substantial benefits compared with TAU controls, who showed signs of deterioration during the treatment period. Cognitive analytic therapy is more effective than TAU in improving outcomes associated with personality disorder. More elaborate and controlled evaluations of CAT are needed in the future.

  12. 21 CFR 803.53 - If I am a manufacturer, in which circumstances must I submit a 5-day report?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... must I submit a 5-day report? 803.53 Section 803.53 Food and Drugs FOOD AND DRUG ADMINISTRATION... must I submit a 5-day report? You must submit a 5-day report to us, on Form 3500A or an electronic...) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial...

  13. Prospective Randomized Controlled Trial of Liberal Vs Restricted Perioperative Fluid Management in Patients Undergoing Pancreatectomy.

    PubMed

    Grant, Florence; Brennan, Murray F; Allen, Peter J; DeMatteo, Ronald P; Kingham, T Peter; D'Angelica, Michael; Fischer, Mary E; Gonen, Mithat; Zhang, Hao; Jarnagin, William R

    2016-10-01

    The aim of this study is to examine, by a prospective randomized controlled trial, the influence of liberal (LIB) vs restricted (RES) perioperative fluid administration on morbidity following pancreatectomy. Randomized controlled trials in patients undergoing major intra-abdominal surgery have challenged the historical use of LIB fluid administration, suggesting that a more restricted regimen may be associated with fewer postoperative complications. Patients scheduled to undergo pancreatic resection were consented for randomization to a LIB (n = 164) or RES (n = 166) perioperative fluid regimen. Sample size was designed with 80% power to decrease Grade 3 complications from 35% to 21%. Between July 2009 and July 2015, we randomized 330 patients undergoing pancreaticoduodenectomy (PD, n = 218), central (n = 16), or distal pancreatectomy (DP, n = 96). Patients were equally distributed for all demographic and intraoperative characteristics. Intraoperatively, LIB patients received crystalloid 12 mL/kg/h and RES patients 6 mL/kg/h. Cumulative crystalloid given (median, range, mL) days 0 to 3 was LIB: 12,252 (6600 to 21,365), RES 7808 (2700 to 16,274) P < 0.0001. Sixty-day mortality was 2 of 330 (0.6%). Median operative time for PD was 227 minutes (105 to 462) and DP 150 (44 to 323). Grade 3 complications occurred in 20% of LIB and 27% of RES patients (P = 0.6). Median length of stay was 7 and 5 days for PD and DP, respectively, in both arms. In a high volume institution, major perioperative complications from pancreatic resection were not significantly influenced by fluid regimens that differed approximately 1.6-fold.

  14. Randomized controlled trials and challenge trials: design and criterion for validity.

    PubMed

    Sargeant, J M; Kelton, D F; O'Connor, A M

    2014-06-01

    This article is the third of six articles addressing systematic reviews in animal agriculture and veterinary medicine. This article provides an overview of clinical trials, both randomized controlled trials (RCTs) and challenge trials, where the disease outcome is deliberately induced by the investigator. RCTs are not the only study design used in systematic reviews, but are preferred when available as the gold standard for evaluating interventions under real-world conditions. RCTs are planned experiments, which involve diseased or at-risk study subjects and are designed to evaluate interventions (therapeutic treatments or preventive strategies, including antibiotics, vaccines, management practices, dietary changes, management changes or lifestyle changes). Key components of the RCT are the use of one or more comparison (control) groups and investigator control over intervention allocation. Important design features in RCTs include as follows: how the population is selected, approach to allocation of intervention and control group subjects, how allocation is concealed prior to enrolment of study subjects, how outcomes are defined, how allocation to group is concealed (blinding) and how withdrawals from the study are managed. Guidelines for reporting important features of RCTs have been published and are useful tools for writing, reviewing and reading reports of RCTs.

  15. Granulocyte-colony stimulating factor for mobilizing bone marrow stem cells in subacute stroke: the stem cell trial of recovery enhancement after stroke 2 randomized controlled trial.

    PubMed

    England, Timothy J; Abaei, Maryam; Auer, Dorothee P; Lowe, James; Jones, D Rhodri E; Sare, Gillian; Walker, Marion; Bath, Philip M W

    2012-02-01

    Granulocyte-colony stimulating factor (G-CSF) is neuroprotective in experimental stroke and mobilizes CD34(+) peripheral blood stem cells into the circulation. We assessed the safety of G-CSF in recent stroke in a phase IIb single-center randomized, controlled trial. G-CSF (10 μg/kg) or placebo (ratio 2:1) was given SC for 5 days to 60 patients 3 to 30 days after ischemic or hemorrhagic stroke. The primary outcome was the frequency of serious adverse events. Peripheral blood counts, CD34(+) count, and functional outcome were measured. MRI assessed lesion volume, atrophy, and the presence of iron-labeled CD34(+) cells reinjected on day 6. Sixty patients were recruited at mean of 8 days (SD ± 5) post ictus, with mean age 71 years (± 12 years) and 53% men. The groups were well matched for baseline minimization/prognostic factors. There were no significant differences between groups in the number of participants with serious adverse events: G-CSF 15 (37.5%) of 40 versus placebo 7 (35%) of 20, death or dependency (modified Rankin Score: G-CSF 3.3 ± 1.3, placebo 3.0 ± 1.3) at 90 days, or the number of injections received. G-CSF increased CD34(+) and total white cell counts of 9.5- and 4.2-fold, respectively. There was a trend toward reduction in MRI ischemic lesion volume with respect to change from baseline in G-CSF-treated patients (P=0.06). In 1 participant, there was suggestion that labeled CD34(+) cells had migrated to the ischemic lesion. This randomized, double-blind, placebo-controlled trial suggests that G-CSF is safe when administered subacutely. It is feasible to label and readminister iron-labeled CD34(+) cells in patients with ischemic stroke. URL: www.controlled-trials.com. Unique identifier: ISRCTN63336619.

  16. Impact of Length or Relevance of Questionnaires on Attrition in Online Trials: Randomized Controlled Trial

    PubMed Central

    Kalaitzaki, Eleftheria; White, Ian R; Khadjesari, Zarnie; Murray, Elizabeth; Linke, Stuart; Thompson, Simon G; Godfrey, Christine; Wallace, Paul

    2011-01-01

    Background There has been limited study of factors influencing response rates and attrition in online research. Online experiments were nested within the pilot (study 1, n = 3780) and main trial (study 2, n = 2667) phases of an evaluation of a Web-based intervention for hazardous drinkers: the Down Your Drink randomized controlled trial (DYD-RCT). Objectives The objective was to determine whether differences in the length and relevance of questionnaires can impact upon loss to follow-up in online trials. Methods A randomized controlled trial design was used. All participants who consented to enter DYD-RCT and completed the primary outcome questionnaires were randomized to complete one of four secondary outcome questionnaires at baseline and at follow-up. These questionnaires varied in length (additional 23 or 34 versus 10 items) and relevance (alcohol problems versus mental health). The outcome measure was the proportion of participants who completed follow-up at each of two follow-up intervals: study 1 after 1 and 3 months and study 2 after 3 and 12 months. Results At all four follow-up intervals there were no significant effects of additional questionnaire length on follow-up. Randomization to the less relevant questionnaire resulted in significantly lower rates of follow-up in two of the four assessments made (absolute difference of 4%, 95% confidence interval [CI] 0%-8%, in both study 1 after 1 month and in study 2 after 12 months). A post hoc pooled analysis across all four follow-up intervals found this effect of marginal statistical significance (unadjusted difference, 3%, range 1%-5%, P = .01; difference adjusted for prespecified covariates, 3%, range 0%-5%, P = .05). Conclusions Apparently minor differences in study design decisions may have a measurable impact on attrition in trials. Further investigation is warranted of the impact of the relevance of outcome measures on follow-up rates and, more broadly, of the consequences of what we ask participants to

  17. 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.

  18. AcuTrials®: an online database of randomized controlled trials and systematic reviews of acupuncture

    PubMed Central

    2013-01-01

    Background The growing quantity of Complementary and Alternative Medicine literature requires databases enabled with increasingly powerful search capabilities. To address this need in the area of acupuncture research, a bibliographic database of randomized controlled trials (RCTs) and systematic reviews called AcuTrials® has been developed by the Oregon College of Oriental Medicine. AcuTrials® introduces a comprehensive keyword thesaurus that categorizes details of treatment protocols and research design to an extent not currently available in MEDLINE or other databases. Description AcuTrials®, which went live in January of 2010 and is updated monthly, currently contains over 1250 articles from more than 300 journals. Articles included are English language RCTs and systematic reviews that report on medical conditions in human subjects treated by needle acupuncture. Study details are indexed by 14 key domains, such as acupuncture style and needling protocol, to create an acupuncture-relevant, searchable keyword catalogue. Keywords follow the National Library of Medicine (NLM) MeSH terminology when possible, and new keywords were created in cases where no appropriate MeSH terms were available. The resulting keyword catalogue enables users to perform sensitive, targeted searches for particular aspects of acupuncture treatment and research design. Conclusions AcuTrials® provides an extensive and innovative keyword catalogue of acupuncture research, allowing users to efficiently navigate, locate and assess the evidence base in ways not currently possible with other databases. By providing a more powerful suite of search options, the AcuTrials® database has the potential to enhance the accessibility and quality of acupuncture research. PMID:23866767

  19. Impact of industry collaboration on randomised controlled trials in oncology.

    PubMed

    Linker, Anne; Yang, Annie; Roper, Nitin; Whitaker, Evans; Korenstein, Deborah

    2017-02-01

    Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88-6·83], p < 0001), intention-to-treat analysis (RR 1·32, 95% CI [1·04-1·67], p = 02), and blinding of patients (RR 3·05, 95% CI [1·71-5·44], p < 0001), clinicians (RR 3·36, 95% CI [1·83-6·16], p≤·001) and outcomes assessors (RR 3·03, 95% CI [1·57-5·83], p = 0002). They did not differ in use of overall survival as a primary end-point (RR 1·27 95% CI [0·72-2·24]) and were similarly likely to report positive results (RR 1·11 95% CI [0·85-1·46], p = 0.45). Studies with funding only did not differ from those without funding. Oncology RCTs with industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial

    PubMed Central

    2012-01-01

    Background Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by

  1. Effect of supervised exercise training during pregnancy on neonatal and maternal outcomes among overweight and obese women. Secondary analyses of the ETIP trial: A randomised controlled trial

    PubMed Central

    Garnæs, Kirsti Krohn; Nyrnes, Siri Ann; Salvesen, Kjell Åsmund; Salvesen, Øyvind; Mørkved, Siv

    2017-01-01

    Background Maternal obesity associates with complications during pregnancy and childbirth. Our aim was to investigate if exercise during pregnancy in overweight/obese women could influence birth weight or other neonatal and maternal outcomes at delivery. Material and methods This is a secondary analysis of a randomised controlled trial of exercise training in pregnancy for women with body mass index (BMI) ≥ 28 kg/m2. Ninety-one women (31.3 ± 4.3 years, BMI 34.5 ± 4.2 kg/m2) were allocated 1:1 to supervised exercise during pregnancy or to standard care. The exercise group was offered three weekly training sessions consisting of 35 minutes of moderate intensity walking/running followed by 25 minutes of strength training. Data from 74 women (exercise 38, control 36) were analysed at delivery. Results Birth weight was 3719 ± 695 g in the exercise group and 3912 ± 413 g in the control group (CI -460.96, 74.89, p = 0.16). Birth weight > 4000 g was 35% in the exercise group and 52% in the control group (p = 0.16). Mean gestational age at delivery was 39.1 weeks in the exercise group and 39.5 weeks in the control group (CI -1.33, 0.43, p = 0.31). No significant between-group differences were found in neonatal body size, skinfold thickness, placental weight ratio, or Apgar score. The prevalence of caesarean section was 24% in the exercise group and 17% in the control group (CI 0.20, 2.05, p = 0.57). Mean length of hospital stay was 4.8 days in the exercise group and 4.5 days in the control group (CI -0.45, 1.00, p = 0.45). Conclusions Offering supervised exercise during pregnancy for overweight and obese women did not influence birth weight or other neonatal and maternal outcomes at delivery. However our trial was limited by low sample size and poor adherence to the exercise protocol, and further research is needed. Trial registration ClinicalTrials.gov NCT01243554 PMID:28323893

  2. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial.

    PubMed

    Schweickert, William D; Pohlman, Mark C; Pohlman, Anne S; Nigos, Celerina; Pawlik, Amy J; Esbrook, Cheryl L; Spears, Linda; Miller, Megan; Franczyk, Mietka; Deprizio, Deanna; Schmidt, Gregory A; Bowman, Amy; Barr, Rhonda; McCallister, Kathryn E; Hall, Jesse B; Kress, John P

    2009-05-30

    Long-term complications of critical illness include intensive care unit (ICU)-acquired weakness and neuropsychiatric disease. Immobilisation secondary to sedation might potentiate these problems. We assessed the efficacy of combining daily interruption of sedation with physical and occupational therapy on functional outcomes in patients receiving mechanical ventilation in intensive care. Sedated adults (>/=18 years of age) in the ICU who had been on mechanical ventilation for less than 72 h, were expected to continue for at least 24 h, and who met criteria for baseline functional independence were eligible for enrolment in this randomised controlled trial at two university hospitals. We randomly assigned 104 patients by computer-generated, permuted block randomisation to early exercise and mobilisation (physical and occupational therapy) during periods of daily interruption of sedation (intervention; n=49) or to daily interruption of sedation with therapy as ordered by the primary care team (control; n=55). The primary endpoint-the number of patients returning to independent functional status at hospital discharge-was defined as the ability to perform six activities of daily living and the ability to walk independently. Therapists who undertook patient assessments were blinded to treatment assignment. Secondary endpoints included duration of delirium and ventilator-free days during the first 28 days of hospital stay. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00322010. All 104 patients were included in the analysis. Return to independent functional status at hospital discharge occurred in 29 (59%) patients in the intervention group compared with 19 (35%) patients in the control group (p=0.02; odds ratio 2.7 [95% CI 1.2-6.1]). Patients in the intervention group had shorter duration of delirium (median 2.0 days, IQR 0.0-6.0 vs 4.0 days, 2.0-8.0; p=0.02), and more ventilator-free days (23.5 days, 7.4-25.6 vs 21

  3. Nasal oxytocin for social deficits in childhood autism: a randomized controlled trial.

    PubMed

    Dadds, Mark R; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-03-01

    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 youths (7-16 years old) with autism spectrum disorders were administered 24 or 12 international units (depending on weight) intranasal placebo or oxytocin once daily over four consecutive days. The oxytocin or placebo was administered during parent-child interaction training sessions. Parent and child behaviours were assessed using parent reports, clinician ratings, and independent observations, at multiple time points to measure side-effects; social interaction skills; repetitive behaviours; emotion recognition and diagnostic status. Compared to placebo, intranasal oxytocin did not significantly improve emotion recognition, social interaction skills, or general behavioral adjustment in male youths with autism spectrum disorders. The results show that the benefits of nasal oxytocin for young individuals with autism spectrum disorders may be more circumscribed than suggested by previous studies, and suggest caution in recommending it as an intervention that is broadly effective.

  4. Is sham laser a valid control for acupuncture trials?

    PubMed

    Irnich, Dominik; Salih, Norbert; Offenbächer, Martin; Fleckenstein, Johannes

    2011-01-01

    Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation). We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44%) healthy volunteers (age: 28 ± 10.7 years) identified the used laser device after the first session and 14 (41%) after the second session. Hence, both treatments were undistinguishable (P = .26). Deqi-like sensations occurred in 46% of active laser (2.34 VAS) and in 49.0% of sham laser beams (2.49 VAS). The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se.

  5. Is Sham Laser a Valid Control for Acupuncture Trials?

    PubMed Central

    Irnich, Dominik; Salih, Norbert; Offenbächer, Martin; Fleckenstein, Johannes

    2011-01-01

    Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation). We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44%) healthy volunteers (age: 28 ± 10.7 years) identified the used laser device after the first session and 14 (41%) after the second session. Hence, both treatments were undistinguishable (P = .26). Deqi-like sensations occurred in 46% of active laser (2.34 VAS) and in 49.0% of sham laser beams (2.49 VAS). The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se. PMID:21772922

  6. [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.

  7. 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

  8. The relationship between overactivity and opioid use in chronic pain: a 5-day observational study.

    PubMed

    Andrews, Nicole Emma; Strong, Jenny; Meredith, Pamela Joy; Fleming, Julia Ann

    2016-02-01

    With increasing concerns about the potential harm of long-term opioid therapy, there is a need for the development and implementation of alternative treatment strategies for patients with chronic pain who have been using opioids for a prolonged period of time. Based on the findings from a recent qualitative investigation that suggested there may be a bidirectional association between opioid reliance and habitual overactivity behaviour (activity engagement that significantly exacerbates pain), this study was designed to quantitatively investigate the association between opioid use and habitual overactivity over a 5-day period in a group of chronic pain patients. Participants provided a list of their prescribed pain medication, completed a self-report measure of habitual overactivity, and then commenced 5 days of data collection. Data collection required participants to wear an activity monitor and to complete a diary that detailed their daily activities and the time at which they took medication. Individuals reporting higher levels of habitual overactivity were more likely to be prescribed opioids. In addition, higher levels of habitual overactivity were associated with more frequent pro re nata ("as needed") opioid use over the 5 days, and with a discrepancy between the prescribed and actual oral morphine-equivalent daily dose, where more medication was taken than was prescribed. There was no predominant context for pro re nata use. The results of this study support the idea that habitual overactivity behaviour may play a role in the development of reliance on opioid medication and that such an association may provide a potential treatment target for opioid therapy rationalisation.

  9. Randomized, placebo-controlled trial of K1 acupoint acustimulation to prevent cisplatin- or oxaliplatin-induced nausea

    PubMed Central

    Shen, Yehua; Liu, Luming; Chiang, Joseph S.; Meng, Zhiqiang; Garcia, M. Kay; Chen, Zhen; Peng, Huiting; Bei, Wenying; Zhao, Qi; Spelman, Amy R.; Cohen, Lorenzo

    2014-01-01

    Background More than 70% of cancer patients experience chemotherapy-induced nausea and vomiting (CINV). We examined the effects of electrostimulation of the K1 acupoint located on the sole of the foot, as it is thought to have potential to control CINV. Methods In this trial, 103 patients diagnosed with primary or metastatic liver cancer were recruited before trans-catheter arterial infusion (TAI) of cisplatin (CDDP) or oxaliplatin (OXA) and randomized to group A (N=51; treated with the antiemetic tropisetron and acustimulation at the K1 acupoint for 20 minutes, 1-2 hours before TAI on the first day and then daily for the subsequent 5 days) or group B (N=53; treated with tropisetron and electrostimulation at a placebo point on the heel). The rate, intensity, and duration of nausea and vomiting were collected at baseline and then daily for 5 days after TAI. Quality of life was assessed daily using the MD Anderson Symptom Inventory (MDASI) and the EuroQoL scale. Results No differences were found between groups A and B in the incidence and degree of nausea or vomiting on day 1 or the consecutive 5 days. Patients in group A had better EuroQoL scores than did patients in group B (A: 72.83 versus B: 65.94, P = 0.04) on day 4 but not on the other days. No group differences were noted at any time point for MDASI scores. Conclusions Electrostimulation of K1 combined with antiemetics did not result in initial prevention of CDDP- or OXA-induced nausea or vomiting. PMID:25204437

  10. Disclosing the potential impact of placebo controls in antidepressant trials

    PubMed Central

    Chen, Stephanie C.; McCullumsmith, Cheryl

    2015-01-01

    Background Although placebo-control clinical trials that withhold effective treatments can be permissible, how best to inform participants of the placebo design has received little attention. Aims To determine the effect of disclosing quantitative outcome estimates of individual treatment v. entering placebo-control randomised control trial (RCT) on willingness to enrol in such an RCT. Method We randomised 278 adult patients at a depression clinic to receive standard disclosure (n = 129) or enhanced (n = 149) quantitative outcome estimates (based on decision analysis) of individual treatment v. RCT, and assessed their willingness to enrol in the RCT. Results A greater proportion of those in the standard arm preferred enrolling in RCT (41.3% v. 23.8%, P = 0.002). Those in the standard arm preferred RCT more for direct benefit than altruism reasons, whereas the opposite was true in the enhanced arm. Conclusions Disclosing the quantitative outcome implications of placebos may select for fewer but more altruistic participants. Declaration of interest S.Y.H.K. was a DSMB member of a clinical trial sponsored by Hoffman-LaRoche and he receives royalties from Oxford University Press for his book Evaluation of Capacity to Consent to Treatment and Research. C.M. has served in the past year on a scientific advisory board and as a consultant for Janssen Pharmaceuticals. Copyright and usage This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence. PMID:27703715

  11. Impact of length or relevance of questionnaires on attrition in online trials: randomized controlled trial.

    PubMed

    McCambridge, Jim; Kalaitzaki, Eleftheria; White, Ian R; Khadjesari, Zarnie; Murray, Elizabeth; Linke, Stuart; Thompson, Simon G; Godfrey, Christine; Wallace, Paul

    2011-11-18

    There has been limited study of factors influencing response rates and attrition in online research. Online experiments were nested within the pilot (study 1, n = 3780) and main trial (study 2, n = 2667) phases of an evaluation of a Web-based intervention for hazardous drinkers: the Down Your Drink randomized controlled trial (DYD-RCT). The objective was to determine whether differences in the length and relevance of questionnaires can impact upon loss to follow-up in online trials. A randomized controlled trial design was used. All participants who consented to enter DYD-RCT and completed the primary outcome questionnaires were randomized to complete one of four secondary outcome questionnaires at baseline and at follow-up. These questionnaires varied in length (additional 23 or 34 versus 10 items) and relevance (alcohol problems versus mental health). The outcome measure was the proportion of participants who completed follow-up at each of two follow-up intervals: study 1 after 1 and 3 months and study 2 after 3 and 12 months. At all four follow-up intervals there were no significant effects of additional questionnaire length on follow-up. Randomization to the less relevant questionnaire resulted in significantly lower rates of follow-up in two of the four assessments made (absolute difference of 4%, 95% confidence interval [CI] 0%-8%, in both study 1 after 1 month and in study 2 after 12 months). A post hoc pooled analysis across all four follow-up intervals found this effect of marginal statistical significance (unadjusted difference, 3%, range 1%-5%, P = .01; difference adjusted for prespecified covariates, 3%, range 0%-5%, P = .05). Apparently minor differences in study design decisions may have a measurable impact on attrition in trials. Further investigation is warranted of the impact of the relevance of outcome measures on follow-up rates and, more broadly, of the consequences of what we ask participants to do when we invite them to take part in research

  12. Pulmonary complications following major head and neck surgery with tracheostomy: a prospective, randomized, controlled trial of prophylactic antibiotics.

    PubMed

    Ong, Soo-Kim; Morton, Randall P; Kolbe, John; Whitlock, Ralph M L; McIvor, Nicholas P

    2004-09-01

    To test the hypothesis that extended postoperative antibiotic cover would reduce the incidence of pulmonary complications in patients undergoing major head and neck surgery with tracheostomy. A prospective, randomized, controlled trial was carried out to determine the efficacy of an extended course (5 days) of intravenous amoxicillin-clavulanic acid in reducing the rate of atelectasis and pulmonary infections postoperatively. Other possible risk factors that might predispose to pulmonary complications were also evaluated. Tertiary referral center for head and neck surgery. Consecutive patients younger than 80 years with planned surgery for carcinoma of the oral cavity, pharynx, or larynx were enrolled. Patients with diabetes, those who had received antibiotics within 1 week before surgery, and those with preexisting pulmonary disease were excluded. Patients were randomly assigned no antibiotics or a 5-day course of intravenous amoxicillin-clavulanic acid postoperatively. The development of pulmonary complications (pulmonary infection or atelectasis). Eighty-six patients were enrolled; 73 patients met the criteria for analysis. Thirty-four (47%) developed pulmonary complications; 29 (40%) had a pulmonary infection. An extended course of antibiotics did not reduce the rate of pulmonary infections (P =.57). Positive risk factors for a pulmonary infection were presence of preoperative obstructive lung function and postoperative atelectasis. An extended course of antibiotics did not prevent the development of postoperative pulmonary infections in patients undergoing major head and neck surgery with tracheostomy. Poor pulmonary function and postoperative atelectasis emerged as significant risk factors for pulmonary infection.

  13. 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.

  14. UK Dermatology Clinical Trials Network's STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial.

    PubMed

    Craig, Fiona F; Thomas, Kim S; Mitchell, Eleanor J; Williams, Hywel C; Norrie, John; Mason, James M; Ormerod, Anthony D

    2012-04-28

    Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network's STOP GAP Trial has been designed to address this lack of trial evidence. The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by lesion size, and

  15. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial.

    PubMed

    Abrams, D I; Jay, C A; Shade, S B; Vizoso, H; Reda, H; Press, S; Kelly, M E; Rowbotham, M C; Petersen, K L

    2007-02-13

    To determine the effect of smoked cannabis on the neuropathic pain of HIV-associated sensory neuropathy and an experimental pain model. Prospective randomized placebo-controlled trial conducted in the inpatient General Clinical Research Center between May 2003 and May 2005 involving adults with painful HIV-associated sensory neuropathy. Patients were randomly assigned to smoke either cannabis (3.56% tetrahydrocannabinol) or identical placebo cigarettes with the cannabinoids extracted three times daily for 5 days. Primary outcome measures included ratings of chronic pain and the percentage achieving >30% reduction in pain intensity. Acute analgesic and anti-hyperalgesic effects of smoked cannabis were assessed using a cutaneous heat stimulation procedure and the heat/capsaicin sensitization model. Fifty patients completed the entire trial. Smoked cannabis reduced daily pain by 34% (median reduction; IQR = -71, -16) vs 17% (IQR = -29, 8) with placebo (p = 0.03). Greater than 30% reduction in pain was reported by 52% in the cannabis group and by 24% in the placebo group (p = 0.04). The first cannabis cigarette reduced chronic pain by a median of 72% vs 15% with placebo (p < 0.001). Cannabis reduced experimentally induced hyperalgesia to both brush and von Frey hair stimuli (p < or = 0.05) but appeared to have little effect on the painfulness of noxious heat stimulation. No serious adverse events were reported. Smoked cannabis was well tolerated and effectively relieved chronic neuropathic pain from HIV-associated sensory neuropathy. The findings are comparable to oral drugs used for chronic neuropathic pain.

  16. Phenobarbital versus morphine in the management of neonatal abstinence syndrome, a randomized control trial.

    PubMed

    Nayeri, Fatemeh; Sheikh, Mahdi; Kalani, Majid; Niknafs, Pedram; Shariat, Mamak; Dalili, Hosein; Dehpour, Ahmad-Reza

    2015-05-15

    Evaluating the efficacy of the loading and tapering dose of Phenobarbital versus oral Morphine in the management of NAS. This randomized, open-label, controlled trial was conducted on 60 neonates born to illicit drugs dependent mothers at Vali-Asr and Akbar-Abadi hospitals, Tehran, Iran, who exhibited NAS requiring medical therapy. The neonates were randomized to receive either: Oral Morphine Sulfate or a loading dose of Phenobarbital followed by a tapering dose. The duration of treatment required for NAS resolution, the total hospital stay and the requirement for additional second line treatment were compared between the treatment groups. The Mean ± Standard Deviation for the duration of treatment required for the resolution of NAS was 8.5 ± 5 days in the Morphine group and 8.5 ± 4 days in the Phenobarbital group (P = 0.9). The duration of total hospital stay was 12.6 ± 5.6 days in the Morphine group and 12.5 ± 5.3 days in the Phenobarbital group (P = 0.7). 3.3 % in the Morphine group versus 6.6 % in the Phenobarbital group required adjunctive treatment (P = 0.5). There were no significant differences in the duration of treatment, duration of hospital stay, and the requirement for adjunctive treatment, between the neonates with NAS who received Morphine Sulfate and neonates who received a loading and tapering dose of Phenobarbital. This study is registered at the Iranian Registry of Clinical Trials ( www.irct.ir ) which is a Primary Registry in the WHO Registry Network. (Registration Number =  IRCT201406239568N8 ).

  17. Aqueous acupuncture for postoperative pain--a matched controlled trial.

    PubMed

    Chen, S C; Lu, S N; Lai, C T; Jean, J Y; Hsiao, C L; Hsu, P T

    1991-09-01

    The analgesic effects of acupuncture are well-documented. Aqueous acupuncture, or point injection, is a conveniently modified modern acupuncture method. This matched controlled trial was carried out to evaluate the effects of aqueous acupuncture in postoperative pain control. A total of 12 patients were selected as age-, sex- and operative-style-matched controls. In treating group, 2 to 5 ml of 20% glucose solution was injected into Ho-Ku (LI 4) and Yang-Ling-Chuan (GB 34) when patients had regained conciousness from operation anesthesia. The pain intensity were recorded as score system included verbal, sleep disturbance and use of narcotics. In comparisons with the control group, the intensity of postoperative pain, and the amounts and frequency of narcotics used were significantly lower in the study group, especially for the first 12 postoperative hours. Aqueous acupuncture is a convenient and effective procedure in postoperative pain control.

  18. The Sexunzipped Trial: Optimizing the Design of Online Randomized Controlled Trials

    PubMed Central

    Pavlou, Menelaos; Copas, Andrew; McCarthy, Ona; Carswell, Ken; Rait, Greta; Hart, Graham; Nazareth, Irwin; Free, Caroline; French, Rebecca; Murray, Elizabeth

    2013-01-01

    Background Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions. Evaluations of digital interventions are increasingly conducted online. Trial administration and data collection online offers many advantages, but concerns remain over fraudulent registration to obtain compensation, the quality of self-reported data, and high attrition. Objective This study addresses the feasibility of several dimensions of online trial design—recruitment, online consent, participant identity verification, randomization and concealment of allocation, online data collection, data quality, and retention at 3-month follow-up. Methods Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the “Sexunzipped” online trial between November 2010 and March 2011 (n=2036). Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website. Participants were also randomly allocated to a postal request (or no request) for a urine sample for genital chlamydia testing and receipt of a lower (£10/US$16) or higher (£20/US$32) value shopping voucher compensation for 3-month outcome data. Results The majority of the 2006 valid participants (90.98%, 1825/2006) were aged between 18 and 20 years at enrolment, from all four countries in the United Kingdom. Most were white (89.98%, 1805/2006), most were in school or training (77.48%, 1545/1994), and 62.81% (1260/2006) of the sample were female. In total, 3.88% (79/2036) of registrations appeared to be invalid and another 4.00% (81/2006) of participants gave inconsistent responses within the questionnaire. The higher value compensation (£20/US$32) increased response rates by 6-10%, boosting retention at 3 months to 77.2% (166/215) for submission of

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

    PubMed Central

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

    2015-01-01

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

  20. Enhancing Cognitive Abilities with Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial.

    PubMed

    Hardy, Joseph L; Nelson, Rolf A; Thomason, Moriah E; Sternberg, Daniel A; Katovich, Kiefer; Farzin, Faraz; Scanlon, Michael

    2015-01-01

    A variety of studies have demonstrated gains in cognitive ability following cognitive training interventions. However, other studies have not shown such gains, and questions remain regarding the efficacy of specific cognitive training interventions. Cognitive training research often involves programs made up of just one or a few exercises, targeting limited and specific cognitive endpoints. In addition, cognitive training studies typically involve small samples that may be insufficient for reliable measurement of change. Other studies have utilized training periods that were too short to generate reliable gains in cognitive performance. The present study evaluated an online cognitive training program comprised of 49 exercises targeting a variety of cognitive capacities. The cognitive training program was compared to an active control condition in which participants completed crossword puzzles. All participants were recruited, trained, and tested online (N = 4,715 fully evaluable participants). Participants in both groups were instructed to complete one approximately 15-minute session at least 5 days per week for 10 weeks. Participants randomly assigned to the treatment group improved significantly more on the primary outcome measure, an aggregate measure of neuropsychological performance, than did the active control group (Cohen's d effect size = 0.255; 95% confidence interval = [0.198, 0.312]). Treatment participants showed greater improvements than controls on speed of processing, short-term memory, working memory, problem solving, and fluid reasoning assessments. Participants in the treatment group also showed greater improvements on self-reported measures of cognitive functioning, particularly on those items related to concentration compared to the control group (Cohen's d = 0.249; 95% confidence interval = [0.191, 0.306]). Taken together, these results indicate that a varied training program composed of a number of tasks targeted to different cognitive

  1. The Walking School Bus and Children's Physical Activity: A Pilot Cluster Randomized Controlled Trial

    PubMed Central

    Watson, Kathy; Baranowski, Tom; Nicklas, Theresa A.; Uscanga, Doris K.; Hanfling, Marcus J.

    2011-01-01

    OBJECTIVE: To evaluate the impact of a “walking school bus” program on children's rates of active commuting to school and physical activity. METHODS: 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 conditions was at the school level. Study staff walked with children to and from school up to 5 days/week. Outcomes were measured the week before (time 1) and during weeks 4 and 5 of the intervention (time 2). The main outcome was the weekly rate of active commuting, and a secondary outcome was moderate-to-vigorous physical activity. Covariates included sociodemographics, distance from home to school, neighborhood safety, child BMI z score, parent self-efficacy/outcome expectations, and child self-efficacy for active commuting. A mixed-model repeated measures regression accounted for clustering by school, and stepwise procedures with backward elimination of nonsignificant covariates were used to identify significant predictors. RESULTS: Intervention children increased active commuting (mean ± SD) from 23.8% ± 9.2% (time 1) to 54% ± 9.2% (time 2), whereas control subjects decreased from 40.2% ± 8.9% (time 1) to 32.6% ± 8.9% (time 2) (P < .0001). Intervention children increased their minutes of daily moderate-to-vigorous physical activity from 46.6 ± 4.5 (time 1) to 48.8 ± 4.5 (time 2), whereas control children decreased from 46.1 ± 4.3 (time 1) to 41.3 ± 4.3 (time 2) (P = .029). CONCLUSIONS: The program improved children's active commuting to school and daily moderate-to-vigorous physical activity. PMID:21859920

  2. Searching for two things at once: establishment of multiple attentional control settings on a trial-by-trial basis.

    PubMed

    Roper, Zachary J J; Vecera, Shaun P

    2012-12-01

    Recent work has demonstrated that attention can be configured to multiple potential targets in spatial search. However, this previous work relied on a fixed set of targets across multiple trials, allowing observers to offload attentional control settings to longer-term representations. In the present experiments, we demonstrate multiple attentional control settings that operate independently of space (Experiments 1 and 2). More important, we show that observers can be cued to different control settings on a trial-by-trial basis (Experiment 3). The latter result suggests that observers were capable of maintaining multiple control settings when the demands of the task required an attentional search for specific feature values. Attention can be configured to extract multiple feature values in a goal-directed manner, and this configuration can be can be dynamically engaged on a trial-by-trial basis. These results support recent findings that reveal the high precision, complexity, and flexibility of attentional control settings.

  3. An uncontrolled examination of a 5-day intensive treatment for pediatric OCD.

    PubMed

    Whiteside, Stephen P; Jacobsen, Amy Brown

    2010-09-01

    This study examined the feasibility of a 5-day intensive treatment for pediatric obsessive-compulsive disorder (OCD). Fifteen children with OCD received a week-long treatment based on exposure and response prevention (ERP). The intervention also emphasized teaching children and parents how to conduct ERP independently at home. All families completed the week-long treatment and symptoms improved significantly as measured by self- and parent-report forms, as well as the Children's Yale-Brown Obsessive-Compulsive Scale, F(2, 22)=45.67, p<.05. Total CY-BOCS scores decreased significantly from pretreatment (M=28.00, SD=4.24) to posttreatment [M=16.00, SD=6.0, F(1, 11)=34.38, p<.05] and from posttreatment to 5-month follow-up [M=11.5, SD=7.3; F(1, 11)=12.94, p<.05]. This level of improvement was consistent with other intensive treatments for pediatric OCD. The study suggests that the 5-day program is a promising treatment for children with OCD who do not have access to local providers.

  4. [Antibacterial activity of urine after administration of ofloxacin for 5 days].

    PubMed

    Drugeon, H; Veyries, M L; Levacher, M; Garnier, M; Aymard, G; Giroud, J P; Rouveix, B

    2000-01-01

    The antibacterial activity of ofloxacin was evaluated in urine over a period of 96 h after oral administration for 5 days of 200 mg twice a day in 12 healthy female volunteers. Bacteriostatic and bactericidal activity of urines were studied for five strains of enterobacterias recovered from urinary infections: two strains of Escherichia Coli Nal-S and Nal-R, two strains of Proteus mirabilis Nal-S and Nal-R, and one strain of Klebsiella pneumoniae Nal-S. Mean urinary concentrations of ofloxacin were very high during the first 12 h following last intake. They were still above 7 mg/l till the 48th hour and above 1.6 mg/l till the 72nd hour. Bactericidal activity of urine was present for 72 h in respect of four strains studied at that time; urine was not bactericidal as regards E. coli Nal-R. After 5 days of oral treatment with ofloxacin (200 mg b.i.d.), urine retains a bactericidal activity for at least 72 h against bacterial strains of urinary tract infections.

  5. Does the adolescent patellar tendon respond to 5 days of cumulative load during a volleyball tournament?

    PubMed

    van Ark, M; Docking, S I; van den Akker-Scheek, I; Rudavsky, A; Rio, E; Zwerver, J; Cook, J L

    2016-02-01

    Patellar tendinopathy (jumper's knee) has a high prevalence in jumping athletes. Excessive load on the patellar tendon through high volumes of training and competition is an important risk factor. Structural changes in the tendon are related to a higher risk of developing patellar tendinopathy. The critical tendon load that affects tendon structure is unknown. The aim of this study was to investigate patellar tendon structure on each day of a 5-day volleyball tournament in an adolescent population (16-18 years). The right patellar tendon of 41 players in the Australian Volleyball Schools Cup was scanned with ultrasound tissue characterization (UTC) on every day of the tournament (Monday to Friday). UTC can quantify structure of a tendon into four echo types based on the stability of the echo pattern. Generalized estimating equations (GEE) were used to test for change of echo type I and II over the tournament days. Participants played between eight and nine matches during the tournament. GEE analysis showed no significant change of echo type percentages of echo type I (Wald chi-square = 4.603, d.f. = 4, P = 0.331) and echo type II (Wald chi-square = 6.070, d.f. = 4, P = 0.194) over time. This study shows that patellar tendon structure of 16-18-year-old volleyball players is not affected during 5 days of cumulative loading during a volleyball tournament.

  6. Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial

    PubMed Central

    2013-01-01

    Background Homeopathic drug proving is a basic concept in homeopathy. This study aimed to record symptoms produced by a homeopathic drug compared with placebo. Methods This multicentre, randomised, double-blind, placebo-controlled phase 1 trial consisted of a 7-day run-in period, a 5-day intervention period and a 16-day post-intervention observation period. Subjects, investigators and statisticians were blinded for intervention groups and identity of the homeopathic drug. Subjects in the intervention group received Okoubaka aubrevillei (potency C12) and subjects in the placebo group received the optically identical sucrose globules. Dosage in both groups was five globules taken five times per day over a maximum period of 5 days. Subjects documented the symptoms they experienced in a semistructured online diary. The primary outcome parameter was the number of characteristic proving symptoms compared with placebo after a period of 3 weeks. Characteristic symptoms were categorised using content analysis. Secondary outcome parameters were the qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms was quantitatively analysed on an intention-to-treat basis using analyses of covariance with the subject’s expectation and baseline values as covariates. Results Thirty-one subjects were included (19 Okoubaka and 12 placebo). Data for 29 participants could be analysed. No significant differences in number of characteristic symptoms in both groups were observed between Okoubaka (mean ± standard deviation 5.4 ± 6.0) and placebo (4.9 ± 5.6). The odds ratio for observation of a characteristic symptom was 1.11 (95% confidence interval 0.4 to 3.05, P = 0.843). Females and subjects expecting a higher number of symptoms at baseline or feeling more sensitive to homeopathic drugs experienced more characteristic symptoms regardless of allocation. The qualitative analysis showed

  7. Controlled human malaria infection trials: How tandems of trust and control construct scientific knowledge.

    PubMed

    Bijker, Else M; Sauerwein, Robert W; Bijker, Wiebe E

    2016-02-01

    Controlled human malaria infections are clinical trials in which healthy volunteers are deliberately infected with malaria under controlled conditions. Controlled human malaria infections are complex clinical trials: many different groups and institutions are involved, and several complex technologies are required to function together. This functioning together of technologies, people, and institutions is under special pressure because of potential risks to the volunteers. In this article, the authors use controlled human malaria infections as a strategic research site to study the use of control, the role of trust, and the interactions between trust and control in the construction of scientific knowledge. The authors argue that tandems of trust and control play a central role in the successful execution of clinical trials and the construction of scientific knowledge. More specifically, two aspects of tandems of trust and control will be highlighted: tandems are sites where trust and control coproduce each other, and tandems link the personal, the technical, and the institutional domains. Understanding tandems of trust and control results in setting some agendas for both clinical trial research and science and technology studies.

  8. One session of high-intensity interval training (HIIT) every 5 days, improves muscle power but not static balance in lifelong sedentary ageing men

    PubMed Central

    Sculthorpe, Nicholas F.; Herbert, Peter; Grace, Fergal

    2017-01-01

    Abstract Background: Declining muscle power during advancing age predicts falls and loss of independence. High-intensity interval training (HIIT) may improve muscle power, but remains largely unstudied in ageing participants. Methods: This randomized controlled trial (RCT) investigated the efficacy of a low-frequency HIIT (LfHIIT) intervention on peak muscle power (peak power output [PPO]), body composition, and balance in lifelong sedentary but otherwise healthy males. Methods: Thirty-three lifelong sedentary ageing men were randomly assigned to either intervention (INT; n = 22, age 62.3 ± 4.1 years) or control (n = 11, age 61.6 ± 5.0 years) who were both assessed at 3 distinct measurement points (phase A), after 6 weeks of conditioning exercise (phase B), and after 6 weeks of HIIT once every 5 days in INT (phase C), where control remained inactive throughout the study. Results: Static balance remained unaffected, and both absolute and relative PPO were not different between groups at phases A or B, but increased significantly in INT after LfHIIT (P < 0.01). Lean body mass displayed a significant interaction (P < 0.01) due to an increase in INT between phases B and C (P < 0.05). Conclusions: 6 weeks of LfHIIT exercise feasible and effective method to induce clinically relevant improvements in absolute and relative PPO, but does not improve static balance in sedentary ageing men. PMID:28178145

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. Improving venous ulcer healing: designing and reporting randomised controlled trials.

    PubMed

    Weller, Carolina D; McNeil, John; Evans, Sue; Reid, Christopher

    2010-02-01

    The randomised controlled trial (RCT) is often considered the gold standard for judging the benefits of treatments. The application of randomised controlled clinical trials to treatments of venous ulcer healing has lagged behind that of other areas of medicine. To interpret the results of an RCT, readers must understand a variety of aspects of their design, analysis and interpretation. Venous ulcer disease has a high prevalence and has a significant socioeconomic impact in most parts of the world. The management of venous ulcers causes a considerable strain on the health system and is likely to worsen in future. The multi-layer high compression system is described as the current gold standard for treating venous ulcers. A recent meta-analysis of bandaging systems found that multi-layer compression bandages appeared to be superior to single-layer bandages in promoting venous ulcer healing. However, it was noted that many of the studies had small sample sizes and the quality of research in the area was poor. The consolidating standards of reporting trials (CONSORT) statement can help clinicians to discern high-quality studies from ones of poorer quality. This paper discusses how CONSORT can help clinicians and researchers to design and report quality studies to contribute to evidence-based venous ulcer healing.

  14. Kava in generalized anxiety disorder: three placebo-controlled trials.

    PubMed

    Connor, Kathryn M; Payne, Victoria; Davidson, Jonathan R T

    2006-09-01

    In this study, we evaluated the efficacy and safety of kava kava (Piper methysticum) in generalized anxiety disorder. Data were analyzed from three randomized, double-blind, placebo-controlled trials of kava, including one study with an active comparator (venlafaxine), in adult outpatients with DSM-IV generalized anxiety disorder. The pooled sample (n=64) included the following number of participants: kava, n=28; placebo, n=30; and venlafaxine, n=6. Given the comparability of the study designs, the data comparing kava and placebo were then pooled for further efficacy and safety analyses. No significant differences were observed between the treatment groups in any of the trials. In the pooled analyses, no effects were found for kava, while a significant effect in favor of placebo was observed in participants with higher anxiety at baseline. No evidence of hepatotoxicity was found with kava, and all of the treatments were well tolerated. Findings from these three controlled trials do not support the use of kava in DSM-IV generalized anxiety disorder.

  15. Computerized management of diabetes: a synthesis of controlled trials.

    PubMed

    Balas, E A; Boren, S A; Griffing, G

    1998-01-01

    Computerized management of diabetes is the use of information technology to improve diabetic patient outcomes. The computer can be used to provide educational information to patients and facilitate the storage and transmittal of clinical data between patients and clinicians. The objective of this paper was to evaluate computerized management of diabetes in changing the health outcomes. Clinical trial reports were identified through systematic electronic database and manual searches. Four eligibility criteria were applied: diabetes clinical area; prospective, contemporaneously controlled clinical trial with random assignment of the intervention; computer generated information for patients in the intervention group and no similar intervention in the control group; and measurement of effect on the outcome of care (health status, social functioning, patient/family satisfaction). Data were abstracted using a standardized abstraction form and the quality of methodology was scored. Of 15 eligible clinical trials, 12 (80%) reported positive outcomes or significant benefits. A total of 48 outcome measures were reported, an average of 3.2/study. Significantly improved clinical outcomes included Hemoglobin A1c (HbA1c), blood glucose, and hypoglycemic events. Patient-computer interaction appears to be a valuable supplement to interaction with clinicians. Considering the need to enhance patient participation in the care of chronic illnesses, initial evidence indicates computers can play a more significant role in the future.

  16. Protocol to evaluate the impact of yoga supplementation on cognitive function in schizophrenia: a randomised controlled trial.

    PubMed

    Bhatia, Triptish; Mazumdar, Sati; Mishra, Nagendra Narayan; Gur, Raquel E; Gur, Ruben C; Nimgaonkar, Vishwajit Laxmikant; Deshpande, Smita Neelkanth

    2014-10-01

    Schizophrenia (SZ) is a chronic illness that is treated symptomatically. Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy. Yoga can improve cognitive function among healthy individuals. A recent open trial indicated significant benefits of yoga training (YT) in conjunction with conventional pharmacotherapy among patients with SZ. To describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated. Secondarily, the effects of YT on daily functioning living skills are evaluated. Consenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT, adjunctive physical exercise (PE) or treatment as usual (proposed N = 234 total, N = 78 in each group). The trial involves YT or PE 5 days a week and lasts 3 weeks. Participants are evaluated thrice over 6 months. Cognitive functions measured by Trail Making Test, University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures. A total of 309 participants have been randomised as of 31 August 2013, which exceeded beyond 294 proposed after attrition. Once participants begin YT or PE they generally complete the protocol. No injuries have been reported. Short term YT is feasible and acceptable to Indian SZ patients. If beneficial effects of YT are detected, it will provide a novel adjunctive cognitive remediation strategy for SZ patients.

  17. Protocol to evaluate the impact of yoga supplementation on cognitive function in schizophrenia: a randomised controlled trial

    PubMed Central

    Bhatia, Triptish; Mazumdar, Sati; Mishra, Nagendra Narayan; Gur, Raquel E.; Gur, Ruben C.; Nimgaonkar, Vishwajit Laxmikant; Deshpande, Smita Neelkanth

    2015-01-01

    Background Schizophrenia (SZ) is a chronic illness that is treated symptomatically. Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy. Yoga can improve cognitive function among healthy individuals. A recent open trial indicated significant benefits of yoga training (YT) in conjunction with conventional pharmacotherapy among patients with SZ. Aims To describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated. Secondarily, the effects of YT on daily functioning living skills are evaluated. Methods Consenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT, adjunctive physical exercise (PE) or treatment as usual (proposed N = 234 total, N = 78 in each group). The trial involves YT or PE 5 days a week and lasts 3 weeks. Participants are evaluated thrice over 6 months. Cognitive functions measured by Trail Making Test, University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures. Results A total of 309 participants have been randomised as of 31 August 2013, which exceeded beyond 294 proposed after attrition. Once participants begin YT or PE they generally complete the protocol. No injuries have been reported. Conclusions Short term YT is feasible and acceptable to Indian SZ patients. If beneficial effects of YT are detected, it will provide a novel adjunctive cognitive remediation strategy for SZ patients. PMID:25241756

  18. Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review

    PubMed Central

    Caldwell, Patrina H. Y.; Hamilton, Sana; Tan, Alvin; Craig, Jonathan C.

    2010-01-01

    Background Recruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs. Methods and Findings A systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00–2.18], attendance at an education session [RR 1.14, 95% CI 1.01–1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14–1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11–2.74), and also monetary incentives (RR1.39, 95% CI 1.13–1.64 to RR 1.53, 95% CI 1.28–1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of

  19. The Declaration of Helsinki and clinical trials: a focus on placebo-controlled trials in schizophrenia.

    PubMed

    Carpenter, William T; Appelbaum, Paul S; Levine, Robert J

    2003-02-01

    The authors' goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies.

  20. 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.

  1. Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation. Methods/design A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009. Discussion The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation. Trial registration NCT01086930 (12th March 2010) ACTRN12609000695202 (12th August 2009) PMID:21235821

  2. 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.

  3. A Randomised Controlled Trial of complete denture impression materials

    PubMed Central

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p < 0.0001). Conclusion There is significant evidence that dentures made from silicone impressions were preferred by patients. Clinical significance Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  4. Prevention of unintentional weight loss in nursing home residents: a controlled trial of feeding assistance.

    PubMed

    Simmons, Sandra F; Keeler, Emmett; Zhuo, Xiaohui; Hickey, Kelly A; Sato, Hui-Wen; Schnelle, John F

    2008-08-01

    To determine the effects of a feeding assistance intervention on food and fluid intake and body weight. Crossover controlled trial. Four skilled nursing homes (NHs). Seventy-six long-stay NH residents at risk for unintentional weight loss. Research staff provided feeding assistance twice per day during or between meals, 5 days per week for 24 weeks. Research staff independently weighed residents at baseline and monthly during a 24-week intervention and 24-week control period. Residents' food and fluid intake and the amount of staff time spent providing assistance to eat was assessed for 2 days at baseline and 3 and 6 months during each 24-week period. The intervention group showed a significant increase in estimated total daily caloric intake and maintained or gained weight, whereas the control group showed no change in estimated total daily caloric intake and lost weight over 24 weeks. The average amount of staff time required to provide the interventions was 42 minutes per person per meal and 13 minutes per person per between-meal snack, versus usual care, during which residents received, on average, 5 minutes of assistance per person per meal and less than 1 minute per person per snack. Two feeding assistance interventions are efficacious in promoting food and fluid intake and weight gain in residents at risk for weight loss. Both interventions require more staff time than usual NH care. The delivery of snacks between meals requires less time than mealtime assistance and thus may be more practical to implement in daily NH care practice.

  5. 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.

  6. 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

  7. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    PubMed Central

    2013-01-01

    Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. Methods/Design The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. Discussion The results of the trial will be used to produce a maximally

  8. Sweet Sixteen: The Prospective Clinical Trials of John L. Cameron, MD-The Clinician-Scientist: From Alternate-Allocation to Randomized Controlled Trials.

    PubMed

    Yeo, Charles J

    2017-09-15

    : The era of randomized controlled trials was ushered in by the British epidemiologist-statistician Austin Bradford Hill, with his work on the use of streptomycin in patients with tuberculosis. John L. Cameron, can be linked to 16 prospective clinical trials over his career thus far, starting with alternate-allocation trials and transitioning to prospective, randomized, placebo-controlled trials. These trials studied various topics in surgery-from pancreatitis to surgical site infections, to drain trials, a trial in Crohn disease and multiple trials in pancreatic surgery and cancer. Herein are described the "sweet sixteen" prospective clinical trials of Dr Cameron.

  9. Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

    PubMed Central

    2012-01-01

    Background Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Methods Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Results Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). Conclusions In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. Trial Registration ClinicalTrials.gov: NCT00761813 PMID:22225733

  10. Playback Station #2 for Cal Net and 5-day-recorder tapes

    USGS Publications Warehouse

    Eaton, Jerry P.

    1978-01-01

    A second system (Playback Station #2) has been set up to play back Cal Net 1" tapes and 5-day-recorder 1/2" tapes. As with the first playback system (Playback Station #1) the tapes are played back on a Bell and Howell VR3700B tape deck and the records are written out on a 16-channel direct-writing Siemens "0scillomink." Separate reproduce heads, tape guides, and tape tension sensor rollers are required for playing back 111 tapes and 1/2" tapes, but changing these tape deck components is a simple task that requires only a few minutes. The discriminators, patch panels, selector switches, filters, time code translators, and signal conditioning circuits for the time code translators and for the tape-speed-compensation signal are all mounted in an equipment rack that stands beside the playback tape deck. Changing playback speeds (15/16 ips or 3 3/4 ips) or changing from Cal Net tapes to 5-day-recorder tapes requires only flipping a few switches and/or changing a few patch cables on the patch panel (in addition to changing the reproduce heads, etc., to change from 1" tape to 1/2" tape). For the Cal Net tapes, the system provides for playback of 9 data channels (680 Hz thru 3060 Hz plus 400 Hz) and 3 time signals (IRIG-E, IRIG-C, and WWVB) at both 15/16 ips (x1 speed) and 3 3/4 ips (x4 speed). Available modes of compensation (using either a 4688 Hz reference or a 3125 Hz reference) are subtractive, capstan, capstan plus subtractive, or no compensation.

  11. Evaluation of 5-day therapy with telithromycin, a novel ketolide antibacterial, for the treatment of tonsillopharyngitis.

    PubMed

    Norrby, S R; Quinn, J; Rangaraju, M; Leroy, B

    2004-07-01

    A pooled analysis of two double-blind, multicentre, Phase III studies compared oral telithromycin 800 mg once-daily for 5 days with penicillin V 500 mg three-times-daily or clarithromycin 250 mg twice-daily for 10 days in the treatment of Streptococcus pyogenes (group A beta-haemolytic streptococcus; GABHS) tonsillopharyngitis. Patients aged > or = 13 years with acute GABHS tonsillopharyngitis were randomised to receive telithromycin (n = 430), penicillin (n = 197) or clarithromycin (n = 231). Clinical isolates of S. pyogenes (n = 590) obtained from throat swab samples on study entry were tested for their in-vitro susceptibility to telithromycin, clarithromycin and azithromycin. Telithromycin demonstrated in-vitro activity against the clinical isolates of S. pyogenes (MIC50/90 0.03/0.06 mg/L) higher than clarithromycin or azithromycin (MIC50/90 0.06/0.06 mg/L and 0.12/0.25 mg/L, respectively), including erythromycin-resistant strains. At the post-therapy/test of cure (TOC) visit (days 16-23), satisfactory bacteriological outcome was demonstrated for 88.3% (234/265) and 88.6% (225/254) of telithromycin- and comparator-treated patients, respectively (per-protocol population). Overall, GABHS eradication rates were 88.7% (235/265) for telithromycin and 89.0% (226/254) for comparators. The clinical cure rates at the post-therapy/TOC visit were 93.6% (248/265) and 90.9% (220/242) for telithromycin and pooled comparators, respectively. Telithromycin was generally well-tolerated. Most adverse events considered to be possibly related to study medication were gastrointestinal and of mild intensity. Discontinuations as a result of adverse events were few in both treatment groups. In conclusion, telithromycin 800 mg once-daily for 5 days was as effective as penicillin V or clarithromycin for 10 days in the treatment of GABHS tonsillopharyngitis.

  12. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial

    PubMed Central

    Verspyck, Eric; de Vienne, Claire; Muszynski, Charles; Bubenheim, Michael; Chanavaz-Lacheray, Isabella; Dreyfus, Michel; Deruelle, Philippe; Benichou, Jacques

    2017-01-01

    Objective To assess the impact of maintenance nifedipine therapy on pregnancy duration in women with preterm placenta previa bleeding. Methods PPADAL was a randomized, double-blind, placebo-controlled trial conducted between 05/2008 and 05/2012 in five French hospitals. The trial included 109 women, aged ≥ 18 years, with at least one episode of placenta previa bleeding, intact membranes and no other pregnancy complication, at gestational age 24 to 34 weeks and after 48 hours of complete acute tocolysis. Women were randomly allocated to receive either 20 mg of slow-release nifedipine three times daily (n = 54) or placebo (n = 55) until 36 + 6 weeks of gestation. The primary outcome for the trial was length of pregnancy measured in days after enrolment. Main secondary outcomes were rates of recurrent bleeding, cesarean delivery due to hemorrhage, blood transfusion, maternal side effects, gestational age at delivery and adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage > grade 2, perventricular leukomalacia > grade 1, or necrotizing enterocolitis). Analysis was by intention to treat. Results Mean (SD) prolongation of pregnancy was not different between the nifedipine (n = 54) and the placebo (n = 55) group; 42.5 days ± 23.8 versus 44.2 days ± 24.5, p = 0.70. Cesarean due to hemorrhage performed before 37 weeks occurred more frequently in the nifedipine group in comparison with the placebo group (RR, 1.66; 95% confidence interval, 1.05–2.72). Adverse perinatal outcomes were comparable between groups; 3.8% for nifedipine versus 5.5% for placebo (relative risk, 0.52; 95% confidence interval 0.10–2.61). No maternal mortality or perinatal death occurred. Conclusion Maintenance oral nifedipine neither prolongs duration of pregnancy nor improves maternal or perinatal outcomes. Trial registration ClinicalTrials.gov NCT00620724 PMID:28333939

  13. Randomised controlled trials may underestimate drug effects: balanced placebo trial design.

    PubMed

    Lund, Karen; Vase, Lene; Petersen, Gitte L; Jensen, Troels S; Finnerup, Nanna B

    2014-01-01

    It is an inherent assumption in randomised controlled trials that the drug effect can be estimated by subtracting the response during placebo from the response during active drug treatment. To test the assumption of additivity. The primary hypothesis was that the total treatment effect is smaller than the sum of the drug effect and the placebo effect. The secondary hypothesis was that non-additivity was most pronounced in participants with large placebo effects. We used a within-subject randomised blinded balanced placebo design and included 48 healthy volunteers (50% males), mean (SD) age 23.4 (6.2) years. Experimental pain was induced by injections of hypertonic saline into the masseter muscle. Participants received four injections with hypertonic saline along with lidocaine or matching placebo in randomised order: A: received hypertonic saline/told hypertonic saline; B: received hypertonic saline+lidocaine/told hypertonic saline; C: received hypertonic saline+placebo/told hypertonic saline+pain killer; D: received hypertonic saline+lidocaine/told hypertonic saline+pain killer. The primary outcome measure was the area under the curve (AUC, mm(2)) of pain intensity during injections. There was a significant difference between the sum of the drug effect and the placebo effect (mean AUC 6279 mm(2) (95% CI, 4936-7622)) and the total treatment effect (mean AUC 5455 mm(2) (95% CI, 4585-6324)) (P = 0.049). This difference was larger for participants with large versus small placebo effects (P = 0.015), and the difference correlated significantly with the size of the placebo effect (r = 0.65, P = 0.006). Although this study examined placebo effects and not the whole placebo response as in randomised controlled trials, it does suggest that the additivity assumption may be incorrect, and that the estimated drug effects in randomised controlled trials may be underestimated, particularly in studies reporting large placebo responses. The implications for

  14. Randomised Controlled Trials May Underestimate Drug Effects: Balanced Placebo Trial Design

    PubMed Central

    Lund, Karen; Vase, Lene; Petersen, Gitte L.; Jensen, Troels S.; Finnerup, Nanna B.

    2014-01-01

    Background It is an inherent assumption in randomised controlled trials that the drug effect can be estimated by subtracting the response during placebo from the response during active drug treatment. Objective To test the assumption of additivity. The primary hypothesis was that the total treatment effect is smaller than the sum of the drug effect and the placebo effect. The secondary hypothesis was that non-additivity was most pronounced in participants with large placebo effects. Methods We used a within-subject randomised blinded balanced placebo design and included 48 healthy volunteers (50% males), mean (SD) age 23.4 (6.2) years. Experimental pain was induced by injections of hypertonic saline into the masseter muscle. Participants received four injections with hypertonic saline along with lidocaine or matching placebo in randomised order: A: received hypertonic saline/told hypertonic saline; B: received hypertonic saline+lidocaine/told hypertonic saline; C: received hypertonic saline+placebo/told hypertonic saline+pain killer; D: received hypertonic saline+lidocaine/told hypertonic saline+pain killer. The primary outcome measure was the area under the curve (AUC, mm2) of pain intensity during injections. Results There was a significant difference between the sum of the drug effect and the placebo effect (mean AUC 6279 mm2 (95% CI, 4936–7622)) and the total treatment effect (mean AUC 5455 mm2 (95% CI, 4585–6324)) (P = 0.049). This difference was larger for participants with large versus small placebo effects (P = 0.015), and the difference correlated significantly with the size of the placebo effect (r = 0.65, P = 0.006). Conclusion Although this study examined placebo effects and not the whole placebo response as in randomised controlled trials, it does suggest that the additivity assumption may be incorrect, and that the estimated drug effects in randomised controlled trials may be underestimated, particularly in studies reporting large

  15. Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial

    PubMed Central

    2013-01-01

    Background Failure to recruit to target or schedule is common in randomized controlled trials (RCTs). Innovative interventions are not always fully developed before being tested, and maintenance of fidelity to the intervention during trials can be problematic. Missing data can compromise analyses, and inaccurate capture of risks to participants can influence reporting of intervention harms and benefits. In this paper we describe how challenges of recruitment and retention of participants, standardisation and quality control of interventions and capture of adverse events were overcome in the ProAct65+ cluster RCT. This trial compared class-based and home-based exercise with usual care in people aged 65 years and over, recruited through general practice. The home-based exercise participants were supported by Peer Mentors. Results (1) Organisational factors, including room availability in general practices, slowed participant recruitment so the recruitment period was extended and the number invited to participate increased. (2) Telephone pre-screening was introduced to exclude potential participants who were already very active and those who were frequent fallers. (3) Recruitment of volunteer peer mentors was difficult and time consuming and their acceptable case load less than expected. Lowering the age limit for peer mentors and reducing their contact schedule with participants did not improve recruitment. (4) Fidelity to the group intervention was optimised by introducing quality assurance observation of classes by experienced exercise instructors. (5) Diaries were used to capture data on falls, service use and other exercise-related costs, but completion was variable so their frequency was reduced. (6) Classification of adverse events differed between research sites so all events were assessed by both sites and discrepancies discussed. Conclusions Recruitment rates for trials in general practice may be limited by organisational factors and longer recruitment

  16. Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. Methods/Design This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. Discussion This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been

  17. Granulocyte colony-stimulating factor improves survival of patients with decompensated cirrhosis: a randomized-controlled trial.

    PubMed

    Prajapati, Ritesh; Arora, Anil; Sharma, Praveen; Bansal, Naresh; Singla, Vikas; Kumar, Ashish

    2017-04-01

    Liver transplantation is the only curative option for patients with decompensated cirrhosis; however, many patients die while awaiting transplantation. Granulocyte colony-stimulating factor (GCSF) has shown promising results in improving outcomes in patients with advanced liver disease. We evaluated the efficacy of GCSF in patients with decompensated cirrhosis in an open-labeled randomized-controlled trial. Consecutive patients with decompensated cirrhosis were randomized to receive either GCSF 300 μg twice daily for 5 days plus standard medical therapy (SMT) (GCSF+SMT group) or SMT alone (SMT alone group). Outcomes were assessed at 6 months from randomization. A total of 126 patients [median age: 53 (range: 31-76) years, 85% men] received GCSF+SMT and 127 patients received SMT alone. Baseline characteristics were similar in both the groups. The 5-day GCSF therapy did not lead to any significant adverse effects. At 6 months, in the GCSF+SMT group, 17 patients had died and nine were lost to follow-up, whereas in the SMT-alone group, 30 patients had died and 11 were lost to follow-up. By intention-to-treat analysis, cumulative survival was significantly higher in the GCSF+SMT group (79 vs. 68%; P=0.025). Also, significantly more patients (66%) showed improvement or stability in the Child-Turcotte-Pugh score at 6 months in the GCSF+SMT group compared with the SMT-alone group (51%, P=0.021). GCSF therapy improves survival and clinical outcome in patients with decompensated cirrhosis. It may be useful in patients awaiting transplantation to prevent worsening during the waiting period. Further studies are needed to explore whether repeated periodic GCSF courses can further increase the survival and decrease the need for liver transplantation.Clinical trial registered at https://clinicaltrials.gov vide NCT02642003.

  18. PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial.

    PubMed

    Kilby, Mark; Khan, Khalid; Morris, Katie; Daniels, Jane; Gray, Richard; Magill, Laura; Martin, Bill; Thompson, Peter; Alfirevic, Zarko; Kenny, Simon; Bower, Sarah; Sturgiss, Stephen; Anumba, Dilly; Mason, Gerald; Tydeman, Graham; Soothill, Peter; Brackley, Karen; Loughna, Pamela; Cameron, Alan; Kumar, Sailesh; Bullen, Phil

    2007-07-01

    The primary objective is to determine whether intrauterine vesicoamniotic shunting for fetal bladder outflow obstruction, compared with conservative, noninterventional care, improves prenatal and perinatal mortality and renal function. The secondary objectives are to determine if shunting for fetal bladder outflow obstruction improves perinatal morbidity, to determine if improvement in outcomes is related to prognostic assessment at diagnosis and, if possible, derive a prognostic risk index and to determine the safety and long-term efficacy of shunting. A multicentre randomised controlled trial (RCT). Fetal medicine units. Pregnant women with singleton, male fetus with isolated lower urinary tract obstruction (LUTO). Following ultrasound diagnosis of LUTO in a male fetus and exclusion of other structural and chromosomal anomalies, participation in the trial will be discussed with the mother and written information given. Consent for participation in the trial will be taken and the mother randomised via the internet to either insertion of a vesicoamniotic shunt or expectant management. During pregnancy, both groups will be followed with regular ultrasound scans looking at viability, renal measurements and amniotic fluid volume. Following delivery, babies will be followed up by paediatric nephrologists/urologists at 4-6 weeks, 12 months and 3 and 5 years to assess renal function via serum creatinine, renal ultrasound and need for dialysis/transplant. The main outcome measures will be perinatal mortality rates and renal function at 4-6 weeks and 12 months measured via serum creatinine, renal ultrasound and need for dialysis/transplant. Wellbeing of Women. ESTIMATED COMPLETION DATE: September 2010. TRIAL ALGORITHM: [flowchart: see text].

  19. A multicentre, randomized, controlled trial of oseltamivir in the treatment of influenza in a high-risk Chinese population.

    PubMed

    Lin, Jiang-Tao; Yu, Xue-Zhong; Cui, De-Jian; Chen, Xu-Yan; Zhu, Ji-Hong; Wang, Yu-Zhen; Wu, Xiao-di

    2006-01-01

    To evaluate the efficacy and safety of oseltamivir treatment in a population at high risk for influenza. This was a randomized, open-label, controlled trial involving Chinese patients with chronic respiratory diseases (chronic bronchitis, obstructive emphysema, bronchial asthma or bronchiectasis) or chronic cardiac disease. Patients showing symptoms of influenza were randomly assigned to receive oral oseltamivir 75 mg twice daily for 5 days (oseltamivir group), or symptomatic treatment (control group) within 48 h after symptom onset. The main outcome measures were duration and severity of illness in influenza-infected patients. Other outcome measures included incidence of complications, antibiotic use, hospitalization and total medical cost. Of the 118 recruited patients, 56 were identified as influenza-infected through laboratory tests (oseltamivir, N = 27; control, N = 29). Relative to symptomatic treatment, oseltamivir significantly reduced the duration of influenza symptoms by 36.8% (p = 0.0479), and the severity by 43.1% (p = 0.0002). In addition, oseltamivir significantly reduced the duration of fever by 45.2% (p = 0.0051), and the time to return to baseline health status by 5 days (p = 0.0011). The incidence of complications (11% vs. 45%, p = 0.0053) and antibiotic use (37% vs. 69%, p = 0.0167) were also significantly lower in the oseltamivir group compared with the control group. The cost of treating influenza and its complications was comparable between the two groups (p = 0.2462). Oseltamivir is effective and well tolerated in high-risk patients with chronic respiratory or cardiac diseases. It can reduce the duration and severity of influenza symptoms and decrease the incidence of secondary complications and antibiotic use, without increasing the total medical cost.

  20. 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.

  1. Phase I controlled trials of WR-2721 and cyclophosphamide

    SciTech Connect

    Glick, J.H.; Glover, D.; Weiler, C.; Norfleet, L.; Yuhas, J.; Kligerman, M.M.

    1984-09-01

    WR-2721 is an organic thiophosphate compound which in the animal model selectively protects against the hematologic toxicity of cyclophosphamide by factors of 1.5 to 2.0. Controlled Phase I trials of WR-2721 and cyclophosphamide were initiated to determine if WR-2721 protected against cyclophosphamide's hematolgic toxicity. Fifteen patients received WR-2721 prior to cyclophosphamide and were subsequently retreated 4 weeks later with the same cyclophosphamide dose alone. With WR-2721 pretreatment, 11/15 (73%) patients had improved WBC counts. In the second trial, 25 patients received the reverse sequence: an initial dose of cyclophosphamide alone, followed 4 weeks later by WR-2721 prior to the same dose of cyclophosphamide. With WR-2721 pretreatment, 12/25 (48%) patients had improved nadir WBC counts. No patient developed microscopic or gross hematuria or inappropriate antidiuretic hormone secretion. These data suggest that WR-2721 provides significant protection against cyclophosphamide-induced granulocytopenia, but the dose modification factors and degree of clinical benefit remain to be established. The current recommended WR-2721 dose for Phase II trials is 740 mg/m/sup 2/ administered over 15 minutes.

  2. Increasing child pedestrian and cyclist visibility: cluster randomised controlled trial.

    PubMed

    Mulvaney, C A; Kendrick, D; Watson, M C; Coupland, C A C

    2006-04-01

    Visibility aids have the potential to reduce child pedestrian and cyclist injury but scarce data exist relating to their use or to interventions for increasing visibility aid use among children. This cluster randomised controlled trial was designed to assess the use of free visibility aids one and eight weeks after their provision among primary school children in Nottingham, UK. One class from each of 20 schools representing 377 children aged 7, 8, and 9 years old participated in the trial and were randomly assigned to treatment and control arms. Children in the intervention arm received two visibility aids, namely, a reflective and fluorescent slap wrap (an item that can be worn around an arm or trouser leg and is readily removed), and a reflective durable sticker in addition to educational material on the importance of being seen in the dark. Observers visited schools to observe use of reflective and fluorescent slap wraps, stickers, piping and patches on coats, and bags at baseline and at one and eight weeks after distribution of the visibility aids. The study used random effects logistic regression to calculate odds ratios (OR) and confidence intervals (CI). The results showed that children provided with free visibility aids were significantly more likely to use any visibility aid at one week (adjusted OR 59.5, 95% CI 18.5 to 191.0) and eight weeks (adjusted OR 5.9, 95% CI 3.4 to 10.4) after distribution than children in the control arm. Providing free visibility aids and an educational booklet on road safety significantly increases use of visibility aids for up to eight weeks during the winter among primary school children. On the basis of an eight week follow up trial in Nottingham of 20 classes of children aged 7 to 9 years old, these results suggest that campaigns providing free visibility aids to primary school children should be encouraged.

  3. Increasing child pedestrian and cyclist visibility: cluster randomised controlled trial

    PubMed Central

    Mulvaney, C A; Kendrick, D; Watson, M C; Coupland, C A C

    2006-01-01

    Study objective Visibility aids have the potential to reduce child pedestrian and cyclist injury but scarce data exist relating to their use or to interventions for increasing visibility aid use among children. This cluster randomised controlled trial was designed to assess the use of free visibility aids one and eight weeks after their provision among primary school children in Nottingham, UK. Design One class from each of 20 schools representing 377 children aged 7, 8, and 9 years old participated in the trial and were randomly assigned to treatment and control arms. Children in the intervention arm received two visibility aids, namely, a reflective and fluorescent slap wrap (an item that can be worn around an arm or trouser leg and is readily removed), and a reflective durable sticker in addition to educational material on the importance of being seen in the dark. Observers visited schools to observe use of reflective and fluorescent slap wraps, stickers, piping and patches on coats, and bags at baseline and at one and eight weeks after distribution of the visibility aids. The study used random effects logistic regression to calculate odds ratios (OR) and confidence intervals (CI). Main result The results showed that children provided with free visibility aids were significantly more likely to use any visibility aid at one week (adjusted OR 59.5, 95% CI 18.5 to 191.0) and eight weeks (adjusted OR 5.9, 95% CI 3.4 to 10.4) after distribution than children in the control arm. Conclusions Providing free visibility aids and an educational booklet on road safety significantly increases use of visibility aids for up to eight weeks during the winter among primary school children. On the basis of an eight week follow up trial in Nottingham of 20 classes of children aged 7 to 9 years old, these results suggest that campaigns providing free visibility aids to primary school children should be encouraged. PMID:16537347

  4. 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).

  5. [Psychotherapy in bipolar disorders -- randomised controlled trials of treatment efficacy].

    PubMed

    Rode, Sibylle; Wagner, Petra; Bräunig, Peter

    2006-03-01

    On the basis of a vulnerability-stress-model psycho-educative, cognitive-behavioural, family-oriented and interpersonal approaches of psychotherapy for bipolar disorders are described. This is followed by a review of randomised controlled trials investigating the treatment efficacy of psychotherapeutic interventions. These studies show positive results particularly for psychoeducation, cognitive-behavioural therapy and family-oriented therapy. Finally, it is discussed in which respects evidence for the successful implementation of psychotherapy is still missing and why it is so important to move towards manualized psychotherapeutic programs.

  6. 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

  7. 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

  8. Physical activity for smoking cessation in pregnancy: randomised controlled trial.

    PubMed

    Ussher, Michael; Lewis, Sarah; Aveyard, Paul; Manyonda, Isaac; West, Robert; Lewis, Beth; Marcus, Bess; Riaz, Muhammad; Taylor, Adrian; Daley, Amanda; Coleman, Tim

    2015-05-14

    To determine the effectiveness of a physical activity intervention for smoking cessation during pregnancy. Parallel group, randomised controlled, multicentre trial. 13 hospitals in England, April 2009 to January 2014. 789 pregnant smokers, aged 16-50 years and at 10-24 weeks' gestation, who smoked at least one cigarette daily and were prepared to quit smoking one week after enrollment were randomised (1:1); 785 were included in the intention to treat analyses, with 392 assigned to the physical activity group. Interventions began one week before a target quit date. Participants were randomised to six weekly sessions of behavioural support for smoking cessation (control) or to this support plus 14 sessions combining supervised treadmill exercise and physical activity consultations. The primary outcome was continuous smoking abstinence from the target quit date until end of pregnancy, validated by exhaled carbon monoxide or salivary cotinine levels. To assess adherence, levels of moderate-vigorous intensity physical activity were self reported and in a 11.5% (n=90) random subsample of participants, physical activity was objectively measured by an accelerometer. No significant difference was found in rates of smoking abstinence at end of pregnancy between the physical activity and control groups (8% v 6%; odds ratio 1.21, 95% confidence interval 0.70 to 2.10). For the physical activity group compared with the control group, there was a 40% (95% confidence interval 13% to 73%), 34% (6% to 69%), and 46% (12% to 91%) greater increase in self reported minutes carrying out physical activity per week from baseline to one week, four weeks, and six weeks post-quit day, respectively. According to the accelerometer data there was no significant difference in physical activity levels between the groups. Participants attended a median of four treatment sessions in the intervention group and three in the control group. Adverse events and birth outcomes were similar between the two

  9. 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

  10. Hyperimmune IV immunoglobulin treatment: a multicenter double-blind randomized controlled trial for patients with severe 2009 influenza A(H1N1) infection.

    PubMed

    Hung, Ivan F N; To, Kelvin K W; Lee, Cheuk-Kwong; Lee, Kar-Lung; Yan, Wing-Wa; Chan, Kenny; Chan, Wai-Ming; Ngai, Chun-Wai; Law, Kin-Ip; Chow, Fu-Loi; Liu, Raymond; Lai, Kang-Yiu; Lau, Candy C Y; Liu, Shao-Haei; Chan, Kwok-Hung; Lin, Che-Kit; Yuen, Kwok-Yung

    2013-08-01

    Experience from influenza pandemics suggested that convalescent plasma treatment given within 4 to 5 days of symptom onset might be beneficial. However, robust treatment data are lacking. This is a multicenter, prospective, double-blind, randomized controlled trial. Convalescent plasma from patients who recovered from the 2009 pandemic influenza A(H1N1) (A[H1N1]) infection was fractionated to hyperimmune IV immunoglobulin (H-IVIG) by CSL Biotherapies (now BioCSL). Patients with severe A(H1N1) infection on standard antiviral treatment requiring intensive care and ventilatory support were randomized to receive H-IVIG or normal IV immunoglobulin manufactured before 2009 as control. Clinical outcome and adverse effects were compared. Between 2010 and 2011, 35 patients were randomized to receive H-IVIG (17 patients) or IV immunoglobulin (18 patients). One defaulted patient was excluded from analysis. No adverse events related to treatment were reported. Baseline demographics and viral load before treatment were similar between the two groups. Serial respiratory viral load demonstrated that H-IVIG treatment was associated with significantly lower day 5 and 7 posttreatment viral load when compared with the control (P = .04 and P = .02, respectively). The initial serum cytokine level was significantly higher in the H-IVIG group but fell to a similar level 3 days after treatment. Subgroup multivariate analysis of the 22 patients who received treatment within 5 days of symptom onset demonstrated that H-IVIG treatment was the only factor that independently reduced mortality (OR, 0.14; 95% CI, 0.02-0.92; P = .04). Treatment of severe A(H1N1) infection with H-IVIG within 5 days of symptom onset was associated with a lower viral load and reduced mortality. ClinialTrials.gov; No.: NCT01617317; URL: www.clinicaltrials.gov.

  11. Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol.

    PubMed

    Vleet, Thomas Van; DeGutis, Joseph; Dabit, Sawsan; Chiu, Christopher

    2014-02-07

    Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care. While previous interventions for spatial neglect have targeted patients' overt spatial deficits (e.g., reduced contralesional visual scanning), far fewer have directly targeted patients' non-spatial deficits (e.g., sustained attention deficits). Considering that non-spatial deficits have shown to be highly predictive of long-term disability, we developed a novel computer based training program that targets both sustained (tonic) and moment-to-moment (phasic) aspects of non-spatial attention (Tonic and Phasic Alertness Training, TAPAT). Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients. The purpose of the current trial (referred to as the REmediation of SPatial Neglect or RESPONSE trial) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 114 patients with spatial neglect. Patients will either perform, at their home, the experimental TAPAT training program or an active control computer games condition for thirty minutes/day, five days a week, over three months. Patients will be assessed on a battery of cognitive and functional outcomes on three occasions: a) immediately before training, b) within forty-eight hours post completion of total training, and c) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in neglect, employs highly sensitive computer-based assessments of cognition as well as

  12. The Ethics of Randomized Controlled Trials in Social Settings: Can Social Trials Be Scientifically Promising and Must There Be Equipoise?

    ERIC Educational Resources Information Center

    Fives, Allyn; Russell, Daniel W.; Canavan, John; Lyons, Rena; Eaton, Patricia; Devaney, Carmel; Kearns, Norean; O'Brien, Aoife

    2015-01-01

    In a randomized controlled trial (RCT), treatments are assigned randomly and treatments are withheld from participants. Is it ethically permissible to conduct an RCT in a social setting? This paper addresses two conditions for justifying RCTs: that there should be a state of equipoise and that the trial should be scientifically promising.…

  13. The Ethics of Randomized Controlled Trials in Social Settings: Can Social Trials Be Scientifically Promising and Must There Be Equipoise?

    ERIC Educational Resources Information Center

    Fives, Allyn; Russell, Daniel W.; Canavan, John; Lyons, Rena; Eaton, Patricia; Devaney, Carmel; Kearns, Norean; O'Brien, Aoife

    2015-01-01

    In a randomized controlled trial (RCT), treatments are assigned randomly and treatments are withheld from participants. Is it ethically permissible to conduct an RCT in a social setting? This paper addresses two conditions for justifying RCTs: that there should be a state of equipoise and that the trial should be scientifically promising.…

  14. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

    PubMed

    Haverkamp, Leonie; Brenkman, Hylke J F; Seesing, Maarten F J; Gisbertz, Suzanne S; van Berge Henegouwen, Mark I; Luyer, Misha D P; Nieuwenhuijzen, Grard A P; Wijnhoven, Bas P L; van Lanschot, Jan J B; de Steur, Wobbe O; Hartgrink, Henk H; Stoot, Jan H M B; Hulsewé, Karel W E; Spillenaar Bilgen, Ernst J; Rütter, Jeroen E; Kouwenhoven, Ewout A; van Det, Marc J; van der Peet, Donald L; Daams, Freek; Draaisma, Werner A; Broeders, Ivo A M J; van Stel, Henk F; Lacle, Miangela M; Ruurda, Jelle P; van Hillegersberg, Richard

    2015-07-29

    For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5

  15. Cervical Spondylotic Myelopathy Surgical (CSM-S) Trial: Randomized Controlled Trial Design and Rationale

    PubMed Central

    Ghogawala, Zoher; Benzel, Edward C.; Heary, Robert F.; Riew, K. Daniel; Albert, Todd J.; Butler, William E.; Barker, Fred G.; Heller, John G.; McCormick, Paul C.; Whitmore, Robert G.; Freund, Karen M.; Schwartz, J. Sanford

    2014-01-01

    Background Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There is significant practice variation and uncertainty as to the optimal surgical approach for treating CSM. Objective The primary objective is to determine if ventral surgery is associated with superior SF-36 Physical Component Summary (PCS) outcome at one year follow-up compared to dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM. The study will also investigate whether post-operative sagittal balance is an independent predictor of overall outcome and will compare health resource utilization for ventral and dorsal procedures. Methods The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 PCS score. Secondary outcomes include disease specific outcomes, overall health-related quality of life (EuroQol-5D), and health resource utilization. Expected Outcomes This will be the first randomized controlled trial to compare directly the health-related quality of life outcomes for ventral versus dorsal surgery for treating CSM. Discussion An NIH-funded (1R13AR065834-01) investigator meeting was held prior to initiating the trial in order to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths, limitations, and concerns regarding the study. The final protocol was approved for funding by PCORI (CE-1304-6173). The RCT began enrollment on April 1, 2014. PMID:24991714

  16. Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience.

    PubMed

    Zielinski, Stephanie M; Viveiros, Helena; Heetveld, Martin J; Swiontkowski, Marc F; Bhandari, Mohit; Patka, Peter; Van Lieshout, Esther M M

    2012-01-08

    Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. ClinicalTrials.gov: NCT00761813.

  17. 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

  18. Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol

    PubMed Central

    2012-01-01

    Background The prevalence of maternal drug use during pregnancy in North America has been estimated to be as high as 6-10%. The consequences for the newborn include increased risk for perinatal mortality and ongoing physical, neurobehavioral, and psychosocial problems. Methadone is frequently used to wean women off street drugs but is implicated as a cause of adverse fetal/neonatal outcomes itself. The purpose of our study was to test the ability of maternal acupuncture treatment among mothers who use illicit drugs to reduce the frequency and severity of withdrawal symptoms among their newborns. Methods We randomly assigned chemically dependent pregnant women at BC Women’s Hospital in Vancouver, British Columbia to daily acupuncture treatments versus usual care. By necessity, neither our participants nor acupuncturists were blinded as to treatment allocation. Our primary outcome was days of neonatal morphine treatment for symptoms of neonatal withdrawal. Secondary neonatal outcomes included admission to a neonatal ICU and transfer to foster care. Results We randomized 50 women to acupuncture and 39 to standard care. When analyzed by randomized groups, we did not find benefit of acupuncture; the average length of treatment with morphine for newborns in the acupuncture group was 2.7 (6.3) compared to 2.8 (7.0) in the control group. Among newborns of women who were compliant with the acupuncture regime, we observed a reduction of 2.1 and 1.5 days in length of treatment for neonatal abstinence syndrome compared to the non-compliant and control groups, respectively. These differences were not statistically significant. Conclusions Acupuncture may be a safe and feasible treatment to assist mothers to reduce their dosage of methadone. Our results should encourage ongoing studies to test the ability of acupuncture to mitigate the severity of neonatal abstinence syndrome among their newborns. Clinical Trial Registration http://www.clinicaltrials.gov registry: W05

  19. Recruiting to Clinical Trials on the Telephone - a randomized controlled trial.

    PubMed

    Foss, Kim Thestrup; Kjærgaard, Jesper; Stensballe, Lone Graff; Greisen, Gorm

    2016-11-21

    Informed consent is an essential element of clinical research. Obtaining consent, however, may be challenging. The use of the telephone for giving information and obtaining consent may be practical but little formal research has been done. We examined the use of the telephone for the purpose of informing expectant mothers about The Danish Calmette Study; a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers received an invitation letter with a Participant Information Sheet about The Danish Calmette Study, the present trial, and a Consent Form. Two to 4 weeks later we contacted the mothers to discuss potential participation in the present trial. At this initial telephone contact, and after consent from the mothers, we randomized expectant mothers to receive the verbal information about The Danish Calmette Study by telephone, or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about The Danish Calmette Study and satisfaction with the information process. The outcome was measured using a questionnaire 2 days after the information was provided, and 2.5 months after the birth of the child. The communication score obtained 2 days after information was given was significantly reduced in the telephone group, effect size -0.74 (95% confidence interval (CI), -1.11 to -0.36). The effect sizes of the subscores were -0.87 (95% CI, -1.25 to -0.49) for satisfaction and -0.22 (95% CI, -0.58 to 0.14) for comprehension. The effect sizes were slightly reduced when assessed 2.5 months after the birth. The communication score was reduced in the telephone group. This was due to a reduction in satisfaction, while no difference in the comprehension could be found in comparison to the control group. This may be ethically acceptable as both groups had high satisfaction scores. ClinicalTrials.gov, registered on 5 October 2015 with trial registration number NCT

  20. 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

  1. 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

  2. A randomised controlled trial of complete denture impression materials.

    PubMed

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, p<0.0001). There is significant evidence that dentures made from silicone impressions were preferred by patients. Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures. ISRCTN 01528038. This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. 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.

  4. 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

  5. Financial incentives for smoking cessation in pregnancy: randomised controlled trial.

    PubMed

    Tappin, David; Bauld, Linda; Purves, David; Boyd, Kathleen; Sinclair, Lesley; MacAskill, Susan; McKell, Jennifer; Friel, Brenda; McConnachie, Alex; de Caestecker, Linda; Tannahill, Carol; Radley, Andrew; Coleman, Tim

    2015-01-27

    To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit. Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. 612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking, at least 16 years of age, less than 24 weeks pregnant, and had an exhaled carbon monoxide breath test result of 7 ppm or more. 306 women were randomised to incentives and 306 to control. The control group received routine care, which was the offer of a face to face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services, and four, weekly support phone calls. The intervention group received routine care plus the offer of up to £400 of shopping vouchers: £50 for attending a face to face appointment and setting a quit date; then another £50 if at four weeks' post-quit date exhaled carbon monoxide confirmed quitting; a further £100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks; a final £200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks' gestation. The primary outcome was cotinine verified cessation at 34-38 weeks' gestation through saliva (<14.2 ng/mL) or urine (<44.7 ng/mL). Secondary outcomes included birth weight, engagement, and self reported quit at four weeks. Recruitment was extended from 12 to 15 months to achieve the target sample size. Follow-up continued until September 2013. Of the 306 women randomised, three controls opted out soon after enrolment; these women did not want their data to be used, leaving 306 intervention and 303 control group participants in the

  6. Comparison between 5-day aprepitant and single-dose fosaprepitant meglumine for preventing nausea and vomiting induced by cisplatin-based chemotherapy.

    PubMed

    Ando, Yosuke; Hayashi, Takahiro; Ito, Kaori; Suzuki, Eri; Mine, Naoyuki; Miyamoto, Ayumi; Oya, Miyuki; Matsuda, Hidezo; Isaji, Ami; Nakanishi, Toru; Imaizumi, Kazuyoshi; Shibata, Tomoyuki; Okada, Tatsuyoshi; Sakurai, Kazuo; Naito, Kensei; Uyama, Ichiro; Kawada, Kenji; Takahashi, Hiroshi; Yamada, Shigeki

    2016-02-01

    We aimed to compare the preventive effect of 5-day administration of aprepitant with single administration of fosaprepitant meglumine against nausea and vomiting symptoms due to highly emetogenic chemotherapy regimens comprising cisplatin (CDDP). Subjects were inpatients who underwent chemotherapy for gastric cancer, esophageal cancer, lung cancer, or head and neck cancer with a regimen comprising 60 mg/m(2) or higher dose of CDDP. In this randomised, open-label, controlled study, the subjects were assigned to a group given aprepitant for 5 days or a group given a single administration of fosaprepitant meglumine. The nausea and vomiting symptoms that emerged within 7 days after the first CDDP administration were investigated with a questionnaire form; the results were compared between the two groups. Risk factors affecting nausea and vomiting symptoms were also investigated. Of the 101 patients enrolled, 93 patients were included (48 in the 5-day aprepitant group and 45 in the single fosaprepitant meglumine group). No significant intergroup differences in the complete response rate or the complete control rate were found over the entire period. The nausea score tended to increase from day 3 in both groups, but no significant intergroup difference was observed. Furthermore, the investigation of risk factors affecting moderate or severe nausea symptoms indicated that the fosaprepitant meglumine administration was not a risk factor. Single administration of fosaprepitant meglumine was not inferior to 5-day administration of aprepitant for preventing acute and delayed nausea and vomiting symptoms occurring after administration of CDDP (60 mg/m(2) or higher).

  7. A Comparison of Randomised Controlled Trials in Health and Education

    ERIC Educational Resources Information Center

    Torgerson, Carole J.; Torgerson, David J.; Birks, Yvonne F.; Porthouse, Jill

    2005-01-01

    Health care and educational trials face similar methodological challenges. Methodological reviews of health care trials have shown that a significant proportion have methodological flaws. Whether or not educational trials have a similar proportion of poor-quality trials is unknown. The authors undertook a methodological comparison between health…

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

    PubMed

    Malmivaara, Antti

    2016-09-01

    Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

  13. Democratic therapeutic community treatment for personality disorder: randomised controlled trial.

    PubMed

    Pearce, Steve; Scott, Lisle; Attwood, Gillian; Saunders, Kate; Dean, Madeleine; De Ridder, Ritz; Galea, David; Konstantinidou, Haroula; Crawford, Mike

    2017-02-01

    Democratic therapeutic community (DTC) treatment has been used for many years in an effort to help people with personality disorder. High-quality evidence from randomised controlled trials (RCTs) is absent. To test whether DTC treatment reduces use of in-patient services and improves the mental health of people with personality disorder. An RCT of 70 people meeting DSM-IV criteria for personality disorder (trial registration: ISRCTN57363317). The intervention was DTC and the control condition was crisis planning plus treatment as usual (TAU). The primary outcome was days of in-patient psychiatric treatment. Secondary outcomes were social function, mental health status, self-harm and aggression, attendance at emergency departments and primary care, and satisfaction with care. All outcomes were measured at 12 and 24 months after randomisation. Number of in-patient days at follow-up was low among all participants and there was no difference between groups. At 24 months, self- and other directed aggression and satisfaction with care were significantly improved in the DTC compared with the TAU group. DTC is more effective than TAU in improving outcomes in personality disorder. Further studies are required to confirm this conclusion. © The Royal College of Psychiatrists 2017.

  14. 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

  15. The Speed of Increasing milk Feeds: a randomised controlled trial.

    PubMed

    Abbott, Jane; Berrington, Janet; Bowler, Ursula; Boyle, Elaine; Dorling, Jon; Embleton, Nicholas; Juszczak, Edmund; Leaf, Alison; Linsell, Louise; Johnson, Samantha; McCormick, Kenny; McGuire, William; Roberts, Tracy; Stenson, Ben

    2017-01-28

    In the UK, 1-2% of infants are born very preterm (<32 weeks of gestation) or have very low birth weight (<1500 g). Very preterm infants are initially unable to be fed nutritional volumes of milk and therefore require intravenous nutrition. Milk feeding strategies influence several long and short term health outcomes including growth, survival, infection (associated with intravenous nutrition) and necrotising enterocolitis (NEC); with both infection and NEC being key predictive factors of long term disability. Currently there is no consistent strategy for feeding preterm infants across the UK. The SIFT trial will test two speeds of increasing milk feeds with the primary aim of determining effects on survival without moderate or severe neurodevelopmental disability at 24 months of age, corrected for prematurity. The trial will also examine many secondary outcomes including infection, NEC, time taken to reach full feeds and growth. Two thousand eight hundred very preterm or very low birth weight infants will be recruited from approximately 30 hospitals across the UK to a randomised controlled trial. Infants with severe congenital anomaly or no realistic chance of survival will be excluded. Infants will be randomly allocated to either a faster (30 ml/kg/day) or slower (18 ml/kg/day) rate of increase in milk feeds. Data will be collected during the neonatal hospital stay on weight, infection rates, episodes of NEC, length of stay and time to reach full milk feeds. Long term health outcomes comprising vision, hearing, motor and cognitive impairment will be assessed at 24 months of age (corrected for prematurity) using a parent report questionnaire. Extensive searches have found no active or proposed studies investigating the rate of increasing milk feeds. The results of this trial will have importance for optimising incremental milk feeding for very preterm and/or very low birth weight infants. No additional resources will be required to implement an optimal

  16. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial.

    PubMed

    Clark, William F; Huang, Shih-Han; Garg, Amit X; Gallo, Kerri; House, Andrew A; Moist, Louise; Weir, Matthew A; Sontrop, Jessica M

    2017-01-01

    In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease. Parallel-group randomized controlled trial. Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. Adults (n = 631) with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m(2)) and microalbuminuria. The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight), over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. The between-group change in eGFR from baseline (prerandomization) to 12 months after randomization. Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation), and health-related quality of life. The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using linear regression. Supplementary analyses will examine alternative definitions of eGFR change, including annual percentage change, rate of

  17. A controlled trial of cognitive remediation in schizophrenia.

    PubMed

    van der Gaag, Mark; Kern, Robert S; van den Bosch, Robert J; Liberman, Robert P

    2002-01-01

    A randomized, controlled trial of a 3-month cognitive remediation program was examined for its efficacy at ameliorating deficits in social and emotion perception in 42 hospitalized patients with schizophrenia. Generalization of training effects to attention, memory, and executive functioning was also examined. The program included an eclectic mix of self-instruction, memory enhancement, inductive reasoning, and compensatory training procedures, while the control condition included participation in a leisure group that was matched to the experimental group for staff involvement time. Patient care management, including type and dose of antipsychotic medication, remained constant throughout the study period. The results indicated that the cognitive training program improved emotion perception, with some evidence of generalization to measures of executive functioning; other areas of neurocognitive functioning were largely unaffected. While cognitive training programs may improve targeted areas of neurocognitive processing, broad generalization effects to domains outside those targeted for intervention are not likely concomitants.

  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. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

    PubMed Central

    Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

    2015-01-01

    Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis

  20. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    PubMed

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  1. Interhemispheric structure and variability of the 5-day planetary wave from meteor radar wind measurements

    NASA Astrophysics Data System (ADS)

    Iimura, H.; Fritts, D. C.; Janches, D.; Singer, W.; Mitchell, N. J.

    2015-11-01

    A study of the quasi-5-day wave (5DW) was performed using meteor radars at conjugate latitudes in the Northern and Southern hemispheres. These radars are located at Esrange, Sweden (68° N) and Juliusruh, Germany (55° N) in the Northern Hemisphere, and at Tierra del Fuego, Argentina (54° S) and Rothera Station, Antarctica (68° S) in the Southern Hemisphere. The analysis was performed using data collected during simultaneous measurements by the four radars from June 2010 to December 2012 at altitudes from 84 to 96 km. The 5DW was found to exhibit significant short-term, seasonal, and interannual variability at all sites. Typical events had planetary wave periods that ranged between 4 and 7 days, durations of only a few cycles, and infrequent strongly peaked variances and covariances. Winds exhibited rotary structures that varied strongly among sites and between events, and maximum amplitudes up to ~ 20 m s-1. Mean horizontal velocity covariances tended to be largely negative at all sites throughout the interval studied.

  2. Divorce and eating behaviors: a 5-day within-subject study of preadolescent obesity risk.

    PubMed

    Mauskopf, Susan S; O'Leary, Allison K; Banihashemi, Adria; Weiner, Michelle; Cookston, Jeffrey T

    2015-04-01

    Obesity rates have more than doubled among children and have tripled among adolescents since the 1980s, and currently more than one third of children and adolescents are overweight or obese. Parental divorce is a time of family upheaval, yet little is known about the family processes that link family structure and obesity. The current study gathered a 5-day eating behavior questionnaire from 37 preadolescents (mean=10.26 years; standard deviation=1.32; 32.4% female) and one parent to explore whether marital status was linked to obesity risk behaviors (i.e., high consumption of sugar-sweetened beverages (SSBs), low consumption of produce, skipping breakfast, and eating dinners away from the home) and whether family context (e.g., parent time spent with child, parental acceptance, and family routines) mediated that link. Results showed that preadolescents in divorced families consumed more SSBs than preadolescents in married families, and there was a trend for less-frequent breakfast consumption among preadolescents in the divorced families. Of the three family context variables, only family routines explained the link between family structure and obesity risk. This study highlights the importance of family processes during divorce to understand the etiology and prevalence of child and adolescent obesity.

  3. Enzyme response of traumatized tissue after intracortical injection into 5 day old rat brain

    PubMed Central

    Robinson, N.

    1972-01-01

    Penetration of a microneedle and injection of 4 μl. saline into the neocortex of the 5 day old rat brain produced no changes in behaviour of the rats up to 21 days post-injection. Within 24 hours sections indicated that tissue damage was apparent only at the pia-arachnoid membrane and where fluid was released; elsewhere the needle pathway was identified by the enzyme response. The enzyme histochemistry showed a marked increase in glial cell activity of some phosphatases within 24 hours at the site of injury; the pia-arachnoid and outer limiting membrane also showed abnormally high phosphatase reactions. NADH2-diaphorase was the only dehydrogenase that was raised in some nerve and glial cells at 24 hours post-injection but other dehydrogenases, mainly LDH and SDH, showed changes at four days post-injection. The phosphatases and 5'-nucleotidase previously showing intense glial cell enzyme reactions appeared to reach peaks of activity at eight days, and at 16 days the onset of scarring was apparent. In the pia-arachnoid enzyme activity increased to 21 days. Some enzymes, particularly AChE and MAO, showed no alterations of note throughout. Images PMID:4405286

  4. 5-day storage of platelet concentrates in CLX containers: effect of type of agitation.

    PubMed

    Snyder, E L; Bookbinder, M; Kakaiya, R; Ferri, P; Kiraly, T

    1983-01-01

    To determine the degree of platelet damage produced by different modes of agitation during storage of concentrates for 5 days in CLX blood bags, we studied pH, platelet counts, release of LDH and beta thromboglobulin, morphology and osmotic recovery. Platelets were maintained at 20-24 degrees C on elliptical, 6-rpm circular, 2-rpm circular and flat bed agitators. At 72-120 h platelet concentrates stored on the flat bed shaker had significantly lower pH values than units stored on the elliptical or on either of the circular rotators (p less than 0.05). The percent LDH discharged was highest for the units stored on the elliptical rotator (p less than 0.05). Remaining tests of platelet function were not significantly different for concentrates stored on any of the four agitators. Flat bed shakers were unable to resuspend the platelet 'button' which formed after the final preparative centrifugation. Based on our in vitro studies, we conclude that due to problems with low pH values, flat bed shakers may not be optimal for storing platelet concentrates in CLX blood bags and that some other form of agitation should be used.

  5. 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

  6. 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).

  7. The Tinnitus Retraining Therapy Trial (TRTT): study protocol for a randomized controlled trial.

    PubMed

    Scherer, Roberta W; Formby, Craig; Gold, Susan; Erdman, Sue; Rodhe, Charles; Carlson, Michele; Shade, Dave; Tucker, Melanie; Sensinger, Lee McCaffrey; Hughes, Gordon; Conley, George S; Downey, Naomi; Eades, Cynthia; Jylkka, Margaret; Haber-Perez, Ada; Harper, Courtney; Russell, Shoshannah Kantor; Sierra-Irizarry, Benigno; Sullivan, Mark

    2014-10-15

    Subjective tinnitus is the perception of sound in the absence of a corresponding external sound for which there is no known medical etiology. For a minority of individuals with tinnitus, the condition impacts their ability to lead a normal lifestyle and is severely debilitating. There is no known cure for tinnitus, so current therapy focuses on reducing the effect of tinnitus on the patient's quality of life. Tinnitus retraining therapy (TRT) uses nonpsychiatric tinnitus-specific educational counseling and sound therapy in a habituation-based protocol to reduce the patient's tinnitus-evoked negative reaction to, and awareness of, the tinnitus, with the ultimate goal of reducing the tinnitus impact on the patient's quality of life. Some studies support the efficacy of TRT, but no trial to date has compared TRT with the current standard of care or evaluated the separate contributions of TRT counseling and sound therapy. The Tinnitus Retraining Therapy Trial (TRTT) is a randomized, double-blind, placebo-controlled, multicenter trial for individuals with intolerable tinnitus. The TRTT is enrolling active-duty and retired military personnel and their dependents with functionally adequate hearing sensitivity and severe tinnitus at US Air Force, Navy, and Army medical centers. Eligible study participants are randomized to TRT, partial TRT, or standard care to determine the efficacy of TRT and its components (TRT counseling and sound therapy). The primary outcome is change in score on the Tinnitus Questionnaire assessed longitudinally between baseline and follow-up (3, 6, 12, and 18 months following treatment). Secondary outcomes include subscale score changes in the Tinnitus Questionnaire, overall and subscale score changes in the Tinnitus Functional Index and Tinnitus Handicap Inventory, and change in the visual analog scale of the TRT Interview Form. Audiological outcomes include tinnitus pitch and loudness match and measures of loudness discomfort levels. The incidence

  8. Pressure ulcers: effectiveness of risk-assessment tools. A randomised controlled trial (the ULCER trial).

    PubMed

    Webster, Joan; Coleman, Kerrie; Mudge, Alison; Marquart, Louise; Gardner, Glenn; Stankiewicz, Monica; Kirby, Julie; Vellacott, Catherine; Horton-Breshears, Margaret; McClymont, Alice

    2011-04-01

    To evaluate the effectiveness of two pressure-ulcer screening tools against clinical judgement in preventing pressure ulcers. A single blind randomised controlled trial. A large metropolitan tertiary hospital. 1231 patients admitted to internal medicine or oncology wards. Patients were excluded if their hospital stay was expected to be 2 days or less. Participants allocated to either a Waterlow (n=410) or Ramstadius (n=411) screening tool group or to a clinical judgement group (n=410) where no formal risk screening instrument was used. Incidence of hospital acquired pressure ulcers ascertained by regular direct observation. Use of any devices for the prevention of pressure ulcers, documentation of a pressure plan and any dietetic or specialist skin integrity review were recorded. On admission, 71 (5.8%) patients had an existing pressure ulcer. The incidence of hospital-acquired pressure ulcers was similar between groups (clinical judgement 28/410 (6.8%); Waterlow 31/411 (7.5%); Ramstadius 22/410 (5.4%), p=0.44). Significant associations with pressure injury in regression modelling included requiring a dietetic referral, being admitted from a location other than home and age over 65 years. The authors found no evidence to show that two common pressure-ulcer risk-assessment tools are superior to clinical judgement to prevent pressure injury. Resources associated with use of these tools might be better spent on careful daily skin inspection and improving management targetted at specific risks. The trial was registered with the Australian and New Zealand Clinicat Trials Registry (ACTRN 12608000541303).

  9. Testing the activitystat hypothesis: a randomised controlled trial protocol

    PubMed Central

    2012-01-01

    Background The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. Methods This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey) aged 18–60 years old will be recruited for this study (n=146). Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water) and physical activity (accelerometry). Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks), mid- and end-intervention (three and six weeks) with three (12 weeks) and six month (24 week) follow-up. All assessors will be blinded to group

  10. Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial.

    PubMed

    Harvey, Lisa A; Dunlop, Sarah A; Churilov, Leonid; Hsueh, Ya-Seng Arthur; Galea, Mary P

    2011-01-17

    Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation. A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009. The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation. NCT01086930 (12th March 2010)ACTRN12609000695202 (12th August 2009).

  11. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial.

    PubMed

    Verspyck, Eric; de Vienne, Claire; Muszynski, Charles; Bubenheim, Michael; Chanavaz-Lacheray, Isabella; Dreyfus, Michel; Deruelle, Philippe; Benichou, Jacques

    2017-01-01

    To assess the impact of maintenance nifedipine therapy on pregnancy duration in women with preterm placenta previa bleeding. PPADAL was a randomized, double-blind, placebo-controlled trial conducted between 05/2008 and 05/2012 in five French hospitals. The trial included 109 women, aged ≥ 18 years, with at least one episode of placenta previa bleeding, intact membranes and no other pregnancy complication, at gestational age 24 to 34 weeks and after 48 hours of complete acute tocolysis. Women were randomly allocated to receive either 20 mg of slow-release nifedipine three times daily (n = 54) or placebo (n = 55) until 36 + 6 weeks of gestation. The primary outcome for the trial was length of pregnancy measured in days after enrolment. Main secondary outcomes were rates of recurrent bleeding, cesarean delivery due to hemorrhage, blood transfusion, maternal side effects, gestational age at delivery and adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage > grade 2, perventricular leukomalacia > grade 1, or necrotizing enterocolitis). Analysis was by intention to treat. Mean (SD) prolongation of pregnancy was not different between the nifedipine (n = 54) and the placebo (n = 55) group; 42.5 days ± 23.8 versus 44.2 days ± 24.5, p = 0.70. Cesarean due to hemorrhage performed before 37 weeks occurred more frequently in the nifedipine group in comparison with the placebo group (RR, 1.66; 95% confidence interval, 1.05-2.72). Adverse perinatal outcomes were comparable between groups; 3.8% for nifedipine versus 5.5% for placebo (relative risk, 0.52; 95% confidence interval 0.10-2.61). No maternal mortality or perinatal death occurred. Maintenance oral nifedipine neither prolongs duration of pregnancy nor improves maternal or perinatal outcomes. ClinicalTrials.gov NCT00620724.

  12. A Preliminary Randomized Double Blind Placebo-Controlled Trial of Intravenous Immunoglobulin for Japanese Encephalitis in Nepal

    PubMed Central

    Rayamajhi, Ajit; Nightingale, Sam; Bhatta, Nisha Keshary; Singh, Rupa; Ledger, Elizabeth; Bista, Krishna Prasad; Lewthwaite, Penny; Mahaseth, Chandeshwar; Turtle, Lance; Robinson, Jaimie Sue; Galbraith, Sareen Elizabeth; Wnek, Malgorzata; Johnson, Barbara Wilmot; Faragher, Brian

    2015-01-01

    Background Japanese encephalitis (JE) virus (JEV) is a mosquito-borne flavivirus found across Asia that is closely related to West Nile virus. There is no known antiviral treatment for any flavivirus. Results from in vitro studies and animal models suggest intravenous immunoglobulin (IVIG) containing virus-specific neutralizing antibody may be effective in improving outcome in viral encephalitis. IVIG’s anti-inflammatory properties may also be beneficial. Methodology/Principal Findings We performed a pilot feasibility randomized double-blind placebo-controlled trial of IVIG containing anti-JEV neutralizing antibody (ImmunoRel, 400mg/kg/day for 5 days) in children with suspected JE at two sites in Nepal; we also examined the effect on serum neutralizing antibody titre and cytokine profiles. 22 children were recruited, 13 of whom had confirmed JE; 11 received IVIG and 11 placebo, with no protocol violations. One child (IVIG group) died during treatment and two (placebo) subsequently following hospital discharge. Overall, there was no difference in outcome between treatment groups at discharge or follow up. Passive transfer of anti-JEV antibody was seen in JEV negative children. JEV positive children treated with IVIG had JEV-specific neutralizing antibody titres approximately 16 times higher than those treated with placebo (p=0.2), which was more than could be explained by passive transfer alone. IL-4 and IL-6 were higher in the IVIG group. Conclusions/Significance A trial of IVIG for JE in Nepal is feasible. IVIG may augment the development of neutralizing antibodies in JEV positive patients. IVIG appears an appealing option for JE treatment that warrants further study. Trial Registration ClinicalTrials.gov NCT01856205 PMID:25886645

  13. 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.

  14. Controlled release metoprolol for aortic regurgitation: a randomised clinical trial.

    PubMed

    Broch, Kaspar; Urheim, Stig; Lønnebakken, Mai Tone; Stueflotten, Wenche; Massey, Richard; Fosså, Kristian; Hopp, Einar; Aakhus, Svend; Gullestad, Lars

    2016-02-01

    Chronic aortic regurgitation (AR) creates a volume load on the left ventricle, which induces adaptive responses. With time, excessive left ventricular (LV) dilatation may precipitate heart failure. β-adrenergic receptor antagonists (β-blockers) are beneficial in patients with heart failure, but their effect in AR is unclear. This trial was designed to evaluate the effect of controlled release metoprolol on LV remodelling in patients with AR. In this double blind trial, 75 asymptomatic patients aged 44±14 years, 89% males, fulfilling at least two echocardiographic criteria for moderate or severe chronic AR, were randomised to receive metoprolol CR/XL up-titrated to 200 mg/day, or matching placebo. The primary endpoint was LV end diastolic volume, measured by MRI after 6 months of treatment. After 6 months, the difference in the baseline-adjusted LV end diastolic volume between patients allocated to metoprolol and those allocated to placebo was 8 (95% CI -8 to 25) mL (p=0.32). The adjusted LV ejection fraction was 2.7 (95% CI 0.1 to 5.3) percentage points higher in the metoprolol group than in the placebo group (p=0.04). The exercise capacity and peak oxygen consumption did not differ between treatment arms. Serum concentrations of N-terminal pro-B-type natriuretic peptide were 138 (95% CI 71 to 205) pg/mL higher in the metoprolol group (p<0.001). There were no serious adverse events in either treatment arm. Treatment with metoprolol of adults with chronic, moderate to severe AR had no effect on LV volumes. ClinicalTrials.gov Identifier: NCT01157572-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  15. 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.

  16. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison.

    PubMed

    Duncan, Larissa G; Cohn, Michael A; Chao, Maria T; Cook, Joseph G; Riccobono, Jane; Bardacke, Nancy

    2017-05-12

    Childbirth fear is linked with lower labor pain tolerance and worse postpartum adjustment. Empirically validated childbirth preparation options are lacking for pregnant women facing this problem. Mindfulness approaches, now widely disseminated, can alleviate symptoms of both chronic and acute pain and improve psychological adjustment, suggesting potential benefit when applied to childbirth education. This study, the Prenatal Education About Reducing Labor Stress (PEARLS) study, is a randomized controlled trial (RCT; n = 30) of a short, time-intensive, 2.5-day mindfulness-based childbirth preparation course offered as a weekend workshop, the Mind in Labor (MIL): Working with Pain in Childbirth, based on Mindfulness-Based Childbirth and Parenting (MBCP) education. First-time mothers in the late 3rd trimester of pregnancy were randomized to attend either the MIL course or a standard childbirth preparation course with no mind-body focus. Participants completed self-report assessments pre-intervention, post-intervention, and post-birth, and medical record data were collected. In a demographically diverse sample, this small RCT demonstrated mindfulness-based childbirth education improved women's childbirth-related appraisals and psychological functioning in comparison to standard childbirth education. MIL program participants showed greater childbirth self-efficacy and mindful body awareness (but no changes in dispositional mindfulness), lower post-course depression symptoms that were maintained through postpartum follow-up, and a trend toward a lower rate of opioid analgesia use in labor. They did not, however, retrospectively report lower perceived labor pain or use epidural less frequently than controls. This study suggests mindfulness training carefully tailored to address fear and pain of childbirth may lead to important maternal mental health benefits, including improvements in childbirth-related appraisals and the prevention of postpartum

  17. 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…

  18. 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…

  19. Aerobic exercise increases phosphate removal during hemodialysis: a controlled trial.

    PubMed

    Orcy, Rafael; Antunes, Maria Fernanda; Schiller, Tamires; Seus, Thamires; Böhlke, Maristela

    2014-04-01

    Previous studies have suggested that exercise during hemodialysis (HD) could increase the efficacy of solute removal, although this hypothesis has not been conclusively evaluated. The goal of this study was to compare the removal of low-molecular weight solutes between HD sessions, with and without aerobic exercise. It was a controlled clinical trial, including HD patients in a randomly cross-over design, such that each patient received a HD session with exercise (intervention) and the next one without exercise (control), three times each. In the exercise sessions, patients pedaled on a cycle ergometer for 60 minutes. The total mass of removed urea, potassium, creatinine, and phosphate were calculated from the solutes concentration in dialysate (continuous spent sampling of dialysate). This was evaluated in a total of 132 HD sessions of patients with a mean age of 54 ± 15 years, 75% male and HD vintage of 3 (2-13) years. Phosphate removal in dialysate during intervention sessions was significantly higher (5.6 [2.5-18.9] vs. 5.1 [1.5-11.2] mg/min) than during control sessions, P = 0.04. The median mass of phosphate removed during control HD session was 1226 (367.8-2697.2) vs. 1348.6 (613.0-4536.2) mg/session during intervention sessions. The exercise did not modify the removal of urea (control 122.6 [61.3-286.0] vs. exercise 112.4 [51.1-250.3] mg/min, P = 0.44), creatinine (control 5.6 [2.5-13.8] vs. exercise 5.6 [2.5-12.8] mg/min, P = 0.49), or potassium (control 13.3 [11.2-15.8] vs. exercise 13.8 [6.6-15.8] mEq/min, P = 0.49). Aerobic exercise during HD increases the efficacy of phosphate removal, without changing urea, creatinine and potassium removal. The implications of this finding in mineral and bone disease and cardiovascular disease need to be evaluated on future clinical trials.

  20. A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan.

    PubMed

    Traeger, Adrian C; Skinner, Ian W; Hübscher, Markus; Lee, Hopin; Moseley, G Lorimer; Nicholas, Michael K; Henschke, Nicholas; Refshauge, Kathryn M; Blyth, Fiona M; Main, Chris J; Hush, Julia M; Pearce, Garry; Lo, Serigne; McAuley, James H

    Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain. We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures. Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results. ACTRN12612001180808 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808). Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

  1. 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.

  2. Immediate versus delayed postpartum use of levonorgestrel contraceptive implants: a randomized controlled trial in Uganda.

    PubMed

    Averbach, Sarah; Kakaire, Othman; Kayiga, Herbert; Lester, Felicia; Sokoloff, Abby; Byamugisha, Josaphat; Dehlendorf, Christine; Steinauer, Jody

    2017-06-10

    Use of long-acting, highly effective contraception has the potential to improve women's ability to avoid short interpregnancy intervals, which are associated with an increased risk of maternal morbidity and mortality, and preterm delivery. In Uganda, contraceptive implants are not routinely available during the immediate postpartum period. The purpose of this study was to compare the proportion of women using levonorgestrel contraceptive implants at 6 months after delivery in women randomized to immediate or delayed insertion. This was a randomized controlled trial among women in Kampala, Uganda. Women who desired contraceptive implants were randomly assigned to insertion of a 2-rod contraceptive implant system containing 75 mg of levonorgestrel immediately following delivery (within 5 days of delivery and before discharge from the hospital) or delayed insertion (6 weeks postpartum). The primary outcome was implant utilization at 6 months postpartum. From June to October 2015, 205 women were randomized, 103 to the immediate group and 102 to the delayed group. Ninety-three percent completed the 6 month follow-up visit. At 6 months, implant use was higher in the immediate group compared with the delayed group (97% vs 68%; P < .001), as was the use of any highly effective contraceptive (98% vs 81%; P = .001). Women in the immediate group were more satisfied with the timing of implant placement. If given the choice, 81% of women in the immediate group and 63% of women in the delayed group would choose the same timing of placement again (P = .01). There were no serious adverse events in either group. Offering women the option of initiating contraceptive implants in the immediate postpartum period has the potential to increase contraceptive utilization, decrease unwanted pregnancies, prevent short interpregnancy intervals, and help women achieve their reproductive goals. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Dexmedetomidine versus Propofol Sedation Reduces Delirium after Cardiac Surgery: A Randomized Controlled Trial.

    PubMed

    Djaiani, George; Silverton, Natalie; Fedorko, Ludwik; Carroll, Jo; Styra, Rima; Rao, Vivek; Katznelson, Rita

    2016-02-01

    Postoperative delirium (POD) is a serious complication after cardiac surgery. Use of dexmedetomidine to prevent delirium is controversial. The authors hypothesized that dexmedetomidine sedation after cardiac surgery would reduce the incidence of POD. After institutional ethics review board approval, and informed consent, a single-blinded, prospective, randomized controlled trial was conducted in patients 60 yr or older undergoing cardiac surgery. Patients with a history of serious mental illness, delirium, and severe dementia were excluded. Upon admission to intensive care unit (ICU), patients received either dexmedetomidine (0.4 μg/kg bolus followed by 0.2 to 0.7 μg kg h infusion) or propofol (25 to 50 μg kg min infusion) according to a computer-generated randomization code in blocks of four. Assessment of delirium was performed with confusion assessment method for ICU or confusion assessment method after discharge from ICU at 12-h intervals during the 5 postoperative days. Primary outcome was the incidence of POD. POD was present in 16 of 91 (17.5%) and 29 of 92 (31.5%) patients in dexmedetomidine and propofol groups, respectively (odds ratio, 0.46; 95% CI, 0.23 to 0.92; P = 0.028). Median onset of POD was on postoperative day 2 (1 to 4 days) versus 1 (1 to 4 days), P = 0.027, and duration of POD 2 days (1 to 4 days) versus 3 days (1 to 5 days), P = 0.04, in dexmedetomidine and propofol groups, respectively. When compared with propofol, dexmedetomidine sedation reduced incidence, delayed onset, and shortened duration of POD in elderly patients after cardiac surgery. The absolute risk reduction for POD was 14%, with a number needed to treat of 7.1.

  4. Clinical Effects of Dry Needling Among Asymptomatic Individuals With Hamstring Tightness: A Randomized Controlled Trial.

    PubMed

    Geist, Kathleen; Bradley, Claire; Hofman, Alan; Koester, Rob; Roche, Fenella; Shields, Annalise; Frierson, Elizabeth; Rossi, Ainsley; Johanson, Marie

    2016-11-11

    Randomized controlled trial. The aim of this study was to determine the effects of dry needling on hamstring extensibility and functional performance tests among asymptomatic individuals with hamstring muscle tightness. Dry needling has been shown to increase range of motion in the upper quarter and may have similar effects in the lower quarter. Twenty-seven subjects with hamstring extensibility deficits were randomly assigned to side of treatment (dominant or non-dominant) and group (blunt needling or dry needling). The first session included measurement of hamstring extensibility and performance on four unilateral hop tests, instruction in home hamstring stretching exercises and needling distal to the ischial tuberosity and mid-bellies of the medial and lateral hamstrings. A second session, 3-5 days following the first session included outcome measures and a second needling intervention, and a third session, 4-6 weeks following the first session included outcome measures only. A 2x3x2 ANOVA was used to statistically analyze the data. Hamstring extensibility showed a significant side x time interaction (p<.05). The single hop for distance, timed six meter hop, and the crossover hop test had a significant main effect of time (p<.05). The triple hop for distance showed a significant side x time x group interaction (p<.05). It does not appear dry needling results in increased extensibility beyond that of stretching alone in asymptomatic individuals. Our study findings suggest that dry needling may improve certain dimensions of functional performance, although no clear conclusion can be made. Intervention, level 2b.

  5. Intravenous amantadine on freezing of gait in Parkinson's disease: a randomized controlled trial.

    PubMed

    Lee, Jee Young; Oh, Sohee; Kim, Jong Min; Kim, Ji Sun; Oh, Eungseok; Kim, Hee-Tae; Jeon, Beom S; Cho, Jin Whan

    2013-12-01

    To compare the effects of intravenous amantadine and placebo therapy on freezing of gait in patients with Parkinson's disease, this randomized, double-blind, placebo-controlled, multicenter trial compared the efficacy of 5 days intravenous amantadine and placebo treatments on freezing of gait in 42 subjects randomly allocated 2:1 to amantadine or placebo groups. Changes in freezing of gait questionnaire (FOG-Q) scores and in unified Parkinson's disease rating scale (UPDRS) scores, from baseline to immediately (V1) and 1 month (V2) after treatments, were assessed. Among the 42 patients (amantadine n = 29, placebo n = 13, a mean age 65.5 ± 9.4 years and a mean FOG-Q score 17.4 ± 3.2), 40 subjects completed treatment. There was no significant group difference on the primary outcome measure as total FOG-Q score changes at V1. However a significant beneficial effect of amantadine on freezing was seen at V2 in the UPDRS Part II freezing and FOG-Q item 3 scores, and there was significant improvement in the UPDRS Part IV total score and in the UPDRS Part II getting out of bed score in the amantadine group at both V1 and V2. There was no serious adverse event reported during the study. The intravenous amantadine therapy did not show a significant improvement on overall FOG-Q scores in patients with moderate-to-severe freezing; however, it might be beneficial by attenuating freezing severity and improving patients' mobility. To prove this finding further studies with larger sample sizes are warranted in the future.

  6. Amiodarone prophylaxis for tachycardias after coronary artery surgery: a randomised, double blind, placebo controlled trial.

    PubMed Central

    Butler, J; Harriss, D R; Sinclair, M; Westaby, S

    1993-01-01

    BACKGROUND--Arrhythmias are a common cause of morbidity after cardiac surgery. This study assessed the efficacy of prophylactic amiodarone in reducing the incidence of atrial fibrillation or flutter and ventricular arrhythmias after coronary artery surgery. METHODS--A double blind, randomised, placebo controlled trial. 60 patients received a 24 hour intravenous infusion of amiodarone (15 mg/kg started after removal of the aortic cross clamp) followed by 200 mg orally three times daily for 5 days, and 60 patients received placebo. RESULTS--6 patients (10%) in the amiodarone group and 14 (23%) in the placebo group needed treatment for arrhythmias (95% confidence interval (95% CI) for the difference between groups was 0 to 26%, p = 0.05). The incidence of supraventricular tachycardia detected clinically and requiring treatment was lower in the amiodarone group (8% amiodarone v 20% placebo, 95% CI 0 to 24%, p = 0.07). The incidence detected by 24 hour Holter monitoring was similar (17% amiodarone v 20% placebo). Untreated arrhythmias in the amiodarone group were either clinically benign and undetected (n = 3) or the ventricular response rate was slow (n = 2). Age > 60 years was a positive risk factor for the development of supraventricular tachycardia in the amiodarone group but not in the placebo group. Fewer patients had episodes of ventricular tachycardia or fibrillation recorded on Holter monitoring in the amiodarone group (15% amiodarone v 33% placebo, 95% CI 3 to 33%, p = 0.02). Bradycardia (78% amiodarone v 48% placebo, 95% CI 14% to 46%, p < 0.005) and pauses (7% amiodarone v 0% placebo) occurred in more amiodarone treated patients. Bradycardia warranted discontinuation of treatment in one patient treated with amiodarone. CONCLUSIONS--The incidence of clinically significant tachycardia was reduced by amiodarone. The ventricular response rate was slowed in supraventricular tachycardia, but the induction of bradycardia may preclude the routine use of amiodarone

  7. Simvastatin and Vitamin D for Migraine Prevention: A Randomized Controlled Trial

    PubMed Central

    Buettner, Catherine; Nir, Rony-Reuven; Bertisch, Suzanne M.; Bernstein, Carolyn; Schain, Aaron; Mittleman, Murray A.; Burstein, Rami

    2015-01-01

    Objective To assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine. Methods We performed a randomized, double-blind, placebo-controlled trial with a 12-week baseline period and 24-week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice daily plus vitamin D3 1000 international units capsules twice daily or matching placebo tablets and capsules. Results Compared to placebo, participants using simvastatin plus vitamin D3 demonstrated a greater decrease in number of migraine days from the baseline period to intervention weeks 1-12: a change of -8.0 (IQR: -15.0 to -2.0) days in the active treatment group versus +1.0 (IQR: 1.0 to +6.0) days in the placebo group, P<0.001; and to intervention weeks 13-24: a change of -9.0 (IQR: -13 to -5) days in the active group versus +3.0 (IQR: -1.0 to +5.0) days in the placebo group, P<0.001. In the active treatment group, 8 patients (25%) experienced 50% reduction in the number of migraine days at 12 weeks and 9 (29%) at 24 weeks post randomization. In comparison, only 1 patient (3%) in the placebo group (p=0.03) experienced such reduction. Adverse events were similar in both active treatment and placebo groups. Interpretation The results demonstrate that simvastatin plus vitamin D is effective for prevention of headache in adults with episodic migraine. Given statins ability to repair endothelial dysfunction, this economical approach may also reduce the increased risk for vascular diseases among migraineurs. PMID:26418341

  8. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials.

    PubMed

    Logan, Jennifer K; Tang, Chad; Liao, Zhongxing; Lee, J Jack; Heymach, John V; Swisher, Stephen G; Welsh, James W; Zhang, Jianjun; Lin, Steven H; Gomez, Daniel R

    2017-03-15

    Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Platelet function testing during 5-day storage of single and random donor plateletpheresis.

    PubMed

    Akay, O Meltem; Gündüz, Eren; Başyiğit, Hatice; Gulbas, Zafer

    2007-06-01

    Platelet concentrates are routinely manufactured from whole blood by differential centrifugation (random donor platelets-RDP) or by plateletpheresis (single donor platelets-SDP). These platelet concentrates have a storage period of 5 days and many different approaches exist to measure the condition of platelets during their storage. In this study, platelet aggregation testing using adenosine diphosphate (ADP) and collagen and flow cytometric platelet activation analysis using CD41 FITC and CD62 PE before and after ADP was performed on days 1, 3 and 5 of storage of platelet preparations. Thirty three RDPs, stored in Baxter and Kansuk blood bags and 18 SDPs stored in Fresenius blood bags were evaluated. In RDPs and in SDPs; ADP and collagen induced PA responses were decreased significantly on the 3rd and 5th days compared to 1st day. CD62 positive platelet percentage after ADP were decreased significantly on the 3rd and 5th days compared to the 1st day in Kansuk bags. Flow cytometric analysis revealed minor changes in CD41 expression after ADP on the 3rd day compared to 1st day and on the 5th day compared to 3rd day. Differences in CD62 positive platelet percentage were not significant between the RDPs and SDPs. Our results suggest that: (1) ADP and collagen induced PA responses decrease both in RDPs and SDPs during storage. (2) Flow cytometric analysis does not show major significant changes in platelet activation after ADP during storage. (3) Continous shaking on the agitator does not cause a significant change in CD62 positive platelet percentage during storage. (4) Platelet aggregation responses in RDPs stored in Baxter and Kansuk blood bags do not differ during storage.

  10. Outcomes of a 5-day physiotherapy programme for functional (psychogenic) motor disorders.

    PubMed

    Nielsen, G; Ricciardi, L; Demartini, B; Hunter, R; Joyce, E; Edwards, M J

    2015-03-01

    Patients with functional motor disorder (FMD) are commonly seen by physiotherapists and there is growing evidence to support a physical rehabilitation approach. There are, however, few descriptions in the literature of the content of successful physiotherapy treatment. This prospective cohort study reports the practicalities and outcomes of a pilot 5-day physiotherapy programme. Patients were referred from a specialist movement disorders clinic. The treatment consisted of education and movement retraining, with a long-term self-management focus. Education and movement retraining was based on a pathophysiological model for FMD that stresses the importance of self-focussed attention and illness belief. Patients were assessed at baseline, end of treatment and 3-month follow-up. 47 patients completed the programme, mean symptom duration was 5.5 years, 64 % were unemployed due to ill health. At the end of treatment, 65 % rated their symptoms as "very much improved" or "much improved", this reduced to 55 % at 3 months. At follow-up, there was a significant improvement in physical domains of the SF-36, Berg Balance Scale and 10 Metre Timed Walk. Measures of mental health did not change. This prospective cohort study adds to the growing evidence that supports the use of specialist physiotherapy treatment for FMD. Improvements here were made despite the cohort having characteristics associated with poor prognosis. We argue that specific treatment techniques are important and have the potential to improve physical function, quality of life and may prove to be a cost-effective treatment for selected patients with FMD.

  11. Response of mice to continuous 5-day passive hyperthermia resembles human heat acclimation.

    PubMed

    Sareh, Houtan; Tulapurkar, Mohan E; Shah, Nirav G; Singh, Ishwar S; Hasday, Jeffrey D

    2011-05-01

    Chronic repeated exposure to hyperthermia in humans results in heat acclimation (HA), an adaptive process that is attained in humans by repeated exposure to hyperthermia and is characterized by improved heat elimination and increased exercise capacity, and acquired thermal tolerance (ATT), a cellular response characterized by increased baseline heat shock protein (HSP) expression and blunting of the acute increase in HSP expression stimulated by re-exposure to thermal stress. Epidemiologic studies in military personnel operating in hot environments and elite athletes suggest that repeated exposure to hyperthermia may also exert long-term health effects. Animal models demonstrate that coincident exposure to mild hyperthermia or prior exposure to severe hyperthermia can profoundly affect the course of experimental infection and injury, but these models do not represent HA. In this study, we demonstrate that CD-1 mice continuously exposed to mild hyperthermia (ambient temperature ~37°C causing ~2°C increase in core temperature) for 5 days and then exposed to a thermal stress (42°C ambient temperature for 40 min) exhibited some of the salient features of human HA, including (1) slower warming during thermal stress and more rapid cooling during recovery and (2) increased activity during thermal stress, as well as some of the features of ATT, including (1) increased baseline expression of HSP72 and HSP90 in lung, heart, spleen, liver, and brain; and (2) blunted incremental increase in HSP72 expression following acute thermal stress. This study suggests that continuous 5-day exposure of CD-1 mice to mild hyperthermia induces a state that resembles the physiologic and cellular responses of human HA. This model may be useful for analyzing the molecular mechanisms of HA and its consequences on host responsiveness to subsequent stresses.

  12. Randomized controlled trials 5: Determining the sample size and power for clinical trials and cohort studies.

    PubMed

    Greene, Tom

    2015-01-01

    Performing well-powered randomized controlled trials is of fundamental importance in clinical research. The goal of sample size calculations is to assure that statistical power is acceptable while maintaining a small probability of a type I error. This chapter overviews the fundamentals of sample size calculation for standard types of outcomes for two-group studies. It considers (1) the problems of determining the size of the treatment effect that the studies will be designed to detect, (2) the modifications to sample size calculations to account for loss to follow-up and nonadherence, (3) the options when initial calculations indicate that the feasible sample size is insufficient to provide adequate power, and (4) the implication of using multiple primary endpoints. Sample size estimates for longitudinal cohort studies must take account of confounding by baseline factors.

  13. 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

  14. 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.

  15. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial).

    PubMed

    Garnæs, Kirsti Krohn; Mørkved, Siv; Salvesen, Øyvind; Moholdt, Trine

    2016-07-01

    .04). Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg) compared to the control group (mean 128.1 mm Hg), with a mean difference of -7.73 mm Hg (95% CI -13.23, -2.22; p = 0.006). No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5) mm Hg in the exercise group (significant between-group difference, p = 0.001), and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7) mm Hg (significant between-group difference, p = 0.02). We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol. In this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women. ClinicalTrials.gov NCT01243554.

  16. Stress debriefing after childbirth: a randomised controlled trial.

    PubMed

    Priest, Susan R; Henderson, Jenni; Evans, Sharon F; Hagan, Ronald

    2003-06-02

    To test whether critical incident stress debriefing after childbirth reduces the incidence of postnatal psychological disorders. Randomised single-blind controlled trial stratified for parity and delivery mode. Two large maternity hospitals in Perth. 1745 women who delivered healthy term infants between April 1996 and December 1997 (875 allocated to intervention and 870 to control group). An individual, standardised debriefing session based on the principles of critical incident stress debriefing carried out within 72 hours of delivery. Diagnosis of stress disorders or depression in the 12 months postpartum, using structured psychological interview and criteria of the Diagnostic and statistical manual of mental disorders, 4th edition. Follow-up information was available for 1730 women (99.1%), 482 of whom underwent psychological interview. There were no significant differences between control and intervention groups in scores on Impact of Events or Edinburgh Postnatal Depression Scales at 2, 6 or 12 months postpartum, or in proportions of women who met diagnostic criteria for a stress disorder (intervention, 0.6% v control, 0.8%; P = 0.58) or major or minor depression (intervention, 17.8% v control, 18.2%; relative risk [95% CI], 0.99 [0.87-1.11]) during the postpartum year. Nor were there differences in median time to onset of depression (intervention, 6 [interquartile range, 4-9] weeks v control, 4 [3-8] weeks; P = 0.84), or duration of depression (intervention, 24 [12-46] weeks v control, 22 [10-52] weeks; P = 0.98). There is a high prevalence of depression in women during the first year after childbirth. A session of midwife-led, critical incident stress debriefing was not effective in preventing postnatal psychological disorders, but had no adverse effects.

  17. 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

  18. 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.

  19. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial

    PubMed Central

    French, Helen P; Cusack, Tara; Brennan, Aisling; White, Breon; Gilsenan, Clare; Fitzpatrick, Martina; O'Connell, Paul; Kane, David; FitzGerald, Oliver; McCarthy, Geraldine M

    2009-01-01

    Background Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC), pain severity (numerical rating scale), patient perceived change (7-point Likert scale), quality of life (SF-36), mood (hospital anxiety and depression scale), patient satisfaction, physical activity (IPAQ) and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The results will contribute

  20. Does an intensive self-management structured education course improve outcomes for children and young people with type 1 diabetes? The Kids In Control OF Food (KICk-OFF) cluster-randomised controlled trial protocol.

    PubMed

    Price, Katherine J; Wales, Jerry; Eiser, Christine; Knowles, Julie; Heller, Simon; Freeman, Jenny; Brennan, Alan; McPherson, Amy; Wellington, Jerry

    2013-01-24

    The Kids In Control OF Food (KICk-OFF) is a cluster-randomised controlled trial, which aims to determine the efficacy of a 5 day structured education course for 11-year-olds to 16-year-olds with type 1 diabetes (T1DM) when compared with standard care, and its cost effectiveness. Less than 15% of children and young people with T1DM in the UK meet the recommended glycaemic target. Self-management education programmes for adults with T1DM improve clinical and psychological outcomes, but none have been evaluated in the paediatric population. KICk-OFF is a 5-day structured education course for 11-year-olds to 16- year-olds with T1DM. It was developed with input from young people, parents, teachers and educationalists. 36 paediatric diabetes centres across the UK randomised into intervention and control arms. Up to 560 participants were recruited prior to centre randomisation. KICk-OFF courses are delivered in the intervention centres, with standard care continued in the control arm. Primary outcomes are change in glycaemic control (HbA1c) and quality of life between baseline and 6 months postintervention, and the incidence of severe hypoglycaemia. Sustained change in self-management behaviour is assessed by follow-up at 12 and 24 months. Health economic analysis will be undertaken. Data will be reported according to the CONSORT statement for cluster-randomised clinical trials. All analyses will be by intention-to-treat with a two-sided p value of <0.05 being regarded as statistically significant. The study commenced in 2008. Data collection from participants is ongoing and the study will be completed in 2013. The study has been approved by the Sheffield Research Ethics Committee. Results will be reported in peer reviewed journals and conferences. Current Controlled Trials ISRCTN37042683.

  1. A double-blind, placebo-controlled randomized trial of creatine for the cancer anorexia/weight loss syndrome (N02C4): an Alliance trial.

    PubMed

    Jatoi, A; Steen, P D; Atherton, P J; Moore, D F; Rowland, K M; Le-Lindqwister, N A; Adonizio, C S; Jaslowski, A J; Sloan, J; Loprinzi, C

    2017-08-01

    Multiple pilot studies, including one in colorectal cancer patients, suggest that creatine, an amino acid derivative, augments muscle, improves strength, and thereby could palliate the cancer anorexia/weight loss syndrome. In this randomized, double-blind, placebo-controlled trial, incurable patients with this syndrome were assigned creatine (20 g/day load×5 days followed by 2 g/day orally) versus identical placebo. Patients were weighed once a week for 1 month and then monthly. Patients were also assessed over 1 month for appetite and quality of life (validated questionnaires), fist grip strength, body composition (bioelectrical impedance), and adverse events. The primary endpoint was 10% or greater weight gain from baseline during the first month. Within this combined cohort of 263 evaluable patients (134 received creatine and 129 placebo), only 3 gained ≥10% of their baseline weight by 1 month: two creatine-treated and the other placebo-exposed (P = 1.00). Questionnaire data on appetite, quality of life, and activities of daily living showed no statistically significant differences between groups. Similarly, no statistically significant differences between groups were observed for fist-grip strength or body composition. Rates and severity of adverse events were comparable between groups. Finally, a median survival of 230 and 239 days were observed in the creatine and placebo groups, respectively (P = 0.70). Creatine, as prescribed in this trial, had no effect on the cancer anorexia/weight loss syndrome.

  2. Effects of the Finnish Alzheimer disease exercise trial (FINALEX): a randomized controlled trial.

    PubMed

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

    2013-05-27

    Few rigorous clinical trials have investigated the effectiveness of exercise on the physical functioning of patients with Alzheimer disease (AD). To investigate the effects of intense and long-term exercise on the physical functioning and mobility of home-dwelling patients with AD and to explore its effects on the use and costs of health and social services. A randomized controlled trial. A total of 210 home-dwelling patients with AD living with their spousal caregiver. The 3 trial arms included (1) group-based exercise (GE; 4-hour sessions with approximately 1-hour training) and (2) tailored home-based exercise (HE; 1-hour training), both twice a week for 1 year, and (3) a control group (CG) receiving the usual community care. The Functional Independence Measure (FIM), the Short Physical Performance Battery, and information on the use and costs of social and health care services. All groups deteriorated in functioning during the year after randomization, but deterioration was significantly faster in the CG than in the HE or GE group at 6 (P = .003) and 12 (P = .015) months. The FIM changes at 12 months were -7.1 (95% CI, -3.7 to -10.5), -10.3 (95% CI, -6.7 to -13.9), and -14.4 (95% CI, -10.9 to -18.0) in the HE group, GE group, and CG, respectively. The HE and GE groups had significantly fewer falls than the CG during the follow-up year. The total costs of health and social services for the HE patient-caregiver dyads (in US dollars per dyad per year) were $25,112 (95% CI, $17,642 to $32,581) (P = .13 for comparison with the CG), $22,066 in the GE group ($15,931 to $28,199; P = .03 vs CG), and $34,121 ($24,559 to $43,681) in the CG. An intensive and long-term exercise program had beneficial effects on the physical functioning of patients with AD without increasing the total costs of health and social services or causing any significant adverse effects. anzctr.org.au Identifier: ACTRN12608000037303.

  3. Reporting of consistency of blood pressure control in randomized controlled trials of antihypertensive drugs: a systematic review of 1372 trial reports.

    PubMed

    Fischer, Urs; Webb, Alastair J S; Howard, Sally C; Rothwell, Peter M

    2012-07-01

    Hypertension is a powerful treatable risk factor for stroke. Reports of randomized controlled trials (RCTs) of antihypertensive drugs rightly concentrate on clinical outcomes, but control of blood pressure (BP) during follow-up is also important, particularly given that inconsistent control is associated with a high risk of stroke and that antihypertensive drug classes differ in this regard. We performed a systematic review of reporting of BP control in RCTs of antihypertensive drugs. We searched bibliographic databases (1950-2009) for systematic reviews of RCTs of BP-lowering and identified the main report of all trials. We identified 94 larger trials (>100 participants/arm, >1-year follow-up) and 1278 smaller/shorter trials. Ninety-one (96.8%) larger trials reported some data on mean BP during follow-up, but none reported effects on the consistency of control of BP over time. Although 81 (86.2%) larger trials reported group distribution of BP at baseline (usually SD), only 22 (23.4%) reported such data at any follow-up visit. Eleven (11.7%) larger trials reported group distribution of the change in BP from baseline to follow-up, but 61 (64.9%) reported no data at all on group distribution of BP at follow-up. Thirty-nine (41.5%) trials reported the proportion of patients reaching some BP target during follow-up, but no trial reported data on the consistency of control to target within individuals over time. Similar proportions were observed in the 1278 smaller/short trials. Reporting of BP control is limited in RCTs of BP-lowering drugs. We suggest reporting guidelines.

  4. [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.

  5. Acupressure therapy for morning sickness. A controlled clinical trial.

    PubMed

    Hyde, E

    1989-01-01

    A prospective, controlled clinical trial examined the efficacy of acupressure therapy for morning sickness, using a two group, random assignment, crossover design. Subjects in Group 1 (N = 8) used acupressure wristbands for five days, followed by five days without therapy. Subjects in Group 2 (N = 8) had no therapy for five days, followed by five days use of wristbands. The Multiple Affect Adjective Checklist and Sickness Impact Profile were used, and extent of nausea was assessed at baseline, day five, and day ten. Use of acupressure wristbands relieved morning sickness for 12 of 16 subjects (chi 2 = 5.31 with Yates' correction factor, df = 1, p less than .025). Acupressure therapy resulted in statistically significant (p less than .05) reductions in anxiety, depression, behavioral dysfunction, and nausea. Limitations of the study and suggestions for future research are presented.

  6. Vegetarian diet in mild hypertension: a randomised controlled trial.

    PubMed Central

    Margetts, B M; Beilin, L J; Vandongen, R; Armstrong, B K

    1986-01-01

    In a randomised crossover trial 58 subjects aged 30-64 with mild untreated hypertension were allocated either to a control group eating a typical omnivorous diet or to one of two groups eating an ovolactovegetarian diet for one of two six week periods. A fall in systolic blood pressure of the order of 5 mm Hg occurred during the vegetarian diet periods, with a corresponding rise on resuming a meat diet. The main nutrient changes with the vegetarian diet included an increase in the ratio of polyunsaturated to saturated fats and intake of fibre, calcium, and magnesium and a decrease in the intake of protein and vitamin B12. There were no consistent changes in urinary sodium or potassium excretion or body weight. In untreated subjects with mild hypertension, changing to a vegetarian diet may bring about a worthwhile fall in systolic blood pressure. PMID:3026552

  7. 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.

  8. 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.

  9. Controlled trial of plasma exchange in treatment of Raynaud's syndrome.

    PubMed Central

    O'Reilly, M J; Talpos, G; Roberts, V C; White, J M; Cotton, L T

    1979-01-01

    Twenty-seven patients with Raynaud's syndrome had their digital vessel patency assessed by Doppler ultrasound after different thermal stresses. Digital vessel patency rates differed significantly after stresses at 15 degrees C and 45 degrees C. In a randomised controlled trial placebo and heparin had no effect either on patients' symptoms or on the patency of their digital vessels. Plasma exchange improved both symptoms and vessel patency rates at 15 degrees C and 21 degrees C. Improvement in seven out of eight of these patients has been maintained for six months. Assessing digital vessel patency by Doppler techniques allow continuous, atraumatic, and safe evaluation of the effects of different methods of treatment on the patency of the digital vessels and has helped to indicate that plasma exchange is a useful adjunct in the management of patients with severe Raynaud's syndrome. PMID:376042

  10. 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.

  11. [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.

  12. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial.

    PubMed

    Costanzo, Maria Rosa; Ponikowski, Piotr; Javaheri, Shahrokh; Augostini, Ralph; Goldberg, Lee; Holcomb, Richard; Kao, Andrew; Khayat, Rami N; Oldenburg, Olaf; Stellbrink, Christoph; Abraham, William T

    2016-09-03

    Central sleep apnoea is a serious breathing disorder associated with poor outcomes. The remedé system (Respicardia Inc, Minnetonka, MN, USA) is an implantable device which transvenously stimulates a nerve causing diaphragmatic contraction similar to normal breathing. We evaluated the safety and effectiveness of unilateral neurostimulation in patients with central sleep apnoea. We recruited patients from 31 hospital-based centres in Germany, Poland, and the USA in this prospective, multicentre, randomised trial. Participants had to have been medically stable for at least 30 days and have received appropriate guideline recommended therapy, be aged at least 18 years, be expected to tolerate study procedures, and willing and able to comply with study requirements. Eligible patients with an apnoea-hypopnoea index (AHI) of at least 20 events per h, tested by a polysomnography, underwent device implantation and were randomly assigned (1:1) by a computer-generated method stratified by site to either stimulation (treatment) or no stimulation (control) for 6 months. The primary effectiveness endpoint in the intention-to-treat population was the comparison of the proportions of patients in the treatment versus control groups achieving a 50% or greater AHI reduction from baseline to 6 months, measured by a full-night polysomnography assessed by masked investigators in a core laboratory. The primary safety endpoint of 12-month freedom from serious adverse events related to the procedure, system, or therapy was evaluated in all patients. This trial is active, but not recruiting, and is registered with ClinicalTrials.gov (NCT01816776). Between April 17, 2013, and May 28, 2015, we randomly assigned 151 eligible patients to the treatment (n=73) or control (n=78) groups. In the analysis of the intention-to-treat population, significantly more patients in the treatment group (35 [51%] of 68) had an AHI reduction from baseline of 50% or greater at 6 months than had those in the

  13. Efficacy and adverse effects of medical marijuana for chronic noncancer pain: Systematic review of randomized controlled trials.

    PubMed

    Deshpande, Amol; Mailis-Gagnon, Angela; Zoheiry, Nivan; Lakha, Shehnaz Fatima

    2015-08-01

    To determine if medical marijuana provides pain relief for patients with chronic noncancer pain (CNCP) and to determine the therapeutic dose, adverse effects, and specific indications. In April 2014, MEDLINE and EMBASE searches were conducted using the terms chronic noncancer pain, smoked marijuana or cannabinoids, placebo and pain relief, or side effects or adverse events. An article was selected for inclusion if it evaluated the effect of smoked or vaporized cannabinoids (nonsynthetic) for CNCP; it was designed as a controlled study involving a comparison group, either concurrently or historically; and it was published in English in a peer-review journal. Outcome data on pain, function, dose, and adverse effects were collected, if available. All articles that were only available in abstract form were excluded. Synthesis A total of 6 randomized controlled trials (N = 226 patients) were included in this review; 5 of them assessed the use of medical marijuana in neuropathic pain as an adjunct to other concomitant analgesics including opioids and anticonvulsants. The 5 trials were considered to be of high quality; however, all of them had challenges with masking. Data could not be pooled owing to heterogeneity in delta-9-tetrahydrocannabinol potency by dried weight, differing frequency and duration of treatment, and variability in assessing outcomes. All experimental sessions in the studies were of short duration (maximum of 5 days) and reported statistically significant pain relief with nonserious side effects. There is evidence for the use of low-dose medical marijuana in refractory neuropathic pain in conjunction with traditional analgesics. However, trials were limited by short duration, variability in dosing and strength of delta-9-tetrahydrocannabinol, and lack of functional outcomes. Although well tolerated in the short term, the long-term effects of psychoactive and neurocognitive effects of medical marijuana remain unknown. Generalizing the use of medical

  14. 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.

  15. 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

  16. A controlled trial of sildenafil in advanced idiopathic pulmonary fibrosis.

    PubMed

    Zisman, David A; Schwarz, Marvin; Anstrom, Kevin J; Collard, Harold R; Flaherty, Kevin R; Hunninghake, Gary W

    2010-08-12

    Sildenafil, a phosphodiesterase-5 inhibitor, may preferentially improve blood flow to well-ventilated regions of the lung in patients with advanced idiopathic pulmonary fibrosis, which could result in improvements in gas exchange. We tested the hypothesis that treatment with sildenafil would improve walk distance, dyspnea, and quality of life in patients with advanced idiopathic pulmonary fibrosis, defined as a carbon monoxide diffusion capacity of less than 35% of the predicted value. We conducted a double-blind, randomized, placebo-controlled trial of sildenafil in two periods. The first period consisted of 12 weeks of a double-blind comparison between sildenafil and a placebo control. The primary outcome was the proportion of patients with an increase in the 6-minute walk distance of 20% or more. Key secondary outcomes included changes in oxygenation, degree of dyspnea, and quality of life. The second period was a 12-week open-label evaluation involving all patients receiving sildenafil. A total of 180 patients were enrolled in the study. The difference in the primary outcome was not significant, with 9 of 89 patients (10%) in the sildenafil group and 6 of 91 (7%) in the placebo group having an improvement of 20% or more in the 6-minute walk distance (P=0.39). There were small but significant differences in arterial oxygenation, carbon monoxide diffusion capacity, degree of dyspnea, and quality of life favoring the sildenafil group. Serious adverse events were similar in the two study groups. This study did not show a benefit for sildenafil for the primary outcome. The presence of some positive secondary outcomes creates clinical equipoise for further research. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00517933.)

  17. Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences.

    PubMed

    Conroy, Elizabeth J; Harman, Nicola L; Lane, J Athene; Lewis, Steff C; Murray, Gordon; Norrie, John; Sydes, Matt R; Gamble, Carrol

    2015-12-01

    The Medical Research Council Guidelines for Good Clinical Practice outlines a three-committee trial oversight structure--the day-to-day Trial Management Group, the Data Monitoring Committee and the Trial Steering Committee. In this model, the Trial Steering Committee is the executive committee that oversees the trial and considers the recommendations from the Data Monitoring Committee. There is yet to be in-depth consideration establishing the Trial Steering Committee's role and functionality. A survey to establish Trial Steering Committee's current practices, role and the use and opinion on the Medical Research Council guidelines was undertaken within UK Clinical Research Collaborative registered Clinical Trials Units. Completed surveys were obtained from 38 of 47 fully and partially registered Units. Individual items in the survey were analysed and reported spanning current Trial Steering Committee practices including its role, requirement and experience required for membership; methods to identify members; and meeting frequency. Terms (a document describing the committee's remit, objectives and functionality) were obtained and analysed from 21 of 33 Units with documents in place at their Unit. A total of 20 responders suggested aspects of the current Medical Research Council Guidelines that need improvement. We present the first survey reporting on practices within UK Clinical Research Collaborative registered Clinical Trials Units on the experience and remits of Trial Steering Committees. We have identified a widespread adoption of Medical Research Council Guidelines for Trial Steering Committees in the United Kingdom, but limitations in this existing provision have been identified that need to be addressed. © The Author(s) 2015.

  18. 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

  19. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    PubMed

    French, Helen P; Cusack, Tara; Brennan, Aisling; White, Breon; Gilsenan, Clare; Fitzpatrick, Martina; O'Connell, Paul; Kane, David; Fitzgerald, Oliver; McCarthy, Geraldine M

    2009-01-19

    Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6-8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC), pain severity (numerical rating scale), patient perceived change (7-point Likert scale), quality of life (SF-36), mood (hospital anxiety and depression scale), patient satisfaction, physical activity (IPAQ) and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The results will contribute to the evidence base regarding the clinical

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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.

  5. Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.

    PubMed

    Barnes, Thomas R E; Leeson, Verity C; Paton, Carol; Costelloe, Céire; Simon, Judit; Kiss, Noemi; Osborn, David; Killaspy, Helen; Craig, Tom K J; Lewis, Shôn; Keown, Patrick; Ismail, Shajahan; Crawford, Mike; Baldwin, David; Lewis, Glyn; Geddes, John; Kumar, Manoj; Pathak, Rudresh; Taylor, Simon

    2016-04-01

    Negative symptoms of schizophrenia represent deficiencies in emotional responsiveness, motivation, socialisation, speech and movement. When persistent, they are held to account for much of the poor functional outcomes associated with schizophrenia. There are currently no approved pharmacological treatments. While the available evidence suggests that a combination of antipsychotic and antidepressant medication may be effective in treating negative symptoms, it is too limited to allow any firm conclusions. To establish the clinical effectiveness and cost-effectiveness of augmentation of antipsychotic medication with the antidepressant citalopram for the management of negative symptoms in schizophrenia. A multicentre, double-blind, individually randomised, placebo-controlled trial with 12-month follow-up. Adult psychiatric services, treating people with schizophrenia. Inpatients or outpatients with schizophrenia, on continuing, stable antipsychotic medication, with persistent negative symptoms at a criterion level of severity. Eligible participants were randomised 1 : 1 to treatment with either placebo (one capsule) or 20 mg of citalopram per day for 48 weeks, with the clinical option at 4 weeks to increase the daily dosage to 40 mg of citalopram or two placebo capsules for the remainder of the study. The primary outcomes were quality of life measured at 12 and 48 weeks assessed using the Heinrich's Quality of Life Scale, and negative symptoms at 12 weeks measured on the negative symptom subscale of the Positive and Negative Syndrome Scale. No therapeutic benefit in terms of improvement in quality of life or negative symptoms was detected for citalopram over 12 weeks or at 48 weeks, but secondary analysis suggested modest improvement in the negative symptom domain, avolition/amotivation, at 12 weeks (mean difference -1.3, 95% confidence interval -2.5 to -0.09). There were no statistically significant differences between the two treatment arms over 48-week

  6. Comparison of the effects of adenine-ribose with adenosine for maintenance of ATP concentrations in 5-day hypothermically perfused dog kidneys.

    PubMed

    McAnulty, J F; Southard, J H; Belzer, F O

    1988-10-01

    The quality of preservation of kidneys is dependent upon a number of factors, one of which may be the concentration of adenine nucleotides in the tissue during long-term perfusion preservation. In this study we have investigated how adenine (5 mM) and ribose (5 mM) in combination affect the concentration of adenine nucleotides in dog kidney cortical tissue after 5 days of continuous hypothermic perfusion preservation. These results were compared to kidneys perfused with adenosine and without any added purine precursors of adenine nucleotide synthesis. Additionally, we investigated how these conditions affected renal tissue slice function after 5 days of preservation and how adenine plus ribose affected renal function after autotransplantation in the dog. Adenosine is nearly completely degraded during 5 days of perfusion but there was little loss of adenine (10%). The adenosine triphosphate concentration in kidney cortical tissue was higher in adenine/ribose-perfused kidneys (1.41 +/- 0.19 mumol/g) than in adenosine-perfused kidneys (0.71 +/- 0.1 mumol/g) after 5 days of preservation. Tissue slices prepared from kidneys preserved in the presence of adenine plus ribose were metabolically more functional (slice volume control and electrolyte pump activity) than slices from adenosine-perfused kidneys. Adenine plus ribose had no detrimental effects on kidneys preserved for 3 days as tested in the autotransplant model but did not yield successful 5-day preservation. Because of some potentially detrimental factors in using adenosine as an adenine nucleotide synthesis precursor, we have now switched to the combination of adenine and ribose for perfusion preservation of kidneys both in the laboratory and in the clinic.

  7. Efficacy of nonswallow nasogastric tube intubation: a randomised controlled trial.

    PubMed

    Fan, Luo; Liu, Qin; Gui, Li

    2016-11-01

    To prospectively identify the effect of the nonswallow procedure of nasogastric tube insertion. Nasogastric intubation is one of the most important and basic skills in treatment and nursing. Patients generally experience discomfort and encounter complications during this procedure. Thus, practitioners need a more convenient, effective, quicker and safer method to improve the performance of this procedure. This prospective randomised controlled trial was conducted from March to May 2014 in the four units of Gansun Province Hospital in Lanzhou, China. A total of 80 participants were randomly assigned to an experimental group (n = 40) and a control group (n = 40). Participants in the experimental group underwent a nonswallow procedure for nasogastric tube insertion. There were statistically significant differences in nasogastric tube insertion between the study groups. A marked increase in the success rate at first intubation as well as a markedly reduced occurrence of nausea, tearing, mucosal injury and changes in vital signs (i.e. heart rate, breath, systolic pressure) were observed compared with the control group. No differences in the success rates at second and third intubation were observed between the groups. The nonswallow procedure of nasogastric tube intubation relieves discomfort and ensures the safety of patients. Patients subjected to nasogastric intubation are more likely to benefit from the nonswallow procedure when nasogastric tube insertion is performed. © 2016 John Wiley & Sons Ltd.

  8. 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.

  9. 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.

  10. 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.

  11. Vitamin K Supplementation in Postmenopausal Women with Osteopenia (ECKO Trial): A Randomized Controlled Trial

    PubMed Central

    Cheung, Angela M; Tile, Lianne; Lee, Yuna; Tomlinson, George; Hawker, Gillian; Scher, Judy; Hu, Hanxian; Vieth, Reinhold; Thompson, Lilian; Jamal, Sophie; Josse, Robert

    2008-01-01

    Background Vitamin K has been widely promoted as a supplement for decreasing bone loss in postmenopausal women, but the long-term benefits and potential harms are unknown. This study was conducted to determine whether daily high-dose vitamin K1 supplementation safely reduces bone loss, bone turnover, and fractures. Methods and Findings This single-center study was designed as a 2-y randomized, placebo-controlled, double-blind trial, extended for earlier participants for up to an additional 2 y because of interest in long-term safety and fractures. A total of 440 postmenopausal women with osteopenia were randomized to either 5 mg of vitamin K1 or placebo daily. Primary outcomes were changes in BMD at the lumbar spine and total hip at 2 y. Secondary outcomes included changes in BMD at other sites and other time points, bone turnover markers, height, fractures, adverse effects, and health-related quality of life. This study has a power of 90% to detect 3% differences in BMD between the two groups. The women in this study were vitamin D replete, with a mean serum 25-hydroxyvitamin D level of 77 nmol/l at baseline. Over 2 y, BMD decreased by −1.28% and −1.22% (p = 0.84) (difference of −0.06%; 95% confidence interval [CI] −0.67% to 0.54%) at the lumbar spine and −0.69% and −0.88% (p = 0.51) (difference of 0.19%; 95% CI −0.37% to 0.75%) at the total hip in the vitamin K and placebo groups, respectively. There were no significant differences in changes in BMD at any site between the two groups over the 2- to 4-y period. Daily vitamin K1 supplementation increased serum vitamin K1 levels by 10-fold, and decreased the percentage of undercarboxylated osteocalcin and total osteocalcin levels (bone formation marker). However, C-telopeptide levels (bone resorption marker) were not significantly different between the two groups. Fewer women in the vitamin K group had clinical fractures (nine versus 20, p = 0.04) and fewer had cancers (three versus 12, p = 0

  12. A controlled trial of the father's role in breastfeeding promotion.

    PubMed

    Pisacane, Alfredo; Continisio, Grazia Isabella; Aldinucci, Maria; D'Amora, Stefania; Continisio, Paola

    2005-10-01

    To investigate whether supporting fathers to recognize the relevance of their role in the success of breastfeeding and teaching them how to prevent and to manage the most common lactation problems would result in more women breastfeeding. A controlled trial, in which the participating fathers were allocated in 2-month blocks to a child care training session, was conducted of 280 mothers considering breastfeeding and their 280 partners at a university obstetric department in Naples, Italy. Support and advice about breastfeeding was provided to all of the mothers. Among the fathers of the intervention group, the training session included the management of breastfeeding; among those of the control group, it did not. Primary outcome was the prevalence of full breastfeeding at 6 months. Secondary outcomes were the proportion of women who perceived their milk to be insufficient, who stopped breastfeeding because of problems, and who reported to have received help in breastfeeding management by their partners. The prevalence of full breastfeeding at 6 months was 25% (35 of 140) in the intervention group and 15% (21 of 140) in the control group and that of any breastfeeding at 12 months was 19% (27) and 11% (16), respectively. Perceived milk insufficiency was significantly more frequent among the mothers of the control group (38 [27%] of 140 vs 12 [8.6%] of 140), as well as breastfeeding interruption because of problems with lactation (25 [18%] of 140 vs 6 [4%] of 140). Moreover, significantly more women in the intervention group reported receiving support and relevant help with infant feeding management from their partners (128 [91%] of 140 vs 48 [34%] of 140). Among the women who had reported difficulties with lactation in the intervention and control groups (96 [69%] and 89 [64%], respectively), the prevalence of full breastfeeding at 6 months was 24% and 4.5%, respectively. Teaching fathers how to prevent and to manage the most common lactation difficulties is

  13. Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): economic evaluation of a randomised controlled trial.

    PubMed

    Hollinghurst, Sandra; Redmond, Niamh; Costelloe, Céire; Montgomery, Alan; Fletcher, Margaret; Peters, Tim J; Hay, Alastair D

    2008-09-09

    To estimate the cost to the NHS and to parents and carers of treating febrile preschool children with paracetamol, ibuprofen, or both, and to compare these costs with the benefits of each treatment regimen. Cost consequences analysis and cost effectiveness analysis conducted as part of a three arm, randomised controlled trial. Children between the ages of 6 months and 6 years recruited from primary care and the community with axillary temperatures >or=37.8 degrees C and 5 days comparing cost with children's temperature, discomfort, activity, appetite, and sleep; cost effectiveness analysis at 48 hours comparing cost with percentage of children "recovered." Difficulties in recruiting children to the trial lowered the precision of the estimates of cost and some outcomes. At 48 hours, cost to the NHS was pound11.33 for paracetamol, pound8.49 for ibuprofen, and pound8.16 for both drugs. By day 5 these costs rose to pound19.63, pound18.36, and pound13.92 respectively. For parents and carers, the 48 hour costs were pound23.86 for paracetamol, pound20.60 for ibuprofen, and pound25.07 for both, and the day 5 costs were pound26.35, pound29.90, and pound24.02 respectively. Outcomes measured at 48 hours and 5 days were inconclusive because of lack of power; the cost effectiveness analysis at 48 hours provided little evidence that one treatment choice was significantly more cost effective than another. At 4 hours ibuprofen and the combined treatment were superior to paracetamol in terms of the trial primary outcome of time without fever; at 24 hours the combined treatment performed best on this outcome. There is no strong evidence of a difference in cost between the treatments, but clinical and cost data together indicate that using both drugs together may be most cost effective over the course of the illness. This treatment option

  14. Prevention of atherosclerotic complications: controlled trial of ketanserin. Prevention of Atherosclerotic Complications with Ketanserin Trial Group.

    PubMed Central

    1989-01-01

    STUDY OBJECTIVE--To determine whether ketanserin, an antagonist at the serotonin receptor, prevents important vascular events such as death, myocardial infarction, major stroke, and amputation of a leg in patients with claudication. DESIGN--Double blind, randomised, placebo controlled trial after a single blind run in period of placebo treatment for one month. SETTING--One hundred and forty seven outpatient clinics in 14 countries. PATIENTS--Total of 3899 patients over 40 years old who had had documented intermittent claudication for at least two months and in whom the ratio of systolic blood pressure in the ankle to that in the arm was less than or equal to 0.85 in both arteries of at least one foot. INTERVENTION--After the one month placebo run in period patients were randomly allocated to take 20 mg ketanserin three times daily for the first month and 40 mg three times daily thereafter or to take the same number of placebo tablets. Five months after the onset of the trial, on the recommendation of the ethical and safety committee, four patients stopped taking ketanserin and two stopped taking placebo because they had a corrected QT interval greater than 500 ms. Four months later the committee recommended that all patients taking diuretics should stop receiving trial treatment (167 of those taking ketanserin and 144 of those taking placebo). END POINT--The first primary event after randomisation. Primary events were definite myocardial infarction, major stroke, amputation above the ankle, excision of ischaemic viscera, and death due to other vascular causes. MEASUREMENTS and MAIN RESULTS--There were 136 study end points in the 1930 patients treated with ketanserin, who were followed up for 2063 patient years, and 132 study end points in the 1969 patients treated with placebo, who were followed up for 2129 patient years. A harmful interaction of ketanserin and potassium losing diuretics resulted in an increase in the number of deaths. After patients taking

  15. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial)

    PubMed Central

    Trinder, J; Brocklehurst, P; Porter, R; Read, M; Vyas, S; Smith, L

    2006-01-01

    Objective To ascertain whether a clinically important difference exists in the incidence of gynaecological infection between surgical management and expectant or medical management of miscarriage. Design Randomised controlled trial comparing medical and expectant management with surgical management of first trimester miscarriage. Setting Early pregnancy assessment units of seven hospitals in the United Kingdom. Participants Women of less than 13 weeks' gestation, with a diagnosis of early fetal demise or incomplete miscarriage. Interventions Expectant management (no specific intervention); medical management (vaginal dose of misoprostol preceded, for women with early fetal demise, by oral mifepristone 24-48 hours earlier); surgical management (surgical evacuation). Main outcome measures Confirmed gynaecological infection at 14 days and eight weeks; need for unplanned admission or surgical intervention. Results 1200 women were recruited: 399 to expectant management, 398 to medical management, and 403 to surgical management. No differences were found in the incidence of confirmed infection within 14 days between the expectant group (3%) and the surgical group (3%) (risk difference 0.2%, 95% confidence interval - 2.2% to 2.7%) or between the medical group (2%) and the surgical group (0.7%, - 1.6% to 3.1%). Compared with the surgical group, the number of unplanned hospital admissions was significantly higher in both the expectant group (risk difference - 41%, - 47% to - 36%) and the medical group (- 10%, - 15% to - 6%). Similarly, when compared with the surgical group, the number of women who had an unplanned surgical curettage was significantly higher in the expectant group (risk difference - 39%, - 44% to - 34%) and the medical group (- 30%, - 35% to - 25%). Conclusions The incidence of gynaecological infection after surgical, expectant, and medical management of first trimester miscarriage is low (2-3%), and no evidence exists of a difference by the method of

  16. 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

  17. What can qualitative research do for randomised controlled trials? A systematic mapping review

    PubMed Central

    O'Cathain, A; Thomas, K J; Drabble, S J; Rudolph, A; Hewison, J

    2013-01-01

    Objective To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. Design Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sources MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteria Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. Conclusions A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit

  18. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol.

    PubMed

    Lester, Richard T; Mills, Edward J; Kariri, Antony; Ritvo, Paul; Chung, Michael; Jack, William; Habyarimana, James; Karanja, Sarah; Barasa, Samson; Nguti, Rosemary; Estambale, Benson; Ngugi, Elizabeth; Ball, T Blake; Thabane, Lehana; Kimani, Joshua; Gelmon, Lawrence; Ackers, Marta; Plummer, Francis A

    2009-09-22

    The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya. A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to receive either a structured weekly SMS ('short message system' or text message) slogan (the intervention) or current standard of care support mechanisms alone (the control). Our hypothesis is that using a structured mobile phone protocol to keep in touch with patients will improve adherence to ART and other patient outcomes. Participants are evaluated at baseline, and then at six and twelve months after initiating ART. The care providers keep a weekly study log of all phone based communications with study participants. Primary outcomes are self-reported adherence to ART and suppression of HIV viral load at twelve months scheduled follow-up. Secondary outcomes are improvements in health, quality of life, social and economic factors, and retention on ART. Primary analysis is by 'intention-to-treat'. Sensitivity analysis will be used to assess per-protocol effects. Analysis of covariates will be undertaken to determine factors that contribute or deter from expected and determined outcomes. This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting.

  19. Does magnesium sulfate delay the active phase of labor in women with premature rupture of membranes? A randomized controlled trial.

    PubMed

    Mirzamoradi, Masoumeh; Behnam, Marzieh; Jahed, Tayebeh; Saleh-Gargari, Soraya; Bakhtiyari, Mahmood

    2014-09-01

    Administration of many drugs including magnesium sulfate (MS) has considerable influences on pregnancy outcomes. The present study investigates the effects of MS administration on reaching the active phase of labor in women with premature rupture of membrane (PROM) and subsequent fetal complications. A double blind, randomized, placebo-controlled trial was performed among primipara women referred to the PROM center in Tehran, Iran between March 2010 and August 2012. Patients were equally allocated into two groups; the intervention group who received MS (n = 46) and the control (placebo) group (n = 46). Both groups received a corticosteroid, 1g oral azithromycin (oral) and 2 g ampicillin (IV) every 6 hours for 48 hours, followed by amoxicillin (500 mg orally 3 times daily) for an additional 5 days. None of the research staff were aware of the treatment allocation of patients in order for blinding purposes. Administration of MS in intervention group increases this period 2.7 times compared to the control group. In women whose gestational age was <30 weeks, MS administration increased the active phase of labor up to 77%. Administration of magnesium sulfate reduced the risk of respiratory distress syndrome significantly (p = 0 .002), without producing any adverse pregnancy outcomes. Magnesium sulfate increases delay in reaching the active phase of labor in mothers with PROM, without producing adverse birth outcomes. (Registration ID in IRCT; IRCT2012091810876N1). Copyright © 2014. Published by Elsevier B.V.

  20. Evaluation of the Tobacco Heating System 2.2. Part 8: 5-Day randomized reduced exposure clinical study in Poland.

    PubMed

    Haziza, Christelle; de La Bourdonnaye, Guillaume; Skiada, Dimitra; Ancerewicz, Jacek; Baker, Gizelle; Picavet, Patrick; Lüdicke, Frank

    2016-11-30

    The Tobacco Heating System (THS) 2.2, a candidate Modified Risk Tobacco Product (MRTP), is designed to heat tobacco without burning it. Tobacco is heated in order to reduce the formation of harmful and potentially harmful constituents (HPHC), and reduce the consequent exposure, compared with combustible cigarettes (CC). In this 5-day exposure, controlled, parallel-group, open-label clinical study, 160 smoking, healthy subjects were randomized to three groups and asked to: (1) switch from CCs to THS 2.2 (THS group; 80 participants); (2) continue to use their own non-menthol CC brand (CC group; 41 participants); or (3) to refrain from smoking (smoking abstinence (SA) group; 39 participants). Biomarkers of exposure, except those associated with nicotine exposure, were significantly reduced in the THS group compared with the CC group, and approached the levels observed in the SA group. Increased product consumption and total puff volume were reported in the THS group. However, exposure to nicotine was similar to CC at the end of the confinement period. Reduction in urge-to-smoke was comparable between the THS and CC groups and THS 2.2 product was well tolerated. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  1. Immunosuppression for progressive membranous nephropathy: a UK randomised controlled trial

    PubMed Central

    Howman, Andrew; Chapman, Tracey L; Langdon, Maria M; Ferguson, Caroline; Adu, Dwomoa; Feehally, John; Gaskin, Gillian J; Jayne, David RW; O'Donoghue, Donal; Boulton-Jones, Michael; Mathieson, Peter W

    2013-01-01

    Summary Background Membranous nephropathy leads to end-stage renal disease in more than 20% of patients. Although immunosuppressive therapy benefits some patients, trial evidence for the subset of patients with declining renal function is not available. We aimed to assess whether immunosuppression preserves renal function in patients with idiopathic membranous nephropathy with declining renal function. Methods This randomised controlled trial was undertaken in 37 renal units across the UK. We recruited patients (18–75 years) with biopsy-proven idiopathic membranous nephropathy, a plasma creatinine concentration of less than 300 μmol/L, and at least a 20% decline in excretory renal function measured in the 2 years before study entry, based on at least three measurements over a period of 3 months or longer. Patients were randomly assigned (1:1:1) by a random number table to receive supportive treatment only, supportive treatment plus 6 months of alternating cycles of prednisolone and chlorambucil, or supportive treatment plus 12 months of ciclosporin. The primary outcome was a further 20% decline in renal function from baseline, analysed by intention to treat. The trial is registered as an International Standard Randomised Controlled Trial, number 99959692. Findings We randomly assigned 108 patients, 33 of whom received prednisolone and chlorambucil, 37 ciclosporin, and 38 supportive therapy alone. Two patients (one who received ciclosporin and one who received supportive therapy) were ineligible, so were not included in the intention-to-treat analysis, and 45 patients deviated from protocol before study end, mostly as a result of minor dose adjustments. Follow up was until primary endpoint or for minimum of 3 years if primary endpoint was not reached. Risk of further 20% decline in renal function was significantly lower in the prednisolone and chlorambucil group than in the supportive care group (19 [58%] of 33 patients reached endpoint vs 31 [84%] of 37, hazard

  2. 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

  3. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial)

    PubMed Central

    Garnæs, Kirsti Krohn; Mørkved, Siv; Salvesen, Øyvind; Moholdt, Trine

    2016-01-01

    of 0.1 (95% CI 0.02, 0.95; p = 0.04). Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg) compared to the control group (mean 128.1 mm Hg), with a mean difference of −7.73 mm Hg (95% CI −13.23, −2.22; p = 0.006). No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5) mm Hg in the exercise group (significant between-group difference, p = 0.001), and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7) mm Hg (significant between-group difference, p = 0.02). We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol. Conclusions In this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women. Trial Registration ClinicalTrials.gov NCT01243554 PMID:27459375

  4. Vitamin E supplementation and macular degeneration: randomised controlled trial

    PubMed Central

    Taylor, Hugh R; Tikellis, Gabriella; Robman, Luba D; McCarty, Catherine A; McNeil, John J

    2002-01-01

    Objective To determine whether vitamin E supplementation influences the incidence or rate of progression of age related maculopathy (AMD). Design Prospective randomised placebo controlled clinical trial. Setting An urban study centre in a residential area supervised by university research staff. Participants 1193 healthy volunteers aged between 55 and 80 years; 73% completed the trial on full protocol. Interventions Vitamin E 500 IU or placebo daily for four years. Main outcome measures Primary outcome: development of early age related macular degeneration in retinal photographs. Other measures included alternative definitions of age related macular degeneration, progression, changes in component features, visual acuity, and visual function Results The incidence of early age related macular degeneration (early AMD 3) was 8.6% in those receiving vitamin E versus 8.1% in those on placebo (relative risk 1.05, 95% confidence interval 0.69 to 1.61). For late disease the incidence was 0.8% versus 0.6% (1.36, 0.67 to 2.77). Further analysis showed no consistent differences in secondary outcomes. Conclusion Daily supplement with vitamin E supplement does not prevent the development or progression of early or later stages of age related macular degeneration. What is already known on this topicAge related macular degeneration is the leading cause of loss of vision and blindness in elderly people; for people aged ⩾90 years, two out of every three will be affected and one in four will become blindCurrently, there are no methods of prevention or treatment in most cases, though a third of cases are due to cigarette smokingAntioxidant vitamins have been suggested as a possible preventionWhat this study addsDaily supplementation with 500 mg vitamin E for four years did not alter the incidence or progression of AMD PMID:12098721

  5. 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.

  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. 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

  8. Effect of handwashing on child health: a randomised controlled trial.

    PubMed

    Luby, Stephen P; Agboatwalla, Mubina; Feikin, Daniel R; Painter, John; Billhimer, Ward; Altaf, Arshad; Hoekstra, Robert M

    More than 3.5 million children aged less than 5 years die from diarrhoea and acute lower respiratory-tract infection every year. We undertook a randomised controlled trial to assess the effect of handwashing promotion with soap on the incidence of acute respiratory infection, impetigo, and diarrhoea. In adjoining squatter settlements in Karachi, Pakistan, we randomly assigned 25 neighbourhoods to handwashing promotion; 11 neighbourhoods (306 households) were randomised as controls. In neighbourhoods with handwashing promotion, 300 households each were assigned to antibacterial soap containing 1.2% triclocarban and to plain soap. Fieldworkers visited households weekly for 1 year to encourage handwashing by residents in soap households and to record symptoms in all households. Primary study outcomes were diarrhoea, impetigo, and acute respiratory-tract infections (ie, the number of new episodes of illness per person-weeks at risk). Pneumonia was defined according to the WHO clinical case definition. Analysis was by intention to treat. Children younger than 5 years in households that received plain soap and handwashing promotion had a 50% lower incidence of pneumonia than controls (95% CI (-65% to -34%). Also compared with controls, children younger than 15 years in households with plain soap had a 53% lower incidence of diarrhoea (-65% to -41%) and a 34% lower incidence of impetigo (-52% to -16%). Incidence of disease did not differ significantly between households given plain soap compared with those given antibacterial soap. Handwashing with soap prevents the two clinical syndromes that cause the largest number of childhood deaths globally-namely, diarrhoea and acute lower respiratory infections. Handwashing with daily bathing also prevents impetigo.

  9. 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.

  10. 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.

  11. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study

    PubMed Central

    2011-01-01

    Background Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Methods Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28). Results Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating. Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. Conclusions These results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. Trial registration ISRCTN66587262 PMID:21223551

  12. Generalizability of findings from randomized controlled trials: application to the National Institute of Drug Abuse Clinical Trials Network.

    PubMed

    Susukida, Ryoko; Crum, Rosa M; Ebnesajjad, Cyrus; Stuart, Elizabeth A; Mojtabai, Ramin

    2017-07-01

    To compare randomized controlled trial (RCT) sample treatment effects with the population effects of substance use disorder (SUD) treatment. Statistical weighting was used to re-compute the effects from 10 RCTs such that the participants in the trials had characteristics that resembled those of patients in the target populations. Multi-site RCTs and usual SUD treatment settings in the United States. A total of 3592 patients in 10 RCTs and 1 602 226 patients from usual SUD treatment settings between 2001 and 2009. Three outcomes of SUD treatment were examined: retention, urine toxicology and abstinence. We weighted the RCT sample treatment effects using propensity scores representing the conditional probability of participating in RCTs. Weighting the samples changed the significance of estimated sample treatment effects. Most commonly, positive effects of trials became statistically non-significant after weighting (three trials for retention and urine toxicology and one trial for abstinence); also, non-significant effects became significantly positive (one trial for abstinence) and significantly negative effects became non-significant (two trials for abstinence). There was suggestive evidence of treatment effect heterogeneity in subgroups that are under- or over-represented in the trials, some of which were consistent with the differences in average treatment effects between weighted and unweighted results. The findings of randomized controlled trials (RCTs) for substance use disorder treatment do not appear to be directly generalizable to target populations when the RCT samples do not reflect adequately the target populations and there is treatment effect heterogeneity across patient subgroups. © 2017 Society for the Study of Addiction.

  13. Global Liver Proteomics of Rats Exposed for 5 Days to Phenobarbital Identifies Changes Associated with Cancer and with CYP Metabolism

    PubMed Central

    Dail, Mary B.; Shack, L. Allen; Chambers, Janice E.; Burgess, Shane C.

    2008-01-01

    A global proteomics approach was applied to model the hepatic response elicited by the toxicologically well-characterized xenobiotic phenobarbital (PB), a prototypical inducer of hepatic xenobiotic metabolizing enzymes and a well-known nongenotoxic liver carcinogen in rats. Differential detergent fractionation two-dimensional liquid chromatography electrospray ionization tandem mass spectrometry and systems biology modeling were used to identify alterations in toxicologically relevant hepatic molecular functions and biological processes in the livers of rats following a 5-day exposure to PB at 80 mg/kg/day or a vehicle control. Of the 3342 proteins identified, expression of 121 (3.6% of the total proteins) was significantly increased and 127 (3.8%) significantly decreased in the PB group compared to controls. The greatest increase was seen for cytochrome P450 (CYP) 2B2 (167-fold). All proteins with statistically significant differences from control were then analyzed using both Gene Ontology (GO) and Ingenuity Pathways Analysis (IPA, 5.0 IPA-Tox) for cellular location, function, network connectivity, and possible disease processes, especially as they relate to CYP-mediated metabolism and nongenotoxic carcinogenesis mechanisms. The GO results suggested that PB's mechanism of nongenotoxic carcinogenesis involves both increased xenobiotic metabolism, especially induction of the 2B subfamily of CYP enzymes, and increased cell cycle activity. Apoptosis, however, also increased, perhaps, as an attempt to counter the rising cancer threat. Of the IPA-mapped proteins, 41 have functions which are procarcinogenic and 14 anticarcinogenic according to the hypothesized nongenotoxic mechanism of imbalance between apoptosis and cellular proliferation. Twenty-two additional IPA nodes can be classified as procarcinogenic by the competing theory of increased metabolism resulting in the formation of reactive oxygen species. Since the systems biology modeling corresponded well to PB

  14. 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.

  15. 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

  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. Exercise therapy for osteoporosis: results of a randomised controlled trial.

    PubMed Central

    Preisinger, E; Alacamlioglu, Y; Pils, K; Bosina, E; Metka, M; Schneider, B; Ernst, E

    1996-01-01

    OBJECTIVE: To define the effects of therapeutic exercise on bone density and back complaints. METHODS: A randomised controlled trial with parallel groups was conducted in an outpatient clinic, Medical School, University of Vienna. Ninety two sedentary post-menopausal women with back problems were randomly allocated to either exercise (groups 1 and 2) or control (group 3, no exercise, n = 31); the exercise group was retrospectively subdivided into compliant (group 1, n = 27) and not fully compliant patients (group 2, n = 34). Regular, initially supervised therapeutic exercise aimed at restoring biomechanical function was performed for four years. Bone density in the forearm was measured by single photon absorptiometry at entry and after four years; subjective back complaints were documented. RESULTS: A significant decrease in bone density was observed in groups 2 and 3; no change was noted in group 1; back complaints decreased in group 1 only. CONCLUSIONS: Sedentary postmenopausal women may benefit from regular long term therapeutic exercise in terms of subjective back complaints and slowed loss of bone mass. PMID:8889112

  18. 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.

  19. 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.

  20. 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

  1. A systematic examination of the citation of prior research in reports of randomized, controlled trials.

    PubMed

    Robinson, Karen A; Goodman, Steven N

    2011-01-04

    A randomized, controlled trial (RCT) should not be started or interpreted without accounting for evidence from preceding RCTs addressing the same question. Research has suggested that evidence from prior trials is often not accounted for in reports of subsequent RCTs. To assess the extent to which reports of RCTs cite prior trials studying the same interventions. Meta-analyses published in 2004 that combined 4 or more trials were identified; within each meta-analysis, the extent to which each trial report cited the trials that preceded it by more than 1 year was assessed. The proportion of prior trials that were cited (prior research citation index), the proportion of the total participants from prior trials that were in the cited trials (sample size citation index), and the absolute number of trials cited were calculated. 227 meta-analyses were identified, comprising 1523 trials published from 1963 to 2004. The median prior research citation index was 0.21 (95% CI, 0.18 to 0.24), meaning that less than one quarter of relevant reports were cited. The median sample size citation index (0.24 [CI, 0.21 to 0.27]) was similar, suggesting that larger trials were not selectively cited. Of the 1101 RCTs that had 5 or more prior trials to cite, 254 (23%) cited no prior RCTs and 257 (23%) cited only 1. The median number of prior cited trials was 2, which did not change as the number of citable trials increased. The mean number of preceding trials cited by trials published after 2000 was 2.4, compared with 1.5 for those published before 2000 (P < 0.001). The investigators could not ascertain why prior trials were not cited, and noncited trials may have been taken into account in the trial design and proposal stages. In reports of RCTs published over 4 decades, fewer than 25% of preceding trials were cited, comprising fewer than 25% of the participants enrolled in all relevant prior trials. A median of 2 trials was cited, regardless of the number of prior trials that had been

  2. Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial.

    PubMed

    Stevanovic, Ana; Beckers, Stefan Kurt; Czaplik, Michael; Bergrath, Sebastian; Coburn, Mark; Brokmann, Jörg Christian; Hilgers, Ralf-Dieter; Rossaint, Rolf

    2017-01-26

    Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment. Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators. The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical

  3. 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

  4. 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.

  5. 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.

  6. Brain Training Game Boosts Executive Functions, Working Memory and Processing Speed in the Young Adults: A Randomized Controlled Trial

    PubMed Central

    Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Nozawa, Takayuki; Kambara, Toshimune; Sekiguchi, Atsushi; Miyauchi, Carlos Makoto; Kotozaki, Yuka; Nouchi, Haruka; Kawashima, Ryuta

    2013-01-01

    Background Do brain training games work? The beneficial effects of brain training games are expected to transfer to other cognitive functions. Yet in all honesty, beneficial transfer effects of the commercial brain training games in young adults have little scientific basis. Here we investigated the impact of the brain training game (Brain Age) on a wide range of cognitive functions in young adults. Methods We conducted a double-blind (de facto masking) randomized controlled trial using a popular brain training game (Brain Age) and a popular puzzle game (Tetris). Thirty-two volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into eight categories (fluid intelligence, executive function, working memory, short-term memory, attention, processing speed, visual ability, and reading ability). Results and Discussion Our results showed that commercial brain training game improves executive functions, working memory, and processing speed in young adults. Moreover, the popular puzzle game can engender improvement attention and visuo-spatial ability compared to playing the brain training game. The present study showed the scientific evidence which the brain training game had the beneficial effects on cognitive functions (executive functions, working memory and processing speed) in the healthy young adults. Conclusions Our results do not indicate that everyone should play brain training games. However, the commercial brain training game might be a simple and convenient means to improve some cognitive functions. We believe that our findings are highly relevant to applications in educational and clinical fields. Trial

  7. 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

  8. Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom.

    PubMed

    Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth

    2011-10-01

    Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

  9. 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

  10. 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

  11. Early Administration of Selenium in Patients with Acute Traumatic Brain Injury: A Randomized Double-blinded Controlled Trial.

    PubMed

    Moghaddam, Omid Moradi; Lahiji, Mohammad Niakan; Hassani, Valiollah; Mozari, Shakiba

    2017-02-01

    The present study was carried out to examine this hypothesis that administration of selenium can prevent the development of injuries by brain trauma and thus can modulate patients' functional recovery and also improve posttraumatic outcome. This double-blinded controlled trial was carried out on 113 patients who were hospitalized following traumatic brain injury (TBI) with Glasgow Coma Scale score of 4-12 that were randomly assigned to receive selenium within 8 h after injury plus standard treatment group or routine standard treatment alone as the control. The primary endpoint was to assess patients' functional recovery at 2 months after the injury based on extended Glasgow Outcome Scale score (GOS-E). Secondary outcomes included the changes in Full Outline of Unresponsiveness score (FOUR) score, Sequential Organ Failure Assessment (SOFA) score, and acute physiology and chronic health evaluation (APACHE) III score, side effects of selenium, length of Intensive Care Unit (ICU) stay, and length of hospital stay. There was no difference in the length of ICU and hospital stay, the trend of the change in FOUR and SOFA scores within 15 days of first interventions, and the mean APACHE III score on the 1(st) and 15(th) days between the two groups. Mortality was 15.8% in selenium group and 19.6% in control group with no between-group difference. No difference was revealed between the two groups in appropriate outcome according to GOS-E score at 60 ± 10 days and also 30 ± 5 days according to the severity of TBI. This human trial study could not demonstrate beneficial effects of intravenous infusion of selenium in the improvement of outcomes in patients with acute TBI.

  12. Early Administration of Selenium in Patients with Acute Traumatic Brain Injury: A Randomized Double-blinded Controlled Trial

    PubMed Central

    Moghaddam, Omid Moradi; Lahiji, Mohammad Niakan; Hassani, Valiollah; Mozari, Shakiba

    2017-01-01

    Aim: The present study was carried out to examine this hypothesis that administration of selenium can prevent the development of injuries by brain trauma and thus can modulate patients’ functional recovery and also improve posttraumatic outcome. Materials and Methods: This double-blinded controlled trial was carried out on 113 patients who were hospitalized following traumatic brain injury (TBI) with Glasgow Coma Scale score of 4–12 that were randomly assigned to receive selenium within 8 h after injury plus standard treatment group or routine standard treatment alone as the control. The primary endpoint was to assess patients’ functional recovery at 2 months after the injury based on extended Glasgow Outcome Scale score (GOS-E). Secondary outcomes included the changes in Full Outline of Unresponsiveness score (FOUR) score, Sequential Organ Failure Assessment (SOFA) score, and acute physiology and chronic health evaluation (APACHE) III score, side effects of selenium, length of Intensive Care Unit (ICU) stay, and length of hospital stay. Results: There was no difference in the length of ICU and hospital stay, the trend of the change in FOUR and SOFA scores within 15 days of first interventions, and the mean APACHE III score on the 1st and 15th days between the two groups. Mortality was 15.8% in selenium group and 19.6% in control group with no between-group difference. No difference was revealed between the two groups in appropriate outcome according to GOS-E score at 60 ± 10 days and also 30 ± 5 days according to the severity of TBI. Conclusion: This human trial study could not demonstrate beneficial effects of intravenous infusion of selenium in the improvement of outcomes in patients with acute TBI. PMID:28250601

  13. 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.

  14. 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.

  15. Motivational interviewing for modifying diabetes risk: a randomised controlled trial

    PubMed Central

    Greaves, Colin J; Middlebrooke, Andrew; O'Loughlin, Lucy; Holland, Sandra; Piper, Jane; Steele, Anna; Gale, Tracy; Hammerton, Fenella; Daly, Mark

    2008-01-01

    Background Around 10–15% of adults aged over 40 years have pre-diabetes, which carries a high risk of progression to type 2 diabetes. Intensive lifestyle intervention reduces progression by as much as 58%. However, the cost and personnel requirements of these interventions are major obstacles to delivery in NHS primary care. Aim To assess the effectiveness of a low-cost intervention, delivered in primary care by non-NHS staff, to reduce the risk of diabetes through weight loss and physical activity. Design of study Pragmatic single-blind randomised controlled trial with researchers and statistician blinded to group allocation. Setting UK primary care. Method One-hundred and forty-one participants with a body mass index of 28 kg/m2 or more, but without diabetes or heart disease, received either information leaflets or individual behavioural counselling using motivational interviewing techniques. The intervention was delivered by five counsellors recruited from the local community. The primary outcomes were the proportions of participants meeting predefined targets for weight loss (5%) and moderate physical activity (150 minutes/week) after 6 months. Results Using intention-to-treat analysis, more people in the intervention group achieved the weight-loss target (24% versus 7% for controls; odds ratio [OR] = 3.96; 95% confidence interval [Cl] = 1.4 to 11.4; number needed to treat [NNT] = 6.1 (95% Cl = 4 to 21). The proportion achieving the physical activity target did not increase significantly (38% versus 28% for controls; OR = 1.6; 95% Cl = 0.7 to 3.8). Conclusion Short-term weight loss, at a level which, if sustained, is clinically meaningful for reducing diabetes risk, is achievable in primary care, without excessive use of NHS monetary or personnel resources. PMID:18682011

  16. 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

  17. Tranexamic acid mouthwash--a prospective randomized study of a 2-day regimen vs 5-day regimen to prevent postoperative bleeding in anticoagulated patients requiring dental extractions.

    PubMed

    Carter, G; Goss, A

    2003-10-01

    This prospective randomized study analyses the use of a prescribed 4.8% tranexamic acid post-operative mouthwash over 2 days vs 5 days to prevent bleeding in patients taking warfarin who require dental extractions. Eighty-five patients therapeutically anticoagulated with warfarin for various conditions, ranging in age from 21 to 86 years and requiring dental extractions, were randomly divided into two groups. Group A postoperatively received a 4.8% tranexamic acid mouthwash to be used over a 2-day period. Group B received the same mouthwash and instructions postoperatively, to be taken over 5 days. All procedures were performed on an ambulatory basis under local anaesthetic by the same surgeon. Patients were reviewed 1, 3, and 7 days postoperatively to assess bleeding. Eighty-two of the 85 patients encountered no postoperative problems. Two patients in group A and one in group B had minor postoperative bleeds that required minor ambulatory intervention to control. This study shows that a 2-day postoperative course of a 4.8% tranexamic acid mouthwash is as equally effective as a 5-day course in controlling haemostasis post-dental extractions in patient's anticoagulated with warfarin.

  18. The "House Calls" trial: a randomized controlled trial to reduce racial disparities in live donor kidney transplantation: rationale and design.

    PubMed

    Rodrigue, James R; Pavlakis, Martha; Egbuna, Ogo; Paek, Matthew; Waterman, Amy D; Mandelbrot, Didier A

    2012-07-01

    Despite a substantially lower rate of live donor kidney transplantation among Black Americans compared to White Americans, there are few systematic efforts to reduce this racial disparity. This paper describes the rationale and design of a randomized controlled trial evaluating the comparative effectiveness of three different educational interventions for increasing live donor kidney transplantation in Black Americans. This trial is a single-site, urn-randomized controlled trial with a planned enrollment of 180 Black Americans awaiting kidney transplantation. Patients are randomized to receive transplant education in one of three education conditions: through group education at their homes (e.g., House Calls), or through group (Group-Based) or individual education (Individual Counseling) in the transplant center. The primary outcome of the trial is the occurrence of a live donor kidney transplant, with secondary outcomes including living donor inquiries and evaluations as well as changes in patient live donor kidney transplantation readiness, willingness, knowledge, and concerns. Sex, age, dialysis status, and quality of life are evaluated as moderating factors. Findings from this clinical trial have the potential to inform strategies for reducing racial disparities in live donor kidney transplantation. Similar trials have been developed recently to broaden the evaluation of House Calls as an innovative disparity-reducing intervention in kidney transplantation. Copyright © 2012 Elsevier Inc. All rights reserved.

  19. Statin Induced Regression of Cardiomyopathy Trial: A Randomized, Placebo-controlled Double-blind Trial

    PubMed Central

    Hersi, Ahmad; Giannoccaro, J. Peter; Howarth, Andrew; Exner, Derek; Weeks, Sarah; Eitel, Ingo; Herman, R. Cameron; Duff, Henry; Ritchie, Debbie; Mcrae, Maureen; Sheldon, Robert

    2016-01-01

    Background: Hypertrophic cardiomyopathy (HCM), characterized by a thickened, fibrotic myocardium, remains the most common cause of sudden cardiac death in young adults. Based on animal and clinical data, we hypothesized that atorvastatin would induce left ventricular (LV) mass regression. Methods: Statin Induced Regression of Cardiomyopathy Trial (SIRCAT) was a randomized, placebo-controlled study. The primary endpoint was change in LV mass measured by cardiac magnetic resonance imaging 12 months after treatment with once-daily atorvastatin 80 mg or placebo. A key secondary endpoint was diastolic dysfunction measured echocardiographically by transmitral flow velocities. SIRCAT is registered with www.clinicaltrials.gov (NCT00317967). Results: Of 222 screened patients, 22 were randomized evenly to atorvastatin and placebo. The mean age was 47 ± 10 years, and 15 (68%) were male. All subjects completed the protocol. At baseline, LV masses were 197 ± 76 g and 205 ± 82 g in the placebo and atorvastatin groups, respectively. After 12 months treatment, the LV masses in the placebo and atorvastatin groups were 196 ± 80 versus 206 ± 92 g (P = 0.80), respectively. Echocardiographic indices were not different in the two groups at baseline. After 12 months, diastolic dysfunction as assessed using transmitral flow velocities E/E', A/A', and peak systolic mitral velocity showed no benefit from atorvastatin. Conclusions: In patients with HCM, atorvastatin did not cause LV mass regression or improvements in LV diastolic function. PMID:28400935

  20. Using historical control information for the design and analysis of clinical trials with overdispersed count data.

    PubMed

    Gsteiger, Sandro; Neuenschwander, Beat; Mercier, Francois; Schmidli, Heinz

    2013-09-20

    Results from clinical trials are never interpreted in isolation. Previous studies in a similar setting provide valuable information for designing a new trial. For the analysis, however, the use of trial-external information is challenging and therefore controversial, although it seems attractive from an ethical or efficiency perspective. Here, we consider the formal use of historical control data on lesion counts in a multiple sclerosis trial. The approach to incorporating historical data is Bayesian, in that historical information is captured in a prior that accounts for between-trial variability and hence leads to discounting of historical data. We extend the meta-analytic-predictive approach, a random-effects meta-analysis of historical data combined with the prediction of the parameter in the new trial, from normal to overdispersed count data of individual-patient or aggregate-trial format. We discuss the prior derivation for the lesion mean count in the control group of the new trial for two populations. For the general population (without baseline enrichment), with 1936 control patients from nine historical trials, between-trial variability was moderate to substantial, leading to a prior effective sample size of about 45 control patients. For the more homogenous population (with enrichment), with 412 control patients from five historical trials, the prior effective sample size was approximately 63 patients. Although these numbers are small relative to the historical data, they are fairly typical in settings where between-trial heterogeneity is moderate. For phase II, reducing the number of control patients by 45 or by 63 may be an attractive option in many multiple sclerosis trials.

  1. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes.

    PubMed

    Kingery, W S

    1997-11-01

    The purpose of this review was to identify and analyze the controlled clinical trial data for peripheral neuropathic pain (PNP) and complex regional pain syndromes (CRPS). A total of 72 articles were found, which included 92 controlled drug trials using 48 different treatments. The methods of these studies were critically reviewed and the results summarized and compared. The PNP trial literature gave consistent support (two or more trials) for the analgesic effectiveness of tricyclic antidepressants, intravenous and topical lidocaine, intravenous ketamine, carbamazepine and topical aspirin. There was limited support (one trial) for the analgesic effectiveness of oral, topical and epidural clonidine and for subcutaneous ketamine. The trial data were contradictory for mexiletine, phenytoin, topical capsaicin, oral non-steroidal anti-inflammatory medication, and intravenous morphine. Analysis of the trial methods indicated that mexiletine and intravenous morphine were probably effective analgesics for PNP, while non-steroidals were probably ineffective. Codeine, magnesium chloride, propranolol, lorazepam, and intravenous phentolamine all failed to provide analgesia in single trials. There were no long-term data supporting the analgesic effectiveness of any drug and the etiology of the neuropathy did not predict treatment outcome. Review of the controlled trial literature for CRPS identified several potential problems with current clinical practices. The trial data only gave consistent support for analgesia with corticosteroids, which had long-term effectiveness. There was limited support for the analgesic effectiveness of topical dimethylsulfoxyde (DMSO), epidural clonidine and intravenous regional blocks (IVRBs) with bretylium and ketanserin. The trial data were contradictory for intranasal calcitonin and intravenous phentolamine and analysis of the trial methods indicated that both treatments were probably ineffective for most patients. There were consistent trial

  2. Effectiveness of audiovisual interventions on stress responses in adolescents with ENT surgery in hospital: randomized controlled trial protocol.

    PubMed

    Liu, Cai Yun; Xu, Lei; Zang, Yu Li

    2014-06-01

    To investigate the circadian pattern of cortisol secretion and other stress indictors in association with audiovisual stimuli in adolescents having otorhinolaryngological surgery in hospital. Hospitalization for surgery is a major stressful life event for adolescents causing negative consequences, including anxiety. Recent studies suggest that entertaining and educational interventions might be effective at reducing such adversities, but little is known about the pattern of these responses and effects. Randomized controlled trial. Adolescents with otorhinolaryngological surgery in hospital without any contraindictions for salivary cortisol enzyme immunoassays will be recruited and randomly allocated to experimental, placebo and control. Stress indicators will be collected regularly for 5 days. Standard audiovisual interventions will be displayed for experimental and placebo groups including a simultaneous video-recording of facial and behavioural changes on the second afternoon postadmission and stress indicators will be collected pre- and three times with 20-minute interval postintervention. Follow-up will be conducted to evaluate the longer term effects at 2 weeks, 1-month and 3 months postadmission, respectively. Descriptive and comparative analyses of stress indicators will be performed to examine group differences. Competitive funding was obtained from the Independent Innovation Foundation of Shandong University for interdisciplinary research in 2012. This study will help identify timeslots for interventions for integrating strength-building into stress response reduction in adolescents hospitalized for surgery. © 2013 John Wiley & Sons Ltd.

  3. Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial.

    PubMed

    Santos, Ina S; Bassani, Diego G; Matijasevich, Alicia; Halal, Camila S; Del-Ponte, Bianca; da Cruz, Suélen Henriques; Anselmi, Luciana; Albernaz, Elaine; Fernandes, Michelle; Tovo-Rodrigues, Luciana; Silveira, Mariangela F; Hallal, Pedro C

    2016-09-02

    Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants. The study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months. The negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in

  4. Economic evaluation and randomised controlled trial of extracorporeal membrane oxygenation: UK collaborative trial

    PubMed Central

    Roberts, Tracy E

    1998-01-01

    Objective: To compare the resource implications and short term outcomes of extracorporeal membrane oxygenation and conventional management for term babies with severe respiratory failure. Design: Cost effectiveness evaluation alongside a randomised controlled trial. Setting: 55 approved recruiting hospitals in the United Kingdom. These hospitals provided conventional management, but infants randomised to extracorporeal membrane oxygenation were transferred to one of five specialist centres. Subjects: 185 mature newborn infants (gestational age at birth >35 weeks, birth weight >2 kg) with severe respiratory failure (oxygenation index >40) recruited between 1993 and 1995. The commonest diagnoses were persistent pulmonary hypertension due to meconium aspiration, congenital diaphragmatic hernia, isolated persistent fetal circulation, sepsis, and idiopathic respiratory distress syndrome. Main outcome measure: Cost effectiveness based on survival at 1 year of age without severe disability. Results: 63 (68%) of the 93 infants randomised to extracorporeal membrane oxygenation survived to 1 year compared with 38 (41%) of the 92 infants who received conventional management. Of those that survived, one infant in each arm was lost to follow up and the proportion with disability at 1 year was similar in the two arms of the trial. One child in each arm had severe disability. The estimated additional cost of extracorporeal membrane oxygenation per additional surviving infant without severe disability was £51 222 and the cost per surviving infant with no disability was £75 327. Conclusions: Extracorporeal membrane oxygenation for term neonates with severe respiratory failure would increase overall survival without disability. Although the policy will increase costs of neonatal health care, it is likely to be as cost effective as other life extending technologies. Key messagesExtracorporeal membrane oxygenation increases survival for term neonates in respiratory failure

  5. Antibiotic prophylaxis for pit viper envenomation: prospective, controlled trial.

    PubMed

    Kerrigan, K R; Mertz, B L; Nelson, S J; Dye, J D

    1997-05-01

    The efficacy of prophylactic antibiotics for preventing infectious complications at the site of pit viper envenomation has not been well studied. We undertook a prospective, controlled trial of antibiotic treatment versus no antibiotic treatment among 114 victims of crotalid envenomation in Ecuador's Amazon rain forest. A group of 59 patients received intravenous gentamicin and chloramphenicol, and 55 patients did not. All other aspects of care were identical. There were no statistically significant differences between antibiotic-treated and untreated patients with regard to demographics, delay in treatment, clinical and laboratory evidence of severity of envenomation, or use of antivenin. Nine abscesses occurred, six in the antibiotic-treated group and three in the untreated group. The results of this study did not show any statistically significant differences in outcome in terms of the number of abscesses that occurred between antibiotic-treated and untreated patients. Based on this lack of differences, routine use of prophylactic antibiotics for prevention of infectious complications of crotalid envenomation cannot be recommended.

  6. 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.

  7. 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

  8. Panax ginseng in randomised controlled trials: a systematic review.

    PubMed

    Shergis, Johannah L; Zhang, Anthony L; Zhou, Wenyu; Xue, Charlie C

    2013-07-01

    Panax ginseng C.A. Meyer is a common herb with many purported health benefits. However, there is no conclusive evidence supporting its use in the treatment of any particular disease. We conducted a systematic review to evaluate randomised controlled trials. Four English databases were searched with no publication date restriction. Included studies evaluated P. ginseng in patients with any type of disease or in healthy individuals. We assessed the quality of studies using the Cochrane risk of bias tool. Of the 475 potentially relevant studies, 65 met the inclusion criteria. These studies examined P. ginseng's effects on psychomotor performance (17 studies), physical performance (ten), circulatory system (eight), glucose metabolism (six), the respiratory system (five), erectile dysfunction (four), immunomodulation (four), quality of life/mood (four), antioxidant function (two), cancer (two), menopausal symptoms (two) and dry mouth (one). The risk of bias was unclear in most studies. Authors evaluated adverse events in 40 studies, with 135 minor events and no serious adverse events reported. P. ginseng shows promising results for improving glucose metabolism and moderating the immune response. This may have implications for several diseases including type 2 diabetes and chronic respiratory conditions. Further studies are needed to explore P. ginseng's potential as an effective treatment for these and other health conditions.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. [Review of controled clinical trials of behavioral treatment for obesity].

    PubMed

    Márquez-Ibáñez, B; Armendáriz-Anguiano, A L; Bacardí-Gascón, M; Jiménez-Cruz, A

    2008-01-01

    The increased prevalence of obesity has been associated to an increment in chronic-degenerative diseases. The behavioral conduct therapies (BCT) have been used to help subjects develop a series of skills to reach a healthy weight. We conducted a review of the literature of BCT from controlled clinical trials registered at PubMed from January 2000 to november 2006. We found five long-term (> or = 12 months) studies and analyzed each study. The percent of weight loss at the end of follow up ranged from 3% to 9% of the initial weight; the percent of retention fluctuated from 92% at three months to 55% at 24 months. There were no similar reported studies conducted in Latino or Hispanic population. These results suggest that the change in loss of weight with BCT are modest at the end of the follow up period and that most of the studies report low adherence to treatment. It is recommended that public and private funds are needed to implement effective and safe multicentric long term randomized studies on different cultural populations, including most Latin-American countries.

  15. A randomised controlled trial of the efficacy of supported employment.

    PubMed

    Hoffmann, H; Jäckel, D; Glauser, S; Kupper, Z

    2012-02-01

      Although numerous randomised controlled trials indicated the superiority of supported employment (SE), we still have too little evidence that SE is more effective than traditional vocational rehabilitation programmes (TVR) in Western European countries with highly developed social security and welfare systems, sophisticated rehabilitation programmes and high thresholds to the open labour market. The aim of this study is to prove the efficacy of SE in Switzerland.   Following a 2-week intake assessment, 100 unemployed persons with stabilised severe mental illness (SMI) were randomly assigned to either the SE programme (n=46) or to the most viable locally available TVR (n=54). Follow-up lasted 24 months.   After the first year, the rate of competitive employment reached a mean level of 48.2% in the SE group and of 18.5% in the TVR group. 58.7% of the SE group were ever competitively employed as opposed to 25.9% of the TVR group. In the second year, SE group participants were competitively employed for 24.5 weeks as compared with 10.2 in the TVR group. The groups showed no significant differences in the non-vocational outcome criteria.   The SE programme in Switzerland also proved more effective than TVR and seems to be applicable to the socio-economic context of Western European countries. © 2011 John Wiley & Sons A/S.

  16. Myocardial Infarct Size by CMR in Clinical Cardioprotection Studies: Insights From Randomized Controlled Trials.

    PubMed

    Bulluck, Heerajnarain; Hammond-Haley, Matthew; Weinmann, Shane; Martinez-Macias, Roberto; Hausenloy, Derek J

    2017-03-01

    The aim of this study was to review randomized controlled trials (RCTs) using cardiac magnetic resonance (CMR) to assess myocardial infarct (MI) size in reperfused patients with ST-segment elevation myocardial infarction (STEMI). There is limited guidance on the use of CMR in clinical cardioprotection RCTs in patients with STEMI treated by primary percutaneous coronary intervention. All RCTs in which CMR was used to quantify MI size in patients with STEMI treated with primary percutaneous coronary intervention were identified and reviewed. Sixty-two RCTs (10,570 patients, January 2006 to November 2016) were included. One-third did not report CMR vendor or scanner strength, the contrast agent and dose used, and the MI size quantification technique. Gadopentetate dimeglumine was most commonly used, followed by gadoterate meglumine and gadobutrol at 0.20 mmol/kg each, with late gadolinium enhancement acquired at 10 min; in most RCTs, MI size was quantified manually, followed by the 5 standard deviation threshold; dropout rates were 9% for acute CMR only and 16% for paired acute and follow-up scans. Weighted mean acute and chronic MI sizes (≤12 h, initial TIMI [Thrombolysis in Myocardial Infarction] flow grade 0 to 3) from the control arms were 21 ± 14% and 15 ± 11% of the left ventricle, respectively, and could be used for future sample-size calculations. Pre-selecting patients most likely to benefit from the cardioprotective therapy (≤6 h, initial TIMI flow grade 0 or 1) reduced sample size by one-third. Other suggested recommendations for standardizing CMR in future RCTs included gadobutrol at 0.15 mmol/kg with late gadolinium enhancement at 15 min, manual or 6-SD threshold for MI quantification, performing acute CMR at 3 to 5 days and follow-up CMR at 6 months, and adequate reporting of the acquisition and analysis of CMR. There is significant heterogeneity in RCT design using CMR in patients with STEMI. The authors provide recommendations for standardizing

  17. A Placebo-Controlled Augmentation Trial of Prazosin for Combat Trauma PTSD

    DTIC Science & Technology

    2012-06-01

    of Prazosin for Combat Trauma PTSD PRINCIPAL INVESTIGATOR: Murray Raskind, M.D...31 May 2012 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Placebo-Controlled Augmentation Trial of Prazosin for Combat Trauma PTSD 5b. GRANT...controlled trial to evaluate the efficacy and tolerability of the alpha-1 adrenergic antagonist, prazosin , for reducing trauma nightmares and sleep

  18. 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…

  19. Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

    PubMed

    Wang, Shengjun; Jiang, Hongli; Yu, Qin; She, Bin; Mao, Bing

    2017-01-05

    The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS). This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms' clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores. This trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high-quality evidence on the efficacy and safety of LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM. Chinese Clinical Trial Registry, ChiCTR-IPR-15006504 . Registered on 4 June 2015.

  20. 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

  1. When Ethics Constrains Clinical Research: Trial Design of Control Arms in “Greater Than Minimal Risk” Pediatric Trials

    PubMed Central

    de Melo-Martín, Inmaculada; Sondhi, Dolan

    2011-01-01

    Abstract For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations. PMID:21446781

  2. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol

    PubMed Central

    Cox, Helen; Tilbrook, Helen; Aplin, John; Chuang, Ling-Hsiang; Hewitt, Catherine; Jayakody, Shalmini; Semlyen, Anna; Soares, Marta O.; Torgerson, David; Trewhela, Alison; Watt, Ian; Worthy, Gill

    2010-01-01

    A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is funded by Arthritis Research Campaign (arc) and is being conducted by the University of York. 262 patients will be recruited from GP practices in 5 centres in England. Patients will be randomised to receive usual care or 12 weekly classes of yoga. A yoga programme will be devised that can be delivered by yoga teachers of the two main national yoga organisations in the UK (British Wheel of Yoga and Iyengar Yoga Association (UK)). Trial registration: Current controlled trials registry ISRCTN81079604 (date registered 30/03/2007). PMID:20347837

  3. 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

  4. Short-course oral co-trimoxazole versus intramuscular benzathine benzylpenicillin for impetigo in a highly endemic region: an open-label, randomised, controlled, non-inferiority trial.

    PubMed

    Bowen, Asha C; Tong, Steven Y C; Andrews, Ross M; O'Meara, Irene M; McDonald, Malcolm I; Chatfield, Mark D; Currie, Bart J; Carapetis, Jonathan R

    2014-12-13

    Impetigo affects more than 110 million children worldwide at any one time. The major burden of disease is in developing and tropical settings where topical antibiotics are impractical and lead to rapid emergence of antimicrobial resistance. Few trials of systemic antibiotics are available to guide management of extensive impetigo. As such, we aimed to compare short-course oral co-trimoxazole with standard treatment with intramuscular benzathine benzylpenicillin in children with impetigo in a highly endemic setting. In this randomised, controlled, non-inferiority trial, Indigenous Australian children aged 3 months to 13 years with purulent or crusted non-bullous impetigo were randomly assigned (1:1:1) to receive benzathine benzylpenicillin (weight-banded injection), twice-daily co-trimoxazole for 3 days (4 mg/kg plus 20 mg/kg per dose), or once-daily co-trimoxazole for 5 days (8 mg/kg plus 40 mg/kg per dose). At every visit, participants were randomised in blocks of six and 12, stratified by disease severity. Randomisation was done by research nurses and codes were in sealed, sequentially numbered, opaque envelopes. Independent reviewers masked to treatment allocation compared digital images of sores from days 0 and 7. The primary outcome was treatment success at day 7 in a modified intention-to-treat analysis. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000858291. Between Nov 26, 2009, and Nov 20, 2012, 508 patients were randomly assigned to receive benzathine benzylpenicillin (n=165 [156 analysed]), twice-daily co-trimoxazole for 3 days (n=175 [173 analysed]), or once-daily co-trimoxazole for 5 days (n=168 [161 analysed]). Treatment was successful in 133 (85%) children who received benzathine benzylpenicillin and 283 (85%) who received pooled co-trimoxazole (absolute difference 0·5%; 95% CI -6·2 to 7·3), showing non-inferiority of co-trimoxazole (10% margin). Results for twice-daily co-trimoxazole for 3

  5. Central Retinal Enrichment Supplementation Trials (CREST): Design and Methodology of the CREST Randomized Controlled Trials

    PubMed Central

    Beatty, Stephen; Stack, Jim; Dennison, Jessica; O’Regan, Sarah; Meagher, Katherine A.; Peto, Tunde; Nolan, John

    2014-01-01

    Purpose The Central Retinal Enrichment Supplementation Trials (CREST) aim to investigate the potential impact of macular pigment (MP) enrichment, following supplementation with a formulation containing 10 mg lutein (L), 2 mg zeaxanthin (Z) and 10 mg meso-zeaxanthin (MZ), on visual function in normal subjects (Trial 1) and in subjects with early age-related macular degeneration (AMD; Trial 2). Methods CREST is a single center, double-blind, randomized clinical trial. Trial 1 (12-month follow-up) subjects are randomly assigned to a formulation containing 10 mg L, 10 mg MZ and 2 mg Z (n = 60) or placebo (n = 60). Trial 2 (24-month follow-up) subjects are randomly assigned to a formulation containing 10 mg L, 10 mg MZ, 2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention A; n = 75) or 10 mg L and 2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention B; n = 75). Contrast sensitivity (CS) at 6 cycles per degree represents the primary outcome measure in each trial. Secondary outcomes include: CS at other spatial frequencies, MP, best-corrected visual acuity, glare disability, photostress recovery, light scatter, cognitive function, foveal architecture, serum carotenoid concentrations, and subjective visual function. For Trial 2, AMD morphology, reading speed and reading acuity are also being recorded. Conclusions CREST is the first study to investigate the impact of supplementation with all three macular carotenoids in the context of a large, double-blind, randomized clinical trial. PMID:24621122

  6. Central Retinal Enrichment Supplementation Trials (CREST): design and methodology of the CREST randomized controlled trials.

    PubMed

    Akuffo, Kwadwo Owusu; Beatty, Stephen; Stack, Jim; Dennison, Jessica; O'Regan, Sarah; Meagher, Katherine A; Peto, Tunde; Nolan, John

    2014-04-01

    The Central Retinal Enrichment Supplementation Trials (CREST) aim to investigate the potential impact of macular pigment (MP) enrichment, following supplementation with a formulation containing 10 mg lutein (L), 2 mg zeaxanthin (Z) and 10 mg meso-zeaxanthin (MZ), on visual function in normal subjects (Trial 1) and in subjects with early age-related macular degeneration (AMD; Trial 2). CREST is a single center, double-blind, randomized clinical trial. Trial 1 (12-month follow-up) subjects are randomly assigned to a formulation containing 10 mg L, 10 mg MZ and 2 mg Z (n = 60) or placebo (n = 60). Trial 2 (24-month follow-up) subjects are randomly assigned to a formulation containing 10 mg L, 10 mg MZ, 2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention A; n = 75) or 10 mg L and 2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention B; n = 75). Contrast sensitivity (CS) at 6 cycles per degree represents the primary outcome measure in each trial. Secondary outcomes include: CS at other spatial frequencies, MP, best-corrected visual acuity, glare disability, photostress recovery, light scatter, cognitive function, foveal architecture, serum carotenoid concentrations, and subjective visual function. For Trial 2, AMD morphology, reading speed and reading acuity are also being recorded. CREST is the first study to investigate the impact of supplementation with all three macular carotenoids in the context of a large, double-blind, randomized clinical trial.

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. 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

  13. 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.

  14. 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

  15. Online Adaptation and Over-Trial Learning in Macaque Visuomotor Control

    PubMed Central

    Braun, Daniel A.; Aertsen, Ad; Paz, Rony; Vaadia, Eilon; Rotter, Stefan; Mehring, Carsten

    2011-01-01

    When faced with unpredictable environments, the human motor system has been shown to develop optimized adaptation strategies that allow for online adaptation during the control process. Such online adaptation is to be contrasted to slower over-trial learning that corresponds to a trial-by-trial update of the movement plan. Here we investigate the interplay of both processes, i.e., online adaptation and over-trial learning, in a visuomotor experiment performed by macaques. We show that simple non-adaptive control schemes fail to perform in this task, but that a previously suggested adaptive optimal feedback control model can explain the observed behavior. We also show that over-trial learning as seen in learning and aftereffect curves can be explained by learning in a radial basis function network. Our results suggest that both the process of over-trial learning and the process of online adaptation are crucial to understand visuomotor learning. PMID:21720526

  16. 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

  17. Randomized, double-blind study of short-course (5 day) grepafloxacin versus 10 day clarithromycin in patients with acute bacterial exacerbations of chronic bronchitis.

    PubMed

    Langan, C E; Zuck, P; Vogel, F; McIvor, A; Peirzchala, W; Smakal, M; Staley, H; Marr, C

    1999-10-01

    The efficacy and safety of grepafloxacin were compared with clarithromycin in a randomized, double-blind, multicentre clinical trial of 805 patients with acute bacterial exacerbations of chronic bronchitis (ABECB). Patients were randomized to receive grepafloxacin 400 mg od for either 5 (n = 273) or 10 days (n = 268) or clarithromycin 250 mg bd for 10 days (n = 261). Patients were assessed pre-treatment, 3-5 days during treatment, 1-3 days post-treatment and at follow-up (21-28 days post-treatment). The clinical success rates for the evaluable patients were 91% in the 5 day grepafloxacin group, 95% in the 10 day grepafloxacin group and 86% in the clarithromycin group. At follow-up, respective rates were 72%, 81% and 73%. A total of 513 pathogens were isolated from the pre-treatment sputum specimens of 400 (49%) patients. The primary pathogens were Haemophilus influenzae (36% of isolates), Haemophilus parainfluenzae (27%), Moraxella catarrhalis (12%), Streptococcus pneumoniae (11%) and Staphylococcus aureus (3%). Pathogens were eradicated or presumed eradicated at post-treatment in 85%, 91% and 58% of evaluable patients treated with grepafloxacin for 5 days, grepafloxacin 10 days and clarithromycin 10 days, respectively. The eradication rates in both grepafloxacin groups were significantly greater than the clarithromycin group (P<0.001). All treatments were well tolerated and incidence of drug-related adverse events in each group was comparable. This study demonstrates that both a 5 and a 10 day regimen of grepafloxacin 400 mg od are as clinically and bacteriologically effective as in the treatment of ABECB clarithromycin 250 mg bd. for 10 days.

  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. A Randomized Control Trial Comparing 2 Levofloxacin-Containing Second-Line Therapies for Helicobacter pylori Eradication.

    PubMed

    Chuah, Seng-Kee; Liang, Chih-Ming; Lee, Chen-Hsiang; Chiou, Shue-Shian; Chiu, Yi-Chun; Hu, Ming-Luen; Wu, Keng-Liang; Lu, Lung-Sheng; Chou, Yeh-Pin; Chang, Kuo-Chin; Kuo, Chung-Huang; Kuo, Chung-Mou; Hu, Tsung-Hui; Tai, Wei-Chen

    2016-05-01

    Summary of Trial Design.Lengthy exposure to quinolone-containing triple therapy in Helicobacter pylori eradication leads to the development of drug resistance. Sequential therapy with a quinolone and metronidazole -containing regimen appears to be an effective treatment option. This randomized controlled trial aimed to compare the efficacy of 5-plus 5 days' levofloxacin and metronidazole-containing sequential therapy (EALM) with that of 10-day levofloxacin-containing triple therapy (EAL) in second-line H pylori eradication treatment.One hundred and sixty-four patients who had failed the H pylori eradication attempts using the standard triple therapy (proton pump inhibitor bid, clarithromycin 500 mg bid, amoxicillin 1 g bid × 7 days) were randomly assigned to either an EALM therapy group (n = 82; esomeprazole 40 mg bid and amoxicillin 1 g bid for 5 days, followed by esomeprazole 40 mg bid, levofloxacin 500 mg qd, and metronidazole 500 mg tid, for 5 days) or a 10-day EAL therapy group (n = 82; levofloxacin 500 mg qd, amoxicillin 1 g bid, and esomeprazole 40 mg bid). One patient was lost to follow-up in each group. Follow-up for H pylori status was performed 4 to 8 weeks later.Eradication rates for the EALM and EAL groups were 90.2% (74/82, 95% confidence interval [CI] = 83.7%-96.8%) and 80.5% (66/82, 95% CI = 71.7%-89.2%, P = 0.077) in the intention-to-treat analysis; and 91.4% (74/81, 95% CI = 85.1%-97.6%) and 81.5% (66/81, 95% CI = 72.8%-90.1%, P = 0.067) in the per-protocol analysis. The adverse events for the EALM and EAL groups were 23.5% versus 11.1%, P = 0.038 but were all very mild and were well tolerated except for 1 patient with poor compliance. The compliances were 98.8% and 100%, respectively, between the 2 groups. An antibiotic resistance to levofloxacin was the clinical factor influencing the efficacy of H. pylori eradication therapy in the EAL group, and dual resistance to levofloxacin and

  20. Feasibility of Reducing the Duration of Placebo-Controlled Trials in Schizophrenia Research

    PubMed Central

    Hu, Qiaoyan; Davis, John M.; Carpenter, William T.

    2008-01-01

    Use of placebo-controlled trials in medical and psychiatric research has been controversial, although a consensus is emerging about conditions under which placebo-controlled trials are ethica